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
CHANNEL
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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
nly
O
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
OPTIONS
1
4
7
CLEAR
2
5
8
0
3
6
9ENTER
CANCEL
SYSTEM
ON

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