BD Alaris CCneXus1 Directions For Use Manual
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BD Alaris CCneXus1 Directions For Use Manual

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BD Alaris
neXus CC Syringe Pump
™
Model: CCneXus1
en Directions For Use

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Summary of Contents for BD Alaris CCneXus1

  • Page 1 BD Alaris neXus CC Syringe Pump ™ Model: CCneXus1 en Directions For Use...

  • Page 2: Table Of Contents

    BD Alaris™ neXus CC Syringe Pumps Contents About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Conventions Used in this Manual .
  • Page 3 BD Alaris™ neXus CC Syringe Pumps Operating the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Advanced Features .
  • Page 4 BD Alaris™ neXus CC Syringe Pumps BD Alaris™ neXus Editor Software Profile Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Dose Rate Units .
  • Page 5 BD Alaris™ neXus CC Syringe Pumps Wi-Fi Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Radio Equipment Directive Declaration of Conformity Statement .

  • Page 6: About This Manual

    About This Manual About This Manual The user must be thoroughly familiar with the BD Alaris™ neXus CC Syringe 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 7: Overview

    Hard Limits may not be overridden . The BD Alaris™ neXus CC Syringe Pump with a data set loaded, provides automatic alerts when a dosing limit, bolus limit, loading dose limit, age 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 .

  • Page 8: Clinical Benefits

    Compatibility The BD Alaris™ neXus CC Syringe Pump is compatible with the following: • The Alaris™ Gateway Workstation v1 .3 .x and v1 .6 .x and the BD Alaris™ MRI Capsule v1 .3 .x – see ‘ A ssociated Products’...

  • Page 9: Features Of The Pump

    BD Alaris™ neXus CC Syringe Pumps Overview Features of the Pump Release lever for High visibility ON / OFF Pressure transducer Display rotating cam alarm indicator PURGE / BOLUS MUTE PRESSURE OPTIONS Finger Grips Extension set Shelf for chevron Positive Plunger...

  • Page 10: Controls

    BD Alaris™ neXus CC Syringe Pumps Overview 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 . Note: Logs are maintained for power down events including when the Pump is powered down or unexpected power loss .

  • Page 11: Main Display Features

    Guardrails™ Hard Limit, as defined in the data set . The warning cannot be overridden . 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 via Wi-Fi to ACE .

  • Page 12: Labelling Symbols

    Do not dispose of battery in municipal waste . Separate collection for battery is required . Not for Municipal Waste Fuse Rating Operating Temperature Range – Pump can be used between 0 and 40 degrees centigrade Pump is able to communicate with BD Alaris™ Communication Engine via Wi-Fi Medical Device BDDF00281 Issue 4 11/64...

  • Page 13: 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 14: Pole Clamp Installation

    BD Alaris™ neXus CC Syringe Pumps Getting Started Do not mount the Pump with the AC power inlet or the syringe pointing upwards . This could affect the electrical safety in the event of a fluid spill or lead to the infusion of air which may be in the syringe .

  • Page 15: Workstation Or Equipment Rail Installation

    Note: The Pump will stop communicating over Wi-Fi once docked to a Workstation and will disable its internal wireless module . The Pump will instead use the Workstation as a conduit for connecting to BD Alaris™ Communication Engine, as long as the Workstation is powered on and is functional .

  • Page 16: Securing The Syringe With Optional Lock Box

    BD Alaris™ neXus CC Syringe Pumps Getting Started Securing the Syringe with Optional Lock box Lock box operation The optional lock box is a available in two configurations: • Rate Unlocked lock box – is designed to allow the • Rate Locked lock box – is designed to prevent rate user to adjust rate whilst infusing .
  • Page 17 BD Alaris™ neXus CC Syringe Pumps Getting Started Close Lock box 1 . Load the syringe according to the instructions in the ‘Loading and Confirming a Syringe’ section . 2 . Ensure the extension set is connected to the syringe and threaded through the lock box .

  • Page 18: Operating Precautions

    BD Alaris™ neXus CC Syringe Pumps Getting Started Operating Precautions Disposable Syringes and Extension Sets The Pump has been calibrated for use with single-use disposable syringes . To best ensure correct and accurate operation, only use three piece Luer lock versions of the syringe brand specified on the Pump or described in this manual .
  • Page 19 BD, is at your sole risk, and BD does not provide any warranty for or endorsement on any BD Alaris™ neXus CC Syringe Pump that has been so modified or altered . BD product warranty shall not apply in the event the BD Alaris™...
  • Page 20 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 21: Operation

    BD Alaris™ neXus CC Syringe Pumps Operation Operation Syringe Loading Prepare Syringe and Administration Set To decrease potential start-up delays, delivery inaccuracies and delayed generation of occlusion alarms each time a new syringe is loaded: • Use smallest syringe size possible, for example, if infusing 9ml of fluid, use a 10ml syringe .
  • Page 22 BD Alaris™ neXus CC Syringe Pumps Operation Loading and Confirming a Syringe • To securely load and confirm a syringe carefully follow the steps below . An incorrect loading of a syringe may result in misidentification of the syringe type and size . If then confirmed, this may lead to significant inaccuracy of the infusion rate and may also affect Pump performance .
  • Page 23 TYPE Note: If the PURGE SYRINGE option has been enabled in the data set via BD Alaris™ neXus Editor then the prompt to purge screen is displayed and the extension set can be purged as required, however ensure that the extension set is not connected to the patient during this process .

  • Page 24: Operating The Pump

    BD Alaris™ neXus CC Syringe Pumps Operation Operating the Pump When operating the Pump, the user should position themselves at a distance of 0 .5 metres from the display . 1 . Connect the Pump to an AC power supply using the AC power cable .
  • Page 25 Adjust Weight and OK to confirm, if required . c) Press OK to confirm setup . Go to step 8 . Steps for Drugs setup may vary, depending on how the profile is configured in the data set via the BD Alaris™ neXus Editor .
  • Page 26 BD Alaris™ neXus CC Syringe Pumps Operation Note: Fast Start is a Pump feature to automatically reduce the mechanical slack between the plunger mechanism and syringe at the start of an infusion . If infusion rate running exceeds or is under the Guardrails™ Soft Limits then the display will show INFUSING with either Up or Down arrows on both sides .

  • Page 27: Advanced Features

    In Hands-On Bolus, press and hold the (flashing) BOLUS softkey to deliver the required bolus . The bolus rate can be adjusted . The bolus volume is limited in the data set via BD Alaris™ neXus Editor . 1 . During infusion press the button once to display the bolus screen .

  • Page 28: Purge

    BD Alaris™ neXus CC Syringe Pumps Advanced Features Manual Bolus The Manual Bolus is delivered by moving the plunger drive mechanism forward while the Pump is infusing . This method of delivering a bolus is not recommended as best clinical practice .

  • Page 29: Rate Lock

    BD Alaris™ neXus CC Syringe Pumps Advanced Features Rate Lock If Rate Lock is enabled, when the infusion rate has been set and the infusion started, the rate lock prompt will appear on the display following any rate titrations, bolus infusions and loading dose infusions .

  • Page 30: Set Vtbi Over Time

    BD Alaris™ neXus CC Syringe Pumps Advanced Features Set VTBI over Time This option allows a VTBI and delivery time to be specified . The rate necessary to deliver the required volume within the specified time is calculated and displayed .

  • Page 31: Pump Details

    3 . Select the Drug from the displayed list using the keys, press OK to confirm . Drugs are configured via BD Alaris™ neXus Editor software based on the units available (time / weight based): • Gram base: ng, mcg/μg, mg and g •...

  • Page 32: Standby

    This option shows the Pump’s current date and time . This can be updated via Pump’s Service mode by Qualified Service Personnel or will automatically update when the Pump connects to the BD Alaris™ Communication Engine, if one is deployed at the facility .

  • Page 33: In Line Pressure Monitoring Features

    Note: xx is the AUTO OFFSET pressure and is determined by the user . This adjustment, AUTO OFFSET value 15– 100mmHg, is configurable by profile within the data set via BD Alaris™ neXus Editor . At pressures up to 100mmHg the AUTO OFFSET value is added .

  • Page 34: Alarms And Warnings

    BD Alaris™ neXus CC Syringe Pumps Alarms and Warnings Alarms and Warnings Alarms are indicated by a combination of an audible alarm, flashing alarm indicator and a descriptive message in the display . 1 . First press the button to silence the alarm for two minutes, then check the display for an alarm message . Press CANCEL to cancel the alarm message .
  • Page 35 BD Alaris™ neXus CC Syringe Pumps Alarms and Warnings Display Alarm Priority Description and Troubleshooting Guide VTBI DONE (STOP) High The pre-set Volume To Be Infused is complete and the Pump has stopped infusing . END OF INFUSION High The Pump has reached the end of the infusion and the Pump has stopped infusing .

  • Page 36: Alarm Priority Level Indicators

    BD Alaris™ neXus CC Syringe Pumps Alarms and Warnings Note: The audio sound pressure level is at least 45dB depending on configuration of the alarm sound level . Setting the alarm sound pressure level lower than the ambient sound pressure level can impede user recognition of alarm conditions .

  • Page 37: Third Edition Alarms

    BD Alaris™ neXus CC Syringe Pumps Alarms and Warnings Third Edition Alarms Display Alarm Priority Description and Troubleshooting Guide <Error Code and Message> High The alarm system has detected an internal malfunction . Note the malfunction code . Remove Pump from service for examination by Qualified Service Personnel .

  • Page 38: Alarm Priority Level Indicators

    BD Alaris™ neXus CC Syringe Pumps Alarms and Warnings Display Alarm Priority Description and Troubleshooting Guide TITRATION NOT CONFIRMED Medium The infusion rate has been changed, but has not been confirmed after five seconds of no activity the user will be notified by an auditory cue .

  • Page 39: Prompts

    BD Alaris™ neXus CC Syringe Pumps Alarms and Warnings Prompts Prompts are indicated by an audible alarm and message . They cannot be silenced and do not have a visual indicator . Display Icon Description and Troubleshooting Guide DOSE WOULD EXCEED The dose rate has been set to a value which exceeds a Guardrails™...

  • Page 40: Configuration

    (available in Technician Mode) and others through the data set via BD Alaris™ neXus Editor Software . Access codes should only be entered by Qualified Service Personnel . Use BD Alaris™ neXus Editor to configure general options, drug library and units enabled for each profile and to configure Syringe Brands and Models to be enabled .

  • Page 41: Bd Alaris™ Nexus Editor Software Profile Configuration

    BD Alaris™ neXus Editor Software Profile Configuration The following options are only configurable via the BD Alaris™ neXus Editor Software (PC based) . See BD Alaris™ neXus Editor Directions For Use for details on how to configure Profile Configurations .
  • Page 42 BD Alaris™ neXus CC Syringe Pumps Configuration General Syringe Pump Configurations Setting Description Back Off An automatic feature which is activated following an occlusion . The Pump action reverses and pumps backwards to release the pressure which has built up in the infusion system, this minimises the post occlusion bolus .

  • Page 43: Dose Rate Units

    BD Alaris™ neXus CC Syringe Pumps Configuration Dose Rate Units All of the following dose rate units can be used when defining the Guardrails™ dose rate settings . The following dose rate units can be configured for use in Dosing Only mode . Checking the ALL checkbox will select all of the listed units .

  • Page 44: Bd Alaris™ Nexus Editor Software Profile Drug Library

    BD Alaris™ neXus Editor Software Profile Drug library The following drug parameters are only configurable via the BD Alaris™ neXus Editor Software . See BD Alaris™ neXus Editor Directions For Use for details on how to configure Profile Drug Library . These parameters are used when the Pump is operated with a drug name selected .

  • Page 45: Associated Products

    BD Alaris™ neXus CC Syringe Pumps Associated Products Associated Products Recognised Syringes The Pump is calibrated and labelled for use with single-use disposable Luer lock syringes . Only use the size and type of syringe specified on the Pump display .
  • Page 46 . • In no event shall BD be liable for any damages of any kind or nature, including without limitation, direct or indirect, special, consequential, or incidental damages arising from, or in connection with the use of syringes not listed in the ‘Recognised Syringes’...

  • Page 47: Alaris™ Gateway Workstation V1 .3 .X Or V1 .6 .X

    BD Alaris™ neXus CC Syringe Pumps 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 48: Compatible Extension Sets

    The Pump uses standard, single-use, disposable extension sets and syringes with Luer lock connectors . 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 . Contact your local BD representative for availability .

  • Page 49: Low Sorbing Sets

    BD Alaris™ neXus CC Syringe Pumps Associated Products Low Sorbing Sets G30453V Opaque White PVC low sorbing Syringe Extension Set with occlusion sensing disc . (200cm) . Priming Volume: 1 .5ml G30302M Polyethylene Lined Syringe Extension Set with occlusion sensing disc and clamp . (200cm) .

  • Page 50: Maintenance

    CC Syringe Pump software, controls battery use, charge and temperature . Any use of battery packs that are not manufactured by BD in the BD Alaris™ neXus CC Syringe 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 51: Cleaning And Storage

    BD Alaris™ neXus CC Syringe Pumps Maintenance Cleaning and Storage 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 52: Disposal

    . If you wish to discard electrical and electronic equipment, please contact your BD affiliate office or distributor for further information .

  • Page 53: Technical Data

    BD Alaris™ neXus CC Syringe Pumps Technical Data Technical Data Specifications Infusion Specifications Maximum infusion rate can be set as part of the configuration in the data set via BD Alaris™ neXus Editor . Infusion Rate Syringe Size 0 .1ml/h to 150ml/h 5ml syringes 0 .1ml/h to 300ml/h...

  • Page 54: Critical Volume

    BD Alaris™ neXus CC Syringe Pumps Technical Data Critical Volume The bolus which can occur in the event of a single internal fault condition with a 50ml syringe is: Maximum overinfusion is 0 .87ml . Purge Specifications The purge rate is limited to the maximum rate for the syringe and can be set as part of the configuration .

  • Page 55: System Accuracy

    . See also ‘Trumpet Curves and Start-Up Curves’ section in this manual . Data Set Specification A maximum of 30 profiles can be set, with a total number of 3000 drugs per data set . See BD Alaris™ neXus Editor Software Directions For Use for more details .

  • Page 56: Ac Power Supply

    BD Alaris™ neXus CC Syringe Pumps Technical Data AC Power Supply 115–230V AC, 50–60Hz, 30VA (under maximum charging conditions) 10VA (nominal) . Dimensions 335mm (w) × 121mm (h) × 200mm (d) Weight 2 .4kg (excluding power cable) Protection against fluid ingress IP32 –...

  • Page 57: In Line Pressure Monitoring Occlusion Pressure Limits

    The following graphs show the typical values for time to alarm and bolus volume that can be expected in the event of an occlusion when the BD Plastipak 50ml syringe is selected with a G30402M extension set with occlusion sensing disc .
  • Page 58 BD Alaris™ neXus CC Syringe Pumps Technical Data Unintended bolus volume at 5 .0ml/h Unintended bolus volume at 5 .0ml/h back off disabled back off enabled — typical — typical 1.20 0.35 — 0 .3ml 0.30 1.00 threshold 0.25 0.80 0.20...

  • Page 59: Irda, Rs232 And Nurse Call Specification

    IrDA / RS232 / Nurse call Feature The IrDA or RS232 / Nurse call is a feature on the Pump that allows connection to a PC or another BD Alaris™ neXus CC Syringe Pump . This allows data to be transferred between the Pump and a PC or another BD Alaris™ neXus CC Syringe Pump, (e .g .
  • Page 60 BD Alaris™ neXus CC Syringe Pumps Technical Data RS232 / Nurse call Connection Data RS232 / Nurse call Specification Item Description Connector D Type – 9 Pin TXD/RXD EIA RS232-C Standard TXD Output Voltage Range Minimum: −5V (mark), +5V (space) Typical: −7V (mark), +7V (space) with 3kΩ...

  • Page 61: Trumpet Curves And Start-Up Curves

    • For applications where flow uniformity is a concern, rates of 1 .0ml/h or above are recommended . With a Pressure Extension Set fitted, G30402M – Standard disposable extension set Start-up trend . BD Plastipak 5ml at 0 .1ml/h Trumpet curve . BD Plastipak 5ml at 0 .1ml/h 30.0...
  • Page 62 BD Alaris™ neXus CC Syringe Pumps Technical Data Start-up trend . BD Plastipak 50ml at 5 .0ml/h Trumpet curve . BD Plastipak 50ml at 5 .0ml/h Time (mins) Observation Window (mins) Maximum Minimum Linear Mean Error Error = −0 .1%...

  • Page 63: Products And Spare Parts

    Lock box Accessory (Rate Locked) 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 BDDF00281 Issue 4 62/64...

  • Page 64: Contact Us

    BD Alaris™ neXus CC Syringe Pumps 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 bd_anz@bd .com België +32(0)53 720 556 info .benelux@bd .com...

  • Page 65: Document History

    BD Alaris™ neXus CC Syringe Pumps Document History Document History Issue Date Software Version Description April 2020 5 .0 .x Initial release September 2020 5 .0 .x Specifications October 2020 5 .0 .x Recognised Syringes February 2021 5 .0 .x...
  • Page 66 BD Switzerland Sàrl, Route de Crassier 17, Business Park Terre-Bonne, Batiment A4, 1262 Eysins, Switzerland bd.com BD, the BD Logo, Alaris and Guardrails are trademarks of Becton, Dickinson and Company or its affiliates. © 2021 BD. All rights reserved.

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