Alaris Syringe Pump (with Plus Software) MK4 Directions for Use Issue 9

Alaris™ Syringe Pumps 

Contents

Page

Introduction... 2 About This Manual... 3 Creating a Data Set... 4 Features of the Pump... 5 Controls and Indicators... 6 Symbol Definitions... 7 Main Display Features... 8 Operating Precautions... 9 Getting Started... 12 Securing the Syringe with Optional Lock box... 14 Syringe Loading... 15 Starting the Pump... 18 Basic Features... 20 Pressure Features... 24 Alarms and Warnings... 25 Configured Options... 28 Specifications... 33 Recognised Syringes... 36 Associated Products... 37 Compatible Extension Sets... 38 Maintenance... 40 Occlusion Pressure Limits... 42 IrDA, RS232 and Nurse call Specification... 44 Trumpet Curves and Start-up Curves... 46 Products and Spare Parts... 48 Service Contacts... 49

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Alaris™ Syringe Pumps Introduction

Introduction This Directions for use can be used with the following Mark 4 (MK4) pumps:• Alaris™ CC Guardrails™ Syringe Pump • Alaris™ CC Syringe Pump • Alaris™ GH Guardrails™ Syringe Pump • Alaris™ GH Syringe Pump Note: All the above products are hereinafter referred to as Pump except where different features are applicable then the specific pump will be stated or symbol used, see 'Conventions used in this Manual' section.

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The Pumps can be identified as MK4 version by the MK4 on the label on the rear case, see image right, or by verifying the software version as 4.1.8 or above on power up.

All the pumps above mentioned function with a wide range of standard, single-use, disposable Luer lock syringes together with extension sets. The pump accepts syringe sizes from 5ml to 50ml. A full list of recognised syringes can be found in the 'Recognised Syringes' section. A list of recommended extension sets can be found in the 'Compatible Extension Sets' section. The Alaris Editor software for the pump allows the hospital to develop a best-practice data set of intravenous (IV) medication dosing guidelines for patient-specific care areas, referred to as profiles. Each profile contains a specific library of drugs, as well as pump configurations appropriate for the care area. A profile also contains Hard Limits that cannot be overridden during infusion programming. The Alaris CC Guardrails Syringe Pump and the Alaris GH Guardrails Syringe Pump profiles also contain Guardrails Soft Alerts that can be overridden, based on clinical requirements. The hospital defined data set is developed and approved through pharmacy and clinical input, and then configured into the pump by qualified technical personnel. The Alaris CC Guardrails Syringe Pump and the Alaris GH Guardrails Syringe 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 Alaris CC Guardrails Syringe Pump and the Alaris CC Syringe Pump feature an in-line pressure sensor technology, capable of highly accurate, real time pressure monitoring. Improving the early detection of occlusions, by reducing time to alarm, and preventing the potential risk of post occlusion bolus.

Intended Purpose The Alaris Syringe Pump is intended for use by medical staff for purposes of controlling infusion rate and volume.

Conditions of Use The Alaris Syringe Pump should only be operated by a clinician competent in use of automated syringe pumps and post-placement management of intravenous catheters.

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CareFusion cannot guarantee the continued system accuracy with other manufacturer’s syringes as identified in the ‘Recognised Syringes’ table. Manufacturers may change syringe specification significant to system accuracy without prior notification.

Indications The Alaris Syringe Pump is indicated for infusion of therapeutics including: • • • • • • •

analgesics antimicrobials blood products chemotherapy nutrition subcutaneous epidural (Alaris CC Syringe Pump and Alaris CC Guardrails Syringe Pump only)

Contraindications The Alaris Syringe Pumps are contraindicated for: • enteral therapies • epidural infusion therapies (Alaris GH Syringe Pump and Alaris GH Guardrails Syringe Pump only) 1000DF00693 Issue 9

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Alaris™ Syringe Pumps About This Manual

About This Manual Users are advised to read, to understand this manual and to be thoroughly familiar with the pumps prior to operating. 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. Where stated, a minimum infusion rate refers to a nominal rate of 1.0ml/h, and an intermediate infusion rate refers to a nominal rate of 5.0ml/h. The complete range of infusion rates, settings and values are shown in the 'Specifications' section.

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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. This symbol indicates that the option is relevant for the Alaris CC Syringe Pump and the Alaris CC Guardrails Syringe Pump only.

GH

This symbol indicates that the option is relevant for the Alaris GH Syringe Pump and the Alaris GH Guardrails Syringe Pump only.

Guardrails

This symbol indicates that the option is relevant for the Alaris CC Guardrails Syringe Pump and the Alaris GH Guardrails Syringe Pump only.

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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™ Syringe Pumps 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 and upload a data set according to the following process. Refer to the Alaris Editor help file for further details and operating precautions. 1. Create a new Data Set (Using the Alaris Editor) • Select new data set type:

a) Plus Data Set - to create a new data set for the Alaris GH Syringe Pump or the Alaris CC Syringe Pump b) Plus Guardrails Data Set - to create a new data set for the Alaris GH Guardrails Syringe Pump or the Alaris CC Guardrails Syringe Pump

2. Master Lists (Using the Alaris Editor) • Master Drugs

A predefined list of drug names and concentrations. This list, as well as alternate names and concentrations defined in the Master Drug List, will be accessible when creating a Profile Drug Library

• Master Syringe Library

A predefined list of the currently supported syringes available for selection within the profile

3. Create Care Area Profiles (Using the Alaris Editor) • Drug Library

Drugs and concentrations for a Profile with defaults, minimum limits, maximum limits and occlusion alarm level. Up to 100 drug set-ups can be entered for each of the available 30 Profiles.

• Configuration

Pump configuration settings, General Options and Units for Dosing Only.

4. Review, Approve and Export Data Set (Using the Alaris Editor) • Review and Approve

It is recommended that the entire data set report is printed, reviewed and signed as proof of approval by an authorised person, according to hospital protocol. A signed copy of the data set report should be archived by the hospital for future reference. Once a data set has been agreed it must be approved within the Alaris Editor using a secure password.

• Export

Export data set to allow data set to be uploaded to a pump by the Alaris Transfer Tool.

5. Upload data set to the pump (Using the Alaris Transfer Tool) Note: Selection of one profile will be required when uploading the data set to the Alaris GH Syringe Pump or the Alaris CC Syringe Pump. 6. Prior to clinical use, check that the Data Set ID on the approved data set report matches the Data Set ID shown on the pump. 7. Switch the pump off. 8. 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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Drug parameters have to be in accordance to local protocols and prescribed information. Data set transfers should only be performed by qualified technical personnel.

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Alaris™ Syringe Pumps Features of the Pump

Features of the Pump ON/OFF Pressure transducer

Release lever for MDI

Display

RUN

High visibility Alarm Indicator

PURGE/BOLUS

MUTE PRESSURE OPTION

Finger Grips Extension set hook HOLD Rating Plate (see Symbol Definitions for an explanation of the symbols used)

Shelf for chevron keys and softkeys

Positive Plunger Grippers

Syringe Clamp

Pressure transducer

Release lever for Rotating Cam

Medic

Rotating Cam to lock on to horizontal rectangular bars Carrying Handle

al Dev ice Int erface

(MDI)

IR Communications port

Potential Equalisation (PE) connector 1000DF00693 Issue 9

Folded Pole Clamp

RS232 Connector

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Extension set hook

Alaris™ Syringe Pumps Controls and Indicators

Controls and Indicators Controls: Symbol

Description

a b h R

ON/OFF button - Press once to switch the pump ON. Press and hold down for 3 seconds to switch the pump OFF. 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 (configurable). When not in alarm press and hold until three audible 'beeps' are sounded for 15 minutes silence. PURGE/BOLUS button - Press to access PURGE or BOLUS soft keys. Press and hold down soft key to operate. PURGE - primes the extension set with fluid or drug during initial set up.

i

• Pump is on hold • Extension set must not be connected to the patient • Volume Infused (VI) is not added BOLUS - fluid or drug delivered at an accelerated rate. • Pump is infusing • Extension set should be connected to the patient • VI is added

d e f

g

OPTION button - Press to access optional features, see 'Basic Features' section. PRESSURE button - Use this button to display the pumping pressure and alarm level. This button will also display the pressure trend display. CHEVRON keys - Double or single for faster/slower increase or decrease of values shown on display. BLANK SOFTKEYS - Use in conjunction with the prompts shown on the display.

Indicators: Symbol

j S

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

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Alaris™ Syringe Pumps Symbol Definitions

Symbol Definitions Labelling Symbols: Symbol

Description Consult accompanying documents

x y l

Potential Equalisation (PE) Connector RS232/Nurse call Connector Defibrillation-proof type CF applied part (Degree of protection against electrical shock)

IP32

Protected against direct sprays of water up to 15° from vertical and protected against solid objects greater than 2.5mm.

r

Alternating Current

s T t U W

Note: IP33 applies if AC power cable retainer kit, part number 1000SP01294, is fitted.

Device complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC. Date of Manufacture Manufacturer Not for Municipal Waste Fuse Rating

+40°C



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

EC REP

Authorised representative in the European Community

0°C

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Alaris™ Syringe Pumps Main Display Features

Main Display Features Alaris CC Syringe Pump and Alaris CC Guardrails Syringe Pump Display Syringe type fitted / Profile / Drug name

Pump Status

Infusion Rate

Volume Infused

Pressure Information

Volume Infused Option

Alaris GH Syringe Pump and Alaris GH Guardrails Syringe Pump Display

VTBI Option

GH

Syringe type fitted / Profile / Drug name

Pump Status

Volume Infused

Infusion Rate

Pressure Information

Volume Infused Option

VTBI Option

Screen Icons Symbol

Description

l

Time remaining display icon - Indicates time before syringe will require replacement.

N

BATTERY icon - Indicates battery charge level to highlight when the battery will require recharging or re-connection to mains power supply.

INFUSING

Guardrails Soft Alert icons - Indicates the pump is running at a rate or dose above (pointing up) or below (pointing down) a Guardrails Soft Alert.

INFUSING

Guardrails

Hard limit Warning icon - Indicates the setting entered is not permitted as it is under or exceeds a Hard Limit.

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Alaris™ Syringe Pumps Operating Precautions

Operating Precautions Disposable Syringes and Extension Sets

m

•

The pump has been calibrated for use with single-use disposable syringes. To ensure correct and accurate operation, only use 3 piece Luer lock versions of the syringe make specified on the pump or described in this manual. Use of non-specified syringes or extension sets may impair the operation of the pump and the accuracy of the infusion.

n

•

Uncontrolled flow or syphoning may result if the syringe is located incorrectly in the pump, or if it is removed from the pump before the extension set is properly isolated from the patient. Isolation may include closing a tap in the patient line or activating a flow stop clamp.

•

The user must be thoroughly familiar with instructions in this Directions For Use and understand how to load and confirm the syringe on the pump. Incorrect syringe loading may result in misidentification of the syringe type and size leading to significant under or over infusion.

•

Secure the extension set to the pump using the extension set hook at the rear of the pump. This provides protection against accidental dislodging of the syringe from the pump.

•

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

•

Always clamp or otherwise isolate the patient line before unclamping or removing a syringe from the pump. Failure to do so may result in unintended administration.

o

Mounting the Pump

I

•

When more than one pump is being used on a patient, those containing high risk, critical medications must be positioned as close to the patient's heart level as possible to avoid the risk of variations in flow or siphoning.

•

Raising a pump whilst infusing may result in a bolus of the infusate, whereas lowering a pump whilst infusing may result in a delay in the infusion (an underinfusion).

•

Do not mount the pump in a vertical position with the syringe pointing upwards as this could lead to an infusion of air which may be in the syringe. To protect against the introduction of air the user should regularly monitor the progress of the infusion, syringe, extension line and patient connections and follow the priming procedure specified herein.

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 appropriately trained technical 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 necessary. Adverse delivery of medication or fluids can be caused by the substantial variation in pressures created within the infusion system by 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 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 technical personnel or CareFusion for further information).

•

The 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™ Syringe Pumps Operating Precautions

Operating Pressure •

This is a positive pressure pump designed to achieve very accurate fluid administration by automatically compensating for resistance encountered in the infusion system.

•

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

Alarm Conditions

J

•

Guardrails

Guardrails Safety Software

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

•

The Guardrails Safety Software incorporates soft dosing limits and pump configuration parameters based on hospital protocol. The software adds a test of reasonableness to drug programming based on the limits defined by the hospital. Qualified personnel must ensure the appropriateness of the drug dosing limits, the compatibility of the drugs, and the performance of each pump, as part of the overall infusion. Potential hazards include drug interactions, and inappropriate delivery rates and pressure alarms.

•

When loading a data set with the Guardrails Safety Software, the user must ensure the correct profile is selected prior to starting an infusion.

Hazards

A V

•

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

•

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

•

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 in the installation or its arrangement is in doubt, the pump should be operated from the battery.

•

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 the 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.

•

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

•

Care must be taken when removing covers or handling moving mechanisms.

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Alaris™ Syringe Pumps Operating Precautions

Electromagnetic Compatibility & Interference

M

K

•

The 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.

•

This pump is a CISPR 11 Group 1 Class A 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.

•

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. (Consult Technical Service Manual for further information).

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Alaris™ Syringe Pumps Getting Started

Getting Started Initial Set-up

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Before operating the pump read this Directions For Use manual carefully.

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 Syringe Pump • User Support CD (Directions For Use) • AC Power Cable (as requested) • Protective Packaging 3. Connect the pump to the AC power supply for at least 2½ hours to ensure that the internal battery is charged (verify that the S is lit).

Language Selection 1. On initial start-up the pump will display the Select Language screen. 2. Select the required language from the list displayed using the f keys. 3. Press the OK softkey to confirm your selection.

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• The pump may be used safely with the pre-installed default data set. Any data set created for installation must be approved by an appropriately qualified person with clinical authority in accordance with hospital protocol prior to upload and activation. • The pump will automatically operate from its internal battery if the pump is switched on without being connected to the AC 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.

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Alaris™ Syringe Pumps Getting Started

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Do not mount the pump with the AC power inlet or the syringe pointing upwards. This could affect the electrical safety in the event of a fluid spill or lead to the infusion of air which may be in the syringe.

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.

Recessed area

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.

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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.

*

*

Never mount the pump such that the I.V. infusion stand becomes top heavy or unstable.

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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 The rotating cam can be fitted to the rectangular bar on the Docking Station/Workstation* or the equipment rail measuring 10 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. Hold the pump horizontally, push the pump firmly onto the rectangular bar or equipment rail. 3. The pump should click into position when fitted to the bar. 4. Ensure that the pump is positioned securely. Verify Pump is secure by gently pulling the Pump away from the Docking Station/ Workstation* without using the release lever. When the Pump is securely attached, it should not come off the Docking Station/ Workstation*. 5. To release, push the release lever and pull the Pump forwards. Warning: Pump may fall off the Docking Station/Workstation* if not properly mounted which could result in user and/or patient harm. Rectangular bar

Release lever (push to release) Rotating cam

* Alaris Gateway Workstation and Alaris DS Docking Station

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Alaris™ Syringe Pumps

Securing the Syringe with Optional Lock box

Securing the Syringe with Optional Lock box Lock box operation The optional lock box is a available in two configurations:

• Rate Unlocked lock box - is designed to allow the user to adjust rate whilst infusing.

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• Rate Locked lock box - is designed to prevent rate change whilst infusing. If using this lock box users would need to put the Pump on hold and open the lock box to change the rate.

When mounting a Pump with lock box ensure that there is sufficient clearance for the cover to be fully opened, a gap of 130mm minimum below the Pump is recommended.

Open Lock box:

1. Insert the key into the lock and turn key either way to unlock.

2. Lock box will move to the right and can then be opened.

Close Lock box: 1. Load the syringe according to the instructions in the 'Loading and Confirming a Syringe' section. 2. Ensure the extension set is connected to the syringe and threaded through the lock box. Note: For the Alaris CC Syringe Pump models the pressure disc must be fitted prior to closing the lock box. 3. Set up the Pump according to the instructions in the 'Starting the Pump' section prior to closing the lock box for the Rate Locked version only.

4. Close the cover until it makes contact with the pump case.

5. Push the lock box from right to left until a click is heard.

6. Remove the key.

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• When transporting the Pump with lock box fitted it is recommended that two hands are used when holding or carrying the Pump. • If lock or lock box appears to be damaged, remove the pump from service for examination by qualified service personnel. • When the Pump is not in use ensure the lock box is locked. • Lock box keys should be stored separately and take care not to lock keys inside lock box. • Refer to the 'Routine Maintenance' section for instructions on cleaning and maintenance.

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Alaris™ Syringe Pumps Syringe Loading

Syringe Loading Prepare Syringe and Administration Set To decrease potential start-up delays, delivery inaccuracies and delayed generation of occlusion alarms each time a new syringe is loaded: • Use smallest syringe size possible, for example, if infusing 9 ml of fluid, use a 10 ml syringe. • Use the PURGE SYRINGE or PURGE option on the Pump to decrease the delay in the start of the infusion , see Starting the Pump section.

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Warning: Use the smallest compatible syringe size necessary to deliver the fluid or medication; this is especially important when infusing high risk or life-sustaining medications at low infusion rates, especially flow rates < 0.5 ml/h.

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Warning: Purge the Pump system before starting an infusion or after replacing a near-empty syringe with a replacement syringe. When Purging ensure that the extension set is not connected to the patient.

Practice Recommendations: • Tubing internal diameter: Smallbore or microbore tubing is recommended when infusing at low rates • Filters: Internal volume, dead space, of in-line filters should be minimized • Connection sites: Critical drugs should be connected as close to the vascular access site as possible

Positioning of Pump

Ensure that the Pump is as close to level of patient’s heart as possible. Patient’s heart level should be in line with the middle of the Pump or the pressure disc for the Alaris CC Syringe Pumps.

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Warning: Adjusting the Pump's height relative to the patient's heart level can lead to temporary increases or decreases in fluid delivery

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Caution: If using multiple syringe pumps and it is not clinically feasible to have all Pumps level with the patient’s heart, place the high risk or life-sustaining medications as close to the patient’s heart level as possible. Caution: When infusing multiple high risk or life-sustaining medications, consider placing the Pumps infusing at the lowest rates as close to the level of the patient’s heart as possible.

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Alaris™ Syringe Pumps Syringe Loading

Loading and Confirming a Syringe Warning: To securely load and confirm a syringe carefully follow the steps below. An incorrect loading of a syringe may result in misidentification of the syringe type and size. If then confirmed, this may lead to significant inaccuracy of the infusion rate and may also affect pump performance.

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Only use a syringe of the type stated on the pump or in this manual. Using an incorrect syringe could adversely affect the accuracy of the infusion rate and may also affect pump performance. When drawing fluid into the syringe, draw enough to compensate for any dead space volume in the extension set and syringe at the end of infusion as this cannot be fully infused.





Finger Grips Plunger Grippers

Plunger Flange

Plunger

Plunger Holder

Syringe Barrel Barrel Flange Syringe Clamp

Syringe Flange Clamp Place the pump on a stable horizontal surface or secure as described previously. Prepare, load and prime the single-use disposable syringe and extension set using standard aseptic techniques. 1. Squeeze the finger grips together on the plunger holder and slide the mechanism to the right. 2. Pull the syringe clamp forward and down.

3. Insert the syringe ensuring that the barrel flange is located in the slots on the syringe flange clamp.

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To ensure the syringe is loaded correctly, place the barrel flange in the space between the syringe clamp and the syringe flange clamp. This is correct if the syringe remains in position before the syringe clamp is closed.

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Alaris™ Syringe Pumps Syringe Loading

4. Lift the syringe clamp until it locks against the syringe barrel.

5. Squeeze the finger grips on the plunger holder and slide the mechanism to the left until it reaches the plunger end. 6. Release the finger grips. Ensure that the plunger grippers are securing the plunger in place and the finger grip returns to its original position.

7. Ensure that the syringe type and size match those displayed on the pump then press CONFIRM. If required, the make of syringe can be changed by pressing the TYPE softkey. ON HOLD

IVAC

CONFIRM

50

TYPE

Note: If the PURGE SYRINGE option has been enabled then the prompt to purge screen is displayed and the extension set can be purged as required, however ensure that the extension set is not connected to the patient during this process.

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CareFusion recommends limiting the number of configured syringe types and sizes available for selection on the pump using the Alaris Editor. Secure the extension set using the extension set hook at the rear of the pump. This provides protection against accidental dislodging of the syringe from the pump. Ensure that both plunger grippers are fully locked onto the plunger flange and the upper finger grip has returned to its original position.

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Fast Start is a Pump feature to automatically reduce the mechanical slack between the plunger mechanism and syringe at the start of an infusion, as required.

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Alaris™ Syringe Pumps Starting the Pump

Starting the Pump 1. Connect the pump to an AC power supply using the AC power cable. 2. Press the a button. • The pump will run a short self-test.

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Warning: two beeps are activated during this self-test and the red alarm beacon illuminates and then clears. No action is required during this self-test.

• Check the display test pattern and ensure that no rows are missing. • Check that the displayed time and date are correct. • Finally check display shows the data set name, version number and released date and time. Note: A warning - REPAIRING LOGS, may be displayed if event log information was not completely stored at the previous power down. This is for information only, the pump will continue to power up as normal. 3. CLEAR SETUP • Selecting NO will keep previous setup and go to step 8. • Selecting YES will clear previous setup and will go to step 4.

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Clear setup screen will only be displayed if a previous setup was used.

4. CONFIRM PROFILE Note: The CONFIRM PROFILE screen will not be displayed for the Alaris GH Syringe Pump, the Alaris CC Syringe Pump or if there is only one profile available in the data set. a) NO will display select profile screen –– Select profile from list, if required press ALL to update the list displayed to include all the profiles within the data set. –– Press OK to confirm.

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ALL softkey will only be displayed if there are some profiles in the data set not being displayed, since their selectable status is disabled.

b) YES will display drug select screen or clear setup screen. 5. DRUG SELECT? - Select one of the following: Note: The DRUG SELECT screen will not be displayed if there are no drugs setup in the profile. • ml/h - allows infusions to be given in ml/h only, after selecting OK to confirm. Go to step 8. • DOSING ONLY - enables the pump to be set-up with a dosing protocol, after selecting OK to confirm. Go to step 6.

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No concentration or dose rate limits are used when ml/h or DOSING ONLY modes are selected.

• DRUG NAME - select a drug name from profile's drug library, after selecting OK to confirm. Go to step 7. Note: Drugs are listed in alphabetical groups as follows: A-E, F-J, K-O, P-T and U-Z. Select group containing the drug name required and then the required drug and all other drugs can be seen. 6. DOSING ONLY a) Select Dosing unit and OK to confirm. b) Select Concentration Amount and OK to confirm. Use UNITS softkey to change concentration unit, if required. c) Select Total Volume to be used and OK to confirm. d) Adjust Weight and OK to confirm, if required. e) Press OK to confirm dosing information. Go to step 8. 7. DRUG NAME a) Select Concentration required, press OK to confirm Concentration or MODIFY to change Drug amount and total volume to be used. If the dose amount and total volume are not defined in the data set then they will need to be set as follows: –– Adjust dose amount and OK to confirm. Use UNITS softkey to change concentration unit, if required. –– Adjust Total Volume and OK to confirm b) Adjust Weight and OK to confirm, if required. c) Press OK to confirm setup. Go to step 8.

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Steps for Drug Name setup may vary dependant on how the profile is configured in the Alaris Editor.

8. Load the syringe according to the procedure in this manual.

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Alaris™ Syringe Pumps Starting the Pump

9. Insert the pressure disc into the pressure transducer.

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Pressure Transducer - Detects if an extension set with a pressure disc is fitted. The pressure transducer will measure positive pressures within the extension set. Warning - To remove or insert pressure disc from or into pressure transducer assembly, insert finger into the recess in the pressure disc and pull forward or push back with care. Do not pull the extension set to remove or to insert the pressure disc.

10. Ensure that the syringe type and size match those displayed on the pump then press CONFIRM. If required, the make of syringe can be changed by pressing the TYPE softkey. Note: If the PURGE SYRINGE option has been enabled then the prompt to purge screen is displayed and the extension set can be purged as required, however ensure that the extension set is not connected to the patient during this process.. 11. Purge (if required) - Press the i button and then press and hold the PURGE softkey until fluid flows and the purging of the extension set is complete. Release the softkey. The volume used during purging will be displayed.

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Purge extension set, massaging pressure disc to prevent ballooning and ensuring all air removal.

12. Check the rate shown if set and change the rate if necessary using the f keys. 13. Connect the extension set to the patient access device. 14. Press b to commence operation. • The amber stop light will be replaced by the flashing green start light to indicate that the pump is in operation. INFUSING will be displayed. Note: If infusion rate exceeds the Hard Limit then the pump will not start and the display will show DOSE NOT PERMITTED.

Guardrails • If the infusion settings are within the Guardrails Soft Alerts then the amber stop light will be replaced by the flashing green start light to indicate that the pump is in operation. INFUSING will be displayed. Note: If infusion rate exceeds or is under the Guardrails Soft Alerts then check infusion setting, to continue with infusion at set rate press b and then confirm OVERRIDE LIMIT by pressing YES. If OVERRIDE LIMIT is not required press NO and adjust rate to be within the Guardrails Soft Alerts.

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If infusion rate running exceeds or is under the Guardrails Soft Alerts then the display will show INFUSING with either Up or Down arrows on both sides.

15. Press h to halt the operation. ON HOLD will be displayed. The amber stop light will replace the green start light.

w • Fully Dedicated - to start an infusion a pressure disc must be fitted. • Semi Dedicated - to start an infusion with DRUG NAME or DOSING ONLY selected a pressure disc must be fitted.

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