Alaris GP Guardrails Models 9002TIG03 and G Volumetric Pump Directions for Use Issue 1

Alaris™ GP (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 Creating a Data Set... 5 Features of the Volumetric Pump... 6 Controls and Indicators... 7 Controls:... 7 Indicators:... 7 Symbol Definitions... 8 Labelling Symbols:... 8 Main Display Features... 9 Main Display - If VTBI has not been set (flow sensor must be used)... 9 Main Display - If VTBI is set... 9 Screen Icons... 9 Operating Precautions... 10 Infusion Sets... 10 Using Collapsible bags, Glass Bottles & Semi Rigid containers...10 Steps for the Collapsible bags... 10 Steps for Semi-rigid containers... 10 Operating Environment... 10 Operating Pressure... 11 Alarm Conditions... 11 Electromagnetic Compatibility and Interference... 11 Earth Conductor... 11 Hazards... 12 Getting Started... 13 Initial Set Up... 13 Power Input... 13 Factory Default Data Set... 13 Pole Clamp Installation... 14 Docking Station / Workstation* or Equipment Rail Installation... 14 The Alaris Safety Clamp... 15 Loading an Infusion Set... 16 Starting the Infusion... 19 Basic Features... 20 Drugs and Dosing...20 Selecting the INFUSION SETUP... 20 ml/h... 20 Dosing Only... 20 Drugs... 20 Clear Volume Infused... 21 Setting a VTBI... 21 KVO (Keep Vein Open) Rate... 21 Pressure... 22 Priming the Infusion Set...22 BDDF00535 Issue 1

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Alaris™ GP (Guardrails™) Volumetric Pump 

Bolus Infusions... 22 Bolus Mode - Disabled... 22 Bolus Mode Enabled - HANDSON and HANDS ON and HANDSFREE... 23 Rate Titration... 23 Rate Lock (If enabled)... 24 Adjusting Existing Dosing or Protocol Infusions - Set By ml/h / Set by Doserate... 24 Selecting the SET BY ml/h Option... 24 Selecting the SET BY DOSERATE Option... 24 Dosing Summary... 24 Add Drug (Only available when infusing)... 24 Infusion Setup... 24 Primary Setup... 25 Secondary Setup... 25 Setting VTBI over Time... 25 Adjust Alarm Volume... 25 Event Log... 25 Pump Details... 25 Profile Filter (Only available on the Alaris GP Guardrails Volumetric Pump)... 25 Standby... 25 Changing the Infusion Set... 26 Changing the Fluid Container... 26 SmartSite™ Needle-Free System Instructions... 26 Secondary (Piggyback) Infusions... 27 Setting up a secondary infusion... 27 Typical Secondary infusions... 27 Service Configuration Mode... 28 Alarm Presets... 28 Configured Options... 28 Date & Time... 28 Pump Reference... 28 Language... 28 Backlight & Contrast... 29 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... 35 Prompts... 38 Advisories... 38 Restarting an Infusion following an Air-in-Line Alarm... 39 Flow Sensor Operation (Optional)... 40 Infusion Sets... 41 Associated Products... 44 The Alaris Gateway Workstation... 44 The Alaris DS Docking Station... 44 BDDF00535 Issue 1

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Alaris™ GP (Guardrails™) Volumetric Pump 

Maintenance... 45 Routine Maintenance Procedures... 45 Battery Operation... 45 Cleaning and Storage... 46 Cleaning the Pump... 46 Cleaning the door... 46 Cleaning and storing the infusion set... 46 Cleaning the Flow Sensor... 46 Storing the Pump... 46 Disposal... 47 Specifications... 48 Electrical Protection... 48 Electrical/Mechanical Safety... 48 Electro Magnetic Compatibility (EMC)... 48 Electrical Safety... 48 Classification... 48 AC Power Supply... 48 Fuse Type... 48 Dimensions... 48 Protection against fluid ingress... 48 Environmental Specifications... 48 Battery Specifications... 48 Memory Retention... 49 Alarm Conditions... 49 IrDA, RS232 and Nursecall Specification... 50 IrDA / RS232 / Nursecall Feature... 50 RS232 / Nursecall Connection Data... 50 IrDA... 50 Infusion Specifications... 51 System Accuracy:... 51 Occlusion Alarm Limits... 51 Maximum Pumping Pressure:... 51 Maximum Occlusion Alarm Pressure:... 51 Post Downstream Occlusion Bolus:... 51 Bolus Volume Accuracy:... 51 Maximum time for activation of occlusion alarm:... 51 Administering a Bolus... 51 Starting the Infusion / Set-up... 51 Air Sensor:... 52 Air in line detection:... 52 Critical Volume... 52 The Alaris Safety Clamp... 52 Notes... 52 Trumpet and Flow Rate Curves... 53 Products and Spare Parts... 55 Spare Parts... 55 Alaris Editor Software... 55 Document History... 55 Contact Us... 56 Customer Service Information... 56

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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 Service 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.

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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.

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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™ 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; • Non-Guardrails Data Set - Creates a new Non-Guardrails data set for the Alaris Infusion Pumps to be edited in the application. • 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 BD 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.

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Data set transfers should only be performed by Qualified Service 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®® Alaris Guardrails®

GP plus

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 ON/OFF button - Press once to switch the Pump on. Press and hold down for approximately three seconds to switch the Pump off.

a

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 alarm for two minutes. The alarm will resound after this time. To reenable the alarm audio press the MUTE button a second time.

R

Note:

Attention alarm only: when not in alarm press and hold until four audible beeps are heard to extend the silence period to 15 minutes.

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 Attention (Consult accompanying document)

x

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 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™ 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 BD single use infusion sets described in this Directions For Use.

•

It is recommended that infusion sets are changed according to the instructions in the 'Changing the Infusion Set' section. Carefully read the Directions For Use supplied with the infusion set prior to use.

•

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

•

When combining several apparatus and/or instruments with infusion sets and other tubing, for example via a 3-way tap or multiple infusion, the performance of the Pump may be affected and should be monitored closely.

•

Uncontrolled flow may result if the infusion set is not properly isolated from the patient i.e. closing a tap in the set or activating an in-line clamp / roller clamp.

•

BD infusion sets are fitted with an in-line clamp, which can be used to occlude tubing in case it is required to stop fluid flow.

•

The Pump is a positive pressure pump, which should use infusion sets fitted with Luer lock fittings or equivalent locking connectors.

•

To infuse from a burette, close the roller clamp above the burette and open the clamp on the vent on top of the burette.

•

Discard infusion set if the packaging is not intact or the protector cap is detached. Ensure sets are not kinked as this may occlude the tubing.

Using Collapsible bags, Glass Bottles & 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 •

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™ GP (Guardrails™) Volumetric Pump Operating Precautions

Operating Pressure •

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

Alarm Conditions •

Several alarm conditions detected by this Pump will stop the infusion and generate visual and audible alarms. Users must perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating.

•

Alarm tone settings are preserved in the case of a power loss, however some system faults will result in loss of alarm settings. The new alarm tone settings will be stored when powering down from tech mode after a change. The settings will be lost if a cold-start is performed, but should be saved for faults that don't require a cold start.

Alaris®

GP

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 BD representative.

•

Magnetic Resonance Imaging (MRI): The Pump contains ferromagnetic materials which are susceptible to interference with magnetic field generated by the MRI devices. Therefore, the Pump is not considered an MRI compatible Pump as such. If use of the Pump within an MRI environment is unavoidable, then BD highly recommends securing the Pump at a safe distance from the magnetic field outside the identified ‘Controlled Access Area’ in order to evade any magnetic interference to the Pump; or MRI image distortion. This safe distance should be established in accordance with the manufacturers’ recommendations regarding electromagnetic interference (EMI). For further information, please refer to the product technical service manual (TSM). Alternatively, contact your local BD representative for further guidance.

•

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.

•

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.

MR

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 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 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.

•

Warning: Alaris GP (Guardrails) Volumetric Pump should not be modified or altered in any way, except where explicitly directed or authorised by BD. Any use of Alaris GP (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 GP (Guardrails) Volumetric Pump that has been so modified or altered. BD product warranty shall not apply in the event the Alaris GP (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 GP (Guardrails) Volumetric Pump.

•

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

Al

GP aris®

m V

•

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Alaris™ GP (Guardrails™) Volumetric Pump Getting Started

Getting Started

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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 • AC Power Cable (as requested) • Alaris Editor Software and/or Alaris Transfer Tool - per hospital

• Directions For Use (CD) • Protective Packaging • Electronic Instructions For Use Insert

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).

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• 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 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.

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• 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.

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 Alarm Volume Adjustable Occlusion Alarm Pressure Pressure Max Rate Titration Infusion Rate Max Rate Lock Bolus Mode

µg/24h mg/24h unit/24h mmol/24h ml/kg/min ng/kg/h µg/kg/min µg/kg/h

Bolus Rate Default

Medium Disabled L5 L8 Disabled 1200ml/h Disabled Hands-On Only 500ml/h

mg/kg/min

Bolus Rate Max Bolus Volume Max

1200ml/h 5ml

mg/kg/h 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

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• 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

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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 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

*

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*

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. 3. 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*.

Alaris®

GP

4. 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.

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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

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NO FLOW 1. Push

2. Push

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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

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• 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. • 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.

• 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

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Alaris™ GP (Guardrails™) Volumetric Pump Getting Started Step

Notes

6. Close roller clamp. 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 (Blue) Adaptor on infusion set (Blue) 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

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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™ GP (Guardrails™) Volumetric Pump Getting Started 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™ GP (Guardrails™) Volumetric Pump Getting Started

Starting the Infusion

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

SELECT

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).

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

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.

SELECT WITH OK

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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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