Care Fusion Alaris GW Directions For Use Manual

Alaris® GW Volumetric Pump
Directions For Use
en
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Alaris® GW Volumetric Pumps
Introduction ..............................................................................................2
About This Manual ........................................................................................2
Quick Start Guide .........................................................................................2
Features of the Alaris® GW Volumetric Pump ...............................................................3
Controls and Indicators ....................................................................................4
Symbol Definitions ........................................................................................5
Operating Precautions ....................................................................................6
Getting Started ...........................................................................................9
Starting the Infusion with a Flow Sensor (Recommended) .................................................12
Starting the Infusion without a Flow Sensor ...............................................................13
Secondary / Piggyback Infusions ..........................................................................14
Basic Features ............................................................................................15
User Selectable Options ..................................................................................18
Configurable Options ....................................................................................19
Alarms ...................................................................................................20
Warnings ................................................................................................21
Flow Sensor Operation ...................................................................................22
Compatible Infusion Sets .................................................................................23
Associated Products ......................................................................................26
Maintenance .............................................................................................27
Cleaning and Storage ....................................................................................28
Specifications ............................................................................................29
IrDA, RS232 and Nurse Call Specification ..................................................................32
Trumpet and Flow Rate Curves ...........................................................................33
Technical Description ....................................................................................34
Products and Spare Parts .................................................................................35
Service Contacts .........................................................................................36
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Alaris® GW Volumetric Pumps
Introduction
Introduction
The Alaris® GW Volumetric Pump (herein after referred to as 'Pump') is a small lightweight volumetric infusion pump that provides accurate and reliable infusions over a range of rates.
The ideal pump for general care and critical care.
Intended Purpose
The Alaris® GW Volumetric Pump is intended for use by medical staff for the purpose of controlling infusion rate and volume.
Conditions for Use
The Alaris® GW 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® GW Volumetric Pump is indicated for the infusion of fluids, medications, parenteral nutrition, blood and blood products through clinically acceptable routes of administration; such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces. The Alaris® GW Volumetric Pump is indicated for use on adults and paediatrics.
Contraindications
The Alaris® GW Volumetric Pump is contraindicated for enteral therapies.
About This Manual
The user must be thoroughly familiar with the pump described in this manual prior to use. All illustrations used in this manual show typical settings and values which may be used in setting up the functions of the pump. These settings and values are for illustrative use only. The complete range of settings and values are detailed in the specifications
section.
It is important to ensure that you only refer to the most recent version of the Directions for Use and Technical Service
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Manual for your CareFusion products. These documents are referenced on www.carefusion.com. Copies can be obtained by contacting your local CareFusion representative.
Conventions used in this manual
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.
Important Information: Wherever this symbol is shown an Important note is found. These notes highlight
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an aspect of use that is important for the user to be aware of when operating the pump.
Quick Start Guide
1. Half fill the drip chamber.
2. Press
3. Load the infusion set and open in-line clamp.
4. Prime (
5. Enter rate using
6. Press
7. Enter VTBI using
8. Press
9. If necessary, press
10. Connect Infusion set to the patient access device.
11. Press
a to switch pump on.
E) set: Press b once. Whilst E is displayed press b again and hold to clear all visible air from the line.
h / f.
e once to confirm and scroll to VTBI.
h / f , or, if using a Flow sensor, the VTBI can be switched off by scrolling f until OFF is displayed.
e to confirm and scroll to VI.
c to clear VI.
d to start infusion.
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Alaris® GW Volumetric Pumps
Features of the Alaris® GW Volumetric Pump
Features of the Alaris® GW Volumetric Pump
Display Indicators
Flow Stop Mechanism ­When activated the mechanism
will stop fluid flow.
Air Sensor
Bevel ­Releases the flow
stop mechanism lever arm when the door is closed.
Door Latch ­Press outer latch to
open the pump door.
Main Display ­Displays the infusion rate, VTBI, VI
and time remaining for VTBI / Time infusions. Display will flash when pump is operating on battery.
Keypad
Flow Direction Label
Pressure Sensor
Tubing Guide ­Guide to assist in the loading
of the Infusion set.
Release Lever ­For Rotating cam.
Rotating Cam ­To lock onto the
rectangular bars.
Mains Fuses
Mains Inlet
Potential Equalisation (PE) connector
RS232 / Nurse call Connector
Flow Sensor Interface
Folded Pole Clamp
Infra Red Communications port (IrDA)
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Controls and Indicators
Controls
Symbol Description
ON/OFF button - Press once to switch the pump ON. Press and hold down for approximately 3 seconds to
a
switch the pump OFF.
Alaris® GW Volumetric Pumps
Controls and Indicators
d
c
b
l
e
hf
Indicators: (when illuminated)
RUN/HOLD button - Press to start the infusion or to put the infusion on hold.
CLEAR/SILENCE button - Press to silence alarm for 1 minute. The alarm will resound after this time. Resets
numeric values to zero.
PRIME/BOLUS button - Primes the Infusion set. Administers bolus during the infusion.
PRIMARY/SECONDARY button - Switches the pump between Primary and Secondary infusion modes. (If
enabled).
ENTER button - Scrolls between rate, time, VTBI and total volume infused (VI). Enters values for selected infusion / configuration parameters. Confirms the rate during an infusion titration.
CHEVRON keys - Increases or decreases the infusion rate, TIME limit and VTBI. Press and hold to increase the selection speed. Used to adjust user selectable options
Symbol Description
S
RATE The pump is displaying the infusion rate in millilitres per hour (ml/h).
VTBI The pump is displaying the Volume To Be Infused (VTBI) in millilitres (ml).
VI The pump is displaying the Volume Infused (VI) in millilitres (ml).
TIME The pump is displaying the infusion time in hours : mins.
MICRO The pump is operating in the MICRO Mode. When not illuminated the pump is in the STANDARD Mode.
SEC The pump is operating in the SECONDARY Mode. When not illuminated the pump is in the PRIMARY Mode.
ml/hr
AC POWER indicator - When illuminated the pump is connected to an AC power supply.
(Millilitres / hour) When ml is illuminated the pump displays the rate, VTBI or VI. When the hr is illuminated the pump displays the rate or infusion time.
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Symbol Definitions
Labelling Symbols:
Symbol Description
Alaris® GW Volumetric Pumps
Symbol Definitions
w
x
>
k
O
r
s T
t
+
U
Attention Consult accompanying documents
Potential Equalisation (PE) Connector
RS232/Nursecall Connector.
Type CF applied part. (Degree of protection against electrical shock)
Protected against vertically falling drops of water
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
Not for Municipal Waste
W
EC REP Authorised representative in the European Community
V
W
X
Y
Fuse rating
Infusion indicator - Infusing at a normal rate.
Infusion indicator - Infusing in MICRO mode.
Infusion indicator - Displays fluid drops detected by the flow sensor when infusing at a normal rate.
Infusion indicator - Displays fluid drops detected by the flow sensor when infusing in MICRO mode.
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Operating Precautions
Infusion Sets
• To ensure correct and accurate operation, only use CareFusion single use infusion sets described in the 'Compatible Infusion Sets' section of this Directions for Use. Use an infusion set with an anti-siphon valve whenever possible. The anti-siphon valve prevents free flow from occurring if an infusion set is incorrectly loaded or removed from the pump.
• 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. 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
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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® GW 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.
Mounting the Pump
Alaris® GW Volumetric Pumps
Operating Precautions
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• The fluid height in the container must not be more than 1 metre above the patients heart.
• Do not mount the pump in a vertical position with the AC power inlet pointing upwards as this could affect
electrical safety, in the event of a fluid spill over the pump.
Operating Pressure
• The pumping pressure alarm system is not designed to provide protection against, or detection of, IV complications which can occur.
Alarm Conditions
• Several alarm conditions detected by this pump will stop the infusion and generate visual and audible alarms. Users must perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating.
Using Collapsable bags, Glass Bottles & Semi Rigid containers
• It is recommended that the air vent be opened on the Alaris® GW 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.
Steps for the Collapsable 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.
Steps for Semi-rigid containers
2.
Spike the container
1.
Close the roller clamp
3.
Fill drip chamber to fill line
Open the air vent to allow pressure equalisation - ready for infusion
5.
Prime the set by opening / closing the roller clamp
4.
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Alaris® GW Volumetric Pumps
Operating Precautions
Operating Environment
• When using any infusion pump in conjunction with other pumps or devices requiring vascular access, extra care is advised. Adverse delivery of medication or fluids can be caused by the substantial variation in pressures created within the local vascular system by such pumps. Typical examples of those pumps are used during dialysis, bypass or cardiac assist applications.
• This pump is suitable for use in Hospital and clinical environments other than domestic establishments and those directly connected to the public single phase AC mains power supply network that supplies buildings used for domestic purposes. However, it may be used in domestic establishments under the supervision of Medical professionals with additional necessary appropriate measures. (Consult Technical Service Manual, appropriately trained qualified service personnel or CareFusion for further information).
• This pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide.
Electromagnetic Compatibility and Interference
• This pump is protected against the effects of external interference, including high energy radio frequency emissions, magnetic fields and electrostatic discharge (for example, as generated by electrosurgical and cauterising equipment, large motors, portable radios, cellular telephones etc.) and is designed to remain safe when unreasonable levels of interference are encountered.
• Therapeutic Radiation Equipment: Do not use the pump in the vicinity of any Therapeutic Radiation Equipment. Levels of radiation generated by the radiation therapy equipment such as Linear Accelerator, may severely affect functioning of the pump. Please consult manufacturer’s recommendations for safe distance and other precautionary requirements. For further information, please contact your local CareFusion representative.
• Magnetic Resonance Imaging (MRI): The pump contains ferromagnetic materials which are susceptible to interference with magnetic field generated by the MRI devices. Therefore, the pump is not considered an MRI compatible pump as such. If use of the pump within an MRI environment is unavoidable, then CareFusion highly recommends securing the pump at a safe distance from the magnetic field outside the identified Controlled Access Area in order to evade any magnetic interference to the pump; or MRI image distortion. This safe distance should be established in accordance with the manufacturers’ recommendations regarding electromagnetic interference (EMI). For further information, please refer to the product technical service manual (TSM). Alternatively, contact your local CareFusion representative for further guidance.
• Accessories: Do not use any non-recommended accessory with the pump. The pump is tested and compliant with the relevant EMC claims only with the recommended accessories. Use of any accessory, transducer or cable other than those specified by CareFusion may result in increased emissions or decreased pump immunity.
• 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 qualified service 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/EN60601-1-2 and IEC/EN60601-2-24. If the pump interacts with other equipment, measures should be taken to minimise the effects, for instance by repositioning or relocation.
• For further information on electromagnetic compatibility, please consult Technical Service Manual, 1000SM00006.
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d
m
V
*
Alaris® GW Volumetric Pumps
Operating Precautions
Earth Conductor
• The Alaris® GW 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
• An explosion hazard exists if the pump is used in the presence of flammable anaesthetics. Exercise care to locate the pump away from any such hazardous sources.
• A fire hazard may exist if the pump is used in the presence of high oxygen concentrations.
• Dangerous Voltage: An electrical shock hazard exists if the pump’s casing is opened or removed. Refer all
servicing to qualified service personnel.
• 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 qualified service personnel.
• If this pump is dropped, subjected to excessive moisture, fluid spillage, humidity or high temperature, or otherwise suspected to have been damaged, remove it from service for inspection by qualified service personnel. When transporting or storing the pump, use original packaging where possible, and adhere to temperature, humidity and pressure ranges stated in the Specifications section and on the outer packaging.
• Warning: Alaris® GW Volumetric Pumps should not be modified or altered in any way, except where explicitly directed or authorised by CareFusion. Any use of Alaris® GW Volumetric Pumps which have been altered or modified otherwise than in strict application of directions provided by CareFusion, is at your sole risk, and CareFusion does not provide any warranty for or endorsement on any Alaris® GW Volumetric Pump that has been so modified or altered. CareFusion’s product warranty shall not apply in the event the Alaris® GW 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® GW Volumetric Pump.
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Alaris® GW Volumetric Pumps
Getting Started
Getting Started
Before operating the pump read this Directions For Use (DFU) manual carefully.
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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® GW Volumetric Pump
• User Support CD (Directions For Use)
• AC Power Cable (as requested)
• Protective Packaging
3. Connect the pump to the AC power supply for at least 2½ hours to ensure that the internal battery is charged (verify that the is lit).
The pump will automatically operate from its internal battery if the pump is switched on without being connected
A
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.
S
Pole Clamp Installation
A 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.
Recessed area
1. Pull the folded pole clamp towards you and unscrew the clamp to leave enough room for the size of the pole.
2. Place pump around pole and tighten screw until the clamp is secured to the pole.
Never mount the pump such that the Infusion stand becomes
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top heavy or unstable.
Ensure pole clamp is folded away and stored within recessed area at the rear of the pump before connecting to a Docking Station/Workstation* or when not in use.
Prior to each use, check the pole clamp:
• does not show any signs of excessive wear,
• does not show any signs of excessively loose movement in the
extended, mountable position.
If these signs are observed, the pumps should be taken out of service for examination by qualified service personnel.
Docking Station/Workstation* or Equipment Rail Installation
Rectangular bar
Release lever
Rotating cam
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 'clicks' securely into position onto the rail or bar.
4. To release, push the release lever and pull the pump forwards.
It is recommended that infusion bags be located on a hanger directly above the pump with which they are being
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*Alaris® DS Docking Station and Alaris® Gateway Workstation.
used. This minimises the potential for confusion of Infusion sets when multiple volumetric pumps are used.
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Loading an Infusion Set
Ensure the appropriate Infusion set for the fluid/drug to be infused has been selected.
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Follow the instructions supplied with the individual Infusion set.
Use of non-specified Infusion sets may impair the operation of the pump and the accuracy of the infusion. For Alaris® GW Volumetric Pump Infusion sets refer to 'Infusion Sets' section of the DFU.
Position the IV fluid container to avoid spillage onto the pump.
Ensure that the tubing is inserted completely into the pumping channel, avoiding any slack.
When using 273-003, 273-003V, 273-303E and 273-303EV Infusion sets, ensure a separation of at least 50cm is maintained between the pump and the upper Back Check Valve.
Alaris® GW Volumetric Pumps
Getting Started
1. Close the in-line clamp on the Infusion set. Press the door latch to open the tubing cover door.
2. Release the flow stop mechanism by pushing the lever arm up and to the right.
3. Avoiding any slack, insert the infusion set from left to right into the slot provided, following the flow direction label. Make sure that the infusion set is pressed firmly past the constriction points and into the slots on either side of the casing.
4. Re-engage the flow stop mechanism by pushing the lever left and down.
5. Close the tubing cover door. Use the recesses in the cover door to press the door firmly to ensure the latch is correctly applied. Open in-line clamp on the Infusion set.
6. Observe fluid chamber and check for no fluid flow.
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Alaris® GW Volumetric Pumps
Power On/Off
To power up the pump:
1. Press the a button once and release.
2. Check:
• A high pitch sounder is activated for 3 seconds during this time the main speaker 'beeps' once upon power up sequence.
• All display segments and all indicators are lit.
• If an error occurs during self-test the pump will alarm.
3. After this self-test the pump will display last rate setting entered or zero, depending on the configuration.
To power down the pump:
1. Press and hold a. The pump will display OFF3-OFF2-OFF1.
2. If the
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Priming the Infusion Set
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a button is released during the countdown the pump will not power down and it will return to its previous state.
If the pump alarms, segments / indicators do not light up correctly or 2 audible sounds are not heard, then the pump must be powered down immediately, and qualified service personnel contacted. If transportation to an engineer is necessary, it is recommended to use the original protective packaging.
Use an infusion set with an anti-siphon valve whenever possible. The anti-siphon valve prevents free flow from occurring if an infusion set is incorrectly loaded or removed from the pump. Infusion sets with an anti-siphon valve can only be primed when loaded in the pump.
When using infusion sets without an anti-siphon valve eg. 273-004, 273-007 and 273-008, the infusion set can be primed without using the pump. Use of a flow sensor is recommended when using an infusion set without an anti­siphon valve. The flow sensor will cause the pump to alarm if a significant deviation from the set infusion rate occurs.
Getting Started
1. Ensure the pump is switched on and in-line clamp is open.
2. Load the Infusion set (see 'Loading the Infusion Set').
3. Press
4. Press and Hold
5. Attach the set to the patient or other Infusion set.
6. Start the infusion (see 'Starting the Infusion').
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b button once E will be displayed.
b button while E is still displayed, prime the Infusion set until there is no visible air in the IV line (according to
hospital protocol).
Use the prime function to fill the Infusion sets before starting an infusion.
Never connect the Infusion set to the patient during the priming process.
The prime (
E) volume delivered will not be subtracted from the VTBI, or added to the total volume infused.
Automatic Set Detection
The pump automatically tests that a compatible CareFusion Infusion set has been loaded correctly (refer to 'Compatible Infusion Sets' section of this DFU). The test will occur at the start of the first infusion after the pump is switched on or after the door has been opened; the pump will run in reverse for 10 seconds and then forward for 10 seconds, the test takes a maximum of 20 seconds to complete. During this operation the clinician may observe a blood return that will be more evident if using a small catheter.
If the pump fails to detect a correct CareFusion Infusion set or detects a possible set misload, then the pump will alarm and display
Q refer to 'Alarms and Warnings' section of this DFU.
Please contact your local CareFusion representative if further information or support is required regarding the Automatic Set Detection operation or the application of this pump in specific clinical settings, e.g. neonatal.
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