BD Alaris
™
neXus CC Syringe Pump
Model: CCneXus1-S
en
Directions For Use
Page 1: ...BD Alaris neXus CC Syringe Pump Model CCneXus1 S en Directions For Use...
Page 2: ...Controls 10 Indicators 10 Main Display Features 11 Screen Icons 11 Labelling Symbols 12 Getting Started 13 Initial Set up 13 Language Selection 13 Power Input 13 Wi Fi Configuration 13 Pole Clamp Inst...
Page 3: ...ed 33 Pressure Level without Pressure Disc fitted 33 Alarms and Warnings 34 Original Alarms 34 Alarm Priority Level Indicators 36 Third Edition Alarms 37 Alarm Priority Level Indicators 38 Prompts 39...
Page 4: ...e Specifications 56 Keep Vein Open KVO Rate 56 End Of Syringe Rate 56 Volume To Be Infused VTBI 56 VTBI Complete Rate 56 Near End Of Infusion Alarm 56 End Of Infusion EOI Alarm 56 Maximum Pumping Pres...
Page 5: ...59 Potential Equalisation Conductor 59 EMC 59 Occlusion Pressure Limits 60 IrDA RS232 and Nurse call Specification 63 Trumpet Curves and Start up Curves 65 Products and Spare Parts 68 Spare Parts and...
Page 6: ...l any product described Reproduction disclosure or use other than for the intended purpose without specific written authorization of Becton Dickinson and Company or one of its affiliates is strictly f...
Page 7: ...y 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...
Page 8: ...Xus CC Syringe Pump incorporates an in line pressure monitoring system which allows clinicians to monitor the pressure in the infusion set in real time In line pressure monitoring significantly shorte...
Page 9: ...roducts Standard single use disposable extension sets and syringes with Luer lock connectors see Compatible Extension Sets and Recognised Syringes The Active RFID asset tag supplied by BD with this Pu...
Page 10: ...tential Equalisation PE connector Rating plate see Labelling Symbols for key to symbols Pressure transducer Rotating cam to lock on to horizontal rectangular bars High visibility alarm indicator Relea...
Page 11: ...n soft key to operate PURGE primes the extension set with fluid or drug during initial set up Pump is on hold Extension set must not be connected to the patient Volume Infused VI is not added BOLUS fl...
Page 12: ...RY icon Indicates battery charge level to highlight when the battery will require recharging or re connection to AC power supply Note This can be enabled disabled with the BD Alaris neXus Editor softw...
Page 13: ...inst solid objects greater than 2 5mm Note IP33 applies if AC power cable retainer kit part number 1000SP01294 is fitted Alternating Current Device complies with the requirements of Council Directive...
Page 14: ...ppropriately qualified person with clinical authority in accordance with hospital protocol prior to upload and activation The Pump will automatically operate from its internal battery if the Pump is s...
Page 15: ...screw the clamp to leave enough room for the size of the pole Place Pump around pole and tighten screw until the clamp is secured to the pole Ensure the pole clamp is folded away and stored within the...
Page 16: ...mp is positioned securely Verify Pump is secure by gently pulling the Pump away from the Workstation without using the release lever When the Pump is securely attached it should not come off the Works...
Page 17: ...g Rate Locked lock box is designed to prevent rate change whilst infusing If using this lock box users would need to put the Pump on hold and open the lock box to change the rate When mounting a Pump...
Page 18: ...t makes contact with the Pump case 5 Push the lock box from right to left until a click is heard 6 Remove the key Pumps with a lock box fitted should only be used when fitted to an Alaris Gateway Work...
Page 19: ...cal medications must be positioned as close to the patient s heart level as possible to avoid the risk of variations in flow or siphoning Raising a Pump whilst infusing may result in a bolus of the in...
Page 20: ...rrangement is in doubt the Pump should be operated from the battery Do not open the RS232 Nurse Call protective covering when not in use Electrostatic discharge ESD precautions are required when conne...
Page 21: ...esidential environment for which CISPR 11 class B is normally required this equipment might not offer adequate protection to radio frequency communication services The user might need to take mitigati...
Page 22: ...that the extension set is not connected to the patient Practice Recommendations Tubing internal diameter Smallbore or microbore tubing is recommended when infusing at low rates Filters Internal volume...
Page 23: ...e accuracy of the infusion rate and may also affect Pump performance When drawing fluid into the syringe draw enough to compensate for any dead space volume in the extension set and syringe at the end...
Page 24: ...e that the syringe type and size match those displayed on the Pump then press CONFIRM If required the make of syringe can be changed by pressing the TYPE softkey CONFIRM TYPE BD PLASTIPAK 50 ON HOLD N...
Page 25: ...t has been activated a Confirm the details shown on the screen for data set name release date and time version and ID code by selecting OK softkey b PROFILE screen will be displayed if more than one i...
Page 26: ...th care Do not pull the extension set to remove or to insert the pressure disc 11 Ensure that the syringe type and size match those displayed on the Pump then press CONFIRM If required the brand of sy...
Page 27: ...uired press NO and adjust rate to be within the Guardrails Soft Limits Note Fast Start is a Pump feature to automatically reduce the mechanical slack between the plunger mechanism and syringe at the s...
Page 28: ...and Hands On The Hands Free Bolus is delivered with a single press of the flashing BOLUS softkey The default rate default and maximum bolus volume are set by drug profile in the data set and can be ch...
Page 29: ...infused 3 When purging is complete release the PURGE softkey Press the QUIT softkey to exit back to the main display The Pump will not purge if the RATE LOCK has been enabled During PURGE the pressure...
Page 30: ...t infusing at the new rate Note Press the QUIT softkey to exit titration and return to original rate Note If the new infusion rate setting exceeds or is under a Guardrails Soft Alert confirmation is r...
Page 31: ...key 3 Scroll through the log using the f keys Press the QUIT softkey to exit the log Note When the event log reaches full capacity the oldest events will be overwritten by the most recent events Data...
Page 32: ...menu 2 Select ADJUST ALARM VOLUME Note The Pump will beep at the selected alarm volume setting The user must assess whether the alarm volume setting is loud enough for the intended operating environm...
Page 33: ...Service Personnel Note For information on Network Status codes please refer to the Technical Service Manual Wireless Connection The Pump disables wireless communication when docked to a Workstation an...
Page 34: ...evel press the e button The display will change to show a 20 minute pressure trend graph displaying the pressure alarm level and the current pressure level 2 Press the f keys to increase or decrease t...
Page 35: ...el DRIVE DISENGAGED High The drive system has been disengaged during operation Check the finger grips and the position of the syringe OCCLUSION High Excessive pressure measured at the syringe plunger...
Page 36: ...m only occurs if rate titration is enabled Pressing QUIT will cancel the titration and keep the original rate VTBI DONE KVO CONTINUE Medium The pre set Volume To Be Infused is complete and the Pump co...
Page 37: ...essure level lower than the ambient sound pressure level can impede user recognition of alarm conditions Alarm Priority Level Indicators Priority Audio Indicator Visual Indicator Beacon High One urgen...
Page 38: ...nger loses contact with the plunger button If there is no identifiable cause for the Check Syringe alarm s then the Pump should be removed from clinical use and examined by Qualified Service Personnel...
Page 39: ...pply is reconnected NEAR END OF INFUSION Low The Pump is nearing the end of the infusion This value can be configured Optional reminder signals may sound they are auditory signals that have four beeps...
Page 40: ...OVERRIDE LIMIT is not required press the NO softkey and adjust dose above Guardrails Soft Limit BOLUS DOSE NOT PERMITTED The bolus dose has been set above a Guardrails Hard Limit Check bolus setting a...
Page 41: ...or Information Notice for details 1 Use the f keys to select alternative alarm tones 2 When the desired alarm tone has been selected press OK softkey 3 When all modifications have been carried out pr...
Page 42: ...he Attention alarm Drug Override Mode Always Confirmation of setting will be required for any changes made to the dose rate that are outside of the Guardrails Soft Limits Smart Confirmation of setting...
Page 43: ...of syringe volume KVO at EOI Sets whether the Keep Vein Open KVO at End Of Infusion is available KVO Rate Sets the Keep Vein Open rate at which the Pump will operate when End of Infusion is reached Pu...
Page 44: ...hours minute hour 24 hours ng ng min ng h ng 24h ng kg min ng kg h ng kg 24h g g min g h g 24h g kg min g kg h g kg 24h mg mg min mg h mg 24h mg kg min mg kg h mg kg 24h g g min g h g 24h g kg min g k...
Page 45: ...Default Duration The default duration over which the loading dose will be delivered Pause After Loading Dose If Pause After Loading Dose is enabled then a low priority alarm will be generated when th...
Page 46: ...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 For syringe brands and...
Page 47: ...l 300141 50ml 300144 Braun Omnifix 5ml 4617053V 10ml 4617100V 20ml 4617207V 30ml 4617304F 50ml 4617509F Braun Perfusor 20ml 8728615 50ml 8728844F 06 8728844F 04 8728844F 20 Codan Perfusion 50ml 62 845...
Page 48: ...specification significant to system accuracy without prior notification Subject to the above BD branded Luer lock syringes can be confirmed as BD Plastipak syringes due to there being no significant...
Page 49: ...duct 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...
Page 50: ...at extension sets are changed in accordance with the Directions For Use Carefully read the Directions For Use supplied with the extension set prior to use Please note these drawings are not to scale S...
Page 51: ...g disc 200cm Priming Volume 1 3ml Light Protected Sets G30653V Opaque White PVC Syringe Extension Set with occlusion sensing disc 200cm Priming Volume 1 5ml MFX2294 Opaque White PVC Syringe Extension...
Page 52: ...E Polyethylene Lined Syringe Extension Set with occlusion sensing disc and clamp 205cm Priming Volume 1ml MFX2214 Amber Polyethylene Lined Syringe Extension Set with occlusion sensing disc and clamp 3...
Page 53: ...d by Qualified Service Personnel only with reference to the TSM Refer to Technical Service Manual for calibration procedures The units of measurement used in the calibration procedure are standard SI...
Page 54: ...face discoloration Concentrated isopropyl alcohol based cleaners will degrade plastic parts Before cleaning always switch off and disconnect from the AC power supply Never allow liquid to enter the ca...
Page 55: ...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 handlin...
Page 56: ...10 10 0 to 99 9 0 1 1 0 100 to 999 1 10 1000 to 1200 10 100 0 1 to 9 9 0 1 1 Infusion rate increment changes when the double decimal option is disabled in the General Options The Volume Infused range...
Page 57: ...on 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 100 to 500ml h The purge volume range is 0 5 to 5ml During P...
Page 58: ...Pump is used with the recommended syringes Infusion volume accuracy may be compromised at rates below 1 0ml h Differences in factors such as size and plunger force in recognised syringes can cause va...
Page 59: ...ompliance 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 Mem...
Page 60: ...sport and Storage Atmospheric Pressure 50kPa to 106kPa Electrical Mechanical Safety Complies with EN IEC 60601 1 and EN IEC 60601 2 24 Potential Equalisation Conductor The function of the Potential Eq...
Page 61: ...umping force For this reason the occlusion alarm needs to be set with an operating margin of at least one level between the alarm and normal infusion levels The ability to set a small operating margin...
Page 62: ...set with occlusion sensing disc Time to alarm at 0 1ml h hr min 15 45 0 00 2 24 4 48 7 12 9 36 12 00 14 24 16 48 19 12 0 200 400 600 800 1000 typical mmHg Time to alarm at 1 0ml h Time to alarm at 5...
Page 63: ...1 20 1 40 0 2 5 8 10 typical ml 0 00 0 05 0 10 0 15 0 20 0 25 0 30 0 35 0 2 4 6 8 10 typical 0 3ml threshold Occlusion Level Occlusion Level Tests at low alarm levels may alarm immediately the force a...
Page 64: ...within one second after the alarm condition is detected Refer to the Technical Service Manual for further information regarding the RS232 interface The assessment for the suitability of any software...
Page 65: ...minimum Enable Active low 7V to 12V Active high 7V to 12V powers up the isolated RS232 circuitry Inactive Floating open circuit allows isolated RS232 circuitry to power down Isolation Socket Pump 1 5k...
Page 66: ...ed over particular time periods or observation windows not continuous data versus operating time Over long observation windows short term fluctuations have little effect on accuracy as represented by...
Page 67: ...20 0 10 0 0 0 10 0 20 0 30 0 0 5 10 15 20 25 30 35 Time mins Observation Window mins Maximum Error Minimum Error Linear Mean 4 0 Start up trend BD Plastipak 50ml at 1 0ml h Trumpet curve BD Plastipak...
Page 68: ...0 10 0 0 0 10 0 20 0 30 0 0 5 10 15 20 25 30 35 Time mins Observation Window mins Maximum Error Minimum Error Linear Mean 2 5 Start up Trend BD Plastipak 50 ml at 1 0 ml h Trumpet Curve BD Plastipak...
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Page 71: ...Syringe Pumps Document History Document History Issue Date Software Version Description 1 April 2020 5 0 x Initial release 2 September 2020 5 0 x Specifications 3 October 2020 5 0 x Recognised Syringe...
Page 72: ...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...