Alaris System with Guardrails Model 8015 User Manual sw ver 9.33 July 2019

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

General Contact Information ...iv Introduction ...vi Approved Parts Recommendation ... .ix Installation...x 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 SpO2 Module Models 8210 and 8220 ... Section 4 Alaris EtCO2 Module Model 8300 ... Section 5 Alaris Auto-ID Module Model 8600 ... Section 6 Appendix A Troubleshooting and Maintenance...A-1 Alaris Systems Manager Connections...A-2 Alarms and Alerts ...A-3 Storage ...A-23 Battery Care and Maintenance ...A-23 Wireless Connection...A-25 Cleaning...A-27 Service Information...A-32 Regulations and Standards...A-34 Compliance...A-34 Trademarks...A-45

Order Number: Printed Copy: P00000367 © 2019 CareFusion Corporation or one of its affiliates. All rights reserved. DME: 10000355800-00

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General Contact Information CareFusion 303, Inc. 10020 Pacific Mesa Blvd, San Diego, CA 92121, United States 888-876-4287 Authorized European Representative (& 5(3 BD Switzerland Sàrl, Route de Crassier 17, Business Park Terre-Bonne, Batiment A4, 1262 Eysins, Switzerland Authorized Australian Representative Becton Dickinson Pty Ltd, 66 Waterloo Road, Macquarie Park, NSW 2113, Australia Authorized New Zealand Representative Becton Dickinson Ltd, 14b George Bourke Drive, Mt Wellington, Auckland 1060, New Zealand carefusion.com Customer Advocacy - North America (Clinical and technical feedback.) Phone: 888.812.3266 Email: [email protected]

Customer Advocacy - International (Clinical and technical feedback.) Email: [email protected]

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: 0800 389 6972 Email: [email protected]

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: 0800 917 8776 Email: [email protected] www.bd.com/en-uk/customer-support

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

Australia/New Zealand Technical Service - Australia (Maintenance and service information support; troubleshooting, service assistance.) Phone: 1300 729 258 http://www.bd.com/anz/contactus.asp

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Alaris System User Manual – with v9.33 Model 8015

General Contact Information (Continued) Technical Service - New Zealand (Maintenance and service information support; troubleshooting, service assistance.) Phone: 0508 422 734 http://www.bd.com/anz/contactus.asp Customer Service - Australia (Product return and order placement.) Phone: 1800 833 372 Email: [email protected]

Customer Service - New Zealand (Product return and order placement.) Phone: 0508 422 734 Email: [email protected]

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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 portable, 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.

WARNING Read all instructions before using the Alaris System. CAUTION

Only

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. 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.

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Introduction (Continued) Intended Use 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 EtCO2 module will monitor and alarm when a patient physiological condition is out of range. The Alaris System will alarm when the monitoring modules (SpO2 and/or EtCO2) are unable to detect patient vital signs. The SpO2 module will monitor and alarm when a patient physiological condition is out of range.

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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

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Introduction (Continued) Product/Feature

Defined Term

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

Introduction (Continued 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. If it becomes necessary to replace the following cables or accessories, use only approved parts listed in the technical service manual. Use of other parts may affect the electromagnetic compliance of the Alaris System. • PC unit power cord • PC unit serial cable • PCA dose request cord • Handheld barcode scanner

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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.

3.

x

Clean PCUs and all modules before placing the instruments in clinical use. Follow the procedure in Cleaning section of the Appendix page A-27.

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

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Table of Contents 1-iv

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

Getting Started Introduction 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.

WARNING Read all instructions, including those

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

Only

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.

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

Getting Started 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 1-2

PC Unit Section 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. 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.

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

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.

Aligned IUI Connectors

IUI Connector

Top View

IUI Connectors Not Aligned 45°

Front View

Top View PC Unit Section Alaris System User Manual – with v9.33 Model 8015

General Setup and Operation 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 1-4

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

General Setup and Operation 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, 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.

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 1-6

PC Unit Section 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 MAINTENANCE REMINDER message appears at power up. If necessary, the reminder can be temporarily bypassed by pressing the CONFIRM soft key. 1.

2.

MAINTENANCE REMINDER

B

Module(s) due for routine preventive maintenance:

Module A: YYYY-MM-DD

Notify the appropriate facility personnel when a MAINTENANCE REMINDER occurs and remove instrument requiring maintenance (see "Attach and Detach Module").

CONFIRM

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.

MAINTENANCE REMINDER

B

Module(s) due for routine preventive maintenance:

CONFIRM

Adjust Display Contrast 1.

Press DISPLAY CONTRAST soft key.

Midtown Hospital

NEW PATIENT ?

Yes

“Yes” Clears Previous Patient Data

No

>Select Yes or No DISPLAY CONTRST

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

General Setup and Operation 1-7