Hospira MedNet operating Manual

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Page 1

System Operating Manual

For Use With List 20709-04

430-04685-004 (Rev. 01/06)

Page 2

For Systems With Hospira MedNetTM Software

Change History

Title Description of Change Pages Affected

430-04685-001 (Rev. 7/05)

430-04685-002 (Rev. 09/05)

430-04685-003 (Rev. 10/05)

430-04685-003 (Rev. 01/06)

Original Release All

Second Release All

Third Release All

Fourth Release All

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LifeCare PCA

Infusion System

Section 1, Descriptive Information . . . . . . . . . . . . . . . 1-1

PRODUCT DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

NDICATIONS FOR USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

patient selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

user qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

ONTRAINDICATIONS FOR USE . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

ONVENTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

warnings, cautions, and notes . . . . . . . . . . . . . . . . . . . . . 1-4

EFINITIONS (GENERAL AND CLINICAL) . . . . . . . . . . . . . . . . . . . 1-6

RECAUTIONS AND WARNINGS . . . . . . . . . . . . . . . . . . . . . . . . 1-11

unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

loading dose/dose limits . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13

maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13

alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

epidural administration . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

battery operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15

sets and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16

electrical artifacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16

interconnecting of equipment . . . . . . . . . . . . . . . . . . . . . 1-18

UIDANCE ON EMC COMPATIBILITY . . . . . . . . . . . . . . . . . . . . 1-18

FCC I

NFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19

US FCC statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19

FCC interference statement . . . . . . . . . . . . . . . . . . . . . . 1-19

radio frequency exposure statement . . . . . . . . . . . . . . . 1-20

Section 2, Principles of Operation . . . . . . . . . . . . . . . 2-1

FEATURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

drug recognition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

modes of delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

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biomedical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

other features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

DMINISTRATION EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Section 3, Equipment Description . . . . . . . . . . . . . . . .3-1

FRONT PANEL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

IAL CRADLE ASSEMBLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

EAR PANEL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

PERATING BUTTONS & KEYS . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Section 4, Basic Operation . . . . . . . . . . . . . . . . . . . . . 4-1

OPERATING THE PCA INFUSER . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

intravenous pca infuser administration . . . . . . . . . . . . . . . 4-2

epidural pca infuser administration . . . . . . . . . . . . . . . . . . 4-2

OADING A VIAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

UIDED START UP FOR PREFILLED VIALS . . . . . . . . . . . . . . . . . . 4-6

UIDED START UP FOR CUSTOM VIALS . . . . . . . . . . . . . . . . . . 4-12

ETTING STARTED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

NPACKING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

connecting the patient pendant . . . . . . . . . . . . . . . . . . . 4-19

system self-tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

data retention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

DJUSTING SETTINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21

changing alarm volume . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

changing contrast of main display . . . . . . . . . . . . . . . . . 4-23

changing or confirming time and date . . . . . . . . . . . . . . 4-24

EW PATIENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

URGING THE SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28

OADING DOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30

Section 5, Select Mode . . . . . . . . . . . . . . . . . . . . . . . .5-1

MODES OF DELIVERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

pca only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

continuous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

pca+continuous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

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PCA ONLY MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

ONTINUOUS MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

PCA+C P D

ONTINUOUS MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13

ROTOCOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18

OSE LIMIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21

programming the 4 (or 1) hour dose limit . . . . . . . . . . . . 5-22

programming a dose limit . . . . . . . . . . . . . . . . . . . . . . . . 5-22

programming no dose limit . . . . . . . . . . . . . . . . . . . . . . . 5-23

clearing or changing a dose limit . . . . . . . . . . . . . . . . . . 5-25

LEARING THE HISTORY AND/OR RX SETTINGS . . . . . . . . . . . . 5-27

SING REVIEW/CONFIRMATION SCREENS . . . . . . . . . . . . . . . . 5-28

HANGING SETTINGS DURING SETUP . . . . . . . . . . . . . . . . . . . 5-29

stopping infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29

turning the infuser off . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29

AKING CHANGES AFTER SETUP . . . . . . . . . . . . . . . . . . . . . . 5-30

reviewing the current settings . . . . . . . . . . . . . . . . . . . . 5-30

changing settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30

changing the CCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32

LEARING SHIFT TOTALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33

HANGING A VIAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34

DDING A SUPPLEMENTAL LOADING DOSE . . . . . . . . . . . . . . . 5-36

HECKING HISTORY & SETTINGS . . . . . . . . . . . . . . . . . . . . . . 5-37

ISTORY AND EVENT LOG . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38

Section 6, Advanced Programming

with Hospira MedNetTM Software . . . . . . . . 6-1

GUIDED START-UP USING H

OSPIRA MEDNET TM SOFTWARE . . . . . . . . . . . . . . . . . . . . . . 6-1

ELECT CCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

PDATING THE DRUG LIBRARY . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

OFT LIMIT OVERRIDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

ARD LIMIT VIOLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

MPORTANT SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

no rule sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

soft limit override . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

wireless . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12

UTOPROGRAMMING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12

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Section 7, Troubleshooting . . . . . . . . . . . . . . . . . . . . . 7-1

STATUS MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

NFUSER ALARM SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

ILENCING AN ALARM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

LARMS AND MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

NFUSER STALLING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Section 8, Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 8-1

INFUSER STORAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

LEANING AND SANITIZING . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

ATTERY MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

ERVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Section 9, Specifications . . . . . . . . . . . . . . . . . . . . . . .9-1

STORED OCCLUSION VOLUME . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

IME FROM OCCLUSION TO ALARM . . . . . . . . . . . . . . . . . . . . . . 9-5

ELIVERY RATE ACCURACY . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

trumpet curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

RUMPET CURVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8

Section 10, Prescription Delivery Limits . . . . . . . . . .10-1

Appendix A, Generating Bar Code Labels

(Hospira MedNet

Software Enabled) . A-1

equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

example of label layout & sample . . . . . . . . . . . . . . . . . . . A-3

label diagram

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4

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Appendix B, Network Printer Setup . . . . . . . . . . . . . . B-1

equipment needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

printing event history log . . . . . . . . . . . . . . . . . . . . . . . . . B-2

OWNLOADING LOGS TO A PC . . . . . . . . . . . . . . . . . . . . . . . . . B-3

equipment needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

Appendix C, Warranty . . . . . . . . . . . . . . . . . . . . . . . . C-1

Index, . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1

Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . Back

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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Software

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LifeCare PCA® Infusion System

Section 1 Descriptive Information

The latest patient controlled analgesia (PCA) offered by Hospira,

LifeCare PCA Software, allows clinicians to administer, or patients to selfadminister analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits.

Infusion System with Hospira MedNetTM

The LifeCare PCA clinical settings that includes but is not limited to the following:

MEDICAL LABOR/DELIVERY/POST

SURGICAL OPERATING ROOM ONCOLOGY

CRITICAL CARE UNITS POST ANESTHESIA CARE

Infusion System is used in a wide range of

BURN UNIT

PARTUM

EDIATRICS

NIT (PACU)

Product Description

The primary drug safety features of the LifeCare PCA® Infuser device are the Hospira MedNet

reader that are designed to enhance patient safety and automate drug identification. Other enhancements include new programming features and the ability to read pharmacygenerated 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.

Software and the bar code

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Descriptive Information

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.

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 MedNetTM 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.

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.

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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 selfadminister 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.

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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Descriptive Information

Conventions

This section describes the conventions used throughout this manual:

Convention Application Example

ITALIC REFERENCE TO A SECTION,

[BRACKETED ALLCAPS]

ITALIC SMALLCAPS>SOFTKEY OPTIONS

INITIAL CAPS LOWERCASE SCREEN DISPLAYS AND

BOLD EMPHASIS ...SETS ARE SUPPLIED

FIGURE, OR TABLE.

EYS OR BUTTONS ON THE

DEVICE ARE DISPLAYED IN

[BRACKETED ALLCAPS] OR WITH A GRAPHIC.

DEVICE LABELS (AS APPROPRIATE)

(See Front Panel on

page 3-2.

[ON/OFF]

)

PREVIOUS>

SELECT DELIVERY MODE

STERILE AND ARE FOR....

WARNINGS, CAUTIONS, AND NOTES

Alert Messages used throughout this manual are described below. Pay particular attention to these messages.

WARNING

A Warning Message contains special safety emphasis and must be observed at all times. Failure to observe a Warning Message is potentially life threatening.

CAUTION: A CAUTION USUALLY APPEARS IN FRONT OF A

PROCEDURE COULD HARDWARE RESULT

OR STATEMENT. IT CONTAINS INFORMATION THAT

PREVENT IRREVERSIBLE PRODUCT DAMAGE OR

FAILURE. FAILURE TO OBSERVE A CAUTION COULD

IN SERIOUS PATIENT OR USER INJURY.

NOTE: A Note highlights information that helps explain a

concept or procedure.

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LifeCare PCA® Infusion System

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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Descriptive Information

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 Specifications on 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)

Connectivity Engine (CE)

Continuous Infusion program characterized by a

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.

A component of the infuser that controls Ethernet and wireless communication between the network server and infuser.

constant, fixed-rate dose.

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TERMS DEFINITIONS

Custom Syringe or Vial

Default Drug Library (DDL)

Dose Limit User-programmable parameter specifying

Drug Library Download

A bar coded Hospira/Abbott sterile empty vial that is custom-filled by a pharmacy.

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.

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.

The process of moving the User-defined Drug Library from the network server to the infuser.

Drug Library Installation

History Displays

Hospira MedNet Software

The process of moving the User-defined Drug Library from the CE to the infuser.

Rx Settings, PCA Summary and the Event

Log

Network based application software used to upload event logs and download the user-defined drug library to the infuser.

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Descriptive Information

TERMS DEFINITIONS

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 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.

[SILENCE] key and the

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TERMS DEFINITIONS

On The infuser is turned on using either A/C or

battery power. The infuser is not necessarily pumping when

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).

ON.

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.

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Descriptive Information

TERMS DEFINITIONS

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

Warning An indication to advise the clinician of a

A drug library that contains hospital defined clinical care areas (CCAs) and rule sets

created with Hospira MedNet

possible dangerous condition.

Software.

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LifeCare PCA® Infusion System

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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Descriptive Information

• Always close the slide clamp on the PCA Infuser administration

set before removing or the replacing syringe, and before discontinuing 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 automatically 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 hazard 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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LifeCare PCA® Infusion System

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 window (other than scratches) can be cleaned by using one of the recommended cleaning solutions.

page 8-1.

• 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 containing 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

See Section 8 Maintenance on

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Descriptive Information

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 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 infuser 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 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.

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LifeCare PCA® Infusion System

Adequate monitoring equipment is recommended for continuous monitoring of the patient during epidural administration. Patients must be observed frequently for side effects in a fullyequipped and staffed environment for at least 24 hours following completion of drug administration by the epidural route.

CAUTION: DELAYED RESPIRATORY DEPRESSION FOLLOWING

CONTINUOUS FREE MORPHINE SULFATE HAS BEEN REPORTED.

EPIDURAL ADMINISTRATION OF PRESERVATIVE-

• 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 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: W

PATIENT BATTERY CHARGED

, DO NOT OPERATE THE PCA INFUSER WITH THE

HEN THE PCA INFUSER IS CONNECTED TO A

REMOVED. USE OF A PROPERLY MAINTAINED AND

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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Descriptive Information

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 Y site. Use Hos-

pira/Abbott combination of List 6514 and 6517.

LifeCare PCA® Infuser set, List 3559, 6516, or a

• 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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LifeCare PCA® Infusion System

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 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. However, there is no guarantee that interference will not occur in a particular installation. If this equipment causes harmful interference 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, 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.

• Maintaining a minimum separation distance of 2 ½ ft between

the infusion pump system and portable/mobile RF communications 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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Descriptive Information

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 606011-1. 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 systems 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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LifeCare PCA® Infusion System

• 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 equip-

ment. If the device must be used adjacent to or stacked with other equipment, monitor the devices to verify normal operation.

• USE ONLY components specifically labeled for use with the

PCA Infusion System to help ensure the device operates as intended.

• If you suspect external RF sources or other equipment are influ-

encing device operation, contact the Biomedical Engineering Department for additional guidelines concerning electromagnetic immunity.

• Contact the Biomedical Engineering Department for additional

information in the technical service manual concerning operating devices near RF sources.

FCC Information

FCC ID: STJ-20709

US FCC (FEDERAL COMMUNICATIONS COMMISSION) STATEMENT

• This device complies with part 15 of the FCC Rules. Operation

is subject to the following two conditions: (1) This device may not cause interference, and (2) This device must accept any interference, including that may cause undesired operation of this device.

FCC INTERFERENCE STATEMENT

• This equipment has been tested and found to comply with the

limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy. If not installed and used in accordance with the instructions, it may cause harmful interference to radio communications. However, there is no guarantee that interference will

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Descriptive Information

not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try and correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.

• Increase the distance between the equipment and the

receiver.

• Connect the equipment to an outlet on a circuit different

from that to which the receiver is connected.

• Consult the dealer or an experienced radio/TV technician

for help.

• Changes or modifications not expressly approved by Hospira

could void the user's authority to operate the equipment.

RADIO FREQUENCY EXPOSURE STATEMENT

• The Wireless LAN radio device in the Connectivity Engine

peripheral board with this infusion device has been evaluated and found compliant to the requirements of the following Radio Frequency exposure standards:

• Federal Communications Commission, OET Bulletin 65

(Edition 97-01), Supplement C (Edition 01-01), Evaluating Compliance with FCC Guidelines for Human Exposure to Radio frequency Electromagnetic Fields, July 2001.

• Industry Canada, Evaluation Procedure for Mobile and

Portable Radio Transmitters with respect to Health Canada's Safety Code 6 for Exposure of Humans to Radio Frequency Fields, Radio Standards Specification RSS-102 Issue 1 (Provisional): September 1999.

• The radiated output power of this Wireless LAN device is far

below the FCC radio frequency exposure limits. The Wireless LAN device has been evaluated with one inch separation of human body from the antenna and found to be compliant with FCC RF exposure limits.

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LifeCare PCA® Infusion System

Section 2 Principles of Operation

The PCA Infuser is a portable infusion pump that allows a patient to self-administer analgesia within programmed limits as well as providing continuous infusion of a desired drug. Generally, a clinician following a physician’s order programs the infuser with operating parameters, which may include the following:

• Drug Dose and Concentration

• Loading Dose

• Delivery Mode Setting

• PCA

• CONTINUOUS

• PCA+CONTINUOUS

• PCA Dose

• Lockout Interval

• Continuous Rate

• 1 or 4 Hour Dose Limit

(factory setting 4-hour when using DDL)

• Protocols

(Hospital configured programs stored in the infuser)

Available operating parameters and their allowed ranges are determined based on the confirmed vial and the delivery mode selected. The loading dose and dose limits are optional. This programmed flexibility allows the physician to tailor an effective pain management program unique to each patient.

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Principles of Operation

The PCA Infuser may be programmed to deliver the following:

• PCA doses (PCA Mode)

• Continuous background infusion

with no PCA doses permitted (CONTINUOUS Mode).

• Continuous rate and PCA doses

(PCA+CONTINUOUS Mode).

Analgesic drugs may be delivered through the PCA Infuser intravenously by any of the three modes cited above. In addition, Preservative-Free Morphine Sulfate Injection, USP, or other approved analgesic drugs can be administered epidurally through a recommended Low Priming Volume PCA Set without a Yadapter. The epidural route may be used to provide analgesia by any of the three modes of infuser operation.

A lockout Interval controls the frequency that a patient may receive a PCA dose of analgesic. If the infuser is set in the PCA or PCA+CONTINUOUS Mode, the patient may request a bolus of analgesic during therapy by pressing the patient pendant button; this causes the infuser to release the specified bolus of analgesic into the IV line. After a Loading or Supplemental Loading Dose delivery, the patient cannot receive any additional patient requested boluses until the lockout interval has elapsed, assuming the dose limit has not been exceeded (see Dose

Limit on page 5-21).

The alarm system sounds an audible alarm to alert the user of various conditions or a malfunction (see Alarms and

Messages on page 7-4).

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LifeCare PCA® Infusion System

Features

The following features are addressed in this section:

• Drug Recognition

• Modes Of Delivery

• Programming

• Battery

• Biomedical

• Options

• Other Features

DRUG RECOGNITION

• Bar code reader identifies drug name and concentration in the

vial (prefilled Hospira/Abbott vials only).

• Bar code reader identifies the drug name and concentration of

custom-filled vials when appropriate pharmacy-generated bar

codes are used and Hospira MedNet

MODES OF DELIVERY

• PCA Only

• Continuous

• PCA + Continuous

Software is enabled.

PROGRAMMING

• Keypad with large numbers, decimal point & icons for easy use

• Prompting alphanumeric display

BATTERY

• 8 V Battery

• Battery for emergency backup and temporary portable

operation (approx. 2.5 hrs.)

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Principles of Operation

BIOMEDICAL

• RJ-45 Ethernet Connector

• Software is Field Upgradable

• Diagnostic Setup Options

• Alarm History

• Ability to Store Protocols for Hospira/Abbott Prefilled Vials and

Custom (Sterile Empty) Vials

• Nurse Call Relay Connector

OPTIONS

• Infusion History

OTHER FEATURES

• Prefilled and Sterile Empty Vials

• Wireless Antenna

• Autoprogramming

• Microprocessor Control

• Liquid Crystal Display (LCD) and Light-Emitting Diode (LED)

Display

• Panel Back Illumination

• Security Features

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LifeCare PCA® Infusion System

Administration Equipment

The following sets may be used in any delivery mode. The following sets are supplied sterile and are for single use only administration sets:

List 3559:

List 6514:

List 6516:

List 6517:

PCA Set, Mini-Bore with Integral Anti-Siphon Valve-SL 170 cm. Approximate priming volume

2.3 mL. For use in PCA mode via intravenous route.

PCA Extension Set with Backcheck Valve-SL 25 cm. Approximate priming volume 1.1 mL. For use in conjunction with Set 6517 to convert from Continuous to PCA Mode via Intravenous route.

PCA Set-Long, Mini-Bore with Integral AntiSiphon Valve-SL 218 cm. Approximate Priming Volume 2.6 mL. For use in PCA Mode when extra length needed via Intravenous route.

PCA Continuous Infusion Set, Mini-Bore with Integral Anti-Siphon Valve-SL 203 cm. Approximate Priming Volume 1.5 mL.

For use in Continuous and PCA+Continuous Modes via intravenous route.

For use in PCA, Continuous, and PCA + Continuous modes via epidural route.

** See the current product sales catalog for available drugs and sets **

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Principles of Operation

NOTES

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LifeCare PCA® Infusion System

Section 3 Equipment Description

The following subjects are addressed in this section:

• Front Panel

• Vial Cradle Assemble

•Rear Panel

• Operating Buttons & Keys

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Front Panel

Security Door

Vial Cradle Clips

Vial

Cradle Release Mechanism (Holder)

Equipment Description

LED

Display

LCD

Display

Softkeys

Door Lock

Keypad

Buttons

AC Power

Indicator

PCA

Bar code Reader Window

Injector

Battery Power Indicator

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LifeCare PCA® Infusion System

Vial Cradle Assemble

Wireless

Cradle Release Mechanism

Vial Base

Antenna

Upper Vial

Retainer

Bar code Reader Window (

vial bar code must face toward window

Vial Stopper

Vial Lip

Injector

Injector Flange (Vial Plunger)

Luer-Lock Fitment

)

Vial Cradle

Clips

Vial Sensor

Switch

(Top Vial

Cradle Clip)

Lower Vial

Retainer

(Middle

Bracket)

Injector

Flange

Retainer

Injector

Sensor

Switch (back

of retainer)

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Rear Panel

Equipment Description

Patient Pendant Jack

Patient Pendant Cable Fastener

Patient Pendant (blue handle)

Univers al IV Pole Clamp with Dual

Lock

NOTE: Pole Clamp is locked when security door is closed and locked. Unit cannot be removed from IV pole

Nurse Call Jack*

Ground Test Point

Patient

Pendant

Button

Ethernet Jack/ Printer Connector*

Battery and Fuse Access Door

* See pages 1-16 through 1-20 prior to interconnecting equipment.

AC Cord Connector

Stabilizer foot

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LifeCare PCA® Infusion System

Operating Buttons & Keys

The [ON/OFF] Button controls the power of the PCA Infuser.

The

[CLEAR] Button is used to

clear an entry.

The

[ENTER] Button is used to

select and accept various screen options.

The

[EXIT] Button is used to

return to the main display from non-programming screens.

The

[SILENCE/VOLUME] Button is

used to temporarily silence an alarm while correcting a condition to temporarily silence an alarm while correcting a condition, to temporarily mute the keypad for two minutes, or to adjust alarm volume when the infuser is in run mode.

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Equipment Description

The [START/PAUSE] Button is used to start or pause a continuous infusion or PCA bolus.

The [

HISTORY] Button is used

to display parameter settings, dose history, review Rx, and review the event log. It also provides access to the Print History Softkey (Hospira

Mednet enabled).

The numeric Buttons are used to enter values for any field requiring numeric data.

The used for entering numbers with a decimal point. An example would be 10.5 mg.

Software not

[DECIMAL POINT] Button is

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LifeCare PCA® Infusion System

Keys (or Softkeys) are touchkeys which are located to the right of the main display. They perform a variety of functions correlating to the description displayed on the screen.

An example of a softkey in this manual is PCA O

Battery indicator illuminates continuously when infuser is running on battery power.

AC (mains) power indicator illuminates when infuser is plugged into AC power.

NLY>.

LED displays the dose delivered.

When displaying dose delivery in micrograms, a vertical “walking stick” appears on the right side of the display.

When displaying dose delivering in milligrams, the “walking stick” appears on the left side of the display.

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Equipment Description

PCA Patient Pendant is used by the patient to deliver the drug upon the press of the button.

WARNING

PATIENT PENDANT IS ONLY TO BE PRESSED BY THE PATIENT.

If the Patient Pendant is partially pressed, a Pendant Fault Message will appear. This can be corrected by releasing the button. A PCA bolus will not be delivered during a Pendant Fault condition.

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Section 4 Basic Operation

The following subjects are addressed in this section:

• Operating the PCA Infuser

• Loading a Vial

• Guided Start up for Prefilled Vials

• Guided Start up for Custom Vials

• Getting Started

• Adjusting Settings

• New Patient

• Purging the System

• Loading Dose

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Basic Operation

Operating the PCA Infuser

The following topics are addressed in this section:

• Intravenous PCA Infuser Administration

• Epidural PCA Infuser Administration

INTRAVENOUS PCA INFUSER ADMINISTRATION

1 Connect the syringe to the set and manually

prime set.

2 Attach primary IV set line to recommended PCA

Infuser set, list #’s 3559, 6516, or 6517 attached to list 6514 via backcheck valve port.

3 Prime IV set and the lower portion of the PCA

Infuser set, and close the manual clamp on the IV set.

EPIDURAL PCA INFUSER ADMINISTRATION

NOTE: The administration of drugs is restricted to those

analgesic drugs approved for continuous epidural administration.

Recommended use of the epidural route is for labor and delivery, acute pain control, or post-operative analgesia for periods up to 96 hours.

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LifeCare PCA® Infusion System

WARNING

It is strongly recommended that the epidural infusion system be prominently identified as epidural. Failure to identify it as epidural may result in incorrect administration of intravenous rather than epidural formulations. In addition, failure to identify the epidural infusion could result in confusion with other infusion systems delivering concomitant intravenous formulations.

If a patient access device is not indwelling, prime and establish epidurally. Confirm proper placement. Attach recommended low priming volume infuser set, without Y-injection sites, to patient access device.

CAUTION: E I

NFUSER AND/OR CONTINUOUS MODES SHOULD BE LIMITED

PERSONNEL FAMILIAR WITH ASSOCIATED TECHNIQUES AND

TO PATIENT PLACEMENT MIGRATION INTRATHECAL CONTINUOUS

RESUSCITATIVE EQUIPMENT, OXYGEN, NALOXONE AND

WITH OTHER

RESUSCITATIVE DRUGS. ADEQUATE MONITORING

EQUIPMENT

THE PATIENT DURING EPIDURAL ADMINISTRATION. PATIENTS

BE OBSERVED FOR SIDE-EFFECTS FREQUENTLY IN A FULLY

MUST EQUIPPED FOLLOWING

CAUTION: D

CONTINUOUS FREE MORPHINE SULFATE HAS BEEN REPORTED.

PIDURAL ADMINISTRATION OF DRUGS BY PCA

MANAGEMENT PROBLEMS. PROPER EPIDURAL

OF THE CATHETER IS ESSENTIAL SINCE CATHETER

COULD RESULT IN INTRAVASCULAR AND

ADMINISTRATION. FACILITIES PRACTICING

EPIDURAL ADMINISTRATION MUST BE EQUIPPED

IS RECOMMENDED FOR CONTINUOUS MONITORING

AND STAFFED ENVIRONMENT FOR AT LEAST 24 HOURS

COMPLETION OF EPIDURAL DRUG ADMINISTRATION.

ELAYED RESPIRATORY DEPRESSION FOLLOWING

EPIDURAL ADMINISTRATION OF PRESERVATIVE-

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Basic Operation

If over-delivery occurs during administration, observe the patient carefully for signs of the following:

• Compression on spinal cord (disorientation, headache, or

transient neuralgia)

• Drug overdose

The epidural space has 58 openings through which fluid can exit. Pressure build-up during administration is transient. However, if a large volume of fluid is administered over a short period, the pressure will take longer to return to normal.

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LifeCare PCA® Infusion System

Loading a Vial

WARNING

Failure to use compatible Hospira/Abbott vial/injector and Hospira/Abbott PCA Infuser sets with integral antisiphon valve may cause an inaccurate dose delivery to the patient.

1. Squeeze Cradle Release Mechanism together at the top of the holder and move to the uppermost position.

NOTE: Always verify that the bar

code reader window is clean before inserting vial.

2. When inserting bottom of glass vial into middle black bracket, ensure

DRUG NAME

that the bar code label faces the bar code reader on the right side of the vial compartment.

CAUTION: DO NOT POSITION VIAL

UPPER VIAL CLIP FIRST. VIAL LIP

INTO

CRACK OR CHIP.

MAY

3. Insert bottom of glass vial into the middle black bracket.

4. Gently press upper end of glass vial into upper black bracket.

5. Squeeze the top of the Cradle Release Mechanism and move down until the vial injector snaps into the bottom bracket.

6. Select

CONTINUE>.

7. If vial bar code is not read by the infuser, slowly rotate the vial and position with the bar code on the right until bar code has been read.

CAUTION: VIAL AND INJECTOR MUST BE SECURELY LOCKED

THE INFUSER BEFORE BEGINNING DELIVERY.

INTO

430-04685-004 4- 5

Page 48

Basic Operation

WARNING

Cracked vials may not show evidence of leakage until delivery pressure is applied.

NOTE: If the device is

turn the device

INJECTOR

selected. Proper loading (engaging injector flange) silences the alarm.

ON and activate a non-silenceable CHECK

alarm within 30 seconds after CONTINUE> is

OFF, improper loading of syringe will

Guided Start up for Prefilled Vials

NOTE: If LifeCare PCA Infuser is Hospira MedNet enabled,

see Section 6 for Operation.

1 Press BUTTON, or load

drug vial into cradle, to power on the infuser.

See Loading a Vial on page 4-5. Upon initial start-

up, the self-test begins. It may take several seconds for the Hospira logo to appear on the screen.

This screen is followed by another screen displaying self-test information that includes the following: time, date, drug library, software version, and copyright data. During the self-test, the infuser reads the bar code label.

LIFECARE PCA

SELF TEST

LOCKOUT

CONT. RATE

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LifeCare PCA® Infusion System

2 Select CONTINUE> to advance

to the next screen.

The NEW PATIENT SCREEN appears if the infuser has been off for 4 hours or less. Select

YES> or NO>.

3 If NO> is selected, the

History and Rx settings are kept.

4 If the YES> option is

selected, the History and Rx settings are cleared. Select CONFIRM> to confirm choice and continue. A screen appears to confirm that History was cleared.

LIFECARE PCA

SELF TEST

COMPLETE

RAM. . . . . . .OK

FLASH. . . . .OK

CPU ID. . . . .OK

CPU. . . . . . .OK

TIMER. . . . .OK

SYSTEM SETTINGS

CONTINUE

NEW PATIENT?

YES

HISTORY AND

RX SETTINGS

CLEARED

430-04685-004 4- 7

Page 50

Basic Operation

5 Select CONFIRM> to accept

the inserted drug, or remove the vial if it is not correct.

6 Select either YES> or NO> to

purge the system.

See Purging the System on page 4-28 for more

information.

7 If YES> is selected,

disconnect the set from the patient, and press and hold the PURGE> Softkey.

MORPHINE PF

1 mg/mL

CONFIRM 1 mg/mL MORPHINE PF TO RX REMOVE VIAL IF NOT CORRECT

CONFIRM

MORPHINE PF

1 mg/mL

PURGE ? PURGING RECOMMENDED

YES

MORPHINE PF

1 mg/mL

DISCONNECT SET FROM PATIENT PRESS AND HOLD PURGE KEY

While purging is occurring,

PURGE

the word PURGING is displayed.

NOTE: Purging is recommended to remove system slack when a new vial is inserted. The maximum volume delivered during a purge is 3 mL.

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LifeCare PCA® Infusion System

Upon release of the PURGE> Softkey, the display asks if the purge is complete.

8 Select YES> to continue, or

select NO> to purge again until complete.

9 After purging is complete,

reconnect set to patient.

10 Set Loading Dose (if

desired) by selecting YES>.

See Loading Dose on page 4-30

for more information.

11 Enter a Loading Dose within

the displayed range. Then press .

ENTER

MORPHINE PF

1 mg/mL

PURGE COMPLETE ?

YES

MORPHINE PF

1 mg/mL

SET LOADING DOSE ?

YES

MORPHINE PF

1 mg/mL

ENTER LOADING DOSE THEN PRESS ENTER BUTTON

0.1 - 10 mg

2 mg

milligrams

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Basic Operation

12 The DELIVER LOADING DOSE NOW

SCREEN allows the option of

delivering the loading dose

MORPHINE PF

1 mg/mL

DELIVER LOADING DOSE NOW ?

now or after the programming is complete.

DELIVER LATER

13 If YES> was selected,

press the BUTTON to infuse the programmed Loading

Dose.

NOTE: The loading dose mode is the only mode that the infuser will deliver with the door unlocked.

MORPHINE PF

1 mg/mL

PRESS START BUTTON TO INFUSE 2 mg LOADING DOSE

WARNING

Always monitor the infuser when delivering medication with the door unlocked.

YES

14 If the DELIVER LATER option is selected, the screen

advances to the S

4- 10 430-04685-004

ELECT DELIVERY MODE SCREEN.

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LifeCare PCA® Infusion System

15 The screen displays the

amount of analgesic delivered as it infuses. The bottom of the screen displays text confirming that the Loading Dose is being delivered. Upon completion, the red LED (above the LCD) displays the amount delivered.

16 The SELECT MODE SCREEN

appears. See Modes of

Delivery on page 5-2 for more

information.

MORPHINE PF

1 mg/mL

PRESS PAUSE BUTTON TO STOP

1 mg

milligrams

INFUSING

LOADING DOSE

MORPHINE PF

1 mg/mL

SELECT DELIVERY MODE

PCA ONLY

PCA + CONT.

CONTINUOUS

PROTOCOLS

430-04685-004 4- 11

Page 54

Basic Operation

Guided Start up for Custom Vials

NOTE: Custom vials without

pharmacy-generated bar codes can only be used with the default drug library.

1 Press BUTTON, or load

LIFECARE PCA

SELF TEST

LOCKOUT

CONT. RATE

drug vial into cradle, to power on the infuser. See

Loading a Vial on page 4-5.

Upon initial start-up, the self-test begins. It may take several seconds for the Hospira logo to appear on the screen.

This screen is followed by another screen displaying self-test information that includes the following: time, date, drug library, software version and copyright data. During the self-test, the infuser reads the bar code label.

2 Select CONTINUE> to advance

to the next screen.

LIFECARE PCA

SELF TEST

COMPLETE

RAM. . . . . . .OK

FLASH. . . . .OK

CPU ID. . . . .OK

CPU. . . . . . .OK

TIMER. . . . .OK

SYSTEM SETTINGS

CONTINUE

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LifeCare PCA® Infusion System

3 The NEW PATIENT SCREEN

appears if the infuser has been off for 4 hours or less. Select YES> or NO>.

NEW PATIENT?

4 If NO> is selected, the

YES

History and Rx settings are kept.

5 If the YES> option is

selected, the History and Rx settings are cleared. Select CONFIRM> to confirm choice and continue. A screen appears to confirm that history was cleared.

NOTE: An Alpha Vial is a type of sterile empty vial that can be customized by your hospital pharmacy. Other vials, when available and used, may be identified as Beta, Gamma, etc..

6 Select CONFIRM> to accept

the inserted drug, or remove the vial if it is not correct.

HISTORY AND

RX SETTINGS

CLEARED

ALPHA VIAL

CONFIRM CUSTOM VIAL TO RX REMOVE VIAL IF NOT CORRECT

CONFIRM

430-04685-004 4- 13

Page 56

Basic Operation

7 Select either YES> or NO> to

purge the system. See

Purging the System on page 4-28

for more information.

8 If YES> is selected,

disconnect the set from the patient, and press and hold the PURGE> Softkey.

While purging is occurring, the word PURGING is displayed.

NOTE: Purging is recommended to remove system slack when a new vial is inserted. The maximum volume delivered during a purge is 3mL.

ALPHA VIAL

PURGE ? PURGING RECOMMENDED

YES

ALPHA VIAL

DISCONNECT SET FROM PATIENT PRESS AND HOLD PURGE KEY

PURGE

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LifeCare PCA® Infusion System

Upon release of the PURGE> Softkey, the display asks if the purge is complete.

9 Select YES> to continue, or

select NO> to purge again until complete.

10 After purging is complete,

reconnect set to patient.

11 Select desired units of

measure.

For the demonstration purposes Micrograms is selected.

ALPHA VIAL

PURGE COMPLETE ?

ALPHA VIAL

SELECT UNITS OF MEASURE

MILLIGRAMS

(mg)

MICROGRAMS

(mcg)

YES

430-04685-004 4- 15

Page 58

Basic Operation

12 Enter desired drug

concentration within the displayed range.

NOTE: Only whole numbers may be entered when using micrograms (mcg). If a decimal entry is attempted, the display will inform the user that the decimal point is not allowed. Press

[CLEAR] to zero the value.

Then enter a whole value within the displayed range.

13 Then press .

ENTER

14 Confirm the drug

concentration by selecting CONFIRM>.

ALPHA VIAL

ENTER DRUG CONCENTRATION THEN PRESS ENTER BUTTON

1 - 100 mcg/mL

micrograms

CONFIRM 10 mcg/mL CONCENTRATION TO PHYSICIAN RX

mcg

ALPHA VIAL

10 mcg/mL

CONFIRM

15 Set Loading Dose (if

desired) by selecting YES>.

See Loading Dose on page 4-30

ALPHA VIAL

10 mcg/mL

SET LOADING DOSE ?

for more information.

YES

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LifeCare PCA® Infusion System

16 Enter a Loading Dose within

the displayed range.Then press .

ENTER

17 The DELIVER LOADING DOSE NOW

SCREEN allows the option of

delivering the loading dose now or after the programming is complete.

18 If YES> was selected,

press the BUTTON to infuse the programmed Loading

Dose.

ALPHA VIAL

10 mcg/mL

ENTER LOADING DOSE THEN PRESS ENTER BUTTON

1 - 100 mcg

20 mcg

micrograms

ALPHA VIAL

10 mcg/mL

DELIVER LOADING DOSE NOW ?

YES

DELIVER LATER

ALPHA VIAL

10 mcg/mL

PRESS START BUTTON TO INFUSE 20 mcg LOADING DOSE

NOTE: The loading dose mode is the only mode that the infuser will deliver with the door unlocked.

430-04685-004 4- 17

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Basic Operation

WARNING

Always monitor the infuser when delivering medication with the door unlocked.

19 If the DELIVER LATER option is selected, the screen

advances to the SELECT DELIVERY MODE SCREEN.

20 The screen displays the

The SELECT MODE SCREEN appears. See Modes of

Delivery on page 5-2 for more

information.

ALPHA VIAL

10 mcg/mL

PRESS PAUSE BUTTON TO STOP

15 mcg

micrograms

INFUSING

LOADING DOSE

ALPHA VIAL

10 mcg/mL

SELECT DELIVERY MODE

PCA ONLY

PCA + CONT.

CONTINUOUS

PROTOCOLS

4- 18 430-04685-004

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LifeCare PCA® Infusion System

Getting Started

This section details the PCA Infuser setup procedures.

UNPACKING

Inspect the PCA Infuser packaging for possible shipping damage. If damage is found, contact the delivery company immediately.

Unpack the PCA Infuser carefully, and inspect the PCA Infuser thoroughly for damage. Retain the packing slip and save all packing material in case the PCA Infuser is damaged or fails the infuser self-test and has to be returned to Hospira.

CAUTION: C I

NFUSER TO AVOID PRODUCT DAMAGE. DO NOT USE THE PCA

NFUSER IF IT APPEARS DAMAGED IN ANY WAY. THE BATTERY

NOT BE CHARGED UPON RECEIPT.

MAY

CAUTION: I

CONTACT HOSPIRA.

AREFULLY UNPACK AND SETUP THE PCA

F THE PCA INFUSER APPEARS TO BE DAMAGED,

CONNECTING THE PATIENT PENDANT

The Patient Pendant should be plugged into the unit prior to programming.

1 Connect Patient Pendant plug into the back of

unit opening labeled Patient Pendant.

2 Tighten connector ring snugly to confirm proper

attachment.

YSTEM SELF-TESTS

Connect the AC power (mains) cord to an AC power receptacle, then confirm that the power plug icon is illuminated on the front of the infuser.

430-04685-004 4- 19

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Basic Operation

To verify readiness for operation, a systematic self-testing of the processing, delivery, and safety systems is performed whenever the PCA Infuser is turned on.

CAUTION: D

FAILS THE SYSTEM SELF-TESTS.

O NOT PLACE THE PCA INFUSER IN SERVICE IF

NOTE: If the quality of the earth grounding source is in

doubt, use battery power.

Self-test failures are reported in the Malfunction Log as a Malfunction Condition.

If an alarm occurs during the Power On Self-Test, identify the alarm message, then take corrective action (see

section, Alarms

and Messages on page 7- 4).

Power the infuser from service and contact the hospital biomedical department or the local Hospira representative.

Unlock the door and press the turn the power on. Check the screen display and listen for a beep that indicates the audio is working. Wait for the self-tests to complete. If a vial was not previously inserted and the self-test was successful, put a vial (with a fully primed set) into the infuser.

NOTE: When operating on battery power, a Message displays to prompt for an AC power connection.

ON. If the alarm recurs, remove the PCA Infuser

[ON/OFF] BUTTON, or insert the vial to

LOW BATTERY

CAUTION: D

BATTERY CHARGED

O NOT OPERATE THE PCA INFUSER WITH THE

REMOVED. USE OF A PROPERLY MAINTAINED AND

BATTERY HELPS ENSURE PROPER OPERATION.

To ensure a fully charged battery, connect the PCA Infuser to AC power for a minimum of 16 hours while in the

OFF MODE.

DATA RETENTION

Delivery program settings and programming option selections are retained in memory unless erased.

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LifeCare PCA® Infusion System

The infuser will automatically erase the program and the history if infuser is off for more than 4 hours. If the infuser is restarted after

being off for 4 hour or less, the clinician to either keep the current program and history, or erase the program and history.

The infuser has the capacity of recording up-to 20,000 events. The PCA Infuser displays up to 400 events by pressing the [

HISTORY] Button. Events recorded include opening or closing of the

security door, starting or stopping continuous infusion, an alarm condition, and so on. All event descriptions are preceded with time of occurrence.

NEW PATIENT SCREEN allows the

Adjusting Settings

Press BUTTON to power on

the infuser. Upon initial start-up, the self-test begins. It may take several seconds for the Hospira logo to appear on the screen.

LIFECARE PCA

SELF TEST

LOCKOUT

CONT. RATE

430-04685-004 4- 21

Page 64

Basic Operation

2 Select SYSTEM SETTINGS> to

view the Change Settings Menu.

3 Adjust settings by selecting

the appropriate softkey.

CHANGING ALARM VOLUME

LIFECARE PCA

SELF TEST COMPLETE

RAM. . . . . . .OK

FLASH. . . . .OK

CPU ID. . . . .OK

CPU. . . . . . .OK

TIMER. . . . .OK

SYSTEM SETTINGS

CONTINUE

SELECT SETTING TO CHANGE

VOLUME

CONTRAST

TIME/DATE

CONTINUE

1 Select VOLUME>.

SELECT SETTING TO CHANGE

VOLUME

CONTRAST

TIME/DATE

CONTINUE

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LifeCare PCA® Infusion System

2 Select desired volume, then

SAVE & EXIT>.

The current setting flashes at this screen.

CHANGING CONTRAST OF MAIN DISPLAY

SELECT ALARM VOLUME

1 Select CONTRAST>.

SELECT SETTING TO CHANGE

HIGH

MEDIUM

LOW

CANCEL

SAVE & EXIT

VOLUME

CONTRAST

TIME/DATE

CONTINUE

2 Select desired adjustment

softkey repeatedly until contrast is optimized for viewing.

3 Select SAVE & EXIT>.

430-04685-004 4- 23

ADJUST LCD CONTRAST TO DESIRED LEVEL

LIGHTER

DARKER

CANCEL

SAVE & EXIT

Page 66

Basic Operation

CHANGING OR CONFIRMING TIME AND DATE

WARNING

Changing the date or time will clear all totals. The current program will remain intact when the time/date function is accessed. Lockouts or limits in place when the time/date is changed will remain in effect.

1 Select TIME/DATE>. After

selecting TIME/DATE>, a warning screen appears to indicate that changing the date or time will clear all totals.

SELECT SETTING TO CHANGE

VOLUME

CONTRAST

TIME/DATE

CONTINUE

2 When the WARNING SCREEN

appears, select CONTINUE>.

3 Set Time with number

buttons using four digits. Enter hour as two digits (01:00) and minutes as two digits (01:07 PM).

WARNING!

CHANGING THE

DATE OR TIME

WILL CLEAR ALL TOTALS!

CONTINUE

4- 24 430-04685-004

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LifeCare PCA® Infusion System

4 Select AM/PM> to alternate

between AM and PM.

NOTE: Time may be displayed using the 12 or 24 hour clock. The default setting is the 12 hour clock. The clock selection option is available in the Biomed Mode.

5 After changing the time,

select NEXT> to change the date.

6 To change the date, set the

date with the Numbers Buttons.

The current setting for Date will flash.

NOTE: Date must be entered in MM/DD/YY sequence.

SET TIME WITH NUMBERS BUTTONS TOGGLE AM/PM

10:43 PM

AM/PM

SET DATE WITH NUMBERS BUTTONS

01/15/05

430-04685-004 4- 25

Page 68

7 Select NEXT> again after

changing to the desired date. The CONFIRMATION SCREEN appears. Select CONFIRM> to verify the changed settings.

8 Then select CONTINUE> to exit

the Change System Settings Menu and display the VIAL CONFIRMATION SCREEN (if the vial is loaded properly).

Basic Operation

CONFIRM CURRENT TIME AND DATE SETTINGS

9:21 PM

01/15/05

CONFIRM

CHANGE

CANCEL

4- 26 430-04685-004

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LifeCare PCA® Infusion System

New Patient 1

The NEW PATIENT SCREEN appears if the infuser has

been off for 4 hours or less.

Select YES> or NO>.

NEW PATIENT?

NOTE: If the infuser has been off for more than 4 hours, the History and Rx settings are automatically

cleared and the

NEW PATIENT

SCREEN is not shown.

2 If YES> is selected, the

History and Rx settings are cleared. If NO> is selected, the History and Rx settings are kept, and a screen appears offering the option to CLEAR HISTORY> or

CONTINUE>.

YES

HISTORY AND

RX SETTINGS

CLEARED

430-04685-004 4- 27

Page 70

Basic Operation

Purging the System

WARNING

The patient must be disconnected from the PCA Infuser set before the purge cycle.

After the infuser is turned on and the self-tests are complete, the purge system prompt appears. Confirm that the PCA Infuser set is disconnected from the patient’s IV line before pressing Y initiate the purge cycle.

To remove system slack when a new syringe is installed, we recommend purging the infuser before beginning operation.

ES> to

Press and hold the approximately 250 mL/hr. As soon as fluid is seen at the end of the administration set, and no air remains in the set, release the key. After the and the infuser prompts you to respond if flow was seen. If flow was not seen, the cycle may be repeated until a total of 3 mL has been delivered.

NOTE: The infuser only allows the user to purge if Manual Purge is enabled in Biomed Mode. If it is disabled, purging is

not an option.

NOTE: Prime the system before purging. Remove all air from the syringe before loading it into the infuser.

NOTE: Drug delivered during the purge cycle is not stored in system memory and will not be displayed.

CAUTION: I

IF A PURGE IS NOT PERFORMED AFTER A SYRINGE CHANGE, THE INFUSER COMPLIANCE PRESSED NORMALLY COMPLIANCE

MAY BE DELIVERED. IF 0.3 ML OF FLUID REPRESENTS A

FLUID

PURGE> key. The flow rate during purging is

PURGE> key is released, the purge cycle will stop

N C ONTINUOUS AND PCA+CONTINUOUS M ODES,

AUTOMATICALLY PERFORMS A SMALL SYSTEM

STEP TO REMOVE SLACK WHEN [START] IS

(WITH THE DOOR LOCKED). ALTHOUGH, FLUID IS NOT

DELIVERED TO THE PATIENT DURING THE

STEP, UNDER SOME CONDITIONS UP TO 0.3 ML OF

4- 28 430-04685-004

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LifeCare PCA® Infusion System

HAZARD TO THE PATIENT, DISCONNECT THE SET DURING THIS OPERATION

1 If YES> is selected,

disconnect the set from the patient, and press and hold the PURGE> Softkey.

NOTE: While purging is occurring, the word be displayed.

NOTE: Purging is recommended to remove system slack when a new vial is inserted. The maximum volume delivered during a purge is 3 mL.

PURGING will

Upon release of the PURGE> Softkey, the display asks if the purge is complete.

2 Select YES> to continue, or

select NO> to purge again until complete.

MORPHINE PF

1 mg/mL

DISCONNECT SET FROM PATIENT PRESS AND HOLD PURGE KEY

PURGE

MORPHINE PF

1 mg/mL

PURGE COMPLETE ?

YES

Reconnect set to patient.

430-04685-004 4- 29

Page 72

Basic Operation

Loading Dose

After the drug concentration has been confirmed, an optional loading dose may be programmed to provide an immediate bolus to the patient.

1 Set Loading Dose (if

desired) by selecting YES>.

If NO> is selected, the screen advances to the SELECT MODE SCREEN. See Modes of Delivery

on page 5-2 for information on

modes.

NOTE: A supplemental loading dose can also be delivered after the programming sequence is complete and infusing by opening

the door and selecting the

LOADING DOSE> key.

2 Enter a Loading Dose within

the displayed range.

3 Then press .

ENTER

MORPHINE PF

1 mg/mL

SET LOADING DOSE ?

YES

MORPHINE PF

1 mg/mL

ENTER LOADING DOSE THEN PRESS ENTER BUTTON

0.1 - 10 mg

2 mg

milligrams

4- 30 430-04685-004

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LifeCare PCA® Infusion System

4 The next screen offers the

options of infusing the loading dose now or later

MORPHINE PF

1 mg/mL

DELIVER LOADING DOSE NOW ?

(after programming is complete). If DELIVER LOADING

YES

DOSE NOW ? is desired, press the YES> Softkey to infuse

DELIVER LATER

the programmed Loading Dose.

5 If the DELIVER LATER option is

desired, the screen advances to the SELECT DELIVERY MODE SCREEN. See Modes of Delivery on page 5-2 for

more information.

6 If YES> was selected,

press the BUTTON to infuse the programmed Loading

Dose.

MORPHINE PF

1 mg/mL

PRESS START BUTTON TO INFUSE 2 mg LOADING DOSE

430-04685-004 4- 31

Page 74

Basic Operation

The screen displays the amount of analgesic delivered as it infuses. The bottom of the screen displays text confirming that the Loading Dose is being delivered. Upon completion, the red LED (above the LCD) displays the amount delivered.

After delivery is complete, the

SELECT

MODE SCREEN appears. See Modes of

Delivery on page 5-2.

MORPHINE PF

1 mg/mL

PRESS PAUSE BUTTON TO STOP

0.5 mg

milligrams

INFUSING

LOADING DOSE

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LifeCare PCA® Infusion System

Section 5 Select Mode

This section addresses these topics:

• Modes of Delivery

• PCA Only Mode

• Continuous Mode

• PCA+Continuous Mode

• Protocols

• Dose Limit

• Clearing the History and/or Rx Settings

• Using Review/Confirmation Screens

• Changing Settings During Setup

• Making Changes After Setup

• Clearing Shift Totals

• Changing a Vial

• Adding a Supplemental Loading Dose

• Checking History & Settings

• History and Event Log

430-04685-004 5 - 1

Page 76

Select Mode

Modes of Delivery

The PCA Infuser delivers analgesia in one of three modes:

• PCA ONLY

• CONTINUOUS

• PCA+CONTINUOUS

PROTOCOLS

Protocols for Hospira/Abbott prefilled drug vials and sterile empty vials are created in the Biomed Mode or through the Hospira

MedNet

There are 10 stored protocols available (without Hospira

MedNet available (with Hospira MedNet

PCA ONLY

A patient initiated dose may be administered using the patient pendant when the PCA AVAILABLE Message appears. After completing the dose, the infuser enters either the preset LOCKOUT Interval or the DOSE LIMIT REACHED State (if a dose limit has been entered). Further delivery is prohibited in both of these conditions.

Software.

Software enabled) or 90 stored protocols (5 per CCA)

Software enabled).

Interrupting delivery by pressing loss of power, reaching the dose limit, emptying the vial, or a malfunction alarm may result in partial doses.

The screen message alerts the user that the PCA Infuser is not available, and a different audible tone occurs if the patient pendant button is pressed (unless deactivated in Biomed Mode).

NOTE: Dose Limit periods are specified as 1 and 4 hours on an infuser with the Default Drug Library. Dose Limit periods on infusers with a User-defined Drug Library, may be defined as 1, 4, 6, or 12 hours.

[START/STOP], opening the door,

5 - 2 430-04685-004

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LifeCare PCA® Infusion System

CONTINUOUS

A programmed Continuous infusion is started by pressing the

[START/PAUSE] Button after the door is closed and locked. The

patient pendant is disabled in CONTINUOUS Mode. Upon reaching the DOSE LIMIT, if entered, the infuser stops drug

delivery, and the designated displayed.

NOTE: Dose Limit periods are specified as 1 and 4 hours on an infuser with the Default Drug Library. Dose Limit periods on infusers with a User-defined Drug Library may be defined as 1, 4, 6, or 12 hours.

NOTE: In CONTINUOUS or PCA+CONTINUOUS Mode, The

[START/PAUSE] Button must be pressed within 30 seconds of

locking the door or the infuser sounds an alarm.

HR LIMIT REACHED Message is

PCA+CONTINUOUS

A programmed PCA+Continuous infusion is started by pressing the

[START/PAUSE] Button after the door is closed and locked. A

patient initiated PCA dose may be administered using the patient pendant when the PCA AVAILABLE Message appears. When the patient-initiated dose is activated, the PCA dose is delivered prior to the CONTINUOUS infusion rate. After the PCA dose is completed, the infuser enters the LOCKOUT Interval. While in the lockout period, the CONTINUOUS infusion remains in progress, but the patient initiated dose cannot be activated. If a Dose limit

has been reached, the infuser stops all drug delivery.

NOTE: Dose Limit periods are specified as 1 and 4 hours

on an infuser with the Default Drug Library. Dose Limit periods on infusers with a User-defined Drug Library may be defined as 1, 4, 6, or 12 hours.

NOTE: In CONTINUOUS or PCA+CONTINUOUS Mode, The

[START/PAUSE] Button must be pressed within 30 seconds of

locking the door or the infuser sounds an alarm.

430-04685-004 5 - 3

Page 78

Select Mode

PCA Only Mode

For detailed startup information including vial insertion, clearing settings, purging, and setting a Loading Dose,

Vial on page 4 - 5.

For information on adjusting system settings such as contrast and volume

see Adjusting Settings on page 4 - 21.

see Loading a

1 Unlock door and press

Button, or load drug vial into cradle, to power on the infuser. Upon initial start-up the self-test begins. It may take several seconds for the Hospira logo to appear on the screen.

LIFECARE PCA

SELF TEST

LOCKOUT

CONT. RATE

2 Select CONTINUE> to advance

to the next programming screen.

3 Select YES> or NO> at the NEW PATIENT SCREEN if the

infuser has been OFF 4 hours or less. See New

Patient on page 4-27 for more information.

4 Select CONFIRM> to accept the inserted drug, or remove the

vial if it is not correct. See New Patient on page 4-27 for more information.

5 Select either YES> or NO> to purge the system. See

Purging the System on page 4-28 for more information.

6 If YES> is selected, disconnect the set from the

patient, and press & hold the P

5 - 4 430-04685-004

URGE> Softkey.

Page 79

LifeCare PCA® Infusion System

7 Select YES> to continue, or select NO> to purge

again until complete.

8 Reconnect set to patient.

9 Set Loading Dose (if desired) by selecting YES>.

See Loading Dose on page 4-30 for more information.

10 Enter a Loading Dose within the displayed range.

11 Then press .

ENTER

12 Select YES> to infuse the

programmed Loading Dose. Select DELIVER LATER> to delay loading dose delivery.

13 From the Select Delivery

Mode SCREEN, select PCA

NLY>.

MORPHINE PF

1 mg/mL

DELIVER LOADING DOSE NOW ?

YES

DELIVER LATER

MORPHINE PF

1 mg/mL

SELECT DELIVERY MODE

PCA ONLY

PCA + CONT.

CONTINUOUS

PROTOCOLS

430-04685-004 5 - 5

Page 80

Select Mode

14 Enter the desired PCA dose

using the numeric keypad. If the value is entered

incorrectly, press to

L R

change value.

15 Then press .

ENTER

If programming changes need to be made, select PREVIOUS> to return to the preceding screen.

16 Enter a lockout Interval

value. (The value range is displayed on the screen.)

If the value is entered

incorrectly, press to change value.

L R

MORPHINE PF

1 mg/mL

ENTER PCA DOSE THEN PRESS ENTER BUTTON

0.1 - 5 mg

2 mg

milligrams

MORPHINE PF

1 mg/mL

ENTER LOCKOUT INTERVAL

THEN PRESS ENTER BUTTON

5 - 120 min

10 min

minutes

17 Then press .

ENTER

If programming changes need to be made, select

REVIOUS> to return to the preceding screen.

5 - 6 430-04685-004

Page 81

LifeCare PCA® Infusion System

18 Set a specific dose limit by

selecting YES> and advancing to the Dose Limit

MORPHINE PF

1 mg/mL

SET A DOSE LIMIT ?

Enter Value SCREEN. Or select NO> to choose No

YES

Dose Limit.

No Dose Limit will be

selected for this example.

If Hospira MedNetTM Software is enabled and a upper hard or soft limit has been assigned for that CCA and drug, then a DOSE LIMIT entry is required, and this screen will not be displayed.

NOTE: See Dose Limit on page 5-21 (1 or 4 hour) for complete information about this feature.

19 Select CONFIRM> to verify the

NO DOSE LIMIT selection.

MORPHINE PF

1 mg/mL

CONFIRM NO DOSE LIMIT ?

Select PREVIOUS> to return to the preceding screen.

CONFIRM

430-04685-004 5 - 7

Page 82

Select Mode

20 Select CONFIRM> to verify

settings. Or, select PREVIOUS> to return to the preceding screen.

21 Close and lock door. Place

MORPHINE PF

PCA ONLY

PCA DOSE

LOCKOUT

4 HOUR LIMIT

key in a secure location. After locking the door the PCA bolus is available for infusion. Patient presses pendant to initiate PCA dose.

Approximately 10 seconds after the door is locked, the

MORPHINE PF

PCA ONLY

DOOR LOCKED Message disappears. After delivering

PCA LOCKOUT

NO 4 HR LIMIT

the PCA dose, the PCA LOCKOUT Message appears

indicating the PCA Infuser is locked out.

milligrams

TOTAL DELIVERED

PCA DOSE =

If the Patient Pendant is partially pressed, a Pendant Fault Message appears. This is corrected by releasing the button.

1 mg/mL

2 mg

10 min

CONFIRM

1 mg/mL

7.5 mg

2 mg

When the Dose Limit is reached, a message is displayed to indicate the Dose Limit has been reached.

NOTE: A clinician may stop a PCA dose delivery in progress without unlocking the door by pressing the [STOP/PAUSE] BUTTON.

5 - 8 430-04685-004

Page 83

LifeCare PCA® Infusion System

Continuous Mode

For detailed startup information including vial insertion, clearing settings, purging, and setting a Loading Dose,

Vial on page 4 - 5.

For information on adjusting system settings such as contrast and volume

see Adjusting Settings on page 4 - 21.

see Loading a

1 Unlock door and press

Button, or load drug vial into cradle, to power on the infuser. Upon initial start-up the self-test begins. It may take several seconds for the Hospira logo to appear on the screen.

LIFECARE PCA

SELF TEST

LOCKOUT

CONT. RATE

2 Select CONTINUE> to advance

to the next programming screen.

3 Select YES> or NO> at the NEW PATIENT SCREEN if the

infuser has been OFF 4 hours or less.

See New Patient on page 4-27 for more information.

4 Select CONFIRM> to accept the inserted drug, or

remove the vial if it is not correct. See New Patient

on page 4-27 for more information.

5 Select either YES> or NO> to purge the system.

See Purging the System on page 4-28 for more

information.

430-04685-004 5 - 9

Page 84

Select Mode

6 If YES> is selected, disconnect the set from the

patient, and press & hold the PURGE> Softkey.

7 Select YES> to continue, or select NO> to purge

again until complete.

8 After purging, reconnect set to patient.

9 Set Loading Dose (if desired) by selecting YES>.

See Loading Dose on page 4-30 for more information.

Enter a Loading Dose within the displayed range.

Then press .

ENTER

10 Select YES> to infuse the

programmed Loading Dose. Select DELIVER LATER> to delay loading dose delivery.

11 From the Select Delivery

Mode S CONTINOUOUS>.

CREEN, select

MORPHINE PF

1 mg/mL

DELIVER LOADING DOSE NOW ?

YES

DELIVER LATER

MORPHINE PF

1 mg/mL

SELECT DELIVERY MODE

PCA ONLY

PCA + CONT.

CONTINUOUS

PROTOCOLS

5 - 10 430-04685-004

Page 85

LifeCare PCA® Infusion System

12 Enter a continuous rate

using the keypad. The value range is displayed on the screen.

If value is entered

incorrectly, press to change value.

13 Then press .

ENTER

L R

MORPHINE PF

1 mg/mL

ENTER CONT. RATE THEN PRESS ENTER BUTTON

0.5 - 100 mg/hr

milligrams

If programming changes need to be made, select PREVIOUS> to return to the preceding screen.

14 Set a specific dose limit by

selecting YES> and advancing to the Dose Limit

MORPHINE PF

1 mg/mL

SET A DOSE LIMIT ?

Enter Value SCREEN. Select NO> to choose No Dose

YES

Limit.

No Dose Limit will be

selected for this example.

If Hospira MedNetTM Software is enabled and a upper hard or soft limit has been assigned for that CCA and drug, then a D

OSE LIMIT entry is required,

and this screen will not be displayed.

NOTE: The pre-programmed Dose Limit is 1 or 4 hours. The Hospira MedNet 12 hours).

For complete information on this feature,

see Dose Limit on page 5 - 21

Software range is larger (1, 4, 6, or

430-04685-004 5 - 11

Page 86

Select Mode

15 Select CONFIRM> to verify No

Dose Limit selection.

Select PREVIOUS> to return to the preceding screen.

16 Select CONFIRM> to verify

settings. Or, select PREVIOUS> to return to the preceding screen.

17 Close and lock door. Place

key in a secure location.

18 Press to begin therapy.

Approximately 10 seconds

MORPHINE PF

1 mg/mL

CONFIRM NO DOSE LIMIT ?

CONFIRM

MORPHINE PF

1 mg/mL

CONTINUOUS

CONT. RATE

4 HOUR LIMIT

CONFIRM

MORPHINE PF

1 mg/mL

CONTINUOUS

2 mg/hr

after door is locked and is pressed, the DOOR LOCKED

Message disappears.

When the Dose Limit is reached, a message is

2 mg

milligrams

TOTAL DELIVERED

CONT. RATE =

2 mg/hr

displayed that indicates the Dose Limit has been reached.

5 - 12 430-04685-004

Page 87

LifeCare PCA® Infusion System

PCA+Continuous Mode

For detailed startup information including vial insertion, clearing settings, purging, and setting a Loading Dose,

Vial on page 4 - 5.

For information on adjusting system settings such as contrast and volume

see Adjusting Settings on page 4 - 21.

see Loading a

1 Unlock door and press

Button, or load drug vial into cradle, to power on the infuser. Upon initial start-up the self-test begins. It may take several seconds for the Hospira logo to appear on the screen.

LIFECARE PCA

SELF TEST

LOCKOUT

CONT. RATE

2 Select CONTINUE> to advance

to the next programming screen.

3 Select YES> or NO> at the NEW PATIENT SCREEN if the

infuser has been OFF 4 hours or less. See New

Patient on page 4-27 for more information.

4 Select CONFIRM> to accept the inserted drug, or

remove the vial if it is not correct. See New Patient on

page 4-27 for more information.

5 Select either YES> or NO> to purge the system. See

Purging the System on page 4-28 for more information.

6 If YES> is selected, disconnect the set from the

patient, and press & hold the P

430-04685-004 5 - 13

URGE> Softkey.

Page 88

Select Mode

7 Select YES> to continue, or select NO> to purge

again until complete.

8 Reconnect set to patient.

9 Set Loading Dose (if desired) by selecting YES>.

See Loading Dose on page 4-30 for more information.

10 Enter a Loading Dose within the displayed range.

Then press .

ENTER

11 Select YES> to infuse the

programmed Loading Dose. Select DELIVER LATER> to delay loading dose delivery.

12 From the SELECT MODE SCREEN,

select PCA + CONT>.

MORPHINE PF

1 mg/mL

DELIVER LOADING DOSE NOW ?

YES

DELIVER LATER

MORPHINE PF

1 mg/mL

SELECT DELIVERY MODE

PCA ONLY

PCA + CONT.

CONTINUOUS

PROTOCOLS

5 - 14 430-04685-004

Page 89

LifeCare PCA® Infusion System

13 Enter PCA dose value using

the keypad. The value range is displayed on the screen.

If value is entered

incorrectly, press to change value.

Then press .

ENTER

L R

MORPHINE PF

1 mg/mL

ENTER PCA DOSE THEN PRESS ENTER BUTTON

0.1 - 5 mg

2 mg

milligrams

If programming changes need to be made, select PREVIOUS> to return to the preceding screen.

14 Enter a Lockout Interval

value. (Value range is displayed on thescreen.)

If the value is entered

incorrectly, press to change the value.

L R

MORPHINE PF

1 mg/mL

ENTER LOCKOUT INTERVAL

THEN PRESS ENTER BUTTON

5 - 120 min

10 min

minutes

Then press .

ENTER

If programming changes need to be made, select PREVIOUS> to return to the preceding screen.

430-04685-004 5 - 15

Page 90

Select Mode

15 Enter a Continuous Rate.

The value range is displayed on screen.

If the value is entered

incorrectly, press to change the value.

Then press .

ENTER

L R

MORPHINE PF

1 mg/mL

ENTER CONT. RATE THEN PRESS ENTER BUTTON

0.1 - 20 mg/hr

milligrams

If programming changes need to be made, select PREVIOUS> to return to the preceding screen.

16 Set a specific dose limit by

selecting YES> and advancing to the DOSE LIMIT

MORPHINE PF

1 mg/mL

SET A DOSE LIMIT ?

ENTER VALUE SCREEN. Or select NO> to choose NO DOSE LIMIT.

YES

Setting a specific Dose Limit will be selected for this

example.

If Hospira MedNetTM Software is enabled and a upper hard or soft limit has been assigned for that CCA and drug, then a D

OSE LIMIT entry is required,

and this screen will not be displayed.

NOTE: The pre-programmed Dose Limit is 1 or 4 hours. The Hospira MedNet 12 hours).

For complete information on this feature

Software range is larger (1, 4, 6, or

see Dose Limit on page 5 - 21.

5 - 16 430-04685-004

Page 91

LifeCare PCA® Infusion System

17 Enter the Dose Limit value

using the numeric keypad (the range is displayed on the screen).

If the value is entered

incorrectly, press to change value.

Then press .

ENTER

L R

MORPHINE PF

1 mg/mL

ENTER 4 HOUR DOSE LIMIT THEN PRESS ENTER BUTTON

0.1 - 80 mg

40 mg

milligrams

If programming changes need to be made, select PREVIOUS> to return to the preceding screen.

18 Select CONFIRM> to verify

settings. Or, select PREVIOUS> to return to the preceding screen.

19 Close and lock door. Place

key in a secure location. After locking the door the

MORPHINE PF

1 mg/mL

PCA+CONT

PCA DOSE

LOCKOUT

CONT. RATE

4 HOUR LIMIT

CONFIRM

10 min

2 mg/hr

40 mg

PCA bolus is available for infusion. The patient presses pendant to initiate PCA dose.

2 mg

430-04685-004 5 - 17

Page 92

Select Mode

20 Press to begin therapy.

MORPHINE PF

1 mg/mL

Approximately 10 seconds

after door is locked and

PCA+CONT.

PCA AVAILABLE

is pressed, the DOOR LOCKED Message disappears.

When the Dose Limit is reached, a message is

TOTAL DELIVERED

2 mg

milligrams

CONT. RATE

2 mg/hr

displayed that indicates the Dose Limit has been reached.

Protocols

For detailed startup information including vial insertion, clearing settings, purging, and setting a Loading Dose,

Vial on page 4 - 5.

For information on adjusting system settings such as contrast and volume

see Adjusting Settings on page 4 - 21.

NOTE: Protocols may be established by the hospital via Hospira MedNet MedNet

programming from the Rx Rules application. Only Protocols associated with the inserted drug vial will be available.

Software enabled devices allow for protocol

Software or via Biomed Mode. Hospira

see Loading a

1 Unlock door and press

Button, or load drug vial into cradle, to power on the infuser. Upon initial start-up, the self-test begins. It may

LIFECARE PCA

SELF TEST

LOCKOUT

CONT. RATE

take several seconds for the Hospira logo to appear on the screen.

5 - 18 430-04685-004

Page 93

LifeCare PCA® Infusion System

2 Select CONTINUE> to advance to the next

programming screen.

3 Select YES> or NO> at the NEW PATIENT SCREEN if the

infuser has been OFF 4 hours or less. For more information see New Patient on page 4 - 27.

4 Select CONFIRM> to accept the inserted drug, or

remove the vial if it is not correct. See New Patient on

page 4-27 for more information.

5 Select either YES> or NO> to purge the system. For

more information see Purging the System on page 4 -

28.

6 If YES> is selected, disconnect the set from the

patient, and press and hold the PURGE>.

7 Select YES> to continue, or select NO> to purge

again until complete.

8 After purging, reconnect set to patient.

9 Set Loading Dose (if desired) by selecting YES>.

For more information see Loading Dose on page 4 -

30.

10 Enter a Loading Dose within the displayed range.

Then press .

430-04685-004 5 - 19

ENTER

Page 94

Select Mode

11 Press to infuse

programmed Loading Dose. Select DELIVER LATER> to delay loading dose delivery. From the SELECT DELIVERY MODE SCREEN, select

PROTOCOLS>.

12 Press to accept

ENTER

protocol, or select NEXT PROTOCOL> and PREVIOUS> to

view other stored protocols if available.

13 Select CONFIRM> to accept

the chosen protocol settings. Or press PREVIOUS> to return to the preceding screen.

14 Close and lock the door.

Place key in a secure location.

MORPHINE PF

1 mg/mL

SELECT DELIVERY MODE

PCA ONLY

PCA + CONT.

CONTINUOUS

PROTOCOLS

MORPHINE PF PRESS ENTER

TO SELECT

PCA DOSE

LOCKOUT

4 HOUR LIMIT

NEXT PROTOCOL

MORPHINE PF

PCA+CONT

PCA DOSE

LOCKOUT

CONT. RATE

4 HOUR LIMIT

2 mg

10 min

1 mg/mL

2 mg

10 min

2 mg/hr

40 mg

CONFIRM

15 Press to begin therapy. Approximately 10

seconds after door is locked and is pressed, the DOOR LOCKED MESSAGE disappears.

5 - 20 430-04685-004

Page 95

LifeCare PCA® Infusion System

Dose Limit

The dose limit is a physician prescribed value that serves to limit the total dosage delivered in any 4 hour (or 1 hour) period. This optional feature provides added safety that limits the total drug delivered in all delivery modes.

NOTE: Dose limit periods are specified as 1 and 4 hours on a infuser using the Default Drug Library (DDL); on infusers using User-Defined Drug Libraries created with the Hospira

MedNet hours. There is a NO Dose Limit option as well with DDL and User Defined Drug Library. The PCA Infuser is factory set to program a 4 hour dose limit. For the purpose of simplifying this section, examples will be written for a 4 hour dose limit program.

NOTE: A supplemental Loading Dose may be delivered at any time during operation by opening the door and selecting the L

When the sum of all doses (PCA dose, CONTINUOUS dose, and any applicable loading or supplemental loading dose) in a rolling 4 hour period equals or exceeds the 4 hour dose limit, the

patient’s requests for PCA doses are denied, and a

REACHED Message appears. In all modes, the infuser stops

delivery when the 4 hour dose limit is reached, except during administration and delivery of a supplemental loading dose.

Software, the dose limit periods are 1, 4, 6, or 12

OADING DOSE> key.

4 HR LIMIT

As the oldest dose (either PCA dose, CONTINUOUS dose, or a supplemental loading dose) ages out of the 4 hour dose record,

the

4 HR LIMIT REACHED Message disappears. The infuser

accepts patient initiated dose requests in PCA Only and PCA+CONTINUOUS Modes (if the programmed PCA Lockout Interval has elapsed) and resumes infusion at the continuous rate in the CONTINUOUS and PCA+CONTINUOUS Modes.

NOTE: Setting a new dose limit will not erase the previous dose history.

430-04685-004 5 - 21

Page 96

Select Mode

PROGRAMMING THE 4 (OR 1) HOUR DOSE LIMIT

The opportunity to program this feature is presented in two entry screens. The first screen prompts the clinician to choose whether

or not to set a Dose Limit. Selecting N

O> brings up the CONFIRM NO

DOSE LIMIT SCREEN. Selecting YES> brings up the DOSE LIMIT ENTER VALUE SCREEN. This requires that the clinician enter a value within

the displayed range.

NOTE: If Hospira MedNet upper hard or soft limit for that CCA and drug has been

assigned, then a

DOSE LIMIT entry is required.

Software is enabled, and a

PROGRAMMING A DOSE LIMIT

1 Select YES> at the DOSE LIMIT

SELECTION SCREEN.

The display advances to the

DOSE LIMIT ENTER VALUE SCREEN.

2 Enter the 4 HOUR DOSE LIMIT

value using the numeric keypad.

NOTE: Entry of zero for the 4 HR Dose Limit, using the numeric keypad, is NOT accepted by the

PCA Infuser; see

No Dose Limit on page 5 - 23

Then press .

Programming

ENTER

MORPHINE PF

1 mg/mL

SET A DOSE LIMIT ?

YES

MORPHINE PF

1 mg/mL

ENTER 4 HOUR DOSE LIMIT THEN PRESS ENTER BUTTON

0.1 - 80 mg

40 mg

milligrams

5 - 22 430-04685-004

Page 97

LifeCare PCA® Infusion System

3 Select CONFIRM> to accept

the chosen protocol settings. Or press PREVIOUS> to return to the preceding screen.

4 Close and lock the door.

Place key in a secure

MORPHINE PF

1 mg/mL

PCA+CONT

PCA DOSE

LOCKOUT

CONT. RATE

4 HOUR LIMIT

CONFIRM

2 mg

10 min

2 mg/hr

40 mg

location.

5 Press to begin therapy. Approximately 10

seconds after door is locked and is pressed, the DOOR LOCKED MESSAGE disappears.

PROGRAMMING NO DOSE LIMIT

1 Select NO> at the DOSE LIMIT

SELECTION SCREEN.

The display advances to the Confirm NO DOSE LIMIT SCREEN.

MORPHINE PF

1 mg/mL

SET A DOSE LIMIT ?

YES

430-04685-004 5 - 23

Page 98

Select Mode

PCA DOSE

LOCKOUT

CONT. RATE

4 HOUR LIMIT

MORPHINE PF

1 mg/mL

CONFIRM NO DOSE LIMIT ?

CONFIRM

MORPHINE PF

1 mg/mL

PCA+CONT

10 min

2 mg/hr

CONFIRM

2 mg

2 Select CONFIRM> to verify the

selection of the No Dose limit.

NOTE: When NO LIMIT has been programmed, the message

NO 4 HR LIMIT will be displayed

after the door has been locked.

3 Select CONFIRM> to accept

the chosen protocol settings. Or press PREVIOUS> to return to the preceding screen.

4 Close and the lock door.

Place key in a secure location.

5 Press to begin therapy. Approximately 10

seconds after door is locked and is pressed, the DOOR LOCKED MESSAGE disappears.

5 - 24 430-04685-004

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LifeCare PCA® Infusion System

CLEARING OR CHANGING A DOSE LIMIT

1 Unlock door to stop the

infuser.

2 Select CHANGE RX>.

NOTE: CHANGE CCA> will only

display if Hospira MedNet

Software has been enabled.

3 Select NEXT> to display

more change options.

4 Select DOSE LIMIT>.

MORPHINE PF

1 mg/mL

PAUSED

PCA + CONT

LOCK DOOR TO BEGIN

LOADING DOSE

CHANGE RX

CLEAR SHIFT

CHANGE CCA

MORPHINE PF

1 mg/mL

SELECT SETTING TO CHANGE

MODE

PCA DOSE

CONT. RATE

SAVE & EXIT

MORPHINE PF

1 mg/mL

SELECT SETTING TO CHANGE

LOCKOUT

DOSE LIMIT

SAVE & EXIT

430-04685-004 5 - 25

Page 100

Select Mode

5 Set a specific dose limit by

selecting YES> then advance to the DOSE LIMIT ENTER VALUE SCREEN. Or, select NO> to choose NO DOSE LIMIT.

No Dose Limit will be selected for this example.

6 Select CONFIRM> to verify the

NO DOSE LIMIT selection. Or, select PREVIOUS> to return to the preceding screen.

7 Press SAVE & EXIT> at the

next screen. This will bring up the REVIEW/CONFIRMATION SCREEN.

MORPHINE PF

1 mg/mL

SET A DOSE LIMIT ?

YES

MORPHINE PF

1 mg/mL

CONFIRM NO DOSE LIMIT ?

CONFIRM

MORPHINE PF

1 mg/mL

SELECT SETTING TO CHANGE

LOCKOUT

DOSE LIMIT

SAVE & EXIT

5 - 26 430-04685-004

Hospira MedNet operating Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of Contents

Section 1 Descriptive Information

Product Description

Indications for Use

PATIENT SELECTION

USER QUALIFICATIONS

Contraindications For Use

Conventions

WARNINGS, CAUTIONS, AND NOTES

Definitions (General and Clinical)

Precautions and Warnings

UNPACKING

GENERAL

PROGRAMMING

LOADING DOSE/DOSE LIMITS

OPERATION

MAINTENANCE

ALARMS

EPIDURAL ADMINISTRATION

BATTERY OPERATION

SETS AND ACCESSORIES

ELECTRICAL ARTIFACTS

INTERCONNECTING OF EQUIPMENT

Guidance on EMC Compatibility

FCC Information

US FCC (FEDERAL COMMUNICATIONS COMMISSION) STATEMENT

FCC INTERFERENCE STATEMENT

RADIO FREQUENCY EXPOSURE STATEMENT

Section 2 Principles of Operation

Features

• Drug Recognition

• Modes Of Delivery

PROGRAMMING

BATTERY

BIOMEDICAL

OPTIONS

OTHER FEATURES

Administration Equipment

Section 3 Equipment Description

Front Panel

Vial Cradle Assemble

Rear Panel

Operating Buttons & Keys

Section 4 Basic Operation

Operating the PCA Infuser

• Intravenous PCA Infuser Administration

• Epidural PCA Infuser Administration

Loading a Vial

Guided Start up for Prefilled Vials

Guided Start up for Custom Vials

Getting Started

UNPACKING

CONNECTING THE PATIENT PENDANT

DATA RETENTION

Adjusting Settings

CHANGING ALARM VOLUME

CHANGING CONTRAST OF MAIN DISPLAY

CHANGING OR CONFIRMING TIME AND DATE

NEW PATIENT

Purging the System

Loading Dose

Section 5 Select Mode

Modes of Delivery

• PCA ONLY

PROTOCOLS

CONTINUOUS

PCA+CONTINUOUS

PCA Only Mode

Continuous Mode

PCA+Continuous Mode

Protocols

Dose Limit

PROGRAMMING THE 4 (OR 1) HOUR DOSE LIMIT

PROGRAMMING A DOSE LIMIT

PROGRAMMING NO DOSE LIMIT

CLEARING OR CHANGING A DOSE LIMIT