Cardinal Health Alaris GP Manual

s
Directions For Use - English
Alaris®GP Volumetric Pump

1000DF00152 Issue 1 1/42
Contents
Page
 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
 About this Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
 Creating a Data Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
 Features of the Alaris® GP Volumetric Pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
 Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
 Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
 Main Display Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Operating Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
 The Alaris® Safety Clamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
 Loading an Infusion Set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
 Starting the Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Basic Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
 Drugs and Dosing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
 Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
 Secondary (Piggyback) Infusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Service Configuration Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Pump Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Drug List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Prompts and Restarting an Infusion following an Air-in-Line Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Flow Sensor Operation (Optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Infusion Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Associated Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Cleaning and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
IrDA, RS232 and Nursecall Specification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Infusion Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Trumpet and Flow Rate Curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Products and Spare Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
Service Contacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41

1000DF00152 Issue 1 2/42
Introduction
About this Manual
The user must be thoroughly familiar with the pump described in this manual prior to use.
All illustrations used in this manual show typical settings and values which may be used in setting up the functions of the pump.
These settings and values are for illustrative use only. The complete range of settings and values are detailed in the specifications section.
The Alaris® GP Volumetric Pump (hereinafter referred to as 'Pump') is a small lightweight volumetric infusion pump that provides accurate
and reliable infusions over a range of rates.
The Alaris® GP 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. Each data set contains a specific library of drugs, as well as a pump configuration
appropriate for the care area.
The hospital defined data set is developed and approved through pharmacy and clinical input, and then transferred into the Alaris® GP
Volumetric Pump by qualified technical personnel.
INTENDED USE:
The pump is designed to meet the infusion requirements within the operating environment specified in this Directions For Use (DFU)
including general wards, critical and intensive care, operating rooms and accident and emergency rooms.
This pump is suitable for use by appropriately trained clinicians or nurses. This pump can be used for Intravenous modes, supporting fluid
therapy, drug therapy, blood transfusions and parenteral nutrition.
The Asena® brand name has been recently changed to the Alaris® brand name. This change in brand name has no effect on the intended
use or functionality of the product. Recommended disposable products for use with this product may refer to either the Asena® brand name
or Alaris® brand name and both types are suitable for use with this infusion pump.

1000DF00152 Issue 1 3/42
Creating a Data Set
To create a data set for the Alaris® GP Volumetric Pump, first the hospital will need to develop, review, approve, upload according to the
following process. Refer to the Alaris® GP Editor help file for further details and operating precautions.
1. Create Care Area data set (Using Alaris® GP Editor)
Drug List Drug names and concentrations for a data set with default value and maximum
limits.
Up to 100 unique drug names/drug protocol set-ups.
Pump Configuration* Pump configuration settings and units for dosing only.
2. Review, approve and export data set (Using Alaris® GP Editor)
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® GP Transfer Tool, or to back up a data set, or
to move the data set to another PC.
3. Upload data set to Alaris® GP Volumetric Pump (Using Alaris® GP Transfer Tool)
* See note in Pump Configuration section.
AData set transfers should only be performed by qualified technical personnel.
Drug parameters have to be in accordance with local regulation and prescribed information.

1000DF00152 Issue 1 4/42
Features of the Alaris® GP Volumetric Pump
Alarm indicator
Flow sensor
connector
RS232/Nursecall
connector (cover
removed for clarity)
Release lever for rotating cam
Folded pole clamp
Rotating cam to lock onto
horizontal rectangular bars.
Mains fuses cover
Mains inlet
IR communications port
Potential Equalisation (PE)
Connector
Alaris®
GP
Display
Run
Bolus
Hold
Options
AC power indicator
Softkeys
Chevrons
Mute
Pressure
Battery indicator
On/Off
Door
Door Lever
Handle
Medical device
interface (MDI)

1000DF00152 Issue 1 5/42
Controls and Indicators
Symbol Description
aON/OFF button - Press once to switch the pump ON. Press and hold down
for approximately 3 seconds to switch the pump OFF.
bRUN button - Press to start the infusion. The green LED will flash during
infusion.
hHOLD button - Press to put the infusion on hold. The amber LED will be lit
while on hold.
cMUTE button - Press to silence alarm for (approximately) 2 minutes. The
alarm will resound after this time.
i
BOLUS button - Press to access BOLUS softkey. Press and hold down softkey
to operate.
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.
dOPTION button - Press to access optional features.
ePRESSURE button - Use this button to display the pumping pressure and
adjust the alarm limit.
fCHEVRON keys - Double or single for faster / slower increase / decrease of
values shown on display.
gBLANK SOFTKEYS - Use in conjunction with the prompts shown on the
display.
Symbol Description
SAC POWER indicator - When illuminated the pump is connected to an AC
power supply and the battery is being charged.
jBATTERY 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.
Controls:
Indicators:

1000DF00152 Issue 1 6/42
Symbol Definitions
Symbol Description
wAttention (Consult accompanying document)
xPotential Equalisation (PE) Connector
RS232/Nursecall Connector.
Defibrillation-proof type CF applied part. (Degree of protection against electrical shock)
Protected against vertically falling drops of water
rAlternating Current
sDevice complies with the requirements of the EC Directive 93/42/EEC. Registered with the CE
Mark.
TDate of Manufacture
tManufacturer
Connector for Flow Sensor
AImportant Information
UNot for Municipal Waste
WFuse rating
Labelling Symbols:
IPX1

1000DF00152 Issue 1 7/42
Main Display Features
Infusion Status/
Drug Name/Primary or
Secondary
(Only if secondary is enabled in the
data set)
Infusion Rate
Clear Volume
Infused
Set VTBI Option
Volume Infused
Softkeys
Softkey Identifiers
ON HOLD
RATE
VOLUME VTBI
ml/h
VOLUME ml
25.0
50.0
Screen icon:
Main Display - If VTBI is set:
Main Display - If VTBI has not been set (flow sensor must be used):
Infusion Status/
Drug Name/Primary or
Secondary
(Only if secondary is enabled in the
data set)
Infusion Rate
Clear Volume
Infused
Set VTBI Option
Volume Infused
Softkeys
Softkey Identifiers
ADRENALINE*
RATE
VOLUME VTBI
25.0 ml/h
µg/kg/24h
16.7
1h 48m 00s
VTBI
VOLUME
ml
ml
45.0
50.0
Time Remaining
Volume to be 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.
*DRUG PROTOCOL symbol - Indicates drug protocol is in use.
PRESSURE INFORMATION icon - Shows the pressure from level 0 being the first bar to level
8. Alarm limits: level 2, 5 or 8.
Dose Rate
ON HOLD
RATE
SET RATE WITH
If the rate has not been set
and is showing at 0.0ml/h,
then message a) will be
displayed.
a)
b)
c)
If programmed rate is
between 0.0ml/h and
1.0ml/h exclusive in drug
protocol, message b) will
be shown.
If programmed rate is
greater than the Infusion
Rate Max in drug protocol,
message c) will be shown.
ON HOLD
RATE
RATE TOO LOW
ON HOLD
RATE
RATE TOO HIGH

1000DF00152 Issue 1 8/42
Infusion Sets
To ensure correct and accurate operation, only use Cardinal Health 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.
The infusion set may be fitted with an in-line clamp, which can be used to occlude tubing in case it is
required to stop fluid flow.
The Alaris® GP Volumetric 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 Alaris® GP Volumetric Pump set 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.
Operating Environment
 When using any infusion pump in conjunction with other pumps or devices requiring vascular access,
extra care is advised. Adverse delivery of medication or fluids can be caused by the substantial variation
in pressures created within the fluid channels of such pumps. Typical examples of those pumps are
used during dialysis, bypass or cardiac assist applications.
 The pump is suitable for use in all establishments, including domestic establishments and those directly
connected to the public low voltage power supply network that supplies buildings used for domestic
purposes.
 This pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or
oxygen or nitrous oxide.
Operating Pressure
The pumping pressure alarm system is not designed to provide protection against, or detection
of extravasation or tissuing, complications which can occur.
Operating Precautions
Steps for Semi-rigid containers
4.
5.
3.
2.
Spike the
container
Fill drip
chamber to
fill line
Prime the set by
opening / closing the
roller clamp
1.
Close the
roller clamp
Open the air vent
to allow pressure
equalisation - ready
for infusion
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.

1000DF00152 Issue 1 9/42
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.
Electromagnetic Compatibility and Interference
M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.
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/EN60601-
1-2. If the pump interacts with other equipment, measures should be taken to minimise the effects, for
instance by repositioning or relocation.
Earth Conductor

The Alaris®GP Volumetric Pump is a Class I device, therefore must be earthed when connected to an AC
power supply.
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.
Hazards
B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.
VDo not open the RS232/Nurse Call protective covering when not in use. Electrostatic discharge
(ESD) precautions are required when connecting RS232/Nurse Call. Touching the pins of the
connectors may result in ESD protection failure. It is recommended that all actions must be taken by
appropriately trained personnel.
If this pump is dropped, subjected to excessive moisture, fluid spillage, humidity or high
temperature, or otherwise suspected to have been damaged, remove it from service for inspection
by a qualified service engineer. When transporting or storing the pump, use original packaging
where possible, and adhere to temperature, humidity and pressure ranges stated in the
Specifications section and on the outer packaging.
If this pump behaves abnormally, remove from service and contact a qualified service engineer.
Latex Content
 The Alaris® GP Volumetric Pump does not contain any latex.
Operating Precautions (Continued)
Alaris®
GP
Alaris®
GP
Alaris®
GP