CareFusion Alaris 8015, Alaris 8100, Alaris 8220, Alaris 8110, Alaris 8600 User Manual

User Manual

Alaris™ System with Guardrails™ Suite MX

(with Alaris™ PC unit, Model 8015 Software Version 9.33)

February 2017

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CLEAR

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Table of Contents

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

General Contact Information

......................................................................................................iv

Introduction ................................................................................................................................... v

Approved Parts Recommendation .................................................................................. viii

Installation

................................................................................................................................... viii

Alaris PC Unit Model 8015................................................................................... Section 1

Alaris Pump Module, Model 8100 Alaris Syringe Module, Model 8110 ............... Section 2

Alaris PCA Module Model 8120 ........................................................................... Section 3

Alaris SpO

Alaris EtCO

Module Models 8210 and 8220 ........................................................ Section 4

2

Module Model 8300 ........................................................................ Section 5

2

Alaris Auto-ID Module Model 8600 ...................................................................... Section 6

Appendix

Troubleshooting and Maintenance..........................................................................................A-1

Alaris Systems Manager Connections...............................................................................A-2

Alarms and Alerts ..............................................................................................................A-3

Storage ............................................................................................................................A-24

Battery Care and Maintenance ........................................................................................ A-24

Wireless Connection........................................................................................................A-26

Cleaning...........................................................................................................................A-28

Service Information..........................................................................................................A-33

Regulations and Standards...................................................................................................A-35

Compliance......................................................................................................................A-35

Trademarks......................................................................................................................A-46

Order Number:

Printed Copy: P00000158
© 2005-2017 CareFusion Corporation or one of its affiliates. All rights reserved.

Alaris System User Manual – with v9.33 Model 8015 iii

General Contact Information

CareFusion
10020 Pacific Mesa Blvd
San Diego, California 92121
United States

Authorized European Representative
CareFusion UK 305 Ltd., The Crescent,
Jays Close, Basingstoke, Hampshire RG22 4BS, UK

Authorized Australian/New Zealand Representative
CareFusion Australia and New Zealand
Unit 3, 167 Prospect Highway
Seven Hills
NSW 2147
Australia

carefusion.com

Customer Advocacy - North America

(Clinical and technical feedback.)

Phone: [phone] Email: [e-mail]

Customer Advocacy - International

(Clinical and technical feedback.)

Email: [e-mail]

Technical Support - North America

(Maintenance and service information support; troubleshooting.)

Phone, United States: 888.812.3229

Phone, Canada: 800.387.8309

Technical Support - United Kingdom

(Maintenance and service information support; troubleshooting.)

Phone: [phone]

Email: [e-mail]

Customer Order Management - North America

(Product return, service assistance, and order placement.)

Phone, United States: 800.482.4822

Phone, Canada: 800.387.8309

Customer Care - United Kingdom

(Product return, service assistance, and order placement.)

Phone: [phone]

Email: [e-mail]

Technical Support and Customer Service - International

(Maintenance and service information support. Product return, service assistance, and order placement)

www.carefusion.com/customer-support/customer-service

Technical Support - Australia/New Zealand

(Maintenance and service information support; troubleshooting, service assistance.)

Phone: [phone]

Email: [e-mail]

iv Alaris System User Manual – with v9.33 Model 8015

Introduction

The Alaris™ PC unit section of this User Manual provides
procedures and information applicable to the Alaris System and
the PC unit. Each of the other major sections provides product­specific procedures and information.

The Alaris System is a modular system intended for adult,
pediatric, and neonatal care. It consists of the PC unit, the
Guardrails™ Suite MX, and up to four detachable infusion and/
or monitoring modules (channels). The Alaris Auto-ID module
can be included as a fifth module. The use of the Alaris System
is restricted to one patient at a time.

Guardrails Suite MX for the Alaris System brings a new level of
medication error prevention to the point of patient care. The
Guardrails Suite MX features medication dosing, concentration
delivery rate, and optional initial programming guidelines for up
to 30 patient-specific care areas, referred to as Profiles. Each
Profile contains a specific Drug Library, an IV Fluid library, and
channel labels, as well as instrument configurations
appropriate for the care area. Optional drug- or IV Fluid-specific
Clinical Advisories provide visual messages. Dosing limits for
each Guardrails drug entry or rate limits for each IV Fluid entry
can be a Hard Limit that cannot be overridden during infusion
programming and/or a Soft Limit that can be overridden, based
on clinical requirements.

WARNING

Read all instructions before using

the Alaris System.

CAUTION

nly

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A Data Set is developed and approved by the facility’s
own multi-disciplinary team using the Guardrails Editor
software, the PC-based authoring tool. A Data Set is then
transferred to the Alaris System by qualified personnel. The
approved Data Sets are maintained by the Editor Software for
future updates and reference.

Information about an Alert that occurs during use is
stored within the PC unit, and can be accessed using the
Guardrails CQI Reporter software.

Documentation provided with Alaris System products
might reference product not present in your facility or not yet
available for sale in your area.

A superscript number (for example,



) identifies additional

information provided as a NOTE at the end of the procedure.

Alaris System User Manual – with v9.33 Model 8015 v

Intended Use

Introduction (Continued)

The Alaris™ System with Guardrails™ Suite MX is intended for
use in professional healthcare facilities that utilize infusion
devices for the delivery of fluids, medications, blood, and blood
products. The Alaris System with Guardrails Suite MX is
intended to provide trained healthcare caregivers a way to
automate the programming of infusion parameters, thereby
decreasing the amount of manual steps necessary to enter
infusion data.

All data entry and validation of infusion parameters is
performed by the trained healthcare professional according to a
physician's order. The Alaris System with Guardrails Suite MX
is an interoperable system capable of communicating and
exchanging data accurately, effectively, securely, and
consistently with different information technology systems,
software applications, and networks, in various settings; and
exchanging data such that the clinical or operational purpose
and meaning of the data are preserved and unaltered.

Essential Performance

The Alaris infusion modules are designed to accurately deliver
the programmed amount of the medication or fluid over the
programmed time period. The Alaris infusion modules ensure
that an infusion is not being inadvertently delivered when the
user expects the system to be in a paused, stopped, or off
condition. The Alaris infusion modules employ measurement
systems to detect and alarm for conditions adverse to safe
administration of fluid. These include measurements of proper
infusion set loading (free flow detection), pressure (occlusion
detection), and air-in-line detection.

The EtC0

module will monitor and alarm when a patient

2

physiological condition is out of range.

The Sp0

module will monitor and alarm when a patient

2

physiological condition is out of range

vi Alaris System User Manual – with v9.33 Model 8015

Introduction (Continued)

WARNINGS AND CAUTIONS:

Product-specific warnings and cautions, covered in the
applicable sections of this User Manual, provide information
needed to safely and effectively use the Alaris System.

WARNING

A statement that alerts the user to the

possibility of injury, death, or other serious adverse reactions
associated with the use or misuse of the device.

CAUTION

A statement that alerts the user to the
possibility of a problem with the device associated with the use
or misuse of the device.

DEFINED TERMS:

The following table identifies the defined terms used
throughout this document for certain trademarked products
and product features.

Product/Feature Defined Term

Alaris™ Auto-ID module Auto-ID module

Alaris™ EtCO2 module EtCO2 module

Alaris™ PCA module PCA module

Alaris™ PC unit PC unit

Alaris™ Pump module Pump module

Alaris™ SpO2 module SpO2 module

Alaris™ Syringe module Syringe module

Alaris™ System Maintenance System Maintenance

Alaris™ Systems Manager Systems Manager

Guardrails™ alert Alert

Guardrails™ clinical advisory Clinical Advisory

Guardrails™ CQI Reporter CQI Reporter

Guardrails™ data set Data Set

Guardrails™ drug library Drug Library

Guardrails™ Editor Editor Software

Alaris System User Manual – with v9.33 Model 8015 vii

Introduction (Continued)

Product/Feature Defined Term

Guardrails™ hard limit Hard Limit

Guardrails™ IV fluid IV Fluid

Guardrails™ limit Limit

Guardrails™ PCA pause
protocol

Guardrails™ soft limit Soft Limit

SmartSite™ needle-free valve Needle-Free Valve

PCA Pause Protocol

Approved Parts Recommendation

CareFusion recommends the use of CareFusion manufactured
parts in the operation and maintenance of your CareFusion
equipment. Customer's use of repair or service parts, add-ons,
or disposables that are not approved by CareFusion is at
Customer's own risk and may void the product warranty
provided by CareFusion. Any 510(k) clearance from the Food
and Drug Administration (FDA) or regulatory approval secured
by CareFusion to market Alaris pumps was based on use of
only CareFusion manufactured parts and equipment. If non­CareFusion parts, add-ons or disposables are used for the
maintenance, repair or operation of your CareFusion
equipment, those parts were not validated by CareFusion for
safety and efficacy with our Alaris products, nor were they
included in the review and approval/clearance of the products.

Installation

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

Prior to placing the Alaris System in use:

1. Perform check-in procedure using System Maintenance

software.

2. Whether or not Profiles feature has been enabled

(see PC unit section, "System Options," "System
Configurations").

NOTE:

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

Data Set must be uploaded to the PC unit.

viii Alaris System User Manual – with v9.33 Model 8015



Alaris PC Unit

Model 8015

Alaris System User Manual – with v9.33 Model 8015 Section 1

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Table of Contents

Getting Started

Introduction............................................................................................................................................. 1-1

General Setup and Operation

Attach and Detach Module..................................................................................................................... 1-3

Attach Module................................................................................................................................. 1-3

Detach Module ............................................................................................................................... 1-4

Add Module While System is Powered On..................................................................................... 1-5

Start-Up.................................................................................................................................................. 1-6

Power On System........................................................................................................................... 1-6

Respond to Maintenance Reminder ............................................................................................... 1-7

Adjust Display Contrast .................................................................................................................. 1-7

Select New Patient and Profile Options.......................................................................................... 1-8

Adjust Audio Volume ...................................................................................................................... 1-10

Lock/Unlock Tamper Resist............................................................................................................ 1-11

Power Off System .................................................................................................................................. 1-12

System Options...................................................................................................................................... 1-13

Display Contrast ............................................................................................................................. 1-13

Patient ID........................................................................................................................................ 1-13

Clinician ID ..................................................................................................................................... 1-16

Power Down All Channels .............................................................................................................. 1-17

Anesthesia Mode............................................................................................................................ 1-18

Battery Runtime.............................................................................................................................. 1-21

System Configurations ................................................................................................................... 1-21

Serial Numbers............................................................................................................................... 1-23

Software Versions .......................................................................................................................... 1-24

Time of Day .................................................................................................................................... 1-25

Network Status ............................................................................................................................... 1-26

Wireless Connection....................................................................................................................... 1-29

Data Set Status .............................................................................................................................. 1-30

Maintenance Due ........................................................................................................................... 1-31

General Information

Warnings and Cautions.......................................................................................................................... 1-33

General........................................................................................................................................... 1-33

Electromagnetic Compatibility ........................................................................................................ 1-36

Features and Displays............................................................................................................................ 1-37

Features and Definitions................................................................................................................. 1-37

Operating Features, Controls, Indicators........................................................................................ 1-39

Displays .......................................................................................................................................... 1-42

System Configurable Settings................................................................................................................ 1-43

Specifications ................................................................................................................................. 1-44

Symbols.......................................................................................................................................... 1-46

PC Unit Section Table of Contents
Alaris System User Manual – with v9.33 Model 8015 1-iii

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Table of Contents PC Unit Section
1-iv Alaris System User Manual – with v9.33 Model 8015

Introduction

Getting Started

This section of the User Manual provides PC unit (Model

8015) and Alaris

System instructions and information. It is used

in conjunction with:

• PC Unit/ Pump Module Technical Service Manual

• Product-specific sections of this User Manual

• 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 provides
a common user interface for programming infusions and
monitoring, which helps to reduce complexity at the point of
care. The display uses color to clearly communicate critical
programming, infusion, monitoring and hospital-defined policy
information.

The wireless network card provides wireless communication
capability between the Alaris System and Alaris Systems
Manager. The combined use of the Alaris System and Alaris
Systems Manager is integrated into a facility’s existing network
infrastructure.

When enabled, the Alaris Systems Manager allows the
exchange of information between the Alaris Systems Manager
and the Alaris System. The PC unit can be operated
manually or in concert with the information exchanged with the
Alaris Systems Manager. If communication with the wireless
network is interrupted (for example, out of range), the Alaris
System can be used, as intended, in the manual mode.

WARNING

Read all instructions, including those

for the attached module(s) and
applicable accessories, before using
the Alaris System.

CAUTION

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PC Unit Section Getting Started
Alaris System User Manual – with v9.33 Model 8015 1-1

Introduction (Continued)

Alarms and Alerts: See "Appendix A - Troubleshooting and

Maintenance" for specific PC unit alarms and alerts.

Contraindications: None known.

Electromagnetic Environment: See "Appendix" section

of this User Manual ("Regulations and Standards,"
"Compliance").

Getting Started PC Unit Section
1-2 Alaris System User Manual – with v9.33 Model 8015

General Setup and Operation

Attach and Detach Module

Modules can be attached to either side of the PC unit or to
either side of another module. The process to attach or detach
is the same for either side, whether attaching/detaching
to/from a PC unit or another module.

An individual hospital/facility can choose to permanently attach
modules. To remove permanently attached modules, contact
qualified service personnel.Inserting a finger or other object
into the IUI connector, when the module is attached to the PC
unit, could result in electrical shock.

WARNING

Attach Module

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

Application of adhesive tape or other materials to the sides of
the PC unit and modules can prevent proper latching.

1. Position free module at a 45° angle, aligning IUI

connectors.

IUI Connector

Inserting a finger or other object into
the IUI connector, when the module
is attached to the PC unit, could
result in electrical shock.

Aligned IUI Connectors

Top View

45°

IUI Connectors Not Aligned

Front View

Top View

PC Unit Section General Setup and Operation
Alaris System User Manual – with v9.33 Model 8015 1-3

Attach and Detach Module (Continued)

Attach Module (Continued)

2. Rotate free module down against PC unit or attached

module until release latch snaps in place.

WARNING

When properly secured/snapped, the

release latch provides a very secure

connection between modules. If not
properly latched, a module can be
dislodged during operation.

WARNING

Failure to perform these operations
can result in improper instrument
operations.

WARNING

Failure to follow these instructions
may result in potential hazards
associated with damaged IUI
connectors.

Detach Module

1. Ensure that module is powered off before detaching.

2. Push module release latch and then rotate module up

and away from PC unit or attached module (opposite to
motion shown in "Attach Module" procedure) to disengage
connectors.

• Alaris System reidentifies and shows appropriate
module identification (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.

Release Latch

General Setup and Operation PC Unit Section
1-4 Alaris System User Manual – with v9.33 Model 8015

Attach and Detach Module (Continued)

Add Module While System is Powered On

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 are
reidentified. Module re-identification does NOT interrupt or
affect infusion or monitoring on active modules.

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

• If any of the following conditions are observed, affected
module must be removed from use and inspected by
qualified personnel:

◦ LED segments are not illuminated on displays during

power-on test.

◦ Indicator lights do not illuminate.
◦ Appropriate module identification does not appear.

PC Unit Section General Setup and Operation
Alaris System User Manual – with v9.33 Model 8015 1-5

Start-Up

Power On System

1. Connect PC unit to an external AC power source.

2. Press

SYSTEM ON key.

3. System self test begins:

• Diagnostics test causes all LED display segments
and Status Indicator lights of attached module(s) to
illuminate briefly.

• Power Indicator illuminates.

• Appropriate module identification (A, B, C, or D) is
displayed on attached module(s).

• An audio tone sounds.

• If PM Reminder option is enabled and scheduled
preventive maintenance is due,

REMINDER screen appears.

• At completion of system-on test,

MAINTENANCE

New Patient? screen

appears.

• If either of the following conditions is observed, PC unit
or affected attached module must be removed from
use and inspected by qualified personnel:

◦ System fails any part of self test.
◦ Main Display does not appear backlit, appears

irregular, or has evidence of a row of pixels not
functioning properly.

NOTE:

Previous infusion parameters are automatically cleared after



8 hours.

 The self test provides the clinician with verification of the

operational safety and correct functioning of alarms for the
Alaris System.

General Setup and Operation PC Unit Section
1-6 Alaris System User Manual – with v9.33 Model 8015

Start-Up (Continued)

Respond to Maintenance Reminder

If the

Preventive Maintenance (PM) Reminder option is enabled
and the PC unit or an attached module is due for preventive
maintenance, a
at power up. If necessary, the reminder can be temporarily
bypassed by pressing the

1. Notify the appropriate facility personnel when a

MAINTENANCE REMINDER occurs and remove instrument

requiring maintenance (see "Attach and Detach Module").

2. If Alaris System was powered off to replace PC unit,

reinitiate start-up process.

OR

MAINTENANCE REMINDER message appears

CONFIRM soft key.

MAINTENANCE REMINDER

Module(s) due for routine

B

preventive maintenance:

Module A:

YYYY-MM-DD

CONFIRM

If an attached module (such as a Pump module) was
powered off and removed,

MAINTENANCE REMINDER

display reflects removal of that module. To continue
start-up process, press

CONFIRM soft key.

Adjust Display Contrast

1. Press

DISPLAY CONTRAST soft key.

MAINTENANCE REMINDER

Module(s) due for routine

B

preventive maintenance:

CONFIRM

Midtown Hospital

NEW PATIENT ?

“Yes” Clears Previous
Patient Data

>Select Yes or No

DISPLAY

CONTRST

Yes

No

PC Unit Section General Setup and Operation
Alaris System User Manual – with v9.33 Model 8015 1-7

Start-Up (Continued)

Adjust Display Contrast (Continued)

2. To adjust display for optimum viewing, use Lighter/Darker

soft keys.

3. To return to main screen, press

CONFIRM soft key.

Select New Patient and Profile Options

The following procedures assume the Profiles feature is
enabled.

1. Select required

NEW PATIENT? option.

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

• To confirm programming is for same patient and retain
all stored patient parameters, press No soft key.

System Options

Display Contrast

®

>Adjust Display to
Desired Contrast

CONFIRM

Midtown Hospital

NEW PATIENT ?

“Yes” Clears Previous
Patient Data

Lighter

Darker

Yes

No

◦ Last used Profile is displayed.
◦ If Profiles feature is disabled, main menu appears.

2. Accept or change current Profile:

• To accept current Profile, press Yes soft key.

Main screen appears.

• To change Profile, press No soft key and continue with
next step.

Profile selection screen appears.

>Select Yes or No

DISPLAY

CONTRST

Midtown Hospital
Adult ICU

Adult ICU ?

“Yes” Confirms Same
Profile

>Select Yes or No

Yes

No

General Setup and Operation PC Unit Section
1-8 Alaris System User Manual – with v9.33 Model 8015

Start-Up (Continued)

Select New Patient and Profile Options (Continued)

3. To select a Profile, press corresponding left soft key.

To view additional choices, press

4. To confirm Profile selection, press

PAGE DOWN soft key.

CONFIRM soft key.

Main screen appears.

Patient ID Entry Feature

The option to enter and display a 16-character alphanumeric
patient identifier is always available. The instrument can be
configured to automatically display the Patient ID Entry
screen during start-up or to provide access only through the
Systems Options menu (see "System Options").

If Yes 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 entry
keys and/or alpha speed keys.

◦ An alphanumeric identifier, of up to 16 characters, can

be entered.

◦ Press soft key next to a letter group to list letters in

that group. Press soft key next to an individual letter to
enter that letter.

Midtown Hospital
Profiles

Adult ICU

Adult General Care

Neonatal

Peds ICU

Neonatal ICU

>Press CONFIRM

Patient ID Entry

A

B

C

D

E

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

>Enter Patient ID and Press
CONFIRM

EXIT

CONFIRM

CONFIRM

1 of 2

PAGE
DOWN

PAGE

DOWN

A-E

F-J

K-O

P-T

U-Y

◦ To access letter "Z" and special characters (hyphen,

underscore, space), press

◦ To clear an entire entry, press
◦ To back up a single character at a time, press

PAGE DOWN soft key.

CLEAR key.

CANCEL

key.

• To scan barcode on patient identification band,
see"Alaris Auto-ID Module Model 8600", section 6 of this
User Manual.

PC Unit Section General Setup and Operation
Alaris System User Manual – with v9.33 Model 8015 1-9

A

p

Start-Up (Continued)

Adjust Audio Volume

1. Press AUDIO ADJUST soft key.

WARNING

The user should check that the
current alarm preset is appropriate
prior to use on each patient.

WARNING

hazard can exist if different Alarm
Presets are used for the same or
similar equipment in a single area,
such as an Intensive Care Unit or a
Cardiac O

erating Theatre.

Midtown Hospital
Adult ICU

VTBI = 250.0 mL

VOLUME
INFUSED

AUDIO

ADJUST

2. To change volume to desired level, press either Louder
or Softer soft key. To sample alarm loudness level, press

Test soft key.

3. To return to PC unit screen, press

MAIN SCREEN soft key.

After 30 seconds without a key press, Main Display
appears.

NOTE:

The Minimum Audio Volume defaults to level 1. Levels 1-5 may be
set per profile. The user is able to lower the device AUDIO
VOLUME to the minimum limit set. When the minimum AUDIO
VOLUME LEVEL has been reached, the Louder/Softer soft keys
are unavailable and the PC unit emits an illegal key press audio.

CAUTION

Setting the audio volume to the
lowest level will lower all system
alarms, including secondary alarms
such as End of Infusion.

Audio Volume Adjust

Test

3

Softer

>Change Setting or
Cancel

Louder

MAIN

SCREEN

General Setup and Operation PC Unit Section
1-10 Alaris System User Manual – with v9.33 Model 8015

Start-Up (Continued)

Lock/Unlock Tamper Resist

1. Initiate operation of applicable module.

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

• An advisory tone (if Key Click Audio is enabled)

and a three-second

PANEL LOCKED prompt on Main

Display confirm activation.

• When Tamper Resist is active, keypad panel is locked;

however, clinician can:

◦ Silence audio alarm.
◦ View volume(s) infused.
◦ View and test audio alarm setting.
◦ View selected parameters on attached modules.

Any other key press results in a visual

PANEL LOCKED

prompt and, if Key Click Audio is enabled, an illegal
key–press audio advisory.

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

An advisory tone (if Key Click Audio is enabled) and a
three-second

PANEL UNLOCKED prompt on Main Display

confirm activation.

Midtown Hospital
Adult ICU

VTBI = 250.0 mL

PANEL LOCKED

VOLUME

INFUSED

Midtown Hospital
Adult ICU

VTBI = 250.0 mL

AUDIO

ADJUST

PANEL UNLOCKED

VOLUME
INFUSED

AUDIO

ADJUST

PC Unit Section General Setup and Operation
Alaris System User Manual – with v9.33 Model 8015 1-11

Power Off System

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 flashes

Powering Down.

• To interrupt power down sequence, quickly press any key

(except

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

SYSTEM ON) on PC unit.

Powering Down

General Setup and Operation PC Unit Section
1-12 Alaris System User Manual – with v9.33 Model 8015

System Options

Display Contrast

1. Press OPTIONS key.

2. Press Display Contrast soft key.

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

SILENCE

OPTIONS

1

2

4

5

7

8

CLEAR

0

System Options 1 of 3

Display Contrast

Patient ID

Clinician ID

Power Down All Channels

Anesthesia Mode

>Select an Option or
EXIT

EXIT

SYSTEM

ON

3

6

ENTER

9

CANCEL

PAGE

DOWN

Patient ID

Enter

1. Press

2. Press Patient ID

PC Unit Section General Setup and Operation
Alaris System User Manual – with v9.33 Model 8015 1-13

OPTIONS key.

soft key.

System Options 1 of 3

Display Contrast

Patient ID

Clinician ID

Power Down All Channels

Anesthesia Mode

>Select an Option or
EXIT

EXIT

PAGE

DOWN

System Options (Continued)

Patient ID (Continued)

Enter (Continued)

3. Scan or manually enter patient identifier:

• To manually enter patient identifier, use numeric data

entry keys and/or alpha speed keys.
◦ An alphanumeric identifier, of up to

16 characters,

can be entered.

◦ Press soft key next to a letter group to list letters

in that group. Press soft key next to an individual
letter 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, press

CANCEL key.

• To scan barcode on patient identification band, see

AUTO-ID section of this User Manual.

4. To verify correct entry, press

CONFIRM soft key.

Patient ID Entry

CONFIRM

A-E

F-J

K-O

P-T

U-Y

PAGE

DOWN

A

B

C

D

E

123456789CD_ _ _ _ _

>Enter Patient ID and Press
CONFIRM

EXIT

General Setup and Operation PC Unit Section
1-14 Alaris System User Manual – with v9.33 Model 8015

SILENCE

Modify

System Options (Continued)

Patient ID (Continued)

1. Press

OPTIONS key.

2. Press Patient ID soft key.

3. To clear entire entry, press

OR

CLEAR key.

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

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

• An alphanumeric identifier, of up to 16 characters, can

be entered.

• Press soft key next to a letter group to list letters in

that group. Press soft key next to an individual letter to
enter that letter.

OPTIONS

1

4

7

CLEAR

SYSTEM

ON

2

3

5

6

ENTER

9

8

0

CANCEL

OR

• To access letter "Z" and special characters (hyphen,

underscore, space), press

5. To verify correct entry, press

New Patient ID Entry verification screen appears.

PC Unit Section General Setup and Operation
Alaris System User Manual – with v9.33 Model 8015 1-15

PAGE DOWN soft key.

CONFIRM soft key.

Patient ID Entry

CONFIRM

A-E

F-J

K-O

P-T

U-Y

PAGE

DOWN

A

B

C

D

E

234567891EF_ _ _ _ _

>Enter Patient ID and Press
CONFIRM

EXIT

Modify (Continued)

System Options (Continued)

Patient ID (Continued)

6. To accept modified Patient ID, press Yes soft key.

Main screen appears with new Patient ID.

OR

To retain original (old) Patient ID, press No soft key.

Main screen appears with old Patient ID.

Clinician ID

1. Press

OPTIONS key.

2. Press Clinician ID soft key.

Patient ID Entry

Patient ID
123456789CD
will be changed to
234567891EF

Is this correct?

>Press Yes or No

System Options 1 of 3

Display Contrast

Patient ID

Clinician ID

Power Down All Channels

Anesthesia Mode

>Select an Option or
EXIT

EXIT

Yes

No

PAGE

DOWN

3. Scan or manually enter clinician identifier:

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

• An alphanumeric identifier, of up to 16 characters, can

be entered.

• Press soft key next to a letter group to list letters in

that group. Press soft key next to an individual letter to
enter that letter.

• To access letter "Z" and special characters (hyphen,

underscore, space), press

• To clear an entire entry, press

• To back up a single character at a time, press

PAGE DOWN soft key.

CLEAR key.

CANCEL

key.

General Setup and Operation PC Unit Section
1-16 Alaris System User Manual – with v9.33 Model 8015

System Options (Continued)

Clinician ID (Continued)

4. To verify correct entry, press CONFIRM soft key.

Power Down All Channels

1. Press

OPTIONS key.

2. Press Power Down All Channels soft key.

Clinician ID Entry

CONFIRM

PAGE

DOWN

PAGE

DOWN

A-E

F-J

K-O

P-T

U-Y

A

B

C

D

E

123456789CD_ _ _ _ _

>Enter Clinician ID and Press
CONFIRM

EXIT

System Options 1 of 3

Display Contrast

Patient ID

Clinician ID

Power Down All Channels

Anesthesia Mode

>Select an Option or
EXIT

EXIT

3. Press Yes soft key.

During power off sequence, Main Display flashes

POWERING DOWN.

System Options

Power Down
All Channels?

>Press Yes or No

Yes

No

PC Unit Section General Setup and Operation
Alaris System User Manual – with v9.33 Model 8015 1-17

System Options (Continued)

Anesthesia Mode

When the Anesthesia Mode is enabled and then the pause
feature is used - the module remains in an indefinite pause until
restarted.

When Anesthesia Mode is enabled:

• A channel can be paused indefinitely without an alarm.

• The air-in-line associated with the Profile can be set up to

500 micro liters.

• All limits are set to Soft.

• Limit Checking mode is set to Smart.

• Key-press audio is turned off.

• Auto-Restart for Anesthesia Mode is set to 9 and is not

configurable.

• Panel Lock through Tamper Resist Mode or Authorized

User Mode is not available.

• Guardrails drug list defaults to drugs designated by Editor

Software as anesthesia only. All Guardrails drugs in a
Profile can be viewed by pressing ALL DRUGS soft key.

• Bolus Dose is automatically available for:

WARNING

When the Alaris System is set up for
use in Anesthesia Mode, it is
important to select the Profile that
corresponds with the care area the
patient will be taken to when the
Anesthesia Mode is discontinued.
This ensures that the Alaris System
will be in the correct Profile following
the use of the Anesthesia Mode.

◦ Guardrails drugs that have Bolus Dose limits defined
◦ generic drug calculation setup

• Anesthesia Mode, alternating with other required prompts,

is displayed in prompt bar of Main Display.

• Callback audio for paused module is permanently silenced.

• Review of drug calculation setup page is omitted when

restoring a stopped drug calculation.

• Clinical Advisories are not displayed.

NOTE:

If an infusion is paused in regular mode and then the anesthesia
mode is enabled - the device will alarm at the 2 minute warning.

Enable

1. Press

OPTIONS key.

System Options 1 of 3

Display Contrast

Patient ID

Clinician ID

Power Down All Channels

Anesthesia Mode

>Select an Option or
EXIT

EXIT

PAGE

DOWN

General Setup and Operation PC Unit Section
1-18 Alaris System User Manual – with v9.33 Model 8015

System Options (Continued)

Anesthesia Mode (Continued)

Enable (Continued)

2. Press Anesthesia Mode soft key.

3. Press Enable soft key.

4. Press

CONFIRM soft key.

Disable

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

• System Options menu.

• Disconnecting from AC power.

• Connecting to AC power.

From System Options Menu

1. Press

OPTIONS key.

System Options

Anesthesia Mode

Enable

Disable

Pump Module
Air Detection =

microliters

75

>Select an Option or Press
CONFIRM

Change

CONFIRM

2. Press Anesthesia Mode soft key.

3. Press Disable soft key.

4. Press

CONFIRM soft key.

Anesthesia Mode no longer appears on Main Display,

indicating it has been disabled.

PC Unit Section General Setup and Operation
Alaris System User Manual – with v9.33 Model 8015 1-19

System Options (Continued)

Anesthesia Mode (Continued)

Disable (Continued)

Connect to AC Power

1. Connect system to AC power.

2. To continue using Anesthesia Mode, press Yes soft key.

OR

To discontinue Anesthesia Mode, press No soft key.

AC power cord was
connected.
Continue

>Select Yes or No

Yes

No

?ANESTHESIA MODE

Disconnect from AC Power

1. Disconnect system from AC.

• Anesthesia Mode is automatically disabled.

• All currently running infusions continue.

• A prompt appears as an alert that Anesthesia Mode

has been discontinued.

2. Press

CONFIRM soft key.

Anesthesia mode was
when AC power
disconnected.
continue normal operation.

>Press CONFIRM

discontinued

cord was

Press CONFIRM to

CONFIRM

General Setup and Operation PC Unit Section
1-20 Alaris System User Manual – with v9.33 Model 8015

Battery Runtime

1. Press OPTIONS key.

System Options (Continued)

2. Press

PAGE DOWN soft key.

3. Press Battery Runtime soft key.

4. To return to main screen, press

CANCEL key or EXIT soft

key.

System Options 2 of 3

Battery Runtime

System Configurations

Serial Numbers

Software Versions

Time of Day

>Select an Option or
EXIT

PAGE UP

EXIT

System Options

Estimated battery
runtime at current
operating parameters

PAGE

DOWN

9.5 hours

>Press CANCEL or EXIT

EXIT

System Configurations

1. Press OPTIONS key.

2. Press

3. Press System Configuration soft key.

PC Unit Section General Setup and Operation
Alaris System User Manual – with v9.33 Model 8015 1-21

PAGE DOWN soft key.

System Options 2 of 3

Battery Runtime

System Configurations

Serial Numbers

Software Versions

Time of Day

>Select an Option or
EXIT

PAGE UP

EXIT

PAGE

DOWN

System Options (Continued)

4. Press PC Unit soft key.

5. To review various system configuration settings, press

PAGE DOWN and PAGE UP soft keys.



System Configuration - Module

Factory Default:

Shared Infusion Settings

PC Unit

Pump Module

SPO2 Module

>Press CANCEL or EXIT

EXIT

System Config - PCU 1 of 3

Alarm audio:

Anesthesia Mode: Disabled

Battery meter:

Clock setup:

Limit Checking:

>Press CANCEL or EXIT

EXIT

Yes

PAGE

DOWN

Profile 1

Disabled

09:00

ALWAYS

PAGE

DOWN

System Config - PCU 2 of 3

Key click audio:

Max Pt. BSA:

Max Pt. weight:

Patient ID Entry:

>Press CANCEL or EXIT

PAGE

EXIT

UP

Enabled

2

2 m

500 kg

Disabled

PAGE

DOWN

General Setup and Operation PC Unit Section
1-22 Alaris System User Manual – with v9.33 Model 8015

System Options (Continued)

System Configurations (Continued)

6. To return to main screen, press CANCEL key or EXIT soft
key.

NOTE:

The Profiles option is listed only if it is disabled.



 The Limit Checking and Max Pt. BSA options are listed only if

the Profiles option is enabled and a valid Data Set is loaded.

Serial Numbers

1. Press

OPTIONS key.

System Config - PCU 3 of 3

PM Reminder:

Tamper resist:

>Press CANCEL or EXIT

PAGE

EXIT

UP

Disabled

Disabled

2. Press

PAGE DOWN soft key.

3. Press Serial Numbers soft key.

Serial numbers for PC unit and all attached modules
display.



System Options 2 of 3

Battery Runtime

System Configurations

Serial Numbers

Software Versions

Time of Day

>Select an Option or
EXIT

PAGE UP

EXIT

PAGE

DOWN

PC Unit Section General Setup and Operation
Alaris System User Manual – with v9.33 Model 8015 1-23

System Options (Continued)

Serial Numbers (Continued)

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

NOTE:

"nnnn-nnnnnnnn" in the illustrated display represents a model



and serial number.

Software Versions

1. Press

2. Press

OPTIONS key.

PAGE DOWN soft key.

3. Press Software Versions soft key.

Serial Number Review

PC Unit:

Module A:

Module B:

Module C:

Module D:

>Press CANCEL or EXIT

System Options 2 of 3

Battery Runtime

System Configurations

Serial Numbers

Software Versions

Time of Day

nnnn-nnnnnnnn

nnnn-nnnnnnnn

nnnn-nnnnnnnn

nnnn-nnnnnnnn

nnnn-nnnnnnnn

EXIT

>Select an Option or

4. To review software version information, press View soft
key next to applicable module.

OR

To return to main screen, press EXIT soft key.

EXIT

PAGE UP

EXIT

Software Rev. Review

PC Unit:

Module A:

Module B:

Module C:

Module D:

>Select an Option or
EXIT

EXIT

PAGE

DOWN

View

View

View

View

View

OR

General Setup and Operation PC Unit Section
1-24 Alaris System User Manual – with v9.33 Model 8015

System Options (Continued)

Software Versions (Continued)

5. To return to previous screen, press EXIT soft key.

NOTE:

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



version.

Time of Day

1. Press OPTIONS key.

2. Press

PAGE DOWN soft key.



Software Rev. Review

Module Software: A

Main processor:

Main boot block:

Keyboard:

>Press CANCEL or EXIT

EXIT

nn.nn

nn.nn

nn.nn

3. Press Time of Day soft key.

4. If time is correct, press

OR

CONFIRM soft key.

To change time, press Change Time soft key.



System Options 2 of 3

Battery Runtime

System Configurations

Serial Numbers

Software Versions

Time of Day

>Select an Option or
EXIT

PAGE UP

EXIT

System Options

Time of Day

Current time:

09:00

>CONFIRM Time-of-Day

EXIT

CONFIRM

PAGE

DOWN

Change

Time

PC Unit Section General Setup and Operation
Alaris System User Manual – with v9.33 Model 8015 1-25

System Options (Continued)

Time of Day (Continued)

5. Enter current Time of Day.

6. Press

CONFIRM soft key.

System Options

Time of Day

Current time:

__:__

>Enter Current Time

CONFIRM

EXIT

System Options

Time of Day

Current time:

14:30

>Press CONFIRM

CONFIRM

EXIT

Change

Time

Change

Time

NOTE:

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



Network Status

The displayed status updates immediately when a status
change takes place.

1. Press

2. Press

General Setup and Operation PC Unit Section
1-26 Alaris System User Manual – with v9.33 Model 8015

OPTIONS key.

PAGE DOWN soft key two times.

System Options (Continued)

Network Status (Continued)

3. To view network status and wireless status information,
press Network Status soft key.

4. Enter password (refer to v9.5 or later System Maintenance
software instructions) and press

• Information based on a wireless status of

DISASSOCIATED, CONFIGURING, ASSOCIATING,
ASSOCIATED, or AUTHENTICATING is displayed.

• If wireless status is

ASSOCIATED, following

information is displayed:
◦ Wireless connectivity:

Authentication, and Encryption types being

BSSID—MAC address of access point that

used;
system is connected to; Speed—transfer rate up to
11 Mbps for 802.11b, 54 Mbps for 802.11a or

802.11b/g and 72 Mbps for 802.11a/b/g/n.

CONFIRM soft key.

DISABLED,

SSID, Channel,

System Options 3 of 3

Network Status

Wireless Connection

Data Set Status

Maintenance Due Yes

>Select an Option or
EXIT

EXIT

PAGE UP

System Options

Viewing Network Status
is only to be used by
qualified personnel.

* _ _ _ _

>Enter Password or
EXIT

CONFIRM

EXIT

System Options

Wireless Status

ASSOCIATED

Status :

AM SWEPXXXXXXXX

SSID :

XXXXXXXXXXXXXXX

BSSID :

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

Channel :

1 (2.412 Ghz)

Authentication :

Encryption:

Speed: 11 Mbps

>Press CANCEL to Exit

OPEN
40 bit WEP

Link Quality

Signal Strength

NET

STATUS

NET

ADDRESS

35%
75%

SERVER

STATUS

◦ Link Quality—a minimum of 20% recommended

for good wireless connectivity.

◦ Signal Strength—

greater than 20% recommended

for good wireless connectivity.

5. To view network connectivity information, press

STATUS soft key.

• A status of

CONFIGURING, INVALID CONFIG, or CONNECTED is

DISABLED, DISCONNECTED,

NET

displayed.

• If status is

CONNECTED:

◦ PC unit is connected to wireless network.
◦ Profile being used is displayed.

PC Unit Section General Setup and Operation
Alaris System User Manual – with v9.33 Model 8015 1-27

System Options (Continued)

Network Status (Continued)

6. To view network address information, press NET

ADDRESS

•

MAC Address of wireless RF card attached to PC unit

soft key.

is displayed.

DHCP displays NO, PC unit is set to use a Static IP

• If

address.

• When PC unit is connected to wireless network,

IP Address, Subnet Mask, Gateway, and

DNS

information is displayed.

System Options

Network Status

Status :
Uptime :

Bytes Sent:

Bytes Recv:

>Press CANCEL to Exit

WIRELESS

STATUS

CONNECTED
03:45:35

13, 890

1,200,150

NET

ADDRESS

Pre-v9.5 PC unit:

System Options

Network Status

Status:
Uptime:

Profile:

Bytes Sent:

Bytes Received:

>Press CANCEL to Exit

WIRELESS

STATUS

CONNECTED

03:45:35

Site 1

13, 890

1,200,150

NET

ADDRESS

SERVER
STATUS

SERVER

STATUS

7. To view server connectivity information, press SERVER

STATUS soft key.

v9.5 and later PC unit:

System Options

Network Address

MAC Address:

DHCP:

IP Address:
Subnet Mask:
Gateway:

DNS Primary:
DNS Secondary:

>Press CANCEL to Exit

WIRELESS

STATUS

NET

STATUS

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

Yes

192.168.0.55

255.255.255.0

192.168.0.1

192.168.0.1

192.168.0.3

SERVER
STATUS

General Setup and Operation PC Unit Section
1-28 Alaris System User Manual – with v9.33 Model 8015

System Options (Continued)

Network Status (Continued)

• Information based on a status of DISABLED,

DISCONNECTED, CONNECTING, or CONNECTED is

displayed.

• If status is CONNECTED, PC unit is connected to Alaris

Systems Manager and the following information
is displayed:

◦ Uptime—length of time PC unit has been

connected.

◦ Server Address—IP Address of Alaris Systems

Manager.

◦ TCP Port being used to establish connection.
◦ Encryption type (AES 128-bit) used to encode

data on payload and protect patient-sensitive
information sent through wireless network.

◦ Bytes Sent—cumulative total of data sent.
◦ Bytes Received—cumulative total of data

received.

◦ Server Name first 20 characters of fully qualified

domain name of Alaris Systems Manager.

v9.5 and later PC unit:

System Options

Server Status

Status:
Uptime:

Server Address:
Server Name:

TCP Port:

Local Timeout:
Server Timeout:
Encryption:
Bytes Sent:
Bytes Received:
Last Disconnect:

>Press CANCEL to Exit

WIRELESS

STATUS

CONNECTED
00:00:02

192.168.0.2
AlarisServer1.JDhospit
3613
20ms
20ms
AES 128-bit
1,103,470,776
94,300
UNKNOWN

NET

ADDRESS

STATUS

NET

Wireless Connection

1. Press

2. Press

OPTIONS key.

PAGE DOWN soft key two times.

3. Press Wireless Connection soft key.

If Wireless Connection soft key is inactive (grayed
out), the PC unit has the following configuration:

• the System Maintenance software was used to disable

wireless connection

• the CF card flashing process was done without the

programming of the proper AppConfig file (v9.12 or
later) For more information, refer to the Alaris PC Unit

Model 8015 Software and Hardware Upgrade
Instructions to v9.33.

• A valid network configuration was never transferred

To enable wireless connection, use v9.5 or later System
Maintenance software. Send the PC unit to Biomed to resolve
wireless connectivity issues.

System Options 3 of 3

Network Status

Wireless Connection

Data Set Status

Maintenance Due Yes

>Select an Option or
EXIT

EXIT

PAGE UP

PC Unit Section General Setup and Operation
Alaris System User Manual – with v9.33 Model 8015 1-29

System Options (Continued)

Wireless Connection (Continued)

4. Wireless connection can be disabled or enabled:

• To disable wireless communication, press Disable

soft key.
◦ If wireless connection is disabled, it remains

disabled until PC unit is powered off. Setting
defaults to Enable when PC unit is powered back
on.

◦ v10.33 or later System Maintenance software

instructions also includes a procedure on how to
disable a wireless RF card on a PC unit being used
in a non-wireless environment. Wireless
connection remains disabled until System
Maintenance software is used to enable it.

• To enable wireless connection, press Enable

Pre-v9.5 PC unit: View Network Status after
pressing Enable

soft key. If a Status of DISABLED is

identified, System Maintenance software was used to
disable wireless connection. Use v9.5 or later System
Maintenance software to enable wireless connection.

Data Set Status

1. Press

OPTIONS key.

soft key.

System Options

Wireless
Connection

>Press ENABLE or
DISABLE

Enable

Disable

2. Press

3. To view Data Set status, press Data Set Status soft key.

PAGE DOWN soft key two times.

System Options 3 of 3

Network Status

Wireless Connection

Data Set Status

Maintenance Due Yes

>Select an Option or
EXIT

EXIT

PAGE UP

General Setup and Operation PC Unit Section
1-30 Alaris System User Manual – with v9.33 Model 8015

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

System Options (Continued)

Data Set Status (Continued)

A status of Current, Pending, Transferring, or Not
Activated is displayed.

Maintenance Due

1. Press

2. Press

OPTIONS key.

PAGE DOWN soft key two times.

3. Press Maintenance Due soft key.

System Options

Data Set Status

B

Current:

(none available)

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

Pending:

Midtown Hospital
Dataset ID: 83442BB
Not Activated

>Press EXIT

EXIT

System Options 3 of 3

Network Status

Wireless Connection

Data Set Status

Maintenance Due Yes

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



System Options

Maintenance Due Dates

Module(s) due for routine

B

preventative maintenance:

PC Unit:

.

Module A:

Module B:

Module C:

Module D:

>Press CANCEL or EXIT

YYYY-MM-DD

YYYY-MM-DD

YYYY-MM-DD

YYYY-MM-DD

YYYY-MM-DD

EXIT

PAGE
DOWN

>Select an Option or
EXIT

EXIT

PAGE UP

System Options

Maintenance Due Dates

Module(s) due for routine

B

preventative maintenance:

Bar Code:

.

Bar Code:
(Hand held)

>Press CANCEL or EXIT

PAGE UP

YYYY-MM-DD

YYYY-MM-DD

EXIT

PC Unit Section General Setup and Operation
Alaris System User Manual – with v9.33 Model 8015 1-31

NOTE:
 PAGE DOWN

attached.

System Options (Continued)

Maintenance Due (Continued)

soft key appears only if an Auto-ID module is

General Setup and Operation PC Unit Section
1-32 Alaris System User Manual – with v9.33 Model 8015

Warnings and Cautions

General

WARNINGS

• Explosion risk if used in the presence of flammable
anesthetic agents or gasses.

• Assess patient’s condition before silencing an alarm. Do
not silence alarm if patient safety might be compromised.

• Before each use, verify that the alarm limits are
appropriate for the patient.

• The Alaris System performs a self check during power
up. The PC unit should beep, no errors should occur, and if
a module is connected, all LED segments should flash. If
the Alaris System fails the self check, remove the failing
PC unit or module from use.

• When properly secured/snapped, the release latch
provides a very secure connection between modules. If not
properly latched, a module can be dislodged during
operation.

General Information

• Disconnect from main (AC) and battery power when
performing maintenance.

• Use only CareFusion batteries. The use of third party
batteries could affect the safety and efficacy of Alaris
products.

• The battery cannot be repaired and should not be opened.

• The battery is intended as a backup system. Leave the
power cord connected to a hospital grade AC power source
whenever available.

• Battery replacement should be performed by qualified
service personnel while the instrument is not in use.

PC Unit Section General Information
Alaris System User Manual – with v9.33 Model 8015 1-33

Warnings and Cautions (Continued)

General (Continued)

WARNINGS

• Electrical shock hazard. Do not open case. Refer to
qualified service personnel.

Due to the

•
some data can be lost if a connection cannot be established
or is lost. The Alaris Systems Manager and wireless
network card are designed to minimize these incidents but
cannot eliminate them.

• The Alaris System is not intended to replace supervision
by medical personnel. The user must become thoroughly
familiar with the Alaris System features, operation, and
accessories prior to use.

intermittent nature of a wireless environment

,

General Information PC Unit Section
1-34 Alaris System User Manual – with v9.33 Model 8015

Warnings and Cautions (Continued)

General (Continued)

CAUTIONS

• Always use a grounded three-wire receptacle. Where
the integrity of the protective earth grounding system is in
doubt, operate on internal battery.

• Hyperbaric Chamber Operation:
◦ The Alaris System is not certified for use in oxygen-

enriched environments.

◦ The Alaris System, with the exclusion of the

EtCO
malfunction alarms due to the hyperbaric chamber
environment or unintentional key presses when used in
a hyperbaric chamber.

◦ The healthcare facility's hyperbaric safety director is

responsible for all equipment used in the hyperbaric
chamber environment.

module, has been verified to operate with no

2

• Should an instrument or accessory be dropped or
severely jarred, it should be immediately taken out of use
and inspected by qualified service personnel to ensure its
proper function prior to reuse.

• If an instrument appears damaged, contact CareFusion for
authorization to return it for repair.

PC Unit Section General Information
Alaris System User Manual – with v9.33 Model 8015 1-35

Warnings and Cautions (Continued)

Electromagnetic Compatibility

WARNINGS

• Do not use the Alaris System near Magnetic Resonance
Imaging (MRI), including Stereotaxis technology.

• Do not use the Alaris System near Therapeutic Radiation
equipment, such as Linear Accelerators.

• Use of any accessory, transducer or cable other than
those specified can result in increased emissions or
decreased Alaris System immunity.

• Do not use an RF device within 7.8 inches/20 cm of the
Radio Card on the PC unit. FCC approval of the Radio
Card excludes co-location with any other transmitter.

• Per FCC regulations, maintain a distance of at least

7.8 inches/20 cm between the Radio Card on the PC unit
and a human body.

General Information PC Unit Section
1-36 Alaris System User Manual – with v9.33 Model 8015

Warnings and Cautions (Continued)

Electromagnetic Compatibility (Continued)

CAUTIONS

• The Alaris System should not be used adjacent to or
stacked with other equipment. If adjacent or stacked use

is necessary, monitor the Alaris System to verify that it is
operating normally in that setup.

• Portable and mobile RF communications can affect
medical electrical equipment.

• Interconnected data communications systems must be
certified to IEC 60950 (data processing equipment) or
IEC 60601–1 (electromedical equipment).

• The Alaris System is intended for use by healthcare
professionals only. This is a CISPR 11 Class B Group 1
medical system. In a domestic environment, this system
can cause radio interference. Reorienting, relocating or
shielding the system, or filtering the connection to the public
mains network, are examples of steps that can be taken to
reduce or eliminate interference.

• Medical electrical equipment needs special precautions
regarding EMC and needs to be installed and used
according to the EMC information provided in the
"Appendix" section of this User Manual (see "Regulations
and Standards," "Compliance").

Features and Displays

Features and Definitions

See the product-specific section of this User Manual that applies to the attached module(s) for features
and definitions specific to that module.

Feature Definition

Clinician ID An optional alphanumeric 16-character clinician identifier that can be

entered and displayed.

Data Set Created using Editor Software authoring tool and then transferred to

PC unit. A Data Set reflects facility’s best-practice guidelines for
administration and includes: Profile Drug Libraries, Clinical Advisories,
instrument configurations, and Channel Label Libraries.

IV Drug

PC Unit Section General Information
Alaris System User Manual – with v9.33 Model 8015 1-37

Features and Displays (Continued)

Features and Definitions (Continued)

Feature Definition

Guardrails Suite MX Designed to help prevent programming errors by:

• Customizing device configurable settings to meet need of selected
hospital/facility area/unit (Profile).

• Comparing user-programming with hospital-defined best-practice
guidelines.

• Providing a visual and audio prompt if an out-of-limits entry is made.

Patient ID An optional alphanumeric

entered and displayed

• When enabled, ID entry defaults to Startup screen.

• When disabled, ID entry is only accessible from System Options
screen.

Profile A unique set of system configuration settings and best-practice guidelines

for a specific patient population or patient type, and can consist of
following components:

• Instrument configuration settings.

• A Drug Library, which includes drug names, standard concentrations,
dosing units, duration limits, and optional associated Clinical Advisories
for 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 delivery.

• A Channel Label Library with text (alphanumeric) labels, which allows
identification (on modules) that can be used to indicate route of delivery
(for example, epidural).

Profile settings are established by the facility’s own multi-disciplinary team
prior to system implementation. Profile parameters are used to create a
Data Set, which is then transferred to the PC unit.

16-character patient identifier that can be

System Configuration Allows system settings to be customized. If Profiles feature is enabled, the

system settings defined for selected Profile are automatically activated.

Tamper Resist Provides a quick one-touch lockout of the front panel keypad when the

infusion is running, during a delay, or a SpO
monitoring. You cannot lockout the front panel keypad during KVO. An
alarm can be silenced even though the panel is locked.

General Information PC Unit Section
1-38 Alaris System User Manual – with v9.33 Model 8015

or EtCO2 module is actively

2

Features and Displays (Continued)

Operating Features, Controls, Indicators

Main Display

Soft Keys: When pressed,

allows selection of options or
infusion parameters appearing
on Main Display adjacent to
soft key.

Silence Key: When pressed

during an alarm, silences audio
for 2 minutes.

Options Key: When pressed,

allows access to available
System or Channel Options.

Soft Keys (see above)

Battery Indicator: When

illuminated, indicates
Alaris System is operating
on battery power.

ower Indicator: When

lluminated, indicates

laris System is connected

o an AC power source.

Wireless Network
Indicator: When illuminated,

indicates Alaris System is
connected to Alaris Systems
Manager. When blinking,
indicates data transfer.

IUI Connector, Left

(not visible)

Clear Key: When

pressed, clears current
selected parameter setting
to "0".

Module Release Latch:

When pressed, allows
module to be removed.

IUI Connector, Right

System On Key: When

pressed, changes Alaris System
from standby to operating mode.

Up Key: When pressed,
increases parameter with each
key press or scrolls up when
pressed and held.

Down Key: When pressed,
decreased parameter with each
key press or scrolls down when
pressed and held.

Enter Key: When pressed,
confirms current parameter entry.

Cancel Key: When pressed,

sequentially backs out of current
setup sequence.

Decimal Key: When pressed,

inserts a decimal point in numeric
data.

Numeric Keypad

PC Unit Section General Information
Alaris System User Manual – with v9.33 Model 8015 1-39

Features and Displays (Continued)

Operating Features, Controls, Indicators (Continued)

Rear Panel - IEC 802.11 a/b/g/n Wireless

Network Card

IUI Connector, Right IUI Connector, Left

Power Cord Strap
Use this bolt to reorient
Pole Clamp 90° for
attachment to a bed rail
instead of a pole.

Primary Audio Speaker

Rear Cover

Wireless

Antenna/Network

Card

Connector Plug over RJ45
Communication Data Port.

Tamper Resist Switch

General Information PC Unit Section
1-40 Alaris System User Manual – with v9.33 Model 8015

Features and Displays (Continued)

Operating Features, Controls, Indicators (Continued)

Rear Panel - Compact Flash b/g or a/b/g
Wireless Card

IUI Connector, Right IUI Connector, Left

Use this bolt to reorient
Pole Clamp 90° for
attachment to a bed rail
instead of a pole.

Primary Audio Speaker

Connector Plug over RJ45
Communication Data Port.

Power Cord Strap

Compact Flash Wireless Network

Card (see illustration below for

LED location)

Tamper Resist Switch

Wireless Network Card LED

Flashes green when

Alaris System is powered up.

PC Unit Section General Information
Alaris System User Manual – with v9.33 Model 8015 1-41

Features and Displays (Continued)

Displays

The displays illustrated throughout this document are for
illustration purposes only. The display content varies,
depending on configuration settings, hospital-defined Data
Set uploaded using the Guardrails Suite MX, and many other
variables.

A color versus monochrome display option is available when
creating a hospital-defined, best-practice Data Set. If no
Data Set is present or the Profiles feature is disabled, the
default is a color display. During normal operation, the title
and prompt bars are blue when a color display is enabled.
See "Troubleshooting and Maintenance," "Alarms, Errors,
Messages" for additional color categories.

Main Display

Title Bar

Module Status

• A solid letter display indicates
module is operating.

• An outlined letter display
indicates module is attached
and ready for use.

Soft Keys

Module Selected Indicator

"Inactive" Soft Key

Non-highlighted indicates a
non-selected soft key.

"Active" Soft Key

Highlighted indicates a
selected soft key.

Prompt Bar

Look here for user prompts.

Midtown Hospital
Adult ICU

VTBI = 250.0 mL

VOLUME
INFUSED

Infusion Setup

RATE

VTBI

>Press START

PAUSE

40 mL/h

_250 mL

AUDIO

ADJUST

SECOND-

ARY

START

General Information PC Unit Section
1-42 Alaris System User Manual – with v9.33 Model 8015

System Configurable Settings

If the configuration settings need to be changed from the
Factory default settings, refer to the applicable Technical
Service Manual or contact CareFusion Technical Support,
for technical, troubleshooting, and preventive maintenance
information.

With the Profiles feature enabled, the settings are configured
independently for each Profile. A hospital-defined, best­practice Data Set must be uploaded to enable the Profiles
feature. Date and Time is a system setting and is the same in
all Profiles.

Feature Default Setting Options

Alarm Audio Profile 1 Profile 1, 2, 3, or 4

Anesthesia Mode Disabled Enabled - Disabled

Battery Meter Disabled Enabled - Disabled

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

Key Click Audio Enabled Enabled - Disabled

Max Patient Weight 500 kg 0.1 - 500 kg

Patient ID Entry Disabled Enabled - Disabled

PM Reminder

(Preventive Maintenance)

Profiles Disabled Enabled - Disabled

Tamper Resist Disabled Enabled - Disabled

Enabled Enabled - Disabled

PC Unit Section General Information
Alaris System User Manual – with v9.33 Model 8015 1-43

Specifications and Symbols

Specifications

Battery Operation: Battery run time is a function of the number of modules attached and module

activity. With a new, fully charged battery, the system operates as follows before
a "BATTERY DISCHARGED" message occurs:

• 1 hour with four Pump modules infusion at 999 mL/h and one Auto-ID module

• 6 hours with one Pump module infusing at 25 mL/h

• 6 hours with one Pump module infusing at 25 mL/h

• 3 hours with four Pump modules infusing at 25 mL/h

• 3 hours with four Pump modules infusing at 25 mL/h and one Auto-ID module

• 4.5 hours with one active SpO2 module

• 6 hours with one Syringe module or PCA module infusing at 5 mL/h

• 3 hours with four Syringe modules, or one PCA module and three Syringe
modules, infusing at 5 mL/h

• 4 hours with one active EtCO2 module

Communication Data Port: RS-232 with an RJ45 connector.

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

and one Auto-ID module

Electric Classification: Class 1, Internally Powered Equipment

Electronic Memory: The System configuration/data set is stored in compact flash memory along with

operating software.

The events and error logs, CQI, and historical reporting logs, and the system
alarm settings are stored in the on-board flash memory in the Alaris PC unit and
modules. This is nonvolatile memory and can be held indefinitely or until replaced
with new data. Logs and alarm settings are maintained even during a total loss of
power to the system. The date and time of system power down is captured in the
event log. The older log entries are purged as the log file reaches capacity. The
Alaris System's Tamper Resist Mode/Authorized User Modes restricts access to
making changes to logs or to the storage of logs.

Module-specific parameters are stored for 8 hours when system is turned
off. After 8 hours of continuous off-time, or if a module is detached, module­specific trend data (if applicable) and module-specific operating parameters are
automatically purged. If a PCA, SpO2 or EtCO2

module is detached and replaced
with another PCA, SpO2, or EtCO2 module, its module-specific trend data is
purged.

Memory will not be lost due to a weak/discharged battery as data is stored on
flash memory as noted.

Compact flash memory: Stores application software, audio wave files, Data Set,

and hex files data for operating system software, all
needed to operate the Alaris System.

On-board flash memory: Contains software needed to initially turn on Alaris

System. Stores boot software application, and events,
errors and battery logs.

General Information PC Unit Section
1-44 Alaris System User Manual – with v9.33 Model 8015

Specifications and Symbols (Continued)

Specifications (Continued)

Environmental Conditions:

Symbol Meaning Operating Storage/Transport

Atmospheric
Pressure

Relative Humidity

(Avoid prolonged
exposure to
relative humidity
>85%)

Temperature
Range

525 - 4560 mmHg

(700 - 6080 hPa)

20 - 90%

Noncondensing

41 - 104°F

(5 - 40°C)

375 - 760 mmHg
(500 - 1013 hPa)

5 - 85%

Noncondensing

-4 - 140°F

(-20 - 60°C)

Equipment Orientation: To ensure proper operation, Alaris System must remain in an upright position.

Fluid Ingress Protection: IPX1, Drip Proof

Mode of Operation: Continuous

Power Requirements: 100 - 240V ~, 50/60 Hz, 150 VA MAX

Shock Protection: Type CF, Defibrillator-Proof patient applied part

Weight: 7.2 lbs

PC Unit Section General Information
Alaris System User Manual – with v9.33 Model 8015 1-45

Specifications and Symbols (Continued)

Symbols

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

Symbol Meaning

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

Warnings or Caution: Refer to accompanying documentation.

Canadian and U.S. Certification Mark: Products bearing this mark have been tested

C

US

and certified in accordance with applicable U.S. and Canadian electrical safety and
performance standards.

Communications connector for RS-232 attachment.

IPX1

MM-YYYY

Consult Instructions for Use.

Follow Instructions for Use

Type CF defibrillation-proof patient applied part.

Electrostatic discharge (ESD).

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

Protection against fluid ingress: Drip Proof.

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

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

General Information PC Unit Section
1-46 Alaris System User Manual – with v9.33 Model 8015

Specifications and Symbols (Continued)

Symbols (Continued)

Symbol Meaning

Manufacturer

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

Radio frequency (RF) transmission.

nly

O

EC REP

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

Tamper Resist activate/deactivate switch.

Conformité Européenne (CE marking) notified body 0086: British Standards Institution.

Australian Communications Authority.

Federal Communications Commission.

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

Authorized representative in European Community.

PC Unit Section General Information
Alaris System User Manual – with v9.33 Model 8015 1-47

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General Information PC Unit Section
1-48 Alaris System User Manual – with v9.33 Model 8015

Figure , “Alaris Pump Module, Model 8100 Alaris Syringe Module, Model 8110,” on

™

page -5Alaris

Pump Module/Alaris™ Syringe Module

Alaris Pump Module, Model 8100

Alaris Syringe Module, Model 8110

L

A

M

R

A

FU

S

E

N

I

RATE (mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

FU

S

N

E

I

S

T

A

M

N

R

A

L

S

T

A

N

D

B

Y

A

D

B

Y

RATE (mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

Alaris System User Manual – with v9.33 Model 8015 Section 2

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INTENTIONALLY

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Table of Contents

Getting Started

Introduction............................................................................................................................................. 2-1

Prepare Administration Set (Pump Module)........................................................................................... 2-3

Load................................................................................................................................................ 2-3

Remove .......................................................................................................................................... 2-6

Prime .............................................................................................................................................. 2-6

Prepare Syringe and Administration Set (Syringe Module).................................................................... 2-7

Load ....................................................................................................................................................... 2-11

Prime—Using Options Menu.................................................................................................................. 2-15

Prime—Manual....................................................................................................................................... 2-20

Programming

Introduction............................................................................................................................................. 2-23

Manual Programming with Guardrails Suite MX

Manual Programming—Primary Infusion ............................................................................................... 2-24

Continuous Infusion........................................................................................................................ 2-27

Bolus Dose ..................................................................................................................................... 2-33

Intermittent Infusion ........................................................................................................................ 2-40

Fluid Infusion .................................................................................................................................. 2-45

Manual Programming—Secondary Infusion (Pump Module) ................................................................. 2-51

Setup .............................................................................................................................................. 2-51

Infusion ........................................................................................................................................... 2-52

Stop Secondary and Return to Primary.......................................................................................... 2-57

Programming with Interoperability and Guardrails Suite MX

Programming with Interoperability—Initial Primary Infusion................................................................... 2-62

Continuous Infusion........................................................................................................................ 2-67

Fluid Infusion .................................................................................................................................. 2-69

Intermittent Infusion ........................................................................................................................ 2-70

Programming with Interoperability—Subsequent Primary Infusion (Pump Module) .............................. 2-72

Continuous Infusion........................................................................................................................ 2-74

Fluid Infusion .................................................................................................................................. 2-76

Intermittent Infusion ........................................................................................................................ 2-78

Programming with Interoperability—Secondary Infusion (Pump Module).............................................. 2-81

Infusion ........................................................................................................................................... 2-81

Stop Secondary and Return to Primary.......................................................................................... 2-86

Programming—NO Guardrails Suite MX Protection

Manual Programming—NO Guardrails Suite MX Protection.................................................................. 2-88

Basic Infusion without Drug Calculation ......................................................................................... 2-88

Promote Basic Infusion to Guardrails Software Protection Infusion ............................................... 2-89

Basic Infusion with Drug Calculation .............................................................................................. 2-89

Bolus Dose ..................................................................................................................................... 2-92

Secondary Infusion................................................................................................................................. 2-94

Infusion ........................................................................................................................................... 2-94

Stop Secondary and Return to Primary.......................................................................................... 2-95

Pump and Syringe Modules Section Table of Contents
Alaris System User Manual – with v9.33 Model 8015 2-iii

General Programming

Pause, Change, Restart Infusion ........................................................................................................... 2-96

Pause and Restart Infusion ............................................................................................................ 2-96

Change Rate or VTBI During Infusion ............................................................................................ 2-97

Restore Infusion ............................................................................................................................. 2-97

View and Clear Volume Infused............................................................................................................. 2-98

Channel Labels ...................................................................................................................................... 2-99

Select.............................................................................................................................................. 2-99

Remove .......................................................................................................................................... 2-101

Anesthesia Mode.................................................................................................................................... 2-102

Delay Options......................................................................................................................................... 2-102

Delay Infusion................................................................................................................................. 2-103

Schedule a Callback....................................................................................................................... 2-106

Pause Infusion................................................................................................................................ 2-107

Multidose Mode...................................................................................................................................... 2-108

Volume/Duration Enabled............................................................................................................... 2-110

Volume/Duration Disabled.............................................................................................................. 2-111

Select Pressure Limit ............................................................................................................................. 2-113

Pump Module ................................................................................................................................. 2-113

Syringe Module............................................................................................................................... 2-114

General Setup and Operation

System Start-Up/Setup........................................................................................................................... 2-121

Set Up for Gravity Infusion (Pump Module).................................................................................... 2-121

Change Solution Container (Pump Module)................................................................................... 2-121

Change Syringe During Infusion (Syringe Module) ........................................................................ 2-122

General Information

Warnings and Cautions.......................................................................................................................... 2-125

General........................................................................................................................................... 2-125

Administration Sets......................................................................................................................... 2-128

Epidural Administration................................................................................................................... 2-132

Guardrails Suite MX ....................................................................................................................... 2-133

Administration Set/Syringe Information .................................................................................................. 2-133

SmartSiteTM Infusion Set (Pump Module)....................................................................................... 2-134

Safety Clamp Fitment (Pump Module) ........................................................................................... 2-135

Compatible Syringes (Syringe Module) .......................................................................................... 2-136

Features and Displays............................................................................................................................ 2-137

Features and Definitions................................................................................................................. 2-137

Operating Features, Controls, Indicators........................................................................................ 2-143

Displays .......................................................................................................................................... 2-146

Drug Calculation Definitions and Formulas ............................................................................................ 2-147

Configurable Settings............................................................................................................................. 2-148

Shared Infusion .............................................................................................................................. 2-149

Pump Module ................................................................................................................................. 2-150

Syringe Module............................................................................................................................... 2-151

Specifications ......................................................................................................................................... 2-152

Pump Module ................................................................................................................................. 2-152

Syringe Module............................................................................................................................... 2-155

Table of Contents Pump and Syringe Modules Section
2-iv Alaris System User Manual – with v9.33 Model 8015

Symbols.................................................................................................................................................. 2-159

Trumpet and Start-Up Curves ................................................................................................................ 2-160

Pump Module ................................................................................................................................. 2-160

Syringe Module............................................................................................................................... 2-161

Graphs............................................................................................................................................ 2-162

Pump and Syringe Modules Section Table of Contents
Alaris System User Manual – with v9.33 Model 8015 2-v

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Pump and Syringe Modules Section

2-vi Alaris System User Manual – with v9.33 Model 8015

Introduction

This section of the User Manual provides Pump module (Model

8100) and Syringe module (Model 8110) instructions and
information. It is used in conjunction with:

• Alaris™ product administration set instructions

• Drug product labeling

• PC unit section of this User Manual

• AlarisTM Pump Module Set Compatibility Card

• AlarisTM Syringe Module Set Compatibility Card

• Pump Module Technical Service Manual

• Syringe Module Technical Service Manual

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

Essential Performance

The Alaris infusion modules are designed to accurately deliver
the programmed amount of the medication or fluid over the
programmed time period. The Alaris infusion modules ensure
that an infusion is not being inadvertently delivered when the
user expects the system to be in a paused, stopped, or off
condition. The Alaris infusion modules employ measurement
systems to detect and alarm for conditions adverse to safe
administration of fluid. These include measurements of proper
infusion set loading (free flow detection), pressure (occlusion
detection), and air-in-line detection.

Getting Started

WARNING

Read all instructions, for both the

infusion modules and PC unit, before
using the Alaris System.

The EtC0

module will monitor and alarm when a patient

2

physiological condition is out of range.

The Sp0

module will monitor and alarm when a patient

2

physiological condition is out of range.

The Pump and Syringe modules are intended for facilities that
utilize infusion and/or syringe pumps for the delivery of fluids,
medications, blood, and blood products using continuous or
intermittent delivery through clinically acceptable routes of
administration; such as, intravenous (IV), intra-arterial (IA),
subcutaneous, epidural, enteral, or irrigation of fluid spaces.
The Pump and Syringe modules are indicated for use on
adults, pediatrics, and neonates. Up to four Pump and/or
Syringe modules can be connected to the Alaris System.

Pump and Syringe Modules Section Getting Started
Alaris System User Manual – with v9.33 Model 8015 2-1

Introduction (Continued)

If a procedure/information applies to a specific module, the
following identifiers indicate the module it applies to.

FU

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N

M

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B

A

Y

L

A

RATE(mL/h)

CHANNEL
SELECT

Pump module:

Syringe module:

Administration Sets/Syringes: See "General Information" for
specific "Administration Set/Syringe Information.

Alarms and Alerts: See “Appendix A” "Troubleshooting and
Maintenance" for module-specific alarms and alerts.

PAUSE

CHANNEL
OFF

RESTART

FU

S

N

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I

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T

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M

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D

A

B

L

Y

A

RATE(mL/h)

CHANNEL
SELECT

PAUSE

CHANNEL
OFF

RESTART

Contraindications: None known.

Electromagnetic Environment: See "Appendix A" section of

this User Manual ("Regulations and Standards,"
"Compliance").

Getting Started Pump and Syringe Modules Section
2-2 Alaris System User Manual – with v9.33 Model 8015

Prepare Administration Set (Pump Module)

FU

S

E

N

I

S

T

A
N

M

D

R

B

A

Y

L

A

RATE(mL/h)

CHANNEL
SELECT

PAUSE

CHANNEL

OFF

RESTART

For instructions on how to go from checking in a Pump module
to preparing it for an infusion setup, see "General Setup and
Operation."

Load

1. Ensure that the instrument is as close

FU

S

E

N

I

S

T

A

N

M

D

to the level of patient’s heart as

R

A

L

A

B

Y

possible - the patient’s heart should
be in line with
key.

CHANNEL SELECT

Align with Patient’s heart level

RATE(mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

WARNING

• Administration Sets:

• Use only Alaris Pump

TM

module/GEMINI

Infusion

System administration sets.

The

use

of any other set can
cause improper instrument
operation, resulting in an
inaccurate fluid delivery or other
potential
compatible
please refer to the Alaris

hazard. For a list of

administration sets,

TM

Pump

Module Set Compatibility Card.

• Discard if packaging is not intact or
protector caps are unattached.

CAUTION

• Ensure that the device is as close
to level of patient’s heart as
possible. Patient’s heart level
should be in line with the
CHANNEL SELECT key.

• Use compatible components
which have the smallest internal
volume or "deadspace" to
minimize residual volumes
between the syringe and the
patient when administering
medications or fluids at low
infusion rates (e.g.,< 5 mL/h, and
especially flow rates < 0.5 mL/h).
This reduces the amount of time it
takes for fluid to reach the patient,
maintains delivery accuracy, and
reduces occlusion detection
times.

Pump and Syringe Modules Section Getting Started
Alaris System User Manual – with v9.33 Model 8015 2-3

Prepare Administration Set (Pump Module) (Continued)

Load (Continued)

2. If a new set is being loaded, prime the set, see Prime on
page 2-6.

3. Open the Pump module door.

4. Load administration set, as follows:

a. Hold upper fitment above fitment recess and lower into

recess.

b. Ensure that tubing is not twisted.

FU

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N

M

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A

Y

L

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RATE(mL/h)

CHANNEL
SELECT

PAUSE

CHANNEL

OFF

RESTART

CAUTION

• Avoid use of manifolds with ports
containing high pressure valves.
High pressure valves require
additional pressure (e.g., 50 - 200
mmHg) to open and allow fluid
flow. These high pressure valves
may cause a significant delay in
therapy followed by a sudden
bolus once the valve is opened,
particularly at low infusion rates
(e.g., < 5 mL/h, and especially
flow rates < 0.5 mL/h).

• Failure to follow proper

administration set loading
instructions might lead to an

instrument malfunction.

• Before operating the instrument,
verify that the administration set is

free from kinks and correctly
installed.

• Insert upper fitment before
installing safety clamp



fitment.

• When

reloading an

administration set, leave the

safety clamp



fitment in the
closed position (see “General
Information,” “Safety Clamp
Fitment”).

Getting Started Pump and Syringe Modules Section
2-4 Alaris System User Manual – with v9.33 Model 8015

Prepare Administration Set (Pump Module) (Continued)

Load (Continued)

FU

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N

M

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B

A

Y

L

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RATE(mL/h)

CHANNEL
SELECT

PAUSE

CHANNEL

OFF

RESTART

c. Press safety clamp fitment into recess below

mechanism.

d. Using a finger tip, firmly push tubing toward back of

Air-in-Line (AIL) Detector.

5. Close door and latch, as follows:

a. Close door and hold in a closed

position by grasping door and
instrument case with one hand.

b. Gently lower latch.

Safety clamp device is automatically



disengaged.

CAUTION

To reduce the potential for nuisance

AIL alarms, ensure that tubing is

fully inserted in the AIL Detector.

Safety Clamp Fitment

Push tubing toward
back of AIL Detector.



WARNING

• Do not touch the administration
set while closing the door. Failure
to follow this instruction can result
in infusion rate inaccuracy.

•To prevent a potential free-
flow condition, ensure that no
extraneous object (for example,
bedding, tubing, glove) is
enclosed or caught in the Pump
module door.

6. Open roller clamp.

7. Verify that no fluid is flowing through drip chamber.

Pump and Syringe Modules Section Getting Started
Alaris System User Manual – with v9.33 Model 8015 2-5

Prepare Administration Set (Pump Module) (Continued)

Remove

1. Close roller clamp.

2. Open Pump module door.

Set’s safety clamp fitment automatically closes to prevent
accidental free-flow.

3. Remove set, as follows:

a. Gently pull tubing below Air-in-Line Detector forward

and out.

FU

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A

Y

L

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RATE(mL/h)

CHANNEL
SELECT

PAUSE

CHANNEL

OFF

RESTART

White Slide Clamp

(shown in closed position)

b. Lift upper fitment from upper fitment receptacle.

4. If set is being removed to begin a gravity flow:

a. Depress the blue ridged release tab on upper side of

safety clamp device.

b. Slide the white slide clamp into blue fitment (open

position).

c. Adjust the flow rate using set’s roller clamp.

Prime

1. Prepare primary solution container in accordance with
manufacturer’s User Manual.

2. Open administration set package, remove set, and close
roller clamp. (Refer to set’s User Manual.)

3. Insert administration set spike into prepared fluid
container, following accepted hospital/facility procedure,
and hang container 20 inches above Pump module.

4. Fill drip chamber to

⅔ full.

Getting Started Pump and Syringe Modules Section
2-6 Alaris System User Manual – with v9.33 Model 8015

Prepare Administration Set (Pump Module) (Continued)

Prime (Continued)

5. If container requires venting, open vent cap on
administration set spike.

6. To prime tubing and clear air from injection sites and
tubing fitments, slowly open roller clamp.

7. When priming is complete, close roller clamp.

FU

S

E

N

I

S

T

A
N

M

D

R

B

A

Y

L

A

RATE(mL/h)

CHANNEL
SELECT

PAUSE

CHANNEL

OFF

RESTART

8. Verify no fluid flow.

Prepare Syringe and Administration Set (Syringe Module)

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

2.3 mL of fluid, use a 3 mL syringe).

• Use compatible components which have the smallest

internal volume or "deadspace." For example:

◦ Tubing internal diameter: Smallbore or microbore tubing

is recommended when infusing at low rates

◦ Tubing length: Tubing length should be minimized, when

possible

◦ Filters: Internal volume (deadspace) of in-line filters

should be minimized

◦ Connection sites: The number of connection sites such

as stopcocks and y-sites should be limited, and high risk
or life-sustaining solutions should be connected as close
to the vascular access site as possible

FU

S

N

E

I

S
T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL
SELECT

PAUSE

CHANNEL
OFF

RESTART

Pump and Syringe Modules Section Getting Started
Alaris System User Manual – with v9.33 Model 8015 2-7

Prepare Syringe and Administration Set (Syringe Module) (Continued)

WARNINGS

• Raising a syringe pump may result in a bolus of medication

or fluid due to changes in hydrostatic pressure. Lowering a
syringe pump while infusing may result in a delay in the
infusion (or possible under-infusion) due to the changes in
hydrostatic pressure.

• Ensure syringe sizes and models are compatible with the

Syringe module. Use of incompatible syringes can cause
improper pump operation resulting in inaccurate fluid
delivery, insufficient occlusion (blockage) sensing, and
other potential problems.

• 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 (for example, < 5 mL/h, and especially flow
rates < 0.5 mL/h). Using a larger syringe when infusing at
low rates can lead to inadequate syringe pump
performance including delivery inaccuracies, delay of
therapy, and delayed generation of occlusion alarms. This
is due to the increased friction and compliance of the
syringe stopper with larger syringes.

FU

S

N

E

I

S
T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL
SELECT

PAUSE

CHANNEL
OFF

RESTART

• Electronically prime the syringe pump system before

starting an infusion or after replacing a near-empty syringe
with a replacement syringe.

• Failure to use the PRIME SET WITH SYRINGE feature

after every syringe change can significantly delay the
infusion delivery start-up time and lead to delivery
inaccuracies.

Getting Started Pump and Syringe Modules Section
2-8 Alaris System User Manual – with v9.33 Model 8015

Prepare Syringe and Administration Set (Syringe Module) (Continued)

•

CAUTION

• Use compatible components which have the smallest

internal volume or "deadspace" to minimize residual
volumes between the syringe and the patient when
administering medications or fluids at low infusion rates
(e.g.,< 5 mL/h, and especially flow rates < 0.5 mL/h). This
reduces the amount of time it takes for fluid to reach the
patient, maintains delivery accuracy, and reduces occlusion
detection times

• Ensure that the device is as close to level of patient ’s heart

as possible. Patient’s heart level should be in line with the

CHANNEL SELECT key.

FU

S

N

E

I

S
T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL
SELECT

PAUSE

CHANNEL
OFF

RESTART

• Use the

PRIME SET WITH SYRINGE channel option on the

Alaris Syringe module to speed up the engagement of the
module’s mechanical components and decrease the
syringe’s internal friction (see "Prime - Using Options
Menu").

• If using a pre-run infusion practice (to allow for medication

equilibration prior to connection to the patient), ensure that
the distal end of the administration set is level with or higher
than the device.

• Avoid use of manifolds with ports containing high pressure

valves. High pressure valves require additional pressure
(e.g., 50 - 200 mmHg) to open and allow fluid flow. These
high pressure valves may cause a significant delay in
therapy followed by a sudden bolus once the valve is
opened, particularly at low infusion rates (e.g., < 5 mL/h
and especially flow rates < 0.5mL/h).

These recommendations are especially important when
infusing high-risk or life-sustaining medications at low
infusion rates (for example, < 5 mL/h and especially at flow
rates < 0.5 mL/h).

Pump and Syringe Modules Section Getting Started
Alaris System User Manual – with v9.33 Model 8015 2-9

Prepare Syringe and Administration Set (Syringe Module) (Continued)

For instructions on how to go from checking in a Syringe
module to preparing it for an infusion setup, including how to
change a syringe during infusion, see "General Setup and
Operation."

1. Prepare syringe (For a list of compatible syringes, refer to
Compatible Syringes (Syringe Module) on page 2-136 and
the Alaris
accordance with manufacturer’s User Manual.

2. Prepare administration set in accordance with
manufacturer’s User Manual.

3. Attach upper fitting of administration set to syringe tip.

NOTE:

For a list of compatible syringes, refer to Compatible Syringes
(Syringe Module) on page 2-136 and the AlarisTM Syringe
Module Set Compatibility Card. For a listing of administration
sets, refer to the AlarisTM Pump Module Set Compatibility Card.

TM

Syringe Module Set Compatibility Card) in

FU

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N

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I

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T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL
SELECT

PAUSE

CHANNEL
OFF

RESTART

Getting Started Pump and Syringe Modules Section
2-10 Alaris System User Manual – with v9.33 Model 8015

Prepare Syringe and Administration Set (Syringe Module) (Continued)

FU

S

N

E

I

S
T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

Load

4. Ensure that instrument is as close to level of patient’s heart
as possible—patient’s heart level should be in line with

CHANNEL SELECT key.

• Keep the Alaris System level with the patient’s heart to

maintain positive pressure.

• If using a pre-run infusion practice (to allow for

medication equilibration prior to connection to the
patient), ensure that the distal end of the administration
set is level with or higher than the device.

WARNING

Before loading or unloading the

syringe, always turn off fluid flow to
the patient, using the tubing clamp or
stopcock. Uncontrolled fluid flow
can occur when the administration
set is not clamped or turned off, and
can cause serious injury or death.

FU

S

N

E

I

S

T

A

M

N

R

A

L

A

RATE (mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

D

B

Y

Align with Patient
heart level

WARNING

Raising a syringe pump may result in
a bolus of medication or fluid due to
changes in hydrostatic pressure.
Lowering a syringe pump while
infusing may result in a delay in the
infusion (or possible under-infusion)
due to the changes in hydrostatic
pressure.

Pump and Syringe Modules Section Getting Started
Alaris System User Manual – with v9.33 Model 8015 2-11

Prepare Syringe and Administration Set (Syringe Module) (Continued)

Load (Continued)

.

5. Open syringe barrel clamp.

a. Pull syringe barrel clamp out and hold.

b. Rotate clamp to left (clockwise or counter clockwise)

until it clears syringe chamber.

c. Gently release clamp.

Syringe Barrel Clamp Open

6. Raise drive head to its fully extended position.

a. Twist gripper control clockwise and hold in position.

b. While holding gripper control in open position, raise

drive head to full extension.

c. Gently release gripper control.



Drive Head Fully Extended

Gripper Control/Drive
Head Release in Open
Position

Plunger Grippers Open

M

R

A

L

A

FU

S

N

E

I

RATE (mL/h)

CHANNEL
SELECT

PAUSE

FU

S

N

E

I

S
T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

S

T

A

N

D

B

Y

7. Insert syringe (from front of instrument) by sliding flat edge
of syringe barrel flange between barrel flange grippers.

FU

S

N

E

I

S
T

A

M

N

R

D

A

B

L

Y

A

oz

60

2

55

50

45

RATE(mL/h)

CHANNEL
SELECT

PAUSE

CHANNEL

RESTART

OFF

oz

60

2

55

50

45

1½

40

35

oz

30

1

25

20

15

½

10

5

WARNING

Before loading the syringe, check it

for damage or defects.

CAUTION

When initially loading the syringe,

allow for the volume of fluid
contained in the administration set
and retained in the syringe at the
end of an infusion, as this “dead
space” will not be infused.

Getting Started Pump and Syringe Modules Section
2-12 Alaris System User Manual – with v9.33 Model 8015

40

Prepare Syringe and Administration Set (Syringe Module) (Continued)

Load (Continued)

FU

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I

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T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

8. Lock syringe in place.

a. Pull syringe barrel clamp out and hold.

b. Rotate clamp to right (clockwise or counter clockwise)

until it lines up with syringe.

c. Gently release clamp against syringe.

9. Lower drive head and lock plunger in place with plunger
grippers.

a. Twist gripper control clockwise and hold in position.

b. While holding gripper control in open position, gently

lower drive head until it makes contact with plunger
flange.

c. Gently release gripper control.

d. Ensure that plunger grippers lock and hold plunger in

place.

Gripper Control in

Closed Position

Drive Head Flush

with Plunger Flange

Plunger Grippers Closed

A

L

A

N

I

M

R

RATE(mL/h)

FU

S

E

S

T

A

N

D

B

Y

oz

60

2

55

50

45

1½



WARNING

Ensure that syringe barrel, flange,
and plunger are installed and
secured correctly. Failure to install
syringe correctly can result in
uncontrolled fluid flow to the patient,
and can cause serious injury or
death.

FU

S

E

N

I

S

T

A

M

N

R

D

A

B

L

Y

A

oz

60

2

55

RATE(mL/h)

CHANNEL

SELECT

PAUSE

50

45

1½

40

35

oz

30

1

25

20

Syringe Barrel Clamp Closed

CAUTION

•To avoid an occlusion when
loading a smaller size syringe,
use extra care to close off
administration set tubing and
gently lower drive head against
syringe plunger.

• For smaller syringes (such as;
3, or 5 mL), stabilize the syringe

1,

plunger with thumb and index
finger while carefully lowering
the drive head. Ensure that the
syringe plunger head makes
contact with the small black
sensor, located on the bottom of
the drive head (between the
plunger grippers).

Pump and Syringe Modules Section Getting Started
Alaris System User Manual – with v9.33 Model 8015 2-13

Syringe Module

SELECT

Prepare Syringe and Administration Set (Syringe Module) (Continued)

Load (Continued)

FU

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N

E

I

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T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

10. Insert pressure sensing disc (if used), as follows:

a. Orient pressure sensing disc, as follows:

• fluid side up (patient side down)

• cavity forward (membrane toward instrument)



WARNING

When the pressure sensing disc
is not being used and an occlusion

occurs, there is a risk of infusing
pressurized buildup of infusates
upon correction of the occlusion. To
avoid an inadvertent bolus, relieve
the pressure before restarting the
infusion.

Slot in Pressure

Sensing Disc

Housing

Pressure

Sensing Disc

Fluid Side

Patient Side

b. Gently slide pressure sensing disc up into slot in

pressure sensing disc housing.

c. Apply firm upward pressure on pressure sensing disc

PAUSE

CHANNEL

RESTART

OFF

(not tubing) until disc snaps into place.

Pressure Sensing Disc

Getting Started Pump and Syringe Modules Section
2-14 Alaris System User Manual – with v9.33 Model 8015

Prepare Syringe and Administration Set (Syringe Module) (Continued)

Load (Continued)

FU

S

N

E

I

S
T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

NOTES:

 The gripper control is spring loaded. When twisted to the open

position and then released, it (and the plunger grippers) returns
to the closed position.

 The following Syringe module features are available only with

extension sets fitted with a pressure sensing disc:

Auto Pressure
Back Off (upon occlusion)
Customized Pressure Alarm Settings (see “Occlusion
Pressure” feature definition)
Dynamic Pressure Display
Numeric Pressure Display
Fast Start
(See “General Information,” “Features and Displays” for
definitions.)

Prime—Using Options Menu

The Priming option can be enabled at the time the
Alaris System is configured for use. The Priming selection
(

PRIME soft key) is available only after the syringe and infusion

type have been selected, and prior to beginning an infusion.

If a pressure sensing disc is in use, it should be removed from
the instrument before priming. See the applicable procedure
(as follows) depending on whether or not a pressure sensing
disc is used.

WARNING

Electronically prime the syringe
pump system before starting an
infusion or after replacing a near
empty syringe with a replacement
syringe. Using the syringe pump's
prime feature engages the
mechanical components of the pump
and decreases the syringe's friction
and compliance to minimize startup
delays and delivery inaccuracies,
especially at low infusion rates.
Failure to use the prime feature on
the syringe pump after every syringe
change and/or tubing change can
significantly delay the infusion
delivery startup time and lead to
delivery inaccuracies.

WARNING

When priming:

• Ensure that administration set is
not connected to patient.

• Ensure that air is expelled from
line prior to beginning infusion
(unexpelled air in line could have
serious consequences).

Failure to prime correctly can delay
infusion delivery and cause the total
volume to be infused to read higher
than the actual total delivered to the
patient.

CAUTION

During priming, the pressure limit

alarms are temporarily increased to
their maximum level.

Pump and Syringe Modules Section Getting Started
Alaris System User Manual – with v9.33 Model 8015 2-15

Prepare Syringe and Administration Set (Syringe Module) (Continued)

Prime—Using Options Menu (Continued)

FU

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N

E

I

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T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

Administration Set

With Pressure

Sensing Disc

1. Ensure that administration set is not connected to patient.

2. If installed, remove pressure sensing disc from instrument.

Using a finger, apply firm downward pressure on pressure
sensing disc (not tubing) until disc snaps loose from slot in
pressure sensing disc housing.

3. Press

OPTIONS key.

CAUTION

The pressure sensing disc, if left
installed during priming, can trap air
that might not be totally expelled.
To ensure that entrapped air is
eliminated, it is recommended
that the pressure sensing disc be
removed prior to priming and the
membrane gently massaged with a
finger while priming. After priming
is completed, reinstall the pressure
sensing disc.

SILENCE

OPTIONS

SYSTEM

ON

1

2

3

4

5

6

ENTER

9

CANCEL

4. Press Prime Set with Syringe soft key.

7

8

CLEAR

0

Channel Options 1 of 2

A

Guardrails Drugs

Guardrails IV Fluids

Multidose

Pressure Limit - 550 mmHg

Prime Set with Syringe

>Select an Option or EXIT

EXIT

PAGE

DOWN

Getting Started Pump and Syringe Modules Section
2-16 Alaris System User Manual – with v9.33 Model 8015

Prepare Syringe and Administration Set (Syringe Module) (Continued)

Prime—Using Options Menu (Continued)

FU

S

N

E

I

S
T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

Administration Set

With Pressure Sensing

Disc (Continued)

If pressure sensing disc was not removed prior to pressing
Prime Set with Syringe soft key, a pressure sensing disc
removal prompt is displayed.

5. Invert pressure sensing disc so that patient side is up.

6. Hold pressure sensing disc between two fingers.

A

AA

It is recommended that the
Pressure Sensing Disc be
removed during priming.

Press CONFIRM and
continue priming.

>Press CONFIRM

Patient Side

CONFIRM

20

15

½

10

5

7. Press and hold

PRIME soft key.

A

Prime Set with Syringe

CAUTION: Do
not prime with
disposable set
connected to
patient!

Prime Volume

0 mL

>Press and Hold PRIME

EXIT

PRIME

Pump and Syringe Modules Section Getting Started
Alaris System User Manual – with v9.33 Model 8015 2-17

Syringe Module

Prepare Syringe and Administration Set (Syringe Module) (Continued)

Prime—Using Options Menu (Continued)

FU

S

N

E

I

S
T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

Administration Set

With Pressure Sensing

Disc (Continued)

8. Gently massage pressure sensing disc to ensure that all
air is expelled. The disc must remain inverted only until the
air is expelled. Continue to gently massage disc
throughout priming to ensure that it does not become
under- or over- filled.

9. Continue to prime until fluid flows and priming is complete.

Fluid is delivered during priming only while
key is pressed. Each press of

PRIME soft key delivers up

PRIME soft

to 2 mL of priming fluid at the maximum rate of the
selected syringe per continuous press. To deliver
additional amounts, press

PRIME soft key again.(See Rate

Restriction by Syringe Size: on page 2-157)

10. When priming is complete, release pressure sensing disc

PRIME soft key.

and

Volume used during priming is displayed but not added to
VTBI or VI.

A

Prime Set with Syringe

CAUTION: Do
not prime with
disposable set
connected to
patient!

Prime Volume

2mL

>Press and Hold PRIME

EXIT

PRIME

11. Reinstall pressure sensing disc, as follows:

a. Orient pressure sensing disc, as follows:

• fluid side up (patient side down)

• cavity forward (membrane toward instrument)

b. Gently slide pressure sensing disc up into slot in

pressure sensing disc housing.

Getting Started Pump and Syringe Modules Section
2-18 Alaris System User Manual – with v9.33 Model 8015

Slot in Pressure

Sensing Disc

Housing

Pressure

Sensing Disc

Patient Side

Fluid Side

Prepare Syringe and Administration Set (Syringe Module) (Continued)

Prime—Using Options Menu (Continued)

FU

S

N

E

I

S
T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

Administration Set

With Pressure Sensing

Disc (Continued)

c. Apply firm upward pressure on pressure sensing disc

(not tubing) until disc snaps into place.

12. To return to main screen, press

If

EXIT soft key is pressed before pressure sensing disc is

EXIT soft key.

reinstalled, a prompt to reinstall pressure sensing disc is
displayed.

Pressure Sensing Disc

A

AA

Re-install Pressure Sensing
Disc.

>Press CONFIRM

CONFIRM

Administration Set

With No Pressure

Sensing Disc

1. Press

2. Press Prime Set with Syringe soft key.

Pump and Syringe Modules Section Getting Started
Alaris System User Manual – with v9.33 Model 8015 2-19

OPTIONS key.

Channel Options 1 of 2

A

Guardrails Drugs

Guardrails IV Fluids

Multidose

Pressure Limit - 550 mmHg

Prime Set with Syringe

>Select an Option or EXIT

EXIT

PAGE
DOWN

Prepare Syringe and Administration Set (Syringe Module) (Continued)

Prime—Using Options Menu (Continued)

3. Press and hold PRIME soft key until fluid flows and priming
is complete.

FU

S

N

E

I

S
T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

Fluid is delivered during priming only while
key is pressed. Each press of

PRIME soft key delivers up

PRIME soft

to 2 mL of priming fluid per continuous press. To deliver
additional amounts, press

4. Release

PRIME soft key.

PRIME soft key again.

Volume used during priming is displayed but not added to
VTBI or VI.

5. To return to main screen, press

EXIT soft key.

Prime—Manual

Use the following procedures to manually prime the
administration set.

WARNING

When priming:

• Ensure that administration set is
not connected to patient.

• Ensure that air is expelled from
line prior to beginning infusion
(unexpelled air in line could have
serious consequences).

Failure to prime correctly can delay
infusion delivery and cause the total
volume to be infused to read higher
than the actual total delivered to the
patient.

Getting Started Pump and Syringe Modules Section
2-20 Alaris System User Manual – with v9.33 Model 8015

Prepare Syringe and Administration Set (Syringe Module) (Continued)

Prime—Manual (Continued)

FU

S

N

E

I

S
T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

Administration Set

With Pressure

Sensing Disc

1. Ensure that administration set is not connected to patient.

2. If installed, remove pressure sensing disc from instrument.

Using a finger, apply firm downward pressure on pressure
sensing disc (not tubing) until disc snaps loose from slot in
pressure sensing disc housing.

3. Invert pressure sensing disc so that patient side is up.

4. Hold pressure sensing disc between 2 fingers.



CAUTION

The pressure sensing disc, if left
installed during priming, can trap air
that might not be totally expelled.
To ensure that entrapped air is
eliminated, it is recommended
that the pressure sensing disc be
removed prior to priming and the
membrane gently massaged with a
finger while priming. After priming
is completed, reinstall the pressure
sensing disc.

20

15

½

10

5

5. Slowly prime set while gently massaging pressure sensing

Patient Side

disc to ensure that all air is expelled. The disc must remain
inverted only until the air is expelled. Continue to gently
massage disc throughout priming to ensure that it does
not become under- or over-filled.

6. When priming is complete (no air exists), close set clamp.

NOTE:

 When manually priming (per hospital/facility protocol) and an

administration set having a pressure sensing disc is in use,
depress the disc between 2 fingers while priming and prime
uphill (distal end of pressure sensing disc/tubing pointing
upward).

Pump and Syringe Modules Section Getting Started
Alaris System User Manual – with v9.33 Model 8015 2-21

Prepare Syringe and Administration Set (Syringe Module) (Continued)

Prime—Manual (Continued)

FU

S

N

E

I

S
T

A

M

N

R

D

A

B

L

Y

A

RATE(mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

Administration Set

With No Pressure

Sensing Disc

1. Prime per hospital protocol.

2. When priming is complete (no air exists), close set clamp.

Eliminate Mechanical Slack

To eliminate mechanical slack or free play, and minimize
start-up delays and delivery inaccuracies, especially when
infusing at low flow rates, it is recommended that the
instrument be primed per the following procedure.

1. Load syringe (see "Load" procedure). If a pressure
sensing disc is being used, do not install disc until priming
is complete.

2. Select syringe and infusion type (see "Programming"
chapter).

3. Open administration set clamp.

4. Prime, as follows, using Priming option (see "Prime -Using
Options Menu"):

a. Follow applicable procedure (based on whether or

not pressure sensing disc is installed) through step to
press and hold

PRIME soft key.

b. Prime until fluid drips from end of tubing.

c. Complete procedure (installing pressure sensing disc,

if applicable, and exiting options menu).

Getting Started Pump and Syringe Modules Section
2-22 Alaris System User Manual – with v9.33 Model 8015

Introduction

The Alaris System can be programmed with Guardrails Suite
MX Protection or with no Guardrails Suite MX protection:

• Guardrails Suite MX Protection

• Manual Programming (see page 2-24)

• Programming with Interoperability (see page 2-58)

• Auto-ID (Refer to Section "Auto-ID")

• No Guardrails Suite MX Protection

• Manual Programming Basic Infusion

• Manual Programming Basic Infusion with Drug
Calculation

References throughout this procedure to specific drugs and
drug doses are for illustration purposes only. Refer to specific
drug product labeling for information concerning appropriate
administration techniques and dosages.

Programming

See "General Information," "Features and Displays" and the
PC unit section of this User Manual for information about:

• Displays

• Operating Features, Controls, Indicators

The majority of user interface programming is identical for both
the Pump module and Syringe module. When referring to both
modules, the term "infusion modules" is used. The modules are
referred to singularly as the Pump module and the Syringe
module.

Pump and Syringe Modules Section Programming
Alaris System User Manual – with v9.33 Model 8015 2-23

Manual Programming with Guardrails Suite MX

Manual Programming—Primary Infusion

The following procedures are to be used only when the drug
to be infused is listed in the Drug Library. To access the Drug
Library, a hospital-defined best-practice Data Set must be
transferred to the Alaris System and the Profile feature must be
enabled.

1. Perform following steps (see PC unit section of this
manual, "General Setup and Operation," "Start-Up"):

a. Power on system.

b. Choose Yes or No to New Patient?

c. Confirm current Profile or select a new Profile.

d. Enter patient identifier, if required.

FU

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Y

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RATE(mL/h)

RATE(mL/h)

CHANNEL
SELECT

CHANNEL
SELECT

PAUSE

PAUSE

CHANNEL

OFF

CHANNEL

OFF

RESTART

RESTART

2. Prepare and load syringe/administration set (see "Getting
Started").

3. Prime (see "Getting Started").

Manual Programming with Guardrails Suite MX Pump and Syringe Modules Section
2-24 Alaris System User Manual – with v9.33 Model 8015

Manual Programming—Primary Infusion (Continued)

4. Press CHANNEL SELECT key.

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RATE(mL/h)

RATE(mL/h)

CHANNEL
SELECT

CHANNEL
SELECT

PAUSE

PAUSE

CHANNEL

OFF

CHANNEL

OFF

RESTART

RESTART

5. Syringe module: Select syringe type and size, as



6.

follows; otherwise, proceed to step
syringe is loaded correctly, but not recognized, check

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RATE(mL/h)

for the following:

CHANNEL
SELECT

PAUSE

CHANNEL

OFF

RESTART

If the installed

a. If a label is between the syringe barrel and the barrel

clamp, make sure that the label does not erroneously
enlarge the barrel size of the syringe.

b. If a needle-free valve or other component is added to

the syringe, ensure that it is no larger than the diameter
of the syringe barrel.

NOTE:

Thick labeling or adding a component to the syringe that is larger
than the diameter of the syringe may prevent the device from
correctly recognizing the installed syringe. If the issue continues
despite the above troubleshooting, send the device to your
facility’s biomedical engineering department for servicing.

Pump Module

Syringe Module

WARNING

Ensure that the displayed syringe
manufacturer and syringe size

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correctly identify the installed
syringe. Mismatches might
cause an under-infusion or

A

RATE(mL/h)

CHANNEL
SELECT

PAUSE

CHANNEL
OFF

RESTART

over-infusion to the patient that
could result in serious injury and/or
death. For a list of compatible
syringes, refer to Compatible

Syringes (Syringe Module) on page
2-136 and the Alaris
Module Set Compatibility Card.

TM

Syringe

Pump and Syringe Modules Section Manual Programming with Guardrails Suite MX
Alaris System User Manual – with v9.33 Model 8015 2-25

Manual Programming—Primary Infusion (Continued)

c. Press soft key next to installed syringe type and size. If

a default syringe list has been enabled and correct
syringe cannot be found, press the
key to select from a list of all compatible syringes.

d. To accept, press

CONFIRM soft key.

ALL SYRINGES soft

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RATE(mL/h)

RATE(mL/h)

CHANNEL
SELECT

CHANNEL
SELECT

PAUSE

PAUSE

CHANNEL

OFF

CHANNEL

OFF

RESTART

RESTART

WARNING

Selecting an incorrect syringe may
cause an under infusion or over
infusion to the patient.

Syringe Selection

A

A

BD 30 mL

Monoject 30 mL

>Select Syringe Size

ALL

CONFIRM

SYRINGES

Syringe Selection

A

A

BD 30 mL

Monoject 30 mL

6. Start applicable infusion, as described in following
procedures:

Continuous Infusion
Bolus Dose
Intermittent Infusion
Fluid Infusion

NOTE:

 At the start of a Syringe module infusion program, the system

prompts to select and confirm the syringe type and size.
The system automatically detects the syringe size, and lists
syringe types and sizes that most closely match the installed
syringe. If the syringe is not recognized, Syringe not

recognized is displayed.

NOTE:

It is possible to program an infusion with a rate that is
displayed with two decimal places (one-hundredth of a mL per
hour) on the PC unit for the Pump module. However, due to
space limitations on the Pump module rate display, the rate
is displayed to the nearest one-tenth of a mL per hour on the
Pump module. This value is only used for display purposes
and the Pump module is actually infusing at the more precise
rate noted on the PC unit.

>Confirm Syringe Size

ALL

CONFIRM

SYRINGES

Manual Programming with Guardrails Suite MX Pump and Syringe Modules Section
2-26 Alaris System User Manual – with v9.33 Model 8015

Manual Programming—Primary Infusion (Continued)

Continuous Infusion

When using a drug listed in the Drug Library, the drug
parameters are automatically calculated, based on:

• drug selected

• weight entry (if required)

• rate or dose entry

•

VTBI entry (Syringe module—if other than All)

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RATE(mL/h)

RATE(mL/h)

CHANNEL
SELECT

CHANNEL
SELECT

PAUSE

PAUSE

CHANNEL

OFF

CHANNEL

OFF

RESTART

RESTART

1. Press Guardrails Drugs soft key.

2. Press soft key next to desired drug.

• To view additional drugs/concentrations, press a soft

key next to a letter group to navigate through alphabet,
and/or

PAGE UP and PAGE DOWN soft keys.

Infusion Menu

A

Guardrails Drugs

Guardrails IV Fluids

Basic infusion

>Select an Option or EXIT

RESTORE

EXIT

Guardrails Drugs

A

A

Adult ICU

Alteplase

AMIODArone

DOBUTamine

DOPamine

Heparin

A-E

F-J

K-O

P-T

U-Z

>Select Drug

DRUG
CALC

PAGE

DOWN

EXIT

• If applicable, an optional hospital-defined therapy or

clinical indication for delivery of this infusion could
appear—as in illustrated example, which reflects use
of Alteplase. Different limits can be defined for same

Guardrails Drugs

A

A

Adult ICU

Alteplase

MI

Stroke

drug with different therapeutic indications.

Therapy indication appears on drug or
confirmation screen. Once drug or
confirmed, therapy indication appears in title bar.

Pump and Syringe Modules Section Manual Programming with Guardrails Suite MX
Alaris System User Manual – with v9.33 Model 8015 2-27

IV fluid

IV fluid has been

>Select Therapy Type

DRUG

EXIT

LIBRARY

Manual Programming—Primary Infusion (Continued)

Continuous Infusion (Continued)

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RATE(mL/h)

RATE(mL/h)

CHANNEL
SELECT

CHANNEL
SELECT

PAUSE

PAUSE

CHANNEL

OFF

CHANNEL

OFF

RESTART

RESTART

• If applicable, a weight-based or non weight-based

option for delivery of this infusion could appear (as in
illustrated example, which reflects use of Heparin).

• If applicable, multiple concentration listings for delivery

of this infusion could appear (as in illustrated example,
which reflects use of Dopamine).

3. To continue programming, press Yes soft key.



®

Guardrails Drugs

A

A

Adult ICU

Heparin

Non-Weight based dosing

Weight based dosing

>Select Dose Unit Type

DRUG

EXIT

LIBRARY

Guardrails Drugs

A

A

Adult ICU

DOPamine

400mg/250mL

800mg/250mL

>Select Concentration

DRUG

EXIT

LIBRARY

Bolus Dose units appear if Bolus Dose is enabled.

OR

To change selection, press No soft key.

Manual Programming with Guardrails Suite MX Pump and Syringe Modules Section
2-28 Alaris System User Manual – with v9.33 Model 8015

Manual Programming—Primary Infusion (Continued)

Continuous Infusion (Continued)

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RATE(mL/h)

RATE(mL/h)

CHANNEL
SELECT

CHANNEL
SELECT

PAUSE

PAUSE

CHANNEL

OFF

CHANNEL

OFF

RESTART

RESTART

• If YES was selected and facility has defined a Clinical

Advisory for that drug, a message appears. To indicate
information has been noted and continue
programming, press

CONFIRM soft key.

• If Yes was selected to continue programming, drug

amount and diluent volume (if defined in Drug Library)
are automatically entered for selected drug.

Alteplase

A

Stroke

Clinical Advisory:

This dosing is for Acute
Ischemic STROKE

>Press CONFIRM

CONFIRM

Alteplase

A

Stroke

DRUG

AMOUNT

100 mg

DILUENT
VOLUME

100 mL

PATIENT
WEIGHT

Used

TIME

hour

UNITS

DOSING

mg/kg/h

UNITS

[Conc]: 1 mg/mL

>Press NEXT to Confirm

DRUG

NEXT

LIBRARY

• If selected drug had "_ _ / _ _ mL" concentration, drug

amount and diluent volume need to be entered.

• If selected drug is not weight-based, Not Used is

displayed in

PATIENT WEIGHT field.

• If hospital/facility practice guidelines identify selected

drug as weight-based, prompt for a patient weight in
kilograms appears (as in illustrated example, which
reflects use of Alteplase).



4. Verify correct parameters and press NEXT soft key to
confirm.

Alteplase

A

Stroke

DRUG

AMOUNT

100 mg

DILUENT
VOLUME

100 mL

PATIENT

____kg

WEIGHT

TIME

hour

UNITS

DOSING

mg/kg/h

UNITS

[Conc]: 1 mg/mL

>Enter Patient Weight

DRUG

LIBRARY

Pump and Syringe Modules Section Manual Programming with Guardrails Suite MX
Alaris System User Manual – with v9.33 Model 8015 2-29

Manual Programming—Primary Infusion (Continued)

Continuous Infusion (Continued)

5. An optional hospital-defined and editable starting value for
Continuous Infusion dose might already be entered.

OR

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RATE(mL/h)

RATE(mL/h)

CHANNEL
SELECT

CHANNEL
SELECT

PAUSE

PAUSE

CHANNEL

OFF

CHANNEL

OFF

RESTART

RESTART

To make a rate or dose entry, press applicable soft key,

RATE or DOSE, and use numeric data entry keys (other

value is calculated and displayed).

6. To enter volume to be infused, press

VTBI soft key and

enter value.

• Pump module:

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◦ When

CHANNEL
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PAUSE

CHANNEL

OFF

RESTART

decimal places (one-hundredth of a mL).

VTBI is less than 10 mL, entry can be to two

◦ In Drug Calculation mode, system infuses at

calculated rate rounded to nearest one-hundredth
of a mL per hour (as displayed on the programming
screen on the PC unit). The rate shown in Rate
Display on the Pump module is rounded to nearest
one-tenth of a mL per hour.

OR

Alteplase

A

AA

Stroke

CONTINUOUS INFUSION

RATE

___mL/h

VTBI

____mL

DOSE

_____mg/kg/h

[Conc]: 1 mg/mL

>Select Rate or Dose

SETUP

BOLUS

Alteplase

A

AA

Stroke

CONTINUOUS INFUSION

RATE

56.7 mL/h

VTBI

____

mL

DOSE

_ 0.81 mg/kg/h

[Conc]: 1 mg/mL

>Select VTBI

BOLUS

SETUP

BOLUS soft key appears only if Bolus Dose is enabled

•

within selected Profile, drug is bolusable, and a VTBI is
entered.

Manual Programming with Guardrails Suite MX Pump and Syringe Modules Section
2-30 Alaris System User Manual – with v9.33 Model 8015

Manual Programming—Primary Infusion (Continued)

Continuous Infusion (Continued)

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RATE(mL/h)

RATE(mL/h)

CHANNEL
SELECT

CHANNEL
SELECT

PAUSE

PAUSE

CHANNEL

OFF

CHANNEL

OFF

RESTART

RESTART

• Syringe module:

◦ If ALL Mode is enabled for syringe configuration in

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PAUSE

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RESTART

Data Set,
estimated available volume in syringe is displayed.

OR

ALL is displayed in VTBI field and

If ALL Mode is disabled for syringe configuration in
Data Set, estimated available volume in syringe is
displayed when

VTBI soft key is pressed.

◦ To enter or change a numeric VTBI value, press

VTBI soft key and enter value.

◦ To deliver entire contents of syringe: Keep an

VTBI value, or press ALL soft key to change a

numeric

VTBI value to ALL.

ALL

Alteplase

A

AA

Stroke

CONTINUOUS INFUSION

RATE

VTBI

DOSE

56.7 mL/h
ALL

_ 0.81 mg/kg/h

Available:

(55.5 mL)

[Conc]: 1 mg/mL

>Select VTBI

START

BOLUS

SETUP

PAUSE

7. Verify correct parameters and press

START soft key.

• For a Continuous Infusion, the drug name and dose
will scroll on the module Message Display

Alteplase

AA

A

Stroke

CONTINUOUS INFUSION

RATE

56.7 mL/h

VTBI

100

mL

DOSE

0.81 mg/kg/h

[Conc]: 1 mg/mL

>Press START

PAUSE

SETUP

BOLUS

START

Pump and Syringe Modules Section Manual Programming with Guardrails Suite MX
Alaris System User Manual – with v9.33 Model 8015 2-31

Manual Programming—Primary Infusion (Continued)

Continuous Infusion (Continued)

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RATE(mL/h)

RATE(mL/h)

CHANNEL
SELECT

CHANNEL
SELECT

PAUSE

PAUSE

CHANNEL

OFF

CHANNEL

OFF

RESTART

RESTART

• If the programmed continuous dose infusion is outside
the Soft Limit for that care area, an audio alert sounds
and a visual prompt appears before programming can
continue. If Yes soft key is pressed, programming
continues; if No soft key is pressed, infusion needs to
be reprogrammed.

• If the programmed continuous dose infusion is outside
the Hard Limit for that care area, an audio alert sounds
and a visual prompt appears before programming can
continue. Infusion needs to be reprogrammed.

• If a dose outside of the Soft Limits has been entered
and verified as correct, Message Display also shows
either "LLL" for a low dose or "

" for a high dose.

Alteplase

A

Stroke

Dose exceeds
Guardrail limit of

0.81 mg/kg/h.
Proceed?

>Press Yes or No

Alteplase

A

Stroke

Dose exceeds

Reprogram

Guardrails hard
limit of 0.82 mg/kg/h.

>Press REPROGRAM

Yes

No

• If a Soft Limit is overridden, G icon is displayed. When
G soft key is pressed, all applicable out-of-range limits

are listed.

Midtown Hospital
Adult ICU

VTBI = 250 mL

A

VOLUME

INFUSED

AUDIO

ADJUST

G

Manual Programming with Guardrails Suite MX Pump and Syringe Modules Section
2-32 Alaris System User Manual – with v9.33 Model 8015

Manual Programming—Primary Infusion (Continued)

Continuous Infusion (Continued)

8. Syringe module:

• Unclamp tubing and attach administration set to

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RATE(mL/h)

CHANNEL
SELECT

PAUSE

CHANNEL

OFF

RESTART

NOTES:

 The facility can choose to pre-populate standard drug

 Patient weight can be edited during a Continuous Infusion.

 Once a patient weight is entered and an infusion is started for

patient.

• Unclamping tubing and starting infusion before

attaching administration set to patient minimizes
any potential bolus that can be released from
pressure built up in set due to normal syringe
loading and priming.

concentrations, or leave a custom concentration (_ _ / _ _ mL)
and allow the clinician to enter the desired concentration.

any module, the patient weight is automatically entered for any
additional weight-based calculation. The patient weight
remains an editable field, therefore patient weight can be
adjusted for any module. Changing the patient weight on one
module does not affect the patient weight on any other module.

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RATE(mL/h)

RATE(mL/h)

CHANNEL
SELECT

CHANNEL
SELECT

PAUSE

PAUSE

CHANNEL

OFF

CHANNEL

OFF

RESTART

RESTART

NOTE:

It is possible to program an infusion with a rate that is
displayed with two decimal places (one-hundredth of a mL per
hour) on the PC unit for the Pump module. However, due to
space limitations on the Pump module rate display, the rate
is displayed to the nearest one-tenth of a mL per hour on the
Pump module. This value is only used for display purposes
and the Pump module is actually infusing at the more precise
rate noted on the PC unit.

Bolus Dose

A Bolus Dose can be programmed at the beginning of, or
during, a continuous infusion. The drug being programmed
must be a bolusable drug selected from the Drug Library or a
non-library drug, as described in the following
procedures.



1. Set up infusion as described in "Continuous Infusion"
procedure, but do not start infusion.

Pump and Syringe Modules Section Manual Programming with Guardrails Suite MX
Alaris System User Manual – with v9.33 Model 8015 2-33

Manual Programming—Primary Infusion (Continued)

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RATE(mL/h)

RATE(mL/h)

CHANNEL
SELECT

CHANNEL
SELECT

PAUSE

PAUSE

CHANNEL

OFF

CHANNEL

OFF

RESTART

RESTART

Bolus Dose (Continued)

2. Press BOLUS soft key.

• If the programmed continuous dose infusion is outside

the Soft Limit for that care area, an audio alert sounds
and a visual prompt appears before programming can
continue. If Yes soft key is pressed, programming
continues; if No soft key is pressed, infusion needs to
be reprogrammed.

• If the programmed continuous dose infusion is outside

the Hard Limit for that care area, an audio alert sounds
and a visual prompt appears before programming can
continue. The infusion needs to be reprogrammed.

3. An optional hospital-defined and editable starting value
for Bolus Dose and/or bolus rate duration might already be
entered.

OR

To enter Bolus Dose, use numeric data entry keys.

• After a Bolus Dose and weight (if used) are entered,

bolus VTBI and concentration [conc] alternate in Main
Display.

Alteplase

AA

A

Stroke

CONTINUOUS INFUSION

RATE

56.7 mL/h

VTBI

100

mL

DOSE

0.81 mg/kg/h

[Conc]: 1 mg/mL

>Press START

PAUSE

A

AA

Alteplase
Stroke

SETUP

BOLUS

START

BOLUS DOSE

DOSE

____unit/kg

PATIENT
WEIGHT

DURATION

[Conc]: 1 mg/mL

>Enter Bolus Dose

CONT-

SETUP

INUOUS

• If no weight has previously been programmed in

system and Bolus Dose is weight-based, weight entry
is empty.

• If the programmed continuous dose is weight-based,

programmed weight is displayed.

• If Bolus Dose is not weight-based, Not Used is

displayed in

PATIENT WEIGHT field.

• A Bolus Dose can be either weight based or non

weight-based independent of whether the Continuous
Infusion is weight based or non weight-based.

4. Enter or change patient weight (if used), use applicable
following procedure, depending on whether or not
continuous dose is weight-based.

Manual Programming with Guardrails Suite MX Pump and Syringe Modules Section
2-34 Alaris System User Manual – with v9.33 Model 8015