Hospira Lifecare PCA3 User manual

430-04684-002 (Rev. 01/06)
System
Operating
Manual
Hospira, Inc., Lake Forest, IL 60045, USA
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430-04684-002 (Rev. 01/06)
Change History
Title Description of Change
Pages
Affected
430-04684-001
(Rev. 1/05)
Initial Release All
430-04684-002
(Rev. 01/06)
Second Release All
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Contents
1) DESCRIPTIVE INFORMATION . . . . . . . . . . . . . . . . 1-1
1.1 PRODUCT DESCRIPTION ................... 1-1
1.2 INDICATIONS FOR USE ..................... 1-2
patient selection . . . . . . . . . . . . . . . . . . . . . . . . 1-2
user qualification . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.3 CONTRAINDICATIONS FOR USE . . . . . . . . . . . . . . . 1-3
1.4 CONVENTIONS .......................... 1-4
warnings, cautions, and notes . . . . . . . . . . . . . . 1-4
1.5 DEFINITIONS (GENERAL AND CLINICAL). .. . . . . . . 1-6
1.6 PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
artifacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
programming . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
loading dose/dose limits . . . . . . . . . . . . . . . . . 1-11
operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
epidural administration . . . . . . . . . . . . . . . . . . 1-13
battery operation . . . . . . . . . . . . . . . . . . . . . . . 1-14
sets and accessories . . . . . . . . . . . . . . . . . . . . 1-15
2) PRINCIPLES OF OPERATION . . . . . . . . . . . . . . . . 2-1
2.1 FEATURES ............................. 2-2
drug recognition . . . . . . . . . . . . . . . . . . . . . . . . 2-2
modes of delivery . . . . . . . . . . . . . . . . . . . . . . . 2-2
programming . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
bio medical . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
other features . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.2 ADMINISTRATION EQUIPMENT ............... 2-4
administration sets . . . . . . . . . . . . . . . . . . . . . . 2-4
2.3 PRINTER KITS . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
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3) EQUIPMENT DESCRIPTION . . . . . . . . . . . . . . . . . . 3-1
3.1 COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.2 OPERATING BUTTONS & KEYS . . . . . . . . . . . . . . . 3-4
4) BASIC OPERATION . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.1 GETTING STARTED . . . . . . . . . . . . . . . . . . . . . . . 4-1
unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
connecting the patient pendant . . . . . . . . . . . . 4-1
system self-tests . . . . . . . . . . . . . . . . . . . . . . . . 4-2
data retention . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
4.2 OPERATING THE PCA 3 . . . . . . . . . . . . . . . . . . . 4-3
intravenous PCA administration . . . . . . . . . . . . . 4-3
epidural PCA administration . . . . . . . . . . . . . . . . 4-4
4.3 LOADING VIAL . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
4.4 ADJUSTING SETTINGS ..................... 4-7
changing alarm volume . . . . . . . . . . . . . . . . . . . 4-8
changing contrast of main display . . . . . . . . . . . 4-9
changing or confirming time and date . . . . . . . . 4-9
4.5 GUIDED START-UP FOR PREFILLED VIALS . . . . . . 4-12
purging the system . . . . . . . . . . . . . . . . . . . . . 4-13
loading dose. . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
4.6 GUIDED START-UP FOR CUSTOM VIALS . . . . . . . 4-17
5) SELECT MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.1 MODES OF DELIVERY . . . . . . . . . . . . . . . . . . . . . 5-1
protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
PCA only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
continuous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
PCA+continuous . . . . . . . . . . . . . . . . . . . . . . . . 5-2
5.2 PROGRAMMING PCA ONLY ................. 5-3
5.3 CONTINUOUS MODE . . . . . . . . . . . . . . . . . . . . . . 5-7
5.4 PCA + CONTINUOUS MODE ............... 5-10
5.5 PROTOCOLS ........................... 5-16
5.6 DOSE LIMIT (1 OR 4 HOUR) . . . . . . . . . . . . . . . . 5-18
dose limit calculation . . . . . . . . . . . . . . . . . . . . 5-18
programming the 4 (or 1) hr dose limit. . . . . . . 5-20
to program a dose limit . . . . . . . . . . . . . . . . . . 5-20
to program NO dose limit . . . . . . . . . . . . . . . . . 5-21
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to clear or change dose limit . . . . . . . . . . . . . . 5-22
clearing the history & Rx settings. . . . . . . . . . . 5-23
5.7 USING REVIEW SCREENS . . . . . . . . . . . . . . . . . . 5-24
5.8 CHANGING SETTINGS DURING SETUP ........ 5-25
5.9 STOPPING INFUSION OR TURNING PUMP OFF ... 5-26
5.10 MAKING CHANGES AFTER SETUP .......... 5-27
to review current settings . . . . . . . . . . . . . . . . 5-27
to change settings . . . . . . . . . . . . . . . . . . . . . . 5-28
to clear shift totals . . . . . . . . . . . . . . . . . . . . . . 5-29
to change a vial . . . . . . . . . . . . . . . . . . . . . . . . 5-30
to add a supplemental loading dose . . . . . . . . 5-32
5.11 CHECKING HISTORY & SETTINGS . . . . . . . . . . . 5-33
5.12 PRINTER SETUP . . . . . . . . . . . . . . . . . . . . . . . . 5-34
5.13 PRINTING EVENT HISTORY LOG . . . . . . . . . . . . 5-39
5.14 DOWNLOADING TO APC. . . . . . . . . . . . . . . . . . 5-40
5.15 HISTORY AND EVENT LOG . . . . . . . . . . . . . . . . 5-43
6) TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.1 STATUS MESSAGES ...................... 6-1
6.2 PUMP ALARM SYSTEM . . . . . . . . . . . . . . . . . . . . . 6-2
6.3 SILENCING AN ALARM . . . . . . . . . . . . . . . . . . . . . 6-3
6.4 ALARMS AND MESSAGES . . . . . . . . . . . . . . . . . . . 6-4
7) MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.1 PUMP STORAGE . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2 CLEANING AND SANITIZING .. .. .. .. .... ..... 7-1
7.3 BATTERY MAINTENANCE . . . . . . . . . . . . . . . . . . . 7-3
service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
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8) SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.1 STORED OCCLUSION VOLUME . . . . . . . . . . . . . . . 8-4
8.2 TIME FROM OCCLUSION TO ALARM . . . . . . . . . . . . 8-4
8.3 DELIVERY RATE ACCURACY . . . . . . . . . . . . . . . . . 8-4
trumpet curves . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
8.4 TRUMPET CURVES . . . . . . . . . . . . . . . . . . . . . . . . 8-7
9) PRESCRIPTION DELIVERY LIMITS . . . . . . . . . . . . 9-1
10) WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
© 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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1) Descriptive Information
The LifeCare®PCA 3TM Infusion System is the newest Hospira
LifeCare®PCA device. Like its predecessor, the PCA Plus II, the
PCA 3 system can be used in a wide range of clinical settings,
including but not limited to:
The PCA 3 Infusion pump allows clinicians to administer or
patients to self-administer, analgesia safely and effectively within
clinician programmed limits. The epidural route can be used to
provide anesthesia or analgesia.
1.1 Product Description
The primary feature of the PCA 3 is the bar code reader, which is
designed to automate drug identification. Other enhancements
include new programming features, a numeric keypad to directly
enter programming values, and a device weight of less than 12
pounds.
The PCA 3 system includes a microprocessor based infusion
device with keypad controls, patient pendant, a bar coded drug
vial, and a compatible administration set (see Section 2.3 for list
of compatible sets). The pump has a serial port for connection to
a computer or printer, and the software is field upgradeable. It 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.
General Floor Labor/Delivery/
Post Partum
Burn Unit
Medical/Surgical Operating Room Oncology
Critical Care
Units
Post Anesthesia
Care Unit (PACU)
Pediatrics
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1- 2 1) Descriptive Information
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The vials are single-use, bar coded and prefilled with a
prescription drug by Hospira, or sterile and empty to be custom-
filled by the hospital pharmacy.
The PCA 3 system is capable of the following modes of delivery:
•PCA ONLY
•CONTINUOUS ONLY
•PCA+CONTINUOUS
The PCA 3 system also provides the ability to store frequently
used prescriptions called Protocols. The protocols are only
available for Hospira pre-filled vials and must be set up through
the service mode by a hospital-designated authority.
1.2 Indications for Use
PCA is a method of pain management that permits patients to
treat their pain by self-administering doses of analgesics. PCA
can be used to manage all types of pain, but is most commonly
used to manage acute pain.
PATIENT SELECTION
Patients selected for use of PCA should be able to understand
the relationship between pain, pushing the PCA patient pendant
and pain relief, and can physically self-administer a PCA dose
using the patient pendant.
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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.
USER QUALIFICATIONS
All clinicians should be appropriately trained on programming of
the PCA 3 pump prior to use.
The PCA 3 is intended for use at the direction or under the
supervision of licensed physicians or certified healthcare
professionals. They must be trained in the use of the pump,
administration of parenteral and epidural fluids and drugs, and
the prevention of related IV complication 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.
1.3 Contraindications For Use
The PCA 3 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 not
stable under infusion conditions, should not be used with this
system.
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1- 4 1) Descriptive Information
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1.4 Conventions
This section describes the conventions used throughout this
manual, as follows:
WARNINGS, CAUTIONS, AND NOTES
Alert messages used throughout this manual are described
below. Pay particular attention to these messages.
CONVENTION APPLICATION EXAMPLE
Italic Reference to a
section, figure, or
table
Function or mode
specific
instructions
(See Section 3-1,
Components)
Primary Only:
Attach an empty
container.
[BRACKETED
ALL-CAPS]
Keys or buttons
on the device are
displayed in
[BRACKETED
ALL-CAPS] or
with a graphic.
[START/PAUSE]
or
ItalicSmallcaps> Softkey Options CHOOSE>
Initial Caps
lowercase
Screen displays
and device labels
(as appropriate)
Therapy
Dose Calculation
Bold Emphasis ...sets are
supplied Sterile
and are for....
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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 A CAUTION
COULD RESULT IN SERIOUS PATIENT OR USER INJURY.
NOTE: A Note highlights information that helps explain a
concept or procedure.
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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1.5 Definitions (General and Clinical)
TERM DEFINITION
1 Hour Dose Limit Programmed parameter specifying
the maximum amount of drug that
can be administered in a rolling
(continuously advancing) one hour
time period.
4 Hour Dose Limit Programmed parameter specifying
the maximum amount of drug that
can be administered in a rolling
(continuously advancing) four hour
time period.
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 product specification, Section
9).
Continuous Infusion therapy characterized by a
constant fixed-rate dose.
Custom Syringe or
Vial
Bar coded Hospira sterile empty
vial which is custom-filled by a
licensed pharmacy.
Default Generally refers to the factory
setting for parameters or options.
History Displays Parameter Settings, Dose
History and Event Log. Also
provides access to Print History
softkey.
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LifeCare PCA 3 Infusion System 1- 7
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Lockout Interval Programmed time interval
specifying the minimum time that
must pass after a PCA dose or
Loading Dose is administered
before the next PCA dose can be
infused. The bolus requests made
during this period are not delivered.
Loading Dose An optional dose delivered before
starting normal function of the
pump (or thereafter by unlocking
the door).
Occlusion Inability of the instrument to infuse
fluid to the patient. Possible causes
of occlusions include kinked
tubing, plugged tubing, etc.
Maximum
Occlusion Pressure
The maximum pressure observed in
response to a patient line
occlusion.
Patient Pendant Hand-held pendant connected to
the instrument that allows the
patient to request a bolus PCA dose
by pressing a button.
PCA mode Infusion therapy characterized by
bolus doses administered on
patient demand subject to a lockout
interval and, optionally, a 1 or 4
hour dose limit.
PCA 3 Vial Bar coded vial compatible with the
PCA 3 instrument that is either
prefilled or custom filled with a
drug.
PCA 3 Instrument Programmable patient controlled
infusion pump.
PCA 3 Set Tubing which connects the PCA 3
Vial to the patient.
TERM DEFINITION
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1- 8 1) Descriptive Information
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1.6 Precautions
•Product damage may occur unless proper care is
exercised during the unpacking and setup process. The
battery may not be fully charged upon receipt.
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
Prime Manually removing air from the
syringe and line.
Purge Running the mechanism to remove
system slack when a new vial/
injector is installed. (The system
must be primed first and
disconnected from the patient.)
Warning An indication to advise the
clinician:
A) of a possible dangerous
condition such as a low battery
B) that an attempt has been made to
use a function in the wrong
sequence, wrong time, or with the
wrong values, such as an invalid
key attempt
TERM DEFINITION
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LifeCare PCA 3 Infusion System 1- 9
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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 3 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 those encountered next to
an electrosurgical 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 clinician.
•Use of radio frequency emitting devices such as cellular
telephones and 2-way radios in close proximity of this
device may affect its operation.
GENERAL
•Possible explosion hazard exists if 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
incompatibility with fluid or drug being delivered through
the IV line.
•Coupling together of more than one pump into one
patient line may significantly affect the infusion rate of at
least one of the pumps.
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•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 vials and Hospira PCA sets with
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 into pump.
•Always close slide clamp on PCA administration set
before removing or replacing syringe, and before
discontinuing infusion.
•Patient must be disconnected from the PCA set before
the purge cycle.
•Vial and injector must be securely locked into the infuser
before beginning delivery.
PROGRAMMING
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 pump
automatically performs a small system compliance step
to remove slack when the [START/PAUSE] key is
pressed (with 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 hazard to the
patient, the set should be disconnected during this
operation.
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LifeCare PCA 3 Infusion System 1- 11
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•At flow rates less than 0.5 mL/hr, there may be a
significant delay before flow is established if 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
•A loading dose is included in the 4-hour (or 1) dose limit
calculation ONLY if administered after the 4-hour dose
limit has been programmed. If the loading dose is
administered prior to setting the 4-hour dose limit, it will
NOT be included in the 4-hour dose limit calculation. The
loading dose is always included in the total dose
delivered.
•A supplemental “booster” dose can be delivered at any
time during setup or operation, even if the 4-hour dose
limit is already reached or will be exceeded after delivery.
•Setting a new 4-hour dose limit will not erase the
previous 4-hour dose history.
•The concentration can only be changed by removing and
re-inserting a custom vial or by turning the pump OFF
then ON again. Once the concentration is programmed
and confirmed, it cannot be changed without performing
one of these two actions. If the concentration is
changed, the current settings and consequently the dose
limit accumulation are cleared.
•Partial boluses can be the result of interrupting delivery
by pressing [START/STOP] (PCA + Cont.), opening the
door (PCA Only), loss of power, reaching the dose limit,
emptying the vial, or a malfunction alarm.
•If the loading or supplemental “booster” dose causes the
4-hour dose limit to be exceeded, the complete dose will
still be delivered. The volume beyond the 4-hour dose
limit will count towards the “next” rolling 4-hour dose
limit.
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1- 12 1) Descriptive Information
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•Always monitor the PCA 3 when delivering medication
with the door open.
•Patient Pendant is only to be pressed by the intended
patient.
OPERATION
•Perform close assessment and monitoring of patients
receiving potent analgesic medication for possible
adverse reactions.
•The PCA 3 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
•Always confirm bar code reader window is clean. Blood,
fingerprints, condensation, and other elements may
obstruct the view of the bar code reader. Elements on the
window (other than scratches) can be cleaned by using
one of the recommended cleaning solutions in the
Section 7, Maintenance.
•Window scratches cannot be wiped clean and will
probably lead to window replacement.
•To avoid mechanical or electrical damage, do not
immerse the pump 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 containing combinations of
isopropyl alcohol and dimethyl benzyl ammonium
chloride.
•Do not sterilize by heat, steam, ETO, or radiation.
•Do not place the PCA 3 in service if it fails the self-test.
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LifeCare PCA 3 Infusion System 1- 13
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•Hospira will be responsible for the effect on safety,
reliability, and performance of this device only if:
adjustments, modifications, or repairs are performed by
persons authorized by Hospira; the 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.
ALARMS
•If the MALFUNCTION alarm sounds, press the [ON/OFF]
key to turn the pump off. Then turn the pump back on. If
the malfunction alarm repeats, remove the pump from
service.
EPIDURAL ADMINISTRATION
•Recommended use of the epidural route is to provide
anesthesia 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 infusion 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 administration of
drugs other than those indicated for epidural use could
result in serious injury to the patient.
•For epidural administration, the use of pump sets
without Y-sites, and "epidural" stickers indicating
ongoing epidural administration are recommended.
•Administration of drugs via the epidural route should be
limited to personnel familiar with associated techniques
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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
WARNING
DISCONNECT AC POWER CORD BEFORE
REMOVING BATTERY DOOR.
CAUTION: DONOT OPERATE THE PCA 3 WITH THE
BATTERY REMOVED ON PATIENTS. USE OF APROPERLY
MAINTAINED AND CHARGED BATTERY HELPS ENSURE PROPER
OPERATION.
•The battery may not be fully charged upon receipt.
Connect the PCA 3 to AC power for at least 16 hours.
PCA3NDC.book Page 14 Tuesday, January 10, 2006 2:01 PM