Care Fusion Alaris Manual

Directions for Use
AlarisTM System
(with AlarisTM PC Unit, Model 8015)
Supports GuardrailsTM Suite MX with GuardrailsTM Point-Of-Care software and up to v9.12 Operating System software.
December 2016
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Alaris System DFU – up to v9.12 Model 8015
Order Numbers:
Printed Copy: P00000182
© 2005-2016 CareFusion Corporation or one of its affiliates. All rights reserved.
Each of the Alaris product-specific sections has its own table of contents.
General Contact Information............................................................................................. iii
Introduction ........................................................................................................................v
Installation........................................................................................................................ vii
Alaris™ PC Unit Model 8015 .......................................................................................... 1-i
Alaris™ Pump Module, Model 8100 Alaris™ Syringe Module, Model 8110 ................... 2-i
Alaris™ PCA Module Model 8120 .................................................................................. 3-i
Alaris™ SpO2 Module Models 8210 and 8220............................................................... 4-i
Alaris™ EtCO2 Module Model 8300 ............................................................................... 5-i
Alaris™ Auto-ID Module Model 8600.............................................................................. 6-i
Appendix
Maintenance ...........................................................................................................................A-1
Cleaning.............................................................................................................................A-1
Service Information............................................................................................................A-3
Warranty ............................................................................................................................A-4
Regulations and Standards.....................................................................................................A-5
Compliance........................................................................................................................A-5
Trademarks......................................................................................................................A-14
Table of Contents

Alaris System DFU – up to v9.12 Model 8015 iii
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 & New Zealand
Unit 3, 167 Prospect Highway
Seven Hills
NSW 2147
Australia
carefusion.com
Customer Advocacy - North America
(Clinical and technical feedback.)
Phone: [phone]
E-mail: [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]
E-mail: [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]
E-mail: UK-Customer-Ser[email protected]
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]
E-mail: [email protected]
General Contact Information

iv Alaris System DFU – up to v9.12 Model 8015
Customer Care - Australia
(Product return and order placement.)
Phone: [phone]
Email: [email protected]
Customer Care - New Zealand
(Product return and order placement.) Phone: [phone]
Email: nz-customerser[email protected]
General Contact Information (Continued)

Alaris System DFU – up to v9.12 Model 8015 v
The AlarisTM 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
GuardrailsTM Suite MX, and up to four detachable infusion
and/ or monitoring modules (channels). The Auto-ID
Module can be included as a fifth module.
The Alaris System supported by this DFU uses a new
generation PC Unit (Model 8015) which provides wireless
connectivity right out of the box, and an enhanced display
(including color) to clearly communicate critical
programming, infusion, monitoring and hospital-defined
policy information. Alaris System wireless communication
makes it easier than ever to increase the safety of IV
medication and continuously improve clinical best
practices, regardless of existing wireless infrastructure.
The Model 8010 Nurse Call Accessory might not yet be
available for use or compatible with the Model 8015.
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,
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.
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.
Introduction
Read all instructions before using
the Alaris System.
WARNING
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CAUTION

Alaris System DFU – up to v9.12 Model 8015 vi
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 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.
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 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 is an alert to a potential hazard which
could result in serious personal injury and/or product
damage if proper procedures are not followed.
Ais 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 trademarked products
and product features.
Introduction (Continued)
Product/Feature Defined Term
Alaris Auto-ID module Auto-ID Module
Alaris EtCO2module EtCO2Module
Alaris PCA module PCA Module
Alaris PC unit PC Unit
Alaris Pump module Pump Module
DANGER
WARNING
CAUTION

vii Alaris System DFU – up to v9.12 Model 8015
DEFINED TERMS: (Continued)
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
Introduction (Continued)
Product/Feature Defined Term
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
SmartSiteTM needle-free valve Needle-Free Valve
SmartSite positive bolus needle-free valve Needle-Free Valve
Installation

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Alaris System DFU – up to v9.12 Model 8015 Section 1
Alaris™PC Unit
Model 8015
SILENCE
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CLEAR
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Alaris System DFU – up to v9.12 Model 8015 1-i
PC Unit Section
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
Secure to Pole Using Optional Locking Pole Clamp ..................................................................... 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 ........................................................................................................... 1-10
Power Off System ................................................................................................................................. 1-11
System Options ..................................................................................................................................... 1-12
Display Contrast ............................................................................................................................ 1-12
Patient ID ....................................................................................................................................... 1-12
Clinician ID .................................................................................................................................... 1-15
Power Down All Channels ............................................................................................................. 1-16
System Configurations .................................................................................................................. 1-20
Serial Numbers .............................................................................................................................. 1-22
Software Versions ......................................................................................................................... 1-23
Time of Day ................................................................................................................................... 1-24
Network Status .............................................................................................................................. 1-25
Wireless Connection ...................................................................................................................... 1-28
Data Set Status ............................................................................................................................. 1-29
Maintenance Due .......................................................................................................................... 1-30
General Information
Warnings and Cautions ......................................................................................................................... 1-31
General .......................................................................................................................................... 1-31
Electromagnetic Compatibility ....................................................................................................... 1-33
Features and Displays ........................................................................................................................... 1-34
Features and Definitions ................................................................................................................ 1-34
Operating Features, Controls, Indicators .......................................................................................1-36
Displays ......................................................................................................................................... 1-38
System Configurable Settings ............................................................................................................... 1-39
Troubleshooting and Maintenance
General ................................................................................................................................................. 1-43
Alaris Server Connections ..................................................................................................................... 1-43
Alarms, Errors, Messages ..................................................................................................................... 1-44
Display Color ................................................................................................................................. 1-44
Definitions ...................................................................................................................................... 1-44
Audio Characteristics ..................................................................................................................... 1-45
Alarms ........................................................................................................................................... 1-46
Table of Contents

1-ii Alaris System DFU – up to v9.12 Model 8015
PC Unit Section
Errors ............................................................................................................................................. 1-46
Messages ...................................................................................................................................... 1-47
Storage .................................................................................................................................................. 1-48
Battery Care and Maintenance .............................................................................................................. 1-48
Battery Type and Charging ............................................................................................................ 1-48
Battery Charging ............................................................................................................................ 1-48
Battery Storage and Use Conditions .............................................................................................1-49
Proper Battery Maintenance .......................................................................................................... 1-49
Battery Cautions and Disposal ...................................................................................................... 1-49
Inspection Requirements ....................................................................................................................... 1-50

Alaris System DFU – up to v9.12 Model 8015 Getting Started 1-1
PC Unit Section
This section of the DFU provides PC Unit (Model 8015) and
AlarisTM 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. 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, Alaris Server,
and Mobile Server. The combined use of the Alaris System and
Alaris Server:
• Reduces number of manual steps needed to program
an infusion (by providing information obtained from
Alaris Server). All data entry and validation of infusion
parameters are performed, according to a physician's
order, by a trained healthcare professional.
• Is integrated into a facility’s existing network infrastructure.
When enabled, the Alaris Server allows the exchange of
information between the Alaris Server and the Alaris System.
The PC Unit can be operated manually or in concert with
the information exchanged with the Alaris Server. 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.
The Mobile Systems Manager does not utilize existing wireless
infrastructure. It is intended to be used as a not-fully-functional
substitution for the full Systems Manager in hospitals/facilities
that do not have wireless communications installed. It can also
be used in hospitals/facilities using the full Systems Manager
but where wireless coverage is poor.
Getting Started
Introduction
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 DFU – up to v9.12 Model 8015
PC Unit Section
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").
Introduction (Continued)

Alaris System DFU – up to v9.12 Model 8015 General Setup and Operation 1-3
PC Unit Section
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.
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.
General Setup and Operation
Attach and Detach Module
Attach Module
45°
IUI Connectors

1-4 General Setup and Operation Alaris System DFU – up to v9.12 Model 8015
PC Unit Section
2. Rotate free module down against PC Unit or attached
module until release latch snaps in place.
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.
Attach and Detach Module (Continued)
Attach Module (Continued)
Detach Module
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
Release Latch

Alaris System DFU – up to v9.12 Model 8015 General Setup and Operation 1-5
PC Unit Section
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 reidentification 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.
1. Attach PC Unit to pole.
2. Insert PCA Module syringe door key into key lock on pole
clamp knob.
3. To lock PC Unit to pole, turn key in direction of arrow
(clockwise).
Pole clamp knob spins in place, preventing PC Unit from
being removed from pole.
4. To unlock PC Unit from pole, turn key in opposite direction
of arrow (counter clockwise).
Pole clamp knob no longer spins in place, allowing
PC Unit to be removed from pole.
Attach and Detach Module (Continued)
Add Module While System is Powered On
Secure to Pole Using Optional Locking Pole Clamp
Key Lock

1-6 General Setup and Operation Alaris System DFU – up to v9.12 Model 8015
PC Unit Section
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, MAINTENANCE
REMINDER screen appears.
• At completion of system-on test, 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.
Start-Up
Power On System
NOTE:
Previous infusion parameters are automatically cleared after
8 hours.

Alaris System DFU – up to v9.12 Model 8015 General Setup and Operation 1-7
PC Unit Section
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. If necessary, the reminder can be temporarily
bypassed by pressing the CONFIRM soft key.
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
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.
1. Press DISPLAY CONTRAST soft key.
Start-Up (Continued)
Respond to Maintenance Reminder
Adjust Display Contrast
CONFIRM
B
MAINTENANCE REMINDER
Module(s) due for routine
preventive maintenance:
Module A:
YYYY-MM-DD
CONFIRM
B
MAINTENANCE REMINDER
Module(s) due for routine
preventive maintenance:
Midtown Hospital
Yes
No
NEW PATIENT ?
>Select Yes or No
“Yes” Clears Previous
Patient Data
DISPLAY
CONTRST

1-8 General Setup and Operation Alaris System DFU – up to v9.12 Model 8015
PC Unit Section
2. To adjust display for optimum viewing, use Lighter/Darker
soft keys.
3. To return to main screen, press CONFIRM soft key.
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.
◦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.
Start-Up (Continued)
Adjust Display Contrast (Continued)
Select New Patient and Profile Options
System Options
>Adjust Display to
Desired Contrast
Display Contrast
Lighter
Darker
CONFIRM
®
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