PharmGuard® Toolbox 2 Software User’s Manual/media/M/Smiths... · Toolbox 2 Software, Version 3, please call the appropriate number given below. Our staff at Smiths Medical is

PharmGuard® Toolbox 2 Software

User’s Manual

This manual and its contents are valid for use with software Version 3

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ii

User’s ManualPharmGuard® Toolbox 2

Technical AssistanceIf you have comments or questions concerning the installation and/or administration of the PharmGuard® Toolbox 2 Software, Version 3, please call the appropriate number given below.

Our staff at Smiths Medical is available to help.

H Manufacturer: Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 USA 1 800.258.5361 (USA) +1 214.618.0218

@ European representative: Smiths Medical Czech Republic a.s. Olomoucká 306, Hranice 1 - Město,753 01 Hranice, Czech RepublicTel: +44 (0) 1233 722100

www.smiths-medical.com

A printed copy of this manual is available upon request.

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Table of ContentsImportant Notices ......................................................1

Format Conventions ................................................................1Warnings .....................................................................................1Cautions .......................................................................................1

Introduction ................................................................3

Intended Use ...............................................................3

Symbols .......................................................................3

Glossary .......................................................................4

PharmGuard® Toolbox 2 Data ....................................5Working within the Database ..............................................5Configuration Data ..................................................................5

Configuration .........................................................................5Drug Program Library .............................................................5History Data ...............................................................................5PharmGuard™ Safety Data ....................................................6Evidence-based Log ................................................................6

Creating and Organizing a Configuration ................7Drug Programs & Drug Classifications ..............................7Drug Profiles & Library Categories .....................................7Delivery Modes .........................................................................7Library Mapping .......................................................................7Other Profile Settings .............................................................7Common Properties ................................................................7Graphics .......................................................................................7

Working with PharmGuard® Toolbox 2 .................. 10Dialog Windows ..................................................................... 10

Property Grid ....................................................................... 11Context Menus .................................................................... 12Shortcut Keys ....................................................................... 12

Menus and Toolbars ................................................ 13Configuration Tab Menu Commands ............................. 13

Configuration Tab Toolbar Commands ...................... 13Drug Program Library Tab Menu Commands ............. 14

Drug Program Library Tab Toolbar Commands ....... 14

Software Security .................................................... 15Logging In ................................................................................ 15Logging Out ............................................................................ 15Changing Passwords ............................................................ 16

Communicating with a Pump ................................. 17Connecting to a Pump ........................................................ 17

Opening a Serial Port (Medfusion® Model 3500 pump V6) ............................................................................... 18Opening a Network Connection (Medfusion® Model 4000 pump) ............................................................ 18

Disconnecting From a Pump ............................................ 19Closing a Connection ....................................................... 19

Refresh Pump Information................................................. 19Create Package... (Medfusion® Model 4000 pump) .. 20Teaching and Learning Data ............................................. 21

Teaching Data ...................................................................... 21Learning Data ...................................................................... 21

Device Setup ........................................................................... 22Setting Up a Device ........................................................... 22

Importing Syringes .................................................. 24When opening PharmGuard® Toolbox 2 for the first time .................................................................................... 25Importing ................................................................................. 26

Working with Records and Legacy Files ................ 29Creating a New Configuration Data Record ................ 29Opening an Existing Configuration Data Record ...... 30Opening a Legacy Configuration .................................... 31

Renaming a Configuration ......................................... 32Opening History Data .......................................................... 33

Closing a Record ................................................................ 34Saving a Record .................................................................. 35

Autorecovery of Unsaved Records ........................... 36Saving a Duplicate Record .............................................. 36Exporting Configuration Records ................................ 37

Sharing Configuration Records .................................. 37Record (Configuration) Promotion ................................. 38

Changing a Record’s Promotion Level ........................ 38Promoting from Teachable ............................................. 39

Syringe Management .............................................. 40Updating Syringes ............................................................. 41

Managing Syringes ............................................................... 42Missing Syringes Alerts ....................................................... 43

Deselecting Syringes ........................................................ 43Dragging/Dropping or Copying/Pasting Profiles and Drug Programs ........................................................... 44Import Failed ....................................................................... 45List of Syringes Selected in Configuration ................ 46

Configuration Window ............................................ 47Configuration Tab ................................................................. 47Configuration Tab ................................................................ 48Common Properties ............................................................. 49

Changing the Major Version .......................................... 50Profiles ....................................................................................... 51

Creating a New Profile ...................................................... 51Renaming a Profile ............................................................ 51Moving a Profile .................................................................. 51Cutting, Copying, and Pasting a Profile ...................... 52Dragging and Dropping a Profile ................................. 52

General Tab .............................................................. 53Alarm Setup ............................................................................ 54Auto Prompts .......................................................................... 54Flush ........................................................................................... 55General Customization........................................................ 55Limits ......................................................................................... 56Occlusion Detection ............................................................. 57Selecting a Quick Library .................................................... 58Delivery Modes Tab .............................................................. 59

Working with Delivery Modes Lists ............................. 59Infusion Units Tab .................................................................. 60Syringe Models Tab .............................................................. 61

Working with the Profile Syringe Models List .......... 62Program Options Tab ........................................................... 63

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User’s ManualPharmGuard® Toolbox 2Working with Program Options Lists .......................... 63

Library Mapping Tab ............................................................ 64Working with Library Mapping Lists ........................... 65

Drug Program Library Tab ...................................... 66Library Explorer ...................................................................... 67Working with Drug Classifications .................................. 68

Creating a Drug Classification ...................................... 68Naming and Renaming a Drug Classification .......... 68Removing a Drug Classification .................................... 68Cutting/Copying/Pasting a Drug Classification ...... 68Dragging/Dropping a Drug Classification ................ 68

Working with Drug Programs ........................................... 69Creating a Drug Program ............................................... 69Naming and Renaming a Drug Program ................... 69Removing a Drug Program ............................................. 69Cutting/Copying/Pasting Drug Programs ................. 69Dragging/Dropping a Drug Program ......................... 70

Drug Alerts .............................................................................. 71Creating a Drug Alert ........................................................ 71Renaming a Drug Alert .................................................... 72Removing a Drug Alert .................................................... 72

Customizing Drug Program Properties ......................... 73General ............................................................................... 74Infusion Units ................................................................... 75Main ..................................................................................... 75Options ............................................................................... 78

Assigning a Drug Program to a Drug Classification .. 81Creating a New Drug Classification ............................. 81Renaming a Drug Classification .................................... 81Removing a Drug Classification .................................... 81

Selecting a Drug Alert ......................................................... 82

History Data ............................................................. 83

Reports ..................................................................... 85Viewing Reports .................................................................... 85Custom Reports ..................................................................... 86Report View Window ........................................................... 86

Selecting a Report File ..................................................... 88Refreshing a Report ........................................................... 88Working with Reports....................................................... 88

Report Navigation ................................................................. 89Opening Report Sections ................................................ 89Working with the Group Tree ........................................ 89Viewing a Specific Page ................................................... 89Finding Text .......................................................................... 89Zooming ................................................................................ 90

Page Setup ............................................................................... 91Printing a Report ................................................................... 91

Exporting a Report ............................................................ 92

Setting Application Options ................................... 93General Options ..................................................................... 93

Show/Hide the Status Bar and Toolbar ...................... 93Appearance ............................................................................. 94

Customizing the Font and Color of an Item ............. 94

Index... ...................................................................... 95

1


Important NoticesWARNING: Read this entire manual before using the Phar-mGuard® Toolbox 2 Software, Version 3 (Pharm-Guard® Toolbox 2). Failure to follow the instructions and impor-tant information contained in this manual, or improper/in-adequate review and verification of created Configurations can lead to death or serious injury. Warnings, cautions and other important safety information can be found in this section and throughout the manual.

Format ConventionsA WARNING indicates a hazard that has the potential to cause injury or death to a patient or user. The following example is the format convention for warnings specified in this manual.

WARNING:

A CAUTION indicates a hazard that has the potential to cause damage to the product or other property. The following example is the format convention for cautions specified in this manual.

CAUTION:

Warnings• PharmGuard® Toolbox 2 is intended for use by

trained, authorized personnel under the direction of trained medical professionals.

• Before using PharmGuard® Toolbox 2, users must be thoroughly familiar with this manual, including all warnings, cautions, and instructions for use.

• Failure to strictly adhere to the Intended Use of this product can result in serious injury or death.

• Failure to log out from PharmGuard® Toolbox 2 poses a serious security risk for unauthorized use. Always log out or exit the application when finished working with PharmGuard® Toolbox 2.

Note: Only users with the Promotion or Administration Security Right are allowed to change the Promotion Level of a record.

• When saving duplicate Configuration Data records, the new record will have the same Promotion Level as the source record. For example, if the original record’s Promotion Level is Teachable, the duplicate record will also be Teachable. For this reason you should change the Promotion Level to Working to avoid having two Teachable Configurations and the wrong one being sent to pump inadvertently. Refer to “Changing a Record’s Promotion Level” for instructions.

Cautions• Keep passwords confidential and periodically change

them to protect against possible security violations.

• PharmGuard® Toolbox 2 does not have an Undo func-tion for any operations or procedures.

• When utilizing the Device Setup Dialog, teaching the initially displayed date to the pump will set the pump’s Next Preventative Maintenance Date forward by one year (365 days).

• If a Drug Classification is deleted, the operation can-not be reversed. In addition, all Drug Programs to which it has been assigned will lose that association.

• If a Drug Program is deleted, the operation cannot be reversed.

• If a Drug Alert is deleted, the operation cannot be reversed. In addition, all Drug Programs to which it has been assigned will lose that association.

• The pump’s internal clock sets the date and time of all History and PharmGuard™ Safety Events. The pump’s Time and Date settings must be set accurately; other-wise, event times will not be correct. Refer to “Device Setup” for more information.

• Report View windows are owned by the Pharm-Guard® Toolbox 2 windows in which the Report was generated. This means that when the Pharm-Guard® Toolbox 2 window is closed, all owned Report View windows will also be closed.

• Care should be taken when changing a Report’s Page Setup. Some Reports require a minimum page layout and might not display or print as expected.

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User’s ManualPharmGuard® Toolbox 2Usability:

The content in this manual is valid for use with Medfusion® Syringe Infusion Pumps, Model 4000 (all software versions) and Model 3500 V6.

• PharmGuard® Toolbox 2 does not automatically detect the presence of a pump. For this reason, the pump information displayed in the Pump Information panel, far right panel in the Status bar, may not be accurate. The software only updates Pump Information when performing pump related operations such as refreshing, teaching and learning.

• Creating a Report File is an advanced feature of PharmGuard® Toolbox 2 and requires additional software and knowledge about computer report creation.

3


IntroductionPharmGuard® Toolbox 2, Version 3 is an accessory software application for compatible Medfusion® Syringe Pumps (Model 4000 all software versions, and Model 3500 V6). It provides comprehensive management and analysis capabilities, unlocking the advanced safety features of compatible pumps.

PharmGuard® Toolbox 2 can be used to:

• Securely create and deploy custom Configurations to compatible Medfusion® pumps.

• Collect data for analysis of Drug Program usage and variations from the Drug Program’s custom infusion parameters.

• Collect History Data for analysis of a single pump’s operational, infusion and alarm history.

• View data in printer-friendly report format using Standard Reports installed with PharmGuard® Toolbox 2, or Custom Reports created with compatible software.

WARNINGS: • PharmGuard® Toolbox 2 is intended for use by

trained, authorized personnel under the direction of trained medical professionals.

• Before using PharmGuard® Toolbox 2, users must be thoroughly familiar with the contents of this manual, including all warnings, cautions, and instructions for use.

Intended UsePharmGuard® Toolbox 2 is intended to provide a vehicle to create and securely teach custom pump Configurations and named Drug Programs to compatible Medfusion® pumps. Drug Programs have associated custom infusion parameters, which contain specific information used in the operation of the pump. The software also collects pump operational, infusion and alarm history information, drug program usage counts, and associated PharmGuard™ Safety Event information from compatible Medfusion® pumps. It is intended to provide a useful dataset users can analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into Medfusion® pumps.

Although PharmGuard® Toolbox 2 does not directly control pump infusions or make infusion related calculations, the software does provide the means to define pump limits and assist with infusion setup.

There should be a well-defined review and test process performed before installing a Configuration onto pumps for use with patients. The Configuration should be developed, sent to several test pumps for validation and then approved via your facility’s appropriate review. Only after completing this process should a Configuration be made available to pumps for patient use.

Correct use of PharmGuard® Toolbox 2 should be based on the following principles:

• A Review Board should thoroughly review all custom Configuration and infusion properties for accuracy.

• An authorized user should promote custom Configurations to the Teachable promotion level. At this promotion level, PharmGuard® Toolbox 2 assumes the data has been validated and can be taught to pumps for use in a medical capacity.

• An authorized user should teach Teachable custom Configuration and infusion properties to pumps.

• Through the infusion pump’s interface, an authorized user should step through all custom Configuration and infusion properties to verify all properties are correct.

WARNING: Failure to strictly adhere to the Intended Use of this product can result in serious injury or death.

SymbolsThe following is a list of symbols that appear on the product (or on it’s packaging), along with an explanation of what these symbols mean:

f Caution

1 Consult instructions for use

< Catalog number

= Batch code

H Manufacturer

@ Authorized Representative in the European Community

6 Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician

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GlossaryThe following is a list of terms to be familiar with when using PharmGuard® Toolbox 2.

Access Control - ensures and restricts who can connect and what can be done to the database. Access control in the software is accomplished through the creation of User Groups and User Accounts, as well as automatic locks implemented when a user has opened a Configuration as an editor.

Administrator - the person(s) in the facility with overall management responsibilities for the PharmGuard® Toolbox 2 database. The administrator will have full access privileges in the application, and is responsible for setting up all user groups and user accounts.

Available Models (Syringe Management tab) - this list contains all of the syringe models available for use in the entire database, minus those moved to the Configuration Syringe Models list.

Category - drugs are classified by category to allow for easier reference. Categories are selected in the pump after selection of the Profile.

Configuration - sometimes referred to as the library, or dataset.

Configuration Syringe Models (Syringe Management and Configuration tab) - This list contains all of the syringe models for possible use in the Configuration (choices are made on the Syringe Management tab, and automatically populate the list on the Syringe Models tab on the Configuration tab).

Database - a structured collection of records or data that is stored in a computer system. Because of the nature of the database structure, only one user at a time can be logged in as an editor in a Configuration. Other users can only open the Configuration in a “read only” mode until the user editing has closed their editing session.

Delivery Mode - the Infusion Type used by a drug program.

Drug Classifications - PharmGuard® Toolbox 2 uses Drug Classifications to organize Drug Programs in the Drug Program Library and to list programs under the Library Mapping tab. Drug Classifications appear only in PharmGuard® Toolbox 2 and will not appear in the pump menu.

Drug Program - a Drug Program is a named collection of custom infusion properties that can be used to predefine drug specific infusions deployed to pumps and later recalled by pump users to assist with pump setup. The specific program includes parameters specifically related to a single drug. This includes data such as hard and soft upper and lower limits, concentration etc.

Drug Program Library - the Drug Classifications and individual Drug Programs make up the Drug Program Library.

Generic delivery mode - see manual delivery modes

Manual delivery mode - an Infusion Type not associated directly with a Drug Program, and that can be programmed directly on the pump. Manual delivery modes are added to the Selected Modes list on the Configuration > Delivery Modes

tab

Medfusion™ Standard Syringes Series 2 - the standard set of syringes included in the Medfusion™ Standard Configuration, and supplied on a separate CD with PharmGuard® Toolbox 2.

PharmGuard™ Supported Syringes (PSS) Series 2 - additional syringe file(s) that can be imported into PharmGuard® Toolbox 2.

Profile - PharmGuard® Toolbox 2 has up to 16 profiles to allow for segmentation of drug information by care area or type of therapy.

Quick Library - a quick library allows the selected drug programs to appear on the pump screen directly after the Profile is selected. If all the required drug program properties are entered and the correct syringe is loaded on the pump, the pump user will receive a prompt to start the infusion directly after selecting the drug, without having to program any parameters.

Read Only - refers to something that can be read, but not written to or modified. Read only allows multiple users to view the database, but not make any changes or save operations within it.

Security Rights - restrict the access to various functions in the software. For example, some User Groups may have the ability to create, edit, and save records, some may have the ability to change the Promotion level, and others may have the ability to “teach” Configurations to pumps. See Access Control.

Syringe Model - name of manufacturer brand i.e. B-D®, Monoject®, etc. Defines the Syringe Model to associate with the Drug Program. Any Medfusion™ Standard Syringes Series 2 or PharmGuard™ Supported Syringes (PSS) Series 2 used at your facility can be selected.

Profile Syringe Models (on the Syringe Models tab) - this list shows the syringes made available in the selected Profile and will be available to be selected by the pump user.

User Accounts - Access accounts set up for individuals who require access to the software. User accounts are members of specific User Groups, which determine the Security Rights that individual accounts have access to.

User Groups - define the Security Rights granted to all User Accounts that are members of the respective group.

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PharmGuard® Toolbox 2 DataThrough PharmGuard® Toolbox 2, two distinct Data Types are worked with:

• Configuration Data

• History Data

These Data Types are a PC representation of the custom settings available from compatible Medfusion® pumps. Each Data Type is saved as a separate database to the location of your choosing and encrypted for protection.

All newly created Configurations are stored as database records. Legacy Configurations (those created on earlier version of the software) which may exist as files may be imported into the database, but must be converted into a database record.

Usability: The maximum allowed size of the database is 2GB on a Windows 32 bit OS. Once the database has reached this size, an error message is generated whenever additions to the database are attempted.

Working within the DatabaseWhen PharmGuard® Toolbox 2 is installed on a shared network drive, multiple users have access to it. The Administrator will have developed various User Groups (which determine which functions a user will be able to perform), as well as User Accounts within each User Group.

Due to the way a database structures data, there are limits on usage. For instance, only one User at a time may be logged into a Configuration in the editing mode. Pharm-Guard® Toolbox 2 automatically “locks” the open Configuration when this occurs. Other Users can log in only as “read only” (where they can view the Configuration but not make any changes) until the User editing has saved and logged off.

It is possible that a User editing forgets to close the Configuration, or should PharmGuard® Toolbox 2 terminate unexpectedly under certain conditions, the Configuration may stay in the locked state, and other Users will only be allowed to log on to view the Configuration (“read only”), but not edit. Contact the Administrator if this occurs.

Configuration DataConfiguration Data is made up of properties that represent the Configuration of a Medfusion® pump and a Drug Program Library. This data makes it possible to customize the interface and behavior of the infusion pumps to meet the needs of specific clinical environments and predefine drug specific infusions for recall at the pump.

ConfigurationConfiguration is the part of Configuration Data that allows customization of the Medfusion® pump’s interface and behavior. This covers everything from the pump’s Language and Alarm Loudness to the layout of the pump’s Main Menu.

The Configuration is also linked to the Drug Program Library, making it possible to map Drug Programs to a pump-specific layout. Configurations are uniquely identified by an automatically generated Dataset identification.

Usability: Pumps can store one Configuration containing up to sixteen Profiles. A Profile may contain up to 288 Drug Programs (for a theoretical total of 4608 Drug Programs in a Configuration). The actual number of Profiles and Drug Programs that can be stored is dependent on the amount of available pump memory.

Drug Program LibraryThe Drug Program Library is a collection of named Drug Programs and associated custom infusion parameters that are organized into custom Drug Classifications, then mapped into Categories for use on the pump. By itself the Drug Program Library is a Repository for Drug Programs and has no connection to a pump. To use the Drug Programs defined in the Drug Program Library at a pump, Drug Programs must be mapped to Library Categories defined in the Configuration. This process of mapping Drug Programs to Library Categories is known as Library Mapping.

Usability: Pumps organize Drug Programs on a per Profile basis. Each Profile can have a maximum of 8 Library Categories with up to 36 Drug Programs each, resulting in a maximum of 288 entries per Profile. The actual number of Library Categories and Drug Programs that can be mapped is dependent on the amount of available pump memory.

History DataHistory Data is a log of time stamped events that indicates a pump’s operational, infusion, and alarm history. History Data is available from all supported pump versions.

Usability: History Data learned from pumps is combined with PharmGuard™ Safety Event data and displayed collectively.

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PharmGuard™ Safety DataPharmGuard™ Safety Data is a subset of history data, and is made up of Drug Program usage information and an Evidence-based Log of safety events.

Evidence-based LogThe Evidence-based Log is a collection of PharmGuard™ Safety Events indicating selection of a Drug Program that is then not confirmed for use, or variations from custom infusion parameters defined in Drug Programs. The following list describes the PharmGuard™ Safety Event types:

Warning Occurs when a clinician selects a Drug Program and selects NO on the confirmation screen or enters a value that is outside the range defined by the Drug Program but reen-ters a value in range before continuing.

Override Occurs when a clinician enters a value that is outside the range defined by the Drug Pro-gram but accepts the override confirmation and continues with the value entered.

Abandon Occurs when a clinician selects a Drug Pro-gram and turns the pump off at the confirma-tion screen or enters a value that is outside the range defined by the Drug Program but either exits the programming process all together or turns the pump off.

Hard Limit Occurs when a clinician enters a value that is outside the Maximum/Minimum range defined by the Drug Program or by the physi-cal limits of the pump (syringe size, etc.). This range is considered to be a safety limit boundary.

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Creating and Organizing a ConfigurationDrug Programs & Drug ClassificationsThe Drug Library is made up of various Drug Programs, used to deliver medication.

Drug Programs are created on the Drug Program Library tab, and consist of customized infusion parameters specifically related to a single drug. A Drug Program includes such data as the type of infusion, hard and soft upper and lower limits, concentration units, delivery units, doses, time limits, various delivery options, etc.

Drug Programs are also assigned to one or more Drug Classifications. Drug Classifications are used only to aid in “mapping” Drug Programs into Library Categories, where the various Drug Programs are grouped for use on the pump. In order to appear on the Library Mapping tab, Drug Programs must be assigned to at least one Drug Classification. If the Drug Program is not assigned to a Drug Classification, it cannot be mapped and therefore cannot be used on a pump.

Drug Profiles & Library CategoriesProfiles allow for segmentation of Library Categories (and their various Drug Programs) by care area, types of therapy, infusion type or a combination of these parameters (or any other grouping you might choose).

Library Categories are named categories used to organize Drug Programs within a Profile. Categories can be named by infusion type, types of therapy, care area, alphabetical listing, or any other grouping you might choose. Each Profile requires it’s own set of Library Categories.

Once created, each named Library Category in a Profile is automatically added to the bottom of the “Selected Modes” list on the Delivery Modes tab for that Profile.

Delivery ModesIf manual delivery modes are desired within the Profile, move the desired manual delivery mode from the “Available Modes” list to the “Selected Modes” list. Manual delivery modes are infusion types that are programmed entirely at the pump without safety parameters, and not associated with a specific drug.

Library MappingOnce Drug Programs are associated with at least one created Drug Classification, they can be “mapped” to the created Library Categories for each created Profile. This is accomplished on the Library Mapping tab on the Configuration tab.

Other Profile SettingsThere are various other settings applied to each Profile, including General settings, Infusion Units, Syringe Models and Program Options.

Common PropertiesThe Common Properties apply to the entire Configuration, and consist of data about the Configuration, as well as settings that control the appearance of certain values.

GraphicsThe graphics on the following pages show the general requirements for programming a Configuration. The Syringe Management tab is discussed on page 42. The screen shots used in these graphics (and throughout the product labeling) are examples only; your Configuration may look very different.

8


Create Profile Names

Set Common Properties

Select General settings, Infusion

Units, Syringe Models and Program Options

for each Profile

Create Drug Program Names

Create Drug Classifications

Customize Drug Program

properties including assignment to Drug

Classification(s)

9


Key

Associated with creation of Drug Library

General Profile and Configuration set-tings

Once the Configuration is “Taught” (sent/downloaded) to a pump, it looks like this:

The Main menu shows available Profiles

Selecting a Profile displays its available Categories and manual delivery modes

Selecting a Category displays its available Drug Programs

Create Library Categories

Select Classification(s) that contain the Drug Programs wanted for

the Category

Drug Programs in Classification(s);

select those wanted for the Category &

add to Selected Drug Programs list

Drug Programs included in Category

Available manual delivery modes; add to Selected Modes list as

desired

Library Categories & manual delivery modes as they will appear on

the pump screen

10


Working with PharmGuard® Toolbox 2PharmGuard® Toolbox 2 is a Microsoft Windows®-based application. It utilizes many of the features typically seen in other Microsoft Windows® applications. PharmGuard® Toolbox 2 includes extensive Online Help to assist with software usage and utilizes Windows Common Controls for input and output.

Dialog WindowsPharmGuard® Toolbox 2 uses Dialog windows in various places throughout the software to display and gather information. Although the information displayed or gathered is different for each function, there are common elements that will be seen when working with Dialog windows.

Use the Context Sensitive Help button to access Popup Help Messages available from the Controls on the Dialog window. When the Context Sensitive Help button is clicked, the mouse cursor will change to the Help cursor.

When one of the Controls is clicked in, a Popup Help Message is displayed, with a short description of the Control. Cancel the Context Sensitive Help selection process by pressing the Esc key on the PC’s keyboard. The Help Button is used to access the Help Topic associated with the Dialog window.

When the Help button is clicked, the Help topic associated with the Dialog window will display in the Help Viewer. The Resize Gripper indicates that the Dialog window can be resized. Position the mouse cursor over the edge of the window, press and hold the left mouse button, and drag the window to the size desired.

Context Sensitive Help button

Popup Helpmessage

Help Topic button

Resize gripper

11

User’s ManualPharmGuard® Toolbox 2Property GridPharmGuard® Toolbox 2 uses Property Grids in various places throughout the software to display and gather multiple properties related to a single item. For example, a Drug Program is a single item that has many properties that define the characteristics of the Drug Program. These properties are displayed and customized through the Property Grid shown in the diagram.

As can be seen in the diagram, Property Grids are divided into two columns. The left column displays the property’s name and the right displays its associated value.

When working with properties that require entry of a value (generally seen as (none) or an indication of what type of value needs to be entered, i.e., MM:SS for entry of a minutes:seconds value), the simplest way to customize the property is to double-click the property name (left column) and begin typing. The new text automatically replaces the highlighted value (right column). This also allows values to be easily changed back to (none); double-click the property then press the Backspace or Delete key on the PC’s keyboard.

Other properties are customized by selecting a value from a list by clicking the drop-down button in the right column of the respective property. For these types of properties it is also possible to iterate through the possible values by double clicking the property name or its value. Still other properties are customized through a separate dialog window by clicking the browse button in the right column of the respective property.

A short Help Tip associated with the selected property is shown in the Help panel located at the bottom of all property grids.

Usability: “(none)” indicates that no value is associated with the property. To restore a value back to “(none)” either completely clear the value (double-click the property and press the PC’s Backspace or Delete key) or enter zero.

Double-click property and begin typing

Highlighted value replaced by typed value

12

User’s ManualPharmGuard® Toolbox 2Context MenusMany windows implemented by PharmGuard® Toolbox 2 utilize Context Menus to provide quick access to common operations. Simply right-click in a window and a Context Menu will pop up (if the window clicked implements a Context Menu).

Shortcut KeysShortcut keys are used to quickly perform operations using the keyboard. Look at the respective item under the main menu to see which shortcut key is associated with an operation. For example, press CTRL + N at the same time to display the New Configuration window.

13


Menus and ToolbarsThe menus and toolbars are always listed at the top of the main PharmGuard® Toolbox 2 window. They are a combination of commonly used Windows® functions and functions that are unique to PharmGuard® Toolbox 2. The items available are dependent on the tab selected in the active window.

Configuration Tab Menu CommandsWhen the Configuration tab is selected, the following menus and toolbar is displayed:

Menu Button Commands / OptionsRestore, Move, Size, Minimize, Maximize, Close, Next

New Configuration, Open Configuration, Open History, Close, Save, Save As, Import Configuration, Import Syringe File, Promote Configuration, Export Configuration, Create Package, Exit

Cut, Copy, Paste, Delete, Up, Down, Sort (Ascending, Descending)

Toolbar, Status Bar, Profiles, Common Properties, Report (Configuration Report, Drug Program Report), List Selected Syringes for This Configuration

New Profile, Major Version, Rename Configuration

Connect, Disconnect, Refresh, Learn (Configuration Data, History Data), Teach Configuration, Device Setup

Update License, Administration (Login, Logout, Change Password, User Groups, User Accounts, Unlock Con-figuration, Delete Configuration), Options

Cascade, Tile Horizontal, Tile Vertical, Arrange Icons, Close All, Next, Previous, version and name of open Con-figuration (if applicable)

Help Topics, About

Configuration Tab Toolbar Commands

Toolbar Button

Short Cut Keys

Action

New Configuration Ctrl + N Opens the New Configuration selection window.

Open Configuration ---------- Opens the Select Configuration From Database window.

Save Configuration Ctrl + S Saves the Configuration.

Cut To Clipboard Ctrl + X Cuts highlighted content and places content on the clipboard.

Copy To Clipboard Ctrl + C Copies content to the clipboard.

Paste From Clipboard Ctrl + V Pastes content from the clipboard.

Teach Configuration ---------- (This button is only active when a Configuration is in Teachable status and a pump is connected.) Teaches the Configuration program to a pump.

Report ---------- Opens a list of reports to select for viewing in the Report view window.

14


Drug Program Library Tab Menu CommandsWhen the Drug Program Library tab is selected, the following menus and buttons display (only those items not described in the previous table are described here, as the functions are the same):

Menu OptionsSelect All

Library Explorer, Drug Program Properties

New Drug Classification, New Drug Program, Drug Alerts

Drug Program Library Tab Toolbar Commands

Toolbar Button

Short Cut Keys

Action

Add New Library Item (new drug)

---------- Click drop-down arrow to display options—(new) Drug Classification and Drug Program.

15


Software SecurityPharmGuard® Toolbox 2 implements security independently of the underlying Operating System and requires logging in when using the software. Once logged in, access to features and operations is based on the Security Rights granted by Software Administrators. When finished using PharmGuard® Toolbox 2, always log out or exit the application. When logging out or exiting, all open records, and Network Connections will be closed. If any record has been modified, you will be prompted to save it.

When the application launches, the login window is displayed. Users must specify their User name and Password to open the application.

WARNING: PharmGuard® Toolbox 2 is intended for use by trained, authorized personnel under the direction of trained medical professionals.

Logging In• Select Tools > Administration > Login….

• In the PharmGuard® Toolbox 2 Login window, type your user name and password in the spaces provided.

• Click OK to log in or Cancel to exit the window.

Logging Out • Select Tools > Administration > Logout.

• All open records are closed, prompting you to save if needed, and the Network Connection is closed, if needed.

• Exiting the application will automatically log you out.

WARNING: Failure to log out from PharmGuard® Toolbox 2 poses a serious security risk for unauthorized use. Always log out or exit the application when finished working with PharmGuard® Toolbox 2.

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Changing Passwords• Select Tools > Administration > Change

Password….

• In the Change Password window, enter the current password, then the new password.

• Enter the new password again to confirm the new password.

• Finally, click OK to change the password or Cancel to exit the window.

CAUTION: Keep passwords confidential and periodically change them to protect against possible security violations.

Usability: Passwords must be at least four characters long.

Note: If a user’s password is forgotten, the database Administrator can reset it. If the Administrator password is lost or forgotten, the Administrator will need to uninstall PharmGuard® Toolbox 2, then reinstall it to create a new password. (If the application is uninstalled, the Administrator must then locate the security file and delete it before reinstalling the application.)

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Communicating with a PumpPharmGuard® Toolbox 2 is capable of communicating with compatible infusion pumps. The Medfusion® Model 3500 pump V6 communicates via RS232 serial links. The Medfusion® Model 4000 pump communicates on a network either wirelessly or directly over Ethernet.

Usability:

• PharmGuard® Toolbox 2 does not automatically detect the presence of a pump. For this reason, the pump information displayed in the Pump model panel, far right panel in Status bar (the bottom of the program window, see example below), may not be accurate. The software only updates Pump model when performing pump related operations such as refreshing, teaching and learning.

Medfusion® Model 4000 pump only:

• Before any communication is possible, the pump’s Network Settings must be configured (LAN settings and/or Wireless Settings). See the pump Network Settings Manual (supplied with the pump) for more information.

• In order to communicate with the pump, the pump must be enabled for external commands each time connection to it is attempted. Information about enabling external commands can be found in the pump Network Settings Manual (supplied with the pump), and is limited to those persons who have access to the Biomed menu passcode.

• When the pump is connected via either LAN or wirelessly, the pump’s IP address, port and serial number are displayed in the Status bar (bottom of the program window, see example below).

Medfusion® Model 3500 pump V6 only:

• PharmGuard® Toolbox 2 can open and communicate over one Serial Port at a time. To use a different Serial Port, you must first close the open port.

• When PharmGuard® Toolbox 2 is connected to a Serial Port, the Serial Port name and number is displayed in the Status Bar (bottom of the program window).

Connecting to a PumpTo communicate with a compatible infusion pump, a connection must first be opened. This makes it possible to Teach data to pumps and Learn data from pumps.

Generally these connection options are used by Biomed personnel when testing pump functionality. As such, the pump should be in the room with the user.

Before attempting to connect to the pump, turn the pump on.

• Medfusion® Model 4000 pump: open the pump’s Biomed menu. Enable the pump for external commands or the connection attempt will fail (“Enable External Com” is one of the menu items in the Network Settings menu in the pump’s Biomed menu).

Note (Medfusion® Model 4000 pump only): Rarely, transient network issues may occur that interrupt communication with pumps, particularly when teaching or learning very large Configurations. When this happens, PharmGuard® Toolbox 2 may close the connection to the pump and display an error message. If this occurs, reconnect to the pump (Pump > Connect); it may also be necessary to turn the pump off, then turn the pump back on and “Enable External Com” again before attempting to reconnect.

• Medfusion® Model 3500 pump V6: plug the RS232 cable into the connection port provided on the back of the pump, then into an available serial port on the PC.

Status Bar

Configuration Promotion Level Username

Shown only when connected to a pump;Pump model and current software version

Configuration Version Type

Shown only when connected to a pump; pump serial number and IP address:Port; if connected via a serial port, the port number is displayed (for example, COMn where n is the physical port number)

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User’s ManualPharmGuard® Toolbox 2Opening a Serial Port (Medfusion® Model 3500 pump V6)

• Select Pump > Connect....

• In the Connect window, click the radial button to select Serial Port.

• Select the serial port; if necessary, click the drop down button to select the port to open.

• Click OK to connect or Cancel to exit the window.

• The Wait (W) icon appears as the connection to the pump is attempted. If successful, the Wait (W) icon disappears and the pump information is displayed in the lower right of the Status Bar (see previous page).

CAUTION: PharmGuard® Toolbox 2 has been tested with one brand of USB-serial port adapter, the Edgeport family of adapters made by I/O Networks, now part of Digi International. The Edgeport family does not use long names (long names my cause connection problems with PharmGuard Toolbox 2). If a USB-serial adapter is required, it is strongly recommended that only the Edgeport adapters be used. These have proven to be reliable adapters with industrial quality software drivers.

Opening a Network Connection (Medfusion® Model 4000 pump)Usability: Before connection is possible, first enter the pump’s Biomed menu and enable it for external commands. Not all users will have access to these functions.

• Select Pump > Connect….

• In the Connect window, verify Network Device is selected, and enter the Host or IP Address of the pump, and enter the specific Pump Serial Number.

• Click OK to open the connection or Cancel to exit the window.

• The Wait (W) icon appears as the connection to the pump is attempted. If successful, the Wait (W) icon disappears and the pump information is displayed in the lower right of the Status Bar (see previous page).

Usability: Depending on how the pump was configured, the IP address of the pump may be assigned by the network for each session, and therefore may change at each connection.

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Disconnecting From a PumpAfter you finish using PharmGuard® Toolbox 2 or pump communication is no longer needed, close the connection.

Closing a Connection• Select Pump > Disconnect to close the connection.

Refresh Pump InformationTo verify the presence of an infusion pump and update the Pump model panel (far right panel in the Status bar), Refresh the communication link using the Refresh operation.

• Select Pump > Refresh to refresh pump information.

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Create Package... (Medfusion® Model 4000 pump)If your facility uses the PharmGuard® Server, custom Configurations may be saved using the “Create Package...” feature and deployed via the PharmGuard® Server to all pumps on the network that are configured for PharmGuard® Server.

WARNING: Once the package is deployed via the PharmGuard® Server, there is no way to recall it. Always verify and validate the Configuration on single pumps prior to sending it to the PharmGuard® Server.

Create Package... creates a data package of the custom Configuration, which is then saved to the network. In the PharmGuard® Server interface, navigate to the saved package’s location and select it for deployment. The Configuration is then deployed to all pumps on the network via the PharmGuard® Server (see the User Manual supplied with the PharmGuard® Server).

In order to use Create Package..., first promote the Configuration to the Teachable level (see page 38).

• Open the validated custom Configuration.

• Verify the Configuration promotion level is Teachable.

• Choose File > Create Package....

• The default is to save the package (*.cpkg file) to the last folder accessed by the application. If you would like to save it to another location on the network, click the drop-down button in the “Save in” window, and navigate to the desired location.

Usability: The package must be saved to a location on the network where the PharmGuard® Server will be able to access it.

• Click Save.

The PharmGuard® Server interface is then used to deploy the package to all pumps configured for PharmGuard® Server (see the User Manual supplied with the PharmGuard® Server for specific information). The package is stored in the pump’s System Update Status in the Biomed menu until installed.

Note: The “package” is an encoded file containing the settings and programming created in the custom Configuration, and that the pump will use. It cannot be viewed or edited (only the original Configuration that was used to create the package can be viewed or edited).

See the Medfusion® Model 4000 pump Technical Service and/or Operator’s Manual for instructions on installing the new Configuration on the pump.

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Teaching and Learning DataTeaching is the process of sending (or downloading) bulk data to compatible pumps. PharmGuard® Toolbox 2 Configurations are the only data types that can be taught to pumps. Conversely, Learning is the process of receiving (or uploading) bulk data from compatible infusion pumps. All PharmGuard® Toolbox 2 data types (Configuration, PharmGuard™ Safety Data and History Data) can be learned from infusion pumps.

Note (Medfusion® Model 4000 pump only): Rarely, transient network issues may occur that interrupt communication with pumps, particularly when teaching or learning very large Configurations. When this happens, PharmGuard® Toolbox 2 may close the connection to the pump and display an error message. If this occurs, reconnect to the pump (Pump > Connect); it may also be necessary to turn the pump off, then turn the pump back on and “Enable External Com” again before attempting to reconnect.

Teaching DataPharmGuard® Toolbox 2 can teach Configurations to compatible pumps. To access the Teach operations, a connection must be opened, using the steps described in “Communicating with a Pump”, and the Configuration must be at the Teachable Promotion Level.

• Refer to “PharmGuard® Toolbox 2 Data” (page 5) for information about PharmGuard® Toolbox 2 Configurations and pump compatibility.

• Refer to “Record (Configuration) Promotion” (page 38) for information about record promotion.

While teaching, PharmGuard® Toolbox 2 will display a unique four-character alphanumeric code (CRC code) associated with the Configuration. This value will also be displayed by the pump during power up (CONFIG CRC) and can be used to assure the pump has the correct Configuration.

• Make sure the pump is powered on and the connection (see page 17) to the pump is open.

• Open the PharmGuard® Toolbox 2 Configuration to be Taught.

• Verify the Configuration is at the Teachable Promotion Level. If not, promote it to Teachable Promotion Level. Please refer to the Record (Configuration) Promotion section for information about promotion levels.

• Select Pump > Teach Configuration.

• Medfusion® Model 4000 pump: The Configuration is then sent to the pump (but not installed). Once a new Configuration has been taught to a pump, either start the install process through the pump’s System Update Status feature in the Biomed menu, or press ë to turn the pump off (which activates the System Update process).

• Medfusion® Model 3500 pump V6: The Configuration is installed immediately on being sent to the pump. Press ë to turn the pump off then back on finalize the process.

Usability: Some action may need to be performed through the pump’s interface. Simply follow the directions presented on the pump interface.

Learning DataPharmGuard® Toolbox 2 can learn Configuration, PharmGuard™ Data, and History Data from compatible infusion pumps. Refer to “PharmGuard® Toolbox 2 Data” (page 5) for information about PharmGuard® Toolbox 2 data types and pump compatibility.

• Make sure the pump is powered on and the connection (see page 17) to the pump is open.

• Select Pump > Learn, then select the option corresponding to the type of data to be learned.

Usability: When the Learn process is started, a window corresponding to the PharmGuard® Toolbox 2 data type being Learned will be displayed. If the Learn process is successful, the new window will update to display the learned data. If Learn is not successful, a Failure window will be displayed.

Note: When Configuration Data is Learned from a pump, Drug Alert names default to “DrugAlertX”, where “X” is a number, regardless of what the original Drug Alert name was in the Configuration that was sent to the pump during the Teach process. This is because of the way the pump handles certain functions such as Drug Alerts (they are associated specifically with individual Drug Programs, not as named items in their own right), as well as certain Drug Program mapping functions. Because of this, a learned Configuration from a pump is automatically assigned to the “Learned” promotion level, which can only be viewed (but not changed), and changing the promotion level or sending the Configuration to a pump will not be allowed.

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Device SetupDevice Setup provides the ability to set a single pump’s preventative maintenance date and internal clock. The pump’s clock can also be set to a specific time zone and to adjust automatically for Daylight Saving time.

Device setup must be performed on the Medfusion® Model 3500 pump V6. However, since the Medfusion® Model 4000 pump can communicate directly with a network, and thus synchronize the internal clock with network time, it is an optional feature and is not required to be set.

When Device Setup is selected, PharmGuard® Toolbox 2 reads the current information carried by the pump. The dialog window displays the Next Preventative Maintenance date as carried by the pump, plus one year (365 days), labeled as Preventative Maintenance date in the Syringe Pump Setup window.

CAUTION: When utilizing the Device Setup Dialog, teaching the initially displayed date to the pump will set the pump’s Next Preventative Maintenance Date forward by one year (365 days).

Setting Up a Device• Select Pump >Device Setup....

• Medfusion® Model 3500 pump V6 only: The pump serial number is displayed. If a V6 Software Update was performed on the pump, the serial number space will be blank. If this is the case, enter the pump serial number (shown on a label on the bottom of the pump).

• Enter a Preventative maintenance date in the space provided or choose a date from the calendar by clicking the drop-down button .

• Select the check box next to “Set pump’s internal clock on teach” to have PharmGuard® Toolbox 2 automatically set the pump’s internal clock when Teaching. The time is calculated from the local time of the computer plus the time zone setting specified in the setup window (see the next bullet).

• Click the drop-down button and select a time zone from the list.

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User’s ManualPharmGuard® Toolbox 2• Select the check box next to “Adjust for daylight saving

time” to allow the pump to automatically adjust for daylight saving time.

• Specify when daylight saving begins.

• Specify when daylight saving ends.

• Specify the time when the clocks switch.

• Specify the magnitude of the time change. • Click Teach to send this data to the connected pump

or Close to exit the window.

• Clicking Teach will present a Yes/No confirmation window. Upon clicking Yes, there is no further confirmation of completion presented. The pump display does not change to confirm Teach completion, and the Device Setup window remains open.

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Importing SyringesEach manufactured syringe has unique characteristics. These characteristics differ by manufacturer, and syringe model and size. The Medfusion® pumps use the specific characteristics to accurately deliver fluid.

Medfusion™ Standard Syringes Series 2 and PharmGuard™ Supported Syringes (PSS) Series 2 are accessory products that allow importing syringes into the PharmGuard® Toolbox 2 database for use in Drug Programs within an active Configuration. They are custom files that define the characteristics of syringes. Syringe files are developed by Smiths Medical for selected syringe models and sizes. Before a Configuration data record can be created or opened, first import one or more Medfusion™ Standard Syringe Series 2 or PharmGuard™ Supported Syringes (PSS) Series 2 files into the database. A variety of files are available for use; contact Smiths Medical for a complete list of available syringes.

Once imported, open or create a Configuration data record, and select which syringes to use in a Configuration. Within that Configuration, also select which syringes to associate with one or more Profiles and Drug Programs.

Read the Instructions for Use supplied with the Medfusion™ Standard Syringes Series 2 or PharmGuard™ Supported Syringes (PSS) Series 2 for important information.

25


When opening PharmGuard® Toolbox 2 for the first timeThe first time PharmGuard® Toolbox 2 is opened, the application will recognize that currently no syringe files are available, and will display a message:

User accounts with editing rights:

• Click Yes to begin the syringe import process (see importing, on the following page), or click No (clicking No will allow PharmGuard® Toolbox 2 to open, however you will not be able to open or create a Configuration until at least one syringe has been imported).

User account without editing rights:

• Click OK and contact the Administrator for assistance in importing syringes.

26


ImportingNote: When importing syringes, all other users must be logged out of PharmGuard® Toolbox 2 to prevent any conflicts with the import process.

• If necessary, select File > Import Syringe File….

• From the Select syringe file to import window, navigate to the disk location of the syringe file to be imported.

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User’s ManualPharmGuard® Toolbox 2• Click Open; if the import is successful, a Syringe

Import Report is displayed, with a list of syringes imported to the database, as well as the version (shown in parentheses). Click OK.

• If there is a problem with the file, PharmGuard® Toolbox 2 will display an error message such as the following:

Contact the Administrator for help in identifying why the import failed. Once successfully imported, the syringes will be displayed in the Selected Syringes list, and in the Available Models list on the Syringe Management tab of a Configuration data record.

28


Usability: If the PharmGuard® Toolbox 2 configuration database is stored on a shared network drive, the Medfusion™ Standard Syringes Series 2 or PSS Series 2 file(s) will only need to be imported into it once and will then be available to everyone accessing the database. However, if individual copies of the database are on separate computers, the files will need to be imported onto each of those computers for the syringe files to be available on them.

29


Working with Records and Legacy FilesPharmGuard® Toolbox 2 uses a database for storing and managing data. Because of this, information is stored and referred to as Records, rather than files. This manual differentiates these two labels, even though in the Windows® methodology there will still be some crossover of naming conventions.

Legacy refers to Configurations or files that were created in PharmGuard® Toolbox versions prior to this release (Version 1.5 and lower). PharmGuard® Toolbox 2 works with Configuration Data (extension *.medcfg) files, which may be imported to the database as records.

Refer to the following sections for more information.

Note: First import one or more Medfusion™ Standard Syringes Series 2 and/or PharmGuard™ Supported Syringes (PSS) Series 2 before attempting to create or open a Configuration data record. If the database does not have imported syringes available, an error message will display and you will not be allowed to create/open a record.

Creating a New Configuration Data RecordThrough PharmGuard® Toolbox 2, Configuration Data for the supported pump versions can be created. Configuration Data can be validated and securely deployed to pumps.

• Use one of the following methods to create a new Configuration data record:

- Select File > New....- Press Ctrl+N.

- Click the New Configuration button.

A new Configuration automatically opens to the Syringe Management tab.

Usability: The Configuration will initially be created with no name. Save the Configuration manually to set its name.

When the new Configuration Record is initially saved, relevant information can be entered into a Comment field. This is a one-time entry that is attached to the record and cannot be re-entered or edited after saving the record.

30


Opening an Existing Configuration Data RecordUse one of the following methods to open an existing Configuration Data Record:

• Select File > Open Configuration.

• Click the Open Configuration button.

When the Select Configuration From Database window opens, select an existing Configuration. A variety of information attached to the Configuration also displays in the window. To be able to edit the Configuration once it’s opened, click Edit. To be able to view (but not change) the Configuration, click View.

31


Opening a Legacy ConfigurationThere are two methods for importing a legacy Configuration into the database.

From ‘Select Configuration’ window

• Click File > Open Configuration and then click the Import From File button at the bottom of the Select Configuration From Database window.

• Select a legacy Configuration from the local disk/network. Only files with *.medcfg extension will be displayed and selectable.

• The imported legacy Configuration now appears in the ‘Select a configuration to open’ list, and can be opened to view or edit.

From ‘File’ menu

• Click File > Import Configuration....

• Select a legacy Configuration from the local disk/network (see above). Only files with *.medcfg extension will be displayed and selectable.

• When the import is complete a success message is displayed. To open the imported Configuration for editing, click Edit; to view the imported Configuration (with no editing), click View; or click Close to close the message without opening the imported Configuration.

Usability: You must use the methods described above to open or import a Configuration in PharmGuard® Toolbox 2. Previous versions (V1.5 and lower) of PharmGuard® Toolbox allowed opening/importing Configurations directly from a Windows® Explorer panel by double-clicking the file, however this method is disabled in PharmGuard® Toolbox 2.

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User’s ManualPharmGuard® Toolbox 2Note: If an attempt is made to import a Configuration that contains syringes that are not imported and available in the PharmGuard® Toolbox 2 application, the import will fail. The syringes must be imported before attempting to open the Configuration (see page 45). Additionally, if the Configuration being imported contains obsolete syringes, the application will display a warning, then allow removal or replacement of the obsolete syringes during the conversion process (however the import will not be prevented).

Renaming a Configuration Use the following method to rename a Configuration record.

• Select Configuration > Rename Configuration.

• (The OK button is inactive until a new name is typed). Type in the new name, then click OK or click Cancel to exit the window.

33


Opening History DataPharmGuard™ Safety Data records and History Data records are combined in the database and accessed under the History name.

To open History records stored in the database:

• Select File > Open History. A History window displays, containing History records that are stored in the database, based on download date and pump ID.

• Select or filter records by Date Range and/or Pump, as well as by the type of history you want to review:

• Version: Select the check box, then click the drop-down button to choose either the 3500 V6 or 4000 V1 (or leave at (Any) to view history for all pump models).

• Pump: Select the check box, then click the drop-down button to choose a specific pump (or leave at (Any) to view history for all pumps listed).

• Date Range: There are two date entry boxes, On or after and On or before. Both boxes are activated by the check box and allow direct entry, or click the drop-down button

to open a calendar view.

Selecting the same date in each will produce only results for that date.

• Select the check box for any specific information to filter. The default is all selected. Click the check box again to deselect an item.

If no pump is entered or the check box is left blank, then records for all pumps within the date range are displayed.

• After selecting criteria, click Apply Filter.

Refer to “History Data” (page 83) for more information.

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User’s ManualPharmGuard® Toolbox 2Closing a Record

When a record or Configuration is no longer needed, always close it. PharmGuard® Toolbox 2 enables closing individually or all at once. Use one of the following three methods:

• Select File > Close to close the active window.

• Click the Close button located in the caption bar of the active window.

• Select Window > Close All to close all open windows.

Usability: No matter the method used to close, if a record has been changed, as indicated by an asterisk (*) in the window’s caption bar, you will be prompted to save it.

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User’s ManualPharmGuard® Toolbox 2Saving a RecordA record that has been altered but not yet saved, or that is newly downloaded but not yet saved, is considered Contaminated.

A learned Configuration is read-only, and cannot be changed to any other promotion level.

• Select File > Save or click the Save File button. These options will only be enabled when the record is in contaminated state.

• If a Record has not yet been named, the database Save As window will open. All Configuration records are saved to database.

• Click Save to complete the action or Cancel to exit the window.

• PharmGuard® Toolbox 2 will check the Concentration field of each Drug Program for completion prior to performing any Save process. If the fields are partially completed or contain values that would cause setup problems with the pump, PharmGuard® Toolbox 2 will reject the Save process, display each incomplete Drug Program and request completion or correction.

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User’s ManualPharmGuard® Toolbox 2Autorecovery of Unsaved RecordsIn the event a user is automatically logged out (due to the Auto Logout option setting) or a computer/network shutdown, a recovery copy is saved and added to the Configuration folder. The name of recovered Configurations will always have “RC” at the end of the name. Use the “Rename Configuration” function to rename an autorecovered record.

Saving a Duplicate Record• From the Save As window, enter the name in the

space provided, then click Save to save the record or click Cancel to exit the window.

• From the Save File window, enter the Configuration name in the space provided.

• Click Save to complete the action or Cancel to exit the window.

WARNING: When saving duplicate Configuration records, the new record will have the same Promotion Level as the source record. For example, if the original record’s Promotion Level is Teachable, the duplicate record will also be Teachable. For this reason, it is recommended to change the Promotion Level to Working to avoid having two Teachable Configurations and the wrong one being sent to pump inadvertently. Refer to “Changing a Record’s Promotion Level” for instructions.

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User’s ManualPharmGuard® Toolbox 2Exporting Configuration RecordsThe Export feature allows saving records as a .bin (Binary Format) file, or a .medcfg (Configuration Data record). An exported Configuration will be necessary in order to “share” the record and allow it to be imported. The .medcfg is needed when importing a Configuration into PharmGuard® Toolbox 2 (a .bin file is used with the “Virtual” Medfusion® pump, a Smiths Medical internal demonstration device).

• With the Configuration open in PharmGuard® Toolbox 2, click File > Export Configuration....

• Choose the type of file to export the record as: .medcfg.

• Specify where to save the exported record (the default is to save it in the database folder). If desired click the drop-down button and navigate to where you want to save the record.

If desired, rename the record.

• Click Save to export the record or click Cancel to exit the window.

Sharing Configuration RecordsIMPORTANT: If the Configuration uses ANY imported syringes, the recipient who you are sending the record to must import those same syringes into PharmGuard® Toolbox 2 BEFORE attempting to import/open the Configuration. Otherwise an error message will display and the Configuration will not import.

Occasionally it may be necessary to share Configuration records electronically. First, export the record as a .medcfg as instructed above. In order for the recipient to be able to open the record, they must first have PharmGuard® Toolbox 2, Version 3 installed on their computer. To email a Configuration record perform the following:

• Open a new email in your standard email program, then click the command to attach a file (it may be either Insert, Attach, etc.)

• Navigate to the folder where the exported record is stored.

• Choose the .medcfg record you want to attach to the email.

• If necessary, attach the .syringe file(s) (for any imported syringes used in the Configuration) to the email.

• After addressing the email, send it.

For the recipient to import the file:

• Instruct them to open the email in their standard email program, then follow the procedure for saving an attachment (it may be to right-click a file and click File > Save As, or some other procedure).

• Navigate to the folder where they want the record to be stored.

• Click Save.

• Repeat for each file.

• In PharmGuard® Toolbox 2, import any Medfusion™ Standard Syringes Series 2 or PharmGuard™ Supported Syringes (PSS) Series 2 as needed for the record. It is necessary to import the syringes before attempting to open the Configuration.

• Follow the instructions for opening an imported Configuration (see page 31).

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Record (Configuration) PromotionAs a way to control which PharmGuard® Toolbox 2 Configuration records can be modified or taught to a pump, PharmGuard® Toolbox 2 implements a Promotion strategy based on four levels of promotion—Working, Teachable, Archived, and Learned.

Working Configuration records can be changed, but cannot be taught to a pump. When a Configu-ration record is created, it is initially assigned a Working Promotion Level.

Teachable Configuration records can be viewed and taught to a pump, but cannot be changed (all settings and pages will be “greyed out”). Con-figuration records at the Teachable Promotion Level should be closely controlled, and never sent to pumps for use on patients until they have been fully validated.

Archived Configuration records can be viewed, but they cannot be modified or taught to pumps. Archived records are considered retired and no longer valid for teaching.

Learned Learned is an assigned promotion level, and cannot be selected or changed. A Configura-tion that is “Learned” from an existing pump is automatically assigned to the Learned Promo-tion level. The Configuration can be viewed, but cannot be modified or taught to pumps.

Only users with the Promotion Security Right are allowed to change the Promotion Level of a Configuration.

Usability: No matter the Promotion Level of the record (except Learned), an authorized user can change the Promotion Level of the Configuration to any level desired. For example, a record marked as Archived can be restored to a Working level for continued use by an organization.

Changing a Record’s Promotion Level• Select File > Promote Configuration....

• At the Promotion Level window, select the desired Promotion Level.

• Click OK to change the record’s Promotion Level or Cancel to exit the window.

Usability: If the Configuration record being Promoted has been modified, you will be prompted to save the record.

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User’s ManualPharmGuard® Toolbox 2Promoting from TeachableWhen a “Teachable” Configuration is promoted to Working, PharmGuard® Toolbox 2 first saves a copy of the Teachable Configuration (with the Configuration Version added to the name) before creating the Working Configuration (the Configuration version number is also incremented).

40


Syringe ManagementThere are limits to the number of syringes that can be selected and used in a Configuration, therefore it is important to manage the syringes in the database. To aid in this management process, a Syringe Management tab is part of PharmGuard® Toolbox 2. In this tab, select which syringes to make available in the Configuration. The selections made on this tab determine which syringes will be included on the Syringe Models tab (part of the Configuration tab) for each of the profiles, and which can be selected for use in a Drug Program.

It is recommended that only those syringes available for use in your facility be selected. The maximum number of syringes that can be selected for use in any Configuration is 255.

41

User’s ManualPharmGuard® Toolbox 2Updating SyringesOccasionally manufacturers make changes to the dimensions of their syringes. In these instances, the changes may affect dimensions that are used in the Medfusion™ Standard Syringes Series 2 and/or PharmGuard™ Supported Syringes (PSS) Series 2 files, and further by the Medfusion® pump when a Configuration is sent to the pump.

If this is the case, Smiths Medical must update the affected syringe files.

When importing these updated files, or when opening a Configuration with a newer version of the files, the software recognizes that a newer version of an already imported syringe is available, and underlines the syringe in the Selected Syringes list.

Right-click the underlined syringe to access the update menu. Click “Update Selected Syringe Data” to update only the syringe that was right-clicked, or click “Update All Syringe Data” to update all of the syringes that have updates available.

Update Selected Syringe DataUpdate All Syringe Data

42


Managing SyringesThe Syringe Management tab consists of three lists; the Available Models, Selected Syringes and Configuration Syringe Models lists.

All imported syringes are displayed in the Selected Syringes list, along with a checkbox next to each syringe model/size. Click the checkbox to select each desired syringe to make it available for use in the Configuration. The Available Models list displays syringe models imported, but not selected for use in the Configuration. The Configuration Syringe Models list dis-plays all syringe models selected for use in the Configuration.

At least one Syringe Model must be selected. These Models can then be specified for use in any of the Profiles created in the Configuration via the Syringe Models tab of the Configuration tab (see page 61) as well as in Drug Programs. The maximum number of syringes that can be selected for a Configuration is 255. In addition, no more than 32 different Syringe Models may be selected and no more than 16 syringes (i.e., different sizes) of a specific model.

Usability: Note that the Selected Syringes list is the only area where the syringe size can be selected for a Profile. On the Configuration > Syringe Models tab, only the brand is shown.

43


Missing Syringes AlertsDeselecting SyringesIf an attempt is made to deselect a syringe that is currently being used in a Drug Program or is one of the Profile Syringe Models in a Profile, an error message is displayed listing each of the Drug Programs and Profiles in which the syringe is used.

The missing syringe is used in a Drug Program and in the Selected Models list (on the Configuration tab) for various Profiles; if you click Replace, the Select Replacement window displays; if you click OK, the syringe will be deleted from the Drug Program(s) and Profile(s), without being replaced.

• To exit the window without deselecting the syringe, click Cancel.

• Clicking OK will not only deselect the syringe specified, but will AUTOMATICALLY DELETE IT FROM THE DRUG PROGRAM(S) AND/OR PROFILE(S) INDICATED IN THE LIST.

Note: Clicking OK will allow deselection of a syringe that may be the only syringe in the Profile Syringe Models list for a Profile (see the Configuration tab). However, every Profile must have at least one syringe in the Profile Syringe Models list, so when attempting to Promote the Configuration, an error message to select at least one Syringe Model will be displayed.

• Click Replace to open the Select Replacement window, where a replacement syringe can be selected.

• In the Select Replacement list, click the replacement syringe for the Drug Program(s) or Profile(s) to use, then click OK (or click Cancel to exit the window without replacing the syringe).

Once the syringe has been replaced, make sure that the replacement model is selected for each of the Profiles (on the Configuration tab) in which it is used (see page 61).

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User’s ManualPharmGuard® Toolbox 2Dragging/Dropping or Copying/Pasting Profiles and Drug ProgramsWhen dragging & dropping or copying & pasting a Profile and/or Drug Program into a Configuration in which the imported syringes have not been added to the Configuration Syringe Models list, the Missing Syringes Alert is also activated, however in this case the only choice is OK.

• Make note of the syringe(s), Profile(s) and Drug Program(s) shown in the alert window.

• Click OK.

• Click the Syringe Management tab and click the check box for the missing syringe(s) to select it/them for use in the Configuration (it/they will be added to the Configuration Syringe Models list).

• Click the Configuration tab, and select the Profile that had a missing syringe; on the Syringe Models tab, add the missing syringe(s) to the Profile Syringe Models list. Repeat for each Profile with missing syringes.

• If necessary, click the Drug Program Library tab and add the syringes to the Drug Program(s).

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User’s ManualPharmGuard® Toolbox 2Import FailedIf importing a legacy Configuration that contains syringes which are not also imported into PharmGuard® Toolbox 2, the import will fail and an alert will display.

Note the missing syringe model, and the Drug Programs and Profiles that contain the missing syringe(s).

There are two methods for remedying the situation:

• Obtain the missing Medfusion™ Standard Syringes Series 2 and/or PharmGuard™ Supported Syringes (PSS) Series 2 file and import the syringes into PharmGuard® Toolbox 2, then import the Configuration.

• If you have a previous version of PharmGuard® Toolbox (Version 2), open the Configuration in that application and make sure that the missing syringe is not in the Selected Models list for any of the Profiles, and is not used in any of the Drug Programs.

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User’s ManualPharmGuard® Toolbox 2List of Syringes Selected in ConfigurationTo view a list of the syringes currently selected in any Configuration:

• From the Syringe Management tab, click View > List Selected Syringes For This Configuration....

• The list displays the total number of syringes selected for use in the Configuration, along with the Model (brand and size).

• Click OK to close the list.

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Configuration WindowThe Configuration window implements the interface through which PharmGuard® Toolbox 2 Configurations are defined, which are then deployed to compatible Medfusion® pumps. This ability makes it possible to customize which features are available for use at the pump and how they are accessed.

PharmGuard® Toolbox 2 Configurations are made up of three distinct elements:

• Pump Configuration Parameters

• Drug Program Library

• Syringe Management

The Configuration Window is divided into three corresponding areas, accessed through the tabs located in the top left-hand corner of the Configuration Window. This division results in the Configuration Window being organized as shown in the conceptual diagram. It shows a single PharmGuard® Toolbox 2 Configuration as managed by the Configuration Window and displayed through the Configuration tab, Drug Program Library tab and Syringe Management tab.

Usability: PharmGuard® Toolbox 2, Version 3 supports Configurations for Medfusion® Model 4000 all software versions, and Medfusion® Model 3500 V6 pump software.

Configuration TabThe Configuration tab has three areas—Common Properties, Profile Properties, and Profiles. The Common Properties area allows customization of global properties. The Profile Properties area is dependent on the Profile selected in the Profiles area. Profiles allow customization of up to sixteen named Profiles and associated Profile Properties that can be recalled at the pump to define a pump’s interface and operational behavior.

Note: Many properties have a default setting of (none). If a value is entered and saved, then later you want to change it back to (none), either completely clear the value (double-click the property and press the PC’s Backspace or Delete key) or enter zero, and the software will automatically change it to (none).

Con�guration Window

Main Window

ConfigurationData File

Configuration Tab

Drug ProgramLibrary Tab

Syringe Management

Tab

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Configuration Tab This is an example of the Configuration tab with multiple profiles:

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Common PropertiesThe Common Properties area contains properties that are global to the Configuration and the pumps for which the Configuration is targeted. Properties are divided into two categories—Configuration and General.

Property DescriptionApproximate Size Read-only property that displays the size of the Configuration as a percentage of available pump memory.

As the Configuration is modified, the value will change to indicate how much memory is being used. The green bar indicates that the Configuration size is 50% or less of allowed size. A yellow bar indicates the Configuration size is 51% to 100% of the allowed size. If the Configuration size exceeds 100%, the yellow bar will turn Red, and setting the Promotion level to Teachable will not be allowed.

Configuration Ver-sion

Tracks when the Configuration is revised and saved. The revision is broken up into three parts:

Example:

The first two digits are the “major revision”. The major revision should be used when a Configuration has had substantial changes. Manually change the major revision by selecting Configuration > Major Version (see instructions on next page). The middle two numbers are the “minor revision”. The minor revision is automatically incremented each time the Configuration promotion level is changed from “Teachable” to Working”, or when the revision (third set of five numbers) exceeds 10000. The third set of five numbers is the revision, and increments automatically each time the Configuration is saved.

Dataset ID Read-only property that displays the Configuration’s Dataset Identification code string. The Dataset Iden-tification code is intended to uniquely identify the Configuration. PharmGuard® Toolbox 2 automatically generates this property when the record’s Promotion Level is changed to Teachable.

Promotion Level Read-only property that displays the record’s current Promotion Level. It can be one or four values—Work-ing, Teachable, Archived or Learned. Refer to “Record (Configuration) Promotion” (page 38) for more information.

Pump Version Read-only property that displays the Configuration version corresponding to the pump versions being targeted.

Date Separator Change the character used for date separator in the pump from dash (“-”) to slash (“/”).

Decimal Separator Change the character used for decimal separator in the pump from period (“.”) to comma (“,”).

Device ID Defines a pump identification string. It is displayed by the pump during start up and can contain a maxi-mum of 15 characters. The default is an empty string.

Hospital Free form string that defines the hospital name. This property is only used when displaying reports. When a new Configuration is created, this field is filled by the name entered in the Default Hospital Name from the General tab (Tools > Options > General tab).

01.00.00001

Major revision

Minor revision

Revision

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Property DescriptionLanguage Defines the pump’s language. Select from additional languages as they become available. English is the

default.

Changing the Major VersionWhen substantial or significant changes are made to a Configuration, its Major Version number can be changed.

• Select Configuration > Major Version....

• The current major version is shown. Click the up-down buttons to change the version number (using this feature, a lower number cannot be selected).

• Click OK to change the Major Version, or Cancel to exit the window.

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ProfilesPump software Configuration Data introduces what are known as Profiles. A Profile is a named collection of Configuration Properties, Categories and Drug Programs that can be recalled at the pump to define a pump’s interface and operational behavior. This allows customizing a pump based on specific care areas and environment. A maximum of sixteen order-dependent Profiles are allowed.

Creating a New Profile• Select Configuration > New Profile to create a new

Profile and add it to the Profiles list. OR

Click the New Profile button, or right-click in the Profiles list and select New in the context menu.

• Upon creation, the new Profile is in naming mode; type the name, and press Enter. Names are limited to between 1 and 20 characters.

Renaming a Profile• Click on the Profile you want to rename in the Profiles

list, then click again to start the inline editing process. OR

Right-click on the name of the Profile you want to rename in the Profiles list and select Rename in the context menu.

• Modify the name and press Enter to save the changes or press Esc to cancel the changes.

Moving a ProfileUse one of these methods to move a selected Profile up or down in the Profiles list:

• Select a Profile in the list and right-click, select the Up or Down option in the context menu to move the Profile up or down in the list.

Or select a Profile in the list and click the Up or Down buttons.

• To list the Profiles alphabetically, click the Ascending Sort button or the Descending Sort button.

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User’s ManualPharmGuard® Toolbox 2Cutting, Copying, and Pasting a ProfileUse cut/paste or copy/paste to cut/copy and paste Profiles within the same Configuration, or between Configurations of the same version type (see page 44 for important information regarding missing imported syringes).

• To place a Profile in the Profiles list on the System clipboard, right-click on the name of Profile and select Cut in the context menu, press Ctrl + X, or click the Cut button.

• To copy a Profile to the System clipboard, right-click and select Copy in the context menu, press Ctrl + C, or click the Copy button.

• To paste a Profile from the System clipboard to a Profiles list, right-click on the Profiles list and select Paste, press Ctrl + V, or click the Paste button.

Dragging and Dropping a ProfileUse Drag & Drop to move Profiles between Configurations of the same version type (see page 44 for important information regarding missing imported syringes).

• Assure that both Configurations are open and the Profiles panels are visible (Hint: Select Window > Tile Horizontal).

• In the Profiles list on the ‘host’ Configuration tab, select the Profile you want to move.

• Press and hold the left mouse button and drag the Profile to the destination Profiles panel.

• Release the mouse button to drop the Profile in the destination Profiles panel. To leave the original Profile in place, move a copy by pressing the Ctrl key while dragging and dropping the Profile.

Note: All Drug Programs, Drug Classifications, Library Mapping, and Profile-specific properties associated with the Profile will also be moved or copied. This procedure is only valid between Configurations of the same pump version.

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General TabThe General tab is specific for a single Profile only. Each Profile created will have an associated range of settings based on the General tab. Use the General tab to customize the settings and properties defined below for each Profile within a Configuration that is sent to a pump. These properties allow you to define various limits imposed by a pump and the general operational behavior of a pump.

Note: Differences in properties available for settings are based on Configuration versions as they relate to specific infusion pump software.

This is an example of the General tab.

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Alarm SetupUse the properties in this section of the General tab to define settings for various alarms at the pump. These property settings will apply to all Drug Programs within the Profile.

Property DescriptionAlarm Loudness Defines the loudness level of a pump’s alarm. Select from five levels—Level 1 (softest), Level 2,

Level 3, Level 4, and Level 5 (loudest). The default is Level 2.

Alarm Silence Time Defines the number of minutes until an alarm will automatically resound after the pump’s Alarm Silence í key is pressed. Alarm Silence Time is a numeric value of either 1 or 2 min-utes. The default is 2 minutes.

Alarm Style Defines the tone style a pump will use when sounding an alarm. Select from three alarm styles, Medfusion™ Defined and International Standard, or Medfusion™ Multi-tone. Medfusion™ Defined is the default.

Near Empty Alarm Priority Defines the priority level at which the pump generates the Syringe Near Empty Alarm. Select from two levels—Low and Medium. The default is Low.

Near Empty Time Defines the number of minutes, prior to a syringe being empty, at which time a Syringe Near Empty Alarm occurs. The range is 0 to 240 minutes. The default is 5 minutes.

Note: Setting this value to zero will disable the Syringe Near Empty Alarm.

Auto PromptsUse the properties in this section of the General tab to enable or disable various automatic prompts at the pump. These property settings will apply to all Drug Programs within the Profile.

Auto Prompts that are enabled will automatically add a step to program the feature as part of each appropriate Drug Program or manual mode on the pump.

Property DescriptionBolus Dose Defines if a pump user will be prompted to enter a Bolus Dose during infusion setup. Select from two val-

ues—Enabled and Disabled. The default is Disabled.

Confirm Setting Defines if a pump user will be prompted to Confirm Infusion Settings when setting up an infusion. Select from two values—Enabled and Disabled. The default is Disabled.

Enter User ID to Program

Defines if a pump user will be prompted to enter their User ID when programming an infusion. Select from two values—Enabled and Disabled. The default is Disabled.

Prompt to Prime Defines if a pump user will be prompted to Prime as a last step in setting up an infusion. Select from two values—Enabled and Disabled. The default is Disabled.

Re-enter Weight Defines if a pump user will be prompted to re-enter a patient’s weight to confirm the setting (provid-ing additional safety for weight-based drug profiles). Select from two values—Enabled and Disabled. The default is Disabled.

Standby Time Defines if a pump user will be prompted to enter a Standby time during infusion setup. Select from two values—Enabled and Disabled. The default is Disabled.

Volume Limit Defines if a pump user will be prompted to enter a Volume Limit during infusion setup. Select from two values—Enabled and Disabled. The default is Disabled.

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FlushUse the properties in this section of the General tab to enable or disable flush features. These property settings will apply to all intermittent-type Drug Programs within the Profile (timed infusions, such as volume over time, dose over time, etc.).

Property DescriptionFlush Defines if the Flush features will be available on the pump. Select from two values—Enabled and

Disabled. The default is Disabled.

If disabled, neither of the settings below (Flush Time or Maximum Flush Volume) can be used.

Flush Time Defines if a pump user will be prompted to enter a flush time on the pump. Select from two values—Enabled and Disabled. The default is Disabled.

Maximum Flush Volume Defines the maximum flush volume (in mL) allowed by the pump. Maximum flush volume is a numeric value in the range of 0 to 60 mL. The default is (none).

General CustomizationUse the properties in this section of the General tab to define various features which will apply to all Drug Programs within the Profile.

Property DescriptionAuto Lock Time Defines the number of seconds the pump will wait before automatically locking the pump’s

interface. Auto Lock Time is a numeric value in the range 0 to 999 seconds. The default is (none).

Notes: • Setting this value to zero (0) or (none) will disable the Auto Lock feature.

• Set an Unlock Passcode when setting the Auto Lock Time. If you do not, the pump will automatically lock but can easily be unlocked from the pump’s interface.

Bolus Change in mL Defines if a pump user can change a Bolus Dose or Loading Dose in mL. Select from two val-ues—Enabled and Disabled. The default is Disabled.

Bolus Time Feature Defines if a pump user will need to enter a time when setting a Bolus Dose in a manual deliv-ery mode. Select from two values—Enabled and Disabled. The default is Enabled.

Bolus Total Dose Defines if a pump user will be allowed to enter a Bolus Dose or Loading Dose as a Total Dose rather than the standard dose/kg in weight based modes. Select from two values—Enabled and Disabled. The default is Disabled. (This feature is not available on Medfusion® Model 4000 V1.0 pumps.)

Enter User ID on Override Defines if the pump will prompt a user to enter a one- to four-digit ID when overriding a Drug Program infusion property. Select from two values—Enabled and Disabled. The default is Disabled.

Key Click Loudness Defines the click loudness level when pressing pump keys. Select from five levels—Off, Level 2, Level 3, Level 4, and Level 5. The default is Level 2.

Note: The audio part of the Limit priority alert is tied to Key click loudness. If key click loud-ness is set to Off, there will be no audible tone accompanying Limit priority alerts (visual alerts will still appear in the display). The volume will otherwise sound at the loudness level selected for key clicks - Level 2 (quietest), Level 3, Level 4, or Level 5 (loudest).

Profile Passcode Allows setting a four-digit passcode which the clinician must enter to access the Profile at the pump. This is a four-digit code in the range of 1000 to 9999. The default is (none).

Program Display Defines if the pump will display the delivered Program Dose (PDD) or the delivered Program Volume (PVD). Select from two values—Volume and Dose. The default is Volume.

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Property DescriptionQuick Library Refer to “Library Mapping” (page 64) for information about Library Categories.

Defines the Library Category that will be used as the Quick Library. Click the Quick Library row, then click on the Browse button (which will appear to the right of the row). Clicking this button opens the Library Category Selection window, which allows selecting a Library Category to use as the Quick Library. Click the check box to select a Category as the Quick Library; click the check box again to deselect the Category. The default is (none).

Note: If a Library Category is selected as the Quick Library the Library Category will be re-moved from the Available Modes list or the Selected Modes list respectively (on the Delivery Modes tab). The Library Category will be added back to the Available Modes list if the Quick Library property is cleared.

Support 1 mL Syringe Defines if 1 mL syringe support is enabled, allowing the use of 1 mL syringes on the pump. Additionally, some 1 mL syringe external diameters are the same as 3 mL syringes, and if this option is enabled (and both syringes are selected in the Profile Syringe Models List) the user will be prompted to select either the 1 mL or 3 mL during the loading process. Select from two values—Enabled and Disabled. The default is Enabled.

Unlock Passcode Defines the passcode that must be entered at a pump to unlock its interface. Unlock Passcodes can be any four-digit numeric code in the range 1000 to 9999. The default is (none), meaning the Unlock Passcode is not used. To clear the Unlock Passcode, simply delete the contents of this property.

LimitsUse the properties in this section of the General tab to define limits which will apply to all Drug Programs within the Profile.

Property DescriptionMaximum Body Surface Area Defines the maximum allowed value for the Body Surface Area infusion parameter. Maximum

Body Surface Area is a numeric value in the range 0.01 to 4 m2. The default is 4 m2.

Maximum Bolus Rate Defines the maximum bolus infusion rate allowed by the pump. Select from three rates: Syringe Size × 5 mL/hr (example: 5 mL syringe × 5 mL/hr = 25 mL/hr maximum bolus rate), Sy-ringe Size × 10 mL/hr (example: 5 mL syringe × 10 mL/hr = 50 mL/hr maximum bolus rate), or Syringe Size Max mL/hr (see the flow rate table in the Medfusion™ Standard Syringes Series 2 and/or PharmGuard™ Supported Syringes (PSS) Series 2 Instructions for Use). The default is Syringe Size × 10 mL/hr.

Maximum Flow Rate Defines the maximum flow rate allowed by the pump. Maximum Flow Rate is a numeric value in the range 0.1 to 1130 mL/hr, and is dependent on the syringe size being used. The default rate is 1130 mL/hr.

Maximum Patient Weight Defines the maximum allowed value for the Patient Weight infusion parameter. Maximum Patient Weight is a numeric value in the range 0.25 to 250 kg. The default is 250 kg.

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Occlusion DetectionUse the properties in this section of the General tab to customize the occlusion sensing features available at the pump. These property settings will apply to all Drug Programs within the Profile.

Property DescriptionFlowSentry™ Defines if the FlowSentry™ pressure monitor (for rapid occlusion detection) feature is enabled.

Select from two values—Enabled and Disabled. The default is Enabled.

FlowSentry™ Sensitivity Defines the sensitivity of the FlowSentry™ pressure monitor algorithm during normal infusion. Select from four values—Low - least sensitive, Normal, High, and Very High - most sensitive. The default is Normal.

Flow Sentry™ Startup Sensitivity

Defines the sensitivity of the FlowSentry™ pressure monitor algorithm during infusion startup. Select from four values—Low - least sensitive, Normal, High, and Very High - most sensitive. The default is Normal.

Occlusion Limit Defines the pressure at which the pump will consider the line occluded. Select from four lim-its—Very Low (Approx. 4 psi, 206.9 mmHg), Low (Approx. 8 psi, 413.7 mmHg), Normal (Approx. 12 psi, 620.6 mmHg), and High (Approx. 16 psi, 827.4 mmHg). The default is Normal (Approx. 12 psi, 620.6 mmHg). (When using 1 mL syringes, the occlusion limit is fixed at Very High (Approx. 50 psi, 2585 mmHg) and cannot be changed.)

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Selecting a Quick LibraryA quick library allows the selected drug programs to appear on the screen directly after the Profile is selected. If all the required drug program properties are entered and the correct syringe is loaded on the pump, the pump user will receive a prompt to start the infusion directly after selecting the drug, without having to program any parameters.

To select a Quick Library, on the General tab click the Quick Library row (in the General Customization section), then click the Browse button to the right of the right column. A Library Categories window opens where one Library Category can be selected for use as the Quick Library. To deselect the selected Library Category, remove the check mark from the check box.

Only one Quick Library can be selected per Profile.

Note: Library Categories must be created before trying to select a Quick Library. If no Library Categories are present, an error message is displayed when the Browse button is clicked.

Usability:

• When a Library Category is selected, the name of the Library Category will display as a pump soft key and the key is limited to a maximum of thirteen characters. Therefore, if the Library Category selected has a name greater than thirteen characters it will have to be shortened in order to use it as the Quick Library.

• In order for the Quick Library to function properly on the pump, specific values (concentration, dose, etc.) must be entered in the Main section of the Drug Program (see page 66)

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Delivery Modes TabOn the Delivery Modes tab, select the Manual Delivery Modes and Library Categories that will be available to pump users and customize the layout of the selected Delivery Modes. The Selected Modes list is what will be shown in the pump menu for the selected Profile once the Configuration is sent to a pump. Manual Delivery Modes are infusion types not associated with any particular drug, and can be selected and programmed completely on the pump; Library Categories contain Drug Programs with specific setup information (based on the drug) contained in the setup screens in the pump. Use the two lists—Available Modes and Selected Modes. Delivery Modes selections are valid only for the Profile in which they are listed; each new Profile created within a Configuration will have its own Delivery Modes selection opportunities.

• The Available Modes list contains the available Manual Delivery Modes and Library Categories not selected in the Selected Modes list.

• The Selected Modes list contains the Manual Delivery Modes and Library Categories selected for use at a pump. It also allows customizing the order in which the selected Delivery Modes are listed by a pump.

• A Category must be created in the Library Mapping tab (see page 65). Once created, the Category is automatically added to the bottom of the Selected Modes list under the Delivery Modes tab.

Working with Delivery Modes ListsTo work with the Delivery Modes lists, follow the steps below:

• To add a Delivery Mode to the Selected Modes list, select the desired Mode from the Available Modes list and click the Add button or double-click the item in the Available Modes list.

• To add all Delivery Modes to the Selected Modes list, click the Add All button.

• To remove a Delivery Mode from the Selected Modes list, select the Mode you wish to remove and click the Remove button or double-click the item in the Selected Modes list.

• To remove all Delivery Modes from the Selected Modes list, click the Remove All button.

• To change the ordering of a Delivery Mode, select the Mode you wish to move in the Selected Modes list and then click the Up or Down button to move the Mode up or down in the list.

• To order the selected Delivery Modes alphabetically, click the Ascending or Descending button.

Note: Library Categories are automatically added to the bottom of the Selected Modes list under the Delivery Modes tab when created under the Library Mapping tab. Conversely, they are removed from the Delivery Modes tab when deleted under the Library Mapping tab. If a Library Category is selected as the Quick Library the Library Category will be removed from the Available Modes list or the Selected Modes list respectively. The Library Category will be added back to the Available Modes list if the Quick Library property is cleared.

Usability: The Medfusion® pump Main Menu displays up to eight Delivery Modes (or Categories) on a screen, divided into two columns with a maximum of four lines each. One Page Break can be inserted at any point from two through eight if less than eight entries on one of the Main Menu screens is preferred. If more than eight Delivery Modes are selected, the pump user will have to advance to the next page using the More soft key (it is recommended to place the Categories within the first eight entries and use the page break to separate Categories from Manual Delivery Modes).

Note: The Profile Settings and Biomed modes cannot be removed from the Selected Modes list.

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Infusion Units TabOn the Infusion Units tab, select the Concentration Units and Delivery Units available to pump users for dosing Infusion Types within Manual Delivery Modes. This is done using two lists—Infusion Type and Concentration Units. The Infusion Type list displays the Infusion Types with custom unit selection capability. When an Infusion Type is selected, the Units list check boxes will update to reflect the settings. Enable and disable Concentration/Delivery unit combinations by checking the check box next to the respective combination. All Infusion Types default to Enabled for all unit combinations.

Usability: Selections made on this tab only apply to the Manual Delivery Modes and will not affect the Drug Programs developed in the Drug Program Library.

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Syringe Models TabOn the Syringe Models tab, select the Syringe Models that will be available to pump users within a specific Profile and customize the layout of the selected Syringe Models. This is done using two lists—Configuration Syringe Models and Profile Syringe Models.

• The Configuration Syringe Models list contains all of the syringes moved to the list on the Syringe Management tab (see page 40), minus those moved to the Profile Syringe Models list.

• The Profile Syringe Models list contains the syringes (moved from the Configuration Syringe Models list) selected for use in the Profile. The Profile Syringe Models list for each Profile must include at least one syringe model.

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User’s ManualPharmGuard® Toolbox 2Working with the Profile Syringe Models ListFollow these steps to work with the Profile Syringe Models list:

• To add a syringe to the Profile Syringe Models list, select the desired Model from the Configuration Syringe Models list and click on the Add button or double-click the item in the list.

• To remove a syringe from the Profile Syringe Models list (returning it to the Configuration Syringe Models list), select the Model you wish to remove and click on the Remove button or double-click the item.

• To change the ordering of a Syringe Model, select the Model you wish to move in the Profile Syringe list and then click the Up or Down button to move the Model up or down the list, respectively.

• To order the selected Syringe Models alphabetically, click the Ascending or Descending button.

Usability: The Medfusion® pump Main Menu displays up to eight Syringe Models on a screen, divided into two columns with a maximum of four lines each. If more than eight syringes are selected, the pump user will have to advance to the next page using the More soft key.

Note: Syringe Models may be selected in a Drug Program that are not included in the Selected Models list for the Profile. This is due to the fact that when customizing Drug Programs, all of the syringes selected for use in the Configuration on the Syringe Management tab are included in the list of syringes (since Drug Programs may be included in more than one Profile). In this case, the selected syringe file will be sent to the pump along with the Configuration, however it will only appear in the specific Category in which the Drug Program(s) appear. These types of syringe selections will count against the maximum number of syringes that can be used in a Configuration.

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Program Options TabOn the Program Options tab, select the Program Options that will be available to pump users and customize the layout of the selected Program Options. This is done using two lists—Available Options and Selected Options.

• The Available Options list contains the available Program Options not selected in the Selected Options list.

• The Selected Options list contains the Program Options selected for use at a pump. It also allows customizing the order in which the selected Program Options are listed on a pump.

Working with Program Options ListsFollow these steps to work with the Program Options lists:

• To add a Program Option to the Selected Options list, select the desired Option from the Available Options list and click on the Add button or double-click the item in the Available Options list.

• To add all Program Options to the Selected Options list, click on the Add All button.

• To remove a Program Option from the Selected Options list, select the Option you wish to remove and click on the Remove button or double-click the item in the Selected Options list.

• To remove all Program Options from the Selected Options list, click on the Remove All button.

• To change the ordering of a Program Option, select the Option you wish to move in the Selected Options list and then click on the Up or Down button to move the Option up or down the list, respectively.

• To order the selected Program Options alphabetically, click the Ascending or Descending button.

Usability: The Medfusion® pump Main Menu displays up to eight Program Options on a screen, divided into two columns with a maximum of four lines each. If more than eight Options are selected, the user must advance to the next page using the More softkey.

Note: For descriptions of the various Program Options, and how they can be used in an infusion, see the Options section of the Operator’s Manual supplied with the Medfusion® pump.

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Library Mapping TabOn the Library Mapping tab, create Library Categories that are selectable under the Delivery Modes tab and linked to Drug Programs. Drug Programs are defined under the Drug Program Library tab and assigned to Drug Classifications under that tab. When a Configuration is sent to a pump, Library Categories are selectable under the Profiles in a pump’s Main Menu, and the Drug Programs linked to the Library Category will be listed when the respective Library Category is selected.

Use the four lists to map a Library to the Library Mapping tab:

• Library Categories

• Drug Classifications

• Available Drug Programs

• Selected Drug Programs

In the Library Categories list, create, rename and delete Library Categories. When a Library Category in the Library Categories list is selected, the Drug Classifications list will be populated with all Drug Classifications defined under the Drug Program Library tab. When one or more Drug Classifications are selected (by checking the box), Drug Programs associated with the selected Drug Classifications will appear in the Available Drug Programs list (minus those moved to the Selected Drug Programs list). The Selected Drug Programs list contains the Drug Programs linked to the selected Library Category. The Selected Drug Programs list also allows customizing the order in which the selected Drug Programs are listed in the pump menu.

Usability: The Medfusion® pump Main Menu displays up to four Drug Programs on a screen. If more than four Drug Programs are selected, the user will have to advance to the next page using the More soft key.

65

User’s ManualPharmGuard® Toolbox 2Working with Library Mapping ListsFollow these steps to work with the Library Mapping lists:

• To create a Library Category, click the New Library Category button located at the top of the Library Categories list or right-click inside the listing panel and select New. Up to eight categories per Profile can be created. Category names may be from 1 to 20 characters in length.

• To delete a Library Category, select the Library Category and click the Delete Library Category button located at the top of the Library Categories list or right-click on the respective Library Category and select Delete.

• To rename a Library Category, click on the Library Category then click again to start the edit process or right-click the respective Library Category, and select Rename. Note that Library Category names must be unique and can contain a maximum of 20 characters (the Quick Library can contain a maximum of 13 characters).

Usability: The creation of a new Library Category in Library Mapping will automatically place that Category in the Selected Modes list under the Delivery Modes tab. You will still need to move Drug Programs to the Selected Drug Programs panel during the Library Mapping process. After creating the Category, navigate to the Delivery Modes tab to arrange Categories on the Selected Modes list.

The Medfusion® pump Main Menu displays up to four Drug Programs on a screen. If more than four Drug Programs are selected, the user will have to advance to the next page using the More soft key.

In the Library Mapping tab, each Drug Program’s Display Text is displayed in the available or selected lists. To see a Drug Program’s full name, hover the mouse over the respective Drug Program for a few seconds.

• To add a Drug Program to the Selected Drug Programs list, select the desired Drug Program from the Available Drug Programs list and click on the Add

button or double-click the item in the Available Drug Programs list.

• To add all Drug Programs to the Selected Drug Programs list, click on the Add All button.

• To remove a Drug Program from the Selected Drug Programs list, select the Drug Program you wish to remove and click the Remove button or double-click the item in the Selected Drug Programs list

• To change the ordering of a Drug Program, select the Drug Program you wish to move in the Selected Drug Programs list and then click on the Up or Down button to move the Drug Program up or down the list, respectively.

• To order the selected Drug Programs alphabetically, click the Ascending or Descending button.

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Drug Program Library TabThe Drug Program Library tab is comprised of three areas—Library Explorer, Drug Programs, and Drug Program Properties.

Follow this basic procedure for preparing Drug Programs to be mapped:

• Create a new Drug Classification and name it.

• Create a new Drug Program and name it.

• Define the properties and characteristics of the new Program in the Drug Program Properties panel.

• Assign the Program to at least one Drug Classification. A Drug Program may be associated with more than one Drug Classification. Drug Programs that are created but not specifically assigned to Classifications cannot be mapped.

• Create and define Drug Alerts as necessary, and assign Alert(s) to Drug Programs.

• In Library Explorer, selectively list Drug Programs in the Drug Programs area by checking one or more Drug Classification(s), list Drug Programs using an Index string and list Drug Programs using a Search string.

• In the Drug Programs area, select one or more Drug Programs to customize in the Drug Program Properties area.

• If more than one Drug Program is selected, the properties available to customize are limited to Syringe Model and Drug Classification. All other properties must be individually customized by selecting a single program.


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Library ExplorerThe Library Explorer implements three tabs that allow selecting the Drug Classification through which Drug Programs will be listed in the Drug Programs area:

• Under the Drug Classifications tab, select to list only those Drug Programs that are members of the checked Drug Classification(s) or all Drug Programs, by checking the All Drug Classifications option.

• Under the Index tab, list Drug Programs by entering characters in the space provided. As characters to Look for are entered, the Drug Programs area will up-date to display the matching Drug Programs. Limit the search by checking Drug Classifications. Only Drug Programs that are members of the checked Drug Clas-sifications will be searched.

• Under the Search tab, perform advanced searches based on a word or phrase entered in the space provided. Further restrict the search to Match case and Match whole word.

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Working with Drug ClassificationsPharmGuard® Toolbox 2 uses Drug Classifications to organize Drug Programs in the Drug Program Library and to list programs under the Library Mapping tab. View and work with Drug Classifications through the corresponding Library Explorer tab. A Drug Program must have at least one Classification to appear on the Library Mapping tab.

Note: Drug Classifications only appear in PharmGuard® Toolbox 2, they do not appear on the pump.

Creating a Drug Classification • To add a new Drug Classification, select Library

> New Drug Classification or click the Add New Library Item button and select the Drug Classification option.

Naming and Renaming a Drug Classification• When creating a new Drug Classification, it is already

in Naming mode. Enter the name of the new Drug Classification. The naming field is unlimited, however if a name is too long it will be truncated as part of the library mapping process.

• To rename a drug classification, click on the Drug Classification in the Drug Classifications list, then click it again to start the inline edit process.

Optionally, right-click on the Drug Classification and select the Rename option to start the inline edit process.

• Press Enter to save changes or Esc to cancel the rename operation.

Removing a Drug Classification• Select the Drug Classification you want to remove in

the Library Explorer.

• Press Delete or right-click and select Delete in the context menu to permanently remove the Drug Classification.

CAUTION: If a Drug Classification is deleted, the operation cannot be reversed. In addition, all Drug Programs to which it has been assigned will lose that association.

Cutting/Copying/Pasting a Drug Classification• Select the Drug Classifications you want to cut or copy

to the System clipboard in the Library Explorer.

• To move a Drug Classification to the System clipboard use one of the following methods:

- Right-click and select the Cut option from the context menu.

- Click the Cut button.

- Press Ctrl + X.

• To copy a Drug Classification to the System clipboard use one of the following methods:

- Right-click and select Copy from the context menu.

- Click the Copy button.

- Press Ctrl + C.• To paste a Drug Classification from the System

clipboard use one of the following methods:

- Right-click in the Library Explorer and select Paste from the context menu.

- Click the Paste button.

- Press Ctrl + V.

Dragging/Dropping a Drug ClassificationUse Drag & Drop to move Classifications between Configurations.

Note: Using Drag/Drop will always result in the Classification being removed from the original (or “host”) Configuration for placement in the “Destination” Configuration. Use Copy/Paste to maintain the Classification in both Configurations.

• Assure that both Configurations are open and the Drug Program Libraries are visible (Hint: Select Window > Tile Horizontal).

• In the ‘host’ Library Explorer, select the Drug Classification you want to move.

• Press and hold the left mouse button and drag the Drug Classification to the destination Library Explorer.

• Release the mouse button to drop the Drug Classification in the destination.

• All Drug Programs associated with the Drug Classification will also be moved or copied.

This procedure is only valid between Configurations of the same version.

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Working with Drug ProgramsA Drug Program is a named collection of custom infusion properties that can be used to predefine drug specific infusions deployed to pumps and later recalled by pump users to assist with pump setup. Drug Programs are listed in the Drug Programs area and can be sorted either ascending or descending by clicking the respective button.

Creating a Drug Program Use one of the following methods to create a new Drug Program:

• Select Library > New Drug Program.

• Press Ctrl + P.

• Click the arrow next to the New button and select Drug Program.

• Right-click and select New from the context menu.

Naming and Renaming a Drug Program• When creating a new Drug Program, it is already

in Naming mode. Enter the name for the new Drug Program. The naming field is unlimited, however if a name is too long it will be truncated as part of the library mapping process.

• To rename, click on the Drug Program in the Drug Programs list, then click it again to start the inline edit process.

• Optionally, right-click and select Rename from the context menu to start the inline edit process.

• Press Enter to save the change or Esc to cancel the rename operation.

Removing a Drug Program• In the Drug Program List, select the Drug Program to

be removed.

• Press Delete or right-click and select Delete from the context menu to permanently remove the Drug Program.

CAUTION: If a Drug Program is deleted, the operation cannot be reversed.

Cutting/Copying/Pasting Drug ProgramsSee the next page for important information regarding syringes.

• Select one or more Drug Programs you want to cut or copy to the System clipboard in the Drug Programs list.

• To move a Drug Program(s) to the System clipboard use one of the following methods:

- Right-click and select the Cut option from the context menu.

- Click the Cut button.

- Press Ctrl + X.• To copy the Drug Program(s) to the System clipboard

use one of the following methods:

- Right-click and select Copy from the context menu.

- Click the Copy button.

- Press Ctrl + C.• To paste Drug Program(s) from the System clipboard

use one of the following methods:

- Right-click in the Library Explorer and select Paste from the context menu.

- Click the Paste button.

- Press Ctrl + V.The name of the copied and pasted Drug Program automatically has “Copy of” added to it, and appears alphabetically in the “C” section of the list.

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User’s ManualPharmGuard® Toolbox 2Dragging/Dropping a Drug ProgramUse Drag & Drop to move Drug Programs between Configurations of the same version.

Note: Using Drag/Drop will always result in the Drug Program being removed from the original (or “host”) Configuration for placement in the “Destination” Configuration. Use Copy/Paste to maintain the Drug Program(s) in both Configurations.

• Assure that both Configurations are open and the Drug Program Libraries are visible (Hint: Select Window > Tile Horizontal).

• In the ‘host’ Drug Programs panel, select the Drug Program you want to move.

• Press and hold the left mouse button and drag the Drug Program(s) to the destination Drug Programs panel.

• Release the mouse button to drop the Drug Program(s) in the destination.

This procedure is only valid between Configurations of the same version.

Note: Syringe Models may be selected in a Drug Program that are not included in the Selected Models list for the Profile. This is due to the fact that when customizing Drug Programs, all of the syringes selected for use in the Configuration on the Syringe Management tab are included in the list of syringes (since Drug Programs may be included in more than one Profile). In this case, the selected syringe file will be sent to the pump along with the Configuration, however it will only appear in the specific Category in which the Drug Program(s) appear. These types of syringe selections will count against the maximum number of syringes that can be used in a Configuration.

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Drug AlertsUse Drug Alerts to display Clinical Advisories to pump users when selecting a Drug Program at a pump. When a pump user selects a Drug Program and it has a Drug Alert associated with it, the pump user will see the Drug Alert as entered in the Drug Alerts window.

Note: There are no default Drug Alerts. Drug Alerts must be created.

Creating a Drug Alert• Select Library > Drug Alerts….

At the Drug Alerts window, click the New button, or right-click in the Drug Alerts list and select New in the context menu.

• When creating the Drug Alert, it is already in Naming mode. Enter the name for the new Drug Alert.

• Press Tab or click in any of the 3 lines in the Drug Alert text area. Up to 3 lines of text with 50 characters per line are allowed. When the text in the line is entered, press Tab to move to the next line (or click in the next line) and enter the next line of text.

The information at the bottom of the Drug Alert text area shows the line the cursor is on (Ln2, or the second line in this example), and how many characters are currently on the line (Ch 28, or 28 characters in this example). If text is highlighted, it also indicates how many characters are highlighted (Sel 0 in this example, since no text is highlighted).

• When finished creating a Drug Alert, click Save to save it then click the Close button, or click Close and save the Drug Alert when prompted.

Usability: Always check the Drug Alert message created to make sure it displays properly on the pump. Different charac-ters take up differing amounts of space on the pump display, so some Drug Alerts with more than 40 characters per line will take up too much space and not display properly.

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User’s ManualPharmGuard® Toolbox 2Renaming a Drug Alert

• Select the Drug Alert you want to rename in the Drug Alerts list.

• Click on the name of the Drug Alert, then click it again or right-click and select Rename from the context menu to start the inline edit operation.

• Press Enter to save the changes or Esc to cancel the rename operation.

Removing a Drug Alert• Select Library > Drug Alerts….

• Select the Drug Alert you want to remove from the Drug Alerts list.

• Press Delete or right-click and select Delete from the context menu to permanently remove the Drug Alert.

CAUTION: If a Drug Alert is deleted, the operation cannot be reversed. In addition, all Drug Programs to which it has been assigned will lose that association.

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Customizing Drug Program PropertiesThe Drug Programs Properties area contains a Property Grid where the infusion properties associated with a selected Drug Program can be customized. The properties displayed in the Property Grid are dependent on the Configuration version and the selected infusion mode or type.


Usability:

• Once the Infusion Type is selected, the fields associated with that infusion type are displayed.

• If a property like Main Rate has Units associated with it, they are automatically added by the Property Grid and cannot be changed when customizing the respective property. They are determined by other properties customized in the Property Grid.

• When entering a value, the units do not have to be included; simply enter the numeric value and the Units will be automatically appended.

• “(none)” indicates that no value is associated with the property. To restore a value back to “(none)” either completely clear the value (double-click the property and press the PC’s Backspace or Delete key) or enter zero.

Double-click property and begin typing

Highlighted value replaced by typed value

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User’s ManualPharmGuard® Toolbox 2GeneralIn the General section, determine general parameters of the drug program, such as how it will appear on the pump display (if different from the Drug Name), the type of infusion, syringe specific information, specify a drug alert and drug classification, and add an ID and/or description (if desired).

Property Description(Drug Name) Defines the name of the Drug Program. This name must be unique in the Drug Program Library and

can be any length. Changing the name in this panel will reflect in the name displayed in the Drug Program panel, and vice versa. The default is DrugName1, or whatever was typed in the Drug Pro-grams panel when creating a New drug name.

Display Text This field is optional. It defines the text displayed by the pump. If this property is not provided, the program’s Drug Name will be used and truncated if needed. Pump software can display a maximum of 30 characters. The default is an empty string.

Drug Classifications Defines the Drug Classification(s) in which the Drug Program is a member. A Drug Program can be made a member of multiple Drug Classifications by clicking the Browse button in the right column of the Property Grid. Clicking this button opens the Drug Classification Selection window and allows selecting Drug Classifications. The default is (none).

Usability: You will not be able to select a Drug Program for Library Mapping if it is not a member of at least one Drug Classifica-tion. It is recommended that you always add Drug Programs to at least one Drug Classification.

Infusion Type Defines the type to use when infusing the drug associated with the Drug Program. Select from eighteen Infusion Types—(none), mL/hr, Volume Over Time, Intermittent Volume/Time, dose/min, dose/hr, dose/time, dose/day, dose/kg/min, dose/kg/hr, dose/kg/time, dose/kg/day, dose/m2/min, dose/m2/hr, dose/m2/time, dose/m2/day, mL/kg/hr, mL/kg/min, and mL/kg/time. The default is (none). If an Infusion Type is not selected, the Drug Program cannot be used on a pump (an “invalid” notification on the pump will display when it is selected).

Syringe Model This field is optional. Defines the Syringe Model to associate with the Drug Program. The default is (none), or select a specific model from the drop-down list, which includes all of the syringe models in the Configuration Syringe Models list (selected on the Syringe Management tab).

Note: See Syringe Management (page 40) for information on imported syringes. The syringe model specified should be in the Configuration Syringe and Profile Syringe Models lists of the Profiles which the Drug Program is associated (via the Drug Classification). It is possible to select a syringe in a Drug Program that does not appear in the Selected Models list (on the Syringe Models tab). In this case, the selected syringe file will be sent to the pump along with the Configuration, however it will only appear in the specific Category in which the Drug Program(s) appear. These types of syringe selections will count against the maximum number of syringes that can be used in a Configuration.

Syringe Size This field is optional. Defines the Syringe Size to associate with the Drug Program. The sizes that can be selected are dependent on the Syringe Model and will be reflected once a Syringe Model is selected. The default is (none), meaning the pump will automatically detect the syringe size based on the Syringe Model and syringe detection sensors.

Drug Alert This field is optional. Displays the Drug Alert associated with the Drug Program. A Drug Program can be associated with one Drug Alert by clicking the Browse button in the right column of the Property Grid. Clicking this button opens the Drug Alert Selection window and allows selecting a Drug Alert. The default is (none).

ID This field is optional. Enter an identification string to associate with the Drug Program. This property is not used by the pump, but can be used to associate tracking information with the Drug Program and it is used by the standard Drug Program Report. The default is an empty string.

Description This field is optional. Enter a short description for the Drug Program. The pump does not use this property, but it is used by the Standard Library Reports. The default is an empty string.

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User’s ManualPharmGuard® Toolbox 2Infusion UnitsDepending on the type of infusion selected in the Infusion Type area of the General section, infusion units may be required.

Property DescriptionConcentration Units Defines the Concentration Units to associate with the Drug Program. Select from seven Concentra-

tion Units—(none), Millimoles (mMol), milliequivalents (mEq), units, grams (g), milligrams (mg), and micrograms (mcg), resulting in a final concentration unit of (selected unit)/mL. The default is (none).

Note: This field cannot be left as (none); a selection must be made before specifying Delivery Units.

Delivery Units Defines the Delivery Units to associate with the Selected Infusion Type. The units that can be selected are dependent on the Concentration Units and will be reflected once the Concentration Units are selected. The default is (none).

Note: This field cannot be left as (none); a selection must be made for a Drug Program to be valid at the pump.

MainIn this section specify the infusion parameters for the Drug Program. Different Infusion Types have different parameters associated with them, so depending on the Infusion Type chosen in the General Section you may or may not see all of the parameters specified in this table. They are listed in alphabetical order for this reason.

Property DescriptionBody Surface Area Defines a Body Surface Area (BSA) to associate with the Drug Program. This property is only avail-

able for the dose/m2/… infusion types. The default is (none).

Concentration Defines the concentration per mL of the drug. If a value is provided, Concentration cannot be changed by pump users. If a Concentration is not provided, associated limits must be provided otherwise the pump will not allow Drug Program setup to continue. Enter a value in the range 0 to 99999 (see note below). Units are dependent on the Concentration Units selected. The default is (none).

Note: Setting a 5 digit Concentration value (for example, 99991) will automatically result in any hard or soft Concentration Limits (Concentration High/Low and/or Maximum/Minimum) to reset to (none). This is to prevent a conflict that would make the Drug Program unusable at the pump. Attempting to re-enter a hard or soft limit with a 5 digit Concentration in place will result in an error (example: “Concentrations are out of order.”) being displayed.

Concentration High Defines the upper PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a con-centration value. When a value above this limit is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. Enter a value in the range 0 to 9999; units are dependent on the Concentration Units selected. The default is (none).

Concentration Low Defines the lower PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a con-centration value. When a value below this limit is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. Enter a value in the range 0 to 9999. The default is (none).

Concentration Maximum Defines the absolute maximum (hard limit) Concentration the pump will allow when a pump user manually enters the Concentration for a Drug Program with an undefined Concentration. Enter a value in the range 0 to 9999; units are dependent on the Concentration Units selected. The default is (none). On the pump, if a user attempts to enter a value outside the range programmed here, a PharmGuard™ Safety event is generated.

Concentration Minimum Defines the absolute minimum (hard limit) Concentration the pump will allow when a pump user manually enters the Concentration for a Drug Program with an undefined Concentration. Enter a value in the range 0 to 9999; units are dependent on the Concentration Units selected. The default is (none). On the pump, if a user attempts to enter a value outside the range programmed here, a PharmGuard™ Safety event is generated.

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Property DescriptionDose Defines the rate at which the Dose is infused. Enter a value in the range 0 to 9999; units are depen-

dent on the Infusion Type/Mode and possibly the Delivery Units selected. The default is (none). If a dose is entered, it appears as the default value during programming, but can be changed by the pump user.

Dose High Defines the upper PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a Dose value. When a value above this limit is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. Enter a value in the range 0 to 9999; units are de-pendent on the Infusion Type/Mode and possibly the Delivery Units selected. The default is (none).

Dose Low Defines the lower PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a Dose value. When a value below this limit is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. Enter a value in the range 0 to 9999; units are de-pendent on the Infusion Type/Mode and possibly the Delivery Units selected. The default is (none).

Dose Maximum Defines the absolute maximum (hard limit) Dose the pump will allow. Enter a value in the range 0 to 9999; units are dependent on the Infusion Type/Mode and possibly the Delivery Units selected. The default is (none). On the pump, if a user attempts to enter a value outside the range pro-grammed here, a PharmGuard™ Safety event is generated.

Dose Minimum Defines the absolute minimum (hard limit) Dose the pump will allow. Enter a value in the range 0 to 9999; units are dependent on the Infusion Type/Mode and possibly the Delivery Units selected. The default is (none). On the pump, if a user attempts to enter a value outside the range pro-grammed here, a PharmGuard™ Safety event is generated.

Main Rate Defines the rate at which the pump should infuse during the main infusion. Enter a value in the range 0 to 1130 mL/hr. The maximum allowable rate is also dependent on the syringe size used. The default is (none). If a main rate is entered, it appears as the default value during programming, but can be changed by the pump user.

Main Rate High Defines the upper PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a Main Rate value. When a value above this limit is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. Enter a value in the range 0 to 1130 mL/hr. The default is (none).

Main Rate Low Defines the lower PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a Main Rate value. When a value below this limit is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. Enter a value in the range 0 to 1130 mL/hr. The default is (none).

Main Rate Maximum Defines the absolute maximum (hard limit) infusion rate the pump will allow. Enter a value in the range 0 to 1130 mL/hr. The default is (none). On the pump, if a user attempts to enter a value out-side the range programmed here, a PharmGuard™ Safety event is generated.

Main Rate Minimum Defines the absolute minimum (hard limit) infusion rate the pump will allow. Enter a value in the range 0 to 1130 mL/hr. The default is (none). On the pump, if a user attempts to enter a value out-side the range programmed here, a PharmGuard™ Safety event is generated.

Maximum Total Dose Defines the absolute maximum total dose allowed for the Drug Program. Enter a value in the range of 0 to 9999. This property is only available in the dose/kg/time and the dose/m2/time infusion types. Units are dependent on the Delivery Units selected. The default is (none).

Patient Weight Defines a Patient Weight to associate with the Drug Program. This property is only available with the …/kg/… Infusion Types/Modes. The default is (none). If a patient weight is entered, it appears as the default value during programming, but can be changed by the pump user.

Time Defines the time in which the Volume is to be infused. Enter the hours and minutes separated by a colon ‘:’ in the range 00:00:xx to 23:59:xx. This property is only available in .../Time Infusion Types/Modes. The default is (none).

Time High Defines the upper PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a Time. When a time is entered above this value, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. This property is only available in .../Time Infusion Types The default is (none).

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Property DescriptionTime Low Defines the lower PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a Time.

When a time is entered below this value, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. This property is only available in ../Time Infusion Types. The default is (none).

Time Maximum Defines the absolute maximum (hard limit) Time the pump will allow. This property is only avail-able in ../Time Infusion Types. The default is (none).

Time Minimum Defines the absolute minimum (hard limit) Time the pump will allow. This property is only avail-able in ../Time Infusion Types. The default is (none).

Volume Defines the volume of fluid to be delivered over the infusion Time. Enter a value in the range 0 to 500 mL. The default is (none). If a volume is entered, it appears as the default value during program-ming, but can be changed by the pump user.

Volume High Defines the upper PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a Vol-ume. When a volume is entered above this limit, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. Enter a value in the range 0 to 500 mL. The default is (none).

Volume Low Defines the lower PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a Volume. When a volume is entered below this limit, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. Enter a value in the range 0 to 500 mL. The default is (none).

Volume Limit Defines a medication Volume Limit to associate with the Drug Program. Enter a value in the range 0 to 500 mL. The default is (none).

Volume Maximum Defines the absolute maximum (hard limit) volume the pump will allow. Enter a value in the range 0 to 500 mL. The default is (none). On the pump, if a user attempts to enter a value outside the range programmed here, a PharmGuard™ Safety event is generated.

Volume Minimum Defines the absolute minimum (hard limit) volume the pump will allow. Enter a value in the range 0 to 500 mL. The default is (none). On the pump, if a user attempts to enter a value outside the range programmed here, a PharmGuard™ Safety event is generated.

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User’s ManualPharmGuard® Toolbox 2OptionsThe Options shown in this area depend on the infusion type selected. Additionally, different infusion types may have different options associated with them, so not all of the optional fields shown in this table will be available for every infusion type.

Property DescriptionBolus Enables or disables the ability to deliver a Bolus Dose. Select from two values—Enabled and Dis-

abled. This property is not available for .../time infusion types. The default is Disabled. If a bolus is enabled, a bolus dose can be programmed by the pump user. In order to be available in Drug Programs, Bolus must be enabled.

Bolus Dose Defines a Bolus Dose to associate with the Drug Program. For mL/hr Infusion Type/Mode enter a val-ue in the range 0 to 60 mL. For all others, enter a value in the range 0 to 9999. Units are dependent on the Infusion Type/Mode and possibly the Concentration and Delivery Units selected. The default is (none). If entered, Bolus Dose will appear automatically during infusion programming on the pump.

Bolus Dose High Defines the upper PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a Bolus Dose value. When a value above this limit is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. For mL/hr Infusion Type/Mode enter a value in the range 0 to 60 mL. For all others, enter a value in the range 0 to 9999; units are dependent on the Infusion Type/Mode and possibly the Concentration and Delivery Units selected. The default is (none).

Bolus Dose Low Defines the lower PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a Bolus Dose value. When a value below this limit is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. For mL/hr Infusion Type/Mode enter a value in the range 0 to 60 mL. For all others, enter a value in the range 0 to 9999; units are dependent on the Infusion Type/Mode and possibly the Concentration and Delivery Units selected. The default is (none).

Bolus Dose Maximum Defines the absolute maximum (hard limit) Bolus Dose the pump will allow. For mL/hr Infusion Type/Mode enter a value in the range 0 to 60 mL. For all others, enter a value in the range 0 to 9999; units are dependent on the Infusion Type/Mode and possibly the Concentration and Delivery Units selected. The default is (none). Attempting to enter a value outside the minimum/maximum range causes a PharmGuard™ Safety event to be generated.

Bolus Dose Minimum Defines the absolute minimum (hard limit) Bolus Dose the pump will allow. For mL/hr Infusion Type/Mode enter a value in the range 0 to 60 mL. For all others, enter a value in the range 0 to 9999; units are dependent on the Infusion Type/Mode and possibly the Concentration and Delivery Units selected. The default is (none). Attempting to enter a value outside the minimum/maximum range causes a PharmGuard™ Safety event to be generated.

Bolus Time Defines the time in which the Bolus Dose is to be infused. Enter the minutes and seconds separated by a colon ‘:’ in the range xx:00:00 to xx:59:00. The default is (none).

Bolus Time High Defines the upper PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a time value. When a value above this limit is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. The default is (none).

Bolus Time Low Defines the lower PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a time value. When a value below this limit is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. The default is (none).

Bolus Time Maximum Defines the absolute maximum (hard limit) Bolus Time the pump will allow. The default is (none). On the pump, if a user attempts to enter a value outside the range programmed here, a Pharm-Guard™ Safety event is generated.

Bolus Time Minimum Defines the absolute minimum (hard limit) Bolus Time the pump will allow. The default is (none). On the pump, if a user attempts to enter a value outside the range programmed here, a Pharm-Guard™ Safety event is generated.

Bolus Time Units Sets the entry and display characteristics of Bolus Time. Choices are minutes and MM:SS (minutes and seconds). This feature is available for all Infusion Types except …/Time. The default is MM:SS. The pump user will only be allowed to enter time in the fields defined by the unit selection.

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Property DescriptionKVO Rate Maximum Defines a Keep-Vein-Open (KVO) infusion rate to associate with the Drug Program. Enter a value in

the range 0 (minimum) to 9.9 mL/hr (maximum). The default is (none).

Loading Enables or disables the ability to deliver a Loading Dose. Select from two values— Enabled and Disabled. The default is Disabled. In order to be available in Drug Programs, Loading Dose must be enabled. If enabled, a Loading Dose can be programmed by the pump user.

Loading/Bolus Rate Maxi-mum

Defines the maximum rate allowed when infusing a Loading or Bolus Dose. For mL/hr Infusion Type/Mode enter a value in the range 0 to 1130 mL/hr. For all others, enter a value in the range 0 to 9999; units are dependent on the Infusion Type/Mode and possibly the Delivery Units selected. The maxi-mum allowable rate is also dependent on the syringe size used. The default is (none).

Loading Dose Defines a Loading Dose to associate with the Drug Program. For mL/hr Infusion Type/Mode enter a value in the range 0 to 60 mL. For all others, enter a value in the range 0 to 9999; units are depen-dent on the Infusion Type/Mode and possibly the Concentration and Delivery Units selected. The default is (none). If a loading dose value is entered, it appears as the default value during program-ming, but can be changed by the pump user.

Loading Dose High Defines the upper PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a Load-ing Dose value. When a value above this limit is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. For mL/hr Infusion Type/Mode enter a value in the range 0 to 60 mL. For all others, enter a value in the range 0 to 9999; units are dependent on the Infusion Type/Mode and possibly the Delivery Units selected. The default is (none).

Loading Dose Low Defines the lower PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a Loading Dose value. When a value below this limit is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. For mL/hr Infusion Type/Mode enter a value in the range 0 to 60 mL. For all others, enter a value in the range 0 to 9999; units are dependent on the Infusion Type/Mode and possibly the Delivery Units selected. The default is (none).

Loading Dose Maximum Defines the absolute maximum (hard limit) Loading Dose the pump will allow. For mL/hr Infusion Type/Mode enter a value in the range 0 to 60 mL. For all others, enter a value in the range 0 to 9999; units are dependent on the Infusion Type/Mode and possibly the Delivery Units selected. The default is (none). On the pump, if a user attempts to enter a value outside the range programmed here, a PharmGuard™ Safety event is generated.

Loading Dose Minimum Defines the absolute minimum (hard limit) Loading Dose the pump will allow. For mL/hr Infusion Type/Mode enter a value in the range 0 to 60 mL. For all others, enter a value in the range 0 to 9999; units are dependent on the Infusion Type/Mode and possibly the Delivery Units selected. The default is (none). On the pump, if a user attempts to enter a value outside the range programmed here, a PharmGuard™ Safety event is generated.

Loading Time Defines the time in which the Loading Dose is to be infused. Enter the minutes and seconds sepa-rated by a colon ‘:’ in the range 00:00:00 to 12:00:00. The default is (none).

Loading Time High Defines the upper PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a Load-ing time. When a time above this value is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. The default is (none).

Loading Time Low Defines the lower PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a Loading time. When a time below this value is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. The default is (none).

Loading Time Maximum Defines the absolute maximum (hard limit) Loading Time the pump will allow. The default is (none).

Loading Time Minimum Defines the absolute minimum (hard limit) Loading Time the pump will allow. The default is (none).

Loading Time Units Sets the entry and display characteristics of Loading Time. Choices are: MM:SS (minutes and sec-onds), HH:MM (hours and minutes) and minutes. This feature is available for all Infusion Types except …/Time. The default is MM:SS. The pump user will only be allowed to enter time in the fields defined by the unit selection.

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Property DescriptionTime Between Starts In Intermittent Volume Over Time Infusion Type/Mode, this defines the time to wait between infu-

sions as set by the Volume and Time properties. Enter the hours and minutes separated by a colon ‘:’ in the range 00:00:xx to 23:59:xx. The default is (none).

Time Between Starts High

In Intermittent Volume Over Time Infusion Type/Mode, this defines the upper PharmGuard™ Safety limit (soft limit) when a pump user enters a time. When a time above this value is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. The default is (none).

Time Between Starts Low

In Intermittent Volume Over Time Infusion Type/Mode, this defines the lower PharmGuard™ Safety limit (soft limit) to apply when a pump user enters a time. When a time below this limit is entered, the pump user is prompted to override the limit and a PharmGuard™ Safety event is generated. The default is (none).

Time Between Starts Maxi-mum

Defines the absolute maximum (hard limit) Time Between Starts the pump will allow. The default is None. On the pump, if a user attempts to enter a value outside the range programmed here, a PharmGuard™ Safety event is generated.

Time Between Starts Mini-mum

Defines the absolute minimum (hard limit) Time Between Starts the pump will allow. The default is None. On the pump, if a user attempts to enter a value outside the range programmed here, a PharmGuard™ Safety event is generated.

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Assigning a Drug Program to a Drug ClassificationTo make a Drug Program a member of a Drug Classification:

• Click the Browse button in the right column of the Drug Classification property in the Drug Program Properties Property Grid. The Drug Classifications window displays. You can Select multiple Drug Classifications in which the Drug Program may be a member.

• Click the check box next to the Drug Classification you want to assign. Deselect or reassign them using the check box.

• Create, rename, and remove Drug Classifications in this window, as described in the following sections.

• Click OK to save the changes when finished or Cancel to exit the window.

Creating a New Drug Classification• Click the New button or right-click in the list and

select New from the context menu.

• Enter the Drug Classification’s name.

• Press Enter to continue or Cancel to exit the window.

Renaming a Drug Classification• Select the Drug Classification to rename.

• Click once to select the Drug Classification’s name and click again to begin the edit process, or right-click and select Rename from the context menu to start the inline edit process.

• Press Enter to save the name or Esc to cancel the rename operation.

Removing a Drug Classification• Select the Drug Classification you want to remove.

• Click the Delete button or right-click and select Delete from the context menu.

CAUTION: If a Drug Classification is deleted, the operation cannot be reversed. In addition, all Drug Programs to which it has been assigned will lose that association.

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Selecting a Drug AlertTo associate a Drug Alert with a Drug Program:

• Click the Browse button in the right column of the Drug Alert property in the Drug Program Properties Property Grid. The Drug Alerts window from which you can select one Drug Alert to associate with the Drug Program displays.

• Click OK when finished to save the changes or Cancel to exit the window.

Note: Drug Alerts must be created prior to the selecting and association procedure. Refer to “Creating a Drug Alert” (page 71), for more information.

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History DataHistory data combines PharmGuard™ Safety data and History events. A database for each pump model contains ALL pump history data, which can be combined in the history view. Data evaluation entails application of filters and field sorting. Filter by version (3500 V6 or 4000 V1, or “any”, which combines both), pump (and further filter for a single pump or range of serial numbers), by date (“on or before <date>” or “on or after <date>”), or a combination of both. See page 33 for information on opening history data.

The information displayed in the History window includes: Time, Pump, Event, Description, User, Drug Name, Profile, Library Category, Parameter, Range/Limit, Value Entered, and Final Value. When the information is for a single pump only, a “Sequence #” (number) is also displayed.

Usability: The maximum allowed size of each of the two databases is 2GB on a Windows 32 bit OS. Once the database has reached this size, an error message is generated whenever additions to the database are attempted.

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Column DescriptionSequence # When history data is filtered for a single pump, the sequence number (or where the “event” occurred in

the pump’s entire sequence of events) is displayed.

Time The date and time at which an event was generated.

Pump The Serial Number of the source pump on which the event was generated.

Event The base category of the event, i.e. power, alarm, PharmGuard™ event, program, transition, program change, calibration, clear.

Description The type within the category, i.e. PharmGuard™ event types include Abandon, Warning, Override, and Hard Limit; transition events include start infusion, stop infusion, etc.; power events include battery power, AC power, etc.

User The pump user’s numeric ID option, entered when setting up an infusion or when overriding a pre-defined infusion property. At times this value may not be available, for example:

• The user overrides a value, at which time they may be prompted for their user ID, and the user turns the pump off without entering a user ID.

• This option was not used in the Configuration.

In either of these cases, an event is generated but user ID will not be available.

Drug Name The name entered in the (Drug Name) field under Drug Program Properties > General.

Profile The Profile that was active when a PharmGuard™ Safety event was generated.

Category Name The Library Category from which a Drug Program was selected.

Parameter The infusion property that caused a PharmGuard™ event, or Drug Entry if the event is associated with drug selection. Only those infusion properties with PharmGuard™ Safety limits are applicable.

Range/Limit For PharmGuard™ events, the upper and lower limits associated with the Parameter defined in a Drug Program. The Range field is not used for Drug Entry events.

Value Entered The value entered that caused the pump to generate a PharmGuard™ Safety event. The Value Entered field is not used for Drug Entry events.

Final Value The final user-entered overridden or corrected value used by the pump during the infusion. The Final Value field is not used for Drug Entry events.

When a History Event in the table is selected, the Event Properties area will update and display all information associated with the respective event. Refer to “Open History Data” (page 33) for more information.

Usability: There is no separate download of PharmGuard™ Safety data.

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ReportsThere are two elements to displaying Reports in PharmGuard® Toolbox 2—Source Data and a Report File. As can be seen in the diagram, Source Data is combined with a compatible Report File resulting in the final Report displayed in a Report View window.

Source Data is provided by PharmGuard® Toolbox 2 and can be any of the PharmGuard® Toolbox 2 Data types. Report Files are external files that must be available to PharmGuard® Toolbox 2 to display Reports.

This approach to displaying Reports has two advantages:

1. Makes it possible to share Report Files over a network.

2. Makes it possible to create custom Report Files and use them with PharmGuard® Toolbox 2 to display Reports.

Viewing Reports• All PharmGuard® Toolbox 2 Data types can be viewed

in Report format by selecting View > Report, then click the report type, or by clicking the View Report

button, then clicking the type of report.

Main Window

SourceData

Report View

Report

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Custom ReportsPharmGuard® Toolbox 2 divides Reports into two categories—Standard Reports and Custom Reports.

• Standard Reports are stock Report Files created by Smiths Medical and installed with PharmGuard® Toolbox 2. These are general-purpose reports that have been fully validated for use with PharmGuard® Toolbox 2.

• Custom Reports can be created using Crystal Reports 2008, a compatible off-the-shelf Report authoring software.

The simplest approach to creating a Custom Report is to start with one of the Standard Reports installed with PharmGuard® Toolbox 2. Simply make a copy of the Report File, open the copy in Crystal Reports and make changes. Alternately, start from scratch by creating a new report file and linking it to one of the Schemas installed with the software.

Creating Report Files is an advanced feature of PharmGuard® Toolbox 2 and requires additional software and knowledge about computer report creation.

Usability: PharmGuard® Toolbox 2 uses Crystal Reports 2008 to render reports. Crystal Reports is a report authoring software package and is available from Business Objects, Inc.

Report View WindowPharmGuard® Toolbox 2 provides rich reporting capability allowing viewing of Configuration, PharmGuard™ Safety data, and History data in printer friendly Report Format. This is done using a window known as the Report View. Through a Report View window, choose the report file to use when rendering the data, navigate to the report, print the report, and export the report.

Usability:

• The Report View window is implemented as a separate window that stays on top of the PharmGuard® Toolbox 2 Main Window. Restore control to the Main Window at any time by minimizing or closing the Report View window.

• Report View windows are displayed in the Window Task Bar, typically located at the bottom of the screen. If a Report View window is minimized, restore it by clicking the respective Task Bar button.

• A Report View window does not have to be closed when modifying a Report’s source data. However, the report will have to be refreshed for the change to be applied.

CAUTION: Report View windows are owned by the PharmGuard® Toolbox 2 windows in which the Report was generated. This means that when the PharmGuard® Toolbox 2 window is closed, all owned Report View windows will also be closed.

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88

User’s ManualPharmGuard® Toolbox 2Selecting a Report FileWhen a Report is generated from one of the PharmGuard® Toolbox 2 windows, after selecting the Source Data, the user selects the Report Type to display for the respective Data Type. Once the Report View window has opened, select to view the Source Data using a different report. Simply select a report by clicking the drop-down button in the list located at the top of the Report View window.

Note that the Default Report for the respective PharmGuard® Toolbox 2 Data Type is indicated by a check mark and the statement “[default]”. The Reports listed in the drop-down list are defined by the Software Administrators.

Refreshing a Report

If the Report’s Source Data is modified, the Report will need to be refreshed for the changes to be displayed. Select View > Refresh or click the Refresh Report button. All tabs will close when refreshing a report.

Working with ReportsOnce a report has been selected and the report successfully displays, working with Reports comes down to navigation, printing, and exporting.

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User’s ManualPharmGuard® Toolbox 2Viewing a Specific Page

• Select View > Go to Page… or click the Go to Page button.

• From the Go to Page window, enter the Page number or click one of the Up or Down buttons.

• Click OK to jump to the Page number entered or Cancel to exit the window.

Finding Text• Select View > Find… or click the Find button.

• From the Find Text window, enter one or more words in the spaces provided.

• Click Find Next to search for the next occurrence of the text.

• Click Close to close and exit the window.

Report NavigationMany options are available when it comes to basic Report navigation. Use the menu options located under the View menu, the buttons on the toolbar, or use the Context Menu by right clicking in the report area. Navigate to both the First and Last pages of a report, go to both the Previous and Next page in a report, and go directly to a specific page number in the report.

Opening Report SectionsAs the mouse cursor is moved over the report, notice the cursor changes to a hand or a magnifying glass . This indicates that the respective Report section can be opened for viewing in a separate tab. Simply click in the area where the cursor changes and the corresponding section of the Report displays in a new tab.

Usability: Close all tabs by Refreshing the Report. Select View > Refresh or click the Refresh Report toolbar button.

Working with the Group TreeThe Group Tree is located on the left side of the report View window and lists all Groups available in the current report, if any are available. Through the Group Tree, quickly navigate to different report groups within the report by clicking on a Group name. The Group Tree can be shown and hidden using the Group Tree option, under the View menu, or by clicking the Group Tree toolbar button.

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User’s ManualPharmGuard® Toolbox 2Zooming

• Select View > Zoom > Custom... or click the drop-down menu Zoom button and select Custom….

• From the Zoom window, enter a zoom factor in the range 25 to 400 or click one of the Up or down buttons.

• Click OK to zoom the Report or Cancel to exit the window.

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Page Setup• Select File > Page Setup.

• From the Page Setup window, define the page settings.

• Click OK to save the settings or Cancel to exit the window.

CAUTION: Care should be taken when changing a Report’s Page Setup. Some Reports require a minimum page layout and might not display or print as expected.

Printing a Report• Select File > Print… or click the Print button.

• From the Print window, select a Printer and setup print properties.

• Click OK to print the file or Cancel to exit the window.

Usability: Customize printer specified properties by clicking the Properties… button.

\\mduls01.medical.ntwrk.com\MDULP

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User’s ManualPharmGuard® Toolbox 2Exporting a Report

• Select File > Export....

• From the Export window, navigate to the location to save the exported file to and enter the file’s name in the space provided.

• Select an export file format from the Save as type drop-down list:

- Adobe Acrobat (*.pdf )

- Web Page (*.htm, *.html)

- Microsoft Excel (*.xls)

- Microsoft Word (*.doc)

- Rich Text Format (*.rtf )• Click Save to export the Report or Cancel to exit the

window.

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Setting Application OptionsThrough the Options window, customize various interface and operational characteristics of PharmGuard® Toolbox 2. Access the Options window by selecting Tools > Options….

General OptionsUnder the General tab, you can select to:

• Show/hide the Status bar and toolbar

• View/set the Default hospital name

Show/Hide the Status Bar and ToolbarUsability: If the Status Bar is hidden, the information normally displayed there will not be displayed (including any indication when the application is connected to a pump).

• Check the respective check box to show the Status bar and toolbar.

• Clear the respective check box to hide the Status bar and toolbar.

• Show/hide the Status bar and toolbox by selecting the respective item under the View menu.

• Click OK to save and apply settings or Cancel to exit the window.

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AppearancePharmGuard® Toolbox 2 allows customizing the Font and Colors used to display various PharmGuard® Toolbox 2 items. For example, you could display PharmGuard™ Overrides events in the Evidence Based Log with a bold font and a red background.

Customizing the Font and Color of an Item• Select the Item to set from the Show settings for list by

clicking the drop-down button.

• Select the Item’s Font from the Font list by clicking the drop-down button.

• Select the Item’s Font Size from the Size list by clicking the drop-down button.

• To make the font Bold or Italic, check the respective check box.

• Click the Foreground Color button to set the Item’s text color.

• Click the Background Color button to set the Item’s background color.

• To restore an Item’s appearance back to its default, click the Use Defaults button.

• Click OK to save and apply settings or Cancel to exit the window.

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IndexA

Adjust for daylight saving time 22Alarm Setup 54

Alarm Loudness 54Alarm Silence Time 54Alarm Style 54Near Empty Alarm Priority 54Near Empty Time 54

Application Options 93Appearance 94

Customizing the Font and Color of an Item 94General Options 93Show/Hide the Status Bar and Toolbar 93

Assigning a Drug Program to a Drug Classification 81Auto Lock Time 55Auto Prompts 54

Bolus Dose 54Confirm Setting 54Enter User ID to Program 54Prompt to Prime 54Re-enter Weight 54Standby Time 54Volume Limit 54

Available Models list 27

BBolus Change in mL 55Bolus Time Feature 55Bolus Total Dose 55

CChanging a Record’s Promotion Level 38Changing Your Password 16Closing a Record 34Closing a Serial Port 19Common Properties 47, 49

Approximate Size 49Changing the Major Version 50Dataset ID 49Date Separator 49Decimal Separator 49Device ID 49Hospital 50Language 50Promotion Level 49Version 49

Communicating with a Pump 17Communication 17

Connecting to a Pump 17Opening a Network Connection 18Opening a Serial Port 18

Configuration Data 5Working with Records and

Legacy Files 29

Configuration Records 29Closing a Record 34Creating a New Configuration Data Record 29Exporting Configuration Records 37Opening a Legacy Configuration 31Opening an Existing Configuration Data Record 30Renaming a Configuration 32Saving a Duplicate Record 36Saving a Record 35Sharing Configuration Records 37Working with Records and Legacy Files 29

Configuration Syringe Models List 61Configuration Tab 47

Common Properties 49Changing the Major Version 50

Profiles 47Profiles Properties 47

Configuration Version 49Configuration Window 47Connecting to a Pump 17

Disconnecting 19Context Menus 12Create Package... 20Creating a New Configuration Data Record 29Creating a New Profile 51Customizing Drug Program Properties 73Custom Reports 86Cutting, Copying, and Pasting a Profile 52

DDatabase

Context Menus 12Dialog Windows 10Property Grid 11Shortcut Keys 12Working Within 5

Data Handling 5Configuration Data 5History Data 5, 33PharmGuard® Safety Data 6

Daylight Saving 22Delivery Modes Tab 59

Working with Delivery Modes Lists 59Deselecting Syringes 43Device Setup 22

Adjust for daylight saving time 22Preventative maintenance date 22Set pump’s internal clock 22Time zone 22

Dialog Windows 10Disconnecting From a Pump 19Downloading a Configuration 21Dragging and Dropping a Profile 52Drug Alerts 71

Creating a Drug Alert 71Removing a Drug Alert 72Renaming a Drug Alert 72

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User’s ManualPharmGuard® Toolbox 2Selecting a Drug Alert 82

Drug Classifications 68Assigning a Drug Program to a Drug Classification 81Creating a Drug Classification 68Cutting/Copying/Pasting a Drug Classification 68Dragging/Dropping a Drug Classification 68Naming and Renaming a Drug Classification 68Removing a Drug Classification 68

Drug Program Library 5Drug Program Library Tab 66

Drug Program Properties 66Drug Programs 66, 69Library Explorer 66, 67

Drug Program Properties 66Assigning a Drug Program to a Drug Classification 81Customizing 73Drug Alerts 71Selecting a Drug Alert 82

Drug Programs 66, 69Creating a Drug Program 69Cutting/Copying/Pasting Drug Programs 69Dragging/Dropping a Drug Program 70Naming and Renaming a Drug Program 69Removing a Drug Program 69

EEdit Configuration 30Enter User ID on Override 55Evidence-based Log 6Export 37Exporting Configuration Records 37

FFlowSentry™ 57

FlowSentry™ Sensitivity 57Flow Sentry™ Startup

Sensitivity 57Flush 55

Enable 55Flush Time 55Maximum Flush Volume 55

GGeneral Customization 57

Auto Lock Time 55Bolus Change in mL 55Bolus Time Feature 55Bolus Total Dose 55Enter User ID on Override 55Key Click Loudness 55Profile Passcode 56Program Display 56Quick Library 56, 58Support 1 mL Syringe 56Unlock Passcode 56

General Tab 53

Alarm Setup 54Alarm Loudness 54Alarm Silence Time 54Alarm Style 54Near Empty Alarm Priority 54Near Empty Time 54

Auto Prompts 54Bolus Dose 54Confirm Setting 54Enter User ID to Program 54Prompt to Prime 54Re-enter Weight 54Standby Time 54Volume Limit 54

Flush 55Flush (enable) 55Flush Time 55Maximum Flush Volume 55

General Customization 56, 57Auto Lock Time 55Bolus Change in mL 55Bolus Time Feature 55Bolus Total Dose 55Enter User ID on Override 55Key Click Loudness 55Profile Passcode 56Program Display 56Quick Library 56, 58Support 1 mL Syringe 56

Limits 56Maximum Body Surface Area 56Maximum Bolus Rate 56Maximum Flow Rate 56Maximum Patient Weight 56

Occlusion Detection 57FlowSentry™ 57FlowSentry™ Sensitivity 57Flow Sentry™ Startup

Sensitivity 57Occlusion Limit 57

Glossary 4

HHistory Data 5, 33, 83

Closing a Record 34Saving a Record 35

IImport Failed (legacy Configuration) 45Import From File 31Importing Syringes 24

Updating 41Infusion Units Tab 60Intended Use 3

97


KKey Click Loudness 55

LLearning 21Legacy Files 29Library Explorer 66, 67

Working with Drug Classifications 68Library Mapping Tab 64

Working with Library Mapping Lists 65Limits 56

Maximum Body Surface Area 56Maximum Bolus Rate 56Maximum Flow Rate 56Maximum Patient Weight 56

Logging in 15Logging Out 15

MMajor Version 49, 50Maximum Body Surface Area 56Maximum Bolus Rate 56Maximum Flow Rate 56Maximum Patient Weight 56Medfusion® Standard Syringes 24Menus and Toolbars 13Missing Syringes Alert 43

Deselecting Syringes 43Dragging/Dropping or Copying/Pasting Profiles and Drug

Programs 44Import Failed (Legacy Configuration) 45

Moving a Profile 51

OOcclusion Detection 57

FlowSentry™ 57FlowSentry™ Sensitivity 57Flow Sentry™ Startup

Sensitivity 57Occlusion Limit 57

Opening a Legacy Configuration 31Opening a Network Connection 18Opening an Existing Configuration Data Record 30Opening a Serial Port 18

Closing 19Opening History Data 33

PPackage, create 20PharmGuard® Safety Data 6

Evidence-based Log 6PharmGuard® Supported Syringes (PSS) 24

Importing Syringes 47Syringe Models Tab 61

Preventative maintenance date 22

Profile Passcode 56Profiles 47, 51, 52

Creating a New Profile 51Cutting, Copying, and Pasting a Profile 52Moving a Profile 51Renaming a Profile 51

Profiles Properties 47Delivery Modes Tab 59General Tab 53Infusion Units Tab 60Library Mapping Tab 64Program Options Tab 63Syringe Models Tab 61

Profile Syringe Models List 61, 62Program Display 56Program Options Tab 63Promotion 38

Archived 38Learned 38Teachable 38Working 38

Property Grid 11Pump Communication 17

QQuick Library 56, 58

RRecord (Configuration) Promotion 38

Changing a Record’s Promotion Level 38Teachable 39

Records 29Refresh Pump Information 19Renaming a Configuration 32Renaming a Profile 51Report Navigation 89

Finding Text 89Opening Report Sections 89Viewing a Specific Page 89Working with the Group Tree 89Zooming 90

Reports 85Custom Reports 86Report Navigation 89Report View Window 86Viewing Reports 85

Report View Window 86Exporting a Report 92Page Setup 91Printing a Report 91Refreshing a Report 88Report Navigation 89Selecting a Report File 88Working with Reports 88

98


SSaving a Duplicate Record 36Saving a Record 35Security 15

Changing Your Password 16Logging in 15Logging Out 15

Selecting a Drug Alert 82Selecting a Quick Library 58serial number 22Set pump’s clock 22Set time zone 22Sharing Configuration Records 37Shortcut Keys 12Status Bar 17Support 1 mL Syringe 56Symbols (definitions) 3Syringe Management 40

Available Models list 27Configuration Syringe Models List 61Imported Syringes 24Missing Syringes Alert 43

Syringe Models Tab 61Configuration Syringe Models List 61Profile Syringe Models List 61, 62

TTeaching 21, 39Teaching and Learning Data 21

Create Package... 20File Promotion 38Learning 21Teaching 21

UUnlock Passcode 56Uploading pump data 21

VViewing Reports 85

WWorking with Delivery Modes Lists 59Working with Library Mapping Lists 65Working with Program Options Lists 63

Page Intentionally Blank

s

Medfusion, PharmGuard, FlowSentry, and the Medfusion and Smiths Medical design marks are trademarks of Smiths Medical. The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. All other names and marks mentioned are the trade names, trademarks or service marks of their respective owners.

© 2019 Smiths Medical. All rights reserved.

10017535-001 2019-09

H Manufacturer: Smiths Medical ASD, Inc.6000 Nathan Lane NorthMinneapolis, MN 55442 USATel: 1 800 258 5361 (US/CA)Tel: +1 614 210 7300

@ European Representative:Smiths Medical Czech Republic a.s.Olomoucká 306, Hranice 1 - Město,753 01 Hranice, Czech RepublicTel: +44 (0) 1233 722100

www.smiths-medical.com

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