Alaris neXus GP Volumetric GPneXus1 Directions for Use Issue 4 sw 5.1x Dec 2020

BD Alaris™ neXus GP Volumetric Pump 

Contents

Page

About This Manual... 4 Conventions used in this manual... 4

Overview... 5 Introduction... 5 Intended Purpose... 5 Intended Users... 5 Patient Target Groups... 5 Clinical Benefits... 5 Conditions for Use... 6 Indications... 6 Contraindications... 6 Undesirable Side-Effects... 6 Compatibility... 6 Features of the Volumetric Pump... 7 Controls... 8 Indicators... 8 Main Display Features... 9 Screen Icons... 10 Labelling Symbols... 11

Getting Started... 12 Initial Set Up... 12 Power Input... 12 Wi-Fi Configuration... 12 Factory Default Data Set... 13 Pole Clamp Installation... 14 Workstation or Equipment Rail Installation... 15 Alaris™ Safety Clamp... 16 Operating Precautions... 17

Operation... 21 Loading an Infusion Set... 21 Flow Sensor Operation (Optional)... 24 Starting the Infusion... 25 Changing the Infusion Set... 27 Changing the Fluid Container... 27

Advanced Features... 28 Drugs and Dosing... 28 Selecting the INFUSION SETUP... 28 Clear Volume Infused... 29 Setting a VTBI... 29 KVO (Keep Vein Open) Rate... 30 Pressure... 30 Priming the Infusion Set... 30 Bolus Infusions... 31 Bolus Mode – Disabled... 31 Bolus Mode Enabled – HANDSON and HANDSON and HANDSFREE... 31 Rate Titration... 32 BDDF00558 Issue 4

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BD Alaris™ neXus GP Volumetric Pump 

Rate Lock (If enabled)... 33 Adjusting Existing Dosing or Protocol Infusions... 33 Selecting the SET BY ML/H Option... 33 Selecting the SET BY DOSERATE Option... 33 Dosing Summary... 33 Add Drug (Only available when infusing)... 33 Infusion Setup... 34 Primary Setup... 34 Secondary Setup... 34 Setting VTBI over Time... 34 Adjust Alarm Volume... 34 Event Log... 34 Pump Details... 34 Profile Filter... 35 Standby... 35 Date and Time... 35 Network Status... 35 Wireless Connection... 35 SmartSite™ Needle-Free System Instructions... 36 Secondary (Piggyback) Infusions... 37

Alarms... 39 ORIGINAL ALARMS... 39 3RD EDITION ALARMS... 44 Prompts... 48 Advisories... 48 Restarting an Infusion following an Air-in-Line Alarm... 49

Configuration... 50 Configured Options... 50 BD Alaris™ neXus Editor Software Profile Configuration... 51 Drug Library available via the BD Alaris™ neXus Editor Software... 53 Display of Units... 53

Associated Products... 54 Alaris™ Gateway Workstation v1.3.x or v1.6.x... 54 Infusion Sets... 55

Maintenance... 59 Routine Maintenance Procedures... 59 Battery Operation... 59 Cleaning and Storage... 60 Disposal... 61

Technical Data... 62 Specifications... 62 IrDA, RS232 and Nursecall Specification... 65 Infusion Specifications... 66 Trumpet and Flow Rate Curves... 68

Products and Spare Parts... 70 Spare Parts... 70 Software... 70

Document History... 71 BDDF00558 Issue 4

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BD Alaris™ neXus GP Volumetric Pump 

Contact Us... 72 Customer Service Information... 72

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BD Alaris™ neXus GP Volumetric Pump About This Manual

About This Manual The User must be thoroughly familiar with the BD Alaris™ neXus GP Volumetric Pump (hereinafter referred to as Pump) described in this manual prior to use. All illustrations used in this manual show typical settings and values which may be used in setting up the functions of the Pump. 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 (DFU) 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.

Conventions used in this manual Bold

Used for Display names, software commands, controls and indicators referenced in this manual, for example, Battery Indicator, PURGE, ON/OFF button.

‘Single quotes’

Used to indicate cross-references made to another section of this manual. For example, see ‘Flow Sensor Operation’.

Italics

Used to refer to other documents or manuals. For example, refer to the relevant Directions For Use for further information. Also used to define custom terminology specific to a manual e.g. The BD Alaris™ neXus GP Volumetric 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 the Pump. Caution symbol. A caution is a statement that alerts the User to the possibility of a problem with the Pump associated with its use or misuse. Such problems may include Pump malfunction, Pump failure, damage to the 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.

User

Trained and qualified users who interact with the device. See ‘Intended Users’.

Qualified Service Personnel

Trained and qualified personnel who perform service and repair activities, and upload and download data to the product.

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BD Alaris™ neXus GP Volumetric Pump Overview

Overview Introduction The BD Alaris™ neXus GP Volumetric Pump is a small lightweight volumetric infusion pump that provides accurate and reliable infusions over a range of rates. The BD Alaris™ neXus GP Volumetric Pump can be programmed to deliver fluids utilising rate, volume over time, dose rate calculation, and pre-programmed drug dosing protocols containing drug 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 patients-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 GP Volumetric Pump with a data set loaded, provides automatic alerts when a dosing limit, bolus limit 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 GP Volumetric Pump can connect to the BD Alaris™ Communication Engine, if one is deployed at the medical facility. When connected, either by docking to a connected Alaris™ Gateway Workstation or via hospital Wi-Fi, Pump infusion data, logs and configuration information will be automatically collected. Note: Any serious incident that occurs in relation to this Pump should be reported to the manufacturer, and to the relevant local regulatory authority.

Intended Purpose The BD Alaris™ neXus GP Volumetric 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 GP Volumetric Pump is intended to be used for the purpose of controlling rate and volume. The BD Alaris™ neXus GP Volumetric Pump is indicated for use on adults and paediatrics.

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

Patient Target Groups The BD Alaris™ neXus GP Volumetric Pumps will be used on paediatric and adult patients, with a variety of medical or surgical conditions. The Pumps will be used on patients weighing up to, and in excess of 250Kg.

Clinical Benefits The BD Alaris™ neXus GP Volumetric 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.

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BD Alaris™ neXus GP Volumetric Pump Overview

Conditions for Use The BD Alaris™ neXus GP Volumetric Pumps are restricted medical devices intended for use by qualified, trained personnel to deliver either continuous or intermittent infusion therapy of: • Fluids • Medications • Nutritional supplements • Blood and blood products

Indications The BD Alaris™ neXus GP Volumetric 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 GP Volumetric Pump is contraindicated for enteral or epidural therapies.

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

Compatibility The BD Alaris™ neXus GP Volumetric Pump is compatible with the following: • The Alaris™ Gateway Workstation v1.3.x and v1.6.x – see ‘Associated Products’ • Standard, single-use, disposable infusion sets – see ‘Infusion Sets’ • The Active RFID asset tag supplied by BD with this Pump • The following minimum versions of 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 v 2.0 - BD Alaris™ CQI Event Reporter V4.4

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BD Alaris™ neXus GP Volumetric Pump Overview

Features of the Volumetric Pump Alarm indicator

Door Display

Softkeys Chevrons Control keys and indicators (See overleaf)

Door lever

Handle Release lever for rotating cam

Flow sensor connector RS232/Nursecall connector (cover removed for clarity)

Rotating cam to lock on to horizontal rectangular bars

Folded pole clamp

Medical Device Interface (MDI)

AC Power fuses cover AC Power inlet IR communications port

Potential Equalisation (PE) connector

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Controls Symbol

Description

a b h

ON/OFF button – Press once to switch the Pump on. Press and hold down for approximately three seconds to switch the Pump off. Note: Logs are maintained for power down events including when the Pump is powered down or unexpected power loss. 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.

R

MUTE button – Press to silence alarm for two minutes. The alarm will resound after this time. 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 to extend the silence period to 15 minutes.

i

PRIME/BOLUS button – Press to access PRIME or BOLUS softkey. Press and hold down softkey to operate. PRIME – primes the infusion set with fluid when setting up an infusion for the first time. • Pump is on hold. • Infusion set is not connected to a patient. • Volume infused (VI) is not added to the total volume infused displayed. BOLUS – fluid or drug delivered at an accelerated rate. • Pump is infusing • Infusion set is connected to patient. • Volume infused (VI) is added to the total volume infused displayed.

d e f g

OPTION button – Press to access optional features. PRESSURE button – Use this button to display the pumping pressure and adjust the alarm limit. CHEVRON keys – Double or single for faster / slower increase / decrease of values shown on display. BLANK SOFTKEYS – Use in conjunction with the prompts shown on the display.

Indicators Symbol

S j

Description AC POWER indicator – When illuminated the Pump is connected to an AC power supply and the battery is being charged. 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.

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BD Alaris™ neXus GP Volumetric Pump Overview

Main Display Features Main Display – If VTBI has not been set (flow sensor must be used) Infusion Status / Drug Name / Profile Name / Primary or Secondary (Only if secondary is enabled in the data set)

a)

ON HOLD RATE

Infusion Rate

25.0

If the ON rate has not been set and is HOLD ON HOLD SET RATE WITH showing at 0.0ml/h, RATE TOO LOW then message RATE a) will be displayed. RATE

ml/h

Volume Infused

VOLUME

50.0 ml

Softkey Identifiers

VOLUME

VTBI

b)

WiFi

If programmed rate is between ON HOLD 0.0ml/hRATE andTOO 0.1ml/h HIGH exclusive in drug protocol, message b) will be ON HOLD RATE shown.RATE TOO LOW

Clear Volume Infused Set VTBI Option

RATE

Main Display – If VTBI is set

(Only if secondary is enabled in the data set)

Infusion Rate

c)

ADRENALINE RATE

Dose Rate Volume to be Infused Volume Infused Time remaining Softkey Identifiers

ON HOLD ON HOLD RATE TOO LOW RATE TOO HIGH RATE ON HOLD RATE SET RATE WITH RATE

Softkeys

Infusion Status / Drug Name / Profile Name / Primary or Secondary

ON HOLD

SET RATE WITH RATE

RATE

45.0 ml VOLUME 50.0 ml 1h 48m 00s VTBI

VTBI

WiFi

Softkeys

Clear Volume Infused Set VTBI Option

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RATE TOO HIGH

If programmed rate is greater than the INFUSION RATE MAX in drug protocol, message c) will be shown.

25.0 ml/h 16.7 µg/kg/24h

VOLUME

ON HOLD

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Screen Icons Symbol

Description Time remaining display icon – Indicates time remaining before VTBI will be completed. If the time is greater than 24 hours then 24+ will be displayed.

N

Battery icon – Indicates battery charge level to highlight when the battery will require recharging. Pressure Information icon – Shows the pressure from level 0 being the first bar to level 8. Alarm limits: level 0 – 8.

? !

Indicates that the value entered is outside of the Soft Limits, as defined in the data set. The warning can be overridden (Indicates Guardrails™ safety protocol is in use). Indicates that the value entered is outside of the Guardrails™ Hard Limits, as defined in the data set. The warning cannot be overridden. This symbol is also used to prompt the User to set the rate. Indicates that the Pump is running at a rate below (pointing down) a Guardrails™ Soft Limit. Indicates that the Pump is running at a rate above (pointing up) a Guardrails™ Soft Limit.

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 to ACE via Wi-Fi.

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Labelling Symbols Symbol

Description Attention (Consult accompanying document)

Potential Equalisation (PE) Connector

RS232/Nursecall Connector

Defibrillation-proof type CF applied part (Degree of protection against electrical shock)

IP33

Protected from solid objects greater than 2.5mm. Protected against direct sprays up to 60° from the vertical. Alternating Current Device complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC. Date of Manufacture

Manufacturer Connector for Flow Sensor

U W

Not for Municipal Waste Fuse rating Operating Temperature Range – Pump can be used between 0 and 40 degrees centigrade. Pump is able to communicate via Wi-Fi.

Medical Device.

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BD Alaris™ neXus GP Volumetric Pump Getting Started

Getting Started Before operating the Pump read this Directions For Use (DFU) manual carefully.

Initial Set Up 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: • AC Power Cable (as requested) • BD Alaris™ neXus GP Volumetric Pump • Directions For Use (CD)

• Electronic Instructions For Use Insert • 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). • The Pump will automatically operate from its internal battery if the Pump is switched on without being connected to the 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.

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Factory Default Data Set The Pump is supplied with the following factory default data set: Parameter

Factory Default Setting

Default Units Enabled for Dosing Only

AC Fail Warning

Enabled

ml/h

Audio Volume

Medium

ng/kg/min

Alarm Volume Adjustable

Disabled

µg/min

Occlusion Alarm Pressure

L5

µg/h

Pressure Max

L8

µg/kg/min

Rate Titration

Disabled

µg/kg/h

Infusion Rate Max

1200ml/h

mg/h

Rate Lock

Disabled

mg/kg/min

Bolus Mode

Hands-On Only

mg/kg/h

Bolus Rate Default

500ml/h

g/h

Bolus Rate Max

1200ml/h

U/h

Bolus Volume Max

5ml

U/kg/h

Weight Default

1kg

mmol/h

Weight Soft Min

1kg

mmol/kg/min

Weight Soft Max

150kg

mmol/kg/h

AIL Limit

100µL

Primary VTBI Max

9999ml

Secondary Infusion

Disabled

Prime Rate

200ml/h

Prime Volume Max

20ml

Near End of Infusion

5 minutes

KVO

5ml/h • Refer to ‘Display of Units’ section of this DFU for configurable units. • The default data set does not have drug-specific Guardrails™ limits. To set the limits use the BD Alaris™ neXus Editor software to create a custom data set. Care should be taken when specifying the Guardrails™ limits.

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Pole Clamp Installation Mount the Pump on the pole or Workstation as close to patient heart level as possible.

Prior to each use, check the pole clamp: • does not show any signs of excessive wear, • 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. 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. 1. Pull the folded pole clamp towards you and unscrew the clamp to leave enough room for the size of the pole.

Recessed area

*

2. Place Pump around pole and tighten screw until the clamp is secured to the pole.

*

Never mount the Pump such that the IV infusion stand becomes top heavy or unstable.

Ensure the pole clamp is folded away and stored within the recessed area at the rear of the Pump before connecting to a Workstation or when not in use.

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BD Alaris™ neXus GP Volumetric Pump Getting Started

Workstation or Equipment Rail Installation The rotating cam can be fitted to the rectangular bar on the Workstation or equipment rails measuring 10mm by 25mm. 1. Align the rotating cam on the rear of the Pump with the rectangular bar on the Workstation or the equipment rail.

Rectangular bar Release lever (push to release)

2. Push the Pump firmly onto the rectangular bar or equipment rail. 3. 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.

®

Alaris

GP

4. 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.

Rotating cam

Pump may fall off the Workstation if not properly mounted which could result in User and/or patient harm. It is recommended that infusion bags be located on a hanger directly above the Pump with which they are being used. This minimises the potential for confusion of infusion sets when multiple volumetric pumps are used. Pump can only be mounted on the horizontal section of the Workstations.

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BD Alaris™ neXus GP Volumetric Pump Getting Started

Alaris™ Safety Clamp Alaris™ Safety Clamp*:

Safety Clamp In Non Occluded Position: When a new infusion set is removed from packaging the Safety Clamp will be in this position**:

Safety Clamp Tab

Clamp in NON OCCLUDED POSITION

Safety Clamp Frame

FLOW ENABLED Safety Clamp Slider Safety Clamp In Occluded Position:

Manually Operating The Safety Clamp

After infusion set is loaded into the Pump, opening the door activates door hooks which will pull the Safety Clamp slider out, as shown:

To move the slider into the non occluded position manually, push up Safety Clamp Tab and push Safety Clamp Slider completely into Frame:

Clamp is in OCCLUDED POSITION

1. Push up

Æ

NO FLOW

2. Push

Ê

• Pushing on the Safety Clamp Slider enables full set flow to the patient. Therefore it is recommended to always close the roller clamp as well. • However, if gravity infusion is required, push up Safety Clamp Tab and push orange Safety Clamp Slider completely into Frame to enable flow. The gravity infusion can be regulated using the roller clamp on the set. * Hereinafter referred to as Safety Clamp. ** This is necessary to avoid tube damage during storage and to ensure correct sterilisation and allows immediate priming.

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BD Alaris™ neXus GP Volumetric Pump Getting Started

Operating Precautions Infusion Sets • To ensure correct and accurate operation, only use BD single use infusion sets described in this Directions For Use. • It is recommended that infusion sets are changed according to the instructions in the ‘Changing the Infusion Set’ section. Carefully read the Directions For Use supplied with the infusion set prior to use. • Use of non-specified infusion sets may impair the operation of the Pump and the accuracy of the infusion. • When combining several apparatus and/or instruments with infusion sets and other tubing, for example via a 3-way tap or multiple infusion, the performance of the Pump may be affected and should be monitored closely. • Uncontrolled flow may result if the infusion set is not properly isolated from the patient i.e. closing a tap in the set or activating an in-line clamp / roller clamp. • BD infusion sets are fitted with an in-line clamp, which can be used to occlude tubing in case it is required to stop fluid flow. • The Pump is a positive pressure pump, which should use infusion sets fitted with Luer lock fittings or equivalent locking connectors. • To infuse from a burette, close the roller clamp above the burette and open the clamp on the vent on top of the burette. • Discard infusion set if the packaging is not intact or the protector cap is detached. Ensure sets are not kinked as this may occlude the tubing.

Using Collapsible bags, Glass bottles and Semi-rigid containers • It is recommended that the air vent be opened on the Pump sets if using glass bottles or semi-rigid containers, to reduce the partial vacuum formed as the fluid is infused from the container. This action will ensure the Pump can maintain volumetric accuracy whilst the container empties. The action of opening the air vent for semi-rigid containers should take place after the spiking of the container and priming of the drip chamber. Steps for Semi-rigid containers Steps for Collapsible bags Follow steps 1 to 3 as shown for the semirigid containers, however do not open 2. 3. 4. vent as in step 4, but prime the set as Spike the Fill drip Open the air vent container chamber to allow pressure per step 5. Ensure the bag outlet is fully to fill line equalisation – ready pierced before filling the drip chamber. for infusion Note: Ensure that the air vent is 5. closed prior to filling the drip Prime the set by 1. opening / closing the chamber. Close the roller clamp

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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 Qualified Service Personnel as soon as is practically possible. • The Pump may also be used outside the ambulance as long as the temperature is within the specified range as stated in the ‘Specifications’ section and on the Pump label. • When using any infusion pump in conjunction with other pumps or devices requiring vascular access, extra care is advised. Adverse delivery of medication or fluids can be caused by the substantial variation in pressures created within the fluid channels of 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. • This Pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide.

Operating Pressure • The pumping pressure alarm system is not designed to provide protection against, or detection of extravasation or tissuing, complications which can occur.

Alarm Conditions Alaris®

GP

• 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 a 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 don’t require a cold start.

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Electromagnetic Compatibility and Interference

M

• 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. • This Pump has been evaluated against the EMC-limits according to IEC/EN 60601-1-2 and IEC/EN 60601-2-24. • 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 to the Pump; or MRI image distortion. This safe distance should be established in accordance with the manufacturers’ recommendations regarding electromagnetic 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.

Alaris®

GP

• The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radiofrequency 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 IEC/EN 60601-2-24 and IEC/EN 60601-1-2. • 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; 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.

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