BD Alaris GP Directions For Use Manual

BD Alaris GP Directions For Use Manual

Volumetric pump (with plus software)
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Alaris™ GP (Guardrails™)
Volumetric Pump
(with Plus Software)
Models: 9002TIG03, 9002TIG03-G
Directions For Use
en

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Summary of Contents for BD Alaris GP

  • Page 1 Alaris™ GP (Guardrails™) Directions For Use Volumetric Pump (with Plus Software) Models: 9002TIG03, 9002TIG03-G...
  • Page 2: Table Of Contents

    Alaris™ GP (Guardrails™) Volumetric Pump Contents Page Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Intended Purpose .
  • Page 3 Profile Filter (Only available on the Alaris GP Guardrails Volumetric Pump) . . . . . . . . . . . . . . .
  • Page 4 Alaris™ GP (Guardrails™) Volumetric Pump Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45 Routine Maintenance Procedures .
  • Page 5: Introduction

    (IV), subcutaneous or irrigation of fluid spaces . The Alaris GP Volumetric Pump and Alaris GP Guardrails Volumetric Pump are indicated for use on adults and paediatrics .
  • Page 6: Creating A Data Set

    4 . Upload data set to the Pump (Using Alaris Transfer Tool) Note: One profile selection will be required when uploading the data set to the Alaris GP Volumetric Pump . 5 . Verify that the correct data set is loaded into the Pump and accept it .
  • Page 7: Features Of The Volumetric Pump

    Alaris™ GP (Guardrails™) Volumetric Pump Features of the Volumetric Pump Features of the Volumetric Pump Alarm indicator Alaris® Alaris ® ® Guardrails Guardrails ® plus Door Display Softkeys Chevrons Mute Bolus Pressure Hold Options Battery indicator AC power indicator On/Off Door Lever Handle Release lever for rotating...
  • Page 8: Controls And Indicators

    Alaris™ GP (Guardrails™) Volumetric Pump 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 three seconds to switch the Pump off . Note: Logs are maintained for power down events including when the Pump is powered down or unexpected power loss .
  • Page 9: Symbol Definitions

    Alaris™ GP (Guardrails™) Volumetric Pump 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) . IP33 Protected from solid objects greater than 2 .5mm . Protected against direct sprays up to 60°...
  • Page 10: Main Display Features

    Alaris™ GP (Guardrails™) Volumetric Pump Main Display Features Main Display Features Main Display - If VTBI has not been set (flow sensor must be used) Infusion Status / ON HOLD ON HOLD Drug Name / Profile Name / SET RATE WITH Primary or Secondary (Only if RATE secondary is enabled in the...
  • Page 11: Operating Precautions

    Uncontrolled flow may result if the infusion set is not properly isolated from the patient i .e . closing a tap in the set or activating an in-line clamp / roller clamp . • BD infusion sets are fitted with an in-line clamp, which can be used to occlude tubing in case it is required to stop fluid flow . •...
  • Page 12: Operating Pressure

    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’...
  • Page 13: Hazards

    BD, is at your sole risk, and BD does not provide any warranty for or endorsement on any Alaris GP (Guardrails) Volumetric Pump that has been so modified or altered . BD product warranty shall not apply in the event...
  • Page 14: Getting Started

    • The default data set does not have drug related Guardrails limits . To set the limits use the Alaris Editor software . Care should be taken when specifying the Guardrails limits . * Only available on the Alaris GP Guardrails Volumetric Pump . Issue 1...
  • Page 15: Pole Clamp Installation

    Alaris™ GP (Guardrails™) Volumetric Pump Getting Started Pole Clamp Installation Mount the Pump on the pole or Docking Station/Workstation as close to patient heart level as possible . Prior to each use, check the pole clamp: • does not show any signs of excessive wear, •...
  • Page 16: The Alaris Safety Clamp

    Alaris™ GP (Guardrails™) Volumetric Pump Getting Started 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**: Clamp in NON OCCLUDED POSITION Safety Clamp Frame Safety Clamp Tab...
  • Page 17: 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 and Alaris GP Guardrails Volumetric Pump infusion sets, (refer to 'Infusion Sets' section of the DFU) •...
  • Page 18 Alaris™ GP (Guardrails™) Volumetric Pump Getting Started Step Notes 6 . Close roller clamp . 7 . Open door and load infusion set as follows: • Ensure infusion set tubing above the Pump is as straight as possible with no kinks Top set retainer (Blue) Adaptor on...
  • Page 19 Alaris™ GP (Guardrails™) Volumetric Pump Getting Started Step Notes iii) Ensure infusion set is fully inserted into tubing guide and all air is removed from the infusion set . Tubing Guide 8 . Close door and open roller clamp . Ensure no drops are falling in the drip chamber .
  • Page 20: Starting The Infusion

    Note: The CONFIRM PROFILE screen is only shown if more than one profile (For Alaris GP Guardrails Volumetric Pump only) is available in the data set . If a profile has been filtered, then the option to select ALL will be displayed in the profile selection screen .
  • Page 21: Basic Features

    Alaris™ GP (Guardrails™) Volumetric Pump Basic Features Basic Features Drugs and Dosing The following options enable the Pump to be set-up for use with a specific drug protocol . Drugs are pre-configured in the Alaris Editor to enable rapid selection of the drug protocol, dosing units and default rate . For increased security when using a configured drug, maximum and minimum safety limits can be set for concentrations and dose rates via the Alaris Editor .
  • Page 22: Clear Volume Infused

    Alaris™ GP (Guardrails™) Volumetric Pump Basic Features Clear Volume Infused 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 . This option enables the volume infused to be cleared .
  • Page 23: Pressure

    Alaris™ GP (Guardrails™) Volumetric Pump Basic Features Pressure To check and adjust the pressure level, press the button . The display will change to show the PRESSURE current pumping pressure level and the pressure alarm limit . The default pressure alarm limit can be set via the Alaris Editor .
  • Page 24: Bolus Mode Enabled - Handson And Hands On And Handsfree

    Note: Rate may be restricted by the Bolus Rate Max which is configured in the Alaris Editor . Note: If the BOLUS exceeds the soft (Alaris GP Guardrails Volumetric Pump only) or hard limits, a prompt will display . Note: The bolus rate will be automatically set to the current infusion rate, when the default bolus rate is lower than the current infusion rate .
  • Page 25: Rate Lock (If Enabled)

    Alaris™ GP (Guardrails™) Volumetric Pump Basic Features 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 to confirm .
  • Page 26: Primary Setup

    3 . Review the information and then press the QUIT softkey . Profile Filter (Only available on the Alaris GP Guardrails Volumetric Pump) This option allows selected profiles to be filtered from view . It can be enabled/disabled via the Alaris Editor .
  • Page 27: Changing The Infusion Set

    . Note: For product questions or needle-free valve educational materials, contact your BD representative . Consult facility protocols . Consult other organizations that publish guidelines useful in developing facility protocols . Issue 1...
  • Page 28: Secondary (Piggyback) Infusions

    Alaris™ GP (Guardrails™) Volumetric Pump 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 .
  • Page 29: Service Configuration Mode

    Alaris™ GP (Guardrails™) Volumetric Pump 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 menu (available in Technician Mode) and others through the Alaris Editor Software . Access codes should only be entered by Qualified Service Personnel .
  • Page 30: Backlight & Contrast

    Weight Default The default patient weight . Weight Soft Min (For Alaris GP Guardrails Volumetric Pump only) The minimum patient weight for weight-based drug dosing calculations before alerting the user . Weight Soft Max (For Alaris GP Guardrails Volumetric Pump only) The maximum patient weight for weight-based drug dosing calculations before alerting the user .
  • Page 31: Large Volume Pump Configuration Settings

    Alaris™ GP (Guardrails™) Volumetric Pump Pump Configuration available via the Alaris Editor Software Large Volume Pump Configuration Settings AIL Limit The single bubble Air-in-line alarm setting . Bolus Mode Controls whether or not the Pump allows bolus delivery method . Bolus Rate Default The default value for bolus rates .
  • Page 32: Drug Library Available Via The Alaris Editor Software

    The default bolus dose for this drug . Applies to Hands-free bolus . Bolus Dose Soft Min (For Alaris GP Guardrails Volumetric Pump only) The minimum bolus dose that the Pump allows before the user is required to confirm the selected bolus dose in response to a warning of the possibility of under-infusion .
  • Page 33: Alarms

    Alaris™ GP (Guardrails™) Volumetric Pump Alarms Alarms Alarms vary by priority and are indicated on the Pump in the following manner: Setting the alarm sound pressure level lower than the ambient sound pressure level can impede User recognition of alarm conditions . The default alarm system is ORIGINAL ALARMS (ISO60601-1-8 2nd Edition alarms) .
  • Page 34 Alaris™ GP (Guardrails™) Volumetric Pump Alarms Display Infusion Status Cause(s) Action • Check flow sensor . • Check fluid level in container . • Ensure all clamps above Pump are open . NO FLOW Infusion stopped Flow sensor detects no flow . •...
  • Page 35 Alaris™ GP (Guardrails™) Volumetric Pump Alarms Medium Priority Alarms Medium priority alarms 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 . See the 'Alarm Priority Level Indicators' table for more details on how medium priority alarms are indicated .
  • Page 36: 3Rd Edition Alarms

    Alaris™ GP (Guardrails™) Volumetric Pump Alarms 3RD EDITION ALARMS High Priority Alarms High priority alarms stop the infusion and are indicated by a combination of an audible sound, flashing red alarm indicator and a message on the display . See the 'Alarm Priority Level Indicators' table for more details on how high priority alarms are indicated . Alarms can be addressed in the following manner: 1 .
  • Page 37 Alaris™ GP (Guardrails™) Volumetric Pump Alarms Display Infusion Status Cause(s) Action • Clamp infusion set using roller clamp . Gross difference between • Check flow sensor . FLOW ERROR Infusion stopped detected drops and expected • Check fluid level in drip chamber . amount of drops .
  • Page 38 Alaris™ GP (Guardrails™) Volumetric Pump Alarms Medium Priority Alarms Medium priority alarms 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 . See the 'Alarm Priority Level Indicators' table for more details on how medium priority alarms are indicated .
  • Page 39: Prompts

    Alaris™ GP (Guardrails™) Volumetric Pump Prompts Prompts Prompts are indicated by an audible alarm and message, they cannot be silenced and do not have a visual indicator . Display Infusion Status Cause(s) Action SET VTBI Pump on hold No VTBI / flow sensor . •...
  • Page 40: Restarting An Infusion Following An Air-In-Line Alarm

    Alaris™ GP (Guardrails™) Volumetric Pump Restarting an Infusion following an Air-in-Line Alarm 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 .
  • Page 41: Flow Sensor Operation (Optional)

    Alaris™ GP (Guardrails™) Volumetric Pump 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 42: Infusion Sets

    The 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 BD . • New sets are continuously being developed for our customers . Please contact your local BD representative for availability .
  • Page 43 Alaris™ GP (Guardrails™) Volumetric Pump Infusion Sets Alaris GP standard infusion sets (no filter) 63200NYB • No Filter • Length: 260cm 60173E • 1 SmartSite Needle-Free Valve Port Model Number: 63200NY • No Filter Artwork Number: 1000AW03032 • Length: 265cm...
  • Page 44 Change Order Change description Drawn by Date 7208 Introduction Angela Coles 12/10/06 Alaris GP low sorbing infusion sets • 15 Micron Filter 60953V • Polyethylene lined PVC tubing • Length: 270cm • Polyethylene lined PVC tubing 63260NY • No Filter •...
  • Page 45: Associated Products

    Alaris™ GP (Guardrails™) Volumetric Pump Associated Products Associated Products The Alaris Gateway Workstation Product SKU 80203UNS0y-xx Supply Voltage 115-230VAC, ~50-60Hz Electrical Rating 460VA (Maximum) Protection Against Electrical Shock Class 1 Classification Continuous Operation Supply to Pump 115-230V, ~50-60Hz, 60VA The Alaris DS Docking Station Product SKU 80283UNS00-xx Supply Voltage...
  • Page 46: 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 BD in the Alaris Volumetric Pump is at your sole risk, and BD does not provide any warranty for or endorsement on any battery packs that are not manufactured by BD .
  • Page 47: Cleaning And Storage

    Alaris™ GP (Guardrails™) Volumetric Pump Cleaning and Storage Cleaning and Storage Cleaning the Pump Before the transfer of the Pump to a new patient and periodically during the use, clean the Pump by wiping over with a lint-free cloth lightly dampened with warm water and a standard disinfectant / detergent solution .
  • Page 48: Disposal

    . If you wish to discard electrical and electronic equipment, please contact your BD 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 49: Specifications

    Alaris™ GP (Guardrails™) Volumetric Pump Specifications Specifications Electrical Protection Class I, Type CF (Defibrillation-proof ) Electrical/Mechanical Safety Complies with IEC/EN60601-1 and IEC/EN60601-2-24 . Electro Magnetic Compatibility (EMC) Complies with IEC/EN60601-1-2 and IEC/EN60601-2-24 . Electrical Safety Typical earth leakage current 78µA . Typical Enclosure Leakage Current (Normal Condition) = 0µA Typical Protective Earth Resistance = 32mOhms The above measurements are for guidance only, IEC/EN60601-1 limits are defined below:...
  • Page 50: Memory Retention

    Alaris™ GP (Guardrails™) Volumetric Pump Specifications Memory Retention The electronic memory of the Pump will be retained for more than 2 years with normal use . Alarm Conditions Alarms Warnings Prompts Advisories AIR IN LINE (SINGLE BUBBLE) AC POWER FAIL ATTENTION DOSE WOULD EXCEED AIR IN LINE (ACCUMULATED)
  • Page 51: Irda, Rs232 And Nursecall Specification

    Alaris™ GP (Guardrails™) Volumetric Pump IrDA, RS232 and Nursecall Specification IrDA, RS232 and Nursecall Specification IrDA / RS232 / Nursecall Feature The IrDA (or RS232 / Nursecall optional feature) is a feature that allows the Pump to be connected to an external device for the purpose of data communication .
  • Page 52: Infusion Specifications

    Infusion Specifications Infusion Specifications System Accuracy: The System includes the Pump and any of the compatible Infusion Sets available from BD . Rate Accuracy is ±5%, achieved under nominal conditions 1a,2 Rate Accuracy is ±10%, achieved under low flow conditions...
  • Page 53: Air Sensor

    Alaris™ GP (Guardrails™) Volumetric Pump Infusion Specifications Air Sensor: Integral Ultrasonic Sensor . Air in line detection: Single Bubble (configurable): 50µl, 100µl, 250µl & 500µl . Bubble accumulation: 1ml over a 15 minute window . Air in line detector accuracy is ±3% . Critical Volume The maximum volume infused following a single fault condition is for rates <...
  • Page 54: Trumpet And Flow Rate Curves

    Alaris™ GP (Guardrails™) Volumetric Pump Trumpet and Flow Rate Curves Trumpet and 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 55 Alaris™ GP (Guardrails™) Volumetric Pump Trumpet and Flow Rate Curves 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) Maximum Error Minimum Error...
  • Page 56: Products And Spare Parts

    The Technical Service Manual (1000SM00013) is now available in electronic format on the World Wide Web at :- bd .com/int-alaris-technical A username and password are required to access our manuals . Please contact a local customer services representative to obtain login details .
  • Page 57: Contact Us

    Alaris™ GP (Guardrails™) Volumetric Pump Contact Us Contact Us For full contact information please refer to bd .com . Customer Service Information Country Telephone Email Australia Freephone: 1 800 656 100 AUS_customerservice@bd .com België +32(0)53 720 556 info .benelux@bd .com...
  • Page 58 BD, the BD Logo, Alaris, Guardrails, IVAC and SmartSite are trademarks of Becton, Dickinson and Company or one of its affiliates. All other trademarks are property of their respective owners. © 2019 BD. All rights reserved. This document contains proprietary information...

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