Service Contacts ................................................................................... 48
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Alaris™ VP Plus Guardrails™ Volumetric Pump
Introduction
Introduction
The Alaris™ VP Plus Guardrails™ Volumetric Pump, hereinafter referred to as the Pump, is a volumetric infusion Pump that provides
accurate and reliable infusions over a range of rates. The Pump has enhanced pressure monitoring capability allowing the clinician to
monitor patient specific in-line pressure changes with high precision.
The Pump includes Guardrails Software and is supplied with a default data set installed. The default data set allows the Pump to be used
in ml/h and dosing only. There are no drug or fluid names loaded in the default data set, so there are no related Guardrails Software
safety limits available. The Alaris Editor software can be used to create a data set to include drugs or fluids, with the related Guardrails
Software limits.
The Alaris Editor Software, available separately as a product or a service, permits the user to create up to 100 standardized drug
protocols for up to 30 clinical areas (profiles). Guardrails Software allows the user to program soft and hard safety limits for each drug.
Soft limits can be overridden at the bedside by the clinician and provide clinical flexibility in patient medication delivery. Hard limits
cannot be overridden helping to prevent clinically significant medication errors. See the Alaris Editor Software help files for further
details for creating, managing and transferring Guardrails Software data sets.
Intended Purpose
The Alaris VP Plus Guardrails Volumetric Pump is intended for use by clinical staff for the purpose of controlling infusion rate and
volume.
Conditions for Use
The Alaris VP Plus Guardrails Volumetric Pump should only be operated by clinical staff competent in the use of automated volumetric
pumps and in the management of infusion therapy. Clinical staff should determine the suitability of the device in their care area for its
intended purpose. References to user within this manual are intended to be restricted to trained clinical staff experienced with infusion
practices.
Indications
The Alaris VP Plus Guardrails Volumetric Pump is indicated for the infusion of fluids, medications, parenteral nutrition, blood and blood
products through clinically acceptable routes of administration; such as intravenous (IV), subcutaneous or irrigation of fluid spaces. The
Alaris VP Plus Guardrails Volumetric Pump is indicated for use on adults, paediatrics and neonates.
Contraindications
The Alaris VP Plus Guardrails Volumetric Pump is contraindicated for:
• Enteral therapies
• Epidural therapies
About This Manual
The user must be thoroughly familiar with the 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. The complete range of settings and values are detailed in the 'specifications
section'.
It is important to ensure that you only refer to the most recent version of the Directions for Use and Technical Service
A
Conventions Used in This Manual
BOLDUsed for Display names, software commands, controls and indicators referenced in this manual, for
'Single quotes'Used to indicate cross-references made to another section of this manual.
ItalicsUsed to refer to other documents or manuals and also used for emphasis.
A
Manual for your CareFusion products. These documents are referenced on www.carefusion.com. Copies can be
obtained by contacting your local CareFusion representative.
example, Battery Indicator, PURGE, ON/OFF button.
Important Information: Wherever this symbol is shown an Important note is found. These notes highlight
an aspect of use that is important for the user to be aware of when operating the Pump.
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Features of the Pump
Alert indicator
Display
Alaris™ VP Plus Guardrails™ Volumetric Pump
Features of the Pump
Door
Softkeys
Chevrons
Run
Prime/Bolus
Hold
Options
AC power indicator
Release lever for rotating
cam
Rotating cam to lock onto
horizontal rectangular
bars
Mute
Pressure
Battery indicator
On/Off
Door Lever
Handle
Flow sensor
interface
RS232/Nursecall
connector (cover
removed for
clarity)
Folded pole
clamp
Mains fuses cover
Mains inlet
IR communications port
Potential Equalisation
(PE) Connector
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interface (MDI)
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Controls and Indicators
Controls
SymbolDescription
ON/OFF button - Press once to switch the Pump on. Press and hold down for approximately three
a
seconds to switch the Pump off.
Alaris™ VP Plus Guardrails™ Volumetric Pump
Controls and Indicators
b
h
c
i
d
RUN button - Press to start the infusion. The green LED will flash during infusion.
HOLD button - Press to put the infusion on hold. The amber LED will be lit while on hold.
MUTE button - Press to silence active alarm, warning or prompt for approximately 2 minutes. The
audio from the active alarm, warning or prompt will continue to sound every 2 minutes until the
condition has been resolved. To silence the active audio for an extended interval of 15 minutes; press
CANCEL, then press and hold the MUTE button until 3 rapid beeps are heard. Once the 15 minute
interval has timed out the mute interval returns to 2 minutes.
PRIME/BOLUS button - Press to access PRIME or BOLUS softkey. Press and hold down softkey to
operate.
PRIME - primes the infusion set with fluid when setting up an infusion for the first time.
• Pump is on hold.
• Infusion set is not connected to a patient.
• Volume infused (VI) is not added to the total volume infused displayed.
BOLUS - delivers fluid or drug at an accelerated rate.
• Pump is infusing.
• Infusion set is connected to patient.
• Volume infused (VI) is added to the total volume infused displayed.
OPTION button - Press to access optional features.
PRESSURE button - Use this button to display the line pressure, trend display, and adjust the
e
downstream occlusion alarm limit.
CHEVRON keys - Double or single for faster/slower increase/decrease of values shown on display.
f
g
BLANK SOFTKEYS - Use in conjunction with the prompts shown on the display.
Indicators
SymbolDescription
AC POWER indicator - When illuminated the Pump is connected to an AC power supply and the
S
j
battery is being charged.
BATTERY indicator - When illuminated the Pump is running on the internal battery. When flashing,
the remaining battery run time is limited.
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Symbol Definitions
Labelling Symbols
SymbolDescription
Caution: If a tool is required to remove a cover then this should be performed by qualified service
w
personnel only.
Consult accompanying documents
Alaris™ VP Plus Guardrails™ Volumetric Pump
Symbol Definitions
x
l
IPX3
r
V
s
T
t
Potential Equalisation (PE) Connector
RS232/Nursecall Connector
Defibrillation-proof type CF applied part (Degree of protection against electrical shock)
Protected against direct sprays up to 60° from the vertical
Alternating Current
Observe Electrostatic Discharge (ESD) precautions
Device complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC
Date of Manufacture
Manufacturer
U
W
EC REP
Connector for Flow Sensor
Not for Municipal Waste
Fuse rating
Authorised representative in the European Community
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Main Display Features
Main Display
Alaris™ VP Plus Guardrails™ Volumetric Pump
Main Display Features
Infusion Status/Drug Name/
Profile Name/Primary or
Secondary
Infusion Rate
Dose Rate
Volume to be Infused
Volume Infused
Time remaining
Softkey Identifiers
Softkeys
Screen Icons
SymbolDescription
Time icon - Indicates time remaining before VTBI will be completed. If the time is greater than 24 hours then 24+
will be displayed. Also indicates pressure sample time on the Pressure Trend screen.
N
Battery icon - Indicates battery charge level to highlight when the battery will require recharging.
NORADrenaline
RATE
VTBI
VOLUME
1 h 48 m 00 s
VOLUME
Clear Volume Infused
25.0
1.2
45.0
50.0
VTBI
Set VTBI Option
ml/h
mcg/kg/min
ml
ml
mmHg
28
60
Line Pressure
Downstream Occlusion
Alarm Limit
?
Line Pressure icon - Shows the current in-line pressure value in mmHg.
Downstream Occlusion Alarm Limit icon - Shows the downstream occlusion alarm limit in mmHg.
Indicates that the value entered is outside of the Guardrails soft limits. When the warning is overridden this
indicates Guardrails safety protocols are in use.
Indicates that the value entered is outside of the Guardrails hard limits. This warning cannot be overridden. This
!
symbol is also used to prompt the user to set the rate.
Indicates that the Pump is running at a rate below a Guardrails soft limit.
Indicates that the Pump is running at a rate above a Guardrails soft limit.
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Operating Precautions
Infusion Sets
• To ensure correct and accurate operation, only use CareFusion single use infusion sets described in this
Directions For Use.
• It is recommended that infusion sets are changed according to the instructions in the 'Changing the
Infusion Set' section. Always read the Directions For Use supplied with the infusion set prior to use.
• Use of non-specified infusion sets may impair the operation of the Pump and the accuracy of the infusion.
• When combining several apparatus and/or instruments with infusion sets and other tubing, for example
via a 3-way tap or multiple infusion, the performance of the Pump may be affected and should be
monitored closely.
• Uncontrolled flow may result if the infusion set is not properly isolated from the patient, i.e. closing a tap
in the set or activating an in-line clamp/roller clamp.
• CareFusion infusion sets are fitted with an in-line clamp, which can be used to occlude tubing in case it is
required to stop fluid flow.
• The Pump is a positive pressure Pump, which should use infusion sets fitted with Luer lock fittings or
equivalent locking connectors.
• To infuse from a burette, close the roller clamp above the burette and open the clamp on the vent on top
of the burette.
• Discard infusion set if the packaging is not intact or the protector cap is detached. Ensure sets are not
kinked as this may occlude the tubing.
Using Collapsible Bags, Glass Bottles and Semi Rigid Containers
• It is recommended that the air vent be opened on the Pump sets if using glass bottles or semi-rigid
containers, to reduce the partial vacuum formed as the fluid is infused from the container. This action will
ensure the Pump can maintain volumetric accuracy while the container empties. The action of opening
the air vent for semi-rigid containers should take place after the spiking of the container and priming of
the drip chamber.
Steps for the Collapsible Bags
• Follow steps 1 to 3 as shown for the semirigid containers, however do not open vent
as in step 4, but prime the set as per step 5.
Ensure the bag outlet is fully pierced before
filling the drip chamber.
Alaris™ VP Plus Guardrails™ Volumetric Pump
Operating Precautions
Steps for Semi-rigid Containers
3.
Fill drip
2.
Spike the
container
1.
Close the
roller clamp
chamber to
approximately
half full
5.
Prime the set, see
'Loading an Infusion
Set' section.
4.
Open the air vent
to allow pressure
equalisation - ready
for infusion
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 fluid channels of such pumps. Typical examples of those pumps are used
during dialysis, bypass or cardiac assist applications.
• The Pump is suitable for use in all establishments, including domestic establishments and those directly
connected to the public low voltage power supply network that supplies buildings used for domestic
purposes.
• This Pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or
oxygen or nitrous oxide.
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^
M
d
Alaris™ VP Plus Guardrails™ Volumetric Pump
Operating Precautions
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. The user must be within proximity to the pump so that they have the ability to
recognize when the Pump is in an alarm state.
• At power-up, the Pump will activate both the alert indicator and the audio alert function. A Pump that
does not activate both must not be used and should be sent to qualified service personnel.
• Should any alarm condition persist after all appropriate mitigations, it is recommended to replace that
particular Pump and quarantine the Pump for the attention of qualified service personnel.
Mounting the Pump
• The most accurate pressure monitoring in the infusion set is achieved when the Pump is positioned close
to the patient's heart level.
• Do not mount the Pump in a horizontal position or with the AC power inlet pointing upwards as this could
affect electrical safety in the event of a fluid spill.
Electromagnetic Compatibility and Interference
• Therapeutic Radiation Equipment: Do not use the Pump in the vicinity of any Therapeutic Radiation
Equipment, such as Linear Accelerators. Levels of radiation generated by Therapeutic Radiation Equipment
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 fields generated by MRI devices, therefore the Pump is not an MRI compatible
Pump. 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 B 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. Nevertheless, this Pump emits electromagnetic
radiation which is within the levels specified by IEC/EN60601-2-24 and IEC/EN60601-1-2. If the Pump
interacts with other equipment, measures should be taken to minimise the effects, for instance by
repositioning or relocation.
Earth Conductor
• The Pump is a Class I device, therefore must be earthed when connected to an AC power supply.
• 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 on the AC power cable has been compromised, the
Pump should be disconnected from the AC power source and operated utilising the internal battery.
• This Pump also has an internal power source.
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m
V
Alaris™ VP Plus Guardrails™ Volumetric Pump
Operating Precautions
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.
• Dangerous Voltage: An electrical shock hazard exists if the Pump’s casing is opened or removed. Refer all
servicing to qualified service personnel.
• 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 qualified service
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 qualified service
personnel. 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.
• If this Pump behaves abnormally, remove from service and contact qualified service personnel.
• Care should be taken to ensure power cables and RS232 cables do not present a trip hazard.
• Care should be taken in the placement of power cables and RS232 cables to prevent accidental tugging.
• Warning: Alaris VP Plus Guardrails Volumetric Pumps should not be modified or altered in any way, except
where explicitly directed or authorised by CareFusion. Any use of Alaris VP Plus Guardrails Volumetric
Pumps which have been altered or modified otherwise than in strict application of directions provided
by CareFusion, is at your sole risk, and CareFusion does not provide any warranty for or endorsement
on any Alaris VP Plus Guardrails Volumetric Pump that has been so modified or altered. CareFusion’s
product warranty shall not apply in the event the Alaris VP Plus Guardrails Volumetric Pump has suffered
damage or premature wear, or malfunctions or otherwise operates incorrectly, as a result of unauthorised
modification or alteration of the Alaris VP Plus Guardrails Volumetric Pump.
• Restarting an Infusion following an Air-in-Line Alarm
The Pump may be restarted by opening the door, assessing and removing any air from the tubing guide
area and in the infusion set on the patient side of the Pump, if required, according to hospital policy. Close
the door and cancel the air-in-line alarm. Restarting the infusion will reactivate the air-in-line system and
will alarm if the preset air-in-line limit is exceeded.
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Alaris™ VP Plus Guardrails™ Volumetric Pump
Getting Started
Getting Started
Before operating the Pump read this Directions For Use (DFU) manual carefully.
A
Initial Set Up
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 :
• Alaris VP Plus Guardrails Volumetric Pump
• Directions For Use (CD)
• AC Power Cable (as requested)
• 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
lit.
• A default data set is already installed in the Pump. The Alaris Editor software can be used to create an approved
A
data set that can be uploaded into the Pump.
• The Pump will automatically operate from its internal battery if the Pump is switched on without being connected
to the power supply.
• Should the Pump fail to perform correctly, replace it in its original protective packaging, where possible and
contact qualified service personnel for investigation.
S is
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Alaris™ VP Plus Guardrails™ Volumetric Pump
Getting Started
Pole Clamp Installation
The pole clamp is fitted to the rear of the Pump and will provide secure fixing to vertical IV poles of a diameter between 15 and 40mm.
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.
Never mount the Pump such that the IV infusion stand
A
becomes top heavy or unstable.
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.
Recessed area
*
*
Docking Station/Workstation* or Equipment Rail Installation
The rotating cam can be fitted to the rectangular bar on the Docking Station/Workstation* or equipment rails measuring 10mm by
25mm.
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. Push the Pump firmly onto the rectangular bar or
equipment rail.
3. The Pump should click into position when fitted to the
bar.
4. Ensure that the Pump is positioned securely. Verify Pump
is secure by gently pulling the Pump away from the
Docking Station/Workstation* without using the release
lever. When the Pump is securely attached, it should not
come off the Docking Station/Workstation*.
5. To release, push the release lever and pull the Pump
forwards.
Rectangular bar
Release lever (push
to release)
Rotating cam
Warning: Pump may fall off the Docking Station/Workstation* if not properly mounted which could result in user and/or
patient harm.
* Alaris DS Docking Station and Alaris Gateway Workstation.
It is recommended that infusion bags be located on a hanger directly above the Pump with which they are being
A
used. This minimises the potential for confusion of infusion sets when multiple volumetric pumps are used.
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Alaris™ VP Plus Guardrails™ Volumetric Pump
The Alaris Safety Clamp*
Safety Clamp in Occluded Position:Safety Clamp in Non-occluded Position:
After the infusion set is loaded into the Pump, opening the
door activates door hooks which will pull the Safety Clamp
Slider out, as shown:
Pressure Disc
When a new infusion set is removed from packaging the Safety
Clamp will be in this position**:
Getting Started
Safety Clamp Frame
Safety Clamp Tab
Safety Clamp
Slider
No Flow
Manually Operating the Safety Clamp:
To move the slider into the non-occluded position manually,
push up Safety Clamp Tab and push Safety Clamp Slider
completely into Safety Clamp Frame:
No Flow
Clamp Is In
Occluded Position
Flow
A
Clamp In Non-occluded
Position
Flow
1. Push up
Æ
2. Push
Ê
Pushing the Safety Clamp Slider completely into Safety Clamp Frame may lead to uncontrolled flow to the patient.
A
* Hereinafter referred to as Safety Clamp.
** This is necessary to avoid tube damage during storage and to ensure correct sterilisation and allows immediate priming.
Therefore, always close the roller clamp before pushing in the Safety Clamp Slider, if required.
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