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Important Notice The Drug Library Editor User Manual is delivered subject to the conditions and restrictions listed in this section. A qualified and authorized local hospital personnel in a non-clinical environment should read the entire User Manual prior to operating the Drug Library Editor Software in order to fully understand the functionality and operating procedures of the Drug Library Editor and its accessories. • Healthcare professionals should not disclose to the patient the pump's security codes, lock levels, or any other information that may allow the patient access to all programming and operating functions. • Improper programming may cause injury to the patient. Prescription Notice Federal United States law restricts this device for sale by or on the order of a physician only {21 CFR 801.109(b) (1)}. The Drug Library Editor Software is for use at the direction of, or under the supervision of, licensed physicians and/or licensed healthcare professionals who are trained in the use of the software. The instructions for use presented in this manual should in no way supersede established medical protocol concerning patient care. 2 Copyright, Trademark and Patent Information © 2015, Q Core Medical Ltd. All right reserved. The Drug Library Editor Software and Q Core (with or without logos) are trademarks and/or service mark and/or know how of Q Core Medical Ltd. The design and other features of the Drug Library Editor are protected under one or more US and Foreign Patents. Disclaimer This user manual and the use thereof are subject to the terms and conditions of the Q Core Drug Library End User License Agreement. The information in this user manual has been carefully examined and is believed to be reliable. No responsibility is assumed for any inadvertent inaccuracies. Q Core Medical Ltd. reserves the right to make changes to any of its products in order to improve reliability, design and performance. The instructions presented in this manual should in no way supersede established medical protocol concerning patient care. The text and drawings herein are for the purposes of illustration and reference only; the specifications on which they are based are subject to change without notice. Warning Use only Q Core Medical Ltd. supplied accessories with the Drug Library Editor Software. Use of accessories other than those specified may result in degraded electromagnetic compatibility performance or safety of this device. Q Core Medical Ltd.’s warranty cover of this device will be null and void and Q Core Medical Ltd. will assume no responsibility for incidents which may occur if the product is not used in accordance to product labeling. Refer to Warnings and Safety Precautions on page 15 for a complete list of warnings and cautions. 3 Drug Library Editor User Manual Technical Assistance For technical questions, troubleshooting assistance and device problems, please contact your local agent/distributor. To locate authorized Hospira service centers near you, refer to Authorized Hospira service centers on page 189. You may also contact Q Core Medical Ltd. support via email to the following address: [email protected] Meaning of the CE Mark Symbol The symbol represents adherence to Council Directive 93/42/EEC (14 June 1993) of the European Communities concerning medical devices. The electromagnetic compatibility (EMC) requirements are part of the essential requirements of the Medical Device Directive. 4 Contents 1. INTRODUCTION ...........................................................9 Product Overview and Indications ....................................................... 9 Features ...............................................................................................10 Terms and Abbreviations ................................................................... 11 Document Conventions ..................................................................... 13 Safety and Compliance Information................................................... 13 Symbols and Labelling .......................................................................14 Compliance with Applicable Standards............................................14 Warnings and Safety Precautions....................................................... 15 General Warnings and Precautions ...................................................15 2. GETTING STARTED.....................................................17 Prerequisites....................................................................................... 17 Hardware Requirements.....................................................................17 Software Requirements ......................................................................17 Installing the DLE Software on your Computer.................................. 18 Uninstalling the DLE Software............................................................ 21 Upgrading the DLE Software from Rev11 to Rev13........................... 22 Exporting Medication List From DLE Rev11 Software .....................23 Exporting Drug Libraries (Worksheets, Archived or Published) From DLE Rev11 Software ..........................25 Installing the DLE Rev13 Software.....................................................27 Importing the Medication List ...........................................................29 Importing the Drug Libraries .............................................................31 3. LOGGING IN AND OUT ..............................................34 Logging Into the DLE Software.......................................................... 34 Logging Out and Exiting the DLE Software....................................... 36 4. MEDICATION LIST......................................................38 Overview ............................................................................................ 38 Parameters in the Medications Tab .................................................... 38 Identifying Medications in the Medication List ................................39 5 Working with the Medication List....................................................... 40 Add a Medication ...............................................................................40 Edit a Medication................................................................................42 Delete a Medication ...........................................................................43 Creating, Importing and Exporting a Medication List .....................44 Medication Search Options................................................................ 52 Medication List Report ....................................................................... 53 5. DRUG LIBRARY DIRECTORY .........................................55 Overview ............................................................................................ 55 Storing Options in the Drug Library................................................... 55 Parameters in the Drug Library Directory View .................................. 56 Drug Library Directory Conventions..................................................57 Working with the Drug Library Directory ........................................... 58 Creating a Worksheet.........................................................................58 Editing a Worksheet ...........................................................................60 Adding or Editing Notes to a Worksheet .........................................62 Deleting a Worksheet or an Archived Drug Library .........................63 Viewing a Drug Library .......................................................................65 Copying Worksheets, Archived or Published Drug Libraries ..........67 Backup and Export Drug Libraries (Worksheets, Archived or Published).................................................69 Import and Restore a Drug Library....................................................71 Export Log ...........................................................................................74 6. SETTING UP CCAS ....................................................76 Overview ............................................................................................ 76 Parameters in the CCA Setup Tab...................................................... 76 Service Lines........................................................................................77 Working with CCA Setup ................................................................... 78 Creating a New CCA ..........................................................................78 Editing a CCA......................................................................................80 Viewing a CCA ....................................................................................82 Deleting a CCA ...................................................................................83 Changing the Display Order of CCA Names ...................................85 CCA Settings...................................................................................... 87 Restore Options ..................................................................................89 System Settings...................................................................................90 6 Alarm Settings.....................................................................................94 Mode Options.....................................................................................96 KVO Settings .....................................................................................100 Hard Limits.........................................................................................101 Delivery Modes .................................................................................106 Dosing Units ......................................................................................108 7. SECURITY ...............................................................109 Overview .......................................................................................... 109 Security Levels.................................................................................. 109 PreProgram Password ...................................................................... 111 Managing Security Passwords.......................................................... 111 8. DRUG LIBRARY MANAGEMENT .................................112 Overview .......................................................................................... 112 Drug Library Management Conventions ........................................113 Managing Drug Libraries ................................................................. 114 Creating Medication Entries (Rule Sets) ........................................... 115 Editing Medication Entries (Rule Sets) ............................................. 123 Viewing Medication Entries (Rule Sets) ............................................ 125 Deleting Medication Entries (Rule Sets) ........................................... 127 Removing Medication Entries (Rule Sets) from a CCA ..................127 Deleting Medication Entries (Rule Sets) from the Master Drug Formulary .....................................................129 Assigning Medication Entry from the Source List to a Target CCA.. 131 Finalizing a Worksheet ..................................................................... 133 Conflicts .............................................................................................134 Closing a Drug Library ..................................................................... 135 9. MEDICATIONS ENTRIES (RULE SETS)..........................136 Overview .......................................................................................... 136 Medication Entry Rules and Conventions ........................................ 136 Medication Rule Sets Parameters .................................................... 137 Generic Name ...................................................................................138 Displayed Name................................................................................139 Rule Sets Types..................................................................................140 Notes..................................................................................................142 Delivery Modes .................................................................................144 7 10. REPORTS..............................................................161 Overview .......................................................................................... 161 Reports Conventions ........................................................................161 Reports Structure ............................................................................. 162 Working with Reports Tab ................................................................ 162 Drug Library Report ..........................................................................163 CCA Drug Library Report .................................................................165 CCA Settings Report ........................................................................166 CCA Settings (On Sapphire) ............................................................167 Printing Reports ............................................................................... 168 Saving Reports ................................................................................. 169 11. UPLOADING A DRUG LIBRARY ................................171 Overview .......................................................................................... 171 Prerequisites..................................................................................... 172 Hardware Requirements...................................................................172 Software Requirements ....................................................................173 Connect the Pumps to the PC via COM Ports ...............................173 Upload a Published Drug Library to the Sapphire Pump ................. 174 12. TROUBLESHOOTING ...............................................179 APPENDIX A: USERS ROLE AND PRIVILEGES 181 Users Roles and Privileges ............................................................... 181 Change Users Passwords ................................................................. 181 APPENDIX B: NEW/UNSUPPORTED CCA SETTINGS 183 System Settings................................................................................ 184 Alarm Settings.................................................................................. 185 Mode Options.................................................................................. 185 KVO Settings.................................................................................... 186 Hard Limits ....................................................................................... 186 Delivery Modes ................................................................................ 188 Dosing Units..................................................................................... 188 8 Chapter 1: Introduction The following sections describe the functions and features of the DLE Software, and provide a summary of safety and regulatory information: Product Overview and Indications ............................................................... 9 Terms and Abbreviations .......................................................................... 11 Document Conventions ............................................................................ 13 Safety and Compliance Information ........................................................... 13 Warnings and Safety Precautions ............................................................... 15 Product Overview and Indications The DLE Software enables creating and editing of the Sapphire Pump Drug Library, allowing for the manipulation of all medications used by the hospital, and for specifying pump settings and pre-determined treatment parameters (rules) for the Sapphire multi-therapy and dedicated pumps (excluding SapphirePlus). The medications are categorized according to ID, Clinical Care Areas (CCAs), dose and hard/soft limits. The software accommodates up to 40 CCAs and up to 8,500 unique medication rule sets. Each CCA can accommodate up to 1,000 medication rule sets, and each unique medication rule set can be assigned to more than one CCA, i.e., up to a total of 40,000 medications. The software supports English, French and Spanish. The DLE Software is intended for use by certified personnel in a non-clinical environment (such as an office). The software should not be used in patient areas or during infusion. The DLE Software is intended for use with Sapphire Infusion Pump software version r13 only. Introduction 9 Features The features of the DLE Software are designed to simplify the use of the Sapphire pump for its users and ensure patient safety. Management and Programming Related Features • • • • • • • Managing multiple libraries: • Archived Drug Libraries are accessible for viewing, and for copying as bases for new libraries. • Several worksheets can be managed and edited at the same time, thus providing flexibility to the user. • Medication Lists and Drug Libraries can be imported from the previous DLE software version. The user can perform Backup and Restore of Drug Libraries. Offering 4 different types of reports for each Drug Library, allowing to display, save and print detailed information about the medication entries and CCA setting. Tracking changes in a Drug Library programming by exporting event log data. Programming of 7 different delivery modes for each medication rule set. Up to 8,500 unique medication rule sets per Drug Library. Clinical Care Area (CCA) supports: • Up to 40 CCAs per Drug Library. • Unique pump configuration per CCA. • Each CCA can be assigned with up to 1,000 medication rule sets. Safety-Related Features • Reducing the risk of over/under dose: Reducing the risk of administrating over/under dose by setting Hard Limits and Soft Limits values per medication, for each Clinical Care Area (CCA). Hard limits are the maximum and minimum values that cannot be exceeded; the soft limits are a recommendation and can be overridden. A warning will be shown during infusion set-up and throughout the infusion, when a soft limit has been exceeded. Introduction 10 • Reducing programming errors: Allowing selection of specific units per medication rule set, thus eliminating conversion errors. Generating relevant alerts for each CCA: Allows configuring different pump settings for a specific CCA, which results in customized alerts to the CCA’s needs. Selecting relevant dose rate units for each CCA: The selected dose rate units will be available for General drugs, specific for each CCA. Security passwords: Enabling the programming of 3 different authorization level codes for each Drug Library, to prevent misuse of the pump. An Additional password is set to allow specific pump users to create, edit or delete PreSet Programs on the pump. • • • Terms and Abbreviations The following table defines common terms and abbreviations used in this manual. Term/Abbreviation Meaning CCA Clinical Care Area Cont. Continuous CSV Comma Separated Value DLE Software Drug Library Editor Software Epi. Int. Epidural Intermittent h Hour ID Identifier Kg Kilogram KVO Keep Vein Open LHL Lower Hard Limit LSL Lower Soft Limit mcg Micrograms MDL Medications List mEq Milliequivalents mg Milligrams Introduction 11 Term/Abbreviation Meaning min Minutes mL Milliliters mmol Millimoles mUnits Milliunits M Units Million Units nanog Nanograms NDC National Drug Code PCA Patient Controlled Analgesia PCEA Patient Controlled Epidural Analgesia PIEB Programmed Intermittent Epidural Bolus Q Core Q Core Medical Ltd. Sapphire pump Q Core Sapphire infusion pump SubQ Subcutaneous TPN Total Parenteral Nutrition UHL Upper Hard Limit USL Upper Soft Limit VI Volume Infused VTBI Volume To Be Infused Introduction 12 Document Conventions The following messages in this manual prompt readers to pay special attention to specific points: Warnings indicate precautions and instructions which, if not followed, may result in personal injury. Cautions indicate instructions which, if not followed, may result in damage to the equipment or to the quality of treatment. Notes provide additional information to help obtain optimal equipment performance. The parameter ranges described in this manual reflect their factory default settings. These ranges may be configured by an authorized technician. Safety and Compliance Information The following section presents important labeling, safety and compliance information: • Symbols and Labelling on page 14 • Compliance with Applicable Standards on page 14 Introduction 13 Symbols and Labelling The following table describes the labels and symbols that appear on the DLE Software manual and CD, and identifies their locations. Symbol Description Location CE certification mark User manual back cover, Communication cable and USB to 4 Port RS232 Adapter. Authorized representative User manual back cover, Communication cable and USB to 4 Port RS232 Adapter. Consult instructions for use Communication cable and USB to 4 Port RS232 Adapter. Name of manufacturer User manual back cover, Communication cable and USB to 4 Port RS232 Adapter. Compliance with Applicable Standards This software is in compliance with the requirements of the International Standard, IEC 62304 ED. 1.0 B:2006 for Medical device software - Software life cycle processes. Introduction 14 Warnings and Safety Precautions The following sections contain important safety information. All warnings and safety precautions should be read carefully before operating the DLE Software. Safety information specific to particular DLE Software functions appears in the relevant sections of this manual. General Warnings and Precautions To ensure safety and proper operation, read the User Manual and any instructions accompanying accessories before operating this software. General Warnings • • • • The DLE Software incorporates dosing limits and Sapphire pump configuration parameters based on hospital protocol. The software adds a test of reasonableness to drug programming based on the limits defined by the hospital. Qualified personnel must ensure the appropriateness of the drug dosing limits, the compatibility of the drugs, and the performance of each Sapphire pump, as part of the overall infusion. Potential hazards include drug interactions, inaccurate delivery rates, inaccurate pressure alarms, and nuisance alarms. References in this document to specific drugs and drug doses are for illustration purposes only. Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages. Refer to the Sapphire User Manual for warnings and cautions before handling the Sapphire pump. To avoid inconsistencies between Drug Libraries and reports, ensure that all the Sapphire pumps are using the same Drug Library version. Introduction 15 General Precautions • • • • • • Use of accessories other than those specified may result in degraded electromagnetic compatibility performance or safety of the Sapphire pump. A data set is designed to incorporate the hospital’s best-practice guidelines. As such, it should be developed and approved by the appropriate clinical decision makers in the hospital. Clinical decision makers involved with data set development for the DLE Software must be familiar with the software product. Only qualified personnel, or persons acting under the direct supervision of qualified personnel, should have access to the DLE Software. Users of the DLE Software should read all instructions before using the software product. The effectiveness of using the DLE Software as a mean of protecting patients and clinicians from programming errors is entirely dependent on the hospital’s policy regarding the establishment, implementation and management of the data set transferred to the Sapphire pump. Hospital data sets should accurately reflect the hospital’s best-practice guidelines. Introduction 16 Chapter 2: Getting Started The following sections present the system requirements, as well as the installation and removal procedures of the Drug Library Editor Software: Prerequisites ............................................................................................ Installing the DLE Software on your Computer ............................................ Uninstalling the DLE Software ................................................................... Upgrading the DLE Software from Rev11 to Rev13 ...................................... 17 18 21 22 Prerequisites Before installing the DLE Software, verify that the following requirements are met: Hardware Requirements • • Screen resolution: 1280 X 1024 (minimum) Monitor DPI: 96 Software Requirements • • • Operating System: Windows XP SP3 (32 or 64 bit), Windows 7 (32 or 64 bit), Windows 8 (32 or 64 bit) MS Excel (2003 or higher) WinRar or other software for handling .zip files Getting Started 17 Installing the DLE Software on your Computer > To I n s ta ll th e Dr u g L i b r a r y E d i t or S of t w a re on y our com put er : 1. After launching the installer, From the Select Language menu, select the desired interface language; then, click Next – the available languages are English, French and Spanish. 2. click Next to continue with the setup wizard. Getting Started 18 3. Read the Q Core Drug Library Editor End User License Agreement, and select the checkbox if terms are accepted. IMPORTANT NOTE: This product is subject to the End User License Agreement included therein. When installing the product on your hard drive, you will be requested to accept the terms of such License Agreement. If you do not accept the license agreement, then you may not install or use the product in any way whatsoever. 4. If you wish to create a shortcut on your desktop and start menu, make sure that the relevant checkbox is selected. 5. Click Install to continue with the setup wizard. Getting Started 19 6. If you wish to open the application or open the User Manual, select the corresponding checkboxes. 7. Click Finish. A folder with the Drug Library Editor Software and the User Manual is created. If the DLE Software is required for use on more than one workstation or computer, verify that all relevant users have network access (Read/Write) to the DLE installation location. This will ensure the consistency and the uniformity of the data in the Drug Libraries. Make sure to use a shared folder only, so that it logs all the software-relevant data. Getting Started 20 Uninstalling the DLE Software > To Un in s ta ll th e D r u g L i b r a r y E d i t or S of t w are from y our com put er : 1. Open the Windows Control Panel. 2. In Control Panel, double click Add or Remove Programs / Uninstall a Program. 3. Select the Drug Library Editor Software, and click Remove/Uninstall. Uninstalling the DLE Software does not remove the data folder which contains the Drug Libraries and Medication List. In order to delete them completely, go to the software folder created for the installation, and delete the folder from your computer. Getting Started 21 Upgrading the DLE Software from Rev11 to Rev13 Due to structure differences in the Rev13 Drug Library, you are required to export Worksheets, Archived or Published Drug Libraries from previous versions, before importing them to the new DLE Rev13 Software. All the medication entries, CCA settings and Security settings are included in the exported file, which can be saved to an external location on the computer or hard drive in a .QCoreDL file format. To upgrade the Drug Library Editor Software on your computer, perform the following procedure step by step: 1. Launch the DLE Rev11 and log in as Editor. 2. Export Medication List from DLE Rev11 Software (page 23). 3. Export Drug Libraries (Worksheets, Archived or Published) From DLE Rev11 Software (page 25). 4. Install the DLE Rev13 Software (page 27). 5. Launch the DLE Rev13 Software and log in as Editor. 6. Import the Medication List (page 29). 7. Import the Drug Libraries (page 31). Getting Started 22 Exporting Medication List From DLE Rev11 Software Exporting the Medication List from DLE Rev11 Software to an external .csv or .QCoreMDL format file, can be done as follows. > To E x po rt a Me d i c a t i on L i st : 1. Launch the previous DLE version, and log in as Editor. 2. From the Medications tab, click Export to Excel. The Save As screen appears. Select a location for the export of the Medication List. 3. Enter a file name. 4. Select .csv or .QCoreMDL format (from the Save As Type field). 5. Click Save. Getting Started 23 6. From the confirmation screen, click OK. The Save As screen closes. The Medication List has been successfully exported to the selected location. Getting Started 24 Exporting Drug Libraries (Worksheets, Archived or Published) From DLE Rev11 Software > To E x po rt a Dru g L i b r a r y : 1. From the Drug Library Directory view, select the required Drug Library (Worksheet, Archived or Published) to export. 2. Click Export. The Save As screen appears. 3. Select a location for the export of the Drug Library. 4. Enter the file name. 5. Click Save. Getting Started 25 6. From the Confirmation screen, click OK. The Save As screen closes. The Drug Library is exported to the selected location. Getting Started 26 Installing the DLE Rev13 Software > To in s ta ll DL E Re v 1 3 S of t w a re : 1. After launching the installer, click Next to continue with the setup wizard. 2. Read the Q Core Drug Library Editor End User License Agreement, and select the checkbox if terms are accepted. IMPORTANT NOTE: This product is subject to the End User License Agreement included therein. When installing the product on your hard drive, you will be requested to accept the terms of such License Agreement. If you do not accept the license agreement, then you may not install or use the product in any way whatsoever. 3. If you wish to create a shortcut on your desktop and start menu, make sure that the relevant checkbox is selected. Getting Started 27 4. Click Install to continue with the setup wizard. 5. If you wish to open the application or open the User Manual, select the corresponding checkboxes. 6. Click Finish. A folder with the Drug Library Editor Software and the User Manual is created. If the DLE Software is required for use on more than one workstation or computer, verify that all relevant users have network access (Read/Write) to the DLE installation location. This will ensure the consistency and the uniformity of the data in the Drug Libraries. Make sure to use a shared folder only, so that it logs all the software-relevant data. Getting Started 28 Importing the Medication List > To I m po rt a Me d i c a t i on L i st : 1. From the Medications tab, click Import from Excel. 2. Navigate to the location of the Medication List to import, and select the desired file. Getting Started 29 3. Click Open. 4. Click OK on the confirmation screen. The Open screen closes and the Medication List is successfully imported to the DLE Software. Getting Started 30 Importing the Drug Libraries > To I m po rt a Dru g L i b r a r y : 1. From the Drug Libraries tab, click Import. Getting Started 31 The Open screen appears. 2. Navigate to the location of the Drug Library to import, and select the desired file. 3. Click Open. 4. Click OK on the confirmation screen. The Open screen closes and the newly imported Worksheet appears in the Drug Library Directory view. Getting Started 32 > Wh e n I m po rtin g a D r u g L i b r a r y f rom D L E Rev 1 1 Soft w are t o DL E Rev1 3 S o ftw a re : 1. CCA settings and medication entry parameters that were not supported in DLE Rev11 Software will be set to the DLE Rev13 default values when the Drug Library is imported into DLE Rev13 Software. The following message is prompted: 2. Click OK to confirm the import, or Cancel to abort. Please note that the Automatic Patient Lockout parameter will also revert to default value (Off) when imported to DLE Rev13 software. For details regarding new/unsupported CCA settings and their default values, refer to Appendix B: New/Unsupported CCA Settings on page 183. When importing a library with more than 8,500 unique medication rule sets, remove the extra rule sets before finalizing the Drug Library. Getting Started 33 Chapter 3: Logging In and Out The following section explains the procedure of logging in and out of the DLE Software: Logging Into the DLE Software ................................................................... 34 Logging Out and Exiting the DLE Software .................................................. 36 Logging Into the DLE Software This section explains how to log into the DLE Software. > To lo g in to th e D L E S of t w a re : 1. Double click the DLE Software icon in the directory where the application was installed, or its shortcut on the desktop. Alternatively, select the DLE Software shortcut in the Start menu, if available. 2. Enter one of the following User IDs and Password (password may contain 8-20 characters). • User ID: Editor Password: Please contact your local distributor service representative to obtain the password. User ID: Loader Password: Please contact your local distributor service representative to obtain the password. User ID: Admin Password: Please contact your local distributor service representative to obtain the password. • • For details regarding different User IDs, refer to Users Roles and Privileges on page 181 Logging In and Out 34 Both the user ID and Password fields are case sensitive. 3. Click Log In. 4. The screen will display a different view according to the user authorization: • Editor User ID: the main screen displays two main tabs - Drug Libraries and Medications. Refer to Chapter 3: Logging In and Out on page 34 through Chapter 10: Reports on page 161 for relevant Editor user functions. Loader User ID: the main screen displays Devices. Refer to Chapter 11: Uploading a Drug Library on page 171 for relevant Loader user functions. Admin User ID: the Set Passwords screen is displayed. Refer to Appendix A: Users Role and Privileges on page 181 for relevant Admin user functions. • • Logging In and Out 35 Logging Out and Exiting the DLE Software This section explains how to log out and exit the DLE Software. Logging out will enable logging in as a different user, and exit will close the software, all changes are saved. > To L o g O u t o f the D L E S of t w a re : 1. To log out of the application, click Log Out. 2. From the Confirmation screen, click OK. > To E x it th e DL E S of t w a re : 1. From any screen, click Exit. Logging In and Out 36 2. From the confirmation screen, click OK. The application is closed. Logging In and Out 37 Chapter 4: Medication List The following section explains the procedure of creating, importing and managing a medication list: Overview ................................................................................................. Parameters in the Medications Tab ............................................................ Working with the Medication List .............................................................. Medication Search Options ....................................................................... Medication List Report .............................................................................. 38 38 40 52 53 Overview The Medications tab contains a list of medications used by the hospital, with information of their recommended strength and volume. These data elements are used in the Drug Libraries that define the rules for the pump. Parameters in the Medications Tab The Medications tab parameters are described in the following table. Parameter Description/Notes Maximum characters Generic Name Medication name (the active ingredient of the medicine) 31 characters Brand Name Medication brand name (the trade name the manufacturer gives the medicine) 31 characters External ID External Identifier (the facility's identifier for a medication) 31 characters Medication List 38 Parameter Description/Notes Maximum characters Strength Strength amount and unit 10 numeric characters + units (grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq) Volume Volume amount and unit 10 numeric characters+ units (mL) NDC National Drug Code 31 characters Received/Updated The date and time the medication was added to the DLE Software. (Automatically added by the software) Identifying Medications in the Medication List The Medication List requires each medication to have an External Identifier (ID), which must be unique. Attempting to use an External ID that is already being used in the system will prompt an error message indicating that the External ID is in use by another medication, and will inform of the medication it is in use with. Medication List 39 Working with the Medication List Add a Medication A single medication can be added to the Medications List view as follows: > To a dd a n e w m ed i c a t i on t o t h e me d i c a t i on l i s t : 1. From the Medications tab, click Add. The Add Medication screen appears. 2. Enter the Medication Name, into the Generic Name field. This field is mandatory. 3. Enter the Brand Name (optional field). Medication List 40 4. Enter the External ID. This field is mandatory. 5. Enter the NDC (optional field). 6. Enter the Strength Amount (optional field). 7. Select the appropriate Strength Unit (optional field). 8. Enter the Volume Amount (optional field). 9. Select the appropriate Volume Unit (optional field). A Generic Name can be identical for different medications, as long as the External ID is unique. 10. Click Add to confirm. The new medication is added to the Medication List view. Received/Updated column will be updated automatically after the medication has been added. Medication List 41 Edit a Medication A medication can be edited from the Medication List view as follows: > To e dit a m e d ic at i on : 1. From the Medications tab, highlight a medication to edit. 2. Click Edit. Alternatively, double click on the medication to edit. The Edit Medication screen appears. 3. From the Edit Medication screen, edit the medication details. 4. Click Save to confirm changes. The new medication information will be updated in the Medication List view. Medication List 42 Delete a Medication A medication can be deleted from the Medications List view as follows: > To de le te a m e d i c a t i on : 1. From the Medications tab, highlight the medication you wish to delete. 2. Click Delete. 3. The Delete Medication screen appears, displaying the medication information in "read only" format. Medication List 43 4. From the Delete Medication screen, click Delete. The medication will be deleted only from the Medication List. If the medication is in use by the Drug Library, and should be removed completely, delete the medication entry from the Drug Library as well. For details regarding deleting a medication entry, refer to Deleting Medication Entries (Rule Sets) on page 127. Creating, Importing and Exporting a Medication List This section explains how to import and export a Medication List file. The Medication List file contains a complete list of all the medications that are being used at the hospital and can be infused by the Sapphire pump. A Medication List file may be imported into the DLE Software multiple times. Each import file should contain all the medications, even if they have been previously imported. Medication List file format Importing a Medication List involves the creation of a Comma Separated Value (.csv) file containing the medication information. Your pharmacy system may support the creation of such a file or any similar format that can then be imported into Excel. The file must contain 6 columns as specified below. • The first line of the file contains the field names as described in the following table, and is ignored by the Medication List Import function. • Each subsequent line in the file should include one medication entry. • Each subsequent line in the file must include data in the Generic Name and External ID fields. External ID and Generic Name are the only mandatory fields. However, the imported file must contain 6 columns, whether or not data was entered in all of them. The import and export can support English characters only. Medication List 44 Generic Name Brand Name External ID Up to 31 characters Up to 31 characters Up to 31 characters Strength Volume NDC Up to 10 numeric characters + units (grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq) Up to 10 numeric characters + units (mL) Up to 31 characters The Medication List can be created as an Excel spreadsheet and saved in .csv format. The following is an example of a 6-column spreadsheet containing the medication list information: Medication List 45 Considerations for the Medication List Import File in .csv format > To e n s u re a Me d i c a t i on L i s t f i l e i s re a d y for i m por t : 1. Save the file to .csv format. Extracts from information systems are commonly Excel files, tab separated files, or pipe-separated files. Each of these can be saved as a .csv file using Excel. 2. Ensure the 6 required columns are in the file in the correct order. 3. Remove any other rows or columns that do not contain required data. 4. Ensure the following data specifications are met: • An External ID for each drug is entered. • A Generic Name that does not contain strength or volume information. 5. It is recommended to remove incompatible medications that cannot be infused by the Sapphire pump. 6. Format the columns in the file to match the import file specifications: • Ensure that all the columns are present and named exactly as they were defined before (case sensitive), even if they do not contain any data. • Ensure that columns are in the proper order. 7. Ensure only English characters are in use. Final check: a. Sort file by External ID. b. A particular External ID should only appear in one row in the file. c. Ensure that each medication has data in both the External ID and Generic Name columns. d. A Generic Name can appear multiple times in the file with different External IDs. Medication List 46 Importing the Medication List Once the file has been formatted as described above, import it to the DLE Software. Medications with new IDs will be added to the current Medication List. Medications with IDs that already exist on the Medication List will be updated with the new definitions. > To I m po rt a Me d i c a t i on L i st : 1. From the Medications tab, click Import from Excel. Medication List 47 2. Navigate to the location of the Medication List to import. 3. Click Open. 4. Click OK on the confirmation screen. Received/Updated column will be filled automatically after the Medication List has been added. The Open screen closes and the Medication List has been successfully imported to the DLE Software. Once completed, the import of the Medication List cannot be undone. Medication List 48 If the Medication List was not imported successfully to the DLE Software, refer to Medication List file format on page 44 to correct the Medication List file accordingly. The following table summarizes the DLE Software behavior when a new medication list is imported, and there are already medications present on the list: Medication ID is present in the Medication List Medication ID is present in the new import file Result Yes No Not changed Yes Yes Update No Yes Added Medication List 49 Export a Medication List Exporting the Medication List from the DLE Software to an external .csv or .QCoreMDL format file, can be done as follows: > To E x po rt a Me d i c a t i on L i st : 1. From the Medications tab, click Export to Excel. Medication List 50 The Save As screen appears. 2. Select a location for the export of the Medication List. 3. Enter the file name. 4. Select .csv or .QCoreMDL format (from the Save As Type field). The Medication List can only be exported to .csv and .QCoreMDL formats. 5. Click Save. 6. From the confirmation screen, click OK. The Save As screen closes. The Medication List has been successfully exported to the selected location. Medication List 51 Medication Search Options The displayed medications can be filtered according to: • Any generic name or external ID - displays the complete medications list. a. Select Any generic name or external ID from the dropdown list. b. Click Apply. • Generic names beginning with (any character) - displays a filtered list of medications beginning with the character entered. a. Select Generic names beginning with (any character) from the dropdown list. b. Enter the required character in the search box. c. Click Apply. • External IDs beginning with (any character) - displays a filtered list of medications beginning with the External ID character entered. a. Select External IDs beginning with (any character) from the dropdown list. b. Enter the required character in the search box. c. Click Apply. Medication List 52 Medication List Report Reports can be saved as a .csv format file according to the data currently displayed on the screen. > To s a ve a re p o rt i n . c sv f or ma t : 1. From the Medications tab, click Export to Excel. The Save As screen appears. 2. Select a location for the export of the Medication List. Medication List 53 3. Enter a file name. 4. Select .csv format and click Save. 5. From the confirmation screen, click OK. Medication List 54 Chapter 5: Drug Library Directory The following sections explain the structure and function of the Drug Library Directory view: Overview ................................................................................................. 55 Storing Options in the Drug Library ............................................................ 55 Parameters in the Drug Library Directory View ............................................ 56 Working with the Drug Library Directory .................................................... 58 Overview A Drug Library is a collection of medication names, rule sets, Clinical Care Areas (CCAs), and Sapphire pump settings. Storing Options in the Drug Library The DLE Software can store Drug Libraries in three states: 1. Worksheets - A Worksheet is a Drug Library that has not yet been approved (finalized) for transfer to the Sapphire pump. Multiple Worksheets can be stored in the DLE Software; however, only one Worksheet can be edited at a time. 2. Published - A Published Drug Library is a Worksheet that has been finalized. Once a Worksheet has been finalized, no more changes can be done to it. Only a Published Drug Library can be uploaded to the Sapphire pump and only one Published Drug Library can exist at a time in the DLE Software (the former Published Drug Library will be archived). Finalizing is the process of converting a Worksheet into a Published Drug Library. For details regarding finalization, refer to Finalizing a Worksheet on page 133. Drug Library Directory 55 3. Archived - A previously Published Drug Library that has been deactivated can no longer be uploaded to the Sapphire pump. Archived Drug Libraries can be copied but cannot be edited or uploaded to the Sapphire pump. In order to create a complete Drug Library, CCA names, pump settings and medication entries must exist in the Worksheet. Worksheets, Published or Archived Drug Libraries, can be created in the following ways: • By creating a new, blank Worksheet. • By copying an existing Worksheet, Published or Archived Drug Libraries. • By importing a .QCoreDL file, which will then be converted to a Worksheet by the DLE Software. Parameters in the Drug Library Directory View The Drug Library Directory view lists the Published Drug Library, and all the Worksheets and Archived Drug Libraries in the DLE Software. The following parameters are displayed in the Drug Library Directory view: Parameter Description Infuser Type Name of the pump compatible with the Drug Library. Drug Library A unique library name Note: The maximum allowed characters is 15. The Drug Library name will be displayed on the Sapphire pump. Status Categorized as one of the following: • Worksheet • Published • Archived Date Modified The date and time the Drug Library was last modified (created automatically by the software). Drug Library Directory 56 Parameter Description Data Finalized The date and time the Drug Library was finalized (created automatically by the software). Note: This field is blank if the Drug Library is a Worksheet. Library Notes Additional information and notes about the Drug Library entered by the user. The Drug Library name cannot be edited after the library is created. Drug Library Directory Conventions The Drug Library Directory uses the following conventions: • Columns in the Drug Library Directory view can be sorted in either ascending or descending order by clicking on the column heading. • Use the vertical and horizontal scroll bar(s) to scroll to an entry. • When highlighting an entry on the Drug Library Directory view, buttons or features that are not available appear disabled. Drug Library Directory 57 Working with the Drug Library Directory Creating a Worksheet A worksheet can be added as follows: > To a dd a n e w Wo r k sh e e t t o t h e D r u g L i b rar i es : 1. From the Drug Library Directory view, click Create. The Create Worksheet screen appears. 2. Enter a Drug Library name. Only English alpha-numeric characters (lower case and upper case) and the following symbols may be used in the Drug Library name field: (, ), -, _, space. Drug Library Directory 58 3. Enter notes and comments (optional). Notes may contain helpful hints to assist in building the Drug Library. 4. Click OK. The Create Worksheet screen closes and the entry appears in the Drug Library Directory view. Drug Library Directory 59 Editing a Worksheet A worksheet can be edited as follows: > To E dit a Wo rk s h e e t : 1. From the Drug Library Directory view, highlight the required Worksheet to edit. 2. Click Edit. Alternatively, double click on the Worksheet name. The Drug Library Management screen appears. Drug Library Directory 60 3. Edit the appropriate parameters. 4. Click Close to return to the Drug Library Directory view. The modifications are saved and the Drug Library Directory view is displayed. For details regarding Editing Worksheets, refer to Chapter 8: Drug Library Management on page 112. Drug Library Directory 61 Adding or Editing Notes to a Worksheet > To a dd o r e dit n ot e s t o a w or k s h e e t : 1. From the Drug Library Directory view, highlight the required Worksheet. 2. Click Notes. The Notes screen appears. 3. In the Notes field, edit or add comments. 4. Click OK to confirm. The note is saved and appears in the Library Notes field of the Drug Library Directory view. The Notes field can be modified only in a Worksheet. Drug Library Directory 62 Deleting a Worksheet or an Archived Drug Library A Worksheet or an Archived Drug Library may be deleted from the Drug Library Directory view. When deleting a Drug Library, it is permanently removed from the software. > To de le te a Wo rks h e e t or a n A rc h i v e d D r ug L i br ar y : 1. From the Drug Library Directory view, highlight the required Worksheet or Archived Drug Library to delete. 2. Click Delete. Deleting a Drug Library will remove it from the DLE Software permanently. Exporting and saving the Drug Library is recommended prior to deletion. Drug Library Directory 63 The Delete Library screen appears. 3. Click OK to confirm. The Worksheet or the Archived Drug Library is permanently deleted and the Drug Library Directory view appears. Drug Library Directory 64 Viewing a Drug Library The View option allows viewing the parameters of the selected Drug Library. When viewing the Drug Library, changes cannot be made. > To v ie w a Dru g L i b r a r y : 1. From the Drug Library Directory view, highlight the required Worksheet, Archived or Published Drug Library. 2. Click View. Drug Library Directory 65 The Drug Library Management view appears. 3. Click Close to return to the Drug Library Directory view. Drug Library Directory 66 Copying Worksheets, Archived or Published Drug Libraries In order to facilitate the creation, or updating of a Drug Library, you may copy Published or Archived Drug Libraries, as well as Worksheets. When copying a Drug Library, all medications entries and CCA settings are included. The copied Drug Library appears as a new Worksheet on the Drug Library Directory view, and must be finalized in order to become available for uploading to the Sapphire pump. > To Co p y a Wo rk s h e e t , A rc h i v e d L i b r a r y or Publ i s hed L i br ar y : 1. From the Drug Library Directory view, highlight the required Worksheet, Archived or Published Drug Library to copy. 2. Click Copy. The Copy Drug Library screen appears. Drug Library Directory 67 3. In the Drug Library field, enter the name of the new Drug Library. Only English alpha-numeric characters (lower case and upper case) and the following symbols may be used in the Drug Library name field: (, ), -, _, space. 4. In the Notes field, add comments (optional). 5. Click OK to confirm. The Drug Library is copied. The new Worksheet appears in the Drug Library Directory view. Drug Library Directory 68 Backup and Export Drug Libraries (Worksheets, Archived or Published) Export Drug Libraries (Worksheets, Archived or Published) in order to create a backup copy, or to share them on other workstations. All the medication entries, CCA settings and Security settings are included in the exported file that can be saved to an external location on the computer or hard drive in a .QCoreDL file format. > To E x po rt a Dru g L i b r a r y : 1. From the Drug Library Directory view, highlight the required Worksheet, Archived or Published Drug Library to export. 2. Click Export. Drug Library Directory 69 The Save As screen appears. 3. Select a location for the export of the Drug Library. 4. Enter the file name. 5. Click Save. 6. From the Confirmation screen, click OK. The Save As screen closes. The Drug Library is exported to the selected location. Drug Library Directory 70 Import and Restore a Drug Library The DLE Software allows the user to restore a Drug Library from a .QCoreDL file that was created and exported by a DLE Software workstation, for backup purposes, or in order to share it on other workstations. The software updates the drug library data structure; then, fully validates the data ranges, precision and relationships before importing the Drug Library. When a Drug Library is imported, it becomes a Worksheet and it must be Finalized in order to be uploaded to the Sapphire pump. > To I m po rt a Dru g L i b r a r y : 1. From the Drug Library Directory view, click Import. Drug Library Directory 71 The Open screen appears. 2. Navigate to the location of the Drug Library to import. Then, click Open. Enter information into the Notes field, if required. 3. From the confirmation screen, click OK. Drug Library Directory 72 The Open screen closes and a newly imported Worksheet appears in the Drug Library Directory view. When importing a Drug Library from DLE Rev11 Software to DLE Rev13 Software, CCA settings and medication entry parameters that were not supported in DLE Rev11 Software will be set to DLE Rev13 defaults. The following message is prompted: Click OK to confirm the import or Cancel to abort. Please note that the Automatic Patient Lockout parameter will also revert to default value (Off) when imported to DLE Rev13 Software.For details regarding new/unsupported CCA settings and their default values, refer to Appendix B: New/Unsupported CCA Settings on page 183. Drug Library Directory 73 Export Log Export the DLE Software log in order to view the changes that were done to the Drug Library. The export log creates .csv file summarizing all the changes made to a specific Worksheet, Archived or Published Drug Library, concerning CCA, medication entries and finalizing status. The .csv file contains the following information: Parameters Description/Notes Event Time The date and time when the change has been done Event The change that has been done User The user that has made the change > To E x po rt a L o g : 1. From the Drug Library Directory view, highlight the required Worksheet, Archived or Published Drug Library. 2. Click Export Log. Drug Library Directory 74 The Save As screen appears. 3. Select a location for the Drug Library log to be exported. 4. Click Save. 5. From the confirmation screen, click OK. 6. The Save As screen closes. The Drug Library log is exported to the selected location. Drug Library Directory 75 Chapter 6: Setting Up CCAs The following sections explain the work procedure used for creating and setting up CCAs, the importance of a Service Line, the special features of Infusion Modes that can be enabled and disabled and definition of Sapphire pump’s hard limits according to user requirements: Overview ................................................................................................. 76 Parameters in the CCA Setup Tab ............................................................... 76 Working with CCA Setup ........................................................................... 78 CCA Settings ............................................................................................ 87 Overview CCA Setup defines the Sapphire pump configuration settings according to the facility requirements. Before adding medication entries to a CCA, a CCA must be added to the Worksheet. Up to 40 CCAs can be added. Parameters in the CCA Setup Tab The following parameters are relevant for the CCA Setup tab: Parameters Description/Notes CCA The name of the Clinical Care Area. Note: The maximum allowed characters is 15. The CCA name will be displayed on the Sapphire pump. Service Line The name of the selected service line. Notes Additional information and notes about the CCA entered by the user. Setting Up CCAs 76 Service Lines When defining a CCA, a Service Line must be selected. The Service Line will be displayed in the DLE Software reports. The following Service Lines are available for use: • • • • • • • • • • • • • • • • • • • • • Ambulatory Anesthesia BehavioralHealth BoneMarrowTransplant BurnUnit EarNoseThroat EmergencyServices Endocrinology Eye Geriatric Hematology IcuCardiac IcuGeneral IcuMedical IcuNeonatal IcuPediatric IcuSurgical LaborAndDelivery MedicineAdult MedicineNeonatal MedicinePediatric • • • • • • • • • • • • • • • • • • • • • ObstetricsGynecology OncologyAdult OncologyPediatric Orthopedics OutPatientSurgery PainManagement Rehabilitation Renal ShortStay SkilledNursing SpecialProcedures SurgicalAdult SurgicalCardioVascular SurgicalPediatric Telemetry TransfusionCenter Transplant Trauma Urology MultipleServiceLine OtherSpecialty The contents of the service line list cannot be changed or edited. Setting Up CCAs 77 Working with CCA Setup To display the CCA Setup view, open a Worksheet for editing and click the CCA Setup tab. For details on opening a Worksheet, refer to Chapter 5: Drug Library Directory on page 55. Creating a New CCA > To c re a te a n e w C C A : 1. From the CCA Setup view, click Add. Setting Up CCAs 78 The Add CCA Name and Notes screen appears. 2. Enter a CCA Name. This field is mandatory. Only English alpha-numeric characters (lower case and upper case) and the following symbols may be used in the CCA Name field: ., %, /, #, *, &, (, ), +, -, _, space. 3. Select a Service Line from the dropdown list. This field is mandatory. 4. Enter notes and comments (optional). 5. In order to save and create the next CCA, click on Save & Add Another. Repeat steps 3-6 of this procedure. 6. When finished, click Save & Close. The Add CCA Name and Notes screen closes and the entry appears in the CCA Setup view. Setting Up CCAs 79 Editing a CCA > To E dit a CCA, a S e r v i c e L i n e or a N ot e : 1. From the CCA Setup view, highlight the required CCA to edit. 2. Click Edit. Alternatively, double click on the CCA name. The Edit CCA Name and Notes screen appears. 3. Edit the appropriate parameters; CCA name, service line or note. 4. In order to save and edit the next CCA, click on Save & Edit Next. Repeat Step 3 of this procedure. Setting Up CCAs 80 5. When finished, click on Save & Close. The Edit CCA Name and Notes screen closes and the changes appear in the CCA Setup view. Setting Up CCAs 81 Viewing a CCA > To V ie w a CCA: 1. From the CCA Setup view, highlight the required CCA to view. 2. Click View. The View CCA Name and Notes screen appears. 3. In order to view the next CCA, click on View Next. 4. When finished, click on Close. Setting Up CCAs 82 Deleting a CCA > To De le te a CCA : 1. From the CCA Setup view, highlight the required CCA to delete. 2. Click Delete. The Delete CCA Name and Notes screen appears. 3. Click Delete. Setting Up CCAs 83 The CCA is permanently deleted from the worksheet. Medication entries assigned to the deleted CCA will remain in the Master Drug Formulary and any other CCAs to which they were assigned. Setting Up CCAs 84 Changing the Display Order of CCA Names > To c h a n ge th e di sp l a y ord e r of C C A n a mes : 1. From the CCA Setup view, click Arrange CCA Names The Arrange CCA Names screen appears. 2. Highlight the required CCA to move. Setting Up CCAs 85 3. Click Move Up or Move Down to reorder the list as required. Reordering CCA names affects only the DLE Software view. 4. Click Save. The Arrange CCA Names screen closes and the new CCA order will be displayed in the CCA Setup view. Select multiple CCAs by selecting the first CCA you wish to move, and then holding the shift key while clicking the last CCA to move. Setting Up CCAs 86 CCA Settings Each CCA can have Sapphire pump specific configuration settings according to the clinical practice requirements. These settings include the System Settings, Alarm Settings, Mode Options, KVO Settings, Hard Limits, Delivery Mode enabling and Dosing Units selection. A new CCA will contain the default Sapphire pump settings until they are changed. The CCA settings apply to all medications in the CCA. > To de fin e CCA s et t i n g s: 1. From the CCA Setup view, highlight the required CCA. 2. Click CCA Settings. Setting Up CCAs 87 3. The CCA Settings screen appears. The settings are arranged in seven separate tabs: • • • • • • • System Settings Alarm Settings Mode Options KVO Settings Hard Limits Delivery Modes Dosing Units 4. Edit the required information. Any entered value that is out of the permitted range will appear in red. 5. When finished, click Save & Close. Setting Up CCAs 88 Restore Options The Restore Defaults and Restore All buttons appear in all of the tabs. Clicking the Restore Defaults button restores settings on the specific viewed tab to their default values. Clicking the Restore All button restores all CCA settings (all seven tabs) to their default values. Setting Up CCAs 89 System Settings The System Settings tab allows viewing and modifying basic pump settings. These settings can be modified according to the clinical requirements. The following settings appear in the System Settings tab: To Modify Parameter Default Value Allows the user to associate an infusion with patient identification parameters. Select On or Off. Off Calculate Concentration Determines if the user enters a final concentration, or Drug Amount and Diluent Volume. Select On or Off. Off Prime Reminder Enables a reminder for the pump user to prime the administration set before starting an infusion. Select On or Off. Off Parameter Description/Notes New Patient Setting Up CCAs 90 To Modify Parameter Default Value Enables a reminder for the pump user to connect the bolus handle before starting a PCA, PCEA or PIEB infusion that includes patient boluses. The reminder (i) Instructs to connect the bolus handle directly to the pump. (ii) Checks functionality – bolus press is recognized by the pump. Select On or Off. Off Allow Delayed Start Enables the user to start an infusion at a later time. The user may either define a specific delay period, or set the pump to Standby. Select On or Off. Off Automatic Patient Lockout A safety feature that enables automatic locking of the screen. A password is required to unlock the screen in order to make changes to the infusion parameters, or to start a new infusion. Activated first during a running infusion. Select On or Off. Off Medium Titration Allows a user with medium authorization level to change rate during a running infusion. Select On or Off. Off US Format Sets the pump date and time to US format. Date will appear as month/day/ year, and time will appear in 12 hour format (am/pm). Select On or Off. Off Parameter Description/Notes Bolus Reminder Setting Up CCAs 91 To Modify Parameter Default Value Provides a distant view of the main parameters during a running infusion. Select On or Off. Off Backlight Allows the user to set the degree of screen brightness for a running infusion. The Off and Partial options of this feature save power and promote longer battery life. Select On, Off or Partial On Keys volume Sets the speaker volume for the auditory signal generated, when the user selects functions and presses keys on the pump. Select Low, High or Off. High Alarm Volume Sets the speaker volume for the auditory alarm signal. Select Minimum or Maximum. Maximum Bolus Handle Sets the Bolus auditory signal, generated when the bolus handle is pressed. When the option is set to Always On, the bolus auditory signal is generated each time the bolus handle is pressed. When set to When Bolusing, an auditory signal is generated when the bolus handle is pressed and Bolus is available. select Always On or When Bolusing. Always On Parameter Description/Notes Screen Saver Setting Up CCAs 92 To Modify Parameter Default Value Allows the user to start infusions, using the same infusion parameters for the same patient. When the option is enabled, the Repeat Last Infusion button appears on the pump Start Up screen. Select On or Off. On Preprogram Allows the user to start an infusion, using predefined infusion parameters. When the option is enabled, the PreSet Programs button appears on the pump Start Up screen. Select On or Off. Off Single Air Detector* Defines the minimal size of a single bubble that triggers an "Air in line" alarm. Select 0.02 mL, 0.04 mL, 0.05 mL, 0.1 mL, 0.2 mL, 0.5 mL or Off. Off Accumulated Air Detector Defines the minimal size of a single bubble to be counted as part of a threshold volume. Select 0.02 mL, 0.04 mL, 0.05 mL, 0.1 mL, 0.2 mL or 0.5 mL. 0.5 mL Accumulated Threshold* Defines the threshold volume – within 15 minutes – that will trigger "Air in line" alarm. Select 0.5 mL, 1 mL or Off. 1 mL Prime Volume The amount of fluid used to prime the administration set when automatic priming is performed. Enter the required value. 2-25 mL in increments of 1 mL. 20 mL Parameter Description/Notes Repeat Last Infusion * Single air detector and Accumulated Threshold cannot be set to Off simultaneously, unless the only available Delivery Modes are Epidural. Click Save & Continue to save the settings and define the settings of the next tab. Click Save & Close to save the settings and exit the CCA Settings menu. Setting Up CCAs 93 Alarm Settings The Alarm Settings tab allows viewing and modifying alarm-related options. These settings can be modified according to clinical requirements. The following settings appear in the Alarm Settings tab: Parameter Description/Notes To Modify Parameter Default Value Occlusion units The format of occlusion units Select BAR, PSI or mmHg BAR Occlusion Pressure The minimum pressure that triggers an Occlusion alarm. Enter the required value. 5.8 PSI, 0.4 BAR or 300 mmHg Occlusion Auto Restart Enables the pump to automatically restart an infusion, up to 5 times an hour, if a downstream occlusion was detected and cleared within 40 seconds. Select On or Off. On Setting Up CCAs 94 To Modify Parameter Default Value The number of consecutive minutes of no interaction with the pump after which a Pump Unattended alarm is triggered. Select 2 min, 5 min or 10 min. 10 min The number of minutes before completion of an infusion at which an Infusion Near End alarm is generated. Select 1 min, 3 min, 5 min, 10 min or Off. 10 min Parameter Description/Notes Pump Unattended Infusion Near End Click Save & Continue to save the settings and define the settings of the next tab. Click Save & Close to save the settings and exit the CCA Settings menu. Setting Up CCAs 95 Mode Options The Mode Options tab allows viewing and modifying mode-specific options. These settings can be modified according to the clinical requirements. The following settings appear in the Mode Options tab: Delivery Mode Parameter Description/Notes Continuous Allow Bolus Allows the user to program a bolus during a Continuous infusion. When this feature is enabled, the Bolus button appears in the pump tool bar during a running infusion. Setting Up CCAs To Modify Parameter Default Value Select On or Off. Off 96 Delivery Mode To Modify Parameter Default Value Allows the user to program a bolus by entering rate, amount and time. When this option is disabled, the bolus is programmed by amount only, and the rate is the default bolus rate. The option is available only when Allow Bolus is enabled. Applicable only for the Continuous delivery mode. Select On or Off. Off Primary Bolus Rate The rate of delivery of a fast dose for a primary infusion. Enter the required value. 1-99.9 mL/h in increments of 0.1 mL/h 100-999 mL/h in increments of 1 mL/h 125 mL/h Continuous Set Secondary Allows the user to program a secondary infusion. Select On or Off Off Continuous Secondary Bolus Rate The rate of delivery of a fast dose for a Secondary infusion. Enter the required value. 1-99.9 mL/h in increments of 0.1 mL/h 100-500 mL/h in increments of 1 mL/h 125 mL/h Parameter Description/Notes Continuous Advanced Bolus Continuous Setting Up CCAs 97 Delivery Mode Parameter Description/Notes To Modify Parameter Default Value PCA Bolus Rate The rate at which a bolus (Patient bolus, Clinician bolus and Loading dose) is delivered. Enter the required value. 0.1-99.9 mL/h in increments of 0.1 mL/h 100-600 mL/h in increments of 1 mL/h 125 mL/h PCA Allow Loading Dose Enables the user to program a loading dose (starting the infusion with a clinician bolus). Select On or Off On PCA Infusion Type Defines the PCA infusion type that is available for the user. Select Cont.+ Bolus, Cont. or Bolus. Cont.+ Bolus PCA Limit Period Specifies the time period to which the dose limit type is applied. Select 1 Hour or 4 Hours. 1 Hour PCEA Bolus Rate The rate at which a bolus (Patient bolus, Clinician bolus and Loading dose) is delivered. Select 125 mL/h or 200 mL/h 125 mL/h PCEA Password Request Enables a safety feature that requires high authorization level password entry for programming and editing actions. Select Yes or No No Setting Up CCAs 98 Delivery Mode To Modify Parameter Default Value Enables the user to program a loading dose (starting the infusion with a clinician bolus). Select On or Off On Infusion Type Defines the PCEA infusion type that is available for the user. Select Cont.+ Bolus, Cont. or Bolus. Cont.+ Bolus PCEA Limit Period Specifies the time period to which the dose limit type is applied. Select 1 Hour or 4 Hours 1 Hour Epidural Intermittent Dose Rate Defines the rate of dose delivery during an Epidural Intermittent infusion. Select 125 mL/h or 200 mL/h 125 mL/h Epidural Intermittent Password Request Enables a safety feature that requires high authorization level password entry for programming and editing actions. Select Yes or No. No Epidural Intermittent Limit Period Specifies the time period to which the dose limit type is applied during PIEB infusion. Select 1 Hour or 4 Hours 1 Hour Epidural Intermittent PIEB Enables the user to program a PIEB infusion. Select On or Off Off Parameter Description/Notes PCEA Allow Loading Dose PCEA Click Save & Continue to save the settings and define the settings of the next tab. Click Save & Close to save the settings and exit the CCA Settings menu. Setting Up CCAs 99 KVO Settings The KVO Settings tab allows viewing and modifying the default rate of fluid that is delivered when the infusion program is completed, to prevent clotting in the infusion cannula. The following settings appear in the KVO Settings tab: Default Value Parameter Description/Notes To modify Parameter Continuous Mode KVO Determines the KVO rate at the end of a continuous infusion. Enter the required value. 0, 0.1-20 mL/h in increments of 0.1 mL/h 3 mL/h Multi-Step Mode KVO Determines the KVO rate at the end of a multi-step infusion. Enter the required value. 0, 0.1-20 mL/h in increments of 0.1 mL/h 3 mL/h PCA Mode KVO Determines the KVO rate at the end of a PCA infusion. Enter the required value. 0, 0.1-20 mL/h in increments of 0.1 mL/h 0 mL/h PCEA Mode KVO Determines the KVO rate at the end of a PCEA infusion. Enter the required value. 0, 0.1-20 mL/h in increments of 0.1 mL/h 0 mL/h Click Save & Continue to save the settings and define the settings of the next tab. Click Save & Close to save the settings and exit the CCA Settings menu. Setting Up CCAs 100 Hard Limits The hard limits are the acceptable range of a given parameter. The Hard Limits tab allows viewing and modifying the upper limit of each parameter, with the exception of bolus lockout (in which both lower and upper limits are editable). The hard limits and the permitted ranges of a parameter are mode-specific. Hard Limit parameters for Continuous (including Secondary), Multi-step, Intermittent, Epidural Intermittent, PCA and PCEA Delivery Modes are presented in the following table: Delivery Mode Description/ Parameter Notes Continuous VTBI The total amount Enter the required value. of fluid to be 1-9999 mL in increments infused. of 1 mL 9999 mL Continuous Rate The speed at Enter the required value. which the fluid is 0.1-99.9 mL/h in infused. increments of 0.1 mL/h 100-999 mL/h in increments of 1 mL/h 999 mL/h Setting Up CCAs To modify Parameter Default Value 101 Delivery Mode Description/ Parameter Notes Secondary VTBI The total amount Enter the required value. of fluid to be 1-9999 mL in increments infused. of 1 mL 9999 mL Secondary Rate The speed at Enter the required value. which the fluid is 0.1-99.9 mL/h in infused. increments of 0.1 mL/h 100-500 mL/h in increments of 1 mL/h 500 mL/h Multi-step VTBI The total amount Enter the required value. of fluid to be 1-9999 mL in increments infused. of 1 mL 9999 mL Multi-step Rate The speed at Enter the required value. which the fluid is 0.1-99.9 mL/h in infused. increments of 0.1 mL/h 100-999 mL/h in increments of 1 mL/h 999 mL/h Multi-step Time The period of time over which the fluid is infused. Intermittent VTBI The total amount Enter the required value. of fluid to be 1-9999 mL in increments infused. of 1 mL 9999 mL Intermittent Maximum Dose Time Enter the required value. The amount of time in which the 00:01-96:00 h:min in dose is increments of 00:01 min delivered. 96:00 [h:min] Intermittent Intermittent The amount of Dose each dose. Epidural Intermittent VTBI Setting Up CCAs To modify Parameter Enter the required value. 00:01-24:00 h:min in increments of 00:01 min Default Value 24:00 [h:min] Enter the required value. 999 mL 0.1-99.9 mL in increments of 0.1 mL 100-999 mL in increments of 1 mL The total amount Enter the required value. of fluid to be 1-9999 mL in increments infused. of 1 mL 9999 mL 102 Delivery Mode Description/ Parameter Notes Epidural Intermittent Intermittent The amount of Dose each dose. Enter the required value. 0.1-30 mL in increments of 0.1 mL 20 mL Epidural Intermittent Enter the required value. Demand The amount of Bolus (PIEB) fluid infused in a 0.1-30 mL in increments single bolus. of 0.1 mL Applies also to Clinician Bolus. 20 mL Epidural Intermittent Bolus Lockout* (PIEB) The minimum and maximum time that must pass between the end of one bolus and the start of the next bolus. PCA VTBI The total amount Enter the required value. of fluid to be 1-9999 mL in increments infused. of 1 mL PCA Continuous The rate of the Rate basal infusion. PCA Demand Bolus Enter the required value. The amount of fluid infused in a 0.1-30 mL in increments single bolus. of 0.1 mL Applies also to Clinician Bolus. 20 mL PCA Loading Dose Enter the required value. An optional feature that starts 0.1-30 mL in increments the infusion with of 0.1 mL a clinician bolus. 20 mL Setting Up CCAs To modify Parameter Enter the required value. 00:01-24:00 h:min in increments of 00:01 min Enter the required value. 0.1-99.9 mL/h in increments of 0.1 mL/h Default Value Minimum 00:01 [h:min] Maximum 24:00 [h:min] 9999 mL 99.9 mL/h 103 Delivery Mode Description/ Parameter Notes PCA Bolus Rate Determined the rate of all the applicable boluses during a PCA infusion (demand or clinician). Enter the required value. 0.1-99.9 mL/h in increments of 0.1 mL/h 100-600 mL/h in increments of 1 mL/h 125 mL/h PCA Bolus Lockout* The minimum and maximum time that must pass between the end of one bolus and the start of the next bolus. Enter the required value. 00:01-24:00 h:min in increments of 00:01 min Minimum 00:01 [h:min] Maximum 24:00 [h:min] PCEA VTBI The total amount Enter the required value. of fluid to be 1-9999 mL in increments infused. of 1 mL PCEA Continuous The rate of the Rate basal infusion. PCEA Demand Bolus Setting Up CCAs To modify Parameter Enter the required value. 0.1-25 mL/h in increments of 0.1 mL/h Enter the required value. The amount of fluid infused in a 0.1-30 mL in increments single bolus. of 0.1 mL Applies also to Clinician Bolus. Default Value 9999 mL 25 mL/h 20 mL 104 Delivery Mode Description/ Parameter Notes PCEA Loading Dose Enter the required value. An optional feature that starts 0.1-30 mL in increments the infusion with of 0.1 mL a clinician bolus. PCEA Bolus Lockout* The minimum and maximum time that must pass between the end of one bolus and the start of the next bolus. To modify Parameter Enter the required value. 00:01-24:00 h:min in increments of 00:01 min Default Value 20 mL Minimum 00:01 [h:min] Maximum 24:00 [h:min] * If the entered value in the minimum lockout field is greater than the entered value in the maximum lockout field, an error message is prompted. Click Save & Continue to save the settings and define the settings of the next tab. Click Save & Close to save the settings and exit the CCA Settings menu. Setting Up CCAs 105 Delivery Modes The DLE Software contains settings that control which delivery modes are available on the Sapphire pump according to the selected CCA. In the Delivery Modes tab view, checkboxes are used to enable each of the following Delivery modes: Parameters to Modify Default Value Enable/disable the Continuous delivery mode. Select On or Off. On Intermittent Enable/disable the Intermittent delivery mode Select On or Off. On TPN Enable/disable the TPN delivery mode Select On or Off. On PCA Enable/ disable the PCA delivery mode Select On or Off. On Multi-step Enable/disable the Multi-step delivery mode Select On or Off. On Parameter Description/Notes Continuous Setting Up CCAs 106 Parameters to Modify Default Value Enable/disable the Epidural Intermittent delivery mode Select On or Off. On Enable/disable the PCEA delivery mode Select On or Off. On Parameter Description/Notes Epidural Intermittent PCEA At least one delivery mode must be enabled. If all delivery modes are disabled, the selected CCA will not be displayed on the Sapphire pump. Make sure that the CCA settings are compatible with the applications used with the Sapphire pumps at your facility. Click Save & Continue to save the settings and define the settings of the next tab. Click Save & Close to save the settings and exit the CCA Settings menu. Setting Up CCAs 107 Dosing Units The Dosing Units tab defines the available dose rate units according to the selected CCA, when the user opts out of the Drug Library, after Choose General is selected on the Sapphire pump. In the Dosing Units tab, checkboxes are used for enabling and disabling each particular dose rate unit. It is also possible to enable and disable dose rate units by category, or by weight based and non-weight based categories. Click Save & Continue to save the settings and define the settings of the next tab. Click Save & Close to save the settings and exit the CCA Settings menu. Setting Up CCAs 108 Chapter 7: Security This chapter reviews the security passwords levels of authorization and explains how to define different security level passwords: Overview ............................................................................................... Security Levels ....................................................................................... PreProgram Password ............................................................................. Managing Security Passwords ................................................................. 109 109 111 111 Overview Security passwords levels control the user’s access to actions and programming options available in the Sapphire pump. These passwords are included in the Drug Library settings that are uploaded to the Sapphire pump. Because the security authorization levels are modular, pump users can access functions according to their authorization level, as well as all functions available to lower authorization levels. Security Levels To ensure patient safety while using the Sapphire pump, the DLE Software can set the following security levels: • Low Level Password: All programming options are disabled, and no settings can be changed. • Medium Level Password: All programming options are disabled, shortcuts such as activate previously entered infusion programs, are enabled. • High Level Password: All the functions and configuration settings are enabled, except for options limited to technician use. Security 109 Technician security level is available in the Sapphire pump as well. The technician password cannot be altered in the DLE Software. Specific actions allowed in each of the security levels are listed in the following table. Authorization Level Allowed Actions Low Stop the pump, and then continue the infusion Turn the pump on and off Administer patient bolus (PCA options) Use the View menu Medium Stop the pump, and then continue an infusion Start infusions using the PreSet Programs feature Start infusions using the Repeat Last Infusion feature Priming with the pump Immediate Taper-down during a TPN infusion (not programmable in DLE) Edit Rate during running infusion (if Medium Titration is enabled) View bolus rate (PCA options) High Start infusions using the New Infusion feature View/Edit parameters Use the Pump Configuration menu Create/Edit PreSet Programs (may require a unique password) Use of all PCA options Changing infusion mode (requires password re-entry) Clinician bolus (requires password re-entry) Do not publish codes to unauthorized people. Do not give access to this publication to home users. Security 110 PreProgram Password The PreProgram password is limited to creating, editing or deleting PreSet Programs. PreProgram password is not a part of the security authorization level hierarchy; Only users with High authorization level are able to create, edit, or delete PreSet Programs that may require using a unique PreProgram password. Managing Security Passwords To display the Security view, open a Worksheet for editing and click the Security tab. For details regarding opening a Worksheet, refer to Chapter 5: Drug Library Directory on page 55. > To c h a n ge s e c u ri t y p a ss w ord s: 1. From the Security tab view, select Custom for the required security level to edit. 2. Enter a 4-digit password in the specified range [1000 - 7000]. The range for PreProgram password is [1000 - 9999]. Passwords for each security level must be unique. Using the same password for more than one security level will prompt an error message. However, a PreProgram password can be identical to any authorization level password. 3. When finished, click Apply to save the changes. Security 111 Chapter 8: Drug Library Management The following section describes how to create and configure a Drug Library: Overview ............................................................................................... 112 Managing Drug Libraries ......................................................................... 114 Creating Medication Entries (Rule Sets) .................................................... 115 Editing Medication Entries (Rule Sets) ...................................................... 123 Viewing Medication Entries (Rule Sets) .................................................... 125 Deleting Medication Entries (Rule Sets) .................................................... 127 Assigning Medication Entry from the Source List to a Target CCA ................ 131 Finalizing a Worksheet ............................................................................ 133 Closing a Drug Library ............................................................................. 135 Overview The Drug Library Management view allows creating, editing and deleting medication entries for the Sapphire pump. The Drug Library Management view appears when opening a Worksheet, Archived or Published Drug Library. This view consists of two panes: • Target List - The Target List is displayed at the top of the Drug Library Management pane and contains: • CCAs set up in the Drug Library, and the medication entries assigned to them. • Source List -The Source List is displayed at the bottom of the Drug Library Management pane and contains: • CCAs set up in the Drug Library, and the medication entries assigned to them. • Master Drug Formulary, a compiled list of all the medication entries in the Drug Library (created in a specific CCA or in the Source List). In order to add medication entries to CCAs, the CCAs must be defined in the drug library first (for details, refer to: Creating a New CCA on page 78). Only medication entries from the Target List will be available on the Sapphire pump. Drug Library Management 112 Drug Library Management Conventions Figure 8.1. Drug Library Management The Drug Library Management view uses the following conventions: 1. The dropdown list in each pane displays the CCAs defined in the Drug Library (#1 in Figure 8.1). 2. The fields in the Target List and Source List panes are identical (#1, #3, #4 and #5 in Figure 8.1). 3. The total number of medications on the selected list is displayed on the right of the list (read-only, #3 in Figure 8.1). 4. View All tab displays the full list of medications available for the selected CCA or the Master Drug Formulary, as well as the note associated with each medication (#4 in Figure 8.1). 5. Delivery mode tabs display the medications available in the selected delivery mode (on the left), and the specific limits assigned to each infusion parameter (on the right) (#5 in Figure 8.1). 6. Columns are re-sizeable and may be sorted in ascending or descending order by clicking on the column header. Drug Library Management 113 7. The Drug Library information (name, infuser type, status, modified date and time, mode and user) is displayed at the bottom of the Drug Library Management view (read-only, #7 in Figure 8.1). 8. The functions available in the Drug Library Management view vary according to the Drug Library status (Worksheet, Archived or Published Drug Library) and the current selection on the screen. Functions that are not available for this view will be disabled (#8 in Figure 8.1). Managing Drug Libraries The following section explains how to manage Drug Libraries for the Sapphire pump: Common actions • Adding, editing and viewing Medication Entries • Finalizing Worksheets • Closing Drug Libraries (Worksheet, Archived or Published Drug Library) Target List options Editing a Medication within a specific CCA Removing Medication Entries from a CCA • • Source List options • Assigning Medication Entries from the Source List to the Target List • Editing a Medication affecting all assigned CCAs • Deleting Medication Entries from the Master Drug Formulary Drug Library Management 114 Creating Medication Entries (Rule Sets) Creating medication entries in the Drug Library can be done by: • Adding a medication entry to the Target List. • Adding a medication entry to the Master Drug Formulary and assigning it to the relevant CCAs in the Target List. The software accommodates up to 40 CCAs and up to 8,500 unique medication rule sets. Each CCA can accommodate up to 1,000 medication rule sets, and each unique medication rule set can be assigned to more than one CCA, i.e. up to a total of 40,000 medications. When adding a medication entry to the Target List, it will be added to the selected CCA (assigned rule set) and to the Master Drug Formulary (unique rule set). When adding a medication entry to the Master Drug Formulary in the Source List, it will be added only to the Master Drug Formulary (unique rule set). Only medication entries assigned to the Target List are available for use with the Sapphire pump. Drug Library Management 115 The following process of creating a medication entry is similar for both the Target List and the Master Drug Formulary: > To add a medication entry to a CCA or to the Master Drug For mulary: 1. Select the required CCA from the Target List or the Master Drug Formulary from the Source List. (See #1 in the image below) 2. From the Target or Source List, click Add. (See #2 in the image below) Drug Library Management 116 The Edit Rule Set screen appears (the selected list name will be displayed on the screen title). For details regarding the Rule Set parameters, refer to Medication Rule Sets Parameters on page 137. 3. Select the Generic Name of the medication entry from the dropdown list. Drug Library Management 117 If the required Generic Name does not appear on the Generic Name list (or if no Generic Names appear on the list), the medication is not on the medication list, but can be added to it. For details about importing a medication list and adding a medication, refer to: Working with the Medication List on page 40. 4. Enter a Displayed Name for the medication entry in the Displayed Name fields. Each field can contain up to 20 characters. It is mandatory to use the first field; the second is optional (recommended for use when the medication is a mixture of 2 substances, or has a name longer than 20 characters). For details regarding the Displayed Name parameter, refer to Displayed Name on page 139. Only English alpha-numeric characters (lowercase and upper case) and the following symbols may be used in the Displayed Name fields: ., %, /, #, *, &, (, ), +, -, _, space. 5. Configure the required concentration by selecting one of the following options (for details about the Rule Sets types options, refer to Rule Sets Types on page 140): • No Concentration: select the checkbox to create an entry for medications when concentration information is not needed. When selecting "No Concentration", the Medication Amount, Medication Unit and Diluent Amount fields disappear, and the Dose Rate units available are: mL/h, mL/min, mL/kg/h and mL/kg/min. • Diluent Only: select the checkbox to create an entry for diluent only medication, and enter a specific diluent amount. When selecting "Diluent only", the Medication Amount and Medication Unit fields disappear, and the Dose Rate units available are: mL/h, mL/min, mL/kg/h and mL/kg/min. The Diluent Only parameter is not used for any calculations. Drug Library Management 118 • Full and Partial Concentration: a. Select the Medication Unit from the dropdown list. • For full concentration enter the Medication Amount and Diluent Amount. The concentration will be calculated according to those values. When the calculated concentration is outside the allowed range of 0.01-9999, the system prompts a warning message. • For partial concentration enter Medication Amount or Diluent Amount. The missing value will be entered by the user on the Sapphire pump. b. Enter Medication Amount according to the selected unit (grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq): • 0.01-99.9, in increments of 0.01. • 100-9999999, in increments of 1. • Leave blank. c. Enter Diluent Amount in mL: • 0.1-99.9, in increments of 0.1. • 100-9999, in increments of 1. • Leave blank. At least one of the parameters has to be entered in order to create and save a medication entry. If both are missing, the DLE Software will prompt a warning message. 6. Enter a note if needed. Notes are a way to define medication-specific remarks that can contain information such as a designated CCA for a rule set, a distinctive limit of which the user should be aware, medication interaction warnings, compatibility information, or catheter suggestions for the medication. Drug Library Management 119 A Note is limited to 256 characters. • Notes are available and viewable only on the DLE Software, and are not displayed on the Sapphire pump. • Notes can help distinguish between rule sets that appear to be identical in the Master Drug Formulary. • When creating a medication entry with identical Displayed Name and Concentration, it is advisable to add a Note for easy differentiation. 7. To determine in which delivery modes this medication entry is available for use, select the required Delivery Modes checkboxes. A medication entry must be available in at least one delivery mode. Drug Library Management 120 8. Select the Dose Rate units from the dropdown list. After the Dose Rate units are selected, the limit is displayed next to it. 9. Enter values for soft and hard limits according to the selected delivery mode (optional). For details regarding specific parameters of each delivery mode, refer to Delivery Modes on page 144. 10. Review the medication entry parameters. 11. Click OK to add the medication entry to the selected list (Target or Source List). If a medication entry is added to the Master Drug Formulary, it must be assigned to the required CCAs in order to be available on the Sapphire pump (for details about assigning medication entries to Target List, refer Drug Library Management 121 to Assigning Medication Entry from the Source List to a Target CCA on page 131). Adding a medication to a CCA that already has the maximum allowed medication entries, will prompt an error message. Remove medications from the CCA in the Target List first, and then assign a new medication to it. Drug Library Management 122 Editing Medication Entries (Rule Sets) Editing medication entries is possible in Worksheet Drug Libraries only (in Published or Archived Drug Libraries, the medication entries can only be viewed). > To e dit a m e d ic at i on e n t r y i n a C C A or i n t he Mas t er Dr ug For m ulary: 1. Select the required CCA from the Target List or the Master Drug Formulary from the Source List. (See #1 in the image below) The medication entries can be sorted according to Generic Name, External ID, Displayed Name, Concentration or Note, by clicking the column title. 2. From the Target or Source List, select a medication entry to edit and click Edit. Alternatively, double click a medication entry to display the Edit Rule Set screen. (See #2 in the image below) Drug Library Management 123 Edit Rule Set screen appears (the selected list name will be displayed on the screen title). 3. Edit the Rule Set parameters as needed. 4. Click OK to save and close the screen. When editing a medication entry in the Master Drug Formulary, the changes are updated in the Master Drug Formulary and in all CCAs containing this medication entry. When editing a medication entry assigned to a single CCA, the medication entry will also be updated in the Master Drug Formulary. If the edited medication entry is assigned to more than one CCA, a copy of the new medication entry will be created in the Master Drug Formulary. Drug Library Management 124 Viewing Medication Entries (Rule Sets) > To vie w a m e d ic at i on e n t r y i n a C C A or i n t he Mas t er Dr ug For m ulary: 1. Select the required CCA from the Target List or the Master Drug Formulary from the Source List. (See #1 in the image below) The medication entries can be sorted according to Generic Name, External ID, Displayed Name, Concentration or Note, by clicking the column title. 2. From the Target or Source List, select a medication entry to view and click View. (See #2 in the image below) In Published and Archived Drug Libraries, it is also possible to double click a medication entry to view it. Drug Library Management 125 The View Rule Set screen appears (the selected list name will be displayed on the screen title). 3. When finished viewing the medication entry, click OK to close the screen. Drug Library Management 126 Deleting Medication Entries (Rule Sets) A medication entry can be removed from a CCA or deleted entirely from the Drug Library. • To remove a medication entry from a specific CCA, remove it from the Target List. • To delete a medication entry from the entire Drug Library, delete it from the Master Drug Formulary. The medication entry deleted will be removed from all CCAs the medication is assigned to. Removing Medication Entries (Rule Sets) from a CCA > To re m o ve a m e d i c a t i on e n t r y f rom a C C A : 1. Select the required CCA from the target List. (See #1 in the image below) The medication entries can be sorted according to Generic Name, External ID, Displayed Name, Concentration or Note, by clicking the column title. 2. From the Target List, select a medication entry to be removed and click Remove (see #2 in the image below). Drug Library Management 127 To remove multiple entries, click the first medication entry, press and hold down the Shift key, and then click the last medication entry to be removed. The Remove Profiles screen appears. 3. Click OK to remove the medication from the current CCA. The medication entry is not removed from the Master Drug Formulary or any other CCA it is listed on. Drug Library Management 128 Deleting Medication Entries (Rule Sets) from the Master Drug Formulary A medication entry deleted from the Master Drug Formulary is removed from all CCAs to which it is assigned. > To de le te a m e d i c a t i on e n t r y f rom t h e M as t er Dr ug For m ul ar y : 1. Select the Master Drug Formulary from the Source List (see #1 in the image below). The medication entries can be sorted according to Generic Name, External ID, Displayed Name, Concentration or Note, by clicking the column title. 2. From the Source List, select a medication entry to delete and click Delete (see #2 in the image below). Drug Library Management 129 The Source List: Delete Rule Set screen appears. Delete one medication at a time. 3. Review the medication entry parameters and click Delete. 4. If the deleted Medication Entry is assigned to CCAs, a pop up window detailing the affected CCAs appears. 5. Click OK to confirm and permanently remove the selected medication entry from the Master Drug Formulary and all CCAs in which it appears. Drug Library Management 130 Assigning Medication Entry from the Source List to a Target CCA > To a s s ig n m e d ic at i on e n t r y f rom t h e S ou rce L i s t t o a Target CCA : 1. Select the required CCA from the Target List (see #1 in the image below). 2. Select the required CCA or the Master Drug Formulary from the Source List (see #2 in the image below). The medication entries can be sorted according to Generic Name, External ID, Displayed Name, Concentration or Note, by clicking the column title. 3. From the Source List, select the medication entry to assign to a target CCA and click Assign to Target CCA (see #3 in the image below). Select all the medication entries in the column by clicking the Generic Name header. To select multiple entries, click the first medication entry, press and hold down the Shift key, and then click the last medication entry to select. Add or remove medications from the selected group by using the Ctrl key. Drug Library Management 131 The Assign Profiles screen appears. 4. Click OK to confirm and assign the selected medication entry to the target CCA. Medication entries that already exist in the Target CCA, cannot be assigned again. Assigning medication entries with identical Displayed Name and Concentration to a target CCA is also not allowed. Drug Library Management 132 Finalizing a Worksheet Finalizing is the process of converting a Worksheet into a Published Drug Library that can be uploaded to the Sapphire pump. Before finalizing a Worksheet, it is recommended that a qualified person such as a hospital pharmacist or a multi-disciplinary committee of clinicians reviews the Drug Library for accuracy, according to the facility policy. When finalizing a Worksheet the previous Published Drug Library is archived. > To F in a liz e a Wo r k sh e e t : 1. From the Drug Library Management view, click Finalize. Once the finalization process begins, it cannot be stopped or reversed. If the DLE Software prompts a conflict window, refer to the Conflicts on page 134. 2. From the Confirmation screen, click OK to finalize the Worksheet. Drug Library Management 133 The Drug Library Management tab closes and the Date Finalized appears in the Drug Libraries Directory view. Before finalizing a Worksheet, make sure that the CCA settings are compatible with the Sapphire pump applications at your facility. Conflicts The Conflicts window provides a detailed description of conflicting parameters. A conflict may be a result of contradiction between CCA hard limits and rule sets limits, or CCA settings and CCA hard limits. In order to finalize the Drug Library the conflict must be resolved. If both Air Detectors are set to Off and the available Delivery Modes includes non epidural modes, the conflict window appears. The following table describes the parameters on the Conflict window: Field Description CCA The CCA in conflict Description The description of the conflict (CCA hard limits and rule sets limits, or CCA settings and CCA hard limits) Value Name The name of the parameter in conflict Original Value The value in conflict with the hard limits Hard Limit Value The parameter hard limit Units The units in mL, mL/h or h:min Drug Library Management 134 Closing a Drug Library > To c lo s e a Dru g L i b r a r y : From the Drug Library Management view, click Close. The Drug Library Management tab closes and the Drug Libraries Directory view appears. The Drug Library can be closed from the other tabs as well: Reports, CCA setup and Security. Drug Library Management 135 Chapter 9: Medications Entries (Rule Sets) The following sections explain the work procedure of setting up Rule Sets, review the Rule Sets parameters and the meaning and use of the different delivery modes: Overview ............................................................................................... 136 Medication Entry Rules and Conventions .................................................. 136 Medication Rule Sets Parameters ............................................................ 137 Overview After listing the medications in the Medications tab, clinical Rule Sets can be set for each medication. Each Rule Set includes the medication’s concentration and specific limits on infusion settings. This chapter reviews the Rule Set parameters and their implications. For specific instructions about creating a medication entry, refer to Creating Medication Entries (Rule Sets) on page 115. Medication Entry Rules and Conventions The DLE Software uses the following conventions for medication entries: 1. Entry of drug-specific limits (hard and soft) is optional, not mandatory. 2. The Rule Set limits must be consistent with the CCAs settings (hard limits). 3. When entering a value that is not allowed, the value may appear in red and a “Validity” message appears. The message specifies the field range, or the reason the value is not permitted. 4. If a required field is not selected or populated, an error message appears. 5. Only English alpha-numeric characters (lower case and upper case) and the following symbols may be used in the Displayed Name fields: ., %, /, #, *, &, (, ), +, -, _, space. Medications Entries (Rule Sets) 136 6. After the Medication Unit is selected, the Dose Rate units field displays the selected unit type and applicable unit type with magnitude change. 7. When selecting a new medication from the Generic Name field of the Rule Set window, type the medication’s first letter in the dropdown list, and navigate to the required medication entry. 8. In the Master Drug Formulary, two medication entries cannot have the same Displayed Name, Concentration parameters, Delivery Modes and Limits. 9. Within a CCA, two medication entries cannot have the same Displayed Name and Concentration parameters. However, it is possible to have the same calculated concentration (for example, 10 mg in 100 mL and 25 mg in 250 mL. Medication Rule Sets Parameters Required fields: a medication Rule Set must include a medication Generic Name, Displayed Name, Concentration, Dose Rate units, and the delivery modes to which the medication is assigned. Medications displayed on the Sapphire pump and the clinician programming sequence, are dependent on the medication Rule Set type, as defined in the DLE Software. The user can program an infusion without a defined drug by using the 'Choose General' key on the Sapphire pump. The user is warned that 'Choose General' bypasses specific drug limits, and the infusion will be programmed without Drug Library limits. Medications Entries (Rule Sets) 137 The following image illustrates the Rule Set window and its parameters. Figure 9.1. Rule Set window The next section lists the medication Rule Sets fields, with a detailed description and the allowed range for each parameter: Generic Name Generic Name is the medication name on the Medication List (see #1 in Figure 9.1). Each medication entry must have a Generic Name, which is selected from the dropdown list and displays the External ID (the facility's identifier for a medication). Strength divided by Volume is displayed only when it is a part of the Medication List. Medications Entries (Rule Sets) 138 Displayed Name Displayed Name is the medication name that will be displayed on the Sapphire pump. The Displayed Name comprises 2 fields. Each field can contain up to 20 characters (see #2 in Figure 9.1). It is only mandatory to use the first field; the second is optional (recommended for use when a medication is a mixture of 2 substances, or has a name longer than 20 characters). By using 2 fields, the user decides how it will be displayed on the Sapphire pump. On the Sapphire pump, a Displayed Name using both fields will be presented in 2 rows on lists. A moving header (banner) will display the Displayed Name during an infusion. On the DLE Rev13 Software, a space will separate the fields in the Drug Library Management tab window. Each medication entry must have a Displayed Name. To avoid potential confusion when creating medication entries, use only the medication name in the Displayed Name fields and ensure that the external ID is identical to the external ID used in your facility’s formulary. Do not include the diluent as part of the medication name. To avoid confusion, do not assign similar names to different medication entries of the same medication. Only English alpha-numeric characters (lower case and upper case) and the following symbols may be used in the Displayed Name field: ., %, /, #, *, &, (, ), +, -, _, space. Medications Entries (Rule Sets) 139 Rule Sets Types No Concentration Use this type of Medication Entry (Rule Set) when only a medication name is required for the Sapphire pump and the concentration or diluent volume are not needed (see #3 in Figure 9.1). A medication entry defined as “No Concentration” will be displayed without any medication amount or concentration on the Sapphire pump, and the units available will be: mL/h, mL/min, mL/kg/h and mL/kg/min. The clinician will not be able to enter a concentration value when programming the Sapphire pump. Diluent Only Use this type of Medication Entry (Rule Set) for solutions where the medication amount is not required (see #3 in Figure 9.1). A medication entry defined as “Diluent Only” will be displayed without any medication amount or concentration on the Sapphire pump and the units available will be: mL/h, mL/min, mL/kg/h and mL/kg/min. Full and Partial Concentration Use this type of Medication Entry (Rule Set) when the medication concentration is required for programming an infusion. The concentration allowed range is 0.01-9999. Full concentration consists of Drug Amount and Diluent Amount, defined in the medication Rule Set. Final concentration is provided by the Drug Library, thus reducing the number of clinician programming steps. Partial concentration consists of Drug Amount or Diluent Volume, leaving the missing value to be entered by the Sapphire pump user. Final concentration is calculated on the Sapphire pump during programming, thus allowing non-standard concentration to be programmed on the Sapphire pump. Medications Entries (Rule Sets) 140 Medication Amount This field allows the entry of Medication Amount in the selected units (see #3 in Figure 9.1). The allowed range for grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.01-99.9, in increments of 0.01 • 100-9999999, in increments of 1 • Leave blank Medication Unit This field allows the selection of the measurement unit for the medication amount (see #3 in Figure 9.1). The appropriate unit can be selected from a dropdown list: grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq. After selecting the Medication Unit, the Dose Rate units will be sorted accordingly. Medication Diluent This field allows setting the volume in which the medication amount is dissolved (see #3 in Figure 9.1). The allowed range for mL: • 0.1-99.9, in increments of 0.1 • • 100-9999, in increments of 1 Leave blank The following images (Figure 9.2) illustrate the medication display on the Sapphire pump. The left figure consists of medication entry with No Concentration as #1, and Diluent only on as #2. The right figure consists of medication entry with Full concentration as #3, and Partial concentration as #4. Medications Entries (Rule Sets) 141 Figure 9.2. Medication display on the Sapphire pump Notes Notes are a way to define medication-specific remarks that can contain information such as a designated CCA for a rule set, a distinctive limit of which the user should be aware, medication interaction warnings, compatibility information, or catheter suggestions for a medication. A note is limited to 256 characters (see #4 in Figure 9.1). • Notes are available and viewable only on the DLE Soft• • ware and are not displayed on the Sapphire pump. Notes can help distinguish between rule sets that appear to be identical in the Master Drug Formulary. When creating a medication entry with identical Displayed Name and Concentration, it is advisable to add a Note for easy differentiation. Medications Entries (Rule Sets) 142 In the Target List or Source List, the notes can be easily viewed in the View All tab. > To a dd, e dit, v iew or d e l e t e a N ot e : 1. Select a medication entry to edit, and click Edit. Alternatively, double click a medication entry to display the Edit Rule Set screen. 2. Type, edit or delete the note as required. Medications Entries (Rule Sets) 143 Delivery Modes A medication entry must have at least one delivery mode. The medication will be listed under the selected delivery mode on the Sapphire pump (see #5 in Figure 9.1). There are seven optional delivery modes: • Continuous • Secondary • Multi-Step • Intermittent • Epidural Intermittent • PCA • PCEA Dose Rate Units For each delivery mode Dose Rate units must be specified (see #6 in Figure 9.1). The available units are sorted according to the selected Medication Units. The optional units are: mL/h, mL/min, mL/kg/h, mL/kg/min, grams/h, grams/min, grams/kg/h, grams/kg/min, mg/h, mg/min, mg/kg/h, mg/kg/min, mcg/h, mcg/min, mcg/kg/h, mcg/kg/min, nanog/h, nanog/min, nanog/kg/h, nanog/ kg/min, mmol/h, mmol/min, mmol/kg/h, mmol/kg/min, Million-Units/h, units/ h, units/min, units/kg/h, units/kg/min, mUnits/h, mUnits/min, mUnits/kg/h, mUnits/kg/min, mEq/h, mEq/min, mEq/kg/h, mEq/kg/min. Setting Limits The DLE Software allows the definition of specific delivery mode limitations for the medications infused using the Sapphire pump (see #7 in Figure 9.1). Upper and lower soft and hard limits can be defined in the rule set for each medication entry. When configuring the limits, the software enforces the following rule: Lower Hard Limit (LHL) < Lower Soft Limit (LSL) < Upper Soft Limit (USL) < Upper Hard Limit (UHL) The DLE Software displays the values range for each parameter according to the concentration and the selected Dose Rate units. Medications Entries (Rule Sets) 144 Hard Limits Hard limits cannot be overridden; the Sapphire pump cannot be programmed with a value that is lower than the lower hard limit or higher than the upper hard limit. The hard limits are displayed when programming on the Sapphire pump. If hard limits are not defined on the Medication Entry, the default limits from the Sapphire pump or the CCA settings will be used as the medication entry hard limits. Soft Limits Soft limits are clinical recommendations which can be exceeded by the clinician. soft limits are not indicated on the Sapphire pump, unless the clinician exceeds them. When the value entered on the Sapphire pump is lower than the lower soft limit or higher than the upper soft limit, the Sapphire pump displays an attention screen, with the details of the exceeded parameter. The Sapphire pump records the confirmation to proceed with the exceeded soft limit in its history logs. For example, if the upper soft limit is set to 15 mL/h and the clinician enters 16 mL/h, the Sapphire pump displays a soft limits Attention screen, indicating that the upper limit has been exceeded. This screen notifies the clinician that the entry is above the soft limits range set for that medication entry. The clinician can choose to either Acknowledge the message and continue programming with the entered value, or Go back and enter a new value instead of the entered value. When a soft limit has been exceeded, an applicable Soft Limits icon will be shown on the Sapphire pump indicators bar during infusion. Medications Entries (Rule Sets) 145 Continuous In the Continuous delivery mode, the pump infuses fluid at a constant rate. The Continuous mode also features Bolus Options – allows to disable the bolus or select a single applicable bolus type – either simple or advanced. A simple bolus is limited by Bolus Amount; an advanced bolus is limited by Bolus Rate, Bolus Amount and Bolus Time. Note that the available parameters vary according to the selected bolus options. Medications Entries (Rule Sets) 146 The Continuous delivery mode parameters are described in the following table: Parameter Description/Notes Range for hard and soft limits Dose Rate The rate of the infusion For mL/h: • 0.1-99.9 in increments of 0.1 • 100-999 in increments of 1 For mL/min, grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Bolus Amount* The total amount of medication that can be administered in a bolus For mL: • 0.1-99.9 in increments of 0.1 • 100-9999 in increments of 1 For grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Max Bolus Amount† Used in case the Bolus Amount parameter is set to a weight based unit For mL: • 0.1-99.9 in increments of 0.1 • 100-9999 in increments of 1 For grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Medications Entries (Rule Sets) 147 Parameter Description/Notes Range for hard and soft limits Rate† The rate of the bolus For mL/h: • 0.1-99.9 in increments of 0.1 Bolus • 100-999 in increments of 1 For mL/min, grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Bolus Time† The amount of time in which the bolus is delivered 00:01-99:59 in increments of 00:01 min * Applicable only when simple or advanced bolus is selected. † Applicable only when advanced bolus is selected. Medications Entries (Rule Sets) 148 Secondary The Secondary delivery mode is used when two medications are administered from two different bags; the user may either alternate between the bags or administer them sequentially. The Secondary mode also features Bolus Options – allows to disable the bolus or select a single applicable bolus type – either simple or advanced. A simple bolus is limited by Bolus Amount; an advanced bolus is limited by Bolus Rate, Bolus Amount and Bolus Time. Note that the available parameters vary according to the selected options. The Secondary delivery mode parameters are described in the following table: Medications Entries (Rule Sets) 149 Parameter Description/Notes Range for hard and soft limits Dose Rate The rate of the infusion For mL/h: • 0.1-99.9 in increments of 0.1 • 100-500 in increments of 1 For mL/min, grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Bolus Amount* The total amount of medication that can be administered in a bolus For mL: • 0.1-99.9 in increments of 0.1 • 100-9999 in increments of 1 For grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Max Bolus Amount† Used in case the Bolus Amount parameter is set to a weight based unit For mL: • 0.1-99.9 in increments of 0.1 • 100-9999 in increments of 1 For grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Medications Entries (Rule Sets) 150 Parameter Description/Notes Range for hard and soft limits Rate† The rate of the bolus For mL/h: • 0.1-99.9 in increments of 0.1 Bolus • 100-500 in increments of 1 For mL/min, grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Bolus Time† The amount of time in which the bolus is delivered 00:01-99:59 in increments of 00:01 min * Applicable only when simple or advanced bolus is selected. † Applicable only when advanced bolus is selected. Medications Entries (Rule Sets) 151 Multi-Step Multi-Step delivery mode allows the pump to deliver a series of up to 25 consecutive infusion steps from the same infusion bag. Each Step is delivered as a Continuous infusion. The Multi-Step mode parameters are described in the following table: Parameter Description/Notes Range for hard and soft limits Dose Rate The rate of each step in the infusion For mL/h: • 0.1-99.9 in increments of 0.1 • 100-999 in increments of 1 For mL/min, grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Medications Entries (Rule Sets) 152 Intermittent The Intermittent delivery mode enables programming dose time and volume infusion to be repeated at regular intervals or cycles. The interval duration is the time between the start of one dose and the start of the next dose. A KVO rate can be programmed to run between doses. The Intermittent delivery mode parameters are described in the following table: Parameter Description/Notes Range for hard and soft limits Dose Time The amount of time in which each dose is delivered 00:01-96:00 in increments of 00:01 min Intermittent Dose The amount of each dose For mL: • 0.1-99.9 in increments of 0.1 • 100-999 in increments of 1 For grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 100-99999999 in increments of 1 Medications Entries (Rule Sets) 153 Epidural Intermittent The Epidural Intermittent delivery mode is used to program epidural doses (boluses) that are given at a rate of 125 or 200 mL/h and are repeated at regular intervals or cycles. The interval duration is the time between the start of one dose and the start of the next dose. The medication can be programmed to run at a Continuous Rate (between doses) to keep the vein open. The Epidural Intermittent delivery mode parameter is described in the following table: Parameter Description/Notes Range for hard and soft limits Intermittent Dose The total amount of medication that can be administered in a dose For mL: • 0.1-30 in increments of 0.1 For grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Medications Entries (Rule Sets) 154 PCA The Patient Controlled Analgesia (PCA) delivery mode allows the pump to deliver medication at a continuous rate (optional) and limited boluses activated by the patient. Dose Limit Type Allows the setting of a single applicable infusion limit type – Number of Boluses or Total Dose. Note that Total Dose is not supported on the pump when the user selects to use the medication with a PreSet program. The checkbox Allow No Limit allows the optional removal of the selected Limit Type and limits from the Sapphire pump during programming. Selecting the checkbox allows the clinician to opt out of the drug limit type restrictions. Note that all other treatment parameters, such as Demand Bolus and Lockout Time, are still programmed and impact the maximum permitted dose. Medications Entries (Rule Sets) 155 The PCA delivery mode parameters are described in the following table: Parameter Description/Notes Range for hard and soft limits Continuous Rate The rate of the basal infusion For mL/h: • 0.1-99.9 in increments of 0.1 For mL/min, grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Loading Dose The total amount of medication that can be administered in a loading dose For mL: • 0.1-30 in increments of 0.1 For grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Demand Bolus The amount of fluid infused in a single patient bolus. For mL: • 0.1-30 in increments of 0.1 For grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Medications Entries (Rule Sets) 156 Parameter Description/Notes Range for hard and soft limits Total dose per period* The total amount of medication that can be administered in a dose For mL: • 0.1-30 in increments of 0.1 For grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Number of boluses per period† The maximum number of patient boluses that can be delivered during a 1 hour or 4 hours period 1-60 in increments of 1 Bolus Lockout The minimum time that must pass between the end of one bolus to the start of the next bolus. Minimum-Maximum defines the range of that minimum lockout time 00:01-24:00 in increments of 00:01 min * Applicable only when Total dose per period limit type is selected. † Applicable only when Number of boluses per period limit type is selected. Medications Entries (Rule Sets) 157 PCEA The Patient Controlled Epidural Analgesia (PCEA) delivery mode allows the pump to deliver medication at a continuous rate and limited boluses activated by the patient. Dose Limit Type Allows for the setting of a single applicable infusion limit type – Number of Boluses or Total Dose. Note that Total Dose is not supported on the pump when the user selects to use the medication with a PreSet program. The checkbox Allow No Limit allows the optional removal of the selected Limit Type and Limits from the Sapphire pump during programming. Selecting the checkbox allows the clinician to opt out of the drug limit type restrictions. Note that all other treatment parameters, such as Demand Bolus and Lockout Time, are still programmed and impact the maximum permitted dose. Medications Entries (Rule Sets) 158 The PCEA delivery mode parameters are described in the following table: Parameter Description/Notes Range for hard and soft limits Continuous Rate The rate of the basal infusion For mL/h: • 0.1-25 in increments of 0.1 For mL/min, grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Loading Dose The total amount of medication that can be administered in a loading dose For mL: • 0.1-30 in increments of 0.1 For grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Demand Bolus The amount of fluid infused in a single patient bolus. For mL: • 0.1-30 in increments of 0.1 For grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Medications Entries (Rule Sets) 159 Parameter Description/Notes Range for hard and soft limits Total Dose per period* The total amount of medication that can be administered in a dose For mL: • 0.1-30 in increments of 0.1 For grams, mg, mcg, nanog, mmol, Million Units, units, mUnits or mEq: • 0.001-9.999 in increments of 0.001 • 10-99.99 in increments of 0.01 • 100-99999999 in increments of 1 Number of Boluses per period† The maximum number of patient boluses that can be delivered during a 1 hour or 4 hours period 1-60 in increments of 1 Bolus Lockout The minimum time that must pass between the end of one bolus to the start of the next bolus. Minimum-Maximum defines the range of that minimum lockout time. 00:01-24:00 in increments of 00:01 min * Applicable only when Total dose per period limit type is selected. † Applicable only when Number of boluses per period limit type is selected. Medications Entries (Rule Sets) 160 Chapter 10: Reports The following sections review the available data and settings reports, and explain how to generate and print them: Overview ............................................................................................... Reports Conventions .............................................................................. Reports Structure ................................................................................... Printing Reports ..................................................................................... Saving Reports ....................................................................................... 161 161 162 168 169 Overview The Drug Library Reports allow creating and printing detailed information of the medication entries and CCA setting to different reports. The following reports are available: • Drug Library: displays detailed information about all the medications entries in the Master Drug Formulary. • CCA Drug Library: displays detailed information about all the medication entries assigned to each CCA. • CCA Settings: displays detailed information about all the CCA settings of each CCA. • CCA Settings (On Sapphire): displays detailed information about all the CCA settings of each CCA, sorted according to the pump menus, for easy comparison. Reports Conventions • • • Reports may span multiple pages and are navigable using the vertical scroll bar, and Prev and Next navigation buttons at the top of the screen. The available reports are displayed in the dropdown list at the top of the screen. Fields appear blank when no data is available. Reports 161 • When a generated report file is larger than 3MB, the DLE internal browser does not display it. To view the report using an external browser, press the Open Report button. Reports Structure The following table describes the general information that appears in the headers of all the reports: Field Description Section The number of the current section out of total sections of the report. Drug Library The name of the Drug Library. Infuser Type The type of the Infusion pump. Date Finalized The date and time that the Published or Archived Drug Library was finalized (not applicable for Worksheets). Library State The state of the Drug Library (Published, Archived, or Worksheet). Additional details will vary depending on the selected report type. The reports structure in the DLE Software cannot be altered or configured by the user. Working with Reports Tab This section explains how to display and work with the DLE Software Reports tab: > To Dis pla y th e R e p or t s t a b : 1. From the Drug Library Directory view, highlight the required Worksheet, Archived or Published Drug Library and double click to open it. 2. Click to select the Reports tab. Reports 162 3. Select a report from the dropdown list at the top-left of the Reports screen. Displaying a report of a large Drug Library might require several minutes to load. Drug Library Report This report displays detailed information of all medications rule sets in the Master Drug Formulary, such as concentrations, assigned CCAs, delivery modes and limits. The following table details the Drug Library report parameters: Parameter Description Generic Name The generic name of the medication. External ID Unique medication ID number. Displayed Name The medication name that displays on the Sapphire pump. Concentration Concentration of Medication Amount divided by Diluent Amount in the selected units. Assigned CCAs CCAs to which the medication is assigned. Delivery Modes Delivery modes assigned to the medication entry. Reports 163 Parameter Description Rule Set Groups The types of rule sets created for the medication. Dosing Unit The dosing unit selected for the medication. LHL Lower Hard Limit - the lower limit that cannot be overridden. LSL Lower Soft Limit - the lower limit that can be overridden. USL Upper Soft Limit - the upper limit that can be overridden. UHL Upper Hard Limit - the upper limit that cannot be overridden. Reports 164 CCA Drug Library Report This report displays detailed information of medications rule sets according to CCAs. The following table details the CCA Drug Library report parameters: Parameter Description CCA Name Name of CCA of the following medications and rule sets. Generic Name The generic name of the medication. External ID Unique medication ID number. Displayed Name The medication name that displays on the Sapphire pump. Concentration Concentration of Medication Amount divided by Diluent Amount in the selected units. Assigned CCAs CCAs to which the medication is assigned. Delivery Mode Delivery modes assigned to the medication entry. Rule Set Groups The types of rule sets created for the medication. Dosing Unit The dosing unit selected for the medication. LHL Lower Hard Limit - the lower limit that cannot be overridden. LSL Lower Soft Limit - the lower limit that can be overridden. Reports 165 Parameter Description USL Upper Soft Limit - the upper limit that can be overridden. UHL Upper Hard Limit - the upper limit that cannot be overridden. CCA Settings Report This report displays full information of the Drug Library CCA settings. The following table details the CCA Settings report parameters: Parameter Description CCA Name Name of CCA of the following settings and rules. Service Line The CCA service line. System Settings System settings of the CCA. Alarm Settings Alarm settings of the CCA. Mode Options Mode Options settings of the CCA. Hard Limits The CCA hard limits that cannot be overridden. KVO settings KVO settings of the CCA. Reports 166 Parameter Description Delivery Modes settings Displays the availability of each delivery mode in the current CCA. Dosing Units Displays the availability of each dose rate unit in the current CCA. CCA Settings (On Sapphire) This report displays the Drug Library CCA settings in the same order displayed on the Sapphire pump menus. The following table details the order of the displayed parameters in the CCA Settings (On Sapphire) report parameters: Parameter Description CCA Name Name of CCA of the following settings and rules. Service Line The CCA service line. Pump Configurations Alarms, Audio Settings, General Settings, Regional. Reports 167 Parameter Description Mode Options PCA, PCEA, Epidural Intermittent. Technician Options Pump Settings - Hard Limits, KVO, Air Detector, Delivery Modes, General. Printing Reports The section explains how to print a report. > To prin t a re p o rt : 1. From the Drug Library Directory view, highlight the required Worksheet, Archived or Published Drug Library and double click to open it. 2. Click to select the Reports tab. 3. Select a report to print from the dropdown list at the top-left of the Reports screen. 4. Click Print. 5. A print dialog box will open for each report (depending on number of CCAs). Reports 168 Saving Reports The section explains how to save a report. Before saving the reports files, it is recommended to create a directory for each report on the local drive. The reports will be saved with the name you entered and a page or CCA number, e.g. DrugLibraryReport (1 of 6).htm. > To S a v e Re po rts : 1. From the Drug Library Directory view, highlight the required worksheet, Archived or Published Drug Library and double click to open it. 2. Click to select the Reports tab. 3. Select a report to save from the dropdown list at the top-left of the Reports screen. 4. Click Save To File. Reports 169 5. Navigate to the location of your choice. 6. Enter a file name. 7. Click Save to save the report in html format. 8. From the confirmation screen, click OK. Reports 170 Chapter 11: Uploading a Drug Library The following sections explain how upload a Published Drug Library to the Sapphire pump: Overview ............................................................................................... 171 Prerequisites .......................................................................................... 172 Connect the Pumps to the PC via COM Ports ............................................ 173 Upload a Published Drug Library to the Sapphire Pump ............................. 174 Overview The DLE Software allows uploading a Published Drug Library to the Sapphire pump. Uploading can be performed simultaneously on 1-8 pumps, using a USB to 4-port serial RS232 adapter which can be purchased separately from Q Core Medical Ltd. The DLE Software version r13 functions on Sapphire multi-therapy and dedicated pumps version r13 only (excluding SapphirePlus). Clarification: Uploading a Published Drug Library can be done simultaneously for up to 8 pumps. Please note that the USB to 4-port serial RS232 adapter can be used for 4 pumps only. To upload a Published Drug Library to more than 4 pumps at a time, prepare an additional USB to a 4-port serial RS232 adapter. Uploading a Drug Library 171 Prerequisites Before beginning the uploading process, verify that the following hardware and software requirements are met. Hardware Requirements • • • • Screen Resolution: 1280x1024 (minimum). Monitor DPI: 96 Communication cable for the Sapphire pump (P/N 05020-110-0213). RS232 connectivity, in either of the following forms: • An RS232 port in the PC Figure 11.1. RS232 port • A USB to 4 Port RS232 Adapter + driver (can be purchased from Q Core Medical Ltd. (P/N 15077-000-0001).) Figure 11.2. USB to 4 Port RS232 Adapter Uploading a Drug Library 172 Software Requirements • • • • Operating System: Windows XP SP3 (32 or 64 bit), Windows 7 (32 or 64 bit), Windows 8 (32 or 64 bit). MS Excel (2003 or higher). WinRar or other software for handling .zip files. Sapphire Infusion Pump Software Version r13 only. Trying to upload a Drug Library to an unsupported pump, or to a pump that is running a software version lower than r13 is not possible, and will result in a message notifying that this action is not supported. Connect the Pumps to the PC via COM Ports This section describes how to connect the pumps to the PC via COM ports. A single pump can be connected using a serial port. For connecting additional pumps, use the USB to 4 port RS232 adapter, following the explanation: > To u s e th e Q Core U S B t o 4 p or t R S 2 3 2 adapt er ( for enabl i ng a ddit io n a l CO M por t s) : The USB to 4 port RS232 adapter provides 4 external COM ports to the computer (P/N 15077-000-0001). Follow the DFU instructions for installation. Uploading a Drug Library 173 Upload a Published Drug Library to the Sapphire Pump The following procedure explains how to upload a Published Drug Library to the Sapphire pump. Before beginning the procedure: • Make sure that you have a record of the Drug Library Rule Sets and CCA Settings. • Connect the pump to a power supply; otherwise verify that • the pump battery is fully charged. When using a USB to 4 Port RS232 Adapter, verify that the adapter driver is installed before connecting the Sapphire pump (follow the DFU instructions for installation). If the DLE Software is required for use on more than one workstation or computer, verify that all relevant users have network access (Read/Write) to the DLE installation location. This will ensure the consistency and the uniformity of the data in the Drug Libraries. Make sure to use a shared folder only, so that is logs all the software-relevant data. > To Uplo a d a P u b l i s h e d D r u g L i b r a r y t o t h e Sapphi re pum p: 1. Turn on the Sapphire pump. 2. Login to the DLE Software as a Loader user (Logging Into the DLE Uploading a Drug Library 174 Software on page 34). 3. Using the communication cable, connect the pump to the computer. When using more then one pump, use the USB to 4 Port RS232 Adapter and connect the pumps to it. (for details regarding how to connect the pump to the PC, refer to: Connect the Pumps to the PC via COM Ports on page 173). 4. Click Add Device to add a Device to the software. Uploading a Drug Library 175 5. Double click on the added Device to select a port from the list of available ports. 6. Repeat steps 3-4 in order to add additional devices as necessary. 7. Click Download on each device. If the download does not begin, repeat step 4 using another port and click Download. The download begins. Progress of the downloading process is reflected in the progress bar. Do not shut the pump down or disconnect it from the computer while downloading is in progress. Uploading a Drug Library 176 8. When the download is complete, log out and exit the DLE Software, and disconnect the pump(s) from the PC. Uploading a Drug Library 177 At this stage the Drug Library is stored on the Sapphire pump, activating it requires the user’s acceptance. > To a c tiv a te th e D r u g L i b r a r y on t h e S a p p hi re pum p: 1. Press Yes from the Attention screen. 2. At the end of the process, the Sapphire pump will restart and the user will be prompted to select a CCA; • If the last active CCA is available in the new Drug Library, the Clinical • a. b. c. 3. Care Area screen will appear. Press Accept, the Start Up screen appears. If the last active CCA is not available in the new Drug Library, the Choose CCA screen will appear. Select the relevant CCA row. To confirm the changed CCA, press OK. The Start Up screen appears. Verify that the required Drug Library was uploaded to the pump by viewing the Drug Library name when turning on the pump. The current Drug Library name can also be viewed using the options menu: > To v ie w th e c u rre n t D r u g L i b r a r y on t h e Sapphi re Pum p: 1. From the Options menu, select View View System. 2. On the toolbar, press Next until the Drug Library name and Drug Library Published date are displayed. Uploading a Drug Library 178 Chapter 12: Troubleshooting The following section lists common problems and their solutions: Problem Probable Cause Solution User cannot create or save or finalize a worksheet. The user does not have writing privileges on the shared folder or workstation where the DLE Rev13 is installed. Verify that the DLE is installed on a shared network folder and that the user has a read/write permission. User cannot upload a Drug Library to a pump. Pump version or pump type is incompatible with the DLE Rev13 Software. Verify that the pump type is compatible with DLE Rev13. If not, update the Sapphire pump version to Rev13, and download the Drug Library to the pump. The user is uploading a drug library to a Rev13 Sapphire pump, which enters boot mode. The DLE displays the "Finished Downloading" message, but the pump Drug Library is not updating. You may be using a DLE Rev11 Software with a Sapphire pump Rev13. DLE Rev11 is not intended for use with a Sapphire pump Rev13. The Drug Library will not be updated. Upgrade the DLE Software from the previous version to Rev13. The user cannot locate the Drug Library after an upgrade to DLE Rev13. Drug Libraries and Medication Lists from the previous version were not imported. Refer to Upgrading the DLE Software from Rev11 to Rev13 on page 22. Troubleshooting 179 Problem Probable Cause Solution The user imported a published Drug Library but it is not finalized. An imported Drug Library will always be converted to Worksheet status. Login as "Editor" to finalize the worksheet. Only then will uploading be possible. User uploaded a Drug Library to the pump, and it is not updating, or there is no update confirmation. The intended update was not finalized in the DLE Rev13 Software. Verify that the intended Drug Library is in the Published status. If not, finalize it, and then upload it to the pump. User uploaded a Drug Library to the Sapphire pump, and it is not updating, or there is no update confirmation. The uploaded drug library might be identical to the one already on the Sapphire pump. Check the Drug Library name and publish date on the Sapphire pump under Troubleshooting Options View View system. 180 Appendix A: Users Role and Privileges Users Roles and Privileges There are 3 optional User ID's for the DLE Software. Each User ID enables access to a different set of actions and editing functions. The User ID options are: 1. Editor - all editing functions are available. 2. Loader - only uploading of a published Drug Library is available. 3. Admin - define passwords for other users. For details regarding settings User ID's passwords, refer to: Change Users Passwords on page 181. Change Users Passwords Users with Admin role and privileges can set the user passwords of the DLE Software. > To c h a n g e pa s s w ord s: 1. Double click the DLE Software icon in the directory the application was saved. 2. Enter User ID and password (password may contain 8-20 characters): • User ID: Admin • Password: please contact local distributor service representative to obtain the password. 3. The Set Passwords screen appears. 4. Select the required User Name from a dropdown list. 5. Enter the new password (8-20 characters). 6. Re-type the new password. 7. Click Apply, repeat steps 4-6 to change additional passwords. 181 8. When finished, click OK. If the current Admin password is not the default password and has been forgotten, refer to Technical Assistance on page 4. 182 Appendix B: New/Unsupported CCA Settings DLE Rev13 contains significantly more data than the previous versions. Therefore, when a Drug Library is imported from a previous version, all new settings and rule set parameters that did not exist in these versions, receive default values in the imported Drug Library. The parameters can be divided into two classes, CCA settings and Rule Sets. These are the default values that they will receive: CCA settings: • Dosing units – All units are available by default on the Sapphire pump, when Choose General is selected. • Hard limits bolus lockout – The minimum value of Bolus Lockout is imported from the CCA settings in previous version; the maximum value was not available in the previous version, and will receive the default value (24:00 h:min). • Automatic patient lockout – This parameter will revert to the default value (Off) when imported to DLE Rev13 Software. Rule Sets: • Bolus options in continuous and secondary modes – All imported rule sets will be set to the "Simple Bolus" option; bolus amount limits are imported. • Dose time in intermittent mode – This feature was defined by dose rate in the previous version. As of version R13, it is defined by dose time, and therefore it cannot be imported; no limits are set for the dose time. • Limit type in PCA and PCEA modes – All imported rule sets will be set with a "Number of Boluses" limit type; Max Boluses per period limits are imported. Following is a list of all the parameters with their default settings. 183 System Settings Parameter Default Value New Patient Off Calculate Concentration Off Prime Reminder Off Bolus Reminder Off Allow Delayed Start Off Automatic Patient Lockout Off Medium Titration Off US Format Off Screen Saver Off Backlight On Keys Volume High Alarm Volume Maximum Bolus Handle Always On Repeat Last Infusion On PreProgram Off Single Air Detector Off Accumulated Air Detector 0.5 mL Accumulated Threshold 1 mL Prime Volume 20 mL 184 Alarm Settings Parameter Default Value Occlusion Units BAR Occlusion Pressure 0.4 Occlusion Automatic Restart On Pump Unattended 10 Min Infusion Near End 10 Min Mode Options Delivery Mode Parameter Default Value Continuous Allow Bolus Off Continuous Advance Bolus Off Continuous Primary Bolus rate 125 mL/h Continuous Set Secondary On Continuous Secondary Bolus rate 125 mL/h PCA Bolus Rate 125 mL/h PCA Allow Loading Dose On PCA Infusion Type Cont. + Bolus PCA Limit Period 1 Hour PCEA Bolus Rate 125 mL/h PCEA Password Request No PCEA Allow Loading Dose No PCEA Infusion Type Cont. + Bolus PCEA Limit Period 1 Hour 185 Delivery Mode Parameter Default Value Epidural Intermittent Dose Rate 125 mL/h Epidural Intermittent Password Request No Epidural Intermittent Limit Period 1 Hour Epidural Intermittent PIEB Off KVO Settings Parameter Default Value Continuous Mode KVO 3 mL/h Multi-Step Mode KVO 3 mL/h PCA Mode KVO 0 mL/h PCEA Mode KVO 0 mL/h Hard Limits Delivery Mode Parameter Default Value Continuous VTBI 9999 mL Continuous Rate 999 mL/h Secondary VTBI 9999 mL Secondary Rate 500 mL/h Multi-step VTBI 9999 mL Multi-step Rate 999 mL/h Multi-step Time 24:00 h:min Intermittent VTBI 9999 mL Intermittent Dose Time 96:00 h:min 186 Delivery Mode Parameter Default Value Intermittent Intermittent Dose 999 mL Epidural Intermittent VTBI 9999 mL Epidural Intermittent Intermittent Dose 20 mL Epidural Intermittent Demand Bolus 20 mL Epidural Intermittent Bolus Lockout Minimum 00:01 h:min Maximum 24:00 h:min PCA VTBI 9999 mL PCA Continuous Rate 99.9 mL/h PCA Demand Bolus 20 mL PCA Loading Dose 20 mL PCA Bolus Rate 125 mL/h PCA Bolus Lockout Minimum 00:01 h:min Maximum 24:00 h:min PCEA VTBI 9999 mL PCEA Continuous Rate 25 mL/h PCEA Demand Bolus 20 mL PCEA Loading Dose 20 mL PCEA Bolus Lockout Minimum 00:01 h:min Maximum 24:00 h:min 187 Delivery Modes Under this tab all delivery modes are selected by default. Continuous – On Intermittent – On TPN – On PCA – On Multi-step – On Epidural Intermittent – On PCEA – On Dosing Units Under this tab all dose rate units are selected by default. 188 Authorized Hospira service centers For service related questions or repair please contact: In the USA: [email protected] In Canada: [email protected] In Europe: [email protected] In Asia Pacific: [email protected] To report a customer complaint please contact: In the USA: Phone: 1-800-441-4100 (8am-5pm CT, M-F) Email: [email protected] In Canada: [email protected] In EMEA (Europe): [email protected] In Latin America: [email protected] In Asia Pacific: [email protected] To report a customer complaint via fax: USA: 1-224 212 4080 Rest of World: 0 1 224 212 4080 189