GemStar Technical Service Manual March 2009

©Hospira, Inc.

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

Hospira GemStar

Technical Service Manual

Contents Section 1 INTRODUCTION... 1.1 SCOPE... 1.2 CONVENTIONS... 1.3 ACRONYMS AND ABBREVIATIONS . . 1.4 USER QUALIFICATION... 1.5 ARTIFACTS... 1.6 ELECTROMAGNETIC COMPATIBILITY . 1.7 INSTRUMENT INSTALLATION... 1.7.1 UNPACKING... 1.7.2 INSPECTION... 1.7.3 SELF TEST... 1.8 OVERVIEW... 1.8.1 THERAPIES... 1.8.2 SAFETY FEATURES... 1.8.3 POWER SOURCES... 1.8.4 OPERATION...

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

Section 2 WARRANTY... 2-1

Section 3 SYSTEM OPERATING MANUAL... 3-1

Section 4 THEORY OF OPERATION... 4.1 ELECTROMECHANICAL SYSTEM... 4.1.1 CPU SYSTEM... 4.1.1.1 CPU... 4.1.1.2 MEMORY... 4.1.1.3 FPGA... 4.1.2 CPU SUPERVISORY FUNCTIONS... 4.1.2.1 SUPPLY MONITORING... 4.1.2.2 POWER ON RESET... 4.1.2.3 MEMORY AND TIME RETENTION... 4.1.2.4 WATCHDOG FUNCTION... 4.1.2.5 CPU ERROR CHECKING/WATCHDOG CIRCUITRY . 4.1.2.6 WDT PIC/BEEPER PIC/BEEPER DRIVER... 4.1.3 DISPLAY MODULE/BACKLIGHT... 4.1.4 KEYPAD/LEDS... 4.1.5 BOLUS SWITCHES... 4.1.6 TIME-OF-DAY CLOCK... 4.1.7 POWER INPUT SENSING/SELECTION CIRCUITRY... 4.1.8 INTERNAL POWER SUPPLIES... 4.1.9 ON/OFF CONTROL... 4.1.9.1 POWER ON... 4.1.9.2 POWER OFF...

Technical Service Manual

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

Hospira GemStar

CONTENTS

4.1.10 MOTOR DRIVE CIRCUITS... 4.1.10.1 SPEED CONTROL... 4.1.10.2 POWER CONSERVATION... 4.1.10.3 MOTOR... 4.1.10.4 TACHOMETER... 4.1.10.5 REDUNDANT MOTOR CONTROL... 4.1.11 MOTOR TACHOMETER POWER CONSERVATION . 4.1.12 OUTPUT SHAFT ENCODER... 4.1.13 AIR-IN-LINE SENSING... 4.1.14 PROXIMAL PRESSURE MEASUREMENT... 4.1.15 DISTAL PRESSURE MEASUREMENT... 4.1.16 RS-232 INTERFACE SYSTEM... 4.2 CASSETTE SYSTEM... 4.2.1 BODY AND TOP... 4.2.2 DIAPHRAGM... 4.2.3 FLOW STOP...

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. 4-7 . 4-7 . 4-8 . 4-8 . 4-9 . 4-9 . 4-9 . 4-10 . 4-10 . 4-11 . 4-11 . 4-12 . 4-12 . 4-12 . 4-13 . 4-13

Section 5 MAINTENANCE, INSPECTION, AND OPERATION TEST... 5-1 5.1 ROUTINE MAINTENANCE... 5-1 5.1.1 CLEANING AND SANITIZING... 5-1 5.1.1.1 CLEANING THE CASSETTE POCKET AND TUBING CHANNEL . 5-3 5.1.2 INSPECTION... 5-3 5.1.2.1 MATERIALS REQUIRED... 5-4 5.1.2.2 LATCH MECHANISM INSPECTION... 5-4 5.1.2.3 AIR SENSOR INSPECTION... 5-5 5.1.2.4 PLUNGER AND PRESSURE SENSOR INSPECTION... 5-6 5.1.2.5 TOP ENDCAP INSPECTION... 5-7 5.1.2.6 BOTTOM ENDCAP INSPECTION... 5-8 5.1.2.7 BEZEL, GRIP, AND KEYPAD INSPECTION... 5-9 5.1.2.8 BATTERY DOOR AND COMPARTMENT INSPECTION... 5-10 5.1.2.9 POWER ON TEST... 5-12 5.1.2.10 RECHARGEABLE BATTERY PACK... 5-13 5.1.2.11 DOCKING STATION... 5-14 5.1.2.12 AC ADAPTOR... 5-16 5.1.2.13 REMOTE BOLUS CORD AND SWITCH... 5-17 5.2 OPERATION TEST... 5-17 5.2.1 EQUIPMENT REQUIRED... 5-18 5.2.2 TEST SETUP... 5-18 5.2.3 POWER TEST... 5-18 5.2.4 KEYPAD TEST... 5-18 5.2.5 DISPLAY TEST... 5-19 5.2.6 LED TEST... 5-19 5.2.7 VOLUME ACCURACY TEST... 5-19 5.2.8 DISTAL OCCLUSION TEST... 5-19 5.2.9 PROXIMAL OCCLUSION TEST... 5-20 5.2.10 AIR-IN-LINE TEST... 5-20 5.2.11 PRINTING THE TEST RESULTS... 5-20 5.2.12 RESTORING FOR USE... 5-21 5.3 PERIODIC MAINTENANCE INSPECTION... 5-21

Hospira GemStar

Technical Service Manual

FIGURES

Section 6 TROUBLESHOOTING... 6.1 TECHNICAL ASSISTANCE... 6.2 TROUBLESHOOTING REFERENCES... 6.2.1 TROUBLESHOOTING TOOLS... 6.2.2 ALERT/ALARM MESSAGE INDEX... 6.2.3 PRINTING DEVICE HISTORY... 6.3 SERVICE ALARM CODES... 6.3.1 SERVICE ALARM CODES - QUICK REFERENCE . 6.3.2 SERVICE ALARM CODES - DETAILS... 6.4 OPERATIONAL ALARMS...

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. 6-1 . 6-1 . 6-1 . 6-2 . 6-2 . 6-3 . 6-4 . 6-4 . 6-7 6-29

REPLACEABLE PARTS AND REPAIRS... 7.1 REPLACEABLE PARTS... 7.2 REMOVAL AND ASSEMBLY PROCEDURES... 7.2.1 SAFETY AND EQUIPMENT PRECAUTIONS... 7.2.2 BOTTOM ENDCAP REMOVAL... 7.2.3 EJECT BUTTON AND TOP ENDCAP REMOVAL... 7.2.4 BEEPER ASSEMBLY REMOVAL... 7.2.5 PWA AND MECHANISM REMOVAL... 7.2.6 BEZEL ASSEMBLY REMOVAL... 7.2.7 ASSEMBLING THE BEZEL TO THE CASE... 7.2.8 ASSEMBLING PWAS TO THE MECHANISM... 7.2.9 ASSEMBLING PWAS AND MECHANISM INTO THE CASE .

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. 7-1 . 7-1 . 7-1 . 7-1 . 7-2 . 7-3 . 7-4 . 7-5 . 7-9 . 7-9 7-11 7-14

Section 7

Section 8 SPECIFICATIONS... 8-1

Section 9 DRAWINGS... 9-1

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Technical Service Manual

I-1

Hospira GemStar

TABLES

Figures Figure 1-1. Illustration of the Infuser... Figure 5-1. Cassette Pocket and Tubing Channel... Figure 5-2. Cassette Retention and Ejection... Figure 5-3. Air Sensor Inspection... Figure 5-4. Plunger and Pressure Sensor Inspection... Figure 5-5. Top Endcap Inspection... Figure 5-6. Bottom Endcap Inspection... Figure 5-7. Bezel, Grip, and Keypad Inspection... Figure 5-8. Battery Door Engagement... Figure 5-9. Battery Door Inspection... Figure 5-10. Battery Compartment Inspection... Figure 5-11. Power On Test... Figure 5-12. Rechargeable Battery Pack... Figure 5-13. Docking Station... Figure 5-14. AC Adaptor... Figure 5-15. Remote Bolus Cord and Switch... Figure 7-1. Bottom View with Endcap Removed... Figure 7-2. Eject Button and Top Endcap... Figure 7-3. Top View with Endcap Removed... Figure 7-4. Bottom of the Case... Figure 7-5. Accessing the Display Cable... Figure 7-6. Accessing the Keypad Cable... Figure 7-7. Sliding the PWAs and Mechanism... Figure 7-8. Top and Middle PWAs... Figure 7-9. Pressure Sensors... Figure 7-10. Air-In-Line Sensor... Figure 7-11. Middle PWA and Mechanism... Figure 7-12. Separating the Bezel and the Case... Figure 7-13. Bezel and Case Extrusion Assembly... Figure 7-14. Bezel Tail... Figure 7-15. Installing Standoffs... Figure 7-16. Routing the Pressure Sensor Cables... Figure 7-17. Insulation Tape Over Proximal and Distal Connectors . Figure 7-18. Middle PWA and Mechanism Assembly... Figure 7-19. Air Sensor Connection on Bottom PWA... Figure 7-20. Middle and Bottom PWAs... Figure 7-21. Top and Middle PWAs... Figure 7-22. Top PWA Insulator... Figure 7-23. PWAs/Mechanism Assembly... Figure 7-24. Keypad Cable Connector... Figure 7-25. PWAs and Mechanism Installed in the Case... Figure 7-26. Silicone Cords... Figure 7-27. Case Screws... Figure 7-28. Eject Button... Figure 7-29. Aligning the Tubing Grooves... Figure 7-30. Installing Endcap Screws... Figure 9-1. Illustrated Parts Breakdown - Front View... Figure 9-2. Illustrated Parts Breakdown - Back View... Figure 9-3. GemStar Subassembly...

Hospira GemStar

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Technical Service Manual

Tables Table 1-1. Table 1-2. Table 1-3. Table 5-1. Table 6-1. Table 6-2. Table 6-3. Table 6-4. Table 6-5. Table 9-1. Table A-1. Table A-2. Table A-3. Table A-4.

Conventions... Configuration List Numbers... Safety Features... Cleaning Solutions... Troubleshooting Tools... Alert/Alarm Message Index... Service Alarm Codes - Quick Reference... Service Alarm Codes - Details... Operational Alarms... Illustrated Parts Breakdown... Guidance and Manufacturer’s Declaration - Electromagnetic Emissions . Guidance and Manufacturer’s Declaration - Electromagnetic Immunity . Guidance and Manufacturer’s Declaration - Electromagnetic Immunity for Life-Supporting Equipment and Systems... Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Infuser...

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Section 1

INTRODUCTION The Hospira GemStar® is a single-channel infuser designed for use in home care and hospital settings. The infuser kit contains the following components: - Hospira GemStar infuser - Two AA disposable batteries - System Operating Manual

1.1

SCOPE This manual is organized into the following sections: ❏

Section 1 Introduction

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Section 2 Warranty

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Section 3 System Operating Manual

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Section 4 Theory of Operation

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Section 5 Maintenance and Service Tests

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Section 6 Troubleshooting

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Section 7 Replaceable Parts, Repairs, and Service

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Section 8 Specifications

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Section 9 Drawings

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Appendices

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Index

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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 the Hospira GemStar System Operating Manual.

 Note: The terms “infusion system”, “infuser”, and “device” are used interchangeably throughout the manual.  Note: Figures are rendered as graphic representations to approximate actual product. Therefore, figures may not exactly reflect the product.  Note: Screen representations are examples only, and do not necessarily reflect the most current configuration. Technical Service Manual

1-1

Hospira GemStar

SECTION 1 INTRODUCTION

1.2

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

Conventions

Use

Example

Italic

Reference to a section, figure, table, or publication

(see Section 6.1)

BOLD ALL CAPS

Keys

Press [YES/ENTER] to continue.

ALL CAPS

Display messages

The infuser displays END OF INFUSION.

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. It 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.

Hospira GemStar

1-2

Technical Service Manual

1.3

ACRONYMS AND ABBREVIATIONS

1.3

ACRONYMS AND ABBREVIATIONS Acronyms and abbreviations used in this manual are as follows. A Ampere AC Alternating current A/D Analog-to-digital ADC Analog-to-digital converter CPU Central processing unit CRC Cyclic redundancy check DC Direct current DMM Digital multimeter ECG Electrocardiogram EEG Electroencephalogram EEPROM Electrically erasable programmable read-only memory EL Electroluminescent EMC Electromagnetic compatibility EMG Electromyogram ESD Electrostatic discharge ETO Ethylene oxide FET Field effect transistor FPGA Field programmable gate array hr hour Hz Hertz IC Integrated circuit IO Input/output IV Intravenous kHz Kilohertz LCD Liquid crystal display LED Light emitting diode mA Milliampere mcg Microgram mg Milligram MHz Megahertz mL Milliliter ms Millisecond mV Millivolt OS Output shaft PFI Power fail input PIC Programmable integrated circuit Technical Service Manual

1-3

Hospira GemStar

SECTION 1 INTRODUCTION

PWA Printed wiring assembly PWM Pulse width modulator RAM Random access memory ROM Read-only memory RPM Revolutions per minute TPN Total parenteral nutrition UART Universal asynchronous receiver/transmitter V Volts VAC Volts alternating current VCC Collector voltage supply VDC Volts direct current VPWR Primary power source Vrms Volts root mean squared VTBI Volume to be infused µA Microampere µs Microsecond

1.4

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

1.5

ARTIFACTS Non-hazardous, 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 the 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.

Hospira GemStar

1-4

Technical Service Manual

1.6

ELECTROMAGNETIC COMPATIBILITY

1.6

ELECTROMAGNETIC COMPATIBILITY The Hospira GemStar is compliant with IEC/EN 60601-1-2 (2001), and has been tested and found to comply with electromagnetic compatibility (EMC) limits for the Medical Device Directive 93/42/EEC (EN 55011 Class B and EN 60601-1-2:2001). These limits are designed to provide reasonable protection against harmful interference in a typical medical installation (see the System Operating Manual). CAUTION: Portable and mobile RF communications equipment, such as cellular telephones, two-way radios, Bluetooth® devices, and microwave ovens in close proximity to the infuser may affect or degrade performance of the device. Operation of the infuser under such conditions should be avoided. There is a shared responsibility between manufacturers, customers, and users to assure that medical equipment and systems are designed and operated as intended. Medical electrical equipment requires special precautions regarding electromagnetic compatibility. The electromagnetic environment should be managed to permit the infuser to perform as intended without disturbing other equipment. The infuser should not be used adjacent to or stacked with other equipment. If the device must be used adjacent to or stacked with other equipment, monitor the equipment to assure there is no electromagnetic interference, and verify normal infuser operation.

1.7

INSTRUMENT INSTALLATION CAUTION: Infuser damage may occur unless proper care is exercised during unpacking and installation. Instrument installation consists of unpacking, inspection, and self test.

1.7.1

UNPACKING Inspect the shipping container as detailed in Section 1.7.2. Use care when unpacking the infuser. Retain the packing slip and save all packing material in the event it is necessary to return the infuser to the factory. Verify the shipping container contains a copy of the System Operating Manual.

1.7.2

INSPECTION Inspect the shipping container for damage. Should any damage be found, contact the delivering carrier immediately. CAUTION: Inspect the infuser for evidence of damage. Do not use the device if it appears to be damaged. Should damage be found, contact Hospira. Inspect the infuser periodically for signs of defects. Also inspect the infuser after repair or during cleaning. Replace any damaged or defective external parts.

Technical Service Manual

1-5

Hospira GemStar

SECTION 1 INTRODUCTION

1.7.3

SELF TEST CAUTION:

Do not place the infuser in service if the self test fails.

At power-on, the infuser immediately enters an initialization mode and performs the following self tests: - RAM test

- Power loss completion test

- ROM checksum calculation

- CRC verifications on all RAM areas protected by CRCs

- Motor control test - Stuck key test - PIC watchdog test - CONFIG register test

- CRC on calibration data stored in the EEPROM - Calibration data verification

- Battery voltage test The initialization mode completes in approximately 30 seconds. During this time the infuser displays a message that the self tests are being performed. If any test fails, the infuser alarms.

 Note: The device does not infuse during the initialization mode. After successful completion of the initialization mode, if there is not a current program in the infuser, the device enters programming mode so the user can enter a new program. If a program is already in the infuser, the user may choose between the following options: - Use the current program. The infuser enters stop mode after the program is reviewed. - Enter a new program. The infuser enters programming mode, then enters stop mode after the program is reviewed.

 Note: If the infuser has been powered off for less than five minutes, a program review is not required. 1.8

OVERVIEW The following sections describe therapy options, differences between therapies, safety features, power sources, and basic operation of the infuser. See Figure 1-1 for an illustration of the infuser.

Hospira GemStar

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Technical Service Manual

1.8

OVERVIEW

1.8.1

THERAPIES The Hospira GemStar offers the following types of therapy: - Pain Management

- Continuous

- Total Parenteral Nutrition (TPN)

- mL/hr Only

- Intermittent

- Variable Time

- Weight Dosed The availability of these programs may vary, depending upon the configuration of the infuser in use. The infuser is shipped from the factory with one of the configurations described in Table 1-2. The infuser configuration is easily identified by the end cap color. Table 1-2. Therapies

Configuration List Numbers

13086 - Gray

Pain Management

13087- Blue

13088 - Yellow

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TPN

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Intermittent

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Weight Dosed

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Continuous

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mL/hr Only

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Variable Time

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Technical Service Manual

1-7

Hospira GemStar

SECTION 1 INTRODUCTION

1.8.2

SAFETY FEATURES Table 1-3 describes the special safety features of the Hospira GemStar. Table 1-3.

Safety Features

Safety Feature

Description

Proximal occlusion detection

Strain gauge

Distal occlusion detection

Strain gauge Settings: Low, Medium, and High Sensitivity

Air-in-Line detection

Ultrasonic settings: 0.5 mL, 2 mL, and Off

Motor monitoring circuit

Redundant and independent monitoring systems

Motor parameter monitoring

Motor encoder and camshaft flag monitored by optical sensor

Self tests

Initialization and self test at power-on Continuous self tests during operation

1.8.3

POWER SOURCES The infuser can be powered by two internal AA disposable batteries, an external rechargeable battery pack, AC mains adaptor, or docking station. External supply voltage must not exceed 3.3 VDC. Install two fresh, disposable AA batteries for backup power when using an external power source. The infuser will continue to operate on backup power if the external power source fails. CAUTION: To assure proper operation when using internal batteries, always replace both batteries with fresh, disposable AA batteries when a change is required. Use of rechargeable batteries in the battery compartment is not recommended. CAUTION: Always connect to a grounded AC outlet when using the AC adaptor. Use only an AC adaptor specifically labeled for use with the Hospira GemStar to charge the battery pack. During charging, if the battery pack becomes hot to the touch, immediately disconnect from AC power and contact Hospira. CAUTION: Do not touch exposed connectors on the bottom of the infuser. Exposed connectors are susceptible to electrostatic discharge (ESD) damage.

Hospira GemStar

1-8

Technical Service Manual

1.8

OVERVIEW

1.8.4

OPERATION The infuser is microprocessor-based and is programmed using a 23-key keypad on the front of the device (see Figure 1-1). The 16-character-by-4-line backlight display indicates the status of the infuser. The Hospira GemStar has up to seven therapies available, depending on its configuration. Delivery rates and Bolus dosage amounts are programmed in milliliters (mL), milligrams (mg), or micrograms (mcg). A loading dose is programmable for immediate or delayed delivery. Bolus doses can be programmed to begin delivery on-demand. To program the infuser, the operator selects the following: - Therapy type - Delivery type: volume delivery (mL), or mass delivery (mg or mcg) - Concentration (only if mass delivery is selected) - Delivery rate - Loading dose, if desired - Bolus dose, if desired - Total amount to be delivered: Volume to be infused (VTBI) If mass delivery is selected, the infuser automatically converts mg or mcg to the nearest number of tenths-of-mL. The amount of fluid delivered is shown on the display. When a Bolus is programmed, a minimum lockout time between Boluses must also be programmed. In addition to the lockout time, the operator can also program the maximum total volume that can be delivered in a selected period. The infuser contains a time-of-day clock and event history storage capability. Program settings, significant events that take place while a protocol is running, and the associated time and date, can be reviewed on the display. The event history can be printed to a compatible printer or downloaded as an ASCII text file to a computer with the use of the serial printer cable. For specific instructions regarding infuser operation and optional system components, see the System Operating Manual.

Technical Service Manual

1-9

Hospira GemStar

SECTION 1 INTRODUCTION

TOP ENDCAP BOLUS BUTTON

CASSETTE EJECT BUTTON TOP VIEW

TOP ENDCAP

DISPLAY

STOP

POWER

START

R

Hospira

GRIP

1 4 7

KEYPAD

PURGE

2 5 8 0

3 6 9

HELP

NO

STOP POWER

STOPT BEZEL

ON/OFF BACK-UP

CHANGE

OPTIONS

YES ENTER

BOTTOM ENDCAP FRONT VIEW

AC POWER CONNECTOR DATAPORT CONNECTOR BOLUS CONNECTOR

BATTERY DOOR RECESS

3 VDC

BOLUS

CONNECTOR LABEL BOTTOM ENDCAP

BATTERY DOOR

BATTERY PACK CONNECTOR BOTTOM VIEW

Figure 1-1.

Hospira GemStar

Illustration of the Infuser

1 - 10

Technical Service Manual

Section 2

WARRANTY Subject to the terms and conditions herein, Hospira, Inc., herein referred to as Hospira, warrants that (a) the product shall conform to Hospira's standard specifications and be free from defects in material and workmanship under normal use and service for a period of one year after purchase, and (b) the replaceable battery shall be free from defects in material and workmanship under normal use and service for a period of 90 days after purchase. Hospira makes no other warranties, express or implied, 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.

Technical Service Manual

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Hospira GemStar

SECTION 2 WARRANTY

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Hospira GemStar

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Technical Service Manual