BD Alaris neXus GPneXus1 Directions For Use Manual

Volumetric pump
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BD Alaris
neXus GP
Volumetric Pump
Model: GPneXus1
en Directions For Use

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Summary of Contents for BD Alaris neXus GPneXus1

  • Page 1 BD Alaris neXus GP ™ Volumetric Pump Model: GPneXus1 en Directions For Use...
  • Page 2: Table Of Contents

    BD Alaris™ neXus GP Volumetric Pump Contents Page About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Conventions used in this manual .
  • Page 3 BD Alaris™ neXus GP Volumetric Pump Rate Lock (If enabled) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Adjusting Existing Dosing or Protocol Infusions .
  • Page 4 BD Alaris™ neXus GP Volumetric Pump Contact Us . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 Customer Service Information .
  • Page 5: About This Manual

    About This Manual About This Manual The User must be thoroughly familiar with the BD Alaris™ neXus GP Volumetric Pump (hereinafter referred to as 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 .
  • Page 6: Overview

    . The BD Alaris™ neXus GP Volumetric Pump is intended to be used for the purpose of controlling rate and volume . The BD Alaris™ neXus GP Volumetric Pump is indicated for use on adults and paediatrics .
  • Page 7: Conditions For Use

    BD Alaris™ neXus GP Volumetric Pump Overview Conditions for Use The BD Alaris™ neXus GP Volumetric Pumps are restricted medical devices intended for use by qualified, trained personnel to deliver either continuous or intermittent infusion therapy of: • Fluids • Medications •...
  • Page 8: Features Of The Volumetric Pump

    BD Alaris™ neXus GP Volumetric Pump Overview Features of the Volumetric Pump Alarm indicator Door Display Softkeys Chevrons Control keys and indicators (See overleaf) Door lever Handle Release lever Flow sensor connector for rotating cam RS232/Nursecall connector (cover removed for clarity)
  • Page 9: Controls

    BD Alaris™ neXus GP Volumetric Pump Overview 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 10: Main Display Features

    BD Alaris™ neXus GP Volumetric Pump Overview 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...
  • Page 11: Screen Icons

    Indicates that the Pump is running at a rate above (pointing up) a Guardrails™ Soft Limit . WiFi Indicates when the Pump is connected, via Wi-Fi, to the BD Alaris™ Communication Engine (ACE) . WiFi Indicates when the Pump is not connected to ACE via Wi-Fi .
  • Page 12: Labelling Symbols

    BD Alaris™ neXus GP Volumetric Pump Overview 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 13 BD Alaris™ neXus GP Volumetric Pump Overview Keep Dry Catalogue number Serial Number Medical Device BDDF00558 Issue 5 12/72...
  • Page 14: Getting Started

    Wi-Fi Configuration The Pump is able to utilize a hospital Wi-Fi network to connect to the BD Alaris™ Communication Engine if one is deployed at the facility . A Wi-Fi Configuration Package must be first created and transferred to the Pump using the BD Alaris™...
  • Page 15: Factory Default Data Set

    • Refer to ‘Display of Units’ section of this DFU for configurable units. • The default data set does not have drug-specific Guardrails™ limits. To set the limits use the BD Alaris™ neXus Editor software to create a custom data set. Care should be taken when specifying the Guardrails™...
  • Page 16: Pole Clamp Installation

    BD Alaris™ neXus GP Volumetric Pump Getting Started Pole Clamp Installation Mount the Pump on the pole or 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 17: Workstation Or Equipment Rail Installation

    BD Alaris™ neXus GP Volumetric Pump Getting Started Workstation or Equipment Rail Installation The rotating cam can be fitted to the rectangular bar on the Workstation or equipment rails measuring 10mm by 25mm . 1 . Align the rotating cam on the rear of the Pump...
  • Page 18: Alaris™ Safety Clamp

    BD Alaris™ neXus GP Volumetric Pump Getting Started 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...
  • Page 19: Operating Precautions

    / 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 20 BD Alaris™ neXus GP Volumetric Pump Getting Started Operating Environment • Intended environments include general wards, critical and intensive care, operating rooms, accident and emergency rooms . The Pump may be used in an ambulance environment . Ensure that the Pump is appropriately attached using the provided pole clamp . The Pump is designed to withstand possible bumps and vibrations whilst being used in an ambulance, complying with the standard EN 1789 .
  • Page 21 • 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 .
  • Page 22 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 BD Alaris™ neXus GP Volumetric Pump that has been so modified or altered .
  • Page 23: Operation

    • 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 BD infusion sets specified in the ‘Infusion Sets’ section of the DFU. • Position the fluid container to avoid spillage onto the Pump.
  • Page 24 BD Alaris™ neXus GP Volumetric Pump Operation Step Notes 5 . Hang the fluid container at a minimum height of 45 cm from the bottom of the Pump to the bottom of the fluid container . Raise the fluid container higher than the minimum height when possible, to minimise loops and kinks in the infusion set tubing .
  • Page 25 BD Alaris™ neXus GP Volumetric Pump Operation Step Notes i) Fit top adaptor of infusion set into top set retainer . Top Set Retainer ii) Insert Safety Clamp into retainer . • Avoid any stretching of the silicone segment when...
  • Page 26: Flow Sensor Operation (Optional)

    BD Alaris™ neXus GP Volumetric Pump Operation 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 27: Starting The Infusion

    BD Alaris™ neXus GP Volumetric Pump Operation Starting the Infusion When operating the Pump, Users should position themselves at a distance of approximately 0.5 metres from the display. Prime and load the set (Refer to ‘Priming the Infusion Set’ and ‘Loading an Infusion Set’).
  • Page 28 Note: The green run LED will flash to show that the Pump is infusing . Note: If the BD Alaris™ Communication Engine is deployed at the facility and the Pump is not docked to a Workstation, it is recommended to wait until the Pump connects via Wi-Fi prior to starting the infusion (Wi-Fi symbol is not crossed out on the bottom right of the pump screen) .
  • Page 29: Changing The Infusion Set

    BD Alaris™ neXus GP Volumetric Pump Operation Changing the Infusion Set 1 . Press to put the Pump ON HOLD . 2 . Close in-line clamp and ensure the access to the patient is isolated . 3 . Disconnect the infusion set from the patient .
  • Page 30: Advanced Features

    The following options enable the Pump to be set-up for use with a specific drug protocol . Drugs are pre-configured in the BD Alaris™ neXus Editor to enable rapid selection of the drug protocol, dosing units and default rate . For increased security when using a configured drug, Guardrails™...
  • Page 31: Clear Volume Infused

    BD Alaris™ neXus GP Volumetric Pump Advanced Features Drugs 1 . Select the required DRUGS alphabetical row from the list using the keys . SELECT 2 . Press OK to confirm . 3 . Select the drug from the displayed list using the keys, press OK to confirm .
  • Page 32: Kvo (Keep Vein Open) Rate

    • Ensure the infusion set is not connected to a patient before priming the set. • The prime rate and prime volume limit are configured in the data set via the BD Alaris™ neXus Editor. • The default prime rate is 600ml/h.
  • Page 33: Bolus Infusions

    . Bolus can be used at the start of an infusion or during an infusion . The bolus feature can be configured in the data set via the BD Alaris™ neXus Editor to: a) Bolus Mode – Disabled b) Bolus Mode –...
  • Page 34: Rate Titration

    . Rate Titration If Rate Titration is enabled (in the data set via BD Alaris™ neXus Editor) the infusion rate TITRATE or dose rate (if available) can be adjusted while infusing .
  • Page 35: Rate Lock (If Enabled)

    BD Alaris™ neXus GP Volumetric Pump Advanced 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 .
  • Page 36: Infusion Setup

    5 . Press OK softkey to enter the value or BACK to return to the VTBI . Adjust Alarm Volume This option allows adjustment of the volume if enabled in the data set via BD Alaris™ neXus Editor . 1 . Press the button to access the OPTIONS menu .
  • Page 37: Profile Filter

    Note: If only one profile is available and all others are disabled in this option, the CONFIRM PROFILE screen will not display upon start up . Standby This option allows the Pump to be placed on standby mode . It can be enabled/disabled in the data set via the BD Alaris™ neXus Editor . 1 . Press the button to access the OPTIONS menu .
  • Page 38: Smartsite™ Needle-Free System Instructions

    . 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 .
  • Page 39: Secondary (Piggyback) Infusions

    BD Alaris™ neXus GP Volumetric Pump Advanced Features 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 40 BD Alaris™ neXus GP Volumetric Pump Advanced Features Typical Secondary infusions Secondary Fluid Container IV Pole Usually a smaller container e .g . 50ml, Extension Hook (approx . 26cm) 100ml, 200ml or 250ml . Normally included with the secondary Infusion set . Primary...
  • Page 41: Alarms

    Pump itself, or via the BD Alaris™ neXus Editor software . Note: Alarm settings are not lost in case of short power loss . When power is lost for no more than 30 seconds, the alarm settings are restored .
  • Page 42 BD Alaris™ neXus GP Volumetric Pump Alarms Display Infusion Status Cause(s) Action DOWNSTREAM Infusion stopped A blockage has occurred • Check fluid path between Pump and downstream . patient for clamps, connectors, kinks or OCCLUSION blockages . • Examine access site for signs of complications (redness, swelling, pain, heat) .
  • Page 43 BD Alaris™ neXus GP Volumetric Pump Alarms Display Infusion Status Cause(s) Action BATTERY EMPTY Infusion stopped The internal battery is • Connect to power supply immediately exhausted . The Pump will or switch Pump off . automatically switch off in the immediate future .
  • Page 44 BD Alaris™ neXus GP 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 ‘ A larm Priority Level Indicators’ table for more details on how medium priority alarms are indicated .
  • Page 45 BD Alaris™ neXus GP Volumetric Pump Alarms Attention Tones Attention tones 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 ‘ A larm Priority Level Indicators’ table for more details on how Attention tones are indicated .
  • Page 46: 3Rd Edition Alarms

    BD Alaris™ neXus GP 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 ‘ A larm Priority Level Indicators’ table for more details on how high priority alarms are indicated .
  • Page 47 BD Alaris™ neXus GP Volumetric Pump Alarms Display Infusion Status Cause(s) Action UPSTREAM Infusion stopped A blockage has occurred • Check all infusion set clamps above the upstream . Pump are fully open . OCCLUSION Possible container empty . • Check that the fluid container is correctly positioned above the Pump, see ‘Loading an Infusion Set’...
  • Page 48 BD Alaris™ neXus GP Volumetric Pump Alarms Display Infusion Status Cause(s) Action SET MISLOAD Pump on hold Set loaded incorrectly . • Clamp infusion set using roller clamp . • Investigate and correct set loading . FLOW SENSOR Infusion stopped Flow sensor unplugged •...
  • Page 49 BD Alaris™ neXus GP Volumetric Pump Alarms Low Priority Alarms Low priority alarms alert the User but may not stop the infusion and are indicated by an audible sound, a solid amber warning indicator and a message on the display . See the ‘ A larm Priority Level Indicators’ table for more details on how low priority alarms are indicated .
  • Page 50: Prompts

    BD Alaris™ neXus GP Volumetric Pump Alarms 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 51: Restarting An Infusion Following An Air-In-Line Alarm

    BD Alaris™ neXus GP Volumetric Pump Alarms 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 52: Configuration

    Enter the access code on the Pump for SERVICE mode, then select CONFIGURATION; see the Technical Service Manual for details . Use BD Alaris™ neXus Editor to configure the Pump configuration, drug library and units enabled for each data set . Alarm Presets The BD Alaris™...
  • Page 53: Bd Alaris™ Nexus Editor Software Profile Configuration

    Configuration BD Alaris™ neXus Editor Software Profile Configuration The following options are only configurable in the data set via the BD Alaris™ neXus Editor Software (PC application) . See BD Alaris™ neXus Editor Directions For Use for further details .
  • Page 54 BD Alaris™ neXus GP Volumetric Pump Configuration 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 55: Drug Library Available Via The Bd Alaris™ Nexus Editor Software

    Drug Library available via the BD Alaris™ neXus Editor Software The following drug parameters are only configurable in the data set via the BD Alaris™ neXus Editor Software (PC application) . See BD Alaris™ neXus Editor help files for further details .
  • Page 56: Associated Products

    BD Alaris™ neXus GP Volumetric Pump Associated Products Associated Products Alaris™ Gateway Workstation v1.3.x or v1.6.x Product SKU 80300UNSy-xx or 80223UNSy-xx Supply Voltage 115–230V AC, ~50–60Hz Electrical Rating 460VA (Maximum) Protection Against Electrical Shock Class 1 Classification Continuous Operation Supply to Pump 115–230V, ~50–60Hz, 60VA...
  • Page 57: 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 58 BD Alaris™ neXus GP Volumetric Pump Associated Products Standard Infusion Sets (No Filter) • No Filter 63200NYB • Length: 260cm • 1 SmartSite™ Needle-Free Valve Port Model Number: 63200NY 60173E • No Filter Artwork Number: 1000AW03032 Change History: Issue Change Order...
  • Page 59 BD Alaris™ neXus GP Volumetric Pump Associated Products Light Resistant Infusion Sets • 15 Micron Filter 60643 • Length: 250cm Burette Infusion Sets • 2 SmartSite™ Needle-Free Valve Ports 60103E • 1 Burette (150ml) • Length: 275cm • 4 SmartSite™ Needle-Free Valve Ports 63441E •...
  • Page 60 BD Alaris™ neXus GP Volumetric Pump Associated Products Secondary Infusion Sets • Male Luer and hanger 72213N-0006 • Length: 76cm • 1 SmartSite™ Needle-Free Valve Port • Male Luer with Backcheck Valve • Length: 35cm 72951NE (For use with 60950E)
  • Page 61: Maintenance

    Volumetric Pump software, controls battery use, charge and temperature . Any use of battery packs that are not manufactured by BD in the BD Alaris™ neXus 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 62: Cleaning And Storage

    BD Alaris™ neXus GP Volumetric Pump Maintenance 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 63: Disposal

    . If you wish to discard electrical and electronic equipment, please contact your BD affiliate office or distributor for further information .
  • Page 64: Technical Data

    BD Alaris™ neXus GP Volumetric Pump Technical Data Technical Data Specifications Electrical Protection Class I, Type CF (Defibrillation-proof) Electrical/Mechanical Safety Complies with IEC/EN 60601-1 and IEC/EN 60601-2-24 . Electro Magnetic Compatibility (EMC) Complies with IEC/EN 60601-1-2 and IEC/EN 60601-2-24 .
  • Page 65 Radio Equipment Directive Declaration of Conformity Statement Hereby, BD Switzerland Sàrl, declares that the radio equipment type ‘BD Alaris™ neXus GP’ is in compliance with Directive 2014/53/EU . The full text of the EU declaration of conformity is available at the following internet address: https://www .bd .com/en-uk/Infusion/Conformity-Declaration-GP-neXus...
  • Page 66 BD Alaris™ neXus GP Volumetric Pump Technical Data Alarm Conditions Alarms Prompts Advisories AIR IN LINE LEVER OPEN SET VTBI DOSE WOULD EXCEED (Single Bubble) AIR IN LINE VTBI DONE LOCKED DOSE UNDER (Accumulated) DOOR OPEN SET CLOCK DOSE NOT PERMITTED...
  • Page 67: Irda, Rs232 And Nursecall Specification

    BD Alaris™ neXus GP Volumetric Pump Technical Data 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 68: Infusion Specifications

    Technical Data 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 69 BD Alaris™ neXus GP Volumetric Pump Technical Data Starting the Infusion / Set-up Infusion Parameter Range Infusion Rate 0 .1 – 99 .9ml/h in steps of 0 .1ml/h 100 – 999ml/h in steps of 1ml/h 1000 – 1200ml/h in steps of 10ml/h VTBI Primary (0 –...
  • Page 70: Trumpet And Flow Rate Curves

    BD Alaris™ neXus GP Volumetric Pump Technical Data 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 71 BD Alaris™ neXus GP Volumetric Pump Technical Data 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)
  • Page 72: Products And Spare Parts

    AC Power Lead – European Software Part Number Description 1000SP02156 BD Alaris Communication Engine v2 .0 1000SP02157 BD Alaris CQI Event Reporter v4 .4 1000SP02158 BD Alaris Technical Utility v2 .0 1000SP02159 BD Alaris neXus Editor v5 .0 BDDF00558 Issue 5 71/72...
  • Page 73: Document History

    December 2020 5 .1 .x Firmware version update October 2021 5 .1 .x Fuse update Contact Us For full contact information please refer to bd .com . Customer Service Information Country Telephone EMAIL Australia Freephone: 1 800 656 100 bd_anz@bd .com België...
  • Page 74 BD Switzerland Sàrl, Route de Crassier 17, Business Park Terre-Bonne, Batiment A4, 1262 Eysins, Switzerland bd.com BD, the BD Logo, Alaris, Guardrails, IVAC and SmartSite are trademarks of Becton, Dickinson and Company or its affilates. © 2021 BD. All rights reserved.

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