Cardinal Health Alaris Manual

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Directions for Use
Alaris®System
(with PC Unit, Model 8000)
Supports Guardrails®Suite MX with Guardrails®Point-Of-Care software and v9 Operating System software.
February 2007
Alaris®Products

Alaris®System (with v9 Model 8000) DFU
Order Numbers:
Electronic Copy: 10015905
Printed Copy: 10110697 ©2006, 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Table of Contents
Each of the Alaris®product-specific Sections has its own table of contents.
General Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
PC Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Pump and Syringe Modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
PCA Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
SpO2Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
EtCO2Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Auto-ID Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Nurse Call Accessory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Communications Interface Board Accessory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Appendix
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Service Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Regulations and Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-14

i
Alaris®System (with v9 Model 8000) DFU
General Contact Information
Cardinal Health
Alaris®Products
10221 Wateridge Circle
San Diego, California 92121
cardinal.com/alaris
Technical Support - North America
Maintenance and service information support; troubleshooting.
Customer Care - North America
Instrument return, service assistance, and order placement.
United States - Phone:
858.458.6003
800.854.7128, Ext. 6003
Canada - Phone:
Within Canada: 800.387.8309
From United States: 800.908.9918
United States - Phone: [phone] Canada - Phone: [phone]
Customer Advocacy - North America
Clinical and technical feedback.
Phone: [phone], Ext. 7812
E-Mail: [email protected]

ii Alaris®System (with v9 Model 8000) DFU
The Alaris®PC unit Section of this Directions for Use ("DFU")
provides procedures and information applicable to the Alaris®
System and the PC Unit. Each of the other major Sections
provides product-specific procedures and information.
The Alaris®System is a modular system intended for adult,
pediatric and neonatal care in today’s growing professional
healthcare environment. It consists of the PC Unit, the
Guardrails®Suite MX, and up to 4detachable infusion and/or
monitoring modules (channels). The Auto-ID Module can be
included as a fifth module.
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 15 patient-specific care areas, referred
to as profiles. Each profile contains a specific Drug Library
and channel labels, as well as instrument configurations
appropriate for the care area. Optional drug-specific Clinical
Advisories provide visual messages. Dosing limits for each
Guardrails®drug entry may be a Hard Limit that cannot be
overridden during infusion programming and/or a Soft Limit
that can be overridden, based on clinical requirements.
A Data Set is developed and approved by the facility’s own
multi-disciplinary team using the 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 CQI
Reporter.
Documentation provided with Alaris®System products
may 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.
Introduction
Read all instructions before using
the Alaris®System.
WARNING
nly
O
CAUTION

iii
Alaris®System (with v9 Model 8000) DFU
Introduction (Continued)
WARNINGS AND CAUTIONS:
Product-specific warnings and cautions, covered in the
applicable Sections of this DFU,provide information needed to
safely and effectively use the Alaris®System.
A DANGER is an alert to an imminent hazard which
could result in serious personal injury and/or product damage
if proper procedures are not followed.
A WARNING is an alert to a potential hazard which could
result in serious personal injury and/or product damage if
proper procedures are not followed.
A CAUTION is an alert to a potential hazard which could
result in minor personal injury and/or product damage if proper
procedures are not followed.
DEFINED TERMS:
The following table identifies the defined terms used throughout
this document for certain products and product features.
Product / Feature Defined Term
Alaris®Auto-ID module Auto-ID Module
Alaris®EtCO2module EtCO2Module
Alaris®Mobile Systems Manager Mobile Systems Manager
Alaris®PCA module PCA Module
Alaris®PC point-of-care unit PC Unit
Alaris®Pump module Pump Module
Alaris®SpO2module SpO2Module
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
Guardrails®hard limit Hard Limit
Guardrails®IV fluid IV Fluid
Guardrails®limit Limit
Guardrails®PCA pause protocol PCA Pause Protocol
Guardrails®soft limit Soft Limit
SmartSite®needle-free valve Needle-Free Valve
SmartSite®positive bolus needle-free valve Needle-Free Valve

iv Alaris®System (with v9 Model 8000) DFU
NOTE:
To enable the Profiles feature, a hospital-defined best-practice
Data Set must be uploaded to the PC Unit.
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. Verify whether or not Profiles feature has been enabled
(see PC Unit Section, "System Options", "System
Configurations"). 
Installation

1
Alaris®System (with v9 Model 8000) DFU, Section
SILENCE
OPTIONS
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CLEAR
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ENTER
CANCEL
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Alaris®PC Unit
Model 8000

Table of Contents
Table of Contents i
Alaris®System (with v9 Model 8000) DFU
PC Unit Section
GETTING STARTED
INTRODUCTION................................................................................................................................................................................................. 1-1
GENERAL SETUP AND OPERATION
ATTACHING AND DETACHING MODULES.......................................................................................................................................... 1-3
Attaching Module(s)................................................................................................................................................................................ 1-3
Detaching Module(s)............................................................................................................................................................................... 1-4
Adding Module(s) While System is Powered On........................................................................................................................ 1-4
START-UP.............................................................................................................................................................................................................. 1-5
Powering On System.............................................................................................................................................................................. 1-5
Responding to Maintenance Reminder.......................................................................................................................................... 1-6
Adjusting Display Contrast................................................................................................................................................................... 1-6
Selecting New Patient and Profile Options................................................................................................................................... 1-7
Adjusting Audio Volume........................................................................................................................................................................ 1-9
Locking/Unlocking Tamper Resist.................................................................................................................................................... 1-10
POWER OFF SYSTEM.................................................................................................................................................................................... 1-11
SYSTEM OPTIONS........................................................................................................................................................................................... 1-11
Display Contrast....................................................................................................................................................................................... 1-11
Patient ID..................................................................................................................................................................................................... 1-12
Clinician ID.................................................................................................................................................................................................. 1-14
Power Down All Channels.................................................................................................................................................................... 1-15
Anesthesia Mode..................................................................................................................................................................................... 1-16
Battery Runtime........................................................................................................................................................................................ 1-19
System Configurations.......................................................................................................................................................................... 1-19
Serial Numbers......................................................................................................................................................................................... 1-21
Software Versions................................................................................................................................................................................... 1-22
Time of Day................................................................................................................................................................................................ 1-23
Network Status......................................................................................................................................................................................... 1-24
Wireless Connection.............................................................................................................................................................................. 1-26
Data Set Status......................................................................................................................................................................................... 1-27
Maintenance Due..................................................................................................................................................................................... 1-28
GENERAL INFORMATION
WARNINGS AND CAUTIONS...................................................................................................................................................................... 1-31
General......................................................................................................................................................................................................... 1-31
Electromagnetic Compatibility............................................................................................................................................................ 1-32
FEATURES AND DISPLAYS......................................................................................................................................................................... 1-33
Features and Definitions....................................................................................................................................................................... 1-33
Operating Features, Controls, Indicators...................................................................................................................................... 1-35
Displays........................................................................................................................................................................................................ 1-37
SYSTEM CONFIGURABLE SETTINGS.................................................................................................................................................. 1-38
SPECIFICATIONS AND SYMBOLS........................................................................................................................................................... 1-39
Specifications............................................................................................................................................................................................ 1-39
Symbols....................................................................................................................................................................................................... 1-40

ii Table of Contents Alaris®System (with v9 Model 8000) DFU
PC Unit Section
TROUBLESHOOTING AND MAINTENANCE
GENERAL.............................................................................................................................................................................................................. 1-43
ALARM, ERRORS, MESSAGES................................................................................................................................................................. 1-43
Definitions................................................................................................................................................................................................... 1-43
Audio Characteristics............................................................................................................................................................................. 1-44
Alarms........................................................................................................................................................................................................... 1-45
Errors............................................................................................................................................................................................................. 1-45
Messages.................................................................................................................................................................................................... 1-46
STORAGE.............................................................................................................................................................................................................. 1-47
BATTERY CARE AND MAINTENANCE.................................................................................................................................................. 1-47
Battery Type and Charging.................................................................................................................................................................. 1-47
Battery Charge.......................................................................................................................................................................................... 1-48
Battery Care............................................................................................................................................................................................... 1-48
Battery Cautions and Disposal.......................................................................................................................................................... 1-48
INSPECTION REQUIREMENTS................................................................................................................................................................. 1-49

Getting Started
Introduction
Getting Started 1-1
Alaris®System (with v9 Model 8000) DFU
PC Unit Section
This Section of the DFU provides PC Unit (Model 8000) and
Alaris®System instructions and information. It is used in
conjunction with:
• PC Unit / Pump Module Technical Service Manual
• Product-specific sections of this DFU
• System Maintenance software (and its instructions) for Alaris®
System check-in, maintenance, and wireless configuration
The PC Unit is the core of the Alaris®System and provides
a common user interface for programming infusions and
monitoring, which helps to reduce complexity at the point of
care.
Alarms, Errors, Messages: See "Troubleshooting and
Maintenance" for specific PC Unit alarms, errors and
messages.
Contraindications: None known.
Electromagnetic Environment: See "Appendix" Section of
this DFU ("Regulations and Standards", "Compliance").
Read all instructions, including
those for the attached module(s) and
applicable accessories, before using
the Alaris®System.
WARNING
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CAUTION

1-2 Getting Started Alaris®System (with v9 Model 8000) DFU
PC Unit Section
THIS PAGE
INTENTIONALLY
LEFT BLANK

Attaching and Detaching Module(s)
General Setup and Operation 1-3
General Setup and Operation
Alaris®System (with v9 Model 8000) DFU
PC Unit Section
NOTES:
Individual hospital/facility may choose to permanently attach
modules. To remove permanently attached modules, contact
qualified service personnel.
Application of adhesive tape or other materials to the sides of
the PC Unit and modules may prevent proper latching.
The Alaris®System is designed to operate a maximum of 4
infusion or monitoring modules. Modules added in excess of
4are recognized by the system. The Auto-ID Module can be
included as a fifth module. The module(s) can be attached
in any position; however, when mounted on an IV pole, it is
recommended that a balanced configuration be maintained.
1. Position free module at a 45°angle, aligning IUI
connectors.
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.
45°
2. Rotate free module down against PC Unit or attached
module, until release latch snaps in place. 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
IUI Connectors
Release Latch
Attaching Module(s) 

1-4 General Setup and Operation Alaris®System (with v9 Model 8000) DFU
PC Unit Section
NOTE:
If any of the following conditions are observed, the 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 (A, B, Cor D) is not
displayed.
If the affected module operates normally when it is attached
via the alternate IUI connector, it may be used until a
replacement module can be substituted.
Attaching and Detaching Modules (Continued)
Detaching Module(s)
1. Ensure module(s) is powered off before detaching.
2. Push module release latch and then rotate module(s) up
and away from PC Unit or attached module (opposite to
motion shown above) to disengage connectors.
• Alaris®System reidentifies and shows appropriate
module identification (A, B, Cor D), from left to right.
• Appropriate module position(s) (A, Bor C) for
remaining module(s) appear on Main Display.
Add module as described in "Attaching Module(s)".
• System tests module, causing all LED segments and
indicator lights of displays to illuminate briefly.
• Appropriate module identification display (A, B, Cor 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 reidentification does NOT interrupt or
affect infusion or monitoring on active modules.
• Module positions (A, B, Cor D) appear on Main Display.
Adding Module(s) While System is Powered On 

General Setup and Operation 1-5
Alaris®System (with v9 Model 8000) DFU
PC Unit Section
NOTES:
Previous infusion parameters are automatically cleared after
8hours.
If any of the following conditions are observed, the PC Unit or
the affected attached module must be removed from use and
inspected by qualified personnel:
• LED segments are not illuminated during system-on test.
• Indicator lights do not illuminate.
• Appropriate module identification (A, B, Cor D) is not
displayed.
• Audio tone does not sound.
• Main Display does not appear backlit, appears irregular, or
has evidence of a row of pixels not functioning properly.
If the affected module operates normally when it is attached
via an alternate IUI connector, it may be used until a
replacement module can be substituted.
1. Connect PC Unit to an external AC power source.
2. Press
SYSTEM ON.
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, Cor D)
displays on attached module(s).
• An Audio tone sounds.
• If PM Reminder option is enabled and scheduled
preventive maintenance is due, MAINTENANCE
REMINDER screen appears.
• At completion of system-on test, New Patient? screen
appears.
Start-Up
Powering On System 

1-6 General Setup and Operation Alaris®System (with v9 Model 8000) DFU
PC Unit Section
Start-Up (Continued)
If the Preventive Maintenance (PM) Reminder option is enabled
and the PC Unit or an attached module is due for preventive
maintenance, a MAINTENANCE REMINDER message appears
at power up.
1. Remove and, if needed, replace module requiring
maintenance with a new module (see "Attaching and
Detaching Modules").
2. If Alaris®System was powered off to replace PC Unit,
reinitiate start-up process.
OR
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.
Responding to Maintenance Reminder 
CONFIRM
B
MAINTENANCE REMINDER
Module(s) due for routine
preventive maintenance:
Module A:
YYYY-MM-DD
NOTES:
If necessary, the reminder can be temporarily bypassed by
pressing the CONFIRM soft key.
Notify the appropriate facility personnel when a
MAINTENANCE REMINDER occurs.
CONFIRM
B
MAINTENANCE REMINDER
Module(s) due for routine
preventive maintenance:
Adjusting Display Contrast
1. Press DISPLAY CONTRST soft key. Midtown Hospital
Yes
No
NEW PATIENT ?
>Select Yes or No
“Yes” Clears Previous
Patient Data
DISPLAY
CONTRST

General Setup and Operation 1-7
Alaris®System (with v9 Model 8000) DFU
PC Unit Section
Start-Up (Continued)
System Options
>Adjust Display to
Desired Contrast
DisplayContrast
Lighter
Darker
CONFIRM
Guardrails Suite MX (v8)
®
©2001-2005 Cardinal Health, inc.
or one of its subsidiaries. All rights
reserved. Guardrails® is a registered
trademark of Cardinal Health, inc. or
one of its subsidiaries.
2. To adjust display for optimum viewing, use Lighter/Darker
soft keys.
3. To return to main screen, press CONFIRM soft key.
Adjusting Display Contrast (Continued)
Selecting 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.
OR
• To confirm programming is for same patient and retain
all stored patient parameters, press No soft key.
♦Last used profile displays. 
Midtown Hospital
Yes
No
NEW PATIENT ?
>Select Yes or No
“Yes” Clears Previous
Patient Data
DISPLAY
CONTRST
Midtown Hospital
Adult ICU
Yes
No
>Select Yes or No
Adult ICU ?
“Yes” Confirms Same
Profile
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.

1-8 General Setup and Operation Alaris®System (with v9 Model 8000) DFU
PC Unit Section
The option to enter and display a 16-character alphanumeric
patient identifier is always available. The instrument may
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. 
• To scan bar code on patient identification band, see
Auto-ID Module Section of this DFU.
EXIT
A
B
C
D
PAGE
DOWN
>Enter Patient ID and Press
CONFIRM
E
K-O
F-J
P-T
U-Y
A-E
Patient ID Entry
________________
CONFIRM
Patient ID Entry Feature
Start-Up (Continued)
Midtown Hospital
Profiles
>Press CONFIRM
CONFIRM
PAGE
DOWN
Neonatal
Peds ICU
Neonatal ICU
Adult General Care
Adult ICU
1of2
Selecting New Patient and Profile Options (Continued)
3. To select a profile, press corresponding left soft key. 
4. To confirm profile selection, press CONFIRM soft key.
• Main screen appears.
NOTES:
If the Profiles feature is disabled, the main menu appears.
To view additional choices, press PAGE DOWN soft key.

General Setup and Operation 1-9
Alaris®System (with v9 Model 8000) DFU
PC Unit Section
Selecting New Patient and Profile Options (Continued)
Start-Up (Continued)
Patient ID Entry Feature (Continued)
Adjusting Audio Volume
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.
Louder
>Change Setting or
Cancel
Audio Volume Adjust
Test
Softer
MAIN
SCREEN
3
VTBI = 250.0 mL
VOLUME
INFUSED
AUDIO
ADJUST
Midtown Hospital
Adult ICU
1. Press AUDIO ADJUST soft key.
NOTES:
An alphanumeric identifier, of up to 16 characters, can be
entered.
Press the soft key next to a letter group to list letters in that
group. Press the soft key next to an individual letter to enter
that letter.
To access the letter "Z" and special characters (hyphen,
underscore, space), press the PAGE DOWN soft key.
To clear an entire entry, press CLEAR key.
To back up a single character at a time, press CANCEL key.

1-10 General Setup and Operation Alaris®System (with v9 Model 8000) DFU
PC Unit Section
Start-Up (Continued)
1. Initiate operation of applicable module(s).
2. Press and hold Tamper Resist Switch, on back of PC Unit,
for 3to 4seconds (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 may:
♦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 3to 4seconds.
• An advisory tone (if Key Click Audio is enabled) and
a three-second PANEL UNLOCKED prompt on Main
Display confirm activation.
PANEL LOCKED
VTBI = 250.0 mL
VOLUME
INFUSED
AUDIO
ADJUST
Midtown Hospital
Adult ICU
PANEL UNLOCKED
VTBI = 250.0 mL
VOLUME
INFUSED
AUDIO
ADJUST
Midtown Hospital
Adult ICU
Locking/Unlocking Tamper Resist