OMNI-FLOW 4000 PLUS System Operating Manual Rev Aug 1996

Contents Section 1 INTRODUCTION

...

1 -1

1.1 FEATURES OF THE IV MEDICATION MANAGEMENT SYSTEM ... 1 - 1 1.2 SAFETYFEATURES ... l-2 1.3 WARNINGS,CAUTIONS,ANDNOTES ... l-3 1.4 INSTRUMENT INSTALLATION PROCEDURES ... 1 - 3 1.4.1 UNPACKING INSTRUCTIONS ... 1 - 3 1.4.2 INSPECTION ... l-4 1.4.3 40OOPLUSSELFTEST ... l-4 1.4.4 PRINTERSETUP ... l-4 Section 2 EQUIPMENT DESCRIPTION

...2

-1

2.1 BACKLITDISPLAYSCREEN ... 2-l 2.2 ESCAPEFUNCTION ... 2-l 2.3 BASESCREEN ... 2-l ... 2 - 2 2.4 PROGRAMMING INPUT INDICATOR (CURSOR) 2.5 LED STATUS INDICATORS ... 2 - 3 2.6 NOTATIONAREAS ... 2-3 2.7 PRINTER ... 2-4 Section 3 SETUP...

..=-...3-1

3.1 SETUPPROCEDURES ... 3-l 3.1.1 RESTOREPREVIOUSPROGRAMMING ... 3-2 ... 3 - 2 3.1.2 INITIATE NEW PROGRAMMING 3.1.3 RESPONSETOLOWBAlITERYCONDI’TION ... 3-3 3.2 PRIMING PROCEDURES: PRIMARY ADMINISTRATION SET ... 3 - 4 3.2.1 CASSE’ITEPRIMINGMODES ... 3-6 3.2.1.1 CASSETTEPOWERPRIME(LINEA). ... 3-6 3.2.1.2 GRAVITYPRIME ... 3-6 3.2.2 PRIMINGTHECASSETI’E ... 3-6 3.2.3 PATIENTLINEPRIMINGMODES ... 3-7 3.2.3.1 PATlENTLINEPOWERPRIME ... 3-7 3.2.3.2 PATIENTLINEGRAVITYPRIME ... 3 - 7 3.2.4 PRIMINGTHEPATIENTLINE. ... 3-7 3.2.5 CASSE-ITE~ST ... 3-8 3.2.5.1 CASSE’lTETESTFAILED ... 3-8 3.2.5.2 CASSE’ITETEST SATISFACTORY ... 3 - 9 3.3 PRIMING PROCEDURES: PRIMARY ADMINISTRATION SET 3-9 WITHGRAVITYFLGWPREVENTIONVALVE ... ... 3 - 10 3.4 PRIMING PROCEDURES: SECONDARY ADMINISTRATION SET ... 3 - 11 3.5 CONNECTINGASYRINGETOTHECASSE-ITE 3 12 ... 3.6 CONNECTING A SYRINGE AND SYRINGE ADAPTOR TO THE CASSETTE ... 3 13 3.7 REMOVINGTHE CASSETTE FROMTHE DEVICE

Omni-Flow 4000 Plus IV Medication Management System

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Contents Section 4 PROGRAMMING

...4

-1

...4 -1 4.1 MAINTENANCE INFUSIONS 4.2 CONTINUOUS INFUSIONS ..._ ...4 -2 4.2.1 ML/HRINFUSIONS... 4-2 4.2.1.1 PROGRAMMING OR CHANGING AN ML/HR INFUSION... 4 - 2 4.2.1.2 CHANGING AN ML/HR INFUSION TO AN ALTERNATE UNITOFMEASUREINFUSION ... 4-3 4.2.2 ALTERNATE UNITS OFMEASURE (MCG/KG/MIN) INFUSIONS... 4 - 4 4.2.2.1 PROGRAMMING A NEW ALTERNATE UNIT OF MEASURE INFUSION ..._ ...4 -4 4.2.2.2 CHANGING AN ALTERNATE UNITOF MEASURE INFUSION . . 4 - 5 4.2.2.3 CHANGING AN ALTERNATE UNIT OF MEASURE INFUSIONTOML/HRINFUSION ... 4-5 4.2.3 CHANGINGTHEGLOBALBODYWEIGHT ... 4-6 4.2.4 CONCURRENTFLOW.. ... 4-7 4.3 INTERMITTENT INFUSIONS ..._ ...4 -8

Section 5 ADDITIONAL OPERATING FEATURES

...5 -1

5.1 TOSTOPANYOFTHELINES ... 5-l 5.2 HOLDANDRESUMEFUNCTIONS ... 5-2 ... 5-2 5.2.1 HOLDINDMDUALLINESORALLLINES ... 5-3 5.2.2 RESUMEINFUSIONSAFTERHOLD 5.3 LINESIJATUSFUNCTION ... 5-3 5.4 SPECLAL FUNCTIONS. ...5 - 4 5.4.1 DESCRB?-I’ION OF SPECIAL FUNCTIONS ... 5 - 5 5.5 AUTOMATIC AIR DETECTION AND ELIMINATION ... 5 - 11 5.6 EMPTYINGTHECOLLECTIONBAG ... 5- 11 5.7 BA?TERY OPERATION ... 5 - 12 5.8 ACCESSING HISTORY REPORTS ... 5 - 13 5.8.1 ACCESSING HISTORY REPORTS WITHOUT A PRINTER ... 5 - 13 5.8.2 ACCESSING HISTORY REPORTS WITH A PRINTER ... 5 - 14 5.8.2.1 DEVICESTATUSREPORT. ... 5-14 5.8.2.2 IVHISTORYREPORT ... 5- 14 Section 6 ALARMCONDITIONSANDDISPLAYS .

... 6-l

6.1 FLUIDDELIVERYALARMS ... 6-2 ..6- 3 6.2 PUMPING ALARMS.. ... 6.3 WARNINGALARMS ...6-3 Section 7 TROUBLESHOOTING

... 1...7

7.1 TROUBLESHOOTING GUIDE

...7 -1

Section 8 CLEANING AND DISINFECTING 430-06371-804 (Rev. 7195)

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System Operating Manual

Contents Section 9 WARNINGS, CAUTIONS AND PRECAUTIONS

9-l

...

9-l 9-2 9-3

9.1 WARNINGS. ... 9.2 CAUTIONS ... 9.3 PRECAUTIONS ... Section 10 SERVICE AND PERFORMANCE INFORMATION...

10 - 1

Section 11 4oooPLussETs

11 - 1

...

11.1 IVADMINISTRATIONSETS ... 11.2ACCESSORY SETS ...

11 - 1 11-2

Section 12 SPECIFICATIONS...

12 - 1

Section 13 KEYPAD DESCRIPTION...

13 - 1

Section 14 WARRANTY...

14 - 1

Copyright 1996

Abbott Laboratories

All Rights Reserved

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

Omni-Flow 4000 Plus IV Medication Management System

V

430-06371 -CO4 (Rev. 8/96)

Section 1

INTRODUCTION The Omni-Flow 4000 Plus IV Medication Management System incorporates all the features of the 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.

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 Infuses irom combinations of bags, bottles. and syringes Automatic air detection and elimination Needleless connections Additional capabilities of the 4000 Plus include: 0 Programmable in Mcg/Kg/Min on ail channels Q RS-232 communication (for printers) CI Date/time stamp (optional) of blood chemistry, hematology, vital signs, and other medication administration Q Detailed documentation, through the following printed reports (on demand): - Device Status Report: Line status A, B, C, and D (ON, OFF, PGM, HLD, INF, DLY) 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

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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 P Programming and memory retention following power OFF D Selective hold for each medication Iine 0 Advanced programming to preprogram all lines and place lines on hold until needed 0 Automatic power prime of Line A for minimum solution waste 0 Prioritized alarms stacked and presented sequentially for resolution CI Additional alarms: full collection bag, transfer to battery, external communications fault CI User selected power-up defaults: - Time: 12-hour AM/PM or 24-hour military format - KVO: ,l.O to 99.9 mL/hr - Patient line occlusion alarm - 1 to 12 psi (in 1 psi increments) - Units of temperature: degrees Centigrade or Fahrenheit - Callbacks 0 Local display of IV History Report on LCD Display

1.2 SAFETY FEATURES The 4000 Plus maximizes safety and reliability with the following features: The device automatically performs a self test of its electrical and mechanical components when the [ON/CHARGE] switch is placed in the ON position If the ION/CHARGEl switch is turned to CHARGE during infusion, the device retains the most recent progr amming and infusion data in a nonvolatile memory. The data is reinstated during power up (see Section 3. I, Setup procedures) If the duplicate programming 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 identiiies a variety of potential malfunctions within the device, cassette, and interface. This 36-second cassette test is activated every time the [PRIME PATIENT LINE) (ENTER) key sequence is pressed Note: The user can bypass the cassette test; however, Abbott Laboratories recommends the routine use of this test.

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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 usuaIly appears in front of a procedure or statement. It contains 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.

1.4 INSTRUMENT INSTALLATION PROCEDURES In order to fully utilize 4000 Plus capabilities. it is important to become thoroughly familiar with the System Operating Manual prior to use.

WARNING 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. DO NOT PLACE THE DEVICE IN SERVICE IF lT FAILS THE SELF TEST. Note: Instrument instahation should be performed by qualified personnel only.

1.4.1

UNPACKING INSTRUCTIONS Each shipping carton should contain the following items: 0 Omni-Flow 4000 Plus IV Medication Management System with attached power cord c3 Omni-Fiow 4000 Plus System Operating Manual Carefully remove the device from the shipping carton. The carton should be retained in the event the device needs to be shipped.

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1.4.2

INSPECTION Should any damage be found, contact Inspect the packing container for visible shipping damage. the delivering carrier immediately. Freight claims or insurance claims must be 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. Do 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. See Section 3.5, Removing the Unlock the cassette locking lever and remove the shipping cassette. Cassettefrom fhe Device, for additional information on removing a cassette. Discard the shipping cassette: do not use.

1.4.3 4000 PLUS SELF TEST Do not place the 4000 Plus in service until the self test has been conducted. See Section 3.1, Setup Procech.ues, for detailed information on the device self test.

1.4.4

PRINTER SETUP The 4000 Plus allows the user to print history report information. The device works with several 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: 1. 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.

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1.4 INSTRUMENT INSTALLATION PROCEDURES DIP02

_iii!??I DIP@2

Note: DIP02 switches are set for serial input. 2. Connect the printer cable to the serial port labeled RS-232 on the printer. 3. 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 1 -I, 4000 Plus, Rear view. 4. 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. 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 ALARM VOLUME KNOB

SERIAL RS-232 OB-9 COMMUNICATION PORT

EQUIPOTENTIAL POST (SOME MODELS)

COLLECTION BAG HANGER

POWER CORD

RS-232 OB-25 (SOME MODELS)

NURSE CALL

NOTE: CONNECTOR NOT ACTIVE

WARNING LABEL

Figure l-l. 4000 Plus, Rear View

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430-06371-004 (Rev. 4/93)

Section 2

EQUIPMENT DESCRIPTION The 4000 Plus incorporates a number of prog ’ g aids to simplify the setup and operation of the device. While performing setup or progr amming functions it may be helpful to refer to Section 13, Ikypad Description Figure 13-1,400O Plus, Front View, details the keypad. Note: In-text references to device keypad are shown in uppercase letters; corresponding text on keypad may be in lowercase letters. Note: Figures are rendered as graphic representations to approximate actual product; therefore, figures may not reflect the product exactly.

2.1

BACKLIT DISPLAY SCREEN The 8O-character display screen is back& to aid visibility in dim or dark areas. The light comes on and stays on for two minutes when any key on the keypad is pressed. The display screen * g information, infusion status information, and alarm provides prompting messages, prog messages to aid in the setup and use of the device.

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. Press the [ESCAPE] key to return the display to the base screen and restart a programming sequence.

2.3

BASE SCREEN The base screen appears during the normal device operation and shows which lines are ON, OFF, or programmed to start in the future (PGM); the current infusion rates of each line; and the cumulative infusion rate at that time. A:OFF B:OFF

0

0

C:OFF 0

TOTAL 12:30PM ML/HR 0

D:OFF 0

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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 to the user that a programming sequence is not complete. This reminder tone ceases upon return to the base screen. The base screen utilizes the following indicators to assist in determining the pumping status of each individual line: ON

Indicates the line is currently running in the coRtiRuous mode of operation. Indicates the line is infusing an intenniftent dose to the patient. Also appears if LineAis running in the maintenance mode of operation.

DIL

Indicates that Line A is diluting a drug on another line. Indicates that Line A is_flushing the cassette and patient line after or before an intermittent infusion.

PGM

Indicates that an intermittent line is programmed to deliver a dose of medication sometime in the future, AND/OR if line A is running in maintenance mode while another line is delivering an intermittent dose.

MD

Indicates that line operation is suspended either due to an alarm condition or the user placing it on hold.

DLY

Indicates a programmed intermittent infusion (PGM) is being delayed due to a preceding intermittent infusion, being on hold (HLD), or 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. The cursor must be moved to the next entry point on the screen. Press the [NEXT] key to move the cursor forward. To move to a previous entry point, press the [LAST] key to move the cursor backwards. To clear any entry where the cursor is flashing, press the [CLEAR ENTRYI key. Note: Several 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., if a rate is entered, but not a In these cases, the cursor total volume on a continuous infusion, the screen cannot be advanced). automaticahy moves to the entry point which is missing the required programming information.

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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: D Off when the line is off D Flashing when the line is infusing medication tJ 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: P AC POWER - illuminated (green) when the device is operating on AC power. LI BATTERY - illuminated (yellow) when the device is operating on battery power. Q ALARM-ill uminated (red) when the device is in an alarm condition. See Ij’igure 13-1, 4000 Plus, l+ont View, for location of the LED indicators.

2.6

NOTATION AREAS The white area next to the alphabetical line designations (A, B, C, D) on the front panel are for making notations about the medication or the programming on that line. Anon-permanent felt-tip pen or pencil should be used for these notations. This area can be cleaned with an alcohol swab or a soft eraser.

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2.7

PRINTER A printer (optional) can be attached to the 4000 Plus and used to print history report information. See Figure 2-I, Seiko DPU-41 I printer (Optima& For more information on using the printer, refer to Section 58.2, Accessing History Reports with a Printer.

s gg -

m OFF LINE/PAPER END

DPUJl 1 THERMAL PRINTER

6216H602

Figure 2-1. Seiko DPU-411 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.

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Section 3

SETUP See Section 13, The following sections detail setup and priming procedures for the 4000 Plus. Keypad Description, me 13-1,400O Plus, Front View and Section 1, Intmniuction, Figure l-l, 4000 Plus, Rear Viw, for overview illustrations of the device. Note: Prior to placing the 4000 Plus in service, fully recharge the battery by connecting the device to AC power for at least 24 hours.

3.1

SETUP PROCEDURES WARNING ARRANGE TUBING, CORDS, AND CABLES TO MINIMIZE THE RISK OF PATIENT STRANGULATION OR ENTANGLEMENT. CAUTIOlt When programming the device, the confirmatory response beep should be clearly audible. If the co&rmatory beep is inaudible, adjust the ALARM VOLUME knob located on If after adjustment the beep is still inaudible, contact the back of the device. Abbott Laboratories Tech&al Support Operations. To set up the 4000 Plus, proceed as follows: 1. Use the pole clamp to attach the device to an IV pole. 2. Connect the power cord to a properly grounded 1 lo/120 volt AC outlet. 3. Toggle the (ON/CHARGE] switch to the ON position. Note: A service code may be displayed if the device is turned on with a cassette locked in 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 ]ON/CHARGE) switch to CHARGE, then ON). The service code is cleared. 4. Confkm that the green AC POWER indicator is illuminated and that all other LED indicator

lights are off.

The self test lasts approximately six At power on, the device performs its self-test diagnostics. seconds during which time the screen displays the following message: >>>>>>>> SELF TEST IN PROGRESS ABBOTT 4000 PLUS

<<<<<<<(

Upon successful completion of the self test, the Restore Previous Programming screen displays the following setup questions: RESTORE PREVIOUS PROGRAMMING CLEAR IV HISTORY YIN? NO Omni-Flow 4000 Plus IV Medication Management System

Y/N?

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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 To restore previous progr amming at the Restore Previous Programming screen, proceed as follows: 1. Select YES to Restore Previous Programming Y/IV?. the device.

Previous programming is restored to

When YES is selected to Restore Preuious Programming Y/IV?, the following data is restored: 0 IV Flow Sheet Q Line Progr amming: Any lines that were not OFF are put on HLD 2. Select NO to Clear N Histo y Y/N?. Previous IV history is retained. Note: Select YES to Clear IV History Y/N? to remove previous patient IV history. 3. Press the [ENTER] key to enter all setup instructions into device memory. Note: During a power shut down, programmed start times for lines are delayed for as long as the power is down. Upon power up and restoring previous programming, the user should review the programmed information before pressing the [RESUME] key to begin programmed infusions. Note; To reduce the likelihood of restoring corrupted line programming after Service Code conditions occur, the Restore Previous Programming 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 PRESS [ENTER] 11:05 AM 4-JUN-92

3.1.2

INITIATE NEW PROGRAMMING To initiate new progr amming at the Restore Preuims Programming screen, proceed as follows: 1. Select NO to Restore Previous Programming Y/N?. Previous programming is removed from the device. 2. Press the [ENTER] key. The Insert Cassette and Lock In Place screen is displayed: INSERT CASSETTE AND LOCK IN PLACE. 11:30 AM ZO-MAR-92 PRESS [ENTER]

Confirm the correct date and time are displayed on the Insert Cassette and Lock In Place screen. If the date and time are correct, press the [ENTER] key. Proceed to Section 3.2, Priming Procedures: Primay Administration Set

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3.1 SETUP PROCEDURES

If the date and time are incorrect on the Insert Cassette and Lack In Place screen, press the (ESCAPE] key. The Bypass Cassette Test screen is displayed: BYPASS CASSETTE TEST? NO PRESS [ENTER] Press the (YES/NO] key to change NO to YES. Press the [ENTER] key. The base screen is displayed:

I

A:OFF B:OFF C:OFF 0

0

D:OFF TOTAL

0

0

0

12:3OPM ML/HR

I

Refer to Section 5.4, Special ~&ions, for detailed instructions on using [SPECIAL FUNCTIONI( 1 I to set date, time, and display format. When date and time are correct, cycle the device power by toggling the ION/CHARGE] switch to CHARGE, then ON. Cycling the power returns the device to the SelfTest screen, followed by the Restore Previous Programming screen. Repeat Steps 1 and 2 as follows: 1. Select NO to Restore Previous Programming Y/N?. Previous programming is removed from

the device. 2. Press the (ENTER] key. The Insert Cassette and Lock In Place screen is displayed. Coniirm the correct date and time are displayed on the screen. 3. Proceed to Section 3.2, Priming Procedures: Primay Administration Set. Note: Do not bypass the cassette test.

3.1.3

RESPONSE TO LOW BATTERY CONDITION If a low battery condition is detected by the device self test, the Current Time screen is displayed: CURRENT TIME 11:35 PM 24 HR TIME Y/N? NO DATE (DD-MM-W) : 30-MAR-92 [ENTERI

1. Confii the correct date and time are displayed on the Current Time screen. 2. If the date and time are incorrect, use the (NEXT] key and [LAST] key to position the cursor 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. 3. Upon data entry completion, press the [ENTER] key. The KVO Rate screen is displayed:

I

KVO RATE: l.OML/HR MAX OCCLUSION: lOPSI

[ENTER1

I

4. Confirm that the correct information displays on the KVO Rate screen. 5. If the default values are to be changed, use the [NEXT] and [LAST] keys to position the Enter values for KVO and Maximum Patient Line Occlusion cursor as appropriate. 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. Omni-Flow 4000 Plus IV Medication Management System

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430-06371 -A04 (Rev. 4/94)

Section 3 SETUP

6. Press the (ENTER] key to accept the default values. The Enable AU Callbacks screen is

displayed:

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

F:YES

7. Determine if the default settings shown on the

[ENT:]

Enable AU Callbacks screen are appropriate.

8. To change the Callbacks or Temperature Units option, use the [NEXT] and (LAS?1 keys to position the cursor as appropriate. Press the (YES/NO1 key to toggle to the desired setting. 9. Press the [ENTER] key. The Insert Cassette and Lock in Place screen is displayed:

INSERT CASSETTE AND LOCK IN PLACE. 30-OCT-92 pmss [E NT E R]

11:30 AM

3.2

PRIMING PROCEDURES: PRIMARY ADMINISTRATION SET To prime the 4000 Plus with a primary administration set, proceed as follows: 1. Select the desired Omni-Flow Primary Set. Remove set from package, close the upper clamp for Line A, and confirm that all luer lock connections on cassette are secure. CAUTION: Use only Abbott Omni-Flow Primary Sets on the device. Refer to the administration package insert for complete instructions. 2. 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.

3. 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. 4. 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 l?gure 3-1, 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 Figure 3-2, Locking the Cassette in Place).

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3.2 PRIMING PROCEDURES: PRIMARY ADMINISTRATION SET

CAUTION: Turn the cassette 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. 5. 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 Plus, Rear View).

CASSETTE HOLDER

COLLECTION BAG

9307AOO2

Figure 3-1. Inserting the Cassette.

_

CASSETTE ~8 UNLOCKED

OPEN

<

9216H02-4

Figure 3-2. Locking the Cassette in Place.

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Section 3 SETUP

3.2.1

CASSETTE PRIMING MODES The 4000 Plus has two priming modes: cassette power prime and cassette gravity prime. can be primed using either mode.

Line A

When priming the cassette, the fluid goes into the collection bag. HOLD DOWN [C A S SETTE ] KEY INTO COLLECTION BAG.

0~ <A> TO PRI ME PRESS [E NT ER]

3.2.1.1

CASSETTE POWER PRIME (LINE A) When the prime cassette screen is displayed and the [PRIME CASSETTE] key is pressed and released, the pumping action of the system pulls fluid from Line Ainto the cassette. At each device 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, Gravity pulls fluid into the cassette until the (PRIME the system reverts to gravity prime. CASSETTE] key is released. Note: See Section 3.3, Priming Procedures: Secondary Administration Sets, regarding priming secondary administration sets Tom the device.

for information

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. HOLD DowN [CASSETT E] KEY INTO COLLECTION BAG.

<B> ~0 PRIME PRESS [E:;T]

ON

2. Press the [ENTER] key when priming is complete.

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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 When the prime Patient Line screen is displayed and the (PRIME PATIENT LINE] key is pressed, 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 mL of fluid. This volume is sufficient to prime the entire microbore 60 inch patient line. Note: When using power prime, con&m the patient line is fully cleared of all air before connecting to patient. Additional gravity priming may be required to fully clear air from the line. 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.

3.2.4

PRIMING THE PATIENT LINE TO prime the patient line i?om lines B, C, or D, proceed as follows: 1. Press and hold the [PRIME PATIENT LINE] key until all air is cleared from the patient line. DO'~~N [PATIENT LINE ] KEY ON <B> TO PRIME PATIENT LINE. PRESS [ ENTER ]

HOLD

2. When priming is complete, press the (ENTER] key. Note: When using the gravity flow prevention valve set, see Section 3.3, Priming Procedures: Primary Administration Set With Grauity Plow Prevention Value. Omni-Flow 4000 Plus 1V Medication Management System

3-7

430-0637 l-004 (Rev. 4193)