Alaris neXus Syringe Pump CCneXus1 Directions for Use Issue 4 Ver 5.0x Feb 2021

BD Alaris™ neXus CC Syringe Pumps 

Contents About This Manual... 5 Conventions Used in this Manual... 5

Overview... 6 Introduction... 6 Intended Purpose... 6 Intended Users... 6 Clinical Benefits... 7 Conditions for Use... 7 Indications... 7 Contraindications... 7 Undesirable Side-Effects... 7 Compatibility... 7 Features of the Pump... 8 Controls... 9 Indicators... 9 Main Display Features... 10 Screen Icons... 10 Labelling Symbols... 11

Getting Started... 12 Initial Set-up... 12 Language Selection... 12 Power Input... 12 Wi‑Fi Configuration... 12 Pole Clamp Installation... 13 Workstation or Equipment Rail Installation... 14 Securing the Syringe with Optional Lock box... 15 Operating Precautions... 17

Operation... 20 Syringe Loading... 20 Prepare Syringe and Administration Set... 20

BDDF00281 Issue 4

1/64

BD Alaris™ neXus CC Syringe Pumps 

Operating the Pump... 23

Advanced Features... 26 Bolus Infusion... 26 Purge... 27 Volume To Be Infused (VTBI)... 27 Clear Volume... 27 Rate Lock... 28 Rate Titration... 28 Dosing Summary... 28 Set VTBI over Time... 29 24 Hour Log... 29 Event Log... 29 Data Set Details... 29 Infusion Setup... 29 Pump Details... 30 Add Drug... 30 Adjust Alarm Volume... 30 Profile Filter... 30 Standby... 31 Date and Time... 31 Network Status... 31 Wireless Connection... 31 In Line Pressure Monitoring Features... 32 Auto Set Pressure (If enabled)... 32 Pressure Level with Pressure Disc fitted... 32

Alarms and Warnings... 33 Original Alarms... 33 Alarm Priority Level Indicators... 35 Third Edition Alarms... 36 Alarm Priority Level Indicators... 37 Prompts... 38

Configuration... 39 Configured Options... 39 Alarm Presets... 39 Additional Configured Options Available... 39

BDDF00281 Issue 4

2/64

BD Alaris™ neXus CC Syringe Pumps 

BD Alaris™ neXus Editor Software Profile Configuration... 40 Dose Rate Units... 42 BD Alaris™ neXus Editor Software Profile Drug library... 43 Profile Syringe Library... 43

Associated Products... 44 Recognised Syringes... 44 Alaris™ Gateway Workstation v1.3.x or v1.6.x... 46 BD Alaris™ MRI Capsule v1.3.x... 46 Compatible Extension Sets... 47 Standard Sets... 47 Blood Sets... 47 TPN Sets... 47 Low Sorbing Sets... 48 Light Protected Sets... 48 NICU Sets... 48

Maintenance... 49 Routine Maintenance Procedures... 49 Battery Operation... 49 Cleaning and Storage... 50 Disposal... 51

Technical Data... 52 Specifications... 52 Infusion Specifications... 52 Bolus Specifications... 52 Bolus Volume Accuracy*... 52 Critical Volume... 53 Purge Specifications... 53 Keep Vein Open (KVO) Rate... 53 End Of Syringe Rate... 53 Volume To Be Infused (VTBI)... 53 VTBI Complete Rate... 53 Near End Of Infusion Alarm... 53 End Of Infusion (EOI) Alarm... 53 Maximum Pumping Pressure Limit... 53 Occlusion Accuracy... 53 System Accuracy... 54 Data Set Specification... 54 Electrical Classification... 54 Battery Specifications... 54 BDDF00281 Issue 4

3/64

BD Alaris™ neXus CC Syringe Pumps 

Wi‑Fi Specifications... 54 Radio Equipment Directive Declaration of Conformity Statement... 54 Memory Retention... 54 Fuse Type... 54 AC Power Supply... 55 Dimensions... 55 Weight... 55 Protection against fluid ingress... 55 Alarm Conditions... 55 Environmental Specifications... 55 Electrical/Mechanical Safety... 55 Potential Equalisation Conductor... 55 EMC... 55 In Line Pressure Monitoring Occlusion Pressure Limits... 56 IrDA, RS232 and Nurse call Specification... 58 Trumpet Curves and Start-up Curves... 60

Products and Spare Parts... 62 Spare Parts and Accessories... 62 Software... 62

Contact Us... 63 Customer Service Information... 63

Document History... 64

BDDF00281 Issue 4

4/64

BD Alaris™ neXus CC Syringe Pumps 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. These settings and values are for illustrative use only. The complete range of settings and values are detailed in the specifications section. • Keep this manual for future reference during the Pump’s operational life. • It is important to ensure that you only refer to the most recent version of the Directions For Use and Technical Service Manual for your BD products. These documents are referenced on bd.com. Paper copies of the Directions For Use can be obtained free of charge by contacting your local BD representative. An estimated delivery time will be provided when the order is placed. This document contains proprietary information of Becton, Dickinson and Company or one of its affiliates, and its receipt or possession does not convey any rights to reproduce its contents, or to manufacture or sell 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 forbidden.

Conventions Used in this Manual Bold ‘Single quotes’ Italics

Used for Display names, software commands, controls and indicators referenced in this manual, for example, Battery Indicator, PURGE, ON/OFF button. Used to indicate cross-references made to another section of this manual. For example, see ‘Recognised Syringes’ section. Used to refer to other documents or manuals. For example, Refer to the relevant Directions For Use (DFU) for further information. Also used to define custom terminology specific to a manual e.g. The BD Alaris™ neXus CC Syringe Pump (hereinafter referred to as Pump). Warning symbol. A warning is a statement that alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of a Pump. Caution symbol. A caution is a statement that alerts the user to the possibility of a problem with a Pump associated with its use or misuse. Such problems may include Pump malfunction, Pump failure, damage to a Pump or damage to other property. The caution statement includes the precaution(s) that should be taken to avoid the hazard.

Note:

Notes contain supplementary information or emphasize a point or procedure.

BDDF00281 Issue 4

5/64

BD Alaris™ neXus CC Syringe Pumps Overview

Overview Introduction

These Directions For Use can be used with the BD Alaris™ neXus CC Syringe Pump (Model: CCneXus1). The BD Alaris™ neXus CC Syringe Pump is a small lightweight Pump that provides accurate and reliable infusions over a range of rates. If the model number is CCneXus1-S, then refer to the relevant Directions For Use for those Pumps. Note: Any serious incident that occurs in relation to this Pump should be reported to the manufacturer, and to the relevant local regulatory authority. The BD Alaris™ neXus CC Syringe Pump functions with a wide range of standard, single-use, disposable Luer lock syringes together with extension sets. The Pump accepts syringe sizes from 5ml to 50ml. A full list of recognised syringes can be found in the ‘Recognised Syringes’ section. A list of recommended extension sets can be found in the ‘Compatible Extension Sets’ section. The BD Alaris™ neXus CC Syringe Pump can be programmed to deliver fluids utilising rate, volume over time, dose rate calculation, and pre-programmed drug dosing protocols containing concentration values, and Guardrails™ dosing safety limits. The BD Alaris™ neXus Editor software is a medical device accessory which allows the hospital to develop a best-practice data set of IV medication dosing guidelines for patient-specific care areas referred to as profiles. Each profile contains a specific library of drugs, as well as an appropriate Pump configuration. A profile also contains Guardrails™ Soft and Hard Limits, based on clinical requirements. Soft limits may be overridden during infusion programming and 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. The hospital-defined data set is developed and approved through pharmacy and clinical input, and then transferred into the Pump by Qualified Service Personnel, either manually using BD Alaris™ neXus Transfer Tool or automatically via BD Alaris™ Communication Engine. The BD Alaris™ neXus CC Syringe Pump can connect to the BD Alaris™ Communication Engine, if one is deployed at the medical facility. Then connected, either by docking to a connected Alaris™ Gateway Workstation or via hospital Wi‑Fi. Pumps infusion data, logs and configuration information will be automatically detected.The BD Alaris™ neXus CC Syringe Pump features an in-line pressure sensor technology, capable of highly accurate, real time pressure monitoring. Improving the early detection of occlusions, by reducing time to alarm, and reducing the potential risk of post occlusion bolus.

Intended Purpose The BD Alaris™ neXus CC Syringe Pumps are used within hospitals, healthcare facilities and during medical ambulance ground transport to deliver either continuous or intermittent therapy through clinically acceptable routes of administration. The BD Alaris™ neXus CC Syringe Pump is intended to be used for the purpose of controlling rate and volume. The BD Alaris™ neXus CC Syringe Pump is indicated for use on adults, paediatrics and neonates.

Intended Users The primary users of the BD Alaris™ neXus CC Syringe Pump are: • Nurse • Physician • Biomedical Engineer/Technician • Nurse Educator Secondary users of the BD Alaris™ neXus CC Syringe Pump include: • Pharmacist • Materials Manager

BDDF00281 Issue 4

6/64

BD Alaris™ neXus CC Syringe Pumps Overview

Clinical Benefits The BD Alaris™ neXus CC Syringe Pump provides continuous or intermittent infusion of parenteral fluids and or drugs to treat a variety of medical conditions. Electronic infusion devices are used when the patient’s critical medical condition dictates a more immediate, accurate and sustained impact from the fluids and medications than can be achieved with oral therapies or other forms of intravenous administration (e.g. gravity administration or IV pushes). The fluids and drugs being administered either sustain normal physiologic bodily functions or provide therapeutic effects to combat disease or an unhealthy patient condition due to injury or other compromised status. 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. In-line pressure monitoring significantly shortens the time to alarm in the event of an occlusion.

Conditions for Use The BD Alaris™ neXus CC are restricted medical devices intended for use by qualified, trained personnel to deliver either continuous or intermittent infusion therapy of: • Fluids • Medications • Nutritional supplements • Blood and blood products BD cannot guarantee the continued system accuracy with other manufacturers’ syringes as identified in the ‘Recognised Syringes’ table. Manufacturers may change syringe specification significant to system accuracy without prior notification.

Indications The BD Alaris™ neXus CC Syringe Pumps are indicated for delivery of therapies through the following clinically acceptable routes: • Intravenous (IV) • Subcutaneous • Irrigation of fluid spaces

Contraindications The BD Alaris™ neXus CC Syringe Pump is contraindicated for: • Enteral therapies

Undesirable Side-Effects The BD Alaris™ neXus CC Syringe Pump has no undesirable side-effects associated with its use when used in accordance with the Directions For Use.

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 ‘Associated Products’ • 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 Pump • The following software products are also compatible – see ‘Products and Spare Parts’ -

BD Alaris™ neXus Editor v5.0

-

BD Alaris™ neXus Transfer Tool v5.0

-

BD Alaris™ Technical Utility v2.0

-

BD Alaris™ Communication Engine v2.0

-

BD Alaris™ CQI Event Reporter v4.4 BDDF00281 Issue 4

7/64

BD Alaris™ neXus CC Syringe Pumps Overview

Features of the Pump Pressure transducer

ON / OFF RUN

Release lever for rotating cam

Display

High visibility alarm indicator PURGE / BOLUS MUTE PRESSURE OPTIONS

Finger Grips Extension set hook Release lever for rotating cam

Shelf for chevron keys and softkeys

HOLD

Syringe Clamp

Positive Plunger Grippers

Rating plate (see ‘Labelling Symbols’ for key to symbols) Pressure transducer

M e dic al Dev

Rotating cam to lock on to horizontal rectangular bars Carrying handle

ice In

terfac e (M D

I)

IR communications port

Potential Equalisation (PE) connector BDDF00281 Issue 4

Folded pole clamp

RS232 Connector

8/64

Extension set hook

BD Alaris™ neXus CC Syringe Pumps Overview

Controls Symbol

Description

a b h R

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. RUN button – Press to start the infusion. The green LED will flash during infusion. HOLD button – Press to put the infusion on hold. The amber LED will be lit while on hold. MUTE button – Press to silence alarm for two minutes. To re-enable the alarm audio press the MUTE button a second time. Note: Attention alarm only: when not in alarm press and hold until four audible beeps are heard for 15 minutes silence. PURGE / BOLUS button – Press to access PURGE or BOLUS soft keys. Press and hold down soft key to operate. PURGE – primes the extension set with fluid or drug during initial set up. • Pump is on hold

i

• Extension set must not be connected to the patient • Volume Infused (VI) is not added BOLUS – fluid or drug delivered at an accelerated rate. • Pump is infusing • Extension set should be connected to the patient • VI is added

OPTIONS button – Press to access additional feature options. d PRESSURE button – Use this button to display the pumping pressure and alarm level. This e button will also display the pressure trend display. keys – Double or single for faster/slower increase or decrease of values shown on f CHEVRON display. BLANK SOFTKEYS – Use in conjunction with the prompts shown on the display. g

Indicators Symbol

j S

Description BATTERY indicator – When illuminated the Pump is running on the internal battery. When flashing the battery power is low with less than 30 minutes of use remaining. AC POWER indicator – When illuminated the Pump is connected to an AC power supply and the battery is being charged.

BDDF00281 Issue 4

9/64

BD Alaris™ neXus CC Syringe Pumps Overview

Main Display Features Syringe type fitted / Profile / Drug name

Pump Status

Pressure Information

WiFi

Infusion Rate

Volume Infused

Volume Infused Option

VTBI Option

Screen Icons Symbol

Description

l

Time remaining display icon – Indicates time before syringe will require replacement.

N

BATTERY 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 software

INFUSING INFUSING

Guardrails Soft Alert icons – Indicates the Pump is running at a rate or dose above (pointing up) or below (pointing down) a Guardrails™ Soft Alert. Hard Limit Warning icon – Indicates the setting entered is not permitted as it is over or under a Guardrails™ Hard Limit, as defined in the data set. The warning cannot be overridden.

WiFi WiFi

Indicates when the Pump is connected, via Wi‑Fi, to the BD Alaris™ Communication Engine (ACE). Indicates when the Pump is not connected via Wi‑Fi to ACE.

BDDF00281 Issue 4

10/64

BD Alaris™ neXus CC Syringe Pumps Overview

Labelling Symbols Symbol

Description Consult accompanying documents

Potential Equalisation (PE) Connector

y

RS232/Nurse call Connector Defibrillation-proof type CF applied part (Degree of protection against electrical shock)

IP32

Protected against direct sprays of water up to 15° from vertical and protected against 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 93/42/EEC as amended by 2007/47/EC

Date of Manufacture

Manufacturer

Do not dispose of battery in municipal waste. Separate collection for battery is required. Not for Municipal Waste

W

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

BD Alaris™ neXus CC Syringe Pumps Getting Started

Getting Started Initial Set-up Before operating the Pump read this Directions For Use manual carefully.

1. Check that the Pump is complete, undamaged and that the voltage rating specified on the label is compatible with your AC power supply. 2. Items supplied are: • BD Alaris™ neXus CC Syringe Pump • User Support CD (Directions For Use) • AC Power Cable (as requested) • Protective Packaging 3. Connect the Pump to the AC power supply for at least 2½ hours to ensure that the internal battery is charged (verify that the S is lit).

Language Selection 1. On initial start-up the Pump will display the Select Language screen. 2. Select the required language from the list displayed using the f keys. 3. Press the OK softkey to confirm your selection. • The Pump will require a data set to be uploaded and activated prior to using the Pump. Any data set created for installation must be approved by an appropriately 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 switched on without being connected to the AC power supply. • Should the Pump fail to perform correctly, replace in its original protective packaging, where possible and contact Qualified Service Personnel for investigation.

Power Input The Pump is powered from the AC Power supply through a standard IEC AC Power connector or the Alaris™ Gateway Workstation (Workstation) when docked. When connected to the AC Power supply the AC Power indicator is illuminated. • To isolate the Pump from AC Power supply remove the AC Power connector from the source socket. • The Pump should be positioned to allow access for disconnecting the AC Power connector.

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™ Technical Utility (ATU) by Qualified Service Personnel.

BDDF00281 Issue 4

12/64

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.

Pole Clamp Installation The pole clamp is fitted to the rear of the Pump and will provide secure fixing to vertical IV poles of a diameter between 15 and 40mm.

Recessed area

Pull the folded pole clamp towards you and unscrew 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 recessed area at the rear of the Pump before connecting to an Alaris™ Gateway Workstation (Workstation) or when not in use.

*

*

Never mount the Pump such that the IV infusion stand becomes top heavy or unstable. Prior to each use, check that the pole clamp: • Does not show any signs of excessive wear, and • Does not show any signs of excessively loose movement in the extended, mountable position. If these signs are observed, the Pump should be taken out of service for examination by Qualified Service Personnel.

BDDF00281 Issue 4

13/64

BD Alaris™ neXus CC Syringe Pumps Getting Started

Workstation or Equipment Rail Installation The rotating cam can be fitted to the rectangular bar on the Workstation or the equipment rail measuring 10 by 25mm. 1. Align the rotating cam on the rear of the Pump with the rectangular bar on the Workstation or the equipment rail. 2. Hold the Pump horizontally, push the Pump firmly onto the rectangular bar or equipment rail. 3. The Pump should click into position when fitted to the bar. 4. Ensure that the Pump 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 Workstation. 5. To release, push the release lever and pull the Pump forwards. 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. Pump may fall off the Workstation if not properly mounted which could result in user and/or patient harm. Rectangular bar

Release lever (push to release) Rotating cam

BDDF00281 Issue 4

14/64

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 user to adjust rate whilst infusing.

• 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 with lock box ensure that there is sufficient clearance for the cover to be fully opened. A gap of 130mm minimum below the Pump is recommended.

Open Lock box

1. Insert the key into the lock and turn key either way to unlock.

BDDF00281 Issue 4

2. Lock box will move to the right and can then be opened.

15/64

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. Note: The pressure disc must be fitted prior to closing the lock box. 3. Set up the Pump according to the instructions in the ‘Starting the Pump’ section prior to closing the lock box for the Rate Locked version only.

4. Close the cover until it 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 Workstation or an IV Pole. • When transporting the Pump with lock box fitted it is recommended that two hands are used when holding or carrying the Pump. • If lock or lock box appears to be damaged, remove the Pump from service for examination by Qualified Service Personnel. • When the Pump is not in use ensure the lock box is locked. • Lock box keys should be stored separately. Take care not to lock keys inside lock box. • Refer to the ‘Routine Maintenance Procedures’ section for instructions on lock box cleaning and maintenance.

BDDF00281 Issue 4

16/64

BD Alaris™ neXus CC Syringe Pumps Getting Started

Operating Precautions Disposable Syringes and Extension Sets

m

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. Use of non-specified syringes or extension sets may impair the operation of the Pump and the accuracy of the infusion.

n

Uncontrolled flow or syphoning may result if the syringe is located incorrectly in the Pump, or if it is removed from the Pump before the extension set is properly isolated from the patient. Isolation may include closing a tap in the patient line or activating a flow stop clamp. The user must be thoroughly familiar with instructions in these Directions For Use and understand how to load and confirm the syringe on the Pump. Incorrect syringe loading may result in misidentification of the syringe type and size leading to significant under or over infusion. Secure the extension set to the Pump using the extension set hook at the rear of the Pump. This provides protection against accidental dislodging of the syringe from the Pump. When combining several apparatus and/or instruments with extension sets and other tubing, for example via a 3-way tap, the performance of the Pump may be impacted and should be monitored closely. Always clamp or otherwise isolate the patient line before unclamping or removing a syringe from the Pump. Failure to do so may result in unintended administration.

Mounting the Pump When more than one Pump is being used on a patient, those containing high risk, critical 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 infusate, whereas lowering a Pump whilst infusing may result in a delay in the infusion (an underinfusion).

I

Do not mount the Pump in a vertical position with the syringe pointing upwards as this could lead to an infusion of air which may be in the syringe. To protect against the introduction of air the user should regularly monitor the progress of the infusion, syringe, extension line and patient connections and follow the priming procedure specified herein.

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. If the Pump is dropped or experiences any severe physical disturbances, arrange a thorough inspection by appropriately trained technical personnel as soon as is practically possible. When using any infusion pump in conjunction with other pumps or devices requiring vascular access, extra care is necessary. Adverse delivery of medication or fluids can be caused by the substantial variation in pressures created within the infusion system by such pumps. Typical examples of those pumps are used during dialysis, bypass or cardiac assist applications. The Pump is suitable for use in hospital and clinical environments other than domestic establishments that have access to single phase AC power supply. The Pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide.

BDDF00281 Issue 4

17/64

BD Alaris™ neXus CC Syringe Pumps Getting Started

Operating Pressure This is a positive pressure Pump designed to achieve very accurate fluid administration by automatically compensating for resistance encountered in the infusion system. The pumping pressure alarm system is not designed to provide protection against, or detection of, IV complications which can occur. Alarm Conditions

J

Several alarm conditions detected by this Pump will stop the infusion and generate visual and audible alarms. Users must perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating. Alarm tone settings are preserved in the case of power loss, however some system faults will result in loss of alarm settings. The new alarm tone settings will be stored when powering down from tech mode after a change. The settings will be lost if a cold-start is performed, but should be saved for faults that do not require a cold start.

Hazards An explosion hazard exists if the Pump is used in the presence of flammable anaesthetics. Exercise care to locate the Pump away from any such hazardous sources. Dangerous Voltage: An electrical shock hazard exists if the Pump’s casing is opened or removed. Refer all servicing to Qualified Service Personnel. When connected to an external power source, a three-wire (Live, Neutral, Earth) supply must be used. If the integrity of the external protective conductor in the installation or its arrangement 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 connecting RS232/Nurse Call. Touching the pins of the connectors may result in ESD protection failure. It is recommended that all actions must be taken by appropriately trained personnel.

L

If the Pump is dropped, subjected to excessive moisture, fluid spillage, humidity or high temperature, or otherwise suspected to have been damaged, remove it from service for inspection by Qualified Service Personnel. When transporting or storing the Pump, use original packaging where possible, and adhere to temperature, humidity and pressure ranges stated in the ‘Specifications’ section and on the outer packaging. BD Alaris™ neXus CC Syringe Pump should not be modified or altered in any way, except where explicitly directed or authorised by BD. Any use of BD Alaris™ neXus CC Syringe 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 CC Syringe Pump that has been so modified or altered. BD product warranty shall not apply in the event the BD Alaris™ neXus CC Syringe Pump has suffered damage or premature wear, or malfunctions or otherwise operates incorrectly, as a result of unauthorised modification or alteration of the BD Alaris™ neXus CC Syringe Pump. Care must be taken when removing covers or handling moving mechanisms. All Pumps in a single care area should be configured with the same alarm tones to avoid user confusion.

BDDF00281 Issue 4

18/64

BD Alaris™ neXus CC Syringe Pumps Getting Started

Electromagnetic Compatibility and Interference Medical Electrical Equipment requires additional precautions regarding EMC. Commissioning, installation and use should be in accordance with the EMC information provided within this Directions For Use and the Technical Service Manual. Therapeutic Radiation equipment: Do not use the Pump in the vicinity of any Therapeutic Radiation Equipment. Levels of radiation generated by the radiation therapy equipment such as Linear Accelerator, may severely affect functioning of the Pump. Please consult manufacturer’s recommendations for safe distance and other precautionary requirements. For further information, please contact your local BD representative. Magnetic Resonance Imaging (MRI): The Pump contains ferromagnetic materials which are susceptible to interference with magnetic field generated by the 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’ in order to evade any magnetic interference (EMI). For further information, please refer to the product Technical Service Manual (TSM). Alternatively, contact your local BD representative for further guidance. The Pump is compatible with HF surgical equipment provided the Pump is located at distance greater than 15cm (6 inches) from the active component of the HF surgical device. Direct contact between HF surgical equipment and the Pump and or associated accessories and cabling must be avoided. 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. The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it used in a residential 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 mitigation measures, such as relocating or repositioning the Pump. This Pump emits a certain level of electromagnetic radiation, which is within the levels specified by EN/IEC 60601-2-24 and EN/IEC 60601-1-2. The Class B digital Device limits are designed to provide reasonable protection against harmful interference when the device is operated as intended. The device generates, uses and can radiate radio frequency energy. If it is not installed and used in accordance with the applicable Directions For Use, it might cause harmful interference to radio communications. Operation of this device in a residential area is likely to cause harmful interference, in which case the user is required to correct the interference at their own expense. There is, however, no guarantee that the interference will not occur in a particular installation. Approval of the wireless module excludes co-location with any other transmitter. The Pump should not be used adjacent to or stacked with other equipment outside of the Alaris™ Gateway Workstation or the BD Alaris™ MRI Capsule; however, if adjacent or stacked use is necessary, the Pump should be observed to verify normal operation in the configuration in which it will be used. Portable RF Communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the Pump including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. In some circumstances the Pump may be affected by an electrostatic discharge through air at levels close to or above 15kV; or by radio frequency close to or above 10V/m. If the Pump is affected by this external interference the Pump will remain in a safe mode; the Pump will duly stop the infusion and alert the user by generating a combination of visual and audible alarms. Should any encountered alarm condition persist even after user intervention, it is recommended to replace that particular Pump and quarantine the Pump for the attention of appropriately trained personnel (Consult Technical Service Manual for further information).

BDDF00281 Issue 4

19/64