Hospira 20709-04 User manual

430-04685-005 (Rev. 06/2007)
System
Operating
Manual
For Use With List 20709-04
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LifeCare PCA® Infusion System
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Section 1
Descriptive Information
The latest patient controlled analgesia (PCA) offered by Hospira,
LifeCare PCA®Infusion System with Hospira MedNet®Software,
allows clinicians to administer, or patients to self-administer
analgesia, safely and effectively within clinician programmed
limits and/or hospital-defined medication limits.
The LifeCare PCA®Infusion System is used in a wide range of
clinical settings that includes but is not limited to the following:
Product Description
The primary drug safety features of the LifeCare PCA®Infuser
device are the Hospira MedNet®Software and the bar code
reader that are designed to enhance patient safety and automate
drug identification. Other enhancements include new
programming features and the ability to read pharmacy-
generated bar codes.
The PCA Infusion System includes a microprocessor based
infusion device with keypad controls, patient pendant, a bar
coded drug vial, and a compatible administration set
(see Administration Equipment on page 2-5 for list of compatible sets). The
infuser has an Ethernet port for computer or printer connections.
MEDICAL LABOR/DELIVERY/POST
PARTUM BURN UNIT
SURGICAL OPERATING ROOM ONCOLOGY
CRITICAL CARE UNITS POST ANESTHESIA CARE
UNIT (PACU) PEDIATRICS
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The LifeCare PCA®Infuser contains a Connectivity Engine
module that provides wired Ethernet and wireless 802.11 a/b/g
local area networking capabilities. This allows the Hospira
MedNet® networked application software to download drug
libraries to the infuser and enable the auto-programming feature.
The infuser is intended to operate on AC power, but an internal
battery is provided to maintain operation for short periods of time
when AC power is not available.
The vials are single-use, bar coded, and prefilled with a
prescription drug by Hospira/Abbott, or the vials are sterile and
empty to be custom-filled by the hospital pharmacy.
The PCA Infuser offers the following modes of delivery:
•PCA ONLY
•CONTINUOUS ONLY
•PCA+CONTINUOUS
The PCA Infuser is able to store frequently used prescriptions
called protocols. The protocols are available for Hospira/Abbott
prefilled vials and custom syringes. The protocols must be set up
by a hospital-designated authority in the Biomed Mode or through
Hospira MedNet®Software (if enabled).
Indications for Use
The LifeCare PCA®Infusion System with Hospira MedNet®
Software is intended for accurate, volumetric, infusion of
analgesic drugs by continuous or patient demanded intravenous
administration. It is intended for short-term continuous (less than
96 hours) epidural administration of analgesic drugs.
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LifeCare PCA® Infusion System
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WARNING
For epidural use, 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.
PATIENT SELECTION
Patients selected to use the PCA Infuser should be able to
understand the relationship between pain and pushing the PCA
Infuser patient pendant for pain relief. Patients selected for the
use of the PCA Infuser should be able to physically self-
administer a PCA dose using the patient pendant.
WARNING
Patient Pendant Is only to be pressed by the patient.
USER QUALIFICATIONS
All clinicians should be appropriately trained to program the PCA
Infuser prior to use.The PCA Infuser is intended for use at the
direction or under the supervision of licensed physicians or
certified health care professionals. Clinicians must be trained in
infuser use, administration of parenteral and epidural fluids and
drugs, and the prevention of related IV complications and
precautions to prevent accidental infusion of air. Training should
emphasize the assessment and monitoring of patients receiving
potent analgesic medications, and the appropriate treatment for
possible adverse reactions.
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Contraindications For Use
The PCA Infuser should not be used for patient controlled
analgesia by patients who do not have the cognitive ability to
understand the use of self-administered pain medication, nor
have the physical capacity to operate the patient pendant, if
required.
Drugs not compatible with silicone rubber or PVC plastic, or
drugs not stable under infusion conditions should not be used
with this system.
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LifeCare PCA® Infusion System
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Conventions
This section describes the conventions used throughout this
manual:
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.
NOTE: A Note highlights information that helps explain a
concept or procedure.
Convention Application Example
ITALIC REFERENCE TO ASECTION,
FIGURE, OR TABLE.(See Front Panel on
page 3-2.)
[BRACKETEDALL-
CAPS] KEYS OR BUTTONS ON THE
DEVICE ARE DISPLAYED IN
[BRACKETEDALL-
CAPS]OR WITH AGRAPHIC.
[ON/OFF]
OR
ITALIC SMALLCAPS>SOFTKEY OPTIONS PREVIOUS>
INITIAL CAPS LOWERCASE SCREEN DISPLAYS AND
DEVICE LABELS (AS
APPROPRIATE)
SELECT DELIVERY MODE
BOLD EMPHASIS ...SETS ARE SUPPLIED
STERILE AND ARE FOR....
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This symbol directs the user to consult accompanying
documents.
NOTE: Figures are rendered as graphic representations to
approximate the actual product. Therefore, figures may not
exactly reflect the product.
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LifeCare PCA® Infusion System
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Definitions (General and Clinical)
TERMS DEFINITIONS
Accuracy The degree to which the instrument is
capable of delivering the volume of
analgesic drug that is displayed or targeted
to be delivered. Accuracy shall be specified
as the maximum allowable delivery error
from a targeted or displayed value
(see Section 9 Specificationson page 9-1).
Autoprogramming Complete or partial program received from
a bar code enabled Point-of-Care System
requiring clinician confirmation prior to
administration.
Battery Fault A battery that will not accept a full charge.
Bolus A fixed amount of drug delivered in a short
amount of time. A PCA dose.
Button A hard key on the front panel or on the
patient pendant.
Clinical Care Area
(CCA)
An area of the hospital that authorized
hospital staff is permited to use specific
drugs. The clinician selects a CCA after
turning on the infuser. The hospital may
create from one to eighteen CCA’s.
Connectivity
Engine (CE)
A component of the infuser that controls
Ethernet and wireless communication
between the network server and infuser.
Continuous Infusion program characterized by a
constant, fixed-rate dose.
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Custom Syringe
or Vial
A bar coded Hospira/Abbott sterile empty
vial that is custom-filled by a pharmacy.
Default Drug
Library (DDL)
A pre-programmed drug library embedded
in the infuser software. The infuser uses
the DDL until a User-defined Drug Library
is installed and supersedes the DDL.
Dose Limit User-programmable parameter specifying
the maximum amount of drug that can be
administered via PCA dose and continuous
delivery in a programmable rolling time
period consisting of discrete accumulation
periods of 6 minutes.
NOTE: Dose Limit periods are specified as
1 and 4 hours on an infuser with the DDL;
on infusers with a User-defined Drug
Library, the dose limit periods can be
defined as 1, 4, 6, or 12 hours.
Drug Library
Download
The process of moving the User-defined
Drug Library from the network server to the
infuser.
Drug Library
Installation
The process of moving the User-defined
Drug Library from the CE to the infuser.
History Displays RxSettings, PCASummaryand the Event
Log.
Hospira MedNet®
Software
Network based application software used
to upload event logs and download the
user-defined drug library to the infuser.
TERMS DEFINITIONS
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LifeCare PCA® Infusion System
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Infusing The infuser is ON and a DELIVERY SCREEN is
displayed. The infusing mechanism may or
may not be actually infusing at any given
time.
LCD Liquid Crystal Display
LED Light Emitting Diode
Loading Dose An optional dose programmed during
Setup before entering the program.
The loading dose can be administered at
any time by the clinician during the
programmed therapy. For more information
see Loading Dose on page 4-30.
Lockout Interval A programmed time interval specifying the
minimum time that must pass after a
loading dose or PCA dose (bolus) is
administered; this time interval specifies
when the next PCA dose can begin
infusing. Bolus requests made during the
lock out interval are denied.
Muting Period The period between the silencing of an
alarm by pressing the [SILENCE] key and the
resumption of the alarm.
Occlusion A blockage in the PCA Infuser set that
prevents the infuser from pumping fluid into
the patient. Possible causes of occlusions
are kinked or plugged non-patent IV tubing.
Occlusion
Pressure
The maximum pressure produced as a
result of an occlusion in the PCA Infuser
set.
TERMS DEFINITIONS
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