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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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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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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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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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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On The infuser is turned on using either A/C or
battery power. The infuser is not
necessarily pumping when ON.
Patient Pendant A hand held pendant connected to the
infuser that allows the patient to request a
PCA dose (bolus) by pressing a button.
PCA Mode Infusion therapy characterized by bolus
doses administered on patient demand
subject to a lockout interval and, optionally,
a dose limit.
PCA Set Tubing connecting the PCA Vial to the
patient.
PCA Vial Vial compatible with the infuser that is
either prefilled with drug by Abbott or
Hospira (standard vial) or filled by the
hospital pharmacy (custom vial).
Prime Manually removing air from the syringe and
line.
Purge The process during which the pumping
mechanism is run to remove air from the
PCA set.
Rule Set A list of upper, lower, soft and/or hard limits
for delivery parameters. Rule sets reside in
the User-Defined Drug Library and are
associated with a specific vial within a
CCA.
TERMS DEFINITIONS
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Rx Settings The current programmed therapy. Includes
PCA Dose, PCA Lockout Interval,
Continuous Rate, Loading Dose and Dose
Limit amount.
Soft Keys The five keys to the right of the device’s
LCD display. Each key’s function is
dependent on the screen displayed data.
Stored Protocols Frequently used therapy settings stored in
the infuser's memory. Stored protocols can
be recalled again, making it unnecessary
for the operator to program the same
therapy settings each time they are
needed. Stored protocols are determined
by the health care facility.
Standard Syringe A prefilled bar coded drug vial in which the
infuser identifies the drug and
concentration. The drug and concentration
are found in the Drug Library by using the
bar code on the vial. Standard syringes are
also known as prefilled drug vials.
User-defined Drug
Library
A drug library that contains hospital defined
clinical care areas (CCAs) and rule sets
created with Hospira MedNet®Software.
Warning An indication to advise the clinician of a
possible dangerous condition.
TERMS DEFINITIONS
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Precautions and Warnings
UNPACKING
Product damage may occur unless proper care is exercised
during the unpacking and setup process. The battery may not be
fully charged upon receipt.
GENERAL
This section addresses general safety and operational procedures.
•Possible explosion hazard exists if used in the presence of
flammable anesthetics.
WARNING
Possible explosion hazard exists if the infuser is used
in the presence of flammable anesthetics.
•Potent analgesic medications are used with this device. Refer
to drug package insert for precautions and possible adverse
reactions.
•Refer to analgesic package enclosure for possible incompatibil-
ity with fluid or drug being delivered through the IV line.
•Coupling together of more than one infuser into one patient line
may significantly affect the infusion rate of at least one of the
infusers.
•Do not use sharp objects such as pens, scissors, or fingernails
to press keys. Such objects may damage keys and cause a
malfunction.
•Arrange tubing, cords, and cables to minimize the risk of patient
strangulation or entanglement.
•Failure to use Hospira/Abbott vials and Hospira/Abbott PCA
Infuser sets with the integral anti-siphon valve may cause an
inaccurate dose delivery to the patient.
•The system must be primed prior to purging. Remove all air
from vial before placing it into the infuser.
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•Always close the slide clamp on the PCA Infuser administration
set before removing or the replacing syringe, and before discon-
tinuing infusion.
•Patient must be disconnected from the PCA Infuser set before
the purge cycle.
•Vial and injector must be securely locked into the infuser before
beginning delivery.
PROGRAMMING
This section presents known infuser programming cautions.
WARNING
For custom syringes, confirm that the displayed
concentration (mg/mL) or (mcg/mL) exactly matches
the concentration value and drug name on the syringe.
If they do not match, under/overdosage may result.
•In the CONTINUOUS and PCA+CONTINUOUS modes, if a
purge is not performed after a syringe change, the infuser auto-
matically performs a small system compliance step to remove
slack when the [START/PAUSE]key is pressed (with the door
locked). Although, fluid is not normally delivered to the patient
during the compliance step, under some conditions up to 0.3
mL of fluid may be delivered. If 0.3 mL of fluid represents a haz-
ard to the patient, disconnect the set during this operation.
•At flow rates less than 0.5 mL/hr, there may be a significant
delay before flow is established if the system is not purged.
•Selections are rounded up to the nearest tenth of a digit for mg/
mL values or to the nearest digit for mcg/mL values.
LOADING DOSE/DOSE LIMITS
This section presents Loading Dose and Loading Dose
information and cautions.
•The loading dose is always included in the total dose delivered.
•Setting a new dose limit will not erase the previous dose history.
•Always monitor the PCA Infuser when delivering medication
with the door open.
•Patient Pendant is only to be pressed by the intended patient.
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WARNING
Patient Pendant is only to be pressed by the patient.
OPERATION
This section presents operational information and cautions.
•Perform close assessment and monitoring of patients receiving
potent analgesic medication for possible adverse reactions.
•The PCA Infuser is not intended to be used for frequent, long-
term portable operation. Keep plugged into a properly grounded
AC receptacle whenever possible, and reserve battery power
for temporary portable operation and emergency backup. If the
AC receptacle is in doubt, use battery power.
MAINTENANCE
This section addresses infuser maintenance.
•Always confirm that the bar code reader window is clean.
Blood, fingerprints, condensation, and other elements may
obstruct the view of the bar code reader. Elements on the win-
dow (other than scratches) can be cleaned by using one of the
recommended cleaning solutions. SeeSection8 Maintenanceon
page8-1.
•Window scratches cannot be wiped clean and will probably lead
to window replacement.
•To avoid mechanical or electrical damage, do not immerse the
infuser in any fluids or cleaning solutions.
•Some cleaning and sanitizing compounds 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 contain-
ing combinations of isopropyl alcohol and dimethyl benzyl
ammonium chloride.
•Do not sterilize by heat, steam, ETO, or radiation.
•Do not place the PCA Infuser in service if it fails the self-test.
•Hospira will be responsible for the safety effect, reliability, and
performance of this device only if: adjustments, modifications,
or repairs are performed by persons authorized by Hospira; the
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LifeCare PCA® Infusion System
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electrical setup at the point of use complies with appropriate
local requirements; and the device is used in accordance with
the instructions for use identified in this operating manual.
•Hospital policies and guidelines must always be followed to ensure
patient safety and to minimize the potential for patient hazards.
ALARMS
This section presents alarm information.
•If the MALFUNCTION Alarm Message is seen and sounds, press
the [ON/OFF] key to turn the infuser off. Then turn the infuser
back on. If the malfunction alarm repeats, remove the infuser from
service.
EPIDURAL ADMINISTRATION
This section contains epidural administration information.
•Recommended use of the epidural route is to provide anesthe-
sia or analgesia for periods up to 96 hours.
•It is strongly recommended that the epidural infusion system be
prominently identified as EPIDURAL. Failure to identify the infu-
sion system as epidural could result in incorrect administration
of intravenous rather than epidural formulations. In addition,
failure to identify the epidural infusion system could result in
confusion with other infusion systems delivering concomitant
intravenous formulations.
•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 admin-
istration of drugs other than those indicated for epidural use
could result in serious injury to the patient.
•For epidural administration, the use of infuser sets without Y-
sites, and epidural stickers indicating ongoing epidural adminis-
tration are recommended.
•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 cath-
eter is essential since catheter migration could result in intra-
vascular or intrathecal administration. Facilities practicing
epidural administration must be equipped with resuscitative
equipment, oxygen, naloxone, and other resuscitative drugs.
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Adequate monitoring equipment is recommended for continu-
ous 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 follow-
ing completion of drug administration by the epidural route.
CAUTION: 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. How-
ever, if a large volume of fluid is administered over a short time
period, the pressure will take longer to return to normal. If over
delivery occurs during administration, observe the patient
closely for signs of spinal cord compression (disorientation,
headache, transient neuralgias) and drug overdose.
BATTERY OPERATION
This section documents battery information.
WARNING
Unplug the AC power cord before removing the battery door.
CAUTION: WHEN THE PCA INFUSER IS CONNECTED TO A
PATIENT, DO NOT OPERATE THE PCA INFUSER WITH THE
BATTERY REMOVED. USE OF APROPERLY MAINTAINED AND
CHARGED BATTERY HELPS ENSURE PROPER OPERATION.
•The battery may not be fully charged upon receipt. Connect the
PCA Infuser to AC power for at least 16 hours.
•Use AC power whenever possible. Connect to AC power during
storage to ensure a fully charged battery during a power outage.
•Always connect the infuser to a properly grounded receptacle
unless battery operation is desired. If quality earth grounding
source is in doubt, use battery power.
•If the low-battery alarm sounds, connect to AC power immediately.
WARNING
The infuser cannot communicate via the network if the
Low Battery Warning alarm has sounded.
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SETS AND ACCESSORIES
Use Hospira/Abbott LifeCare PCA®Set List 6517 whenever the
infuser is in CONTINUOUS or PCA+CONTINUOUS Modes.
•When using PCA or PCA+CONTINUOUS Mode, another fluid
line may be attached to the distal backcheck Ysite. Use Hos-
pira/Abbott LifeCare PCA®Infuser set, List 3559, 6516, or a
combination of List 6514 and 6517.
•It is recommended that highly viscous solutions and drugs, col-
loidal suspensions, and emulsions should not be delivered
through the inline backcheck valve of the PCA Infuser set.
Valve functionality may be compromised by the presence of
residue.
•Refer to vial and set package inserts for precautions and infor-
mation on proper handling.
ELECTRICAL ARTIFACTS
This section addresses electrical artifacts and their remedies.
•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 PCA Infusion System is designed to operate normally in
the presence of most encountered electromagnetic interference
(EMI) conditions. In the event of extreme levels of interference,
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such as those encountered next to an electrosurgical generator,
it is possible that the normal operation of a sensor or microcom-
puter 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 the patient or clinician.
•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. How-
ever, there is no guarantee that interference will not occur in a
particular installation. If this equipment causes harmful interfer-
ence with radio, television, or 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, micro-
wave ovens, in close proximity to this device may affect wire-
less 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.
•Maintaining a minimum separation distance of 2 ½ ft between
the infusion pump system and portable/mobile RF communica-
tions equipment
•List Number 20709 is compliant to IEC/EN 60601-1-2 (2001)
and have been tested and found to comply with EMC limits for
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the Medical Device Directive 93/42/EEC (EN 55011 Class B
and IEC/EN 60601-1-2:2001).
For more information see Contact Information on back.
INTERCONNECTING OF EQUIPMENT
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.
Guidance on EMC Compatibility
•There is a shared responsibility between manufacturers, cus-
tomers, and users to ensure that medical equipment and sys-
tems are designed and operated as intended. Medical electrical
equipment requires precautions regarding electromagnetic
compatibility, and must 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.
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