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Alaris™ GH Syringe Pump
Models: 80023xx01, 80023xx00
Directions For Use
en
Contents
Page
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Introduction
The Alaris™ GH Syringe Pump (herein after referred to as "pump") is a fully featured syringe pump suitable for critical care and general infusion applications.
The Alaris™ GH Syringe Pump is compatible with a wide range of standard, single-use, disposable Luer lock syringes. It accepts syringe sizes from 5 ml to 50 ml. See the 'Compatible Syringes' section for a full list of compatible syringes.
Intended Purpose
The Alaris™ GH Syringe Pump is intended for use by medical staff for purposes of controlling infusion rate and volume.
Conditions of Use
The Alaris™ GH Syringe Pump should only be operated by a clinician competent in use of automated syringe pumps and post-placement management of intravenous catheters. w
CareFusion cannot guarantee the continued system accuracy with other manufacturer’s syringes as identified in the
‘Compatible Syringes’ table. Manufacturers may change syringe specification significant to system accuracy without prior notification.
Indications
The Alaris™ GH Syringe Pump is indicated for infusion of therapeutics including:
• analgesics
• antimicrobials
• blood products
• chemotherapy
• subcutaneous
• nutrition
Contraindications
The Alaris™ GH Syringe Pumps is contraindicated for:
• enteral therapies
• epidural
About This Manual
The user must be thoroughly familiar with the Alaris™ GH Syringe Pump described in this manual prior to use.
All illustrations used in this manual show typical settings and values which may be used in setting up the functions of the pump. These settings and values are for illustrative use only. Where stated, a minimum infusion rate refers to a nominal rate of 1.0ml/h, and an intermediate infusion rate refers to a nominal rate of 5.0ml/h. The complete range of infusion rates, settings and values are shown in the
Specifications section.
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It is important to ensure that you only refer to the most recent version of the Directions for Use and Technical Service
Manual for your CareFusion products. These documents are referenced on www.carefusion.com. Copies can be obtained by contacting your local CareFusion representative.
Quick Start Guide
1. Press the a
button to turn the pump on.
2.
CLEAR SETUP?
-
NO
retains previous data.
YES
clears previous data.
3. Load syringe.
4. Confirm correct size and brand of syringe.
5. Ensure extension set is attached to syringe, but disconnected from patient.
If the PURGE SYRINGE option has been enabled then the prompt to purge screen is displayed and the set can be purged as required.
6. INFUSION RATE - Change rate if necessary using the f
keys.
7. PURGE - Press the i
button followed by the
PURGE
softkey.
8. Connect extension set to the patient access device.
9. Press the b
button to start the infusion.
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Features of the Alaris™ GH Syringe Pump
ON/OFF
RUN
Display
Release lever for
MDI
High visibility
Alarm Indicator
PURGE/BOLUS
MUTE
PRESSURE
OPTION
Extension set hook
HOLD Shelf for chevron keys and softkeys
Rating Plate (see Symbol Definitions for an explanation of the symbols used)
Release lever for
Rotating
Cam
M
edica
l
D
ev
i
ce
I
nt
erf
a
ce
(M
DI)
Syringe Clamp Positive Plunger
Grippers
Finger
Grips
Rotating Cam to lock on to horizontal rectangular bars
Carrying
Handle
IR Communications port
Potential
Equalisation
(PE) connector
Folded Pole
Clamp
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RS232
Connector
(optional)
Extension
set hook
Controls and Indicators
Controls:
Symbol Description
a
ON/OFF
button - Press once to switch the pump ON. Press and hold down for 3 seconds to switch the pump OFF.
b
RUN
button - Press to start the infusion. The green LED will flash during infusion.
h
HOLD
hold.
button - Press to put the infusion on hold. The amber LED will be lit while on c
MUTE
button - Press to silence alarm for 2 minutes (configurable). Press and hold until 3 beeps are heard for 15 minutes silence.
i
PURGE/BOLUS
button - Press to access
PURGE
or
BOLUS
soft keys. Press and hold down soft key to operate.
PURGE
the extension set during set up. l
Pump is on hold l
Extension set is not connected to the patient l
Volume Infused (VI) is not added
BOLUS -
fluid or drug delivered at an accelerated rate. l
Pump is infusing l
Extension set is connected to the patient l
VI is added d
OPTION
button - Press to access optional features (see Basic Features).
e
PRESSURE
level.
button - Use this button to display the pumping pressure and alarm f
CHEVRON
keys - Double or single for faster/slower increase or decrease of values shown on display. g
BLANK SOFTKEYS
- Use in conjunction with the prompts shown on the display.
Indicators:
Symbol Description
j
BATTERY
indicator - When illuminated the pump is running on the internal battery.
When flashing the battery power is low with less than 30 minutes of use remaining.
S
AC POWER
indicator - When illuminated the pump is connected to an AC power supply and the battery is being charged.
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Symbol Definitions
Labelling Symbols:
Symbol Description
w
Attention (Consult accompanying documents) x
Potential Equalisation (PE) Connector y
RS232/Nurse call Connector (Optional) l
Defibrillation-proof type CF applied part (Degree of protection against electrical shock)
O
Protected against vertically falling drops of water r
Alternating Current s
Device complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC.
T
Date of Manufacture t
Manufacturer
U
Not for Municipal Waste
W
Fuse Rating
EC REP
Authorised representative in the European Community
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Main Display Features
Pump
Status
Syringe type fitted /
Drug name
Pressure
Information
ON HOLD
+ ADJUST -
VOLUME
0.0
ml
VOLUME
IVAC 50
VTBI
Screen Icons:
Infusion
Rate
Volume
Infused
Volume Infused
Option
VTBI
Option
Symbol Description
l
TIME REMAINING DISPLAY
icon - Indicates time before syringe will require replacing.
N
BATTERY
icon - Indicates battery charge level to highlight when the battery will require recharging.
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I
J
Operating Precautions
Disposable Syringes and Extension Sets
•
Always clamp or otherwise isolate the patient line before unclamping or removing a syringe from the pump. Failure to do so may result in unintended administration.
•
This Alaris™ GH Syringe Pump has been calibrated for use with single-use disposable syringes. To ensure correct and accurate operation, only use 3 piece Luer lock versions of the syringe make specified on the pump or described in this manual. Use of non-specified syringes or extension sets may impair the operation of the pump and the accuracy of the infusion.
•
Uncontrolled flow or syphoning may result if the syringe is located incorrectly in the pump, or if it is removed from the pump before the extension set is properly isolated from the patient. Isolation may include closing a tap in the patient line or activating a flow stop clamp.
•
Secure the extension set to the pump using the extension set hook at the rear of the pump. This provides protection against accidental dislodging of the syringe from the pump.
•
When combining several apparatus and/or instruments with extension sets and other tubing, for example via a 3-way tap, the performance of the pump may be impacted and should be monitored closely.
Mounting the Pump
•
When more than one pump is being used on a patient, those containing high risk, critical medications must be positioned as close to the patient's heart level as possible to avoid the risk of variations in flow or siphoning.
•
Raising a Pump whilst infusing may result in a bolus of the infusate, whereas lowering a Pump whilst infusing may result in a delay in the infusion (an underinfusion).
•
Do not mount the pump in a vertical position with the syringe pointing upwards as this could lead to an infusion of air which may be in the syringe. To protect against the introduction of air the user should regularly monitor the progress of the infusion, syringe, extension line and patient connections and follow the priming procedure specified herein.
Operating Environment
•
When using any infusion pump in conjunction with other pumps or devices requiring vascular access, extra care is advised. Adverse delivery of medication or fluids can be caused by the substantial variation in pressures created within the local vascular system by such pumps. Typical examples of those pumps are used during dialysis, bypass or cardiac assist applications.
•
This pump is suitable for use in Hospital and clinical environments other than domestic establishments and those directly connected to the public single phase AC mains power supply network that supplies buildings used for domestic purposes. However, it may be used in domestic establishments under the supervision of Medical professionals with additional necessary appropriate measures. (Consult Technical
Service Manual, appropriately trained technical personnel or CareFusion for further information).
•
This pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide.
Operating Pressure
•
This is a positive pressure pump designed to achieve very accurate fluid administration by automatically compensating for resistance encountered in the infusion system.
•
The pumping pressure alarm system is not designed to provide protection against, or detection of, IV complications which can occur.
Alarm Conditions
•
Several alarm conditions detected by this pump will stop the infusion and generate visual and audible alarms. Users must perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating.
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M
K
Operating Precautions (continued)
Electromagnetic Compatibility and Interference
•
This pump is protected against the effects of external interference, including high energy radio frequency emissions, magnetic fields and electrostatic discharge (for example, as generated by electrosurgical and cauterising equipment, large motors, portable radios, cellular telephones etc.) and is designed to remain safe when unreasonable levels of interference are encountered.
•
Therapeutic Radiation Equipment:
Do not use the pump in the vicinity of any Therapeutic Radiation
Equipment. Levels of radiation generated by the radiation therapy equipment such as Linear Accelerator, may severely affect functioning of the pump. Please consult manufacturer’s recommendations for safe distance and other precautionary requirements. For further information, please contact your local
CareFusion representative.
•
Magnetic Resonance Imaging (MRI):
The pump contains ferromagnetic materials which are susceptible to interference with magnetic field generated by the MRI devices. Therefore, the pump is not considered an MRI compatible pump as such. If use of the pump within an MRI environment is unavoidable, then
CareFusion highly recommends securing the pump at a safe distance from the magnetic field outside the identified ‘Controlled Access Area’ in order to evade any magnetic interference to the pump; or
MRI image distortion. This safe distance should be established in accordance with the manufacturers’ recommendations regarding electromagnetic interference (EMI). For further information, please refer to the product technical service manual (TSM). Alternatively, contact your local CareFusion representative for further guidance.
•
Accessories:
Do not use any non-recommended accessory with the pump. The pump is tested and compliant with the relevant EMC claims only with the recommended accessories. Use of any accessory, transducer or cable other than those specified by CareFusion may result in increased emissions or decreased pump immunity.
•
This pump is a CISPR 11 Group 1 Class A device and uses RF energy only for its internal function in the normal product offering. Therefore, its RF emissions are very low and are not likely to cause any interference with the nearby electronic equipment. However, this pump emits a certain level of electromagnetic radiation which is within the levels specified by IEC/EN60601-1-2 and IEC/EN60601-2-24. If the pump interacts with other equipment, measures should be taken to minimise the effects, for instance by repositioning or relocation.
•
In some circumstances the pump may be affected by an electrostatic discharge through air at levels close to or above 15kv; or by radio frequency radiation close to or above 10v/m. If the pump is affected by this external interference the pump will remain in a safe mode; the pump will duly stop the infusion and alert the user by generating a combination of visual and audible alarms. Should any encountered alarm condition persist even after user intervention, it is recommended to replace that particular pump and quarantine the pump for the attention of appropriately trained technical personnel. (Consult Technical
Service Manual for further information).
Hazards
•
An explosion hazard exists if the pump is used in the presence of flammable anaesthetics. Exercise care to locate the pump away from any such hazardous sources.
A
•
Dangerous Voltage: An electrical shock hazard exists if the pump’s casing is opened or removed. Refer all servicing to qualified service personnel.
V
L
•
When connected to an external power source, a three-wire (Live, Neutral, Earth) supply must be used. If the integrity of the external protective conductor in the installation or its arrangement is in doubt, the pump should be operated from the battery.
•
Do not open the RS232/Nurse Call protective covering when not in use. Electrostatic discharge
(ESD) precautions are required when connecting RS232/Nurse Call. Touching the pins of the connectors may result in ESD protection failure. It is recommended that all actions must be taken by appropriately trained personnel.
•
If this pump is dropped, subjected to excessive moisture, fluid spillage, humidity or high temperature, or otherwise suspected to have been damaged, remove it from service for inspection by a qualified service engineer. When transporting or storing the pump, use original packaging where possible, and adhere to temperature, humidity and pressure ranges stated in the Specifications section and on the outer packaging.
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Getting Started
Initial Set-up
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Before operating the pump read this Directions For Use manual carefully.
1. Check that the pump is complete, undamaged and that the voltage rating specified on the label is compatible with your AC power supply.
2. Items supplied are: l
Alaris™ GH Syringe Pump
l
User Support CD (Directions For Use)
l
AC Power Cable (as requested)
l
Protective Packaging
3. Connect the pump to the AC power supply for at least 2½ hours to ensure that the internal battery is charged (verify that the
S
is lit).
Language Selection
1. On initial start-up the pump will display the Select Language screen.
2. Select the required language from the list displayed using the f keys.
3. Press the
OK
softkey to confirm your selection.
w
The pump will automatically operate from its internal battery if the pump is switched on without being connected to the AC power supply.
Should the pump fail to perform correctly, replace in its original protective packaging, where possible and contact a qualified service engineer for investigation.
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Getting Started (continued)
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Do not mount the pump with the AC power inlet or the syringe pointing upwards. This could affect the electrical safety in the event of a fluid spill or lead to the infusion of air which may be in the syringe.
Pole Clamp Installation
The pole clamp is fitted to the rear of the pump and will provide secure fixing to vertical I.V. poles of a diameter between 15 and 40 mm.
1. Pull the folded pole clamp towards you and unscrew the clamp to leave enough room for the size of the pole.
2. Place pump around pole and tighten screw until the clamp is secured to the pole.
Recessed area
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Ensure the pole clamp is folded away and stored within the recessed area at the rear of the pump before connecting to a Docking Station/
Workstation* or when not in use.
Never mount the pump such that the IV infusion stand becomes top heavy or unstable.
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Prior to each use, check the pole clamp:
• does not show any signs of excessive wear,
• does not show any signs of excessively loose movement in the extended, mountable position.
If these signs are observed, the pumps should be taken out of service for examination by qualified service personnel.
Docking Station/Workstation* or Equipment Rail Installation
Rectangular bar Release lever (push to release)
Rotating cam
The rotating cam can be fitted to the rectangular bar on the Docking Station/Workstation* or the equipment rail measuring 10 by 25 mm.
1. Align the rotating cam on the rear of the pump with the rectangular bar on the Docking Station/Workstation* or the equipment rail.
2. Hold the pump horizontally, push the pump firmly onto the rectangular bar or equipment rail.
Ensure that the pump 'clicks' securely into position onto the bar.
3. To release, push the release lever and pull the pump forwards.
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*Alaris™ DS Docking Station and Alaris™ Gateway Workstation.
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Syringe Loading
Prepare Syringe and Administration Set
To decrease potential start-up delays, delivery inaccuracies and delayed generation of occlusion alarms each time a new syringe is loaded:
• Use smallest syringe size possible, for example, if infusing 9 ml of fluid, use a 10 ml syringe.
• Use the
PURGE SYRINGE
or
PURGE
option on the Pump to decrease the delay in the start of the infusion , see
Starting the Pump
section.
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Warning: Use the smallest compatible syringe size necessary to deliver the fluid or medication; this is especially important when infusing high risk or life-sustaining medications at low infusion rates, especially flow rates < 0.5 ml/h.
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Warning: Purge the Pump system before starting an infusion or after replacing a near-empty syringe with a replacement syringe. When Purging ensure that the extension set is not connected to the patient.
Practice Recommendations
• Tubing internal diameter: Smallbore or microbore tubing is recommended when infusing at low rates
• Filters: Internal volume, dead space, of in-line filters should be minimized
• Connection sites: Critical drugs should be connected as close to the vascular access site as possible
Positioning of Pump
Ensure that the Pump is as close to level of patient’s heart as possible.
Patient’s heart level should be in line with the middle of the Pump.
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Warning: Adjusting the Pump's height relative to the patient's heart level can lead to temporary increases or decreases in fluid delivery.
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Caution: If using multiple syringe pumps and it is not clinically feasible to have all Pumps level with the patient’s heart, place the high risk or life-sustaining medications as close to the patient’s heart level as possible.
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Caution: When infusing multiple high risk or life-sustaining medications, consider placing the Pumps infusing at the lowest rates as close to the level of the patient’s heart as possible.
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Syringe Loading (continued)
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Loading and Confirming a Syringe
Warning: To securely load and confirm a syringe carefully follow the steps below. An incorrect loading of a syringe may result in misidentification of the syringe type and size. If then confirmed, this may lead to significant inaccuracy of the infusion rate and may also affect pump performance.
Only use a syringe of the type stated on the pump or in this manual. Using an incorrect syringe could adversely affect the accuracy of the infusion rate and may also affect pump performance.
When drawing fluid into the syringe, draw enough to compensate for any 'dead space' volume in the extension set and syringe at the end of infusion as this cannot be fully infused.
Finger
Grips
Plunger
Flange
Plunger
Grippers
Plunger
Plunger
Holder
Syringe
Barrel
Barrel
Flange
Syringe
Clamp
Syringe Flange Clamp
Place the pump on a stable horizontal surface or secure as described previously.
Prepare, load and prime the single-use disposable syringe and extension set using standard aseptic techniques.
1. Squeeze the finger grips together on the plunger holder and slide the mechanism to the right.
2. Pull the syringe clamp forward and down.
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Syringe Loading (continued)
Loading and confirming a Syringe (continued)
3. Insert the syringe ensuring that the barrel flange is located in the slots on the syringe flange clamp. w
To ensure the syringe is loaded correctly, place the barrel flange in the space between the syringe clamp and the syringe flange clamp. This is correct if the syringe remains in position before the syringe clamp is closed.
4. Lift the syringe clamp until it locks against the syringe barrel.
5. Squeeze the finger grips on the plunger holder and slide the mechanism to the left until it reaches the plunger end.
6. Release the finger grips. Ensure that the plunger grippers are securing the plunger in place and the finger grip returns to its original position.
7. Ensure that the syringe type and size match those displayed on the pump then press
CONFIRM
. If required, the make of syringe can be changed by pressing the
TYPE
softkey.
ON HOLD IVAC 50
CONFIRM TYPE
Note:
If the
PURGE SYRINGE
option has been enabled then the prompt to purge screen is displayed and the extension set can be purged as required, however ensure that the extension set is not connected to the patient during this process.
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CareFusion recommends limiting the number of configured syringe types and sizes available for selection on the pump.
Secure the extension set using the extension set hook at the rear of the pump. This provides protection against accidental dislodging of the syringe from the pump.
Ensure that both plunger grippers are fully locked onto the plunger flange and the upper finger grip has returned to its original position.
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Starting the pump
1. Connect the pump to an AC power supply using the AC power cable.
Press the a
button. l
The pump will run a short self-test. Ensure that two beeps are activated during this test. l Check the display test pattern and ensure that no rows are missing. l
Check that the displayed time and date are correct.
Note:
A warning -
REPAIRING LOGS
, may be displayed if event log information was not completely stored at the previous power down.
This is for information only, the pump will continue to power up as normal.
2.
CLEAR SETUP? -
Answering
NO
will retain all previous rate and volume settings.
YES
will automatically reset the rate and volume settings to zero.
3. LOAD SYRINGE - Load the syringe according to the procedure in this manual.
4. CONFIRM SYRINGE - Check that the syringe type and size being used matches the display. If required, the make of syringe can be changed by pressing the
TYPE
button. Press
CONFIRM
when the correct type and size are shown.
If the PURGE SYRINGE option has been enabled then the prompt to purge screen is displayed and the set can be purged as required.
5. INFUSION RATE - Check the rate shown if old patient data has been retained and change the rate if necessary using the keys.
f
6. PURGE (if required) - Press the i
button and then press and hold the
PURGE
softkey until fluid flows and the purging of the syringe extension line is complete. Release the softkey. The volume used during purging will be displayed.
7. CONNECT TO PATIENT - Connect the extension set to the patient access device.
8. START - Press b
to commence operation.
INFUSING
START light to indicate that the pump is in operation.
will be displayed. The AMBER STOP light will be replaced by the flashing GREEN
9. STOP - Press h
to halt the operation.
ON HOLD
will be displayed. The amber light will replace the green light.
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Basic Features
Purge
The i button allows the delivery of a limited volume of fluid in order to purge the extension set prior to being connected to a patient or after changing a syringe.
1. Press the i
button when the pump is not infusing. Ensure that the extension set is not connected to the patient.
2. Press and hold the
PURGE
softkey until fluid flows and the purging of the IV infusion set is complete. The volume used during purging will be displayed, but it is not added to the volume infused.
3. When purging is complete release the
PURGE
softkey. Press the
QUIT
softkey to exit back to the main display.
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The pump will not purge if the rate lock has been enabled. During PURGE the pressure limit alarms are temporarily increased to their maximum level.
Bolus Infusion
Bolus
- Administering a controlled volume of fluid or drug at an increased rate for diagnostic or therapeutic purposes. The pump should always be infusing and always attached to the patient. (Drugs given by an IV bolus could achieve immediate and high drug concentration levels.)
Bolus can be used at the start of an infusion or during an infusion.
The bolus feature can be configured to: a) b)
BOLUS Disabled
BOLUS Enabled i) Hands On only
ii)
BOLUS Disabled
Hands On and Hands Free
If configured to
Disabled
, pressing the i
button will have no effect and the pump will continue to infuse at the set rate.
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A Hands On bolus and Hands Free bolus cannot be administered if the "RATE LOCK" is active.
During BOLUS the pressure limit alarm is temporarily increased to the maximum level.
BOLUS Enabled - Hands On
In "Hands on" Bolus, press and hold the (flashing)
BOLUS
soft key to deliver the required bolus. The bolus rate can be adjusted. The bolus volume is limited in the configuration.
1. During infusion press the i
button once to display the bolus screen.
2. Use the f
keys to adjust the bolus rate if required.
3. To deliver the bolus press and hold the
BOLUS
softkey. During the bolus, the volume being infused is displayed. When the desired bolus volume has been delivered or the bolus volume limit is reached, release the softkey. The bolus volume is added to the total volume infused.
BOLUS Enabled - Hands On and Hands Free
The "Hands Free" Bolus is delivered with a single press of the (flashing)
BOLUS
soft key. On intial use the bolus rate and bolus volume are at default values and can be changed. On subsequent uses, the bolus rate and bolus volume will remain as per previously set and can be changed as required. Following
CLEAR SETUP
, the default bolus rate is determined via the configuration and the default bolus volume is
0.1ml.
1. During infusion press the above).
i
button to display the "Hands Free" bolus selection screen.
2. Press the
YES
softkey to go to "Hands Free" selection bolus screen, press the
HANDS ON
softkey for "Hands On" bolus (see section
3. Use the f
keys to set the bolus volume/dose required; If necessary press the
RATE
softkey to adjust the bolus delivery rate
(150/300/600/900/1200ml/h).
Note:
Rate may be restricted by the syringe size and the
CAP BOLUS RATE
.
4. Press the flashing
BOLUS
softkey once to begin the delivery of the preset bolus. The display will show the bolus being delivered, the bolus counting down and revert to main infusion display upon completion of the bolus.
5. To terminate a bolus being delivered press
STOP
softkey. This will stop the bolus and continue infusing at the set rate. Press the button to stop the bolus delivery and place the pump on hold. h
6. If the bolus volume reaches the set bolus volume limit the bolus will stop and the pump will revert to infuse at the set infusion rate and continue infusing. w
If the "Hands Free" bolus option is active, then this feature will be cancelled following any interruption in delivery, e.g. occlusion, even if the bolus delivery is incomplete.
If the volume to be infused (VTBI) is reached during a bolus, the VTBI complete alarm will sound. Press alarm or CANCEL to acknowledge the alarm. See 'VTBI' section for more details on VTBI operation.
c
to silence the
Manual Bolus
The "Manual Bolus" is delivered by moving the plunger drive mechanism forward while the pump is infusing. This method of delivering a bolus is not recommended as best clinical practice.
The syringe must be confirmed and the plunger mechanism has to move from an engaged position to disengage and then re-engage position.
A minimum travel of 1mm (leadscrew pitch) must be detected to register.
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Basic Features (Continued)
Pressure Level
1. To check and adjust the pressure level press the current pressure level.
e button. A bar graph will be displayed showing the pressure alarm level and the
2. Press the
3. Press f
keys to increase or decrease the alarm level. The new level will be indicated on the display.
to exit the screen.
w
The interpretation of pressure readings and occlusion alarms are the responsibility of the clinician depending on the specific application.
Rate Titration
If Rate Titration is
enabled
the rate can be adjusted
while infusing
:
1. Select the new rate using the f keys.
The message < START TO CONFIRM > will flash on screen and pump continues to infuse at the original rate.
2. Press the b button to confirm the new infusion rate and start infusing at the new rate.
If Rate Titration is
disabled
the rate can only be adjusted
whilst on hold:
1. Press the h button to put the pump on hold.
2. Select the new rate using the f
keys.
3. Press the b
button to start infusing at the new rate.
Volume to be Infused (VTBI)
This option allows a specific volume to be infused to be set. Rate at the end of this VTBI can also be set, selecting from stop, KVO, or continuous infusion at the set rate.
1. Press the
VTBI
softkey to select the volume to be infused option.
2. Enter the volume to be infused using the f
keys and press the
OK
softkey.
3. Select the rate at the end of the VTBI using the f
keys to scroll through the on-screen choices. The default is stop.
4. Press the
OK
softkey to enter the rate and exit the VTBI menu.
Clear Volume
This option enables the volume infused to be cleared.
1. Press the
VOLUME
softkey to display the
CLEAR VOLUME
option.
2. Press the
YES
softkey to clear the volume. Press the
NO
softkey to retain the volume.
Selecting YES resets the volume infused in the 24H LOG option.
Rate Lock
If Rate Lock is enabled, when the infusion rate has been set and the infusion started (or following a bolus infusion) the rate lock prompt will appear on the main display.
To select the rate lock function press the
YES
softkey. Press the
NO
softkey if the rate lock is not required.
When rate lock is enabled, the following are unavailable:
l
Changing the infusion rate / titration
l
Bolus / purge
l
Switching the pump off
l
VTBI over time infusions.
To disable the rate lock if selected:
1. Press the d
button to access the options menu.
2. Select the
UNLOCK RATE
option using the f
keys and press the
OK
softkey.
To enable the rate lock if not selected:
1. Press the d
button to access the options menu.
2. Select and press the
OK
softkey.
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Basic Features (Continued)
?
Set VTBI over Time
This option allows a specific VTBI and delivery time to be set. The rate necessary to deliver the required volume within the specified time is calculated and displayed.
1. Stop the infusion. Press the d
button to access the options menu.
2. Select the
SET VTBI OVER TIME
option using the f
keys and press the
OK
softkey.
3. Adjust the volume to be infused using the f keys. When the desired volume has been reached press the
OK
softkey.
4. Enter the time over which the volume is to be infused. The infusion rate will automatically be calculated. Press the
OK
softkey to enter the value.
5. Select the rate at VTBI end from the list using the f keys and press the
OK
softkey. The default is STOP.
?
24 Hour Log
This option allows the 24 hour log of volume infused to be reviewed.
1. Press the d button to access the options menu.
2. Select the
24H LOG
option using the f
keys and press the
OK
softkey.
The display shows the hourly volume infused. The volume infused shown in brackets is the total volume infused since the volume was last cleared. See example below:
07:48 - 08:00 4.34ml (4.34ml)
08:00 - 09:00 2.10ml (6.44ml)
09:00 - 10:00 2.10ml (8.54ml)
VOLUME CLEARED
3. Press the
QUIT
softkey to exit the log.
?
Event Log
This option allows the event log to be reviewed. It can be enabled/disabled.
1. Press the d button to access the options menu.
2. Select the
EVENT LOG
option using the f keys and press the
OK
softkey.
3. Scroll through the log using the f
keys. Press the
QUIT
softkey to exit the log.
?
Drug Name
This option enables the selection of a drug from the drug names set up in configuration.
1. Press the d button to access the options menu.
2. Select . Note: Selecting
CLEAR DRUG NAME
will clear the drug name.
3. Press the
OK
softkey to confirm the drug name or press the
QUIT
softkey to exit the option.
1000DF00328 Issue 6
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Alarms and Warnings
Alarms are indicated by a combination of an audible alarm, flashing alarm indicator and a descriptive message in the display.
1. First press the c button to silence the alarm for a maximum of 2 minutes*, then check the display for an alarm message. Press to cancel the alarm message.
CANCEL
2. If the infusion has stopped, rectify the cause of the alarm then press the b button to resume the infusion.
w
If the pump initiates a safety processor alarm condition (an audible high pitched continuous shrill accompanied with a red alarm indicator) and there is no error message displayed on the pump, remove the pump from service for examination by a qualified service engineer.
Display
DRIVE DISENGAGED
CHECK SYRINGE
BATTERY EMPTY
NEAR END OF INFUSION
END OF INFUSION
TITRATION NOT CONFIRMED
VTBI DONE
AC POWER FAIL
Error Code and Message
ATTENTION
OCCLUSION
BATTERY LOW
(with “3 Beeps”)
Description and Troubleshooting Guide
The drive system has been disengaged during operation. Check the finger grips and the position of the syringe.
Excessive pressure measured at the syringe plunger exceeding the alarm limit. Identify and remove the cause of the blockage in the drive, syringe, or administration system before restarting the infusion.
Incorrect size of syringe has been fitted, the syringe has not been positioned correctly or has been disturbed during operation. Check the syringe location and the position
.
A
CHECK SYRINGE
alarm may indicate the incorrect size of syringe has been fitted; the syringe has not been positioned correctly, or has been disturbed during operation, for example, the user opens the syringe clamp, or If the syringe plunger loses contact with the plunger button.
If there is no identifiable cause for the
CHECK SYRINGE
alarm(s) then the pump should be removed from clinical use and examined by Qualified Service Personnel in accordance with the
Alaris Syringe Pump Technical Service Manual.
Battery charge low with 30 minutes operation remaining. Battery indicator will flash and after 30 minutes a continuous audible alarm will indicate that the battery is exhausted. Reconnect to the
AC power supply to continue operation and charge the internal battery.
The internal battery is exhausted. Connect the pump to the AC power supply.
The pump is nearing the end of the infusion.This value can be configured.
The pump has reached the end of the infusion. A pre-set volume will remain in the syringe to minimise the risk of the infusion of air bubbles into the set. This value can be configured.
The infusion rate has been changed, but has not been confirmed and 2 minutes* has expired without any operation. Press the c
button to silence the alarm, then press the
CANCEL
softkey to clear this message and silence the alarm.
Check infusion rate and confirm by pressing the b
button or press the h
button to revert to the previous rate. Press the b
button to start infusion. (This alarm only occurs if rate titration is enabled).
The pre-set Volume To Be Infused is complete.
AC Power has been disconnected and the pump is operating on battery power, if this occurs when the pump is infusing the message "
INFUSION CONTINUES
" will be displayed. Reconnect
AC power supply or press the c
button to silence the alarm and continue with battery operation.
The alarm will automatically cancel if the AC power supply is reconnected.
The alarm system has detected an internal malfunction. Note the malfunction code. Remove pump from service for examination by a qualified service engineer.
Three beeps will sound if the pump has been left ON for more than 2 minutes* (referred to as
CALLBACK
in the log) without starting the operation. Press the c
button to silence the alarm for a further 2 minutes*. Alternatively press and hold down the c button and wait for 3 beeps in succession, this will put the warning alarm on standby for 15 minutes.
Alarm Indicator Colour
AMBER
RED
Alarms indicated
AC POWER FAIL; NEAR END OF INFUSION; VTBI DONE (KVO or CONTINUE), ATTENTION; TITRATION
NOT CONFIRMED; BATTERY LOW.
All others.
*Configurable option.
1000DF00328 Issue 6
18/32
Configured Options
This menu comprises a list of options which are configurable by the user.
1. Turn the pump
OFF
.
2. Whilst holding down the b
button turn the pump
ON
.
3. The main display will show
000
. Enter the access code for Configured Options using the the digits. A full list of access codes can be found in the Technical Service Manual.
f
keys, pressing
NEXT
to move through
4. When the complete code shows on screen, press
OK
to enter. The Configured Options menu will be displayed.
General Options
1. Select from the menu using the f keys and press the
OK
softkey.
2. Select the option you wish to enable/disable or adjust and press the
MODIFY
softkey.
3. When all the desired modifications have been carried out press the
QUIT
softkey.
4. Either select the next configuration option from the menu or turn the pump
OFF
, returning it to operation as required.
NURSE CALL FITTED
NURSE CALL INVERT
RS232 SELECTED
NEOI WARNING
EOI POINT
KVO AT EOI
KVO RATE
BACK OFF
AUTO SAVE
RATE LOCK
QUIET MODE
AC FAIL
RATE TITRATION
PRESSURE DISPLAY
CAP PRESSURE
PRESSURE DEFAULT
CAP RATE
PURGE RATE
PURGE VOLUME LIMIT
PURGE SYRINGE
BOLUS
DEFAULT BOLUS
CAP BOLUS RATE
BOLUS VOL LIMIT
MANUAL BOLUS
CALL BACK TIME
VTBI CLEAR RATE
EVENT LOG DISPLAY
BATTERY ICON
AUDIO VOLUME
AUTO NIGHT MODE
Enables Nurse Call (hardware option).
When enabled, the nurse call output is inverted.
Sets the pump's communications to use RS232 (hardware option).
Sets the Near End Of Infusion warning time, as time left to End Of Infusion.
Sets the End Of Infusion point.
When enabled the pump will switch to running at the KVO rate when EOI is reached.
Sets the Keep Vein Open (KVO) rate at which the pump will operate if KVO at EOI is enabled.
When enabled the motor will reverse to relieve line pressure when an occlusion occurs.
When disabled the infusion information is cleared on power up.
When enabled the rate can be locked to prevent unwanted changes of the set infusion rate.
When enabled the button beeps are muted.
When enabled the AC Power Failure Alarm will sound if the AC power is disconnected.
When enabled the rate can be changed whilst the pump is infusing.
Enables / disables the Pressure Icon on the main display.
Sets the maximum pressure value.
Sets the default occlusion alarm level.
Sets the maximum value for infusion rate.
Sets the purge rate.
Sets the maximum permissible purge volume.
Prompt to purge syringe after confirmation.
Enables / disables the bolus feature.
Sets the default bolus rate.
Sets the maximum value for bolus rate.
Sets the maximum permissible bolus volume.
Volume infused will be increased if plunger is manually moved in and syringe remains confirmed.
Adjusts the time for the pump to sound the call back alarm.
Rate will be set to zero when VTBI has been set-up with stop as the end rate.
Enables / disables the event log.
Enables / disables the Battery Icon on the main display.
Sets the alarm volume of the pump at high, medium or low.
Backlight dims between hours 21:00 and 06:00.
1000DF00328 Issue 6
19/32
Configured Options (Continued)
Drug Set-up
This option is used to set up a list of drug names.
1. Select from the menu using the f
keys and press the
OK
softkey.
2. Select the required drug and press the
OK
softkey.
3. In order to use a drug it must be enabled. Press the
YES
softkey to enable the selected drug.
4. To add or change a drug name use the f
keys to scroll through the alphabet, pressing the next position. On completion press the
OK
softkey.
NEXT
to select a letter and move on to
5. When the set-up is complete turn the pump OFF, then return the pump into operation as required. Alternatively, select the next configuration option from the menu.
Clock Set
1. Select from the Configured Options menu using the f keys and press the
OK
softkey.
2. Use the f
keys to adjust the date displayed, pressing the
NEXT
softkey to access the next field.
3. When the correct time and date are displayed press the
OK
softkey to return to the Configured Options menu.
Hospital Name
This option allows the user to programme in the name of the hospital, ward or department. This will appear during the power-up display sequence.
1. Select
NAME
from the Configured Options menu using the f
keys and press the
OK
softkey.
2. Use the keys to adjust the character displayed, pressing
NEXT
to access the next position.
3. When the correct name is displayed press
OK
to return to the Configured Options menu.
Enable Syringes
This option is used to pre-configure the type and size of syringe permitted for use on the pump. Select all possible syringes which may be used and disable any that should not be used.
1. Select from the Configured Options menu using the f keys and press the
OK
softkey.
2. Use the f within the brand.
keys to scroll through the list of syringes, pressing
MODIFY
to enable/disable a syringe brand and individual models
3. When all modifications are complete press
QUIT
to return to the Configured Options menu.
Language
This option is used to set the language of messages shown on the pump display.
1. Select from the Configured Options menu using the f
keys and press the
OK
softkey.
2. Use the f
keys to select the language.
3. When the desired language has been selected press
SELECT
softkey to return to the Configured Options menu.
Contrast
This option is used to set the contrast on the pump display.
1. Select from the Configured Options menu using the f
keys and press the
OK
softkey.
2. Use the f
keys to select a contrast ratio value. The contrast of the display will change when scrolling through the numbers.
3. When the desired value has been reached press the
OK
softkey to return to the Configured Options menu.
1000DF00328 Issue 6
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Alaris™ GH Syringe Pump Configured Options Record
General Options
Enter the pump-specific information for your records on a copy of this page.
Option Range
Software Version
NURSE CALL FITTED
NURSE CALL INVERT
RS232 SELECTED
NEOI WARNING
EOI POINT
KVO AT EOI
KVO RATE
BACK OFF
AUTO SAVE
RATE LOCK
QUIET MODE
AC FAIL
RATE TITRATION
PRESSURE DISPLAY
CAP PRESSURE
PRESSURE DEFAULT
CAP RATE
PURGE RATE
PURGE VOLUME LIMIT
PURGE SYRINGE
BOLUS
DEFAULT BOLUS
CAP BOLUS RATE
BOLUS VOL LIMIT
MANUAL BOLUS
CALL BACK TIME
VTBI CLEAR RATE
EVENT LOG DISPLAY
BATTERY ICON
AUDIO VOLUME
AUTO NIGHT MODE
Default
1.5.10 and 2.0.0
1.9.x and
2.3.x and above
Disabled
Disabled
Disabled
1min
1.0%
Enabled
1.0ml/h
Disabled
Enabled
Disabled
Disabled
Enabled
Disabled
Disabled
L3
L10
L3
Max infusion rate 1200ml/h
200ml/h
2.0ml
200ml/h
2.0ml
Enabled
Max bolus rate
Disabled
Enabled
500ml/h
Max bolus rate
5.0ml
Disabled
Medium
Enabled
1200ml/h
5.0ml
Disabled
2mins
Disabled
Enabled
Enabled
Medium
Enabled
Disabled
Disabled
Disabled
5mins
1.0%
Enabled
1.0ml/h
Enabled
Enabled
Disabled
Disabled
Enabled
Disabled
Enabled
Enabled/Disabled
Enabled/Disabled
Enabled/Disabled
1min - 15mins
0.1% - 5% of syringe volume
Enabled/Disabled
0.1ml/h - 2.5ml/h
Enabled/Disabled
Enabled/Disabled
Enabled/Disabled
Enabled/Disabled
Enabled/Disabled
Enabled/Disabled
Enabled/Disabled
L0 - L10 (50mmHg - 1000mmHg)
L0 - L10 (50mmHg - 1000mmHg)
1.0ml/h - 1200ml/h
100ml/h - 500ml/h
0.5ml - 5.0ml
Enabled/Disabled
Enabled/Disabled
10ml/h - 1200ml/h
10ml/h - 1200ml/h
0.5ml (0.1ml)* - 25.0ml
Enabled/Disabled
0.1mins - 15mins
Enabled/Disabled
Enabled/Disabled
Enabled/Disabled
Low, medium, high
Enabled/Disabled
* For software versions 1.9.x and 2.3.x and above
Setting
Make
Hospital Name
Approved by
Date
Size(s)
1000DF00328 Issue 6
3
4
5
6
1
2
Serial No.
Configured by
Date
21/32
9
10
11
12
7
8
Software Version
Specifications
Infusion Specifications -
Maximum infusion rate can be set as part of the configuration.
0.1ml/h - 150ml/h 5ml syringes
0.1ml/h - 300ml/h
0.1ml/h - 600ml/h
0.1ml/h - 900ml/h
0.1ml/h - 1200ml/h
10ml syringes
20ml syringes
30ml syringes
50ml syringes
The Volume Infused range is 0.0ml - 9990ml.
Bolus Specifications -
Maximum Bolus rates can be set as part of the configuration. Bolus rates are user adjustable, in increments of 10ml/h.
10 ml/h - 150ml/h
10 ml/h - 300ml/h
10 ml/h - 600ml/h
5ml syringes
10ml syringes
20ml syringes
10 ml/h - 900ml/h
10 ml/h - 1200ml/h
30ml syringes
50ml syringes
The bolus volume limit can be set as part of the configuration.
Minimum: 0.5ml (0.1ml - v2.3.x and above or v1.9.x);
Maximum 25.0ml
Increments of 0.1ml; default 5.0ml
During BOLUS the pressure limit alarms are temporarily increased to their maximum level.
Critical Volume -
The bolus which can occur in the event of a single internal fault condition with a 50 ml syringe is :
Maximum Overinfusion - 0.87ml
Purge Specifications -
The purge rate is limited to the maximum rate for the syringe and can be set as part of the configuration.
100ml/h - 500ml/h.
The purge volume range is 0.5ml - 5ml.
During PURGE the pressure limit alarms are temporarily increased to their maximum level.
Keep Vein Open (KVO) Rate -
0.1 ml/h - 2.5ml/h.
End Of Syringe Rate -
Stop, KVO (0.1ml/h to 2.5ml/h), or set rate if lower than KVO.
Volume To Be Infused (VTBI) -
0.1ml - 100ml (0.1ml - 1000ml - v2.3.x and above or v1.9.x),
1min - 24h
VTBI Complete Rate -
Stop, KVO (0.1ml/h to 2.5ml/h), set rate if lower than KVO or continue at set rate.
Near End Of Infusion Alarm -
1min - 15min to end of infusion, or 10% of syringe volume, whichever is smaller.
End Of Infusion (EOI) Alarm -
0.1% - 5% of syringe volume
Electrical Classification -
Class I product. Continuous Mode Operation, Transportable
Maximum Pumping Pressure Limit -
Highest alarm level 1000mmHg (nominal at L-10)
Occlusion Accuracy (% of full scale)* -
Pressure mmHg
Temp.
23°C
L-0 L-3 L-5 L-10
approx. approx. approx. approx.
50 mmHg 300 mmHg 500 mmHg 1000 mmHg
±18% ±21% ±23% ±28%
System Accuracy -
Volumetric Mean +/- 2% (nominal).
Derating -
Temperature +/- 0.5% (5 - 40ºC)
High Rates +/-2.0% (rates > syringe volume/h eg.
>50ml/h in a 50ml syringe.)
Important: System accuracy is +/-2% typical by volume as measured using the trumpet curve test method defined in IEC/EN60601-2-24 at rates of 1.0ml/h (23ºC) and above when the pump is used with the recommended syringes. Caution: Infusion volume accuracy may be compromised at rates below 1.0ml/h. Differences in factors such as size and plunger force in compatible syringes can cause variations in accuracy and trumpet curves. See also trumpet curves section in this manual.
Battery Specifications -
Rechargeable sealed NiMH. Automatically charges when the pump is connected to AC power.
Mean Time To Battery Empty from fully charged @ 5ml/h and 20°C under normal conditions is 6 hours*
*95% lower confidence interval of 5 hours 50 minutes
Charging takes 2½ hours from discharge to 90% charge.
Memory Retention -
The electronic memory of the pump will be retained for more than 6 months when not powered up.
Fuse Type -
2 x T 1.25A, slow blowing.
AC Power Supply -
115 - 230VAC, 50 - 60Hz, 20VA (nominal).
Dimensions -
310 mm (w) x 121 mm (h) x 200 mm (d). Weight: 2.7 kg (excluding power cable).
Protection against fluid ingress -
IPX1 - Protected against vertically falling drops of water.
Alarm Conditions -
Drive Disengaged
Check Syringe
Near End Of Infusion
VTBI Done
Internal Malfunction
Titration not confirmed
Occlusion
Battery Low / Battery Empty
End of Infusion
AC Power Fail
Attention (Nurse Callback)
Environmental Specifications -
Operating Temperature
Operating Relative Humidity
+5°C - +40°C
20% - 90%
Operating Atmospheric Pressure
700hPa - 1060hPa
Transport and Storage Temperature
-30°C - +50°C
Transport and Storage Relative Humidity
Transport and Storage Atmospheric Pressure
Electrical/Mechanical Safety -
10% - 95%
500hPa - 1060hPa
Complies with IEC/EN60601-1 and IEC/EN60601-2-24.
EMC -
Complies with IEC/EN60601-1-2 and IEC/EN60601-2-24.
* - Using most common 50ml syringes under normal conditions
(95% confidence / 95% of pumps).
1000DF00328 Issue 6
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Recognised Syringes
The pump is calibrated and labelled for use with single-use disposable Luer lock syringes. Only use the size and type of syringe specified on the pump display. The full list of permitted syringe models is dependent on the software version of the pump.
IVAC®
AstraZeneca
B Braun Omnifix
B Braun Perfusor
BD Perfusor
BD Plastipak
BD Precise
Codan
Codan Perfusion
Fresenius Injectomat
Monoject**
Pentaferte
Rapiject*
Terumo
5ml
ü
ü
ü
ü
ü
10ml
ü
ü
ü
ü
ü
ü
ü
20ml
ü
ü
ü
ü
ü
ü
ü
ü
30ml
ü
ü
ü
ü
ü
ü
ü
ü
50ml
ü
ü
ü
ü
ü
ü
ü
ü
ü
ü ü
*
- The Rapiject 50ml syringe is a specialised syringe with a large diameter barrel. To provide protection against accidental dislodging always ensure the infusion line is secured using the infusion set hook - see Loading a Syringe section.
** - TYCO / Healthcare KENDALL - MONOJECT.
w
To minimise the risk of incorrect confirmation of the syringe type it is recommended that only syringe types available in the hospital are configured on the pump.
w
CareFusion has characterized a range of syringes as identified in the ‘Recognised Syringes’ table. CareFusion cannot guarantee the continued system accuracy of these recognised syringes* as the manufacturer may change syringe specification significant to system accuracy without prior notification.
Subject to the above, BD branded luer lock syringes can be confirmed as BD Plastipak syringes due to there being no significant variance in dimensions.
In no event shall CareFusion be liable for any damages of any kind or nature, including without limitation, direct or indirect, special, consequential, or incidental damages arising from, or in connection with the use of syringes not listed in the ‘Recognised Syringes’ table.
1000DF00328 Issue 6
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The Alaris™ DS Docking Station
Associated Products
The Alaris™ Gateway Workstation
1000DF00328 Issue 6
24/32
Compatible Extension Sets
The pump uses standard, single-use, disposable extension sets and syringes with Luer lock connectors. The user is responsible for verifying the suitability of a product used, if it is not recommended by CareFusion.
Standard Sets
G40015
Standard PVC Syringe Extension Set (150 cm).
Priming Volume: 2.6ml
G40020B
G402EP
Standard PVC Syringe Extension Set (200 cm).
Priming Volume: 1.5ml
Extension set, Luer lock connectors. Kink resistant DEHP free PVC yellow striped tubing. Bore 1mm. Length 200cm.
Priming volume 1.6ml.
Light Protected Sets
G40215
Amber PE Syringe Extension Set (150 cm).
Priming Volume: 1.2ml
G40320
White PVC Syringe Extension Set (200 cm).
Priming Volume: 3.6ml
Low Sorbing Sets
G40615
Polyethylene Syringe Extension Set (150 cm).
Priming Volume: 1.5ml
G40620
Polyethylene Syringe Extension Set (200 cm).
Priming Volume: 2ml
G40720
Polyethylene Lined Syringe Extension Set with clamp. (200 cm).
Priming Volume: 1.5ml
04105010509
Polyethylene Syringe Extension Set (100 cm).
Priming Volume: 1ml w
For availability please contact your local CareFusion, Alaris™ Product representative because new sets are continuously being developed for our customers.
It is recommended that extension sets are changed in accordance with the Directions for Use.
Carefully read the Directions For Use supplied with the extension set prior to use.
Please note these drawings are not to scale
1000DF00328 Issue 6
25/32
Compatible Extension Sets (Continued)
The pump uses standard, single-use, disposable extension sets and syringes with Luer lock connectors. The user is responsible for verifying the suitability of a product used, if it is not recommended by CareFusion.
Patient Controlled Analgesia (PCA) Sets
30822
PVC Syringe Extension Set with clamp (152 cm).
Priming Volume: 0.5ml
30832
PVC ‘Y’ Syringe Extension Set with back check valve and 2 clamps (178 cm).
Priming Volume: 1.5ml
30842E
PVC Syringe Extension Set with back check valve, SmartSite® Needle-Free Valve Port and clamp (30 cm).
Priming Volume: 1.4ml
30852
PVC ‘Y’ Syringe Extension Set with anti-siphon valve, back check valve and 2 clamps (183 cm).
Priming Volume: 1.8ml
30862
PVC Syringe Extension Set with anti-siphon valve and clamp (156 cm).
Priming Volume: 0.6ml
04102215162
PVC Syringe Extension Set with rotating luer. (150 cm).
Priming Volume: 2.9ml
04100010162
PVC Syringe Extension Set (105 cm).
Priming Volume: 7.2ml w
For availability please contact your local CareFusion, Alaris™ Product representative because new sets are continuously being developed for our customers.
It is recommended that extension sets are changed in accordance with the Directions for Use.
Carefully read the Directions For Use supplied with the extension set prior to use.
Please note these drawings are not to scale
1000DF00328 Issue 6
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Maintenance
Routine Maintenance Procedures
To ensure that this pump remains in good operating condition, it is important to keep it clean and carry out the routine maintenance procedures described below.
Interval
As per Hospital Policy
Each usage
Before the transfer of the pump to a new patient and as required
Routine Maintenance Procedure
Thoroughly clean external surfaces of the pump before and after prolonged period of storage.
1. Inspect AC power supply plug and cable for damage.
2. Inspect case, keypad and plunger for damage.
3. Check Start up self test operation is correct.
Clean the pump by wiping over with a lint-free cloth lightly dampened with warm water and a standard disinfectant / detergent solution. w w
If the pump is dropped, damaged, subjected to excessive moisture or high temperature, immediately take it out of service for examination by a qualified service engineer.
All preventative and corrective maintenance and all such activities shall be performed at a compliant work place in accordance with the information supplied. CareFusion will not be responsible should any of these actions be performed outside the instructions or information supplied by CareFusion. For Preventative and Corrective
Maintenance instructions please refer to the Technical Service Manual (TSM).
All servicing should only be performed by a qualified service engineer with reference to the TSM.
Please refer to Technical Service Manual for calibration procedures. The units of measurement used in the calibration procedure are standard SI (The International System of Units) units.
Battery Operation
The internal rechargeable battery allows continued operation when the AC power is unavailable, for example during patient transfer or AC power failure. Mean Time To Battery Empty from fully charged @ 5ml/h and 20°C under normal conditions is 6 hours*. From the battery low alarm it will take about 2½ hours to 90% charge when reconnected to the AC power supply, whether the pump is in use or not.
The battery is maintenance free, sealed Nickel Metal Hydride and requires no routine servicing. However, to achieve optimum operation, ensure that the battery is fully recharged after full discharge, before storage, and at regular 3 month intervals during storage.
It is recommended that only a qualified service engineer replaces the battery. For further information regarding the replacement of batteries refer to the Technical Service Manual.
The battery pack used in this Alaris™ Syringe Pump is manufactured by CareFusion and includes a proprietary PCB (printed circuit board) designed specifically for the Alaris™ Syringe Pump, and in conjunction with Alaris™ Syringe Pump software, controls battery use, charge and temperature. Any use of battery packs that are not manufactured by CareFusion in the Alaris™ Syringe Pump is at your sole risk, and
CareFusion does not provide any warranty for or endorsement on any battery packs that are not manufactured by CareFusion. CareFusion’s product warranty shall not apply in the event the Alaris™ Syringe Pump has suffered damage or premature wear, or malfunctions or otherwise operates incorrectly, as a result of use with a battery pack that is not manufactured by CareFusion.
*95% lower confidence interval of 5 hours 50 minutes
1000DF00328 Issue 6
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Maintenance (continued)
Cleaning and Storage
Before the transfer of the pump to a new patient and periodically during the use, clean the pump by wiping over with a lint-free cloth lightly dampened with warm water and a standard disinfectant / detergent solution.
Do not use the following disinfectant types:
• Disinfectants which are known to be corrosive to metals must not be used, these include:
• NaDcc (such as Presept),
• Hypochlorites (such as Chlorasol),
• Aldehydes (such as Cidex),
• Cationic Surfactants >1% (such as Benzalkonium Chloride),
• Mixture of Alcohol & Chemicals with Cationic surfactants >1% Chlorohydrocarbons (such as Amberclens).
• Use of Iodine (such as Betadine) will cause surface discoloration.
• Concentrated Isopropyl alcohol based cleaners will degrade plastic parts.
Recommended cleaners are:
Brand
Hibiscrub
Virkon
Concentration
20% (v/v)
1% (w/v)
The following products were tested and are acceptable for use on the Alaris Enteral Plus Syringe Pump if used in accordance with the specified manufacturer’s guidelines.
• Warm soapy water
• Mild detergent in water (e.g. Young’s Hospec)
• 40% Isopropyl Alcohol in water
• Chlor-Clean
• Clinell Universal Wipes
• Hibiscrub
• Tristel Fuse sachets
• Tristel Trio wipes system
• Tuffie 5 wipe
• Virkon Disinfectant w
Before cleaning always switch OFF and disconnect from the AC power supply. Never allow liquid to enter the casing and avoid excess fluid build up on the pump. Do not use aggressive cleaning agents as these may damage the exterior surface of the pump. Do not steam autoclave, ethylene oxide sterilise or immerse this pump in any fluid.
The syringe and extension sets are disposable single use items and should be discarded after use according to their manufacturers’ instructions.
If the pump is to be stored for an extended period it should be first cleaned and the internal battery fully charged. Store in a clean, dry atmosphere at room temperature and, if available, employ the original packaging for protection.
Once every 3 months during storage, carry out functional tests as described in the Technical Service Manual and ensure that the internal battery is fully charged.
Disposal
Information on Disposal for Users of Waste Electrical and Electronic Equipment
This U symbol on the product and/or accompanying documents means that used electrical and electronic products should not be mixed with household waste.
If you wish to discard electrical and electronic equipment, please contact your CareFusion affiliate office or distributor for further information.
Disposing of this product correctly will help to save valuable resources and prevent any potential negative effects on human health and the environment which could otherwise arise from inappropriate waste handling.
Information on Disposal in Countries outside the European Union
This symbol is only valid in the European Union. The product should be disposed of taking environmental factors into consideration. To ensure no risk or hazard, remove the internal rechargeable battery and the Nickel Metal Hydride battery from the control board and dispose of as outlined by the local country regulations. All other components can be safely disposed of as per local regulations.
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Occlusion Pressure Limits
Time to alarm following occlusion is achieved in less than 30 minutes at rates of 1 ml/h and higher by the appropriate selection of occlusion levels.
The following graphs show the typical values for time to alarm and bolus volume that can be expected in the event of an occlusion when the BD Plastipak 50 ml syringe is selected with a G40020B standard extension set.
Time to alarm - 1.0 ml/h
Time to alarm - 5.0 ml/h
typical typical
Occlusion Level
Bolus Volume without back off
typical
Occlusion Level
Bolus Volume with back off
typical
Occlusion Level
Occlusion Level
Tests at low alarm levels may alarm immediately - the force at these levels is commonly less than the friction in the syringe (with no additional fluid pressure). The result is that the pressure relating to the low forces will be less than the nominal quoted occlusion pressure.
Bolus volume following occlusion will be minimised by the back off feature if enabled. The back off will reduce the line pressure by removing the volume stored in the occluded line and deducting this volume from the volume infused.
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IrDA, RS232 and Nurse Call Specification
IrDA / RS232 / Nurse Call Feature
RS232 / Nurse Call Connection Data
The RS232 / Nurse call feature is an optional feature on Alaris™
Syringe Pumps. It allows the pump to be monitored remotely and/ or controlled via a suitable central monitoring or computer system.
When the pump is started by a command from the serial interface, communication must take place over the serial interface, a communication must take place every 15 seconds or the pump will alarm, display communications failure and stop infusing. This failure protects against failure of the communications, including the removal of the RS232 cable.
w
Baud Rate
Start Bits
Data Bits
Parity
Stop Bits
The nurse call interface provides a remote backup to the internal audible alarm. It should not be relied upon to replace monitoring of the internal alarm.
Refer to the Technical Service Manual for further information regarding the RS232 interface. Since it is possible to control the syringe pump using the RS232 interface at some distance from the pump and hence remote from the patient, responsibility for the control of the pump is vested in the software run on the computer control system.
The assessment for the suitability of any software used in the clinical environment to control or receive data from the pump lies with the user of the equipment. This software should include detection of the disconnection or other failure of the RS232 cable. The protocol is detailed in the Technical Service Manual and is for general information only.
Any connected analogue and digital components are required to meet IEC/EN60950 for data processing and IEC/EN60601 for medical devices. Anyone connecting additional devices to the signal input or output is a system configurator and responsible for meeting the requirements of the system standard IEC/
EN60601-1-1.
IrDA
38.4 kBaud
1 Start Bit
8 Data Bits
No Parity
1 stop bit
Nurse call Specification -
Connector
D Type - 9 Pin
TXD/RXD
EIA
TXD Output Voltage Range
Minimum: -5V (mark), +5V
(space)
Typical: -7V (mark), +7V (space) with 3kΩ load to ground
RXD Input Voltage Range
-30V - +30V max.
RXD Input Thresholds
Low: 0.6V minimum / High: 3.0V
maximum
RXD Input Resistance
3kΩ minimum
Enable
Active, Low:-7V to -12V
Active, High:+7V to +12V, powers up the isolated RS232
circuitry
Isolation Socket/Pump
Inactive: Floating/open circuit, allows isolated RS232 circuitry to power down.
Baud Rate
Start Bits
Data Bits
Parity
1.5kV (dc, or ac peak)
38.4 kBaud
1 Start Bit
8 Data Bits
No Parity
Stop Bits
1 stop bit
Nurse Call Relay Contacts
Pins 1, 8 + 9, 30V dc, 1A rating
Typical Connection Data -
1 Nurse call (Relay) Normally Closed (NC C)
2 Transmit Data (TXD) Output
3 Received Data (RXD) Input
4 Power Input (DSR)
5 Ground (GND)
6 Not used
7 Power Input (CTS)
8 Nurse call (Relay) Normally open (NC O)
9 Nurse call (Relay) Common (NC COM)
1000DF00328 Issue 6
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Trumpet Curves and Start-up Curves
In this pump, as with all infusion systems, the action of the pumping mechanism and variations in individual syringes cause short-term fluctuations in rate accuracy.
The following curves show typical performance of the system in two ways: 1) the delay in onset of fluid flow when infusion commences (start-up curves), and 2) the accuracy of fluid delivery over various time periods is measured (trumpet curves).
The start-up curves represent continuous flow versus operating time from the start of the infusion. They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity. Trumpet curves are derived from the second hour of this data. Tests performed per IEC/EN60601-2-24 standard.
Trumpet curves are named for their characteristic shape. They display discrete data averaged over particular time periods or 'observation windows', not continuous data versus operating time. Over long observation windows, short term fluctuations have little effect on accuracy as represented by the flat part of the curve. As the observation window is reduced, short term fluctuations have greater effects as represented by the "mouth" of the trumpet.
Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered. Short term fluctuations in rate accuracy may have clinical impact depending on the half-life of the drug being infused, therefore the clinical effect cannot be determined from the trumpet curves alone.
w
Start-up and trumpet curves may not be indicative of operation under negative pressure.
Differences in factors such as size and plunger force in compatible syringes produced by other manufacturers can cause variations in accuracy and trumpet curves as compared to those represented. Additional curves for compatible syringes are available upon written request.
For applications where flow uniformity is a concern, rates of 1.0 ml/h or above are recommended.
Start-up Trend. BD Plastipak 50ml @ 0.1ml/h
Trumpet Curve. BD Plastipak 50ml @ 0.1ml/h
Time (mins)
Start-up Trend. BD Plastipak 50 ml @ 1.0 ml/h
Observation Window (mins)
Trumpet Curve. BD Plastipak 50 ml @ 1.0 ml/h
Time (mins)
Start-up Trend. BD Plastipak 50 ml @ 5.0 ml/h
Observation Window (mins)
Trumpet Curve. BD Plastipak 50 ml @ 5.0 ml/h
Time (mins)
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Observation Window (mins)
Spare Parts
A comprehensive list of spare parts for this pump is included within the Technical Service Manual.
The Technical Service Manual (1000SM00001) is now available in electronic format on the World Wide Web at :-
www.carefusion.co.uk/alaris-technical/
A username and password are required to access our manuals. Please contact local customer services representative to obtain login details.
Part Number
1000SP01122
1001FAOPT91
1001FAOPT92
Description
Internal Battery Pack
AC Power Lead - UK
AC Power Lead - European
1000DF00328 Issue 6
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For service contact your local Affiliate Office or Distributor.
AE
CareFusion,
PO Box 5527,
Dubai, United Arab Emirates.
Tel: (971) 4 28 22 842
DE
CareFusion,
Tullastr. 8-12
69126 Heidelberg,
Deutschland.
Tel: (49) 6221 305 0
Fax: (971) 4 28 22 914
AU
CareFusion,
3/167 Prospect Highway,
PO Box 355
Seven Hills, NSW 2147,
Australia.
Tel: (61) 1800 833 372
Fax: (61) 1800 833 518
BE
CareFusion,
Erembodegem-Dorp 86
B-9320 Erembodegem
Belgium.
Tel: +32 (0) 2 267 38 99
Fax: +32 (0) 2 267 99 21
CA
CareFusion,
235 Shields Court,
Markham,
Ontario L3R 8V2,
Canada.
Tel: (1) 905-752-3333
Fax: (49) 6221 305 216
DK
CareFusion,
Firskovvej 25 B,
2800 Lyngby,
Danmark.
Service Contacts
Tlf. (45)70 20 30 74
Fax. (45)70 20 30 98
ES
CareFusion,
Edificio Veganova,
Avenida de La Vega, nº1,
Bloque 1 - Planta 1,
28108 Alcobendas, Madrid,
España.
Tel: (34) 902 555 660
Fax: (34) 902 555 661
FR
CareFusion,
Parc d’affaire le Val Saint Quentin
2, rue René Caudron
78960 Voisins le Bretonneux
France
Tél: (33) 01 30 02 81 41
HU
CareFusion,
Döbrentei tér 1,
H-1013 Budapest,
Magyarország.
Tel: (36) 1 488 0232
Tel: (36) 1 488 0233
Fax: (36) 1 201 5987
IT
CareFusion,
Via Ticino 4,
50019 Sesto Fiorentino,
Firenze, Italia.
Tél: (39) 055 30 33 93 00
Fax: (39) 055 34 00 24
NL
CareFusion,
De Molen 8-10,
3994 DB Houten,
Nederland.
Tel: +31 (0)30 2289 711
Fax: +31 (0)30 2289 713
NO
CareFusion,
Fjordveien 3
1363 HØVIK
Norge.
Tel: (47) 64 00 99 00
Fax: (1) 905-752-3343
CH
BD Switzerland,
Terre-Bonne Business Park ,
Building A4
Route de Crassier 17,
1262 Eysins
Switzerland
Phone: ++41 21 556 3000
Fax: (33) 01 30 02 81 31
FI
CareFusion,
Kuortaneenkatu 2,
00510 Helsinki
Tel: +358 207871 090
Fax : ++41 21 556 3099
CN
康尔福盛（上海）商贸有限公司
地址：上海市浦东新区张杨路
500号24楼E.F.G.H单元
电话： +86-21-60369369
400 878 8885
传真： +86-21-60369399
GB
BD,
1030 Winnersh Triangle,
Eskdale Road, Winnersh,
RG41 5TS
United Kingdom.
Tel: (44) 0800 917 8776
NZ
CareFusion,
14B George Bourke Drive,
Mt Wellington 1060,
PO Box 14-518,
Panmure 1741, Auckland,
New Zealand
Tel: 09 270 2420
Freephone: 0508 422734
Fax: 09 270 6285
PL
Becton Dickinson Polska Sp. z o.o.
ul. Osmańska 14
02-823 Warszawa
Polska.
Tel: (48) 22 377 11 00
Fax: (48) 22 377 11 01
PT
CareFusion,
Avda. São Miguel, 296 Atelier 14
2775-751 Carcavelos, Lisboa
Portugal
Tel: +351 219 152 593
Fax: +351 219 152 598
SE
CareFusion,
Marieviksgatan 25, Box 47204
117 43 Stockholm
Sverige
US
CareFusion,
10020 Pacific Mesa Blvd.,
San Diego, CA 92121,
USA.
Tel: (1) 800 854 7128
Fax: (1) 858 458 6179
ZA
CareFusion,
Unit 2 Oude Molen Business Park,
Oude Molen Road, Ndabeni,
Cape Town 7405, South Africa.
Tel: (27) (0) 860 597 572
Tel: (27) 21 510 7562
Fax: (27) 21 5107567
Rev. Q
1000DF00328 Issue 6
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Page Intentionally Left Blank
1000DF00328 Issue 6
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Alaris, Guardrails, SmartSite and IVAC are registered trademarks of CareFusion Corporation or one of its affiliates. All rights reserved.
All other trademarks are property of their respective owners.
© 2018 CareFusion Corporation or one of its affiliates. All rights reserved.
This document contains proprietary information of CareFusion Corporation or one of its affiliates, and its receipt or possession does not convey any rights to reproduce its contents, or to manufacture or sell any product described. Reproduction, disclosure, or use other than for the intended purpose without specific written authorization of
CareFusion Corporation or one of its affiliates is strictly forbidden.
t
CareFusion Switzerland 317 Sarl,
A-One Business Centre, Z.A Vers –La-
Pièce n° 10, CH-1180, Rolle
EC REP
CareFusion UK 305 Ltd., The Crescent,
Jays Close, Basingstoke, Hampshire,
RG22 4BS, UK
1000DF00328 Issue 6
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