Abbott Omni-Flow 4000 User manual

Download

IV Medication Management System

For use with list 40051-04

System

Operating

Manual

Abbott

Laboratories North Chicago, IL 60064 USA

430-0637

1 -CO4 (Rev.

8/W

VERSION

1.11

SERIES

Section 1 INTRODUCTION

- 1

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

1.1 FEATURES OF THE

1.2

SAFETYFEATURES

1.3

WARNINGS,CAUTIONS,ANDNOTES

MEDICATION MANAGEMENT SYSTEM

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

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

1.4 INSTRUMENT INSTALLATION PROCEDURES

1.4.1 UNPACKING INSTRUCTIONS

1.4.2 INSPECTION

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

1.4.3 40OOPLUSSELFTEST

1.4.4 PRINTERSETUP

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

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

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

Section 2 EQUIPMENT DESCRIPTION

2.1 BACKLITDISPLAYSCREEN

2.2 ESCAPEFUNCTION

2.3 BASESCREEN

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

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

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

2.4 PROGRAMMING INPUT INDICATOR (CURSOR)

2.5 LED STATUS INDICATORS

2.6 NOTATIONAREAS

2.7 PRINTER

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

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

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

Section 3

SETUP . . . . . . . . . . . . . . . . . . . .

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

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l-2 l-3

l-4 l-4 l-4

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

2-l 2-l 2-l

2 2-3 2-4

3.1 SETUPPROCEDURES

3.1.1 RESTOREPREVIOUSPROGRAMMING

3.1.2 INITIATE NEW PROGRAMMING

3.1.3

RESPONSETOLOWBAlITERYCONDI’TION

3.2 PRIMING PROCEDURES: PRIMARY ADMINISTRATION SET

3.2.1 CASSE’ITEPRIMINGMODES CASSETTEPOWERPRIME(LINEA). GRAVITYPRIME

3.2.2

3.2.1.1

3.2.1.2

PRIMINGTHECASSETI’E

3.2.3 PATIENTLINEPRIMINGMODES

3.2.3.1

PATlENTLINEPOWERPRIME

3.2.3.2 PATIENTLINEGRAVITYPRIME

3.2.4 PRIMINGTHEPATIENTLINE.

3.2.5

CASSE-ITE~ST

3.2.5.1

3.2.5.2

CASSE’lTETESTFAILED

CASSE’ITETEST

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

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

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

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

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

SATISFACTORY

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

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

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

...........

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

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

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

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

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

3.3 PRIMING PROCEDURES: PRIMARY ADMINISTRATION SET WITHGRAVITYFLGWPREVENTIONVALVE

3.4 PRIMING PROCEDURES: SECONDARY ADMINISTRATION SET

3.5 CONNECTINGASYRINGETOTHECASSE-ITE

3.6 CONNECTING A SYRINGE AND SYRINGE ADAPTOR TO THE CASSETTE

3.7 REMOVINGTHE CASSETTE

FROMTHE DEVICE

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

........

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

...

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

3 3 3 3

3-l 3-2

3 3-3

3 3-6 3-6 3-6 3-6 3-7 3-7

3 3-7 3-8 3-8

3-9

2 4

Omni-Flow 4000 Plus

Medication Management System

iii

430-06371-004 (Rev.

4/!33)

Contents

Section PROGRAMMING

4.1 MAINTENANCE INFUSIONS

4.2 CONTINUOUS INFUSIONS

4.2.1

ML/HRINFUSIONS.

4.2.1.1 PROGRAMMING OR CHANGING AN

4.2.1.2 CHANGING AN UNITOFMEASUREINFUSION

4.2.2 ALTERNATE UNITS OFMEASURE

4.2.2.1

PROGRAMMING A NEW ALTERNATE UNIT OF MEASURE INFUSION

4.2.2.2 CHANGING

4.2.2.3 CHANGING AN ALTERNATE UNIT OF MEASURE INFUSIONTOML/HRINFUSION

4.2.3 CHANGINGTHEGLOBALBODYWEIGHT

4.2.4 CONCURRENTFLOW..

4.3 INTERMITTENT INFUSIONS

Section 5 ADDITIONAL OPERATING FEATURES

TOSTOPANYOFTHELINES

5.1 HOLDANDRESUMEFUNCTIONS

5.2

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

5.2.1 HOLDINDMDUALLINESORALLLINES

5.2.2 RESUMEINFUSIONSAFTERHOLD

LINESIJATUSFUNCTION

5.3 SPECLAL

5.4

5.4.1

AUTOMATIC AIR DETECTION AND ELIMINATION

5.5

EMPTYINGTHECOLLECTIONBAG

5.6

BA?TERY

5.7

ACCESSING HISTORY REPORTS

5.8

5.8.1

FUNCTIONS.

DESCRB?-I’ION

OPERATION

ACCESSING HISTORY REPORTS WITHOUT A PRINTER

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

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

OF SPECIAL FUNCTIONS

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

5.8.2 ACCESSING HISTORY REPORTS

5.8.2.1

5.8.2.2

DEVICESTATUSREPORT. IVHISTORYREPORT

ML/HR

INFUSION TO AN ALTERNATE

ALTERNATE

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

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

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

WITH

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

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

ML/HR

INFUSION

(MCG/KG/MIN)

INFUSIONS

. . . . . . . . . . _ . . . . . . . . . . . . . . . .

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

UNITOF MEASURE INFUSION

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

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

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

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

........

A PRINTER

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

..........

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

4-2

. . .

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

. . . . . . . _ . . . . . . . . . . . . .

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

. . . . . . . . . . . . . . . . . _ . . . . . . . .

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

4-3

. . . .

4-5

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

4-6

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

4-7

5 5- 5 5 5 5 5-14 5-

5-l 5-2 5-2 5-3 5-3

5 5

12 13 13 14

Section 6

ALARMCONDITIONSANDDISPLAYS

6.1

FLUIDDELIVERYALARMS

6.2 PUMPING

6.3 WARNINGALARMS

Section

ALARMS..

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

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

TROUBLESHOOTING

7.1 TROUBLESHOOTING GUIDE

Section 8 CLEANING AND DISINFECTING

430-06371-804 (Rev.

7195)

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

6-l

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

6-2

..6- 3

6-3

. . . 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

System Operating Manual

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

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

Section 9

WARNINGS, CAUTIONS AND PRECAUTIONS

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

Contents

9-l

9.1 WARNINGS.

9.2 CAUTIONS

9.3 PRECAUTIONS

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

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

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

Section 10

SERVICE AND PERFORMANCE INFORMATION . . . . . . . . . . . . . . . . . . . .

Section 11

4oooPLussETs

IVADMINISTRATIONSETS

11.1

11.2ACCESSORY

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

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

SETS

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

Section 12

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

Section 13 KEYPAD

DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9-l 9-2 9-3

11 11-2

Section 14

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

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.

Omni-Flow 4000 Plus IV Medication Management System

(Rev.

8/96)

430-06371

-CO4

Section 1

INTRODUCTION

The Omni-Flow 4000

Omni-Flow 4000, with added data communications capability and new data entry screens which

incorporate automatic calculation, plus programming from alternate units of measure entry.

Plus IV Medication Management System incorporates all the features of the

1.1 FEATURES OF THE IV MEDICATION

MANAGEMENT SYSTEM

Incorporating microprocessor electronic design and safety features, the 4000 Plus represents a

major advance in instrumentation for the delivery and management of intravenous therapy. The 4000 Plus includes the following capabilities of the Omni-Flow 4000:

Four-channel medication delivery through a single patient line Programmable Multi-dose containers Programmable automatic in-line dilution Programmable automatic flushing between incompatible medications Any combination of both continuous and intermittent infusions Real-time clock

irom

Infuses Automatic air detection and elimination Needleless connections

combinations of bags, bottles. and syringes

Additional capabilities of the 4000 Plus include:

ail

Programmable in

RS-232 communication (for printers)

Date/time stamp (optional) of blood chemistry, hematology, vital signs, and other medication administration

Detailed documentation, through the following printed reports (on demand):

Device Status Report:

Line status A, B, C, and D (ON, OFF, PGM, HLD, INF, Dilution and flush data Current infusion regimen details Time and volume remaining in dose

IV Flow Sheet

Omni-Flow 4000 Plus IV Medication Management System

Mcg/Kg/Min

channels

l-l

DLY)

430-06371-004 (Rev.

4/93)

Section 1 INTRODUCTION

IV History Report:

Line mode changes: off, on, intermittent infusion, hold, dilute, delay, flush, KVO,

programmed

Records details of infusion: as programmed, actual delivered, regimen changed Records non-infusion event documentation: blood, hematology, blood chemistry,

vital signs All events date/time stamped

Programming and

Selective hold for each medication

Advanced programming to preprogram all lines and place lines on hold

Automatic power prime of Line A for minimum solution waste

Prioritized alarms stacked and presented sequentially for resolution

Additional alarms: full collection bag, transfer to battery, external communications fault

User selected power-up defaults:

memory

retention following power OFF

IineD

until

needed

- Time: 12-hour AM/PM or 24-hour military format

KVO:

to 99.9

mL/hr,l.O

1 to 12 psi (in 1 psi increments)- Patient line occlusion alarm

- Units of temperature: degrees Centigrade or Fahrenheit Callbacks-

Local display of IV History Report on LCD Display

1.2 SAFETY FEATURES

The 4000 Plus

maximiz

The device automatically performs a when the [ON/CHARGE] switch is placed in the ON position

ION/CHARGEl

If the most recent during power up (see Section 3.

The device maintains duplicate programming memory.

information does not match, the device alarms A two-step procedure is required to remove the cassette from the device To change pumping instructions (rates, volume, stopping lines), two keys must be pressed

in order A comprehensive self test

cassette, and interface. This 36-second cassette test is activated every time the [PRIME PATIENT LINE) (ENTER) key sequence is pressed

progr

safety and reliability with the following features:

self

test of its electrical and mechanical components

switch is turned to CHARGE during infusion, the device retains the

amming

and infusion data in a nonvolatile memory. The data is reinstated

procedures)

Setup

If the duplicate programming

identiiies

a variety of potential malfunctions within the device,

Note: The user can bypass the cassette test; however, Abbott Laboratories recommends the routine use of this test.

430-06371-004 (Rev.

4/93)

l-2

System Operating Manual

1.3 WARNINGS, CAUTIONS, AND NOTES

1.3

WARNINGS, CAUTIONS, AND NOTES

Throughout this manual, three types of alert messages are used: warnings, cautions, and notes,

as described below. Pay attention to all alert messages.

WARNING

A WARNING CONTAINS SPECIAL SAFETY EMPHASIS AND MUST BE OBSERVED AT ALL

TIMES.

FAILURE TO OBSERVE A WARNING IS POTENTIALLY LIFE THREATENING.

CAUTION: A CAUTION information that could prevent irreversible damage or hardware failure. Neglecting to pay attention to a CAUTION could result in serious injury.

Note:

A Note highlights information that helps explain a concept or procedure.

usuaIly

appears in front of a procedure or statement. It contains

1.4 INSTRUMENT INSTALLATION PROCEDURES

utilize

In order to fully the System Operating Manual prior to use.

PRODUCT DAMAGE MAY OCCUR UNLESS PROPER CARE IS EXERCISED DURING THE

UNPACKING AND INSTALLATION PROCESS. THE BATTERY PACK MAY NOT BE FULLY CHARGED UPON RECEIPT. TEST.

Note:

Instrument

4000 Plus capabilities. it is important to become thoroughly familiar with

WARNING

FAILS THE SELF

instahation

should be performed by qualified personnel only.

DO NOT PLACE THE DEVICE IN SERVICE IF

1.4.1

UNPACKING INSTRUCTIONS

Each shipping carton should contain the following items:

Omni-Flow 4000 Plus IV Medication Management System with attached power cord

Omni-Fiow

Carefully remove the device from the shipping carton. The carton should be retained in the event the device needs to be shipped.

Omni-Flow 4000 Plus IV Medication Management System

4000 Plus System Operating Manual

430-06371-004 (Rev.

4193)

Section

INTRODUCTION

1.4.2

INSPECTION

Inspect the packing container for visible shipping damage.

the delivering carrier immediately.

Freight claims or insurance claims must be

Should any damage be found, contact

filed

within seven

days. Inspect the device for damage.

Do not use the device if it appears to be damaged; contact the

Abbott Laboratories Technical Service Center.

CAUTION: If device appears to be damaged, do not operate: return for service.

Plug the power cord into a 1

lO/

120 volt AC outlet. The device is ready for immediate AC use.

not operate the device on battery power until it has been plugged into an electrical outlet for at least 24 hours.

Locate the [ON/CHARGE] switch on the back of the device and toggle the switch to the ON position. Unlock the cassette locking lever and remove the shipping cassette.

Cassettefrom

fhe Device, for additional information on removing a cassette. Discard the shipping

See Section 3.5,

Removing

the

cassette: do not use.

1.4.3 4000

Do not place the 4000 Plus in service until the

Procech.ues,

PLUS SELF TEST

self test has been conducted. See Section 3.1, Setup

for detailed information on the device self test.

1.4.4

PRINTER SETUP

The 4000 Plus allows the user to print history report information.

serial printers. The user should become thoroughly familiar with the system operating manual

which is included with the printer.

The following DIP switch configuration is for the Seiko DPU-4 11

printer. The printer operating manual should detail the printer DIP switch locations. To set up the Seiko DPU-411 printer for use with the 4000 Plus, proceed as follows:

Set the printer DIP switch configuration as shown in the following display:

DIP01

Note:

DIP01 switches set input data format, number of columns, and characters.

The device works with several

430-0637

l-004

(Rev.

4193)

l-4

System Operating Manual

DIP02

1.4 INSTRUMENT INSTALLATION PROCEDURES

_iii!??I

Note:

DIP02 switches are set for serial input.

serial

Connect the printer cable to the

Connect the other end of the printer cable to the nine-pin serial port labeled IRS-232 on the

rear of the 4000 Plus. See Figure

Connect the AC power plug to the printer and the AC adapter to an AC outlet.

Note:

If necessary, the Seiko DPU-4 11 printer can be operated on battery power.

port labeled RS-232 on the printer.

-I, 4000 Plus,

Rear

DIP@2

view.

5. Tum the printer switch to the ON position. The LED power-on light is on, and the printer

LED reads OFF-LINE. Press the printer [ON-LINE] switch, and

con&m

the ON-LINE LED

is on.

POLE

CLAMP

KNOB

ON/CHARGE SWITCH

SERIAL RS-232 OB-9

COMMUNICATION

PORT

COLLECTION

BAG

HANGER

RS-232 OB-25

(SOME MODELS)

NOTE:

CONNECTOR

NOT ACTIVE

Figure

l-l. 4000

ALARM VOLUME KNOB

EQUIPOTENTIAL POST (SOME MODELS)

POWER CORD

NURSE CALL

WARNING LABEL

Plus, Rear View

Omni-Flow 4000 Plus IV Medication Management System

1-5

430-06371-004 (Rev.

4/93)

Section 2

EQUIPMENT

The 4000 Plus incorporates a number of prog the device. While performing setup or progr

Ikypad

13,

Note:

keypad may be in lowercase letters.

Note: Figures are

figures may not reflect the product exactly.

Description

In-text references to device keypad are shown in uppercase letters; corresponding text on

Figure

rendered as graphic representations to approximate actual product; therefore,

DESCRIPTION

’

g aids to simplify the setup and operation

13-1,400O

amming

Plus,

functions it may be helpful to refer to Section

View, details the keypad.

Front

2.1

BACKLIT DISPLAY SCREEN

8O-character

The

on and stays on for two minutes when any key on the keypad is pressed. The display screen provides prompting messages, prog messages to aid in the setup and use of the device.

display screen is

back& to aid visibility in dim or dark areas.

g information, infusion status information, and alarm

The light comes

2.2

ESCAPE FUNCTION

The (ESCAPE] key can be utilized any time the user is unsure of the next step or is unable to exit

a particular display screen. restart a programming sequence.

Press the [ESCAPE] key to return the display to the base screen and

2.3

BASE SCREEN

The base screen appears during the normal device operation and shows which lines are ON, OFF,

(PGM);

or programmed to start in the future cumulative infusion rate at that time.

A:OFF B:OFF C:OFF

0 0 0

the current infusion rates of each line; and the

D:OFF

0 0

TOTAL

12:30PM

ML/HR

Omni-Flow 4000 Plus IV Medication Management System

2-l

430-06371-004 (Rev.

4/93)

Section 2 EQUIPMENT DESCRIPTION

The base screen is the device status screen. During programming or operation, an intermittent beeping tone alerts the user that the device is not in the base screen. The beeping tone is a reminder

ramming sequence is not complete. This reminder tone ceases upon return

to the user that a

prog

to the base screen.

The base screen

utilizes

each individual line:

Indicates the line is currently running in the

Indicates the line is infusing an

running in the maintenance mode of operation.

DIL

LineAis Indicates that Line A is Indicates that Line A

intermittent infusion.

PGM

Indicates that an intermittent line is programmed to deliver a dose of medication sometime in the future,

AND/OR

line

A is running in maintenance mode while another

intermittent

Indicates that line operation is suspended either due to an

dose.

the user placing it on hold.

DLY

Indicates a programmed intermittent infusion preceding intermittent infusion, being on hold (HLD), or due to a

the following indicators to assist in determining the pumping status of

diluting

is_flushing

a drug on another line.

the cassette and patient line after or before an

intenniftent

dose to the patient. Also appears if

coRtiRuous

(PGM)

mode of operation.

line

is delivering an

alarm

condition or

is being delayed due to a

flush

OFF

Indicates the line has been stopped and is OFF.

2.4

PROGRAMMING INPUT INDICATOR (CURSOR)

A flashing programming input indicator (cursor) automatically appears on the display screen at the first information entry point. Press the [NEXT] key to move the cursor forward.

[LAST] key to move the cursor backwards. To clear any entry where the cursor is flashing, press

the [CLEAR

Note: Several

ENTRYI

key.

programming screens do not allow an advance to the next screen if all the necessary programming information has not been entered on that screen (i.e., total volume on a continuous infusion, the screen cannot be advanced). automaticahy

moves to the entry point which is missing the required programming information.

The cursor must be moved to the next entry point on the screen.

To move to a previous entry point, press the

rate is entered, but not a

In these cases, the cursor

430-06371-004 (Rev.

4193)

2-2

System Operating Manual

2.5 LED STATUS INDICATORS

2.5

LED STATUS INDICATORS

The front panel LED indicators located next to the alphabetical line designations (A, B, C. D), indicate their status as follows:

Off when the line is off

Flashing when the line is infusing medication

On steadily when the line is programmed to start at a future time or the infusion of a line is suspended (on hold).

The LED indicators located on the left side of the front panel indicate their status as follows:

AC POWER

BATTERY

LI Q

ALARM-ill

Ij’igure

See

illuminated (green) when the device is operating on AC power.

illuminated (yellow) when the device is operating on battery power.

13-1,

uminated

4000

(red) when the device is in an alarm condition.

l+ont View, for location of the LED indicators.

Plus,

2.6

NOTATION AREAS

The white area next to the alphabetical line designations (A, B, C, making notations about the medication or the programming on that line. pen or pencil should be used for these notations. or a soft eraser.

This area can be cleaned with an alcohol swab

on the front panel are for

Anon-permanent felt-tip

Omni-Flow 4000 Plus IV Medication Management System

2-3

430-06371-004 (Rev.

4193)

Section 2 EQUIPMENT DESCRIPTION

2.7

PRINTER

A printer (optional) can be attached to the 4000 Plus and used to print history report information.

See Figure to Section

58.2,

DPU-41

2-I, Seiko

printer

(Optima&

Accessing History Reports with a Printer.

s gg

For more information on using the printer, refer

OFF LINE/PAPER END

DPUJl

Figure 2-1. Seiko

THERMAL PRINTER

DPU-411

6216H602

Printer (Optional)

Note: The Seiko DPU411 printer illustrated in Figure 2-I is one of several printers which can be used with the

4000

Plus.

430-06371-004 (Rev.

4/93) 2-4

System Operating Manual

Section

SETUP

The following sections detail setup and priming procedures for the 4000 Plus.

Intmniuction,

Keypad Description,

Plus,

4000

Note:

to AC power for at least 24 hours.

Rear Viw, for overview illustrations of the device.

Prior to placing the 4000 Plus in service, fully recharge the battery by connecting the device

13-1,400O

Plus,

Front View and Section

See Section

3.1

SETUP PROCEDURES

WARNING

ARRANGE TUBING, CORDS, AND CABLES TO MINIMIZE THE RISK OF PATIENT

STRANGULATION OR ENTANGLEMENT.

CAUTIOlt

audible. the back of the device. Abbott Laboratories

To set up the 4000 Plus, proceed as follows:

When

If the

programming

co&rmatory beep is inaudible, adjust the

Tech&al

the device, the confirmatory response beep should be clearly

ALARM

If after adjustment the beep is still inaudible, contact

Support Operations.

VOLUME knob located on

Figure

13,

l-l,

Use the pole clamp to attach the device to an IV pole.

Connect the power cord to a properly grounded 1

3. Toggle the (ON/CHARGE] switch to the ON position.

Note:

the cassette holster. If the service code appears, remove the cassette and cycle the power to the device (power the device off, then on by toggling the then

Confkm

lights are off.

At power on, the device performs its self-test diagnostics. seconds during which time the screen displays the following message:

Upon successful completion of the self test, the Restore Previous Programming screen displays the following setup questions:

A service code may be displayed if the device is turned on with a cassette locked in

ON). The service code is cleared.

that the green AC POWER indicator is illuminated and that all other LED indicator

>>>>>>>> SELF TEST IN PROGRESS

ABBOTT 4000 PLUS

RESTORE PREVIOUS PROGRAMMING CLEAR IV HISTORY

YIN? NO

lo/120 volt AC outlet.

]ON/CHARGE)

The self test lasts approximately six

<<<<<<<(

Y/N?

[ENTE:;

switch to CHARGE,

Omni-Flow 4000 Plus IV Medication Management System 3-l

430-06371-804 (Rev.

7/95)

Section 3 SETUP

Note: The

Restore Previous Programming screen displays two setup questions. Select YES or NO to each query before pressing the [ENTER] key. The [ENTER] key enters all setup instructions into device memory.

3.1.1

RESTORE PREVIOUS PROGRAMMING

progr

To restore previous

Select YES to Restore Previous Programming Y/IV?. Previous programming is restored to

1. the device.

When YES is selected to Restore

IV Flow Sheet

Line Progr

Select NO to Clear

Note:

Select YES

amming

amming:

at the Restore Previous Programming screen, proceed as follows:

Preuious

Programming Y/IV?, the following data is restored:

Any lines that were not OFF are put on HLD

Histo

y Y/N?. Previous IV history is retained.

Clear

History Y/N? to remove previous patient IV history.

Press the [ENTER] key to enter all setup instructions into device memory.

Note:

power is down.

During a power shut down, programmed start times for lines are delayed for as long as the

Upon power up and restoring previous programming, the user should review the

programmed information before pressing the [RESUME] key to begin programmed infusions.

Note;

conditions occur, the Restore Previous Programming

To reduce the likelihood of restoring corrupted line programming after Service Code

option is not available after the occurrence of certain Service Code alarms. In this case, the following screen is displayed after turning power on:

INSERT CASSETTE AND LOCK IN PLACE

4-JUN-92

PRESS [ENTER]

11:05

3.1.2

INITIATE NEW PROGRAMMING

To initiate new progr

Select NO to Restore Previous Programming Y/N?. Previous programming is removed from

the device.

Press the [ENTER] key. The Insert Cassette and Lock In

amming

at the Restore

Preuims Programming screen, proceed as follows:

Place

screen is displayed:

INSERT CASSETTE AND LOCK IN PLACE.

11:30

ZO-MAR-92 PRESS [ENTER]

Confirm the correct date and time are displayed on the Insert Cassette and Lock In If the date and time are correct, press the [ENTER] key.

Proceed to Section 3.2, Priming Procedures:

Primay Administration Set

430-0637 1 -A04 (Rev.

4194)

3-2

System Operating Manual

Place

screen.

If the date and time are incorrect on the Insert Cassette and (ESCAPE] key. The Bypass Cassette Test screen is displayed:

BYPASS CASSETTE TEST? NO

PRESS [ENTER]

3.1 SETUP PROCEDURES

Lack

In Place screen, press the

Press the

Refer to Section 5.4, Special

to set date, time, and display format. toggling the ION/CHARGE] switch to CHARGE, then ON. the

SelfTest

(YES/NO] key to change NO to YES. Press the [ENTER] key. The base screen is displayed:

A:OFF B:OFF C:OFF

0 0 0

~&ions,

D:OFF

TOTAL

for detailed instructions on using [SPECIAL

12:3OPM

When date and time are correct, cycle the device power by

Cycling the power returns the device to

screen, followed by the Restore Previous Programming screen.

Repeat Steps 1 and 2 as follows:

Select NO to Restore

Programming Y/N?.

Previous programming is removed from

the device.

Insert

Press the (ENTER] key.

The

Cassette and Lock In Place screen is displayed.

the correct date and time are displayed on the screen.

Proceed to Section 3.2, Priming Procedures:

Note:

Do not bypass the cassette test.

Primay Administration Set.

3.1.3

RESPONSE TO LOW BATTERY CONDITION

ML/HR

FUNCTIONI(

Coniirm

a low battery condition is detected by the device self test, the Current

11:35

CURRENT TIME DATE

(DD-MM-W) :

Confii

If the date and time are incorrect, use the (NEXT] key and

the correct date and time are displayed on the Current

PM 24

30-MAR-92

TIME Y/N? NO

[ENTERI

[LAST]

as appropriate. Overwrite the old data with the new data. Note:

Refer to Section 5.4, Special Functions, for more detailed information on setting date

and time.

Upon data entry completion, press the [ENTER] key. The KVO Rate screen is displayed:

KVO RATE:

MAX OCCLUSION:

Confirm

If the default

that the correct information displays on the KVO Rate screen.

cursor as appropriate.

l.OML/HR

lOPSI

values

are to be changed, use the [NEXT] and [LAST] keys to position the

[ENTER1

Enter values for KVO and Maximum Patient Line Occlusion

Pressure. The values entered become the default settings for the device. Note: Default settings remain in device memory when the device is turned off or on.

Time

screen is displayed:

Time

screen.

key to position the cursor

Omni-Flow 4000 Plus IV Medication Management System

3-3

430-06371

-A04

(Rev.

4/94)

Section 3 SETUP

6. Press the

(ENTER] key to accept the default values. The

Enable

Callbacks

displayed:

ENABLE ALL CALLBACKS Y/N? TEMPERATURE UNITS

Determine if the default settings shown on the

C:NO

F:YES

Enable

[ENT:]

AU Callbacks screen are appropriate.

8. To change the Callbacks or Temperature Units option, use the [NEXT] and position the cursor as appropriate.

Press the [ENTER] key. The Insert Cassette and Lock in

INSERT CASSETTE AND LOCK IN PLACE.

30-OCT-92

pmss [E NTER]

Press the

(YES/NO1

key to toggle to the desired setting.

11:30

Place

screen is displayed:

3.2

PRIMING PROCEDURES: PRIMARY ADMINISTRATION SET

screen is

(LAS?1

keys to

To prime the 4000 Plus with a primary administration set, proceed as follows:

Select the desired Omni-Flow Primary Set.

for Line

CAUTION:

and confirm that all luer lock connections on cassette are secure.

Use only Abbott Omni-Flow Primary Sets on the device. Refer to the

Remove set

from

package, close the upper clamp

administration package insert for complete instructions.

Prepare IV

container: close all clamps, remove spike protector, insert spike through outlet hole in container, and squeeze drip chamber to adjust fluid level until approximately half full. Hang the container.

Confii fluid level is correct.

Grasp cassette so that the collection bag and patient line are

at the top and the luer lock connectors are pointing to the right.

Confii

that the (ON/CHARGE] switch is ON, and the cassette lever is in the unlocked

position. Insert cassette into holster located along the right side of device (see

Inserting

the Cassette). Slowly turn the cassette locking lever to the locked position. The

cassette is locked in place. To secure, press down on the cassette lever (see

Locking the Cassette

Place).

l?gure

Figure

3-1,

3-2,

430-0637

-A04 (Rev.

4194)

3-4

System Operating Manual

CAUTION:

Turn

the

cassette

3.2 PRIMING PROCEDURES: PRIMARY ADMINISTRATION SET

locking lever slowly to lock cassette in place.

Note:

Con&m

the cassette

locking lever is in the locked position. The cassette lever must

be locked in place and properly secured before any operation can continue. Open all clamps on the set and confirm no fluid is flowing in drip chamber. Attach collection

5. bag to hanger located on the bottom right comer of the device (see Figure l-l, 4000 Plus,

Rear View).

CASSETTE

HOLDER

COLLECTION

BAG

Figure 3-1. Inserting the Cassette.

CASSETTE

UNLOCKED

OPEN

Figure 3-2. Locking the Cassette in Place.

9307AOO2

9216H02-4

Omni-Flow 4000 Plus IV Medication Management System

3-5

430-06371-004 (Rev.

4193)

Section 3 SETUP

3.2.1

CASSETTE PRIMING MODES

The 4000 Plus has two priming modes: cassette power prime and cassette gravity prime.

Line A

can be primed using either mode.

When priming the cassette, the fluid goes into the collection bag.

<A>

HOLD

DOWN [C AS SETTE ] KEY

INTO COLLECTION BAG.

TO PRI ME

PRESS [ENTER]

3.2.1.1

CASSETTE POWER PRIME (LINE A)

When the prime cassette screen is displayed and the [PRIME CASSETTE] key is pressed and

Ainto

released, the pumping action of the system pulls fluid from Line

the cassette.

stroke, the system measures cassette pressure; when cassette pressure is above threshold, it is

fully primed. A device stroke limit of 25 is set in the event there is a cassette leak.

3.2.1.2

GRAVITYPRIME

When the prime cassette screen is displayed and the (PRIME CASSETTE1 key is pressed and held, the system reverts to gravity prime.

Gravity pulls fluid into the cassette until the (PRIME

CASSETTE] key is released.

At each device

Note: See

regarding priming secondary administration sets

Section 3.3, Priming Procedures: Secondary Administration Sets, for information

Tom

the device.

3.2.2

PRIMING THE CASSETTE

The cassette is primed from lines B, C, and D by gravity flow as follows:

1. Press and hold the [PRIME CASSETTE] key on lines B, C, or D until solution enters the collection bag.

PRIME

DowN

HOLD INTO COLLECTION BAG. PRESS

Press the [ENTER] key when priming is complete.

[CASSETT E] KEY ON

<B>

[E:;T]

4193)

3-6

System Operating Manual430-06371-004 (Rev.

3.2

PRIMING PROCEDURES: PRIMARY ADMINISTRATION SET

3.2.3

PATIENT LINE PRIMING MODES

The patient (distal) line may be primed either by power prime or by gravity prime.

WARNING

DO NOT CONNECT LINE TO PATIENT WHILE PRIMING PATIENT LINE.

Note: Priming the

patient line can only occur when ALL lines are OFF.

3.2.3.1

PATIENT LINE POWER PRIME

prime

When the

then released, the pumping action of the system pulls fluid from Line A into the cassette. At each device stroke, the system measures cassette pressure; when cassette pressure is above threshold,

it is fully primed. After reaching the pressure threshold, the patient line is opened and an additional

13 strokes are pumped, corresponding to 3

microbore 60 inch patient line.

Note:

When using power prime,

to patient.

Note:

In the event of an occlusion alarm, use the appropriate aseptic techniques to remove the

filter cap at the distal end of the patient line

3.2.3.2 PATIENT LINE GRAVITY PRIME

When the [PRIME PATIENT LINE] key is pressed and held, the system reverts to gravity prime. Gravity pulls fluid into the cassette until the [PRIME PATIENT LINE] key is released.

Patient Line screen is displayed and the (PRIME PATIENT LINE] key is pressed,

of fluid. This volume is

sufficient

to prime the entire

con&m the patient line is fully cleared of all air before connecting

Additional gravity priming may be required to fully clear air from the line.

3.2.4

PRIMING THE PATIENT LINE

i?om

prime the

Press

patient line

and hold the [PRIME PATIENT LINE] key until all air is cleared from the patient line.

DO'~~N

HOLD

PRIME PATIENT LINE.

2. When priming is complete, press the (ENTER] key.

Note:

When using the

gravity

Administration Set With

Omni-Flow 4000 Plus

Medication Management System 3-7

lines B, C, or D, proceed as follows:

[PATIENT

flow

Grauity

LINE ] KEY ON

PRESS

prevention valve set, see Section 3.3, Priming

Plow Prevention Value.

<B>

[ ENTER ]

Procedures:

430-0637 l-004 (Rev.

Primary

4193)

Section 3 SETUP

3.2.5 CASSETTE TEST

The device performs a cassette test for approximately 36 seconds.

CAUTIONz

It is extremely important to always perform the cassette test when inserting a

new cassette.

CASSETTE TEST IN PROGRESS

ABBOTT 4000 PLUS

When the cassette test is completed, one of two screens is displayed: Possible Faulty Cassette

?&~pe

screen, or Select Infusion

screen.

3.2.5.1

CASSETTE TEST FAILED

the cassette

fails the cassette test, the device alarms and the Possible Faulty Cassette screen is

displayed:

-POSSIBLE FAULTY REPRIME OR REPLACE CASSETTE

CASSETTE-

[MUTE1

If the cassette fails the cassette test, proceed as follows:

Silence the alarm by pressing the (MUTE] key. To clear the alarm, press the (MUTE1 key again. Check for air bubbles, and

Prime the cassette as described in Section 3.2.2. Prime the patient line as described in

reprime

if necessary.

Section 3.2.4.

Ifit

fails the cassette test again, replace cassette. Prime new cassette as described in Section

3.2.2.

Prime the patient line as described in Section 3.2.4. If two cassettes fail in a row,

send the device to clinical engineering.

430-06371-004 (Rev.

4193)

3-8

System Operating Manual

3.3 PRIMING PROCEDURES: PRIMARY ADMINISTRATION SET WITH GRAVITY FLOW PREVENTION VALVE

3.2.5.2 CASSETTE TEST SATISFACTORY

If the cassette test is satisfactorily completed, the following screen is displayed:

SELECT INFUSION TYPE

PRESS [CONTINUOUS] OR [INTERMITTENT]

To prepare for connecting IV containers or syringes to the remaining three lines, press the

[ESCAPE] key. The base screen is displayed.

THE DEVICE IS NOW READY FOR CONNECTING REMAINING THREE LINES.

lV CONTAINERS OR SYRINGES TO THE

3.3

PRIMING PROCEDURES: PRIMARY ADMINISTRATION SET WITH GRAVITY FLOW PREVENTION VALVE

from

CAUTIONS: cassette is removed from the device without closing the clamps. The gravity flow prevention

valve does not prevent mixing of drug lines. Close all clamps before removing cassette. The gravity flow prevention valve requires pressure to open (1.5 to 5.0 psi). The device

occlusion pressure setting may require adjustment to prevent nuisance occlusion alarms.

Note:

insert of the administration set. These instructions apply to the 4000 Plus only. To prime the

valve,

These

proceed as follows:

The gravity flow prevention valve protects the patient

instructions offer an alternative priming procedure to those found on the package

4000

Plus with a primary administration set containing the gravity flow prevention

free flow if the

Remove the primary set from package, close the upper clamp for Line A, and

all luer lock connections on the cassette are secure. CAUTION:

administration package insert for complete instructions.

Prepare IV container: close all clamps, remove spike protector, insert spike hole in container, and squeeze drip chamber to adjust fluid level until approximately half full. Hang the container.

Confirm fluid level is correct. Grasp cassette so that the collection bag and patient line are at the top and the luer lock connectors are pointing to the right.

Confii position. Insert cassette into holster located along the right side of device (see Figure Inserting

cassette is locked Locking

Omni-Flow 4000 Plus IV Medication Management System

Use only Abbott Omni-Flow

that the (ON/CHARGE] switch is ON, and the cassette lever is in the unlocked

the

Cassette). Slowly turn the cassette locking lever to the locked position. The

place.

the Cassette in Place).

To secure, press down on the cassette lever (see Figure 3-2,

primary

3-9

confii

Sets on the device. Refer to the

throu$

430-06371 -A04 (Rev.

that

outlet

3-l.

4/94)

Section 3 SETUP

CAUTION: Turn the cassette locking lever slowly to lock cassette in place.

Note:

be locked in place and properly secured before any operation can continue.

Open all clamps on the set and confirm no fluid is flowing in drip chamber. Attach collection bag to hanger located on the bottom right comer of the device (see Figure l-l, 4000

Rear View).

Prime the cassette using the Line A [PRIME CASSETTE] key until all air is cleared from the cassette into the collection bag. Press the [ENTER] key.

Attach any extension set or other devices to the gravity flow prevention valve located at the

distal end of the patient line (do not attach to a venipuncture device).

Press the Line A (PRIME PATIENT LINE] key to power prime the patient line. flow prevention valve prevents gravity prime mode from priming the patient line.

Note:

unul

Press the (ESCAPE] key. When the Cassette Test Screen displays, enter YES to bypass the cassette test and return to the base screen.

10.

When the base screen displays, press Line A [PRIME PATIENT LINE] to power prime the

patient line.

Press the

test.

12.

Determine if the venipuncture device is indwelling. indwelling, prepare and insert the venipuncture device in the patient per hospital procedure.

13.

Attach the primed patient line to the venipuncture device.

Con&m

the cassette

locking lever is in the locked position. The cassette lever must

Plus,

The gravity

additional power primes are needed to prime the patient line, repeat Steps 9 and

primed.

[ENTER] key when the patient line is fully primed. The device preforms a cassette

If the venipuncture device is not

THE LINE IS NOW READY FOR PROGRAMMING.

3.4

PRIMING PROCEDURES:

SECONDARY ADMINISTRATION SET

To prime the 4000 Plus with a secondary administration set, proceed as follows:

Select the

desired Omni-Flow Secondary Set.

CAUTION: Use only Abbott Omni-Flow Secondary Sets. Refer to the administration package insert for complete instructions.

Prepare IV

container:

close all clamps, remove spike protector, insert spike through outlet hole in container, and squeeze drip chamber to adjust fluid level until approximately half full. Hang container.

Confirm fluid level is correct. Remove distal cap

Remove the luer lock protector for the cassette line to be used. cassette.

Remove set from package; close clamp.

from

secondary set.

Connect secondary set to

Note: An

prime prior to connecting the

430-0637 1 -A04 (Rev.

alternative method

is to

secondq

4l94)

open the

clamp and clear all air from the set by gravity

set to the cassette.

System Operating Manual

3.5 CONNECTING A SYRINGE TO THE CASSETTE

Prime the line by pressing the appropriate [PRIME CASSETTE] key until no air bubbles are

visible in the connection site or cassette.

THE LINE IS NOW READY FOR PROGRAMMING.

4000

To prime the as follows:

1. Put all lines on hold.

2. Connect and prime secondary set as described above.

3. Press the [RESUME] key, then the [ENTER] key.

CAUTION:

or&inaUy

Fluid

bag. sequence.

Plus with a secondary administration set while other lines are running, proceed

fluid

Priming directs

in the cassette may be displaced into the collection bag by the priming

air

and

out through the cassette and into the collection

3.5

CONNECTING A SYRINGE TO THE CASSETTE

Note:

To connect a syringe to the cassette, proceed as follows:

Note:

during cassette prime. THE LINE IS NOW READY FOR PROGRAMMING.

For syringe infusions, only use 20 cc to 60 cc size syringes.

Remove luer lock protector for the cassette line to be used.

compatible stop-cock or syringe support elbow into the cassette.

Connect the syringe to the stop-cock or elbow, with the syringe in a vertical position (see Figure

3-3, Syringe Connected to the Cassette).

cassette.

If air bubbles are visible in the connection sight or cassette, prime the line by pressing the

appropriate [PRIME CASSETTE] key. Syringes may not prime easily with gravity flow.

Open fluid pathway from syringe to the

Some force may be required on the plunger

Connect an Omni-Flow

Figure 3-3. Syringe Connected to the Cassette

Omni-Flow 4000 Plus IV Medication Management System

3-11

430-06371 -A04 (Rev.

4/94)

Section 3 SETUP

3.6 CONNECTING A SYRINGE AND SYRINGE

ADAPTOR TO THE CASSETTE

A syringe adaptor serves to vent the syringe, making it less susceptible to plunger stopper resistance. When programming the 4000 Plus and using the syringe adaptor, it is recommended

that the Syringe option be set to NO.

To attach a syringe and syringe adaptor to the cassette, proceed as follows:

Prepare the syringe using aseptic technique.

Attach the adapter to the syringe (see Figure 3-4, Connecting Syringe

to Cassette).

Attach an Omni-Flow compatible stop-cock or a syringe support elbow to the adaptor (see

Figure 3-4).

Prime the adaptor and stop-cock/syringe support elbow.

Remove the luer lock protection for the cassette line to be used. or syringe support elbow to the cassette.

and

Syringe Adaptor

Connect primed stop-cock

THE LINE IS NOW READY FOR PROGRAMMING.

Figure 3-4. Connecting Syringe and Syringe Adaptor to

'SYRINGE

Cassette

4l94)430-06371-A04 (Rev.

System Operating Manual

3.7 REMOVING THE

CASSRTE

FROM THE DEVICE

3.7

REMOVING THE CASSETTE FROM THE DEVICE

WARNING

REMOVING UNRESTRICTED FLOW. All CLAMPS MUST BE CLOSED TO PREVENT FLOW TO PATIENT

AND/OR MIXING OF DRUGS.

To remove a cassette from the 4000 Plus, proceed as follows:

Confirm that the ION/CHARGE] switch is ON and all lines are OFF.

Close clamps on all lines to prevent free flow and/or mixing of drugs.

3. Lift cassette locking lever and turn counterclockwise. Allow approximately 3 seconds for the piston to retract.

4. Pull cassette from holster.

CASSElTE FROM DEVICE WITHOUT CLOSING LINE CLAMPS MAY RESULT IN

cassette becomes jammed or a Pump Service Code 0800 occurs while inserting or removing

If the cassette, proceed as follows:

Cycle the device power. Toggle the [ON/CHARGE] switch to CHARGE, then ON.

Push the cassette completely down in the holster until it is securely seated.

Confih-m

Proceed with programming.

the self test completes.

Omni-Flow 4000 Plus IV Medication Management System

3-13

430-06371 -A04 (Rev.

4/94)

Section 4

PROGRAMMING

amming

When during programming.

CAUTION:

into the

progr

drip

After

chamber on each appropriate

the 4000 Plus, listen for the device response (audible

programming

confirmatory

the device, ensure that pumping has begun by

fill

stroke for each line in use.

verifying

beep)

flow

4.1 MAINTENANCE INFUSIONS

The 4000

to deliver when an intermittent line is infusing) or in the maintenance mode (device stops delivering

when an intermittent line is infusing and restarts when the intermittent line stops infusing).

If an intermittent with dilution programmed on Lines B. C, or D is put on hold, and a maintenance infusion was previously prgrammed on Line programming on Line A continues.

To set up line A, proceed as follows:

Plus can infuse on Line A in either the continuous mode of operation (device continues

the dilution is put on hold and the maintenance

Press the [MAINTENANCE INFUSION]

key for Line A

A> MAINTENANCE

TOTAL VOLUME: 0 ML

Set

Note:

flushing or diluting mode. If Line A is flushing or diluting, the display only allows the entry of a new source container volume.

Omni-Flow 4000 Plus IV Medication Management System

a rate using the numeric keys, then press the [NEXT] key.

Note:

appears on the display screen. specifications.

Set a Total Volume to be infused using the numeric keys, then press the start the line.

The

Maintenance or continuous rate on Line A can only be changed when Line A is not in the

If the line rate chosen exceeds the combined maximum rate of the device. a message

A> MAINTENANCE

TOTAL VOLUME: 250ML

base screen is displayed:

A: INF B: OFF C: OFF D: OFF TOTAL

5.0

RATE:5_0ML/HR

Refer to Section 12,

RATE:5.0ML/HR

0 0 0

4-l

[ENTER]

5.0

12:30

Spec~@cations,

ML/HR

for rate range

[ENTER]

430-0637 l-004 (Rev.

key to

4193)

Section 4 PROGRAMMING

4.2

CONTINUOUS INFUSIONS

The 4000

the user two methods of programming:

Note:

continuous mode, press the [CONTINUOUS INFUSION] key. Use the [NEXT] and

Plus infuses up to four medications at the same time in the continuous mode and offers

ML/HR

To change either the rate in MCG or

mL/hr,

MCG/KG/MIN.

and

or total volume on any line operating in the

[LASTI

keys to move the cursor to the desired field that requires a change. Any change may be made while the line is operating; there is no need to stop the flow. After making a change, press the

[ENTER]

key

and the device begins operating at the new rate and/or volume immediately.

Note:

without

Note:

ConcurrentFlow).

Note:

not stop.

Continuous infusions may not be programmed over Maintenance or Intermittent infusions

first

stopping the Maintenance or Intermittent infusion.

Concurrent flow exists when two or more drugs are given simultaneously (see Section

Continubus

infusions are rate

specific

and alarm when dose is complete. The infusion does

4.2.4,

The device keeps pumping at programmed rate and does not go to KVO.

4.2.1

ML/HR

The following sections detail the required steps to program an

change an

INFUSIONS

mL/hr

infusion.

mL/hr

infusion and the steps to

4.2.1.1

PROGRAMMING OR CHANGING AN

mL/hr

To program a new

Press the [CONTINUOUS INFUSION] key for

RATE:

Note:

If [CONTINUOUS INFUSION] was pressed in error or there is a need to begin again,

infusion, or change an existing

VOL:

OMCG/KG/MIN OMG IN OML [ENTER]

press the [ESCAPE] key to return to the base screen.

The cursor appears in the RATE field. Enter the delivery rate. Use the

VOL

the cursor to the

Note:

If the line

field.

rate chosen exceeds the combined maximum rate of the device, a message

appears on the display screen.

Enter the volume to be delivered.

Refer to Section 12,

specifications.

Press the [ENTER] key to start the infusion.

ML/HR INFUSION

mL/hr

the

line used. The following screen is displayed:

OML WT: OKGOMLIHR

Spectfications,

infusion, proceed as follows:

[NEml key to move

DeZiue

y Rate Range, for

430-06371-004 (Rev.

4/93)

4-2

System Operating Manual

4.2.1.2

CHANGING AN

ML/HR INFUSION TO AN ALTERNATE UNIT OF MEASURE

INFUSION

To change an existing

Press the [CONTINUOUS INFUSION] key for the line used. For example, when using line

mL/hr

B, the following screen is displayed:

4.2 CONTINUOUS INFUSIONS

infusion to an alternate unit of measure infusion, proceed as follows:

RATE:

Since the line has previously been programmed in ML/HR

Use the

Note: If

Use the [NEXT] key to move the cursor to the

field.

[NEXTI

programming in MCG/MIN is desired, enter a body weight of one (1).

MCG/KG/MIN

Use the

Note: If

[NEXTI [NEXTI

RATE:

3.OOMCG/KG/MIN

15.0ML/HR

OMCG/KG/MIN OMG IN

key to enter the appropriate global body weight, if one does not already exist.

rate.

key to move the cursor to the key to move the cursor to the

16.9ML/HR

entry is made in the Volume field, the volume entered in the

VOL:

2OOMG

25OML

w"r:

OML

field, and enter the medication dose. field.

WI':

25OML

OKG

CENTER1

mL/hr,

MCG/KG/MUV

the cursor will appear in the

field, and enter the

Enter the diluent volume.

75.OKG

[ENTER]

field becomes

the default container volume.

Note: The

To start the infusion, press the [ENTER] key. The following screen is displayed:

calculated delivery rate in

ML/HR

appears in the

ML/HI?

Rate field.

D:OFF

A:INF B:ON C:OFF

35.0 16.9

In this

example, the base screen shows Line A has been programmed as a maintenance at

mL/hr.

Line B runs at 16.9

until stopped.

(The

mL/hr

rate for Line B is the calculated result of the

TOTAL

mL/hr

in a continuous mode of operation and continues

program.) The base screen only displays delivery rates in

Omni-Flow 4000 Plus IV Medication Management System 4

51.9

12:30PM

ML/HR

mL/hr.

MCG/KG/MIN

430-06371-004 (Rev.

4/93)

Section 4 PROGRAMMING

4.2.2

ALTERNATE UNITS OF MEASURE

‘I&e

following sections detail the required steps to program an alternate unit of measure infusion

(MCG/KG/MIN)

INFUSIONS

and the steps to change a unit of measure infusion.

The

Note:

4000 Plus will not accept

specified (non-zero): rate

weight

&VT).

MCG/KG/MIN

(MCG/KG/MIN),

dose amount

programming unless all data fields are

(MG],

diluent volume (ML], and body

4.2.2.1 PROGRAMMING A NEW ALTERNATE UNIT OF MEASURE INFUSION

To program a new alternate unit of measure (MCG/KG/MIN) infusion, proceed as follows:

Press the [CONTINUOUS INFUSION] key for the line used.

For example, when using line

B, the following screen is displayed:

RATE:

OMCIG/KG/MIN

The cursor is in the

OML/HR

ML/H.R

field. Use the (NEXT] key to move the cursor to the

VOL:

OMG IN

WT:

OML

OKG

rENTERi

VOL

field,

and enter the container volume.

VOL

Note:

If no entry is made in the

field, the volume entered in the ML field becomes the

default container volume.

Use the

[NEXTl

key to move the cursor to the

weight, if one does not already

Note:

Use the

Note: The

To start the

programming in MCG/MIN is desired, enter a body weight of one

[NEXTI

key to move the cursor to the

[NEXTI

key to move the cursor to the

[NEXTI

key to move the cursor to the

calculated delivery rate in

infusion,

A:INF B:ON C:OFF

35.0

press the [ENTER] key. The following screen is displayed:

16.9 0

&St.

D:OFF

ML/HR

TOTAL

51.9

WTfield

MCG/KG/MINfield

appears in the

12:3OpM

and enter the appropriate global body

(

1).

and enter the desired rate.

field, and enter the medication dose.

field.

ML/HR

Enter the diluent volume.

ML/HI?

Rate field.

In this example, the base screen shows Line A has been programmed as a maintenance at 35

mL/hr.

Line B runs at 16.9

until stopped.

(The

mL/hr

rate for Line B is the calculated result of the

program.) The base screen only displays delivery rates in

in a continuous mode of operation and continues

MCG/KG/MIN

mL/hr.

Repeat Steps 1 through 7 for each line to operate in a continuous mode of operation.

430-06371X104 (Rev.

4/93) 4-4

System Operating Manual

4.2.2.2

CHANGING AN ALTERNATE UNIT OF MEASURE INFUSION

4.2 CONTINUOUS INFUSIONS

To change an alternate unit of measure infusion

Press the [CONTINUOUS INFUSION] key for the line used. For example, when using line

(MCG/KG/MIN],

B, the following screen is displayed:

RATE:

3.00MCG/KG/MIN

Since the

line has previously been programmed in Alternate units of Measure,

will appear in the

16.9ML/HRB>

MCG/KG/MIN

VOL:

2OOMG

field.

250ML WT:

Confirm

Lmchanged.

Note: If

Enter new

Use the

Note: If

programming in MCG/MIN is desired, enter a body weight of one

MCG/KG/MIN

[NEXTI

key to move the cursor to the

[NEXTj

key to move the cursor to the ML field.

no entry is made in the

rate.

Volume

field, the volume entered in the

the default container volume.

Note: The

To start the infusion, press the [ENTER] key. The following screen is displayed:

calculated delivery rate in

ML/HR

appears in the

proceed as follows:

75.OKG

25OML

[ENTER]

the cursor

(

1).

to remain

that global body weight is

field, and enter the medication dose.

Enter the diluent volume.

field becomes

ML/HI?

Rate field.

35.0 16.9

D:OFF

TOTAL A:INF B:ON C:OFF

51.9

12:3OpM

ML/HR

In this example, the base screen shows Line A has been programmed as a maintenance at 35 until stopped. program.) The base screen only displays delivery rates in

4.2.2.3

mL/hr.

Line B runs at 16.9

mL/hr

(The

mL/hr

rate for Line B is the calculated result of the

in a continuous mode of operation and continues

mL/hr.

CHANGING AN ALTERNATE UNIT OF MEASURE INFUSION TO INFUSION

To change an alternate unit of measure infusion to

1. Press the

[CONTINUOL

S INFUSION] key for the line used. For example, when using line

mL/hr,

proceed as follows:

B, the following screen is displayed:

RATE:

3.OOMCG/KG/MIN

2. Since the

line was previously programmed in alternate units of measure, the cursor will

appear in the

Use the [LAST] key to move the cursor to the

16.9MWHR

MCG/KG/MIN

field.

VOL: 250ML WT:

2OOMG

IN 250ML [ENTER]

W7’field.

75.OKG

Press [CLEAR

body weight.

MCG/KG/MIN

MLJHR

ENTRY to clear the

Omni-Flow 4000 Plus IV Medication Management System

4-5

430-06371-004 (Rev.

4/93)

Section 4 PROGRAMMING

Use the [LAST] key to move the cursor to the

Note:

If the line

rate chosen exceeds the combined maximum rate of the device, a message

VOL

ML/MI

appears on the display screen. Refer to Section 12.

field.

Enter the volume to be delivered.

field and enter the desired rate.

Spec~$ica.tions.

DeUuey

Rate Range, for

specifications.

Press the [ENTER] key to start the infusion.

4.2.3 CHANGING THE GLOBAL BODY WEIGHT.

The global body weight is established when the first weight and concentration are entered on a

continuous line. Entries in both fields are required to program in MCG. The patient weight must

be consistent on all lines with the exception of 1 kg to program in MCG/MIN. If another weight is

entered, the following screen is displayed:

GLOBAL BODY WEIGHT CANNOT BE CHANGED

[ESC

WHILE LINES ARE INFUSING

Global body weight can be changed only while lines are stopped or while no other line is running in

MCG/KG/MIN.

When a new body weight is entered, the following screen is displayed:

BODY WT. CHANGED FROM _KG

[ENTER] TO ACCEPT [ESCAPE] TO REVISE

Pressing [ENTER] starts the line and establishes a new

TO-KG

global

body weight. The [ESCAPE] key

causes the line programming screen to appear with the cursor in the global body weight field. When subsequent lines programmed in MCG are restarted, the new global

and the

mL/h.r

rate is adjusted based on the

MCG/KG/MIN

field and new weight.

body

weight appears

To accept the new global body weight and adjusted delivery rate for lines programmed in MCG,

press the [CONTINUOUS INFUSION] key for the respective line, and then confii the new setting

by pressing the [ENTER] key.

If a line was previously programmed with a weight of 1 kg, its body weight is retained when the

global body weight is changed.

If the global body weight is changed to 1 kg, or 1 kg is changed to global body weight, the

MCG/KG/MmT

and Concentration fields

mL/hr

value remains unchanged.

To change from MCG programming to

are

tiL/hr

erased as the cursor is moved ii-om the

programming,

enter a zero in the body weight field.

field. The

When [ENTER] is pressed, or as the cursor is moved from the weight field, it erases the

MCG/KG/MIN

into this screen. The previous

field and Concentration field values. The global body weight appears upon re-entry

mL/hr

value remains until changed.

430-0637 l-004 (Rev.

4/93)

4-6

System Operating Manual

4.2.4

CONCURRENT FLOW

4.2 CONTINUOUS INFUSIONS

Variation in patient response

may occur when delivering certain short half-life drugs if the difference of the delivery rates between the lines is large. Drugs with a short half-life (approximately six minutes or less when given intravenously] include the following:

Nitroglycerine

Nitroprusside

Norepinephrine

P CI

Oxytocin

Procainamide

Trimethaphan

Note:

Dobutamine

Dopamine

Epinephrine

Esmolol

Isoproterenol

Lidocaine

This list is not intended to be all-inclusive of drugs with a short half-life (critical drugs]. Clinicians should be familiar with the pharmacodynamics of any critical drug before administration.

The following delivery rate guidelines represent a worst-case

scenaxio

of a nitroprusside infusion in combination with one or more drugs. This example represents an unlikely extreme since it considers a 20 second half-life for nitroprusside which is widely regarded as the drug with the shortest half-life in humans (reference the British Journal of Anesthesiology). These guidelines for nitroprusside would avoid variations in patient response in such an extreme case:

If nitroprusside (with a 20 second half-life) is to be infused at a rate of less than 10.0

mL/hr, the combined infusion rate of drugs on the other three lines should be no greater than five times the critical drug (nitroprusside) rate.

If nitroprusside (with a 20 second half-life) is to be infused at a rate of 10.0 to 20.0

mL/hr, the combined infusion rate of drugs on the other three lines should be no greater than 10 times the critical drug (nitroprusside) rate.

mL/hr

Ifnitroprusside (with a 20 second half-life) is to be infused at a rate of 20.0

or greater, the combined infusion rate of drugs on the other three lines can be programmed at any desired rate.

This information is presented to inform clinicians of a rare situation that could be misinterpreted

if they are unfamiliar with this phenomenon. CAUTION:

When infusing short half-life drugs at a low flow rate, automatic air elimination interrupts the delivery of medication to the patient. This medication interruption is dependent upon the infusion rate aud may cause a change in patient parameters.

Omni-Flow 4000 Plus IV Medication Management System

4-7

430-06371-004 (Rev.

4/93)

Section 4 PROGRAMMING

4.3

INTERMITTENT INFUSIONS

The

4000 Plus can infuse

be infused on Lines B, C, and D.

To set up lines B, C, and D as intermittent infusions, proceed as follows:

Press the

Input the volume of EACH dose infused.

[INTERMITTENT

EACH DOSE:

(RATE:

EACH

(RATE:

as many as three intermittent medications. These medications can only

INFUSION] key on the line used.

(HRS:MIN)

0:OO

[ENTER1

(HRS:MIN)

CENTER]

OML OVER

OML/HR)

DOSE:5O.OML

OML/HR)

OVER

X: 1

Press

the

Note: Note:

[NEXTI

EACH

(RATE:

Rate has been automatically calculated.

the

line

Input the total time EACH dose is to be infused.

key.

DOSE:50_OML

15OML/HR)

rate chosen exceeds the combined maximum rate of the device, an alert message appears on the display. specifications.

STARTING LINE WOULD CAUSE MAXIMUM RATE

REPROGRAM

50.oML

If this

Press the

TO BE EXCEEDED

is a single dose, proceed to Step 6.

[NEXf] key. Input the dosing frequency

EACH DOSE:

(RATE:

[NEXTI

EACH

(RATE:

15OML/HR)

key. Input the total number of doses to be delivered

DOSE:50_0ML

15OML/HR)

(HRS:MIN)

0:20

OVER

X: 1

[ENTERI

Refer to Section 12, Specifications, for delivery rate range

[ENTER1

(9)

(the number of hours between doses].

OVER

X:0

Q: 6

OVER

Q: 6 X: 4

0:20

(HRSZMIN)

[ENTERI

(HRS/MIN)

[ENTI:R]

(x).

Note: A

the total of the dosing frequency times the number of doses cannot exceed 24.

Press the [ENTER] key.

Callback

The

default to NO. If

430-06371-004 (Rev.

maximum of 24 hours of intermittent infusions can be programmed for a line: i.e.,

CALLBACK Y/N: NO

DILUTION Y/N: NO

Y/N,

Syringe Y/N,

“10

is correct, proceed to Step 7.

4/93)

SYRINGE Y/N: NO

(ENTER]

and Dilution Y/N queries (as shown in the above screen]

4-8

System Operating Manual

INTERMllTENT INFUSIONS

4.3

To answer YES to any of the queries (Callback Y/N, Syringe Y/N, or

the

[NEXT1

key to move to the desired field. Press the

[YES/NO]

key to

Dilufion

change

Y/N), press

the selection.

When selections are correct, proceed to Step 7.

CALLBACIG

Callback

Callback can be canceled in two ways:

Callback

be called to the device each time the line starts and stops, select YES to

Y/N.

When called to the device, stop the

Y/N; or use

[SPECIAL

stop the line, re-enter the screen, and select NO to

FUNCTION][5]

(see

alarm

by pressing the [MUTE] key twice.

Section

5.4, Special Functions,

for more

information about use of special functions).

SYRINGE: Note: Failure

infusing directly from a syringe, select YES to Syringe Y/N.

to select YES to Syringe

Y/Nmay

cause an occlusion alarm due to a sticking

syringe plunger.

Line

DlLUTION:

To dilute a concentrated medication with the solution running on

A, select

YES to Dilution Y/N. All dilutions are made with the solution on Line A. The only infusions that can be

programmed for dilution are intermittent infusions (B. C, or D). The screens necessary to perform a dilution are accessible during the programming of an intermittent infusion.

If YES is selected to Dilution Y/N, press the [ENTER] key. The following screen is displayed:

DILUTION VOLUME: DILUTION RATE:

OML FROM LINE A

OML/HR

[ENTER]

Input either a per dose dilution volume or a dilution rate. The device calculates the other

value automatically, based on the dose time

[NJZXTI

by pressing the

To begin infusing immediately, press the [ENTER] key.

B>START

TIME NOW

key.)

12:30

HR HR

pr~eviously

[ENTER]

entered.

(Move cursor, if necessary,

Line B has begun to infuse its dose.

150

12:30PM

ML/HR

A:OFF B:INF C:OFF

150

Note:

To cancel the dilution of a particular line, STOP and reprogram the line being diluted

by changing YES to NO.

D:OFF

TOTAL

0 0

Recheck the number of doses remaining in the container and the

start time of the next dose.

Alternately, to delay the start of the line up to 23 hours, input a start time using the keypad

numeric keys.

Correct

AM/PM,

necessary, by pressing the

[NEXT]

key once, then the

[AM/PM1

key.

B>START

AT 4:00 PM

TIME NOW

12:30

Line B now shows that it is programmed to start, but does not start infusing its first dose

until the time set. Press [ENTER] to return to the base screen.

Omni-Flow 4000 Plus IV Medication Management System

[ENTER]

430-06371 -A04 (Rev.

4194)

Section 4 PROGRAMMING

A: ON B:PGM C:OFF

50.0 0 0 0

Note: The line

change for a particular line.

must be OFF to re-enter the intermittent programming screen and make a

If it is currently infusing or programmed to start in the future,

D:OFF

TOTAL

12:30PM

50.0

MLIHR

the line must be stopped before re-entering the programming screen.

Note:

must first be stopped before programmin

Lines which are currently programmed for intermittent or maintenance infusions

g continuous infusions over these lines.

CAUTION: When restarting an intermittent line that has been stopped, the start time and dosing information for the next dose must be reset.

Note:

If two

the device infuses them in alphabetical order (Line B, then C, then

or more intermittent infusions are scheduled to start at exactly the same time,

D).

Only one intermittent infusion can be infusing at a time. The schedule of doses rolls and begins from the time the first dose is given.

Note:

Near the

end of an intermittent infusion with dilution, delivery of the diluent may be completed before delivery of medication is completed (or vice versa], depending on the diluent/medication

ratio. When this occurs, the rate for the completed line will be displayed

as zero, until the full dosage/dilution programmed is delivered.

If an intermittent line is scheduled to start during the infusion delivery time frame of another intermittent line, its scheduled start and dose schedule is delayed until the current intermittent infusion has completed. This feature maintains the proper interval between scheduled intermittent doses.

Note:

To program an automatic flush before or after any intermittent infusions, refer to the

[SPECIAL

FUNCTION][2]

description in Section 5.4, Special

Fw-tctions,

for further

information.

Note: If a flush is

programm

ed to occur after an intermittent infusion, and the intermittent line is placed on hold while the intermittent infusion is running, and then stopped using the

[STOPI

key for that line (or

[SPECLAL

FUNCTION][4])

, the flush will not start. The flush

will occur if the line is active when stopped using the [STOP] key for that line.

Note:

Flushes increase the interval between intermittents by the amount of time allocated

for the flush.

WARNINGS

WHEN ADMINISTERING CRITICAL MEDICATIONS, MONITOR DEVICE PERFORMANCE

FREQUENTLY. THE USE OF THE CALLBACK FEATURE IS RECOMMENDED FOR INTERMITTENT INFUSIONS, DILUTIONS, AND FLUSHES. CALLBACK ALLOWS CONFIRMATION OF SUCCESSFUL COMPLETION OF THE INTENDED THERAPY.

NEAR THE END OF AN INTERMITTENT INFUSION WITH DILUTION, A SMALL AMOUNT OF MEDICATION MAY BE DELIVERED WITHOUT BEING DILUTED. THE DILUTION FROM LINE A MAY COMPLETE BEFORE THE MEDICATION. MEDICATION THAT COULD POTENTIALLY CAUSE PATIENT HARM IF DELIVERED UNDlLUTED(E.G., POTASSIUM CHLORIDE), SHOULD BE DILUTED APPROPRIATELY BEFORE ADMINISTRATION.

-B04

430-0637 1

(Rev.

7/95)

System Operating Manual

Section 5

ADDITIONAL OPERATING

FEATURES

Section 5 details emptying the collection bag, battery operation, and additional operating features of the 4000 Plus, including the following:

Stopping the device lines

Hold and resume

Line status

Special functions

Automatic

Accessing history reports

5.1

air

detection and elimination

TO STOP ANY OF THE LINES

To stop any of the device lines, proceed as follows:

Press the

to start in the future), and the following screen is displayed:

2. Press the

Note:

the appropriate Recheck rate, total volume, and programming instructions, then press the [ENTER] key.

CAUTION: Reprogram subsequent intermittent doses. programmed on Line

will restart after all currently infusing intermittents have completed.

[STOP] key for the line to be stopped (either currently operational or programmed

STOP LINE <A>

PRESS [ENTER]

[ENTER]

To restart a stopped line with the same drugs/fluid and delivery instructions, press

key. The line turns OFF.

RMlTIENT INFUSION] or [CONTINUOUS INFUSION] key for that line.

[INTE

Line A is stopped while it is flushing, only the current flush is stopped.

A will

restart;

any

maintenance

Auy continuous infusion

fnfusion

already programmed

alxeady

Omni-Flow 4000

Plus

IV Medication Management System

5-l

430-06371

-A04

(Rev.

4194)

Section 5 ADDITIONAL OPERATING FEATURES

5.2

HOLD AND RESUME FUNCTIONS

The [HOLD] key is used to place one or more operating lines on hold. The [HOLD] key function

delays continuous and intermittent infusions in progress, and reschedules subsequent (future]

intermittent infusions. All previous intermittent line progr

amming

used while taking pressure readings, changing containers, or

5.2.1

HOLD INDIVIDUAL LINES OR ALL LINES

To place individual lines or all lines on hold, proceed as follows:

is unaffected. Hold may be

performing

other tests.

1.2.Press the [HOLD] key. A

HOLD DELAYS OR RESCHEDULES

Note:

-WARNING- INFUSIONS [ESCAPE] OR PRESS [ENTER]

To cancel the hold operation, press the [ESCAPE] key, and the base screen returns

Warning

screen is displayed:

to the display.

Press the [ENTER] key to continue the hold operation. The following screen is displayed:

HOLD LINES OR TO HOLD ALL

LINES

(USE STATUS KEYS)

PRESS

[ENTER]

To specify the lines to be put on hold, proceed as follows:

Press the [LINE STATUS] key and [NEXT] key for each line to be put on hold.

2. Press the [ENTER] key.

The lines selected, if currently infusing, are placed on hold. The HLD message appears on the base screen for

To ensure that lines which have intermittent infusions with dilution will not be

lines currently infusing.

all

affected,

Line A

may only be placed on hold using the Hold All Lines option.

Note:

lines currently infusing are placed on hold. The HLD message appears on the base screen.

To place all lines on hold, press the [ENTER] key without specifying individual lines. All

A line programmed for future intermittent infusions is displayed as PGM on the base screen. If

start

placed on hold, its programmed

time, and the start time for subsequent intermittent infusions is delayed. Start time is rescheduled to a time which is equivalent to the original start time plus the length of time the line was on hold. A DLY (delayed) status message appears on the base screen.

Lines placed on hold which were currently infusing (continuous or intermittent) are displayed as HLD (on hold) on the base screen. These lines also have subsequent intermittent infusions (if any) rescheduled to a time which is equivalent to the original start time plus the length of time

the line was on hold.

430-06371

-A04 (Rev.

4194)

5-2

System Operating Manual

5.3

LINE STATUS FUNCTION

5.2.2

RESUME INFUSIONS AFTER HOLD

To resume infusions after a hold, proceed as follows:

1. Press the [RESUME] key.

2. Press the

If the device is in hold for more than two minutes, it will alarm and the following Warning screen is displayed:

[ENTER] key.

--WARNING-

MUTE/HOLD TIME EXCEEDED

PRESS [MUTE] OR [RESUME]

Resume infusions as detailed in Steps 1 and 2, or press the [MUTE] key to silence the alarm for two additional minutes.

5.3

LINE STATUS FUNCTION

At any time during the medication infusion, the programming status on each line can be obtained by pressing the appropriate [LINE STATUS] keys.

Note: The

To go from one line status screen to another, press the [LINE STATUS] key desired.

[ENTER] key or the [ESCAPE] key to return to the base screen.

Sample status screens for various operating conditions follow:

line status screens can be accessed only when the base screen appears on the display.

Press the

MAINTENANCE

VOL REM:

Line A

RATE:50.OML/HRA>

85.OML

TIME REM :

operating in a maintenance

42~1~~HR

mode.

A> FLUSHING AFTER B

FLUSH

DIL

REM:5_0ML

Line

A operating

R.EM:25.OML

Line A

A> CONTINUOUS RATE:

VOL REM:

496ML

Line

Omni-Flow 4000 Plus IV Medication Management System

TIME REM:

inflush mode. Rate: 300

TIME REM:

opera&g

lOOML/HR

TIME REM:

A operating in continuous mode.

TOTAL

FLUSH:5.0ML

OHR

DILUTION:50.0MLA>DILUTING LINE C TOTAL

OHR

in dilution mode.

4HR 58MIN

5-3

1MIN

30MIN

mL/hr.

I I

430-06371-004 (Rev.

4/93)

Section 5 ADDITIONAL OPERATING FEATURES

A> VOLUME REMAINING:

B>DOSE

intermit&&

C>DOSE: NEXT DOSE

Intermittentline

STOPPED.

Line A in

CONTINUOUS RATE:

VOL REM:

496ML

Continuous line

REM:35.OML TIME

EACH

line

DOSE:50.0ML Q: 6 X: 4 DIL:

currently

50 .OML OVER OHR 30MIN DIL:

3:00

PM Q: 6 DOSES REM: 3 CB

programme

OFF

200ML

a stopped or

lOOML/HR

TIME REM:

in&z&g

REM:OHR 18MIN CB

o_oPcondition

4HR 58MIN

at 100

mL/hr.

0ML

OML

dose with CallbackinJ&ng (dose in progress) a 50

d to start in thefuture with Callback

Lines

not

started

5.4

SPECIAL FUNCTIONS

The 4000

base screen. Press the [ESCAPE] key at any time to return the display to the base screen.

a special function, press the [SPECLAL FUNCTION] key, followed by the appropriate special

function number (use keypad numeric keys].

screen is displayed:

Plus incorporates a number of special functions which can only be accessed from the

To access

Press the [SPECLAL FUNCTION] key and the following

TO SELECT SPECIAL FUNCTION

PRESS APPROPRIATE NUMBER

DESCRD’TION

External event recording Sets or changes the current time and date Programs a flush either after or

(O-9)

FUNCTION KEY

IO1

[11 [21

before any intermittent line infusion Cancels all subsequent flushes

I31

Stops all lines at once

Selects or cancels Callback

4X)*371-004

(Rev.

4193)

5-4

[41 I51

System Operating Manual

5.4

SPECIAL FUNCTIONS

Selects or changes preset values of

KVO

rate, maximum occlusion pressure, units of temperature, enables Callback, and allows reset of these values to manufacturer’s settings.

Selects the print (format) mode

definition Selects preprogram function Clears IV Flow Sheet

Prints

Flow Sheet

Displays purge totals for all lines

Reset IV History

(*All lines must be

OFF

to select this function.)

5.4.1 .

DESCRIPTION OF SPECIAL FUNCTIONS

I61

I71

ISI*

I91 [AM/PM1 [IV FLOW [CLEAR

ENTRYI

SHEEI’]

The following subsections describe each special function and procedures for their use.

[SPECIAL FUNCTION][O] Records external events.

The 4000 Plus documents certain external events by entering them into the battery backed-up

memory with a date/time stamp, then printing them with the IV History Report. The event fields accept any values entered within the allowable spaces and print out the same.

The

lYES/NOl

key can be used to review the events available, or the number of the desired event

may be entered.

PROC 1 20-MAR-92

Events

Omni-Flow 4000 Plus IV Medication Management System

are as follows:

Blood Sample Chemistry

Blood Sample Hematology

Blood Sample Other

Urine Sample

Oral Medication Administration

Y-Site Injection

Patient Temperature (value can be entered)

Pulse (value can be entered)

Respiration (value can be entered)

10.

CVP (value can be entered)

11.

Blood Pressure Reading (value can be entered)

BLOOD SAMPLE DRAW

3:29

CHEMISTRY

YES /NO ] [ ENTER ]

[

5-5

430-06371-004 (Rev.

493)

Section 5 ADDITIONAL OPERATING FEATURES

Record an went by entering a value, date, and time of actual went and time]: then, press the selection of another event.

[SPECIAL

FUNCTION][l]

[ENTER]

Press the

key. The device returns to the

[ESCAPE]

key to return to the base screen.

(if different

procedure

Sets or changes date and time.

The device maintains date and time values when powered down.

The time format may be based

on 12-hour AM/PM or 24-hour (military) time as the default.

Note: The

time and date can only be changed when ALL lines are OFF.

To change the date and time values, proceed as follows:

Press the [SPECIAL FUNCTION] key, followed by numeric key

CURRENT TIME 12:00 PM 24HR TIME Y/N? NO

DATE(DD-MMM-W):

Input the new time using the numeric keys:

CURRENT TIME

DATE(DD-MMM-W)

21-FEB-92

lo:00

PM 24HR TIME Y/N? NO

: 21-FEB-92

[ENTER1

[ENTER]

[

11.

from current date

0 screen to allow

To change the

display to AM/PM designation, press the

INEm] key to move the cursor, then

press the [AM/PM] key.

CURRENT TIME 10:00 AM 24HR TIME Y/N? NO

21-FEB-92DATE(DD-MMM-YY):

Note:

To display military (24 hour) time, press the [NEXT] key, then press the

[ENTER]

keY.

Set the date, month, and year by pressing the appropriate numeric key. Use the [NEXT] keys to position the cursor in the required field.

CURRENT

DATE(DD-MMM-W): 21-FEB-92

After setting time

DATE(DD-MMM-W):

Press the

[ENTER] key and the base screen is displayed:

A:OFF

B:OFF

0 0

24HR

TIME

lo:00

TIME Y/N? NO

[ENTER]

and date, the display screen appears as follows:

TIME 11:00 AM 24HR TIME Y/N? NO

20-MAR-92

C:OFF

0 0

D:OFF

TOTAL

[ENTER]

1l:OOAM

MIJ/HR

[YES/NO1

[LASTI

and

Note: If the battery pack has become fully discharged, cycle the device. Toggle the

[ON/CHARGE] switch to CHARGE, then ON. Reset the time with the [SPECIAL FUNCTION1 while the battery pack was depleted.

430-06371-004 (Rev.

keys. The internal self check of the

4193)

5-6

real

time clock may have been missed

System Operating Manual

Section 5 ADDITIONAL OPERATING FEATURES

To restart any line, press the infusion type key for the line. Press the [ENTER] key to page through and review the programming screens. Make changes as each screen is reviewed.

Note:

using the [SPECIAL FUNCTION]

[SPECIAL

a flush is programmed to occur after an intermittent infusion and all lines are stopped

[4]

key, the flush will not start.

FUNCTION][5]

Selects or cancels intermittent mode CALLBACK.

The 4000

Plus has the capability to call the user to the device as a line is starting and when it

stops. This feature can only be used with intermittent infusions (B, C, or D). The feature can be

selected during the programming of each of those lines.

To select or cancel intermittent mode CALLBACK, proceed as follows:

Press the [SPECIAL FUNCTION] key, followed by numeric key

PROGRAM CALLBACKS Y/N? B: NO C: NO D: NO

I-

Press the [YES/NO] key then press the [NEXT] and [LAST] keys to either select or deselect

151.

a CALLBACK on a line-by-line basis.

the

Press the [ENTER] key to return to

[SPECIAL

FUNCTION][G]

base screen.

Selects or changes preset values.

The device maintains preset values when powered down. To select or change preset values, proceed as follows:

161.

Press the [SPECIAL FUNCTION] key, followed by numeric key

The following screen is

displayed:

RESET TO MANUFACTURER'S SETTINGS Y/N? NO

ToresettheKVOrate,

maximum occlusion pressure, enable callbacks and set temperature units to manufacturer’s factory settings, use the response.

IfYES is selected, press [ENTER] to reset the values and return to the base screen.

CENTER1

lYES/NO]

key to toggle the desired

Otherwise, press [ENTER] and proceed to Step 3.

Use the numeric keys to adjust the KVO rate from 1.0 to 99.9

Note: The

Alwm

4. Use the [NEXT] key to position the cursor in the

device delivers at the KVO rate as a result of certain alarm conditions.

Conditions and Displays, for further information regarding alarms.

m-urn

mL/hr.

See Section

occlusion pressure field.

Maximum occlusion pressure thresholds from 1 to 12 psi can be selected in 1 psi increment.

Note: The

reports a patient line occlusion. See Section 6,

informationregardingalarms.

maximum occlusion pressure threshold is the pressure at which the device

AZcum

Conditions

and Displays,

for further

KVO RATE: 1.0

MAX OCCLUSION: 10

430-0637 l-804 (Rev.

7/95)

ML/HR

PSICENTERI

5-8

System Operating Manual

5.4

SPECIAL FUNCTIONS

The default values set at the factory are 1.0

mL/hr

for KVO rate, and 10 psi for maximum

occlusion pressure. Press the [ENTER] key to accept these values.

Note: Two

asterisks (**) appear in the lower right comer of the base screen to indicate that

either of these default values has changed. The following screen is displayed:

[ENTER]

Select YES to Enable AU

CaUbacks

Use the

ENABLE ALL CALLBACKS Y/N? TEMPERATURE UNITS C:NO F:YES

[YES/NO]

key to toggle the desired default.

Y/N? and the 4000 Plus will callback after any line stops, starts or intermittent delivery is

completed.

Press the [NEXT] key to position the cursor over the Temperature Units

[YES/NO]

the

Press [ENTER] to accept the values displayed. The values are retained in memory.

Note:

Values are preserved when the device power is cycled, and the memory is checked

key to toggle the desired units of temperature.

C:NO

RYES.

Use

when the device is powered ON. If it is determined that the device memory has been reset to default’values due to an extreme low battery condition or power interruption, the Preset Values screen is displayed.

[SPECIAL

FUNCTlON]m

Selects print mode.

To select print mode, proceed as follows:

Press the [SPECIAL FUNCTION] key, followed by numeric key

1. displayed:

IV HISTORY YIN? NO DEV STATUS YIN? YES

PRINT MODE DEFINITION

Use the

mS/NO]

key in the

lV History field to change the response in the field and specify which printed report is desired. Use of the required and has no effect. The mode selection is preserved in memory and retained when the device is powered ON.

Press the [ENTER] key to enter the selections.

Note:

See

Section 5.8.2, Accessing

of the Device Status and IV History Report print modes.

[SPECIAL

FUNCTION][8]

Selects preprogram function.

[7l.

The following

[ENTER]

Device

[LAST1

[NEXTI

Histo

y Reports with a Printer, for a detailed description

and

keys is not

screen

Status

This function can only be selected when all lines are OFF. To select a preprogram function, proceed as follows:

Press the [SPECIAL FUNCTION] key, followed by numeric key

PREPROGRAM FUNCTION SELECTION Y/N? NO

[RESUME] TO START INFUSIONS

Omni-Flow 4000 Plus IV Medication Management System

[ENTER]

5-9

[Sl.

430-06371

-A04 (Rev.

4l94)

Section 5 ADDITIONAL OPERATING FEATURES

Note: This

screen default response is YES.

Press the key again to return to the base screen.

Note:

as each line of progr for continuous infusions, DLY for intermittent infusions, PGM for a maintenance infusion. The hold condition remains in effect without the usual two-minute warning for lines on hold. The preprogram function should only be selected when all lines, including patient line. are primed. If at least one infusion has already been programmed, the preprogram function can be deselected by stopping

[SPECIAL

To initiate infusion once lines have been preprogrammed,

3. the [ENTER] key.

[SPECIAL

FUNCTION][S]

Records IV

To record

screen shows the current status of the preprogram function. If enabled, the

lYES/NOl

When

selected, all lines and subsequent programming are placed in a hold condition

FUNCTION][S]

key to select or deselect the preprogram function. Press the

amming

is completed. A hold condition is indicated as follows: HLD

all

lines. If no infusions have been programmed,

must be used to deselect preprogram mode.

[ENTER1

press the [RESUME] key, then

FlowSheet data into

History and clears the IV Flow Sheet.

Flow Sheet data into IV History and clear the IV Flow Sheet, proceed as follows:

1. Press the [SPECIAL FUNCTION] key, followed by numeric key

CLEAR IV FLOW SHEET

[ENTER]

To clear the

[SPECIAL

FUNCTION][AM/PM]

lV Flow Sheet, press the [ENTER] key.

191.

Prints IV Flow Sheet (requires AC power).

To print the

Flow Sheet, proceed as follows:

1. Press the [SPECIAL FUNCTION1 key, followed by the [AM/PM] key.

PRINT IV FLOW SHEET

[ENTER]

2. To print the

[SPECIAL

FUNCTION][IV

Flow Sheet, press the [ENTER] key.

FLOW SHEET]

Displays purge totals for all lines.

To display purge totals for all lines, proceed as follows:

Press the [SPECIAL FUNCTION] key, followed by the

2. Press [ENTER] to return to the base screen.

430-0637 1

-A04

(Rev.

4194)

5-10

[IV

FLOW

SHEET1

key.

System Operating Manual

5.5

AUTOMATIC AIR DETECTION AND ELIMINATION

[SPECIAL FUNCTION][CLEAR

ENTRVJ

Resets IV History for new patient.

To reset IV History for a new patient, proceed as follows:

Press the

Use the

[SPECIAL

mS/NO]

prevents patient

CLEAR IV HISTORY Y/N? NO

FUNCTION] key, followed by the [CLEAR

ENTRY]

key to select YES. All prior IV History information is cleared. This function IV

histories being combined.

PRESS [ENTER]

key.

5.5

AUTOMATIC AIR DETECTION AND ELIMINATION

The 4000 Plus air-elimination system automatically detects and eliminates small air bubbles that might appear in the cassette during operation. Upon sensing air in the cassette (approximately

120 microliters), the device automatically clears the air into the collection bag portion of the Omni-Flow Primary Set by flushing the cassette with fluid from Line A.This process causes a temporary interruption of medication delivered to the patient. The device attempts to clear the air twice. user with an air-in-line alarm. See Section 6. this alarm condition.

Should there be more air present than can be cleared automatically, the device alerts the

Conditions and

Alarm

Disp4s,

for information on

Note: If

on hold occlusion is intermittent infusions change

Note: If air

air-in-line or upstream occlusion occurs on Line B, C. or D, only the

(HLD] .

no other lines are infusing, Line A infuses at the selected KVO rate.

detxted on Line A, all the lines currently infusing are put on hold. Subsequent

corn

programmed

(PGM)

to delayed

IDLY).

has entered the cassette from a completely empty container, the device puts the line

on hold and activates an air-in-line alarm. If the hold occurs on Line A,

a.&cted

a.ll

lines go into the hold

line is placed

If the upstream

state.

CAUTION:

When infusing short

half-life

drugs at a low flow rate. automatic air elimination interrupts the delivery of medication to the patient. This medication interruption is dependent upon

the

infusion rate and may cause a change in patient parameters.

5.6

EMPTYING THE COLLECTION BAG

It is important that during device operation the collection bag be checked periodically, and emptied or changed if necessary. The collection bag should be changed or emptied if more than half full or bulging.

Should the collection bag be completely filled during pumping, the following alarm condition

results:

POSSIBLE FULL COLLECTION BAG

OR OCCLUSION LINE A

Omni-Flow 4000 Pius IV Medication Management System

[RESUME]

5-11

430-06371-004 (Rev.

493)

Section 5 ADDITIONAL OPERATING FEATURES

To empty the collection bag, proceed as follows:

Close the collection bag tubing clamp.

Carefully remove the collection bag line from the cassette by turning the luer lock connector counterclockwise.

Dispose of the collected fluid as prescribed by hospital policy. re-used, if permitted by hospital policy, by opening the tubing clamp and gently squeezing and emptying the contents.

Although it is recommended that the collection bag be replaced. it may be reused.

4. the collection bag line to the cassette by turning the luer lock connector clockwise.

the tubing clamp and hang the collection bag on the collection bag hanger.

5.7

BATTERY OPERATION

The collection bag may be

Connect

Open

Note:

Prior to placing the device in service, fully recharge the battery by

connecting

the device to

AC power for at least 24 hours. The 4000 Plus is intended to be used on battery power only for emergency backup

(ie.. AC power

failure or inadvertent disconnection from AC power) or temporary portable operation (i.e., patient

moving from one location to another). The yellow battery indicator illuminates when the device is operating on battery power. The

4000 Plus can operate on battery power for up to five hours at a cumulative delivery rate of

125

n&/lx. Approximately 30 minutes prior to battery pack depletion, a LOW BATI’ERY alarm

sounds and a

CAUTION:

Warning

-WARN I

CORD INTO ELECTRICAL OUTLET OR [MUTE]

If the LOW BATTERY alarm

screen is displayed:

LOW BATTERY. PLUG POWER

NG-

souuds,

connect the device to AC power

immediately.

Press the [MUTE] key to silence the audible alarm for two minutes.

After two minutes, the warning screen and alarm tone return. The device should not be operated on battery power after the LOW BATTERY

alarm sounds. When the battery can no longer provide the necessary power to support

the device, operation ceases.

Recharging occurs any time the device is connected to AC power. the battery pack when device operation has stopped.

The [ON/CHARGE] switch does not have to

be in the ON position for the battery pack to recharge.

It takes

It is strongly recommended that the

hours to fully recharge

4000 Plus be connected to AC power whenever possible to ensure a fully charged battery pack is available for patient ambulation or emergency power outage conditions.

If the device is used frequently for portable operation, battery life may be significantly reduced, and battery alarms may increase.

Reduced battery life

also

increases the battery recharge time.

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

replaced. Leaving the battery in a less than a fully-charged state for any period of time is a primary cause of damage. Battery damage can occur in a matter of hours. resulting in a permanent loss of battery capacity.

Note:

430-06371

A permanently-damaged battery cannot be recharged to full capacity.

-B04 (Rev.

7/95)

5-12

System Operating Manual

5.8 ACCESSING HISTORY REPORTS

CAUTIONz If

the device should be disconnected or

may not maintain device operation. to assure

Do not operate a device with an

Connect the device to AC power whenever practicable

maximum battery

capaciq during patient transport or ambulation.

insticiently

power

fails, an

charged or depleted battery pack.

insaciently

charged battery pack

WARNING

REPEATED OPERATION OF DEVICE TO LOW BATTERY CAPACITY OF THE BATTERY PACK. DEEP BAlTERY

PACK UNUSABLE.

BAlTERY DISCHARGE MAY RENDER THE

CONDlTlON

AFFECTS CHARGE

5.8

ACCESSING HISTORY REPORTS

Section 5.8 provides information on accessing history reports with and without a printer.

5.8.1

ACCESSING HISTORY REPORTS WITHOUT A PRINTER

History reports may be accessed without a printer through the use of the IV Flow Sheet.

The 4000 Plus tracks the total volume infused on each line and the cumulative total. Access to these totals is obtained by pressing the [IV FLOW SHEET] key. The following screen is displayed:

C:LOG

A:LOG B:LOG

350 75.0

D:LOG TOTAL EDIT? NO

0 25.0 450

[ENTER]

To clear the entry of a specific line or the cumulative total, proceed as follows:

To edit line values, press the [YES/NO] key in the Edit field.

clear

Use the [NEXT] key to position the cursor to

Press the [CLEAR

ENTRY]

key.

Move cursor to next line and repeat. Clearing the individual

each desired line and the total.

lines does not automatically clear the total; the total must be cleared separately.

Press the [ENTER] key.

afl’ect

Note: Resetting the IV Flow Sheet in this manner does not

the programming

information and/or performance of the device. Alternately, to

FUNCTION][9]

clear

all lines and the cumulative total simultaneously, press the [SPECIAL

and [ENTER] keys. This special function feature automatically encodes the

IV Flow Sheet information into the IV History and then clears all values to zero.

After turning the device ON, select NO to the RESTORE PREVIOUS PROGRAMMING query

thz

and

IV Flow Sheet information is cleared.

Note: To

use this feature, it is important to confirm the IV Flow Sheet log has been reset to

zero for all values at the beginning of any period being monitored.

Omni-Flow 4000 Plus IV Medication Management System

430-06371-804 (Rev.

7/95)

Section 5 ADDITIONAL OPERATING FEATURES

5.8.2

ACCESSING HISTORY REPORTS WITH A PRINTER

The 4000

time/date stamped external Device Status Report and IV History Report. information on printer setup.

Plus can provide printed reports of infusion status and infusion history, as well as certain

events.

There are two standard reports for local or remote printing:

Co&rm

printer

1.4.4,

See Section

that the printer is connected to the 4000 Plus and turned

Setup. for detailed

on.

5.8.2.1 DEVICE STATUS REPORT

The device status is a snapshot of the current status and the programmed wents on each line at

the time the printed status report is requested.

The Device Status Report includes the following

information:

Line status A, B, C, and D (ON, OFF, PGM, INF, Dilution and flush data

Current infusion regimen details

Time and volume remaining in dose

DLY)

To obtain a Device Status Report, proceed as follows:

Press [SPECIAL FUNCTION],

followed by numeric key

171.

IV HISTORY Y/N? NO

PRINT MODE DEFINITION

History

Select NO for

Press [ENTER]. The 4000 Plus returns to the base screen.

A:OFF

Confirm that the printer is connected to the 4000 Plus, has paper supply, is turned on, and

is ready to Press the [PRINT] key and the date and time is displayed for this print.

0 0

print_

Y/N?. Device Status Y/N? automatically changes to YES.

0 0 0

DEV STATUS Y/N? YES

D:OFF

TOTAL B:OFF C:OFF

12:3OPM

ML/m

tENTEN

printing begins immediately.

Note:

If printer is not ready or is not properly connected, three beeps sound. This function

requires AC power.

5.8.2.2 IV HISTORY REPORT

The portion of or all the data may be printed out at any time. the oldest information is deleted first.

History Report retains a minimum of 48 hours of the most recent historical data.

When the historical data buffer is full,

The

History Report includes the following information:

Press

(ENTER1

and

Any

430-06371-804 (Rev.

7~95)

5-14

System Operating Manual

5.8

ACCESSING HISTORY REPORTS

Line

mode

changes (off, on, intermittent infusion, hold, dilute, delay, flush,

WO]

Non-infusion event documentation (blood, hematology, blood chemistry, vital signs, etc.)

Date/time stamp for all events

obtain an

Press [SPECIAL

With the cursor at

Note:

History Report, proceed as follows:

FUNCTION][71.

IV HISTORY Y/N? NO DEV STATUS Y/N?

PRINT MODE DEFINITION

History Y/N?, select YES and press [ENTER].

By answering YES to

History

Y/N?, Device Status Y/N? automatically changes to

YES

[ENTER]

NO. Press the [PRINT] key and the following screen is displayed:

1O:OoAM

IV HISTORY

117 EVENTS

Using the [NEXT] and [LAST] keys, move the cursor to the data fields to specify the range

FM:20-FEB-91

TO:23-FEB-91

1l:OOPM [ENTER]

of events to print. The [YES/NO] key is used to select the month. The data keypad is then used to enter from and/or specific date and

time,

or number of wents to print.

It is only

necessary to enter data into two of the three category fields to receive a report.

[ENTER] to display the following screen.

Press

SERIAL PORT Y/N? YES

IV HISTORY DESTINATION

To view the IV History on the display screen, select NO to

DISPLAY Y/N? NO

[ENTER1

Serial

Port Y/N? (YES

Display

Y/N’?) and press the [ENTER] key. The first two lines of the most recent IV History went are

displayed on the screen.

Note:

To print the IV History Report, select YES to

See

Table 5-1,

Scanning

History for detailed scanning instructions.

Serial

Port

Y/N? (NO to

Disp4

Y/N??

and press

the [ENTER] key.

fi-om

Note: The

display screen backlight flashes to distinguish it

the status screen.

Press the [ESCAPE] key to return to the base screen.

Table 6-l. Scanning IV History

Key

[NEXT->] [<-LAST]

Scroll up display, display next line of IV History Report

Scroll

down display, display previous line of IV History Report

Function

[AM/PM] Skip to start of next newer event or start of current event

[YES/NO]

Omni-Flow 4000 Plus IV Medication Management System

Skip to start of next older event

5-15

430-06371~B04

(Rev.

7195)

Section 6

ALARM CONDITIONS AND DISPLAYS

Certain alarms may switch fluid delivery to KVO. are interrupted. and the patient’s clinical condition. Clinicians need to be cognizant of such particulars during alarm situations.

CAUTION: operations and fail-es, including interrupted medication or fluid delivery close

supedsion

CAUTlON:

Under most alarm conditions, the device stops operation and generates an alarm for corrective action. the battery pack; replacing the device or cassette; or other procedures described in this manual.

As discussed in previous sections, the 4000 Plus is designed to sound an audible

an appropriate message should system checks identify a problem.

display alerts the healthcare professional of operational problems and permits timely intervention to place the device back into operation quickly without undue risk to the patient.

Section is a troubleshooting guide for failures which may occur but do not condition.

Note: Alarm

recent historical data.

Section

Should excessive alarms occur. remove the device from service.

Corrective actions may include recycling the power: reprogramming the device: recharging

summarize

5.8, Accessing

The clinical consequences vary depending upon the particulars of the infusion(s)

For those patients who are likely to be adversely

and provision for immediate corrective action should be provided.

s various alarm

events

are added to the IV History, which

To aid in alarm analysis, the

History

conditions and recommended corrective actions. Section 7

Reportsl.

In these situations, fluid and/or drug therapies

atTected

The audible alarm and message

necessa.rily

retains

a minimum of 48 hours of the most

History can be reviewed or printed [see

by unintended

from

the device,

alarrn

and display

result in an alarm

Should an alarm sound, proceed as follows:

Press [MUTE] to temporarily silence the audible alarm (for a maximum of two minutes]. The red alarm light remains ON. After two minutes, the audible alarm is reactivated.

Note:

second time to completely cancel the alarm.

Observe the display and determine the cause of the alarm. It is possible to have multiple alarm conditions occur. Each alarm type is prioritized as to current alarm visual display is overwritten, but not lost, if a subsequent higher priority alarm occurs. of occurrence. The

pressing the

Omni-Flow 4000 Plus IV Medication Management System

In the Callback mode or if a faulty cassette alarm occurs, press the

alann

The preceding

fist

press of the [MUTE] key silences the audible alarm;

[MUTE]

key returns the user to the base screen.

is placed on the alarm stack based on priority and time

[MUTEI

severity

and chronology. The

subsequently

430-06371-804 (Rev.

key a

7195)

Section 6 ALARM CONDITIONS AND DISPLAYS

Correct the to resume all infusions. Using the resume function, stacked alarms are displayed by priority. Higher priority alarms are displayed first. If multiple alarms of the same priority exist, such as multiple Upstream Occlusions, the alarms are displayed in reverse chronological order, the most recent alarm displayed first.

Each stacked alarm displayed is accompanied by an audible alarm tone of two seconds duration.

This tone is used to call attention to the alarm condition, but does not require pressing the

key to silence the audible tone.

Note:

When multiple alarms occur, the alarms are presented in order of severity and chronology.

Three distinct

tables, in order of priority.

identii?ed

alann

swerity

problem and press the [RESUME] key, followed by the [ENTER] key,

[MUTE]

classtications

exist.

These classifications are listed in the following

6.1 FLUID DELIVERY ALARMS

A fluid delivery alarm causes ALL lines to be put on hold (HLD). conditions which may cause fluid delivery alarms.

The following table details

ALARM MESSAGE

CASSElTE UNLOCKED

GRAVITY FLOW

DEVICE SERVICE CODE REQUIRED

OCCLUSION IN PATIENT LINE

FULL COLLECTION BAG OR OCCLUSION ON LINE A

AIR-IN-LINE OR OCCLUSION LINE A

POSSIBLE

SERVICE

LINES

PUT ON

HOLD

ALL

ALL Check patient line for closed clamp or

ALL

ALL Check for air bubbles in cassette. Check

Make certain the cassette lever is locked and correctly seated

Turn power OFF, then ON. Restore previous programming and press

[RESUME], then [ENTER]. If failure repeats, remove from service

kinks. Note: Low occlusion pressure settings

may cause patient line occlusion alarms when infusing fluids through microbore tubing at higher rates

Check all lines for closed clamps or kinks.

Check fill capacity of collection bag. Confirm IV bag is a minimum of 17 inches above the device

Line A for closed clamp container volume on Line A. Confirm IV bag is a minimum of 17 inches device

CORRECTIVE ACTION

kinks. Check IV

above the

430-06371-804 (Rev.

7/95) 6-2

System Operating Manual

6.2 PUMPING ALARMS

The following table details conditions which may cause pumping alarms.

LINES

ALARM MESSAGE

PUT ON

HOLD

CORRECTIVE ACTION

PUMPING ALARMS

AIR-IN-LINE OR OCCLUSION

(Lines B, C, D)

UNABLE TO PUMP AT PROGRAMMED

RATE

ALARM LINE ONLY

LINE A REVERTS TO KVO AND LINES B, C, AND D ARE ON

HOLD

Check for air in cassette. Check alarm line for closed clamp or kinks. Check IV container volume on alarm line. Confirm IV bag is a minimum of 17 inches above the device

Check patient line for closed clamp or kinks. Check all lines for closed clamps or kinks. Confirm IV bag is a minimum of 17 inches above the device. Note: Pending alarms must be cleared before reprogramming over Line A, if an error or alarm causes Line A to revert to KVO

6.3

WARNING ALARMS

The following table details conditions which may cause warning alarms.

LINES

ALARM MESSAGE

POSSIBLE EMPTY CONTAINER

BAlTERY

LOW

MUTE/HOLD TIME EXCEEDED

WARNING

POSSIBLE FAULTY CASSETTE

CASSETTE TEST TIMEOUT NONE

Omni-Flow 4000 Plus IV Medication Management System 6-3

WARNING NONE

PUT ON

HOLD

NONE

CORRECTIVE ACTION

Check bag or syringe volume Connect device to AC power and recharge

device for a minimum of 24 hours [RESUME] or [STOP] for all lines on hold

Reprime recurs, replace cassette and repeat cassette test

Press [ENTER] to repeat test Press [ESCAPE] to abort test

cassette and repeat test. If alarm

430-06371

7/95)-B04 (Rev.

Section 7

TROUBLESHOOTING

Certain system operating conditions do not result in audible these conditions could cause device malfunction. These operating conditions are and correctable.

Refer to the Troubleshooting Guide for detailed information regarding no-alarm operating symptoms, probable causes, and corrective actions.

aku-rns;

however. if not corrected,

easily

identifiable

7.1

TROUBLESHOOTING GUIDE

The following table identifies probable causes specific to overdelivery or underdelivery in italics.

Omni-Flow 4000 Plus IV Medication Management System 7-1

430-06371-004 (Rev.

4193)

Sedon 7 TROUBLESHOOTING

SYMPTOM

SUSPECTED AMOUNT Of

LESS THAN AND LINE STATUS SCREEN

TOTAL DELNERY IS MORE THAN

PROGRAMMED ACCORDING TO IV FLOW

SHEETOR

SUSPECTED

AMOUNT

GREATER THAN

SHEET, AND LINE

TOTAL DELNERY IS LESS PROGRAMMED ACCORDING TO IV FLOW

OVERDELIVERY:

SOLUTION

INDlCAlED

LINE STATUS SCREEN

OF SOLUTION IN IV CONTAINER IS

IN IV CONTAINER IS

BY IV FLOW SHEET

LIyvDE/7DELwEf?Y:

FLOW

INMCATED

STATUS SCREEN

‘THAN

PROBABLE CAUSE CORRECTIVE ACTION

IPERATOR PROGRAMMING ERROR REVIEW THE PROGRAM

FUSPECTED EXCESSIVE :XCESSIVE DLLECTION

iuSPEC7ED

-/NCOMf’A?7BLEADM/N/STRATlON

-/VfLOWSHfET WAS CLEARED

-DEL/VERY EXCEEDS 9,999 ML,

CAUSING

:ASSElTE INLET PORTS ARE DAMAGED AND IF DAMAGE IS SUSPECTED TO THE IRE :XTERNAL

‘ALVES

OVERDELIVERY: AIR-/N-LINE LxLwEar

BAG

NuMBEa

LEAKING, WHCH CAUSE REPLACE

LEAKAGE

ACCUMULATKINS CAUSELUID SPILL

FUNCTlON IMPROPERLY

WHlCH

CAUSES

THE

UNDERDELIVERY:

RoLLovER

SET

ENTERED AND CORRECT ANY ERRORS

CHECK TO ENSURE THAT LUER CONNECTlONS ARE SECURE

USED

COMPATlBLE

USE

CYCLE POWER: TURN POWER OFF. TURN POWER ON. RESUME

PROGRAMMING AND RESTART INFUSION. IF THE RESTART

PROBLEM, REMOVE 4000 PLUS

FOR

SERVCING

CASSElTE

IF FLUID SPILL PROBABLE CAUSE OF MALFUNCTION, REPLACE DEVICE.

REMOVE

DEVCE

PERMlTCLEANlNG

SE-tllNGS

ADMlNlSlRAllON

PREVlOUS

DOES NOT CLEAR THE

ACCUMULATKIN IS A

ARER

A FLUID SPILL.

AS SOON AS POSSIBLE

SET

CASSEllE,

4OGfI

:ASSETl-E

OR 4000 PLUS IS DAMAGED AND

HE VALVES ARE NOT FULLY

lrkiOlJT

FIRSTCLOSING OFF ALL TUBING

:LAMPS

FOR EACH LINE

:ASSEllE

LOCKING LEVER IS DAMAGED

APROPERLY FILLED IV FLUID CONTAINER REPROGRAM INFUSION AND/OR RESTART IESULTING

INCORRECT

OPERATlONAL SUSPECT, STOP DELIVERY AND PERFORM

UNLOCKED:ASSETlE LOCKING LEVER

STARTlNG

VOLUME A NEW CONTAINER

IF CASSETTE OR

A CASSETTE TEST

-IF

CASSETTE PASSES TEST, RESTART THE

4000 PLUS AND ESTABLISH CORRECT FLOW. MONlTOR ALL LINES FOR PROPER OPERATION

-IF

CASSETTE FAILS TEST, REPEAT TEST. IF

CASSETTE FAILS AGAIN. REPLACE

SHOULD 4000 PLUS FAIL TO PERFORM CORRECTLY, REPLACE DEVICE

CLOSE TUBING CLAMPS ON ALL LINES BEFORE UNLOCKING LEVER. GRAVITY DELIVERY RESULTS IF MORE THAN ONE LINE IS OPEN

REPLACE

DEVlCE

PLUS RELIABILITY IS

CASSEllE

CASSElTE

LOCKING

ANDX)R MIXING

430-06371-004 (Rev.

4193)

7-2

System Operating Manual

7.1 TROUBLESHOOTING GUIDE

SYMPTOM

LUlD

BACKUP:

LUID

IS BACKING UP ONE OR MORE OF THE

THE DRIP CHAMBER IS FILLING

INES;

PROBABLE CAUSE

CASSEllE LOCKING LEVER AND

CLAMPS ARE NOT CLOSED

CASSETlE

DEVCE CASSETTE

CLOSING DURING DEVICE DELIVERY STROKE

FLUID SPILL

OR 4000 PLUS IS DAMAGED AND

VALVE INTERFACE IS NOT REPLACE

FUNCTlON

ACCUMULATlONS

IMPROPERLY

ALLlU8lNG

CAUSE VALVES

CORRECTIVE

CLOSE TUBING

BEFORE UNLOCKING LEVER. GRAVITY DELIVERY RESULTS IF MORE THAN ONE

GRAVlTY

IF DAMAGE IS SUSPECTED TO THE CASSEllE,

IF CASSETTE OR SUSPECT, STOP DELNERY AND PERFORM A CASSETTE TEST

-IF

MONlTOR ALL LINES FOR PROPER OPERATlON

-IF

CASSETTE FAILS AGAIN, REPLACE

SHOULD 4000 PLUS FAIL TO PERFORM CORRECTLY, REPLACE 4000 PLUS

IF PROBABLE CAUSE OF MALFUNCTION, REPLACE DEVICE.

REMOVE TO PERMIT CLEANING

MODE

CASSEiTE

CASSEllE PASSES TEST, RESTART THE

PLUS

AND ESTABLISH CORRECT FLOW.4000

CASSETTE FAILS TEST, REPEAT TEST. IF

FLUlD

ACCUMULATlON

SPILL

DEVlCE AS

ACTlON

CLAMPS ON ALL

CASSEl-lE

ANDlDR MIXING

LINE

4OGU

RELIA8lLlTY IS

PLUS

IS A

FLUID SPILL,

AFlER

SOON AS POSSIBLE

LHES

LOCKING

IS OPEN

CASSETTE

XCESSIVE PURGING:

BAG

IS FILLING OLLECTlON

TOO QUICKLY

EXCESSIVE AIR-IN-LINE WHICH CAUSES EXCESSIVE DELIVERY TO THE

COLLECTKIN

CASSETIE

DEVICE CASSEllE VALVE INTERFACE IS NOT

CLOSING DURING DEVICE DELNERY STROKE

LUER

PROPERLY SEATED

FLUID SPILL

FUNCTKIN

SECONDARY TUBING IS FLUID FLOW

BAG

OR 4000 PLUS IS DAMAGED

CONNECTlONS ARE NOT

ACCUMULATlONS

IMPROPERLY

CAUSE VALVES

RESTRlCTlNG

AND

CHECK TO ENSURE THAT LUER CONNECTIONS ARE SECURE

4ooO

IF CASSETTE OR SUSPECT, STOP DELIVERY AND PERFORM A CASSETTE TEST

-IF

CASSEllE PASSES TEST, RESTART THE 4000 PLUS AND ESTABLISH CORRECT FLOW. MONlTOR ALL LINES FOR PROPER OPERATION

-IF

CASSETTE FAILS TEST, REPEAT TEST. IF

CASSElTE

SHOULD 4000 PLUS FAIL TO PERFORM CORRECTLY, REPLACE 4000 PLUS

CHECK TO ENSURE THAT LUER CONNECTIONS ARE SECURE

IF FLUID SPILL PROBABLE CAUSE OF MALFUNCTION, REPLACE DEVICE. REMOVE TO PERMIT CLEANING

USE ONLY ABBOTT OMNI-FLOW SECONDARY SETS

FAILS AGAIN, REPLACE CASSEllE

DEVlCE AS SOON AS POSSIBLE

PLUS RELIABILITY IS

ACCUMULATON IS A

AFIER

A FLUID SPILL,

Omni-Flow 4000 Plus IV Medication Management System

430-06371-004 (Rev.

4193)

Section 7 TROUBLESHOOTING

SYMPTOM

FAILURE TO

OCCLUDED LINE IS OBSERVED AND THE OCCLUSKJN

BEEN

DETECTCCCLUSK)N:

ALARM HAS NOT

ACTlVAlED

BATTERY PACK IS DEPLETED:

WHEN OPERATING ON GOES BLANK ANALARM

WiTH OR WITHOUT

BATTERY, THE SCREEN

PROBABLE CAUSE

X3%USION ALARM DELAYED BECAUSE

DELNERY RATE REQUIRES A

.OWER

POINT

dARM

CCLUSION

:ASSETlE OR IEVCE 5

NOT MEASURING THE TRUE PRESSURE IN

LUID 0 FUNCTION IMPROPERLY

HE IMIT POWER: TURN

SETTHG

4000

CASSElTE

CASSEl-lE,

SPILL ACCUMULATIONS CAUSE VALVES

BAIERY

PLUS IS DAMAGED. THE

PRESSURE TRANSDUCER

OR A VALVE

PACK HAS BEEN USED PAST

0CCLUSK)NTlME TO REACH THE .ONGER

IS SET HIGHER THAN

LEAKING

RESET RATE OR

RESETOCCLUSION PRESSURE

IF DAMAGE IS SUSPECTED TO THE CASSEllE, REPLACE CASSEllE

IF CASSETTE OR 4000 PLUS SUSPECT, STOP DELIVERY AND PERFORM A CASSEllE TEST

-IF

CASSEllE PASSES TEST, RESTART THE

4000 PLUS AND ESTABLISH CORRECT FLOW.

MONITOR ALL LINES FOR PROPER OPERAllON

-IF

CASSETTE FAILS

CASSEllE FAILS AGAIN, REPLACE CASSETTE

SHOULD 4000 PLUS FAIL TO PERFORM CORRECTLY, REPLACE DEVICE

IF FLUID SPILL PROBABLE CAUSE OF MALFUNCTION, REPLACE

REMOVE 4000 PLUS AS SOON AS POSSIBLE TO

PERMil

CONNECT UNIT TO AC CURRENT. CYCLE

ITS

ON. RESUME RESTART INFUSION ON AC CURRENT

IF DAMAGE IS SUSPECTED PACK. REPLACE DEVICE

CORRECTNE ACTION

RESETOCCLUSON

SETTlNGISER EXPECTED TO LOWER

TEST, REPEATTEST. IF

ACCUMULATIDN

AFTER A FLUID SPILL,

DEVCE.

CLEANING

POWER OFF. TURN POWER

PREVlDUS PROGRAMMING AND

SETTING

RELIABILfl’Y

IS A

THE BATTERY

OPERATlON ON AC OR

CASSETTE

KEYPAD FAILS TO RESPOND

TEST FAILS

430-06371-004 (Rev.

4193)

BATTERY

All-ERY

PACK IS DEFECTIVE AND CANNOT

E RECHARGED

All-ERY

CHARGER CIRCUIT

3OOPLUSHASBEENEXPDSEDTO XCESSIVE VOLTAGE; FUSE IS OPEN; OWER BOARD IS DAMAGED

ASSElTE

VALVE DIAPHRAGM IS NOT

x)0

PLUS IS DAMAGED AND CASSEllE

ITERFACE

EYPAD IS DAMAGED

IS INADEQUATE

[

7-4 System Operating Manual

DEFECTlVE

8AllERY

REPLACE

BAllERlES DISCHARGE FREQUENTLY,

REPLACE

OPERATE THE

FAILURE PERSISTS, REPLACE

TEST. CASSETTE. IF SECOND CASSEllE FAILS TEST, REPLACE DEVICE

REPLACE DEVICE

PACK

DEVlCE

CASSETIE LOCKING LEVER

TIMES, THEN JNCTIONING PROPERLY SEVERAL

REPEATCASSEl-lE

Section 8

CLEANING AND DISINFECTING

CAUTIONS: To avoid mechanical or electronic damage, do not immerse the device in any fluids or cleaning solutions.

Tom

Do not operate devices that contain residue can interfere with the free movement of the valve stems and/or the pressure-sensing

mechanism.

the device cannot be completely cleaned, return it for service.

solution spills. Sticky or gummy residue

Certain cleaning and sanitizing compounds may slowly degrade components made some plastic materials. Using abrasive cleaners or cleaning solutions not recommended by

Abbott Laboratories may result in product damage.

combinations of isopropyl alcohol and Never use sharp objects such as fingernails, paper clips, or needles to clean any part of the

device. Do not sterilize by heat, steam, ethylene oxide

To avoid device damage, cleaning solutions should be used only as directed in Table 8.1,

Cleaning Solutions. manufacturer for specific information.

It is important to ensure that the cassette channel and all plungers on the right side of the device are free of any material buildup or sticky substance. This area should be checked and cleaned

frequently. Do not use acetone, alcohol, or abrasive cleaners on the device. Clean the device with

a soft, lint-free cloth or swab dampened with soap and water, or a general nonstaining chemical disinfectant. Refer to hospital housekeeping, central service, or infection control for further information.

Note:

Not

all cleaning solutions are sanitizers. Check product labeling.

The disinfecting properties of cleaning solutions vary: consult the

Table 8-l. Cleaning Solutions

dimethyl

benzyl

@TO),

Do not use compounds containing

ammonium chloride.

or radiation.

fkom

Cleaning Solution

Vesphene Manu-Klenz Formula C

Super Edisonite

Household bleach

LifeCare Towelette (subject to availability)

Omni-Flow 4000 Plus IV Medication Management System

II se

Germicidal

Manufacturer

Calgon Vestal Laboratories Per manufacturer’s recommendation Calgon Vestal Laboratories Per manufacturer’s recommendation Diversey Corporation S. M. Edison Chemical Co. Various

Manufactured for Abbott Laboratories

8-l

Preparation

Per manufacturer’s recommendation Per manufacturer’s recommendation Per hospital procedures; do not exceed

one part bleach in ten parts water Per manufacturer’s recommendation;

use undiluted

430-06371 -CO4 (Rev.

8196)

SYMPTOM PROBABLE CAUSE

JNDEFINED PROBLEM:

IiE

SCREEN HAS AN UNREADABLE MESSAGE

JNIT

IS STUCK IN ONE FUNCTION, I.E., FLUSH

CASSElTE OR 4000 PLUS

4O@l

PLUS IS SUBJECTED TO AN EXCESSIVE

ELECTROMAGNETK:

ELECTROSTATIC ELECTRONCS ARE DAMAGED

DlSCHARGE AND THE

DAMAGED

FIELD OR

7.1 TROUBLESHOOTING GUIDE

ACTlONCORRECTlVE

4C00

IF CASSETTE OR SUSPECT, STOP A CASSEllE

-IF

CASSETTE PASSES TEST, RESTART THE

4000 PLUS AND ESTABLISH CORRECT FLOW.

MONITOR AU LINES FOR PROPER

OPERATION

-IF

CASSETTE FAILS TEST, REPEAT TEST. IF

CASSElTE FAILS AGAIN, REPLACE CASSETTE

4000 PLUS FAIL TO PERFORM

SHOULD

CORRECTLY, REPLACE 4000 PLUS

CYCLE

POWER:

POWER ON. RESUME PROGRAMMING AND RESTART INFUSION. IF

THE RESTART DOES NOT CLEAR THE

PROBLEM, REMOVE THE

SERVlClNG

FOR

PLUS RELIABILITY IS

DELlVERY AND PERFORM

‘IEST

TURN

POWER OFF. TURN

PREVlOUS

4OW PLUS

JNRESOLVED SYMPTOM:

IWO PLUS PROBLEM COULD NOT ‘0

JOT

‘RINTER

ANDlDR CORRECTIVE

CAUSE

RESOLVE

SllUATlDN

(OPTIONAL) INOPERATIVE

ACTlON

RANDOM INTERNAL SYSTEM FAILURE

DID

PRINTER

CABLING IS DAMAGED OR PRINTER

IS DAMAGED

NOT SET UP CORRECTLY

IF CASSEllE OR SUSPECT, STOP A

CASSETTE TEST

CASSElTE

-IF

4000

PLUS AND ESTABLISH

MONITOR ALL LINES FOR PROPER OPERATION

-IF

CASSEllE FAILS TEST, REPEAT TEST. IF

CASSEFE

SHOULD4000 PLUS FAIL TO PERFORM CORRECTLY. REPLACE DEVICE

REFER TO PRINTER OPERATING MANUAL FOR TROU8LESHODTlNG AND PRODUCT SERVCING

CONFIRM PAPER IS LOADED, POWER IS ON; AND PRINTER IS ON-LINE

4WO PLUS RELIABILITY IS

DELNERY

PASSES TEST, RESTART THE

FAILS AGAIN, REPLACE CASSEllE

INFORMATION

AND PERFORM

CORRECT FLOW.

Omni-Flow 4000 Plus IV Medication Management System

7-5

430-06371-004 (Rev.

4193)

Section 9

WARNINGS, CAUTIONS AND

PRECAUTIONS

Section 9 is a comprehensive listing of the warnings, cautions, and precautions detailed

throughout this manual.

9.1

WARNINGS

Warnings contain special safety emphasis and must be observed at all times. Failure to observe a warning is

Product damage may occur unless proper care is exercised during the unpacking and installation process. The battery pack may not be fully charged upon receipt. the device in service if it fails the self test.

Do not connect line to patient while priming patient line. Removing cassette from device without closing line clamps may result in unrestricted flow.

All clamps must be closed to prwent flow to patient and/or mixing of drugs.

Continuous infusions are rate specific and not stop. The device keeps pumping at programmed rate and does not go to KVO.

When administering critical medications, monitor device performance frequently. of the callback feature is recommended for intermittent infusions, dilutions, and flushes. Callback allows confirmation of successful completion of the intended therapy.

Near the end of an intermittent infusion with dilution, a delivered without being diluted. medication.

(e.g., potassium chloride), should be diluted appropriately before administration.

Repeated operation of device to low battery condition pack.

A possible explosion hazard exists if the device is used in the presence of flammable

anesthetics.

Arrange tubing, cords, and cables to minimize the risk of patient strangulation or

entanglement.

potent.iaJly

Deep battery discharge may render the battery pack unusable.

life threatening.

alaxm

when dose is complete.

small

amount of medication may be

The dilution from line A may complete before the

Medication that could potentially cause patient harm if delivered undiluted

affects

charge capacity of the battery

Do not place

The infusion does

The use

Omni-Flow 4000 Plus IV Medication Management System

(Rev.

4194)

430-06371

-A04

Section 9 WARNINGS, CAUTIONS AND PRECAUTIONS

9.2 CAUTIONS

A caution usually appears in front of a procedure or statement. It contains information that could prevent result in serious injury.

irreversible damage or hardware failure. Neglecting to pay attention to a caution could

If device appears to be damaged, do not operate: return damaged devices for service.

When prog

the

confirmatory

the device.

ramming the device, a confirmatory response beep should be clearly audible. If

beep is inaudible, adjust the

ALARM

VOLUME knob located on the back of

If after adjustment the beep is still inaudible, contact Abbott Laboratories

Technical Support Operations.

Use only Abbott Omni-Flow Primary Sets on the device.

Refer to the administration package

insert for complete instructions. Use only Abbott

On-m&Flow

Secondary Sets on the device.

Refer to the administration

package insert for complete instructions.

va.lve

The gravity

i?om

the device without closing the clamps. The gravity flow the mixing of drug lines. Close all prevention valve requires pressure to open (1.5 setting may require adjustment to

protects the patient flow prevention

clamps

prevent

before removing the cassette. The gravity flow

nuisance occlusion alarms.

free flow if

prevention

5.0 psi). The device occlusion pressure

the

cassette is removed

valve does not prevent

from

Tum the cassette locking lwer slowly to lock cassette in place.

It is extremely important to always perform the cassette test when inserting a new cassette.

After progr

amming

chamber on each appropriate

the device, ensure that pumping has begun

fill

byveri@ing

stroke for each line in use.

flow into the drip

When restarting an intermittent line that has been stopped, the start time and dosing

information for the next dose must be reset.

When infusing short half-life drugs at a low flow rate, automatic air elimination interrupts

the delivery of medication to the patient. This medication interruption is dependent upon the infusion rate and may cause a change in patient parameters.

If Line A is stopped while it is flushing, only the current flush is stopped.

subsequent intermittent doses.

restart:

any maintenance infusion

Any continuous infusion

already

programmed on Line A will restart after all

programmed on Line A will

Reprogram

currently infusing intermittents have completed. If the LOW Do not operate a device with an insufficiently charged or depleted battery pack.

should be disconnected or if power fails, an

BAmRY

alarm sounds, connect the device to AC power immediately.

If the device

instiiciently

charged battery pack may not maintain device operation. Connect the device to AC power whenever practicable to assure maximum battery capacity during patient transport or ambulation.

For those patients who are likely to be adversely affected by unintended operations and

i?om

failures, including interrupted medication or fluid delivery

the device, close supervision

and provision for immediate corrective action should be provided. Should excessive alarms continue to occur, the device should be removed for service.

To avoid mechanical or electronic damage, do not immerse the device in any fluids or cleaning

solutions. Do not operate devices that contain residue from solution spills. Sticky or gummy residue

f&e

can interfere with the mechanism.

If it cannot be completely cleaned, return the device for service.

movement

the valve

stems and/or the pressure-sensing

430-06371

-B04 (Rev.

7195)

9-2

System Operating Manual

9.3 PRECAUTIONS

Certain cleaning and sanitizing compounds may slowly degrade components made from some plastic materials. Laboratories of isopropyl alcohol and

Never

use sharp objects such as fingernails. paper clips, or needles to clean any part of the

Using abrasive cleaners or cleaning solutions not recommended by Abbott

may

result

in product damage.

dimethyl

benzyl

Do not use compounds containing combinations

an-znonium

chloride.

device. Do not sterilize by heat, steam, ethylene oxide (ETO], or radiation.

cl D

To avoid device damage,

So2u.tion.s.

The disinfecting properties of cleaning solutions vary; consult the manufacturer

cleaning

solutions should be used as directed in Table 8.1, Cleaning

for specific information. Do not attempt to disassemble device or perform repairs.

Federal (USA) law restricts this device to sale by or on the order of a physician or other licensed

practitioner.

Use of radio

frequency

emitting devices such as cellular telephones and 2-way radios in close

proximity of this device may affect its operation.

9.3 PRECAUTIONS

Before operating the 4000 Plus, the user should become thoroughly familiar with the proper use of the device as outlined in this manual. Precautions to be observed in operation of the 4000 Plus follow.

Do not attempt to disassemble or repair the device. service personnel.

the

A service code may be displayed if

the

holster. If

service code appears. remove the cassette and cycle the power. Toggle the

device is turned on with a cassette locked in the cassette

[ON/CHARGE] switch to CHARGE, then ON, to clear the service code.

Turn cassette locking lever slowly to prevent sudden release of spring mechanism.

It is recommended that the cassette test safety feature be routinely performed at each cassette

insertion.

For normal operation, the device must be connected to a hospital grade AC outlet, If quality of AC power source is in doubt, use battery power.

prevent

flow interruption, it is necessary to plug the device into AC power immediately

upon low-battery alarm.

If the battery pack has become fully discharged, cycle the power. Toggle the [ON/CHARGE] switch to CHARGE, then ON, and reset the time with the [SPECIAL

internal self check of the real time clock may have been missed while the battery pack was

depleted.

After progr

amming

chamber on each

the device, ensure that pumping has begun by fti

stroke.

When infusing two or more medications, the user should confirm drug compatibility and program the device accordingly.

When administering critical medications, monitor device performance frequently. The use of

the Callback feature is recommended for intermittent infusions, dilutions, and flushes. Callback allows confirmation of successful completion of the intended therapy.

Refer all service to qualified and trained

FUNCTIONI[ll

verifying

flow into the drip

keys. The

Omni-Flow 4000 Plus IV Medication Management System 9

430-06371-804 (Rev.

7195)

Section 9 WARNINGS, CAUTIONS AND PRECAUTIONS

Certain undiluted drugs are chemically reactive and may adversely affect plastics. These

drugs should be diluted according to manufacturer’s instructions prior to infusion.

lever

Unrestricted fluid flow occurs if the cassette locking IV fluid containers are open. Before unlocking cassette locking closed to

For continual protection against risk of fire, replace fuse with a 250 VAC 0.6 A SB unit.

Do not sterilize, autoclave, or immerse this device in any manner.

The 4000 Plus is an electronic device with many components. Efforts have been made to

prevent

flow to patient and/or mixing of drugs.

is unlocked while the

lever.

all clamps must be

clamps.to

the

ensure the quality and long life of these components; however, any component is subject to

possible failure which may cause the 4000 Plus to malfunction and alarm.Backup systems

to provide intravenous therapy should be available in the event of a device malfunction or

failure.

The 4000 Plus contains electrical components that may be

emissions. Caution should be exercised when the device operates in these

MRI

affected

environments. Shield the device from X-ray by a lead apron. If exposure to RF, X-ray, or

the

emissions does

occur,

cycle the power by turning

device off, then back on, to allow the

by exposure to RF, X-ray,

MRI

self test to repeat. Return the device for service if there is any concern about reliability of operation.

Plus

The 4000

A solution must be placed on Line A for the device to function properly.It is recommended

is not to be used in a hyperbaric chamber.

that a neutral solution be placed on Line A

To cancel the dilution of a particular line, press the [STOP] key and reprogram the line being

diluted by changing the YES to NO. Recheck the number of doses remaining in the container

staxt

and the

Nonhazardous, low-level electrical potentials are commonly observed when fluids are

administered using infusion devices.

time of the next dose.

These potentials are well within accepted safely standards, but may create artifacts on voltage sensing equipment such as ECG, EMG and EEG machines. These artifacts

at a rate that is associated with the infusion rate.

If the

vary 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 electronic noise generated by the infusion device.

Proper setup and maintenance of the monitoring equipment should eliminate the artifact. Refer to the appropriate monitoring system documentation for setup and maintenance instructions.

430-06371-804 (Rev.

7/95)

9-4

System Operating Manual

Section 10

SERVICE AND PERFORMANCE INFORMATION

If the 4000 Plus fails to respond to the operating or troubleshooting procedures listed in this manual, and the cause

cannot be

determined, discontinue use of the device.

CAUTION:

Service and product performance information may be obtained by contacting:

Product

Do not attempt to disassemble device or perform repairs.

Through January 5.1997

Abbott Laboratories

Technical Support Operations

980 Linda Vista Avenue

Mountain View, California 94043

Effective January 6, 1997

Abbott Laboratories

Technical Support Operations

775 Jarvis Drive

Morgan Hill, California 95037

inquiries may be telephoned to the following number:

l-800-24 l-4002

Contact the Abbott Laboratories device for repair. A Returned Goods Authorization must be obtained prior to the return of any 4000 Plus.

Carefully package the device (preferably in the original Laboratories Technical Service Center with the Returned Goods Authorization identified.

Abbott Laboratories cannot assume any responsibility for loss or damage to returned instruments while they are in transit or for the unauthorized return of any instruments.

Note:

Pre-authorization must be received prior to the return of any 4000 Plus.

Omni-Flow 4000 Plus IV Medication Management System

Technica.l

Service Center to obtain authorization to return the

pa&i.@,

10-l

and ship it prepaid to the Abbott

(RGA)

clearly

430-06371 -CO4 (Rev.

8/96)

Section 11

4000 PLUS SETS

Use only Omni-Flow Primary Sets with the 4000 Plus. Primary Omni-Flow Sets can be used as a gravity administration set with the device. Sets are sterile and for single use only.

11.1 IV ADMINISTRATION SETS

The following table lists the intravenous administration sets for use with the 4000 Plus.

LlST

NO.

11167

11168*

11169*

11440

11599*

DE8CRIPTION

Primary Macro-bore Device Set, convertible piercing pin 122 inches in total length with 72 inches of tubing from cassette to

patient, collection bag, roller clamp, one

and luer lock adaptor. Primary Micro-bore Device Set, convertible piercing pin

approximately 80 inches in total length micro-bore tubing from cassette to patient, collection bag, roller clamp, one

Primary Micro-bore Device Set, convertible piercing pin approximately 110 inches in total length with 60 inches of micro-bore tubing from cassette to patient, collection bag, roller clamp, one

LifeShield@ approximately 118 inches in length, collection bag, roller clamp, two prepierced reseal

LifeShield@ approximately 110 inches in total length with 60 inches of micro-bore tubing from cassette to patient, collection bag, roller clamp, two prepierced reseal

Primary Macro-bore Device Set, convertible piercing pin,

Primary Micro-bore Device Set, convertible piercing pin,

‘Y” injection site and luer lock adaptor.

‘Y’

injection sites.

‘r’

‘Y” injection site

with

30 inches of

injection sites.

11606*

11681;

Omni-Flow 4000 Plus IV Medication Management System

Primary Micro-bore Device Set with gravity flow prevention valve,

convertible piercing pin, approximately 110 inches in total length with 60 inches of Micro-bore tubing from cassette to patient, collection bag, roller clamp, one site and luer lock adaptor.

LifeShield@ activated valve port at lower

piercing pin, approximately 110 inches in total length.

Sixty inches of Micro-bore tubing (approx. 2 ml priming capacity], from cassette to patient: collection bag, and roller clamp.

Omni-Flow Primary I.V. Pump Set with capped luer

11-l

‘r’

injection

“y”

injection site. Convertible

430-06371

-A04

(Rev.

4l94)

Section 11 4000 PLUS SETS

11139

4052 1

40522

40524

11137

11140

11141

11181

Secondary Set, convertible piercing pin approximately 40 inches in total length, clamp, luer lock adaptor.

Colorgarda Midlength Secondary

Set, 40 inches, orange striped tubing for line identification, and luer lock adaptor.

Colorgard’ Midlength Secondary

Set, 40 inches, green striped

tubing for line identification, and luer lock adaptor.

Colorgard@

Midlength Secondary

Set, 40 inches, purple striped

tubing for line identification, and luer lock adaptor. Nonvented Soluset, 150 x 15, 40 inches, with male luer lock adaptor. Low absorption proximal nitroglycerin set, vented, 40 inches,

with male luer lock adaptor.

Nonvented Y-type blood set with high capacity, bucket type nylon blood filter, 40 inches, with male luer lock adaptor.

Mid-length secondary set with in-line

IVEX

.22

micron filter, 40 inches.

with male luer lock adaptor.

When infusing highly viscous solutions (i.e., 25% Dextrose) through micro-bore sets, at normal delivery rates, an occlusion pressure of twelve (12) psi should be set for backpressure of approximately 1.5 psi (approximately 75

mmHg)

the

device.

is allowed. Exceeding these

A maximum

parameters may result in occlusion alarms.

11.2 ACCESSORY SETS

LlST

1736

40500

40055

11607

NO.

DESCRlPTION

Low

absorption, distal nitroglycerin extension set, 60 inches, with male

luer lock adaptor. Collection bag. Sterile nonpyrogenic fluid path. Single use only.

Do not

rester&e.

Colorgard three-way stopcock. Omni-Flow compatible, for use with syringes or mid-length secondary sets.

Gravity flow prevention valve, for use with the Omni-Flow medication

management systems. Restricts gravity flow.

11441

Vented syringe adapter.

Note: This list may be updated without notice; contact the Customer Service Department for current listings.

430-0637 1

-A04 (Rev.

4194)

11-2

System Operating Manual

Section 12

SPECIFICATIONS

Pumping Mechanism:

Dimensions:

Weight:

Power Requirements:

Fuse:

AC Line Leakage:

Plug:

Piston Diaphragm

Height: 11

Width:

Approximately 15 lbs

12 inches

Depth: 7

50 Watts, 120 VAC,

Slow blow, 0.6 A, 250 VAC

Less than 20 Micro Amps

Hospital Grade (3 pin)

inches

l/4

l/2 inches

50/60

Case Material:

Battery Type:

Battery Life:

Battery Pack Recharge Time:

Omni-Flow 4000 Plus IV Medication Management System

Structural Foam

12 Volt, Sealed Lead Acid,

Rechargeable

5 hours at 125

(Low Battery alarm activated with 30 minutes of battery life remaining)

24 hours with device OFF

12-1

mL/hr

430-06371

-A04

(Rev.

4194)

Section 12 SPECIFICATIONS

Delivery

Rate Range:

100

1.0

0.1 fi-om

mL/hr

100-700

increments up to 100

maximum for 3-4 lines, 500 maximurn

for single line with syringe)

per hour in

mL/hr

incrementsmL then in 1

(600

mL/hr

Container Volume

and Dose Range:

Rate:

KVO

Fltid Types:

Nurse Call Jack:

External

Communications:

l.OmL-30OOmLin.lmL

100

increments up to

in 1 3000

Preset at 1.0

increments from 100

mL/hr. Selectable from 1.0 mL

per hour

All standard

fluids

mL then

-99.9

including lipid emulsions, blood and packed cells

l/4

inch phono jack

RS-232, DB-9 connector set to 9600 baud

Note:

RS-232 DB-25 connector not active

on some models

Occlusion Pressure:

430-06371-A04 (Rev.

4/94)

Alarms:

Cassette

Unlocked

Air In Line/Upstream Occlusion

Occlusion in Patient Line Possible Empty Container Low Battery Voltage Possible Faulty Cassette Callback Requested Device Failure/Service Required Unable to Pump at Programmed Rate Possible Full Collection Bag

Transfer to Battery Operation

Communications Fault

Preset at 10 psi User

selectable from

12-2

1-12 psi

System Operating Manual

Section 13

KEYPAD DESCRIPTION

Section

DISPLAY SCREEN: The 80-character, backlit, liquid crystal display provides

instructions, programming information, alarm messages, and status information.

-RIG]

[PRINT] KEY:

with [SPECIAL FUNCTION]

[SPECIAL

to access any of the special functions.

[Iv

on each of the lines and the total volume for all four lines.

[PRIME

tubing and the cassette into the collection bag.

air.

[CONTINUOUS INFUSION]

continuous infusion on any line.

describes the front panel of the 4000 Plus.

KEY8 O-9: Use these keys to input infusion rates, volumes, and times.

Press this key to print either the IV Flow Sheet or the

171.

KEYz Press this key (followed by the appropriate numeric key)

FUNCTION]

FLOW

SHEET]

CASSETTE]

PATIENT

The patient line can be primed only when ALL lines are OFF.

KEY:

KEYz

Press this key to display a running total of the volume infused

Press and hold this key to clear air

KEY:

Press and hold this key to clear the patient line of LME]

KEYz

Press this key (on Lines A, B, C, or

History, selected

from

the upstream

to program a

all

[MTERMITTENT

an intermittent infusion of a medication.

[STOP]

10.

stop the operation of any of the lines. lrJNE

11.

programming information for each line. The information remains visible on the display screen until the [ENTER] or [ESCAPE] key is pressed.

LINE INDICATOR LIGHTS: On continuously when a line is programmed to start;

12.

flashing when a line is operating: off when a line is off. NOTATION AREAS: These areas may be used to make notations concerning the

13.

medication and/or programming on each line. Clean with an alcohol swab or a soft eraser. Use a nonpermanent felt-tip pen or pencil.

WTENANCE

14.

maintenance infusion on Line A. Line A stops when an intermittent infusion starts and restarts automatically when the intermittent line stops.

Omni-Flow 4000 Plus IV Medication Management System

KEE

STATUS] KEY:

INFUSION]

Press this key (on Lines A, B, C. or D), then press the [ENTER] key to

INFuSIONl

KEF

Press this key (on Lines A, B, C, or D) to obtain the current

KEY:

Press this key (on Lines B. C, or

Press this key (on Line A only) to program a

13-l

to program

430-06371-004 (Rev.

4193)

Section 13 KEYPAD DESCRIPTION

KEYz

(YE6/NO]

15.

Press this key to answer any of the programming questions on

intermittent infusions or special functions.

KEYz

16.

INEXT]

Press this key to move the cursor to the next information entry point on

a screen.

17.

(ENTEN

KEX Press this key to enter programming information or to advance to

another screen.

KEYz

18.

WT]

Press this key to move the cursor back to the last information entry point

on a screen.

KEYz

19.

20.

[CLEAR

(AM/PlKl

ENTRpj

Press this key when changing the AM/PM time designation.

KEYz

Press this key to clear information at the current cursor

location.

IESCAPE]

21.

KEY: Press this key to return to the base screen, or to return to the programming screen after certain message screens. particular programming sequence is unclear.

CASSETTE

22. cassette in place.

LOCEING

To unlock the cassette, lift up the cassette locking

LEVER:

Move the cassette locking lever clockwise to lock the

counterclockwise.

23.

l’MUTE1

geV:

Press this key to mute the audible alarm for a two-minute period or to

cancel the Callback or Faulty Cassette Alarms.

24. ALARM

25.

BATTERY

LIGHT: This light illuminates when the device is in an alarm mode.

LlGHTz

This light

illuminates when the device is disconnected

power, or when there is an AC power failure.

Use the key to restart any time a

lever

and turn

i?om

26. AC

27.

POWER

KEYz

LIGHT:

This light ill

Use this key to put currently operating lines on hold. Press the BOLD]

key, then press the [ENTER] key.

uminates

All lines (including A) may be put on hold by pressing

when the device is connected to AC power.

IHOLDI

the [ENTER] key again. Any combination of Lines B. C, and D may be put on hold by pressing [LINE STATUS] keys. An alarm sounds after two minutes when lines are on hold.

[REsuMEl

28. to resume device operation following an alarm condition.

EEY: Press this key to review pending alarms, then press the [ENTER] key

Press the

(RESUME1

key,

then press the [ENTER] key to resume device operation after a HOLD condition.

430-06371-004 (Rev.

4193)

13-2

System Operating Manual

Figure

13-l. 4000

Plus, Front View

Omni-Flow 4000 Plus IV Medication Management System

13-3

430-06371-004 (Rev.

4/93)

Abbott Omni-Flow 4000 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

INTRODUCTION

1.2 SAFETY FEATURES

1.4 INSTRUMENT INSTALLATION PROCEDURES

BACKLIT DISPLAY SCREEN

ESCAPE FUNCTION

BASE SCREEN

LED STATUS INDICATORS

NOTATION AREAS

PRINTER

SETUP

SETUP PROCEDURES

CONNECTING A SYRINGE TO THE CASSETTE

PROGRAMMING

4.1 MAINTENANCE INFUSIONS

CONTINUOUS INFUSIONS

INTERMITTENT INFUSIONS

HOLD AND RESUME FUNCTIONS

SPECIAL FUNCTIONS

EMPTYING THE COLLECTION BAG

BATTERY OPERATION

ACCESSING HISTORY REPORTS

ALARM CONDITIONS AND DISPLAYS

6.1 FLUID DELIVERY ALARMS

PUMPING ALARMS

WARNING ALARMS

TROUBLESHOOTING

CLEANING AND DISINFECTING

WARNINGS

9.2 CAUTIONS

9.3 PRECAUTIONS

4000 PLUS SETS

SPECIFICATIONS

KEYPAD DESCRIPTION