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.
Graseby 3400
Syringe Pump
Instruction Manual
Published by Graseby Medical Limited.
All possible care has been taken in the preparation of this publication, but Graseby Medical
Limited accepts no liability for any inaccuracies that may be found.
Graseby Medical reserves the right to make changes without notice both to this publication and
to the product which it describes.
Graseby Medical seek to constantly improve their products, therefore, the specification
of the 3400 pump is subject to change.
Copyright © 2002 Graseby Medical Limited.
No part of this publication may be reproduced, transmitted, transcribed, or stored in a retrieval
system or translated into any human or computer language in any form or by any means without
the prior permission of Graseby Medical Limited.
GRASEBY MEDICAL LIMITED,
Colonial Way,
Watford,
Hertfordshire,
United Kingdom,
WD24 4LG
TELEPHONE: (+44) (0)1923 246434
FAX: (+44) (0)1923 231595
www.graseby.co.uk
REGISTERED IN ENGLAND.
COMPANY No. 995550
Trademarks and acknowledgements:
“Graseby”; “Smiths”; and “Flo-Safer” are all trademarks of Smiths Group plc.
All other trademarks are acknowledged as the property of their respective owners.
Aneasthesia 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 av oid 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 inappr opriate 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 de vice in such
atmospheres may lead to explosion or fire.
4. WARNING: To avoid possib le 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 ma y result in patient injury or user injury.
6. WARNING: In or der to ensure that the intended infusion is performed, data must be
entered correctly . Like wise before confirming any displa yed 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: F ailure to respond promptly to an alarm ma y result in patient injury or death.
8. WARNING: Failure to follo w the
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.
Service Manual’s
maintenance schedule recommendations
iGraseby 3400
Aneasthesia syringe pump
12.WARNING: Correct management of battery charging is essential to ensure that the pump
can operate on batteries for the time specified. Failure to do so may lead to impaired
functioning of the pump, resulting in patient injury or death.
13.WARNING: Do not use a faulty pump. If the pump de velops a fault then an alarm will sound;
the display will indicate a F A UL T 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 c lamp 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 c lamp the line to eliminate the
possibility of a bolus being delivered to the patient. Then inspect the fluid pathwa y for kinks,
clogged catheter , etc. in order to remo ve 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
end of this manual. F ailure 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 an y 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 flo w), ensure that the syringe is
correctly loaded into the pump, that the syringe plunger is properl y 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 o ver-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 detac hed from an IV pole alwa ys 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 3400 Syringe pump and harm
the operator or the patient. As a result, the operator or patient may suffer direct injury, or
the 3400 Syringe pump may fail to operate correctly, leading to patient injury or death.
the Specification
at the
ii
Graseby 3400
Aneasthesia 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 occ lusion pressure will
increase as the diameter of the syringe decreases, i.e. the smaller the syringe the higher
the pressure
Cautions
U.S.A. and
Canada
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: Ref er 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 c leaning and disinfecting agents other than the appr oved ones
specified here.
4. CAUTION: The pump must
solvents. Wipe off spills immediatel y , and do not allo w fluid or residues to remain on the
pump. Additionally , the pump is not designed to be autocla ved, steam-sterilised, ETOsterilised or subjected to temperatures in excess of 45° C (113° F). Failure to observe this
caution may cause serious damage to the pump.
5. CAUTION: If the pump is used in c lose pr oximity to a fluid ba g(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.
not be immersed in any liquids or exposed to str ong organic
Federal law in the U.S.A. and Canada restricts this device to sale b y or on the order of a
licensed Medical Practioner.
iiiGraseby 3400
Aneasthesia syringe pump
iv
Graseby 3400
Anaesthesia Syringe pump
Contents
Page
Introduction........................................................................................2
Features ..............................................................................................3
1. Switching on............................................................................. 4
2. Loading the syringe.................................................................. 5
3. Setting the infusion rate........................................................... 7
4. Giving a bolus infusion............................................................ 9
5. Setting the hands-free bolus preset ........................................ 9
6. Starting the infusion................................................................. 9
7. Using the totaliser .................................................................. 10
8. Stopping the Infusion............................................................. 10
9 Switching off........................................................................... 10
10. Alarms ..................................................................................... 11
11. Battery operation .................................................................... 19
12. Positioning the pump............................................................. 20
13. Cleaning and maintenance..................................................... 20
Graseby 3400
14. Standards ................................................................................ 22
15. Specification ........................................................................... 24
Page 1
Anaesthesia Syringe pump
Introduction
Thank you for choosing a Graseby 3400 Anaesthesia 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 on the pump. It is important that all users of the 3400 have
been trained in how to use the pump.
The pump is a micro-computer controlled device developed by Graseby Medical for the
administration of sterile liquids. This compact, robust pump is designed to sit on a table
top or to be pole mounted.
It can be configured to work with one of a range of brands of syringe, and the the brand
that the pump is presently Configured for is displayed.
The pump caters for syringe sizes of 5, 10, 20, 30, 35, 50 and 60 ml, the size is
automatically sensed and displayed.
The pump can be set to dispense liquids at maintenance rates of 0.1 to 400 ml/hr in steps
of 0.1 ml/hr. The rate is entered via a numeric keypad and can be adjusted whilst the
pump is infusing. Similarly the bolus infusion rate can be adjusted from 0.1 to 1200 ml/hr
in steps of 0.1 ml/hr.
A dose rate calculation is also possible, allowing the infusion rate to be programmed in a
range of units, including ml/hr, mg/kg/hr, mg/kg/min, mg/kg/hr, mg/kg/min, mg/hr and mg/
hr.
A handsfree preset bolus allows a predetermined bolus to be set and delivered, allowing
the user to concentrate on the patient's response to the medication during the bolus
infusion.
Page 2
The pump keeps a running total of the volume of liquid infused, even when an infusion is
stopped and restarted.
Safety features have been built into the pump and its software. The pump carries out self
testing routines every time it is switched on. Users are warned of such incidents as
occlusion or power failure by both visible and audible alarms.
The pump can be run from AC mains power (recommended) or from internal rechargeable
batteries which give more than ten hours of use. All the controls are clear and easy to
use. The pump incorporates a graphic liquid crystal display that provides the user with a
constant indication of the pump’s operation.
Graseby 3400
Anaesthesia Syringe pump
Features
Designed in consultation with users, the main features of the pump are:
• 0.1 to 1200.0ml/hr infusion rate.
• Dose rate calculator.
• "Hands-Free" bolus/induction preset.
• Accepts 5 to 60ml syringes, from all major brands.
• RS232 Serial link for remote monitoring and control of infusion.
• AC mains and battery powered.
• More than 10 hours' battery life.
• Simple menu-driven operation.
• Comprehensive safety self check, with clear alarm messages.
• Drip-proof.
Graseby 3400
Figure 1 Front view of the pump
Page 3
Anaesthesia Syringe pump
1. Switching on
Connect to AC power. (For battery operation refer to Section 11). Insert
the AC power lead into the rear of the pump. Secure the mains lead with
the clamp as shown in Figure 2, to prevent it from being accidentally pulled
out of the pump.
Figure 2 Mains Lead Clamp
The AC power indicator lamp will illuminate when connected to AC power.
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
its ‘set-up’ mode, ready for an infusion rate to be set.
WARNING: Do not use a faulty pump. If the pump develops a fault then an
alarm will sound; the display will indicate a FAUL T 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.
Page 4
Graseby 3400
Anaesthesia Syringe pump
2. Loading the
syringe
2.1
Syringe brand
When the pump is switched on (Section 1) the display will indicate which
syringe brand the pump is calibrated for. The syringes are disposable and are
for single use only.
Syringe brand Syringe sizes
BD PLASTIPAK 5ml, 10ml, 20ml, 30/35ml, 50/60ml.
BRAUN OMNIFIX 5ml, 10ml, 20ml, 30/35ml, 50/60ml.
MONOJECT 5ml, 10ml, 20ml, 50/60ml.
TERUMO 5ml, 10ml, 20ml, 30/35ml, 50/60ml.
FRESENIUS INJECTOMAT 50ml only.
BRAUN PERFUSOR 50ml only, conversion kit required.
IMS PUMPJET 30ml only, prefilled.
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
Graseby 3400
2.2
Fill and prime the syringe and catheter in the normal way, ensuring all the air
is expelled.
WARNING: To av oid patient embolism, ensure that the patient tubing is pur ged
of all air bubbles before administering any medication. The pump pro vides 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 o ver-infusion, do not pur ge the infusion line when the
administration set is connected to the patient. Over-infusion of medication can
result in patient injury or death.
Page 5
Anaesthesia Syringe pump
GM0760-A
Barrel
clamp
Check:
Syringe type and size
corresponds to the type
and size of the syringe
you are using
Check:
Syringe size sensor
is located on top of syringe
Check:
Syringe plunger fits into plunger clamp
groove when clamp is lowered
Check:
Syringe ear is
located in groove
2.3
Insert syringe
Swing the plunger clamp up and away from the body of the pump, until it clicks
and then slide the plunger clamp fully to the right.
Pull the syringe barrel clamp upwards and insert the primed syringe into the
syringe trough. Ensure at the same time that the ear of the syringe is located in
the groove and pushed fully to the left. Ensure that the syringe size sensor is
resting on the syringe barrel.
WARNING: Use only the syringes and administration sets listed in
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.
the
Lower the barrel clamp onto the syringe. Slide the plunger clamp to the left
until it is touching the syringe plunger. Lower the clamp until it clicks over the
syringe plunger. Ensure the plunger cross piece is correctly placed within the
slot in the clamp.
WARNING: To avoid over- or under- infusion, al ways 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.
Page 6
Figure 3 Inserting the syringe
Graseby 3400
Anaesthesia Syringe pump
3. Setting the
infusion rate
3.1 Infusion rate memory
After switch on, the pump will display the infusion rate and units that were
memorised since the last time that the pump was used.
3.2.1 Setting the infusion rate
If the memorised rate is not required it can be altered by pressing the
numeric keys to the right of the display. To facilitate ease of setting up, the
keys are arranged in the same format as an electronic calculator.
The infusion rate can be set to between 0.1 ml/hr and 400.0 ml/hr in steps of
0.1ml/hr. For example, to set an infusion rate of 132.5 ml/hr press
➀ ➂ ➁
3.2.2 Changing the infusion units
If the mass units (dose rate calculator) has been selected in the configuration
program the UNITS menu bar will be displayed. To change the infusion units
press the UNITS menu key until the desired infusion units are shown on the
screen. The infusion rate can then be entered with the numeric keypad.
Press ENTER to confirm the choice of infusion units. The pump will then ask
for the patient weight and/or drug concentration. The values for the patient
weight and/or drug concentration are entered via the numeric keypad and
confirmed with the ENTER menu key. After entering the drug concentration
the END OF MENU, PRESS START TO RUN screen is shown. If the
ENTER key is pressed the pump will display the infusion rate in mass units.
The ml/hr infusion rate will be shown in brackets. Press the START key to
commence the infusion.
.
➄
Graseby 3400
Following the start of an infusion the option to change the units will be
disabled until the pump is turned off. The UNITS key wiII be removed from
the menu bar.
Page 7
Anaesthesia Syringe pump
3.3. Adjusting the infusion rate whilst infusing
3.4 Maximum infusion rates for different syringe sizes
The infusion rate can be adjusted without stopping the infusion, to allow
titration of the drug dose to its physiological effect on the patient.
Whilst infusing press the CHANGE menu key. The pump will display and
continue to infuse at the set infusion rate. The text message...
"NEW RATE = 0.0ml/hr"
appears below the current infusion rate. If infusion units other than ml/hr
are used the screen will show the infusion units in use at the time of
pressing the CHANGE key eg. mg/kg/hr. Enter the desired new infusion
rate via the numeric keypad. Press START to confirm the new infusion
rate. The pump's infusion rate will now change to the new setting, which
will be shown on the LCD screen.
The maximum Infusion Rates for the syringe sizes are:
)lm(eziSegniryS)rh/lm(etaRnoisufnImumixaM
ecnanetniaMrednudna(suloB
)lortnocretupmoc
06/05
53/03
02
01
5
004
004
004
002
001
0021
006
004
002
001
Page 8
The minimum rate is 0.1 ml/hr.
Note: the pump can have a maximum allowable infusion rate set via the
pump's configuration program. If the maximum allowable rate is exceeded
an alarm message is shown briefly (see section 10; Alarms).
3.5 Start-up time
The time taken for a syringe pump to achieve the set infusion rate is known
as the start-up time.
The start-up time is dependant on the infusion rate and the syringe size, the
higher the infusion rate the faster the start-up time. Smaller syringes give
better results at any given flow rate.
Typical start-up times for the pump using a 50ml syringe are:
3 minutes at 5 ml/hr
and
15 minutes at 1 ml/hr.
Graseby 3400
Anaesthesia Syringe pump
4. Giving a
bolus infusion
5. Setting the
hands-free
bolus preset
Press the BOLUS key, the display will show the message "PRESS AGAIN" together
with the bolus infusion rate. If the desired bolus infusion rate is shown press the
BOLUS key immediately and hold it depressed. Whilst running in the bolus mode the
alarm lamp and run lamp will flash. The display will show the BOLUS sign flashing and
the total fluid quantity delivered since the BOLUS button was pressed. This total is
added to the total infused counter. To change the bolus infusion rate press the BOLUS
key, followed by the RATE menu key. The desired bolus rate is then entered via the
numeric keypad. Press the BOLUS key to confirm the new bolus infusion rate.
If the hands-free bolus preset is enabled in the pump's configuration program the
following screen will be shown when the BOLUS key is pressed:
PRESS AGAIN
BOLUS RATE = 1200.0 ml/hr
DOSE RATE
The bolus rate is adjusted by pressing the RATE menu key, keying in the desired bolus
rate with the numeric keypad and pressing the ENTER key to confirm your setting.
The hands-free bolus dose is entered by pressing the DOSE menu key, followed by the
desired preset level using the numeric keypad. The bolus p350mmHg, using a BD
50ml syringe.350mmHg, using a BD 50ml syringe.reset is then confirmed by pressing
the ENTER menu key. The pump will then prompt the user to deliver the hands-free
bolus by pressing the BOLUS key again. If the user does not wish to deliver the set
hands-free bolus at this time simply ignore the PRESS AGAIN screen message, which
will disappear after 10 seconds.
6. Starting the
infusion
Graseby 3400
Press START to begin the infusion at the set infusion rate. The make and size of the syringe
will be displayed briefly, followed by the infusion rate. Check that the syringe size
corresponds with that on the display.
During the infusion the green start lamp will flash and the "pump running" indicator
arrows on the display will flash. In addition the word INFUSING will flash in the display.
If anything occurs to disrupt the infusion the pump will alarm. See section 10; Alarms.
To change the infusion rate without stopping the infusion see section 3.3; Adjusting the
infusion rate whilst infusing.
WARNING: To av oid 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.
Page 9
Anaesthesia Syringe pump
7. Using the totalizer
8. Stopping the infusion
9. Switching off
The totalizer shows how much drug has been infused.
The totalizer can be accessed when the pump is running or when the pump
is stopped. Press the TOTAL menu key. For a few seconds the display
will show "TOTAL: XXX.X ML".
If the dose rate calculator is in use the totalizer will display the mass of
drug infused, based on a calculation using the actual volume infused and
the current drug concentration.
It is recommended that the total infused counter is reset when changing
the drug concentration to prevent any possibility of misinterpretation of the
calculated total mass of drug infused.
If you wish to reset the totalizer, press the RESET totalizer menu 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.
Press the STOP button to stop the infusion. The yellow stop lamp will
illuminate and the pump running indicators in the display will disappear.
First stop the infusion (see section 8) and then press the OFF button to
switch the pump off. The AC power indicator lamp will remain illuminated if
the pump is connected to the AC power and the batteries will continue to
be charged.
Page 10
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.
Graseby 3400
Anaesthesia Syringe pump
10. Alarms
Quiet alarm
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 on battery, low battery, nearly empty
and AC failure alarm). To silence the alarm press the ALARM button.
The following pages give details of the alarm messages and a brief
explanation of their meaning.
When the START button is pressed and a quiet alarm condition is detected
a double beep is sounded accompanied by an alarm display for two
seconds.
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 3400
Page 11
Anaesthesia Syringe pump
10. 1 Syringe plunger clamp disengaged
CLAMP OPEN
ALARM TYPE 2 second quiet alarm.
CAUSE
ACTION Reposition the clamp on the syringe plunger, ensuring the
10. 2 Syringe invalid
SYRINGE INVALID
ALARM TYPE 2 second quiet alarm.
CAUSE
ACTION Ensure the syringe size is appropriate, i.e. 5ml, 10ml,
The syringe plunger clamp has not been correctly
located over the syringe plunger.
The clamp is not correctly placed in the slot in the
plunger clamp.
plunger cross piece is correctly placed in the slot in the
plunger clamp.
The syringe size sensor does not detect a valid syringe in
the syringe trough. Syringe size is too small (or too large).
20ml, 30/35ml or 50/60ml.
Reposition the syringe barrel on the syringe trough.
Page 12
Graseby 3400
10. 3 Rate invalid
RATE INVALID
max rate allowed = xxx.x ml/hr
ALARM TYPE 2 second quiet alarm.
Anaesthesia Syringe pump
CAUSE
ACTION Set the desired infusion rate within the permissible
10.4 Review settings
REVIEW SETTINGS
ALARM TYPE 2 second quiet alarm.
CAUSE
The START button has been pressed with the infusion
rate set to 00.0 ml/hr or, ... the START button has been
pressed with too high an infusion rate set for the syringe
size in use (see section 3.4; Maximum infusion rates for
different syringe sizes) or, ... the infusion rate has been
set higher than the maximum rate set in the configuration mode. The maximum allowable infusion rate for
the syringe size in use will be indicated.
range then start the infusion as described in section 6.
The START button has been pressed with mass units
selected (e.g. mg/kg/hr) and without reviewing the
patient weight or drug concentration.
Graseby 3400
ACTION Press the ENTER menu key to confirm the patient
weight and/or drug concentration. When the screen
message "END OF MENU, PRESS START TO RUN"
is displayed the infusion can be commenced as
described in section 6.
Page 13
Anaesthesia Syringe pump
10.5 Occlusion
OCCLUSION
ALARM TYPE Pulsing loud alarm (silenceable).
CAUSE
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.
10.5.1 Occlusion sensing system
The pump has a sensitive, internal occlusion pressure detector which detects the
pressure build-up on the syringe plunger, an occlusion is usually caused by a
blocked infusion line. The pressure at which the pump's occlusion alarm
activates is adjustable from 1.85 kg to 7.42 kg (250 mmHg to 1000 mmHg). The
factory set occlusion pressure is between 5.7 kg and 6.2 kg (767 and 834 mmHg
respectfully for a perfect BD 60 ml syringe).
There is a pressure buildup on the syringe plunger
clamp, probably because of a blocked infusion line.
The infusion has stopped.
To remove the pressure, swing the syringe plunger clamp
away from the body of the pump and slide to the right. Then
deal with the occlusion. Reposition the plunger clamp. If the
START key is pressed before the plunger has been opened
the pump will not run and the message RELEASE CLAMP
will be displayed briefly. Restart the infusion as described in
section 6.
Page 14
10.5.2 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 mainly the infusion rate. Under
normal conditions and using a non compliant infusion line (i.e. a thick walled nonflexible line), the time to alarm following occlusion at 1.0 ml/hr is approximately
27 minutes at an occlusion pressure setting of about 350mmHg, using a BD 50ml
syringe.
Graseby 3400
This time can be further reduced by reducing the internal occlusion pressure.
A lower pressure will give a shorter time to alarm but there may be an increase
in false alarms. 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 several hours unless smaller syringe sizes are used.
10. 6 The nearly empty alarm system
The pump has a unique intelligent nearly empty alarm system. One of two
messages is displayed:
Anaesthesia Syringe pump
< 3 mins to END
This alarm only operates at infusion
rates at or below 100 ml/hr.
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 10.7).
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 10.7/10.8)
This alarm operates at infusion rates
NEARLY EMPTY
above 100 ml/hr, or when a syringe is
loaded with approximately 2.5 cm or
less syringe plunger travel remaining.
ALARM TYPE Intermittent quiet alarm.
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
Graseby 3400
EMPTY/OCCLUSION alarm sounds (section 10.8)
Page 15
Anaesthesia Syringe pump
10. 7 Infusion ended (KVO mode)
This alarm only operates at infusion
ENDED (KVO = .5)
ALARM TYPE Pulsing loud alarm (silenceable).
rates at or below 100 ml/hr and
follows the "<3mins to END" alarm.
CAUSE
ACTION Press the alarm silence key to silence the audible alarm.
10. 8 Syringe empty
EMPTY/OCCLUSION
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.
If you wish to continue the infusion fill, prime and reload
the next syringe (section 2.2). The small amount of drug
left in the syringe can be infused at the set infusion rate by
stopping and re-starting the pump. To stop the infusion
press STOP.
Note: the KVO mode is not operative when the pump is
controlled by an external computer.
Either the syringe is empty and the infusion is complete or
there is a pressure build up on the syringe plunger clamp,
probably because of a blocked infusion line. The pump
has stopped infusing.
Page 16
ACTION Press the alarm silence key to silence the audible alarm.
Prepare, prime and load a new syringe or switch off the
pump. In the case of an occlusion, action is as in section
10.5.
Graseby 3400
10. 9 Not infusing
NOT INFUSING
ALARM TYPE Intermittent quiet alarm (silenceable).
Anaesthesia Syringe pump
CAUSE
CAUSE
ACTION Commence the infusion as described in section 6 or
10.10 AC power failure
AC MAINS FAIL
ALARM TYPE Intermittent quiet alarm (silenceable).
CAUSE
ACTION This alarm can be silenced and the pump will continue
The pump has been switched on but the START
button has not been pressed.
The infusion may have been stopped (or completed)
and the user has neglected to press the START button
again (or switch the pump off).
switch the pump off.
The AC power supply has been interrupted during an
infusion. The pump will automatically switch to running
on its internal batteries. A fully charged pump will
operate for more than 10 hours.
running on its batteries. Reconnect to the AC power as
soon as possible.
Graseby 3400
Page 17
Anaesthesia Syringe pump
10.11 On battery
ON BATTERY
ALARM TYPE No audible alarm, screen indication only. A 'B' will be
shown within the pump running indicator arrow on the
right of the display.
CAUSE
ACTION Reconnect to AC power supply if desired.
10.12 Low battery
The pump is operating on its internal batteries.
LOW BATTERY
ALARM TYPE Intermittent quiet alarm (not silenceable).
CAUSE
ACTION Reconnect to AC power supply immediately.
10.13 Serial RS232 communications failure
The pump is operating on its internal batteries, but it may
not be possible for the infusion to continue much longer.
COMMS FAILURE
ALARM TYPE Continuous loud alarm (silenceable).
Page 18
CAUSE
ACTION Check the serial interface lead connections and also check
RS232 communications are not available in Australia and some other territories.
The RS232 connection has been disrupted.
the PC pump controlling software. If the alarm condition is
still unresolved Contact the software publisher, Graseby
Medical or a qualified technician.
Graseby 3400
10.14 Fault mode
ALARM TYPE Continuous loud alarm (not silenceable).
Anaesthesia Syringe pump
* FAULT 46 *
11. Battery
operation
CAUSE
WARNING: Do not use a faulty pump. If the pump de velops a fault then an alarm
will sound; the display will indicate a FA UL T 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.
ACTION Make a note of the fault code number and switch the pump off.
When the pump is switched on but not connected to the AC power supply it will (if the
batteries are charged) operate as if connected to the AC power, except that:
• the AC power lamp will not be illuminated and the following message will be
displayed during operation...
There is a fault with the pump.
The Technical Service Manual (part number 00SM - 0132)gives
further iinformation on the pump's fault codes.
ON BATTERY
•a ‘B’ will be shown within the pump running indicator arrow on the right of
the display,
Graseby 3400
• the low battery alarm is operative (section 10.11),
• the batteries will be fully charged if the pump has been connected to mains
power for at least 14 hours. When fully charged the batteries will power the
pump for more than 10 hours.
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.
Page 19
Anaesthesia Syringe pump
12. Positioning
the pump
The pump should be positioned and operated horizontally. It may be placed on
a flat stable surface or mounted on a vertical IV pole or rail using the pole
clamp.
CAUTION: If the pump is used in close pr o ximity to a fluid bag(s), it should where
possible, not be mounted directly underneath the fluid ba g(s). This is to minimise
the possible risk of damage to the pump from fluid ingress should the bag
rupture or leak during use.
WARNING: To avoid the pump becoming detached from an IV pole alw ays 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 3400 syringe
pump and harm the operator or the patient. As a result, the operator or patient
may suffer direct injury, or the 3400 syringe pump may fail to operate correctly,
leading to patient injury or death.
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.
13. Cleaning and maintenance
Cleaning
The pump may be decontaminated by wiping it with a mild disinfectant solution.
Page 20
For example, the disinfectant solution may be made by using
sodiudhypochlorite diluted with water, to give a solution of 0.1% available
chlorine. The chlorine concentration will be stated on the product label. The
solution must be freshly made and used within 24 hours of preparation.
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.
CAUTION: Do not use cleaning and disinf ecting agents other than the appr oved
ones specified here.
CAUTION: The pump must
organic solvents. Wipe off spills immediatel y , 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.
not be immersed in any liquids or exposed to str ong
Graseby 3400
Anaesthesia Syringe pump
Maintenance
Spare parts
The Department of Health, in its publication MDA DB 9503, has
recommended that infusion pumps are checked by a qualified technician at
regular intervals.
Graseby Medical supports this policy and recommends that for all our
products the functional and safety tests listed in the Technical Manuals are
carried out annually.
Additionally, with reference to the Department of Health publication
‘SAB(94) 26 July 1994’, we recommend that any of our products that have
been dropped, or subjected to severe fluid spills, should be removed from
use immediately and checked by a qualified technician.
For technical and repair information refer to the Graseby Medical Technical
Service Manual, part number 00SM-0132.
For further information contact:
Graseby Medical (Customer Care) or your local distributor.
WARNING: Failure to follo w the
recommendations may result in compromised function of the product and
lead to patient injury or death.
CAUTION: Ref er all service, repair and calibrations only to qualified
technical personnel. Unauthorised modifications to the pump must
carried out.
Service Manual’s
maintenance schedule
not be
A list of Spare parts and accessories is provided in each of the following:
• The Graseby Illustrated Parts Catalogue and Price List, part
number 0199-0702.
Graseby 3400
• The Technical Service Manual, part number 00SM-0132.
Page 21
Anaesthesia Syringe pump
14. Standards
Insulation
Safety
EMC
Fluid ingress
CE Marking
The pump is a Class II (double insulated) device.
(Also classified as Internally Powered Equipment).
Type CF (Cardiac Floating) insulation on all inputs.
EN6060-1
EN6060-1-2
IPX1 protection against drops of water falling vertically.
Registered design applied for. UK PATENT NO. 2229497
The CE mark demonstrates that the pump conforms to the requirements in
the European Council Directive 93/42/EEC concerning medical devices.
0473
The number 0473 identifies the Notified Body under which the Quality
Systems operated within Graseby Medical Ltd are assessed.
Refer to the accompanying instructions on how to use the pump.
CLASSIFIED BY Underwriters Laboratories Inc.WITH RESPECT TO
ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH UL 2601-1, CAN/CSA C22.2 No.601.1-M90.
Page 22
The serial RS232 9-pin ‘D’ connector that is situated on the rear of the pump
enables suitable equipment to be connected to the pump for communication
purposes. To maintain patient safety the external equipment must comply
with IEC 601-1UL 2601-1. The communications protocol can be obtained from
Graseby (Customer Care).
Note: RS232 communications are not available in Australia and some
other territories.
Graseby 3400
Anaesthesia Syringe pump
Disposal
When the time comes to dispose of the pump or its accessories do so in the
best way to minimise any negative impact on the environment.
There are three batteries inside the pump that contain harmful lead and sulphuric
acid. First discharge the batteries by operating the pump, then dismantle the
pump and remove all three batteries. Do not open up the batteries as this will
release the acid. Do not incinerate them as they may explode. Separate them
from the everyday waste, as indicated by the graphic symbol on the batteries.
You may be able to use special recycling or disposal schemes. To find out about
these contact your local waste disposal service.
Separate any other parts of the equipment where arrangements can be made for
their recovery, either by recycling or energy recovery. Larger plastic parts are
marked with a material identification code to facilitate recycling.
Important: Existing national or local regulations concerning waste disposal
must take precedence over this advice.
Graseby 3400
Page 23
Anaesthesia Syringe pump
15. Specification
Weight:
Not exceeding 3.5 kg including batteries and pole clamp.
Nominal size:
Flow rate:
Drive accuracy:
Syringe brands:
325 mm x 195 mm x 115 mm (with pole clamp fitted and plunger clamp closed).
50/60ml Syringe = 0.1 to 1200.0 ml/hr.
30/35ml Syringe = 0.1 to 600.0 ml/hr.
20ml Syringe = 0.1 to 400.0 ml/hr.
10ml Syringe = 0.1 to 200.0 ml/hr.
5ml Syringe = 0.1 to 100.0 ml/hr.
The delivery volume is accurate to within ±2% over a complete syringe length
(excluding the start-up time).
BD PLASTIPAK 5ml, 10ml, 20ml, 30/35ml, 50/60ml.
BRAUN OMNIFIX 5ml, 10ml, 20ml, 30/35ml, 50/60ml.
SHERWOOD MONOJECT 5ml, 10ml, 20ml, 50/60ml.
TERUMO 5ml, 10ml, 20ml, 30/35ml, 50/60ml.
FRESENIUS INJECTOMAT 50ml only.
BRAUN PERFUSOR 50ml only, optional, conversion kit required.
IMS PUMPJET 30 30ml only, prefilled.
Page 24
AC power supply:
Battery type:
Battery life:
100 to 240 V at 50 to 60 Hz, 40 VA.
The pump can be internally powered by 3 sealed lead acid (Cyclon) batteries.
More than 10 hours when fully charged and under normal conditions.
Graseby 3400
Anaesthesia Syringe pump
Temperature range:
Adjustable occlusion
pressure:
Storage conditions:
-40° to +70°C, 30 to 90% Rh, 700 to 1060 hPa.
Operating conditions:
+5° to +40°C, 30 to 75% Rh, 700 to 1060 hPa.
As factory set the pump gives an occlusion alarm if the force on the syringe
plunger is between 5.7 and 6.2 kg. This f orce can be adjusted (refer to the
Service Manual).
Graseby 3400
Page 25
Anaesthesia Syringe pump
Page 26
Graseby 3400
For further information, please contact your local distributor or
Graseby Medical direct on +44 (0)1923 246434
Graseby Medical Ltd.Graseby Medical Ltd.
Graseby Medical Ltd.
Graseby Medical Ltd.Graseby Medical Ltd.
Colonial Way, Watford, Herts, UK, WD24 4LG
Telephone: +44 (0)1923 246434, Facsimile: +44 (0)1923 231595
http://www.graseby.co.uk
Part No. 0132-0044-K
August 2002
© 2002 Graseby Medical Ltd
Smiths Medical - A part of Smiths Group plc
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