Hospira LifeCare PCA PCA Infusion System System Operating Manual

430-04685-004.book Page 0 Tuesday, January 10, 2006 10:50 AM

System

Operating

Manual

For Use With List 20709-04

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

430-04685-004.book Page i Tuesday, January 10, 2006 10:50 AM

For Systems With Hospira MedNet TM Software

Change History

Title Description of Change

430-04685-001 Original Release

(Rev. 7/05)

430-04685-002 Second Release

(Rev. 09/05)

430-04685-003 Third Release

(Rev. 10/05)

430-04685-003 Fourth Release

(Rev. 01/06)

Pages Affected

All

All

All

All

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

430-04685-004.book Page ii Tuesday, January 10, 2006 10:50 AM

LifeCare PCA

®

Infusion System

Table of Contents

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

P

RODUCT

D

ESCRIPTION

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

I

NDICATIONS FOR

U

SE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 patient selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 user qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

C

ONTRAINDICATIONS

F

OR

U

SE

. . . . . . . . . . . . . . . . . . . . . . . . . 1-3

C

ONVENTIONS

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

D

EFINITIONS

(G

ENERAL AND

C

LINICAL

) . . . . . . . . . . . . . . . . . . . 1-6

P

RECAUTIONS AND

W

ARNINGS

. . . . . . . . . . . . . . . . . . . . . . . . 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

G

UIDANCE ON

EMC C

OMPATIBILITY

. . . . . . . . . . . . . . . . . . . . 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

F

EATURES

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 drug recognition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 modes of delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

430-04685-004 ii

430-04685-004.book Page iii Tuesday, January 10, 2006 10:50 AM

For Systems With Hospira MedNet

TM

Software

biomedical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 other features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

A

DMINISTRATION

E

QUIPMENT

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

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

F

RONT

P

ANEL

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

V

IAL

C

RADLE

A

SSEMBLE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

R

EAR

P

ANEL

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

O

PERATING

B

UTTONS

& K

EYS

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

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

O

PERATING THE

PCA I

NFUSER

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

L

OADING A

V

IAL

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

G

UIDED

S

TART UP FOR

P

REFILLED

V

IALS

. . . . . . . . . . . . . . . . . . 4-6

G

UIDED

S

TART UP FOR

C

USTOM

V

IALS

. . . . . . . . . . . . . . . . . . 4-12

G

ETTING

S

TARTED

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

U

NPACKING

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19 connecting the patient pendant . . . . . . . . . . . . . . . . . . . 4-19 system self-tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19 data retention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

A

DJUSTING

S

ETTINGS

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21 changing alarm volume . . . . . . . . . . . . . . . . . . . . . . . . . 4-22 changing contrast of main display . . . . . . . . . . . . . . . . . 4-23 changing or confirming time and date . . . . . . . . . . . . . . 4-24

N

EW

P

ATIENT

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

P

URGING THE

S

YSTEM

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28

L

OADING

D

OSE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30

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

M

ODES OF

D

ELIVERY

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 pca only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 continuous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 pca+continuous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

iii 430-04685-004

430-04685-004.book Page iv Tuesday, January 10, 2006 10:50 AM

LifeCare PCA

®


PCA O

NLY

M

ODE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

C

ONTINUOUS

M

ODE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

PCA+C

ONTINUOUS

M

ODE

. . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13

P

ROTOCOLS

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

D

OSE

L

IMIT

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

C

LEARING THE

H

ISTORY AND

/

OR

R

X

S

ETTINGS

. . . . . . . . . . . . 5-27

U

SING

R

EVIEW

/C

ONFIRMATION

S

CREENS

. . . . . . . . . . . . . . . . 5-28

C

HANGING

S

ETTINGS

D

URING

S

ETUP

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

M

AKING

C

HANGES

A

FTER

S

ETUP

. . . . . . . . . . . . . . . . . . . . . . 5-30 reviewing the current settings . . . . . . . . . . . . . . . . . . . . 5-30 changing settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30 changing the CCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32

C

LEARING

S

HIFT

T

OTALS

. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33

C

HANGING A

V

IAL

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34

A

DDING A

S

UPPLEMENTAL

L

OADING

D

OSE

. . . . . . . . . . . . . . . 5-36

C

HECKING

H

ISTORY

& S

ETTINGS

. . . . . . . . . . . . . . . . . . . . . . 5-37

H

ISTORY AND

E

VENT

L

OG

. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38

Section 6, Advanced Programming

with Hospira MedNet

TM

Software . . . . . . . . 6-1

G

UIDED

S

TART

-

UP

U

SING

H

OSPIRA

M

ED

N

ET

TM S

OFTWARE

. . . . . . . . . . . . . . . . . . . . . . 6-1

S

ELECT

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

U

PDATING THE

D

RUG

L

IBRARY

. . . . . . . . . . . . . . . . . . . . . . . . . 6-8

S

OFT

L

IMIT

O

VERRIDE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

H

ARD

L

IMIT

V

IOLATION

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

I

MPORTANT

S

YMBOLS

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11 no rule sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11 soft limit override . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11 wireless . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12

A

UTOPROGRAMMING

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

430-04685-004 iv

430-04685-004.book Page v Tuesday, January 10, 2006 10:50 AM


TM

Software

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

S

TATUS

M

ESSAGES

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

I

NFUSER

A

LARM

S

YSTEM

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

S

ILENCING AN

A

LARM

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

A

LARMS AND

M

ESSAGES

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

I

NFUSER

S

TALLING

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

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

I

NFUSER

S

TORAGE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

C

LEANING AND

S

ANITIZING

. . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

B

ATTERY

M

AINTENANCE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

S

ERVICE

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

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

S

TORED

O

CCLUSION

V

OLUME

. . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

T

IME FROM

O

CCLUSION TO

A

LARM

. . . . . . . . . . . . . . . . . . . . . . 9-5

D

ELIVERY

R

ATE

A

CCURACY

. . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5 trumpet curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6 example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

T

RUMPET

C

URVES

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8

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

Appendix A, Generating Bar Code Labels

(Hospira MedNet

TM

Software Enabled) . A-1 equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2 example of label layout & sample . . . . . . . . . . . . . . . . . . . A-3 label diagram

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

A

-4

v 430-04685-004

430-04685-004.book Page vi Tuesday, January 10, 2006 10:50 AM

LifeCare PCA

®


Appendix B, Network Printer Setup . . . . . . . . . . . . . . B-1 equipment needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1 preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1 procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1 printing event history log . . . . . . . . . . . . . . . . . . . . . . . . . B-2

D

OWNLOADING

L

OGS 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

© Hospira, Inc.

All Rights Reserved

This document and the subject matter disclosed herein are proprietary information. Hospira retains all the exclusive rights of dissemination, reproduction, manufacture and sale. Any party using this document accepts it in confidence, and agrees not to duplicate it in whole or in part nor disclose it to others without the written consent of Hospira.

430-04685-004 vi

430-04685-004.book Page vii Tuesday, January 10, 2006 10:50 AM


TM

Software

NOTES

vii 430-04685-004


LifeCare PCA

®


Section 1

Descriptive Information

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

LifeCare PCA

®

Infusion System with Hospira MedNet

TM

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

The LifeCare PCA

®

Infusion System is used in a wide range of clinical settings that includes but is not limited to the following:

M

EDICAL

S

URGICAL

C

RITICAL

C

ARE

U

NITS

L

ABOR

/D

ELIVERY

/P

OST

P

ARTUM

O

PERATING

R

OOM

P

OST

A

NESTHESIA

C

ARE

U

NIT

(PACU)

B

URN

U

NIT

O

NCOLOGY

P

EDIATRICS

Product Description

The primary drug safety features of the LifeCare PCA

®

Infuser device are the Hospira MedNet

TM

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

430-04685-004 1- 1


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

TM

Software (if enabled).

Indications for Use

The LifeCare PCA

®

Infusion System with Hospira MedNet

TM

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.

1- 2 430-04685-004


LifeCare PCA

®


P

ATIENT

S

ELECTION

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.

U

SER

Q

UALIFICATIONS

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.

430-04685-004 1- 3



Conventions

This section describes the conventions used throughout this manual:

Convention

I

TALIC

[BRACKETED ALL-

CAPS]

I

TALIC

S

MALLCAPS

>

I

NITIAL

C

APS LOWERCASE

B

OLD

Application

R

EFERENCE TO A SECTION

,

FIGURE

,

OR TABLE

.

K

EYS OR BUTTONS ON THE

DEVICE ARE DISPLAYED IN

[BRACKETED ALL-

CAPS]

OR WITH A GRAPHIC

.

S

OFTKEY

O

PTIONS

S

CREEN DISPLAYS AND

DEVICE LABELS

(

AS

APPROPRIATE

)

E

MPHASIS

Example

(

See Front Panel on page 3-2.

)

[ON/OFF]

OR

P

REVIOUS

>

S

ELECT DELIVERY MODE

...

SETS ARE SUPPLIED

S

TERILE

AND ARE FOR

....

W

ARNINGS

, C

AUTIONS

,

AND

N

OTES

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

WARNING

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

CAUTION: A CAUTION

USUALLY APPEARS IN FRONT OF A

PROCEDURE OR STATEMENT

. I

T CONTAINS INFORMATION THAT

COULD PREVENT IRREVERSIBLE PRODUCT DAMAGE OR

HARDWARE FAILURE

. F

AILURE TO OBSERVE A

CAUTION

COULD

RESULT IN SERIOUS PATIENT OR USER INJURY

.

NOTE: A Note highlights information that helps explain a

concept or procedure.

1- 4 430-04685-004


LifeCare PCA

®


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.

430-04685-004 1- 5



Definitions (General and Clinical)

T

ERMS

Accuracy

D

EFINITION S

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

Bolus

A battery that will not accept a full charge.

A fixed amount of drug delivered in a short amount of time. A PCA dose.

Button

Connectivity

Engine (CE)

Continuous

A hard key on the front panel or on the patient pendant.

Clinical Care Area

(CCA)

An area of the hospital that authorized hospital staff is permited to use specific drugs. The clinician selects a CCA after turning on the infuser. The hospital may create from one to eighteen CCA’s.

A component of the infuser that controls

Ethernet and wireless communication between the network server and infuser.

Infusion program characterized by a constant, fixed-rate dose.

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LifeCare PCA

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T

ERMS

Custom Syringe or Vial

Default Drug

Library (DDL)

Dose Limit

Drug Library

Download

D

EFINITION S

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.

User-programmable parameter specifying the maximum amount of drug that can be administered via PCA dose and continuous delivery in a programmable rolling time period consisting of discrete accumulation periods of 6 minutes.

NOTE: Dose Limit periods are specified as

1 and 4 hours on an infuser with the DDL; on infusers with a User-defined Drug

Library, the dose limit periods can be defined as 1, 4, 6, or 12 hours.

The process of moving the User-defined

Drug Library from the network server to the infuser.

Drug Library

Installation

History

The process of moving the User-defined

Drug Library from the CE to the infuser.

Displays

Rx Settings

,

PCA Summary and the

Event

Log

.

Hospira MedNet

TM

Software

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

430-04685-004 1- 7


T

ERMS

Infusing

LCD

LED

Loading Dose

Lockout Interval

Muting Period

Occlusion

Occlusion

Pressure


D

EFINITION S

The infuser is

ON

and a

D

ELIVERY

S

CREEN

is displayed. The infusing mechanism may or may not be actually infusing at any given time.

Liquid Crystal Display

Light Emitting Diode

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

.

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.

The period between the silencing of an alarm by pressing the

[SILENCE]

key and the resumption of the alarm.

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.

The maximum pressure produced as a result of an occlusion in the PCA Infuser set.

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T

ERMS

On

Patient Pendant

PCA Mode

PCA Set

PCA Vial

Prime

Purge

Rule Set

D

EFINITION S

The infuser is turned on using either A/C or battery power. The infuser is not necessarily pumping when

ON

.

A hand held pendant connected to the infuser that allows the patient to request a

PCA dose (bolus) by pressing a button.

Infusion therapy characterized by bolus doses administered on patient demand subject to a lockout interval and, optionally, a dose limit.

Tubing connecting the PCA Vial to the patient.

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).

Manually removing air from the syringe and line.

The process during which the pumping mechanism is run to remove air from the

PCA 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.

430-04685-004 1- 9



T

ERMS

Rx Settings

Soft Keys

Stored Protocols

D

EFINITION S

The current programmed therapy. Includes

PCA Dose, PCA Lockout Interval,

Continuous Rate, Loading Dose and Dose

Limit amount.

The five keys to the right of the device’s

LCD display. Each key’s function is dependent on the screen displayed data.

Frequently used therapy settings stored in the infuser's memory. Stored protocols can be recalled again, making it unnecessary for the operator to program the same therapy settings each time they are needed. Stored protocols are determined by the health care facility.

Standard Syringe

A prefilled bar coded drug vial in which the infuser identifies the drug and concentration. The drug and concentration are found in the Drug Library by using the bar code on the vial. Standard syringes are also known as prefilled drug vials.

User-defined Drug

Library

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

TM

Software

.

Warning

An indication to advise the clinician of a possible dangerous condition.

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Precautions and Warnings

U

NPACKING

Product damage may occur unless proper care is exercised during the unpacking and setup process. The battery may not be fully charged upon receipt.

G

ENERAL

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 incompatibility 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.

430-04685-004 1- 11



•

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.

P

ROGRAMMING

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.

L

OADING

D

OSE

/D

OSE

L

IMITS

This section presents Loading Dose and Loading Dose information and cautions.

•

The loading dose is always included in the total dose delivered.

•

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

•

Always monitor the PCA Infuser when delivering medication with the door open.

•

Patient Pendant is only to be pressed by the intended patient.

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WARNING

Patient Pendant is only to be pressed by the patient.

O

PERATION

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, longterm 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.

M

AINTENANCE

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.

See Section 8 Maintenance on 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

430-04685-004 1- 13



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.

A

LARMS

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.

E

PIDURAL

A

DMINISTRATION

This section contains epidural administration information.

•

Recommended use of the epidural route is to provide anesthesia or analgesia for periods up to 96 hours.

•

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

•

This device can be used to administer only those anesthetics/ analgesics approved for epidural administration (as indicated or allowed by the drugs’ FDA approved labeling). Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient.

•

For epidural administration, the use of infuser sets without Ysites, 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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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: D

ELAYED RESPIRATORY DEPRESSION FOLLOWING

CONTINUOUS EPIDURAL ADMINISTRATION OF PRESERVATIVE

-

FREE MORPHINE SULFATE HAS BEEN REPORTED

.

•

The epidural space has 58 openings through which fluid can exit. Pressure buildup during administration is transient. However, if a large volume of fluid is administered over a short time period, the pressure will take longer to return to normal. If over delivery occurs during administration, observe the patient closely for signs of spinal cord compression (disorientation, headache, transient neuralgias) and drug overdose.

B

ATTERY

O

PERATION

This section documents battery information.

WARNING

Unplug the AC power cord before removing the battery door.

CAUTION: W

HEN THE

PCA I

NFUSER IS CONNECTED TO A

PATIENT

,

DO NOT OPERATE THE

PCA I

NFUSER WITH THE

BATTERY REMOVED

. U

SE OF A PROPERLY MAINTAINED AND

CHARGED BATTERY HELPS ENSURE PROPER OPERATION

.

•

The battery may not be fully charged upon receipt. Connect the

PCA Infuser to AC power for at least 16 hours.

•

Use AC power whenever possible. Connect to AC power during storage to ensure a fully charged battery during a power outage.

•

Always connect the infuser to a properly grounded receptacle unless battery operation is desired. If quality earth grounding source is in doubt, use battery power.

•

If the low-battery alarm sounds, connect to AC power immediately.

WARNING

The infuser cannot communicate via the network if the

Low Battery Warning alarm has sounded.

430-04685-004 1- 15



S

ETS AND

A

CCESSORIES

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 Hospira/Abbott

LifeCare PCA

®

Infuser

set, List 3559, 6516, or a combination of List 6514 and 6517.

•

It is recommended that highly viscous solutions and drugs, colloidal 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 information on proper handling.

E

LECTRICAL

A

RTIFACTS

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,

1- 16 430-04685-004


LifeCare PCA

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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

430-04685-004 1- 17



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.

I

NTERCONNECTING OF

E

QUIPMENT

Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC

Standards (e.g. IEC 60950 for data processing equipment and

IEC 60601-1 for Medical Equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-

1-1. Any person who connects additional equipment to the signal input or output part configures a medical system, and is therefore responsible for ensuring that the system complies with the requirements of the system Standard IEC 60601-1-1. If in doubt, consult the technical service department or your local representative.

Guidance on EMC Compatibility

•

There is a shared responsibility between manufacturers, customers, 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.

1- 18 430-04685-004


LifeCare PCA

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•

Separate the device from all other electronic equipment. If the device must be used near other electrical equipment, monitor the equipment to ensure there is no electromagnetic interference.

•

Devices should not be used adjacent to or stacked with other equipment. If the device must be used adjacent to or stacked 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 influencing 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 (F

EDERAL

C

OMMUNICATIONS

C

OMMISSION

) S

TATEMENT

•

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 I

NTERFERENCE

S

TATEMENT

•

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

430-04685-004 1- 19



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.

R

ADIO

F

REQUENCY

E

XPOSURE

S

TATEMENT

•

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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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.

430-04685-004 2- 1


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

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Features

The following features are addressed in this section:

• Drug Recognition

• Modes Of Delivery

• Programming

• Battery

• Biomedical

• Options

• Other Features

D

RUG

R

ECOGNITION

•

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

TM

Software is enabled.

M

ODES OF

D

ELIVERY

•

PCA Only

•

Continuous

•

PCA + Continuous

P

ROGRAMMING

•

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

•

Prompting alphanumeric display

B

ATTERY

•

8 V Battery

•

Battery for emergency backup and temporary portable operation (approx. 2.5 hrs.)

430-04685-004 2- 3



B

IOMEDICAL

•

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

O

PTIONS

•

Infusion History

O

THER

F

EATURES

•

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

2- 4 430-04685-004


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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 Anti-

Siphon 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 **

430-04685-004 2- 5



NOTES

2- 6 430-04685-004


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Section 3

Equipment Description

The following subjects are addressed in this section:

• Front Panel

• Vial Cradle Assemble

• Rear Panel

•

Operating Buttons & Keys

430-04685-004 3 - 1


Front Panel

Security

Door

Vial

Cradle

Release

Mechanism

(Holder)

Equipment Description

LED

Display

Vial

Cradle

Clips

LCD

Display

Softkeys

Door

Lock

Bar code

Reader

Window

P C A

Keypad

Buttons

AC Power

Indicator

Injector

Battery Power Indicator

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Vial Cradle Assemble

Cradle

Release

Mechanism

Vial Base

Bar code

Reader

Window

(

vial bar code must face toward window

)

Vial

Stopper

Vial Lip

Injector

Injector

Flange (Vial

Plunger)

Luer-Lock

Fitment

Wireless

Antenna

Upper Vial

Retainer

Vial Cradle

Clips

Vial Sensor

Switch

(Top Vial

Cradle Clip)

Lower Vial

Retainer

(Middle

Bracket)

Injector

Flange

Retainer

Injector

Sensor

Switch (back of retainer)

430-04685-004 3 - 3



Rear Panel

Patient

Pendant

Jack

Nurse Call

Jack*

Ground

Test

Point

Patient

Pendant

Cable

Fastener

Patient

Pendant

(blue handle)

Univers al IV

Pole Clamp with Dual

Lock

TM

NOTE: Pole

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

Battery and Fuse

Access

Door

AC Cord

Connector

Stabilizer foot

Patient

Pendant

Button

Ethernet

Jack/

Printer

Connector*

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

3 - 4 430-04685-004


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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.

430-04685-004 3 - 5



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

TM

Software not enabled).

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

The

[DECIMAL POINT]

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

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LifeCare PCA

®


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

NLY

>.

430-04685-004

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

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

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.

3 - 7



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.

3 - 8 430-04685-004


LifeCare PCA

®


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

430-04685-004 4- 1


Basic Operation

Operating the PCA Infuser

The following topics are addressed in this section:

• Intravenous PCA Infuser Administration

• Epidural PCA Infuser Administration

I

NTRAVENOUS

PCA I

NFUSER

A

DMINISTRATION

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.

E

PIDURAL

PCA INFUSER A

DMINISTRATION

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.

4- 2 430-04685-004


LifeCare PCA

®


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.

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.

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

PIDURAL ADMINISTRATION OF DRUGS BY

PCA

I

NFUSER AND

/

OR

CONTINUOUS MODE

S SHOULD BE LIMITED

TO PERSONNEL FAMILIAR WITH ASSOCIATED TECHNIQUES AND

PATIENT MANAGEMENT PROBLEMS

. P

ROPER EPIDURAL

PLACEMENT OF THE CATHETER IS ESSENTIAL SINCE CATHETER

M I G R A T I O N C O U L D R E S U L T I N I N T R A V A S C U L A R A N D

INTRATHECAL ADMINISTRATION

. F

ACILITIES PRACTICING

CONTINUOUS EPIDURAL ADMINISTRATION MUST BE EQUIPPED

WITH RESUSCITATIVE EQUIPMENT

,

OXYGEN

,

NALOXONE AND

OTHER RESUSCITATIVE DRUGS

. A

DEQUATE MONITORING

EQUIPMENT IS RECOMMENDED FOR CONTINUOUS MONITORING

OF THE PATIENT DURING EPIDURAL ADMINISTRATION

. P

ATIENTS

MUST BE OBSERVED FOR SIDE

-

EFFECTS FREQUENTLY IN A FULLY

EQUIPPED AND STAFFED ENVIRONMENT FOR AT LEAST

24

HOURS

FOLLOWING COMPLETION OF EPIDURAL DRUG ADMINISTRATION

.

CAUTION: D

ELAYED RESPIRATORY DEPRESSION FOLLOWING

CONTINUOUS EPIDURAL ADMINISTRATION OF PRESERVATIVE

-

FREE MORPHINE SULFATE HAS BEEN REPORTED

.

430-04685-004 4- 3



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.

4- 4 430-04685-004


LifeCare PCA

®


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.

1

NOTE: Always verify that the bar

code reader window is clean before inserting vial.

1

1

4

2

2. When inserting bottom of glass vial into middle black bracket, ensure that the bar code label faces the bar code reader on the right side of the vial compartment.

CAUTION: D

O NOT POSITION VIAL

INTO UPPER VIAL CLIP FIRST

. V

IAL LIP

MAY CRACK OR CHIP

.

3

5

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

C

ONTINUE

>

.

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: V

IAL AND INJECTOR MUST BE SECURELY LOCKED

INTO THE INFUSER BEFORE BEGINNING DELIVERY

.

430-04685-004 4- 5

flag04a.fm Page 6 Monday, January 23, 2006 9:04 AM


WARNING

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

NOTE: If the device is

OFF

, improper loading of syringe will turn the device

ON

and activate a non-silenceable

CHECK

INJECTOR

alarm within 30 seconds after

C

ONTINUE

>

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

Guided Start up for Prefilled Vials

NOTE: If LifeCare PCA Infuser is Hospira MedNet enabled,

see Section 6 for Operation.

1

Press , or load drug vial into cradle, to

power on the infuser.

See Loading a Vial on page 4-5

. Upon initial startup, 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

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.

4- 6 430-04685-004


LifeCare PCA

®


2

Select C

ONTINUE

> 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

The

N

EW

P

ATIENT

S

CREEN 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.

NEW

PATIENT?

YES

NO

4

If the YES> option is selected, the History and

Rx settings are cleared.

Select C

ONFIRM

> to confirm choice and continue. A screen appears to confirm that History was cleared.

HISTORY AND

RX SETTINGS

CLEARED

430-04685-004 4- 7


5

Select C

ONFIRM

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


MORPHINE PF

1 mg/mL

CONFIRM

1 mg/mL

MORPHINE PF

TO RX

REMOVE VIAL

IF NOT CORRECT

CONFIRM

6

Select either Y

ES

> or N

O

> to purge the system.

See Purging the System on page 4-28

for more information.

MORPHINE PF

1 mg/mL

PURGE ?

PURGING

RECOMMENDED

YES

NO

7

If Y

ES

> is selected, disconnect the set from the patient, and press and hold the P

URGE

> 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 3 mL.

MORPHINE PF

1 mg/mL

DISCONNECT

SET FROM

PATIENT

PRESS AND HOLD

PURGE KEY

PURGE

PREVIOUS

4- 8 430-04685-004


LifeCare PCA

®


Upon release of the P

URGE

>

Softkey, the display asks if the purge is complete.

8

Select Y

ES

> to continue, or select N

O

> to purge again until complete.

9

After purging is complete, reconnect set to patient.

10

Set Loading Dose (if desired) by selecting Y

ES

>.

See Loading Dose on page 4-30


MORPHINE PF

1 mg/mL

PURGE

COMPLETE ?

YES

NO

MORPHINE PF

1 mg/mL

SET LOADING

DOSE ?

YES

NO

11

Enter a Loading Dose within the displayed range. Then

MORPHINE PF

1 mg/mL

ENTER

LOADING DOSE

THEN PRESS

ENTER BUTTON

0.1 - 10 mg

2 mg

milligrams

PREVIOUS

430-04685-004 4- 9



12

The D ELIVER

L

OADING

D

OSE

N

OW

S

CREEN allows the option of delivering the loading dose now or after the programming is complete.

MORPHINE PF

1 mg/mL

DELIVER

LOADING DOSE

NOW ?

YES

DELIVER LATER

13

If YES> was selected, press the B

UTTON

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

PREVIOUS

WARNING

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

14

If the D ELIVER

L

ATER option is selected, the screen advances to the S ELECT

D

ELIVERY

M

ODE S CREEN .

4- 10 430-04685-004


LifeCare PCA

®


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.

MORPHINE PF

1 mg/mL

PRESS

PAUSE BUTTON

TO STOP

1 mg

milligrams

INFUSING

LOADING DOSE

16

The S ELECT

M

ODE S CREEN appears.

See Modes of

Delivery on page 5-2

for more

information.

MORPHINE PF

1 mg/mL

SELECT

DELIVERY MODE

PCA ONLY

PCA + CONT.

CONTINUOUS

PROTOCOLS

PREVIOUS

430-04685-004 4- 11



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 , 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.

LIFECARE PCA

SELF TEST

LOCKOUT

CONT. RATE

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 C

ONTINUE


LIFECARE PCA

SELF TEST

COMPLETE

RAM. . . . . . .OK

FLASH. . . . .OK

CPU ID. . . . .OK

CPU. . . . . . .OK

TIMER. . . . .OK

SYSTEM

SETTINGS

CONTINUE

4- 12 430-04685-004


LifeCare PCA

®


3

The N

EW

P

ATIENT

S


Select YES> or NO>.

4


History and Rx settings are kept.

NEW

PATIENT?

YES

NO

5

If the YES> option is selected, the History and

Rx settings are cleared.

Select C

ONFIRM

> to confirm choice and continue. A screen appears to confirm that history was cleared.

HISTORY AND

RX SETTINGS

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 C

ONFIRM


ALPHA VIAL

CONFIRM

CUSTOM

VIAL TO RX

REMOVE VIAL

IF NOT CORRECT

.

CONFIRM

430-04685-004 4- 13



7

Select either Y

ES

> or N

O


See

Purging the System on page 4-28


ALPHA VIAL

PURGE ?

PURGING

RECOMMENDED

YES

NO

8

If Y

ES


URGE

> Softkey.



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

ALPHA VIAL

DISCONNECT

SET FROM

PATIENT

PRESS AND HOLD

PURGE KEY

PURGE

PREVIOUS

4- 14 430-04685-004


LifeCare PCA

®


Upon release of the

P

URGE

>


9

Select Y

ES


O


10


ALPHA VIAL

PURGE

COMPLETE ?

YES

NO

11

Select desired units of measure.

For the demonstration purposes

Micrograms is selected.

ALPHA VIAL

SELECT UNITS

OF MEASURE

430-04685-004 4- 15



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

C

ONFIRM

>.

ALPHA VIAL

ENTER DRUG

CONCENTRATION

THEN PRESS

ENTER BUTTON

1 - 100 mcg/mL

10

micrograms mcg mL

PREVIOUS

ALPHA VIAL

10 mcg/mL

CONFIRM

10 mcg/mL

CONCENTRATION

TO

PHYSICIAN RX

CONFIRM

PREVIOUS

15


ES

>.



ALPHA VIAL

10 mcg/mL

SET LOADING

DOSE ?

YES

NO

4- 16 430-04685-004


LifeCare PCA

®


16

Enter a Loading Dose within the displayed range.Then

ALPHA VIAL

10 mcg/mL

ENTER

LOADING DOSE

THEN PRESS

ENTER BUTTON

1 - 100 mcg

20 mcg

micrograms

PREVIOUS

17

The D

ELIVER

L

OADING

D

OSE

N

OW

S

CREEN

allows the option of delivering the loading dose now or after the programming is complete.

ALPHA VIAL

10 mcg/mL

DELIVER

LOADING DOSE

NOW ?

YES

DELIVER LATER

18


UTTON


Dose.

NOTE: The loading dose mode is

the only mode that the infuser will deliver with the door unlocked.

ALPHA VIAL

10 mcg/mL

PRESS

START BUTTON

TO INFUSE

20 mcg

LOADING DOSE

PREVIOUS

430-04685-004 4- 17



WARNING


19

If the D ELIVER

L

ATER option is selected, the screen advances to the S ELECT

D

ELIVERY

M

ODE S CREEN .

20



ALPHA VIAL

10 mcg/mL

PRESS

PAUSE BUTTON

TO STOP

15 mcg

micrograms

INFUSING

LOADING DOSE

The S

ELECT

M

ODE

S

CREEN

appears.

See Modes of



ALPHA VIAL

10 mcg/mL

SELECT

DELIVERY MODE

PCA ONLY

PCA + CONT.

CONTINUOUS

PROTOCOLS

PREVIOUS

4- 18 430-04685-004


LifeCare PCA

®


Getting Started

This section details the PCA Infuser setup procedures.

U

NPACKING

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

AREFULLY UNPACK AND SETUP THE

PCA

I

NFUSER TO AVOID PRODUCT DAMAGE

. D

O NOT USE THE

PCA

I

NFUSER IF IT APPEARS DAMAGED IN ANY WAY

. T

HE BATTERY

MAY NOT BE CHARGED UPON RECEIPT

.

CAUTION: I

F THE

PCA I

NFUSER APPEARS TO BE DAMAGED

,

CONTACT

H

OSPIRA

.

C

ONNECTING THE

P

ATIENT

P

ENDANT

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.

S

YSTEM

S

ELF

-T

ESTS

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



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

O NOT PLACE THE

PCA I

NFUSER IN SERVICE IF

IT FAILS THE SYSTEM SELF

-

TESTS

.

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

ON

. If the alarm recurs, remove the PCA Infuser from service and contact the hospital biomedical department or the local Hospira representative.

Unlock the door and press the

[ON/OFF] B

UTTON , or insert the vial to 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

L

OW

B

ATTERY

Message displays to prompt for an AC power connection.

CAUTION: D

O NOT OPERATE THE

PCA I

NFUSER WITH THE

BATTERY REMOVED

. U

SE OF A PROPERLY MAINTAINED AND

CHARGED 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 M

ODE

.

D

ATA

R

ETENTION

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

4- 20 430-04685-004


LifeCare PCA

®


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

N

EW

P

ATIENT

S

CREEN

allows 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

[

H

ISTORY

]

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.

Adjusting Settings

1

Press 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


2

Select S

YSTEM

S

ETTINGS

> to view the Change Settings

Menu.


LIFECARE PCA

SELF TEST

COMPLETE

RAM. . . . . . .OK

FLASH. . . . .OK

CPU ID. . . . .OK

CPU. . . . . . .OK

TIMER. . . . .OK

SYSTEM

SETTINGS

CONTINUE

3

Adjust settings by selecting the appropriate softkey.

SELECT

SETTING

TO CHANGE

VOLUME

CONTRAST

TIME/DATE

CONTINUE

C

HANGING

A

LARM

V

OLUME

1

Select V

OLUME

>.

SETTING

TO CHANGE

VOLUME

CONTRAST

TIME/DATE

CONTINUE

4- 22 430-04685-004


LifeCare PCA

®


2

Select desired volume, then

S

AVE

& E

XIT

>.

The current setting flashes at this screen.

SELECT ALARM

VOLUME

HIGH

MEDIUM

LOW

CANCEL

SAVE & EXIT

C

HANGING

C

ONTRAST OF

M

AIN

D

ISPLAY

1

Select C

ONTRAST

>.

SELECT

SETTING

TO CHANGE

VOLUME

CONTRAST

TIME/DATE

CONTINUE

2

Select desired adjustment softkey repeatedly until contrast is optimized for viewing.

3

Select S

AVE

& E

XIT

>.

ADJUST LCD

CONTRAST TO

DESIRED LEVEL

LIGHTER

DARKER

CANCEL

SAVE & EXIT

430-04685-004 4- 23



C

HANGING OR

C

ONFIRMING

T

IME AND

D

ATE

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 T

IME

/D

ATE

>. After selecting

T

IME

/D

ATE

>

, 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 W

ARNING

S

CREEN appears, select C

ONTINUE

>.

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

PREVIOUS

4- 24 430-04685-004


LifeCare PCA

®


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 N

EXT

> to change the date.

6

To change the date, set the date with the Numbers

Buttons.

SET TIME WITH

NUMBERS

BUTTONS

TOGGLE AM/PM

10:43 PM

AM/PM

NEXT

SET DATE WITH

NUMBERS

BUTTONS

01/15/05

The current setting for Date will flash.

NOTE: Date must be entered in

MM/DD/YY sequence.

NEXT

430-04685-004 4- 25



7

Select N

EXT

> again after changing to the desired date. The C ONFIRMATION

S

CREEN appears. Select

C

ONFIRM

> to verify the changed settings.

8

Then select C

ONTINUE

> to exit the Change System

Settings

Menu and display the V IAL

C

ONFIRMATION S CREEN (if the vial is loaded properly).

CONFIRM

CURRENT

TIME AND DATE

SETTINGS

9:21 PM

01/15/05

CONFIRM

CHANGE

CANCEL

4- 26 430-04685-004


LifeCare PCA

®


New Patient

1

The N

EW

P

ATIENT

S


Select YES> or NO>.

NOTE: If the infuser has been off

for more than 4 hours, the History and Rx settings are automatically cleared and the

N

EW

P

ATIENT

S

CREEN 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 C

LEAR

H

ISTORY

> or

C

ONTINUE

>.

NEW

PATIENT?

YES

NO

HISTORY AND

RX SETTINGS

CLEARED

430-04685-004 4- 27



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

ES

> to initiate the purge cycle.

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

Press and hold the

P

URGE

>

key. The flow rate during purging is 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

P

URGE

>

key is released, the purge cycle will stop 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

N

C

ONTINUOUS AND

PCA+C

ONTINUOUS

M

ODES

,

IF A PURGE IS NOT PERFORMED AFTER A SYRINGE CHANGE

,

THE

INFUSER AUTOMATICALLY PERFORMS A SMALL SYSTEM

COMPLIANCE STEP TO REMOVE SLACK WHEN

[S

TART

]

IS

PRESSED

(

WITH THE DOOR LOCKED

). A

LTHOUGH

,

FLUID IS NOT

NORMALLY DELIVERED TO THE PATIENT DURING THE

COMPLIANCE STEP

,

UNDER SOME CONDITIONS UP TO

0.3

M

L

OF

FLUID MAY BE DELIVERED

. I

F

0.3

M

L

OF FLUID REPRESENTS A

4- 28 430-04685-004


LifeCare PCA

®


HAZARD TO THE PATIENT

,

DISCONNECT THE SET DURING THIS

OPERATION

.

1

If Y

ES


URGE

> Softkey.

MORPHINE PF

1 mg/mL

DISCONNECT

SET FROM

PATIENT

PRESS AND HOLD

PURGE KEY

NOTE: While purging is

occurring, the word

PURGING

will be displayed.

PURGE

PREVIOUS



Upon release of the

P

URGE

>


2

Select Y

ES


O


MORPHINE PF

1 mg/mL

PURGE

COMPLETE ?

YES

NO

Reconnect set to patient.

430-04685-004 4- 29



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


ES

>.

MORPHINE PF

1 mg/mL

SET LOADING

DOSE ?

If

N

O

>

is selected, the screen advances to the S ELECT

M

ODE

S

CREEN .

See Modes of Delivery on page 5-2

for information on modes.

YES

NO

NOTE: A supplemental loading

dose can also be delivered after the programming sequence is complete and infusing by opening the door and selecting the

L

OADING

D

OSE

>

key.

2

Enter a Loading Dose within the displayed range.

3

Then press

ENTER

.

MORPHINE PF

1 mg/mL

ENTER

LOADING DOSE

THEN PRESS

ENTER BUTTON

0.1 - 10 mg

2 mg

milligrams

PREVIOUS

4- 30 430-04685-004


LifeCare PCA

®


4

The next screen offers the options of infusing the loading dose now or later

(after programming is complete). If D ELIVER

L

OADING

D

OSE

N

OW

? is desired, press the

Y

ES

>

Softkey to infuse the programmed Loading

Dose.

MORPHINE PF

1 mg/mL

DELIVER

LOADING DOSE

NOW ?

YES

DELIVER LATER

5

If the D

ELIVER

L

ATER

option is desired, the screen advances to the S ELECT

D

ELIVERY

M

ODE

S

CREEN

.

See Modes of Delivery on page 5-2


6


UTTON


Dose.

MORPHINE PF

1 mg/mL

PRESS

START BUTTON

TO INFUSE

2 mg

LOADING DOSE

PREVIOUS

430-04685-004 4- 31



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

S

ELECT

M

ODE

S

CREEN appears.

See Modes of


.

MORPHINE PF

1 mg/mL

PRESS

PAUSE BUTTON

TO STOP

0.

5

mg

milligrams

INFUSING

LOADING DOSE

4- 32 430-04685-004


LifeCare PCA

®


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


Select Mode

Modes of Delivery

The PCA Infuser delivers analgesia in one of three modes:

•

PCA ONLY

•

CONTINUOUS

•

PCA+CONTINUOUS

P

ROTOCOLS

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

MedNet

TM

Software.

There are 10 stored protocols available (without Hospira

MedNet

TM

Software enabled) or 90 stored protocols (5 per CCA) available (with Hospira MedNet TM

Software enabled).

PCA O

NLY

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.

Interrupting delivery by pressing

[START/STOP]

, opening the door, 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.

5 - 2 430-04685-004


LifeCare PCA

®


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

HR LIMIT REACHED

Message is displayed.


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.

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.


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


Select Mode

PCA Only Mode

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

see

Loading a

Vial on page 4 - 5

.

For information on adjusting system settings such as contrast and volume

see

Adjusting Settings on page 4 - 21

.

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.

2

Select C

ONTINUE

> to advance to the next programming screen.

LIFECARE PCA

SELF TEST

LOCKOUT

CONT. RATE

3

Select Y

ES

> or N

O

> at the N

EW

P

ATIENT

S

CREEN

if the infuser has been OFF 4 hours or less.

See New

Patient on page 4-27


4

Select C

ONFIRM

> 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 Y

ES

> or N

O


See



6

If Y

ES

> is selected, disconnect the set from the patient, and press & hold the P

URGE

> Softkey.

5 - 4 430-04685-004


LifeCare PCA

®


7

Select Y

ES


O


8


9


ES

>.



10


11

Then press

ENTER

.

12

Select Y

ES

> to infuse the programmed Loading Dose.

Select D

ELIVER

L

ATER

> to delay loading dose delivery.

MORPHINE PF

1 mg/mL

DELIVER

LOADING DOSE

NOW ?

YES

DELIVER LATER

13

From the Select Delivery

Mode S

CREEN

, select PCA

O

NLY

>.

MORPHINE PF

1 mg/mL

SELECT

DELIVERY MODE

PCA ONLY

PCA + CONT.

CONTINUOUS

PROTOCOLS

PREVIOUS

430-04685-004 5 - 5


Select Mode

14

Enter the desired PCA dose using the numeric keypad.

If the value is entered incorrectly, press

C

L

R

to change value.

15

Then press

ENTER

.

If programming changes need to be made, select

P

REVIOUS

> to return to the preceding screen.

16

Enter a lockout Interval value. (The value range is displayed on the screen.)


C

L

R

to change value.

17

Then press

ENTER

.

MORPHINE PF

1 mg/mL

ENTER

PCA DOSE

THEN PRESS

ENTER BUTTON

0.1 - 5 mg

2 mg

milligrams

PREVIOUS

MORPHINE PF

1 mg/mL

ENTER

LOCKOUT

INTERVAL

THEN PRESS

ENTER BUTTON

5 - 120 min

10 min

minutes

PREVIOUS


P

REVIOUS


5 - 6 430-04685-004


LifeCare PCA

®


18

Set a specific dose limit by selecting Y

ES

> and advancing to the Dose Limit

Enter Value S CREEN . Or select N

O

> to choose No

Dose Limit.

MORPHINE PF

1 mg/mL

SET A DOSE

LIMIT ?

YES

No Dose Limit will be selected for this example.

NO

PREVIOUS

If Hospira MedNet

TM

Software is enabled and a upper hard or soft limit has been assigned for that

CCA and drug, then a D

OSE

L

IMIT

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 C

ONFIRM

> to verify the

N

O

D

OSE

L

IMIT

selection.

MORPHINE PF

1 mg/mL

CONFIRM NO

DOSE LIMIT ?

Select P

REVIOUS


CONFIRM

PREVIOUS

430-04685-004 5 - 7


Select Mode

20

Select C

ONFIRM

> to verify settings. Or, select

P

REVIOUS


21

Close and lock door. Place key in a secure location.

After locking the door the

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

MORPHINE PF

1 mg/mL

PCA ONLY

PCA DOSE

2 mg

LOCKOUT

10 min

4 HOUR LIMIT

NO

CONFIRM

PREVIOUS

Approximately 10 seconds after the door is locked, the

D

OOR

L

OCKED

Message disappears. After delivering the PCA dose, the PCA

LOCKOUT Message appears indicating the PCA Infuser is locked out.

MORPHINE PF

1 mg/mL

PCA ONLY

PCA LOCKOUT

NO 4 HR LIMIT

7.

5

mg

milligrams

TOTAL DELIVERED

PCA DOSE =

2 mg

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

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


LifeCare PCA

®


Continuous Mode


see

Loading a


.


see


.

1



2

Select C

ONTINUE


LIFECARE PCA

SELF TEST

LOCKOUT

CONT. RATE

3

Select Y

ES

> or N

O

> at the N

EW

P

ATIENT S CREEN if the infuser has been OFF 4 hours or less.



4

Select C

ONFIRM




5

Select either Y

ES

> or N

O


See Purging the System on page 4-28

for more

information.

430-04685-004 5 - 9


Select Mode

6

If Y

ES


URGE

> Softkey.

7

Select Y

ES


O


8

After purging, reconnect set to patient.

9


ES

>.




Then press

ENTER

.

10

Select Y

ES

> to infuse the programmed Loading

Dose. Select D

ELIVER

L

ATER


MORPHINE PF

1 mg/mL

DELIVER

LOADING DOSE

NOW ?

YES

DELIVER LATER

11

From the Select Delivery

Mode S CREEN , select

C

ONTINOUOUS

>.

MORPHINE PF

1 mg/mL

SELECT

DELIVERY MODE

PCA ONLY

PCA + CONT.

CONTINUOUS

PROTOCOLS

PREVIOUS

5 - 10 430-04685-004


LifeCare PCA

®


12

Enter a continuous rate using the keypad. The value range is displayed on the screen.

If value is entered incorrectly, press

C

L

R

to change value.

13

Then press

ENTER

.

MORPHINE PF

1 mg/mL

ENTER

CONT. RATE

THEN PRESS

ENTER BUTTON

0.5 - 100 mg/hr mg

2

milligrams hr

PREVIOUS


P

REVIOUS


14


ES

> and advancing to the Dose Limit

Enter Value S CREEN . Select

N

O

> to choose No Dose

Limit.

MORPHINE PF

1 mg/mL

SET A DOSE

LIMIT ?

YES


NO

PREVIOUS

If Hospira MedNet

TM



OSE

L

IMIT


NOTE: The pre-programmed Dose Limit is 1 or 4 hours.

The Hospira MedNet

TM

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

12 hours).

For complete information on this feature, see

Dose Limit on page 5 - 21

.

430-04685-004 5 - 11


Select Mode

15

Select C

ONFIRM

> to verify No

Dose Limit selection.

Select P

REVIOUS


MORPHINE PF

1 mg/mL

CONFIRM NO

DOSE LIMIT ?

CONFIRM

PREVIOUS

16

Select C

ONFIRM


P

REVIOUS


17


MORPHINE PF

1 mg/mL

CONTINUOUS

CONT. RATE

2 mg/hr

4 HOUR LIMIT

NO

CONFIRM

PREVIOUS

18

Press to begin therapy.

Approximately 10 seconds

MORPHINE PF

1 mg/mL

CONTINUOUS after door is locked and is pressed, the D OOR

L

OCKED

Message disappears.

2 mg

milligrams

When the Dose Limit is reached, a message is displayed that indicates the

Dose Limit has been reached.

TOTAL DELIVERED

CONT. RATE =

2 mg/hr

5 - 12 430-04685-004


LifeCare PCA

®


PCA+Continuous Mode


see

Loading a


.


see


.

1



2

Select C

ONTINUE


LIFECARE PCA

SELF TEST

LOCKOUT

CONT. RATE

3

Select Y

ES

> or N

O

> at the N

EW

P

ATIENT

S

CREEN

if the infuser has been OFF 4 hours or less.

See New

Patient on page 4-27


4

Select C

ONFIRM




5

Select either Y

ES

> or N

O


See



6

If Y

ES


URGE

> Softkey.

430-04685-004 5 - 13


Select Mode

7

Select Y

ES


O


8


9


ES

>.



10


Then press

ENTER

.

11

Select Y

ES

> to infuse the programmed Loading Dose.

Select D

ELIVER

L

ATER


MORPHINE PF

1 mg/mL

DELIVER

LOADING DOSE

NOW ?

YES

DELIVER LATER

12

From the S ELECT

M

ODE S CREEN , select PCA + C

ONT

>.

MORPHINE PF

1 mg/mL

SELECT

DELIVERY MODE

PCA ONLY

PCA + CONT.

CONTINUOUS

PROTOCOLS

PREVIOUS

5 - 14 430-04685-004


LifeCare PCA

®


13

Enter PCA dose value using the keypad. The value range is displayed on the screen.

If value is entered incorrectly, press

C

L

R

to change value.

MORPHINE PF

1 mg/mL

ENTER

PCA DOSE

THEN PRESS

ENTER BUTTON

0.1 - 5 mg

2 mg

milligrams

PREVIOUS

Then press

ENTER

.


P

REVIOUS


14

Enter a Lockout Interval value. (Value range is displayed on thescreen.)


C

L

R

to change the value.

MORPHINE PF

1 mg/mL

ENTER

LOCKOUT

INTERVAL

THEN PRESS

ENTER BUTTON

5 - 120 min

10 min

minutes

PREVIOUS

Then press

ENTER

.


P

REVIOUS


430-04685-004 5 - 15


Select Mode

15

Enter a Continuous Rate.

The value range is displayed on screen.


C

L

R

to change the value.

MORPHINE PF

1 mg/mL

ENTER

CONT. RATE

THEN PRESS

ENTER BUTTON

0.1 - 20 mg/hr mg

2

milligrams hr

PREVIOUS

Then press

ENTER

.


P

REVIOUS


16


ES

> and advancing to the D OSE

L

IMIT

E

NTER

V

ALUE S CREEN . Or select

N

O

> to choose N

O

D

OSE

L

IMIT .

MORPHINE PF

1 mg/mL

SET A DOSE

LIMIT ?

YES

Setting a specific Dose

Limit will be selected for this example.

NO

PREVIOUS

If Hospira MedNet

TM



OSE

L

IMIT


NOTE: The pre-programmed Dose Limit is 1 or 4 hours.

The Hospira MedNet

TM

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

12 hours).

For complete information on this feature

see

Dose Limit on page 5 - 21

.

5 - 16 430-04685-004


LifeCare PCA

®


17

Enter the Dose Limit value using the numeric keypad

(the range is displayed on the screen).


C

L

R

to change value.

MORPHINE PF

1 mg/mL

ENTER 4 HOUR

DOSE LIMIT

THEN PRESS

ENTER BUTTON

0.1 - 80 mg

40 mg

milligrams

PREVIOUS

Then press

ENTER

.

18

Select C

ONFIRM


P

REVIOUS


19


P

REVIOUS



After locking the door the

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

PCA dose.

MORPHINE PF

1 mg/mL

PCA+CONT

PCA DOSE

2 mg

LOCKOUT

10 min

CONT. RATE

2 mg/hr

4 HOUR LIMIT

40 mg

CONFIRM

PREVIOUS

430-04685-004 5 - 17


Select Mode

20

Press to begin therapy.

Approximately 10 seconds after door is locked and is pressed, the D OOR

L

OCKED

Message disappears.

MORPHINE PF

1 mg/mL

PCA+CONT.

PCA AVAILABLE

2 mg

milligrams

When the Dose Limit is reached, a message is displayed that indicates the

Dose Limit has been reached.

TOTAL DELIVERED

CONT. RATE

2 mg/hr

Protocols


see

Loading a


.


see


.

NOTE: Protocols may be established by the hospital via

Hospira MedNet

TM

Software or via Biomed Mode. Hospira

MedNet

TM

Software enabled devices allow for protocol programming from the Rx Rules application. Only Protocols associated with the inserted drug vial will be available.

1


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

5 - 18 430-04685-004


LifeCare PCA

®


2

Select C

ONTINUE


3

Select Y

ES

> or N

O

> at the N

EW

P

ATIENT

S

CREEN if the infuser has been OFF 4 hours or less. For more information see

New Patient on page 4 - 27

.

4

Select C

ONFIRM




5

Select either Y

ES

> or N

O

> to purge the system. For more information see

Purging the System on page 4 -

28

.

6

If Y

ES


URGE

>.

7

Select Y

ES


O


8

After purging, reconnect set to patient.

9


ES

>.

For more information see

Loading Dose on page 4 -

30

.

10


Then press

ENTER

.

430-04685-004 5 - 19


Select Mode

11

Press to infuse programmed Loading Dose.

Select D

ELIVER

L

ATER


From the S ELECT

D

ELIVERY

M

ODE S CREEN , select

P

ROTOCOLS

>.

MORPHINE PF

1 mg/mL

SELECT

DELIVERY MODE

PCA ONLY

PCA + CONT.

CONTINUOUS

PROTOCOLS

PREVIOUS

12

Press protocol, or select N

EXT

P

ROTOCOL

> and P

REVIOUS

> to view other stored protocols if available.

MORPHINE PF

PRESS ENTER

TO SELECT

PCA DOSE

2 mg

LOCKOUT

10 min

4 HOUR LIMIT

NO

NEXT PROTOCOL

#

3

PREVIOUS

13

Select C

ONFIRM

> to accept the chosen protocol settings. Or press P

REVIOUS


14

Close and lock the door.

Place key in a secure location.

MORPHINE PF

1 mg/mL

PCA+CONT

PCA DOSE

2 mg

LOCKOUT

10 min

CONT. RATE

2 mg/hr

4 HOUR LIMIT

40 mg

CONFIRM

PREVIOUS

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


LifeCare PCA

®


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

TM

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

OADING

D

OSE

> key.

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

4 HR LIMIT

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.

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


Select Mode

P

ROGRAMMING THE

4 (

OR

1) H

OUR

D

OSE

L

IMIT

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

C

ONFIRM

N

O

D

OSE

L

IMIT

S

CREEN. Selecting Y

ES

> brings up the

D

OSE

L

IMIT

E

NTER

V

ALUE

S

CREEN. This requires that the clinician enter a value within the displayed range.

NOTE: If Hospira MedNet

TM

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

D

OSE

L

IMIT entry is required.

P

ROGRAMMING A

D

OSE

L

IMIT

1

Select Y

ES

> at the D

OSE

L

IMIT

S

ELECTION S CREEN .

MORPHINE PF

1 mg/mL

SET A DOSE

LIMIT ?

The display advances to the

D

OSE

L

IMIT

E

NTER

V

ALUE S CREEN .

YES

NO

PREVIOUS

2

Enter the 4

HOUR

D

OSE

L

IMIT 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

Programming

No Dose Limit on page 5 - 23

.

MORPHINE PF

1 mg/mL

ENTER 4 HOUR

DOSE LIMIT

THEN PRESS

ENTER BUTTON

0.1 - 80 mg

40 mg

milligrams

PREVIOUS

Then press

ENTER

.

5 - 22 430-04685-004


LifeCare PCA

®


3

Select C

ONFIRM


REVIOUS


4



MORPHINE PF

1 mg/mL

PCA+CONT

PCA DOSE

2 mg

LOCKOUT

10 min

CONT. RATE

2 mg/hr

4 HOUR LIMIT

40 mg

CONFIRM

PREVIOUS

5


P

ROGRAMMING

N

O

D

OSE

L

IMIT

1

Select N

O

> at the D

OSE

L

IMIT

S

ELECTION S CREEN .

MORPHINE PF

1 mg/mL

SET A DOSE

LIMIT ?

The display advances to the

Confirm N O

D

OSE

L

IMIT S CREEN .

YES

NO

PREVIOUS

430-04685-004 5 - 23


Select Mode

2

Select C

ONFIRM

> 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.

MORPHINE PF

1 mg/mL

CONFIRM NO

DOSE LIMIT ?

CONFIRM

PREVIOUS

3

Select C

ONFIRM


REVIOUS


4

Close and the lock door.


MORPHINE PF

1 mg/mL

PCA+CONT

PCA DOSE

2 mg

LOCKOUT

10 min

CONT. RATE

2 mg/hr

4 HOUR LIMIT

NO

CONFIRM

PREVIOUS

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


LifeCare PCA

®


C

LEARING OR

C

HANGING A

D

OSE

L

IMIT

1

Unlock door to stop the infuser.

2

Select C

HANGE

R

X

>.

NOTE:

C

HANGE

CCA

> will only display if Hospira MedNet

TM

Software has been enabled.

MORPHINE PF

1 mg/mL

PAUSED

PCA + CONT

LOCK DOOR

TO BEGIN

LOADING DOSE

CHANGE RX

CLEAR SHIFT

CHANGE CCA

3

Select N

EXT

> to display more change options.

MORPHINE PF

1 mg/mL

SELECT SETTING

TO CHANGE

MODE

PCA DOSE

CONT. RATE

NEXT

SAVE & EXIT

4

Select D

OSE

L

IMIT

>.

MORPHINE PF

1 mg/mL

SELECT SETTING

TO CHANGE

LOCKOUT

DOSE LIMIT

NEXT

SAVE & EXIT

430-04685-004 5 - 25


Select Mode

5


ES

> then advance to the D OSE

L

IMIT

E

NTER

V

ALUE

S

CREEN . Or, select N

O

> to choose N O

D

OSE

L

IMIT .


6

Select C

ONFIRM

> to verify the

N

O

D

OSE

L

IMIT

selection. Or, select P

REVIOUS


MORPHINE PF

1 mg/mL

SET A DOSE

LIMIT ?

YES

NO

PREVIOUS

MORPHINE PF

1 mg/mL

CONFIRM NO

DOSE LIMIT ?

CONFIRM

PREVIOUS

7

Press S

AVE

& E

XIT

> at the next screen. This will bring up the R

EVIEW

/C

ONFIRMATION

S

CREEN

.

MORPHINE PF

1 mg/mL

SELECT SETTING

TO CHANGE

LOCKOUT

DOSE LIMIT

NEXT

SAVE & EXIT

5 - 26 430-04685-004


LifeCare PCA

®


8

Press C

ONFIRM

> to accept a new program.

MORPHINE PF

1 mg/mL

PCA ONLY

PCA DOSE

2 mg

LOCKOUT

10 min

4 HOUR LIMIT

NO

CONFIRM

PREVIOUS

Clearing the

History and/or Rx Settings

1

To clear the HISTORY AND

R

X settings turn the infuser [

OFF

] and

[

ON

]

again to get to the

N

EW

P

ATIENT

Screen.

NEW

PATIENT?

2

Press

ES

> and H

ISTORY AND

R

X settings are cleared.

YES

NO

NOTE: The

N

EW

P

ATIENT

S

CREEN appears if the infuser has been off for 4 hours or less. If off for more than 4 hours, the

HISTORY AND

R

X are automatically cleared and the

N

EW

P

ATIENT

S

CREEN is not displayed.

3

Select C

ONFIRM


MORPHINE PF

1 mg/mL

CONFIRM

1 mg/mL

MORPHINE PF

TO RX

REMOVE VIAL

IF NOT CORRECT

CONFIRM

430-04685-004 5 - 27


Select Mode

Using Review/Confirmation

Screens

Prior to locking the infuser and removing the key, a

R

EVIEW

/

C

ONFIRMATION

S

CREEN appears as shown below. As determined by the programmed mode of delivery, the screen displays the current settings for the applicable parameters (including PCA Dose,

Lockout Interval, Continuous Rate, and Dose Limit).

•

Clinicians should review each programmed parameter and ensure that the displayed program agrees with the physician’s order.

•

If all of the programmed parameters

AGREE with the physician’s order, the clinician accepts the settings by selecting

CONFIRM

>.

MORPHINE PF

1 mg/mL

PCA+CONT

PCA DOSE

2 mg

LOCKOUT

10 min

CONT. RATE

2 mg/hr

4 HOUR LIMIT

40 mg

CONFIRM

•

If one or more of the programmed

PREVIOUS parameters do not agree with the physician’s order, the clinician should select

PREVIOUS>

until the incorrectly programmed parameter(s) is displayed. Depending on the incorrect parameter(s), the programmed values may be changed by either entering the new value by using the numeric keypad and pressing [

ENTER

] or selecting the new setting using the appropriate

S

OFTKEY

>

. Once the appropriate parameters have been changed, the

R

EVIEW

/

C

ONFIRMATION

S

CREEN

will be presented again. The clinician should review each setting to ensure agreement with the physician’s order.

•

Once

CONFIRM>

has been selected, the clinician should close and lock the door.

•

Place the key in a secure location.

•

Upon locking the door, the PCA Infuser is available if the mode is set on PCA ONLY. If mode is set for PCA + CONTINUOUS or

CONTINUOUS, therapy will begin after pressing [START/PAUSE].

5 - 28 430-04685-004


LifeCare PCA

®


Changing Settings During Setup

During setup, select

P

REVIOUS

> to return to the preceding display and enter the desired setting. Each time

P

REVIOUS

> is selected, the message display reverts to the previous setting, until the first setting is displayed.

S

TOPPING

I

NFUSION

1

Close slide clamp on the PCA Infuser administration set.

WARNING

Always close slide clamp on the PCA administration set before removing or replacing the syringe, and before discontinuing infusion.

2

Unlock door.

3

Or, press for Continuous or PCA +

Continuous.

NOTE: If paused longer than two minutes without pressing

an appropriate key, the infuser alarm will sound.

T

URNING THE

I

NFUSER

O

FF

1

Close slide clamp on PCA administration set.

2

Unlock door.

3

Press

430-04685-004 5 - 29


Select Mode

Making Changes After Setup

R

EVIEWING THE

C

URRENT

S

ETTINGS

Settings may be reviewed while the infuser is running or stopped.

1

Press Button twice.

2

Press

EXIT

to return to main menu. Or, select

P

REVIOUS

> to return to the preceding display.

C

HANGING

S

ETTINGS

1

Unlock the door while the infuser is running. The infuser will be paused.

2

Select C

HANGE

R

X

> to change individual settings.

NOTE: C

HANGE

CCA> only displays if Hospira MedNet

TM


3

Select the desired field to change (

EXAMPLE

PCA D

OSE

>).

Or, select N

EXT

> to display more change options, such as Lockout and Dose Limit.

NOTE: If the mode of delivery is

changed, the display prompt for reprogramming uses the same steps outlined in the beginning of this section.

The value previously set for the

PCA dose will flash.

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

NEXT

SAVE & EXIT

5 - 30 430-04685-004


LifeCare PCA

®


4

Enter the desired PCA dose using the numeric keypad.

(The value range is displayed on the screen.) If the value is entered incorrectly, press

C

L

R

to change value.

5

Then press

ENTER

.

MORPHINE PF

1 mg/mL

ENTER

PCA DOSE

THEN PRESS

ENTER BUTTON

0.1 - 5 mg

1 mg

milligrams

PREVIOUS


P

REVIOUS


6

If no settings require change, confirm by selecting S

AVE

& E

XIT

>.

MORPHINE PF

1 mg/mL

SELECT SETTING

TO CHANGE

MODE

PCA DOSE

CONT. RATE

NEXT

SAVE & EXIT

7

Select C

ONFIRM

> to accept the new program.

MORPHINE PF

1 mg/mL

PCA ONLY

PCA DOSE

1 mg

LOCKOUT

10 min

4 HOUR LIMIT

NO

CONFIRM

PREVIOUS

430-04685-004 5 - 31


Select Mode

C

HANGING THE

CCA

1

Unlock the door while the infuser is running. The infuser will pause.

2

Select C

HANGE

CCA> to change the setting.

NOTE:

C

HANGE

CCA>

will only display if Hospira MedNet

TM


WARNING

Changing the CCA clears the RX settings.

MORPHINE PF

1 mg/mL

CARDIOLOGY

PAUSED

PCA + CONT

LOCK DOOR

TO BEGIN

LOADING DOSE

CHANGE RX

CLEAR SHIFT

CHANGE CCA

3

At the WARNING SCREEN select

C

ONTINUE

>.

MORPHINE PF

1 mg/mL

CARDIOLOGY

WARNING!

CHANGING CCA

WILL CLEAR THE

RX SETTINGS

CONTINUE

PREVIOUS

4

Select new CCA.

SELECT CCA

PACU

MEDSURG

PEDIATRICS

ER

NEXT

5 - 32 430-04685-004


LifeCare PCA

®


Clearing Shift Totals

1

Review & record shift totals using the

B

UTTON before clearing the shift totals.

2

Unlock the door while the infuser is running. The infuser will be paused.

MORPHINE PF

1 mg/mL

PAUSED

PCA + CONT

LOCK DOOR

TO BEGIN

3

Select C

LEAR

S

HIFT

> to display the option to clear the total dose delivered.

NOTE:

C

HANGE

CCA>


TM

Software was enabled.

LOADING DOSE

CHANGE RX

CLEAR SHIFT

CHANGE CCA

4

Select Y

ES

> to clear shift totals and return to the previous screen.

MORPHINE PF

1 mg/mL

CLEAR SHIFT

TOTALS ?

Or, select N

O

> to return to previous screen.

NOTE: Selecting Y

ES

> clears the

PCA Summary data and total dose delivered, but does not clear dose limit data.

YES

NO

5

Close and lock the door. Place key in a secure location.

6


430-04685-004 5 - 33


Select Mode

Changing a Vial

1

The alarm message EMPTY SYRINGE appears along with the statement

REPLACE SYRINGE

.

2

Close the slide clamp on the PCA administration set.

NOTE: The screen displays that the infuser is

PAUSED

.

3

Remove the old vial by firmly grasping the glass vial on both sides and pulling straight out.

4

Load the new vial as shown before. (See

Loading a Vial on page 4 - 5

.)

If a change is detected from the previous vial or infused drug, the W ARNING

! D

RUG AND

/

OR

C

ONCENTRATION

C

HANGE

D

ETECTED

S

CREEN appears.

MORPHINE PF

1 mg/mL

WARNING!

DRUG and/or

CONCENTRATION

MAY HAVE

CHANGED!

CONTINUE or

REMOVE VIAL IF

INCORRECT

CONTINUE

5

Verify vial and Rx. If vial and Rx is as intended, select C

ONTINUE

>. Available selections depend on the previous vial drug and concentration in the infuser verses the new vial.

6

Select Y

ES

> when Purge is displayed.

WARNING

Disconnect the patient from the PCA set before the purge cycle.

7

At this point:

5 - 34 430-04685-004


LifeCare PCA

®


A. Disconnect the set from the patient.

B. Release the slide clamp on the PCA administration set.

C. Select & hold the

P

URGE

>

key until fluid is seen at the end of the set and no air remains inside the set.

NOTE: Purging is recommended to remove slack when a

new vial is inserted. The system must be primed before purging. The maximum volume delivered during a purge is

3 mL.

NOTE: The drug delivered during the purge cycle is NOT

stored in system memory and will not be displayed.

CAUTION: I

N

CONTINUOUS

AND

PCA+CONTINUOUS

M

ODES

,

IF A PURGE IS NOT PERFORMED AFTER A SYRINGE

CHANGE

,

THE INFUSER AUTOMATICALLY PERFORMS A SMALL

SYSTEM COMPLIANCE STEP TO REMOVE SLACK WHEN

[START]

IS

PRESSED

(

WITH DOORS LOCKED

). A

LTHOUGH FLUID IS NOT

NORMALLY DELIVERED TO THE PATIENT DURING THE

COMPLIANCE STEP

,

IT IS RECOMMENDED THAT THE SET BE

DISCONNECTED FROM THE PATIENT DURING THIS OPERATION

.

8


URGE

> Softkey, the prompt asks if the purge is complete.

A. Select

Y

ES

>

to continue, or select

N

O

>

to purge again until complete.

B. Reconnect the set to the patient.

C. The

C

ONFIRMATION

Screen appears.

D. Review the entered parameters, and if they are correct, select

C

ONFIRM

>

.

9

Close and lock the door to begin infusion. Press

B

UTTON

if the infuser is in the Continuous or

PCA + Continuous Mode.

430-04685-004 5 - 35


Select Mode

Adding a Supplemental Loading

Dose

1

Unlock the door the infuser will pause.

2

Select L

OADING

D

OSE

>.

NOTE: C

HANGE

CCA

>


TM


MORPHINE PF

1 mg/mL

PAUSED

PCA + CONT

LOCK DOOR

TO BEGIN

LOADING DOSE

CHANGE RX

CLEAR SHIFT

CHANGE CCA

3


4

Then press

ENTER

.

MORPHINE PF

1 mg/mL

ENTER

LOADING DOSE

THEN PRESS

ENTER BUTTON

0.1 - 10 mg

2.

5

mg

milligrams

PREVIOUS

5

Press to infuse the loading dose.

NOTE: The loading dose may be

halted at any time by pressing

[START/PAUSE]

.

6


Place key in a secured place.

MORPHINE PF

1 mg/mL

PRESS

START BUTTON

TO INFUSE

2.5 mg

LOADING DOSE

PREVIOUS

5 - 36 430-04685-004


LifeCare PCA

®


Checking History & Settings

1

To Check History or settings, press

BUTTON

.

2

Press to scroll through history. Or select P

RINT

H

ISTORY

> to print

(if connected to printer).

PRESS HISTORY

OR ENTER

SCROLL

THROUGH

HISTORY

The Print History option does not appear when

Hospira MedNet

TM

Software is enabled.

3

Press

B

UTTON a second time for more information.

When MORE is displayed, more information is stored in infuser history.

NOTE: Partial boluses can be the

result of interrupting delivery by pressing

[START/STOP]

(PCA +

Count.), opening the door (PCA

Only), loss of power, reaching the dose limit, emptying the vial, or a malfunction alarm.

PRINT HISTORY

MORPHINE PF

1 mg/mL

PCA+CONT

PCA DOSE

0.5 mg

LOCKOUT

5 min

CONT. RATE

10 mg/hr

4 HOUR LIMIT

NO

MORE...

PREVIOUS

430-04685-004 5 - 37


Select Mode

4

Continue to press or

ENTER

for more information such as:

•

Last one hour information if configured

•

Last 24-Hour information if configured

•

Current settings

•

Total drug delivered toward the dose limit

•

Event Log

TIME: 8:04 PM

DATE: 07/15/05

S/N: 12920191

DELIVERED:

LOADING DOSE

10 min

4 HOUR DOSE

2 mg/hr

TOTAL DEL.

2 mg

MORE....

PREVIOUS

The Event Log shows all events since the last

Clear History. Up to 400 events are shown.

5

Press

EXIT

to return to the M AIN

D

ELIVERY S CREEN .

6

Close and lock the door. Press [

START

/

PAUSE

] if in

Continuous or PCA+Continous mode.

History and Event Log

The infuser stores data on therapy settings, quantity and/or number of doses delivered, and has the capacity of recording up to 20,000 events. The PCA Infuser displays a chronological record of 400 of the most recent events occurring during infusion by pressing the [

H

ISTORY

]

Button

.

These events include: PCA doses requested, the amount delivered, the change of any settings, the opening or closing of the security door, start or stop of continuous infusion, and alarm conditions (

For more information see

Data

Retention on page 4 - 20

).

5 - 38 430-04685-004


LifeCare PCA

®


Pressing the

[HISTORY]

Button displays this data on the LCD.

Pressing

P

RINT

H

ISTORY

>

generates a hard copy printout of the d ata

.

When the infuser is configured with the HOUR-BY-HOUR history format, the number of PCA injections, partial doses, and patient demands occurring in each one-hour period during the last 24 hours may be displayed or printed. Only the one-hour periods with PCA activity are displayed and printed. When the infuser is configured for the LAST 1 & 24 HOUR history format, PCA activity totals in the last hour and in the last 24 hours are displayed and printed.

NOTE: The HOUR-BY-HOUR and the LAST 1 & 24 HOUR

history totals represent a dynamic summation of past delivery of drugs and events. Data is accumulated in 10 minute time slots. At any given time, the last 10 minute time slot may represent anywhere from 0 to 10 minutes of data.

The hour and 24-hour periods are approximate only and may, in fact, represent as small as 50 minutes of data for the LAST HOUR total and 23 hours 50 minutes for the

LAST 24 HOUR total.

NOTE: PCA requested doses (patient demands) as

recorded in the history display and event log may not reflect the total number of demands. (Maximum of 100 patient demands per 10 minute interval.)

NOTE: Events occurring while printing is in progress are

stored in memory, but not included in the current printout.

NOTE: If the lithium battery, the micro-controller unit, or the

electronics assembly have been replaced, the serial number will NOT display on printouts.

NOTE: See the following pages for a sample history

printout (in the PCA+CONTINUOUS Mode).

430-04685-004 5 - 39


Select Mode

5 - 40 430-04685-004


LifeCare PCA

®


430-04685-004 5 - 41


Select Mode

5 - 42 430-04685-004


LifeCare PCA

®


430-04685-004 5 - 43


Select Mode

NOTES

5 - 44 430-04685-004


LifeCare PCA

®


Section 6

Advanced Programming with Hospira MedNet

TM

Software


•

Guided Start-up Using Hospira MedNet

TM

Software

•

Select CCA

•

Updating the Drug Library

•

Soft Limit Override

•

Hard Limit Violation

•

Important Symbols

•

Autoprogramming

Guided Start-up Using

Hospira MedNet

TM

Software

User Defined Drug Libraries are developed by hospital personnel in conjunction with the pharmacy using Hospira MedNet

TM

Software.

User Defined Drug Libraries allow hospitals to customize drugs in the library with preselected upper and lower delivery limits to ensure patient safety.

Hospira/Abbott prefilled bar coded PCA Vials and custom vials

(with pharmacy-generated bar codes) may be used with the

430-04685-004 6 - 1


Advanced Programming with Hospira MedNet

TM

Software

Hospira MedNet

TM

Software. For instructions on how to produce

pharmacy-generated bar codes

see Appendix A on page A- 1

.

1

Press , or load drug vial into cradle to power infuser [

ON

]

.

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.

LIFECARE PCA

SELF TEST

LOCKOUT

CONT. RATE

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 C

ONTINUE


LIFECARE PCA

SELF TEST

COMPLETE

RAM. . . . . . .OK

FLASH. . . . .OK

CPU ID. . . . .OK

CPU. . . . . . .OK

TIMER. . . . .OK

SYSTEM

SETTINGS

CONTINUE

6 - 2 430-04685-004


LifeCare PCA

®


3

The N

EW

P

ATIENT

S


Select YES> or NO>.

4


History and Rx settings are kept. If YES> is selected, the History and Rx settings are cleared.

5

Select C

ONFIRM


NEW

PATIENT?

YES

NO

MORPHINE PF

1 mg/mL

CONFIRM

1 mg/mL

MORPHINE PF

TO RX

REMOVE VIAL

IF NOT CORRECT

CONFIRM

6

Select the softkey next to the desired CCA. (example

PACU)

If only one CCA has been created, that CCA becomes the default CCA, and this screen is skipped.

If the desired CCA is not displayed, select N

EXT

> to view more options.

SELECT CCA

PACU

ONCOLOGY

ER

PEDIATRICS

NEXT

430-04685-004 6 - 3



TM

Software

7

Select either Y

ES

> or N

O

> to purge the system

See Purging the System on page 4- 28

for more

information.

MORPHINE PF

1 mg/mL

PURGE ?

PURGING

RECOMMENDED

YES

NO

8

If Y

ES


URGE

> Softkey.

MORPHINE PF

1 mg/mL

DISCONNECT

SET FROM

PATIENT

PRESS AND HOLD

PURGE KEY


PURGE

PREVIOUS




URGE

>


9

Select Y

ES


O


10


MORPHINE PF

1 mg/mL

PURGE

COMPLETE ?

YES

NO

6 - 4 430-04685-004


LifeCare PCA

®


11


ES

>.

See Loading Dose on page 4-

30


MORPHINE PF

1 mg/mL

PACU

SET LOADING

DOSE ?

YES

NO

12


Then press

ENTER

.

MORPHINE PF

1 mg/mL

PACU

ENTER

LOADING DOSE

THEN PRESS

ENTER BUTTON

0.1 - 10 mg

2 mg

milligrams

PREVIOUS

13

The D ELIVER

L

OADING

D

OSE

N

OW

S

CREEN allows the option of delivering the loading dose now or after the programming is complete.

MORPHINE PF

1 mg/mL

PACU

DELIVER

LOADING DOSE

NOW ?

YES

DELIVER LATER

430-04685-004 6 - 5



TM

Software

14

If Y

ES

> was selected, press


Dose.

MORPHINE PF

1 mg/mL

PACU

PRESS

START BUTTON

TO INFUSE

2 mg

LOADING DOSE

NOTE: The LOADING

DOSE Mode is the only mode that the infuser will deliver with the door unlocked.

PREVIOUS

WARNING


15

If the D ELIVER

L

ATER option is desired, the screen advances to the S ELECT

D

ELIVERY

M

ODE S CREEN

.

See

Modes of Delivery on page 5- 2


16



MORPHINE PF

1 mg/mL

PACU

PRESS

PAUSE BUTTON

TO STOP

2 mg

milligrams

INFUSING

LOADING DOSE

6 - 6 430-04685-004


LifeCare PCA

®


17

The S

ELECT

M

ODE

S

CREEN

appears.

See Modes of

Delivery on page 5- 2

for more

information.

MORPHINE PF

1 mg/mL

PACU

SELECT

DELIVERY MODE

PCA ONLY

PCA + CONT.

CONTINUOUS

PROTOCOLS

PREVIOUS

Select CCA

The

S

ELECT

CCA S

CREEN displays if a user-defined drug library is installed with more than one CCA. Select the option appropriate for the patient.

SELECT CCA

If there is only one CCA, this screen will not display.

NOTE: The prior CCA flashes.

PACU

MEDSURG

PEDIATRICS

ER

NEXT

NOTE: If the wrong CCA is

unintentionally chosen, turn the

Infuser off, then on, and select the correct CCA.

NOTE: When using the Protocol feature be aware that the

Protocol numbers are unique to each Clinical Care Area.

For example, the protocol for Morphine PF 1mg/mL concentration for PCA + Cont. delivery with a PCA dose of

1mg and continuous rate of 0.5mg may be assigned protocol No. 1 in the Surgical CCA and No. 6 in the Medical

CCA.

430-04685-004 6 - 7



TM

Software

Updating the Drug Library

When the user presses OFF to shut the

Infuser down, if a new user-defined drug library is available for installation the infuser will display the N

EW

D

RUG

L

IBRARY

A

VAILABLE

S

CREEN

.

1

Select N

O

>

to skip the installation and continue using the current library.

The infuser will power off.

Or, Select Y

ES

>

to begin the installing the new drug library.

NEW DRUG

LIBRARY

AVAILABLE

INSTALL NOW?

YES

NO

The Drug Library

Installation Screen will flash the words In Progress on the screen.

CAUTION: W

HEN A NEW DRUG

LIBRARY IS INSTALLING

,

ENSURE

THE

AC

POWER CORD IS PLUGGED

I N U N T I L T H E P R O C E S S I S

COMPLETE

.

CAUTION: T

HE INFUSER CANNOT

COMMUNICATE VIA THE NETWORK IF

THE

L

OW

B

ATTERY

W

ARNING

ALARM HAS SOUNDED

.

DRUG LIBRARY

INSTALL

IN PROGRESS

6 - 8 430-04685-004


LifeCare PCA

®


The infuser displays the

D

RUG

L

IBRARY

I

NSTALL

S

UCCESSFUL

S

CREEN after the libray has been installed successfully.

The infuser will power off automatically.

DRUG LIBRARY

INSTALL

IN PROGRESS

SHUTTING

DOWN

If the Drug Library is not installed within 15 minutes or if it fails to install, the

Infuser displays the U NABLE

TO

I

NSTALL

D

RUG

L

IBRARY SCREEN

, and the infuser will power off automatically.

The previous library will be active when the infuser is re-started.

UNABLE TO

INSTALL

DRUG LIBRARY

SHUTTING

DOWN

430-04685-004 6 - 9



TM

Software

Soft Limit Override

When entering parameters, if a soft limit is exceeded, a soft limit override screen is displayed.

1

Review display for the exceeded parameter.

2

Select CONFIRM> to override the programmed soft limit, or select change to correct the parameter.

MORPHINE PF

1 mg/mL

PCA DOSE

6 mg

IS OVER

5 mg

LIMIT

CONFIRM

CHANGE

All soft limit overrides made during programming are indicated on the I NFUSION S CREEN with an appropriate upper or lower limit arrow.

See

Important Symbols on page 6- 11

for details.

Hard Limit Violation

When entering parameters, if a hard limit is exceeded, a HARD

L

IMIT

V

IOLATION

S

CREEN is displayed. Hard limits cannot be overridden. The only way to continue is to select CHANGE> to change the parameter.

MORPHINE PF

1 mg/mL

PACU

PCA DOSE

NOT

MAX ALLOWED =

8 mg

CHANGE

6 - 10 430-04685-004


LifeCare PCA

®


Important Symbols

N

O

R

ULE

S

ETS

The Cautionary Symbol is displayed on the infusion screen to advise the user to program with caution because the established rule set does not have any soft or hard safety limits.

MORPHINE PF

1 mg/mL

PACU

PCA+CONT.

PCA AVAILABLE

NO 4 HR LIMIT

40 mg

0 mg

milligrams

TOTAL DELIVERED

CONT. RATE =

1 mg/hr

S

OFT

L

IMIT

O

VERRIDE

The upper and lower

Soft Limit Override symbols are displayed on the infusion screen to inform the user that one or more soft limits have been overridden.

MORPHINE

5 mg/mL

PACU

PCA AVAILABLE

NO 4 HR LIMIT

40 mg

0 mg

milligrams

TOTAL DELIVERED

CONT. RATE =

1 mg/hr

430-04685-004 6 - 11



TM

Software

W

IRELESS

The Wireless symbol is displayed to inform the user that the PCA Infuser has an active connection to the wireless network.

MORPHINE PF

1 mg/mL

PACU

WAITING FOR

AUTO PROGRAM

The wireless icon is only displayed on the Waiting for

Autoprogram S CREEN .

MANUAL

PROGRAM

This symbol indicates that the PCA Infuser is connected to the wireless network. It does not indicate if data is currently being sent or received.

The Waiting for Autoprogram Message will display on the screen.

Autoprogramming

Autoprogramming is a new feature for Hospira PCA infusion pumps. It can only be used if the feature has been installed in conjunction with your Hospital Information System (HIS) and Bar code Point-of-Care (BPOC) Unit. It works by scanning bar code labels for the patient and infuser. This information is then transferred to the infuser utilizing either its wireless antenna or shielded RJ-45 Ethernet connector. The feature reduces the number of steps needed to program an infusion.

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NOTE: If the physician’s order for an autoprogram therapy

exceeds the capabilities of the pump, or is above a hospital defined hard drug limit, the infusion parameters for autoprogramming will be rejected, and the order needs to be rechecked. The pump allows the clinician to change soft limits by changing the value when the

S

OFT

L

IMIT

V

IOLATION

S

CREEN appears.

1

Power On the pump by pressing ON/OFF.

2

After the CCA has been selected, the pump is ready for autoprogramming.

3

Scan the patient wristband to pull up the patient’s task list on the BPOC system.

4

Choose the desired IV task from the list on the

BPOC unit.

NOTE: If the scanned medication does not exist in the

Hospira MedNet

TM

Software, Rx Rules medication library, an invalid barcode alarm will be activated.

5

Scan the bar code on the infuser.

6

Verify ALL parameters. If changes are desired, select C

HG

S

ETTINGS

>. Otherwise, if the Rx settings are correct, select C

ONFIRM

>.

7

Verify that the Loading Dose setting is correct. To change the Loading Dose value, select C

HG

S

ETTINGS

>. Otherwise, if the Loading Dose value is correct, select C

ONFIRM

>.

8

To deliver Loading Dose and begin the program, select Y

ES

> on the L

OADING

D

OSE

N

OT

G

IVEN

S

CREEN . To

430-04685-004 6 - 13



TM

Software

cancel the Loading Dose and just start the program, select C

ANCEL

>.

9

Close and lock the door. Press [START] to begin program.

WARNING

The infuser cannot communicate via the network if the

Low Battery Warning alarm has sounded.

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Section 7

Troubleshooting

The PCA Infuser is programmed to display status and alarm messages and to sound an audible tone for most alarm conditions. These messages and alarm conditions are described in the following sections:

•

Status Messages

•

Infuser Alarm System

•

Silencing an Alarm

•

Alarms and Messages

•

Infuser Stalling

Status Messages

Displayed status messages are defined in the following table:

M

ESSAGE

DOOR

LOCKED

PCA

LOCKOUT

D

EFINITION

Message indicates the security door is closed and locked. It displays for 30 seconds and disappears.

Message appears only in the PCA ONLY or

PCA+CONTINUOUS Mode. The message remains until the lockout interval elapses and is displayed after a successful patientoriginated dose delivery.

430-04685-004 7 - 1


Troubleshooting

M

ESSAGE

4 (1) HR LIMIT

REACHED

D

EFINITION

Message displayed if 4 (or 1) hour dose limit has been selected and reached with security door locked without Hospira MedNet

TM

Software enabled.

Message displayed if 1, 4, 6, 8, 12, hour dose limit has been selected and reached with security door locked with Hospira MedNet

TM

Software enabled.

PCA

AVAILABLE

PCA ONLY

Message indicates patient can initiate a dose in PCA ONLY or PCA+CONTINUOUS Mode.

Message displayed when infuser is in PCA

ONLY Mode.

CONTINUOUS Message displayed when infuser is in

CONTINUOUS Mode.

PCA+CONT.

Message displayed when infuser is in

PCA+CONTINUOUS Mode.

INFUSER

PAUSED

Message displayed when infuser is stopped, but door is locked. Or, if door is opened.

Infuser Alarm System

During an Alarm condition, the system performs the following actions:

•

The current display message is saved to the event log.

•

A flashing alarm message appears on the display (

See

Alarms and Messages on page 7-4

).

•

A repetitive, audible tone sounds with all

MALFUNCTION

alarms except

PENDANT FAULT

, which is a single tone with continuous visual flashing. The audible tone volume is adjustable to low, medium, or high by accessing system settings during self-test

7 - 2 430-04685-004


LifeCare PCA

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at Start-up. It can also be accessed by pressing [S ILENCE

/V

OLUME

] when infuser is in RUN Mode. Select desired volume of alarm, then press

S

AVE AND

E

XIT

>

Softkey.

NOTE: The infuser stops delivery when any of following

alarms occur: CHECK

INJECTOR

,

CHECK VIAL

,

CHECK SYRINGE

,

EMPTY SYRINGE

,

OCCLUSION

,

DEAD BATTERY or MALFUNCTION.

Silencing an Alarm

To silence an alarm, press the

[SILENCE]

key, then follow the displayed messages. All alarms except the MALFUNCTION

,

CHECK

VIAL

,

CHECK INJECTOR

, and

CHECK SYRINGE, can be muted.

Clear the cause of the alarm, if possible, and press the

[START/PAUSE] key to resume operation for Continuous or PCA + Continuous

Modes. The original display message will be restored.

NOTE: If the MALFUNCTION alarm sounds, press the

[ON/OFF] key to turn the infuser off. Turn the infuser on. If the malfunction repeats, remove infuser from service. Refer infuser to the hospital’s technical support or contact Hospira

Technical Support Operations.

NOTE: In the event two or more alarms conditions

simultaneously occur, the alarm with shortest muting period will take priority and be displayed first.

If the alarm is muted and a second alarm condition occurs during the muting period, an audible alarm signaling the new condition will immediately occur.

NOTE: Alarm cadence can be configured for different

sounds to differentiate between infusers in the Biomed

Mode or by Hospira MedNet

TM

software.

430-04685-004 7 - 3


Alarms and Messages


M

ESSAGE

Bar code

Not Read

Check

Settings

Occlusion

Check

Syringe

Check Vial

Check

Injector

M

UTING

T

IMES

P

OSSIBLE

C

AUSE

1 minute Vial not loaded properly

C

ORRECTIVE

A

CTION

• Position vial correctly

• Clean bar code reader window

• Open the door.

Complete settings.

1 minute Door locked without appropriate therapy settings

1 minute

None

None

None

Occlusion detected

Syringe (Vial and Injector) not properly loaded

Injector detected and vial not properly loaded

Vial is detected and injector not properly loaded

• Open security door if closed. Remove back pressure by squeezing and releasing the cradle release handles.

Identify and correct the cause of the occlusion. Alarm will self correct.

• Close Slide Clamp

Immediately

• Properly insert syringe into holder assembly

• Properly insert vial into holder assembly or removal of injector

• Properly insert injector into holder assembly or removal of vial

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M

ESSAGE

Decimal

Point Not

Allowed!

Empty

Syringe

Door Open

Infuser

Paused

Low Battery 10 minutes

Dead

Battery

M

UTING

T

IMES

N/A

P

OSSIBLE

C

AUSE

Attempting to select the decimal point button when programming in micrograms

(mcg).

15 minutes

Empty vial detected

N/A

5 minutes

None

C

ORRECTIVE

A

CTION

• Press [Clear] and enter valid whole number.

Door left open or unlocked for more than 2 minutes

Infusion paused for more than 2 minutes

Battery life has less than thirty minutes remaining and is currently operating on battery power

Battery life has expired

• Press [Silence] to silence the alarm.

Unlock and open the security door and squeeze and release handles in order to replace vial. May turn infuser OFF while preparing new vial.

• Close door and Lock

• Press [START/PAUSE] key again, or unlock door

• Apply AC power. failure to connect to

AC power may cause battery damage.

• Apply AC power

430-04685-004 7 - 5



M

ESSAGE

Pendant

Fault - O

Pendant

Fault - S

Check PCA

Infuser Set to Relieve

Pressure

M

UTING

T

IMES

Visible

Flashing

Occurs

P

OSSIBLE

C

AUSE

Pendant not secured into port

Faulty

Connection or pendant

Partial Pendant press

Using PCA Plus

II Patient

Pendant

(white handle)

Visible

Flashing

Occurs

None

Electrical Short in pendant

Pressure in line possible occlussion and vial stiction

C

ORRECTIVE

A

CTION

• Secure pendant into port

• Replace pendant or infuser

• Release pendant button

• Confirm use of PCA

Patient Pendant

(blue handle)

• Replace pendant

• Verify proper placement of injector

• Removal of vial and/ or manual purge of vial and re-insert vial.

Infuser Stalling

If Hospira MedNet

TM

Software is enabled and the infuser stalls or suspends communication with an external devices, such as the

MMU, for an inordinate amount of time, discontinue use and send the infuser to the Biomed Department for restarting.

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LifeCare PCA

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Section 8

Maintenance


•

Infuser Storage

•

Cleaning and Sanitizing

•

Battery Maintenance

•

Service

Infuser Storage

To prolong the life of the PCA Infuser, observe the following storage precautions:

•

Store away from excessive heat, cold, and, humidity

•

Store the PCA Infuser connected to AC (mains) power

•

Switch off using the [ON/OFF] key

430-04685-004 8 - 1


Maintenance

Cleaning and Sanitizing

Establish a routine infuser cleaning schedule to keep it contamination free.

CAUTION: A

LWAYS CHECK THAT THE BAR CODE

READER WINDOW IS CLEAN

. B

LOOD

,

FINGERPRINTS

,

CONDENSATION

,

AND OTHER ELEMENTS MAY OBSTRUCT THE

VIEW OF THE BAR CODE READER

. E

LEMENTS ON THE

WINDOW

(

OTHER THAN SCRATCHES

)

CAN BE CLEANED BY

USING ONE OF THE RECOMMENDED CLEANING SOLUTIONS IN

THIS SECTION

.

CAUTION: T

O AVOID MECHANICAL OR ELECTRONIC

DAMAGE

,

DO NOT IMMERSE THE

PCA I

NFUSER IN ANY

FLUIDS OR CLEANING SOLUTIONS

.

C A U T I O N : S

O M E C L E A N I N G A N D S A N I T I Z I N G

COMPOUNDS MAY SLOWLY DEGRADE COMPONENTS MADE

FROM SOME PLASTIC MATERIALS

. D

O NOT USE COMPOUNDS

CONTAINING COMBINATIONS OF ISOPROPYL ALCOHOL AND

DIMETHYL BENZYL AMMONIUM CHLORIDE

.

CAUTION: D

O NOT STERILIZE BY HEAT

,

STEAM

,

E T H Y L E N E O X I D E

(ETO),

O R R A D I A T I O N

. A

P P L Y

DISINFECTANTS TO THE OUTSIDE SURFACE OF THE INFUSER

ONLY

. U

SING ABRASIVE CLEANERS OR CLEANING

SOLUTIONS NOT RECOMMENDED BY

H

OSPIRA MAY RESULT

IN PRODUCT DAMAGE

.

CAUTION: T

O AVOID INFUSER DAMAGE

,

CLEANING

SOLUTIONS SHOULD ONLY BE USED AS DIRECTED

. T

HE

DISINFECTING PROPERTIES OF CLEANING SOLUTIONS VARY

;

CONSULT THE MANUFACTURER FOR SPECIFIC INFORMATION

.

CAUTION: N

EVER USE SHARP OBJECTS SUCH AS

FINGERNAILS

,

PAPER CLIPS

,

OR NEEDLES TO CLEAN ANY

PART OF THE

PCA I

NFUSER

.

Establish a routine weekly schedule for cleaning the infuser case, front panel, and patient pendant. To clean, proceed as follows:

Turn the PCA Infuser off with the

[ON/OFF] switch, then disconnect from AC power.

8- 2 430-04685-004


LifeCare PCA

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The exposed surfaces of the PCA Infuser may be cleaned with a lint-free cloth dampened by one of the recommended cleaning solutions in the following list, or mild nonabrasive soapy water.

Cleaning

Solution

Manu-Klenz

Formula C

Coverage

Sporicidin

Dispatch

Precise

®

®

®

TM

TM

®

HBV

Household bleach

Manufacturer

Calgon Vestal

Laboratories

Diversey

Corporation

Various

Preparation

Per manufacturer's recommendation


Steris Corporation,

A division of

Calgon Vestal

Laboratories


Sporicidin

International

Caltech Industries



Caltech Industries Per manufacturer's recommendation

Per hospital procedures; do not exceed one part bleach in ten parts water

On a routine basis, clean all of the elements behind the syringe door using cotton-tipped swabs saturated with cleaning solution.

The door may be unlatched from the door handle to facilitate cleaning.

430-04685-004 8 - 3


Maintenance

WARNING

Failure to clean infuser’s outside surfaces after patient use may spread infection. Please follow hospital infection protocols by cleaning the infuser for infection control.

No other routine maintenance is required; the infuser has no other user serviceable parts. All service must be carried out by

Hospira qualified technical personnel. A technical service manual may be ordered from Hospira Technical Service.

Battery Maintenance

WARNING

Disconnect the AC power cord from AC supply before removing the battery door.

CAUTION: D

O NOT OPERATE THE

PCA I

NFUSER ON

PATIENTS WITH THE BATTERY REMOVED

. U

SE OF A

PROPERLY MAINTAINED AND CHARGED BATTERY HELPS

ENSURE PROPER OPERATION

.

CAUTION: I

F THE LOW

-

BATTERY ALARM SOUNDS

,

CONNECT THE

PCA I

NFUSER TO

AC (

MAINS

)

POWER

IMMEDIATELY

.

The PCA Infuser is battery powered for emergency backup and temporary portable operation. A fully charged, conditioned battery provides approximately 2.5 hours of continuous operation from start to low battery alarm, and will deliver at least 30 mL of solution.

The battery charges whenever the PCA Infuser is connected to

AC (mains) power. If the PCA Infuser is switched off, a recharge takes approximately 16 hours. The recharge takes longer if the

PCA Infuser is turned on.

8- 4 430-04685-004


LifeCare PCA

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As a general rule, the more often the battery is partially discharged and recharged, the sooner it will need to be replaced.

Consult a qualified Biomedical technician for battery replacement if necessary.

To maintain maximum battery charge and to prolong battery life, connect the PCA Infuser to AC (mains) power whenever possible.

Service

All servicing or adjustments to the PCA Infuser should be referred to qualified technical personnel. A technical service manual may be ordered from the local Hospira sales office.

430-04685-004 8 - 5


Maintenance

NOTES

8- 6 430-04685-004


LifeCare PCA

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Section 9

Specifications

Administration Sets:

Atmospheric

Pressure:

Battery:

Battery Life:

Casing:

Use only compatible Hospira/Abbott PCA sets with Integral Anti-Siphon Valve

0 - 10,000 feet (0 - 3,000m) or equivalent pressure

One sealed, lead-acid, rechargeable 8 V battery, internal to device. Accessible for ease of field replacement with colorcoded leads and polarized connector.

A conditioned battery at full charge should operate for approximately 2.5 hours of continuous operation before a LOW

BATTERY alarm. The PCA Infuser provides a

LOW BATTERY warning at least 30 minutes prior to shutdown.

High-impact plastic

430-04685-004 9 - 1


Delivery Rate:

Specifications

See

Section 10 Prescription Delivery

Limits on page 10- 1

.

Mode

PCA Mode:

Delivery Rate

Approximately 1 mL in 35 seconds

CONTINUOUS

Mode:

Variable from 0.1 x concentration (mg/hr or mcg/hr) to 20 x concentration (mg/hr or mcg/hr)

PCA+CONT.

Mode:

Variable from 0.1 x concentration (mg/hr or mcg/hr) to 20 x concentration (mg/hr or mcg/hr) + PCA dose (mg)

Dimensions:

Drug Concentration

Settings:

Approximately 8”W 13”H 6”D, excluding pole clamp protrusion and power cord storage.

See

Section 10 Prescription Delivery

Limits on page 10- 1

.

9 - 2 430-04685-004


LifeCare PCA

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Electrical Safety:

Meets IEC/EN/UL 60601-1 standards for:

Spec

Class 1:

Description

AC (mains) supply equipment using protective earth

Type CF:

Equipment providing a higher degree of electyric shock protection

Drip Proof IPX1:

The case is disinfectable and protected against dripping water.

Note: Not to be used in the presence of flammable anesthesics

Electromagnetic

Interference

(EMI) and Radio

Frequency

Interference

(RFI):

The LifeCare PCA® is designed to perform in the typical hospital environment

A qualified service technician should verify performance in any environment where EMI or

RFI levels are excessive

Electrical Leakage:

Fuses:

Lockout Interval

Range:

Maximum Infusion

Pressure:

Risk current limits meets standard

IEC/EN/UL 60601-1

1.0 A, 250 V, Slow Blowing

5 to 120 minutes in

1- minute increments

45 psig

430-04685-004 9 - 3


Maximum

Overinfusion:

Occlusion Alarm

Pressure:

Occlusion Bolus

Volume:

Operating

Temperature:

Power Cord:

Power

Requirements:

Printer Port:

Recharge:

Self-Discharge:

Storage

Temperature:

Weight:


The maximum overinfusion under single fault conditions is 25%

15 psig ± 5psig

2 mL for fully primed set (max)

5° to 40° C, 10% - 90% relative humidity

Hospital-grade AC cord,

10 ft. long, with transparent plug and retainer plate.

105-130 Volts, 57 - 63 Hz, <50 W

Maximum nondestruct voltage is 5 V

After discharge to the

LOW BATTERY operative limit, the battery will recharge to at least 80% of its charge capacity in 16 hours, provided it is plugged into rated AC power. The infuser will operate on AC power in the event the battery is open or shorted.

50% of charge retained for at least one month when unit is neither plugged-in nor operating.

-20° to 60° C, 10% - 90% relative humidity

Approximately 10 lbs. with battery

9 - 4 430-04685-004


LifeCare PCA

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Stored Occlusion Volume

DELIVERY

RATE

0.1 mL/hr

5 mL/hr

20 mL/hr

PRESSURE

LIMIT

(Average)

b

12.8 psig

12.6 psig

12.7 psig

STORED

VOLUME

(Average)

0.92 mL

0.94 mL

0.96 mL

Time from Occlusion to Alarm

DELIVERY

RATE

0.1 mL/hr

5 mL/hr

20 mL/hr

PRESSURE

LIMIT

(Average)

b

12.8 psig

12.6 psig

12.7 psig

TIME TO

OCCLUDE

(Average)

12 hours

11 minutes

3 minutes

Delivery Rate Accuracy

Delivery accuracy is ± 5% at continuous delivery rates greater than 1 mL/hr. For accuracy data at other flow rates, see the following typical trumpet curves. The under-delivery that may occur at rates less than 0.5 mL/hr or bolus volumes less than 0.5 mL may be substantially greater than 5%, and is due primarily to the variability of friction between the syringe plunger and barrel.

This under delivery may include periods of no delivery.

If multiple, partial PCA doses are delivered, the accumulated total reflected in the history totals may be more than the sum of the

PCA doses logged in the event log. This is due to the fact that only a portion of the next 0.1 mg (or 1 mcg) may have been delivered at the time any of the PCA doses were interrupted. As

430-04685-004 9 - 5



these portions accumulate, their combined total may account for

0.1 mg (or 1 mcg).

T

RUMPET

C

URVES

The typical trumpet curve graphs following the example show representative maximum and minimum percent flow rate deviation from the programmed rate over time. This information was developed in accordance with IEC 60601-2-24: 1998, Sub-

Clause 50.102. Refer to this standard for detailed information.

Refer to the

Example on page 9- 6

to read a Trumpet Curve

Graph. The graphs following the Example, plot flow rates at 30 second intervals for the first 2 hours and for the 96th hour of delivery. The graph plots mean delivery rate error (Average of 3 infusers) for the 2nd hour and the 96th hour as a straight line. The graph presents maximum and minimum average delivery rate error for this interval plotted by averaging delivery errors over intervals of 2, 5, 11, 19 and 31 minutes (“Trumpet Curve”).

E

XAMPLE

From the Trumpet Curve Graph sample that follows, find the 5 minute interval (A) at the horizontal axis and read the corresponding points (B) and (C) on the vertical axis. The values are approximately +2.8% and -0.5%.

This means that at the rate of 25 mL/hr the average maximum flow rate fluctuation for any 5 minute time interval during the 2nd hour of operation was within the limits of +2.8% and -0.5% from the nominal rate. The average delivery rate error over the entire

2nd hour was +1.6% (D).

9 - 6 430-04685-004


LifeCare PCA

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For other time intervals look at other points at the horizontal axis and determine corresponding limits as above.

25 ML/HR, 0 mm Hg DELIVERY HEAD, START UP

A

15.0%

10.0%

5.0%

0.0%

-5.0%

-10.0%

-15.0%

0

+

B

Max Positive Error over 5

Minute Interval = +2.8%

+

+ +

D

Average Delivery

Rate Error = +1.6%

C

Max Negative Error over 5

Minute Interval = -0.5%

5 25 10 15 20

Observation Interval (minutes)

Max

+

Min Mean

+

30

A trained professional can use the resulting graphs to select a infuser with the appropriate startup and flow characteristics to suit the clinical application.

NOTE: As an example of how the trumpet curves may be

used, consider the maximum and minimum deviations at the 5 minute average interval. The upper curve provides the maximum expected delivery rate error over a 5 minute interval, the lower curve provides the minimum expected delivery rate error over a 5 minute interval. An example would be Morphine administered at 5 mL/mg. At 5 minutes, the average drug delivery error would be within the range of

+2.8% and -0.5% of the expected nominal rate.

430-04685-004 9 - 7



Trumpet Curves

PCA 3, 0.1 ml/hr, 0 mmHg Delivery Head, 0.9% Saline

Maxima/Minima of 3 Pumps

100.0%

80.0%

60.0%

40.0%

20.0%

0.0%

-20.0%

-40.0%

-60.0%

-80.0%

-100.0%

0 5 10 15 20

Observation Interval (min)

Max Min Mean

25

PCA 3, 1 ml/hr, 0 mmHg Delivery Head, 0.9% Saline


15.0%

10.0%

5.0%

0.0%

-5.0%

-10.0%

-15.0%

0 5 10 15 20


Max Min Mean

PCA 3, 5 ml/hr, 0 mmHg Delivery Head 0.9% Saline


25

15.0%

10.0%

5.0%

0.0%

-5.0%

-10.0%

-15.0%

0 5 10 15 20


Max Min Mean

25

30

30

30

9 - 8 430-04685-004


LifeCare PCA

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15.0%

10.0%

5.0%

0.0%

-5.0%

-10.0%

-15.0%

0

20.0%

15.0%

10.0%

5.0%

0.0%

-5.0%

-10.0%

-15.0%

0

15.0%

10.0%

5.0%

0.0%

-5.0%

-10.0%

-15.0%

-20.0%

-25.0%

0

PCA 3, 5 ml/hr, -100 mmHg Delivery Head, 0.9% Saline


5 10 15 20


Max Min Mean

25

PCA 3, 5 ml/hr, +100 mmHg Delivery Head, 0.9% Saline


5 10 15 20


Max Min Mean

PCA 3, 20 ml/hr, 0 mmHg Delivery Head, 0.9% Saline


25

5 25 10 15 20


Max Min Mean

30

30

30

430-04685-004 9 - 9



NOTES

9 - 10 430-04685-004


LifeCare PCA

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Section 10

Prescription Delivery Limits

Prescription delivery limits for the loading dose, PCA dose, dose limit, and continuous delivery rate parameters vary with the drug and concentration selected. See

Table 10.1 on page 10-2

and

Table 10.2 on page 10-3 for listings of the lower and upper limits.

NOTE: Drug and concentration selections are rounded up to

the nearest tenth of a digit for mg/mL values or to the nearest digit for mcg/mL values. Minimum delivery rate is 0.1 mL/hr for concentrations between 0.1 and 1 mg/mL.

430-04685-004 10 - 1


Prescription Delivery Limits

10 - 2 430-04685-004


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430-04685-004 10 - 3


Prescription Delivery Limits

NOTES

10 - 4 430-04685-004


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Appendix A

Generating Bar Code Labels

(Hospira MedNet

TM

Software Enabled)

Hospira recommends that the hospital or pharmacy department develop clear policies and procedures for the following:

• Generating Bar Code Labels

• Applying Labels to Empty Sterile Vials

• Filling Labeled Empty Sterile Vials

• Validating Correctly Filled and Labeled Vials

Incorrect labels or filled vials may lead to significant and potentially fatal adverse events.

The following are general specifications for producing labels containing pharmacy-generated bar codes for custom drugs.

These labels are adhered on the Hospira/Abbott Sterile Empty

Vials, and should cover the entire existing Sterile Empty Vial bar code. The proper placement of the pharmacy-generated bar code

label on the Sterile Empty Vial is shown in the

Label Diagram on page A-4

. Correct placement of the pharmacy-generated bar

code on the Sterile Empty Vial helps ensure proper reading of the bar codes by the LifeCare PCA

®

Infuser.

430-04685-004 A - 1


E

QUIPMENT

:

1.

Bar code thermal printer - 300 DPI or higher

2.

Bar code label software capable of producing labels

• ANSI X3.182-1990

• EAN/UCC Code 128, Code Set C

(numeric characters only)

• ANSI Grade C or better

• 10 mil (0.010 inches) pitch minimum

• Bar code height is 1 inch

• 18 Characters max

3.

Opaque polyester labels, (non-paper labels) which are water and smudge resistant, are recommended.

A - 2 430-04685-004


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E

XAMPLE OF

L

ABEL

L

AYOUT

& S

AMPLE

Example of a pharmacy-generated bar code label on a PCA vial.

The plunger is shown for reference. The human readable label is on the right side of the vial and is not shown on this illustration.

430-04685-004 A - 3


L

ABEL

D

IAGRAM

The label diagram below depicts the area where the bar code image must be placed within the dimensions shown. The copy area (length and width must be as specified +/- 1/32”. The center bar code includes 1/4” quiet zone on each side of the bar code.

The bar code and comodity number must be black on a white background.

A - 4 430-04685-004


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The dimensions shown on the previous label diagram represent

Hospira's recommendation for placement of the bar code and drug name/concentration on a 3"x2" label.

The guidelines ensure the device's integral bar code reader will align correctly with the bar code on the PCA vial. Your institution may choose to use a different format for placement of the drug name and concentration based on your specific hospital guidelines or size of the label. However, it is recommended that the system be validated before use.

430-04685-004 A - 5


NOTES

A - 6 430-04685-004


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Appendix B

Network Printer Setup

This section provides information about the printing function.

E

QUIPMENT NEEDED

• Infuser

• Computer meeting the printer setup requirements

• Network crossover cable

P

REPARATION

• Connect the crossover cable between the printer network port and the computer.

• Plug infuser & printer into AC power

• Turn on the infuser and printer

P

ROCEDURE

1.

Identify the printer IP settings - refer to printer operating instructions.

2.

Using the printer operating instructions, configure the printer to match the infuser’s printer network settings: the IP address is 192.168.0.222 and subnet mask 255.255.0.0

3.

Test the installation

Disconnect the crossover cable from the PC and connect it to the infuser. Power up the infuser and print the history log.

430-04685-004 B - 1


Network Printer Setup

P

RINTING

E

VENT

H

ISTORY

L

OG

The history event log can be printed by connecting the infuser to a network ready printer. Use the previous instructions to configure the printer.

WARNING

Disconnect the infuser from the patient before connecting the infuser to a printer or computer.

To print from the PCA Infuser, complete the following steps:

1.

Load printer with paper.

2.

Connect a network crossover cable between the printer and the infuser.

3.

Plug infuser & printer into AC power.

4.

Turn-on infuser and confirm drug and concentration.

5.

Press [

History]

touch switch to view the history on the display.

6.

Press Print H

ISTORY

> Softkey to print history log.

NOTE: After the infuser is turned on to initiate printing,

please allow 2-3 minutes for the infuser to complete start-up before attempting to print the event log. If the entire log is not successfully printed (e.g., the header is missing), reprint the log by pressing the Print H

ISTORY

> Softkey .

B - 2 430-04685-004


LifeCare PCA

®


Downloading Logs to a PC

E

QUIPMENT NEEDED

• Infuser

• PC with Hyper Terminal program

• Network crossover cable

P

REPARATION

Connect the crossover cable between the computer and the infuser. Turn on the infuser and the PC.

P

ROCEDURE

1.

Create a Hyper Terminal connection.

430-04685-004 B - 3



2.

Create a PCA Events connection setting:

3.

Establish the connection settings.

• Host address is the IP address of the infuser that connected to the PC.

• Port number is 8889 where the infuser will send the events to the PC.

• Connect using TCP/IP protocol.

B - 4 430-04685-004


LifeCare PCA

®


4.

The Hyper Terminal program is ready to receive events sent from the infuser.

5.

Printing to a PC.

• To print from the PCA Infuser, complete the following steps:

• Press [History] touch switch to view the history on the display.

• Press Print

H

ISTORY

>

Softkey to print history log.

430-04685-004 B - 5



NOTES

B - 6 430-04685-004


LifeCare PCA

®


Appendix C Warranty

Subject to the terms and conditions herein, Hospira, Inc., herein referred to as Hospira, warrants that (a) the product shall conform to Hospira's standard specifications and be free from defects in material and workmanship under normal use and service for a period of one year after purchase, and (b) the replaceable battery shall be free from defects in material and workmanship under normal use and service for a period of 90 days after purchase.

Hospira makes no other warranties, express or implied, as to merchantability, fitness for a particular purpose, or any other matter.

Purchaser's exclusive remedy shall be, at Hospira's option, the repair or replacement of the product. In no event shall Hospira's liability arising out of any cause whatsoever (whether such cause be based in contract, negligence, strict liability, other tort, or otherwise) exceed the price of such product, and in no event shall

Hospira be liable for incidental, consequential, or special damages or losses or for lost business, revenues, or profits.

Warranty product returned to Hospira must be properly packaged and sent freight prepaid.

The foregoing warranty shall be void in the event the product has been misused, damaged, altered, or used other than in accordance with product manuals so as, in Hospira's judgment, to affect its stability or reliability, or in the event the serial number or lot number has been altered, effaced, or removed.

The foregoing warranty shall also be void in the event any person, including the Purchaser, performs or attempts to perform any major repair or other service on the product without having been trained by an authorized representative of Hospira and using Hospira documentation and approved spare parts. For purposes of the preceding sentence, “major repair or other service” means any repair or service other than the replacement

430-04685-004 C- 1


Warranty

of accessory items such as batteries and detachable mains power cords.

In providing any parts for repair or service of the product, Hospira shall have no responsibility or liability for the actions or inactions of the person performing such repair or service, regardless of whether such person has been trained to perform such repair or service. It is understood and acknowledged that any person other than an Hospira representative performing repair or service is not an authorized agent of Hospira.

C- 2 430-04685-004


Index

Index

Numerics

24-Hour information

5-38

4 HR LIMIT

5-21

4 HR LIMIT REACHED Message

5-21

A

AC power

1-2

indicator

3-7

Accuracy alarm

1-8

1-6

system

2-2

Alert messages

1-4

Alpha Vial

4-9

analgesic

1-2, 2-2

delivered

4-32, 6-6

package

1-11

anesthetics

1-2

anti-siphon valve

1-11

Autoprogramming

1-6

B

bar code

1-10

drug vial

1-1 pharmacy-generated

1-1, 4-8, 6-1

reader

1-1, 1-13

battery

1-2, 1-11, 1-13, 1-15

charge

4-16

fault

1-6

indicator

3-7

Biomed Mode

1-2, 5-2, 5-18

bolus

1-6, 2-2, 4-29

doses

1-9

partial

Button

5-37

1-6

C

CAUTION message

1-4

CCA

CE

1-6, 1-9, 1-10, 6-3, 6-7

1-6

Change CCA

5-32

I - 1

Softkey

5-25, 5-30

Change Rx Softkey

5-30

cleaning

infuser

1-13

Clear Button

3-5, 4-12

Clear History

5-38

Clear Shift Softkey

5-33

Clinical Care Area

1-6

(CCA)

6-7

clock

12 hour

4-25

Confirm No Dose Limit Screen

5-22,

5-23

24 hour

4-25

Confirm Softkey

5-26

Confirmation Screen

4-26, 5-35

Connectivity Engine

Continuous

1-6

1-2, 1-6, 2-2, 5-3, 5-35

infusion

mode

5-3

1-12, 2-2, 5-3

5-11, 5-16

rate

CONTINUOUS ONLY

1-2

custom syringes

1-12

D

DDL

1-7, 5-21

DECIMAL POINT Button

3-6

Default Drug Library

1-7, 5-21

Defined Drug Library

6-7

4-6, 4-14, 4-31,

Deliver Later Option

6-6

Deliver Loading Dose Now Screen

4-5,

4-13, 6-5

Delivery

1-12

interruption

5-2

Mode Screen

5-5, 5-10

Modes

5-21

Parameters

Screen

1-8

1-9

Door Locked Message

5-8

430-04685-004


Dose History

1-12, 5-21

Dose Limit

1-7, 1-9, 1-12, 2-1,

5-2, 5-3, 5-16, 5-21, 5-22

new

5-21

pre-programmed

5-11

Dose Limit Enter Value Screen

5-

7, 5-11, 5-16, 5-22

Dose Limit Periods

5-2, 5-21

DOSE LIMIT REACHED State

5-

2

Dose Limit Selection Screen

5-

22, 5-23

drug concentration

1-10, 1-12,

4-12, 4-29

drug delivered

display

4-28

drug identification

1-1

Drug Library

1-10

Download

1-7

Installation

1-7

E

electromagnetic compatibility

1-

18

electromagnetic interference

1-

16

empty syringe message

5-34

ENTER Button

3-5

epidural

1-2

epidural infusion system

4-18

epidural route

1-14, 2-2

epidural space

1-15

Ethernet

cable

1-17

port

1-1

Event History

HOUR-BY-HOUR

5-39

LAST 1 & 24 HOUR

5-39

Event Log

1-7, 5-38

Events recorded

4-17

EXIT Button

3-5

F

FCC Rules

1-19

Index

flow rate

1-12, 4-28

Front Pannel equipment description

3-2

H

hard limit

1-9, 5-16

History

1-7

HOUR-BY-HOUR

5-39

LAST 1 & 24 HOUR

5-39

I

History and Rx settings

4-3, 4-9, 5-27, 6-3

History and Rx Settings

4-9

History Button

3-6, 5-38

History Printout

5-39

Hospira MedNet Software

1-1,

1-2, 5-2, 5-7, 5-11, 5-16, 5-

18, 5-22

HOUR-BY-HOUR history

5-39

HR LIMIT REACHED message

5-

3

incompatibility

1-11

infuse

1-8

Loading Dose

6-6

infuser

5-29

cleaning

1-13

maintenance

1-13

sets

1-14

infusion rate

1-11

infusion therapy

1-9

injector

1-12

K

keypad controls

1-1

L

LCD

1-8

LED

1-8, 3-7

Loading Dose

1-8, 1-12, 2-1,

4-5, 4-12, 4-29, 4-30, 5-5, 5-

10, 5-14, 6-5

Deliver Later

5-10

displayed range

5-5, 5-10,

5-14

I - 2 430-04685-004

430-04685-004.book Page 3 Tuesday, January 10, 2006 10:50 AM halt

5-36

infuse

4-6, 4-13, 4-31

mode

4-6, 6-6

now

4-31

range

4-5, 4-13, 4-30, 6-5

softkey

5-21

supplemental

2-2, 5-21, 5-

36

Lockout Interval

1-8, 1-9, 2-2,

5-2, 5-3

value

5-6

Low Battery Alarm

1-15

Low Battery Message

4-16

Low Priming Volume PCA Set

2-

2

lower limits

1-9

M

Main Delivery Screen.

5-38

malfunction alarm

1-14, 5-2, 5-

37

Medical Device Directive

93/42/EEC (EN 55011 Class B

1-17

IEC/EN 60601-1-2

2001 1-17

micrograms

4-12

Modes of Delivery

CONTINUOUS

1-2, 5-2

PCA ONLY

1-2, 5-2

PCA+CONTINUOUS

1-2, 5-2

Muting Period

1-8

N

New Patient Screen

4-3, 4-9, 4-

17, 4-27, 5-4, 5-9, 5-13, 5-

27, 6-3

Next Protocol Softkey

5-20

No Dose Limit

5-7, 5-26

numeric buttons

3-6

O

Occlusion

1-8

Pressure

1-8

LifeCare PCA

®


ON/OFF Button

3-5, 6-2

one hour information

5-38

operating parameters

2-1

P

partial doses

5-2

Patient Pendant

1-1, 1-3, 1-9,

1-12, 3-8, 4-15, 5-2

patient pendant button

5-2

PCA

1-2, 2-1

requested doses

5-39

PCA + Cont.

6-7

PCA + Continuous

2-2, 5-3, 5-

35

PCA AVAILABLE Message

5-2,

5-3

mode

1-12, 5-21

PCA bolus

5-17

PCA dose

2-2, 5-17

PCA Infusion System

1-1

PCA LOCKOUT Message

5-8

PCA Mode

1-9

PCA Only

1-2, 5-2, 5-5

PCA Patient Pendant

3-8

PCA Set

1-9

PCA Vial

1-9

PCA+CONTINUOUS

1-2

Pendant Fault Message

5-8

Prime

1-9, 1-11, 5-35

system

4-28

Print History

5-37

Softkey

5-39

printer connections

1-1

printouts

5-39

procedures

1-11

program values change

5-28

programmed therapy

1-10

programming features

1-1

Protocols

1-2, 1-10, 5-2, 5-18,

5-20, 6-7 stored

5-2

purge

1-9, 1-11, 5-34, 6-4

430-04685-004 I - 3

430-04685-004.book Page 4 Tuesday, January 10, 2006 10:50 AM complete

4-4

cycle

1-12, 4-28

system

4-28

Purge Softkey

4-4, 4-10, 4-29,

5-4, 5-10, 5-13, 6-4

R

Rear Panel

equipment description

3-4

replace syringe message

5-34

Review/Confirmation Screen

5-

26, 5-28

RF communications

1-17

Rule Set

1-9

Rx Rules

1-10, 5-18

Rx Settings

1-10

S

safety

1-11

Save & Exit Softkey

5-26

screen message alerts

5-2

Select CCA Screen

6-7

Select Delivery Mode

4-31

Screen

4-6, 4-14, 6-6

Select Mode

PCA + Cont

5-14

PCA Only

5-4

Screen

4-30

self-test

1-13, 4-2, 4-8

failures

4-16

set

4-4, 4-11, 4-29, 5-5, 5-

10, 5-14, 6-4

Set List

1-15

settings

5-29, 5-38

adjust system

5-4, 5-9, 5-13

SILENCE key

1-8

SILENCE/VOLUME button

3-5

slack

1-12, 4-28, 5-35

soft limits

1-9, 5-16

Softkeys

1-10, 3-7

Standard Syringe

1-10

START/PAUSE Button

3-6, 5-3,

5-8

START/STOP Button

5-2

Index

status messages

7-1

stopping infusion

5-29

Stored Protocols

1-10

syringe

1-12

change

1-12, 4-28

custom

1-2, 1-7

System Settings

4-21

system slack

4-4, 4-10, 4-28,

6-4

T

therapy settings

1-10, 5-38

training infuser use

1-3

IV complication

1-3

PCA programming

1-3

U

units of measure

4-11

unpacking

1-11

Updating Drug Library

6-1

upper limits

1-9

User-Defined Drug Library

1-9,

1-10, 5-2, 5-3, 5-21, 6-1

V

vial

1-12, 5-2

barcoded

1-2

custom

1-7, 1-9, 4-8, 6-1

custom-filled

1-2

load drug

4-2

PCA

1-9

prefilled

1-2, 1-9, 1-10, 6-1

removal

5-34

standard

1-9

sterile empty

1-2, 1-7

Vial Confirmation Screen

4-26

Vial Cradle equipment description

3-3

vials

prefilled

1-10

W

Warning

1-10

I - 4 430-04685-004


LifeCare PCA

®


warning messages

1-4

Warning! Drug and/or Concentra-

tion Change Detected Screen

5-

34

430-04685-004 I - 5


Notes

430-04685-004


LifeCare PCA

®


Contact Information

For customer service within the United States, contact:

1-877-9-HOSPIRA (1-877-946-7747)

For technical assistance, product return authorization, and to order parts, accessories, or manuals within the United States, contact Hospira Technical Support Operations.

1-800-241-4002

To order parts using the online eCatalog, download technical publications, technical training courses, and additional services, visit the web site at:

WWW.HOSPIRAPARTS.COM

After authorization, ship prepaid product returns to this address:

HOSPIRA

Technical Support Operations

755 Jarvis Drive

Morgan Hill, CA 95037

NOTE: Outside the U.S. contact your local Hospira sales

office.

430-04685-004


CAUTION: F

EDERAL

(USA)

LAW RESTRICTS THIS INFUSER

TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR OTHER

LICENSED PRACTITIONER

.

WARNING

POSSIBLE EXPLOSION HAZARD EXISTS IF THE

I N F U S E R I S U S E D I N T H E P R E S E N C E O F

FLAMMABLE ANESTHETICS.

The PCA Infuser, Hospira MedNet, LifeShield, and E.L.I. are trademarks of Hospira. Teflon, Formula C, Manu-Klenz, Super

Edisonite, Coverage, and Sporicidin are not trademarks of

Hospira.

Equipment providing adequate degree of protection against electrical shock and suitable for application to patient

Type CF

IPX1

Drip Proof

Medical Equipment

Protected against dripping water

Class 1

Mains supply equipment using protective earth

®

UL 60601-1

CSA 601.1

C US

MCN 160992

430-04685-004

Hospira LifeCare PCA PCA Infusion System System Operating Manual

Assistant Bot

System

Operating

Manual

Change History

Title Description of Change

Pages Affected

Table of Contents

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

NOTES

Section 1

Descriptive Information

ATIENT

ELECTION

SER

UALIFICATIONS

ARNINGS

AUTIONS

AND

OTES

NOTE: A Note highlights information that helps explain a

NOTE: Figures are rendered as graphic representations to

Accuracy

Autoprogramming

Battery Fault

Bolus

Button

Connectivity

Engine (CE)

Continuous

Clinical Care Area

(CCA)

Custom Syringe or Vial

Default Drug

Library (DDL)

Dose Limit

Drug Library

Download

NOTE: Dose Limit periods are specified as

Drug Library

Installation

History

Hospira MedNet

Software

Infusing

LCD

LED

Loading Dose

Lockout Interval

Muting Period

Occlusion

Occlusion

Pressure

On

Patient Pendant

PCA Mode

PCA Set

PCA Vial

Prime

Purge

Rule Set

Rx Settings

Soft Keys

Stored Protocols

Standard Syringe

User-defined Drug

Library

Warning

NPACKING

ENERAL

ROGRAMMING

OADING

OSE

OSE

IMITS

PERATION

AINTENANCE

LARMS

PIDURAL