CADD-Solis Installation and Technical Manual Medication Safety Software Feb 2011

This manual pertains only to the CADD™‑Solis Medication Safety Software – Administrator and Point of Care applications. For detailed instructions, specifications, warnings, warranty, and additional information about operating the CADD®‑Solis, CADD®‑Solis VIP and CADD‑Prizm® PCS II Ambulatory Infusion Pumps, refer to the information supplied with the pumps.

Technical Assistance If you have questions or comments about the installation or operation of the CADD™‑Solis Medication Safety Software, contact Smiths Medical at the appropriate number given below, or contact your local distributor. When calling, specify the software version number. Smiths Medical ASD, Inc. St. Paul, MN 55112 USA 1 800.258.5361 (USA) 1 214.618.0218 www.smiths-medical.com

European Distribution: Smiths Medical International Ltd. TN25 4BF, UK +44 (0) 1233 722100 Australian Distribution: Smiths Medical Australasia Pty. Ltd. 61 Brandl Street Eight Mile Plains, QLD 4113, Australia +61 (0) 7 3340 1300

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Table of Contents Technical Assistance...2 Warnings...4 Important Notes...5 About the CADD™-Solis Medication Safety Software System...6 About CADD™-Solis Medication Safety Software – Administrator...6 About CADD™-Solis Medication Safety Software – Point of Care...7 Installation Overview...8 System Requirements...9 About the CADD™-Solis Medication Safety Software Installation... 10 Upgrading from previous versions of CADD™-Solis Medication Safety Software... 10 About the CADD™-Solis Medication Safety Software Database...11 Installing the Database onto a Server...11 Installing CADD™-Solis Medication Safety Software – Administrator... 14 Installing CADD™-Solis Medication Safety Software – Point of Care...15 Standard Installation Method ...15 Alternate Installation Method...17 Initial System Setup...19 Setting database connection in Administrator...19 Logging into Administrator with the default “admin” user account... 20 Transferring data from a previous version of the CADD™-Solis Database... 21 Setting a Library Connection in Point of Care... 22 Connecting to a Pump... 23 Installing Adobe® Reader 9.4... 25 Using CADD™-Solis Medication Safety Software... 26 Ensuring availability of your CADD™-Solis Database... 27 Uninstalling CADD™-Solis Medication Safety Software... 27 Removing Microsoft® SQL Server® 2005 Express Edition or the CADD™‑Solis Database... 28

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Warnings Before operating the CADD™‑Solis Medication Safety Software – Administrator or Point of Care software, read through this CADD™‑Solis Medication Safety Software Installation and Technical Manual and the Help topics available in the Administrator and Point of Care applications. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient. • Follow your facility’s processes for backup and restoration of the Protocol Library Database information. • When using weight-based delivery parameters, ensure that all weights are entered in kilograms. • When using a weight-based Protocol, the Continuous Rate is programmed using units/kg/hr input, and the Demand or PCA Dose amount and Delivery Limit are programmed using units/kg input. The pump LCD screen displays the Continuous Rate in Units (milligram, microgram, milliliter) per hour, and the Demand or PCA Dose, and Delivery limit are displayed in units (milligram, microgram, milliliter); therefore, any further adjustment of doses on the pump will be in units/hr or units. • When assigning a Drug ID to a Drug using a barcode scanner or keyboard, manually verify that the correct barcode information has been entered. • It is strongly recommended that another user verify each new or edited Protocol before it is made active and available to send to a pump. • When printing barcode labels, manually verify that the labels correctly match the Drug. • When applying printed barcode labels to identify Drugs, ensure that your facility follows a clearly-defined process. • When scanning a barcode to assign or read a Drug ID, always visually verify that the correct barcode information was entered into the program after scanning. • Inspect all cable accessories for damage. Do not use the cable accessories if the wires are exposed or if the connector or alignment pins are bent or damaged in any way. • It is strongly recommended that login and/or physical access to the computer that holds the Protocol Library Database is restricted to prevent unauthorized user access. • Always carefully review the program on the pump after it has been programmed to verify that the pump is programmed correctly. • Using an out-of-date Protocol Library or Protocol Library Database could cause incorrect programming of the pump. Your facility should have a clearly-defined process for archiving, backing up, and restoring the Protocol Library Database. • Although the CADD™‑Solis Medication Safety Software is supported in various languages, text entered by the user for names of Protocol Libraries, Protocols, Therapies, Qualifiers, and Drugs and related Notes are not controlled or translated by the Software. When entering, reviewing, and approving such user-provided text, ensure that your facility follows a clearly-defined process.

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Important Notes • The CADD™‑Solis Medication Safety Software – Administrator and Point of Care applications are not intended to replace medical personnel, clinical expertise, or patient assessment. • The user must become familiar with the CADD®‑Solis, CADD®‑Solis VIP, and/or CADD‑Prizm® PCS II (software revision H) Ambulatory Infusion Pumps’ features, operation, and accessories prior to use. • The Help topics pertain only to CADD™‑Solis Medication Safety Software – Administrator and Point of Care applications. For detailed instructions, specifications, warnings, warranty, and additional information about operating the CADD®‑Solis, CADD®‑Solis VIP, or CADD‑Prizm® PCS II (software revision H) Ambulatory Infusion Pumps, refer to the Operator’s Manual supplied with the pump. • Future updates to the computer’s operating system software, Microsoft® .NET Framework, Microsoft® SQL Server®, installation of other software on the Administrator or Point of Care computers, a change to the Regional and Language Options - Standards and Formats setting, or removal of installed components may affect the operations of the CADD™‑Solis Medication Safety Software. Your facility should have a clearly-defined process for qualifying existing software with new operating system versions. • Your facility should consider creating a Protocol Library for use if the network is unavailable or a different Protocol Library is needed and the Administrator user is not available. • If the CADD™‑Solis Medication Safety Software cannot be used to program the pump due to an inability to operate the software or connect to the pump, follow your facility’s policy and procedures for programming the pump manually. • It is recommended that CADD™‑Solis Medication Safety Software be installed on a supported Windows® operating system that does not have extensive customization to its user interface elements. If the Windows® user interface is customized, it is recommended that your facility have a clearly-defined process to verify that screens and text within the CADD™‑Solis Medication Safety Software applications are legible. • For security reasons, and because it allows unrestricted access to the CADD™‑Solis Medication Safety Software system, you should change the default “admin” user account password as soon as possible after initial setup. • If installing the Point of Care application on a PC that is not networked to the Protocol Library Database, Protocol Libraries must be obtained by exporting them from the CADD™‑Solis Medication Safety Software – Administrator using portable media, and then importing them into the Point of Care application. • For CADD-Prizm® PCS II pump reports, the pump must be set to the same Date and Time format as the PC for the reports to display correctly.

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About the CADD™-Solis Medication Safety Software System The CADD™‑Solis Medication Safety Software System consists of the Administrator and the Point of Care software applications. This software allows you to create therapy-based Protocol Libraries to be used with CADD®‑Solis, CADD®‑Solis VIP, and CADD‑Prizm® PCS II (with software revision H) Ambulatory Infusion Pumps. The Software System allows you to: • Create a Protocol Library on a server or on a PC. • Create multiple Protocol Libraries within the Database. Each Protocol Library can be designated and named for a particular area of your facility. • Create multiple pump Protocols within each Protocol Library. • Designate authorized users for each Protocol Library. • Program a pump with a therapy-based set of Protocols. The system can be used in various system configurations, including: • The Protocol Library Database can be located on a Server with one or more Administrator PCs and one or more Point of Care PCs distributed on your network throughout your facility. • The Protocol Library Database can be located on the Administrator PC and one or more Point of Care PCs distributed over your network throughout your facility. • The Point of Care PC can be located separately from a network and the Protocol Libraries can be imported using portable media. For further information and instructions for use for the CADD™‑Solis Medication Safety Software – Administrator or Point of Care applications, refer to the online Help for each software application.

About CADD™-Solis Medication Safety Software – Administrator Indications for Use: The CADD™-Solis Medication Safety Software – Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD®-Solis VIP Ambulatory Infusion Pump, CADD®-Solis Ambulatory Infusion Pump, or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher). The CADD™‑Solis Medication Safety Software – Administrator application can be used to: • Create and manage Protocols and Protocol Libraries • Manage user accounts, permissions, and access to Protocol Libraries • Determine the amount of flexibility users can have in editing Protocols before sending them to a pump • Send a Protocol Library and get history

(CADD®‑Solis and CADD®‑Solis VIP Ambulatory Infusion Pumps only)

• Send a single Protocol (CADD®‑Solis VIP Ambulatory Infusion Pumps only) • Send or get a Pump ID

(CADD‑Prizm® PCS II Ambulatory Infusion Pumps only)

• Print Drug ID barcode labels • View, print, and export log and pump reports 6

The CADD™‑Solis Medication Safety Software – Administrator software consists of three main functions (tabs), applicable to the selected Protocol Library: • Library General Settings: On this tab you can view the pumps to which the selected Protocol Library is applicable, provide a description for the Protocol Library, increment the Protocol Library version number, and set other options for Point of Care users. • Setup Therapies, Qualifiers, and Drugs: This tab allows you to create and edit the Therapies and Qualifiers for the Protocol Library. Drug Name, Unit, and Concentration combinations are also created here. For each Drug combination, a Drug ID can be assigned and a Drug ID barcode label can be printed. • Specify Protocols: This tab is used to create Protocols from the Therapies, Qualifiers, and Drugs in the Protocol Library. You may also edit and delete Protocols, and print Protocol Detail Reports and prescription forms. In addition to these main functions, the File menu provides Protocol Library management features. The Pump Communications menu includes commands for sending Protocols and Libraries and viewing Pump Reports. Application configuration, system tools, and user management features are located under the Settings menu. For information about using CADD™-Solis Medication Safety Software – Administrator, refer to the Administrator online Help.

About CADD™-Solis Medication Safety Software – Point of Care Indications for Use: The CADD™-Solis Medication Safety Software – Point of Care allows use of a computer to send therapy-based protocols developed by the CADD™-Solis Medication Safety Software – Administrator to the CADD®-Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher). CADD™-Solis Medication Safety Software – Point of Care uses a Protocol Library Database, which is set up using the CADD™-Solis Medication Safety Software – Administrator program. You may also use Point of Care to view and print pump reports from the Protocol Library Database. CADD™-Solis Medication Safety Software – Point of Care consists of the following functions (tabs): • Protocol: This tab is where you select the Therapy, related Qualifier, and Drug that you intend to send to the pump. From this tab, you may edit and review the parameters, verify the Drug ID using a barcode scanner, and send the Protocol to the pump. • Reports: This tab is used to retrieve and view reports from the pump. You may pull up a saved CADD®-Solis or CADD-Prizm® PCS II Ambulatory Infusion Pump report from the reports database or from an attached CADD-Prizm® PCS II Ambulatory Infusion Pump. Once the report is displayed, it may be printed and saved. For information about using CADD™-Solis Medication Safety Software – Point of Care, refer to the Point of Care online Help.

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Installation Overview This Installation and Technical Manual describes how to install the CADD™-Solis Medication Safety Software Database, and the CADD™-Solis Medication Safety Software – Administrator and Point of Care applications (available separately from Smiths Medical). Refer to the sections in this manual that are applicable to your particular application and installation. This manual is available on both the CADD™-Solis Medication Safety Software – Administrator and Point of Care installation discs. CADD™-Solis Medication Safety Software Database and Administrator application

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Install CADD™-Solis Medication Safety Software 3.0 Database on the Server

CADD™-Solis

Admin.

See page 11

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Install CADD™-Solis Medication Safety Software – Administrator 3.0

CADD™-Solis

Admin

Administrator user’s PC

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See page 14

Use CADD™-Solis Medication Safety Software – Administator to Transfer Libraries, Usage Logs and Users (if upgrading from CADD™-Solis Medication Safety Software 2.0) CADD™-Solis v2.0 Database

CADD™-Solis v3.0 Database

See page 21

CADD™-Solis Medication Safety Software – Point of Care application

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Install CADD™-Solis Medication Safety Software – Point of Care 3.0 (if using Point of Care at your facility)

Point of Care user’s PC

8

CADD™-Solis

P.O.C.

See page 15

System Requirements The following are the minimum system requirements for the CADD™-Solis Medication Safety Software – Administrator and Point of Care applications: • Operating systems (32-bit): • Microsoft® Windows® XP Professional (SP3) • Microsoft® Windows Vista® Business Edition (SP2) • Microsoft® Windows Server® 2003 (SP2) (Administrator application only) • Microsoft® Windows Server® 2008 (SP2) (Administrator application only) • Microsoft® Windows® 7 Professional • Operating systems (64-bit): • Microsoft® Windows® XP Professional (SP2) • Microsoft® Windows Vista® Business Edition (SP2) • Microsoft® Windows Server® 2003 (SP2) (Administrator application only) • Microsoft® Windows Server® 2008 (SP2) (Administrator application only) • Microsoft® Windows Server® 2008 R2 (Administrator application only) • Microsoft® Windows® 7 Professional • Supported operating system languages: English, Danish, Spanish, French, German, Italian, Japanese, Dutch, Portuguese, and Swedish NOTE: If using the English language CADD®-Solis VIP or CADD-Prizm® PCS II Ambulatory Infusion Pump, it is recommended that you install CADD™-Solis Medication Safety Software onto an English language operating system. This assures consistency in language between CADD™‑Solis Medication Safety Software and the English language pumps. • Microsoft® SQL Server® 2005 or 2008

[Required if installing the CADD™-Solis Medication Safety Software Database onto your own Microsoft® SQL Server® instance. Microsoft® SQL Server® may be installed on Microsoft® Windows Server ® 2003 or 2008 SP2 (x64) which may be optionally hosted using VMware® ESXi virtual server technology.]

• 256 MB of RAM • Hard disk space: 70 MB (application); 350 MB (database) • RS-232 serial port and Interface Cable/Null Modem Cable Set (for connection to a CADD‑Prizm® PCS II Ambulatory Infusion Pump, with software revision H) • USB port and USB Type A to Type Mini-B cable (for connection to a CADD®‑Solis or CADD®‑Solis VIP Ambulatory Infusion Pump) • 1024 × 768 display with 16-bit video card • Mouse or other pointing device • Adobe® Reader 9.4 or greater (for viewing reports exported in PDF format) The following items are required if using the barcode reading and label printing features of CADD™‑Solis Medication Safety Software. For information about installing and configuring barcode reading or printing equipment, refer to the manufacturer’s instructions. • A barcode scanner configured as a Human Interface Device (HID) and compatible with Code 128 barcode • A printer capable of printing a one inch high by three inches wide label as an image • USB ports for connection to the barcode reader and/or barcode label printer 9

About the CADD™-Solis Medication Safety Software Installation IMPORTANT: The CADD™-Solis Medication Safety Software consists of the Administrator and the Point of Care applications. These applications are available separately from Smiths Medical. Whether or not you have Point of Care in addition to Administrator is dependent on the pumps in use at your facility. CADD™-Solis Medication Safety Software can be installed in one of ten supported languages (see “System Requirements” on page 9). The language of CADD™-Solis Medication Safety Software that will be installed is based on the language of the operating system on which it is installed. NOTE: If using the English language CADD®-Solis VIP or CADD-Prizm® PCS II Ambulatory Infusion Pump, it is recommended that you install CADD™-Solis Medication Safety Software onto an English language operating system. This assures consistency in language between CADD™‑Solis Medication Safety Software and the English language pumps. The CADD™-Solis Medication Safety Software – Administrator Installation Disc can be can used to optionally install the following components on a PC or server: • CADD™-Solis Administrator: This is the main software application used to create and manage Protocol Libraries and communicate with various pumps • SQL Server® Express 2005 and Database: This is Microsoft® SQL Server® 2005 Express Edition (SP3) and an empty CADD™-Solis Medication Safety Software 3.0 Database. The CADD™-Solis Medication Safety Software – Point of Care Installation Disc can be used to optionally install the following components on a PC: • CADD™-Solis Point of Care: This is the main software application used to access Protocol Libraries and Protocols, set Patient Specific Parameters for Protocols (where allowed by the Protocol), and to send Protocols to various pumps. • SQL Server® Express 2005 and Database: This is Microsoft® SQL Server® 2005 Express Edition (SP3) and a local CADD™-Solis Medication Safety Software 3.0 Database.

Upgrading from previous versions of CADD™-Solis Medication Safety Software If you have a previous version of CADD™-Solis Medication Safety Software (Administrator and/or Point of Care applications, version 2.0) installed on the PC, it will be removed upon installing CADD™-Solis Medication Safety Software – Administrator or Point of Care 3.0. When installing CADD™-Solis Medication Safety Software – Administrator 3.0, previous versions of the CADD™‑Solis Medication Safety Software Database and its data (comprised of your Protocol Libraries and usage logs) are not removed. After installing CADD™-Solis Medication Safety Software – Administrator 3.0, you can use the Transfer Data feature to transfer libraries, usage logs, and users from any CADD™‑Solis 2.0 Database to your newly‑installed CADD™-Solis 3.0 Database. For more information, see “Transferring data from a previous version of the CADD™-Solis Database” on page 21. IMPORTANT: The Transfer Data feature should be used to transfer data from a previous CADD™-Solis Database version before using the Administrator application to create any new Protocol Libraries or users in the new database. This is because, when transferring data using the Transfer Data feature, existing data in the destination database is deleted. 10

About the CADD™-Solis Medication Safety Software Database The CADD™-Solis Medication Safety Software System uses a Microsoft® SQL Server® database to store your Protocol Libraries, usage logs, and user account information. This database is installable with CADD™‑Solis Medication Safety Software – Administrator on a PC or server, or onto your own instance of Microsoft® SQL Server® 2005 or 2008 (using the SQL script and database files provided on the CADD™‑Solis Medication Safety Software – Administrator 3.0 installation disc).

Installing the Database onto a Server The Setup program included on the CADD™-Solis Medication Safety Software – Administrator installation disc can be used to install the database and other components. Components may be optionally installed. When installing the database onto a server, note the server name. The server name will be needed for the CADD™-Solis Medication Safety Software – Administrator and CADD™-Solis Medication Safety Software – Point of Care installations that will use the database. It is recommended that the CADD™-Solis Medication Safety Software Database be installed on the server before the CADD™-Solis Medication Safety Software – Administrator application is installed on an Administrator user’s PC and before the Point of Care application is installed on a Point of Care user’s PC. The components that can be optionally installed onto the server are: • SQL Server® Express 2005 and Database: This is Microsoft® SQL Server® 2005 Express Edition (SP3) and an empty CADD™-Solis Medication Safety Software 3.0 Database. Microsoft® SQL Server® 2005 Express Edition is an optional component that can be installed if you are not using your own instance of SQL Server® 2005 or 2008. • CADD™-Solis Administrator: This is the main software application used to create and manage Protocol Libraries and communicate with various pumps. For more information, see “About CADD™-Solis Medication Safety Software – Administrator” on page 6. Also, if not already installed, the following software components will be installed automatically: • Microsoft® .NET 4.0 Client • Microsoft® .NET 2.0 To install Microsoft® SQL Server® 2005 Express Edition and the CADD™-Solis Database: NOTE: If you choose to use your own SQL Server® 2005 or 2008 instance instead, skip to the next section. 1. Make sure you are logged into Windows® with a user account that has administrative privileges on the server. 2. Insert the CADD™-Solis Medication Safety Software – Administrator installation disc into the CD drive. 3. If the CD launches automatically and shows the Installation CD home page, click the installation link provided. – OR – If the CD does not launch automatically, click the Windows® Start menu, and then select Run. In the Run dialog box, type d:installersetup.exe (or replace “d:” with the letter for your CD drive). 4. At the CADD™-Solis Administrator “Welcome” screen, click Next to start the installer. 11

5. Review the License Agreement and, if you accept the terms, click to select I accept the terms in the license agreement, and then click Next to proceed. 6. If prompted to install Microsoft® .NET Framework, follow the on-screen instructions to install it. 7. On the Custom Setup screen, ensure that the desired components are selected to be installed. 8. On the Application Destination Folder screen, the default folder location for the installation is shown. To use a different folder, click Change to select it. To use the default destination folder (or your selected folder), click Next. 9. If you have chosen to also install CADD™-Solis Administrator, in the Installation Options screen, select the pump applications and the server name where the database resides. If you are not installing SQL Server® Express, you can click Advanced to change other database connection settings as necessary (default advanced settings are provided). Click Next to continue. 10. At the “Ready to Install the Program” screen, click Install. 11. Follow the on-screen instructions to complete the installation. NOTE: The installation of Microsoft® SQL Server® 2005 Express Edition creates a firewall exception on the server at TCP port 55000 for SQL Server®. To ensure connection to the database, you will need to ensure that both the server and the clients are always available to communicate on this port. To install the CADD™-Solis Database onto your own Microsoft® SQL Server® 2005 or 2008 instance: If you have your own instance of Microsoft® SQL Server® 2005 or 2008 at your facility, you can install the CADD™‑Solis Medication Safety Software Database on that database server rather than install the Microsoft® SQL Server® 2005 Express Edition from the CADD™‑Solis Medication Safety Software – Administrator installer. To install the CADD™-Solis Medication Safety Software Database onto your own Microsoft® SQL Server® 2005 or 2008 instance, a SQL script and database files are included on the CADD™-Solis Medication Safety Software – Administrator installation disc. Use these files and one of the methods listed below to install the database onto your own Microsoft® SQL Server® 2005 or 2008 instance. NOTE: You will need to ensure that both the server and the clients are available on the TCP port you set for your instance of Microsoft® SQL Server®. Method 1, using the SQL script: 1. Use a Microsoft® database management tool, such as Microsoft® SQL Server® Management Studio, to connect to your Microsoft® SQL Server® instance. 2. Open the Create Database.sql file located in the installerDatabase folder on the CADD™‑Solis Medication Safety Software – Administrator installation disc. 3. If desired, replace the default database name in the SQL script, “SmithsSolisC”, with your chosen database name. If changing this default database name, be sure to replace all instances of the name that appear in the script. NOTE: If changing the database name, do not use spaces within your chosen database name. The CADD®-Solis Transfer Data feature is not compatible with database names that include spaces.

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4. Lines 16 and 18 of the SQL script contain a path to the data folder for the Microsoft® SQL Server® instance. If the path to the data folder for your Microsoft® SQL Server instance is different, update the path in lines 16 and 18 appropriately. 5. Execute the script. 6. Create a SQL Server® user and grant them ownership of the database you just created. 7. Your database server name, instance name, database name, port number, and SQL Server® user ID and password will be required when setting up CADD™-Solis Medication Safety Software – Administrator or Point of Care. NOTE: Future updates to the computer’s operating system software, Microsoft® .NET Framework, Microsoft® SQL Server®, installation of other software on the Administrator or Point of Care computer, a change to the Regional and Language Options - Standards and Formats setting, or removal of installed components may affect the operations of the CADD™-Solis Medication Safety Software. Your facility should have a clearly-defined process for qualifying existing software with new operating system versions. Method 2, attaching the .MDF file: 1. Locate the files SmithsSolisC.mdf and SmithsSolisC_log.ldf in the installerDatabase folder on the CADD™-Solis Medication Safety Software – Administrator installation disc, and copy them to your Microsoft® SQL Server® data folder. Make sure the copied files are not set to read-only. 2. Use a Microsoft® database management tool, such as Microsoft® SQL Server® Management Studio, to attach the MDF. 3. Create a SQL Server® user and grant them ownership of the database you just created. 4. Your database server name, instance name, database name, port number, and SQL Server® user ID and password will be required when setting up CADD™-Solis Medication Safety Software – Administrator or Point of Care. NOTE: Future updates to the computer’s operating system software, Microsoft® .NET Framework, Microsoft® SQL Server®, installation of other software on the Administrator or Point of Care computer, a change to the Regional and Language Options - Standards and Formats setting, or removal of installed components may affect the operations of the CADD™-Solis Medication Safety Software. Your facility should have a clearly-defined process for qualifying existing software with new operating system versions.

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Installing CADD™-Solis Medication Safety Software – Administrator The Setup program included on the CADD™-Solis Medication Safety Software – Administrator installation disc can be used to install the following components onto a PC. Components may be optionally installed. NOTE: CADD™-Solis Medication Safety Software – Administrator 3.0 cannot run on the same PC as previous versions of Administrator or Point of Care. Because of this, when installing CADD™-Solis Medication Safety Software – Administrator 3.0, any previous versions of Administrator and Point of Care are uninstalled automatically. The components that can be installed are: • CADD™-Solis Administrator: This is the main software application used to create and manage Protocol Libraries and communicate with various pumps. For more information, see “About CADD™-Solis Medication Safety Software – Administrator” on page 6. • SQL Server® Express 2005 and Database: This is Microsoft® SQL Server® 2005 Express Edition (SP3) and an empty CADD™-Solis 3.0 Database. Microsoft® SQL Server® 2005 Express Edition can be installed if you are not using a database on another PC or server (for more information, see “Installing the Database onto a Server” on page 11). Also, if not already installed, the following software components will be installed automatically: • Microsoft® .NET 4.0 Client • Microsoft® .NET 2.0 • Microsoft® Report Viewer 2010 To run the CADD™-Solis Medication Safety Software – Administrator Setup program: 1. Make sure you are logged into Windows® with a user account that has administrative privileges on the PC. 2. Insert the CADD™-Solis Medication Safety Software – Administrator installation disc into the CD drive. The Administrator and Point of Care applications are available separately from Smiths Medical. 3. If the CD launches automatically and shows the Installation CD home page, click the installation link provided. – OR – If the CD does not launch automatically, click the Windows® Start menu, and then click Run. In the Run dialog box, type d:Installersetup.exe (or replace “d:” with the drive letter for your CD drive). 4. At the CADD™-Solis Administrator “Welcome” screen, click Next to start the installer. 5. Review the License Agreement and, if you accept the terms, click to select I accept the terms in the license agreement, and then click Next. 6. If prompted to install Microsoft® .NET Framework, follow the on-screen instructions to install it. 7. On the Custom Setup screen, click to select the program features to install: • CADD™-Solis Administrator • SQL Server® Express 2005 and Database (if not using a database on a server) 8. Click Next. 9. On the Application Destination Folder screen, the default folder location for the installation is shown. To use another folder, click Change to select the folder accordingly. To use the default destination folder (or your changed folder), click Next. 14

10. On the Installation Options screen, select the desired pump applications and enter the server name where the database resides. If you have not yet installed the database, you may leave the Database Connection server name blank. If you have already installed the CADD™-Solis 3.0 Medication Safety Software Database on another PC or server, enter its server name. If you have not chosen to install the SQL Server® Express and Database component, you can click Advanced to change any other connection settings as necessary (default advanced settings are provided). NOTE: If you do not provide a database server name during installation, you will need to set one within the Administrator application after installation. For more information, see “Setting database connection in Administrator” on page 19. 11. Click Next. 12. At the Ready to Install the Program screen, click Install. 13. Follow the on-screen instructions to complete the installation. NOTE: Future updates to the computer’s operating system software, Microsoft® .NET Framework, Microsoft® SQL Server®, installation of other software on the Administrator or Point of Care computer, a change to the Regional and Language Options - Standards and Formats setting, or removal of installed components may affect the operations of the CADD™-Solis Medication Safety Software. Your facility should have a clearly-defined process for qualifying existing software with new operating system versions.

Installing CADD™-Solis Medication Safety Software – Point of Care Although CADD™-Solis Medication Safety Software – Administrator can be used to send Therapy‑based single protocols to a CADD®‑Solis VIP Ambulatory Infusion Pump, the Point of Care application is required to send single Protocols (developed using the Administrator application) to CADD®‑Solis or CADD‑Prizm® PCS II (software revision H) Ambulatory Infusion Pumps. When installing the CADD™-Solis Medication Safety Software – Point of Care application, it can be configured to access a CADD™-Solis Database that you have installed on a server (as described on page 11), or it can be configured to use its own local instance of Microsoft® SQL Server® Express and the CADD™-Solis Database (installable with the CADD™-Solis Medication Safety Software – Point of Care software). NOTE: CADD™-Solis Medication Safety Software – Point of Care 3.0 cannot run on the same PC as previous versions of Point of Care or Administrator. Because of this, when installing CADD™Solis Medication Safety Software – Point of Care 3.0, any previous versions of Point of Care and Administrator are uninstalled automatically. NOTE: An alternate installation method for Point of Care can be used for unattended installations. This alternate installation should only be used upon the direction of the administrator for the CADD™-Solis Medication Safety Software for your facility. For more information, see page 17.

Standard Installation Method To run the CADD™-Solis Medication Safety Software – Point of Care Setup program: 1. Make sure you are logged into Windows® with a user account that has administrative privileges. 2. Insert the CADD™-Solis Medication Safety Software – Point of Care installation disc into the CD drive. The Point of Care and Administrator applications are available separately from Smiths Medical. 15

3. If the CD launches automatically and shows the Installation CD home page, click the installation link provided. – OR – If the CD does not launch automatically, click the Windows® Start menu, and then click Run. In the Run dialog box, type d:installersetup.exe (or replace “d:” with the drive letter for your CD drive). 4. At the CADD™-Solis Point of Care “Welcome” screen, click Next to start the installer. 5. Review the License Agreement and, if you accept the terms, click to select I accept the terms in the license agreement, and then click Next. 6. If prompted to install Microsoft® .NET Framework, follow the on-screen instructions to install it. 7. At the Setup Type screen, choose either Typical or Custom installation: • If this installation of Point of Care will have access to the CADD™-Solis Database installed on a server, choose Typical. A Typical installation will install only the CADD™-Solis Point of Care application and not Microsoft® SQL Server® 2005 Express and the local database. • If this installation of Point of Care will not have access to the CADD™-Solis Database on a server, choose the Custom option to also install Microsoft® SQL Server® 2005 Express and a local CADD™-Solis Database. NOTE: If using a local database for Point of Care, you will need to import your Protocol Library from a database file previously exported from the Administrator application. For information about exporting and importing Protocol Libraries, see online Help for the Administrator and Point of Care applications. 8. Click Next. 9. On the Application Destination Folder screen, the default folder location for the installation is shown. To use another folder, click Change to select the folder accordingly. To use the default destination folder (or your changed folder), click Next. 10. On the Installation Options screen, select the desired pump applications and enter the server name where the database resides. If you have not yet installed the database, you may leave the Database Connection server name blank. If you have already installed the CADD™-Solis 3.0 Database on another PC or server, enter its server name. If you have not chosen to install the SQL Server® Express and Database component, you can click Advanced to change any other connection settings as necessary (default advanced settings are provided). NOTE: If you do not provide a database server name during installation, you will need to set one within the Point of Care application after installation. For more information, see “Setting a Library Connection in Point of Care” on page 22. 11. Click Next. 12. At the Ready to Install the Program screen, click Install. 13. Follow the on-screen instructions to complete the installation. NOTE: Future updates to the computer’s operating system software, Microsoft® .NET Framework, Microsoft® SQL Server®, installation of other software on the Administrator or Point of Care computer, a change to the Regional and Language Options - Standards and Formats setting, or removal of installed components may affect the operations of the CADD™-Solis Medication Safety Software. Your facility should have a clearly-defined process for qualifying existing software with new operating system versions. 16

Alternate Installation Method NOTE: This alternate installation method for Point of Care should only be used if recommended by the administrator responsible for CADD™-Solis Medication Safety Software at your facility. To facilitate unattended installation, an alternate installation method for CADD™-Solis Medication Safety Software – Point of Care can be used whereby Point of Care (and its prerequisite components) can be installed via command line. For this alternate installation method, a database password must be obtained from Smiths Medical. Prior to deploying Point of Care using this alternate method, you must have already installed CADD™-Solis Medication Safety Software – Administrator following the instructions provided earlier in this guide, and have already created a Protocol Library as described in Administrator online Help. Alternate installation instructions: 1. Install one instance of the Point of Care application on a PC on your network using the standard installation method (as described in the previous section). 2. On the PC on which you installed Point of Care, start the Point of Care application and set its Protocol Library connection (see “Setting a Library Connection in Point of Care” on page 22). After setting the library connection, close the Point of Care application. 3. Save a copy of the SolisPOCConfig.txt file located in the folder C:ProgramDataSmiths Medical (if you are using Microsoft® Windows® Vista or Windows® 7) or C:Documents and SettingsAll Users Application DataSmiths Medical (if you are not using Microsoft® Windows® Vista or Windows® 7). This file will be used later in this process. 4. For each PC to which you want to install Point of Care, use the command line definitions below to install the necessary pre-requisites, followed by the Point of Care application. a. Determine if the following pre-requisites are installed, and install them if necessary: • Microsoft® .NET 4.0 Client • Microsoft® .NET 2.0 b. Install Microsoft® Report Viewer Distributable 2010, located on the CADD™-Solis Medication Safety Software – Point of Care Installation Disc in the following folder: installerISSetupPrerequisitesMicrosoft ReportViewer 2010

Command line for silent installation: ReportViewer2010.exe /q /c:”install.exe /q”

c. Install the pump communications (Jungo) redistributables, located on the CADD™-Solis Medication Safety Software – Point of Care Installation Disc in the following folder: Installerprogram filesSmiths MedicalCADD-Solis MSSCADD-Solis - Point of CareJungo

Depending on your operating system (32- or 64-bit), use the appropriate Jungo files in either the Jungox86 (for 32-bit platforms) or Jungox64 (for 64-bit platforms) directory, and then execute the following command lines to install the Jungo driver and device drivers. For 32-bit platforms: wdreg.exe -inf smmdpapi04_driver.inf install wdreg.exe -inf smmdpapi04_device.inf install For 64-bit platforms: wdreg.exe -inf smmdpapi04x64_driver.inf install wdreg.exe -inf smmdpapi04x64_device.inf install 17

d. Only if using a locally-installed database rather than a database server, Install Microsoft® SQL Server® 2005 Express Edition (SP3). SQL Server® 2005 Express Edition is located on the CADD™‑Solis Medication Safety Software – Point of Care Installation Disc in the following folder: installerISSetupPrerequisitesMicrosoft SQL Server 2005 Express SP3

Command line for silent installation: Sqlexpr.exe /qn ADDLOCAL=SQL_Engine,SQL_Data_Files,Client_Components,Connectivity INSTANCENAME=SMITHSMEDICAL2 DISABLENETWORKPROTOCOLS=0 SECURITYMODE=SQL SAPWD=PASSWORD

NOTE: The SQL password must be obtained from Smiths Medical. The password must be used in place of the word PASSWORD in the command line above. Contact Smiths Medical to receive the required password. IMPORTANT: As with any password, the SQL password must be kept secure to maintain a safe and reliable system. e. Install the CADD™-Solis Medication Safety Software – Point of Care application. The file used for command line installation is located on the CADD™-Solis Medication Safety Software – Point of Care Installation Disc in the installer folder. Use the following command line for a silent installation, where there is no local database: msiexec /I “d:installerPointofCare.msi” /QN /L*V “C:PointofCare.wil”

Use the following command line for a silent installation if you are using a locally-installed (Microsoft® SQL Server® 2005 Express Edition) database: msiexec /I “d:installerPointofCare.msi” /QN /L*V “C:PointofCare.wil” IS_SQLSERVER_SERVER=”<Local Machine Name>SMITHSMEDICAL2, 55000”

Replace <Local Machine Name> with the computer name of the PC on which Point of Care is being installed. NOTE: if upgrading a previous installation, add REINSTALL=ALL REINSTALLMODE=vomus to the command line. NOTE: This command line creates a log file named PointofCare.wil in C:. f. Copy the SolisPOCConfig.txt file (from Step 3 above) to the C:ProgramDataSmiths Medical folder if you are using Microsoft® Windows® Vista or Windows® 7, otherwise, copy the file to C:Documents and SettingsAll UsersApplication DataSmiths Medical. 5. Verify each Point of Care installation. Within the Point of Care “About” dialog box (click Help > About Point of Care), check the following: • Point of Care Version number • The connected Protocol Library Name, Version, and Database Server name

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Initial System Setup Although some setup decisions can be made during the installation of CADD™-Solis Medication Safety Software – Administrator and Point of Care, you can set or modify settings after installation. This section provides initial setup instructions for entering (or modifying) the database connection settings, logging into Administrator using the default “admin” account (so that you can add and edit users), setting a Protocol Library connection in Point of Care, and connecting to pumps. NOTE: For more information about system setup, including managing user accounts and importing and exporting Protocol Libraries for installations that do not have a connection to a database server, see the Administrator online Help.

Setting database connection in Administrator The CADD™-Solis Medication Safety Software – Administrator requires that a database connection is configured before an Administrator user can log in and create or access Protocol Libraries. If the database connection information was not provided during the installation of CADD™-Solis Medication Safety Software – Administrator, it can be set through the Settings menu. To set or modify database connection settings: 1. Start the CADD™-Solis Medication Safety Software – Administrator application: Click the Windows® Start menu, and then select All Programs > Smiths Medical > CADD™-Solis MSS > CADD™‑Solis - Administrator. 2. From the Administrator application menu bar, click Settings > Database Location. 3. In the Database Location dialog box, enter your location and connection settings for the CADD™‑Solis Database. Default settings are provided; change these settings as necessary for your specific database installation. Server Name: (enter the machine name of your database server) Instance Name: SmithsMedical2 Database Name: SmithsSolisC Port Number: 55000 SQL Server User ID: smiths SQL Server User Password: [ Contact Smiths Medical for password ]

4. Within the Verify Permissions area, enter your CADD™-Solis Medication Safety Software User ID and User Password. This user account must have the System Administrator permission to apply any database location and connection changes. The default administrator user account is contained in the database and added upon installation automatically: User ID: admin Password: password

5. Click OK. A message is displayed to confirm successful database connection. IMPORTANT: For security reasons, and because it allows unrestricted access to the CADD™‑Solis Medication Safety Software system, you should change the default “admin” user account password as soon as possible after initial setup. To change this default account, you will need to first log in to Administrator using it (for instructions, see the following section).

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Logging into Administrator with the default “admin” user account A default administrator-level user account (User ID: “admin”) is provided to allow you to perform initial setup of CADD™-Solis Medication Safety Software. After establishing a database connection (as described in the previous section), you will need to log into CADD™-Solis Medication Safety Software – Administrator using the default “admin” user account so that you can create and modify users and perform other tasks. IMPORTANT: For security reasons, and because it allows unrestricted access to the CADD™‑Solis Medication Safety Software system, you should change the default “admin” user account password as soon as possible after initial setup. To log into Administrator using the default “admin” user account: 1. Open the CADD™-Solis Medication Safety Software – Administrator application if it is not already opened: click the Windows® Start menu, and then select All Programs > Smiths Medical > CADD™Solis MSS > CADD™‑Solis Administrator. 2. In the CADD™-Solis Medication Safety Software – Administrator window, click Log In. 3. In the Login dialog box, enter the user account information for the default “admin” user: User ID: admin Password: password

4. Once logged in using the “admin” account, you can create and modify user accounts as desired. As user accounts are stored in the database, users that you create can access any installation of Administrator or Point of Care that has been configured to connect to the same database. A summary of the permissions that may be associated with any user account is provided below. For information about managing user accounts, permissions, and passwords; and using the various features of the Administrator application, see Administrator online Help. • Protocol Administrator: This permission allows all Send Protocols and Send Libraries permissions described below, plus the ability to select pump applications; access log and pump reports; manage user accounts and library permissions; export and import users, Protocol Libraries and usage logs; create, save and delete Protocol Libraries; publish and restore Protocol Libraries; and set Administrator auto logout. • Send Protocols: This permission allows the user to send a single Protocol to a pump from CADD™-Solis Medication Safety Software – Administrator (CADD®-Solis VIP Ambulatory Pump only) or Point of Care (CADD®-Solis and CADD-Prizm® PCS II Ambulatory Infusion Pumps only). • Send Libraries: This permission allows the user to send a Protocol Library to a pump from CADD™-Solis Medication Safety Software – Administrator (CADD®-Solis and CADD®-Solis VIP Ambulatory Infusion Pumps only) or Point of Care (CADD®-Solis Ambulatory Infusion Pumps only). • System Administrator: This permission allows the user to connect to a database/library; manage user accounts and library permissions; export and import users, Protocol Libraries and usage logs; archive data; backup and restore database; import data from 2.0 database; and send a Pump ID to a CADD-Prizm® PCS II Ambulatory Infusion Pump.

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