Alaris GP Volumetric Pump with Plus Software Directions for Use Issue 4

Alaris® GP (Guardrails®) Volumetric Pump 

Contents Page Introduction... 2 About This Manual... 2 Creating a Data Set... 3 Features of the Volumetric Pump... 4 Controls and Indicators... 5 Symbol Definitions... 6 Main Display Features... 7 Operating Precautions... 8 Getting Started... 11 Basic Features... 16 Secondary (Piggyback) Infusions... 23 Service Configuration Mode... 24 Pump Configuration available via the Alaris® Editor Software... 25 Drug Library available via the Alaris® Editor Software...27 Alarms... 28 Warnings... 30 Prompts... 31 Advisories... 32 Restarting an Infusion following an Air-in-Line Alarm... 33 Flow Sensor Operation (Optional)... 34 Infusion Sets... 35 Associated Products... 38 Maintenance... 39 Cleaning and Storage... 40 Specifications... 42 IrDA, RS232 and Nursecall Specification... 44 Infusion Specifications... 45 Trumpet and Flow Rate Curves... 47 Products and Spare Parts... 49 Service Contacts... 50

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Alaris® GP (Guardrails®) Volumetric Pump Introduction

Introduction The Alaris® GP Volumetric Pump and Alaris® GP Guardrails® Volumetric Pump (hereinafter referred to as 'Pump') are small lightweight volumetric infusion pumps that provide accurate and reliable infusions over a range of rates. The Alaris® Editor software is a medical device accessory, which allows the hospital to develop a best-practice data set of IV medication dosing guidelines for patient-specific care areas referred to as profiles. Each profile contains a specific library of drugs, as well as an appropriate pump configuration. A profile also contains hard limits that cannot be overridden during infusion programming. For the Alaris® GP Guardrails® Volumetric Pump only, Guardrails® soft limits are available and can be overridden, based on clinical requirements. The Alaris® GP Guardrails® Volumetric Pump with a data set loaded, provides automatic alerts when a dosing limit, bolus limit, concentration 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 technical personnel.

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

Conditions for Use The Alaris® GP Volumetric Pump and Alaris® GP Guardrails® 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® GP Volumetric Pump and Alaris® GP Guardrails® Volumetric Pump are 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® GP Volumetric Pump and Alaris® GP Guardrails® Volumetric Pump are indicated for use on adults and paediatrics.

Contraindications The Alaris® GP Volumetric Pump and Alaris® GP Guardrails® Volumetric Pump are contraindicated for enteral or epidural therapies.

About This Manual The user must be thoroughly familiar with the pump described in this manual prior to use. The pump has minor functionality differences to the Alaris® GH/CC Guardrails® Syringe Pumps. 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.

A

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.

A

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.

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Alaris® GP (Guardrails®) Volumetric Pump Creating a Data Set

Creating a Data Set To create a data set for the pump, first the hospital will need to develop, review, approve, upload according to the following process. Refer to the Alaris® Editor help file for further details and operating precautions. 1. Create care area data set (Using the Alaris® Editor) Data Set

There are two types of data set which can be created; 1. Non-Guardrails® Data Set - Creates a new Non-Guardrails® data set for the Alaris® Infusion Pumps to be edited in the application. 2. Guardrails® Data Set - Creates a new Guardrails® data set for the Alaris® GP Guardrails® Infusion Pumps to be edited in the application. A Guardrails® Data Set provides additional safety features.

Profile

A unique set of configurations and best-practice guidelines for a specific population, patient type or care area. Each profile consists of: Pump Configuration / Drug Library Up to 30 profiles can be defined for each Data Set for the pump.

Pump Configuration

Pump configuration settings and units for dosing only.

Drug Library

Drug names and concentrations for a data set with default value and maximum limits. Up to 100 unique drug protocol set-ups.

2. Master List (Using the Alaris® Editor) Master Drug List

A CareFusion defined drug is a usability aid to pre populate drug names for the Master Drug Lists. Alternate drug names and concentrations can be created.

3. Review, approve and export data set Review and Approve

Entire data set report to be printed, reviewed and signed as proof of approval by an authorised person, according to hospital protocol. Signed printout to be kept safe by hospital. Data set status to be set to Approved (Password is required).

Export

Export data set for use by the Alaris® Transfer Tool or to back up a data set, or to move the data set to another PC.

4. Upload data set to the pump (Using Alaris® Transfer Tool) Note:

One profile selection will be required when uploading the data set to the Alaris® GP Volumetric Pump.

5. Verify that the correct data set is loaded into the pump and accept it. 6. Switch the pump off. 7. Switch the pump on and verify that the software version screen displays the correct data set version. The pump is now ready to use.

A

Data set transfers should only be performed by qualified technical personnel. The pump serial number and the hospital name are stored in the event log, they can also be obtained via the PUMP DETAILS option, refer to 'Pump Details' section. Drug parameters have to be in accordance with local regulation and prescribed information.

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Alaris® GP (Guardrails®) Volumetric Pump Features of the Volumetric Pump

Features of the Volumetric Pump Alarm indicator Alaris®

GP

Guardrails®

Door

Display Softkeys Chevrons Run Bolus Hold Options AC power indicator

Mute Pressure Battery indicator On/Off Door Lever

Handle Release lever for rotating cam

Flow sensor connector 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® GP (Guardrails®) Volumetric Pump Controls and Indicators

Controls and Indicators 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.

c

MUTE button - Press to silence alarm for (approximately) two minutes (configurable). The alarm will resound after this time. Press and hold until three beeps are heard for 15 minutes silence (If enabled via the Alaris® Editor).

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.

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.

i

• 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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Alaris® GP (Guardrails®) Volumetric Pump Symbol Definitions

Symbol Definitions Labelling Symbols: Symbol

Description

w

Attention (Consult accompanying document)

x

Potential Equalisation (PE) Connector

RS232/Nursecall Connector.

l

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

IPX3

Protected against direct sprays up to 60° from the vertical.

r

Alternating Current

s T t

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 EC REP

Not for Municipal Waste Fuse rating Authorised representative in the European Community

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Alaris® GP (Guardrails®) Volumetric Pump Main Display Features

Main Display Features Main Display - If VTBI has not been set (flow sensor must be used) Infusion Status /

ON HOLD

Drug Name / Profile Name / Primary or Secondary (Only if secondary is enabled in the data set)

RATE

VOLUME VOLUME

Softkey Identifiers

ON HOLD

SET RATE WITH RATE

25.0 ml/h

Infusion Rate Volume Infused

a)

ON HOLD HOLD ON

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

50.0 ml

b)

ON HOLD

RATE TOO LOW HIGH RATE TOO SET RATE WITH RATE RATE

VTBI

Softkeys

Clear Volume Infused

ON HOLD

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

Set VTBI Option

RATE

Main Display - If VTBI is set

ADRENALINE

Infusion Status / Drug Name / Profile Name /Primary or Secondary (Only if secondary is enabled in the data set)

RATE

Infusion Rate Dose Rate

25.0 ml/h 16.7 µg/kg/24h

45.0 ml VOLUME 50.0 ml 1h 48m 00s

c)

ON HOLD RATE

RATE TOO HIGH

If programmed rate is greater than the Infusion Rate Max in drug protocol, message c) will be shown.

VTBI

Volume to be Infused Volume Infused Time remaining Softkey Identifiers

VOLUME

VTBI

Softkeys

Clear Volume Infused

Set VTBI Option

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 Guardrails® soft limits. The warning can be overridden (Indicates Guardrails® safety protocol is in use). Indicates that the value entered is outside of the hard limits. The warning can NOT 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.

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Alaris® GP (Guardrails®) Volumetric Pump Operating Precautions

Operating Precautions Infusion Sets •

To ensure correct and accurate operation, only use CareFusion 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.

•

CareFusion 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 & 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 the Collapsible 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

3.

4.

Fill drip chamber to fill line

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

5.

1. Close the roller clamp

Prime the set by opening / closing 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 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 all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

•

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.

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Alaris® GP (Guardrails®) Volumetric Pump Operating Precautions

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.

Electromagnetic Compatibility and Interference

M

•

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 technical 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/EN60601-2-24 and IEC/EN606011-2. If the pump interacts with other equipment, measures should be taken to minimise the effects, for instance by repositioning or relocation.

Alaris®

GP

Earth Conductor

d

•

The 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® GP (Guardrails®) Volumetric Pump Operating Precautions

Hazards An explosion hazard exists if the pump is used in the presence of flammable anaesthetics. Exercise care to locate the pump away from any such hazardous sources.

•

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

•

Do not open the RS232/Nurse Call protective covering when not in use. Electrostatic discharge (ESD) precautions are required when connecting RS232/Nurse Call. Touching the pins of the connectors may result in ESD protection failure. It is recommended that all actions must be taken by appropriately trained personnel.

•

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 a qualified service engineer. 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 a qualified service engineer.

•

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

•

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

Al

GP aris®

m V

•

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Alaris® GP (Guardrails®) Volumetric Pump Getting Started

Getting Started

A

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® GP or Alaris® GP Guardrails® Volumetric Pump • Directions For Use (CD) • AC Power Cable (as requested) • Protective Packaging • Alaris® Editor Software and/or Alaris® Transfer Tool - per hospital 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

• The Alaris® Editor software can be used to create an approved data set that can be uploaded into the pump. However, a default data set is already installed in the pump (See details below). • 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 a qualified service engineer for investigation.

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

µg/min

Audio Volume

Medium

µg/24h

Alarm Volume Adjustable

Disabled

mg/24h

Occlusion Alarm Pressure

L5

unit/24h

Pressure Max

L8

mmol/24h

Rate Titration

Disabled

ml/kg/min

Infusion Rate Max

1200ml/h

ng/kg/h

Rate Lock

Disabled

µg/kg/min

Bolus Mode

Hands-On Only

µg/kg/h

Bolus Rate Default

500ml/h

mg/kg/min

Bolus Rate Max

1200ml/h

mg/kg/h

Bolus Volume Max

5ml

g/kg/min

Weight Default

1kg

unit/kg/min

Weight Soft Min*

1kg

mmol/kg/min

Weight Soft Max*

150kg

mmol/kg/h

AIL Limit

100µl

Primary VTBI Max

9999ml

Secondary Infusion

Disabled

A

• Refer to 'Display of Units' section of this DFU for configurable units. • The default data set does not have drug related Guardrails® limits. To set the limits use the Alaris® Editor software. Care should be taken when specifying the Guardrails® limits.

* Only available on the Alaris® GP Guardrails® Volumetric Pump.

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Alaris® GP (Guardrails®) Volumetric Pump Getting Started

Pole Clamp Installation The 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. 2. Place pump around pole and tighten screw until the clamp is secured to the pole. Recessed area

*

A

*

Never mount the pump such that the I.V. 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. NOTE:

Ensure that the pump 'clicks' securely into position onto the rail or bar.

Alaris®

GP

3. To release, push the release lever and pull the pump forwards.

Rotating cam

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

A

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 docking stations listed above.

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Alaris® GP (Guardrails®) Volumetric Pump Getting Started

The 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**:

Clamp in NON OCCLUDED POSITION

Safety Clamp Frame Safety Clamp Tab 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

A

NO FLOW 1. Push

2. Push

A

up Æ

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 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® GP (Guardrails®) Volumetric Pump Getting Started

Loading an Infusion Set Loading an Infusion Set: Alaris® Safety Clamp in the NON OCCLUDED position - FLOW ENABLED:

A

• Ensure the appropriate infusion set for the fluid / drug to be infused has been selected. • Follow the instructions supplied with the individual infusion set. • Only use Alaris® GP and Alaris® GP Guardrails® Volumetric Pump infusion sets, (Refer to 'Infusion Sets' section of the DFU) • Position the fluid container to avoid spillage onto the pump. • Ensure that the tubing is inserted completely into the top set retainer through to the tubing guide avoiding any slack. Adaptor on infusion set (Blue) Top set retainer (Blue) Pressure sensor UPSTREAM

Pumping mechanism

1. Remove infusion set from package and close roller clamp. 2. Insert the bag spike into the fluid container and hang appropriately at a minimum height of 300 mm above the pump. 3. Fill the drip chamber to the fill line if shown (Approximately half full). Refer to operating precaution section 'Using Collapsable bags, Glass Bottles & Semi-Rigid containers'. 4. Open roller clamp and prime set slowly (to prevent air bubbles) ensuring all air is removed. To use the pump to prime refer to 'Priming the Infusion Set' section. 5. Close roller clamp.

Pressure sensor - DOWNSTREAM

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

6. Switch the pump on. Open door and load infusion set as follows: • Fit blue adaptor of infusion set into blue top set retainer. • Insert orange safety clamp into orange retainer. 7. Ensure infusion set is fully inserted into 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. Connect the infusion set to the patient access device.

Loading an Infusion Set: Alaris® Safety Clamp in the OCCLUDED position - NO FLOW: 1. Follow steps 1 to 4 as above where necessary. 2. Ensure roller clamp is closed. 3. Switch the pump on. Open door and load infusion set as follows: • Fit blue adaptor of infusion set into blue top set retainer. • Insert orange safety clamp (leaving slider extended) in the occluded position into orange retainer. Alaris® Safety Clamp (Orange) in occluded position (See previous page)

A

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.

4. Ensure infusion set is fully inserted into tubing guide. Tubing guide

5. Close door and open roller clamp. Ensure no drops are falling in the drip chamber. 6. Ensure all air is removed from the set. Connect the infusion set to the patient access device.

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Alaris® GP (Guardrails®) Volumetric Pump Getting Started

Starting the Infusion

A

Prime and load the set (Refer to 'Priming the Infusion Set' and 'Loading an Infusion Set')

1. Ensure the pump is connected to an AC power supply (also operates from battery). 2. Connect flow sensor, if required (See 'Flow Sensor Operation' section). 3. Press the a key. 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 data set name and version number. NOTE:

The pump starts up and displays previous settings.

4. CLEAR SETUP? - Selecting NO will retain all previous rate and volume settings, go to step 7. Selecting YES will automatically reset the rate and volume settings to zero and the CONFIRM PROFILE? screen will be displayed. • ml/h

• Drug Protocol

• Primary/Secondary

• Dosing Only

• Drug Protocol

CLEAR SETUP?

CLEAR SETUP?

PROFILE NAME RATE 300ml/h VTBI 46.5ml

PROFILE NAME CONCENTRATION 0.50mg/50ml =0.01mg/ml RATE 150ml/h =0.00mg/kg/min VTBI 100ml =1.00mg

VOLUME 3.5ml

YES

VIEW WITH

NO

YES

VIEW WITH

CLEAR SETUP? PROFILE NAME PRIMARY SETUP RATE 300 ml/h VTBI 50.0 ml SECONDARY SETUP RATE 150 ml/h VTBI 95.0 ml

NO

YES

VIEW WITH

NO

5. 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 step 6. b) Selecting NO will display the profile selection screen, select correct profile usingf keys and press OK softkey to confirm. Confirm profile screen will display again, press YES softkey and SELECT screen will be displayed, go to step 6. NOTE: The CONFIRM PROFILE screen is only shown if more than one profile (For Alaris® GP Guardrails® Volumetric Pump only) 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 (If enabled).

SELECT

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

A

6. Select either ml/h, DOSING ONLY or DRUGS (A-Z) and press OK to confirm. Then follow the prompts as required (Refer to 'Basic Features -Drugs and Dosing' section). 7. Clear VOLUME infused , if required (Refer to 'Clear Volume Infused' section, this is recommended for a new patient or when a new infusion is set-up). 8. 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 (Refer to 'Setting a VTBI' or 'Setting VTBI over Time' section). 9. Enter or adjust the RATE (if necessary) using the f keys. 10. Press b key 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: • by pressing the h key (recommended action) • by closing the roller clamp • by opening the door

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Alaris® GP (Guardrails®) Volumetric Pump Basic Features

Basic Features Drugs and Dosing The following options enable the pump to be set-up for use with a specific drug protocol. Drugs are pre-configured in the Alaris® Editor to enable rapid selection of the drug protocol, dosing units and default rate. For increased security when using a configured drug, maximum and minimum safety limits can be set for concentrations and dose rates via the Alaris® Editor.

A

When adjusting an infusion using the dose rate, the display may not show any corresponding changes to the infusion rate in ml/h. This does not affect the accuracy of the infusion.

Selecting the INFUSION SETUP 1. Press the d button to first access the options menu. 2. Drugs and dosing set-up options are available by selecting INFUSION SETUP from the list using the f keys. 3. Select from the list of the options (ml/h, DOSING ONLY or DRUGS) as detailed below and press the OK softkey to confirm the selection.

ml/h 1. Select ml/h from the list using the f keys (if necessary). 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

Dosing Only Select DOSING ONLY from the list using the f keys. Press OK to confirm. Select the dosing units from the list using the fkeys, press OK to confirm. 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 fkeys to select the TOTAL VOLUME2, press OK to confirm. 6. Enter WEIGHT1 using the fkeys, 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.

1. 2. 3. 4.

SELECT

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

QUIT 1

Only displayed if weight based units are used.

Total Volume = Drug Volume + Diluent Volume i.e. Total Volume of fluid in the fluid container after a drug is added. 2

Drugs 1. 2. 3. 4. 5. 6. 7.

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

QUIT

1

Select the required DRUGS alphabetical row from the list using the f keys. Press OK to confirm. Select the drug from the displayed list using the fkeys, press OK to confirm. Enter DRUG AMOUNT using the f keys, press OK to confirm selection. Use the fkeys to enter the TOTAL VOLUME2, press OK to confirm. Enter WEIGHT1 using the fkeys, press OK to confirm. 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.

Only displayed if weight based units are used.

Total Volume = Drug Volume + Diluent Volume i.e. Total Volume of fluid in the fluid container after a drug is added. 2

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Alaris® GP (Guardrails®) Volumetric Pump Basic Features

Clear Volume Infused When a new drug or a new concentration has been setup and the previous volume infused has not been cleared, then the message DOSE INFUSED HAS BEEN CLEARED will be displayed.

A

This option enables the volume infused to be cleared.

VOLUME

1. Press the VOLUME softkey on main display to show the clear VOLUME INFUSED option. 2. Press the CLEAR softkey to clear the volume infused. Press the QUIT softkey to retain the volume.

VOLUME INFUSED

374

ml

QUIT

CLEAR

Setting a VTBI This feature allows a specific volume to be infused to be set. The rate at the end (END RATE) of this VTBI can also be set, selecting from STOP, KVO or CONTINUE for continuous infusion at the set rate.

VTBI 1500ml 1000ml 500ml 250ml 200ml 100ml 50ml 0ml

1. Using the f keys: a) Press the VTBI softkey on main display to enter the volume to be infused screen. b) Enter the volume to be infused using the f keys and press OK to confirm. c) Select the END RATE using the f keys to scroll through the on-screen choices. d) Press the OK softkey to confirm and exit the END RATE menu. OR

(OFF)

SELECT WITH OK

BACK

2. Using the BAGS softkey: a) Press the VTBI softkey on main display to enter the volume to be infused screen. b) Select the BAGS softkey, select the required bag volume using the f keys and press OK to confirm the selection. c) Press OK to confirm again, or adjust the VTBI using the f keys and press OK. d) Select the END RATE using the f keys to scroll through the on-screen choices. e) Press the OK softkey to confirm and exit the END RATE menu.

KVO (Keep Vein Open) Rate

RATE

VTBI VOLUME

At the end of VTBI, the pump will first display VTBI DONE/INFUSING KVO. Press CANCEL to display KVO screen.

KVO

5.0

0.0 ml 2.0 ml

The pump continues to infuse at a very low (Default) rate. KVO is used to keep the patients vein open, in order to prevent blood clots and catheter occlusions. ml/h

NOTE:

If the KVO rate (Default 5ml/h) is greater than the set infusion parameters then the pump will continue to infuse at the set infusion rate. The KVO rate will flash on screen to indicate this is not the usual infusion rate.

The pump will beep every 5 seconds while in KVO mode.

0 h 00 m 00 s

VOLUME

VTBI

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Alaris® GP (Guardrails®) Volumetric Pump Basic Features

Pressure

PRESSURE

To check and adjust the pressure level, press the e button. The display will change to show the current pumping pressure level and the pressure alarm limit. The default pressure alarm limit can be set via the Alaris® Editor. 1. Press the f keys to increase or decrease the alarm limit (L0 to L8). The new limit will be indicated on the display. 2. Press OK to exit the screen.

PUMPING PRESSURE

L1

ALARM LIMIT

A

L5

• Higher rates generate higher pumping pressures. To avoid nuisance alarms, L0 and L1 levels should not be used for rates above 200ml/h. • The interpretation of pressure readings and occlusion alarms are the responsibility of the clinician depending on the specific application.

ADJUST WITH OK

• Occlusion levels for the pump are configured in the Alaris® Editor by profile and by drug.

Priming the Infusion Set • Ensure the infusion set is not connected to a patient before priming the set.

A

• The prime rate and prime volume limit are configured in the data set via the Alaris® Editor. • The pump will not prime if rate lock has been activated. During PRIME the pressure alarm limit is temporarily increased to the maximum level (L8).

PRIME RATE

25.0 ml/h

VOLUME

1.8

ml

HOLD KEY BELOW QUIT PRIME

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. 1. Press a key to switch the pump on. 2. Load the infusion set. Refer to 'Loading an infusion set' section. 3. Follow the 'Starting the Infusion' section, but do NOT connect the infusion set to the patient until the set has been primed. 4. Open the roller clamp. 5. Press i button to display the PRIME screen. 6. 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. 7. When priming is complete release the PRIME softkey.

Bolus Infusions Bolus - Administering a controlled volume of fluid or drug at an increased rate for diagnostic or therapeutic purposes. The pump should always be infusing and always attached to the patient (Drugs given by an IV bolus could achieve immediate and high drug concentration levels). Bolus can be used at the start of an infusion or during an infusion. The bolus feature can be configured via the Alaris® Editor to: a) Bolus Mode - Disabled b) Bolus Mode - Enabled i) HANDSON only ii) HANDSON and HANDSFREE

Bolus Mode - Disabled If configured to Disabled, pressing the i button will have no effect and the pump will continue to infuse at the set rate.

A

A Bolus cannot be administered if the feature is disabled for the selected data set or specific drug. During BOLUS the pressure limit alarm is temporarily increased to the maximum level (L8).

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Alaris® GP (Guardrails®) Volumetric Pump Basic Features

Bolus Mode Enabled - HANDSON and HANDS ON and HANDSFREE BOLUS Enabled - HANDSON Only

BOLUS RATE SET WITH

80

VOLUME

BOLUS

In HANDSON bolus, press and hold the (flashing) Bolus softkey to deliver the required bolus. The bolus rate can be adjusted. The bolus volume is limited in the configuration via Alaris® Editor.

ml/h

0.0 ml

HOLD KEY BELOW QUIT

1. During infusion press the i button once to display the BOLUS MODE screen. 2. Use the f keys to adjust the bolus rate if required. 3. To deliver the bolus press and hold the BOLUS softkey. During the bolus, the volume being infused is displayed. When the desired bolus volume has been delivered or the bolus volume limit is reached, release the softkey. The bolus volume is added to the total volume infused displayed.

A

If the volume to be infused (VTBI) is reached during a bolus, the VTBI complete alarm will sound. Press c to silence the alarm or CANCEL to acknowledge the alarm. See VTBI section for more details on VTBI operation. When using infusion set 63280NY the maximum infusion rate is 150ml/h.

BOLUS Enabled - HANDSON and HANDSFREE The HANDSFREE bolus is delivered with a single press of the (flashing) BOLUS softkey. Bolus rate and bolus volume are at default values and can be changed. The default bolus volume is 0.1ml.

BOLUS MODE HANDSFREE?

QUIT

YES

HANDSON

1. During infusion press the i button once to display the BOLUS MODE screen. 2. Press the YES softkey to go to the HANDSFREE bolus screen or press HANDSON softkey to go to the HANDSON bolus (see section above) 3. Use the f keys to adjust the bolus DOSE if required. If necessary press the RATE softkey to adjust the bolus delivery rate. 4. Press the flashing BOLUS softkey once to begin the delivery of the preset bolus. The display will show the bolus being delivered by the bolus counting down and will revert to the main display upon completion of the bolus. 5. To terminate a bolus being delivered press STOP softkey. This will stop the bolus and continue infusing at the set rate. Press the h button to stop the bolus delivery and place the pump on hold. NOTE: If the bolus volume reaches the set bolus volume limit the bolus will stop and the pump will revert to infuse at the set infusion rate and continue infusing. NOTE:

Rate may be restricted by the Bolus Rate Max which is configured in the Alaris® Editor.

NOTE:

If the BOLUS exceeds the soft (Alaris® GP Guardrails® Volumetric Pump only) or hard limits, a prompt will display.

NOTE:

The bolus rate will be automatically set to the current infusion rate, when the default bolus rate is lower than the current infusion rate. A bolus rate cannot be configured lower than the current infusion rate.

NOTE:

When more than one bolus is programmed without clearing the infusion setup, the bolus rate will be set to the previous bolus rate for all subsequent bolus infusions.

Rate Titration If Rate Titration is enabled (via the Alaris® Editor) the infusion rate or dose rate (if available) can be adjusted while infusing.

TITRATE

PRESS RATE

TO CONFIRM

25.0 ml/h µg/kg/24h 16.7

VTBI VOLUME

45.0 ml 50.0 ml

1 h 48 m 00 s

QUIT

1. Select the new rate using the f keys. The message <TITRATE PRESSbTO CONFIRM> will flash on screen and the pump continues to infuse at the original rate. 2. Press the b button to confirm the new infusion rate and start infusing at the new rate. If Rate Titration is disabled the rate can only be adjusted whilst ON HOLD: 1. Press the h button to put the pump ON HOLD. 2. Select the new rate using the f keys. 3. Press the b button to start infusing at the new rate.

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