Alaris System DFU Model 8015 092009

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CHANNELSELECT

CHANNELOFF

MONITOR

A L A R M M ONI T O R S T AN D B Y A L

A R MIN FU S E S T AN D B Y

RATE (mL/h)

RESTART

CHANNELOFF

PAUSE

CHANNELSELECT

SILENCE

OPTIONS

1

4

7

CLEAR

2

5

8

0

3

6

9 ENTER

CANCEL

SYSTEMON

CHANNELSELECT

CHANNELOFF

RESTART

PAUSE

A L A R M IN FU S E S T AN D B Y

RATE (mL/h)

% SpO 2

PULSE (BPM)

A LA R M IN FU S E S T AN D B Y

CHANNELSELECT

CHANNELOFF

PAUSE

RESTART

RATE (mL/h)

Dir cti r UAlaris System

(with Alaris PC Unit, Model 8015)

Supports Guardrails Suite MX with Guardrails Point-Of-Care software and 9 Operating System software.

September 2009


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Alaris System DFU with 9 Model 8015

Order Numbers:Electronic Copy: 11508984Printed Copy: 11508981 2009 CareFusion Corporation or one of its affiliates. All rights reser ed.

Each of the Alaris product-specific sections has its own table of contents.

General Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i

Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

PC Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Pump and Syringe Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

PCA Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

SpO 2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

EtCO 2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Auto-ID Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Appendix

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1Ser ice Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

Regulations and Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-14

T bl C t t


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Alaris System DFU with 9 Model 8015 iii

CareFusionSan Diego, California

Authorized EU Representati eCardinal Health

Basingstoke, United Kingdomcarefusion.com

Customer Ad ocacy - North America(Clinical and technical feedback.)

Phone: 888.876.4287E-mail: [email protected]

Customer Ad ocacy - International(Clinical and technical feedback.)

E-mail: [email protected]

Technical Support - North America(Maintenance and ser ice information support; troubleshooting.)

Phone, United States: 888.876.4287Phone, Canada: 800.387.8309

Technical Support - United Kingdom(Maintenance and ser ice information support; troubleshooting.)

Phone: 0800 389 6972E-mail: [email protected]

Customer Care - North America(Product return, ser ice assistance, and order placement.)

Phone, United States: 888.876.4287

Phone, Canada: 800.387.8309Customer Care - United Kingdom

(Product return, ser ice assistance, and order placement.)Phone: 0800 917 8776

E-mail: UK-Customer-Ser [email protected]

Technical Support and Customer Ser ice - International(Maintenance and ser ice information support.

Product return, ser ice assistance, and order placement)cardinalhealth.com/alaris

G r l C t ct I r ti
http://www.carefusion.com/http://cardinalhealth.com/alarishttp://cardinalhealth.com/alarishttp://www.carefusion.com/


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Alaris System DFU with 9 Model 8015i

The Alaris PC unit section of this Directions for Use ( DFU )pro ides procedures and information applicable to the Alaris System and the PC Unit. Each of the other major sectionspro ides product-specific procedures and information.

The Alaris

System is a modular system intended for adult,pediatric and neonatal care in todays growing professionalhealthcare en ironment. It consists of the PC Unit, theGuardrails Suite MX, and up to four detachable infusion and/or monitoring modules (channels). The Auto-ID Module can beincluded as a fifth module.

The Alaris System supported by this DFU uses a newgeneration PC Unit (Model 8015 ) which pro ides wirelessconnecti ity right out of the box, and an enhanced display(including color) to clearly communicate critical programming,infusion, monitoring and hospital-defined policy information.Alaris System wireless communication makes it easier than

e er to increase the safety of Iv medication and continuouslyimpro e clinical best practices, regardless of existing wirelessinfrastructure.

The Model 8010 Nurse Call Accessory might not yet bea ailable for use or compatible with the Model 8015 .

Guardrails Suite MX for the Alaris System brings a newle el of medication error pre ention to the point of patientcare. The Guardrails Suite MX features medication dosing,concentration deli ery rate and optional initial programmingguidelines for up to 15 patient-specific care areas, referredto as profiles. Each profile contains a specific Drug Library,

an Iv Fluid library and channel labels, as well as instrumentconfigurations appropriate for the care area. Optional drug- or Iv Fluid-specific Clinical Ad isories pro ide isual messages.Dosing limits for each Guardrails drug entry or rate limitsfor each Iv Fluid entry can be a Hard Limit that cannot beo erridden during infusion programming and/or a Soft Limitthat can be o erridden, based on clinical requirements.

A Data Set is de eloped and appro ed by the facilitys ownmulti-disciplinary team using the Editor Software, the PC -basedauthoring tool. A Data Set is then transferred to the Alaris System by qualified personnel. The appro ed Data Sets are

maintained by the Editor Software for future updates andreference.

I tr ducti

R d ll i tructi before usingthe Alaris System.

waRnInG

nlyO

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Alaris System DFU with 9 Model 8015

Information about an Alert that occurs during use isstored within the PC Unit, and can be accessed using theCQI Reporter.

Documentation pro ided with Alaris System products

might reference product not present in your facility or not yeta ailable for sale in your area.

A superscript number (for example, ) identifies additionalinformation pro ided as a NOTE at the end of the procedure.

waRnInGs anD CaUTIons:

Product-specific warnings and cautions, co ered in theapplicable sections of this DFU, pro ide information needed tosafely and effecti ely use the Alaris System.

A DanGeR is an alert to an imminent hazard which

could result in serious personal injury and/or product damage if proper procedures are not followed.

A waRnInG is an alert to a potential hazard which couldresult in serious personal injury and/or product damage if proper procedures are not followed.

A CaUTIon is an alert to a potential hazard which couldresult in minor personal injury and/or product damage if proper procedures are not followed.

DefIneD TeRms:

The following table identifies the defined terms usedthroughout this document for certain trademarked productsand product features.

Pr duct/f tur D i d T r

Alaris Auto-ID module Auto-ID Module

Alaris EtCO 2 module EtCO 2 Module

Alaris Mobile Systems Manager Mobile Systems Manager

Alaris PCA module PCA Module

Alaris PC unit PC Unit

Alaris Pump module Pump Module

I tr ducti (Continued)


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Alaris System DFU with 9 Model 8015i

DefIneD TeRms: (Continued)


Pr duct/f tur D i d T r

Alaris SpO 2 module SpO 2 Module

Alaris Syringe module Syringe Module

Alaris System Maintenance System Maintenance

Alaris Systems Manager Systems Manager

Guardrails alert Alert

Guardrails clinical ad isory Clinical Ad isory

Guardrails CQI Reporter CQI Reporter

Guardrails data set Data Set

Guardrails drug library Drug Library

Guardrails Editor Editor Software

Guardrails hard limit Hard Limit

Guardrails Iv fluid Iv Fluid

Guardrails limit Limit

Guardrails PCA pause protocol PCA Pause Protocol

Guardrails soft limit Soft Limit

SmartSite needle-free al e Needle-Free val e

SmartSite positi e bolus needle-free al e Needle-Free val e


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Alaris System DFU with 9 Model 8015 ii

Instruments are tested and calibrated before they arepackaged for shipment. To ensure proper operation after shipment, it is recommended that an incoming inspection beperformed before placing the instrument in use.

Prior to placing the Alaris

System in use:Perform check-in procedure using System Maintenancesoftware.

verify whether or not Profiles feature has been enabled(see PC Unit section, "System Options," "SystemConfigurations" ).

noTe: To enable the Profiles feature, a hospital-defined best-practice

Data Set must be uploaded to the PC Unit.

1.

2.

I t ll ti


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Alaris System DFU with 9 Model 8015 Section 1

SILENCE

OPTIONS

1

4

7

CLEAR

2

5

8

0

3

6

9 ENTER

CANCEL

SYSTEMON

Alaris PC UnitModel 8015


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Alaris System DFU with 9 Model 8015PC Unit Section

T bl C t t

Table of Contents 1-i

G tti g st rt dIntroduction ............................................................................................................................................. 1-1

G r l s tup d op r tiAttach and Detach Module ..................................................................................................................... 1-3

Attach Module ................................................................................................................................. 1-3Detach Module ................................................................................................................................ 1-4Add Module While System is Powered On ..................................................................................... 1-5Secure to Pole Using Optional Locking Pole Clamp ....................................................................... 1-5

Start-Up .................................................................................................................................................. 1-6Power On System ........................................................................................................................... 1-6Respond to Maintenance Reminder ............................................................................................... 1-7Adjust Display Contrast ................................................................................................................... 1-7Select New Patient and Profile Options .......................................................................................... 1-8Adjust Audio volume ....................................................................................................................... 1-10Lock/Unlock Tamper Resist ............................................................................................................ 1-10

Power Off System ................................................................................................................................... 1-11System Options ...................................................................................................................................... 1-12

Display Contrast.............................................................................................................................. 1-12Patient ID ........................................................................................................................................ 1-12Clinician ID ...................................................................................................................................... 1-15Power Down All Channels .............................................................................................................. 1-16Anesthesia Mode ............................................................................................................................ 1-17Battery Runtime .............................................................................................................................. 1-20System Configurations .................................................................................................................... 1-20Serial Numbers ............................................................................................................................... 1-22Software versions ........................................................................................................................... 1-23Time of Day ..................................................................................................................................... 1-24Network Status ............................................................................................................................... 1-25Wireless Connection ....................................................................................................................... 1-28Data Set Status ............................................................................................................................... 1-29Maintenance Due ............................................................................................................................ 1-29

G r l I r tiWarnings and Cautions .......................................................................................................................... 1-31

General ........................................................................................................................................... 1-31Electromagnetic Compatibility ........................................................................................................ 1-32

Features and Displays ............................................................................................................................ 1-33Features and Definitions ................................................................................................................. 1-33Operating Features, Controls, Indicators ........................................................................................ 1-35Displays .......................................................................................................................................... 1-37

System Configurable Settings ................................................................................................................ 1-38Specifications and Symbols ................................................................................................................... 1-39

Specifications.................................................................................................................................. 1-39Symbols .......................................................................................................................................... 1-40


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1-ii Table of Contents

Tr ubl h ti g d m i t cGeneral ................................................................................................................................................... 1-43Alaris Ser er Connections .................................................................................................................... 1-43Alarms, Errors, Messages ...................................................................................................................... 1-44

Display Color................................................................................................................................... 1-44Definitions ....................................................................................................................................... 1-44

Audio Characteristics ...................................................................................................................... 1-45Alarms ............................................................................................................................................. 1-46Errors .............................................................................................................................................. 1-46Messages ....................................................................................................................................... 1-47

Storage ................................................................................................................................................... 1-48Battery Care and Maintenance ............................................................................................................... 1-48

Battery Type and Charging ............................................................................................................. 1-48Battery Charge ................................................................................................................................ 1-48Battery Care .................................................................................................................................... 1-49Battery Cautions and Disposal ....................................................................................................... 1-49

Inspection Requirements ........................................................................................................................ 1-50


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Getting Started 1-1

This section of the DFU pro ides PC Unit (Model 8015) andAlaris System instructions and information. It is used inconjunction with:

PC Unit/Pump Module Technical Ser ice Manual

Product-specific sections of this DFU

System Maintenance software (and its instructions) for Alaris System check-in, maintenance, and wireless configuration

The PC Unit is the core of the Alaris System and pro idesa common user interface for programming infusions andmonitoring, which helps to reduce complexity at the point of care. The display uses color to clearly communicate criticalprogramming, infusion, monitoring and hospital-defined policyinformation.

The wireless network card pro ides wireless communicationcapability between the Alaris System, Alaris Ser er, andMobile Systems Manager. The combined use of the Alaris System and Alaris Ser er:

Reduces number of manual steps needed to programan infusion (by pro iding information obtained fromAlaris Ser er). All data entry and alidation of infusionparameters are performed, according to a physician'sorder, by a trained healthcare professional.

Is integrated into a facilitys existing network infrastructure.

When enabled, the Alaris Ser er allows the exchangeof information between the Alaris Ser er and the Alaris System. The PC Unit can be operated manually or in concertwith the information exchanged with the Alaris Ser er. If communication with the wireless network is interrupted (for example, out of range), the Alaris System can be used, asintended, in the manual mode.

The Mobile Systems Manager does not utilize existing wirelessinfrastructure. It is intended to be used as a not-fully-functionalsubstitution for the full Systems Manager in hospitals/facilitiesthat do not ha e wireless communications installed. It can alsobe used in hospitals/facilities using the full Systems Manager but where wireless co erage is poor.

R d ll i tructi , including

those for the attached module(s) andapplicable accessories, before usingthe Alaris System.

waRnInG

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CaUTIon

G tti g st rt d

I tr ducti


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1-2 Getting Started

al r , err r , m g : See "Troubleshooting andMaintenance" for specific PC Unit alarms, errors andmessages.

C tr i dic ti : None known.

el ctr g tic e vir t: See "Appendix" section of this DFU ("Regulations and Standards," "Compliance" ).



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General Setup and Operation 1-3

45

IUI Connectors

The Alaris System is designed to operate a maximum of four infusion or monitoring modules. Modules added in excessof four are not recognized by the system. The Auto-ID Modulecan be included as a fifth module. A module can be attachedin any position; howe er, when mounted on an Iv pole, it isrecommended that a balanced configuration be maintained.

Application of adhesi e tape or other materials to the sides of the PC Unit and modules can pre ent proper latching.

Position free module at a 45 angle, aligning IUI connectors.

1.

Modules can be attached to either side of the PC Unit or toeither side of another module. The process to attach or detachis the same for either side, whether attaching/detachingto/from a PC Unit or another module.

An indi idual hospital/facility can choose to permanently attachmodules. To remo e permanently attached modules, contactqualified ser ice personnel.

att ch d D t ch m dul

G r l s tup d op r ti

att ch m dul


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1-4 General Setup and Operation

Release Latch

att ch d D t ch m dul (Continued)

D t ch m dul

Ensure that module is powered off before detaching.

Push module release latch and then rotate module upand away from PC Unit or attached module (opposite tomotion shown in "Attach Module" procedure) to disengageconnectors.

Alaris System reidenti es and shows appropriatemodule identi cation ( A, B, C, or D), from left to right.

Appropriate module position(s) ( A, B, or C) for remaining module(s) appear on Main Display.

1.

2.

Rotate free module down against PC Unit or attachedmodule, until release latch snaps in place.

2.

When properly secured/snapped, ther l l tch pro ides a ery secureconnection between modules. If notproperly latched, a module can bedislodged during operation.

waRnInG

att ch m dul (Continued)


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Add module as described in "Attach Module ."

System tests module, causing all LED segments and

indicator lights of displays to illuminate briefly.Appropriate module identification display ( A, B, C, or D)illuminates. Modules are always labeled left to right, so if a module is added to left of other modules, all modules arereidentified. Module reidentification does NOT interrupt or affect infusion or monitoring on acti e modules.

Module positions ( A, B, C, or D) appear on Main Display.

If any of the following conditions are obser ed, affectedmodule must be remo ed from use and inspected byqualified personnel:

LED segments are not illuminated on displays duringpower-on test.Indicator lights do not illuminate.Appropriate module identification does not appear.

add m dul whil sy t i P r d o

att ch d D t ch m dul (Continued)

Attach PC Unit to pole.

Insert PCA Module syringe door key into key lock on poleclamp knob.

To lock PC Unit to pole, turn key in direction of arrow(clockwise).

Pole clamp knob spins in place, pre enting PC Unit frombeing remo ed from pole.

To unlock PC Unit from pole, turn key in opposite directionof arrow (counter clockwise).

Pole clamp knob no longer spins in place, allowingPC Unit to be remo ed from pole.

1.

2.

3.

4.

Key LockKey Lock

s cur t P l U i g opti l L cki g P l Cl p


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Connect PC Unit to an external AC power source.

Press sYsTem on key.

System self test begins:Diagnostics test causes all LED display segmentsand Status Indicator lights of attached module(s) toilluminate brie y.

Power Indicator illuminates.

Appropriate module identi cation ( A, B, C, or D) isdisplayed on attached module(s).

An Audio tone sounds.

If PM Reminder option is enabled and scheduledpre enti e maintenance is due, maInTenanCeRemInDeR screen appears.

At completion of system-on test, n P ti t? screenappears.

If either of the following conditions are obser ed,PC Unit or affected attached module must be remo edfrom use and inspected by quali ed personnel:

System fails any part of self test.Main Display does not appear backlit, appearsirregular, or has e idence of a row of pixels notfunctioning properly.

noTe: Pre ious infusion parameters are automatically cleared after

8 hours.

1.

2.

3.

st rt-Up

P r o sy t
http://-/?-http://-/?-


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CONFIRM

B

MAINTENANCE REMINDER

Module(s) due for routinepreventive maintenance:

Module A: YYYY-MM-DD

CONFIRM

B

MAINTENANCE REMINDER

Module(s) due for routinepreventive maintenance:

Midtown Hospital

Yes

No

NEW PATIENT ?

>Select Yes or No

Yes Clears PreviousPatient Data

DISPLAYCONTRST

If the Pre enti e Maintenance ( PM) Reminder option is enabledand the PC Unit or an attached module is due for pre enti emaintenance, a maInTenanCe RemInDeR message appears

at power up. If necessary, the reminder can be temporarilybypassed by pressing the ConfIRm soft key.

Notify the appropriate facility personnel when amaInTenanCe RemInDeR occurs and remo e instrumentrequiring maintenance (see "Attach and Detach Module" ).

If Alaris System was powered off to replace PC Unit,reinitiate start-up process.

oR

If an attached module (such as a Pump Module) waspowered off and remo ed, maInTenanCe RemInDeR

display reflects remo al of that module. To continuestartup process, press ConfIRm soft key.

1.

2.

R p d t m i t c R i d r

st rt-Up (Continued)

ad u t Di pl y C tr t

Press DIsPLaY ConTRsT soft key.1.


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Midtown Hospital

Yes

No

NEW PATIENT ?

>Select Yes or No

Yes Clears PreviousPatient Data

DISPLAYCONTRST

Midtown Hospital Adult ICU

Yes

No

>Select Yes or No

Adult ICU ?Yes Confirms SameProfile

System Options

>Adjust Display toDesired Contrast

Display Contrast

Lighter

Darker

CONFIRM

Guardrails Suite MX (v8)

2001-2005 Cardinal Health, inc.or one of i ts subsidiaries. All rightsreserved. Guardrails is a registeredtrademark of Cardinal Health, inc. or one of its subsidiaries.

s l ct n P ti t d Pr il opti

The following procedures assume the Profiles feature isenabled.

Select required new PaTIenT? option.

To indicate programming is for a new patient and clear all stored patient parameters from memory, press Y soft key.

To con rm programming is for same patient and retainall stored patient parameters, press n soft key.

Last used pro le is displayed.If Pro les feature is disabled, main menu appears.

1.

Accept or change current profile:

To accept current pro le, press Y soft key.

Main screen appears.

To change pro le, press n soft key and continue withnext step.

Profile selection screen appears.

2.


To adjust display for optimum iewing, use Light r/D rk r soft keys.

To return to main screen, press ConfIRm soft key.

2.

3.

ad u t Di pl y C tr t (Continued)


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Midtown HospitalProfiles

>Press CONFIRM

CONFIRM PAGEDOWN

Neonatal

Peds ICU

Neonatal ICU

Adult General Care

Adult ICU

1 of 2

EXIT

A

B

C

D

PAGEDOWN

>Enter Patient ID and PressCONFIRM

E

K-O

F-J

P-T

U-Y

A-E

Patient ID Entry

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

CONFIRM

To select a profile, press corresponding left soft key.

To iew additional choices, press PaGe Down soft key.

To confirm profile selection, press ConfIRm soft key.Main screen appears.

3.

4.


s l ct n P ti t d Pr il opti (Continued)

The option to enter and display a 16 -character alphanumericpatient identifier is always a ailable. The instrument canbe configured to automatically display the P ti t ID e try screen during start-up or to pro ide access only through thesy t opti menu (see "System Options" ).

If Y was selected to indicate programming for a new patient,perform one of following steps:

If patient identifier is not required, press ConfIRm or exIT soft key.

To manually enter patient identifier, use numeric data entrykeys and/or alpha speed keys.

An alphanumeric identifier, of up to 16 characters, canbe entered.Press soft key next to a letter group to list letters inthat group. Press soft key next to an indi idual letter toenter that letter.To access letter " Z" and special characters (hyphen,underscore, space), press PaGe Down soft key.To clear an entire entry, press CLeaR key.To back up a single character at a time, press CanCeL key.

To scan bar code on patient identification band, seeAuto-ID Module section of this DFU .

P ti t ID e try f tur


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PANEL LOCKED

VTBI = 250.0 mL

VOLUMEINFUSED

AUDIO ADJUST


VTBI = 250.0 mL

VOLUMEINFUSED

AUDIO ADJUST


Louder

>Change Setting or Cancel

Audio Volume Adjust

Test

Softer

MAINSCREEN

3

Initiate operation of applicable module.

Press and hold Tamper Resist Switch, on back of PC Unit,for 3 to 4 seconds (see "General Information," "Featuresand Displays," "Operating Features, Controls, Indicators" ).

An ad isory tone (if K y Click audi is enabled)and a three-second PaneL LoCKeD prompt on MainDisplay con rm activation.

1.

2.

L ck/U l ck T p r R i t


ad u t audi V lu

To change olume to desired le el, press either L ud r or s t r soft key. To sample alarm loudness le el, pressT t soft key.

To return to PC Unit screen, press maIn sCReen soft key.

After 30 seconds without a key press, Main Displayappears.

2.

3.

Press aUDIo aDjUsT soft key.1.

Setting the audio olume to thel t l v l will lower all systemalarms, including secondary alarmssuch as End of Infusion.

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PANEL UNLOCKED

VTBI = 250.0 mL

VOLUMEINFUSED

AUDIO ADJUST


Powering Down


When Tamper Resist is acti e, keypad panel is locked;howe er, clinician can:

Silence audio alarm.view olume(s) infused.view and test audio alarm setting.view selected parameters on attached modules.

Any other key press results in a isual PaneL LoCKeD prompt and, if K y Click audi is enabled, an illegalkeypress audio ad isory.

To unlock keypad panel, press and hold Tamper ResistSwitch for 3 to 4 seconds.

An ad isory tone (if K y Click audi is enabled) and a

three-second PaneL UnLoCKeD prompt on Main Displayconfirm acti ation.

3.

L ck/U l ck T p r R i t (Continued)

P r o sy t

Press and hold CHanneL off key until a beep is heard(approximately 1.5 seconds) and then release to initiate power down.

During power off sequence, Main Display flashesP ri g D .

To interrupt power down sequence, quickly press any key(except sYsTem on ) on PC Unit.

Once all attached modules are powered off, PC Unitautomatically powers down.


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>Select an Option or EXIT

PAGEDOWNEXIT

Display Contrast

Clinician ID

Power Down All Channels

Anesthesia Mode

Patient ID

System Options 1 of 3


PAGEDOWNEXIT

Display Contrast

Clinician ID


Anesthesia Mode

Patient ID


SILENCE

OPTIONS

1

4

7

CLEAR

2

5

8

0

3

6

9 ENTER

CANCEL

SYSTEMON

P ti t ID

e t r

Press oPTIons key.

Press P ti t ID soft key.

1.

2.

sy t opti

Di pl y C tr t

Press oPTIons key.1.

Press Di pl y C tr t soft key.2.

Adjust display and return to main screen (see "Start-Up,""Adjust Display Contrast" procedure).

3.


25/369



EXIT

A

B

C

D

PAGEDOWN


E

K-O

F-J

P-T

U-Y

A-E

Patient ID Entry

123456789CD_ _ _ _ _

CONFIRM

Scan or manually enter patient identifier:

To manually enter patient identi er, use numeric dataentry keys and/or alpha speed keys.

An alphanumeric identi er, of up to 16 characters,can be entered.Press soft key next to a letter group to list lettersin that group. Press soft key next to an indi idualletter to enter that letter.To access letter " Z" and special characters(hyphen, underscore, space), press PaGe Down soft key.

To clear an entire entry, press CLeaR key.To back up a single character at a time, pressCanCeL key.

To scan bar code on patient identi cation band, seeAuto-ID Module section of this DFU .

To erify correct entry, press ConfIRm soft key.

3.

4.

sy t opti (Continued)

P ti t ID (Continued)

e t r (Continued)


26/369



EXIT

A

B

C

D

PAGEDOWN


E

K-O

F-J

P-T

U-Y

A-E

Patient ID Entry

234567891EF_ _ _ _ _

CONFIRM

SILENCE

OPTIONS

1

4

7

CLEAR

2

5

8

0

3

6

9 ENTER

CANCEL

SYSTEMON

oR



To enter modified patient identifier, use numeric data entrykeys and/or alpha speed keys.

An alphanumeric identi er, of up to 16 characters, canbe entered.

Press soft key next to a letter group to list letters inthat group. Press soft key next to an indi idual letter toenter that letter.

To access letter " Z" and special characters (hyphen,underscore, space), press PaGe Down soft key.

To erify correct entry, press ConfIRm soft key.

New P ti t ID e try erification screen appears.

4.

5.

m di y

Press oPTIons key.

Press P ti t ID soft key.

To clear entire entry, press CLeaR key.

oR

To back up a single character at a time, press CanCeL key.

1.

2.

3.


27/369



>Press Yes or No

Patient ID Entry

Yes

No

Patient ID123456789CDwill be changed to234567891EF

Is this correct?


PAGEDOWNEXIT

Display Contrast

Clinician ID


Anesthesia Mode

Patient ID


To accept modified Patient ID, press Y soft key.

Main screen appears with new Patient ID.

oR

To retain original (old) Patient ID, press n soft key.

Main screen appears with old Patient ID.

6.



m di y (Continued)

Cli ici ID

Press oPTIons key.

Press Cli ici ID soft key.

1.

2.

Scan or manually enter clinician identifier:

To manually enter clinician identifier, use numeric dataentry keys and/or alpha speed keys.

An alphanumeric identi er, of up to 16 characters, canbe entered.

Press soft key next to a letter group to list letters inthat group. Press soft key next to an indi idual letter toenter that letter.

To access letter " Z" and special characters (hyphen,underscore, space), press PaGe Down soft key.

To clear an entire entry, press CLeaR key.

To back up a single character at a time, press CanCeL key.

3.


28/369



System Options

Yes

No

Power Down All Channels?

>Press Yes or No


PAGEDOWNEXIT

Display Contrast

Clinician ID


Anesthesia Mode

Patient ID


EXIT

A

B

C

D

PAGEDOWN

>Enter Clinician ID and PressCONFIRM

E

K-O

F-J

P-T

U-Y

A-E

Clinician ID Entry

123456789CD_ _ _ _ _

CONFIRM

Press Y soft key.

During power off sequence, Main Display flashesPoweRInG Down .

3.

Press oPTIons key.

Press P r D all Ch l soft key.

1.

2.

P r D all Ch l


Cli ici ID (Continued)

To erify correct entry, press ConfIRm soft key.4.


29/369




PAGEDOWNEXIT

Display Contrast

Clinician ID


Anesthesia Mode

Patient ID


a th i m d

When the Anesthesia Mode is enabled while a module ispaused, the module remains in an indefinite pause untilrestarted.

When Anesthesia Mode is enabled:

All limits are set to s t .

Dose checking mode is set to s rt .

Key-press audio is turned off.

Tamper Resist Mode (panel locked) is not a ailable.

Guardrails drug list defaults to drugs designated by Editor Software as anesthesia only. All Guardrails drugs in aprofile can be iewed by pressing aLL DRUGs soft key.

Bolus dose is automatically a ailable for:Guardrails drugs that ha e bolus dose limits definedgeneric drug calculation setup

a th i m d , alternating with other required prompts,is displayed in prompt bar of Main Display.

Callback audio for paused module is permanently silenced.

Re iew of drug calculation setup page is omitted whenrestoring a stopped drug calculation.

Clinical Ad isories are not displayed.

Auto-ID Module is not a ailable.

When the Alaris System is set upfor use in Anesthesia Mode, it isimportant to l ct th pr il thatcorresponds with the care area thepatient will be taken to when theAnesthesia Mode is discontinued.This ensures that the Alaris Systemwill be in the correct profile followingthe use of the Anesthesia Mode.

CaUTIon


e bl

Press oPTIons key.

Press a th i m d soft key.

1.

2.


30/369



System Options

>Select an Option or PressCONFIRM

Anesthesia Mode

Pump Module Air Detection =75 microliters

Enable

Change

CONFIRM

Disable

Di bl

The Anesthesia Mode can be disabled, and normal operationresumed, using either of the following three methods:

System Options menu. Disconnecting from AC power. Connecting to AC power.

fr sy t opti m u

Press oPTIons key.

Press a th i m d soft key.

Press Di bl soft key.Press ConfIRm soft key.

a th i m d no longer appears on Main Display,indicating it has been disabled.

1.

2.

3.4.


a th i m d (Continued)

Press e bl soft key.

Press ConfIRm soft key.

3.

4.

e bl (Continued)


31/369



AC power cord wasconnected.Continue

? ANESTHESIA MODE

Yes

No

>Select Yes or No

CONFIRM

Anesthesia mode waswhen AC power disconnected.continue normal operation.

discontinuedcord was

Press CONFIRM to

>Press CONFIRM

C ct t aC P r

Connect system to AC power.

To continue using Anesthesia Mode, press Y soft key.

oR

To discontinue Anesthesia Mode, press n soft key.

1.

2.

a th i m d (Continued)


Di bl (Continued)

Di c ct r aC P r

Disconnect system from AC.

Anesthesia Mode is automatically disabled.

All currently running infusions continue.

A prompt appears as an alert that Anesthesia Modehas been discontinued.

Press ConfIRm soft key.

1.

2.


32/369



System Configurations

>Select an Option or

EXIT EXIT

Software Versions

Serial Numbers

Battery Runtime

PAGEDOWN

Time of Day

PAGEUP




EXIT

Software Versions

Serial Numbers

Battery Runtime

PAGEDOWN

Time of Day

PAGEUP


System Options

>Press CANCEL or EXIT

EXIT

9.5 hours

Estimated batteryruntime at currentoperating parameters

sy t C igur tiPress oPTIons key.

Press PaGe Down soft key.

Press sy t C igur ti soft key.

1.

2.

3.


B tt ry Ru ti

Press oPTIons key.


Press B tt ry Ru ti soft key.

1.

2.

3.

To return to main screen, press CanCeL key or exIT softkey.4.


33/369




PAGEDOWNEXIT

System Config - PCU 1 of 3

Alarm audio: Profile 1

Battery meter: DisabledClock setup: 09:00

Anesthesia Mode: Disabled

Limit Checking: ALWAYS

Factory Default: Yes

System Configuration - Module

PC UnitPump Module

SPO2 Module


EXIT

Shared Infusion Settings

PAGEDOWN

EXITPAGEUP


500 kgMax Pt. weight:

Patient ID Entry: Disabled


PAGEDOWN

Key click audio: Enabled

2 m 2Max Pt. BSA:

Pending IV Orders: Enabled

To re iew arious system configuration settings, pressPaGe Down and PaGe UP soft keys.

5.

Press PC U it soft key.4.


sy t C igur ti (Continued)


34/369



EXITPAGE

UP


PM Reminder: Disabled


Tamper resist: Disabled



EXIT

Software Versions

Serial Numbers

Battery Runtime

PAGEDOWN

Time of Day

PAGEUP



sy t C igur ti (Continued)

To return to main screen, press CanCeL key or exIT softkey.

6.

noTes: The Pr il option is listed only if it is di bl d .

The Li it Ch cki g (or D Ch cki g ), m Pt. Bsa ,and P di g IV rd r options are listed only if the Pr il option is bl d and a alid Data Set is loaded.

s ri l nu b r

Press oPTIons key.


Press s ri l nu b r soft key.

Serial numbers for PC Unit and all attached modulesdisplay.

1.

2.

3.


35/369



Software Rev. Review

PC Unit:

Module A:

Module B:

Module C:

Module D:

View

View

View

View

View


EXIToR



EXIT

Software Versions

Serial Numbers

Battery Runtime

PAGEDOWN

Time of Day

PAGEUP


Serial Number Review

PC Unit: nnnn-nnnnnnnn

nnnn-nnnnnnnn

nnnn-nnnnnnnn

nnnn-nnnnnnnn

nnnn-nnnnnnnn

Module A:

Module B:

Module C:

Module D:


EXIT

To re iew software ersion information, press Vi softkey next to applicable module.

oR

To return to main screen, press exIT soft key.

4.

s t r V r i

Press oPTIons key.


Press s t r V r i soft key.

1.

2.

3.


To return to main screen, press exIT soft key.4.

noTe: "nnnn-nnnnnnnn" in the illustrated display represents a serial

number.

s ri l nu b r (Continued)


36/369



EXIT


Software Rev. Review

Module Software: A

Main processor: nn.nn

nn.nnnn.nn

Main boot block:Keyboard:



EXIT

Software Versions

Serial Numbers

Battery Runtime

PAGEDOWN

Time of Day

PAGEUP


Time of Day

System Options

Current time:09:00

ChangeTime

CONFIRM

>CONFIRM Time-of-Day

EXIT


To return to pre ious screen, press exIT soft key. 5.

noTe: "nn.nn" in the illustrated display represents a software

ersion.

s t r V r i (Continued)

Press oPTIons key.


Press Ti D y soft key.

1.

2.

3.

If time is correct, press ConfIRm soft key.

oR

To change time, press Ch g Ti soft key.

4.

Ti D y


37/369



Time of Day

System Options

Current time: __:__

ChangeTime

CONFIRM

>Enter Current Time

EXIT

Time of Day

System Options

Current time:14:30

ChangeTime

CONFIRM

>Press CONFIRM

EXIT

The displayed status updates immediately when a statuschange takes place.

Press oPTIons key.

Press PaGe Down soft key two times.

1.

2.

Press ConfIRm soft key.6.

noTe: The format is a 24 -hour clock (military time).

n t rk st tu


Enter current Time of Day.5.

Ti D y (Continued)


38/369





EXIT

Network Status

Maintenance Due Yes

Wireless Connection

Data Set Status

PAGE UP

Viewing Network Statusis only to be used by

qualified personnel.

* _ _ _ _

System Options

EXIT CONFIRM

>Enter Password or EXIT

>Press CANCEL to Exit

Wireless StatusStatus :

Channel : Authentication :

ASSOCIATED

1 (2.142 Ghz)OPEN40 bit WEP

SSID :

BSSID :

AM SWEPXXXXXXXXXXXXXXXXXXXXXXX00:0A:B3:36:9F:88

Encryption:

NETSTATUS

NET ADDRESS

SERVERSTATUS

Link Quality

Signal Strength75%35%

System Options

Speed: 11 Mbps


n t rk st tu (Continued)

To iew network status and wireless status information,press n t rk st tu soft key.

3.

Enter password (can be found in System Maintenancesoftware instructions) and press ConfIRm soft key.

Information based on a wireless status of DIsassoCIaTeD , assoCIaTInG , or assoCIaTeD isdisplayed.

If wireless status is assoCIaTeD , following informationis displayed:

Wireless connecti ity: ssID , Ch l ,auth tic ti , and e crypti types beingused; BssID MAC address of access point thatsystem is connected to; sp d transfer rate up to54 Mbps for 802.11 a/g and 11 Mbps for 802.11 b. Li k Qu lity a minimum of 20% recommendedfor good wireless connecti ity. sig l str gth greater than 20% recommended for good wireless connecti ity.

To iew network connecti ity information, press neTsTaTUs soft key.

A status of DIsaBLeD , DIsConneCTeD ,ConfIGURInG , or ConneCTeD is displayed.

If status is ConneCTeD , PC Unit is connected towireless network.

4.

5.


39/369




Network Address

WIRELESSSTATUS

SERVERSTATUS

System Options

NETSTATUS

DHCP Enabled : YES192.168.0.55

MAC Address: 00:0A:B3:36:9F:88

192.168.0.1

255.255.255.0Subnet Mask:IP Address:

Gateway:

192.168.0.1192.168.0.3

DNS Primary:DNS Secondary:


Network StatusStatus : CONNECTED

WIRELESSSTATUS

NET ADDRESS

SERVERSTATUS

System Options

Uptime : 03:45:35

1,200,150

13, 890Bytes Sent:

Bytes Recv:


Server Status

WIRELESSSTATUS

System Options

NETSTATUS

NET ADDRESS

Uptime:Status:

00:00:02CONNECTED

192.168.0.2Server Address:

Beacons Received20%

TCP Port: 65535

3612 / 4000ms20ms

UNKNOWN

AES 128-bit1,103,470,77694,300

Local Timeout:Server Timeout:

Bytes Sent:Bytes Received:Last Disconnect:

Encryption:

To iew network address information, press neTaDDRess soft key.

maC addr of wireless RF card attached to PC Unitis displayed.

If DHCP e bl d displays no , PC Unit is set to use aStatic IP address.

When PC Unit is connected to wireless network,IP addr , sub t m k , G t y , and DNSinformation display.

6.


n t rk st tu (Continued)

To iew ser er connecti ity information, press seRVeRsTaTUs soft key.

7.

Information based on a status of DIsaBLeD ,seaRCHInG , VeRIfYInG , ConneCTInG , or ConneCTeD is displayed.

If status is ConneCTeD , PC Unit is connected toAlaris Ser er and following information is displayed:

Upti length of time PC Unit has beenconnected. IP addr of Alaris Ser er. TCP P rt being used to establish connection. e crypti type ( AES 128 -bit) used to encodedata on payload and protect patient-sensiti einformation sent through wireless network. Byt s t cumulati e total of data sent.

Byt R c iv d cumulati e total of datarecei ed.


40/369



System Options

WirelessConnection Disable

Enable

>Press ENABLE or DISABLE

Press oPTIons key.


Press wir l C cti soft key.

1.

2.

3. System Options 3 of 3


EXIT

Network Status

Maintenance Due Yes

Wireless Connection

Data Set Status

PAGE UP

wir l C cti

noTe: A wir l C cti setting of Di bl changes to

e bl when the PC Unit is powered off and on. If thewireless communication is to be disabled, the option will needto be reset to Di bl .


To disable wireless communication, press Di bl softkey.

oR

To enable wireless communication, press e bl soft key.

4.To comply with FAA regulations andpre ent potential interference withaircraft communications, di bl

ir l c u ic ti when theAlaris System is used in an aircraft.

waRnInG


41/369



B

EXIT

Current:

Pending:

(none available)

Midtown HospitalDataset ID: 83442BBNot Activated

ID: 83442BB Activated: 2005-09-18 08:45

System Options

>Press EXIT

Data Set Status



EXIT

Network Status

Maintenance Due Yes

Wireless Connection

Data Set Status

PAGE UP



EXIT

Network Status

Maintenance Due Yes

Wireless Connection

Data Set Status

PAGE UP


D t s t st tu

Press oPTIons key.


To iew Data Set status, press D t s t st tu soft key.

1.

2.

3.

A status of Curr t , P di g , Tr rri g , or n tactiv t d is displayed.

m i t c Du

Press oPTIons key.


Press m i t c Du soft key.

1.

2.

3.


42/369



BModule(s) due for routinepreventative maintenance:.


EXIT

Maintenance Due Dates

PC Unit:

Module A:Module B:

Module C:

Module D:

YYYY-MM-DD

YYYY-MM-DD

YYYY-MM-DD

YYYY-MM-DD

YYYY-MM-DD

System Options

PAGEDOWN

BModule(s) due for routinepreventative maintenance:.


EXIT

Maintenance Due Dates

Bar Code:

Bar Code:

(Hand held)

YYYY-MM-DD

YYYY-MM-DD

System Options

PAGE UP


To return to main screen, press exIT soft key. 4.

noTe: PaGe Down soft key appears only if an Auto-ID Module is

attached.

m i t c Du (Continued)


43/369


General Information 1-31

Assess patients condition b r il ci g l r . Donot silence alarm if patient safety might be compromised.

Before each use, v ri y th t th l r li it areappropriate for the patient.

The Alaris System performs a l ch ck duri g p r

up . The PC Unit should beep, no errors should occur, andif a module is connected, all LED segments should flash. If the Alaris System fails the self check, remo e the failingPC Unit or module from use.

When properly secured/snapped, the r l l tch pro ides a ery secure connection between modules. If not properly latched, a module can be dislodged duringoperation.

Disconnect from main ( AC) and battery power whenperforming i t c .

Electrical shock hazard. D t p c . Refer toqualified ser ice personnel.

Due to the i t r itt t tur ir l vir t ,some data can be lost if a connection cannot be establishedor is lost. The Alaris Ser er and wireless network card aredesigned to minimize these incidents but cannot eliminatethem.

To comply with FAA regulations and pre ent potentialinterference with aircraft communications, di bl ir lc u ic ti when the Alaris System is used in anaircraft (see "System Options," "Network Status" ).

The Alaris System is not intended to replace up rvi iby dic l p r l . The user must become thoroughly

familiar with the Alaris

System features, operation andaccessories prior to use.

waRnInGs

e pl i ri k if used in the presence of flammable

anesthetic agents or gasses.

DanGeR

G r l

w r i g d C uti

G r l I r ti


44/369


1-32 General Information

w r i g d C uti (Continued)

el ctr g tic C p tibility

Do not use the Alaris System near Magnetic ResonanceImaging ( mRI ), including Stereotaxis technology.

Do not use the Alaris System near Th r p utic R di ti equipment, such as Linear Accelerators.

Use of any cc ry, tr duc r r c bl other thanthose specified can result in increased emissions or decreased Alaris System immunity.

waRnInGs

G r l (Continued)

Always use a grounded, thr - ir r c pt cl . Where

the integrity of the protecti e earth grounding system is indoubt, operate on internal battery.

Hyp rb ric Ch b r op r ti :

The Alaris System is not certified for use in oxygen-enriched en ironments.The Alaris System, with the exclusion of theEtCO 2 Module, has been erified to operate with nomalfunction alarms due to the hyperbaric chamber en ironment or unintentional key presses when used ina hyperbaric chamber.The healthcare facility's hyperbaric safety director is

responsible for all equipment used in the hyperbaricchamber en ironment.Should an instrument or accessory be dr pp d r

v r ly rr d , it should be immediately taken out of useand inspected by qualified ser ice personnel to ensure itsproper function prior to reuse.

If an instrument appears d g d , contact CareFusion for authorization to return it for repair.

CaUTIons


45/369



The Alaris System should not be used d c t t r t ck d ith th r quip t . If adjacent or stacked use

is necessary, monitor the Alaris System to erify that it isoperating normally in that setup.

P rt bl d bil Rf c u ic ti can affectmedical electrical equipment.

I t rc ct d d t c u ic ti y t mustbe certified to IEC 60950 (data processing equipment) or IEC 606011 (electromedical equipment).

The Alaris System is intended for use by healthcareprofessionals only. This is a CISPR 11 Class B Group 2 medical system. In a domestic en ironment, this systemc c u r di i t r r c . Reorienting, relocating or

shielding the system, or filtering the connection to the publicmains network, are examples of steps that can be taken toreduce or eliminate interference.

Medical electrical equipment d p ci l pr c utir g rdi g emC and needs to be installed and usedaccording to the EMC information pro ided in the"Appendix" section of this DFU (see "Regulations andStandards," "Compliance" ).

CaUTIons

f tur d D i iti

f tur d Di pl y

w r i g d C uti (Continued)

el ctr g tic C p tibility (Continued)

See the product-specific section of this DFU that applies to the attached module(s) for features anddefinitions specific to that module.

f tur D i iti

Cli ici ID An optional alphanumeric 16 -character clinician identifier that can beentered and displayed.

D t s t Created using Editor Software authoring tool and then transferred toPC Unit. A Data Set reflects facilitys best-practice guidelines for Iv Drugadministration and includes: Profile Drug Libraries, Clinical Ad isories,instrument configurations, and Channel Label Libraries.


46/369



f tur d Di pl y (Continued)

f tur d D i iti (Continued)

f tur D i iti

Gu rdr il suit mx Designed to help pre ent programming errors by:Customizing de ice configurable settings to meet need of selectedhospital/facility area/unit (profile).Comparing user programming with hospital-defined best-practiceguidelines.Pro iding a isual and audio prompt if an out-of-limits entry is made.

P ti t ID An optional alphanumeric 16 -character patient identifier that can beentered and displayed

When enabled, ID entry defaults to Startup screen.When disabled, ID entry is only accessible from System Optionsscreen.

Pr il A unique set of system configuration settings and best-practice guidelinesfor a specific patient population or patient type, and can consist of followingcomponents:

Instrument configuration settings.A Drug Library, which includes drug names, standard concentrations,dosing units, duration limits, and optional associated Clinical Ad isoriesfor both continuous and bolus dose infusion.An Iv Fluid library, an optional library consisting of Iv Fluids (for example, TPN ) and limits around rate of deli ery.A Channel Label Library with text (alphanumeric) labels, which allows

identification (on modules) that can be used to indicate route of deli ery(for example, epidural).

Profile settings are established by the facilitys own multi-disciplinary teamprior to system implementation. Profile parameters are used to create aData Set, which is then transferred to the PC Unit.

sy t C igur ti Allows system settings to be customized. If Profiles feature is enabled,system settings defined for selected profile are automatically acti ated.

T p r R i t Pro ides a quick one-touch lockout of front panel keypad.


47/369



SILENCE

OPTIONS

1

4

7CLEAR

2

5

8

0

3

6

9 ENTER

CANCEL

S YS TEMON

op r ti g f tur , C tr l , I dic t r


m i Di pl y

s t K y : When pressed,allows selection of options or infusion parameters appearingon Main Display adjacent tosoft key.

sil c K y: When pressedduring an alarm, silences audiofor 2 minutes.

opti K y: When pressed,allows access to a ailableSystem or Channel Options.

s t K y (see abo e)

B tt ry I dic t r: Whenilluminated, indicates Alaris System is operating on batterypower.

P r I dic t r: Whenilluminated, indicates Alaris System is connected to an ACpower source.

wir l n t rkI dic t r: When illuminated,indicates Alaris System isconnected to Alaris Ser er or Mobile Systems Manager.When blinking, indicates datatransfer.

m dul R l L tch: When pressed, allowsmodule to be remo ed.

Cl r K y: Whenpressed, clears currentselected parameter settingto "0".

sy t o K y: Whenpressed, changes Alaris System

from Standby to Operating mode.

Up K y: When pressed,increases parameter with eachkey press or scrolls up whenpressed and held.

e t r K y: When pressed,confirms current parameter entry.

C c l K y: When pressed,sequentially backs out of currentsetup sequence.

D ci l K y: When pressed,inserts a decimal point in numericdata.

nu ric K yp d

D K y: When pressed,decreases parameter with eachkey press or scrolls down whenpressed and held.

IUI C ct r, L t(not isible )

IUI C ct r, Right


48/369



Wireless Network Card LED

Flashes green when Alaris System is powered up.

Wireless Network Card (seeillustration below for LED location)


op r ti g f tur , C tr l , I dic t r (Continued)

IUI Connector, Right IUI Connector, Left

Connector Plug o er RJ45 Communication Data Port Tamper Resist Switch

Power Cord StrapUse this bolt to reorientPole Clamp 90 for attachment to a bed railinstead of a pole.

Primary Audio Speaker

Optional Pole Locking Clamp:PCA Module syringe door keylocks and unlocks knob.


49/369



The displays illustrated throughout this document are for illustration purposes only. The display content aries,depending on configuration settings, hospital-defined Data

Set uploaded using the Guardrails

Suite MX, and many other ariables.

A color ersus monochrome display option is a ailable whencreating a hospital-defined, best-practice Data Set. If noData Set is present or the Profiles feature is disabled, thedefault is a color display. During normal operation, the titleand prompt bars are blue when a color display is enabled.See "Troubleshooting and Maintenance," "Alarms, Errors,Messages" for additional color categories.

m i Di pl y

VTBI = 250.0 mL

VOLUMEINFUSED

AUDIO ADJUST


Titl B r

m dul st tu A solid letter display indicates

module is operating. An outlined letter display

indicates module is attachedand ready for use.

s t K y

SILENCE

OPTIONS

1

4

7C LEAR

2

5

8

0

3

6

9 ENTER

CANCEL

S YSTEMON

m dul s l ct d I dic t r

"I ctiv " s t K yNonhighlighted indicates anonselected soft key.

"activ " s t K yHighlighted indicates aselected soft key.

Pr pt B r Look here for user prompts.

>Press START

Infusion SetupRATE 40 mL/h

_250 mL

PAUSE SECOND-

ARYSTART

VTBI

SILENCE

OPTIONS

1

4

7CLEA R

2

5

8

0

3

6

9 ENTER

CANCEL

SYST EMON


Di pl y


50/369



If the configuration settings need to be changed from thef ct ry d ult settings, refer to the applicable TechnicalSer ice Manual or contact CareFusion Technical Support,for technical, troubleshooting, and pre enti e maintenanceinformation.

With the Profiles feature enabled, the settings are configuredindependently for each profile. A hospital-defined, best-practice Data Set must be uploaded to enable the Profilesfeature. Date and Time is a system setting and is the same inall profiles.

f tur D ult s tti g opti

Alarm Audio Profile 1 Pro le 1, 2, or 3

Anesthesia Mode Disabled Enabled - Disabled

Battery Meter Disabled Enabled - Disabled

Clock Setup ( Date and Time ) Not Applicable Set date and time

Dose Checking Always Always, Smart

Key Click Audio Enabled Enabled - Disabled

Max Patient Weight 500 kg 0.1 - 500 kg

Patient ID Entry Disabled Enabled - Disabled

PM Reminder (Pre enti e Maintenance )

Enabled Enabled - Disabled

Pro les Disabled Enabled - Disabled

Tamper Resist Disabled Enabled - Disabled

sy t C igur bl s tti g


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sp ci ic ti d sy b l

sp ci ic ti

B tt ry op r ti : Battery run time is a function of the number of modules attached and moduleacti ity. With a new, fully charged battery, the system operates as follows beforea " BATTERY DISCHARGED " message occurs:

6 hours with one Pump Module infusing at 25 mL/h6 hours with one Pump Module infusing at 25 mL/h and one Auto- ID Module3 hours with four Pump Modules infusing at 25 mL/h3 hours with four Pump Modules infusing at 25 mL/h and one Auto- ID Module4.5 hours with one acti e SpO 2 Module6 hours with one Syringe Module or PCA Module infusing at 5 mL/h3 hours with four Syringe Modules, or one PCA Module and three SyringeModules, infusing at 5 mL/h4 hours with one acti e EtCO 2 Module

C u ic ti D t P rt : RS-232 with an RJ45 connector.

Di i : 6.9" W x 8.8" H x 9" D (including pole clamp)

el ctric Cl i ic ti : Class 1, Internally Powered Equipment

el ctr ic m ry : System configuration parameters stored in olatile memory are retained for atleast six months by internal backup lithium battery. Module-specific parametersare stored for 8 hours when system is turned off. After 8 hours of continuousoff-time, or if a module is detached, module-specific trend data (if applicable)and module-specific operating parameters are automatically purged. If a PCA,SpO 2 or EtCO 2 Module is detached and replaced with another PCA, SpO 2, or EtCO 2Module, its module-specific trend data is purged.

e vir t l C diti : op r ti g st r g /Tr p rt

Atmospheric Pressure 525 - 4560 mmHg

(700 - 6080 hPa)

375 - 760 mmHg

(500 - 1013 hPa)Relati e Humidity

(A oid prolongedexposure to relati ehumidity >85%)

20 - 90%Noncondensing

5 - 85%Noncondensing

Temperature Range 41 - 104F(5 - 40C )

-4 - 140F(-20 - 60C )

equip t ori t ti : To ensure proper operation, Alaris System must remain in an upright position.

fluid I gr Pr t cti : IPX1 , Drip Proof

m d op r ti : Continuous

P r R quir t : 100 - 240v ~, 50/60 Hz, 150 vA MAX

sh ck Pr t cti : Type CF, Defibrillator Proof

w ight: 7.2 lbs


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sp ci ic ti d sy b l (Continued)

sy b l

See the product-specific section of this DFU that applies to the attached module(s) for symbols specificto that module.

sy b l m i g

Alternating Current: Indicates de ice should be attached to alternating current source,50 /60 Hz only.

! Caution: Refer to accompanying documentation.

Canadian and U.S. Certification Mark: Products bearing this mark ha e been testedand certified in accordance with applicable U.S. and Canadian electrical safety andperformance standards.

Communications connector for RS-232 attachment.

Consult operating instructions.

Type CF defibrillation-proof equipment.

Electrostatic discharge ( ESD ).

Fuse Replacement: Replace fuse only with same type and rating.

IPX1 Protection against fluid ingress: Drip Proof.

IUI Connector: Inter-Unit Interface connector used to establish power andcommunications between PC Unit and attached modules.

MM-YYYY

Manufacturing Date: Number adjacent to symbol indicates month and year of manufacture.

Potential Equalization Conductor (if so equipped). Note: If integrity of PEC or HospitalEarth System is in question, operate instrument using internal battery power.

Radio frequency ( RF ) transmission.


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sp ci ic ti d sy b l (Continued)

sy b l (Continued)

sy b l m i g

nlyO Caution: Federal ( U.S.A. ) law restricts this de ice to sale by or on order of a physician.

Tamper Resist acti ate/deacti ate switch.

Conformit Europenne ( CE marking) notified body 0086 : British Standards Institution.

N12875

Australian Communications Authority.

Federal Communications Commission.

Pursuant to Directi e 2002 /96 /EC of the European Parliament and of the Council of 27 January 2003 , on waste electrical and electronic equipment (W EEE ).

EC REP Authorized representati e in European Community.


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T H I S PA G EI N T E N T I O N A L LY

L E F T B L A N K


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Troubleshooting and Maintenance 1-43

al ri s rv r C cti

When an Alaris Ser er or Mobile Systems Manager connection is made, the Wireless Network Indicator on thePC Unit lights up. If connection to the Alaris Ser er isinterrupted, the indicator light is extinguished. Some of thecauses for a communications failure include:

Alaris Ser er is not accessible in network, ser er ser icesare not running, or ser er has been shut down.

Wireless connection to access point is down due to wirelessnetwork changes.

Local interference. PC Unit has been mo ed outside wireless co erage area. Wireless network card has been damaged.

If an interruption to the Alaris Ser er connection continues,the facilitys information technology department should beinformed.

Tr ubl h ti g d m i t c

G r l

Troubleshooting and maintenance are intended to beperformed only by qualified personnel, using the Alaris System Technical Ser ice Manuals and the SystemMaintenance software. The Ser ice Manuals and SystemMaintenance software are a ailable from CareFusion.The Ser ice Manuals include routine ser ice schedules,interconnect diagrams, component parts lists and descriptions,test procedures, and other technical information to assistqualified ser ice personnel in repair and maintenance of theinstruments repairable components. The System Maintenancesoftware is used to perform a new instrument check-in,pre enti e maintenance tests, calibration checks, calibration,and other maintenance functions.


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1-44 Troubleshooting and Maintenance

Di pl y C l r

If the option to ha e a color display is enabled, color is used in the title and prompt bars to helpcommunicate the following types of information.

C u ic ti C l r D cripti

Normal Operation Blue All messages other than noted abo e (normal operating displays).

Guardrails limit Yellow visual message indicating a Limit was exceeded.

Informati e Green visual message requiring a response to clear message.

Aler t and Standby Red visual message indicating an error or system inconsistency occurred.

D i iti

To enhance safety and ease of operation, the Alaris Systempro ides a full range of audio and isual alarms, errors, andmessages.

Operating the system near equipment which radiates high-energy radio frequencies (such as electrosurgical/cauterizingequipment, portable radios, cellular telephones) might causefalse alarm conditions. If this happens, reposition the Alaris System away from the source of interference or turn off thesystem and manually regulate the flow with the clamp and/or monitor the ital parameters using an appropriate clinicalalternati e.

See the product-specific section of this DFU that applies to the attached module(s) for alarm, error andmessage definitions specific to that module.

advi ry/m g A sequence of audio and/or isual signals indicating system operatingstatus.

al r An audio and isual signal that a potentially unsafe condition is present.Immediate action is required.

al r sil c Alarms can be silenced for up to 120 seconds by pressing sILenCe key.

err r An audio and/or isual signal that a failure has been detected. Immediateaction is required.

al r , err r , m g


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al r , err r , m g (Continued)

audi Ch r ct ri tic

The Alaris System pro ides arious types of alert information. See the product-specific section of thisDFU that applies to the attached module(s) for audio characteristics specific to that module.

Typ s u d n t

Ad isory/Message One short beep e ery 2 seconds. variable olume; can be silenced for 2 minutes.

Alarm Choice of three alarm audiopro les, selectable in SystemCon guration.

variable olume; can be silenced for 2 minutes.

Error (Hardware Detected) Pairs of long beeps. Fixed maximum decibel olume; cannot besilenced.

Error (Software Detected) Pairs of long beeps. Fixed maximum decibel olume; can be

silenced for 2 minutes.

Illegal Key Press Two short beeps. variable olume; cannot be silenced.

Key Click One short beep. Fixed minimum olume; can be silencedand disabled in System Con guration.

Prompt One short beep e ery 2 seconds. variable olume; can be silenced.

m i t c R i d r A isual message that, when enabled, appears at startup when scheduledpre enti e maintenance is due/o erdue for component of Alaris System(PC Unit or attached module).

Pr pt An audio signal and/or a isual message appearing on bottom line of Main Display or in Message Display. Audio signal can be silenced for 12 seconds by pressing sILenCe key.

D i iti (Continued)


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err r


al r

al r m i g R p

Battery Discharged Operation of all modules stoppeddue to insufficient battery charge.

Connect AC power cord to power source (alarm silenced). To continueoperation of paused modules, pressResTaRT key on affected module.

Channel Disconnected Module disconnected while inoperation or ha e a communicationproblem.

To silence alarm and clear messagefrom screen, press ConfIRm softkey. Reattach module, if needed,ensuring it is securely "clicked" intoplace at Module Release Latch.If alarm is still present, replacemodule.

very Low Battery


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m g

err r m i g R p

Power Supply Error Power supply system malfunction. Disconnect AC power immediately.To continue operation under batterypower, press sILenCe key. ReplacePC Unit.

System Error Error detected on PC Unit.Operation continues on all attachedmodules.

To continue temporary operation,press sILenCe key. ReplacePC Unit.

err r (Continued)

m g m i g R p

Battery Run Time = X.X hours AC power cord is disconnectedfrom power source. Approximateremaining battery run time under current power consumption rate isdisplayed.

Connect AC power cord to power source as soon as possible.

Low Battery Low battery threshold sensed;remaining battery run time islimited.

Connect to power source (alarmsilenced).

Panel Locked Tamper Resist feature is acti e andkey was pressed.

If appropriate, deacti ate Tamper Resist feature using Tamper ResistControl on back of PC Unit.

Panel Unlocked Tamper Resist feature deacti ated. None.

Powering Down Last module powering off. Systemshuts off in indicated number of seconds.

Press any key, except sYsTemon key, to cancel power downsequence.

Replace Battery Occurs at System On. Battery hasless than 50% of original capacity.

To continue normal operation withreduced battery capacity, pressConfIRm soft key. Replace PC Unit.


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Plug the PC Unit into an AC outlet during storage to ensure afully charged battery. The AC indicator light ( ) is on whenthe PC Unit is plugged in.

st r g

The PC Unit is equipped with a 12 olt, 4000 mAh nickelmetal hydride battery. The battery is charging whene er the instrument is plugged into an AC receptacle. The lifeexpectancy of the battery is dependent on the amount of use, the depth of discharge, and the state of the charge thatis maintained. Generally, the battery has the longest life if the instrument is plugged in and battery use is infrequent.Frequent use of battery power and insufficient battery chargecycles significantly decrease the life of the battery.

The quality of the battery is also a significant factor indetermining battery life and runtime. The battery cannot berepaired and should not be opened. Replace the battery withthe same type, size and oltage rating. Use only CareFusionbatteries and accessories.

Batteries should be charged in a room with a temperaturebetween 50 - 80.6 F (10 - 27 C) to minimize charge time andmaximize battery life.

B tt ry C r d m i t c

B tt ry Typ d Ch rgi g

B tt ry Ch rg

The PC Unit is shipped with the battery in a dischargedcondition.

Before the PC Unit is released for use, it should be pluggedinto a hospital grade AC outlet and the battery charged for atleast 8 hours. This ensures proper battery operation when theAlaris System is first set up for patient use.

Whene er possible, lea e the power cord connected to anexternal AC power source while operating the instrument.


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The battery capacity should be checked at least once e ery6 months. Refer to the Alaris System Technical Ser iceManual for test and replacement procedures.

If the PC Unit is to be stored at temperatures in excess of 86 F (30 C) for one or more months, the battery should be remo edand placed in an en ironment of 50 - 86 F (10 - 30 C).

If the batteries are to be stored for more than 1 year, theyshould be charged at least once per year to pre ent leakageand deterioration in performance due to self-discharge.

When the battery is first being put into use, or has been out of use for one or more months, it will not ha e full capacity due todeacti ation of reactants.

Restore such batteries to original performance by repeatingone or two cycles of fully charging and fully discharging.

Some temporary reduction in capacity might become apparentif the battery is partially discharged repeatedly. Doing oneor two cycles of full discharge and full charge can restore fullperformance.

B tt ry C r

B tt ry C r d m i t c (Continued)

B tt ry C uti d Di p l

Battery replacement should be performed by qualified ser icepersonnel while the instrument is not in use.

D t open, incinerate or shortcircuit. Wornout batteries must bedisposed of properly, according tolocal regulations.

CaUTIon


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I p cti R quir t

f ilur t p r r theseinspections can result in improper instrument operation.

waRnInG

Pr v tiv i t c inspections should only beperformed by qualified ser icepersonnel.

CaUTIon

To ensure that the Alaris System remains in good operatingcondition, both regular and pr

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Alaris System DFU Model 8015 092009

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