ICU Medical 80411396001 User Manual
HOSPIRA, INC., LAKE FOREST, IL 60045, USA
430-95597-004, B (Rev. 04/2007)
Plum A+® Infusion Systems
SECTION 1
Descriptive Information
NOTE: In this manual, references to Plum A+® Infusion
System apply to both the Plum A+
Infuser unless otherwise noted.
Plum A+® Infuser
List # 20679/2079204
NOTE: This operating
manual may also be
used with Device List #
12391-04 & 11971-04
when used with Module
List # 20677-04.
®
Infuser and Plum A+®3
Plum A+®3 Infuser
List # 20678-04
CAUTION: THIS
IS TO BE USED
DEVICE
AN IV POLE WITH A
WITH
6-WHEEL BASE AND A
.
SHELF
System Operating Manual 7
For Systems With Hospira MedNet
The Plum A+ and Plum A+3 Volumetric Infusion Systems are
designed to meet the fluid delivery requirements of today’s
evolving healthcare environments. Both are cassette based
multi-function infusion systems. The Plum A+ allows two lines in
and one line out while the Plum A+3 allows six lines in and three
lines out. Each pump can be used for standard, piggyback, or
concurrent delivery. Delivery modes include:
• Standard Infusions • Loading Dose
• Multistep Programming • Dose Calculation
The Plum A+ and Plum A+3 are designed to deliver parenteral,
enteral, or epidural infusions over a broad range of infusion
rates from multiple fluid container types.
Both are designed to be used in most areas of patient care,
including, but not limited to:
®
Software
• General Floor • Labor/Delivery/
Post Partum
• Medical/Surgical • OR/Anesthesia • Hemodialysis
• ICU/CCU • Post Op/Recovery • Oncology
• Pediatrics • Cardiac Cath Lab • Mobile Intensive
• Neonatology • Emergency • Nutritional
• Burn Unit
Care
Product Description
Each system includes a pumping module (hereafter called the
infuser) and an assortment of disposable IV sets (hereafter
called a set), optional accessories, and this operator’s manual.
The Plum A+ host device contains a Connectivity Engine
peripheral module that provides wired Ethernet and wireless
802.11 a/b/g local area networking capabilities. This allows the
Hospira Mednet
drug libraries to the infuser and enable the auto-programming
feature.
®
networked application software to download
8 System Operating Manual
Plum A+® Infusion Systems
Accessory equipment connected to the analog and digital
interfaces must be certified according to the respective IEC
Standards (e.g. IEC 60950 for data processing equipment and
IEC 60601-1 for Medical Equipment). Furthermore, all
configurations shall comply with the system standard IEC
60601-1-1. Any person who connects additional equipment to
the signal input or output part configures a medical system, and
is therefore responsible for ensuring that the system complies
with the requirements of the system Standard IEC 60601-1-1. If
in doubt, consult the technical service department or your local
representative.
Indications for Use
USER QUALIFICATION
The Plum A+ is intended for use at the direction or under the
supervision of licensed physicians or certified healthcare
professionals who are trained in the use of the infuser and the
administration of parenteral, enteral, and epidural fluids and
drugs and whole blood or red blood cell components. The
training should emphasize preventing related IV complications,
including appropriate precautions to prevent accidental infusion
of air. The epidural route can be used to provide anesthesia or
analgesia.
WARNING
ADMINISTER ONLY ANESTHETICS/ANALGESICS
APPROVED FOR EPIDURAL ADMINISTRATION (AS
INDICATED OR ALLOWED BY THE DRUGS’ FDA
APPROVED LABELING). EPIDURAL ADMINISTRATION OF
DRUGS OTHER THAN THOSE INDICATED FOR EPIDURAL
USE COULD RESULT IN SERIOUS INJURY TO THE PATIENT.
System Operating Manual 9
For Systems With Hospira MedNet
Conventions
This section describes the conventions used throughout this
manual, as follows:
CONVENTION APPLICATION EXAMPLE
®
Software
Italic Reference to a
section, figure, or
table
Function or mode
specific instructions
[BRACKETED
ALL CAPS]
[Italic] Softkey Options
Initial Caps
lowercase
Bold Emphasis ...sets are supplied
Keys or buttons on
the device are
displayed in
[BRACKETED ALL
CAPS] or with a
graphic.
Screen displays and
device labels (as
appropriate)
(See Figure 3-1,
Priming Cassette)
Primary Only:
Attach an empty
container.
[START]
or
[Choose]
Program
Dose Calculation
Sterile and are
for....
WARNINGS, CAUTIONS, AND NOTES
Alert messages used throughout this manual are described
below. Pay particular attention to these messages.
WARNING
A WARNING MESSAGE CONTAINS SPECIAL SAFETY
EMPHASIS AND MUST BE OBSERVED AT ALL TIMES.
FAILURE TO OBSERVE A WARNING MESSAGE IS
POTENTIALLY LIFE THREATENING.
10 System Operating Manual
Plum A+® Infusion Systems
CAUTION: A CAUTION USUALLY APPEARS IN FRONT OF A
PROCEDURE
COULD
FAILURE
SERIOUS
NOTE: A Note highlights information that helps explain a
concept or procedure.
NOTE: Figures are rendered as graphic representations to
approximate the actual product. Therefore, figures may not
exactly reflect the product.
OR STATEMENT. IT CONTAINS INFORMATION THAT
PREVENT IRREVERSIBLE PRODUCT DAMAGE OR HARDWARE
. FAILURE TO OBSERVE A CAUTION COULD RESULT IN
PATIENT OR USER INJURY.
This symbol directs the user to consult accompanying
documents.
When visible on the display, this symbol informs the
user to use CAUTION because the specified drug has
NOT been programmed with specified safety limits.
Precautions
The Plum A+ has been designed and manufactured to be safe,
reliable, and easy to use. This section details precautions and
possible hazards.
For safe operation of the Plum A+, observe the following
precautions and hazards.
HEALTHCARE PROFESSIONALS AND PATIENT RELATED
• In vitro studies have suggested that packed red blood cells
with unusually high hematocrit be diluted with bloodcompatible fluids, such as 0.9% sodium chloride injection, to
decrease hemolysis and increase flow rate.
• Setting the primary rate greater than the secondary rate will
result in a more rapid infusion of any residual secondary drug
remaining in the line and the cassette.
• Consult drug labeling to confirm drug compatibility,
concentration, delivery rates, and volumes are all suitable for
secondary, concurrent and piggyback delivery modes.
System Operating Manual 11
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