Download English Sapphire Rev13 Drug Library Editor User Manual

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.
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• 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.
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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.
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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
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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.
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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)
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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.
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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.
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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.
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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).
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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.
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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).
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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.
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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.
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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.
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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.
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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
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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.
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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.
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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.
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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.
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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.
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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
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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
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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
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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.
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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
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