CareFusion Alaris CC Guardrails 80033UND1-G, Alaris GH Guardrails 80023UN-G Series, Alaris GH Guardrails 80023NW-G Series Directions For Use Manual
Alaris® CC Guardrails®
Syringe Pump
Models: 80033UND1-G
Directions For Use
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Contents
Page
Introduction ..............................................................................................2
About This Manual ........................................................................................2
Creating a Data Set .......................................................................................3
Features of the Alaris® CC Guardrails® Syringe Pump ........................................................4
Controls & Indicators ......................................................................................5
Symbol Denitions ........................................................................................6
Main Display Features .....................................................................................7
Operating Precautions ....................................................................................8
Getting Started ..........................................................................................10
Syringe Loading ..........................................................................................12
Starting the pump .......................................................................................15
Basic Features ............................................................................................17
Alarms and Warnings .....................................................................................21
Prompts .................................................................................................22
Congured Options ......................................................................................23
Specications ............................................................................................26
Recognised Syringes .....................................................................................27
Associated Products ......................................................................................28
Compatible Extension Sets ...............................................................................29
Maintenance .............................................................................................31
Occlusion Pressure Limits .................................................................................33
IrDA, RS232 and Nurse call Specication ..................................................................34
Trumpet Curves and Start-up Curves ......................................................................35
Products and Spare Parts .................................................................................36
Service Contacts .........................................................................................37
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Introduction
The Alaris® CC Guardrails® Syringe Pump (herein after referred to as "pump") is a fully featured high end variable pressure syringe pump
suitable for critical care applications.
The Alaris® CC Guardrails® Syringe Pump functions with a wide range of standard, single-use, disposable Luer lock syringes together with
extension sets. It accepts syringe sizes from 5ml to 50ml. A full list of compatible syringes can be found in the Compatible Syringes section.
A list of recommended extension sets can be found in the Compatible Extension Sets section.
The Guardrails® Safety Software for the Alaris® CC Guardrails® Syringe Pump brings a new level of medication error prevention to the point
of patient care. The Guardrails® Safety Software allows the hospital to develop a best-practice Data Set of IV medication dosing guidelines for
patient-specic care areas, referred to as proles. Each prole contains a specic library of drugs, as well as pump congurations appropriate
for the care area. A prole also contains either Guardrails® Hard Limits that cannot be overridden during infusion programming, or Guardrails®
Soft Alerts that can be overridden, based on clinical requirements.
The hospital dened Data Set is developed and approved through pharmacy and clinical input, and then congured into the Alaris® CC
Guardrails® Syringe Pump by qualied technical personnel.
The Alaris® CC Guardrails® Syringe 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.
Intended Purpose
The Alaris® CC Guardrails® Syringe Pump is intended for use by medical sta for purposes of controlling infusion rate and
volume.
Conditions of Use
The Alaris® CC Guardrails® Syringe Pump should only be operated by a clinician competent in use of automated syringe
pumps and post-placement management of intravenous catheters.
CareFusion cannot guarantee the continued system accuracy with other manufacturer’s syringes as identified in the
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‘Compatible Syringes’ table. Manufacturers may change syringe specification significant to system accuracy without
prior notification.
Indications
The Alaris® CC Guardrails® Syringe Pump is indicated for infusion of therapeutics including:
• analgesics
• antimicrobials
• blood products
• chemotherapy
• nutrition
• subcutaneous
• epidural
Contraindications
The Alaris® CC Guardrails® Syringe Pumps is contraindicated for:
• enteral therapies
About This Manual
The user must be thoroughly familiar with the Alaris® CC Guardrails® Syringe 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. Where stated, a minimum infusion rate refers to a nominal rate of 1.0ml/h, and an
intermediate infusion rate refers to a nominal rate of 5.0ml/h. The complete range of infusion rates, settings and values are shown in the
Specifications section.
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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 CareFusion products. These documents are referenced on www.carefusion.com. Copies can be
obtained by contacting your local CareFusion representative.
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Creating a Data Set
To use the Alaris® CC Guardrails® Syringe Pump a Data Set will need to be developed, reviewed, approved, released, uploaded and verified
according to the following process. Refer to the Guardrails® Editor Directions For Use (1000PB01398) for further details and operating
precautions.
1. Create Master Lists (Using Guardrails® Editor)
Master Drugs* A list of drug names and standard concentrations. The Software can store an
unlimited number of entries depending on disk space. Note: When using a
combination of two or more drugs, the dose rate can only be configured for one
drug. Up to 19 characters are available to name the drug or the combination.
Syringe Library Configure syringes enabled for use.
2. Create Care Area Profiles (Using Guardrails® Editor)
Drug Library* Drugs and concentrations for a Profile with minimum & maximum limits and
occlusion alarm level. Up to 100 drug set-ups can be entered for each of the
available 10 Profiles.
Configuration** Pump configuration settings, General Options and Units for Dosing Only.
3. Review, Approve and Release Data Set (Using Guardrails® 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 for use during verification procedure.
Release Data Set status to be promoted to Released (Password is required).
4. Upload Data Set to Alaris® CC Guardrails® Syringe Pump enabled (Using Guardrails® Editor Transfer Tool)
Data Set transfers should only be performed by qualified technical personnel.
5. Verify Data Set Upload
First or Individual Pump Verification On completion of upload, record CRC (Cyclic Redundancy Check) number shown
on the Alaris® CC Guardrails® Syringe Pump. Download the Data Set from the
pump using the Verification Tool. Compare Data Set downloaded with approved
signed Data Set printout. Reviewer should sign the printout and also record the
CRC number on the printout as a record.
Subsequent Pumps Verification On subsequent uploads of the Data Set compare CRC number on pump with CRC
number recorded in First Pump Verification.
* Note: Drug parameters have to be in accordance to local regulation and prescribed information.
** See important note in Configured Options section.
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Features of the Alaris® CC Guardrails® Syringe Pump
Pressure
transducer
ON/OFF
RUN
Display
Release lever for
MDI
High visibility
Alarm Indicator
PURGE/
BOLUS
MUTE
PRESSURE
OPTION
Finger
Grips
Extension set
hook
Rating Plate (see Symbol Definitions for
an explanation of the symbols used)
Release
lever for
Rotating
Cam
HOLD
Shelf for chevron
keys and softkeys
Syringe Clamp
Positive Plunger
Grippers
Pressure
transducer
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a
l
D
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e
I
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f
a
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(
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Rotating Cam to
lock on to horizontal
rectangular bars
Carrying
Handle
IR Communications
Potential
Equalisation
(PE) connector
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Folded Pole
Clamp
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RS232
Connector
Extension set
hook
Controls:
Symbol Description
ON/OFF button - Press once to switch the pump ON. Press and hold down for 3
seconds to switch the pump OFF.
a
RUN button - Press to start the infusion. The green LED will flash during infusion.
b
HOLD button - Press to put the infusion on hold. The amber LED will be lit while on
hold.
h
MUTE button - Press to silence alarm for 2 minutes (configurable). Press and hold
until 3 beeps are heard for 15 minutes silence.
c
PURGE/BOLUS button - Press to access PURGE or BOLUS soft keys. Press and hold
down soft key to operate.
PURGE the extension set during set up.
l Pump is on hold
l Extension set is not connected to the patient
l Volume Infused (VI) is not added
i
BOLUS - fluid or drug delivered at an accelerated rate.
l Pump is infusing
l Extension set is connected to the patient
l VI is added
Controls & Indicators
OPTION button - Press to access optional features (see Basic Features).
d
PRESSURE button - Use this button to display the pumping pressure trend display and
alarm level.
e
CHEVRON keys - Double or single for faster/slower increase or decrease of values
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shown on display.
BLANK SOFTKEYS - Use in conjunction with the prompts shown on the display.
g
Indicators:
Symbol Description
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.
j
AC POWER indicator - When illuminated the pump is connected to an AC power
supply and the battery is being charged.
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Labelling Symbols:
Symbol Description
Attention (Consult accompanying documents)
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Potential Equalisation (PE) Connector
x
RS232/Nurse call Connector (Optional)
y
Defibrillation-proof type CF applied part (Degree of protection against electrical
shock)
l
Symbol Definitions
O
Protected against vertically falling drops of water
r
Alternating Current
Device complies with the requirements of Council Directive 93/42/EEC as amended
by 2007/47/EC.
s
Date of Manufacture
T
Manufacturer
t
Not for Municipal Waste
U
Fuse Rating
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EC REP Authorised representative in the European Community
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Main Display Features
Pump
Status
Infusion
Rate
Screen Icons:
Symbol Description
TIME REMAINING DISPLAY icon - Indicates time before syringe will require replacing.
l
N
BATTERY icon - Indicates battery charge level to highlight when the battery will require recharging.
Guardrails® SOFT ALERT icon - Indicates the pump is running at a rate above (pointing up) or below
(pointing down) a Guardrails® Soft Alert. (Number of arrows vary depending on drug name length)
Syringe type fitted /
Profile / Drug name
Volume
Infused
Volume Infused
Option
Pressure
Information
VTBI
Option
Guardrails® LIMIT WARNING icon - Indicates the setting entered is not permitted as it is under or exceeds a
Guardrails® Hard Limit.
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Operating Precautions
Disposable Syringes and Extension Sets
• Always clamp or otherwise isolate the patient line before unclamping or removing a syringe from the
pump. Failure to do so may result in unintended administration.
• This Alaris® CC Guardrails® Syringe Pump has been calibrated for use with single-use disposable syringes.
To ensure correct and accurate operation, only use 3 piece Luer lock versions of the syringe make specified
on the pump or described in this manual. Use of non-specified syringes or extension sets may impair the
operation of the pump and the accuracy of the infusion.
• Uncontrolled flow or syphoning may result if the syringe is located incorrectly in the pump, or if it is
removed from the pump before the extension set is properly isolated from the patient. Isolation may
include closing a tap in the patient line or activating a flow stop clamp.
• Secure the extension set to the pump using the extension set hook at the rear of the pump. This provides
protection against accidental dislodging of the syringe from the pump.
• When combining several apparatus and/or instruments with extension sets and other tubing, for example
via a 3-way tap, the performance of the pump may be impacted and should be monitored closely.
Mounting the Pump
• When more than one pump is being used on a patient, those containing high risk, critical medications
must be positioned as close to the patient's heart level as possible to avoid the risk of variations in flow or
siphoning.
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• Raising a Pump whilst infusing may result in a bolus of the infusate, whereas lowering a Pump whilst
infusing may result in a delay in the infusion (an underinfusion).
• Do not mount the pump in a vertical position with the syringe pointing upwards as this could lead to
an infusion of air which may be in the syringe. To protect against the introduction of air the user should
regularly monitor the progress of the infusion, syringe, extension line and patient connections and follow
the priming procedure specified herein.
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 technical 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.
Operating Pressure
• This is a positive pressure pump designed to achieve very accurate fluid administration by automatically
compensating for resistance encountered in the infusion system.
• The pumping pressure alarm system is not designed to provide protection against, or detection of, IV
complications which can occur.
Alarm Conditions
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• 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.
Guardrails® Safety Software
• The Guardrails® Safety Software incorporates dosing limits and pump configuration parameters based on
hospital protocol. The software adds a test of reasonableness to drug programming based on the limits
defined by the hospital. Qualified personnel must ensure the appropriateness of the drug dosing limits,
the compatibility of the drugs, and the performance of each pump, as part of the overall infusion. Potential
hazards include drug interactions, and inappropriate delivery rates and pressure alarms.
• When loading a Data Set with the Guardrails® Safety Software, ensure the correct profile is selected prior
to starting an infusion. Failure to use the appropriate profile could cause serious consequences.
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Operating Precautions (continued)
Electromagnetic Compatibility & 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.
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A
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• This pump is a CISPR 11 Group 1 Class A 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.
• 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. (Consult Technical
Service Manual for further information).
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.
• 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 in the installation or its arrangement is in doubt, the pump
should be operated from the battery.
• 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.
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• 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.
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Getting Started
Initial Set-up
Before operating the pump read this Directions For Use manual carefully.
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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:
l Alaris® CC Guardrails® Syringe Pump
l User Support CD (Directions For Use)
l AC Power Cable (as requested)
l 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 S is
lit).
Language Selection
1. On initial start-up the pump will display the Select Language screen.
2. Select the required language from the list displayed using the
3. Press the OK softkey to confirm your selection.
f keys.
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An approved Guardrails® Safety Software Data Set must be uploaded to the Alaris® CC Guardrails® Syringe Pump
prior to use. Guardrails® Editor PC Software is available separately.
The pump will automatically operate from its internal battery if the pump is switched on without being connected
to the AC power supply.
Should the pump fail to perform correctly, replace in its original protective packaging, where possible and contact a
qualified service engineer for investigation.
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Getting Started (continued)
Do not mount the pump with the AC power inlet or the syringe pointing upwards. This could affect the electrical
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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.
safety in the event of a fluid spill or lead to the infusion of air which may be in the syringe.
Pole Clamp Installation
Recessed area
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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.
Never mount the pump such that the IV infusion
stand becomes top heavy or unstable.
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 (push to release)
Rotating cam
The rotating cam can be fitted to the rectangular bar on the Docking Station/Workstation* or the equipment rail measuring 10 by 25 mm.
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. Hold the pump horizontally, push the pump firmly onto the rectangular bar or equipment rail.
Ensure that the pump 'clicks' securely into position onto the bar.
3. To release, push the release lever and pull the pump forwards.
*Alaris® DS Docking Station and Alaris® Gateway Workstation.
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