Alaris GW Volumetric Pump Directions for Use Issue 4

Directions for Use

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Page 1

Alaris® GW Volumetric Pump (with Set Detection Mode disabled)

Directions For Use en

Alaris® GW Volumetric Pumps

Contents Page Introduction... 2 About This Manual... 3 Quick Start Guide... 3 Features of the Alaris® GW Volumetric Pump... 4 Controls and Indicators... 5 Symbol Definitions... 6 Operating Precautions... 7 Getting Started... 10 Starting the Infusion... 14 Secondary / Piggyback Infusions... 15 Basic Features... 16 User Selectable Options... 19 Configurable Options Sheet... 20 Alarms... 21 Warnings... 22 Flow Sensor Operation... 23 Compatible Dedicated Infusion Sets... 24 Associated Products... 27 Maintenance... 28 Cleaning and Storage... 29 Specifications... 30 IrDA, RS232 and Nurse Call Specification... 33 Trumpet and Flow Rate Curves... 34 Technical Description... 35 Products and Spare Parts... 36 Service Contacts... 37

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Alaris® GW Volumetric Pumps Introduction

Introduction The Alaris® GW Volumetric Pump (herein after referred to as 'Pump') is a small lightweight volumetric infusion pump that provides accurate and reliable infusions over a range of rates. To achieve the nominal performance stated in this DFU, CareFusion strongly recommends use of Alaris® GW branded dedicated infusion sets. Facilities intending to use non-dedicated infusion sets with the set detection mode disabled are advised to assess performance prior to clinical use. If adequate performance is not achieved, then Alaris® GW branded dedicated infusion sets should be used or the Alaris® GW Volumetric Pump should be re-calibrated. The use of a flow sensor is mandatory when the automatic set detection mode on the pump is disabled.

DISCLAIMER. This pump has been tested and approved by CareFusion for use only with CareFusion dedicated infusion sets. In the event the user is considering using infusion sets, not approved for use with the Alaris® GW Volumetric Pump, the user should consult an authorized CareFusion representative for compatibility and/or calibration information prior to use. In no event, however, does CareFusion make any representations or warranties concerning the adequacy and safe performance of any non-dedicated infusion sets as it relates to the operation of the pump and the accuracy of the infusion. In no event shall CareFusion be liable for any damages of any kind or nature, including without limitation, direct or indirect, special, consequential, or incidental damages arising from, or in connection with, the use of non-dedicated infusion sets (Infusion sets not manufactured by CareFusion), regardless of whether CareFusion has been advised as to the possibility of such use.

Intended Purpose The Alaris® GW Volumetric Pump is intended for use by medical staff for the purpose of controlling infusion rate and volume.

Conditions for Use The Alaris® GW Volumetric Pump should only be operated by medical staff competent in the use of automated volumetric pumps and in the management of infusion therapy. Medical staff should determine the suitability of the device in their care area for its intended purpose.

Indications The Alaris® GW 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), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces. The Alaris® GW Volumetric Pump is indicated for use on adults and paediatrics.

Contraindications The Alaris® GW Volumetric Pump is contraindicated for enteral therapies.

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Alaris® GW Volumetric Pumps About This Manual

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.

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 CareFusion products. These documents are referenced on www.carefusion.com. Copies can be obtained by contacting your local CareFusion representative.

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.

Important Information: 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.

Quick Start Guide 1. Half fill the drip chamber. 2. Press a to switch pump on. 3. Load the infusion set and open in-line clamp. 4. Prime (E) set: Press b once. Whilst E is displayed press b again and hold to clear all visible air from the line. 5. Enter rate using h / f. 6. Press e once to confirm and scroll to VTBI. 7. Enter VTBI using h / f , or switch off VTBI by scrolling f until OFF is displayed. 8. Press e to confirm and scroll to VI. 9. If necessary, press c to clear VI. 10. Connect Infusion set to the patient access device. 11. Press d to start infusion.

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Alaris® GW Volumetric Pumps

Features of the Alaris® GW Volumetric Pump

Features of the Alaris® GW Volumetric Pump Main Display -

Display Indicators

Displays the infusion rate, VTBI, VI and time remaining for VTBI / Time infusions. Display will flash when pump is operating on battery. Keypad

Flow Stop Mechanism When activated the mechanism will stop fluid flow.

Flow Direction Label

Air Sensor

Pressure Sensor

Bevel Releases the flow stop mechanism lever arm when the door is closed.

Door Latch -

Tubing Guide -

Press outer latch to open the pump door.

Guide to assist in the loading of the Infusion set.

Release Lever For Rotating cam.

Rotating Cam To lock onto the rectangular bars.

RS232 / Nurse call Connector Flow Sensor Interface

Mains Fuses Mains Inlet

Folded Pole Clamp

Potential Equalisation (PE) connector

Infra Red Communications port (IrDA)

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Alaris® GW Volumetric Pumps 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 3 seconds to switch the pump OFF.

RUN/HOLD button - Press to start the infusion or to put the infusion on hold.

CLEAR/SILENCE button - Press to silence alarm for 1 minute. The alarm will resound after this time. Resets numeric values to zero.

PRIME/BOLUS button - Primes the Infusion set. Administers bolus during the infusion.

PRIMARY/SECONDARY button - Switches the pump between Primary and Secondary infusion modes. (If enabled).

ENTER button - Scrolls between rate, time, VTBI and total volume infused (VI). Enters values for selected infusion / configuration parameters. Confirms the rate during an infusion titration.

CHEVRON keys - Increases or decreases the infusion rate, TIME limit and VTBI. Press and hold to increase the selection speed. Used to adjust user selectable options

Indicators: (when illuminated) Symbol

Description AC POWER indicator - When illuminated the pump is connected to an AC power supply.

RATE

The pump is displaying the infusion rate in millilitres per hour (ml/h).

VTBI

The pump is displaying the Volume To Be Infused (VTBI) in millilitres (ml).

The pump is displaying the Volume Infused (VI) in millilitres (ml).

TIME

The pump is displaying the infusion time in hours : mins.

MICRO

The pump is operating in the MICRO Mode. When not illuminated the pump is in the STANDARD Mode.

SEC

The pump is operating in the SECONDARY Mode. When not illuminated the pump is in the PRIMARY Mode.

ml/hr

(Millilitres / hour) When ml is illuminated the pump displays the rate, VTBI or VI. When the hr is illuminated the pump displays the rate or infusion time.

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Alaris® GW Volumetric Pumps Symbol Definitions

Symbol Definitions Labelling Symbols: Symbol

Description

w x > k O r

Attention Consult accompanying documents Potential Equalisation (PE) Connector RS232/Nursecall Connector. Type CF applied part. (Degree of protection against electrical shock) Protected against vertically falling drops of water Alternating Current

s T t + U W

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

Authorised representative in the European Community

REP

X Y

Date of Manufacture Manufacturer Connector for Flow Sensor Not for Municipal Waste Fuse rating

Infusion indicator - Displays fluid drops detected by the flow sensor when infusing at a normal rate. Infusion indicator - Displays fluid drops detected by the flow sensor when infusing in MICRO mode.

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Alaris® GW Volumetric Pumps Operating Precautions

Operating Precautions Infusion Sets •

•

To ensure correct and accurate operation, only use CareFusion single use infusion sets described in the 'Compatible Dedicated Infusion Sets' section of this Directions for Use. Use an infusion set with an antisiphon valve whenever possible. The anti-siphon valve prevents free flow from occurring if an infusion set is incorrectly loaded or removed from the pump. It is recommended that Infusion sets are changed in accordance with the Directions for Use. 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.

•

The Infusion set may be fitted with an in-line clamp, which can be used to occlude tubing in case it is required to stop fluid flow. The Alaris® GW Volumetric 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. CareFusion recommends the use of the IVAC® Model 180 Flow Sensor when using sets without anti-siphon valves or the mandatory use of the IVAC® Model 180 Flow Sensor whenever the pump set detection mode is disabled. The flow sensor automatically monitors the infusion flow rate through the drip chamber and will cause the pump to alarm if a significant deviation from the infusion rate occurs. The flow sensor will detect empty containers.

• • • •

Mounting the Pump

^ %;

•

The fluid height in the container must not be more than 1 metre above the patients heart.

•

Do not mount the pump in a vertical position with the AC power inlet pointing upwards as this could affect electrical safety, in the event of a fluid spill over the pump.

Operating Pressure •

The pumping pressure alarm system is not designed to provide protection against, or detection of, IV complications which can occur.

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.

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Alaris® GW Volumetric Pumps Operating Precautions

Using Collapsable bags, Glass Bottles & Semi Rigid containers •

It is recommended that the air vent be opened on the Alaris® GW Volumetric Pump set 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 the Collapsable bags

Steps for Semi-rigid containers

Follow steps 1 to 3 as shown for the semi-rigid 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.

2. Spike the container

Fill drip chamber to fill line

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

Prime the set by opening / closing the roller clamp

1. Close the roller clamp

Operating Environment •

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 local vascular system by such pumps. Typical examples of those pumps are used during dialysis, bypass or cardiac assist applications.

•

This pump is suitable for use in Hospital and clinical environments other than domestic establishments and those directly connected to the public single phase AC mains power supply network that supplies buildings used for domestic purposes. However, it may be used in domestic establishments under the supervision of Medical professionals with additional necessary appropriate measures. (Consult Technical Service Manual, appropriately trained qualified service personnel or CareFusion for further information).

•

This pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide.

•

Align all Alaris® GW Volumetric Pumps within a particular hospital or clinical environment to the same automatic set detection mode (ie. All On or all OFF) to avoid potential confusion amongst users as to the mode in which the pump is operating under and hence to ensure that the appropriate recommendations for flow sensor usage are followed.

Earth Conductor

•

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

•

This pump also has an internal power source.

•

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.

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Alaris® GW Volumetric Pumps Operating Precautions

Electromagnetic Compatibility and Interference

•

This pump is protected against the effects of external interference, including high energy radio frequency emissions, magnetic fields and electrostatic discharge (for example, as generated by electrosurgical and cauterising equipment, large motors, portable radios, cellular telephones etc.) and is designed to remain safe when unreasonable levels of interference are encountered.

•

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 CareFusion 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 CareFusion 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 CareFusion 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 CareFusion may result in increased emissions or decreased pump immunity.

•

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 radiation 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 qualified service personnel.

•

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. However, this pump emits a certain level of electromagnetic radiation which is within the levels specified by IEC/EN60601-1-2 and IEC/EN60601-2-24. If the pump interacts with other equipment, measures should be taken to minimise the effects, for instance by repositioning or relocation.

•

For further information on electromagnetic compatibility, please consult Technical Service Manual, 1000SM00006.

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.

•

A fire hazard may exist if the pump is used in the presence of high oxygen concentrations.

•

Dangerous Voltage: An electrical shock hazard exists if the pump’s casing is opened or removed. Refer all servicing to qualified service personnel.

•

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 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.

•

Warning: Alaris® GW Volumetric Pumps should not be modified or altered in any way, except where explicitly directed or authorised by CareFusion. Any use of Alaris® GW Volumetric Pumps which have been altered or modified otherwise than in strict application of directions provided by CareFusion, is at your sole risk, and CareFusion does not provide any warranty for or endorsement on any Alaris® GW Volumetric Pump that has been so modified or altered. CareFusion’s product warranty shall not apply in the event the Alaris® GW 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® GW Volumetric Pump.

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Alaris® GW Volumetric Pumps 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® GW Volumetric Pump • User Support CD (Directions For Use) • AC Power Cable (as requested) • Protective Packaging • Model 180 Flow Sensor (Pump model dependent, if not supplied then the flow sensor can be ordered separately) 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.

4. Facilities intending to use non-dedicated infusion sets with the Set Detection Mode disabled are advised to assess performance of the pump and infusion set combination prior to clinical use. If adequate performance is not achieved, then the Alaris® GW branded dedicated infusion sets should be used or the pump should be recalibrated by following the volumetric calibration procedure described in the Technical Service Manual Addendum 1000SM00014.

Factory set calibration values in the Alaris® GW Volumetric Pump are intended specifically to support the use of Alaris® GW branded dedicated infusion sets. Compatibility of factory calibration settings with Alaris® GW branded dedicated infusion sets is controlled by CareFusion. CareFusion reserves the right to make changes to the Alaris® GW Volumetric Pump without notice which may affect its performance with non-dedicated infusion sets. If adequate performance is not achieved, then Alaris® GW branded dedicated infusion sets should be used or the Alaris® GW Volumetric pump should be re-calibrated. It is recommended that the performance of any non-dedicated infusion set is re-evaluated periodically as the set manufacturer may change specifications significant to the performance of the Alaris® GW Volumetric Pump without notice.

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Alaris® GW Volumetric Pumps Getting Started

Pole Clamp Installation A pole clamp is fitted to the rear of the pump and will provide secure fixing to vertical I.V. poles of a diameter between 15 and 40 mm. 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 Infusion stand becomes top heavy or unstable. Ensure pole clamp is folded away and stored within recessed area at the rear of the pump before connecting to a Docking Station/Workstation* or when not in use.

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.

Docking Station/Workstation* or Equipment Rail Installation Rectangular bar

Release lever

Rotating cam

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. 2. Push the pump firmly onto the rectangular bar or equipment rail. 3. Ensure that the pump 'clicks' securely into position onto the rail or bar. 4. To release, push the release lever and pull the pump forwards.

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.

*Alaris® DS Docking Station and Alaris® Gateway Workstation.

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Alaris® GW Volumetric Pumps Getting Started

Loading an Infusion Set

Ensure the appropriate Infusion set for the fluid/drug to be infused has been selected. Follow the instructions supplied with the individual Infusion set. Use of non-specified Infusion sets may impair the operation of the pump and the accuracy of the infusion. For Alaris® GW Volumetric Pump Infusion sets refer to 'Infusion Sets' section of the DFU. Position the IV fluid container to avoid spillage onto the pump. Ensure that the tubing is inserted completely into the pumping channel, avoiding any slack. When using 273-003, 273-003V, 273-303E and 273-303EV Infusion sets, ensure a separation of at least 50cm is maintained between the pump and the upper Back Check Valve. 1. Close the in-line clamp on the Infusion set. Press the door latch to open the tubing cover door.

2. Release the flow stop mechanism by pushing the lever arm up and to the right.

3. Avoiding any slack, insert the infusion set from left to right into the slot provided, following the flow direction label. Make sure that the infusion set is pressed firmly past the constriction points and into the slots on either side of the casing.

4. Re-engage the flow stop mechanism by pushing the lever left and down.

5. Close the tubing cover door. Use the recesses in the cover door to press the door firmly to ensure the latch is correctly applied. Open in-line clamp on the Infusion set.

6. Observe fluid chamber and check for no fluid flow.

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Alaris® GW Volumetric Pumps Getting Started

Power On/Off To power up the pump: 1. Press the a button once and release. 2. Check: • A high pitch sounder is activated for 3 seconds during this time the main speaker 'beeps' once upon power up sequence. • All display segments and all indicators are lit. • If an error occurs during self-test the pump will alarm. 3. After this self-test the pump will display last rate setting entered or zero, depending on the configuration.

To power down the pump: 1. Press and hold a. The pump will display OFF3-OFF2-OFF1. 2. If the a button is released during the countdown the pump will not power down and it will return to its previous state.

If the pump alarms, segments / indicators do not light up correctly or 2 audible sounds are not heard, then the pump must be powered down immediately, and qualified service personnel contacted. If transportation to an engineer is necessary, it is recommended to use the original protective packaging.

Priming the Infusion Set

Use an infusion set with an anti-siphon valve whenever possible. The anti-siphon valve prevents free flow from occurring if an infusion set is incorrectly loaded or removed from the pump. Infusion sets with an anti-siphon valve can only be primed when loaded in the pump. When using infusion sets without an anti-siphon valve eg. 273-004, 273-007 and 273-008, the infusion set can be primed without using the pump. Use of a flow sensor is recommended when using an infusion set without an antisiphon valve. The flow sensor will cause the pump to alarm if a significant deviation from the set infusion rate occurs.

1. 2. 3. 4.

Ensure the pump is switched on and in-line clamp is open. Load the Infusion set (see 'Loading the Infusion Set'). Press b button once E will be displayed. Press and Hold b button while E is still displayed, prime the Infusion set until there is no visible air in the IV line (according to hospital protocol). 5. Attach the set to the patient or other Infusion set. 6. Start the infusion (see 'Starting the Infusion').

Use the prime function to fill the Infusion sets before starting an infusion. Never connect the Infusion set to the patient during the priming process. The prime (E) volume delivered will not be subtracted from the VTBI, or added to the total volume infused.

Automatic Set Detection When using a compatible dedicated CareFusion infusion set (refer to 'Compatible Dedicated Infusion Sets' section), it is recommended that the set detection mode is enabled on the Alaris® GW Volumetric Pump. This mode can be enabled in Technician Mode on the pump (refer to the Technical Service Manual addendum 1000SM00014 for more details). Align all Alaris® GW Volumetric Pumps within a particular hospital or clinical environment to the same automatic set detection mode (ie. All On or all OFF). This will help to avoid potential confusion amongst users as to the mode in which the pump is operating under and hence to ensure that the appropriate recommendations for flow sensor usage are followed. When the automatic set detection is set to On, the pump automatically tests that a compatible CareFusion Infusion set has been loaded correctly (refer to 'Compatible Dedicated Infusion Sets' section). The test will occur at the start of the first infusion after the pump is switched on or after the door has been opened; the pump will run in reverse for 10 seconds and then forward for 10 seconds, the test takes a maximum of 20 seconds to complete. During this operation the clinician may observe a blood return that will be more evident if using a small catheter. If the pump fails to detect a correct CareFusion Infusion set or detects a possible set misload, then the pump will alarm and display Q refer to 'Alarms and Warnings' section of this DFU. Please contact your local CareFusion representative if further information or support is required regarding the Automatic Set Detection operation or the application of this pump in specific clinical settings, e.g. neonatal.

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Alaris® GW Volumetric Pumps Starting the Infusion

Starting the Infusion Check: • • • • •

The pump is switched on. The Infusion set has been primed (refer to 'Priming the Infusion Set' section of this DFU). The in-line clamp is open. The flow sensor is connected (refer to 'Flow Sensor Operation' section of this DFU). U indicates a drop is detected by the flow sensor during infusion.

Standard Mode 1. 2. 3. 4. 5. 6.

Enter infusion rate using the f h keys. Press e button once to confirm the infusion rate. Enter VTBI using the f h keys or switch VTBI off by pressing the f button until OFF is displayed. Press e button to confirm the VTBI. Press c to clear VI if required. Press d button to start infusing.

Standard Mode with VTBI / Time Infusion on 1. 2. 3. 4. 5. 6.

Enter VTBI using the f h keys. Press e button once to confirm the VTBI. Enter TIME using the f h keys. Press e button to confirm the TIME. Press c to clear VI if required. Press d button to start infusing.

Micro Mode 1. 2. 3. 4. 5. 6.

Micro Mode with VTBI / Time Infusion on 1. 2. 3. 4. 5. 6.

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Alaris® GW Volumetric Pumps

Secondary / Piggyback Infusions

Secondary / Piggyback Infusions Secondary (or piggyback) Infusion mode is only available if configured, refer to Configurable Options section of this DFU. Secondary Infusion mode is used to administer an intermittent fluid / drug solution e.g. 4 hourly antibiotic infusion using: • A primary infusion set with an in-line check valve before the Y-Injection site e.g. 273-003 or 273-303E. • A secondary infusion set e.g. 72213 or 72213N.

Primary fluid container must hang lower (approximately 20cm lower) than the secondary fluid container to allow the secondary infusion to run. Primary infusion will restart on completion of the secondary infusion.

1. Set the primary infusion, but do not start (refer to 'Starting the Infusion' section of this DFU). If pump is running press d button to put pump on hold. 2. Prime Secondary Infusion set, following the instructions supplied. 3. Close the in-line clamp on the secondary set. 4. Connect secondary Infusion set into upper Y-injection site of the primary Infusion set. 5. Lower primary fluid container using extension hook supplied with the secondary Infusion set. 6. Press l button and S will be displayed. Rate / Volume

VTBI / TIME

7. Enter required rate using the hf keys.

Enter VTBI using the hf keys.

8. Press e button to scroll to VTBI.

Press e button to scroll to TIME.

9. Enter VTBI using the hf keys.

Enter TIME using hf keys.

10. Open the in-line clamp on the secondary set. 11. Press e button to scroll further, or press d button to start the secondary infusion. 12. Ensure the SEC (Secondary) indicator is lit. Note: The infusion rate will automatically revert to the primary infusion rate when the secondary infusion is complete. On completion of the primary infusion the pump will continue at Keep Vein Open rate (KVO) rate.

During primary / secondary infusion of 2 drugs into a single lumen line, it is essential to ensure drug / fluid compatibility by consulting a drug compatibility chart or local pharmacist, prior to infusion. The secondary set connects to the upper Y-connection on the primary Infusion set. To set the Secondary Infusion the pump must be on G or not running. Secondary infusion rates above 270ml/h may cause simultaneous flow from secondary and primary fluid sources.

Typical Secondary Infusions: IV Pole Secondary Fluid Container Usually a smaller container e.g. 50ml, 100ml, 200ml or 250ml.

Extension Hook

Normally included with the secondary Infusion set.

1 In-line Clamp

Primary Infusion set must hang lower to allow the secondary infusion to run and primary infusion to restart on completion of the secondary. Primary Fluid Container

e.g. roller clamp.

Primary Infusion set

Secondary Infusion Set

e.g. 273-003 with an upper Y-injection site. In-line Clamp e.g Roberts clamp.

e.g. 72213. Usually shorter tubing to reach the Y-site on the primary Infusion set.

Check Valve Prevents secondary infusions from flowing back up the primary Infusion set instead of to the patient.

Upper Y-Injection Site on Primary Infusion Set.

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If using a flow sensor it must be on the primary Infusion set.

Alaris® GW Volumetric Pumps Basic Features

Basic Features Rate Titration 1. Enter the new infusion rate using the f h keys. 2. Press e button to confirm the infusion rate. Note: The rate can be increased or decreased without interrupting the infusion.

If the new rate selected is not confirmed the pump will revert to the current rate and no change in the infusion rate will occur.

Bolus Infusions To administer a bolus infusion: 1. Press b button once and C will be displayed. 2. Press and Hold b button while C is still displayed, release b button after administering the desired bolus volume. Note: Bolus volume given will be added to the total volume infused (VI) and subtracted from the volume to be infused (VTBI).

Panel Lock The Panel Lock feature minimises the risk of unintentional changes to the infusion settings, whilst infusing.

p If Panel Lock is enabled then

displays for all (non-operational) button presses.

Panel Lock prevents button operation with the exception of: • Scrolling between infusion parameters using the e button. • Muting the alarm using the c button. • Pausing / resuming the infusion using the d button.

Optimising the Pumps Performance Pump performance may be optimised by moving a new section of the infusion set in the pumping mechanism every 24 hours. To insert a new section of tubing: 1. Press d to place the infusion on HOLD. 2. Ensure the in-line clamp is closed. 3. Open the pump door, release the flow stop mechanism and move the Infusion set approximately 15cm along. See 'Loading the Infusion Set'. 4. Close the door, press d to restart the infusion.

Hold Mode Press d to pause the infusion. Press d again to resume the infusion. A call back alarm will activate if the pump is left on G for more than 2 minutes.

KVO (Keep Vein Open) Rate At the end of infusion, the pump will continue to infuse at a very low rate (refer to 'Specifications' section of this DFU). KVO is used to keep the patients vein open, in order to prevent blood clots and catheter occlusions.

If the KVO rate is greater than the set infusion parameters then the pump will continue to infuse at the set infusion rate. If the KVO rate has been configured to OFF the pump will stop infusing and generate an alarm.

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Alaris® GW Volumetric Pumps Basic Features

Changing the Infusion Set 1. 2. 3. 4. 5. 6. 7. 8.

Press d to put the pump ON HOLD. Close in-line clamp and ensure the IV access to the patient is isolated. Disconnect the Infusion set from the patient. Open pump door and remove Infusion set from the pump and discard the set and fluid container according to hospital protocol. Place new Infusion set into pump, see 'Loading the Infusion Set'. Squeeze the drip chamber approximately half full or up to fill line (if the drip chamber is marked) with fluid. Prime the set manually. Restart infusion, see 'Getting Started'.

When changing the Infusion set or the fluid container use aseptic technique according to hospital protocol. It is recommended that Infusion sets are changed in accordance with the Directions for Use. Carefully read the Directions For Use supplied with the Infusion set prior to use. The set change interval is 24 hours.

Changing the Fluid Container 1. 2. 3. 4. 5.

Press d to put the pump ON HOLD. Remove bag spike on Infusion set from empty / used container. Discard empty / used container according to hospital protocol. Insert spike into new container. Squeeze the drip chamber approximately half full or up to fill line (if the drip chamber is marked) with fluid. Restart infusion, see 'Getting Started'.

SmartSite® Needle-Free System Instructions SmartSite® Needle-Free Valve is designed to permit safe gravity flow and automated flow, injection and aspiration of fluids without the use of needles by utilising Luer lock and Luer slip connectors.

Precautions: Discard if packaging is not intact or protector caps are unattached. If SmartSite® Needle-Free Valve is accessed by a needle in an emergency the valve will be damaged causing leakage. Replace SmartSite® Needle-Free Valve immediately. SmartSite® Needle-Free Valve contraindicated for blunt cannula system. DO NOT leave slip Luer syringes unattended.

DIRECTIONS - Use Aseptic Technique 1. Prior to every access, swab top of SmartSite® Needle-Free Valve port with 70% Isopropyl alcohol (1-2 seconds) and allow to dry (approximately 30 seconds). NOTE: Dry time is dependent on temperature, humidity, ventilation of the area.

2. Prime valve port. If applicable, attach syringe to SmartSite® Needle-Free Valve port and aspirate miniscule air bubbles. 3. When used with administration sets always refer to individual set directions for use as change interval may vary according to clinical application (e.g. infusions of blood, blood products, and lipid emulsions). NOTE: During use of Needle-Free Valve port, fluid may be observed between the housing and blue piston. This fluid does not enter the fluid path and requires no action. NOTE: For product questions or needle-free valve educational materials, contact your CareFusion representative. Consult facility protocols. Consult other organisations that publish guidelines useful in developing facility protocols.

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Alaris® GW Volumetric Pumps Basic Features

Clearing Air-In-Line 1. Press d button to silence the air-in-line alarm and put the pump on hold. 2. Close the in-line clamp. 3. Open the door to view the air bubble. NOTE: Air-in-line alarms can be activated by both single bubbles and bubbles accumulated over time. 4. Disconnect the Infusion set from the patient and ensure the IV access to the patient is isolated. 5. Close the door. 6. Open the in-line clamp. 7. Press the b button once and E will be displayed. 8. Press and hold the b button while E is still displayed until there is no visible air in the IV line (according to hospital protocol). 9. Close the in-line clamp. 10. Attach the Infusion set to the patient. 11. Open the in-line clamp and restore the IV access to the patient. 12. Press the d button to resume the infusion.

A A

Use aseptic technique according to hospital protocol.

Infusion sets without an in-line anti-siphon valve must be clamped before disconnecting from the patient and the prime (E) procedure will not be necessary to remove the air-in-line, as the air can be removed by gravity.

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Alaris® GW Volumetric Pumps User Selectable Options

User Selectable Options

To set the user options the pump must be on G or in set-up mode, and the relevant user selectable options are enabled. See also 'Configurable Options' section in this DFU.

Press e button and hold for 2 seconds to enter User Selectable Options. Note: Number of e button presses are dependent upon the User Select Mode Options which have been enabled. The following instructions are based upon all options being enabled.

Setting the Occlusion Pressure Level 1. When PrES is displayed. 2. Select HI, nor or Lo using the h f keys to set the occlusion pressure level to High, Normal or Low. 3. Press e button to return to G or set-up mode or next option.

Setting the Alarm Volume 1. Press e button until tonE is displayed. 2. Select an alarm volume between 1 (Low) and 7 (High) using the h f keys. 3. Press e button to return to G or set-up mode, or next option.

Setting a VTBI / Time Infusion 1. 2. 3. 4.

Press e button until R is displayed. Select On or OFF using the h f keys to turn the VTBI / time infusion setting on or off. Press e button to return to G or set-up mode, or next option. Make sure that the TIME indicator is lit if set to on. Note: The TIME increases / decreases in rate dependant units e.g. 10ml @ 99.9ml/h is 6mins, therefore 0:06 is displayed.

Setting to Micro Mode 1. 2. 3. 4.

Press e button until T is displayed. Select On or OFF using the h f keys to turn micro mode on or off. Press e button to return to G or set-up mode, an audible sounder will confirm the status. Make sure that the MICRO indicator is lit if set to on.

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Becton Dickinson

Alaris Volumetric Pump Series

Alaris GW Volumetric Pump Directions for Use Issue 4