Alaris System Maintenance Model 8975 Software User Manual V9.5x May 2010

®

Alaris System Maintenance v9.5.X Software User Manual Part Number: 11614346

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 screens displayed on your computer. Documentation provided with this product might reference product not present in your facility or not yet available for sale in your area.

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. Microstream is a registered trademark of Oridion Medical 1987 Ltd.

If difficulties are encountered while using this software, refer to the applicable Alaris® System Directions for Use (DFU) 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 you return 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.

All other trademarks are the property of their respective owners.

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

CareFusion San Diego, California United States

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

888.876.4287 carefusion.com © 2007-2010 CareFusion Corporation or one of its subsidiaries. All rights reserved.

Technical Support - North America (Maintenance and service information support; troubleshooting.) Phone, United States: 888.876.4287 Phone, Canada: 800.387.8309 Technical Support - United Kingdom (Maintenance and service information support; troubleshooting.) Phone: 0800 389 6972 E-mail: [email protected] Customer Care - North America (Product return, service assistance, and order placement.) Phone, United States: 888.876.4287 Phone, Canada: 800.387.8309 Customer Care - United Kingdom (Product return, service assistance, and order placement.) Phone: 0800 917 8776 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/customer-service Authorized European Representative

CareFusion The Crescent, Jays Close Basingstoke, Hampshire RG22 4BS United Kingdom

Contents Chapter 1-Introduction Defined Terms ... 2 About the Software ... 3 Feature Summary... 4 Warnings... 5 Cautions ... 6

Chapter 2-Installation and Setup System Requirements ... 8 Hardware Requirements ... 8 Software Requirements... 8 Install Software-Standard Installation... 9 Install Software-Custom Installation ... 12 Install Centralized System Maintenance Software Database on a Dedicated Server ... 12 Install Client Tools on Biomedical Technician Workstation... 13 Configure Database Settings... 15 Upgrade/Reinstall Software... 17 Uninstall Software ... 18 System Maintenance Software CD ... 18 Windows Operating System ... 19 Uninstall AlarisSM9DB Database Instance... 20

Chapter 3-Overview Start System Maintenance Software... 22 Menu Bar ... 23

Chapter 4-PC Unit Connection Hardware Connections... 26 Multiple PC Unit Connections... 27

Alaris® System Maintenance v9.5.X Software User Manual

i

Contents

Chapter 5-Application and Database Settings Application Settings... 30 Database Settings... 31 Open Database Settings ... 31 Add a Database Definition... 32 Delete a Database Definition ... 32 Set Active Database Definition... 32 Test Database Definition Connection ... 32 Migrate MSW Databases... 33

Chapter 6-Preventive Maintenance Introduction... 36 General Steps ... 37 Run/Abort Tasks ... 39 Run Tasks Concurrently... 39 Abort Tasks ... 40 Coloring Scheme... 40 Preventive Maintenance... 41 PC Unit ... 41 Test Equipment ... 41 Pump Module... 47 Test Equipment ... 47 Load Administration Set ... 51 Rate Accuracy Test Setup ... 52 Patient-Side Occlusion Pressure Test Setup... 55 Fluid-Side Occlusion Test Setup... 57 PCA Module ... 59 Test Equipment ... 59 Syringe Module... 67 Test Equipment ... 67 Pressure Test/Calibration Setup ... 75 SpO2 Module... 77 Test Equipment ... 77 Disposable SpO2 Sensor Modification and Test Point... 82 EtCO2 Module... 84 Test Equipment ... 84 Leak-Down Test ... 87 Flow Test/Calibration Setup... 89 Auto-ID Module and Handheld Scanner ... 91

Chapter 7-Data Sets and Alerts Transfer a Data Set ... 96 Download Alerts... 99

ii

Alaris® System Maintenance v9.5.X Software User Manual

Contents

Chapter 8-Flash Firmware Flash Firmware ... 106 PC Unit 8000 (PCU1.0) ... 106 PC Unit 8015 (PCU1.5) ... 111

Chapter 9-Configure Components Configuration Packages ... 118 Components of a Configuration Package ... 119 Add a New Configuration Package ... 120 Delete a Configuration Package ... 120 Export a Configuration Package ... 120 Import a Configuration Package ... 121 Export or Import Components of a Configuration Package ... 121 Copy a Configuration Package ... 122 Copy a Component of a Configuration Package ... 122 Specify Network Settings ... 123 Create a Network Profile... 123 Datalink Settings ... 123 Security Settings... 125 Network Settings ... 128 Server Settings... 129 Wireless Network Setting on PC Unit-Disable, Enable, View Status ... 130 Enable Wireless Network... 130 Disable Wireless Network... 131 Specify Auto-ID Module Settings ... 133 Formatting Rules ... 133 Specify Firmware Files... 137 Specify a Data Set File... 137

Chapter 10-Calibration Introduction... 140 Pump Module Calibration... 141 Test Equipment ... 141 Patient-Side Occlusion Pressure Calibration Setup-Pump Module ... 145 PCA Module Calibration ... 148 Test Equipment ... 148 Syringe Module Calibration ... 154 Test Equipment ... 154 EtCO2 Module Calibration ... 161 Test Equipment ... 161

Chapter 11-Tasks Task Groups... 166 Create a New Task Group... 166 Delete a Task Group ... 167 Rename a Task Group... 167

Alaris® System Maintenance v9.5.X Software User Manual

iii

Contents

Tasks List... 168 Edit Tasks List ... 168 Change Tasks List Order ... 168 Task Information ... 170 PC Unit Tasks ... 170 Transfer Network Configuration-Error Handling ... 174 Pump Module Tasks ... 175 Syringe Module and PCA Module Tasks ... 178 SpO2 Module Tasks ... 182 EtCO2 Module Tasks ... 183 Auto-ID Module and Handheld Scanner Tasks... 184 Test Equipment... 185

Chapter 12-Reports and Logs Reports... 188 Report Types... 188 Run Reports ... 188 Logs ... 190 Log Definitions ... 190 Example Log... 193

Glossary ... 199

iv

Alaris® System Maintenance v9.5.X Software User Manual

Chapter 1 Introduction

Alaris® System Maintenance v9.5.X Software User Manual

1

Chapter 1-Introduction

Defined Terms

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 Software

Guardrails® alert

Alert

Guardrails® clinical advisories

Clinical Advisories

Guardrails® CQI report

CQI Report

Guardrails® data set

Data Set

Guardrails® Editor software

Editor Software

2

Alaris® System Maintenance v9.5.X Software User Manual

About the Software

Chapter 1-Introduction

About the Software This software is provided under and subject to a license from CareFusion. System Maintenance Software version 9.5.X allows you 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, you install it on a personal computer and then connect a serial cable between the personal computer and a PC Unit. The System Maintenance software kit includes: • 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 PC Units to a personal computer equipped with System Maintenance Software. The USB serial adapter must meet the following specifications: • • •

Plugs into a USB port on a personal computer. Provides RS-232 male DB9 port(s) for direct connection to PC Units. Draws its power from USB connection-a power adapter is not required.

Alaris® System Maintenance v9.5.X Software User Manual

3

Chapter 1-Introduction

Feature Summary

Feature Summary System Maintenance software can be used to perform the following functions: • Maintain the PC Unit. • Upgrade firmware on the PC Unit and attached modules. • Perform preventive maintenance/check-in. • Set and check preventive maintenance reminder dates. • Troubleshoot and repair instruments. • Module Calibration, as applicable. • Set up, test, and configure the Auto-ID Module. • Download and view instrument logs. • Download CQI data logs. • Transfer Data Sets from the personal computer to the PC Unit. • Configure wireless network settings. • Test communications board interaction with a wireless network. • Disable Wireless Network configuration option. • Support wireless protocols for b, b/g, a/b/g, and d networks. • Support wireless security for WEP, WPA, and WPA2. 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. NOTE

•

•

4

Inspections are intended to comply with requirements specified by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). You can purchase a service agreement from CareFusion for preventive maintenance inspections.

Alaris® System Maintenance v9.5.X Software User Manual

Warnings

Chapter 1-Introduction

Warnings Warnings provide information needed to safely and effectively use the Alaris® product. 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 System Maintenance software be used while the Alaris® System is connected to a patient.

•

System Maintenance software and procedures are intended to be performed only by qualified personnel, or under direct supervision by qualified personnel.

•

Prior to use, CareFusion recommends that you become familiar with each instrument and accessory used with the System Maintenance software. For specific instrument warnings, cautions, inspection requirements, and other related instrument information, refer to the applicable Alaris® System DFU and/or service manual.

•

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.

•

To ensure proper calibration, run the post tests for the Pump Module and the accuracy tests for the Syringe Module after calibration. These tests are displayed in the default Calibration test lists.

•

Ensure that the instrument is in operational status before returning it to patient use.

•

Your PC Unit might not be compatible with every module. To determine module compatibility, refer to the applicable Alaris® System DFU.

Alaris® System Maintenance v9.5.X Software User Manual

5

Chapter 1-Introduction

Cautions

Cautions Cautions provide information needed to safely and effectively use the Alaris® product. 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. CAUTION •

Loading the 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. The threat of higher leakage currents or EMI disturbance levels might be present. Remove the connection at both ends before patient use.

•

By default, the 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.

•

Only one PC Unit should be connected to a group of attached modules at any given time. Connection of multiple PC Units to each other will cause damage to the IUI connectors.

•

Only one SpO2 Module can be connected to the PC Unit at any one time.

•

If a 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.

•

For tests that require water, use distilled water at room temperature between 41°F and 104°F (5°C to 40°C). If water is not within this temperature range, the reading might be inaccurate.

•

If multiple instances of the System Maintenance Software are running (typically on different personal computers), it is possible to assign different IP addresses to the same PC Unit. To ensure this does not occur, assign each PC Unit a single, unique IP address. NOTE: If the System Maintenance Software instances are connected to the same System Maintenance Software databases, this problem cannot occur.

•

Calibration verifications perform strenuous tests on the Syringe Module and PCA Module. In some cases, these tests differ from the check-in/preventive maintenance tests.

•

Following calibration, use calibration verifications (rather than check-in/ preventive maintenance verifications) to verify correct calibration.

•

Use of accessories or cables other than those specified might result in degraded electromagnetic compatibility performance or safety of the Alaris® System.

•

The flow rate out of the gas source and into the EtCO2 Module must be greater than 0.5 liter/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).

6

Alaris® System Maintenance v9.5.X Software User Manual

Chapter 2 Installation and Setup

Alaris® System Maintenance v9.5.X Software User Manual

7

Chapter 2-Installation and Setup

System Requirements

System Requirements To run the System Maintenance software, the personal computer must meet the following minimum hardware and software requirements. CAUTION For optimum performance of the 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 you install the System Maintenance Software must meet the following requirements: • • • • • • • •

processor, Pentium Class, 1 GHz or faster RAM, 512 MB minimum HDD (hard disk drive), 5 GB minimum of free space after the operating system is installed CD-ROM drive video card, SVGA monitor, minimum resolution 1024 x 768; color depth set greater than 256 colors port: configurable RS-232, 9-pin, serial communications; or USB cable, serial communications (provided) NOTES

• •

• • •

If the personal computer has a serial port, use a serial-to-serial cable. If the personal computer has a USB port, use a serial-to-USB cable or a serial-to-serial cable with a USB converter. USB converter products are not supported by CareFusion.

keyboard mouse printer and printer connection (optional)

Software Requirements One of the following operating systems: • Microsoft® Windows 2000 Professional with Service Pack 4 • Microsoft® Windows XP with Service Pack 2 • Microsoft® Windows 2003 Server with Service Pack 1 Other software: •

8

Adobe Acrobat Reader v9.X

Alaris® System Maintenance v9.5.X Software User Manual

Install Software-Standard Installation

Chapter 2-Installation and Setup

Install Software-Standard Installation Follow these steps to install the System Maintenance Software on a personal computer for the first time. If you plan to migrate another version of the System Maintenance database, install the System Maintenance Software and migrate the data using the Migrate MSW file feature (Options > Migrate MSW Data). Read all prompts carefully. During installation it is recommended that no other applications are running and that virus checking is disabled. 1. Insert the System Maintenance Software CD into the CD-ROM drive of the personal computer. If the installation program automatically starts, go to the next step. If the installation program does not automatically start, choose Start > Run, then type d:Setup.exe (where d: is CD drive). Alternatively, browse to the Setup.exe program on the System Maintenance Software CD, click Open, and then click OK. 2. When you are asked if you want to install SQL Server 2005 Express, click Yes.

3. If you are prompted to install prerequisite components, click Install. The components include Microsoft® .NET Framework 2.0, MSXML 6.0, Microsoft Report Viewer 2005, ASM Database (SQL Server Express 2005), and Adobe Reader 9.0.

Alaris® System Maintenance v9.5.X Software User Manual

9

Chapter 2-Installation and Setup

Install Software-Standard Installation

4. After installing prerequisites, or if prerequisites are already installed, the installation Setup Wizard Welcome window is displayed. Click Next.

5. Select the features that you want to install: • Full Install-installs System Maintenance databases and client tools. • Database-installs only System Maintenance databases. • Client Tools-installs only System Maintenance client tools. To install only the database, click Client Tools and click the red X. To install only the client tools, click Database and click the red X.

10

Alaris® System Maintenance v9.5.X Software User Manual

Install Software-Standard Installation

Chapter 2-Installation and Setup

6. Click Browse to choose a location other than the default installation directory. The default directory is C:Program FilesCardinal HealthAlaris ProductsAlaris System Maintenance. If an existing database is found, the following window is displayed. You can use the existing database (default) or overwrite the existing database (previous data will be lost). If a previous System Maintenance database was not found, this window will not be displayed.

7. Click Next to begin installation of the components of the System Maintenance Software. 8. Click Next to confirm installation.

When the installation is finished, an "Installation Complete" message is displayed. It is recommended that you restart your computer if prompted to do so.

Alaris® System Maintenance v9.5.X Software User Manual

11

Chapter 2-Installation and Setup

Install Software-Custom Installation

Install Software-Custom Installation Install Centralized System Maintenance Software Database on a Dedicated Server 1. Insert the System Maintenance Software CD into the CD-ROM drive of the personal computer. If the installation program starts automatically, go to the next step. If the installation program does not start automatically, choose Start > Run, then type d:Setup.exe (where d: is CD drive). Alternatively, browse to the Setup.exe program on the System Maintenance Software CD, click Open, and then click OK. 2. When you are asked if you want to install SQL Server 2005 Express, click Yes.

3. If you are prompted to install prerequisite components, click Install. The components include Microsoft .NET Framework 2.0, MSXML 6.0, Microsoft Report Viewer 2005, ASM Database (SQL Server Express 2005), and Adobe Reader 9.X.

4. Wait until the installation is completed. When the Alaris® System Maintenance welcome wizard is displayed, click Next.

12

Alaris® System Maintenance v9.5.X Software User Manual

Install Software-Custom Installation

Chapter 2-Installation and Setup

5. On the Custom Setup window, ensure that Client Tools is not selected (unless you want to also install the client tools on the same computer as the System Maintenance database).

6. Click Next. 7. Click Finish.

Install Client Tools on Biomedical Technician Workstation Follow these steps to install the client tools on the Biomedical Technician Workstation. 1. Insert the System Maintenance Software CD into the CD-ROM drive of the personal computer. If the installation program starts automatically, go to the next step. If the installation program does not start automatically, choose Start > Run, then type d:Setup.exe (where d: is CD drive). Alternatively, browse to the Setup.exe program on the System Maintenance Software CD, click Open, and then click OK. 2. When you are asked if you want to install SQL Server 2005 Express, click No.

Alaris® System Maintenance v9.5.X Software User Manual

13

Chapter 2-Installation and Setup

Install Software-Custom Installation

3. If you are prompted to install prerequisite components, click Install. The components include Microsoft .NET Framework 2.0, MSXML 6.0, Microsoft Report Viewer 2005, and Adobe Reader 9.0.

4. Wait until the installation is completed. When the Alaris® System Maintenance welcome wizard is displayed, click Next. 5. On the Custom Setup window, ensure that Database is not selected.

6. If the Database option is selected and you chose not to install SQL Server 2005 Express, a message is displayed. Click Ok to close the message window.

14

Alaris® System Maintenance v9.5.X Software User Manual