Alaris 800TIG2ESD1, 800TIG2CZD1, 800TIG2DED1, 800TIG2GBD1, 800TIG2EED1 Directions For Use Manual
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Alaris™ GW 800
Volumetric Pump
Directions For Use
en
s
Alaris™ GW 800 Volumetric Pumps
Contents
Introduction ..............................................................................................3
Intended Purpose ........................................................................................................3
Conditions for Use .......................................................................................................3
Indications ...............................................................................................................3
Contraindications ........................................................................................................3
About This Manual ........................................................................................4
Conventions used in this manual .........................................................................................4
Features of the Alaris GW 800 Volumetric Pump ............................................................5
Controls and Indicators ....................................................................................6
Controls .................................................................................................................6
Indicators: (when illuminated) ............................................................................................6
Symbol Definitions ........................................................................................7
Labelling Symbols: .......................................................................................................7
Operating Precautions ....................................................................................8
Infusion Sets .............................................................................................................8
Mounting the Pump .....................................................................................................8
Operating Pressure .......................................................................................................8
Alarm Conditions ........................................................................................................8
Using Collapsable bags, Glass Bottles & Semi Rigid containers .............................................................8
Operating Environment ..................................................................................................9
Electromagnetic Compatibility and Interference ..........................................................................9
Earth Conductor ........................................................................................................10
Hazards .................................................................................................................10
Getting Started ..........................................................................................11
Initial Set Up ............................................................................................................11
Power Input ............................................................................................................11
Pole Clamp Installation ..................................................................................................12
Docking Station/Workstation* or Equipment Rail Installation .............................................................12
Loading an Infusion Set .................................................................................................13
Power On/Off ..........................................................................................................14
Battery Operation .......................................................................................................14
Priming the Infusion Set ................................................................................................15
Automatic Set Detection ................................................................................................15
Starting the Infusion with a Flow Sensor (Recommended) .................................................16
Standard Mode .........................................................................................................16
Standard Mode with VTBI / Time Infusion on .............................................................................16
Micro Mode .............................................................................................................16
Micro Mode with VTBI / Time Infusion on ................................................................................16
Starting the Infusion without a Flow Sensor ...............................................................17
Standard Mode .........................................................................................................17
Standard Mode with VTBI / Time Infusion on .............................................................................17
Micro Mode .............................................................................................................17
Micro Mode with VTBI / Time Infusion on ................................................................................17
Secondary / Piggyback Infusions ..........................................................................18
Typical Secondary Infusions: .............................................................................................18
Basic Features ............................................................................................19
Rate Titration ...........................................................................................................19
Bolus Infusions ..........................................................................................................19
Panel Lock ..............................................................................................................19
Optimising the Pumps Performance .....................................................................................19
Hold Mode .............................................................................................................19
KVO (Keep Vein Open) Rate ..............................................................................................19
Changing the Infusion Set ...............................................................................................20
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Alaris™ GW 800 Volumetric Pumps
Changing the Fluid Container ...........................................................................................20
SmartSite™ Needle-Free System Instructions .............................................................................20
Clearing Air-In-Line .....................................................................................................21
User Selectable Options ..................................................................................22
Check the Battery Status ................................................................................................22
Setting the Occlusion Pressure Level .....................................................................................22
Setting the Alarm Volume ...............................................................................................22
Setting a VTBI / Time Infusion ............................................................................................22
Setting to Micro Mode ..................................................................................................22
Configurable Options ....................................................................................23
Alarms ...................................................................................................24
Advisories ................................................................................................25
Flow Sensor Operation ...................................................................................26
Flow Sensor Usage ......................................................................................................26
Model 180 Flow Sensor ..................................................................................................26
Compatible Infusion Sets .................................................................................27
Standard Sets ...........................................................................................................27
Blood Sets ..............................................................................................................27
Filter Sets ...............................................................................................................28
Burette Sets .............................................................................................................28
Opaque Sets ............................................................................................................28
Low Sorbing Sets .......................................................................................................28
Secondary Sets .........................................................................................................28
Filter Extension Sets .....................................................................................................29
Oncology Sets ..........................................................................................................29
Associated Products ......................................................................................30
The Alaris Gateway Workstation .........................................................................................30
The Alaris DS Docking Station ...........................................................................................30
Maintenance .............................................................................................31
Routine Maintenance Procedures ........................................................................................31
Battery Operation .......................................................................................................31
Disposal ................................................................................................................31
Cleaning and Storage ....................................................................................32
Cleaning the Pump ......................................................................................................32
Storing the Pump .......................................................................................................32
Cleaning and storing the Infusion set ....................................................................................32
Cleaning the Flow Sensor ...............................................................................................32
Specifications ............................................................................................33
IrDA, RS232 and Nurse Call Specification ..................................................................36
RS232 / IrDA Feature ....................................................................................................36
Nurse Call Feature .......................................................................................................36
RS232 / Nurse Call Connection Data .....................................................................................36
Trumpet and Flow Rate Curves ...........................................................................37
Technical Description ....................................................................................38
Power on Self-Tests .....................................................................................................38
Air-in-Line ..............................................................................................................38
Downstream Occlusion Pressure .........................................................................................38
Upstream Occlusion Pressure ............................................................................................38
Pump Based Free Flow Protection .......................................................................................38
Anti-Bolus Function .....................................................................................................38
Spare Parts ..............................................................................................39
Document History ........................................................................................39
Contact Us ...............................................................................................40
Customer Service Information ...........................................................................................40
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Alaris™ GW 800 Volumetric Pumps
Introduction
Introduction
The Alaris™ GW 800 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.
This Directions for use can be used with the following Alaris GW 800 Volumetric Pumps:-
• 800TIG2GBD1
• 800TIG2CZD1
• 800TIG2DED1
• 800TIG2ESD1
• 800TIG2EED1
• 800TIG2FID1
• 800TIG2FRD1
• 800TIG2HRD1
• 800TIG2HUD1
• 800TIG2ITD1
• 800TIG2NLD1
• 800TIG2PLD1
• 800TIG2SRD1
• 800TIG2SED1
• 800TIG2TRD1
Intended Purpose
The Alaris GW 800 Volumetric Pump is intended for use by medical staff for the purpose of controlling infusion rate and volume.
Conditions for Use
The Alaris GW 800 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.
The user must be thoroughly familiar with the Pump and have been trained as per training document 0000CF02888.
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Indications
The Alaris GW 800 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 800 Volumetric Pump is indicated for use on adults and paediatrics.
Contraindications
The Alaris GW 800 Volumetric Pump is contraindicated for enteral therapies.
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Alaris™ GW 800 Volumetric Pumps
About This Manual
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.
Keep this Manual for future reference during the Pump’s operational life.
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Conventions used in this manual
BOLD Used for Display names, software commands, controls and indicators referenced in this manual, for
'Single quotes' Used to indicate cross-references made to another section of this manual.
Italics Used to refer to other documents or manuals and also used for emphasis.
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It is important to ensure that you only refer to the most recent version of the Directions for Use and Technical Service
Manual for your 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.
example, AC Power Indicator,
Caution: Wherever this symbol is shown an Important note is found. These notes highlight an aspect of
use that is important for the user to be aware of when operating the Pump.
E, ON/OFF button.
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Alaris™ GW 800 Volumetric Pumps
Features of the Alaris GW 800 Volumetric Pump
Features of the Alaris GW 800 Volumetric Pump
Display Indicators
Main Display -
Displays the infusion rate, VTBI, VI
and time remaining for VTBI / Time
infusions. Display will flash when
Pump is operating on battery.
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.
Mute Indicator
Alarm Indicator
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 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™ GW 800 Volumetric Pumps
Controls and Indicators
d
m
b
l
e
hf
Indicators: (when illuminated)
RUN/HOLD button - Press to start the infusion or to put the infusion on hold.
CLEAR/MUTE button - Press to silence alarm or advisories for 1 minute. The audio from the alarm or advisories
will resound after this time. Resets numeric values to zero.
Note: To re-enable the alarm audio press any other button or key to unmute.
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/h
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 h is illuminated the
Pump displays the rate or infusion time.
ALARM Indicator - When flashing indicates the Pump is in an alarm condition.
MUTE Indicator - When flashing indicates the Pump audio alarm is muted.
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Symbol Definitions
Labelling Symbols:
Symbol Description
Consult accompanying documents
Alaris™ GW 800 Volumetric Pumps
Symbol Definitions
x
>
k
IP32
r
s
T
t
+
U
W
Potential Equalisation (PE) Connector
RS232/Nursecall Connector.
Type CF applied part. (Degree of protection against electrical shock)
Protected against direct sprays of water up to 15° from vertical and protected against solid objects greater
than 2.5mm.
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
Fuse rating
V
W
X
Y
,
.
Infusion indicator - Infusing in Standard mode.
Infusion indicator - Infusing in Micro mode.
Infusion indicator - Displays fluid drops detected by the flow sensor when infusing in Standard mode.
Infusion indicator - Displays fluid drops detected by the flow sensor when infusing in Micro mode.
Battery Status indicator - Displays status of battery, battery has greater than 30 minutes run time.
Battery Status indicator - Displays status of battery, battery is low and has approximately 30 minutes or less
run time.
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Operating Precautions
Infusion Sets
• To ensure correct and accurate operation, only use BD 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 800 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 800 Volumetric Pumps
Operating Precautions
^
%;
$
• 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.
• Alarm tone settings are preserved in the case of 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.
Using Collapsable bags, Glass Bottles & Semi Rigid containers
• It is recommended that the air vent be opened on the Alaris GW 800 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
Steps for Semi-rigid containers
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.
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2.
Spike the
container
1.
Close the
roller clamp
3.
Fill drip
chamber to
fill line
8/40
Open the air vent
to allow pressure
equalisation - ready
for infusion
5.
Prime the set by
opening / closing the
roller clamp
4.
/
MR
&
Alaris™ GW 800 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. (Consult Technical Service Manual, appropriately trained Qualified Service
Personnel or BD 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 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 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,
BDTM00005.
BDDF00144 Issue 1
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d
m
V
*
Alaris™ GW 800 Volumetric Pumps
Operating Precautions
Earth Conductor
• The Alaris GW 800 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 800 Volumetric Pumps should not be modified or altered in any way, except where
explicitly directed or authorised by BD. Any use of Alaris GW 800 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 GW 800 Volumetric Pump that has been so
modified or altered. BD product warranty shall not apply in the event the Alaris GW 800 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 800 Volumetric Pump.
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Alaris™ GW 800 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 800 Volumetric Pump
• Electronic Instructions For Use Insert
• 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
lit).
The Pump will automatically operate from its internal battery if the Pump is switched on without being connected
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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 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.
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Alaris™ GW 800 Volumetric Pumps
Getting Started
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
Docking Station/Workstation* or Equipment Rail Installation
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.
Rectangular bar
Warning: Pump may fall off the Docking Station/Workstation* if not properly mounted which could result in user and/or
patient harm.
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.
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. Ensure that the Pump is positioned securely. Verify Pump is
secure by gently pulling the Pump away from the Docking
Station/Workstation* without using the release lever. When the
Pump is securely attached, it should not come off the Docking
Station/Workstation*.
5. To release, push the release lever and pull the pump forwards.
BDDF00144 Issue 1
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