Alaris

Alaris VP Plus Guardrails Model 9003TIG03G Volumetric Pump Directions for Use Issue 3

Directions for Use

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File Name: Alaris - Alaris VP Plus Guardrails Model 9003TIG03G Volumetric Pump Directions for Use Issue 3.pdf

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Alaris™ VP Plus Guardrails™ Volumetric Pump Model: 9003TIG03-G

Directions For Use en

Alaris™ VP Plus Guardrails™ Volumetric Pump

Contents

Page

Introduction... 4 Intended Purpose... 4 Conditions for Use... 4 Indications... 4 Contraindications... 4 About This Manual... 4 Conventions Used in This Manual... 4 Features of the Pump... 5 Controls and Indicators... 6 Controls... 6 Indicators... 6 Symbol Definitions... 7 Labelling Symbols... 7 Main Display Features... 8 Main Display... 8 Screen Icons... 8 Operating Precautions... 9 Infusion Sets... 9 Using Collapsible Bags, Glass Bottles and Semi Rigid Containers... 9 Operating Environment... 9 Alarm Conditions... 10 Mounting the Pump... 10 Electromagnetic Compatibility and Interference... 10 Earth Conductor... 10 Hazards... 11 Getting Started... 12 Initial Set Up... 12 Power Input... 12 Pole Clamp Installation... 13 Docking Station/Workstation* or Equipment Rail Installation... 13 The Alaris™ Safety Clamp*... 14 Loading an Infusion Set... 15 Starting the Infusion... 18 Infusion Setup... 18 Priming the Infusion Set...19 Start Infusion... 19 Bolus... 20 Bolus Infusions... 20 Bolus Mode - Disabled... 20 Bolus Mode - Enabled... 20 BOLUS Enabled - HANDSON Only... 20 BOLUS Enabled - HANDSON and HANDSFREE... 20 Pressure Features... 21 In-Line Pressure Monitoring... 21 Pressure Occlusion Alarm Options... 21 Pressure Trend... 21 BDDF00582 Issue 1

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Alaris™ VP Plus Guardrails™ Volumetric Pump

Basic Features... 22 Clear Volume Infused... 22 Setting a VTBI... 22 KVO (Keep Vein Open) Rate... 22 Selecting the Infusion Setup... 22 Rate Lock... 23 Adjusting Existing Dosing or Protocol Infusions - Set By ml/h / Set By Doserate...23 Dosing Summary... 23 Add Drug... 23 Primary Setup... 23 Set VTBI Over Time... 24 Adjust Alarm Volume... 24 Alarm Volume Ramping... 24 Event Log... 24 Pump Details... 24 Profile Filter... 24 Standby... 24 Changing the Infusion Set... 25 Changing the Fluid Container... 25 SmartSite™ Needle-Free System Instructions... 25 Secondary (Piggyback) Infusions... 26 Typical Secondary infusions... 26 Setting up a secondary infusion... 26 Service Configuration Mode... 27 Alarm Presets... 27 Configured Options... 27 Date and Time... 27 Pump Reference... 27 Language... 28 Backlight and Contrast... 28 Pump Configuration available via the Alaris™ Editor Software... 29 Data Set Configuration Settings... 29 General Pump Configuration Settings... 29 Large Volume Pump Configuration Settings... 30 Drug Library available via the Alaris™ Editor Software... 31 Concentration Settings... 31 Dose Rate Settings... 31 Bolus Settings... 31 Pressure Settings... 31 Display of Units... 31 Alarms... 32 ORIGINAL ALARMS... 32 3RD EDITION ALARMS... 36 Prompts... 39 Advisories... 39 Flow Sensor Operation (Optional)... 40 Specifications... 41

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Alaris™ VP Plus Guardrails™ Volumetric Pump

Associated Products... 44 The Alaris™ Gateway Workstation... 44 The Alaris™ DS Docking Station...44 Infusion Sets... 45 Standard Infusion Sets... 45 Blood Infusion Sets... 45 Burette Sets... 45 TPN Sets... 45 ICU Sets... 45 Oncology Infusion Sets...45 Low Priming Volume Infusion Sets... 46 Secondary Infusion Sets... 46 Maintenance... 47 Routine Maintenance Procedures... 47 Battery Operation... 47 Cleaning and Storage... 48 Cleaning the Pump... 48 Cleaning the Door... 48 Cleaning the Flow Sensor... 48 Storing the Pump... 48 Disposal... 49 Information on Disposal for Users of Waste Electrical and Electronic Equipment... 49 Information on Disposal in Countries outside the European Union... 49 IrDA, RS232 and Nursecall Specification... 50 IrDA/RS232/Nursecall Feature... 50 RS232/Nursecall Connection Data... 50 IrDA... 50 Trumpet and Flow Rate Curves... 51 Products and Spare Parts... 53 Spare Parts... 53 Alaris™ Editor Software... 53 Document History... 53 Contact Us... 54 Customer Service Information... 54

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Alaris™ VP Plus Guardrails™ Volumetric Pump Introduction

Introduction The Alaris™ VP Plus Guardrails™ Volumetric Pump, hereinafter referred to as the Pump, is a volumetric infusion Pump that provides accurate and reliable infusions over a range of rates. The Pump has enhanced pressure monitoring capability allowing the clinician to monitor patient specific in-line pressure changes with high precision. The Pump includes Guardrails™ Software and is supplied with a default data set installed. The default data set allows the Pump to be used in ml/h and dosing only. There are no drug or fluid names loaded in the default data set, so there are no related Guardrails™ Software safety limits available. The Alaris™ Editor software can be used to create a data set to include drugs or fluids, with the related Guardrails™ Software limits. The Alaris™ Editor Software, available separately as a product or a service, permits the user to create up to 100 standardized drug protocols for up to 30 clinical areas (profiles). Guardrails™ Software allows the user to program soft and hard safety limits for each drug. Soft limits can be overridden at the bedside by the clinician and provide clinical flexibility in patient medication delivery. Hard limits cannot be overridden helping to prevent clinically significant medication errors. See the Alaris™ Editor Software help files for further details for creating, managing and transferring Guardrails™ Software data sets.

Intended Purpose The Alaris™ VP Plus Guardrails™ Volumetric Pump is intended for use by clinical staff for the purpose of controlling infusion rate and volume.

Conditions for Use The Alaris™ VP Plus Guardrails™ Volumetric Pump should only be operated by clinical staff competent in the use of automated volumetric pumps and in the management of infusion therapy. Clinical staff should determine the suitability of the device in their care area for its intended purpose. References to user within this manual are intended to be restricted to trained clinical staff experienced with infusion practices.

Indications The Alaris™ VP Plus Guardrails™ Volumetric Pump is indicated for the infusion of fluids, medications, parenteral nutrition, blood and blood products through clinically acceptable routes of administration; such as intravenous (IV), subcutaneous or irrigation of fluid spaces. The Alaris™ VP Plus Guardrails™ Volumetric Pump is indicated for use on adults, paediatrics and neonates.

Contraindications The Alaris™ VP Plus Guardrails™ Volumetric Pump is contraindicated for: • Enteral therapies • Epidural therapies

About This Manual The user must be thoroughly familiar with the 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.

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.

Italics

Used to refer to other documents or manuals and also used for emphasis.

Caution: Wherever this symbol is shown an Important note is found. These notes highlight an aspect of use that is important for the user to be aware of when operating the Pump.

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Alaris™ VP Plus Guardrails™ Volumetric Pump Features of the Pump

Features of the Pump Alert indicator

Door

Display Softkeys Chevrons Run Prime/Bolus Hold Options AC power indicator

Mute Pressure Battery indicator On/Off Door Lever

Handle Release lever for rotating cam

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

Rotating cam to lock onto horizontal rectangular bars

Folded pole clamp

Medical device interface (MDI)

Mains fuses cover Mains inlet IR communications port Potential Equalisation (PE) Connector

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Alaris™ VP Plus Guardrails™ Volumetric Pump Controls and Indicators

Controls and Indicators Controls Symbol

Description 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.

b h

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 active alarm, warning or prompt for 2 minutes. The audio from the active alarm, warning or prompt will continue to sound every 2 minutes until the condition has been resolved. 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 three audible beeps are heard to extend the silence period to 15 minutes.

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 - delivers fluid or drug 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 line pressure, trend display, and adjust the downstream occlusion 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 remaining battery run time is limited.

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Alaris™ VP Plus Guardrails™ Volumetric Pump Symbol Definitions

Symbol Definitions Labelling Symbols Symbol

Description

Caution: If a tool is required to remove a cover then this should be performed by Qualified Service Personnel only.

Consult accompanying documents

Potential Equalisation (PE) Connector

RS232/Nursecall Connector

l IP33 r

Defibrillation-proof type CF applied part (Degree of protection against electrical shock) Protected from solid objects greater than 2.5mm. Protected against direct sprays up to 60° from the vertical Alternating Current Observe Electrostatic Discharge (ESD) precautions

Device complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC

T t

Date of Manufacture Manufacturer

Connector for Flow Sensor

U W

Not for Municipal Waste Fuse rating

+40°C



0°C

Operating Temperature Range - Pump can be used between 0 and 40 degrees centigrade.

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Alaris™ VP Plus Guardrails™ Volumetric Pump Main Display Features

Main Display Features Main Display

NORADrenaline

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

RATE

Infusion Rate Dose Rate

25.0 ml/h 1.2 mcg/kg/min

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

Volume to be Infused Volume Infused Time remaining Softkey Identifiers

VOLUME

mmHg

VTBI

Line Pressure Downstream Occlusion Alarm Limit

Softkeys

Clear Volume Infused

Set VTBI Option

Screen Icons Symbol

Description Time icon - Indicates time remaining before VTBI will be completed. If the time is greater than 24 hours then 24+ will be displayed. Also indicates pressure sample time on the Pressure Trend screen.

Battery icon - Indicates battery charge level to highlight when the battery will require recharging. Line Pressure icon - Shows the current in-line pressure value in mmHg.

Downstream Occlusion Alarm Limit icon - Shows the downstream occlusion alarm limit in mmHg.

? !

Indicates that the value entered is outside of the Guardrails™ soft limits. When the warning is overridden this indicates Guardrails™ safety protocols are in use. Indicates that the value entered is outside of the Guardrails™ hard limits. This 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 a Guardrails™ soft limit. Indicates that the Pump is running at a rate above a Guardrails™ soft limit.

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Alaris™ VP Plus Guardrails™ Volumetric Pump Operating Precautions

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. Always 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 while 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 the Collapsible Bags •

Steps for Semi-rigid Containers

Follow steps 1 to 3 as shown for the semirigid containers, however do not open vent as in step 4, but prime the set as per step 5. Ensure the bag outlet is fully pierced before filling the drip chamber.

3. 2. Spike the container

1. Close the roller clamp

Fill drip chamber to approximately half full

4. Open the air vent to allow pressure equalisation - ready for infusion

5. Prime the set, see 'Loading an Infusion Set' section.

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.

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Alaris™ VP Plus Guardrails™ Volumetric Pump Operating Precautions

Alarm Conditions •

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. The user must be within proximity to the pump so that they have the ability to recognize when the Pump is in an alarm state.

•

At power-up, the Pump will activate both the alert indicator and the audio alert function. A Pump that does not activate both must not be used and should be sent to Qualified Service Personnel.

•

Should any alarm condition persist after all appropriate mitigations, it is recommended to replace that particular Pump and quarantine the Pump for the attention of Qualified Service Personnel.

•

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.

Mounting the Pump

•

The most accurate pressure monitoring in the infusion set is achieved when the Pump is positioned close to the patient's heart level.

•

Do not mount the Pump in a horizontal position or with the AC power inlet pointing upwards as this could affect electrical safety in the event of a fluid spill.

Electromagnetic Compatibility and Interference

•

Therapeutic Radiation Equipment: Do not use the Pump in the vicinity of any Therapeutic Radiation Equipment, such as Linear Accelerators. Levels of radiation generated by Therapeutic Radiation Equipment 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 fields generated by MRI devices, therefore the Pump is not an MRI compatible Pump. 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.

•

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.

•

This Pump is a CISPR 11 Group 1 Class B device and uses RF energy only for its internal function in the normal product offering, therefore its RF emissions are very low and are not likely to cause any interference with the nearby electronic equipment. Nevertheless, this Pump emits electromagnetic radiation which is within the levels specified by IEC/EN60601-2-24 and IEC/EN60601-1-2. If the Pump interacts with other equipment, measures should be taken to minimise the effects, for instance by repositioning or relocation.

Earth Conductor

•

The Pump is a Class I device, therefore must be earthed when connected to an AC power supply.

•

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 on the AC power cable has been compromised, the Pump should be disconnected from the AC power source and operated utilising the internal battery.

•

This Pump also has an internal power source.

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Alaris™ VP Plus Guardrails™ Volumetric Pump Operating Precautions

Hazards

m V

•

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.

•

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 Qualified Service Personnel.

•

If this 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.

•

If this Pump behaves abnormally, remove from service and contact Qualified Service Personnel.

•

Care should be taken to ensure power cables and RS232 cables do not present a trip hazard.

•

Care should be taken in the placement of power cables and RS232 cables to prevent accidental tugging.

•

Warning: Alaris™ VP Plus Guardrails™ Volumetric Pumps should not be modified or altered in any way, except where explicitly directed or authorised by BD. Any use of Alaris™ VP Plus Guardrails™ Volumetric 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 Alaris™ VP Plus Guardrails™ Volumetric Pump that has been so modified or altered. BD product warranty shall not apply in the event the Alaris™ VP Plus Guardrails™ Volumetric Pump has suffered damage or premature wear, or malfunctions or otherwise operates incorrectly, as a result of unauthorised modification or alteration of the Alaris™ VP Plus Guardrails™ Volumetric Pump.

•

Restarting an Infusion following an Air-in-Line Alarm The Pump may be restarted by opening the door, assessing and removing any air from the tubing guide area and in the infusion set on the patient side of the Pump, if required, according to hospital policy. Close the door and cancel the air-in-line alarm. Restarting the infusion will reactivate the air-in-line system and will alarm if the preset air-in-line limit is exceeded.

•

All Pumps in a single care area should be configured with the same alarm tones to avoid User confusion

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Alaris™ VP Plus Guardrails™ 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 : • Alaris™ VP Plus Guardrails™ Volumetric Pump • Directions For Use (CD) • Electronic Directions For Use Insert • 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.

• A default data set is already installed in the Pump. The Alaris™ Editor software can be used to create an approved data set that can be uploaded into the Pump. • 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 it in its original protective packaging, where possible and contact Qualified Service Personnel for investigation.

Power Input The Pump is powered from the AC supply through a standard IEC AC connector. When connected to the AC supply the AC Power indicator is illuminated.

• To isolate the Pump from AC supply remove the AC connector from the source socket. • The Pump should be positioned to allow access for disconnecting the AC connector.

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Alaris™ VP Plus Guardrails™ Volumetric Pump Getting Started

Pole Clamp Installation

w w

Mount the Pump on the pole or Docking Station/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 pumps 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 Docking Station/Workstation* or when not in use.

Docking Station/Workstation* or Equipment Rail Installation The rotating cam can be fitted to the rectangular bar on the Docking Station/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 Docking Station/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. 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 Docking Station/Workstation* without using the release lever. When the Pump is securely attached, it should not come off the Docking Station/Workstation*. 5. To release, push the release lever and pull the Pump forwards. Rotating cam

Warning: Pump may fall off the Docking Station/Workstation* if not properly mounted which could result in user and/or patient harm. * Alaris™ DS Docking Station and Alaris™ Gateway Workstation.

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.

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Alaris™ VP Plus Guardrails™ Volumetric Pump Getting Started

The Alaris™ Safety Clamp* Safety Clamp in Occluded Position:

Safety Clamp in Non-occluded Position:

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

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

Pressure Disc Clamp In Non-occluded Position

Safety Clamp Frame Safety Clamp Tab

Clamp Is In Occluded Position

Safety Clamp Slider

Flow

No Flow

Manually Operating the Safety Clamp: To move the slider into the non-occluded position manually, push up Safety Clamp Tab and push Safety Clamp Slider completely into Safety Clamp Frame: No Flow

Flow

w 1. Push up

2. Push

Pushing the Safety Clamp Slider completely into the Safety Clamp Frame may lead to uncontrolled flow to the patient. Therefore, always close the roller clamp before pushing in the Safety Clamp Slider, if required.

* 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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Alaris™ VP Plus Guardrails™ Volumetric Pump Loading an Infusion Set

Loading an Infusion Set

• Only use dedicated Alaris™ VP Plus Guardrails™ Volumetric Pump infusion sets, refer to 'Infusion Sets' section. • Ensure the appropriate infusion set for the fluid/drug to be infused has been selected. • Follow the instructions supplied with the individual infusion set. • Ensure that the tubing is inserted completely into the top set retainer through to the tubing guide avoiding any slack. • Infusion accuracy is dependant upon correct placement of top adaptor of the infusion set into the top set retainer of the Pump. Failure to properly place the adaptor in the retainer may lead to over or under infusions. • If the door is difficult to close, open the door fully to verify correct loading of the infusion set. • Do not pull or stretch the infusion set, when priming/loading/re-loading the infusion set. • Mount the Pump on the pole or Docking Station/Workstation as close to patient heart level as possible.

Step

Notes

1. Remove infusion set/burette from packaging, apply roller clamp, ensure air vent(s) are closed/clamped.

• Opening the air vent too soon can wet the filter and prevent flow

2. Spike fluid container ensuring spike is fully inserted into the container.

• Where possible the fluid in container should be at room temperature • Spike being fully inserted ensures the fluid path from the container is fully open

3. Fill the drip chamber to at least ½ full.

• Do not overfill the drip chamber when using a flow sensor • When using blood sets, fill the chamber to the top of the filter

4. Prime infusion set slowly, inverting pumping segment. Massage the pressure disc in the direction of the fluid flow to ensure air removal.

• Priming quickly causes turbulence resulting in air bubbles, which may lead to air-in-line alarms • For burette, glass bottles and semi-rigid containers, open air vent(s) after the infusion set has been primed half full. Leave closed for collapsible containers.

5. Hang the fluid container at a minimum height of 45 cm from the bottom of the Pump to the bottom of the fluid container. Raise the fluid container higher than the minimum height when possible, to minimise loops and kinks in the infusion set tubing.

45cm minimum

6. Close roller clamp. BDDF00582 Issue 1

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Alaris™ VP Plus Guardrails™ Volumetric Pump Loading an Infusion Set Step

Notes

7. Open door and load infusion set as follows:

• Ensure infusion set tubing above the Pump is as straight as possible with no kinks

Top set retainer Adaptor on infusion set

Pumping mechanism

Safety Clamp retainer (Orange) Alaris™ Safety Clamp (Orange) Air-in-line sensor Tubing guide

i) Fit top adaptor of infusion set into top set retainer.

Top Set Retainer ii) Insert Safety Clamp into retainer.

• Avoid any stretching of the silicone segment when loading, priming and re-loading the infusion set

w Safety Clamp

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Pushing on the Safety Clamp Slider may lead to uncontrolled flow to the patient. Therefore, always close the roller clamp before pushing on the safety clamp slider.

Alaris™ VP Plus Guardrails™ Volumetric Pump Loading an Infusion Set Step

Notes

iii) Ensure infusion set is fully inserted into tubing guide and all air is removed from the infusion set.

Tubing Guide 8. Close door and open roller clamp. Ensure no drops are falling in the drip chamber. 9. Ensure all air is removed from the set. 10. Connect the infusion set to the patient access device.

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Alaris™ VP Plus Guardrails™ Volumetric Pump Starting the Infusion

Starting the Infusion Infusion Setup

When operating the Pump, Users should position themselves at a distance of approximately 0.5 metres from the display.

1. Connect the Pump to an AC power supply using the AC power cable. 2. Load the primed infusion set, see 'Loading an Infusion Set' section. 3. Connect flow sensor, if required. 4. Press the a button. • The Pump will run a short self-test. Check two beeps are activated during this test. • Check the displayed date and time are correct. Check display shows the correct data set name and version number. NOTE: The Pump starts up and displays previous settings. 5. CLEAR SETUP? - Selecting NO will retain all previous rate and volume settings, go to step 8. Selecting YES will automatically reset the rate and volume settings to zero and the CONFIRM PROFILE? screen will be displayed. 6. CONFIRM PROFILE? screen will show the data set name, version number and profile name: a) Press YES softkey to confirm current profile and go to next step. b) Selecting NO will display the profile selection screen, select correct profile using f keys and press OK softkey to confirm. Confirm profile screen will display again, press YES softkey and SELECT screen will be displayed. NOTE: The CONFIRM PROFILE screen is only shown if more than one profile is available in the data set. If a profile has been filtered, then the option to select ALL will be displayed in the profile selection screen. Selecting ALL will show the filtered profiles. 7. Select either ml/h, DOSING ONLY or DRUGS (A-Z) and press OK to confirm. Then follow the prompts as required. a) ml/h 1. Select ml/h from the list using the f keys. 2. Press OK to confirm. 3. Enter the ml/h rate as prompted on the display in the next screen.

SELECT

ml/h DOSING ONLY DRUGS A B C D E FGHIJ KLMNO PQRST UVWXYZ SELECT WITH OK

QUIT

b) Dosing Only

SELECT

ml/h DOSING ONLY DRUGS A B C D E FGHIJ KLMNO PQRST UVWXYZ SELECT WITH OK

QUIT

1. Select DOSING ONLY from the list using the f keys. 2. Press OK to confirm. 3. Select the dosing units from the list using the f keys, press OK to confirm. 4. Enter DRUG AMOUNT using the f keys and if units need to be changed, select UNITS which will scroll through the units available. Press OK to confirm selection. 5. Use the f keys to select the TOTAL VOLUME1, press OK to confirm. 6. Enter WEIGHT2 using the f keys, press OK to confirm. 7. A summary of the DOSING ONLY information is displayed, to CONFIRM? all details shown press OK. The BACK softkey may be used at any time to return to the previous screen.

c) Drugs 1. Select the required DRUGS alphabetical row from the list using the f keys. 2. Press OK to confirm. 3. Select the drug from the displayed list using the f keys, press OK to confirm. 4. Enter DRUG AMOUNT using the f keys, press OK to confirm selection. 5. Use the f keys to enter the TOTAL VOLUME1, press OK to confirm. 6. Enter WEIGHT2 using the f keys, press OK to confirm. 7. A summary of the DRUG information is displayed, to CONFIRM? all details shown press OK. The BACK softkey may be used at any time to return to the previous screen.

SELECT ml/h DOSING ONLY DRUGS A B C D E FGHIJ KLMNO PQRST UVWXYZ SELECT WITH OK

QUIT

Total Volume = Drug Volume + Diluent Volume i.e. Total Volume of fluid in the fluid container after a drug is added.

Only displayed if weight based units are used. BDDF00582 Issue 1

18/54

Alaris™ VP Plus Guardrails™ Volumetric Pump Starting the Infusion 8. Clear VOLUME infused , if required. This is recommended for a new patient or when a new infusion is set-up. 9. Enter VTBI, if required, by selecting VTBI softkey on main display. Set VTBI by using the BAGS option and/or f keys and press OK to confirm. Select the END RATE using the f keys to scroll through the on-screen choices and press the OK softkey to confirm. 10. Enter or adjust the RATE, if necessary, using the f keys.

Priming the Infusion Set

• Always prime the infusion set prior to connecting to the patient. • The prime rate and prime volume max are configured in the data set via the Alaris™ Editor. • The Pump will not prime if rate lock has been activated. • During PRIME, the downstream occlusion alarm limit is temporarily increased to its maximum.

The i button allows the delivery of a limited volume of fluid in order to prime the infusion set prior to being connected to a patient. 11. Press i button to display the PRIME screen. 12. Press and hold the flashing PRIME softkey until the fluid flows and the priming of the infusion set is complete. The volume used during priming will be displayed, but it is not added to the volume infused. 13. When priming is complete release the PRIME softkey.

Start Infusion 14. Connect the infusion set to the patient access device. 15. Press b button to start the infusion. INFUSING will be displayed. NOTE: The green run LED will flash to show that the Pump is infusing.

If the infusion requires to be stopped immediately, the following actions may be applied: • press the h button, recommended action. • close the roller clamp and then open the door.

BDDF00582 Issue 1

19/54

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