Software User Manual
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Alaris™ System Maintenance v10.19
Software User Manual
May 2015 Part Number: P00000117 DME: 10000270316 Version 00
Alaris, Guardrails, CareFusion, and the CareFusion logo are trademarks or registered trademarks of CareFusion Corporation or one of its affiliates
Alaris™ System Maintenance v10.19 Software User Manual Changes in equipment, software, or procedures occur periodically; information describing these changes will be included in future editions of the guide. The information in this document is subject to change and does not represent a
All other trademarks are the commitment on the part of CareFusion to provide additional services or enhancements. property of their respective Documentation provided with this product might reference product not present in your owners.
facility or not yet available for sale in your area.
CareFusion San Diego, California United States
888.876.4287 carefusion.com ©2010-2015 CareFusion Corporation or one of its affiliates All rights reserved.
North America Customer Advocacy - North America (Clinical and technical feedback.) Phone: 888.812.3266 E-mail: [email protected] Customer Care - North America (Product return, service assistance, and order placement.) Phone, United States: 800.482.4822 Phone, Canada: 800.387.8309 Technical Support - North America (Maintenance and service information support; troubleshooting.) Phone, United States: 888.812.3229 Phone, Canada: 800.387.8309
United Kingdom Technical Support - United Kingdom (Maintenance and service information support; troubleshooting.) Phone: 0800 389 6972 E-mail: [email protected] Customer Care - United Kingdom (Product return, service assistance, and order placement.) Phone: 0800 917 8776 E-mail: [email protected]
International Customer Advocacy - International (Clinical and technical feedback.) E-mail: [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
Australia/New Zealand Technical Support - Australia/New Zealand (Maintenance and service information support; troubleshooting, service assistance.) Phone: +61 1300 729 258 E-mail: [email protected] Customer Care - Australia (Product return and order placement.) Phone: +61 1800 110 511 E-mail: [email protected] Customer Care - New Zealand (Product return and order placement.) Phone: +64 (0) 508 422 734 E-mail: [email protected] Authorized Australian/New Zealand Representative CareFusion Australia & New Zealand Unit 3, 167 Prospect Highway Seven Hills NSW 2147 Australia Authorized European Representative CareFusion The Crescent, Jays Close Basingstoke, Hampshire RG22 4BS United Kingdom
Contents Chapter 1-Introduction About the Software...2 Feature Summary ...3 Warnings ...5 Cautions...6
Chapter 2-Installation System Requirements ...8 Hardware Requirements ...8 Software Requirements...9 Install the Software...9 Errors ...9 Custom Installation...10 Complete (Default)-Stand-Alone Installation...23 Upgrade the Alaris System Maintenance from v9.8 or higher versions to v10.19 ...30 Install on an Alaris Systems Manager Computer ...33 Uninstall the Software ...39 Uninstall the Software ...39 Uninstall the v10.19 Software ...39 Uninstall the SQL Server 2008 Components ...45 Uninstall the SQL Server 2005 Components ...50 Uninstall the SQL Server Components if v9.5 or earlier was uninstalled.50
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Contents
Uninstall the SQL Server Components if v9.7.x was upgraded to v9.8...55
Chapter 3-Startup and Setup Main Window and Menu Bar ...62 Menu Bar ...63 Options Settings ...64 Application Settings ...64 Database Settings...65 Set the PC Unit Security Password...68 Export the Devices...69 To import the CQI database...75 ASM Data Migration ...77 Connect the Alaris PC Unit to the Computer ...78 Hardware Connections ...78 View the Available COM Ports...79 Enable FIPS Mode...80
Chapter 4-Preventive Maintenance Introduction ...84 General Steps...85 Run or Abort Tasks...87 Run Tasks Concurrently...87 Abort Tasks ...88 Coloring Scheme ...88 Preventive Maintenance ...90 Alaris PC Unit Model 8015 ...90 Alaris Pump Module...97 Alaris PCA Module ...109 Alaris Syringe Module...118 Alaris SpO2 Module...128 Alaris EtCO2 Module...135 Setting Up the Jig and the EtCO2 Module...142 Alaris EtCO2 Module Time-to-Calibration and PM Due Operation144 Alaris Auto-ID Module ...146 Handheld Scanner...150
Chapter 5-Data Sets and Alerts Transfer a Data Set ...156 Download Alerts...160
Chapter 6- Manage the Device Firmware Overview ...166 What You Need ...167 Manage the Alaris PC Unit and Modules Firmware ...168
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Chapter 7-Configure the Components Security Features ...178 FIPS Mode...178 Alaris PC Unit Security Password...178 System Maintenance Passphrase ...178 Zeroize Task ...179 Configuration Packages...181 Components of a Configuration Package ...183 Manage a Not-for-Human-Use Environment ...183 Add a Configuration Package...185 Adding an Additional Configuration Package ...186 Delete a Configuration Package ...187 Export a Configuration Package...187 Import a Configuration Package...187 Export or Import Components of a Configuration Package ...188 Copy a Configuration Package ...188 Copy a Component of a Configuration Package ...189 Specify the Network Settings ...189 802.11d Behavior ...189 Create a Network Profile...189 Datalink Settings ...190 Security Settings ...193 Network Settings...197 Server Settings ...198 Wireless Network Setting on the Alaris PC Unit ...199 Enable Wireless Network...199 Disable the Wireless Network...201 Specify the Alaris Auto-ID Module Settings ...202 Formatting Rules...202 Specify the Firmware Files...205 Specify a Data Set File ...206
Chapter 8-Calibration Introduction ...208 Alaris Pump Module Calibration ...209 Calibration ...209 Pressure Calibration Setup...213 Alaris PCA Module Calibration ...216 Alaris Syringe Module Calibration ...222 Alaris EtCO2 Module Calibration ...229
Chapter 9-Tasks Task Groups ...234 Create a New Task Group ...234 Delete a Task Group ...235 Rename a Task Group ...236
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Tasks List ...236 Edit the Tasks List ...236 Change a Tasks List Order ...237 Task Information ...238 Alaris PC Unit Tasks ...238 Transfer Network Configuration-Error Handling...243 Alaris Pump Module Tasks ...245 Alaris Syringe Module and Alaris PCA Module Tasks ...248 Alaris SpO2 Module Tasks ...252 Alaris EtCO2 Module Tasks ...253 Alaris Auto-ID Module Tasks ...255 Handheld Scanner Tasks ...256 Test Equipment...257
Chapter 10-Device Information View the Device Information ...262
Chapter 11-Reports and Logs Reports...268 Report Types...268 Run Reports ...268 Logs ...271 Log Definitions...271 Example Log...274
Glossary ... 281
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Alaris™ System Maintenance v10.19 Software User Manual
Chapter 1 Introduction
Alaris™ System Maintenance v10.19 Software User Manual
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Chapter 1-Introduction
About the Software
About the Software This software is provided under and subject to a license from CareFusion. Alaris™ System Maintenance (ASM) v10.19 software is used to perform routine maintenance on an Alaris System. The functionality of this software replaces maintenance software (MSW) and the Flash tool for the Alaris System. To use this software, install it on a personal computer and then connect a serial cable between the personal computer and an Alaris™ PC unit. The Model 8000 Alaris PC unit is not supported by Alaris System Maintenance software. The Alaris System Maintenance software kit includes: •
Alaris System Maintenance software CD-ROM
•
Serial cable
•
This software user manual (pdf on CD-ROM and printed version)
A USB serial adapter (not supplied) can be used to connect one or more Alaris PC units to a personal computer equipped with Alaris System Maintenance software. The USB serial adapter must meet the following specifications:
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Plugs into a USB port on a personal computer.
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Provides RS-232 male DB9 port(s) for direct connection to Alaris PC units.
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Draws its power from USB connection-a power adapter is not required.
Alaris™ System Maintenance v10.19 Software User Manual
Feature Summary
Chapter 1-Introduction
Feature Summary Alaris System Maintenance software can be used to perform the following functions: •
Maintain the Alaris PC unit.
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Upgrade firmware on the Alaris PC unit (Model 8015) and attached modules.
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Perform preventive maintenance/check-in.
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Set and check preventive maintenance reminder dates.
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Troubleshoot and repair instruments.
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Module calibration, as applicable.
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Set up, test, and configure the Alaris™ Auto-ID module.
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Download and view instrument logs.
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Download CQI data logs.
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Transfer data sets from the personal computer to the Alaris PC unit.
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Configure wireless network settings.
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Test communications board interaction with a wireless network.
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Disable Wireless Network configuration option.
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Configure wireless protocol 802.11 a/b/g/n. Available modes are applicable when the PC Unit is equipped with the appropriate wireless device: °
802.11a
°
802.11b/g
°
802.11a/b/g
°
802.11a/b/g/n
°
802.11a/n
°
802.11b/g/n
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Configure international wireless operation standard 802.11d.
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Configure wireless data encryption with TKIP and AES security protocols.
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Configure wireless security using WEP 40 and 128 bits network protocols.
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Configure wireless security using WPA and WPA2 network protocols.
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°
Personal (PSK)
°
Enterprise EAP: TLS, TTLS and PEAP
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Inner Authentication: MSCHAPv2 and PAP
°
Configurable Client and Server Certificate Formats: BER, DER, PKCS7 and PKCS12 Enable FIPS mode of operation for Alaris PC unit 8015 only (for FIPS 140-2 Compliant PC units, see FIPS 140-2 Compliance Instructions for Alaris Products - Service Manual Supplement for Alaris PC Unit, Alaris Systems Manager, and Alaris System Maintenance Software for more information.
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Chapter 1-Introduction
Feature Summary
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Zeroize Critical Security Parameters (CSP) data. This feature is not supported by non-FIPS 140-2 compliant PC units (Alaris PC unit 8015 only).
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Set up an Alaris PC unit Security Password. This feature is not supported by non-FIPS 140-2 compliant PC units (Alaris PC unit 8015 only).
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Import an AES file with a System Maintenance Passphrase. This feature is not supported by nonFIPS 140-2 compliant PC units (Alaris PC unit 8015 only).
Perform all pre-inspections before instrument use. A qualified technician or biomedical engineer must perform inspections at least once a year or as required in accordance with CareFusion guidelines. Inspections are intended to comply with requirements specified by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). A service agreement can be purchased from CareFusion for preventive maintenance inspections.
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Alaris™ System Maintenance v10.19 Software User Manual
Warnings
Chapter 1-Introduction
Warnings Warnings provide information needed to safely and effectively use the Alaris System Maintenance software. WARNING 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.
WARNING At no time should the Alaris System Maintenance software be used while the Alaris System is connected to a patient.
WARNING Alaris System Maintenance software and procedures are intended to be performed only by qualified personnel, or under direct supervision by qualified personnel.
WARNING Prior to use, CareFusion recommends that you become familiar with each instrument and accessory used with the Alaris System Maintenance software. For specific instrument warnings, cautions, inspection requirements, and other related instrument information, refer to the user manual and/ or service manual for the applicable Alaris System.
WARNING The instrument case should only be opened by qualified service personnel using proper grounding techniques. When the instrument case is opened, electrical shock hazard exists, which can result in serious injury to persons and instrument component damage.
WARNING To ensure proper calibration, run the post tests for the Alaris™ Pump module and the accuracy tests for the Alaris™ Syringe module after calibration. These tests are displayed in the default Calibration test lists.
WARNING Ensure that the instrument is in operational status before returning it to patient use.
WARNING The Alaris PC unit might not be compatible with every module. To determine module compatibility, refer to the user manual for the applicable Alaris System.
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Chapter 1-Introduction
Cautions
Cautions Cautions provide information needed to safely and effectively use the Alaris System Maintenance Software. CAUTION 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. •
Loading the Alaris System Maintenance software is considered a non-clinical service activity. Interconnecting a medical device with a personal computer might cause the safety or electromagnetic environment to change while the connection exists. There is a potential for higher leakage currents or EMI disturbance levels. Remove the connection at both ends before patient use.
•
By default, the Alaris System Maintenance software is set to automatically clear logs after they are downloaded. Once log entries have been cleared, they cannot be downloaded again from the instrument. The log entries remain in the database and can be displayed using the View Reports tab in the main window.
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Only one Alaris PC unit should be connected to a group of attached modules at any given time. Connection of multiple Alaris PC units to each other causes damage to the IUI connectors.
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Only one Alaris™ SpO2 module can be connected to the Alaris PC unit at any one time.
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If an Alaris Pump module fails the patient-side occlusion or rate accuracy verification (RAV) tests, calibration is required. Failure to calibrate and retest the instrument might result in improper instrument operation.
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For tests that require water, use distilled water at room temperature between 41°F and 104°F (5°C to 40°C). If the water is not within this temperature range, the reading might be inaccurate.
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If assigning static IP addresses and multiple instances of the Alaris System Maintenance software are running (typically on different personal computers), it is possible to assign the same IP address to multiple Alaris PC units. To ensure this does not occur, assign each Alaris PC unit a single, unique IP address.
•
If assigning static IP addresses, utilizing Alaris System Maintenance with a centralized database will prevent assigning the same IP address to multiple PC units.
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Calibration verifications perform strenuous tests on the Alaris Syringe module and Alaris™ PCA module. In some cases, these tests differ from the check-in/preventive maintenance tests.
NOTE When creating or modifying a network configuration profile with a security type that requires the use of multiple certificates, all certificates must have a unique file name to ensure that the correct certificate is used during network authentication.
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Following calibration, use calibration verifications (rather than check-in/preventive maintenance verifications) to verify the correct calibration.
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Use of accessories or cables other than those specified might result in degraded electromagnetic compatibility performance or safety of the Alaris System.
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The flow rate out of the gas source and into the Alaris EtCO2 module must be greater than 0.5 liter per minute to ensure accurate readings. It is recommended to place a flow meter between the gas source at the “T” in the line (breather line).
Alaris™ System Maintenance v10.19 Software User Manual
Chapter 2 Installation
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Chapter 2-Installation
System Requirements
System Requirements To run the Alaris System Maintenance software, the personal computer must meet the following minimum hardware and software requirements. CAUTION For optimum performance of the Alaris System Maintenance software, ensure that the personal computer is equipped with the required hardware and software, and do not use the personal computer with unspecified accessories or cables. Use of accessories or cables other than those specified might result in degraded electromagnetic compatibility performance or safety of the Alaris System.
Hardware Requirements The personal computer on which the Alaris System Maintenance software is installed must meet the following requirements: •
Pentium® Class, 1 GHz or faster processor
•
1 GB minimum RAM
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HDD (hard disk drive): 5 GB minimum of free space after the operating system is installed
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CD-ROM drive
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SVGA video card
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Monitor: minimum resolution 1024 × 768; color depth set greater than 256 colors
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Port: configurable RS-232, 9-pin, serial communications, or USB
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Keyboard
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Mouse
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Printer and printer connection (optional)
Other hardware (see Connect the Alaris PC Unit to the Computer on page 78): •
Serial communications cable
•
Serial to USB adapter cable kit
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Alaris™ System Maintenance v10.19 Software User Manual
Install the Software
Chapter 2-Installation
Software Requirements Use one of the following operating systems: •
Microsoft® Windows® XP with Service Pack 3
•
Microsoft Windows 7 with Service Pack 1
•
Microsoft Windows Server® 2008 R2
Other software: •
Microsoft .NET Framework 4.0
NOTE The SQL Server® 2008 Express R2 installation may fail on Windows Server 2008 R2 if the Microsoft .NET Framework is not enabled. This problem occurs because installation of the .NET Framework 3.5 is a prerequisite to this installation. On Windows Server 2008 R2, the .NET Framework 3.5 is included as a Windows component. By default, the .NET Framework 3.5 is not enabled. To avoid this installation failure, you must enable the .NET Framework 3.5 from the Windows Features component before you run the SQL Server 2008 Express R2 installation.
Install the Software Read the following instructions before installing the Alaris System Maintenance software. If v9.5 or earlier Alaris System Maintenance software is installed, it must be uninstalled before the new software can be installed (see Uninstall the Software on page 40). If 9.7x is installed, it must be upgraded to v9.8 before the new software can be installed without the loss of data. If v9.8 or a later version is installed, there is no need to uninstall the software, since Alaris System Maintenance v10.19 upgrades Alaris System Maintenance v9.8 or later versions to v10.19. Read all screen prompts carefully. It is recommended to close all applications and disable virus checking during installation.
NOTE Previous versions of Alaris System Maintenance (ASM) contained a version number in the folder name (example, Alaris System Maintenance v9.7). After upgrading to a newer version, the folder name remains unchanged even though the application has been successfully upgraded. To verify the application version after the upgrade, click Help>About Alaris™ System Maintenance. The dialog box contains the current version information.
Errors If errors are encountered during installation or the installation process is cancelled before it is completed, a message indicates that the wizard was interrupted before the installation could be completed. Error
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Chapter 2-Installation
Install the Software
messages can be found in the ASMInstall.log file, located in the temp directory. To navigate to the temp directory, choose Start > Run, then type %TEMP%, and click OK.
Custom Installation A custom installation allows you to choose the features to be installed. It is strongly recommended to choose a custom installation and configure your system with a centralized database. This allows multiple users of the software to share a database. The custom installation provides the option to install a centralized database on a shared hospital server and is CareFusion’s preferred installation method. The Alaris System Maintenance software database is installed on a hospital server, and the Client Tools in the Alaris System Maintenance software are installed on the computer at each workstation. This provides client access to a centralized database that can be backed up by the facility’s IT department according to the facility’s protocol.
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Alaris™ System Maintenance v10.19 Software User Manual
Install the Software
Chapter 2-Installation
To install the centralized database 1. Insert the Alaris System Maintenance software CD into the CD-ROM drive of the server. 2. Perform one of the following actions: ° °
If the installation program automatically starts, go to step 3. If the installation program does not start automatically, choose Start > Run, then type D:Alaris System Maintenance v10.19.exe (where D: is the CD drive).
If your system does not have Microsoft .NET Framework 4.0 installed, the Alaris System Maintenance software prompts for installation of the applicable software. Depending on the installation requirements, you might need to reboot your system after installation.
NOTE If your system does not have a PDF reader installed, the following warning appears. A PDF reader is required to view the User Manual.
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Chapter 2-Installation
Install the Software
If using...
Then click...
Windows 7, Windows Server 2008 R2
The url link http://get.adobe.com/reader to download the PDF reader.
Windows XP
Go to Adobe® Reader Website to download the PDF reader.
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Alaris™ System Maintenance v10.19 Software User Manual
Install the Software
3.
Chapter 2-Installation
Follow all of the screen prompts. NOTE • If v9.7.x is installed, the following message appears. Click OK. If the existing software is v9.7.x, upgrade to v9.8 before continuing with the installation.
•
If v9.5 or earlier Alaris System Maintenance software is still installed, the following message appears.
4. Click OK and uninstall the existing software manually before continuing with the installation (see Uninstall the Software on page 40). NOTE See Uninstall the SQL Server 2005 Components on page 51 to perform the additional steps needed to remove SQL Server 2005 components from the system.
5. Click Next.
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