Page 1
Alaris™ GP (Guardrails™)
Directions For Use
en
Volumetric Pump
(with Plus Software)
Models: 9002TIG03, 9002TIG03-G
Page 2
Alaris™ GP (Guardrails™) Volumetric Pump
Contents
Introduction ..............................................................................................4
Intended Purpose ......................................................................................4
Conditions for Use .....................................................................................4
Indications ............................................................................................4
Contraindications ......................................................................................4
About This Manual ........................................................................................4
Conventions used in this manual .......................................................................4
Creating a Data Set ........................................................................................5
Features of the Volumetric Pump ..........................................................................6
Controls and Indicators ...................................................................................7
Controls: ...............................................................................................7
Indicators: .............................................................................................7
Symbol Definitions ........................................................................................8
Labelling Symbols: .....................................................................................8
Main Display Features ....................................................................................10
Main Display - If VTBI has not been set (flow sensor must be used) ......................................10
Main Display - If VTBI is set ............................................................................10
Screen Icons ..........................................................................................10
Operating Precautions ...................................................................................11
Infusion Sets ..........................................................................................11
Using Collapsible bags, Glass Bottles & Semi Rigid containers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Steps for the Collapsible bags .........................................................................11
Steps for Semi-rigid containers ........................................................................11
Operating Environment ...............................................................................11
Operating Pressure ...................................................................................12
Alarm Conditions .....................................................................................12
Electromagnetic Compatibility and Interference .......................................................12
Earth Conductor ......................................................................................12
Hazards ..............................................................................................13
Getting Started ..........................................................................................14
Initial Set Up ..........................................................................................14
Power Input ..........................................................................................14
Factory Default Data Set ..............................................................................14
Pole Clamp Installation ................................................................................15
Docking Station / Workstation* or Equipment Rail Installation ..........................................15
The Alaris™ Safety Clamp ..............................................................................16
Loading an Infusion Set ...............................................................................17
Starting the Infusion ..................................................................................20
Basic Features ............................................................................................21
Drugs and Dosing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Selecting the INFUSION SETUP ........................................................................21
ml/h ..................................................................................................21
Dosing Only ..........................................................................................21
Drugs ................................................................................................21
Clear Volume Infused .................................................................................22
Setting a VTBI ........................................................................................22
KVO (Keep Vein Open) Rate ...........................................................................22
Pressure ..............................................................................................23
Priming the Infusion Set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Page
BDDF00535 Issue 4
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Page 3
Alaris™ GP (Guardrails™) Volumetric Pump
Bolus Infusions .......................................................................................23
Bolus Mode - Disabled ................................................................................23
Bolus Mode Enabled - HANDSON and HANDS ON and HANDSFREE .....................................24
Rate Titration .........................................................................................24
Rate Lock (If enabled) .................................................................................25
Adjusting Existing Dosing or Protocol Infusions - Set By ml/h / Set by Doserate .........................25
Selecting the SET BY ml/h Option .....................................................................25
Selecting the SET BY DOSERATE Option ................................................................25
Dosing Summary .....................................................................................25
Add Drug (Only available when infusing) ..............................................................25
Infusion Setup ........................................................................................25
Primary Setup ........................................................................................26
Secondary Setup .....................................................................................26
Setting VTBI over Time ................................................................................26
Adjust Alarm Volume .................................................................................26
Event Log ............................................................................................26
Pump Details .........................................................................................26
Profile Filter (Only available on the Alaris™ GP Guardrails™ Volumetric Pump) ...........................26
Standby ..............................................................................................26
Changing the Infusion Set .............................................................................27
Changing the Fluid Container .........................................................................27
SmartSite™ Needle-Free System Instructions ...........................................................27
Secondary (Piggyback) Infusions ..........................................................................28
Setting up a secondary infusion .......................................................................28
Typical Secondary infusions ...........................................................................28
Service Configuration Mode ..............................................................................29
Alarm Presets .........................................................................................29
Configured Options ...................................................................................29
Date & Time ..........................................................................................29
Pump Reference ......................................................................................29
Language ............................................................................................29
Backlight & Contrast ..................................................................................30
Pump Configuration available via the Alaris™ Editor Software ..............................................30
Data Set Configuration Settings .......................................................................30
General Pump Configuration Settings .................................................................30
Large Volume Pump Configuration Settings ...........................................................31
Drug Library available via the Alaris™ Editor Software .....................................................32
Concentration Settings ...............................................................................32
Dose Rate Settings ....................................................................................32
Bolus Settings ........................................................................................32
Pressure Settings .....................................................................................32
Display of Units .......................................................................................32
Alarms ..................................................................................................33
ORIGINAL ALARMS ..........................................................................33
3RD EDITION ALARMS .......................................................................36
Prompts .................................................................................................39
Advisories ................................................................................................39
Restarting an Infusion following an Air-in-Line Alarm ......................................................40
Flow Sensor Operation (Optional) .........................................................................41
Infusion Sets .............................................................................................42
Associated Products ......................................................................................45
The Alaris™ Gateway Workstation ......................................................................45
The Alaris™ DS Docking Station. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
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Alaris™ GP (Guardrails™) Volumetric Pump
Maintenance .............................................................................................46
Routine Maintenance Procedures .....................................................................46
Battery Operation .....................................................................................46
Cleaning and Storage ....................................................................................47
Cleaning the Pump ...................................................................................47
Cleaning the door ....................................................................................47
Cleaning and storing the infusion set ..................................................................47
Cleaning the Flow Sensor .............................................................................47
Storing the Pump .....................................................................................47
Disposal ..............................................................................................48
Specifications ............................................................................................49
Electrical Protection ..................................................................................49
Electrical/Mechanical Safety ...........................................................................49
Electro Magnetic Compatibility (EMC) .................................................................49
Electrical Safety .......................................................................................49
Classification .........................................................................................49
AC Power Supply .....................................................................................49
Fuse Type ............................................................................................49
Dimensions ..........................................................................................49
Protection against fluid ingress .......................................................................49
Environmental Specifications ..........................................................................49
Battery Specifications .................................................................................49
Memory Retention ...................................................................................50
Alarm Conditions .....................................................................................50
IrDA, RS232 and Nursecall Specification ...................................................................51
IrDA / RS232 / Nursecall Feature .......................................................................51
RS232 / Nursecall Connection Data ....................................................................51
IrDA ..................................................................................................51
Infusion Specifications ...................................................................................52
System Accuracy: .....................................................................................52
Occlusion Alarm Limits ................................................................................52
Maximum Pumping Pressure: ..................................................................52
Maximum Occlusion Alarm Pressure: ...........................................................52
Post Downstream Occlusion Bolus: ....................................................................52
Bolus Volume Accuracy: ..............................................................................52
Maximum time for activation of occlusion alarm: .......................................................52
Administering a Bolus .................................................................................52
Starting the Infusion / Set-up ..........................................................................52
Air Sensor: ............................................................................................53
Air in line detection: ..................................................................................53
Critical Volume .......................................................................................53
The Alaris™ Safety Clamp ..............................................................................53
Notes .................................................................................................53
Trumpet and Flow Rate Curves ...........................................................................54
Products and Spare Parts .................................................................................56
Spare Parts ...........................................................................................56
Alaris™ Editor Software ................................................................................56
Document History ........................................................................................56
BDDF00535 Issue 4
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Page 5
Alaris™ GP (Guardrails™) Volumetric Pump
Introduction
Introduction
The Alaris™ GP Volumetric Pump and Alaris™ GP Guardrails™™ Volumetric Pump (hereinafter referred to as 'Pump') are small lightweight
volumetric infusion pumps that provide accurate and reliable infusions over a range of rates.
The Alaris™ Editor software is a medical device accessory, which allows the hospital to develop a best-practice data set of IV medication
dosing guidelines for patient-specific care areas referred to as profiles. Each profile contains a specific library of drugs, as well as an
appropriate Pump configuration.
A profile also contains hard limits that cannot be overridden during infusion programming.
For the Alaris™ GP Guardrails™ Volumetric Pump only, Guardrails™ soft limits are available and can be overridden, based on clinical
requirements.
The Alaris™ GP Guardrails™ Volumetric Pump with a data set loaded, provides automatic alerts when a dosing limit, bolus limit,
concentration limit, or weight limit has been exceeded. These safety alerts are provided without the need for the Pump to be connected
to a PC or network.
The hospital defined data set is developed and approved through pharmacy and clinical input, and then transferred into the Pump by
Qualified Service Personnel.
Intended Purpose
The Alaris™ GP Volumetric Pump and Alaris™ GP Guardrails™ Volumetric Pump are intended for use by medical staff for the purpose of
controlling infusion rate and volume.
Conditions for Use
The Alaris™ GP Volumetric Pump and Alaris™ GP Guardrails™ Volumetric Pump should only be operated by medical staff competent in
the use of automated volumetric pumps and in the management of infusion therapy. Medical staff should determine the suitability of
the device in their care area for its intended purpose.
Indications
The Alaris™ GP Volumetric Pump and Alaris™ GP Guardrails™ Volumetric Pump are 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™ GP Volumetric Pump and Alaris™ GP Guardrails™ Volumetric Pump are indicated
for use on adults and paediatrics.
Contraindications
The Alaris™ GP Volumetric Pump and Alaris™ GP Guardrails™ Volumetric Pump are contraindicated for enteral or epidural therapies.
About This Manual
The user must be thoroughly familiar with the Pump described in this manual prior to use.
The Pump has minor functionality differences to the Alaris™ GH/CC Guardrails™ Syringe Pumps.
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.
Keep this Manual for future reference during the Pump’s operational life.
w
Conventions used in this manual
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 BD products. These documents are referenced on bd.com. Paper copies of the Directions For Use can
be obtained free of charge by contacting your local BD representative. An estimated delivery time will be provided
when the order is placed.
BOLD Used for Display names, software commands, controls and indicators referenced in this manual, for example,
Battery Indicator, PURGE, ON/OFF button.
'Single quotes' Used to indicate cross-references made to another section of this manual.
Italics Used to refer to other documents or manuals and also used for emphasis.
Warning symbol. A warning is a statement that alerts the user to the possibility of injury, death, or other serious
adverse reactions associated with the use or misuse of a Pump.
Caution symbol. A caution is a statement that alerts the user to the possibility of a problem with a Pump associated
with its use or misuse. Such problems may include Pump malfunction, Pump failure, damage to a Pump or damage
to other property. The caution statement includes the precaution(s) that should be taken to avoid the hazard.
BDDF00535 Issue 4
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Page 6
Alaris™ GP (Guardrails™) Volumetric Pump
Creating a Data Set
Creating a Data Set
To create a data set for the Pump, first the hospital will need to develop, review, approve, upload according to the following process.
Refer to the Alaris™ Editor help file for further details and operating precautions.
1. Create care area data set (Using the Alaris™ Editor)
Data Set There are two types of data set which can be created;
• Non-Guardrails™ Data Set - Creates a new Non-Guardrails™ data set for
the Alaris™ Infusion Pumps to be edited in the application.
• Guardrails™ Data Set - Creates a new Guardrails™ data set for the Alaris™
GP Guardrails™ Infusion Pumps to be edited in the application. A
Guardrails™ Data Set provides additional safety features.
Profile A unique set of configurations and best-practice guidelines for a specific
population, patient type or care area.
Each profile consists of: Pump Configuration / Drug Library
Up to 30 profiles can be defined for each Data Set for the Pump.
Pump Configuration Pump configuration settings and units for dosing only.
Drug Library Drug names and concentrations for a data set with default value and maximum
limits.
Up to 100 unique drug protocol set-ups.
2. Master List (Using the Alaris™ Editor)
Master Drug List A BD defined drug is a usability aid to pre populate drug names for the Master
Drug Lists. Alternate drug names and concentrations can be created.
3. Review, approve and export data set
Review and Approve Entire data set report to be printed, reviewed and signed as proof of approval
by an authorised person, according to hospital protocol. Signed printout to
be kept safe by hospital. Data set status to be set to Approved (Password is
required).
Export Export data set for use by the Alaris™ Transfer Tool or to back up a data set, or
to move the data set to another PC.
4. Upload data set to the Pump (Using Alaris™ Transfer Tool)
Note: One profile selection will be required when uploading the data set to the Alaris™ GP Volumetric Pump.
5. Verify that the correct data set is loaded into the Pump and accept it.
6. Switch the Pump off.
7. Switch the Pump on and verify that the software version screen displays the correct data set version. The Pump is now ready to
use.
Data set transfers should only be performed by Qualified Service Personnel.
w
The Pump serial number and the hospital name are stored in the event log, they can also be obtained via the PUMP
DETAILS option, refer to 'Pump Details' section.
Drug parameters have to be in accordance with local regulation and prescribed information.
It is recommended that prior to deploying a data set to all Alaris Compatible Guardrails Volumetric Pumps via Alaris
Communication Engine (ACE), the Guardrails data set should be deployed, to a sample of pumps on a fully loaded
AGW, in a non-clinical environment, and the pumps checked to ensure the settings and the drug library available on
the pump are the same as included in the approved data set report.
After data set deployment using ACE, if a pump is found to have a corrupted data set, the specific pump, and Alaris
Gateway Workstation (AGW) should be removed from service, and the data set transferred using a RS232 cable. The
AGW should be checked by qualified service personnel.
BDDF00535 Issue 4
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Page 7
Features of the Volumetric Pump
Alarm indicator
Display
Alaris™ GP (Guardrails™) Volumetric Pump
Features of the Volumetric Pump
®
Alaris®
Alaris
Guardrails®
®
Guardrails
GP
plus
GP
Door
Softkeys
Chevrons
Run
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
connector
RS232/Nursecall
connector (cover
removed for
clarity)
Folded pole
clamp
Mains fuses cover
Mains inlet
IR communications port
Potential Equalisation
(PE) Connector
BDDF00535 Issue 4
Medical device
interface (MDI)
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Page 8
Controls and Indicators
Controls:
Symbol Description
ON/OFF button - Press once to switch the Pump on. Press and hold down for approximately three
seconds to switch the Pump off.
a
Note: Logs are maintained for power down events including when the Pump is powered down
or unexpected power loss.
Alaris™ GP (Guardrails™) Volumetric Pump
Controls and Indicators
b
h
R
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 alarm for two minutes. The alarm will resound after this time. To re-
enable the alarm audio press the MUTE button a second time.
Note: Attention alarm only: when not in alarm press and hold until four audible beeps are heard
to extend the silence period to 15 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 - fluid or drug delivered 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.
e
PRESSURE button - Use this button to display the pumping pressure and adjust the alarm limit.
f
CHEVRON keys - Double or single for faster / slower increase / decrease of values shown on display.
g
BLANK SOFTKEYS - Use in conjunction with the prompts shown on the display.
Indicators:
Symbol Description
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 battery power is low with less than 30 minutes of use remaining.
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Page 9
Symbol Definitions
-20 C
Labelling Symbols:
Symbol Description
Attention (Consult accompanying document)
Alaris™ GP (Guardrails™) Volumetric Pump
Symbol Definitions
x
l
IP33
r
T
t
Potential Equalisation (PE) Connector
RS232/Nursecall Connector.
Defibrillation-proof type CF applied part (Degree of protection against electrical shock).
Protected from solid objects greater than 2.5mm.
Protected against direct sprays up to 60° from the vertical.
Alternating Current
Device complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC.
Date of Manufacture
Manufacturer
Connector for Flow Sensor
0°C
15%
50 kPa
U
Not for Municipal Waste
Fuse rating
+40°C
Operating Temperature Limit
+50 C
Transport and Storage Temperature limit
95%
Transport and Storage Humidity limitation
106 kPa
Transport and Storage Atmospheric Pressure limitation
This Way Up
BDDF00535 Issue 4
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Page 10
Fragile
Keep Dry
Catalogue number
Serial Number
Medical device
Alaris™ GP (Guardrails™) Volumetric Pump
Symbol Definitions
BDDF00535 Issue 4
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Page 11
Main Display Features
ON HOLD
RATE
SET RATE WITH
ON HOLD
RATE
SET RATE WITH
ON HOLD
RATE
RATE TOO LOW
Main Display - If VTBI has not been set (flow sensor must be used)
Infusion Status /
Drug Name / Profile Name /
Primary or Secondary (Only if
secondary is enabled in the
data set)
Infusion Rate
Volume Infused
Softkey Identifiers
Softkeys
Clear Volume Infused
Main Display - If VTBI is set
Infusion Status / Drug Name
/ Profile Name / Primary or
Secondary (Only if secondary
is enabled in the data set)
Infusion Rate
Dose Rate
ON HOLD
RATE
50.0
VTBI
ml/h
ml
25.0
VOLUME
VOLUME
Set VTBI Option
ADRENALINE
RATE
25.0
16.7
ml/h
µg/kg/24h
Alaris™ GP (Guardrails™) Volumetric Pump
Main Display Features
a)
ON HOLD
SET RATE WITH
RATE
If the rate has not been set and is
showing at 0.0ml/h, then message a)
will be displayed.
b)
ON HOLD
RATE TOO LOW
RATE
If programmed rate is between 0.0ml/h
and 0.1ml/h exclusive in drug protocol,
message b) will be shown.
c)
ON HOLD
RATE TOO HIGH
RATE
If programmed rate is greater than the
Infusion Rate Max in drug protocol,
message c) will be shown.
Screen Icons
Symbol Description
Volume to be Infused
Volume Infused
Time remaining
Softkey Identifiers
N
?
!
VTBI
VOLUME
1h 48m 00s
VOLUME
Softkeys
Clear Volume Infused
Time remaining display icon - Indicates time remaining before VTBI will be completed. If the time is greater than
24 hours then 24+ will be displayed.
Battery icon - Indicates battery charge level to highlight when the battery will require recharging.
Pressure Information icon - Shows the pressure from level 0 being the first bar to level 8. Alarm limits: level 0 - 8.
Indicates that the value entered is outside of the Guardrails™ soft limits. The warning can be overridden (Indicates
Guardrails™ safety protocol is in use).
Indicates that the value entered is outside of the hard limits. The warning can NOT 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 (pointing down) a Guardrails™ Soft Limit.
Indicates that the Pump is running at a rate above (pointing up) a Guardrails™ Soft Limit.
45.0
50.0
VTBI
Set VTBI Option
ml
ml
BDDF00535 Issue 4
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Page 12
Operating Precautions
Infusion Sets
• To ensure correct and accurate operation, only use BD 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. Carefully 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.
• BD 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 & 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 whilst 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 semi-rigid
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™ GP (Guardrails™) Volumetric Pump
Operating Precautions
Steps for Semi-rigid containers
2.
Spike the
container
3.
Fill drip
chamber to
fill line
4.
Open the air vent
to allow pressure
equalisation - ready
for infusion
5.
1.
Close the
roller clamp
Prime the set by
opening / closing the
roller clamp
Operating Environment
• Intended environments include general wards, critical and intensive care, operating rooms, accident
and emergency rooms. The Pump may be used in an ambulance environment. Ensure that the Pump
is appropriately attached using the provided pole clamp. The Pump is designed to withstand possible
bumps and vibrations whilst being used in an ambulance, complying with the standard EN 1789. If the
Pump is dropped or experiences any severe physical disturbances, arrange a thorough inspection by
Qualified Service Personnel as soon as is practically possible. The Pump may also be used outside the
ambulance as long as the temperature is within the specified range as stated in the 'Specifications' section
and on the Pump label.
• 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 hospital and clinical environments other than domestic establishments
that have access to single phase AC power supply.
• This Pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or
oxygen or nitrous oxide.
BDDF00535 Issue 4
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Page 13
Alaris®
GP
M
MR
Alaris®
GP
Alaris™ GP (Guardrails™) Volumetric Pump
Operating Precautions
Operating Pressure
• The pumping pressure alarm system is not designed to provide protection against, or detection of
extravasation or tissuing, 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.
• Alarm tone settings are preserved in the case of a power loss, however some system faults will result in
loss of alarm settings. The new alarm tone settings will be stored when powering down from tech mode
after a change. The settings will be lost if a cold-start is performed, but should be saved for faults that
don't require a cold start.
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 BD
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 BD
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 BD 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 BD may result in increased emissions or decreased Pump
immunity.
• 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.
• 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. However, this Pump emits a certain level of
electromagnetic radiation which is within the levels specified by IEC/EN60601-2-24 and IEC/EN606011-2. 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.
d
• This Pump also has an internal power source.
• 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.
BDDF00535 Issue 4
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Page 14
V
Alaris®
GP
m
Alaris™ GP (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 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 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 leads and RS232 cables do not present a trip hazard.
• Care should be taken in the placement of power leads and RS232 cables to prevent accidental tugging.
• Alaris™ GP (Guardrails™) Volumetric Pump should not be modified or altered in any way, except where
explicitly directed or authorised by BD. Any use of Alaris™ GP (Guardrails™) Volumetric Pumps which have
been altered or modified otherwise than in strict application of directions provided by BD, is at your sole
risk, and BD does not provide any warranty for or endorsement on any Alaris™ GP (Guardrails™) Volumetric
Pump that has been so modified or altered. BD product warranty shall not apply in the event the Alaris™
GP (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™ GP (Guardrails™)
Volumetric Pump.
• All Pumps in a single care area should be configured with the same alarm tones to avoid User confusion
BDDF00535 Issue 4
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Page 15
Getting Started
Alaris™ GP (Guardrails™) Volumetric Pump
Getting Started
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Before operating the Pump read this Directions For Use (DFU) manual carefully.
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™ GP or Alaris™ GP Guardrails™ Volumetric Pump • Directions For Use (CD)
• AC Power Cable (as requested) • Protective Packaging
• Alaris™ Editor Software and/or Alaris™ Transfer Tool - per
hospital
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).
• The Alaris™ Editor software can be used to create an approved data set that can be uploaded into the Pump.
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However, a default data set is already installed in the Pump (See details below).
• 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 in its original protective packaging, where possible and contact
Qualified Service Personnel for investigation.
• Electronic Instructions For Use Insert
S is
Power Input
The Pump is powered from the AC supply through a standard IEC AC connector. When connected to the AC supply the AC Power
indicator is illuminated.
• To isolate the Pump from AC supply remove the AC connector from the source socket.
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• The Pump should be positioned to allow access for disconnecting the AC connector.
Factory Default Data Set
The Pump is supplied with the following factory default data set:
Parameter Factory Default Setting Default Units Enabled for Dosing Only:
AC Fail Warning Enabled µg/min
Audio Volume Medium µg/24h
Alarm Volume Adjustable Disabled mg/24h
Occlusion Alarm Pressure L5 unit/24h
Pressure Max L8 mmol/24h
Rate Titration Disabled ml/kg/min
Infusion Rate Max 1200ml/h ng/kg/h
Rate Lock Disabled µg/kg/min
Bolus Mode Hands-On Only µg/kg/h
Bolus Rate Default
Bolus Rate Max 1200ml/h mg/kg/h
Bolus Volume Max 5ml g/kg/min
Weight Default 1kg unit/kg/min
Weight Soft Min* 1kg mmol/kg/min
Weight Soft Max* 150kg mmol/kg/h
AIL Limit 100µl
Primary VTBI Max 9999ml
Secondary Infusion Disabled
500ml/h
mg/kg/min
• Refer to 'Display of Units' section of this DFU for configurable units.
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* Only available on the Alaris™ GP Guardrails™ Volumetric Pump.
• The default data set does not have drug related Guardrails™ limits. To set the limits use the Alaris™ Editor software.
Care should be taken when specifying the Guardrails™ limits.
BDDF00535 Issue 4
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Page 16
Alaris™ GP (Guardrails™) Volumetric Pump
Alar
is
®
GP
Getting Started
Pole Clamp Installation
Mount the Pump on the pole or Docking Station/Workstation as close to patient heart level as possible.
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Prior to each use, check the pole clamp:
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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
• 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.
*
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*
Never mount the Pump such that the I.V. infusion stand 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.
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. 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*.
4. To release, push the release lever and pull the Pump
forwards.
Rectangular bar Release lever (push
to release)
Rotating cam
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
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used. This minimises the potential for confusion of infusion sets when multiple volumetric pumps are used.
Pump can only be mounted on the horizontal section of the docking stations listed above.
BDDF00535 Issue 4
15/57
Page 17
Alaris™ GP (Guardrails™) Volumetric Pump
The Alaris™ Safety Clamp
Alaris™ Safety Clamp*: Safety Clamp In Non Occluded Position:
When a new infusion set is removed from packaging the Safety
Clamp will be in this position**:
Clamp in NON OCCLUDED
Safety Clamp Frame
Safety Clamp Tab
FLOW ENABLED
Safety Clamp
Slider
POSITION
Getting Started
Safety Clamp In Occluded Position: Manually Operating The Safety Clamp
After infusion set is loaded into the Pump, opening the door
activates door hooks which will pull the Safety Clamp slider
out, as shown:
Clamp is in OCCLUDED
POSITION
To move the slider into the non occluded position manually, push
up Safety Clamp Tab and push Safety Clamp Slider completely
into Frame:
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NO FLOW
1. Push up
Æ
2. Push
Ê
• Pushing on the Safety Clamp Slider enables full set flow to the patient. Therefore it is recommended to always
close the roller clamp as well.
• However, if gravity infusion is required, push up Safety Clamp Tab and push orange Safety Clamp Slider
completely into Frame to enable flow. The gravity infusion can be regulated using the roller clamp on the set.
* * Hereinafter referred to as to as 'Safety Clamp'.
** ** This is necessary to avoid tube damage during storage and to ensure correct sterilisation and allows immediate priming.
BDDF00535 Issue 4
16/57
Page 18
Alaris™ GP (Guardrails™) Volumetric Pump
Getting Started
Loading an Infusion Set
• Ensure the appropriate infusion set for the fluid / drug to be infused has been selected.
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Step Notes
1. Remove infusion set/burette from packaging, apply roller clamp,
ensure air vent(s) are closed/clamped.
2. Spike fluid container ensuring spike is fully inserted into the
container.
3. Fill the drip chamber to at least ½ full. • Do not overfill the drip chamber when using a flow
4. Prime infusion set slowly, inverting pumping segment. • Priming quickly causes turbulence resulting in air
5. Hang the fluid container at a minimum height of 45 cm from
the bottom of the Pump to the bottom of the fluid container.
Raise the fluid container higher than the minimum height when
possible, to minimise loops and kinks in the infusion set tubing.
• Follow the instructions supplied with the individual infusion set.
• Only use Alaris™ GP and Alaris™ GP Guardrails™ Volumetric Pump infusion sets, (refer to 'Infusion Sets' section
of the DFU)
• Position the fluid container to avoid spillage onto the Pump.
• Ensure that the tubing is inserted completely into the top set retainer through to the tubing guide avoiding any
slack.
• Do not pull or stretch the infusion set, when priming/loading/re-loading the infusion set.
• Mount the Pump on the pole or Docking Station/Workstation as close to patient heart level as possible.
• Opening the air vent too soon can wet the filter and
prevent flow
• Where possible the fluid in container should be at
room temperature
• Spike being fully inserted ensures the fluid path from
the container is fully open
sensor
• When using blood sets, fill the chamber to the top of
the filter
bubbles, which may lead to air in line alarms
• For burette, glass bottles and semi-rigid containers,
open air vent(s) after the infusion set has been primed
half full. Leave closed for collapsible containers.
BDDF00535 Issue 4
45cm
minimum
17/57
Page 19
Step Notes
6. Close roller clamp.
7. Open door and load infusion set as follows:
Alaris™ GP (Guardrails™) Volumetric Pump
Getting Started
• Ensure infusion set tubing above the Pump is as
straight as possible with no kinks
Top set retainer
(Blue)
Adaptor on
infusion set
(Blue)
Pumping
mechanism
i) Fit top adaptor of infusion set into top set retainer.
Top Set Retainer
ii) Insert Safety Clamp into retainer.
Safety Clamp
retainer (Orange)
Alaris™ Safety
Clamp (Orange)
Air-in-line sensor
Tubing guide
• Avoid any stretching of the silicone segment when
loading, priming and re-loading the infusion set
Pushing on the Safety Clamp Slider may lead
to uncontrolled flow to the patient. Therefore,
always close the roller clamp before pushing
on the safety clamp slider.
Safety Clamp
BDDF00535 Issue 4
18/57
Page 20
Step Notes
iii) Ensure infusion set is fully inserted into tubing guide and all air
is removed from the infusion set.
Tubing Guide
8. Close door and open roller clamp. Ensure no drops are
falling in the drip chamber.
9. Ensure all air is removed from the set.
10. Connect the infusion set to the patient access device.
Alaris™ GP (Guardrails™) Volumetric Pump
Getting Started
BDDF00535 Issue 4
19/57
Page 21
Alaris™ GP (Guardrails™) Volumetric Pump
PROFILE NAME
RATE 300ml/h
VTBI 46.5ml
VOLUME 3.5ml
YES
NO
CLEAR SETUP?
VIEW WITH
CLEAR SETUP?
PROFILE NAME
CONCENTRATION
0.50mg/50ml
=0.01mg/ml
RATE 150ml/h
=0.00mg/kg/min
VTBI 100ml
=1.00mg
YES
NO
VIEW WITH
CLEAR SETUP?
PROFILE NAME
PRIMARY SETUP
RATE 300 ml/h
VTBI 50.0 ml
SECONDARY SETUP
RATE 150 ml/h
VTBI 95.0 ml
YES
NO
VIEW WITH
SELECT
OK
ml/h
DOSING ONLY
DRUGS A B C D E
F G H I J
K L M N O
P Q R S T
U V W X Y Z
SELECT WITH
Getting Started
Starting the Infusion
When operating the Pump, Users should position themselves at a distance of approximately 0.5 metres from the
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display.
Prime and load the set (Refer to 'Priming the Infusion Set' and 'Loading an Infusion Set')
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1. Ensure the Pump is connected to an AC power supply (also operates from battery).
2. Connect flow sensor, if required (See 'Flow Sensor Operation' section).
3. Press the
The Pump will run a short self-test. Check two beeps are activated during this test.
Check the displayed date and time are correct. Check display shows the data set name and version number.
Note: The Pump starts up and displays previous settings.
4. CLEAR SETUP? - Selecting NO will retain all previous rate and volume settings, go to step 7. Selecting YES will automatically reset
the rate and volume settings to zero and the CONFIRM PROFILE? screen will be displayed.
• ml/h • Drug Protocol • Primary/Secondary
a key.
• Dosing Only • Drug Protocol
5. CONFIRM PROFILE? screen will show the data set name, version number and profile name:
a) Press YES softkey to confirm current profile and go to step 6.
b) Selecting NO will display the profile selection screen, select correct profile using
confirm. Confirm profile screen will display again, press YES softkey and SELECT screen will be displayed, go to step 6.
Note: The CONFIRM PROFILE screen is only shown if more than one profile (For Alaris™ GP Guardrails™ Volumetric Pump only) is
available in the data set. If a profile has been filtered, then the option to select ALL will be displayed in the profile selection
screen. Selecting ALL will show the filtered profiles (If enabled).
6. Select either ml/h, DOSING ONLY or DRUGS (A-Z) and press OK to confirm. Then follow the
prompts as required (Refer to 'Basic Features -Drugs and Dosing' section).
7. Clear VOLUME infused , if required (Refer to 'Clear Volume Infused' section, this is
recommended for a new patient or when a new infusion is set-up).
8. Enter VTBI (if required) by selecting VTBI softkey on main display. Set VTBI by using the
BAGS option and/or
'Setting VTBI over Time' section).
9. Enter or adjust the RATE (if necessary) using the
10. Press
Note: The green run LED will flash to show that the Pump is infusing.
If the infusion requires to be stopped immediately, the following actions may be applied:
• by pressing the h key (recommended action)
• by closing the roller clamp
• by opening the door
b key to start the infusion. INFUSING will be displayed.
f keys and press OK to confirm (Refer to 'Setting a VTBI' or
f keys and press OK softkey to
f keys.
BDDF00535 Issue 4
20/57
Page 22
Alaris™ GP (Guardrails™) Volumetric Pump
SELECT
OK QUIT
ml/h
DOSING ONLY
DRUGS A B C D E
F G H I J
K L M N O
P Q R S T
U V W X Y Z
SELECT WITH
SELECT
OK
ml/h
DOSING ONLY
DRUGS A B C D E
F G H I J
K L M N O
P Q R S T
U V W X Y Z
SELECT WITH
QUIT
SELECT
OK
ml/h
DOSING ONLY
DRUGS A B C D E
F G H I J
K L M N O
P Q R S T
U V W X Y Z
SELECT WITH
QUIT
Basic Features
Basic Features
Drugs and Dosing
The following options enable the Pump to be set-up for use with a specific drug protocol. Drugs are pre-configured in the Alaris™ Editor
to enable rapid selection of the drug protocol, dosing units and default rate. For increased security when using a configured drug,
maximum and minimum safety limits can be set for concentrations and dose rates via the Alaris™ Editor.
When adjusting an infusion using the dose rate, the display may not show any corresponding changes to the
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Selecting the INFUSION SETUP
1. Press the d button to first access the options menu.
2. Drugs and dosing set-up options are available by selecting INFUSION SETUP from the list using the
3. Select from the list of the options (ml/h, DOSING ONLY or DRUGS) as detailed below and press the OK softkey to confirm the
selection.
ml/h
infusion rate in ml/h. This does not affect the accuracy of the infusion.
f keys.
1. Select ml/h from the list using the f keys (if necessary).
2. Press OK to confirm.
3. Enter the ml/h rate as prompted on the display in the next screen.
Dosing Only
Drugs
1. Select DOSING ONLY from the list using the f keys.
2. Press OK to confirm.
3. Select the dosing units from the list using the
4. Enter DRUG AMOUNT using the
UNITS which will scroll through the units available. Press OK to confirm selection.
5. Use the
6. Enter WEIGHT
7. A summary of the DOSING ONLY information is displayed, to CONFIRM? all details shown
press OK. The BACK softkey may be used at any time to return to the previous screen.
1
Only displayed if weight based units are used.
2
Total Volume = Drug Volume + Diluent Volume i.e. Total Volume of fluid in the fluid container
after a drug is added.
1. Select the required DRUGS alphabetical row from the list using the f keys.
2. Press OK to confirm.
3. Select the drug from the displayed list using the
4. Enter DRUG AMOUNT using the
5. Use the
6. Enter WEIGHT
7. A summary of the DRUG information is displayed, to CONFIRM? all details shown press OK.
The BACK softkey may be used at any time to return to the previous screen.
fkeys to select the TOTAL VOLUME
1
using the fkeys, press OK to confirm.
fkeys to enter the TOTAL VOLUME
1
using the fkeys, press OK to confirm.
f keys and if units need to be changed, select
f keys, press OK to confirm selection.
fkeys, press OK to confirm.
2
, press OK to confirm.
fkeys, press OK to confirm.
2
, press OK to confirm.
1
Only displayed if weight based units are used.
2
Total Volume = Drug Volume + Diluent Volume i.e. Total Volume of fluid in the fluid container
after a drug is added.
BDDF00535 Issue 4
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Page 23
Clear Volume Infused
VOLUME
CLEAR
QUIT
374
ml
VOLUME INFUSED
VTBI
OK
BACK
SELECT WITH
1500ml
1000ml
500ml
250ml
200ml
100ml
50ml
0ml
(OFF)
KVO
RATE
VTBI
VOLUME
VOLUME VTBI
5
.0
ml/h
0
.0
ml
ml
2
.0
0 h 00 m 00 s
When a new drug or a new concentration has been setup and the previous volume infused has not been cleared,
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then the message DOSE INFUSED HAS BEEN CLEARED will be displayed.
Setting a VTBI
KVO (Keep Vein Open) Rate
Alaris™ GP (Guardrails™) Volumetric Pump
Basic Features
This option enables the volume infused to be cleared.
1. Press the VOLUME softkey on main display to show the clear VOLUME INFUSED option.
2. Press the CLEAR softkey to clear the volume infused. Press the QUIT softkey to retain the
volume.
This feature allows a specific volume to be infused to be set. The rate at the end (END RATE) of
this VTBI can also be set, selecting from STOP, KVO or CONTINUE for continuous infusion at the
set rate.
1. Using the
a) Press the VTBI softkey on main display to enter the volume to be infused screen.
b) Enter the volume to be infused using the
c) Select the END RATE using the
d) Press the OK softkey to confirm and exit the END RATE menu.
or
2. Using the BAGS softkey:
a) Press the VTBI softkey on main display to enter the volume to be infused screen.
b) Select the BAGS softkey, select the required bag volume using the
c) Press OK to confirm again, or adjust the VTBI using the
d) Select the END RATE using the
e) Press the OK softkey to confirm and exit the END RATE menu.
At the end of VTBI, the Pump will first display VTBI DONE/INFUSING KVO. Press CANCEL to
display KVO screen.
The Pump continues to infuse at a very low (Default) rate. KVO is used to keep the patients vein
open, in order to prevent blood clots and catheter occlusions.
Note: If the KVO rate (Default 5ml/h) is greater than the set infusion parameters then the
The Pump will beep every 5 seconds while in KVO mode.
f keys:
f keys and press OK to confirm.
f keys to scroll through the on-screen choices.
f keys and
press OK to confirm the selection.
f keys and press OK.
f keys to scroll through the on-screen choices.
Pump will continue to infuse at the set infusion rate. The KVO rate will flash on screen
to indicate this is not the usual infusion rate.
BDDF00535 Issue 4
22/57
Page 24
Pressure
PRIME
RATE
PRIME
QUIT
ml/h
VOLUME
HOLD KEY BELOW
ml
25.0
1
.8
PRESSURE
PUMPING PRESSURE
L1
ALARM LIMIT
L5
ADJUST WITH
OK
Priming the Infusion Set
• Ensure the infusion set is not connected to a patient before priming the set.
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• The prime rate and prime volume limit are configured in the data set via the Alaris™ Editor.
• The default prime rate is 500ml/h.
• The Pump will not prime if rate lock has been activated. During PRIME the pressure alarm limit is temporarily
increased to the maximum level (L8).
Alaris™ GP (Guardrails™) Volumetric Pump
Basic Features
To check and adjust the pressure level, press the e button. The display will change to show the
current pumping pressure level and the pressure alarm limit. The default pressure alarm limit can
be set via the Alaris™ Editor.
1. Press the
be indicated on the display.
2. Press OK to exit the screen.
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f keys to increase or decrease the alarm limit (L0 to L8). The new limit will
• Higher rates generate higher pumping pressures. To avoid nuisance alarms,
L0 and L1 levels should not be used for rates above 200ml/h.
• The interpretation of pressure readings and occlusion alarms are the
responsibility of the clinician depending on the specific application.
• Occlusion levels for the Pump are configured in the Alaris™ Editor by profile
and by drug.
The i button allows the delivery of a limited volume of fluid in order to prime the infusion set
prior to being connected to a patient.
1. Press
2. Load the infusion set. Refer to 'Loading an infusion set' section.
3. Follow the 'Starting the Infusion' section, but do not connect the infusion set to the patient
4. Open the roller clamp.
5. Press
6. Press and hold the (flashing) PRIME softkey until the fluid flows and the priming of the
7. When priming is complete release the PRIME softkey.
a key to switch the Pump on.
until the set has been primed.
i button to display the PRIME screen.
infusion set is complete. The volume used during priming will be displayed, but it is not
added to the volume infused.
Bolus Infusions
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 via the Alaris™ Editor to:
a) Bolus Mode - Disabled
b) Bolus Mode - Enabled
i) HANDSON only
ii) HANDSON and HANDSFREE
Bolus Mode - Disabled
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 Bolus cannot be administered if the feature is disabled for the selected data set or specific drug. During BOLUS
the pressure limit alarm is temporarily increased to the maximum level (L8).
BDDF00535 Issue 4
23/57
Page 25
Bolus Mode Enabled - HANDSON and HANDS ON and HANDSFREE
RATE
SET WITH
BOLUS
QUIT
VOLUME
HOLD KEY BELOW
0.
0
ml
80
ml/h
BOLUS
HANDSFREE?
YES
HANDSONQUIT
BOLUS MODE
TITRATE
RATE
PRESS TO CONFIRM
VTBI
VOLUME
QUIT
25
.0
ml/h
16.
7
µg/kg/24h
45
.0
ml
ml
50
.0
1 h 48 m 00 s
BOLUS Enabled - HANDSON Only
In HANDSON bolus, press and hold the (flashing) Bolus softkey to deliver the required bolus. The
bolus rate can be adjusted. The bolus volume is limited in the configuration via Alaris™ Editor.
1. During infusion press the
2. Use the
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
displayed.
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BOLUS Enabled - HANDSON and HANDSFREE
The HANDSFREE bolus is delivered with a single press of the (flashing) BOLUS softkey. Bolus rate
and bolus volume are at default values and can be changed. The default bolus volume is 0.1ml.
1. During infusion press the
2. Press the YES softkey to go to the HANDSFREE bolus screen or press HANDSON softkey to
go to the HANDSON bolus (see section above)
3. Use the
softkey to adjust the bolus delivery rate.
4. Press the flashing BOLUS softkey once to begin the delivery of the preset bolus. The display
will show the bolus being delivered by the bolus counting down and will revert to the main
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
on hold.
Note: If the bolus volume reaches the set bolus volume limit the bolus will stop and the
Note: Rate may be restricted by the Bolus Rate Max which is configured in the Alaris™
Note: If the BOLUS exceeds the soft (Alaris™ GP Guardrails™ Volumetric Pump only) or hard
Note: The bolus rate will be automatically set to the current infusion rate, when the default
Note: When more than one bolus is programmed without clearing the infusion setup, the
f keys to adjust the bolus rate if required.
If the volume to be infused (VTBI) is reached during a bolus, the VTBI complete
alarm will sound. Press R to silence the alarm or CANCEL to acknowledge the
alarm. See VTBI section for more details on VTBI operation.
When using infusion set 63280NY the maximum infusion rate is 150ml/h.
f keys to adjust the bolus DOSE if required. If necessary press the RAT E
Pump will revert to infuse at the set infusion rate and continue infusing.
Editor.
limits, a prompt will display.
bolus rate is lower than the current infusion rate. A bolus rate cannot be configured
lower than the current infusion rate.
bolus rate will be set to the previous bolus rate for all subsequent bolus infusions.
i button once to display the BOLUS MODE screen.
i button once to display the BOLUS MODE screen.
h button to stop the bolus delivery and place the Pump
Rate Titration
If Rate Titration is enabled (via the Alaris™ Editor) the infusion rate or dose rate (if available) can be
adjusted while infusing.
1. Select the new rate using the
CONFIRM> will flash on screen and the 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.
f keys. The message <TITRATE PRESSbTO
Alaris™ GP (Guardrails™) Volumetric Pump
Basic Features
If Rate Titration is disabled the rate can only be adjusted whilst ON HOLD:
1. Press the
2. Select the new rate using the
3. Press the
BDDF00535 Issue 4
h button to put the Pump ON HOLD.
f keys.
b button to start infusing at the new rate.
24/57
Page 26
Alaris™ GP (Guardrails™) Volumetric Pump
Basic Features
Rate Lock (If enabled)
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 to confirm. Press the NO softkey if the rate lock is not required.
When rate lock is enabled, the following are unavailable:
• Changing the infusion rate / titration
• Bolus / Prime
• Switching the Pump off
• VTBI over time infusions.
• Secondary infusions (if enabled)
To turn rate lock off:
1. Press the
2. Select UNLOCK RATE and press the OK softkey.
To turn rate lock on:
1. Press the
2. Select RATE LOCK and press the OK softkey.
Adjusting Existing Dosing or Protocol Infusions - Set By ml/h / Set by Doserate
To set doserate or flowrate in precise increments it may be necessary to switch between the rate adjust options SET BY DOSERATE and
SET BY ml/h. An arrow to the left of the rate display shows the rate changed when the
the infusion rate.
To set a doserate precisely the arrow must be pointing to the doserate (for example: mg/kg/h); the flowrate will be calculated from the
doserate.
To precisely set a flowrate the arrow must be pointing to flowrate (ml/h); the doserate will be calculated from the flowrate.
d button to access the options menu.
d button to access the options menu.
f keys are used to increase/decrease
Selecting the SET BY ml/h Option
1. Press the d button to access the options menu.
2. Select the SET BY ml/h option using the
flowrate option, the arrow on the display will automatically select the flowrate, the flowrate can be adjusted if necessary.
f keys and press the OK softkey indicated on the screen. This will select the set by
Selecting the SET BY DOSERATE Option
1. Press the d button to access the options menu.
2. Select the SET BY DOSERATE option using the
set by doserate option, the arrow on the display will automatically select the doserate, the doserate can be adjusted if necessary.
f keys and press the OK softkey indicated on the screen. This will select the
Dosing Summary
To review currently selected dosing information:
1. Press the
2. Select DOSING SUMMARY option using the
3. Review the information and then press the QUIT softkey.
d button to first access the options menu.
fkeys and press the OK softkey.
Add Drug (Only available when infusing)
1. Press the d button to access the options menu.
2. Select ADD DRUG option using the
3. Select from DRUGS (A-Z) from the displayed list using the
4. Select drug name using the
fkeys and press the OK softkey.
fkeys, press OK to confirm.
fkeys, press OK to confirm and then follow the on screen prompts as required.
Infusion Setup
To change the Infusion Setup, refer to 'Basic Features - Drugs and Dosing, Selecting the INFUSION SETUP' section.
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Alaris™ GP (Guardrails™) Volumetric Pump
Basic Features
Primary Setup
If a secondary infusion has already been setup (See 'Secondary (Piggyback) Infusions' section), then access to the primary infusion setup
is as follows:
1. Press
2. Press the
3. Select PRIMARY Setup and press the OK softkey to confirm. Make changes to the primary setup as necessary.
Secondary Setup
To setup a secondary infusion refer to 'Secondary (Piggyback) Infusions' section
Setting VTBI over Time
This option allows a specific VTBI and delivery time (Maximum of 24 hours) to be set. The rate necessary to deliver the required volume
within the specified time is calculated and displayed.
1. Stop the infusion. Press
2. Select the SET VTBI OVER TIME option using the
3. Adjust the volume to be infused using the
4. Enter the time over which the volume is to be infused using the
5. Press OK softkey to enter the value or BACK to return to the VTBI.
Adjust Alarm Volume
This option allows adjustment of the volume if enabled.
1. Press the
2. Select ADJUST ALARM VOLUME using the fkeys and press OK softkey to confirm.
3. Select HIGH, MEDIUM or LOW using the fkeys.
4. Press OK softkey to confirm or QUIT to exit screen.
h to put the Pump ON HOLD.
d button to access the options menu.
dbutton to access the options menu.
fkeys and press the OK softkey.
fkeys (Or select BAGS softkey to set the VTBI). When the desired volume has
been reached press the OK softkey.
fkeys . The infusion rate will automatically be calculated.
d button to access the options menu.
Event Log
This option allows the event log to be reviewed. The event log holds up to 99,960 events. When the log is full, the oldest events will be
overwritten by the newest occurring events.
1. Press the
2. Select EVENT LOG using the fkeys and press OK softkey to confirm.
3. View the events using the
4. Select BACK to return to the previous screen, if required.
d button to access the options menu.
f keys.
Pump Details
To review Pump information:
1. Press the
2. Select PUMP DETAILS using the fkeys and press OK softkey to confirm.
3. Review the information and then press the QUIT softkey.
d button to access the options menu.
Profile Filter (Only available on the Alaris™ GP Guardrails™ Volumetric Pump)
This option allows selected profiles to be filtered from view. It can be enabled/disabled via the Alaris™ Editor.
1. Press the
2. Select PROFILE FILTER using the
3. Select profile that requires filtering using the
4. Press MODIFY to disable profile and press OK to confirm or QUIT to return to main display.
Note: If only one profile is available and all others are disabled in this option, the CONFIRM PROFILE screen will not display upon
d button to access the options menu.
f keys, press the OK softkey to confirm.
f keys.
start up.
Standby
This option allows the Pump to be placed on standby mode. It can be enabled/disabled via the Alaris™ Editor.
1. Press the
2. Select STANDBY using the
3. Select CANCEL to return to main display.
d button to access the options menu.
f keys, press the OK softkey to confirm.
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Alaris™ GP (Guardrails™) Volumetric Pump
Basic Features
Changing the Infusion Set
1. Press h
2. Close in-line clamp and ensure the access to the patient is isolated.
3. Disconnect the infusion set from the patient.
4. Open Pump door and remove infusion set from the Pump and discard the set and fluid container according to hospital protocol.
5. Prepare the new infusion set, load infusion set into Pump and close the door, see 'Loading the Infusion Set'.
6. Restart infusion, see 'Getting Started'.
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Changing the Fluid Container
1. Press h to put the Pump ON HOLD.
2. Remove bag spike on infusion set from empty / used container. Discard empty / used container according to hospital protocol.
3. Insert the bag spike into the fluid container and hang following the instructions in the 'Loading an Infusion Set' section.
4. Squeeze the drip chamber approximately half full or up to fill line (if the drip chamber is marked) with fluid.
5. Restart infusion, see "Getting Started".
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to put the Pump ON HOLD.
When changing the infusion set or the fluid container use aseptic technique according to hospital protocol.
It is recommended that infusion sets are changed in accordance with the Directions For Use.
Carefully read the Directions For Use supplied with the infusion set prior to use. The set change interval is generally
72 hours with the following exceptions;
• Transfusion (Blood) Sets
• 60953 Alaris™ GP Low Sorbing Infusion Set
• 60033E Alaris™ GP Low Sorbing Infusion Set
• 60950E Alaris™ GP Oncology Infusion Set
When changing the infusion set or the fluid container use aseptic technique according to hospital protocol.
It is recommended that infusion sets are changed in accordance with the Directions For Use.
Carefully read the Directions For Use supplied with the infusion set prior to use.
SmartSite™ Needle-Free System Instructions
SmartSite™ Needle-Free Valve is designed to permit safe gravity flow and automated flow, injection and aspiration of fluids without the
use of needles by utilising Luer lock and luer slip connectors.
Precautions:
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DIRECTIONS - Use Aseptic Technique
1. Prior to every access, swab top of Needle-Free Valve port with 70% Isopropyl alcohol (1-2 seconds) and allow to dry (approximately
Note: Dry time is dependent on temperature, humidity, ventilation of the area.
2. Prime valve port. If applicable, attach syringe to Needle-Free Valve port and aspirate minuscule air bubbles.
3. When used with administration sets always refer to individual set directions for use as change interval may vary according to clinical
Note: During use of Needle-Free Valve port, fluid may be observed between the housing and blue piston. This fluid does not enter
Note: For product questions or needle-free valve educational materials, contact your BD representative. Consult facility protocols.
Discard if packaging is not intact or protector caps are unattached.
If Needle-Free Valve is accessed by a needle in an emergency the valve will be damaged causing leakage. Replace
Needle-Free Valve immediately.
Needle-Free Valve contraindicated for blunt cannula system.
Do not leave slip luer syringes unattended.
30 seconds).
application (e.g. infusions of blood, blood products, and lipid emulsions).
the fluid path and requires no action.
Consult other organizations that publish guidelines useful in developing facility protocols.
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Alaris™ GP (Guardrails™) Volumetric Pump
Secondary (Piggyback) Infusions
Secondary (Piggyback) Infusions
Secondary (or piggyback) Infusion mode is only available if it has been configured.
The application of secondary infusions should be limited to the intermittent therapy of medications which are not sensitive to the total
time required to complete an infusion.
• Typically antibiotics may be infused using a secondary infusion, where the primary infusion is limited to
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Setting up a secondary infusion
maintenance fluid. If intending to use the secondary infusion facility, the primary infusion should be a
maintenance fluid only and is not indicated for drug therapy.
• The application of secondary infusions for delivery of critical drugs, particularly those with a short half life, is
NOT indicated for use. These drugs should be administered through a dedicated pump channel.
• Dependent upon factors such as fluid viscosity, the secondary infusion rate, head height between the secondary
and primary fluid containers and the use of clamps, flow may occur from the primary fluid container during a
secondary infusion. This could result in drug remaining in the container at the end of the secondary infusion,
delaying its delivery for a period of time which is dependent upon the primary infusion rate. For example,
a secondary infusion of 250ml at 300ml/h could result in approximately 33ml remaining, requiring up to 25
minutes additional time to complete the delivery, assuming a primary infusion rate of 80ml/h (and the use of a
72213N-0006 secondary infusion set and its supplied extension hook). Therefore it is recommended that flow
sensors (if used) are disconnected from the Pump during secondary infusions.
• Regular monitoring for unexpected primary flow is recommended. If flow from the primary fluid container is
not desired during secondary infusion and/or the patient is sensitive to fluid balance, the clamp on the primary
infusion set should be closed. Check that no drops fall in the primary drip chamber.
• On completion of the primary infusion the Pump will continue at Keep Vein Open rate (KVO) rate.
1. Ensure Primary infusion has been setup in ml/h (rate > 0ml/h).
2. Press
3. Press
h to put the Pump ON HOLD.
d to access the OPTIONS screen.
4. Select SECONDARY SETUP, press OK to confirm.
5. Select either ml/h or DRUGS A-Z. Press OK to confirm either
selection.
6. Enter the secondary RATE using the
f keys.
7. Press OK to confirm.
8. Set VTBI using the
f keys (Refer to 'Setting a VTBI'
section).
9. Press OK to confirm.
10. Review PRIMARY/SECONDARY setup summary.
Typical Secondary infusions
IV Pole
Extension Hook (approx.26cm)
Normally included with the secondary Infusion set. Primary
fluid container must hang lower to allow the secondary
infusion to run and primary infusion to restart on completion
of the secondary infusion.
Primary Fluid Container
Primary Infusion set
e.g. 63420E with an upper Y-Site (SmartSite Needle-Free Valve).
In-line Clamp
Check Valve
Prevents secondary infusions from flowing back up the
primary Infusion set instead of to the patient.
11. If correct, press OK to continue, or BACK to adjust VTBI or
RATE of the SECONDARY mode.
12. Press
b to start the infusion in secondary mode. An
advisory screen will be displayed - ENSURE SECONDARY
INFUSION SET OPEN.
13. Press OK to start infusing at the displayed rate.
Setting up a subsequent secondary infusion:
On completion of the secondary VTBI, the Pump will automatically
transition to the primary infusion, an audible beep will be heard.
1. Press
2. Follow instructions 3 to 13 of 'Setting up a secondary infusion'.
1
h to place the primary infusion ON HOLD.
Secondary Fluid Container
2
Usually a smaller container e.g.
50ml, 100ml, 200ml or 250ml.
Secondary Infusion Set
e.g. 72213N-0006. Usually shorter
tubing to reach the Y-site on the
primary Infusion set.
In-line Clamp e.g.
roller clamp.
Upper Y-Site (SmartSite NeedleFree Valve) on Primary Infusion
Set.
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Ensure primary set has a
backcheck valve upstream
from the Y-site.
BDDF00535 Issue 4
®
Alaris®
Alaris
Guardrails®
®
Guardrails
GP
plus
GP
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The secondary set connects to
the upper Y-connection on the
primary Infusion set.
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Alaris™ GP (Guardrails™) Volumetric Pump
Service Configuration Mode
Service Configuration Mode
This section comprises of a list of options which can be configured. Some can be entered via the Pump SERVICE menu (available in
Technician Mode) and others through the Alaris™ Editor Software.
Access codes should only be entered by Qualified Service Personnel.
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Alarm Presets
Pumps with version 2.3.4 software have 2 alarm tones to choose from during configuration:
• ORIGINAL ALARMS: Low, medium and high priority alarm tones that sound like the auditory alarms and warnings from software
versions prior to 2.3.4
• 3RD EDITION ALARMS: Low, medium and high priority alarm tones in accordance with IEC 60601-1-8: 2012 and IEC 60601-224:2012
Enter the access code on the Pump for Alarm Presets, see the Technical Service Manual or Information Notice for details.
1. Use the
2. When the desired alarm tone has been selected press OK softkey.
3. When all modifications have been carried out press QUIT softkey.
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f keys to select alternative alarm tones.
All pumps in a single care area should be configured with the same alarm tones to avoid User confusion.
The Hospital/Facility is responsible for selecting and configuring the desired alarm scheme.
Alaris™ Gateway Workstation (Workstation) with software versions 1.1.3, 1.1.3 MR, 1.1.5, 1.2, 1.3.0, 1.6.0 or 1.5 do not
support the new Pump low priority visual alarms scheme defined in IEC 60601-1-8: 2012. For Pumps with version 2.3.4
software or higher docked into these Workstations there will be a mismatch of alarm priority displayed. As a result,
Near End Of Infusion, AC Power Fail, Add Drug Not Complete, and Attention alarms will display as a medium visual
priority alarms on the Workstation beacon and a low priority alarm on the Pump. Additionally, for certain information
signals, e.g. those associated with Add Drug Not Complete and Titration Not Confirmed, the Workstation beacon will
illuminate while the beacon on the pump will not. In the event of an alarm priority mismatch, the User should refer to
the alarm on the Pump for the correct priority.
Configured Options
Enter the access code on the Pump for SERVICE mode, then select CONFIGURATION, see the Technical Service Manual for details.
Use Alaris™ Editor to configure the Pump configuration, drug library and units enabled for each data set.
Date & Time
1. Select DATE & TIME from the CONFIGURATION menu using the f keys and press the OK softkey.
2. Press the OK softkey to confirm.
3. Use the
4. When the correct date and time are displayed press the OK softkey to return to the CONFIGURATION menu.
5. Press the QUIT softkey to return to the SERVICE menu and press
f keys to adjust the date displayed, pressing the NEXT softkey to access the next field.
ato exit and power down.
Pump Reference
This option is used to add reference text to be shown on the Pump start up display.
1. Select PUMP REFERENCE from the CONFIGURATION menu using the
2. Use the
3. When the desired text has been selected press OK softkey to return to the CONFIGURATION menu.
4. Press QUIT to exit back to the main SERVICE menu and press
f keys to enter the text and NEXT to move to the next character.
a to exit and power down.
f keys and press the OK softkey.
Language
This option is used to set the language of messages shown on the Pump display.
1. Select LANGUAGE from the CONFIGURATION menu using the
2. Use the
3. When the desired language has been selected press OK softkey to return to the CONFIGURATION menu.
4. Press QUIT to exit back to the main SERVICE menu and press
f keys to select the language.
f keys and press the OK softkey.
a to exit and power down.
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Alaris™ GP (Guardrails™) Volumetric Pump
Pump Configuration available via the Alaris™ Editor Software
Backlight & Contrast
This option is used to set the backlight and contrast on the Pump display.
1. Select BACKLIGHT & CONTRAST from the CONFIGURATION menu using the
2. Use the
through the numbers. (Use PARAM to scroll between each option)
3. When the desired value has been reached press the OK softkey, then QUIT to get back to the SERVICE menu and press
and power down.
f keys to adjust BACKLIGHT, CONTRAST and DIMMING. The contrast of the display will change when scrolling
f keys and press the OK softkey.
a to exit
Pump Configuration available via the Alaris™ Editor
Software
The following options are only configurable via the Alaris™ Editor Software (PC based), see Alaris™ Editor help files for further details.
Data Set Configuration Settings
Profile Filtering Controls whether the user is able to filter which profiles will be available on the Pump.
Unit Display The text used to display units.
General Pump Configuration Settings
AC Fail Warning Controls whether, when main power has been disconnected, a warning is generated to inform the
user that the Pump is operating solely on battery power.
Audio Volume Controls the audio volume used for alarms and warnings.
Audio Volume Adjustable Controls whether the user is able to adjust the audio volume setting.
Auto Night Mode Controls whether, between defined times, the Pump makes changes consistent with usage at
night (e.g. dimmed backlight).
Auto save Controls whether, when the Pump is powered down, the active infusion settings are preserved for
restoration at the next power-up.
Battery Icon Controls whether or not the battery icon (which indicates state of charge) is displayed.
Callback Time The time that is allowed to elapse between the user’s last recorded interaction with the Pump and
generation of a callback alarm.
Drug Override Mode Always - Any changes made to the dose rate that are outside of the Guardrails™ Soft Alerts will
require confirmation before starting infusion.
Smart – Confirmation of setting will be required on first dose rate set outside of the Guardrails™
Soft Alert. Any subsequent changes will not require confirmation until after the dose rate has
been confirmed inside the Guardrails™ Soft Alert limits.
Event Log Controls whether or not it is possible for the user to inspect the contents of the event log using
the Pump’s display and keypad.
Pressure Display Controls whether or not the bar graph indication of downstream pressure is displayed.
Quiet Mode Controls whether or not the Pump operates in a mode whereby generation of sound is minimised.
Rate Lock Controls whether the Rate Lock feature is available for use.
Rate Titration Allows the adjustment of the infusion rate while the Pump is infusing, without putting the Pump
on hold.
Standby Mode Controls whether or not standby mode is available on the Pump.
VTBI Clear Rate Controls whether or not the Pump forces the user to dene a new rate following completion of
delivery of a previous VTBI.
Weight Default The default patient weight.
Weight Soft Min (For Alaris™ GP Guardrails™ Volumetric Pump only) The minimum patient weight for weight-based
drug dosing calculations before alerting the user.
Weight Soft Max (For Alaris™ GP Guardrails™ Volumetric Pump only) The maximum patient weight for weight-based
drug dosing calculations before alerting the user.
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Alaris™ GP (Guardrails™) Volumetric Pump
Pump Configuration available via the Alaris™ Editor Software
Large Volume Pump Configuration Settings
AIL Limit The single bubble Air-in-line alarm setting.
Bolus Mode Controls whether or not the Pump allows bolus delivery method.
Bolus Rate Default The default value for bolus rates.
Bolus Rate Max The maximum permissible bolus rate.
Bolus Volume Max The maximum permissible bolus volume.
Occlusion Alarm Pressure The default occlusion limit.
Pressure Max The maximum permitted occlusion limit.
Infusion Rate Max The maximum permissible infusion rate.
KVO Rate The maximum infusion rate when performing KVO delivery.
Near End of Infusion Point The point defined in terms of remaining time at which the infusion is deemed to be Near end i.e.
nearly complete.
Primary VTBI Max The maximum VTBI for primary infusions.
Prime Rate The rate at which priming is performed.
Prime Volume Max Determines the maximum volume that can be purged as part of a given prime operation.
Secondary Infusion Allows the use of a secondary infusion (Piggyback) in the same channel.
Sec. Infusion Rate Max The maximum permissible infusion rate for secondary infusions.
Sec. VTBI Max The maximum permissible setting for the Volume To Be Infused for secondary infusions.
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Alaris™ GP (Guardrails™) Volumetric Pump
Drug Library available via the Alaris™ Editor Software
Drug Library available via the Alaris™ Editor Software
The following drug parameters are only configurable via the Alaris™ Editor Software (PC based), see Alaris™ Editor help files for further
details.
Concentration Settings
Concentration Units The unit for concentration parameters.
Concentration Min The weakest permissible concentration for this drug.
Concentration Max The strongest permissible concentration for this drug.
Dose Rate Settings
Dose Rate Units The unit for dose rate parameters.
Weight based units Controls whether weight based units are enabled or disabled for use.
Dose Rate Default The default dose rate for infusing this drug.
Dose Rate Soft Min (For Alaris™ GP Guardrails™ Volumetric Pump only) The minimum permissible dose rate which does
not generate an alert on the Pump.
Dose Rate Soft Max (For Alaris™ GP Guardrails™ Volumetric Pump only) The maximum permissible dose rate which
does not generate an alert on the Pump.
Dose Rate Hard Max The maximum permissible dose rate for infusing this drug.
Bolus Settings
Bolus Mode Controls bolus delivery method. These settings override the Pump configuration settings in the
profile.
Bolus Dose Units The unit for bolus dose parameters. Applies to Hands-on and Hands-free bolus.
Weight based units Controls whether weight based units are enabled or disabled for use.
Bolus Dose Default The default bolus dose for this drug. Applies to Hands-free bolus.
Bolus Dose Soft Min (For Alaris™ GP Guardrails™ Volumetric Pump only) The minimum bolus dose that the Pump allows
before the user is required to confirm the selected bolus dose in response to a warning of the
possibility of under-infusion. Applies to Hands-free bolus.
Bolus Dose Soft Max (For Alaris™ GP Guardrails™ Volumetric Pump only) The maximum bolus dose that the Pump allows
before the user is required to confirm the selected bolus dose in response to a warning of the
possibility of over-infusion. Applies to Hands-free bolus.
Bolus Dose Hard Max The maximum permissible bolus dose for this drug. Applies to Hands-on and Hands-free bolus.
Bolus Rate Default The default bolus rate for this drug.
Pressure Settings
Occlusion Alarm level The occlusion alarm level can be set from L0-L8.
Display of Units
Units are selected via the Alaris™ Editor.
Micrograms can be displayed as mcg or µg depending upon the configuration in the Alaris™ Editor.
Units can be displayed as U or units depending upon the configuration in the Alaris™ Editor.
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Alaris™ GP (Guardrails™) Volumetric Pump
Alarms
Alarms vary by priority and are indicated on the Pump in the following manner:
Setting the alarm sound pressure level lower than the ambient sound pressure level can impede User recognition of
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ORIGINAL ALARMS
High Priority Alarms
High priority alarms stop the infusion and are indicated by a combination of an audible sound, flashing red alarm indicator and a
message on the display. See the 'Alarm Priority Level Indicators' table for more details on how high priority alarms are indicated.
Alarms can be addressed in the following manner:
1. Check the display for an alarm message and review table below for cause and action. Press
2. When the cause of the alarm has been rectified, press the
alarm conditions.
The default alarm system is ORIGINAL ALARMS (ISO60601-1-8 2nd Edition alarms). 3RD EDITION ALARMS (ISO606011-8 3rd Edition alarms) are also installed. To change the Pump alarm system from ORIGINAL ALARMS to 3RD EDITION
ALARMS please refer to the Technical Service Manual. Please note that this change should only be performed by
Qualified Service Personnel.
R to silence the sound for 2 minutes,
or press a second time to re-enable alarm audio, CANCEL to clear the message. The CANCEL feature clears the alarm signal, but the
signal will return if the alarm condition still exists.
b key to resume the infusion. (Exceptions are DO NOT USE and
BATTERY EMPTY)
Alarms
Display Infusion Status Cause(s) Action
• Assess the amount of air detected by air
• Opening the door may cause an air
Single air bubble exceeds
AIR IN LINE Infusion stopped
AIR IN LINE
DOOR OPEN Infusion stopped
DOWNSTREAM OCCLUSION Infusion stopped
UPSTREAM OCCLUSION Infusion stopped
Infusion stopped
alarm limit.
Set not fitted correctly into air
in line detector.
Accumulated air bubbles
have exceeded alarm limit.
Multiple bubbles smaller
than the single bubble alarm
limit, have been detected at
>1ml over a rolling 15 minute
window period.
Door was opened during an
infusion.
A blockage has occurred
downstream.
A blockage has occurred
upstream.
Possible container empty.
• Remove air according to hospital policy.
• Ensure set is fitted correctly in the air in
• Check level of fluid in container.
• Check enough fluid left in drip
• Restart infusion.
• Review infusion set for air bubbles and
• Check level of fluid in container.
• Check enough fluid left in drip
• Restart infusion.
• Close door or clamp infusion set using
• Restart infusion.
• Check fluid path between Pump and
• Examine access site for signs of
• Check set above the Pump.
• Check all clamps above Pump.
• Check fluid level in container.
• Ensure drip chamber is half filled.
• Ensure that the bag spike is inserted
• Ensure air vent on drip chamber is open
in line detector.
bubble to rise in the set. Check set for
air.
line detector.
chamber.
take appropriate action.
chamber.
roller clamp.
patient for clamps, connectors, kinks or
blockages.
complications (redness, swelling, pain,
heat).
correctly.
on all glass and semi rigid containers.
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Alaris™ GP (Guardrails™) Volumetric Pump
Display Infusion Status Cause(s) Action
• Check flow sensor.
• Check fluid level in container.
• Ensure all clamps above Pump are
NO FLOW Infusion stopped Flow sensor detects no flow.
Gross difference between
FLOW ERROR Infusion stopped
FLOW ERROR (In secondary
infusion mode only)
FREE FLOW Infusion stopped Uncontrolled flow possible.
Infusion stopped Unexpected drops detected.
detected drops and expected
amount of drops.
• Ensure drip chamber is half filled.
• Ensure that the bag spike is inserted
• Check flow sensor is clean.
• Clamp infusion set using roller clamp.
• Check flow sensor.
• Check fluid level in drip chamber.
• Hang secondary container above
• Check drops are from secondary
• Flow sensor disconnection is
• Clamp infusion set using roller clamp.
• Remove Pump from use.
Alarms
open.
correctly.
primary.
container when infusing.
recommended.
The internal battery is
BATTERY EMPTY Infusion stopped
SAFETY CLAMP Pump on hold
SET MISLOAD Pump on hold Set loaded incorrectly.
FLOW SENSOR DISCONNECT Infusion stopped
WRONG SET Pump on hold Safety clamp not detected.
DOOR CLOSE INCOMPLETE Pump on hold
DO NOT USE
LEVER OPEN Infusion stopped Door lever is open
VTBI DONE Infusion stopped Intended VTBI completed. • Set new VTBI or clear VTBI.
SET CLOCK Pump on hold Date / time not set.
SET SERIAL NUMBER Pump on hold Serial number not set.
Pump on hold /
infusion stopped
exhausted. The Pump will
automatically switch off in the
immediate future.
Safety clamp broken or
missing.
Flow sensor unplugged
during infusion.
Safety clamp in non-occluded
position with door open or
obstructed.
Internal error has occurred. • Remove Pump from use.
• Connect to power supply immediately
or switch Pump off.
• Clamp infusion set using roller clamp.
• Replace infusion set.
• Investigate and correct set loading.
• Clamp infusion set using roller clamp.
• Investigate and correct set loading.
• Check / replace flow sensor or set VTBI.
• Clamp infusion set using roller clamp.
• Check set and close door.
• Replace infusion set (If necessary).
• Clamp infusion set using roller clamp.
• Investigate and correct set loading.
• Close door.
• Check door lever.
• Check lever hooks.
• Check lever is not obstructed, if so, free
obstruction.
• Qualified Service Personnel must set
date / time.
• Press CANCEL softkey to continue.
• Contact Qualified Service Personnel to
set the serial number.
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Alaris™ GP (Guardrails™) Volumetric Pump
Alarms
Medium Priority Alarms
Medium priority alarms alert the user but may not stop the infusion and are indicated by an audible sound, a flashing amber warning
indicator and a message on the display. See the 'Alarm Priority Level Indicators' table for more details on how medium priority alarms are
indicated.
1. Check the display for a warning message. Press
audio, CANCEL to clear the message.
2. Rectify the cause of the alarm or proceed with caution.
Display Infusion Status Cause(s) Action
BATTERY LOW Infusion continues
VTBI DONE (KVO/Continue)
AIR-IN-LINE Pump on hold
LOG FAILURE Pump on hold Unable to update event log.
SET NOT FITTED Pump on hold No infusion set fitted. • Fit infusion set.
AC POWER FAIL Infusion continues*
NEAR END OF INFUSION Infusion continues
* If pump was on hold the alarm will still be activated but this message will not be displayed.
Infusing KVO or set
rate
R to silence the sound for 2 minutes, or press a second time to re-enable alarm
Less than 30 minutes of battery
life remaining.
Intended VTBI completed. • Set new VTBI or clear VTBI.
Air detected in infusion set at
the start of infusion.
Set not fitted correctly into air
in line detector.
AC power disconnected or
failed.
Less than XX (Configurable)
minutes of infusion remaining.
• Connect to power supply.
• Check power cable.
• Ensure set is fitted correctly in the air in
line detector.
• Assess air in infusion set.
• Check fluid level in drip chamber.
• Check level of fluid in container.
• Qualified Service Personnel may need
to service the Pump.
• Reconnect to power supply.
• Set new VTBI.
• Prepare new fluid container (Refer to
'Changing the Fluid Container' section)
Attention Tones
Attention tones alert the user but may not stop the infusion and are indicated by an audible sound, a flashing amber warning indicator
and a message on the display. See the 'Alarm Priority Level Indicators' table for more details on how Attention tones are indicated.
1. Check the display for message. Press
CANCEL to clear the message.
2. Rectify the cause of the tone or proceed with caution.
Display Infusion Status Cause(s) Action
ATTENTION Pump on hold
ADD DRUG Infusion continues Drug selection required.
TITRATION Infusion continues Rate titration not confirmed. • Confirm or cancel new rate.
RATE LOCK Infusion continues
KVO
R to silence the sound for 2 minutes, or press a second time to re-enable tone audio,
Pump left on hold for 2 minutes
without starting the infusion.
• Review Pump setup.
• Start infusion or turn off Pump.
• Press
• Select DRUGS A-Z using the
d to access options menu.
f keys.
• Press OK to confirm.
Rate lock not confirmed.
Note: After five seconds the
Infusing KVO or set
rate
User will be notified by an
auditory cue. After two minutes
have expired a medium priority
alarm is generated.
Intended VTBI completed. • Set new VTBI or clear VTBI.
• Select YES or NO as required.
Alarm Priority Level Indicators
Priority Audio Indicator Visual Indicator (Beacon)
HIGH One urgent tone pulse followed by one second pause Flashing Red
MEDIUM One warning tone pulse followed by one second pause Flashing Amber
ATTENTION Three attention tone pulse followed by a three second pause Flashing Amber
Note: Original Alarms legacy attention tone is intended as the reminder or notification having less significance. The low volume
audio sound pressure level may be below 45 dB to avoid distraction.
BDDF00535 Issue 4
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Page 37
Alaris™ GP (Guardrails™) Volumetric Pump
3RD EDITION ALARMS
High Priority Alarms
High priority alarms stop the infusion and are indicated by a combination of an audible sound, flashing red alarm indicator and a
message on the display. See the 'Alarm Priority Level Indicators' table for more details on how high priority alarms are indicated.
Alarms can be addressed in the following manner:
1. Check the display for an alarm message and review table below for cause and action. Press
or press a second time to re-enable alarm audio, CANCEL to clear the message. The CANCEL feature clears the alarm signal, but the
signal will return if the alarm condition still exists.
2. When the cause of the alarm has been rectified, press the
BATTERY EMPTY)
b key to resume the infusion. (Exceptions are DO NOT USE and
Display Infusion Status Cause(s) Action
Single air bubble exceeds
AIR IN LINE Infusion stopped
alarm limit.
Set not fitted correctly into air
in line detector.
R to silence the sound for 2 minutes,
• Assess the amount of air detected by air
in line detector.
• Opening the door may cause an air
bubble to rise in the set. Check set for
air.
• Remove air according to hospital policy.
• Ensure set is fitted correctly in the air in
line detector.
• Check level of fluid in container.
• Check enough fluid left in drip
chamber.
• Restart infusion.
Alarms
AIR IN LINE
DOOR OPEN Infusion stopped
DOWNSTREAM OCCLUSION Infusion stopped
UPSTREAM OCCLUSION Infusion stopped
Infusion stopped
Accumulated air bubbles
have exceeded alarm limit.
Multiple bubbles smaller
than the single bubble alarm
limit, have been detected at
>1ml over a rolling 15 minute
window period.
Door was opened during an
infusion.
A blockage has occurred
downstream.
A blockage has occurred
upstream.
Possible container empty.
• Review infusion set for air bubbles and
take appropriate action.
• Check level of fluid in container.
• Check enough fluid left in drip
chamber.
• Restart infusion.
• Close door or clamp infusion set using
roller clamp.
• Restart infusion.
• Check fluid path between Pump and
patient for clamps, connectors, kinks or
blockages.
• Examine access site for signs of
complications (redness, swelling, pain,
heat).
• Check set above the Pump.
• Check all clamps above Pump.
• Check fluid level in container.
• Ensure drip chamber is half filled.
• Ensure that the bag spike is inserted
correctly.
• Ensure air vent on drip chamber is open
on all glass and semi rigid containers.
NO FLOW Infusion stopped Flow sensor detects no flow.
BDDF00535 Issue 4
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• Check flow sensor.
• Check fluid level in container.
• Ensure all clamps above Pump are
open.
• Ensure drip chamber is half filled.
• Ensure that the bag spike is inserted
correctly.
• Check flow sensor is clean.
Page 38
Alaris™ GP (Guardrails™) Volumetric Pump
Display Infusion Status Cause(s) Action
• Clamp infusion set using roller clamp.
• Check flow sensor.
• Check fluid level in drip chamber.
• Hang secondary container above
• Check drops are from secondary
• Flow sensor disconnection is
FLOW ERROR Infusion stopped
FLOW ERROR (In secondary
infusion mode only)
Infusion stopped Unexpected drops detected.
Gross difference between
detected drops and expected
amount of drops.
Alarms
primary.
container when infusing.
recommended.
FREE FLOW Infusion stopped Uncontrolled flow possible.
The internal battery is
BATTERY EMPTY Infusion stopped
SAFETY CLAMP Pump on hold
SET MISLOAD Pump on hold Set loaded incorrectly.
FLOW SENSOR DISCONNECT Infusion stopped
WRONG SET Pump on hold Safety clamp not detected.
DOOR CLOSE INCOMPLETE Pump on hold
exhausted. The Pump will
automatically switch off in the
immediate future.
Safety clamp broken or
missing.
Flow sensor unplugged
during infusion.
Safety clamp in non-occluded
position with door open or
obstructed.
• Clamp infusion set using roller clamp.
• Remove Pump from use.
• Connect to power supply immediately
or switch Pump off.
• Clamp infusion set using roller clamp.
• Replace infusion set.
• Investigate and correct set loading.
• Clamp infusion set using roller clamp.
• Investigate and correct set loading.
• Check / replace flow sensor or set VTBI.
• Clamp infusion set using roller clamp.
• Check set and close door.
• Replace infusion set (If necessary).
• Clamp infusion set using roller clamp.
• Investigate and correct set loading.
• Close door.
DO NOT USE
LEVER OPEN Infusion stopped Door lever is open
VTBI DONE Infusion stopped Intended VTBI completed. • Set new VTBI or clear VTBI.
SET CLOCK Pump on hold Date / time not set.
SET SERIAL NUMBER Pump on hold Serial number not set.
Pump on hold /
infusion stopped
BDDF00535 Issue 4
Internal error has occurred. • Remove Pump from use.
• Check door lever.
• Check lever hooks.
• Check lever is not obstructed, if so, free
obstruction.
• Qualified Service Personnel must set
date / time.
• Press CANCEL softkey to continue.
• Contact Qualified Service Personnel to
set the serial number.
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Page 39
Alaris™ GP (Guardrails™) Volumetric Pump
Alarms
Medium Priority Alarms
Medium priority alarms alert the user but may not stop the infusion and are indicated by an audible sound, a flashing amber warning
indicator and a message on the display. See the 'Alarm Priority Level Indicators' table for more details on how medium priority alarms are
indicated.
1. Check the display for a warning message. Press
audio, CANCEL to clear the message.
2. Rectify the cause of the alarm or proceed with caution.
Display Infusion Status Cause(s) Action
BATTERY LOW Infusion continues
VTBI DONE (KVO/Continue)
AIR-IN-LINE Pump on hold
LOG FAILURE Pump on hold Unable to update event log.
SET NOT FITTED Pump on hold No infusion set fitted. • Fit infusion set.
Infusing KVO or set
rate
R to silence the sound for 2 minutes, or press a second time to re-enable alarm
Less than 30 minutes of
battery life remaining.
Intended VTBI completed. • Set new VTBI or clear VTBI.
Air detected in infusion set at
the start of infusion.
Set not fitted correctly into
air in line detector.
• Connect to power supply.
• Check power cable.
• Ensure set is fitted correctly in the air in
line detector.
• Assess air in infusion set.
• Check fluid level in drip chamber.
• Check level of fluid in container.
• Qualified Service Personnel may need to
service the Pump.
Low Priority Alarms
Low priority alarms alert the user but may not stop the infusion and are indicated by an audible sound, a solid amber warning indicator
and a message on the display. See the 'Alarm Priority Level Indicators' table for more details on how low priority alarms are indicated.
1. Check the display for message. Press
CANCEL to clear the message.
2. Rectify the cause of the alarm or proceed with caution.
R to silence the sound for 2 minutes, or press a second time to re-enable alarm audio,
Display Infusion Status Cause(s) Action
Pump left on hold for 2
ATTENTION Pump on hold
ADD DRUG* Infusion continues Drug selection required.
RATE LOCK* Infusion continues Rate lock not confirmed. • Select YES or NO as required.
AC POWER FAIL Infusion continues**
NEAR END OF INFUSION Infusion continues
TITRATION* Infusion continues Rate titration not confirmed. • Confirm or cancel new rate.
*Note: After five seconds the User will be notified by an auditory cue. After two minutes have expired a low priority alarm is
generated.
** If pump was on hold the alarm will still be activated but this message will not be displayed.
minutes without starting the
infusion.
AC power disconnected or
failed.
Less than XX (Configurable)
minutes of infusion
remaining.
• Review Pump setup.
• Start infusion or turn off Pump.
• Press
• Select DRUGS A-Z using the
• Press OK to confirm.
• Reconnect to power supply.
• Set new VTBI.
• Prepare new fluid container (Refer to
d to access options menu.
f
keys.
'Changing the Fluid Container' section)
Alarm Priority Level Indicators
Priority Audio Indicator Visual Indicator (Beacon)
HIGH Ten beep sequence followed by a three second pause Flashing Red
MEDIUM Three consecutive beeps followed by a four second pause Flashing Amber
LOW Three consecutive beeps followed by a sixteen second pause Solid Amber
Note: The audio sound pressure level is at least 45 dB depending on configuration of the alarm sound level.
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Page 40
Alaris™ GP (Guardrails™) Volumetric Pump
Prompts
Prompts are indicated by an audible alarm and message, they cannot be silenced and do not have a visual indicator.
Display Infusion Status Cause(s) Action
SET VTBI Pump on hold No VTBI / flow sensor.
• Set VTBI or fit flow sensor.
Prompts
LOCKED Infusion continues
Advisories
Display
DOSE WOULD EXCEED
DOSE UNDER
DOSE NOT PERMITTED
RATE NOT PERMITTED
CONCENTRATION NOT
PERMITTED
Infusion
Status
Pump on hold (If
titration is disabled)
Infusion continues
(If titrating)
Pump on hold (If
titration is disabled)
Infusion continues
(If titrating)
Pump on hold (If
titration is disabled)
Infusion continues
(If titrating)
Pump on hold (If
titration is disabled)
Infusion continues
(If titrating)
Pump on hold
Rate change attempted
whilst locked.
• Unlock rate to adjust infusion
settings.
Cause(s) Action
• Check infusion setting.
Infusion rate set exceeds a
Guardrails™ soft limit.
Infusion rate/dose rate set
is under a Guardrails™ soft
limit.
Dose rate entered is greater
than the dose rate hard
maximum set.
Infusion rate set exceeds a
hard limit.
Concentration set exceeds
hard max limit, or is under
hard minimum limit.
• To confirm CONFIRM DRUG?
press YES.
• To deny CONFIRM DRUG? press
NO.
• Check infusion setting.
• To confirm CONFIRM DRUG?
press YES.
• To deny CONFIRM DRUG? press
NO.
• Check infusion setting and adjust
to appropriate required rate.
• Check infusion setting and adjust
to appropriate required rate.
• Check concentration and adjust
to a more appropriate amount.
WEIGHT ABOVE LIMIT Pump on hold
WEIGHT BELOW LIMIT Pump on hold
BOLUS DOSE NOT PERMITTED Infusion continues
BOLUS DOSE WOULD EXCEED Infusion continues
BOLUS DOSE UNDER Infusion continues
BDDF00535 Issue 4
Patient weight set exceeds a
Guardrails™ soft limit.
Patient weight set is under a
Guardrails™ soft limit.
Bolus dose rate entered is
greater than the bolus dose
rate hard maximum limit.
Bolus dose rate set exceeds a
Guardrails™ soft limit.
Bolus dose rate set is under a
Guardrails™ soft limit.
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• Check weight setting.
• To confirm CONFIRM? press YES.
• To deny CONFIRM? press NO.
• Check weight setting.
• To confirm CONFIRM? press YES.
• To deny CONFIRM? press NO.
• Check the bolus setting and
adjust to a more appropriate
dose.
• Check the bolus setting.
• To confirm OVERRIDE LIMIT?
press YES.
• To deny OVERRIDE LIMIT? press
NO.
• Check the bolus setting.
• To confirm OVERRIDE LIMIT?
press YES.
• To deny OVERRIDE LIMIT? press
NO.
Page 41
Alaris™ GP (Guardrails™) Volumetric Pump
Restarting an Infusion following an Air-in-Line Alarm
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
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Air ingress and bubble formation within the administration set is a known risk of infusion therapy.
This risk is multiplied when (a) multiple infusions are being administered simultaneously, and (b) where drugs or fluids which are known
to have a tendency to degas, are being infused, with a potential consequence of an increase of air accumulation within a patient’s
circulation.
At an elevated risk of suffering potential consequences of air ingress are patient groups with Atrial Septal Defects. It is therefore
recommended for this group that in addition to the existing air in line detection mechanism of the Pump, an air venting filter is used on
the infusion set.
We advise you to also consider using an air venting filter:
Where air venting filters cannot be used consider using anti siphon valves.
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-inline limit is exceeded.
a) for other patient groups known to be at an elevated risk of suffering potential consequences of air ingress, such as neonates and
b) for situations presenting a multiplied risk of air ingress, such as can be found in critical care areas (multiple parallel infusions) or
where drugs or fluids which are known to have a tendency to de-gas are being infused.
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Page 42
Flow Sensor Operation (Optional)
Alaris®
Guardrails
®
GP
Alaris
®
Guardrails
®
GP
plus
• The flow sensor automatically monitors the infusion flow rate through the drip chamber. The flow sensor will
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IVAC™ Model 180 Flow Sensor
cause the Pump to alarm if a significant deviation from the infusion rate occurs. The flow sensor will also be able
to detect empty containers. For this reason we recommend use of a flow sensor wherever possible excluding
secondary infusions.
• When infusing critical drugs, it is recommended to use a flow sensor, in addition to entering a VTBI.
Handles
Pull back handles
Flow sensor
interface
Alaris™ GP (Guardrails™) Volumetric Pump
Flow Sensor Operation (Optional)
Flanges
Drip
chamber
1. Plug the flow sensor into the flow sensor interface located on the top rear part of the Pump.
2. Attach the IVAC™ Model 180 Flow Sensor to the drip chamber of the infusion set, by pulling back the handles. Refer to the illustration
above.
3. Proceed with load, priming, and set-up instructions as described in section 'Getting Started'.
Note: Ensure drip chamber is half full and upright.
Always attach the flow sensor before you start an infusion .
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Avoid using the flow sensor in direct sunlight.
Always ensure lens is clean.
Flow
Sensor
Interface
Cover
Always replace the flow sensor interface cover when the flow sensor is disconnected.
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Page 43
Alaris™ GP (Guardrails™) Volumetric Pump
Infusion Sets
Infusion Sets
The Pump uses standard, single-use, disposable infusion sets. The user is responsible for verifying the suitability of a product used, if it is
not recommended by BD.
• New sets are continuously being developed for our customers. Please contact your local BD representative for
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availability.
• Check infusion set materials and drug compatibility before selecting an infusion set.
• It is recommended that infusion sets are changed according to the instructions in the 'Changing the Infusion Set'
section. Carefully read the Directions For Use supplied with the infusion set prior to use.
Alaris™ GP standard infusion sets (with filter)
60093E • 2 SmartSite Needle-Free Valve Ports
• 15 Micron Filter
• 1 Backcheck Valve
• Length: 270cm
60693 • 1 Injection Port
• 15 Micron Filter
• Length: 255cm
60693E • 1 SmartSite Needle-Free Valve Port
• 15 Micron Filter
• Length: 255cm
60793 • 2 Injection Ports
• 15 Micron Filter
• Length: 255cm
60793E • 2 SmartSite Needle-Free Valve Ports
• 15 Micron Filter
• Length: 255cm
60903 • 15 Micron Filter
• Length: 265cm
60593 • 15 Micron Filter
• Length: 265cm
Alaris™ GP TPN infusion sets
60123E • 2 SmartSite Needle-Free Valve Ports
• 1.2 & 15 Micron Filter
• Length: 275cm
Please note these drawings are not to scale
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Page 44
Alaris™ GP standard infusion sets (no filter)
63200NYB
60173E • 1 SmartSite Needle-Free Valve Port
• No Filter
• Length: 260cm
• No Filter
• Length: 265cm
Alaris™ GP (Guardrails™) Volumetric Pump
Infusion Sets
63110V
63401EB
63402BE
63420EB
63423BE
60393E
• 2 Split Septum Injection Ports
• No Filter
• Length: 290cm
• 1 SmartSite Needle-Free Valve Port
• No Filter
• Length: 275cm
• 1 SmartSite Needle-Free Valve Port
• 1 Backcheck Valve
• No Filter
• Length: 265cm
• 2 SmartSite Needle-Free Valve Ports
• 1 Backcheck Valve
• No Filter
• Length: 295cm
• 3 SmartSite Needle-Free Valve Ports
• 1 Backcheck Valve
• No Filter
• Length: 285cm
Alaris™ GP blood infusion sets
• 2 SmartSite Needle-Free Valve Ports
• 200 Micron Filter
• Length: 275cm
60895
60894
60980
63477EB
60643
• 200 Micron Filter
• Length: 270cm
• 1 Injection Port
• 200 Micron Filter
• Length: 295cm
• Twin Spike
• 1 Injection Port
• 200 Micron Filter
• Length: 295cm
• 2 Non- Vented Spikes
• 180 Micron Filter
• Length: 305cm
• 1 SmartSite Needle-Free Valve Port
Alaris™ GP light resistant infusion sets
• 15 Micron Filter
• Length: 250cm
Please note these drawings are not to scale
BDDF00535 Issue 4
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Page 45
Alaris™ GP burette infusion sets
Alaris™ GP (Guardrails™) Volumetric Pump
Infusion Sets
60103E
63441E
60953V
63260NY
63280NY
• 2 SmartSite Needle-Free Valve Port
• 1 Burette (150ml)
• Length: 275cm
• 4 SmartSite Needle-Free Valve Port
• 1 Burette (150ml)
• Length: 330cm
Alaris™ GP low sorbing infusion sets
• 15 Micron Filter
• Polyethylene lined PVC tubing
• Length: 270cm
• Polyethylene lined PVC tubing
• No Filter
• Length: 295cm
Alaris™ GP syringe adapter infusion sets
• Length: 270cm
Restricted to maximum infusion rate of 150ml/h
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100
60950E
60951E
60952E
60033E
72213N-0006
72951NE (For use with
60950E)
Alaris™ GP oncology infusion sets
• 5 SmartSite Needle-Free Valve Ports
• 15 Micron Filter
• Length: 260cm
• 3 SmartSite Needle-Free Valve Ports
• 15 Micron Filter
• Length: 260cm
• 5 SmartSite Needle-Free Valve Ports
• 15 Micron Filter
• Light Resistant
• Length: 260cm
• 2 SmartSite Needle-Free Valve Ports
• 0.2 Micron Filter
• Length: 265cm
Alaris™ GP secondary infusion set
• Male luer and hanger
• Length: 76cm
• 1 SmartSite Needle-Free Valve Port
• Male luer with Backcheck Valve
• Length: 35cm
Do not use with Pump in
secondary infusion mode when
infusing critical drugs.
Please note these drawings are not to scale
BDDF00535 Issue 4
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Page 46
Associated Products
The Alaris™ Gateway Workstation
Product SKU 80203UNS0y-xx
Supply Voltage 115-230VAC, ~50-60Hz
Electrical Rating 460VA (Maximum)
Protection Against Electrical Shock Class 1
Classification Continuous Operation
Supply to Pump 115-230V, ~50-60Hz, 60VA
Alaris™ GP (Guardrails™) Volumetric Pump
Associated Products
The Alaris™ DS Docking Station
y = Connectivity option - 1, 2 or 3
xx = Configuration
Product SKU 80283UNS00-xx
Supply Voltage 230VAC, 50 or 60Hz
Electrical Rating 500VA (nominal)
Protection Against Electrical Shock Class 1
Classification Continuous Operation
Supply to Pump 20VA max 230V 50-60Hz
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Page 47
Alaris™ GP (Guardrails™) Volumetric Pump
Maintenance
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 Routine Maintenance Procedure
As per Hospital Policy Thoroughly clean external surfaces of the Pump before and after prolonged period of
storage.
Each usage 1. Inspect AC power supply plug and cable for damage.
2. Inspect case, keypad and mechanism for damage.
3. Check Start up self test operation is correct.
Before the transfer of the Pump to a
new patient and as required
If the Pump is dropped, damaged, subjected to excessive moisture or high temperature, immediately take it out of
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service for examination by Qualified Service Personnel.
All preventative and corrective maintenance and all such activities shall be performed at a compliant work place in
accordance with the information supplied. BD will not be responsible should any of these actions be performed
outside the instructions or information supplied by BD. For Preventative and Corrective Maintenance instructions
please refer to the Technical Service Manual (TSM).
All servicing should only be performed by Qualified Service Personnel with reference to the TSM.
Clean the Pump by wiping over with a lint-free cloth lightly dampened with warm water and
a standard disinfectant / detergent solution.
It is important to ensure that you only refer to the most recent version of the Directions for Use and Technical Service
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Manual for your BD products. These documents are referenced on bd.com. Paper copies of the Directions For Use can
be obtained free of charge by contacting your local BD representative. An estimated delivery time will be provided
when the order is placed.
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.
It is recommended that prior to deploying a data set to all Alaris Compatible Guardrails Volumetric Pumps via Alaris
Communication Engine (ACE), the Guardrails data set should be deployed, to a sample of pumps on a fully loaded
AGW, in a non-clinical environment, and the pumps checked to ensure the settings and the drug library available
on the pump are the same as included in the approved data set report.
After data set deployment using ACE, if a pump is found to have a corrupted data set, the specific pump, and Alaris
Gateway Workstation (AGW) should be removed from service, and the data set transferred using a RS232 cable. The
AGW should be checked by qualified service personnel.
Battery Operation
The internal rechargeable battery allows continued operation when the AC power is unavailable, for example during patient transfer or
AC power failure. When connected to the AC power supply for 4 hours, (whether the Pump is in use or not) a new battery pack will be
fully charged.
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.
Charge retention will eventually degrade. Where retention is critical the internal battery should be replaced every 3 years.
It is recommended that only Qualified Service Personnel replace the battery. For further information regarding the replacement of
batteries refer to the Technical Service Manual.
The battery pack used in this Alaris™ Volumetric Pump is manufactured by BD and includes a proprietary PCB (printed circuit board)
designed specifically for the Alaris™ Volumetric Pump, and in conjunction with Alaris™ Volumetric Pump software, controls battery use,
charge and temperature. Any use of battery packs that are not manufactured by BD in the Alaris™ Volumetric Pump is at your sole risk,
and BD does not provide any warranty for or endorsement on any battery packs that are not manufactured by BD. BD product warranty
shall not apply in the event the Alaris™ Volumetric 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 BD.
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Page 48
Alaris™ GP (Guardrails™) Volumetric Pump
Cleaning and Storage
Cleaning and Storage
Cleaning the Pump
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.
Recommended cleaners are:
Brand Concentration
Hibiscrub 20% (v/v)
Virkon 1% (w/v)
The following products were tested and are acceptable for use on the 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
• Hibiscrub
• Tristel Fuse sachets
• Tristel Trio wipes system
• Virkon Disinfectant
Do not use the following disinfectant types:
• Disinfectants which are known to be corrosive to metals must not be used, which include:
• NaDcc (such as Presept),
• Hypochlorites (such as Chlorasol),
• Aldehydes (such as Cidex),
• Cationic Surfactants (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.
Cleaning the door
Refer to the Technical Service Manual for information for removing the door to facilitate cleaning of the fluid path, the use of a screwdriver (torx)
is required and should only be carried out by Qualified Service Personnel.
Cleaning and storing the infusion set
The infusion set is a disposable single use item and should be discarded after use according to hospital protocol.
Cleaning the Flow Sensor
Before the transfer of the flow sensor to a new infusion set and periodically during use, clean the flow sensor by wiping over with a lint-free cloth
lightly dampened with warm water and a standard disinfectant / detergent solution. Ensure the connector does not get wet. Dry flow sensor
before use.
To aid cleaning of flow sensors which have been heavily soiled, contaminated or if the handle operation is not free moving, then the flow sensor
may be immersed and soaked in clean soapy water. The inside of the spring mechanism can be cleaned by activating it whilst submerged in the
water.
After cleaning, the sensor should be allowed to dry fully prior to use.
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.
Please ensure the membrane covering the pumping mechanism is intact prior to cleaning. If faulty, remove from
use and contact Qualified Service Personnel.
The plug of the flow sensor must not be immersed in water as damage will occur.
Storing the Pump
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.
BDDF00535 Issue 4
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Page 49
Alaris™ GP (Guardrails™) Volumetric Pump
Cleaning and Storage
Disposal
Information on Disposal for Users of Waste Electrical & Electronic Equipment
U symbol on the product and/or accompanying documents means that used electrical and electronic products should not be
This
mixed with household waste.
If you wish to discard electrical and electronic equipment, please contact your BD 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
U symbol is only valid in the European Union. The product should be disposed of taking environmental factors into consideration.
This
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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Alaris™ GP (Guardrails™) Volumetric Pump
Specifications
Electrical Protection
Class I, Type CF (Defibrillation-proof)
Electrical/Mechanical Safety
Complies with IEC/EN60601-1 and IEC/EN60601-2-24.
Electro Magnetic Compatibility (EMC)
Complies with IEC/EN60601-1-2 and IEC/EN60601-2-24.
Electrical Safety
Typical earth leakage current 78µA.
Typical Enclosure Leakage Current (Normal Condition) = 0µA
Typical Protective Earth Resistance = 32mOhms
The above measurements are for guidance only, IEC/EN60601-1 limits are defined below:
Earth Leakage Current (Normal Condition) <= 500µA
Enclosure Leakage Current (Normal Condition) <= 100µA
Protective Earth Resistance <= 200mOhms
Specifications
Classification
Continuous mode of operation, Portable Equipment
AC Power Supply
100 - 230 VAC, 50 - 60Hz, 60VA (Maximum).
Fuse Type
2 X T 1.25H, 250V
Dimensions
148mm (w) x 225mm (h) x 148mm (d). Weight: approx. 2.5kg (excluding power cable).
Protection against fluid ingress
IP33 - Protected against direct sprays up to 60° from the vertical.
Environmental Specifications
Condition Operating Transport & Storage
Temperature +0°C - +40°C -20°C - +50°C
Humidity 20% - 90%* 15% - 95%*
Atmospheric Pressure 700hPa - 1060 hPa 500hPa - 1060hPa
*Non condensing.
Battery Specifications
Rechargeable NiMH (Nickel Metal Hydride). Automatically charges when the Pump is connected to AC power.
• Battery Charging - 2.5 hours to 95%.
Battery Life
Infusion Rate Mean Time To Battery Empty from fully charged
25ml/h 5.8 hours
125ml/h 5.65 hours
1200ml/h 3.4 hours
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Alaris™ GP (Guardrails™) Volumetric Pump
Specifications
Memory Retention
The electronic memory of the Pump will be retained for more than 2 years with normal use.
Alarm Conditions
Alarms Warnings Prompts Advisories
AIR IN LINE (SINGLE BUBBLE) AC POWER FAIL ATTENTION DOSE WOULD EXCEED
AIR IN LINE (ACCUMULATED) VTBI DONE SET VTBI DOSE UNDER
DOOR OPEN BATTERY LOW SET NOT FITTED DOSE NOT PERMITTED
DOWNSTREAM OCCLUSION AIR-IN-LINE LOCKED RATE NOT PERMITTED
UPSTREAM OCCLUSION TITRATION
NO FLOW SET CLOCK WEIGHT BELOW LIMIT
FLOW ERROR RATE LOCK
FREE FLOW LOG FAILURE BOLUS DOSE NOT PERMITTED
BATTERY EMPTY SET SERIAL NUMBER BOLUS DOSE WOULD EXCEED
SAFETY CLAMP
SET MISLOAD
FLOW SENSOR DISCONNECTED
WRONG SET
DOOR CLOSE INCOMPLETE
DO NOT USE
LEVER OPEN
NEAR END OF INFUSION BOLUS DOSE UNDER
ADD DRUG
WEIGHT ABOVE LIMIT
CONCENTRATION NOT
PERMITTED
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Alaris™ GP (Guardrails™) Volumetric Pump
IrDA, RS232 and Nursecall Specification
IrDA, RS232 and Nursecall Specification
IrDA / RS232 / Nursecall Feature
The IrDA (or RS232 / Nursecall optional feature) is a feature that allows the Pump to be connected to an external device for the purpose
of data communication.
The nursecall interface provides a remote backup to the internal audible alarm. It should not be relied upon to
w
RS232 / Nursecall Connection Data
Nursecall Specification:
Connector D Type - 9 Pin
TXD/RXD EIA RS232-C Standard
Baud Rate 115k Baud
Start Bits 1 Start Bit
Data Bits 8 Data Bits
Parity No Parity
Stop Bits 1 Stop Bit
Nurse Call Relay Contacts Pins 1, 8 + 9, 30V dc, 1A rating
replace monitoring of the internal alarm. The signal leaves the IrDA port and the RS232 for Nurse call within one
second after the alarm condition is detected.
Refer to the Technical Service Manual for further information regarding the RS232 interface.
The assessment for the suitability of any software used in the clinical environment to control 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.
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.
To connect to the RS232 port use spare part 1000SP01183 - RS232 cable.
Typical Connection Data:
1. Nursecall (Relay) Normally Closed
2. Transmit Data (TXD) Output
3. Received Data (RXD) Input
4. DTR ª DSR (6)
5. Ground (GND)
6. DSR ª DTR (4)
7. Not used
8. Nursecall (Relay) Normally Open
9. Nursecall (Relay) Common
IrDA
Baud Rate 115k Baud
Start Bits 1 Start Bit
Data Bits 8 Data Bits
Parity No Parity
Stop Bits 1 Stop Bit
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Alaris™ GP (Guardrails™) Volumetric Pump
Infusion Specifications
System Accuracy:
The System includes the Pump and any of the compatible Infusion Sets available from BD.
Rate Accuracy is ±5%, achieved under nominal conditions
Rate Accuracy is ±10%, achieved under low flow conditions
Occlusion Alarm Limits
Achieved under nominal conditions
Level L0 L2 L5 L8
1a,4
1a,2
1b,2
Infusion Specifications
Pressure
(mmHg) approx.
90 250 519 811
Maximum Pumping Pressure:
1000 mmHg
Maximum Occlusion Alarm Pressure:
1038 mmHg
Post Downstream Occlusion Bolus:
The management of post downstream occlusion bolus is the responsibilty of the clinician and must be determined
for each situation.
Bolus volume generated at 25 ml/h when the minimum occlusion alarm threshold is reached <0.16 ml
Bolus volume generated at 25 ml/h when the maximum occlusion alarm threshold is reached <0.95 ml
Bolus Volume Accuracy:
Typical: -4.1%, Max: -3.2%, Min: -5.5% 1ml @ 10ml/h
Typical: -1.3%, Max: -0.9%, Min: -1.6% 100ml @ 1200ml/h
Maximum time for activation of occlusion alarm:
At Maximum Pressure, time to alarm at 0.1ml/h is nominally 735 [±50] minutes (Maximum <883 min)
At Minimum Pressure, time to alarm at 0.1ml/h is nominally 82 [±35] minutes (Maximum <112 min)
At Maximum Pressure, time to alarm at 1.0ml/h is nominally 65 [±4] minutes (Maximum <95 min)
At Minimum Pressure, time to alarm at 1.0ml/h is nominally 5 [+6-2] minutes (Maximum <10 min)
At Maximum Pressure, time to alarm at 25ml/h is nominally 119 [±7] seconds (Maximum <3 min)
At Minimum Pressure, time to alarm at 25ml/h is nominally 10 [+8.5-6.5] seconds (Maximum <18.5 sec)
Administering a Bolus
Parameter Range
Bolus Rate 10 - 1200ml/h in steps of 10ml/h
Bolus Volume Displayed 0.0ml - 100.0ml in steps of 0.1ml
Starting the Infusion / Set-up
Infusion Parameter Range
0.1 - 99.9ml/h in steps of 0.1ml/h
Infusion Rate
VTBI Primary (0 - OFF), 1 - 9999ml
VI (Total) 0.1 - 9999ml
100 - 999ml/h in steps of 1ml/h
1000 - 1200ml/h in steps of 10ml/h
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Alaris™ GP (Guardrails™) Volumetric Pump
Infusion Specifications
Air Sensor:
Integral Ultrasonic Sensor.
Air in line detection:
Single Bubble (configurable): 50µl, 100µl, 250µl & 500µl.
Bubble accumulation: 1ml over a 15 minute window.
Air in line detector accuracy is ±3%.
Critical Volume
The maximum volume infused following a single fault condition is for rates < 10ml/h: +/- 0.25 ml, rates < 100ml/h: +/- 0.5ml, rates
≥100ml/h: +/- 2 ml
The Alaris™ Safety Clamp
Set based, Pump activated Safety Clamp Device to prevent free flow
Notes
1a. Nominal conditions are defined as:
Set Rate: 1 to 1200 ml/h;
Recommended disposable: 60593;
Needle: 18 gauge x 40 mm;
Solution Type: De-ionized & Degassed Water;
Temperature: 23°C ± 2°C
Fluid Head Height: +300 ± 30 mm;
Back Pressure: 0 ± 10 mmHg.
1b. Low flow conditions are defined as:
Set Rate: less than 1.0ml/h
Recommended disposable: 60593;
Needle: 18 gauge x 40 mm;
Solution Type: De-ionized & Degassed Water;
Temperature: 23°C ± 2°C
Fluid Head Height: +300 ± 30 mm;
Back Pressure: 0 ± 10 mmHg.
2. The system accuracy will change by the following percentages:
Temperature: nominally -5.7 (±1.5)% at 5 °C and nominally +0.3 (±1.7)% at 40 °C
Fluid Head Height: nominally -3.4 (±1.3)% at -0.5 m and 0.0 (±1.1)% at +0.5 m
Duration: nominally -1.1 [±0.2] % over 24 hours of continuous use
Back Pressure: nominally +2.0 (±1.3)% at -100 mmHg, -13.4 (±1.8)% at +800 mmHg respectively
Atmospheric pressure: ± 5% at 25ml/h at 700hPa
3. Tested using Distilled water, 20% lipid, 50% glucose, 0.9% Normal Saline and 5% Alcohol solutions.
4. The occlusion pressure accuracy will change by the following:
Temperature: Low setting nominally 7 (±12) mmHg at 5 °C and -24 (±17) mmHg at 40 °C respectively
Normal setting nominally 4 (±16) mmHg at 5 °C and -41 (±18) mmHg at 40 °C respectively
High Pressure nominally 4 (±14) mmHg at 5 °C and -38 (±21)
3
mmHg at 40 °C respectively
w
The specified accuracy may not be maintained if the above conditions are not met, see notes 1 to 4.
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Alaris™ GP (Guardrails™) Volumetric Pump
-0.1
-0.1
-0.0
0102030405060708090100 110120
-150.0
-150
-100
150
0510 15 20 25 30 35
150.0
0 5 1 0 15 20 25 30 35
-0
Trumpet and Flow Rate Curves
Trumpet and Flow Rate Curves
In this Pump, as with all infusion systems, the action of the pumping mechanism and variations cause short-term fluctuations in rate
accuracy.
The following curves show typical performance of the system in two ways: 1) the accuracy of fluid delivery over various time periods is
measured (trumpet curves), and 2) the delay in onset of fluid flow when infusion commences (start-up curves).
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 and the degree of inter
vascular integration, the clinical effect cannot be determined from the trumpet curves alone.
The start-up curves represent continuous flow versus operating time for two hours 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.
Start-up Graph at 0.1ml/h (Initial Period) Trumpet Graph at 0.1ml/h (After 24 Hours)
150.00
0.40
0.35
0.30
0.25
0.20
0.15
0.10
0.05
0.00
Flow Rate (ml/h)
5
0
5
0.00
Error (%)
0
0510 15 20 25 30 35
Time (minutes) Observation Window (minutes)
Maximum Error Minimum Error Overall Mean = -5.0%
Trumpet Graph at 0.1ml/h (Initial Period) Trumpet Graph at 0.1ml/h (After 72 Hours)
100
50
0
-50
Error (%)
0.0
Error (%)
-150.0
Observation Window (minutes) Observation Window (minutes)
Maximum Error Minimum Error Overall Mean = -6.0% Maximum Error Minimum Error Overall Mean = 4.0%
Start-up Graph at 1.0ml/h (Initial Period) Trumpet Graph at 1.0ml/h (After 24 Hours)
2.0
1.8
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
Flow Rate (ml/h)
0.0
.2
0102030405060708090 100 110 120
30
20
10
0
-10
Error (%)
-20
-30
0510 15 20 25 30 35
Time (minutes) Observation Window (minutes)
Note: The typical flow rate and trumpet curves are achieved using a recommended infusion set.
The plot range has been increased to ± 150%, to allow visualization of the graph.
BDDF00535 Issue 4
Maximum Error Minimum Error Overall Mean = 0.7%
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Alaris™ GP (Guardrails™) Volumetric Pump
-3
-2
-1
30
0510 15 20 25 30 35
30.0
0 5 10 15 20 25 30 3 5
0510 15 20 25 30 35
15.0
Trumpet and Flow Rate Curves
Trumpet Graph at 1.0ml/h (Initial Period) Trumpet Graph at 1.0ml/h (After 72 Hours)
20
10
0
0
Error (%)
0
0
20.0
10.0
-10.0
Error (%)
-20.0
-30.0
0.0
Observation Window (minutes) Observation Window (minutes)
Maximum Error Minimum Error Overall Mean = 0.7% Maximum Error Minimum Error Overall Mean = 1.0%
Start-up Graph at 25.0ml/h (Initial Period) Trumpet Graph at 25.0ml/h (After 24 Hours)
50
45
40
35
30
25
20
15
10
Flow Rate (ml/h)
5
0
-5
0102030405060708090 100 110 120
15
10
5
0
-5
Error (%)
-10
-15
0510 15 20 25 30 35
Time (minutes) Observation Window (minutes)
Maximum Error Minimum Error Overall Mean = -0.4%
Trumpet Graph at 25.0ml/h (Initial Period) Trumpet Graph at 25.0ml/h (After 72 Hours)
15
10
Error (%)
-5
-10
-15
5
0
10.0
5.0
0.0
-5.0
Error (%)
-10.0
-15.0
0 5 10 15 20 25 30 35
Observation Window (minutes) Observation Window (minutes)
Maximum Error Minimum Error Overall Mean = 0.6% Maximum Error Minimum Error Overall Mean = -0.7%
Note: The typical flow rate and trumpet curves are achieved using a recommended infusion set.
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Alaris™ GP (Guardrails™) Volumetric Pump
Products and Spare Parts
Products and Spare Parts
Spare Parts
A comprehensive list of spare parts for this Pump is included within the Technical Service Manual.
The Technical Service Manual (1000SM00013) is now available in electronic format on the World Wide Web at :-
bd.com/int-Alaris™-technical
A username and password are required to access our manuals. Please contact a local customer services representative to obtain login
details.
Part Number Description
1000SP00487 Internal Battery Pack
1000SP01183 RS232 Cable
1001FAOPT91 AC Power Lead - UK
1001FAOPT92 AC Power Lead - European
Alaris™ Editor Software
Part Number Description
1000SP01462 Alaris™ Editor and Alaris™ Transfer Tool Software Kit
1000SP01463 Alaris™ Transfer Tool Software Kit
Document History
Issue Date Software Version Description
1 July 2019 2.3.4 Initial release
2 October 2020 2.3.4 Updates for regulations
3 October 2020 2.3.4 Updates for regulations
4 December 2021 2.3.x Updates for regulations
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Alaris™ GP (Guardrails™) Volumetric Pump
Contact Us
For full contact information please refer to bd.com.
Customer Service Information
Country Telephone EMAIL
Australia Freephone: 1 800 656 100 bd_anz@bd.com
België +32(0)53 720 556 info.benelux@bd.com
Canada +1 800 387 8309 CanadaCapital@carefusion.com
Danmark +45 43 43 45 66 bddenmark@bd.com
Deutschland +49 6221 305 558 GMB-DE-CustService-Alaris@bd.com
España +34 902271727 Info.Spain@bd.com
France +33 (0) 1 30 02 81 41 mms_infusion@bd.com
Italia +39 02 48 24 01 customer.service-italy@bd.com
Magyarország (36) 1 488 0233 orders.cee@bd.com
Nederland +31(0)20 582 94 20 info.benelux@bd.com
New Zealand Freephone: 0800 572 468 NZ_customerservice@bd.com
Norge +47 64 00 99 00 bdnorge@bd.com
Polska +48 22 377 11 00 Info_Poland@bd.com
Portugal +351 219 152 593 dl-pt-geral@carefusion.com
Россия и страны СНГ +7-495-775-85-82 mms_support_cis@bd.com
South Africa
Suomi +358-9-8870 780 bdsuomi@bd.com
Sverige +46 8-7755160 bdsweden@bd.com
Switzerland +41 61 485 22 66 Customer_Care_Switzerland@bd.com
United Kingdom Freephone: 0800 917 8776 BDUK_CustomerService@bd.com
United States of America Freephone: 800 482 4822 CustCareInfusion@carefusion.com
中国
Freephone: 0860 597 572
+27 11 603 2620
400 878 8885 serviceclientbdf@bd.com
bdsa_customer_centre@bd.com
Document History
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aliates, and its receipt or possession does not
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