CADD-Solis Administrator Guide for Clinicians Ver 3.0 April 2012

Contents Introduction... i Menu Bar Information for Administrator Users... 1 Log In... 7 Creating a Protocol Library ... 7 Setup a Protocol Library... 8 Library General Settings... 8 Setup Therapies, Qualifiers, and Drugs... 10 Specify Protocols... 12 User accounts... 17 Reset Password... 18 Connecting the Pump to the Computer... 21 Send a Protocol Library to a Pump... 21 Get History from the CADD -Solis Pump... 22 ®

View Pump Reports for the CADD -Solis Pump... 23 ®

Log Out... 25 Refer to the Help files within the software for warnings, important notes and additional information. Consult the CADD -Solis medication safety software- administrator installation guide for details on installing the software. ®

Warning: Read the entire Help files located on the CADD -Solis medication safety software - administrator CD-ROM before operating this software program, and read the entire Operator’s Manual before operating the CADD -Solis ambulatory infusion pump. Failure to properly follow warnings, cautions and instructions could result in death or serious injury to the patient. ®

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Introduction The CADD -Solis medication safety software - administrator allows you, the protocol administrator, to set up protocol libraries that will be sent to a CADD -Solis ambulatory infusion pump or used by the CADD -Solis medication safety software - point of care user. ®

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A protocol is a collection of pump settings including a therapy, qualifier, drug and the pump parameters of the CADD -Solis ambulatory infusion pump. ®

A protocol library consists of a collection of these protocols. Each protocol is specific to the protocol library it is in. You will create the protocol libraries and protocols that will be sent to the CADD -Solis pump or used at the point of care. ®

The protocol administrator user can also: > Determine user access to send protocol libraries to the CADD -Solis ambulatory infusion pump. ®

> Determine user access to protocol libraries at the point of care. > Determine the amount of flexibility the point of care user can have in editing the protocols to be sent to the CADD -Solis ambulatory infusion pump. ®

> Determine the level of security for each protocol library. The CADD -Solis medication safety software - administrator can also be used to print barcodes and view reports. ®

Main log in screen

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Menu Bar Information for Administrator Users The menu bar is a row of onscreen buttons that, when clicked, activate certain functions of the program. You may need to be logged in to use some of these functions. The menu bar functions are described on the following pages.

File File

Pump Communications

Log Reports

Print Barcode

Settings

Help

New Library... Save Library As... Delete Library... Export Library... Import Library... Exit

New Library 1. Enter the New Protocol Library Name 2. From the pump drop-down list, select the pump to be used 2 with this new protocol library, if applicable 3. Click OK Save Library As 1. Select the existing Protocol Library you want to copy 2. Type in the new Library Name in the space provided 3. Click OK Delete Library 1. Select the Library you want to delete from the drop-down list 2. Click OK 3. Answer “Are you sure you want to permanently delete the selected library?” by clicking Yes or No Note: Clicking yes will delete the entire library and all protocols associated with it

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Export Library 1. Select the Protocol Libraries you want to export; click in the box next to the name > You may Select All or Clear All by clicking on the appropriate button 2. Select Export Options as desired by clicking to place a check mark next to the desired options: include users, include usage logs, include pump logs, export protocols as not active 3. Click OK 4. Determine the proper location for saving the file, create a filename and click Save Import Library 1. Select one: > Import From Server to import from another database server; enter Server Name and Advanced Connection Settings for the database server > Import From File to import from a previously-exported database file; click Browse and select the location and filename for the exported database file (*.smd file) 2. Verify permission; enter a User ID and User Password if not already logged in 3. Click Get Library List; a list of protocol libraries is displayed 4. Click to place a check mark next to the Protocol Libraries you want to import 5. Select the Import Options as desired by clicking to place a check mark next to the desired options; include users, include usage logs, include pump logs, export protocols as not active Note: Import options will not be available for selection if the source database server or file does not contain the applicable data. For example, usage logs will not be available to import if the protocol library was exported without the usage logs included. 6. Click OK Exit - exits the program

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Pump Communications File

Pump Communications CADD®-Solis Pump

Log Reports

Print Barcode

Settings

Help

> Send Library... Send Protocol... Get History...

Note: A protocol library may be sent to the CADD -Solis pump. The pump must be connected in order to send a library. The pump must be powered on with the home screen displayed. ®

CADD -Solis Pump 1. Click Send Library or Get History See Connecting the Pump to the Computer (page 21) for more details on send library, get history, and view pump reports. ®

Log Reports File

Pump Communications

Log Reports

Print Barcode

Settings

Help

View Log Reports...

View Log Reports 1. Select the type of report you want to generate 2. For the selected report, make filtering selections using drop-down lists. The filtering fields will vary based upon the selected report. 3. Click Show Report to open the report 4. From the View Log Reports window you can print the report using the printer icon on the toolbar or you can export the report by clicking on the export (floppy disc icon) button on the toolbar

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Print Barcode File

Pump Communications

Log Reports

Print Barcode

Settings

Help

Settings

Help

Print Barcode...

Print Barcode 1. Click the desired drug 2. Click Print 3. Select printer and number of copies 4. Click Print to print the barcode

Settings File

Pump Communications

Log Reports

Print Barcode

Pump Selections 1. Select the pump application(s) you want available for use in the administrator program Note: The instructions in this booklet pertain only to the CADD -Solis pump. Other features may be visible if other pumps are selected for use. See the help files for more information on other features.

Pump Selections... Database Location... System Tools... Administrator Auto Logout... Select COM Port... CADD®-Solis Pump Settings User Accounts Change User Password...

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Database Location Note: This task is used to modify the database location settings. The user must have administrator or system permission. 1. Enter the Server Name and Advanced Connection Settings 2. Enter your User ID and Password 3. Click OK System Tools Note: Users with the protocol or system administrator permission can use the archive data, backup database, restore database, and transfer 2.0 data features located under system tools. See the help files for details regarding these features.

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File

Pump Communications

Log Reports

Print Barcode

Administrator Auto Logout 1. Enter the amount of time in the Auto Logout box 2. Click OK

Settings

Help

Pump Selections... Database Location... System Tools... Administrator Auto Logout... Select COM Port... CADD®-Solis Pump Settings User Accounts Change User Password...

CADD -Solis Pump Settings Note: For CADD -Solis pumps, you can choose to allow CADD -Solis medication safety software to set the pump’s clock to the local PC date and time during pump communications (i.e., when sending a library, sending a protocol, or getting history). ®

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1. Click to place a check in the checkbox next to set pump’s clock to PC clock time 2. Click OK User Accounts See User Accounts information (page 17) Change User Password 1. Enter your User ID, if not logged in already 2. Enter your old password 3. Enter a new password, then confirm the new password 4. Click OK

Help Pump Communications

Log Reports

Print Barcode

Settings

Help Administrator Help Topics F1 About Administrator...

1. Click Help or F1 2. Scroll to Administrator Help Topics or About Administrator

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Log in 1. Turn on your computer and log in, if required 2. Double click the CADD -Solis Administrator icon 3. Click Log In 4. Enter your User ID and Password 5. Click OK ®

Creating a Protocol Library To create a new protocol library

Click new Library

Creating a new library

1. Select File from the menu bar and click New Library 2. Enter the New Protocol Library name 3. Confirm pump selection 4. Click OK 5. Create a new library with desired settings. See Set Up a Protocol Library (page 8) Note: See the help files for additional information

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Creating a new protocol library based on an existing protocol library You may create a new protocol library based on one that has already been defined. Note: All of the content of the existing library (user accounts, point of care permissions, library permissions, therapies, qualifiers, drugs and protocols) will be copied to the new protocol library. Protocols that were active in the previously existing protocol library will not be active in the new protocol library. To make a protocol active, see step 7 on page 16. 1. Select File from the menu bar and click Save Library As 2. Select the existing Protocol Library from the list provided 3. Enter the new Protocol Library Name in the “Save Library As” box and click OK 4. Edit the new Protocol Library for desired settings Note: See the help files for additional information

Set up a Protocol Library Library general Settings

Determine main settings for library in this tab

Library General Settings tab

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Once you are logged into the administrator program and have selected a protocol library from the Select Protocol Library drop-down menu, the Library General Settings tab is where you determine the main settings for the library. On this tab you can provide a description of the library, manage the library version, view a library summary report (once the library has been created and contains active protocols), enable point of care options and choose to require users to log in at the point of care (if you will use the point of care in your facility). Library description: Enter an appropriate protocol library description. Use this field to differentiate your protocol libraries. Manage library: Allows you to update or restore a library. Updating a library saves a restorable version of the library and updates the current version number. Restoring a library allows you to revert to a previouslyupdated protocol library version. Note: Restoring a protocol library will replace the current protocol library in use with the version you select to restore. See help files for more information. Library summary report: Allows you to view a summary report containing information about the protocol library and all its active protocols. Point of care settings: If your facility has decided to use point of care, then confirm there is a check mark in the box next to Enable Point of Care Options. If you will not be using the point of care application, remove the check mark by clicking in the box. > Click in the box Require User Login if your facility has determined the users are required to log in when using the point of care application. > If your facility requires users to log in at the point of care, an auto logout time must be designated. Enter the amount of time in minutes that the point of care program may remain inactive before automatically logging out the user. The default is 5 minutes.

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Setup Therapies, Qualifiers, and Drugs

add and edit unique protocol library info

Setup Therapies, Qualifiers, and Drugs tab

The Setup Therapies, Qualifiers, and Drugs tab allows you to create specific therapies, qualifiers and drugs that are unique to each protocol library. Once they have been created, you may also use this tab to view the names, edit the notes, edit a therapy or qualifier name that is not in use, edit a drug ID, and delete any therapy, qualifier or drug name that is not in use. The information added for the therapies, qualifiers and drugs is automatically saved. Build the therapy, qualifier and drug names for use within a protocol library. Verify that the Select Protocol Library menu states the library name you will be setting up. To Add a New Therapy: Select the Setup Therapies, Qualifiers, and Drugs tab. In the Therapies box, click on New. 1. Enter the new Therapy Name

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2. If desired, add Therapy Notes, which will be viewable by the point of care user 3. Click OK To Add a New Qualifier: All qualifiers are specific to the selected therapy. You must create at least one qualifier for each therapy. After a therapy name has been selected, click on New under the qualifiers box. 1. Enter the new Qualifier Name 2. If desired, add Qualifier Notes, which will be viewable by the point of care user 3. Click OK To Add a New Drug: The drugs added are specific to the entire protocol library and can be used throughout. Unlike the qualifiers, you do not need to create new drugs for each therapy. Verify that the drug box title displays the Protocol Library that you want to add a new drug to. 1. In the Drugs available for... box, click on New 2. Enter the Drug Name, Units, Concentration (if applicable) and the Drug ID (if applicable). Use a barcode scanner or manually type in the drug ID. The drug ID must be unique 3. Click OK Complete the Verify New Drug screen by clicking in the box next to each item once you have verified the information. Confirm the drug name and verify the spelling. This is how the drug name will be displayed on the pump. Follow facility policies and procedures for verifying information. Click OK. Note: “In Use” indicates (yes or no) whether a therapy, qualifier and drug have been used to specify a protocol

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Specify Protocols Verify that the Select Protocol Library menu states the library name in which you want to specify protocols. Specifying protocols allows the CADD -Solis pump or point of care user to choose the necessary therapy, qualifier and drug to receive the predetermined parameters. Active indicates (yes or no) whether the Protocol Available to Send to Pump option is enabled. ®

1. Select the Specify Protocols tab 2. Select the pump for which you want to specify protocols by selecting from the drop-down menu (if applicable) The following options are available: > Sort Protocols – Custom sort the order in which the therapy, qualifier and drug names will appear on the pump during pump programming. Note: If custom sorting of protocols is desired, this should be performed after protocols have been created > Manage Templates – Customize the selection of the alarms, security and display/sound settings as a template that can be used when creating new protocols. Note: If a template will be used during the creation of the library, this task should be performed before specifying any protocols. Modifications to protocol templates affect the initial settings when creating new protocols only. Changing a template does not modify any previously created protocols. > New Protocol - Create a new protocol > Edit Protocol - Edit the selected protocol > Print Protocol – View and/or print the protocol details report for the specified protocol > Delete Protocol - Delete the selected protocol > Rx Form - Print the selected protocol prescription form Note: A protocol must be active in order to print a protocol prescription form 3. Click the option you want to perform

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To Manage a Template Using a template when creating new protocols is optional; however, when a template is used, it provides a common starting point for the alarms, security and display/sound settings when creating new protocols. 1. Click on Manage Templates 2. In the manage templates dialog box, click to select the CADD -Solis pump 3. Click Edit Template 4. In the edit template window, click on each tab to modify the alarms, security, and display/sound settings Note: The Delivery 1, Delivery 2, and Delivery 3 tabs contain programmable delivery parameters specific to a protocol. These delivery parameters cannot be modified in a template. ®

5. After modifying the protocol template, click Save. To confirm the changes to the template, click OK at the confirmation message 6. Click Close to close the manage templates dialog box To Create a New Protocol 1. Click on New Protocol. Verify that the pump box displays the CADD -Solis pump ®

New Protocol screen

2. Select a Therapy, Qualifier and Drug from the drop down menus 3. If desired, enter protocol notes in the Protocol Notes box. Notes will be viewable to the point of care user

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4. Choose whether or not to use the modified protocol template for this new protocol. To use the template, click the use template checkbox

Use Template checkbox

New Protocol screen - use template checkbox

5. Click on Next 6. On the Protocol Details screen, adjust settings on each tab as needed. Consult the CADD -Solis Operator’s Manual for a complete description of these pump configurations ®

adjust settings on each tab as needed

Protocol Details screen for protocols created for the CADD -Solis pump ®

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The Delivery 1, Delivery 2, and Delivery 3 tabs contain programmable delivery parameters for the protocol and are specific to their therapy including hard and soft maximum, hard and soft minimum, and other settings. To provide further information, some parameter headings feature tooltip text when you hover the mouse cursor over them; for more information, see the product literature provided with the pump. Note: The checkboxes under General Settings and under each patient specific parameter apply only to how the protocol functions in the point of care program; they do not apply to protocols stored in the pump within an on-board protocol library. These checkboxes will only appear if the point of care options have been enabled on the library general settings tab. Note: Weight-based protocols can only be built if your facility is going to use the point of care application. In the weight-based box, click in the box next to Set as Weight-Based Protocol if you would like this protocol to be weightbased and enter a maximum weight and minimum weight in kilograms (kg) for the protocol. The maximum weight value must be greater than the minimum weight value. Note: When using a weight-based protocol, the continuous rate is programmed using units/kg/hr input, and the PCA/PCEA dose amount and delivery limit are programmed using units/kg input in administrator of point of care applications. Once a protocol is sent to the pump, the pump LCD screen displays the continuous rate in units/hr, and the PCA/PCEA dose, and delivery limit are displayed in units. Units may be milligrams (mg), micrograms (mcg) or milliliters (mL). Values may be entered by typing the value directly into the form field or by using the arrow keys. When entering values verify or confirm values entered are in the correct units for the drug selected. For the continuous rate, PCA/PCEA dose, PCA/PCEA dose lockout, intermittent bolus, bolus interval, delivery limit, maximum PCA/PCEA doses per hour, and clinician bolus fields values must be entered starting from the top down with the hard maximum value first and the hard minimum value last. If the hard minimum value is entered greater than the soft minimum, initial value and soft maximum the values are automatically increased to match the greater value, but cannot exceed what is entered for the hard maximum value. Always verify the values entered into these fields.

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Note: The soft maximum value may not be greater than the hard maximum value. The hard minimum value may not be greater than the soft minimum value. The hard minimum and soft minimum may not be greater than the hard maximum and soft maximum values. The initial value may not be greater than the hard maximum value or less than the hard minimum value. The Alarms tab contains pump alarm, air detector, sensor, reservoir low/empty alarm settings, and preventative maintenance settings for the pump. The Security tab contains security codes and security level settings for the pump. The Display/Sound tab contains pump settings related to backlight intensity; alarm volume and sound settings; date, time and numeric format; and the color theme, support note and/or clinical advisory message visible in the pump software (for CADD -Solis pumps that support this feature). ®

Note: Color choices are available to allow color-customization of protocols according to pain management programs. The color chosen for the protocol in the administrator program will also be the screen color on the CADD -Solis pump when that protocol is sent to the pump. ®

Note: It is important to use colors consistently. For example, if yellow is chosen to represent epidural infusions, yellow should be selected as the background color on the pump and color-coordinated accessories such as yellow CADD medication cassette reservoirs and/or lockboxes. ™

Note: When setting date and time format for pumps other than the CADD -Solis (Revisions A, A1, C, and E) ambulatory infusion pump it is recommended to set the date and time format to match that of the PC to avoid confusion when comparing pump and PC data. ®

The parameters on each tab must be adjusted and verified before the protocol is made active. 7. If you are ready to make the protocol active to be sent to the CADD -Solis pump or for use at the point of care place a check mark in the Active - Protocol Available to Send to Pump box (located at the bottom of the protocol details screen) and click Save If you aren’t ready to make the protocol active, click Save. This will save the protocol so it can be opened for further editing and review. ®

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Warning: 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. Failure to do so could result in undesired programming of the pump and, depending on the type of drug being administered, death or serious injury to the patient. Note: For detailed instructions and information about programming the CADD -Solis ambulatory infusion pump, refer to the product literature supplied with the pump. ®

User accounts The CADD -Solis medication safety software - administrator allows you to create and manage user accounts. User accounts may be created for use in all libraries. Permissions for administrator access and point of care access may be enabled or disabled for each individual user ID. You must be logged in as a protocol or system administrator to add, edit or delete user accounts and set user passwords, user permissions, and library permissions. ®

Create a new user

Manage User Accounts screen

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To Create a New User Account 1. Select Settings from the main menu bar 2. Click User Accounts, then Manage User Accounts 3. Click on the New User button 4. Enter a new User ID and password. The user ID and password must each contain a minimum of three alphanumeric characters (letters, numbers, or a combination of both) 5. Confirm password 6. Set permissions by placing a check in the box next to the desired permission level. Users may have permissions set to protocol administrator, send protocols, send libraries, or system administrator. If protocol libraries have been created, the list of libraries is displayed. To grant the user access to a protocol library, click to place a check next to the library to which you want to give the user access. 7. When finished, click on the Save button To Delete a User 1. Select or type in the User ID 2. Click the Delete button 3. Confirm delete by clicking Yes To Reset a Password 1. Select or type in the User ID 2. Enter the new password and confirm it 3. Verify permissions 4. Click Save To Assign Library Permissions 1. Select Settings from the main menu bar 2. Click User Accounts, then Library Permissions 3. Select a Library Name 4. Click in the box next to the User ID to give the selected user permission to the selected library You may select all or clear all by clicking on the appropriate button 5. Click Save

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