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BD Alaris neXus CC Directions For Use Manual

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

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Summary of Contents for BD Alaris neXus CC

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

  • Page 2: Table Of Contents

    BD Alaris™ neXus CC Syringe Pumps Contents Contents About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Conventions Used in this Manual .
  • Page 3 BD Alaris™ neXus CC Syringe Pumps Contents Rate Titration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Dosing Summary .
  • Page 4 BD Alaris™ neXus CC Syringe Pumps Contents Blood Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 TPN Sets .
  • Page 5 BD Alaris™ neXus CC Syringe Pumps Contents Electrical/Mechanical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Potential Equalisation Conductor .

  • 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: Intended Users

    . The BD Alaris™ neXus CC Syringe Pump incorporates an in-line pressure monitoring system which allows clinicians to monitor the pressure in the infusion set in real time .

  • Page 9: Compatibility

    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 10: 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 11: 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 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 12: 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 13: Labelling Symbols

    Not for Municipal Waste Fuse Rating Operating Temperature Range – Pump can be used between 0 and 40 degrees centigrade +40°C  0°C Pump is able to communicate with BD Alaris™ Communication Engine via Wi-Fi Medical Device BDDF00412 Issue 4 12/70...

  • 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: 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 16: 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 17: 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 18 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 19: 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 20 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 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: 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 23 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 24 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 25: 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 26 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 27 BD Alaris™ neXus CC Syringe Pumps Operation Note: If infusion rate exceeds or is under the Guardrails™ Soft Limits then check infusion setting, to continue with infusion at set rate press and then confirm OVERRIDE LIMIT by pressing YES . If OVERRIDE LIMIT is not required press NO and adjust rate to be within the Guardrails™...

  • Page 28: 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 29: 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 30: 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 31: 24 Hour Log

    BD Alaris™ neXus CC Syringe Pumps Advanced Features 24 Hour Log This option allows the 24 hour log of volume infused to be reviewed . 1 . Press the button to access the OPTIONS menu . 2 . Select the 24H LOG option using the keys and press the OK softkey .

  • Page 32: Add Drug

    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: Network Status

    BD Alaris™ neXus CC Syringe Pumps Advanced Features Network Status This option allows information about the wireless network connection status to be viewed by Qualified Service Personnel . Refer to the Technical Service Manual for the description of network data displayed on these screens .

  • Page 34: 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 35: 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 36 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 37: 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 38: 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 39: 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 40: 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 41: 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 42: 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 43 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 44: 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 45: 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 46: Profile Syringe Library

    BD Alaris™ neXus CC Syringe Pumps Configuration Profile Syringe Library The Profile Syringe Library is created from the predefined Master Syringe Library . Check the boxes of the syringes to be included in the profile . Checking the All Syringes checkbox under Operations selects all the syringes .

  • Page 47: 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 48 . • 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 49: 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 50: 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 51: Tpn Sets

    BD Alaris™ neXus CC Syringe Pumps Associated Products TPN Sets MFX2206E Dedicated Neonatal TPN system light resistant extension set with occlusion sensing disc . (115cm) . Priming Volume: 15ml MFX2211 Dedicated TPN system light resistant extension set with occlusion sensing disc . (200cm) .

  • Page 52: 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 53: 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 54: 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 55: Disposal

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

  • Page 56: 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 57: Bolus Volume Accuracy

    −0 .1% ±5% * – Using BD Plastipak 50ml syringe at 5ml/h under normal conditions (95% confidence / 95% of Pumps) . 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 .

  • Page 58: Occlusion 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 59: Wi-Fi Specifications

    Radio Equipment Directive Declaration of Conformity Statement Hereby, BD Switzerland Sàrl, declares that the radio equipment type ‘BD Alaris™ neXus CC’ 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-CC-neXus...

  • Page 60: Environmental Specifications

    BD Alaris™ neXus CC Syringe Pumps Technical Data Environmental Specifications Condition Acceptable Range Operating Temperature 0°C to +40°C Operating Relative Humidity 20% to 90% non-condensing Operating Atmospheric Pressure 70kPa to 106kPa Transport and Storage Temperature −30°C to +50°C Transport and Storage Relative Humidity...

  • Page 61: Occlusion Pressure Limits

    BD Alaris™ neXus CC Syringe Pumps Technical Data Occlusion Pressure Limits Time to alarm following occlusion is achieved in less than 30 minutes at rates of 1ml/h and higher by the appropriate selection of occlusion levels . Use of the dedicated pressure disc permits the occlusion alarm pressure (mmHg) to be set accurately, with a small operating margin between the alarm and normal infusion pressures .
  • Page 62 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 63 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 50 ml syringe is selected with a G40020B standard extension set .

  • Page 64: 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 65 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 66: Trumpet Curves And Start-Up Curves

    BD Alaris™ neXus CC Syringe Pumps Technical Data Trumpet Curves and Start-up Curves In this Pump, as with all infusion systems, the action of the pumping mechanism and variations in individual syringes cause short-term fluctuations in rate accuracy . The following curves show typical performance of the system in two ways: 1 .
  • Page 67 BD Alaris™ neXus CC Syringe Pumps Technical Data 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 20.0 10.0...
  • Page 68 Maximum Minimum Linear Mean Error Error = −2 .5% Start-up Trend . BD Plastipak 50 ml at 1 .0 ml/h Trumpet Curve . BD Plastipak 50 ml at 1 .0 ml/h Time (mins) Observation Window (mins) Maximum Minimum Linear Mean...

  • Page 69: 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 BDDF00412 Issue 4 68/70...

  • Page 70: 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 71: 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 72 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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