Hospira Plum A+ User manual

430-95597-001 (Rev. 06/05)
ABOptions/
Vol Inf
Back
Prime
For use with List Numbers:
20677, 20678, 20679-04
System Operating Manual
for use
with
for use
with
3
HOSPIRA, INC., LAKE FOREST, IL 60045, USA
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i 430-95597-001 (Rev. 06/05)
Change History
Title
Description of
Changes Pages Affected
430-95597-001
(Rev. 06/05)
First Release All
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Plum A+® Infusion Systems
Contents
Section 1, Descriptive Information . . . . . . . . . . . . . . . 1-1
PRODUCT DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
INDICATIONS FOR USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
user qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
CONVENTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
warnings, cautions, and notes . . . . . . . . . . . . . . . . . . . . . 1-3
PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
healthcare professionals and patient related . . . . . . . . . . 1-4
concurrent flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
epidural administration . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
battery operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
sets and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
backpriming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
bolus related . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
artifacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
GUIDENCE ON EMC COMPATIBILITY . . . . . . . . . . . . . . . . . . . . . . 1-13
FCC INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Section 2, Principles of Operation . . . . . . . . . . . . . . . 2-1
FEATURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
line programming options . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
plumset capabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
air management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
biomedical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
other features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Section 3, Equipment Description . . . . . . . . . . . . . . . 3-1
OPERATING KEYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
INDICATORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
DISPLAY SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
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REAR CASE CONTROLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
ADMINISTRATION SETS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
PREPARING THE ADMINISTRATION SET . . . . . . . . . . . . . . . . . . . . 3-7
PRIMING THE ADMINISTRATION SET . . . . . . . . . . . . . . . . . . . . . . 3-8
LOADING THE CASSETTE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
PREPARING THE SECONDARY LINE . . . . . . . . . . . . . . . . . . . . . 3-10
DISCONTINUING ELECTRONIC FLOW
CONTROL & SETTING GRAVITY FLOW . . . . . . . . . . . . . . . . . . . 3-11
DISCONTINUING FLUID ADMINISTRATION . . . . . . . . . . . . . . . . . . 3-12
Section 4, Basic Operation . . . . . . . . . . . . . . . . . . . . .4-1
GETTING STARTED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
tandem carrier instructions . . . . . . . . . . . . . . . . . . . . . . . . 4-2
system self-tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
data retention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
POWER ON. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
SIMPLE DELIVERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
TITRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
PIGGYBACK DELIVERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
CONCURRENT DELIVERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
STOP AND START WITH ONLY 1 LINE PUMPING . . . . . . . . . . . . . 4-18
STOP AND START WITH BOTH LINES PUMPING . . . . . . . . . . . . . 4-19
BACKPRIMING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
CLEARING SETTINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
UPDATING DRUG LIBRARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
Section 5, Advanced Programs . . . . . . . . . . . . . . . . . .5-1
DOSE CALC (MCG/KG/MIN ON A) . . . . . . . . . . . . . . . . . . . . . . . . 5-2
DOSE CALC (MG/MIN ON B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
LOADING DOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
MULTISTEP PROGRAMMING . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
Section 6, Additional Features . . . . . . . . . . . . . . . . . . .6-1
SIMPLE DELIVERY USING DELAYED START . . . . . . . . . . . . . . . . . 6-1
PIGGYBACK WITH NURSE CALLBACK . . . . . . . . . . . . . . . . . . . . . 6-2
POSSIBLE NON-DELIVERY PROGRAMMED . . . . . . . . . . . . . . . . . . 6-4
USING THE STANDBY FEATURE . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
SELECT OPTION- VOLUMES INFUSED, PRESSURE/POST INFUSION
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RATE, AND LIGHTING/CONTRAST . . . . . . . . . . . . . . . . . . . . . . . . 6-6
VARIABLE RATE CAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
EXAMPLES OF AUTOMATIC CALCULATION . . . . . . . . . . . . . . . . . 6-10
at startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
while running (titration) . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
at kvo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
CHANGING CCA WHILE INFUSING . . . . . . . . . . . . . . . . . . . . . . 6-12
AUTO-PROGRAMMING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Section 7, Alarms and Troubleshooting . . . . . . . . . . . 7-1
WARNING MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
RESPONSE TO ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
GENERAL ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
LINE A ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
LINE B ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
MALFUNCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
GENERAL MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Section 8, Cleaning, Maintenance, and Storage . . . . 8-1
cleaning and sanitizing . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
battery maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
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Section 9, Specifications . . . . . . . . . . . . . . . . . . . . . . .9-1
PHYSICAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
ELECTRICAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
WIRELESS LAN DEVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
VTBI RANGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
ENVIRONMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
DELIVERY RATE RANGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
AIR-IN-LINE ALARM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
OCCLUSION ALARM AND LIMITS . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
TIME TODETECT DOWNSTREAM OCCLUSIONS . . . . . . . . . . . . . . 9-5
BOLUS VOLUME RELEASED AFTER DOWNSTREAM
OCCLUSIONS ARECORRECTED . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
DELIVERY ACCURACY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
ENTERAL & HIGH VISCOSITY FLUIDS EFFECTS . . . . . . . . . . . . . . 9-6
TRUMPET CURVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Section 10, Supplies and Accessories . . . . . . . . . . . .10-1
ADMINISTRATION FLUIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
administration fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
enteral and high viscosity fluids . . . . . . . . . . . . . . . . . . . 10-1
containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
networked application . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Section 11, Warranty . . . . . . . . . . . . . . . . . . . . . . . . .11-1
Section 12, Default Drug Library (DDL) . . . . . . . . . . .12-1
© Copyright 2005 Hospira, Inc. All Rights Reserved
This document and the subject matter disclosed herein are proprietary
information. Hospira retains all the exclusive rights of dissemination,
reproduction, manufacture and sale. Any party using this document accepts
it in confidence, and agrees not to duplicate it in whole or in part nor disclose
it to others without the written consent of Hospira.
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Plum A+® Infusion Systems
430-95597-001 (Rev. 06/05) 1- 1
SECTION 1
Descriptive Information
NOTE: In this manual, references to Plum A+ apply to both
systems unless otherwise noted.
Plum A+®
List # 20679-04
NOTE: This operating
manual may also be
used with Device List
Numbers 12391-04 &
11971-04-03+ which
use Module List
Number 20677-04.
Plum A+®3
List # 20678-04
CAUTION: THIS
DEVICE IS TO BE USED
WITH AN IV POLE WITH A
6-WHEEL BASE AND A
SHELF.
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1- 2 430-95597-001 (Rev. 06/05)
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
• Multistep Programming
• Loading Dose
• 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:
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
802.11b local area networking capabilities. This allows the
• General Floor • Labor/Delivery/
Post Partum
• Burn Unit
• Medical/Surgical • OR/Anesthesia • Hemodialysis
• ICU/CCU • Post Op/Recovery • Oncology
• Pediatrics • Cardiac Cath Lab • Mobile Intensive
Care
• Neonatology • Emergency • Nutritional
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Plum A+® Infusion Systems
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Hospira MednetTM networked application software for drug
library downloads and Auto-programming to the infuser.
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.
Conventions
This section describes the conventions used throughout this
manual, as follows:
CONVENTION APPLICATION EXAMPLE
Italic Reference to a
section, figure, or
table
Function or mode
specific instructions
(See Figure 3-1,
Priming Cassette)
Primary Only:
Attach an empty
container.
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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.
CAUTION: A CAUTION USUALLY APPEARS IN FRONT OF A
PROCEDURE OR STATEMENT. ITCONTAINS INFORMATION THAT
COULD PREVENT IRREVERSIBLE PRODUCT DAMAGE OR HARDWARE
FAILURE. FAILURE TO OBSERVE ACAUTION COULD RESULT IN
SERIOUS PATIENT OR USER INJURY.
[BRACKETED
ALL CAPS]
Keys or buttons on
the device are
displayed in
[BRACKETED ALL
CAPS] or with a
graphic.
[START]
or
V [Italic] Softkey Options V [Choose]
Initial Caps
lowercase
Screen displays and
device labels (as
appropriate)
Program
Dose Calculation
Bold Emphasis ...sets are supplied
Sterile and are
for....
CONVENTION APPLICATION EXAMPLE
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Plum A+® Infusion Systems
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NOTE: A Note highlights information that helps explain a
concept or procedure.
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.
NOTE: Figures are rendered as graphic representations to
approximate the actual product. Therefore, figures may not
exactly reflect the product.
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 blood-
compatible 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.
• Arrange tubing, cords, and cables to minimize the risk of
patient strangulation or entanglement.
• Before opening the door, close clamp on the primary line or
remove the secondary container from the secondary port to
prevent mixing of primary and secondary fluids.
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• Although unlikely, failure of certain robust mechanical
components such as the anti-free flow mechanism or valve
control springs could cause fluid delivery limited to the
contents of the fluid container. Single fault failure of certain
electronic/motor control components would result in no more
than 5 mL of unexpected fluid delivery.
• A small amount of fluid is expelled from the set (less than
0.05 ml) each time the door is opened or closed with a set
installed. If potent drugs are being used, take appropriate
action to guard against overmedication of the patient.
• Before disconnecting a syringe from the cassette, pull up the
plunger slightly to avoid spilling the fluid. For rigid containers,
close the upper slide clamp, open the cassette door, then
remove and invert the cassette (ports down).
• Air bubbles may form distal to the cassette as result of
normal outgassing of dissolved air in the fluid. This may
occur if chilled solution is in use, if the infuser is mounted
significantly above the patient, or when using certain fluids
known to routinely outgas. In these cases, an air eliminating
filter may be used.
• Repeated opening and closing of the door may defeat the
proximal air-in-line alarm and may cause a distal air-in-line
alarm, requiring repriming.
• The screen displays the VTBI (volume to be infused) in
integers when value is above 99.9. Any fraction of a milliliter
delivered is not displayed, but is retained in memory.
• For Plum A+3 users, be aware that changing the weight on
one device does NOT change the weight on the other two
devices. Patient weight must be changed on each device
when delivering weight-based therapy dependent on
medication requirements.
CONCURRENT FLOW
GUIDELINES
When delivering short half-life critical drugs (see Critical Drugs,
this section) using the Plum A+ in the Concurrent mode, the
following delivery rate guidelines should be observed:
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Plum A+® Infusion Systems
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• If the critical drug (with half-life less than 6 minutes) is to be
infused at less than 2 mL/hr, the other infusion should be no
faster than 5 times the critical drug’s rate. Dopamine, for
example, delivered at 1.5 mL/hr should not be accompanied
by an infusion programmed any faster than 7.5 mL/hr.
• If the critical drug (with half-life less than 6 minutes) is to be
infused at 2 - 5 mL/hr the other infusion should be no faster
than ten times the critical drug’s rate. Dopamine, for example,
delivered at 3.5 ml/hr should not be accompanied by an
infusion programmed any faster than 35 mL/hr.
• If the critical drug (with half-life less than 6 minutes) is to be
infused at 5.1 mL/hr or greater, the other infusion can be
programmed at any desired rate.
NOTE: The total of the primary rate plus the secondary rate
cannot exceed 500 mL/hr.
These guidelines apply only when infusing short half-life critical
drugs in Concurrent mode. Individual patient responses may
vary requiring adjustment of delivery rates.
DELIVERY RATE GUIDELINES
SHORT HALF-LIFE (LESS THAN
6 MINUTES) CRITICAL DRUG
INFUSION RATE
MAXIMUM RATE OF
ACCOMPANYING INFUSION
0.5 - 1.9 mL/hr 5 Times the Critical Drug Rate
2 - 5 mL/hr 10 Times the Critical Drug Rate
5.1 or Greater Any Desired Ratio
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CRITICAL DRUGS
Examples of drugs with a short half-life (approximately 6
minutes or less when given IV) include:
For these drugs, the concurrent flow guidelines should be
followed when the infusion rate of the drug will be 5 mL/hr or
less.
NOTE: This list of critical drugs is not intended to be all-
inclusive of critical drugs or drugs with a short half-life.
The clinician should become familiar with the
pharmacodynamics of any critical drug before administration.
This information is presented to inform clinicians of a rare
situation that could be misinterpreted if they are unfamiliar with
this phenomenon.
EPIDURAL ADMINISTRATION
• Recommended use of the epidural route is to provide
anesthesia or analgesia for periods up to 96 hours.
• This device can be used to administer only those 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.
• For epidural administration, the use of Hospira catheters,
Plum sets without Y-sites, and "epidural" stickers indicating
ongoing epidural administration are recommended.
Dobutamine Lidocaine
Dopamine Nitroglycerin
Epinephrine Nitroprusside
Epoprostenol Norepinephrine
Esmolol Oxytocin
Isoproterenol Procainamide
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• Administration of drugs via the epidural route should be
limited to personnel familiar with associated techniques and
patient management problems. Proper epidural placement of
the catheter is essential since catheter migration could result
in intravascular or intrathecal administration. Facilities
practicing epidural administration must be equipped with
resuscitative equipment, oxygen, naloxone, and other
resuscitative drugs. Adequate monitoring equipment (e.g.,
Oximetry) is recommended for continuous monitoring of the
patient during epidural administration. Patients must be
observed frequently for side effects in a fully-equipped and
staffed environment for at least 24 hours following completion
of drug administration by the epidural route. DELAYED
RESPIRATORY DEPRESSION FOLLOWING
CONTINUOUS EPIDURAL ADMINISTRATION OF
PRESERVATIVE-FREE MORPHINE SULFATE HAS BEEN
REPORTED.
• The epidural space has 58 openings through which fluid can
exit. Pressure buildup during administration is transient.
However, if a large volume of fluid is administered over a
short time period, the pressure will take longer to return to
normal. If overdelivery occurs during administration, observe
the patient closely for signs of spinal cord compression
(disorientation, headache, transient neuralgias) and drug
overdose.
BATTERY OPERATION
• When the battery is removed from the Plum A+, do not
operate on patients. Use of a properly maintained and
charged battery helps confirm proper operation.
• The battery may not be fully charged upon receipt. Connect
the infuser to AC power for at least six hours.
• Use AC power whenever possible. Connect to AC power
during storage to ensure a fully charged battery for
emergencies. If the quality of the earth grounding source is in
doubt, use battery power.
• If the low-battery alarm sounds, connect the infuser to AC
power immediately.
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SETS AND ACCESSORIES
• Only compatible LifeCare PlumSets can be used with the
Plum A+. See individual set instructions for additional
information.
• Administration sets should be changed per CDC guidelines
or healthcare provider policy. Discard after use.
• LifeCare IV infusion sets with integral nonblood filters are not
for use in the administration of blood, blood products,
emulsions, suspensions, or any medications not totally
soluble in the solution being administered. These
medications may be administered through the lower Y-
injection site, below the filter.
• When infusing at low delivery rates (5 mL/hr or less) the use
of thick-walled microbore PlumSets is recommended. This
will reduce the amount of the fluid bolus that may be
delivered when a distal line occlusion is released.
• Syringes must be larger than 3 cc. Use syringe adapter (List
11986-48) when using syringes smaller than 10 cc. Some 10
cc syringes may require use of a syringe adapter. Syringes
larger than 10 cc may be attached directly to the secondary
port of the cassette. Use of a syringe adapter may decrease
the occurrence of proximal occlusion alarms.
• Use a 19-gauge or larger needle or catheter at the
venipuncture site for viscous fluids if operating at rates
greater than 500 ml/hr.
See Section 10 for information on sets and accessories.
BACKPRIMING
• Backpriming is not recommended for reconstituting
secondary containers containing dry powders.
• To avoid pressurization when backpriming into a syringe, the
user must confirm there is sufficient empty space to accept
the backprimed fluid.
GENERAL
• Possible explosion hazard exists if used in the presence of
flammable anesthetics.
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• Do not place Plum A+ in service if it fails the self-test.
• Do not operate the Plum A+ with the case opened.
• Keep the cassette door securely closed while the infuser is
not in use, to avoid cassette door damage.
• Values beyond a fields maximum hard limit will be diplayed
as dashes (-- -- --). The user must clear these fields using the
[CLEAR] key prior to entering new values.
• The Plum A+3 is to be used with an IV pole with a 6-wheel
base and a shelf.
CLEANING
For more information on cleaning the infuser, see Section 8.
• To avoid mechanical or electronic damage, do not immerse
the Plum A+ in any fluids or cleaning solutions.
• Do not spray cleaning solutions toward any opening in the
instrument.
• Certain cleaning and sanitizing solutions may slowly degrade
components made from some plastic materials. Using
abrasive cleaners or cleaning solutions not recommended by
Hospira may result in product damage. Do not use
compounds containing combinations of isopropyl alcohol and
dimethyl benzyl ammonium chloride.
• Never use sharp objects such as fingernails, paper clips, or
needles to clean any part of the infuser.
• Do not sterilize by heat, steam, ethylene oxide (ETO), or
radiation.
• To avoid infuser damage, cleaning solutions should only be
used as directed. The disinfecting properties of cleaning
solutions vary; consult the manufacturer for specific
information.
BOLUS RELATED
Use the following procedure to avoid the administration of a
bolus following a distal occlusion (i.e., a closed distal clamp):
• If a secondary container is in use, clamp proximal tubing
before opening cassette door.
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• Open cassette door and remove the cassette.
• Open the flow regulator briefly to dissipate the pressure
and then close it.
• Eliminate the source of occlusion (closed clamp).
• Reinsert the cassette and close the cassette door.
• Open all clamps and resume infusion.
NOTE: When troubleshooting an occlusion where all clamps
are in the OPEN position, use care to avoid delivery of a bolus
by opening the flow regulator to release any built-up pressure.
Close the clamp between the cassette and the patient before
opening the flow regulator to relieve the pressure. See Section
7, Alarms and Troubleshooting, for more information.
ARTIFACTS
• Nonhazardous, low-level electrical potentials are commonly
observed when fluids are administered using infusion
devices. These potentials are well within accepted safety
standards, but may create artifacts on voltage-sensing
equipment such as ECG, EMG, and EEG machines. These
artifacts vary at a rate that is associated with the infusion
rate. If the monitoring machine is not operating correctly or
has loose or defective connections to its sensing electrodes,
these artifacts may be accentuated so as to simulate actual
physiological signals. To determine if the abnormality in the
monitoring equipment is caused by the infusion device
instead of some other source in the environment, set the
infusion device so that it is temporarily not delivering fluid.
Disappearance of the abnormality indicates that it was
probably caused by the electronic noise generated by the
infusion device. Proper setup and maintenance of the
monitoring equipment should eliminate the artifact. Refer to
the appropriate monitoring equipment system documentation
for setup and maintenance instructions.
• The Plum A+ system is designed to operate normally in the
presence of most encountered electromagnetic interference
(EMI) conditions. In the event of extreme levels of
interference, such as encountered next to an electrosurgical
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generator, it is possible that the normal operation of a sensor
or microcomputer might be disrupted. Even in this event, the
outcome would likely be a false alarm or detected system
malfunction and would not result in a hazard to patient or
operator.
• This equipment has been tested and found to comply with the
EMC limits for the Medical Device Directive 93/42/EEC (EN
55011 Class B and IEC/EN 60601-1-2:2001). These limits
are designed to provide reasonable protection against
harmful interference in a typical medical installation. The
equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to other devices
in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. If this
equipment does cause harmful interference with other
devices, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
• Reorient or relocate the receiving device
• Increase the separation between the equipment
• Connect the equipment into an outlet on a circuit
different from that to which the other device(s) is
connected
• Consult the manufacturer or field service technician for
help
• Portable and mobile RF communications equipment, such as
cellular telephones, 2-way radios, Bluetooth devices,
microwave ovens, in close proximity to this device may affect
wireless and wired communications with the Infusion pump
and/or the operation of the Infusion pump. Special
precautions need to be exercised regarding EMC, These
include:
• Use of a shielded Ethernet cable (CAT5 STP or better)
for plugging into the RJ45 Ethernet connector. Using
an unshielded Ethernet cable may result in increased
emissions.
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• Maintaining a minimum separation distance of 2 ½ ft
between the Infusion pump system and portable/
mobile RF communications equipment
• List Numbers 12391 and 11971 are compliant to IEC/EN
60601-1-2 (1993)
List Numbers 20678 & 20679 are compliant to IEC/EN
60601-1-2 (2001) and have been tested and found to comply
with EMC limits for the Medical Device Directive 93/42/EEC
(EN 55011 Class B and EN 60601-1-2:2001).
Guidance on EMC Compatibility
• There is a shared responsibility between manufacturers,
customers and users to ensure that Medical Equipment and
Systems are designed and operated as intended. Medical
electrical equipment needs special precautions regarding
electromagnetic compatibility and needs to be installed and
used according to the electromagnetic compatibility
information provided in this manual.
• The device is suitable for use in all establishments, including
domestic establishments. If extended operation during
power mains interruption is needed, use battery power.
• Always manage the electromagnetic environment.
• The guidance included in this manual provides information
needed to:
• Determine the device’s suitability for use in the
intended environment.
• Manage the electromagnetic environment to permit the
device to perform as intended without disturbing other
equipment.
• Separate the device from all other electronic equipment. If
the device must be used near other electrical equipment,
monitor the equipment to ensure there is no electromagnetic
interference.
• Devices should not be used adjacent to or stacked with other
equipment. If the device must be used adjacent to or stacked
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