Alaris System Maintenance v 9.8 Software User Manual April 2012

Alaris and Guardrails are registered trademarks of CareFusion Corporation or one of its subsidiaries. Masimo is a registered trademark of Masimo Corporation. Nellcor is a registered trademark of Nellcor Puritan Bennett, Inc. All other trademarks are the property of their respective owners. CareFusion San Diego, California United States

The information in this document is subject to change and does not represent a commitment on the part of CareFusion to provide additional services or enhancements. The screens illustrated in this document are for reference purposes only and might be different than the actual screens displayed. Documentation provided with this product might reference product not present in your facility or not yet available for sale in your area. If difficulties are encountered while using this software, refer to the user manual for the applicable Alaris® System, and/or service manual and related service bulletin(s) before contacting CareFusion Technical Support. If necessary, contact a CareFusion representative. Provide a description of the difficulty experienced, any messages that were displayed at the time of the difficulty, and the software version. Before returning the software to CareFusion, contact CareFusion Customer Care to get a return authorization number. Put the software in its original packaging (if available), write the return authorization number on the package, and return it to the nearest facility.

888.876.4287 carefusion.com © 2007-2012 CareFusion Corporation or one of its subsidiaries. All rights reserved.

Customer Advocacy - North America (Clinical and technical feedback.) Phone: 888.876.4287 E-mail: [email protected]

Technical Support - North America (Maintenance and service information support; troubleshooting.) Phone, United States: 888.876.4287 Phone, Canada: 800.387.8309 E-mail: [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 E-mail: [email protected]

Contents Chapter 1-Introduction About the Software... 2 Feature Summary ... 3 Warnings ... 4 Cautions... 5

Chapter 2-Installation System Requirements ... 8 Hardware Requirements ... 8 Software Requirements ... 9 Install Software... 9 Errors ... 9 Custom Installation... 10 Complete (Default)-Stand-Alone Installation... 21 Uninstall Software... 28 Uninstall v9.7.1 or v9.7 Software... 28 Uninstall v9.8 Software ... 28 Uninstall SQL Server 2005 Components ... 32 Uninstall SQL Server Components from v9.4.1  or v9.5 to ASM v9.8 Upgrade ... 32 Uninstall SQL Server Components from v9.7  or v9.7.1 to ASM v9.8 Upgrade ... 38

Alaris System Maintenance Software User Manual

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Contents

Chapter 3-Startup and Setup Main Window and Menu Bar... 48 Menu Bar ... 49 Options Settings ... 50 Application Settings ... 50 Database Settings... 51 Set PC Unit Security Password ... 53 Export Devices ... 55 To import the CQI database ... 60 ASM Data Migration... 60 MSW Databases Migration ... 61 Connect Alaris PC Unit to Computer... 63 Hardware Connections ... 63 View Available COM Ports... 64 Enable FIPS Mode... 65

Chapter 4-Preventive Maintenance Introduction ... 70 General Steps... 71 Run or Abort Tasks ... 73 Coloring Scheme ... 74 Preventive Maintenance ... 75 Alaris PC Unit ... 75

Chapter 5-Data Sets and Alerts Transfer a Data Set ... 134 Download Alerts... 137

Chapter 6-Flash Firmware Flash Firmware... 144 Alaris PC Unit, Model 8000 (PCU1.0) ... 144 Alaris PC Unit, Model 8015 (PCU1.5) ... 149

Chapter 7-Configure Components Security Features ... 158 FIPS Mode... 158 Alaris PC Unit Security Password... 158 System Maintenance Passphrase ... 158 Zeroize Task ... 159 Configuration Packages... 161 Components of a Configuration Package ... 162 Manage a Not-for-Human-Use Environment... 162 Add a Configuration Package... 164 Delete a Configuration Package ... 165 Export a Configuration Package... 165 Import a Configuration Package... 165

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Contents

Export or Import Components of a Configuration Package... 166 Copy a Configuration Package... 166 Copy a Component of a Configuration Package ... 166 Specify Network Settings ... 167 Wireless Network Setting on Alaris PC Unit ... 175 Specify Alaris Auto-ID Module Settings ... 178 Specify Firmware Files... 181 Specify a Data Set File ... 182

Chapter 8-Calibration Introduction ... 184 Alaris Pump Module Calibration ... 185 Calibration ... 185 Alaris PCA Module Calibration ... 192 Alaris Syringe Module Calibration ... 198 Alaris EtCO2 Module Calibration... 205

Chapter 9-Tasks Task Groups ... 210 Create a New Task Group ... 210 Delete a Task Group... 211 Rename a Task Group ... 212 Tasks List ... 212 Edit Tasks List... 212 Change Tasks List Order ... 213 Task Information ... 214 Alaris PC Unit Tasks ... 214 Transfer Network Configuration-Error Handling... 218 Alaris Pump Module Tasks ... 219 Alaris Syringe Module and Alaris PCA Module Tasks ... 222 Alaris SpO2 Module Tasks ... 226 Alaris EtCO2 Module Tasks ... 227 Alaris Auto-ID Module and Handheld Scanner Tasks... 229 Test Equipment... 230

Chapter 10-Reports and Logs Reports... 234 Report Types ... 234 Run Reports ... 234 Logs ... 236 Log Definitions... 236 Example Log ... 239

Glossary ... 245

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Contents

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Chapter 1 Introduction

Alaris System Maintenance v9.8 Software User Manual

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Chapter 1-Introduction

About the Software This software is provided under and subject to a license from CareFusion. v9.8 Alaris® System Maintenance 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 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:

2

•

Plugs into a USB port on a personal computer.

•

Provides RS-232 male DB9 port(s) for direct connection to Alaris PC units.

•

Draws its power from USB connection-a power adapter is not required.

Alaris System Maintenance v9.8 Software User Manual

Feature Summary

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 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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Support wireless protocols for b, b/g, a/b/g, and d networks.

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Support wireless security for WEP, WPA, and WPA2.

•

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.

•

Zeroize Critical Security Parameters (CSP) data. This feature is not supported by non-FIPS 140-2 compliant PC units (Alaris PC unit 8015 only).

•

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).

•

Import an AES file with a System Maintenance Passphrase. This feature is not supported by non-FIPS 140-2 compliant PC units (Alaris PC unit 8015 only).

Perform all preinspections 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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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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Alaris System Maintenance v9.8 Software User Manual

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 multiple instances of the Alaris System Maintenance software are running (typically on different personal computers), it is possible to assign different IP addresses to the same Alaris PC unit. To ensure this does not occur, assign each Alaris PC unit a single, unique IP address.

•

If the Alaris System Maintenance software instances are connected to the same Alaris System Maintenance software databases, this problem cannot occur.

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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.

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Following calibration, use calibration verifications (rather than check-in/ preventive maintenance verifications) to verify 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 and the “T” in the line (breather line).

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Chapter 1-Introduction

- Notes -

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Alaris System Maintenance v9.8 Software User Manual

Chapter 2 Installation

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Chapter 2-Installation

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

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512 MB 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 x 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 Alaris PC Unit to Computer on page 63):

8

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Serial communications cable

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Serial to USB adapter cable kit

Alaris System Maintenance v9.8 Software User Manual

Install Software

Software Requirements Use one of the following operating systems: •

Microsoft® Windows XP with Service Pack 3

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Microsoft Windows 7 with Service Pack 1

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Microsoft Windows Server 2008 R2 - only with existing Alaris Systems Manager on the PC

Other software: •

Microsoft .NET Framework 4.0

Install 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 v9.7.1 or v9.7 Software on page 28). If v9.7 or v9.7.1 is installed, there is no need to uninstall, since v9.8 upgrades v9.7 or v9.7.1 to v9.8. Read all screen prompts carefully. It is recommended to close all applications and to disable virus checking during installation.

NOTE

Previous versions of 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 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.

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Chapter 2-Installation

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. 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 v9.8.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.

3. Follow all of the screen prompts. 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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Alaris System Maintenance v9.8 Software User Manual

Install Software

If using...

Then click...

Windows 7

The url link http://get.adobe.com/reader to download the PDF reader.

Windowx XP

Go to Adobe Reader Website to download the PDF reader.

4.

If v9.5 or earlier Alaris System Maintenance software is still installed, the following message is displayed. Click OK. If the existing software is v9.5 or earlier, uninstall it before continuing with the installation (see Uninstall v9.7.1 or v9.7 Software on page 28).

NOTE

If v9.7 or v9.7.1 is installed, there it is no need to uninstall, since v9.8 upgrades v9.7 or v9.7.1 to v9.8. 5. Click Next.

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Chapter 2-Installation

6. Perform one of the following steps: °

Click Next to install in the default folder.

°

Click Change, select the new destination folder, and then click Next.

7. Click Custom and then click Next.

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Alaris System Maintenance v9.8 Software User Manual

Install Software

8. Click the icon next to Alaris® System Maintenance Client Tools. 9. Click This feature will not be available. Selecting an optional feature is not recommended because it will install unnecessary client tools on the server.

10. Click Next. 11. To select a security password for the Alaris PC Unit, perform one of the following steps: (See Set PC Unit Security Password on page 53 for more information about the password.) •

To continue without setting a password, click Next.

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Chapter 2-Installation

•

To set a password, perform the following steps: °

Click the Set PC Unit Security Password check box. For password information and character requirements, click Help.

°

Click OK to return to the password screen.

°

Type a password.

°

Click Next.

12. Choose one of the following steps:

14

•

Click Next to install in the default folder.

•

Click Change, select the new folder, and click Next.

Alaris System Maintenance v9.8 Software User Manual