OMNI-FLOW 4000 PLUS Technical Service Manual Rev A Nov 2010

Technical Service Manual

137 Pages

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File Size: 1.84 MB

File Name: omni-flow_4000_plus_technical_service_manual_rev_a_.pdf

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Page 1

IV Medication Management System

For use with List Number 40051-04

Technical Service Manual

430-06579-003 (A, 11/10)

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Omni-Flow 4000 Plus

Technical Service Manual

Change History Part Number

Description of Change

430-06579-001 (Rev. 07/93)

Original issue

430-06579-A01 (Rev. 11/93)

Change Page issue Update Cover and Copyright Update Change History and Contents Section 5 Update equipment requirements Update test setup Update system tests Section 6 Update History Alarm table Section 7 Update required tools and materials Update top enclosure assembly replacement and keypad replacement Update Back Cover Update registered trademarks

430-06579-B01 (Rev. 04/95)

Change Page issue Update Cover and Copyright Update Change History and Contents Section 1 Add acronyms and abbreviations Revise section numbering Section 4 Add Section 4.11 Section 5 Revise sections 5.1.2, 5.2.1.4, and Table 5-1 Move Section 5.3 to Section 4.11 Section 6 Update address Add Index Update registered trademarks

Technical Service Manual

Omni-Flow 4000 Plus

CHANGE HISTORY

Part Number

Description of Change

430-06579-C01 (Rev. 08/96)

Change Page issue Update Cover and Copyright Update Change History and Contents Section 4 Update Section 4.7.2.3 Section 5 Add Section 5.1.2 Reformat entire section Section 6 Add new address Add note in Table 6-1 Section 7 Update torque settings Editorial corrections Section 9 Add IPB drawings and Table 9-2 Update Index Update Back Cover

430-06579-002 (Rev. 07/04)

Update entire manual to reflect current style

430-06579-003 (Rev. 11/10)

Third issue

Incorporate Hospira name change

Update Electrical Safety Test Update Section 5 and Section 7 Update graphics

Omni-Flow 4000 Plus

Technical Service Manual

CONTENTS

Contents Section 1 INTRODUCTION... 1.1 SCOPE... 1.2 CONVENTIONS... 1.3 COMPONENT DESIGNATORS... 1.4 ACRONYMS AND ABBREVIATIONS... 1.5 SERIES-SPECIFIC INFORMATION... 1.6 USER QUALIFICATION... 1.7 ARTIFACTS... 1.8 INFUSION SYSTEM INSTALLATION... 1.8.1 UNPACKING... 1.8.2 INSPECTION... 1.8.3 SELF TEST... 1.8.4 REAL TIME CLOCK... 1.8.4.1 SETTING THE REAL TIME CLOCK AT POWER UP . 1.8.4.2 SETTING THE REAL TIME CLOCK USING SPECIAL FUNCTION...

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1-1 1-1 1-2 1-2 1-3 1-4 1-4 1-5 1-5 1-5 1-5 1-6 1-6 1-7

1-7

Section 2 WARRANTY .

. .

2-1

SYSTEM OPERATING MANUAL .

3-1

THEORY OF OPERATION... 4.1 SEQUENCE OF OPERATION... 4.1.1 OFF STATUS... 4.1.2 ON STATUS... 4.1.2.1 SELF TEST... 4.1.2.2 MAIN PROGRAM SOFTWARE FUNCTIONS 4.1.2.3 SETUP... 4.1.2.4 CASSETTE TEST... 4.2 ALARM CONDITIONS... 4.3 SYSTEM MALFUNCTION DETECTION... 4.4 DATA RETENTION... 4.4.1 SIGNIFICANT DATA RETENTION... 4.4.2 IV HISTORY... 4.5 SYSTEM INTERFACE DESCRIPTION... 4.5.1 AC POWER INTERFACE... 4.5.2 USER INTERFACE... 4.5.3 MECHANISM INTERFACE... 4.6 PWA FUNCTIONAL DESCRIPTION... 4.6.1 CONTROL PWA... 4.6.1.1 MICROPROCESSOR AND CLOCK... 4.6.1.2 EPROM AND RAM... 4.6.1.3 REAL TIME CLOCK... 4.6.1.4 PERIPHERAL ACCESS... 4.6.1.5 SERIAL COMMUNICATIONS...

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4-1 4-1 4-1 4-2 4-2 4-2 4-3 4-3 4-3 4-4 4-5 4-5 4-5 4-6 4-6 4-7 4-7 4-8 4-8 4-8 4-8 4-9 4-9 4-9

Section 3 Section 4

Technical Service Manual

Omni-Flow 4000 Plus

CONTENTS

4.6.1.6 LCD BACKLIGHT AND CONTRAST CONTROL... 4.6.1.7 ALARM CIRCUITRY... 4.6.1.8 POWER ON RESET CIRCUITRY... 4.6.1.9 AC POWER INDICATOR... 4.6.2 PUMP PWA... 4.6.2.1 MICROPROCESSOR AND CLOCK... 4.6.2.2 EPROM AND RAM... 4.6.2.3 WATCHDOG TIMER... 4.6.2.4 PERIPHERAL ACCESS... 4.6.2.5 ANALOG-TO-DIGITAL CONVERTER... 4.6.2.6 PRESSURE TRANSDUCER CONDITIONING AND POWER . 4.6.2.7 MOTOR AND SOLENOID CONTROL... 4.6.2.8 OPTICAL SWITCHES... 4.6.3 POWER SUPPLY PWA... 4.6.3.1 AC INPUT RECTIFICATION AND FILTERING... 4.7 MECHANISM FUNCTIONAL DESCRIPTION... 4.8 DISPOSABLE CASSETTE DESCRIPTION... 4.9 PRESSURE MONITORING... 4.9.1 PROXIMAL OCCLUSION... 4.9.2 AIR DETECTION... 4.9.3 CASSETTE PRESSURE EQUALIZATION... 4.9.4 PATIENT OCCLUSION DETECTION...

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4-9 4-10 4-10 4-10 4-10 4-10 4-11 4-11 4-11 4-11 4-12 4-12 4-12 4-13 4-13 4-14 4-16 4-17 4-17 4-17 4-18 4-18

Section 5 MAINTENANCE AND SERVICE TESTS... 5.1 ROUTINE MAINTENANCE... 5.1.1 CLEANING AND SANITIZING... 5.2 PERFORMANCE VERIFICATION TEST... 5.2.1 EQUIPMENT REQUIRED... 5.2.2 INSPECTION... 5.2.3 PUMPING MECHANISM/PRESSURE FINGER CHECK . 5.2.4 TEST SETUP... 5.2.5 SYSTEM TESTS... 5.2.6 COLLECTION SOLENOID TEST... 5.2.7 PATIENT SOLENOID TEST... 5.2.8 CASSETTE TEST... 5.2.9 HIGH FLOW TEST... 5.2.10 VOLUME ACCURACY TEST... 5.2.11 OCCLUSION TEST... 5.2.12 NURSE CALL TEST... 5.2.13 PRINTER PATTERN TEST... 5.2.14 ELECTRICAL SAFETY TEST... 5.2.15 END OF PVT... 5.3 PERIODIC MAINTENANCE INSPECTION... 5.4 BATTERY OPERATION OVERVIEW...

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5-1 5-1 5-1 5-2 5-3 5-3 5-4 5-5 5-6 5-7 5-7 5-7 5-8 5-8 5-9 5-10 5-10 5-11 5-11 5-12 5-12

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6-1 6-1 6-1 6-2 6-4 6-6 6-8 6-9

Section 6 TROUBLESHOOTING... 6.1 TECHNICAL ASSISTANCE... 6.2 ALARM MESSAGES AND SERVICE CODES . 6.2.1 OPERATOR ALARM MESSAGES . . . 6.2.2 SELF TEST SERVICE CODES... 6.2.3 PUMP SERVICE CODES... 6.2.4 SOFTWARE SERVICE CODES... 6.2.5 SYSTEM SERVICE CODES...

Omni-Flow 4000 Plus

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Technical Service Manual

CONTENTS

6.3 TROUBLESHOOTING PROCEDURES... 6.3.1 TROUBLESHOOTING GENERAL PROBLEMS... 6.3.2 TROUBLESHOOTING WITH THE PVT... 6.3.2.1 SYSTEM TEST TROUBLESHOOTING... 6.3.2.2 PVT TROUBLESHOOTING... 6.3.3 TROUBLESHOOTING WITH IV HISTORY... 6.3.3.1 IV HISTORY ALARM STATUS CODES... 6.3.4 TROUBLESHOOTING IN SPECIAL FUNCTION MODE . . . 6.3.4.1 MONITORING CASSETTE PRESSURE AND SYSTEM VOLTAGES... 6.3.4.2 BIOMED PASSWORD LEVEL...

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

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. 6-10 . 6-10 . 6-13 . 6-13 . 6-15 . 6-16 . 6-18 . 6-19

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. 6-20 . 6-21

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. 7-11 . 7-13 . 7-15 . 7-17 . 7-19 . 7-21 . 7-22 . 7-24 . 7-25 . 7-27 . 7-28 . 7-29 . 7-30

Section 7 REPLACEABLE PARTS AND REPAIRS... 7.1 REPLACEABLE PARTS... 7.2 REPLACEMENT AND ADJUSTMENT PROCEDURES... 7.2.1 SAFETY AND EQUIPMENT PRECAUTIONS... 7.2.2 REQUIRED TOOLS AND MATERIALS... 7.2.3 TRANSDUCER OFFSET ADJUSTMENT PROCEDURE . . 7.2.4 AC POWER CORD REPLACEMENT... 7.2.5 FUSE REPLACEMENT... 7.2.6 CASSETTE LOCKING KNOB REPLACEMENT... 7.2.7 NURSE CALL CABLE REPLACEMENT... 7.2.8 POLE CLAMP KNOB REPLACEMENT... 7.2.9 PRINTER INTERFACE CABLE ASSEMBLY REPLACEMENT 7.2.10 SEPARATING THE TOP AND BOTTOM ENCLOSURES . . 7.2.11 BATTERY REPLACEMENT... 7.2.12 CONTROL PWA AND TOP ENCLOSURE ASSEMBLY REPLACEMENT... 7.2.13 LCD REPLACEMENT... 7.2.14 KEYPAD REPLACEMENT... 7.2.15 PUMP PWA REPLACEMENT (SERIAL NUMBER SPECIFIC) 7.2.16 POWER SUPPLY PWA REPLACEMENT... 7.2.17 REAR HOUSING ASSEMBLY REPLACEMENT... 7.2.18 SERIAL RS-232 CONNECTOR REPLACEMENT... 7.2.19 EQUIPOTENTIAL POST REPLACEMENT... 7.2.20 POWER CONNECTOR PLATE REPLACEMENT... 7.2.21 AC LINE FILTER REPLACEMENT... 7.2.22 SWITCH PANEL ASSEMBLY REPLACEMENT... 7.2.23 BAG HANGER REPLACEMENT... 7.2.24 VENT SCREEN REPLACEMENT...

7-1 7-1 7-1 7-1 7-2 7-2 7-4 7-5 7-5 7-6 7-7 7-7 7-8 7-9

Section 8 SPECIFICATIONS .

8-1

. .

9-1

Section 9 DRAWINGS .

Index... I-1

Technical Service Manual

Omni-Flow 4000 Plus

FIGURES

Figures Figure 4-1. Input Valves... Figure 4-2. Valve Cam Assembly... Figure 4-3. Disposable Cassette... Figure 4-4. Cassette Holster... Figure 5-1. Omni-Flow Holster... Figure 5-2. Test Setup... Figure 5-3. Occlusion Test Setup... Figure 7-1. Pump PWA R26 Trim Pot and Test Connector J15 Figure 7-2. Power Cord and Fuse Replacement... Figure 7-3. Cassette Locking Knob... Figure 7-4. Enclosure Screw Placement... Figure 7-5. Top and Bottom Enclosure Separation... Figure 7-6. Battery Replacement... Figure 7-7. Top Enclosure Connectors... Figure 7-8. Top Enclosure Assembly... Figure 7-9. LCD Replacement... Figure 7-10. Bottom View of Keypad ESD Grounding Strip . Figure 7-11. Keypad Replacement... Figure 7-12. Pump PWA... Figure 7-13. Pump PWA Connections... Figure 7-14. Pump Assembly and Rear Housing... Figure 7-15. Power Supply PWA and Motor Base Mechanism. Figure 7-16. Rear Housing Components... Figure 7-17. Switch Panel, RS-232 Connector, and Bag Hanger Figure 7-18. Power Connector Plate... Figure 7-19. AC Line Filter Ground Lug Placement... Figure 9-1. Illustrated Parts Breakdown... Figure 9-2. Exploded View... Figure 9-3. Rear Exploded View... Figure 9-4. Switch Panel Exploded View... Figure 9-5. System Interconnect Block Diagram... Figure 9-6. System Block Diagram... Figure 9-7. Control PWA Block Diagram... Figure 9-8. Pump PWA Block Diagram... Figure 9-9. Power Supply PWA Block Diagram... Figure 9-10. Power Supply Wiring Diagram... Figure 9-11. Pump/Chassis Wiring Diagram...

Omni-Flow 4000 Plus

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. 4-15 . 4-15 . 4-16 . 4-17 . 5-4 . 5-5 . 5-10 . 7-3 . 7-4 . 7-6 . 7-8 . 7-9 . 7-10 . 7-12 . 7-13 . 7-14 . 7-16 . 7-17 . 7-18 . 7-19 . 7-20 . 7-21 . 7-23 . 7-24 . 7-26 . 7-27 . 9-5 . 9-7 . 9-9 . 9-11 . 9-13 . 9-15 . 9-17 . 9-19 . 9-21 . 9-23 . 9-25

Technical Service Manual

TABLES

Tables Table 1-1. Conventions... Table 4-1. AC Power Interface... Table 4-2. User Interface... Table 4-3. Mechanism Interface... Table 5-1. Cleaning Solutions... Table 5-2. Electrical Safety Measurements... Table 6-1. Operator Alarm Messages and Corrective Actions Table 6-2. Self Test Service Codes and Corrective Actions . . Table 6-3. Pump Service Codes and Corrective Actions . . . Table 6-4. Software Service Codes... Table 6-5. System Service Codes... Table 6-6. Troubleshooting General Problems... Table 6-7. System Test Troubleshooting... Table 6-8. PVT Troubleshooting... Table 6-9. IV History Alarm Status Codes... Table 6-10. Special Function Keys... Table 6-11. Cassette Pressure and System Voltages... Table 9-1. Drawings... Table 9-2. Illustrated Parts Breakdown...

Technical Service Manual

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. 1-2 . 4-6 . 4-7 . 4-7 . 5-2 5-11 . 6-2 . 6-4 . 6-6 . 6-8 . 6-9 6-10 6-13 6-15 6-18 6-19 6-21 . 9-1 . 9-1

Omni-Flow 4000 Plus

TABLES

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Technical Service Manual

Section 1

INTRODUCTION The Omni-Flow 4000 Plus™ is a programmable medication administration system designed to deliver up to four separate medications with a single infusion device and single administration set.

1.1

SCOPE This manual is organized into the following sections: ❏ Section 1

Introduction

❏ Section 2

Warranty

❏ Section 3

System Operating Manual

❏ Section 4

Theory of Operation

❏ Section 5

Maintenance and Service Tests

❏ Section 6

Troubleshooting

❏ Section 7

Replaceable Parts and Repair

❏ Section 8

Specifications

❏ Section 9

Drawings

❏ Appendices ❏ Index ❏ Technical Service Bulletins If a problem in device operation cannot be resolved using the information in this manual, contact Hospira (see Section 6.1). Specific instructions for operating the device are contained in its respective System Operating Manual. The terms “infusion system”, “infuser”, and “device” are used interchangeably throughout the manual. Figures are rendered as graphic representations to approximate actual product. Therefore, figures may not exactly reflect the product. Screen representations are examples only, and do not necessarily reflect the most current configuration.

Technical Service Manual

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Omni-Flow 4000 Plus

SECTION 1 INTRODUCTION

1.2

CONVENTIONS The conventions listed in Table 1-2 are used throughout this manual. Table 1-1. Convention

Conventions

Application

Example

Blue Italic

Reference to a section, figure, or table

(see Section 6)

[ALL CAPS] in brackets

Touchswitches, keys, buttons

[START]

ALL CAPS

Screens and displayed messages

LOW BATTERY

Red Bold

Warnings and Cautions

CAUTION: Use proper ESD grounding techniques when handling components.

Throughout this manual, warnings, cautions, and notes are used to emphasize important information, as follows:

WARNING:

A WARNING CONTAINS SPECIAL SAFETY EMPHASIS AND MUST BE OBSERVED AT ALL TIMES. FAILURE TO OBSERVE A WARNING MAY RESULT IN PATIENT INJURY AND BE LIFE-THREATENING.

CAUTION: A CAUTION usually appears in front of a procedure or statement and contains information that could prevent hardware failure, irreversible damage to equipment, or loss of data.

 Note: A note highlights information that helps explain a concept or procedure. 1.3

COMPONENT DESIGNATORS Components are indicated by alpha-numeric designators, as follows: Battery

Diode

Resistor

Capacitor

Fuse

Switch

Crystal

Integrated Circuit

Transistor

The number following the letter is a unique value for each type of component (e.g., R1, R2).

 that Note: Alpha-numeric designators may be followed with a dash (-) number indicates a pin number for that component. For example, U15-13 is pin 13 of the encoder chip [U15] on the interface PWA.

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1.4

ACRONYMS AND ABBREVIATIONS

1.4

ACRONYMS AND ABBREVIATIONS Acronyms and abbreviations used in this manual are as follows: A Ampere AC Alternating current ACIA Asynchronous communication interface adapter A/D Analog-to-digital DC Direct current DLY Delay DMM Digital multimeter DPM Digital pressure meter ECG Electrocardiogram EEG Electroencephalogram EL Electroluminescent EMG Electromyogram EPROM Erasable programmable read-only memory ESD Electrostatic discharge ETO Ethylene oxide FET Field effect transistor Hz Hertz IC Integrated circuit I/O Input/output IV Intravenous KHz Kilohertz KVO Keep vein open LCD Liquid crystal display LED Light emitting diode mA Milliampere MHz Megahertz mL Milliliter MOSFET Metal oxide semiconductor field effect transistor mV Millivolt NMI Non-maskable interrupt OSC Oscillator PAL Programmable array logic PWA Printed wiring assembly PIA Peripheral interface adapter psi Pounds per square inch PVT Performance Verification Test

Technical Service Manual

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Omni-Flow 4000 Plus

SECTION 1 INTRODUCTION

RAM Random access memory ROM Read-only memory RTC Real time clock V Volt VAC Volts AC VDC Volts DC Vbatt Battery voltage µA Microampere µL Microliter

1.5

SERIES-SPECIFIC INFORMATION When a description or a procedure is specific to a particular series or version of the device, the information is shown following the section heading or text (e.g., four-digit serial numbers 3290 and above).

1.6

USER QUALIFICATION The infusion system is for use at the direction or under the supervision of licensed physicians or certified healthcare professionals who are trained in the use of the infusion system and the administration of parenteral and enteral fluids or drugs. Training should emphasize preventing related IV complications, including appropriate precautions to prevent accidental infusion of air.

1.7

ARTIFACTS Nonhazardous, low-level electrical potentials are commonly observed when fluids are administered using infusion devices. These potentials are well within accepted safety standards, but may create artifacts on voltage-sensing equipment such as ECG, EMG, and EEG machines. These artifacts vary at a rate that is associated with the infusion rate. If the monitoring machine is not operating correctly or has loose or defective connections to its sensing electrodes, these artifacts may be accentuated so as to simulate actual physiological signals. To determine if the abnormality in the monitoring equipment is caused by the infuser instead of some other source in the environment, set the 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 infuser. Proper setup and maintenance of the monitoring equipment should eliminate the artifact. Refer to the appropriate monitoring system documentation for setup and maintenance instructions.

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Technical Service Manual

1.8

INFUSION SYSTEM INSTALLATION

1.8

INFUSION SYSTEM INSTALLATION CAUTION: Infusion system damage may occur unless proper care is exercised during product unpacking and installation. The battery may not be fully charged upon receipt of the infusion system. Do not place the infusion system in service if it fails the self test or if the battery is not fully charged. CAUTION: Infusion system performance may be degraded by electromagnetic interference (EMI) from devices such as electrosurgical units, cellular phones, and two-way radios. Operation of the infusion system under such conditions should be avoided. CAUTION: Before operating the infusion system next to, or in a stacked configuration with other electrical equipment, confirm the infusion system’s operational performance in that configuration. The instrument installation procedure consists of unpacking, inspecting, and self test.

1.8.1

UNPACKING Inspect the shipping container as described in Section 1.8.2. Use care when unpacking the infusion system. Retain the packing slip and save all packing materials in the event it is necessary to return the infusion system to the factory. Verify the shipping container includes a copy of the System Operating Manual.

1.8.2

INSPECTION Inspect the infusion system for shipping damage. Should any damage be found, contact the delivering carrier immediately. CAUTION: Do not use the infusion system if it appears to be damaged. Should damage be found, contact Hospira. Inspect the infusion system periodically for signs of defects such as worn accessories, broken connections, or damaged cable assemblies. Also inspect the infusion system after repair or during cleaning. Replace any damaged or defective external parts.

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Omni-Flow 4000 Plus

SECTION 1 INTRODUCTION

1.8.3

SELF TEST CAUTION:

Do not place the infusion system in service if the self test fails.

 Note: When plugging the device into an AC power outlet, grasp the AC power

cord plug and use a forward motion into the socket. Do not use a sideways motion. When unplugging the device, grasp the AC power cord plug and pull straight out. Do not pull out using the power cord cable and do not pull out at an angle.

To conduct the self test, proceed as follows: 1. Connect the power cord to a properly grounded AC outlet. 2. Toggle the [ON/CHARGE] switch on the back of the infuser 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.

3. Confirm the green AC power indicator is illuminated and all other LED indicator lights are off. 4. At power on, the infuser performs its self test diagnostics, during which time the screen displays SELF TEST IN PROGRESS. The self test will complete in approximately six seconds. 5. Remove the shipping cassette from the device.

1.8.4

REAL TIME CLOCK The real time clock maintains accurate time on battery power for approximately one month. If the battery is not recharged during that time, the real time clock settings may become invalid. Infuser operations, such as programming an intermittent infusion, require that the real time clock be operating properly. Set the real time clock under the following circumstances: - Initial installation - Time change - Following complete battery discharge

 Note: The battery discharges any time the infuser is disconnected from AC power. Reconnecting the infuser to AC power does not automatically reset the real time clock.

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Technical Service Manual

1.8

INFUSION SYSTEM INSTALLATION

1.8.4.1

SETTING THE REAL TIME CLOCK AT POWER UP Upon completion of the infuser self-test, the following screen appears: INSERT CASSETTE AND LOCK IN PLACE PRESS [ENTER] 11:30 AM

To set the real time clock, proceed as follows: 1. Using the numeric keypad, enter the hour and minutes. 2. Press the [NEXT] key to change the AM/PM designator, then press the [AM/PM] key. 3. Press the [ENTER] key and confirm the correct time displays. 1.8.4.2

SETTING THE REAL TIME CLOCK USING SPECIAL FUNCTION To set the real time clock using the special function feature, proceed as follows:

 Note: Time can only be changed when all lines are off. 1. Stop all lines from the infuser status screen, as follows: A:OFF B:OFF C:OFF D:OFF TOTAL 12:30 AM 0 0 0 0 0

2. Press the [SPEC. FUNC.] key, then press [1]. The following screen appears: CURRENT TIME 9:00 PM MILITARY TIME: YES NO

[ENTER]

1. Using the numeric keypad, enter the hour and minutes. 2. Press [NEXT] to change the AM/PM designator, then press [AM/PM]. 3. For military time, press [NEXT], then press [YES].

 Note: Depending on the software version, Omni-Flow 4000 Plus

infusers default to either AM/PM time or military time. If military time is selected on an infuser that is configured to AM/PM time, it defaults to AM/PM when the infuser is turned off.

4. Press [ENTER] and confirm the correct time displays.

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SECTION 1 INTRODUCTION

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Section 2

WARRANTY Subject to the terms and conditions herein, Hospira, Inc., hereinafter referred to as Hospira, warrants that (a) the product shall conform to Hospira's standard specifications and be free from defects in material and workmanship under normal use and service for a period of one year after purchase, and (b) the replaceable battery shall be free from defects in material and workmanship under normal use and service for a period of 90 days after purchase. Hospira makes no other warranties, express or implied, and specifically disclaims the implied warranties of merchantability and fitness for a particular purpose. Purchaser's exclusive remedy shall be, at Hospira's option, the repair or replacement of the product. In no event shall Hospira's liability arising out of any cause whatsoever (whether such cause be based in contract, negligence, strict liability, other tort, or otherwise) exceed the price of such product, and in no event shall Hospira be liable for incidental, consequential, or special damages or losses or for lost business, revenues, or profits. Warranty product returned to Hospira must be properly packaged and sent freight prepaid. The foregoing warranty shall be void in the event the product has been misused, damaged, altered, or used other than in accordance with product manuals so as, in Hospira's judgment, to affect its stability or reliability, or in the event the serial or lot number has been altered, effaced, or removed. The foregoing warranty shall also be void in the event any person, including the Purchaser, performs or attempts to perform any major repair or other service on the product without having been trained by an authorized representative of Hospira and using Hospira documentation and approved spare parts. For purposes of the preceding sentence, "major repair or other service" means any repair or service other than the replacement of accessory items such as batteries and detachable AC power cords. In providing any parts for repair or service of the product, Hospira shall have no responsibility or liability for the actions or inactions of the person performing such repair or service, regardless of whether such person has been trained to perform such repair or service. It is understood and acknowledged that any person other than a Hospira representative performing repair or service is not an authorized agent of Hospira.

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SECTION 2 WARRANTY

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Omni-Flow Infusion Systems

OMNI-FLOW 4000 PLUS Technical Service Manual Rev A Nov 2010