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9T

LifeCare@ 4100

:

PCA PLUS II Infuser
With Microgram Delivery

IJ

For use with list 1950-04

System
Operating
Manual

a
Abbott Laboratories
North Chicago, IL 60064
USA

430-04501-BOZ(Rev. 10/96)

Contents

Contents
Section 1

INTRODUCTION . . . .
USER QUALIFICATION’ : : : : : : : : : : : : : : : : : : : : : : : :

l-l
l-1

Section 2

PRINCIPLES OF OPERATION . . . . . . . . . . . . . . . . . . . . . . . . 2

-1

Section 3

EQUIPMENTDESCRIFFION
........................
COMPONENTS
FRONTPANEL TO&-HSWiTCFiES- : : : : : : : : : : : : : : : : : : : :
[PURGESYSTEMI. ........................
hO;;LOROSEI
. . . . . .
. . ..
. . . . .
..

. . . .

3-1
3-l
3 -4
3-4
. . . 3-4
3-4
-4
3 -4
3-4
3 -5
3-5
3-5

[REVIEW/CHANGE] : : : : : : : : : : : : : : : : : : : : : : : : 3
KJP/DOWNARROWSl .......................
[ONI. .............................
[OFFiRECHGl ..........................
[SILENCE/NO1 ..........................
[RESET/START]
.........................
[PRINT]
[HISTORY]’ : : : : : : : : : : : : : : : : : : : : : : : : : : :
DISPLAYS
iiD, : : : : : : : : : : : : : : : : : : 3 -6
LIQUID CRYSTAL DISPLAY
LIGHT-EMITTING DIODE (LED) DISPLAY ...............
POWER SOURCE INDICATORS ...................

:I:
3-6
3-6
3-7

Section 4

INSTRUMENT INSTALLATION PROCEDURE
..................
UNPACKING ............................
INSPECTION
INFUSERSELF-TEST
’:::::::::::::::::::::::::
SETUPPROCEDURE. .........................
....
SETUP ...
VIAL CRADLE ASSEMBLIES. : : : : : : : : : : : : : : : : : : : :
ATTACHING PCA SET TO PATIENT ACCESS DEVICE .............

4-1
4-1
4-1
4-1
4-2
4-2
4 -2
4-3

Section 5

OPERATING THE INFUSER .
5-1
WARM-STARTVS. COLD-START
::::::
::::::
: : : : : : : : : 5-1
PURGING THE SYSTEM
5-2
PROGRAMMINGTHEPCAPiUSI&FiJSER :-: : : : : : : : : : : : : : : 5-3
DRUG AND CONCENTRATION
5-3
INTRAVENOUS PCA
ADMIMSTRiiI~N’ : : : : : : : : : : : : : : : 5
-4
EPIDURAL PCA ADMINISTRATION . . . . . . . . . . . . . . . . . 5
-4
LOADINGDOSE . . . . . . . . . . . . . . . . . . . . . . . . .
5-7
MODESOFDELIVERY . . . . . . . . . . . . . . . . . . . . . . . 5-7
THE4HRDOSELIMIT. . . . . . . . . . . . . . . . . . . . . . . . . 5-9
STARTING INFUSION . . . . . . . . .
5-10
.: : : : : : : : : : : : : :
PCAMODE . . . . . . . . . . . :
S-10
L&Care 4100 Series

iii

430-04501A02 (Rev. 5/94)

Contents

S-10
5-10
5*-11
5-11
5-11
5-11
5-12
5-14
5-14
5-15
5-16

CONTINUOUS MODE ......................
PCA+CONTINUOUS MODE ....................
STOPPING INFUSION ........................
CHANGING INFUSER SETTINGS
CHANGINGSETTINGSDURINGSFiUi : : : : : : : : : : : : : : : : :
CLEARING DOSE HISTORY ......................
CHANGING SETTINGS AFTER SETUP ..................
CHANGING TIME AND DATE ...................
SERVICE MODE SELECTIONS ...................
RETAINING THE SETUP .......................
HISTORYANDEVENTLOG ......................

Section 6

.
.
.
.

MESSAGES AND ALARMS ........................
STATUS MESSAGES
INFUSERALARMSYSTbi : : : : : : :
..............................
SILENCING AN ALARM .....................

Section 7

OPERATIONAL PRECAUTIONS

Section 8

CLEANING THE INFUSER

. 7-1

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

. 8-l

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

Section 9

.
.
.
.

BATTERY OPERATION AND MAINTENANCE .................
SWITCHOVER ...........................
OPERATING TIME .........................
RECHARGING ...........................

Section 10

Section 11

11-1

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

Section 12

....
....
ADMINISTRATION EQUIPMENT
ADMINISTRATION SETS FOR INTRAVENOUS, EPIDURAL USE
..................
EPIDURAL CATHETERS .....................
PCA DRUGS FOR INTRAVENOUS, EPIDURAL USE ...........

Section 13

12-l
12-l
12-l
12-l

13-1

WARRANTY ..............................

430-04501 -A02 (Rev. 5194)

9-1
9-1
9-1
9-l

10-l

SPECIFICATIONS ............................

PRESCRIPTION DELIVERY LIMITS

6-1
6-1
6-1
6-2

iv

System Operating Manual

Figures

Figures
Figure 3-l. Front Panel

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

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

3-l

Figure 3-2. Rear Panel

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

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

3-2

Figure 3-3. Vial Cradle Assembly

...........

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

3-3

Figure 5-l. Warm-Start Sequence

...........

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

5-1

Figure 5-2. Cold-Start Sequence

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

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

5-2

Figure 5-3. Purging the System

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

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

5-3

.....

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

5-6

........

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

5-7

Figure 5-6. Accessing the Three Delivery Mode Display Screens

........... ,

5-8

Figure 5-7. Programming

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

5-8

....

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

5-8

PCA+Continuous Delivery . . . .

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

5-9

Figure 5-4. Programming Drug and Concentration
Figure 5-5. Programming a Loading Dose

PCA-OnIy Delivery

.......

Figure 5-8. Programming Continuous-Only Delivery
Figure S-9. Programming

Figure 5-10. Clearing Dose History and Total Delivered

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

5-11

Figure 5-11. Changing Therapy Settings .................... 5-13
Figure 5-12. Screens for Changing Time and Date

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

5-14

Figure 5-13. Retaining the Setup ....................... 5-15
Figure S-14. Sample History Printout (in PCA+CONTINUOUS Mode)

.........

5-17

1

I

0 Copyright 1996

Abbott Laboratories

All Rights Reserved

This document and the subject matter disclosed herein are proprietary information. Abbott Laboratories
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 Abbott Laboratories.

LifeCare 4100 Series

v

430-04501-802 (Rev. 10/96)

and qualification of the user. oncology centers. training. and medical/surgicaI nursing units. trauma units. Use of the LifeCare PCA PLUS II Infuser by other than physicians or health care professionals should only be undertaken following proper instruction. This operating manual provides: 0 Overview of pump operation a Complete setup and programming instructions 0 Description of alarm and status message systems USER QUALIFICATION The LifeCare PCA PLUS II Infuser is for use by licensed physicians or Iicensed/certified healthcare professionals who are trained in the use of the infuser and in the administration of medical fluids.Section 1 INTRODUCTION The LifeCare PCA PLUS II infusion pump system is designed for safe. ardgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings. bum units. 10/91) . LiieCare 4100 Series l-l 430-04501-002 (Rev. including ICU. SICU. CCU. effective. bone marrow transplant centers.

GeneraIly. or other approved analgesic drugs can be adnrinistered epidurally through a recommended Low Priming Volume PCA Set without a Y-adapter. After PCA dose delivery. Analgesic drugs may be delivered through LifeCare PCA Plus II Infuser intravenously by any of the three modes specified above. number delivered. AlI event descriptions are preceded with time of occurrence (see HZS7DRY AND EVENT LQG. LifeCare 4100 Series 2-l 430-04501-002 (Rev. A “lockout” interval controls the frequency with which a patient may receive a PCA dose of analgesia. Section 5). The epidural route can be used to provide analgesia by any of the three modes of infuser operation. a nurse following a physicians order programs the infuser with operating parameters. the patient may request a bolus of analgesia during therapy by pressing a button on the patient pendant. In addition.. opening or closing of the security door. i. Events recorded include number of PCA doses requested. The PCA PLUS II operates on AC or battery power. and so on. USP. to The PCA PLUS II infuser can be programmed to deliver either PCA doses deliver only a continuous background infusion with no PCA doses permitted (CONTINUOUS mode). an alarm condition. CONTINUOUS. causing the infuser to release the specified bolus of analgesia into the IV line. Preservative-Free Morphine Sulfate Injection.Section 2 PRINCIPLES OF OPERATION The LifeCare PCA PLUS II Infuser is a portable infusion pump that allows a patient to self-administer analgesia within programmed limits. 10191) . It attaches and locks to an IV pole and also has a locking security door to prevent tampering. This programming flexibility allows the physician to tailor an effective pain management program unique to each patient. (PCA mode). PCA. or PCA+CONTlNUOUS setbing. or to deliver a continuous rate and allow PCA doses (PCA+CONTINUOUS mode). the patient cannot receive any additional patient requested boluses until the lockout interval has elapsed. The PCA PLUS II Infuser records therapy settings and up to 200 “events” that may occur during the therapy regimen. The Operating parameters are set from a choice of drug concentration and dose loading dose and 4 hr dose limit are optional.e. The alarm system sounds an audible alarm in the event of a malfunction and digital read-out describes the malfunction. start or stop of continuous infusion. which may include the following: P Loading dose cl PCA dose cl Lockout interval 0 Rate of continuous flow 0 4 hr dose limit 0 Delivery mode setting. If the infuser is set in the PCA or PCA+CONTlNUOUS mode.

Front Panel LieCare 4100 Series 3-l 430-04501 -A02 (Rev.Section 3 EQUIPMENT DESCRIPTION COMPONENTS CRADLE RELEASE MECHANISM VIAL UPPER VIAL RETAINER VIAL CRADLE CLIPS SECURITY DOOR DOOR LOCK \ \ / ! t RETAINER I I I INJECTOR / INJECTOR FLANGE RETAINER 1 FRONT PANEL TOUCHSWITCHES 9404AW2 Figure 3-1. 5194) .

Rear Panel 430-04501 -A02 (Rev. 5194) 3-2 System Operating Manual .Section 3 EQUIPMENT DESCRIPTION AUDIBLE ALARM SWlTCH @-WAY) PRINTER CONNECTOR PATlENT PENDANT CABLE JACK PATIENT PENDANT CABLE FASTENER UNIVERSAL IV POLE CLAMP WlTH DUAL-LOCK TM (NOTE: POLE CLAMP IS LOCKED WHEN SECURITY DOOR IS CLOSED AND LOCKED. UNIT CANNOT BE REMOVED FROM IV POLE WITHOUT KEY) KEYS BATTERY ACCESS ’ COVER (SOlTOM PLATE) AC CORD CONNECTOR PATIENT PENDANT CABLE CONNECTOR 9407AOOl Figure 3-2.

10191) .COMPONENTS TYPE B TYPE A CRADLE RELEASE MECHANISM \ VIAL BASE \ VIAL STOPPER VIAL LIP LOWiR VIAL RETAINER (SPRING LOADED) LOWER VIAL RETAINER INJECTOR q INJE&OR CAUTION: IMPROPER INSERTION MAY CAUSE VIAL TO CRACK Figure 3-3. Vial Cradle Assembly LieCare 4100 Series 3-3 430-04501-002 (Rev.

the numbers scroll one at a time. After setup. UP/DOWN ARROWS Increases or decreases the numerical value displayed. A double audible tone sounds the beginning 430-04501-002 (Rev. a change of any previous settings. Section 5). previously entered settings to be changed/corrected. [LOADING DOSE] Delivers a loading dose during setup and supplemental (booster) doses. Such objects may damage touchswitches and cause a malfunction. allows a review of and. etc. and thereafter in increments of 10. Note: Active touchswitches produce a short tone when pressed. [REVIEW/CHANGE] During setup. scissors. if desired.. [PURGE SYSTEM] Removes slack from the system after a new vial/injector is installed (see PURGING THE SYSTEM. Inactive touchswitches produce a “flutter” tone when pressed.Section 3 EOUIPMENT DESCRIPTION FRONT PANEL TOUCHSWITCHES The LifeCare PCA PLUS II Infuser is programmed using the front panel touchswitches shown in Figure 3-1. Holding the touchswitch speeds the scrolhng rate. CAUTION: DO NOT use sharp objects such as pens. when the security door is open. [YES/ENTER] Enters a YES response following a YES or NO prompt. [ONI Activates a cold-start if the infuser has been off for more than 60 minutes or if the (OFF/RJXHG) touchswitch was pressed until the background display grid on the LCD disappeared (approximately four seconds). to press touchswitches. Front Panel. Pressed and released repeatedly. Enters a user-selected operating parameter in response to an ENTER prompt. or time and date to be changed. 1 O/91) 3-4 System Operating Manual . allows total drug delivered and dose history to be cleared. Brief pauses occur at numerals 5 and 10. fingernails.

Prescription settings. The event log lists the time and key events that occurred during therapy. keep the infuser plugged into an AC power source whenever possible. Executes a printout of time and date. When the infuser is plugged into rated AC power. though at a slower rate than when turned off. and PCA doses (see HZSZORYAMI EVEiVTWG.FRONT PANEL TOUCHSWITCHES of the cold-start sequence. dose history. infusion start/stop times. Temporarily mutes most audible alarms during an alarm condition. A brief audible tone sounds when the infuser is turned off. If pressed and held for approximately four seconds. CHECK INJECTOR. If the same settings are used. and event log are not saved in memory and must be entered. In the PCA+CONTINUOUS mode. they do not need to be re-entered (see RETAINING ‘INE SETUP. background grid on the LCD disappears. dose history. 10/91) . and event log are cleared from memory. [OFF/RECHG] Turns the infuser off while retaining prescription settings. For optimum battery life. such as prescription settings. it automatically recharges the battery. Section 5). Activates a warm-start if the infuser has been off for less than 60 minutes. Section 5). Cl Connect printer cable to printer port on the back of the printer. dose history. various alarms. and prescription settings. All prescription settings. To use the PRINT function: 0 Connect a Centronics-compatible interface printer cable at the printer port on rear panel. patient-activated doses are not permitted until the door is closed and locked and FU?SET/S’Im is pressed. [RESET/START] Starts or stops infusion in CONTINUOUS or PCA+CONTINUOUS modes after the security door is closed and locked. door status. The infuser recharges while operating. Note: The MALFUNCTION. LifeCare 4100 Series 3-5 430-04501-002 (Rev. No audible tone sounds in the beginning of the warm-start sequence. and CHECK SYRINGE alarms cannot be silenced. dose history. Note: The [RESET/START) touchswitch is not active in PCA mode. dose history. and the event log if optional printer is attached. CHECK VIAL. and event log are retained. and event log for 60 minutes. parameter settings. [SILENCE/NO] Inputs a NO response following a YES OR NO prompt request.

Note: To interrupt printing. In approximately 30 seconds. This is recorded in the event log as ROLLOVER 6553.0 milligrams (0 micrograms). Touchswitch must be pressed to advance to the next screen. The LED displays the amount delivered in 0. and the event log (see MSTORY AA!D EVEZVT LOG Section 5). and alarm and operating conditions.Section 3 EQUIPMENT DESCRIPTION P Turn on printer power switch. drug delivered. The LED displays four digits. The printing sequence will start at the beginning when the touchswitch is pressed again. display screen returns to current status display. displays the therapy parameters.. the history of all doses delivered. press the [PRINTI touchswitch. D Press the [PRINTI touchswitch to generate a hard copy printout. or during an alarm condition. 430-04501-002 (Rev.1 milligram or 1 microgram increments. the highest (f%th) digit is dropped. The LCD displays all five digits. The “walki@’ LED is displayed on the right side during microgram delivery. A one-digit “walking” LED on the left side of the display is active during milligram delivery.5 MG (or 65535 UG). It remains lit for approximately 30 seconds after the securily door is locked. DISPLAYS LIQUID CRYSTAL DISPLAY (LCD) The four-line LCD screen displays messages regarding therapy settings. When the total delivered number exceeds four digits. LIGHT-EMITTING DIODE (LED) DISPLAY The four-digit red LED displays critical numerical data. and a decimal point is lit between the tenth and unit digits. The LCD features automatic backlighting. This display is lit whenever the security door is open.. 1 O/91) 3-6 System Operating Manual .5 milligrams (65535 micrograms) of delivery before rolling over to 0. The drug delivered display will record up to 6553. During operation. Backlighting temporarily occurs during touchswitch operation and automatically turns off a&r two minutes of no touchswitch activity. [HISTORY] Reviews the therapy parameters entered.

tl A red battery symbol is lit while the infuser is operating on battery power. 10191) .DISPLAYS POWER SOURCE INDICATORS Two LED-backlit symbols indicate the source of power: 0 A green power cord plug symbol is lit whenever the infuser is connected AC-power line. LifeCare 4100 Series 3-7 to a live 430-04501-002 (Rev.

Retain the packing slip and save all packing material in the event unit is damaged or fails the infuser Self-Test and has to be returned to the factory. POSSIBLE INDUCED HAZARDS TO OPERAllNG PERSONNEL OR TO PATIENTS WILL BE DETECTED BY THE INFUSER SELF-TEST. LifeCare 4100 Series 4-l 430-04501-002 (Rev. hospital-grade 120 VAC. lOI91) . Freight claims or insurance Recourse claims must be filed by the receiving party with the carrier within seven days. damaged. inspect infuser thoroughly for damage. Note: Instrument installation should be performed by qualified personnel only. Ensure that plug symbol to left of LED display on illuminated. Note: Two keys are supplied with the infuser and should be accounted for per hospital procedures. THE BAlTERY MAY NOT BE FULLY CHARGED UPON RECEIPT. to the carrier is lost if claim. To perform infuser Self-Test. Next. Should any damage be found. Unlock and open security door. Hz tiont panel is 2. Do not use infuser if it appears to be INFUSER SELF-TEST Note: Do not place infuser in service until the infuser Self-Test has been conducted.Section 4 INSTRUMENT INSTALLATION PROCEDURE WARNING: PRODUCT DAMAGE MAY OCCUR UNLESS PROPER CARE IS EXERCISED DURING THE UNPACKING AND INSTALLATION PROCESS. proceed as follows: 1. UNPACKING Use care when unpacking the infuser. INSPECTION Inspect the packing container for possible shipping damage to infuser. Plug infuser AC power cord into grounded. contact the delivering carrier immediately. 50-60 receptacle. The shipping container should also contain a copy of the System Operating Manual. is not timely.

0. the infuser can be operated on internal battery power. 1 O/91) 4-2 System Operating Manual . Prime the vial and set by holding it vertically with the administration set extending from the top. VIAL CRADLE ASSEMBLIES As shown in Figure 3-3. If the spring-loaded retainer does not movefreely. and selected electronic functions. Press and release the [ON) touchswitch. The Type A cradle assembly has a spring-loaded lower vial retainer. SETUP PROCEDURE SETUP Secure the PCA infuser to an IV pole using the Dual-Lock mechanism. plug AC power cord into hospital-grade 120 VAC and charge battery for 24 hours. 2. memory. ADMlMSTRATlON EQUIPMENT. To load a vial/injector into the vial cradle assembly. proceed as follows for the appropriate vial cradle assembly: 1. Contact an Abbott representative for further instructions. 4. If the infuser fails the test. the infuser is also locked to the pole clamp to prevent removal of infuser without the key. BAmRY OPERATION AND MAINTENANCE. FOR TYPE A ONLY: Check spring-loaded lower vial retainer (located at the bottom of the vial cradle assembly] to be sure it movesfreely by pressing downward. for additional information.0. The infuser now performs a self-test verifying the integrity of the software. (See Section 9. %ueeze cradle release mechanism (see Figure 3-3) and move to the uppermost position (retracted). and slowly pushing down on the injector until all air is cleared from the vial and the PCA administration set. Unlock and open infuser security door.) Connect the appropriate compatible Abbott PCA set (see Section 12. If AC power is unavailable. refer unit to qualz$ed service personnel 430-04501-002 (Rev. Compare the infuser with Figure 3-3 to determine which type of vial cradle assembly is installed in the unit. In the Type B cradle assembly.Section 4 INSTRUMENT INSTALLATION PROCEDURE 3. Note: When the security door is locked. Plug the AC power cord into a grounded hospital-grade AC receptacle for AC-powered operation. there are two types of vial cradle assemblies: Type A and Type B. do not place in service. the lower vial retainer is an integral part of the assembly and is not spring-loaded. for recommended sets) to an Abbott 30 mL PCAvial/injector. To ensure that battery is charged before placing in service.

WARNING: FAILURE TO USE COMPATIBLE ABBOTT VIAUINJECTOR AND ABBOTT PCA SETS WITH INTEGRAL ANTI-SIPHON VALVE MAY CAUSE AN INACCURATE DOSE DELIVERY TO THE PATIENT. 5. CORD. Eliminate gaps by squeezing the cradle r the injector is locked firmly in 7. ATTACHING PCA SET TO PATIENT ACCESS DEVICE WARNING: ARRANGE TUBING. primed PCA set to patient access device. gently rotate it 360” and inspect forWith cracks those that may have occurred due to excessive force during insertion. primed PCA Set without Y-adapter to patient access device. If flange is not securely locked. Place vial lip in lower vial retainer with upper portion of vial tipped toward operator. remove from the unit and replace with new vial following steps 2 through 7.ATTACHING PCA SET TO PATIENT ACCESS DEVICE 3. Reverify that the viaI is firmly seated against the upper vial retainer. attach distal end of recommended. Establish flow of primary fluid through primary leg of Y-adapter. AND CABLES TO MINIMIZE THE RISK OF PATIENT STRANGULATION OR ENTANGLEMENT. repeat steps 4 and 5. CAUTION: Do not load vial into upper vial clip first. Vial lip may crack or chip. A gap between the vial and upper retainer could cause an under. attach distal end of recommended.or delayed-delivery. 5/94) . 4. WARNING: CRACKED VIALS MAY NOT SHOW EVIDENCE OF LEAKAGE UNTIL DELIVERY PRESSURE IS APPLIED. Proper loading (engaging injector flange) will silence the alarm. LiieCare 4100 Series 4-3 430-04501. lf vial is cracked or broken. Rotate vial so that the drug/concentration label is visible. Visually verity injector flange is locked in retainer. 6. For intravenous PCA administration. Gently push vial into cradle assembly clips with slight downward pressure until vial is securely clamped in cradle. thesuch as vial properly in place. Dispose of damaged vial per hospital procedures. improper loading of the syringe will turn the unit on and activate a nonsilenceable CHECK SYRINGE alarm within 15 seconds. Note: lf the device is off.A02 (Rev. For epidural PCA administration. Squeeze cradle-release mechanism and slide vial cradle downward until the injector locks firmly in place in the injector flange retainer.

Warm-Start Sequence The infuser initiates a cold-start if more than 60 minutes have elapsed since it was turned off. When operating on battery power. Ail previous therapy parameters and history information are retained.Section 5 OPERATING THE INFUSER WARM-START VS. COLD-START When the infuser is turned on by either inserting or removing a vial. Cold-Start Sequence. for the sequence of LCD displays that occur during a cold-start. TIMER-OK. for the sequence of LCD displays that occur during warm-start. TEST COMPLETE \ r I . ROM-OK. . Placing the infuser in the cold-off state is recommended before assigning it to a new patient. RAM-OK.o Figure 5-l. At that point. it is also recommended that the infuser be placed in the cold-off state after use to prolong battery life. CPU-OK. Note: The infuser can also be manually placed in the cold-off state by holding the [OFF] touchswitch until the background grid on the &CD disappears (approtimately four seconds). The infuser initiates a warm-start if it is turned on within 60 minutes of previous use. L&Care 4100 Series 5-l 430-04501-002 (Rev. 10191) . it begins a warm-start or a cold-start sequence.DATE: FEB 10 91 J / H’STORY AND Rx YESORNO J SILENC NO n YES mmm b 4 t \ COhFlRM TO CLEAR HISTORY AND Rx YESORNO \ YES ENTER . most major electronic circuits are turned off. or by pressing the (ON) touchswitch. See Figure 5-1. and all therapy settings and dose history are lost. depending upon the time elapsed since it was last turned OFF. Warm-Start Sequence. . See Figure 5-2. ’ am? TIME: AM 9~08 .

purging the System). the purge cycle will stop and the infuser will prompt the user to respond if flow was seen. Press and hold the [PURGE SYSTEM] touchswitch. Note: The system must be primed prior to purging. Remove all air from the vial before installing into infuser.Section 5 OPERATING THE INFUSER +ljiZ&j Figure 5-2. As soon as fluid is seen at the end of the administration set. After the infuser is turned on or the vial is replaced. If the infuser fails the test. 1 O/91) 5-2 System Operating Manual . Con&m the PCA set is disconnected from the patient’s IV line before pressing the (YES] touchswitch to initiate the purge cycle. In the CONTINUOUS and PCA+CONTlNUOUS modes. the cycle can be repeated once (see Figure 5-3. After about 1. 430-04501-002 (Rev. To remove system slack when a new vial/injector is installed. Cold-Start Sequence Note: During a cold-start the infuser performs a self-test verifying the functional integrity of the unit. If ilow was not seen. the user is prompted to begin the purge cycle.0 mL of fluid is delivered. Note: Drug delivered during the purge cycle is not stored in system memory and will not be displayed. release the touchswitch. if a purge or a loading dose is not performed after a syringe change. it is recommended that the infusion system be purged before beginning operation. the MALFUNCTION alarm is activated and the infuser must be taken out of service. the infuser automatically performs a small system compliance step to remove slack when the [RESET/STXRTl touchswitch is pressed (with door locked). PURGING THE SYSTEM WARNING: PAllENT MUST BE DISCONNECTED FROM THE PCA SET BEFORE THE PURGE CYCLE.

One of six screens is selected. under some conditions up to 0. 10131) . This section describes the various therapy parameters. and contains flow charts outlining the step-by-step procedures for programmin g these parameters into the infuser. If 0.3 mL of fluid may be delivered. PROGRAMMING THE PCA PLUS II INFUSER Entering the therapy regimen requires the user to follow the self-prompting displays on the LCD. the set should be disconnected during this operation. Programming Drug and Concentration). DRUG AND CONCENTRATION Drug selection and concentration are the first therapy parameters entered on the screen.’ IN FIGURE 54. l&Care 4100 Series 5-3 430-04501-002 (Rev.3 mL of fluid represents a hazard to the patient.. Figure 5-3. User responses are entered by pressing the touchswitches.. Four screens have tied values for drug concentration and two screens can be set by the user (see Figure 5-4.PROGRAMMING THE PCA PLUS II INFUSER TO START PURGE DISCONNECT PCA SET FROM PATIENT 10 IF 2 ML IS PURGED A + NOTE DRUGS ONLY BRANCH ‘. Purging the System CAUTION: Although fluid is not normally delivered to the patient during the compliance step.

or List 6517 attached to List 6514 (with integral anti-siphon valve) via backcheck valve port. EPIDURAL PCA ADMINISTRATION Note: The administration of drugs is restricted to those analgesic drugs approved for continuous epidural administration: Morphine Sulfate Injection. To change an initial selection.” FAILURE TO IDENTIFY THE INFUSION SYSTEM AS EPIDURAL COULD RESULT IN INCORRECT ADMINISTRATION OF INTRAVENOUS RATHER THAN EPIDURAL FORMULATIONS. cl Attach Main IV set line to recommended PCA set. 6947. USP (Preservative-Free). Recommended use of the epidural route is for labor and delivery. 430-04501-002 (Rev. FAILURE TO IDENTIFY THE EPIDURAL INFUSION SYSTEM COULD RESULT IN CONFUSION WITH OTHER INFUSION SYSTEMS DELIVERING CONCOMITANT INTRAVENOUS FORMULATIONS. Note: See drug concentration option discussion in CHANGING INFUSER Section. press the [REVIEW/CHANGE] touchswitch. 1 O/91) 5-4 System Operating Manual . WARNING: IT IS STRONGLY RECOMMENDED THAT THE EPIDURAL INFUSION SYSTEM BE PROMINENTLY IDENllFlED AS “EPIDURAL. 65 17. or a Teflonm catheter. USP (Preservative-Free). is recommended for continuous epidural administration of Morphine Sulfate Injection. this INTRAVENOUS PCA ADMINISTRATION 0 Connect injector to PCA set and manually prime. List 3559. is recommended for epidural administration of drugs. All drug parameters specified in Figure 5-4 are available for intravenous administration by PCA. and select 0. Close manual clamp on IV set. SETIINGS. List No. List 6516. 0 Attach recommended low priming volume pump set without Y-injection sites to patient access device. prime and establish epiduraIly.O mg/mL. &ist No. List No. Confirm proper placement.O mg/mL or DRUG: Rx concentration milligrams/ml. IN ADDITION. 0 lf patient access device is not indwelling.5 mg/mL or Morphine 1 . Use of a nylon catheter. and for acute pain control or post-operative analgesia for periods up to 96 hours. Prime IV set and lower portion of PCA set. Use of the low p riming volume set without Y-injection sites.5 mg/mL or 1 . for additional information. 1193.Section 5 OPERATING THE INFUSER The steps illustrated in Figure 5-4 involve selecting the drug and/or concentration. Drug parameters to select: DRUG: Rx Morphine 0.

naloxone and other resuscitative drugs. Patients must be observed for side effects frequently in a fully equipped and staffed environment for at least 24 hours following completion of drug admini&ration by the epidural route. the pressure will take longer to return to normal. observe the patient closely for signs of: Cl Compression on spinal cord . LifeCare 4100 Series 5-5 430-04501-002 (Rev. (e. Facilities practicing continuous epidural administration must be equipped with resuscitative equipment. DELAYED RESPIRATORY DEPRESSION FOLLOWING CONTINUOUS EPIDURAL ADMINISTRATION OF PRESERVATlVE-FREE MORPBINE SULFATE ELAS BEEN REPORTED. Adequate monitoring equipment. oxygen.. if a large volume of fluid is administered over a short lime period. 10/91) .transient neuralgia D Drug overdose The epidural space has 58 openings through which fluid can exit. Proper epidural placement of the catheter is essential since catheter migration could result in intravascular or intrathecal admini&ration.headache .g. If overdelivery occurs during administration.disorientation . oximetry) is recommended for continuous monitoring of the patient during epidural administration.PROGRAMMING THE PCA PLUS II INNSER CAUTION: Epidural a-ration of drugs by PCA and/or CONTINUOUS modes should be limited to personnel familiar with associated techniques and patient management problems. Pressure build-up during administration is transient. However.

1 O/91) 5-6 System Operating Manual .Section 5 OPERATING THE INFUSER 0A Rx MORPHINE Rx MORPHINE SMG/ML? YESORNO < f / No 4 DRUG: Rx MDRPHINE 05 MGfML 3 YESORNO \ .1 TO 10. No Rx MEPERIDINE lOMGML? YESORNO L YESORNO 0.0 MILUGRAMB’ML MlCROGRAMML? YESORNO \ 1 TO 100 MICROGRAMYML IF UG. MG OPll0N:--+@ Figure 5-4. Programming Drug and Concentration 430-04501-002 (Rev.

In the CON’HNUOUS mode. an optional loading dose may be programmed to provide an immediate bolus to the patient (see Figure 5-5. LifeCare 4100 Series 5-7 430-04501-002 (Rev. 10/91) . ID Figure 5-5. If the 4 hr dose limit is set and has been reached. Accessing the Three Delivery Mode Display Screens). the infuser delivers at a pre-set continuous rate. but does not allow the patient to request a PCA dose. Note: A supplemental (booster) dose can be delivered at any time during operation by opening the door and pressing the (LOADING DOSE] touchswitch. subsequent prompts will be for microgram values. 0 PCA 0 CONTINUOUS 0 PCA+CONTlNUOUS In the PCA mode. the infuser administers a bolus of medication only at the patients request provided the lockout interval is not in effect and the dose limit has not been exceeded.PROGRAMMING THE PCA PLUS II INFUSER Note: The following pages show programming in milligrams. the infuser delivers at a pre-set continuous rate and also permits the patient to receive PCAdoses when requested. Programming a Loading Dose MODES OF DELIVERY The PCA PLUS II Infuser delivers analgesia in one of three modes (see Figure 5-6. using the loading dose function may result in exceeding the dose limit. LOADING DOSE After the drug and concentration have been set. provided the lockout interval is not in effect and the 4 hr dose limit has not been exceeded. In the PCA+CONTlNUOUS mode. lf microgram delivery is selected. Prog * g a Loading Dose).

5-8. for programming procedures for each mode.Section 5 OPERATING THE INFUSER 0 .o\ .T SELECT MODE PCA ONLY ? YESORND SELECT MODE PCA+CONllNlKXJS YESORNO (FIGURE 57) (FIGURE %9) (FIGURE 19) Figure 5-6. 1 O/91) 5-8 System Operating Manual . SEITINGS DISPLAYED Figure 5-8.X MG PRESS ENTER YES OR NO # \ I It SILENC NO YES ENTER n-7 \ J J- CONT SE’lTlNGS: TO CONFIRM ’ YES ’ PRESS HISTORY Q ENTER + THEN LOCK DCOR . Accessing the Three Delivery Mode Display Screens See Figures 5-7. Programming Continuous-Only Delivery. and 5-9. Programming PCA-Only Delivery.. Programming PCA+Continuous Delivery. 4fbOSELfMIT: SET? YES OR NO Figure 5-7. Programming PCA-Only Delivery 0F CONTINUOUS RATE: 4 HR DOSE LIMlT: TOSETlJSEt+ XX-X MG/HR PRESS ENTER r 4 HR DOSE LIMlTz TO SET USE 44 XxX. Programming Continuous-Only Delivery 430-04501-002 (Rev.

the infuser switches to a KVO rate of 0. ln this example. the 4 HR LIMIT REACHED message appears. a full PCA dose will still be delivered even if it results in exceeding the 4 hr dose limit (e. the total delivered is 19 mg.THE 4 HR DOSE LIMIT CONTINUOUS RATE TO SET USE 44 XX. patient requests for boluses are unsuccessful and 4 HB LIMIT REACHED message appears. When the sum of all doses (PCA dose and continuous dose) in the rolling four-hour period equals or exceeds the 4 hr dose limit. If the loading dose is administered during initial setup. and the 4 HR LIMIT REACHED message appears. the infuser will again accept patient-initiated dose requests (PCA and PCA+CON’I’lNUOUS modes) and resume infusion at the continuous rate in the CONTINUOUS and PCA+CONIlNUOUS modes.g. Programming PCA+Continuous Delivery THE 4 HR DOSE LIMIT The 4 hr dose limit is a physician-prescribed value that serves to limit the total dosage that can be delivered in any four-hour period. if the 4 hr dose limit is 20 mg. the full PCA dose will be delivered even though it exceeds the dose limit by 2 mg). the LifeCare 4100 Series 5-Q 430-04501-002 (Rev. it will not be included in the 4 hr dose limit. As the oldest dose ages out of the four-hour dose record. In the CONTINUOUS or PCA+CONTINUOUS mode. The loading dose is always included in the total dose delivered.X MG/HR PRESS ENTER + / \ PCA+CONT. SETTING TO CONFIRM PRESSHISTORY THEN LOCK DOOR 4 HR DOSE LIMIT: TO SET USE t + XXX. In the PCA mode. Note: As the dose delivered reaches the 4 hr dose limit.X MG PRESS ENTER J Q HISTORY SEllNGS DtBPlAYED Figure 5-9. Note: A loading dose is included in the 4 hr dose limit calculation ONLY if it is administered after the 4 hr dose limit has been programmed.. and the patient requests a PCA dose of 3 mg. This optional feature provides added safety to limit the dosage drug delivered in all delivery modes.1 ml&r when the 4 hr dose limit is reached. 10/91) .

1 mL/hr. To erase the 4 hr dose limit data. and the 4 HR LIM REACHED message is displayed.1 mL/hr. the unit will alarm. the continuous infusion remains in progress. the infuser switches to a KVO rate of 0. PCA+CONTINUOUS MODE Infusion is started by pressing the [RESET/STARTl touchswitch after the door is closed and locked. a repetitive “walkingw LED symbol indicates delivery in progress. Note: Setting a new 4 hr dose limit will not erase the previous 4 hr dose history. While in the lockout period. the infuser enters either the preset lockout interval or the 4 HR LIMIT REACHED state (if a dose limit has been selected): further delivery is prohibited in both of these conditions. PCA MODE A patient-initiated PCA dose can be administered using the patient pendant when the three-asterisk message ( l **) appears. When the patient-initiated dose is activated. the PCA dose will continue to completion. 1 O/91) 5-10 System Operating Manual . Upon reaching the 4 hr dose limit. for important information about the drug delivered displays. The patient pendant is disabled in the CONTlNUOUS mode. the infuser enters either the lockout interval or the 4 HR LlMIT REACHED state (if selected). and press (YES] when the CONFIRM TO CLEAR HISTORY AND Rx screen appears before changing the concentration iiom microgram to milligram or vice versa. if selected. 430-04501-002 (Rev. After the PCA dose is completed. The [RESET/STm touchswitch is inactive in the PCA mode. even if the 4 hr dose limit is already reached or will be exceeded after delivery. STARTING INFUSION Note: See DISPLAYS.Section 5 OPERATING THE INFUSER 4 hr dose limit message appears during the PCA dose: however. Note: ln all modes of operation. The patient-initiated doses are permitted if infuser is displaying the three-asterisk message ( ***) (after [ RESET/STARTJ is pressed). After completing the dose. Note: A loading (booster) dose can be delivered anytime during setup or operation. but the patient-initiated dose cannot be activated. Section 3. if the [RESET/STARTJ touchswitch is not pressed within five minutes. the PCA dose is dehvered in addition to the continuous infusion rate. turn the infuser off and on. Note: In CONTINUOUS or PCA+CONTlNUOUS mode. the infuser switches to a KVO rate of 0. In the 4 HR LlMlT REACHED state. CONTINUOUS MODE Infusion is started by pressing [REsET/STm after the door is closed and locked.

CHANGING SETTINGS DURING SETUP During setup. CLEARING DOSE HISTORY Press the IREVlEXV/CHANGEl touchswitch once to display the CLEAR screen. the message display will revert to the previous setting. until the first setting is displayed. press RESET before opening the security door. Pressing IYES] does not clear 4 hr dose limit data. lOI91) . To stop infusion in the CONTINUOUS or PCA+CONTlNUOUS mode. close the slide clamp and press the [RESET/STARTJ touchswitch or open the door and press the (OFF/RECHG] touchswitch. Clearing Dose LiieCare 4100 Series Histoy and Total Delivered 5-11 430-04501-002 (Rev. and press the [OFF/RECHG] touchswitch. If changing a setting during operation (CONTINUOUS or PCA+CONTlNUOUS modes). then press IyES] to the CONFIRM CLEAR HISTORY prompt.STOPPING INFUSION STOPPING INFUSION To stop an infusion in the PCA mode.11. Data shown reflects cumulative history since the last clear dose history event. Clearing Dose History and Total Delivery). CHANGING INFUSER SETTINGS Infuser settings can be changed during setup or operation by using the [REVIEW/CHANGE] touchswitch. then on. IF VOLUME # OH CLEAR 3 DOSE HISTORY AND TOTAL DELIVERED YES OR NO SILENCE NO n J (IF PLUME = 0) I (MODE) SETlING TO CONFIRM PRESS HISTORY THEN LOCK DOOR I (FIGURE 5-l 1) Figure 5-l 0. Each time [REVIEW/CHANGE] is pressed. open the door. Press [YES] to clear dose history and the total delivered value from memory (see Figure 5. Note: If in reset for longer than five minutes without pressing an appropriate touchswitch. To clear 4 hr dose limit data. theunitwillalarm. close the slide clamp. turn the infuser off. simply press [REVIEW/CHANGE] to change a setting. Changing Therapy Settings) will also clear the last 24 hour and the last hour totals. Note: Clearing dose history (see Figure 5.10.

turn the infuser OFF and ON. Note: If the concentration is changed from milligram to microgram. and loading dose data will be erased. which may result in a delay of up to four hours in resuming delivery of chug in all operating modes. Changing Therapy Settings). 430-04501-002 (Rev. 24-hour dose history. The CHANGE? screen is now displayed (see Figure 5. the 4 hr dose limit data will not be erased. To erase the 4 hrdose limit data.11. or vice versa. then press [NO] in response to the CLEAR screen. 1 O/91) 5-12 System Operating Manual . and press (YES] when the CONFlRM TO CLEAR HISTORY AND Rx screen appears before changing the concentration from microgram to milligram or vice versa.Section 5 OPERATING THE INFUSER CHANGING SETTINGS AFTER SETUP After setup is complete. However. total delivered. press the [REVIEW/CHANGE] touchswitch once.

(MODE) SElTlNG TO CONFIRM PRESS HISTORY THEN LOCK DDOR SElllNGS DISPLAYED Figure 5-l 1. IF UG.A02 (Rev. 5194) . Changing Therapy Settings LifeCare 4100 Series 5-13 430-04501. * THIS SCREEN DOES NOT APPEAR WHEN THE INFUSER IS SET IN THE PCA-ONLY MODE. MG ONLY OPTION SELECTED (FlGURE 5-4) J (FIGURE 5-12) (FIGURE 57) l (FIGURE 59) (FIGURE 5-9) (FlGURE 5-Q) I YES OR NO (FIGURE 5-7) (FlGURE S-9) l THIS SCREEN DOES NOT APPEAR WHEN THE INFUSER IS SET IN THE CONTlNUOUS-ONLY MODE.CHANGING SEITINGS AFTER SETUP DDSE HISTORY AND TOTAL DEUVERED 0HI IF DRUGS ONLY OPTION SELECTED OR DRUGS. UC. YG OPTION SELECTED (IF “OLUIME * r-l CHANGE ? ANY SEl-llNGSz/ MODE YES OR NO I .

13 and higher) Service Mode options and their descriptions are listed in Table 5-l. This advances the display to the screens for changing time and date (see Figure 5-12. 430-04501 -A02 (Rev. press [NO] at the CLEAR prompt. Contact the hospital bio-mecl technician if selection changes are desired.Section 5 OPERATING THE INFUSER CHANGING TIME AND DATE To change the time and date. DOBE HLBTGRY AND TGTAL DELIVERED ANY SEmNGw AFFER 6 SECONDS OF NO TOUcHSWlTCH ACTIVITY DATE: FEB109l DATE FEB109l USE t4 OR CHANGE PRESSING REVIEWCHANGE ADVANCES (MODE) SElllNG TO CONFIRM PRESS HIBTORY nME: AM 0959 DATE: FEBlO9l (MODE) SRTlNG TO CONFIRM PRESS HIBTORY THEN LOCK DOOR Figure 512. The infuser provides the following selections via Service Mode: Cl Patient Pendant Tone Cl AM/PM (12 hour) or Military (24 hour) 0 Drug Concentration 0 History Format (available only with software version 3. Screens for Changing Time and Date SERVICE MODE SELECTIONS Note: Service Mode selections should be performed by qualified personnel only. Screensfor Changing Time and Date). Seruice Options. 5194) 5-14 System Operating Manual . press [REVIEW/CHANGE]. and again at the CHANGE? prompt.

demands. UG. partial doses) for each hour in the last 24 hours (unless no activity occurs in any one-hour time period) D LAST 1 & 24 HOUR history format provides a summary of PCA activity in the last hour and the last 24 hours only The default setting is last 1 and 24 hour format RETAINING THE SETUP If already programmed with the drug selection/concentration and therapy parameters. Retaining the Setup). and if turned on in the warm-start mode (see WARM-START VS. the next screen offers the option of using the settings in memory or reprogramming the infuser (see Figure 5-13. The default setting is AM/PM time format Drug concentration The following selections are provided: 0 Fixed drug concentration only (Drugs only) 0 User selectable drug concentration only (UG. only) 0 Both fixed and user selectable drug concentrations (Drugs. MG) The default setting is both fixed and user selectable drug concentrations History format The following selections are provided: 0 HOUR-BY-HOUR history format provides a history of PCA activity (injections. The default setting is pendant tone with the successful delivery of PCA dose AM/PM (12 hour) clock Military (24 hour) clock The infuser clock can be set for AM/PM or Military time format. the infuser does not require programmin g if therapy parameters remain the same. 5l94) . MG. COILXTART.IF DRUGS ONLY OPTlON SELECTED (MODE) SEllING TO CONFIRM PRESS HlSTORY THEN LOCK DOOR Figure 513. Service Options Option Description Patient pendant tone The patient pendant tone can be set to sound only with the successful delivery of PCA dose. or to sound every time the patient pendant is pressed (placebo effect).RETAINING THE SETUP Table 51. . After the purge system prompt is answered. This Section). Retaining the Setup LieCare 4100 Series 5-15 430-04501602 (Rev.

Note: The HOUR-BY-HOUR and the LAST 1 & 24 HOUR history totals represent a dynamic summation of past delivery of drugs and events. 430-04501-A02 (Rev. the number of PCA injections. When the infuser is configured for HOUR-BY-HOUR history format. Section 3). and alarm conditions. the hour and 24-hour periods are approximate only and may. JIgure 5. These events include: PCA doses requested. and patient demands occurring in each one-hour period during the last 24 hours can be displayed or printed.Section 5 OPERATING THE INFUSER HISTORY AND EVENT LOG The infuser stores data on therapy settings. quantity and/or number of doses delivered. but not included in the current printout. Only the one-hour periods with PCA activity are displayed and printed. and chronological record of approximately 200 most recent events occurring during infusion. partial doses.14 shows a sample history printout (in the PCA+CONTlNUOUS mode). Pressing the [PRINT) touchswitch generates a hard copy printout of the data if a compatible printer (Centronics interface) is properly connected (see FRONT PAZVEZ-. Data is accumulated in 10 minute time slots. 5/94) S-16 System Operating Manual . start or stop of continuous infusion. the opening or closing of the security door. Note: PCA requested doses (patient demands) as recorded in the history display and event log may not reflect the total number of demands. Pressing the [HISTORY) touchswitch displays this data on the LCD. When the Infuser is configured for LAST 1 & 24 HOUR history format. in fact.] Note: Events occurring while printing is in progress are stored in memory. (Maximum of 100 patient demands per 10 minute interval. PCA activity totals in the last hour and in the last 24 hours are displayed and printed. represent as small as 50 minutes of data for the LAST HOUR total and 23 hours 50 minutes for the LAST 24 HOUR total. the change of any settings. the amount delivered. the last 10 minute time slot may represent anywhere from 0 to 10 minutes of data. At any given time. Therefore. TOUCHSWITCHES.

HISTORY AND EVENT LOG r- ************ * LIFECARE 4100 * HOUR-BY -HOUR: * PATIENT RECORD l **.. . .5 MG AM 11:17 START INF.0 MG 1.5 MG/HR 4 HR LIMIT 10. . A PARTIAL DOSE OF . . . .2 MG + AM 11:26 PRINTOUT AM 11:26 PAT.... 12:21 FEB 10 94 FEB 10 94 0 3 1 FEB 10 94 1 MODE: PCA+CONTINUOUS ---::::::r’ / SETTINGS: / EVENT LOG: CONC 1 MG/ML PCA DOSE 0..5 MG WAS DELIVERED 0. AM 09:26 PCA DEMANDS PCA INJECTED PCA PARTIAL DRUG ADMINISTERED: . ...2 MG 8..2 MG 9407Aoo3 Figure 5-l 4. .. ..0 MG 8. DEMAND AM 11:26 4 HR LM RCHD AM 11:26 PAT..********** AM 11:26 PCA DEMANDS PCA INJECTED PCA PARTIAL PAT1 ENT NAME : ..7 MG VERIFIED BY: ************ END OF RECORD ************ LAST 24 HOURS: PCA DEMANDS 6 PCA INJECTED 10 PCA PARTIAL 1 LOADING DOSE DL TOTAL + DUE TO AN OCCLUSION ALARM DURING DELIVERY.A02 (Rev. DELIVR 0.. DELIVR 0. AM 11:17 INF RST ALM AM 11:17 OCCLUSN ALM AM 11:17 PAT. .2 MG LAST 1 HOUR: PCA DEMANDS PCA INJECTED 3 PCA PARTIAL LOADING DOSE DL TOTAL 0 1 ************ 0.7 MG 1.. PATIENT IO: . Sample History Printout (in PCA+CONTINUOUS Mode) LiieCare 4100 Series s-17 430-04501.0 MG DELIVERED: LOADING 0.2 MG OUT OF A PROGRAMMED ....0 MG TOTAL 8. 5/94) .. ..5 MG LOCKOUT TIME 5 MIN RATE 0....

STATUS MESSAGES Displayed status messages are defined in Table 6-1. which is a continuous tone. audible tone (a Morse code AA signal. 5194) . short-long. i. the system performs the following actions: Cl The current display message is saved. D A flashing alarm message appears on the display (see Table 6-2). short-long) sounds with all alarms except MALFUNCTION. Table 6-l.e. The message remains until the lockout interval elapses. This message appears only when the security door is locked in the PCA or PCA+CONTINUOUS mode 4-HR LIM REACHED Displayed if 4 hr dose limit has been selected and reached with security door locked l ** PCA CONTINUOUS PCA+CONTINUOUS INFUSER IN RESET Indicates that patient can initiate a dose in PCA or PCA+CONTINUOUS mode Displayed when infuser is in PCA mode Displayed when infuser is in CONTINUOUS mode Displayed when infuser is in the PCA+CONTINUOUS mode 1 Displayed when infuser is stopped.Section 6 MESSAGES AND ALARMS The LifeCare PCA PLUS II Infuser is programmed to display status and alarm messages and to sound an audible tone for most alarm conditions. (The audible tone LifeCare 4100 Series 6-l 430-04501 -A02 (Rev. Status Message Definitions I Message DOOR LOCKED Definition I I Displayed for 30 seconds when security door is closed and locked PATIENT LOCKOUT displayed after a successful patient-initiated dose delivery.. These messages and alarm conditions are described below. but door is locked INFUSER ALARM SYSTEM During an alarm condition. Ll A repetitive.

) Note: The infuser stops delivery when any of the following alarms occur: CHECK VIAL. OCCLUSION. 430. If the malfunction repeats. press the lSILENCE/NO] touchswitch. if possible. or high by a switch on the rear panel of the infuser. or MALFUNCTlON. lf an a&m is muted and a second alarm condition occurs during the muting period. CHECK SYRINGE. an audible alarm signaling the new condition will immediately occur. remove infuser from service. 5194) 6-2 System Operating Manual . All alarms except the MALFUNCTION.Section 6 MESSAGES AND ALARMS volume is adjustable to low. The original display message will be restored. the alarm with the shortest muting period will take priority and be displayed first.04501.A02 (Rev. CHECK INJECTOR. and CHECK SYRlNGE alarms can be muted. Note: lf the MALFUNCTION alarm sounds. EMPTY SYRINGE. then follow the displayed prompts. SILENCING AN ALARM To silence an alarm. In the went two or more alarm conditions simultaneously occur. medium. CHECK INJECTOR. and press [RESEI’/STm to resume operation. press [OFF/RCHRG] touchswitch to silence the alarm and turn the infuser off. Clear the cause of the alarm. CHECK VIAL. Refer infuser to the hospital’s technical support or contact the Abbott Technical Service Center at l-800~ABBOTT-3.

Make sure PCA dose is less than 4 hr dose limit DOOR OPEN Two minutes The security door has been left open for more than two minutes without touchswitch activity Close and lock security door if all therapy parameters are entered or press [SILENCE] touchswitch to clear the alarm LifeCare 4100 Series 6-3 430-04501-002 (Rev. Infusion Alarm/Action Table Message Possible Cause Muting Period Action CHECK VIAL (Audible delay 30 seconds) None Vial is improperly installed or missing Properly insert the vial into the vial retainer CHECK INJECTOR (Audible delay 30 seconds) None Injector improperly installed or missing Properly insert injector in the driver/retainer assembly CHECK SYRINGE (Audible delay 30 seconds) None Syringe (vial and injector) improperly installed or missing properly insert vial injector in their proper retainers EMPTY SYRINGE Five minutes The syringe is empty Press the [SILENCE] touchswitch to clear the alarm. Prepare vial/injector. 1 O/91 ) .INFUSER ALARM SYSTEM Table 6-2. Open security door CHECK SETTINGS One minute The Security door is closed and locked before set-up is complete Open the door and verify all settings are proper and entered CHECK 4-HR LIMIT One minute The security door is closed and locked and 4 hr dose limit is set less than PCA dose. Unlock and open security door and turn infuser off.

or closed clamp INFUSER IN RESET Five Minutes Operator pressed the [RESET/START] touchswitch when security door was locked (in CONTINUOUS or PCA+CONTINUOUS mode) and delivery was in process or [RESET/START touchswitch was not pressed after the door was locked in CONTINUOUS or PCA+CONTINUOUS mode LOW BATTERY (Battery symbol will flash) Ten minutes (first two alarms.Section 6 MESSAGES AND ALARMS Table 6-2. Identify and correct the cause of occlusion. an occlusion alarm is reported otherwise l Battery is near discharge level Action Open security door. the delivery is resumed after a short delay. Relieve back-pressure by squeezing and releasing the cradle release handles. if occlusion pressure is reached during PCA dose delivery. Alarm will self-correct Press the [RESET/START] touchswitch to resume delivery Connect line cord to a hospital grade 11 O-l 20 VAC outlet * Note: INFUSER IN RESET message also appears after an alarm condition has been cleared. Press the IRESET/STARTJ touchswitch to resume operation. cannot be silenced a third time). Infusion Alarm/Action Table Message Muting Period Possible Cause One minute Kinked or occluded tubing. if closed. occluded venipuncture device. The unit turns itself off in response to battery discharge condition OCCLUSION Note: In the PCA or PCA+ CONTINUOUS mode. the occlusion clears. 10191) 6-4 System Operating Manual . 430-04501-002 (Rev.

INFUSER Al-ARM SYSTEM Table 5-2. If malfunction repeats. Infusion Alarm/Action Table Message MALFUNCTION XX (Various error codes will be displayed in place of XX to help identify the cause) LifeCare 4100 Series Muting Period None Possible Cause Electronic circuit an&or software failure 6-5 Action Note the malfunction code displayed. 1 O/91 ) . remove infuser from service 430-04501-002 (Rev. Press the [OFF/RECHG] touchswitch to silence alarm and turn infuser off.

A02 (Rev. naloxone and other resuscitative drugs. oximetry. Remove all air from vial before installing into infuser. Adequate monitoring equipment. 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. but may create artifacts on voltage sensing equipment such as ECG. These potentials are well within accepted safety standards. 5194) . Refer to the appropriate monitoring system documentation for setup and maintenance instructions. set the infusion device so that it is temporarily not delivering fluid. ln addition. oxygen. Do not load vial into upper vial clip first. DELAYED RESPIRATORY DEPRESSION FOLLOWING CONTINUOUS EPIDURAL ADMINISTRATION OF PRESERVATIVE-FREE MORPHINE SULFATE HAS BEEN REPORTED. failure to LiieCare 4100 Series 7-l 430. i. The system must be primed prior to purging. Proper epidural placement of the catheter is essential since catheter migration could result in intravascular or intrathecal administration.04501.” Failure to identify the infusion system as epidural could result in incorrect administration of intravenous rather than epidural formulations. lf the monitoring machine is not operating correctly or has loose or defective connections to its sensing electrodes. Proper setup and maintenance of the monitoring equipment should eliminate the artifact. These artifacts vary at a rate that is associated with the infusion rate. Disappearance of the abnormality indicates that it was probably caused by electronic noise generated by the infusion device.transient neuralgia 0 Drug overdose It is strongly recommended that the epidural infusion system be prominently identified as “EPIDURAL. EMG and EEG machines. Vial lip may crack or chip. Facilities practicing continuous epiduml administration must be equipped with resuscitative equipment.disorientation . Cracked vials may not show evidence of leakage until delivery pressure is applied. low level electrical potentials are commonly observed when fluids are administered using infusion devices. If overdelivery occurs during administration. Epidural administration of drugs by PCA and/or CONTINUOUS modes should be hmited to personnel familiar with associated techniques and patient management problems. is recommended for continuous monitoring of the patient during epidural administration.Section 7 OPERATIONAL PRECAUTIONS Nonhazardous. observe the patient closely for signs of: 0 Compression on spinal cord .headache . Patients must be observed for side effects frequently in a fully equipped and staffed environment for at least 24 hours following completion of drug administration by the epidural route.e.

the 4 hr dose limit data will not be erased. press [OFF/RCHRG[ touchswitch to silence the alarm and turn the infuser off. Refer to drug package insert for Perform adequate patient monitoring at all times. precautions and possible adverse reactions. To avoid mechanical or electronic damage. long-term portable operation. mg/mL values or to the nearest Always close slide clamp on PCA administration set before removing or replacing syringe. Do not use abrasive cleaners. lf the MALFUNCTION alarm sounds. Selections are rounded up to nearest tenth of a digit for digit for ug/mL values. A loading (booster) dose can be delivered at any time during setup or operation. Do not immerse the infuser in fluids. which may result in a delay of up to four hours in resuming delivery of drug in all operating modes. A loading dose is included in the 4 hr dose limit calculation ONLY ifit is administered after the 4 hr dose limit has been programmed. Use Abbott LifeCare PCA Set List 6517 whenever the infuser is in CONTINUOUS or PCA+CONTlNUOUS modes. or radiatio The PCA PLUS II infuser is not intended to be used for frequent.Section 7 OPERATIONAL PRECAUTIONS identify the epiduml infusion system could result in confusion with other infusion systems delivering concomitant intravenous formulations. Failure to use compatible Abbott vial/injector and Abbott PCA sets may cause an inaccurate dose delivery to the patient. 430-04501 -A02 (Rev. do not immerse the pump in any fluids or cleaning solutions. If the concentration is changed from milligram to microgram. steam. If the malfunction repeats. These compounds are known to slowly degrade components made from polycarbonate materials. which may scratch transparent door. Setting a new 4 hr dose limit will not erase the previous 4 hr dose history. wen if the 4 hr dose limit is already reached or will be exceeded after delivery. Potent analgesic medications are used with this device. 24-hour dose history. lf the loading dose is administered during initial setup. and loading dose data will be erased. Use only compatible Abbott PCA administration sets with Integral Anti-Siphon Valve with the LifeCare PCA PLUS II Infuser. 5194) 7-2 System Operating Manual . and reserve battery power for temporary portable operation and emergency backup. Do not use alcohol as a clean Do not sterilize by heat. The loading dose is always included in the total dose delivered. Cleaning solutions containing “dimethyl benzyl ammonium chloride” or “phenyl” compounds are not recommended. or vice versa. Keep the infuser plugged into a hospital-grade AC receptacle whenever possible. However. ETO. total delivered. and before discontinuing infusion. it will not be included in the 4 hr dose limit. remove the infuser from service.

At flow rates less than 0.3 set from patient during the compliance step if this amount of fluid would represent a hazard to the patient. Refer to analgesic package enclosure for possible incompatibility with fluid or drug being delivered through the KVO line. there may be a significant delay before flow is established if system is not purged.6516 or a combination of List 6514 and List 6517. Such objects may damage the touchswitches and cause a malfunction.04501. under/overdosage may result. Explosion hazard exists in presence of anesthetics. or tigernails to press touchswitches. scissors. Do not use sharp objects such as pens. DiscoMect mL of fluid may be administered to the patient after a vial Up change. cords. Arrange tubing.5 mL/hr. Stop purging after flow is seen at end of PCA set. Valve functionality may be compromised by the presence of residue. Confirm that the entered concentration (rng/mL) or (l@nL) and drug name exactly matches the concentration value and drug name on the vial. Patient must be disconnected from the PCA set before the purge cycle. use battery power. Use Abbott LifeCare PCA Set List 3559.A02 (Rev. lf they do not match. a KVO line must be attached to the distal backcheck ‘Y” site to maintain patency of venipuncture device.&Care 4100 Series 7-3 430.When using PCA or PCA+CONTlNUOUS mode. colloidal suspensions and emulsions should not be delivered through the inhne backcheck valve on the KVO side of the PCA set. If a properly grounded AC-line source is in doubt. 5194) . to 0. Always connect the infuser to a properly grounded hospital-grade receptacle unless battery operation is desired. I. It is recommended that highly viscous solutions and drugs. and cables to minimize the risk of patient strangulation or entanglement.

Cleaning Solutions Cleaning Solution Manufacturer Preparation Cidex@ Arbrook Laboratories Vesphene@ II se Calgon Vestal Laboratories Per manufacturer’s recommendation Manu-Klenz@ Calgon Vestal Laboratories Per manufacturer’s recommendation Formula Cm DuBois Chemicals Per manufacturer’s recommendation Super Edisonite@ S. proceed as follows: m Turn off infuser and disconnect power cord.g. pencils. m Clean the exposed surfaces of the infuser with a soft. 5194) . Do not immerse the infuser in fluids or cleaning solutions. or needles) to clean the infuser. Do not sterilize by heat. Do not use compounds containing combinations of ispropyl alcohol and dimethyl benzyl ammonium chloride. ETO. lint-free cloth dampened with one of the cleaning solutions listed in Table 8-1. paper clips. Using abrasive cleaners or cleaning solutions not recommended by Abbott Laboratories may result in product damage. pens. steam. Do not use sharp objects (e. Per manufacturer’s recommendation Household bleach Various One part bleach in four parts water LifeCare 4100 Series 8-l Per manufacturer’s recommendation 430-04501 -A02 (Rev. Establish a routine schedule for cleaning the infuser case and front panel To clean the infuser. M. Table 8-1. Do not use alcohol as a cleaning agent Some cleaning and sanitizing compounds may slowly degrade components made from some plastic materials.. Cleaning Solutions. Edison Chemical Co. or radiation.Section 8 CLEANING THE INFUSER CAUTIONS: Do not use abrasive cleaners which may scratch transparent door.

the battery pack may need replacement. provided it is plugged into rated AC power. SWITCHOVER The infuser automatically switches to battery power without interruption whenever the infuser is disconnected from the AC line. RECHARGING After the battery discharges to the LOW BATTERY operative limit. If the battery fails to recharge adequately after 16 hours. lead-acid.Section 9 BATTERY OPERATION AND MAINTENANCE A four-cell. OPERATING TIME A new battery at full charge should operate for at least four hours of continuous operation and deliver at least 30 mL of solution before a LOW BATTERY alarm. the battery will recharge to at least 80% of its charge capacity in 16 hours. After the alarm. long-term portable operation. Note: The PCA PLUS ll Infuser is not intended to be used for frequent. when AC voltage is interrupted. 8 V battery pack permits portable infuser operation and provides backup power during AC-line failures. the infuser should continue to operate for approximately 30 minutes before the system completely shuts down. and reserve battery power for temporary portable operation and emergency backup. sealed. The battery symbol on the front panel is illuminated when the infuser is operating on battery power. LifeCare 4100 Series 9-l 430-04501-002 (Rev. 10/91) . or when AC voltage falls below that required for operation. Keep the infuser plugged into a hospital-grade AC-receptacle whenever possible.

1 x concentration (mg/hr or pg/hr) to 20.1 mL/hr 5 to 100 minutes in l-minute increments 10 to 20 psig 10 to 40’ C (50 to 104O F) ambient temperature 1 lo-120 VAC.0 x concentration (mg/hr or ug/hr] Variable from 0. 50/60 Hz.1 x concentration (mg/hr or ug/hr) to 20.250 amperes.0 x concentration (mg/hr or pg/hr). 25 W 0. + PCA dose (mg) 0. four-cell sealed lead-acid rechargeable battery pack.Section 10 SPECIFICATIONS Dimensions: Weight: 21cmx84cmx15cm@“widex13”highx6”deep] 7 kg (15 lb) Drug Concentration Settings: See Section 11 Delivery Rate: See Section 11 PCA Mode: CONTINUOUS Mode: PCA+CONTlNUOUS Mode: IWO (Eeep Vein Open) Rate: Lockout Interval Range: Backpressure Range: Operating Environment: Power Requirements: Fuse: Battery: Power Cord: LifeCare 4100 Series Approximately 1 mL in 35 seconds Variable from 0. When fully charged. a battery will typically provide a minimum of four hours of operation. A nominal 3-meter (1 O-foot) l&-type line power cord with integral transparent three-prong hospital-grade connector lo. 10/91) .1 430-04501-002 (Rev. time lag One 8 VDC.

Section 10 SPECIFICATIONS Electrical Safety: Administration Sets: 4-30-04501-002 (Rev. 10191) Meets UL 544 and CSA 22.2 standards Use only compatible Abbott PCA sets with integral Anti-Siphon valve 10-2 System Operating Manual .

5 50. Table 11-l. specific to a delivery mode. PCA Mode Prescription Parameter Limits Morphine Sulfate 1. and continuous delivery rate parameters will vary with the drug and concentration selected.0 n g/mL Ilower upper lower upper Loading Dose (in mg) 0. cont. 0.1 and 1. Each table is See Tables 1 l-l through 1 l-3 for listings of the lower and upper limits. 10/91) .1 x 5x 0. 0.1 mg/mL to 10.1 x 30 x 0.0 0. Note: Drug and concentration selections are rounded up to nearest tenth of a digit for mg/mL values or to the nearest digit for pg/mL values.5 mg/mL 10. 4-hour dose limit.0 Morphine Meperidine Sulfate HCL 0.0 mg/mL lowerlupperllowerlupper -ccc 0.1 5.1 mg/hr for concentrations between 0.0 mg/mL.0 mg/mL Marl bhine su ate 5.0 PCA Dose (in mg) 0. cont. cont. PCA dose. Minimum delivery rate is 0.o 100.1 x 30 x cont.’ cont.5 25. cont.0 4 Hr Limit (in mg) 1 .1 x 5 x cont.1 x 10x cont.1 x 10x 0.1 10.0 0. cont. cont. * Concentration LifeCare 4100 Se&s 11-l 430-04501-002 (Rev.1 5.Section 11 PRESCRIPTION DELIVERY LIMITS Prescription delivery limits for loading dose.0 Other Rx 0. cont.0 mg/mL Other Rx 1 pg/mL to 100 pg/mL lower “Ppe’ lower upper 0. cont.

O mg/mL Morphine Sulfate 5.0 0.1 5.0 100. cont.5 1oo.5 25.0 1. PCA+CONTlNUOUS Mode Prescription Parameter Limits Morphine Sulfate 1 .0 0.1 15.0 1.0 0.1 x 30 x cont.1 x 30 x 0.5 100.1 x 10x 0.1 10.1 0.0 0.’ cont. cont.5 150.0 0. cont. cont. 1 O/91) 11 -2 System Operating Manual .0 200. 10.0 1. cont. T t * Concentration Table 11-3.1 x 20 x 0.1 mg/mL to 10. cont.0 1. * Concentration 430-04501-002 (Rev.5 50. PCA Dose (in mg) 0.0 0.1 5. cont.0 mg/mL 1 -L I ower m 1 ‘PPe’ r I JPPe rl lowet upper lower lowei “Ppel IoweJ UPpe’ Loading Dose (in mg) 0.0 0.0 0.0 0.1 x 10x cont.0 mg/mL Other Rx 1 jJg/mL to 100 pg/rnL T lower upper lower Loading Dose (in mg) 0.1 x 20 x 0.0 0.0 300.c 0.0 0.1 x 20 x cont.1 x 30x 0.1 x 20x cont.Section 11 PRESCRIPTION DELIVERY LIMITS 1 Table 11-2.0 0.1 >ONTlN- uous Rate (in m9) 4Hr Limit (in mg) “Ppe’ 5. cont.0 1. cont.1 20.0 100.0 0.1 2.1 10.1 30. cont.1 mg/mL 1 pg/mL to to 100 jJg/mL 10.1 x 5x cont. cont.0 1.1 x 5x 0. CONTINUOUS Rate (in mg) 0.5 uppei lower upper lowei r UPpel lower uppei lower 50. cont.1 x 10x 0.1 0.0 50.1 x 10x cont.0 0.1 x 30 x cont.0 mg/mL Morphine Sulfate 5.0 0.0 200.5 150-c 0. cont.* cont. cont.0 0. cont.1 10. cont.0 mg/mL 1 Other Rx Other Rx 0. 4Hr Limit (in mg) 0.0 0.0 300.0 0. cont. CONTlNUOUS Mode Prescription Parameter Limits Morphine Sulfate 1 .1 20.1 30. 15. cont.0 0. cont.5 1.O mg/mL Other Rx 0.

USP CII. Mini-Bore with Integral Anti-Siphon Valve. Preservative-Free (1 30 mL. Mini-Bore with integral Anti-Siphon Valve-SL. Approximate Priming Volume 1. and EPIDURAL CATHETERS List 1193: Nylon epidural catheter. with catheter adapter and luer plug PCA DRUGS FOR INTRAVENOUS. open-end. 86 inch (2 18 cm). Approximate Priming Volume 2. 67 inch (170 cm). mg/mL). For use in CONTINUOUS and PCA+CONTINUOUS modes via intravenous route Epidural Administration: For use in PCA.5 List 2028: Morphine Sulfate Injection. Mini-Bore with Integral Anti-Siphon Valve-SL. EPIDURAL USE USP CII. For use in PCA mode via intravenous route List 6514: PCA Extension Set with Backcheck Valve-SL. non-radiopaque. Approximate Priming Volume 1. EPIDURAL USE List 3559: PCA Set.1 mL.2 mL. PCA+COZUllNUOUS modes via epidural route.1 mL. with catheter adapter and luer plug List 6947: Teflon epidural catheter. 20G. 80 inch (203 cm).Section 12 ADMINISTRATION EQUIPMENT ADMINISTRATION SETS FOR INTRAVENOUS. 30 mL.0 mL. For use in conjunction with Set 65 17 to convertfiom CONTINUOUS to PCA mode via intravenous route List 6516: PCA Set-Long. For use in PCA mode when extra length needed via intravenous route List 6517: PCA Continuous Infusion Set. 10/91) . For intravenous administration List 2029: LifeCare 4100 Series Morphine Sulfate Injection. 10 inch (25 cm]. Approximate Priming Volume 2. Preservative-Free (0. CONTZNUOUS. 20G. closed-end. 430-04501-002 (Rev. For intravenous administration 12-1 mg/mL).

Section 12 ADMINISTRATION EQUIPMENT List 6023: Morphine Sulfate Injection. For intravenous administration List 6021: Sterile Empty Vial and Injector. USP CII (1 mg/mL). 30 mL. For intravenous administration List 6028: Morphine Sulfate Injection. 10/91) 12-2 System Operating Manual . For intravenous administration List 6030: Meperidine Hydrochloride Injection. USP CII (10 mg/mL). 30 mL. 30 mL. 30 mL 430-04501-002 (Rev. USP CII (5 mg/mL).