CareFusion Alaris GP Guardrails Directions For Use Manual
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CareFusion Alaris GP Guardrails Directions For Use Manual

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Summary of Contents for CareFusion Alaris GP Guardrails

  • Page 1 Alaris® GP Guardrails® Directions For Use Volumetric Pump...

  • Page 2: Table Of Contents

    Contents Page • Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 • About This Manual .

  • Page 3: Introduction

    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.

  • Page 4: Creating A Data Set

    Creating a Data Set To create a data set for the Alaris® GP Guardrails® Volumetric Pump, first the hospital will need to develop, review, approve, upload according to the following process. Refer to the Guardrails® Editor help file for further details and operating precautions. 1.

  • Page 5: Features Of The Alaris® Gp Guardrails® Volumetric Pump

    Features of the Alaris® GP Guardrails® Volumetric Pump Alarm indicator Door Display Softkeys Chevrons Mute Bolus Hold Pressure Options Battery indicator AC power indicator On/Off Door Lever Handle Release lever for rotating cam Flow sensor connector RS232/Nursecall connector (cover removed for clarity) Rotating cam to lock onto Folded pole clamp horizontal rectangular bars.

  • Page 6: Controls And Indicators

    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. RUN button - Press to start the infusion. The green LED will flash during infusion.

  • Page 7: Symbol Definitions

    Symbol Definitions Labelling Symbols: Symbol Description Attention (Consult accompanying document) Potential Equalisation (PE) Connector RS232/Nursecall Connector. Defibrillation-proof type CF applied part. (Degree of protection against electrical shock) IPX3 Protected against spraying water Alternating Current Device complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC.

  • Page 8: Main Display Features

    PRESSURE INFORMATION icon - Shows the pressure from level 0 being the first bar to level 8. Alarm limits: level 2, 5 or 8. Indicates that a Guardrails® safety protocol is not in use. CareFusion recommends the use of Guardrails® safety limits when setting infusions as standard practice.

  • Page 9: Operating Precautions

    Operating Precautions Infusion Sets • To ensure correct and accurate operation, only use CareFusion 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.
  • Page 10 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’...

  • Page 11: Getting Started

    Getting Started Before operating the pump read this Directions For Use (DFU) manual carefully. Initial Set Up Check that the pump is complete, undamaged and that the voltage rating specified on the label is compatible with your AC power supply. Items supplied are : l Alaris® GP Guardrails® Volumetric Pump Directions For Use (CD) AC Power Cable (as requested)
  • Page 12 Getting Started (Continued) 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 Pull the folded pole clamp towards you and unscrew the clamp to leave enough room for the size of the pole.

  • Page 13: The Alaris® Safety Clamp

    The Alaris® Safety Clamp ALARIS® SAFETY CLAMP**: SAFETY CLAMP IN NON OCCLUDED POSITION: When a new infusion set is removed from packaging the Safety Clamp will be in this position*: Safety Clamp Frame Clamp in NON OCCLUDED POSITION Safety Clamp FLOW ENABLED Safety Clamp Slider This is necessary to avoid tube damage during storage and to ensure correct sterilisation and allows immediate priming.

  • Page 14: Loading An Infusion Set

    Loading an Infusion Set Ensure the appropriate infusion set for the fluid/drug to be infused has been selected. Follow the instructions supplied with the individual infusion set. Only use Alaris® GP Guardrails® Volumetric Pump infusion sets, (Refer to 'Infusion Sets' section of the DFU) Position the fluid container to avoid spillage onto the pump.

  • Page 15: Starting The Infusion

    Starting the Infusion PRIME AND LOAD THE SET (Refer to 'Loading an Infusion Set') Ensure the pump is connected to an AC power supply (also operates from battery). Connect flow sensor, if required. (See 'Flow Sensor Operation' section) Press the key. The pump will run a short self-test . Check two beeps are activated during this test . Check the displayed date and time are correct . Check display shows the data set name and version number .

  • Page 16: Basic Features

    Basic Features Drugs and Dosing The following options enable the pump to be set-up for use with a specific drug name and/or drug protocol. Drugs are pre-configured in the Guardrails® Editor to enable rapid selection of the drug name, dosing units and default rate. For increased security using a configured drug, maximum and minimum safety limits are programmable for concentration and dose rates.
  • Page 17 Basic Features (continued) VOLUME Clear Volume Infused VOLUME INFUSED This option enables the volume infused to be cleared. 1. Press the VOLUME softkey on main display to show the clear VOLUME INFUSED option. 2. Press the CLEAR softkey to clear the volume infused. Press the QUIT softkey to retain the volume. When a new drug or a new concentration has been setup and the previous volume infused has not been cleared, then the message DOSE INFUSED HAS BEEN CLEARED will be displayed.
  • Page 18 Basic Features (continued) BOLUS Bolus Infusions RATE Bolus - Administering a controlled volume of fluid or drug at an increased rate for diagnostic or therapeutic SET WITH purposes. The pump should always be infusing and always attached to the patient. (Drugs given by an IV bolus could achieve immediate and high drug concentration levels.) ml/h The bolus feature can be configured via the Guardrails®...
  • Page 19 Basic Features (continued) Rate Lock (If Enabled) If Rate Lock is enabled, when the infusion rate has been set and the infusion started (or following a bolus infusion) the rate lock prompt will appear on the main display. To select the rate lock function press the YES softkey. Press the NO softkey if the rate lock is not required. When rate lock is enabled, the following are unavailable: l Changing the infusion rate / titration l Bolus...
  • Page 20 Basic Features (continued) Clear Drug Name Clearing the drug name is only available if drug name only has been selected: to put the pump ON HOLD. 1. Press button to access the options menu. 2. Press the keys, press OK to confirm. 3. Select DRUG NAME ONLY using the 4.
  • Page 21 This fluid does not enter the fluid path and requires no action. NOTE: For product questions or needle-free valve educational materials, contact your CareFusion representative. Consult facility protocols. Consult other organizations that publish guidelines useful in developing facility protocols.

  • Page 22: Secondary (Piggyback) Infusions

    Secondary (Piggyback) Infusions Secondary (or piggyback) Infusion mode is only available if it has been configured. The application of secondary infusions should be limited to the intermittent therapy of medications which are not sensitive to the total time required to complete an infusion. • Typically antibiotics may be infused using a secondary infusion, where the primary infusion is limited to maintenance fluid . If intending to use the secondary infusion facility, the primary infusion should be a maintenance fluid only and is not indicated for drug therapy .

  • Page 23: Service Configuration Mode

    Service Configuration Mode This section comprises of a list of options which can be configured. Some can be entered via the pump SERVICE CONFIGURATION menu (available in Technician Mode) and others through the Guardrails® Editor Software. Enter the access code on Alaris® GP Guardrails® Volumetric Pump for SERVICE mode, then select SERVICE CONFIGURATION, see the Technical Service Manual for details.

  • Page 24: Pump Configuration Available Via The Guardrails® Editor Software

    Pump Configuration available via the Guardrails® Editor Software The following options are only configurable via the Guardrails® Editor Software (PC based), see Guardrails® Editor help files for further details. GENERAL SETTINGS: AC Fail Warning Controls whether, when main power has been disconnected, a warning is generated to inform the user that the pump is operating solely on battery power.

  • Page 25: Drug List Available Via The Guardrails® Editor Software

    Drug List available via the Guardrails® Editor Software The following drug parameters are only configurable via the Guardrails® Editor Software (PC based), see Guardrails® Editor help files for further details. CONCENTRATION SETTINGS: Concentration Units The unit for concentration parameters. Concentrations The concentrations defined for this drug. The calculated value of drug amount / total volume. Units Only Permits the user to attach a range of concentration limits to a drug name.

  • Page 26: Alarms

    Alarms Alarms stop the infusion and are indicated by a combination of an audible sound, flashing red alarm indicator and a message on the display. 1. Check the display for an alarm message and review table below for cause and action. Press to silence the sound for 2 minutes, CANCEL to clear the message.

  • Page 27: Warnings

    Alarms (Continued) Display Infusion Status Cause Action WRONG SET Pump on hold Safety clamp not detected. • Clamp infusion set using roller clamp. • Check set and close door. • Replace infusion set. (If necessary) DOOR CLOSE Pump on hold Safety clamp in non-occluded •...

  • Page 28: Prompts And Advisories

    Prompts and Advisories Prompts alert the user but may not stop the infusion and are indicated by an audible sound, a flashing amber warning indicator and a message on the display. 1. Check the display for a prompt message. Press to silence the sound for 2 minutes, CANCEL to clear the message. 2.
  • Page 29 Restarting an Infusion following an Air-in-Line Alarm The pump may be restarted by opening the door, assessing and removing any air from the tubing guide area and in the infusion set on the patient side of the pump (if required) according to hospital policy. Close the door and cancel the air-in-line alarm.

  • Page 30: Flow Sensor Operation (Optional)

    Flow Sensor Operation (Optional) The flow sensor automatically monitors the infusion flow rate through the drip chamber. The flow sensor will cause the pump to alarm if a significant deviation from the infusion rate occurs. The flow sensor will also be able to detect empty containers.

  • Page 31: Infusion Sets

    Infusion Sets The Alaris® GP Guardrails® Volumetric Pump uses standard, single-use, disposable infusion sets. The user is responsible for verifying the suitability of a product used, if it is not recommended by CareFusion. • New sets are continuously being developed for our customers . Please contact your local CareFusion representative for availability . • Check infusion set materials and drug compatibility before selecting an infusion set .
  • Page 32 Infusion Sets (Continued) Alaris® GP standard infusion sets 63200NY • No Filter • Length: 260cm • 2 Split Septum Injection Ports Model Number: 63200NY 63110V • No Filter Artwork Number: 1000AW03032 Change History: Issue Change Order Change description Drawn by Date • Length: 290cm 7208 Introduction Angela Coles...
  • Page 33 Infusion Sets (Continued) Alaris® GP burette infusion sets • 2 SmartSite ® Needle-Free Valve Port 60103E • 1 Burette (150ml) • Length: 275cm • 4 SmartSite ® Needle-Free Valve Port 63441E • 1 Burette (150ml) • Length: 330cm Model Number: 63441E Artwork Number: 1000AW03034 Change History: Issue...

  • Page 34: Associated Products

    Associated Products l The Alaris® DS Docking Station l The Alaris® Gateway Workstation 1000DF00498 Issue 3 33/42...

  • Page 35: Maintenance

    Alaris® Volumetric Pump, and in conjunction with Alaris® Volumetric Pump software, controls battery use, charge and temperature. Any use of battery packs that are not manufactured by CareFusion in the Alaris® Volumetric Pump is at your sole risk, and CareFusion does not provide any warranty for or endorsement on any battery packs that are not manufactured by CareFusion.

  • Page 36: Cleaning And Storage

    If you wish to discard electrical and electronic equipment, please contact your CareFusion affiliate office or distributor for further information. Disposing of this product correctly will help to save valuable resources and prevent any potential negative effects on human health and the environment which could otherwise arise from inappropriate waste handling.

  • Page 37: Specifications

    Specifications BATTERY SPECIFICATIONS - Electrical Protection Rechargeable NiMH (Nickel Metal Hydride). Automatically charges Class I, Type CF (Defibrillation-proof ) when the pump is connected to AC power. Electrical/Mechanical Safety Battery Life - For a 24 hour battery charge time, the pump at 25ml/h Complies with IEC/EN60601-1 and IEC/EN60601-2-24. will have a Mean Time To Battery Empty of 6 hours.

  • Page 38: Irda, Rs232 And Nursecall Specification

    IrDA, RS232 and Nursecall Specification IrDA / RS232 / Nursecall Feature RS232 / Nursecall Connection Data The IrDA (or RS232 / Nursecall optional feature) is a feature on Nursecall Specification - Alaris® GP Guardrails® Volumetric Pump that allows the pump Connector D Type - 9 Pin to be connected to an external device for the purpose of data TXD/RXD EIA RS232-C Standard communication...

  • Page 39: Infusion Specifications

    Infusion Specifications Air Sensor: System Accuracy: Integral Ultrasonic Sensor. 1a,2 Rate Accuracy is ±5%, achieved under nominal conditions Air in line detection: 1b,2 Rate Accuracy is ±10%, achieved under low flow conditions Single Bubble (configurable): 50µl, 100µl, 250µl & 500µl. Occlusion Alarm Limits Bubble accumulation: 1ml over a 15 minute window. Achieved under nominal conditions 1a,4 Level...

  • Page 40: Trumpet & Flow Rate Curves

    Trumpet & Flow Rate Curves In this pump, as with all infusion systems, the action of the pumping mechanism and variations cause short-term fluctuations in rate accuracy. The following curves show typical performance of the system in two ways: 1) the accuracy of fluid delivery over various time periods is measured (trumpet curves), and 2) the delay in onset of fluid flow when infusion commences (start-up curves).
  • Page 41 Trumpet & Flow Rate Curves (Continued) Trumpet Graph at 1 .0ml/h (Initial Period) Trumpet Graph at 1 .0ml/h (After 72 Hours) 30.0 20.0 10.0 Trumpet Graph at 25.0 ml/h (After 24 Hours) -10.0 -20.0 -30.0 Observation Window (Minutes) Observation Window (Minutes) Minimum Rate Error Minimum Rate Error Maximum Rate Error Maximum Rate Error Overall Mean Error = 0.7% Overall Mean Error = 1.0% Start-up Graph at 25 .0ml/h (Initial Period) Trumpet Graph at 25 .0ml/h (After 24 Hours) Observation Window (Minutes)

  • Page 42: Products And Spare Parts

    The Technical Service Manual (1000SM00013) is now available in electronic format on the World Wide Web at :- www.carefusion.co.uk/alaris-technical/ A username and password are required to access our manuals. Please contact a local customer services representative to obtain login details.

  • Page 43: Service Contacts

    Service Contacts For service contact your local Affiliate Office or Distributor: CareFusion, CareFusion, CareFusion, CareFusion, 上海代表机构，中国上海市张杨路 PO Box 5527, The Crescent, Jays Close, 14B George Bourke Drive, 500 号， Dubai, United Arab Emirates. Basingstoke, Mt Wellington 1060, 上海时代广场办事处大楼， Hampshire, RG22 4BS, PO Box 14-518, A 座，24 层，...
  • Page 44 Alaris, Guardrails, IVAC and SmartSite are registered trademarks of CareFusion Corporation or one of its subsidiaries. All rights reserved. All other trademarks are property of their respective owners. ©2008-2013 CareFusion Corporation or one of its subsidiaries. All rights reserved. This document contains proprietary information of...

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