Hospira EPS-95150-007 Console Operation & Maintenance Manual

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Page 1

INFUSION SYSTEM

For use with the following list numbers:

11971-04 11973-04 12391-04

60529-04 Veterinary Pump

Technical Service Manual

430-95150-007 (Rev. 01/06)

Page 2

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.

430-95150-007 (Rev. 01/06) Plum A+® Infusion System

Page 3

Change History

Part Number Description of Change

430-95150-001 (Rev. 05/00)

430-95150-002 (Rev. 09/01)

430-95150-003 (Rev. 12/02)

Original issue

Second issue

Third issue

Updated biomed settings in Section 1

Updated Theory of Operation to include 220 V supply in Section 4

Updated Specifications to include international and 220 V in Section 8

Updated schematic drawings to include latest revisions and 220 V

power supply

power

Remove and Destroy Pages

Insert Change Pages

430-95150-A03 (Rev. 04/03)

430-95150-004 (Rev. 09/03)

430-95150-005 (Rev. 07/04)

Change Page Issue

Updated cover and copyright pages

Updated change history

Updated Distal Occlusion Test in Section 5

Updated back cover

Fourth Issue

Updated throughout to include MedNet

Fifth Issue

Incorporated Hospira name change

Added list number

Updated Section 5

Updated schematic drawings

Updated back page

cover

i to ii

5-11 to 5-12

back cover

cover

i to ii

5-11 to 5-12

back cover

Technical Service Manual 430-95150-007 (Rev. 01/06)

Page 4

CHANGE HISTORY

Part Number Description of Change

430-95150-006 (Rev. 08/05)

Sixth Issue

Updated Section 1, Section 6, and Section 8

Added IEC paragraph

Added battery warnings

Updated graphics throughout

Updated back page

Removed International specifications

Removed MedNet references

430-95150-007 (Rev. 01/06)

Seventh Issue

Updated Section 1, Section 5, Section 6, and Section 7

Updated schematic drawings

Updated battery information

Updated back page

Remove and Destroy Pages

Insert Change Pages

430-95150-007 (Rev. 01/06) Plum A+

Infusion System

Page 5

Section 1

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.1 SCOPE . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.2 CONVENTIONS . . . . . . . . . . . . . . . . . . . . . . . . 1-2

1.3 COMPONENT DESIGNATORS . . . . . . . . . . . . . . . . . . 1-2

1.4 ACRONYMS AND ABBREVIATIONS . . . . . . . . . . . . . . . . 1-3

1.5 USER QUALIFICATION . . . . . . . . . . . . . . . . . . . . . 1-5

1.6 ARTIFACTS . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

1.7 INSTRUMENT INSTALLATION PROCEDURE . . . . . . . . . . . . 1-6

1.7.1 UNPACKING . . . . . . . . . . . . . . . . . . . . . . 1-6

1.7.2 INSPECTION . . . . . . . . . . . . . . . . . . . . . . 1-6

1.7.3 SELF TEST. . . . . . . . . . . . . . . . . . . . . . . . 1-7

1.8 BIOMED SETTINGS . . . . . . . . . . . . . . . . . . . . . . 1-9

1.8.1 IV PARAMETERS . . . . . . . . . . . . . . . . . . . . . 1-11

1.8.1.1 COMMON IV PARAMETERS. . . . . . . . . . . . . . 1-12

1.8.1.2 DEFAULT UNITS/DRUG . . . . . . . . . . . . . . . 1-14

1.8.1.3 MACRO IV PARAMETERS . . . . . . . . . . . . . . 1-16

1.8.2 ALARMS LOG . . . . . . . . . . . . . . . . . . . . . . 1-17

1.8.3 SETTING THE TIME AND DATE . . . . . . . . . . . . . . . 1-18

Section 2

WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Section 3

SYSTEM OPERATING MANUAL . . . . . . . . . . . . . . . . . . . . 3-1

Section 4

THEORY OF OPERATION . . . . . . . . . . . . . . . . . . . . . . . 4-1

4.1 GENERAL DESCRIPTION . . . . . . . . . . . . . . . . . . . . 4-1

4.2 ELECTRONIC SUBSYSTEM OVERVIEW . . . . . . . . . . . . . . . 4-2

4.2.1 CPU SUBSYSTEM . . . . . . . . . . . . . . . . . . . . . 4-2

4.2.1.1 CPU . . . . . . . . . . . . . . . . . . . . . . . 4-3

4.2.1.2 SYSTEM MEMORY ADDRESS MAP . . . . . . . . . . . 4-3

4.2.1.3 PROGRAMMABLE READ-ONLY MEMORY . . . . . . . . 4-3

4.2.1.4 STATIC RANDOM ACCESS MEMORY . . . . . . . . . . 4-3

4.2.1.5 CONTROL LOGIC. . . . . . . . . . . . . . . . . . 4-3

4.2.1.6 LCD CONTROLLER . . . . . . . . . . . . . . . . . 4-4

4.2.1.7 LCD BACKLIGHT CONTROL . . . . . . . . . . . . . 4-4

4.2.1.8 LCD CONTRAST CONTROL . . . . . . . . . . . . . . 4-4

4.2.1.9 REAL-TIME CLOCK . . . . . . . . . . . . . . . . . 4-5

4.2.1.10 VOLTAGE MONITOR WATCHDOG TIMER . . . . . . . . 4-5

4.2.1.11 ANALOG-TO-DIGITAL CONVERTER . . . . . . . . . . 4-6

4.2.1.12 DIGITAL-TO-ANALOG CONVERTER . . . . . . . . . . 4-8

4.2.1.13 FRONT PANEL KEYPAD MATRIX . . . . . . . . . . . . 4-8

4.2.1.14 FRONT PANEL [ON/OFF] KEY . . . . . . . . . . . . . 4-8

4.2.1.15 FRONT PANEL LED INDICATORS . . . . . . . . . . . 4-8

4.2.1.16 KEYPAD LOCKOUT INTERFACE . . . . . . . . . . . . 4-9

4.2.1.17 NURSE CALL INTERFACE. . . . . . . . . . . . . . . 4-9

4.2.1.18 AUDIBLE INDICATORS . . . . . . . . . . . . . . . 4-9

4.2.1.19 BARCODE READER INTERFACE . . . . . . . . . . . . 4-9

4.2.1.20 DATAPORT INTERFACE . . . . . . . . . . . . . . . 4-10

Technical Service Manual iii 430-95150-007 (Rev. 01/06)

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CONTENTS

4.2.1.21 POWER SUPPLY INTERFACE . . . . . . . . . . . . . 4-10

4.2.1.22 MECHANISM INTERFACE . . . . . . . . . . . . . . 4-11

4.2.2 POWER SUPPLY SUBSYSTEM . . . . . . . . . . . . . . . . 4-13

4.2.2.1 MAIN SWITCHING REGULATOR. . . . . . . . . . . . 4-13

4.2.2.2 MAIN REGULATOR FAULT DETECTION . . . . . . . . . 4-14

4.2.2.3 SYSTEM POWER . . . . . . . . . . . . . . . . . . 4-14

4.2.2.4 AUXILIARY SUPPLIES . . . . . . . . . . . . . . . . 4-14

4.2.2.5 POWER CONTROL . . . . . . . . . . . . . . . . . 4-15

4.2.2.6 BATTERY VOLTAGE MEASUREMENT . . . . . . . . . . 4-16

4.2.2.7 BATTERY CHARGE/DISCHARGE CURRENT MEASUREMENT 4-16

4.2.2.8 BATTERY CHARGER . . . . . . . . . . . . . . . . 4-16

4.2.3 MECHANISM SUBSYSTEM . . . . . . . . . . . . . . . . . 4-17

4.2.3.1 MOTORS/MOTOR DRIVE. . . . . . . . . . . . . . . 4-17

4.2.3.2 MOTOR POSITION SENSORS . . . . . . . . . . . . . 4-18

4.2.3.3 V2_5 REFERENCE VOLTAGE . . . . . . . . . . . . . 4-19

4.2.3.4 AIR SENSORS . . . . . . . . . . . . . . . . . . . 4-19

4.2.3.5 PRESSURE SENSORS . . . . . . . . . . . . . . . . 4-21

4.2.3.6 PRESSURE SENSOR CALIBRATION . . . . . . . . . . . 4-23

4.2.3.7 CASSETTE TYPE/PRESENCE SELECTION . . . . . . . . . 4-23

4.2.3.8 SERIAL EEPROM . . . . . . . . . . . . . . . . . . 4-23

4.3 PRINTED WIRING ASSEMBLIES . . . . . . . . . . . . . . . . . 4-24

4.3.1 POWER SUPPLY PWA . . . . . . . . . . . . . . . . . . . 4-24

4.3.2 PERIPHERAL PWA . . . . . . . . . . . . . . . . . . . . 4-25

4.3.3 CPU PWA . . . . . . . . . . . . . . . . . . . . . . . . 4-25

4.3.4 DRIVER PWA . . . . . . . . . . . . . . . . . . . . . . 4-26

4.3.5 SWITCH PWA . . . . . . . . . . . . . . . . . . . . . . 4-27

4.3.6 APP PWA . . . . . . . . . . . . . . . . . . . . . . . . 4-27

4.4 REMOTE MOUNTED PERIPHERALS . . . . . . . . . . . . . . . . 4-27

4.4.1 LCD . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

4.4.2 SEALED LEAD ACID BATTERY . . . . . . . . . . . . . . . 4-28

4.4.3 BARCODE READER WAND . . . . . . . . . . . . . . . . . 4-28

4.5 MECHANICAL OVERVIEW . . . . . . . . . . . . . . . . . . . 4-28

4.5.1 CASSETTE . . . . . . . . . . . . . . . . . . . . . . . 4-28

4.5.2 MECHANISM ASSEMBLY . . . . . . . . . . . . . . . . . 4-30

4.5.2.1 MOTOR AND VALVE ASSEMBLIES . . . . . . . . . . . 4-30

4.5.2.2 A/B VALVE SUBSYSTEM . . . . . . . . . . . . . . . 4-31

4.5.2.3 INLET/OUTLET VALVE SUBSYSTEM . . . . . . . . . . 4-32

4.5.2.4 PLUNGER DRIVE SUBSYSTEM. . . . . . . . . . . . . 4-32

Section 5

MAINTENANCE AND SERVICE TESTS . . . . . . . . . . . . . . . . . . 5-1

5.1 ROUTINE MAINTENANCE . . . . . . . . . . . . . . . . . . . 5-1

5.1.1 CLEANING . . . . . . . . . . . . . . . . . . . . . . . 5-1

5.1.2 SANITIZING . . . . . . . . . . . . . . . . . . . . . . 5-2

5.2 PERFORMANCE VERIFICATION TEST . . . . . . . . . . . . . . . 5-2

5.2.1 EQUIPMENT REQUIRED . . . . . . . . . . . . . . . . . . 5-3

5.2.2 INSPECTION . . . . . . . . . . . . . . . . . . . . . . 5-3

5.2.3 TEST SETUP . . . . . . . . . . . . . . . . . . . . . . . 5-4

5.2.4 SELF TEST . . . . . . . . . . . . . . . . . . . . . . . 5-4

5.2.5 CASSETTE ALARM TEST . . . . . . . . . . . . . . . . . . 5-6

5.2.6 FREE FLOW TEST . . . . . . . . . . . . . . . . . . . . . 5-6

5.2.7 DISPLAY TEST . . . . . . . . . . . . . . . . . . . . . . 5-6

5.2.8 KEYPAD VERIFICATION/FUNCTIONAL TEST . . . . . . . . . . 5-7

5.2.9 ALARM LOUDNESS TEST . . . . . . . . . . . . . . . . . 5-8

5.2.10 LOCKOUT SWITCH TEST. . . . . . . . . . . . . . . . . . 5-9

430-95150-007 (Rev. 01/06) iv Plum A+

Infusion System

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CONTENTS

5.2.11 PROXIMAL OCCLUSION TEST . . . . . . . . . . . . . . . . 5-9

5.2.12 PROXIMAL AIR-IN-LINE TEST . . . . . . . . . . . . . . . . 5-10

5.2.13 DISTAL AIR-IN-LINE TEST . . . . . . . . . . . . . . . . . 5-10

5.2.14 DISTAL OCCLUSION TEST . . . . . . . . . . . . . . . . . 5-12

5.2.15 DELIVERY ACCURACY TEST . . . . . . . . . . . . . . . . 5-14

5.2.16 NURSE CALL TEST . . . . . . . . . . . . . . . . . . . . 5-14

5.2.17 ELECTRICAL SAFETY TEST . . . . . . . . . . . . . . . . . 5-15

5.2.18 END OF THE PVT . . . . . . . . . . . . . . . . . . . . . 5-15

5.3 PERIODIC MAINTENANCE INSPECTION . . . . . . . . . . . . . . 5-15

5.4 BATTERY OPERATION OVERVIEW . . . . . . . . . . . . . . . . 5-16

Section 6

TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . 6-1

6.1 TECHNICAL ASSISTANCE. . . . . . . . . . . . . . . . . . . . 6-1

6.2 WARNING MESSAGES . . . . . . . . . . . . . . . . . . . . . 6-1

6.3 ALARM MESSAGES AND ERROR CODES . . . . . . . . . . . . . . 6-2

6.3.1 OPERATIONAL ALARM MESSAGES . . . . . . . . . . . . . 6-2

6.3.2 ERROR CODES REQUIRING TECHNICAL SERVICE . . . . . . . . 6-7

6.4 TROUBLESHOOTING PROCEDURES. . . . . . . . . . . . . . . . 6-13

Section 7

REPLACEABLE PARTS AND REPAIRS . . . . . . . . . . . . . . . . . . 7-1

7.1 REPLACEABLE PARTS . . . . . . . . . . . . . . . . . . . . . 7-1

7.2 REPLACEMENT PROCEDURES . . . . . . . . . . . . . . . . . . 7-3

7.2.1 SAFETY AND EQUIPMENT PRECAUTIONS . . . . . . . . . . . 7-3

7.2.2 REQUIRED TOOLS AND MATERIALS . . . . . . . . . . . . . 7-3

7.2.3 RUBBER FOOT PAD REPLACEMENT . . . . . . . . . . . . . 7-4

7.2.4 BATTERY, BATTERY DOOR, AND DOOR PAD REPLACEMENT . . . 7-6

7.2.5 AC POWER CORD, RETAINER, AND VELCRO STRAP

REPLACEMENT . . . . . . . . . . . . . . . . . . . . . 7-8

7.2.6 PERIPHERAL ASSEMBLY REPLACEMENT . . . . . . . . . . . 7-10

7.2.7 PERIPHERAL ASSEMBLY COMPONENT REPLACEMENT . . . . . . 7-12

7.2.7.1 VOLUME CONTROL KNOB REPLACEMENT. . . . . . . . 7-14

7.2.7.2 PERIPHERAL COVER REPLACEMENT . . . . . . . . . . 7-14

7.2.8 SEPARATING THE FRONT ENCLOSURE, REAR ENCLOSURE,

AND MAIN CHASSIS ASSEMBLY . . . . . . . . . . . . . . . 7-15

7.2.9 FRONT ENCLOSURE, REAR ENCLOSURE, OR MAIN CHASSIS

ASSEMBLY REPLACEMENT . . . . . . . . . . . . . . . . . 7-17

7.2.9.1 SHOE GASKET REPLACEMENT . . . . . . . . . . . . 7-18

7.2.9.2 FRONT/REAR ENCLOSURE GASKET REPLACEMENT . . . . 7-18

7.2.10 REAR ENCLOSURE COMPONENT REPLACEMENT . . . . . . . . 7-19

7.2.10.1 POLE CLAMP EXTRUSION AND BACKING PLATE

REPLACEMENT . . . . . . . . . . . . . . . . . . 7-21

7.2.10.2 POLE CLAMP SHAFT/KNOB ASSEMBLY

AND SHAFT TIP REPLACEMENT . . . . . . . . . . . . 7-21

7.2.10.3 REAR ENCLOSURE AND HANDLE GASKETS

REPLACEMENT . . . . . . . . . . . . . . . . . . 7-22

7.2.11 MINIPOLE ASSEMBLY REPLACEMENT . . . . . . . . . . . . 7-22

7.2.11.1 COTTER RING REPLACEMENT . . . . . . . . . . . . 7-23

7.2.11.2 BAG HANGER REPLACEMENT. . . . . . . . . . . . . 7-24

7.2.11.3 CLUTCH HOUSING REPLACEMENT. . . . . . . . . . . 7-24

7.2.11.4 CLUTCH SPRING REPLACEMENT . . . . . . . . . . . 7-25

7.2.12 MAIN CHASSIS ASSEMBLY COMPONENT REPLACEMENT . . . . . 7-25

7.2.12.1 POWER SUPPLY PWA REPLACEMENT . . . . . . . . . . 7-27

7.2.12.2 KEYPAD REPLACEMENT . . . . . . . . . . . . . . . 7-27

Technical Service Manual v 430-95150-007 (Rev. 01/06)

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FIGURES

7.2.12.3 DISPLAY REPLACEMENT. . . . . . . . . . . . . . . 7-28

7.2.12.4 CPU PWA REPLACEMENT . . . . . . . . . . . . . . 7-29

7.2.12.5 PIEZO ALARM REPLACEMENT . . . . . . . . . . . . 7-31

7.2.12.6 MECHANISM ASSEMBLY REPLACEMENT . . . . . . . . 7-32

7.2.12.7 CASSETTE DOOR AND FLUID SHIELD REPLACEMENT . . . 7-34

7.2.12.8 OPENER HANDLE ASSEMBLY REPLACEMENT . . . . . . 7-37

Section 8

SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Section 9

DRAWINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1

Figures

Figure 1-1. Display and Keypad . . . . . . . . . . . . . . . . . . . . 1-8

Figure 1-2. Biomed Settings . . . . . . . . . . . . . . . . . . . . . . 1-10

Figure 1-3. IV Parameters . . . . . . . . . . . . . . . . . . . . . . . 1-11

Figure 1-4. Common IV Parameters - Version 10.3 . . . . . . . . . . . . . . 1-12

Figure 1-5. Common IV Parameters - Version 11.3 - higher) . . . . . . . . . . . 1-13

Figure 1-6. Default Units/Drug . . . . . . . . . . . . . . . . . . . . . 1-14

Figure 1-7. Dose Units for Drug . . . . . . . . . . . . . . . . . . . . 1-15

Figure 1-8. Conc Units for Drug . . . . . . . . . . . . . . . . . . . . 1-15

Figure 1-9. Macro IV Parameters . . . . . . . . . . . . . . . . . . . . 1-16

Figure 1-10. Alarms Log . . . . . . . . . . . . . . . . . . . . . . . . 1-17

Figure 1-11. Setting the Time and Date . . . . . . . . . . . . . . . . . . 1-18

Figure 4-1. Serial Interface to ADC . . . . . . . . . . . . . . . . . . . 4-7

Figure 4-2. System Startup and Shutdown Timing, Battery Powered . . . . . . . 4-15

Figure 4-3. Stepper Motor Coils. . . . . . . . . . . . . . . . . . . . . 4-18

Figure 4-4. Air Sensor Block Diagram . . . . . . . . . . . . . . . . . . 4-20

Figure 4-5. Pressure Sensor Excitation and Amplifier Block Diagram . . . . . . . 4-22

Figure 4-6. Major Elements of the Dual-Channel Cassette . . . . . . . . . . . 4-29

Figure 4-7. Fluid Path in the Cassette. . . . . . . . . . . . . . . . . . . 4-30

Figure 4-8. Mechanism Valve Pins and Sensor Locations. . . . . . . . . . . . 4-31

Figure 5-1. Display and Keypad . . . . . . . . . . . . . . . . . . . . 5-5

Figure 5-2. Rear View . . . . . . . . . . . . . . . . . . . . . . . . 5-8

Figure 5-3. Special Cassettes with Bubble Sensor Tips Removed . . . . . . . . . 5-10

Figure 5-4. Distal Occlusion Test Setup . . . . . . . . . . . . . . . . . . 5-12

Figure 7-1. Bottom View . . . . . . . . . . . . . . . . . . . . . . . 7-5

Figure 7-2. Battery, Battery Door, and Door Pad . . . . . . . . . . . . . . . 7-7

Figure 7-3. AC Power Cord, Retainer, and Velcro Strap . . . . . . . . . . . . 7-9

Figure 7-4. Rear View . . . . . . . . . . . . . . . . . . . . . . . . 7-11

Figure 7-5. Peripheral Assembly Replacement . . . . . . . . . . . . . . . 7-12

Figure 7-6. Peripheral Assembly Components . . . . . . . . . . . . . . . 7-13

Figure 7-7. Separating the Front Enclosure, Main Chassis, and Rear Enclosure . . . . 7-16

Figure 7-8. Front Enclosure Gaskets . . . . . . . . . . . . . . . . . . . 7-19

Figure 7-9. Rear Enclosure Components. . . . . . . . . . . . . . . . . . 7-20

Figure 7-10. Minipole Assembly . . . . . . . . . . . . . . . . . . . . . 7-23

Figure 7-11. Main Chassis Assembly Components . . . . . . . . . . . . . .

Figure 7-12. Keypad, Display, CPU PWA, and Piezo Alarm . . . . . . . . . . . 7-30

7-26

430-95150-007 (Rev. 01/06) vi Plum A+

Infusion System

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FIGURES

Figure 7-13. CPU PWA Replacement . . . . . . . . . . . . . . . . . . . 7-31

Figure 7-14. Mechanism Assembly Replacement . . . . . . . . . . . . . . . 7-33

Figure 7-15. Fluid Shield Replacement. . . . . . . . . . . . . . . . . . . 7-35

Figure 7-16. Cassette Door and Opener Handle Replacement. . . . . . . . . . . 7-36

Figure 9-1. Illustrated Parts Breakdown . . . . . . . . . . . . . . . . . . 9-5

Figure 9-2. Front Enclosure, Rear Enclosure, and Main Chassis . . . . . . . . . 9-7

Figure 9-3. Front Enclosure Assembly . . . . . . . . . . . . . . . . . . 9-9

Figure 9-4. Rear Enclosure Assembly . . . . . . . . . . . . . . . . . . . 9-11

Figure 9-5. Peripheral Assembly . . . . . . . . . . . . . . . . . . . . 9-13

Figure 9-6. Main Chassis Assembly . . . . . . . . . . . . . . . . . . . 9-15

Figure 9-7. AC Power Cord, Retainer, and Battery Assembly . . . . . . . . . . 9-21

Figure 9-8. CPU PWA and Main Chassis. . . . . . . . . . . . . . . . . . 9-23

Figure 9-9. Mechanism Assembly . . . . . . . . . . . . . . . . . . . . 9-25

Figure 9-10. Power Supply PWA Schematic . . . . . . . . . . . . . . . . . 9-27

Figure 9-11. Peripheral PWA Schematic . . . . . . . . . . . . . . . . . . 9-37

Figure 9-12. CPU PWA Schematic . . . . . . . . . . . . . . . . . . . . 9-45

Figure 9-13. Driver PWA Schematic . . . . . . . . . . . . . . . . . . . . 9-65

Figure 9-14. Switch PWA Schematic . . . . . . . . . . . . . . . . . . . 9-71

Figure 9-15. APP PWA Schematic . . . . . . . . . . . . . . . . . . . . 9-73

Tables

Table 1-1. Conventions . . . . . . . . . . . . . . . . . . . . . . . 1-2

Table 1-2. System Configuration Data . . . . . . . . . . . . . . . . . . 1-10

Table 4-1. Analog Inputs . . . . . . . . . . . . . . . . . . . . . . . 4-7

Table 4-2. Keypad Map . . . . . . . . . . . . . . . . . . . . . . . 4-8

Table 4-3. CPU-Power Supply Interface . . . . . . . . . . . . . . . . . 4-10

Table 4-4. CPU-Mechanism Interface Signals . . . . . . . . . . . . . . . 4-11

Table 4-5. Power Supply PWA Interface Connections. . . . . . . . . . . . . 4-24

Table 4-6. Peripheral PWA Interface Connections . . . . . . . . . . . . . . 4-25

Table 4-7. CPU PWA Interface Connections . . . . . . . . . . . . . . . . 4-26

Table 4-8. Driver PWA Interface Connections . . . . . . . . . . . . . . . 4-26

Table 4-9. APP PWA Interface Connections . . . . . . . . . . . . . . . . 4-27

Table 5-1. Cleaning Solutions . . . . . . . . . . . . . . . . . . . . . 5-2

Table 6-1. Warning Messages . . . . . . . . . . . . . . . . . . . . . 6-2

Table 6-2. Operational Alarm Messages and Corrective Actions . . . . . . . . . 6-3

Table 6-3. Error Codes Requiring Technical Service . . . . . . . . . . . . . 6-7

Table 6-4. Troubleshooting with the PVT . . . . . . . . . . . . . . . . . 6-13

Table 9-1. Drawings . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Table 9-2. IPB for the Infuser . . . . . . . . . . . . . . . . . . . . . 9-2

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Page 10

CONTENTS

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Section 1

INTRODUCTION

The Hospira Plum A+® infusion system is an advanced medication management system designed to meet the fluid delivery requirements of today’s evolving healthcare environments. With its primary line, secondary line, and piggyback fluid delivery capabilities, the Plum A+ applications. Full compatibility with LifeCare accessories make the Plum A+

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

is suited for a wide range of medical, surgical, and critical care

a convenient and cost-effective infusion system.

Plum® Series administration sets and

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 Plum A+ System Operating Manual. Provision is made for the inclusion of the system operating manual in Section 3 of this manual.

and Plum A+®3

 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 version.

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SECTION 1 INTRODUCTION

1.2

CONVENTIONS

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

Table 1-1. Conventions

Convention Application Example

Italic Reference to a section, figure,

table, or publication

[ALL CAPS] In-text references to keys

and touchswitches ALL CAPS Screen displays CASSETTE TEST IN PROGRESS Bold Emphasis CAUTION: Use proper ESD grounding

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

WARNING:

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.

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.

(see Section 6.1)

[START]

techniques when handling components.

 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 BT Diode D Resistor R

Capacitor C Fuse F Switch SW

Crystal Y Integrated Circuit U Transistor Q

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

 Note: Alpha-numeric designators may be followed with a dash (-) number that

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

A/D Analog-to-digital

ADC Analog-to-digital converter

APP Air, pressure, and pin

BCR Barcode reader

CCFT Cold cathode fluorescent tube

CMOS Complementary metal-oxide semiconductor

CPU Central processing unit

DAC Digital-to-analog converter

DC Direct current

DIP Dual in-line package

DMA Direct memory access

DMM Digital multimeter

DPM Digital pressure meter

ECG Electrocardiogram

EEG Electroencephalogram

EEPROM Electrically erasable programmable read-only memory

EMG Electromyogram

EMI Electromagnetic interference

ESD Electrostatic discharge

ETO Ethylene oxide

FPGA Field programmable gate array

FSR Force sensing resistor

hr Hour

Hz Hertz

ID Identification

I/O Input/output

IPB Illustrated parts breakdown

IV Intravenous

KB Kilobyte

Kg Kilogram

kHz Kilohertz

KVO Keep vein open

lbs Pounds

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SECTION 1 INTRODUCTION

MOSFET Metal-oxide semiconductor field-effect transistor

Op-amp Operational amplifier

LCD Liquid crystal display

LED Light emitting diode

L/S Line select

mA Milliampere

MB Megabyte

mcg Microgram

MHz Megahertz

min Minute

mL Milliliter

MMIO Memory-mapped input/output

ms Millisecond

nF Nanofarad

ng Nanogram

pF Picofarad

PROM Programmable read-only memory

PVT Performance verification test

PWA Printed wiring assembly

PWM Pulse width modulator

RAM Random access memory

rms Root-mean-square

RTC Real-time clock

SCC Serial communication controller

SCP Serial communication port

SLA Sealed lead acid

SMT Surface mount technology

SPI Serial peripheral interface

SRAM Static random access memory

TQFP Thin quad flat pack

V Volt

Volts AC

Collector supply voltage

VCO Voltage controlled oscillator

Volts DC

VSC 5 V

supply circuitry

VSO Voltage sweep oscillator

VTBI Volume to be infused

WDI Watchdog input

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1.5 USER QUALIFICATION

µA Microampere

µL Microliter

µV Microvolt

µsec Microsecond

1.5

USER QUALIFICATION

The infusion system 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 and enteral fluids and drugs, and whole blood or red blood cell components. Training should emphasize preventing related IV complications, including appropriate precautions to prevent accidental infusion of air. The epidural route can be used to provide anesthesia or analgesia.

1.6

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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SECTION 1 INTRODUCTION

1.7

INSTRUMENT INSTALLATION PROCEDURE

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

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.

Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g., IEC 60950 for data processing equipment, and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Any person who connects additional equipment to the signal input or output part configures a medical system, and is therefore responsible for ensuring that the system complies with the requirements of IEC 60601-1-1. If in doubt,

contact Hospira Technical Support Operations (see Section 6.1).

The instrument installation procedure 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 infusion system. 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 (see Section 6.1).

Inspect the infusion system periodically for signs of defects such as worn accessories, broken connections, or damaged cable assemblies. Also inspect the infuser after repair or during cleaning. Replace any damaged or defective external parts.

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1.7 INSTRUMENT INSTALLATION PROCEDURE

1.7.3

SELF TEST

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

 Note: Do not place the infuser in service if the battery is not fully charged. To make

certain the battery is fully charged, connect the infuser to AC power for six hours

(see Section 8).

 Note: If an alarm condition occurs during the self test, cycle the power and repeat the

self test. If the alarm condition recurs, note the message and take corrective action

(see Section 6). Repeat the self test. If the alarm condition continues to recur, remove

the infuser from service and contact Hospira.

To perform the self test, see Figure 1-1, and proceed as follows:

1. Connect the AC power cord to a grounded AC outlet. Verify the charge/line indicator

CHARGE illuminates and an alarm beep sounds.

2. Without a cassette installed, turn on the infuser.

3. The LCD screen briefly displays the SELF TEST screen (see Figure 1-1).

 Note: If the SELF TEST screen does not appear, contact Hospira.

4. After the self test is complete, the message “INSERT PLUM SET CLOSE LEVER” appears.

5. Verify the time and date. To set the time and date, see Section 1.8.3.

6. Open the cassette door and insert a primed cassette. Close the cassette door. The cassette test is complete when the “CASSETTE TEST IN PROGRESS” message disappears.

 Note: The message “MECHANISM INITIALIZATION IN PROGRESS” may briefly

appear prior to the “CASSETTE TEST IN PROGRESS” message.

7. A “NEW PATIENT?” message may appear. Press [YES], then turn off the infuser.

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Page 18

SECTION 1 INTRODUCTION

LINE FLOW

INDICATORS

A B

HOSPIRA Plum A+

STATUS REGION

MESSAGE REGION

SOFTKEY LABEL REGION

CHARGE/LINE INDICATOR

Version X.XX MM/DD/YY

START

STOP

CHARGE

ON/OFF

2005

System Self Test

In Progress

1 4

2 5

CLEAR

3 6

WORKING

REGION

SOFTKEYS

SELECT

KEYPAD

SILENCE

Figure 1-1. Display and Keypad

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1.8 BIOMED SETTINGS

1.8

BIOMED SETTINGS

The biomed settings screens contain the following options that can be changed or reviewed by qualified personnel:

- IV parameters

-Alarms log

- Set time and date

All infusers (new or refurbished) are shipped with factory settings (see Table 1-2).

 Note: Biomed screens do not time out for the Infuser Idle alarm or No Action alarm.  Note: The battery will not be detected in the biomed service mode.  Note: Upon entry to biomed mode, any drug library waiting for installation will be

installed, and the infuser will power off at completion.

To access the biomed settings, proceed as follows:

1. Open the door and turn on the device. The infusion system will perform a self test.

2. After the self test is complete, the message “INSERT PLUM SET CLOSE LEVER” appears.

3. Press the decimal [.] key, then [START], and verify the BIOMED SETTINGS screen is displayed (see Figure 1-2).

 Note: The biomed settings screen will display the [CHANGE BATTERY] softkey

on Plum A+ appear on versions 11.3 and lower.

software versions 11.4 and higher. [CHANGE BATTERY] does not

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SECTION 1 INTRODUCTION

Data Options Range Factory Setting

Table 1-2. System Configuration Data

Maximum macro IV mode delivery rate 0.1 - 99.9 mL/hr and

100 - 999 mL/hr

Macro distal occlusion alarm (pressure level)

Deliver together enable Concurrent or Piggyback Piggyback Delayed start/standby enable Yes or No Yes Continue rate Rate or KVO KVO Nurse callback default Yes or No No Time (24 hr) 00:00 - 23:59 in

Date 1/1/2002 - 12/31/2098 Factory date

1 to 15 psi 6.0 psi

one minute increments

999 mL/hr

Factory time

BIOMED SETTINGS

IV Screen Parameters

Alarm Log

Set Time and Date

Select, then Choose

Change Battery

Figure 1-2. Biomed Settings

Choose

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1.8.1

IV PARAMETERS

The IV parameters screen contains the following:

- Common IV parameters

- Default units/drug

- Macro IV parameters

To change the IV parameters, see Figure 1-3, then proceed as follows:

1. Access the biomed settings screen as described in Section 1.8.

2. Select IV Screen Parameters, and press [CHOOSE].

1.8 BIOMED SETTINGS

BIOMED SETTINGS

IV Parameters

Common IV Parameters

Default Units/Drug

Macro IV Parameters

Select, then Choose

Choose

Figure 1-3. IV Parameters

Back

02K03003

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SECTION 1 INTRODUCTION

1.8.1.1

COMMON IV PARAMETERS

To view common IV parameters, see Figure 1-4 or Figure 1-5, then proceed as follows:

1. Access the IV parameters screen as described in Section 1.8.1.

2. Select Common IV Parameters, and press [CHOOSE].

3. Verify the COMMON IV PARAMETERS screen is displayed.

4. Select the desired parameter to be changed.

5. Using the [CHANGE VALUE] softkey, select the desired value.

6. Repeat step 4 and step 5 for each parameter to be changed.

7. If there are no other changes to the common IV parameters, press the [CANCEL/ BACK] softkey.

8. Verify the IV PARAMETERS screen is displayed.

9. If there are no other changes, press the [BACK] softkey to return to the main biomed settings screen, or turn off the infuser.

BIOMED SETTINGS

Common IV Parameters

Continue Rate Deliver Together Concurrent Enable Delay Start Yes Callback Default Yes

Select using Change Value

Change

Value

Figure 1-4. Common IV Parameters (Version 10.3)

Enter

KVO

Cancel/

Back

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BIOMED SETTINGS

Common IV Parameters

1.8 BIOMED SETTINGS

Continue Rate Deliver Together Enable Delay/Standby Callback Default

KVO

Concurrent

Yes

Select using Change Value

Change

Value

Figure 1-5. Common IV Parameters (Version 11.3 - higher)

Enter

Cancel/

Back

02K03004

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SECTION 1 INTRODUCTION

1.8.1.2

DEFAULT UNITS/DRUG

 Note: For default drug settings, see the system operating manual.

To review or change the default units/drug, see Figure 1-6, Figure 1-7, and Figure 1-8, then proceed as follows:

1. Access the biomed settings screen as described in Section 1.8.

2. Access the IV parameters screen as described in Section 1.8.1.

3. Select Default Units/Drug, and press [CHOOSE].

4. Verify the DEFAULT UNITS/DRUG screen is displayed (see Figure 1-6).

5. Using the [PAGE UP] and [PAGE DOWN] softkeys, select the desired drug and press [ENTER].

6. Verify the DOSE UNITS FOR DRUG screen is displayed (see Figure 1-7).

7. Using [PAGE UP] and [PAGE DOWN], select the desired dose units, and press [CHOOSE].

8. Verify the CONC UNITS FOR DRUG screen is displayed (see Figure 1-8).

9. Select the desired Drug Conc in Container, and press [CHOOSE].

10. Verify the DEFAULT UNITS/DRUG screen is displayed.

11. Repeat step 6 through step 10 for each desired drug.

12. If there no other changes, press [CANCEL/BACK] to return to the main biomed settings screen, or turn off the infuser.

Default Units/Drug

No Drug Selected

Abciximab

Acyclovir

Albumin

Aldesleukin

Alfentanil

Alprostadil

Alteplase (rt-PA)

Select, then Enter

Page

Figure 1-6. Default Units/Drug

Page

Down

Enter

Cancel/

Back

02H03005

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Dose Units for Drug

Abciximab

mL/hr grams/hr

mcg/kg/min ng/kg/min

mcg/kg/hr units/kg/hr

mcg/min units/min

mcg/hr units/hr

mg/kg/hr mUn/min

mg/min mEq/hr

mg/hr

Select, then Choose

Choose

Cancel/

Back

02H03006

1.8 BIOMED SETTINGS

Figure 1-7. Dose Units for Drug

Conc Units for Drug

Abciximab

Conc Units for Drug

Drug Conc in Container

mcg

Drug Conc in Container

grams

Select, then Choose

mcg

grams

Choose

Cancel/

Back

Cancel/

02H03007

Back

02H03007

Figure 1-8. Conc Units for Drug

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SECTION 1 INTRODUCTION

1.8.1.3

MACRO IV PARAMETERS

To review or change the macro IV parameters, see Figure 1-9, then proceed as follows:

1. Access the biomed settings screen as described in Section 1.8.

2. Access the IV parameters screen as described in Section 1.8.1.

3. Select Macro IV Parameters, and press [CHOOSE].

4. Verify the MACRO IV PARAMETERS screen is displayed (see Figure 1-9).

5. Select the parameter to be changed.

6. Enter the desired value for the parameter selected.

7. Repeat step 5 and step 6 for each parameter to be changed.

8. If there are no other changes, press [CANCEL/BACK] to return to the IV parameters screen, or turn off the infuser.

BIOMED SETTINGS

Macro IV Parameters

Default Distal Press Max Rate

Enter Value using keypad

Enter

Figure 1-9. Macro IV Parameters

6.0 psi

999 mL/hr

Cancel/

Back

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1.8 BIOMED SETTINGS

1.8.2

ALARMS LOG

 Note: The alarms log will retain the latest 40 alarm and malfunction codes, listed

in order from the most current to the oldest.

To view the alarms log, see Figure 1-10, then proceed as follows:

1. Access the biomed settings screen as described in Section 1.8.

2. Select Alarms Log, and press [CHOOSE].

3. Use the [PAGE UP] and [PAGE DOWN] softkeys to view the alarms log.

4. Press [BACK] to exit the alarms log and return to the main biomed settings screen.

ALARMS LOG

6/23/05 11:43:01 E437 S/W Failure # 202 6/23/05 09:18:10 N190 Neg. Prox. Occl. A 6/22/05 23:44:11 N102 Infuser Idle 2 minutes 6/22/05 21:43:14 N161 Line A VTBI complete 6/22/05 11:44:20 N106 Distal occlusion 6/22/05 09:43:07 N161 Line A VTBI complete 6/22/05 06:23:20 N160 Line B VTBI complete 6/22/05 03:40:13 N101 No action alarm

Page

Figure 1-10. Alarms Log

Page

Down

Back

05K03008

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SECTION 1 INTRODUCTION

1.8.3

SETTING THE TIME AND DATE

 Note: The infuser will automatically display February 29 on leap years.  Note: Daylight savings and time zone changes must be made manually.

To set the time and date, see Figure 1-11, then proceed as follows:

1. Access the biomed settings screen as described in Section 1.8.

2. Select Set Time and Date, and press [CHOOSE].

3. Select the parameter to be changed.

4. Enter the desired value.

5. Repeat step 3 and step 4 for each parameter to be changed.

6. Verify the time and date are correct, then press [ENTER] to return to the biomed settings screen.

7. If there are no other changes to the biomed settings, turn off the infuser.

BIOMED SETTINGS

Set Time and Date

Time : 22 hr:min Year 2005 Month 02 Day 14

Enter value using keypad

Figure 1-11. Setting the Time and Date

Enter

Cancel/

Back

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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, as to merchantability, fitness for a particular purpose, or any other matter.

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, flow detectors, detachable AC power cords, and patient pendants.

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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Section 3

SYSTEM OPERATING MANUAL

A copy of the system operating manual is included with every Plum A+® infusion system. Insert a copy here for convenient reference. If a copy of the system operating manual is not available, contact Hospira Technical Support Operations (see Section 6.1).

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SECTION 3 SYSTEM OPERATING MANUAL

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Section 4

THEORY OF OPERATION

This section describes the Plum A+ the general description, electronic subsystem overview, printed wiring assemblies, remote mounted peripherals, and mechanical overview of the infuser. Related drawings are provided in Section 9.

4.1

GENERAL DESCRIPTION

The infusion system includes the following features:

theory of operation. The theory of operation details

- Dose calculation

- Loading dose

-Multi-step programming

- Therapy selection

-Nurse call

- Delayed start setting

- Standby mode

- Drug label library

- Piggyback and concurrent delivery modes

-Titration

- 0.1-99.9 mL/hr flow rate range for both lines (in 0.1 mL/hr increments)

- 100-999 mL/hr flow rate range for both lines (in 1 mL/hr increments)

- Anti free-flow protection

- Air removal/backpriming

- Air detection (proximal and distal)

- Serial communication

-Alarm history

- Volumes infused (A, B, total volumes)

- KVO at dose end (1 mL/hr or less depending on delivery rate) or continue rate to continue

- Variable distal pressure setting

- Nonpulsatile volumetric accuracy

- Microprocessor control

-Large display

- Panel back illumination on mains power

- Lockout switch

- Standard fullfill, partfill, syringe, and vial use

- Enteral and parenteral fluid delivery

- Blood and blood product delivery

- Battery gauge

Technical Service Manual 4 - 1 430-95150-007 (Rev. 01/06)

- Wide range of standard and specialty administration sets

Page 34

SECTION 4 THEORY OF OPERATION

Alarms include the following:

- Distal occlusion

- Proximal occlusion

- Proximal air-in-line

- Distal air-in-line

-Low battery

- Door open while pumping

- Lockout violation

-VTBI complete

- Valve/cassette test failure

-Nurse call

- No action alarm

- Infuser idle for two minutes

4.2

ELECTRONIC SUBSYSTEM OVERVIEW

This section describes the function and electronic circuitry of three main subsystems in the infuser: CPU subsystem, power supply subsystem, and mechanism subsystem. Schematic diagrams of subsystem PWAs are in Section 9.

 Note: An asterisk (*) denotes an active low or negative true logic signal.

4.2.1

CPU SUBSYSTEM

The CPU subsystem contains the main microcontroller, which is responsible for controlling the display/keypad interface, external communications interfaces, and system management.

The CPU subsystem provides the following functions:

- External memory devices access

-LCD interfaces

-Real-time clock generator interface

-System watchdog

- Analog-to-digital and digital-to-analog converter interface

- Keypad interfaces

- Control and monitor status signals, such as LEDs, audible alarms, volume control, nurse call switch, and lockout switch

- Serial communication with host computer (DataPort)

- Power supply subsystem interface

- Mechanism subsystem interface

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4.2 ELECTRONIC SUBSYSTEM OVERVIEW

4.2.1.1

CPU

The central processing unit (CPU) is a Motorola MC68302. The CPU has a closely coupled 16 bit data bus and 24 bit address bus; MC68000 microprocessor core; a system integration block for peripherals; and an RISC communications processor. The MC68302 is packaged in a 144 pin thin quad flat pack (TQFP) package and operates from a 3.3 V power supply. The on-chip peripheral devices are isolated from the system through the dual port RAM. The 1152 byte dual port RAM has 576 bytes of system RAM and 576 bytes of parameter RAM, which contains various peripheral registers, parameters, and the buffer descriptors for each of the three serial communication controller (SCC) channels and the serial communication port (SCP) channels. The 24 bit address bus is capable of accessing up to 16 MB of data.

4.2.1.2

SYSTEM MEMORY ADDRESS MAP

The CPU has a 24 bit address bus when combined with UDS*/A0. The address bus is a bi-directional, three state bus capable of addressing 16 MB of data that is configured as 16 bits per word (including the IMP internal address space). Each of the four programmable chip-select lines has two registers that define the starting address of a particular address space and the block size.

4.2.1.3

PROGRAMMABLE READ-ONLY MEMORY

The CPU subsystem has two 512 K x 8 bit programmable read-only memory (PROM) memory devices, which provide a total of 1024 KB. The PROM space is expandable up to 2 MB. The PROM memory devices operate off the 3.3 V 0 pin (CS0*), is connected to the PROM chip-enable (CE*) pin (signal CSROM*). This special chip-select signal can support bootstrap operation after reset. The interface to the CPU is the 16 bit data bus, and a 19 bit address bus. The address bus is connected to the ADDR<19:1> lines, and the data bus is connected to the DATA<15:0> lines.

4.2.1.4

supply. The CPU chip-select

STATIC RANDOM ACCESS MEMORY

There are two 512 K x 8 bit CMOS static random access memory (SRAM) devices, which provide a total of 1024 KB of data memory. During an SRAM read or write cycle, the chip-enable (CE*) is controlled by the CPU chip-select pin 1 (CS1*, signal name (CSRAM*)). The SRAM space is expandable up to 2 MB. The SRAM operates off the 3.3 V The CPU subsystem includes the additional SRAM for video buffer and real-time clock.

4.2.1.5

supply.

CONTROL LOGIC

The CPU PWA uses field programmable gate arrays (FPGA), which are high density, high speed, I/O intensive general purpose devices. They are used to implement all the digital control functions, including: memory-map address decoding; memory read-write enable; direct memory access (DMA) request; I/O status signals; chip-select control; motor control; sensor select; and power up/system reset control.

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SECTION 4 THEORY OF OPERATION

4.2.1.6

LCD CONTROLLER

The liquid crystal display (LCD) controller is used to interface the LCD to the CPU. The device displays layered text and graphics, scrolls the display in any direction, and partitions the display into multiple screens. It stores bit-mapped graphic data in external frame buffer memory. The display controller functions include: transferring data from the controlling microprocessor to the buffer memory, reading memory data, converting data to display pixels, and generating timing signals for the buffer memory and LCD panel. The LCD controller accesses 32 KB of frame buffer SRAM (video) via the controller’s video address and data busses (VA<14:0> and VD<7:0>). The LCD controller external clock frequency is 8 MHz. The LCD controller and the display memory are operated off the 3.3 V interface with the 5 V

supply. The output signal levels are shifted up to 5 VDC by buffers for

LCD panel.

The interface to the CPU is through the lower 8 bits of the data bus, which is connected to DATA<7:0> lines, address line A1, and LCD chip-select signal CSLCD* (CS2*). This controller is also configured as 8080 family compatible interface device with all the control signals, such as WRLCD* (WR*) and RDLCD* (RD*), generated by the FPGA logic.

4.2.1.7

LCD BACKLIGHT CONTROL

The LCD panel is backlit by a cold cathode fluorescent tube (CCFT) lamp. The CCFT lamp requires 300 V

to operate; a current controlled DC-to-AC voltage inverter circuit is used

rms

to deliver a current regulated sine wave to the lamp. A switching regulator regulates the CCFT current by monitoring feedback pin 3, and varies its output duty cycle to drive a DC/AC inverter. Intensity control is achieved by superimposing a DC control signal with the feedback signal. The DC control signal is sourced by a voltage divider consisting of a digitally controlled non-volatile potentiometer and three series diodes.

The CPU can adjust LCD backlight intensity by selecting the digitally controlled non-volatile potentiometer and controlling TUBU/D and TUBINC* signals. The potentiometer has a five bit up/down counter with non-volatile memory. It is used to store one of 31 settings of the potentiometer. Each count represents 323 Ω with a range of 323 to 10 KΩ. The current counter value is stored in non-volatile memory after CSTUB* is returned high while the TUBINC* input is also high. The current counter value is not stored if CSTUB* is returned high and TUBINC* is low. The CCFT intensity is directly proportional to the CCFT current, where 0 mA

is minimum intensity and 5 mA

rms

is maximum intensity. The CCFT current is inversely proportional to the counter value.

4.2.1.8

LCD CONTRAST CONTROL

A digitally adjustable LCD bias supply is used to control the LCD contrast over a range of -24 to -8 V converter (DAC). The CPU provides two signals, LCDADJ (ADJ) and LCDCTL (CTL), to interface with this device. On power up or after a reset, the counter sets the DAC output to the mid-range value. Each rising edge of LCDADJ increments the DAC output. When incremented beyond full scale, the counter rolls over and sets the DAC to the minimum value. Therefore, a single pulse applied to LCDADJ increases the DAC set point by one step, and 63 pulses decrease the set point by one step.

. It is digitally adjustable in 64 equal steps by an internal digital-to-analog

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4.2 ELECTRONIC SUBSYSTEM OVERVIEW

4.2.1.9

REAL-TIME CLOCK

The watchdog timekeeper chip includes a complete real-time clock/calendar (RTC), watchdog timer, alarm, and interval timer. The time/date information includes hundredths of seconds, seconds, minutes, hours, date, month, and year. The date at the end of the month is automatically adjusted for months with less than 31 days, including correction for leap year. The watchdog timekeeper operates in either 24-hour or 12-hour format with an AM/PM indicator. The device can be programmed to set up an interval timer, and it can generate an alarm every day, hour, or minute. These alarm functions ma y be used to sch edule real-time related activities. A parallel resonant 32,768 Hz crystal oscillator drives the internal time base.

The external interface is a separate (non-multiplexed) 8 bit data bus and 6 bit address bus, with a contiguous address space of 64 bytes. When system power is turned off, a battery voltage input is available, which makes the RTC data non-volatile. The address bus is connected to the ADDR<6:1> lines, and the data bus is connected to DATA<7:0> lines. Since the CPU accesses are 16 bits wide, the RTC data is on the lower byte of the word. The RTC chip-enable pin (CE*) is active low enabled for read and write operations. It is driven by the FPGA control logic, chip-select RTC signal (CSRTC*), which involves address decoding circuitry.

4.2.1.10

VOLTAGE MONITOR WATCHDOG TIMER

It is important to protect the system during power transitions, and the CPU is reset after the V automatic reset output during power up, power down, or brownout conditions. When the V

and holds the microprocessor in reset for approximately 200 ms after V the threshold. The supervisory circuit includes a chip-select inhibit circuit, which is used to disable access to the real-time clock’s non-volatile SRAM during power transitions and power down mode.

This device also provides a watchdog timer function to monitor the activity of the microprocessor. To service the watchdog timer immediately after reset, the device has a longer time-out period (1.6 second minimum) right after a reset. The normal time-out period (70 ms minimum) is effective after the first transition of watchdog input (WDI) after RESET* is inactive. If the microprocessor does not toggle WDI within the time-out period, both RESET* and watchdog out (WDO*) outputs are asserted low. The RESET* remains active low for a minimum of 140 ms and it resets the CPU. The WDO* remains low as long as the WDI remains either high or low for longer than the watchdog time-out period. After a reset, the software reads this memory-mapped bit to determine if the latest reset was a watchdog time-out.

power supply is applied. The microprocessor supervisory circuit generates an

falls below the reset threshold voltage of 2.9 VDC, the reset signal (RESET*) goes low

rises above

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SECTION 4 THEORY OF OPERATION

4.2.1.11

ANALOG-TO-DIGITAL CONVERTER

The analog-to-digital converter (ADC) monitors the proximal pressure sensor, distal pressure sensor, proximal air sensor, distal air sensor, battery charge/discharge current, battery voltage, buzzer test signal, LCD contrast voltage, CCFT test signal, and two chopper motor drive reference voltages. The ADC is an advanced 10 bit accurate, 11 channel, switched-capacitor, successive-approximation device. It has three inputs and a three-state output (chip-select, I/O clock, address input, and data out) that provide a direct four-wire interface to the serial communication port of the CPU. The ADC is designed to be used in conjunction with multiple serial devices on a common bus; consequently, the data-out pin is driven only when the chip-select (CS*) pin is asserted. Figure 4-1 illustrates the serial interface between the ADC and the CPU.

In addition to a high-speed ADC and versatile control capability, this device has an on-chip 14 channel multiplexer that can select any one of 11 analog inputs or any one of three internal self test voltages. The sample-and-hold function is automatic. The end-of-conversion (EOC) output goes high to indicate that conversion is complete. The CPU polls the EOC signal.

Channel selection and conversion results are transferred through the SCP pins. A serial transfer synchronizing clock (SPCLK) must be fed into the I/O clock input pin when the CS* pin is driven low. The address to be converted is serially transmitted into the address pin, and the conversion results are serially shifted out the data-out pin. Typical access time is 21 microseconds. The APP PWA is the source of the 2.5 V The analog inputs are selected by the channel multiplexer according to the input address

(see Table 4-1). The input multiplexer is a break-before-make type to reduce input-to-input

noise injection resulting from channel switching.

reference voltage.

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4.2 ELECTRONIC SUBSYSTEM OVERVIEW

ANALOG INPUTS

A10

GND

CS*

I/O CLOCK

ADDRESS

DATA OUT

EOC

REF+

REF-

GDIG

Figure 4-1. Serial Interface to ADC

CPU

I/O

SPCLK

SPTXD SCP

SPRXD

I/O (OR INTERRUPT)

2.5V

GANA

98K01022

Table 4-1. Analog Inputs

Signal Name Analog Input Address (hex) Description

PRPRS A0 $00 Proximal pressure sensor

DIPRS A1 $01 Distal pressure sensor

PXAIR A2 $02 Proximal air sensor

DIAIR A3 $03 Distal air sensor

IBATT A4 $04 Battery current

VBATT A5 $05 Battery voltage

BUZTST A6 $06 Buzzer test voltage

LCDTST A7 $07 LCD contrast test voltage

TUBTST A8 $08 CCFT intensity test voltage

MI_STA A9 $09 Motor current A control

MI_STB A10 $0A Motor current B control

$0B (V

$0C V

ref(+)

ref(-)

- V

ref(-)

) / 2

$0D V

Technical Service Manual 4 - 7 430-95150-007 (Rev. 01/06)

ref(+)

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SECTION 4 THEORY OF OPERATION

4.2.1.12

DIGITAL-TO-ANALOG CONVERTER

The dual 8 bit digital-to-analog converter (DAC) generates two analog signals to control the phase A and phase B motor coil currents. The interface between the DAC device and the CPU is the 8 bit data bus, which is connected to DATA15:8. All the control signals for this DAC are generated by FPGA logic devices. Buffer amplifier/ground compensation circuits condition the DAC outputs.

4.2.1.13

FRONT PANEL KEYPAD MATRIX

A 5 x 5 membrane switch keypad matrix is located on the front panel. The keypad column lines (COL4:0) are driven by open collector type memory mapped input ports, while the keypad row lines (ROW4:0), are read by memory mapped input ports (see Table 4-2). The keypad strobing, scanning, and switch de-bouncing is accomplished by software. The keypad interface is designed with ESD protection.

Table 4-2. Keypad Map

COL 0 COL 1 COL 2 COL 3 COL 4

Row 4 Softkey 1 Softkey 2 Softkey 3 Softkey 4

Row 3 START 1 2 3 [

Row 2 STOP 456

Row 1 Charge/Line Indicator 7 8 9 [

Row 0 ON/OFF CLEAR 0 . SILENCE

4.2.1.14

]

]

FRONT PANEL [ON/OFF] KEY

The [ON/OFF] key on the front panel provides a start up (STRTUP) signal to wake up the power supply when the system is shutdown. When activated during normal operation, the [ON/OFF] key interrupts (STRUPD*) the CPU, signaling a request for shutdown.

4.2.1.15

FRONT PANEL LED INDICATORS

The CPU drives the three light emitting diode (LED) indicators embedded in the front panel. Two memory mapped I/O signals activate the two LED lights used to indicate which channel is in delivery mode (LEDAE*, LEDBE*). The AC power on LED indicates the status of AC power (LEDAC) and that the system is in the battery charge mode. A buffered AC on signal (BACON) drives the LED and is active only when AC power is present.

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4.2 ELECTRONIC SUBSYSTEM OVERVIEW

4.2.1.16

KEYPAD LOCKOUT INTERFACE

A lockout switch (SW1) on the peripheral PWA indicates the front panel keypad is locked. A memory mapped input port (LOTSW*) reads the switch. The switch serves as a lockout request and software performs the lockout.

4.2.1.17

NURSE CALL INTERFACE

A nurse call relay switch on the peripheral PWA indicates alarm conditions to a remote operator. A memory-mapped output signal (NURSE) activates the relay during alarm conditions. The relay has both normally open and normally closed contacts. A jumper on the peripheral board selects the contact type. The factory setting is normally open.

4.2.1.18

AUDIBLE INDICATORS

There are two audible indicators on the CPU subsystem. A loud, main audible indicator is mounted on the main chassis. This main alarm is used for alerting the operator to alarm conditions. A keypad beeper (LS1), with lower power and a distinctly different tone, is used to provide audible feedback to the operator. The keypad beeper is driven by a memory-mapped output (KEYALM). It is used to indicate keypad activation, and confirmation to the operator.

The main alarm has an adjustable volume control on the peripheral PWA, mounted on the rear of the device. The main alarm can be activated by either a memory-mapped control (MAINALM), the reset pulse(s), or by a power failure alarm latch. The main alarm will sound a chirp for every reset pulse sent by the watchdog timer IC. Continuous chirping indicates a stuck processor.

The alarm is activated continuously during power failure. If the control software does not shut down power in a proper sequence, a latch on the CPU PWA, powered by a backup supply (0.1 F supercap), will activate a continuous alarm. This continuous alarm sounds until either the backup supply is discharged or the user resets the latch by pressing the front panel [ON/OFF] key. Reliable operation of the main alarm is assured by software monitoring of a buzzer test signal (FBUZTST) via the ADC.

4.2.1.19

BARCODE READER INTERFACE

 Note: The barcode reader feature will not be present on later versions of the Plum A+

The CPU communicates with a barcode wand that is connected to the peripheral PWA from the rear of the infuser. The barcode wand reads and decodes a Code 128 barcode symbology and outputs the barcode data via an RS-232 port using an asynchronous, serial ASCII format. The software controls power to the barcode reader and to the interface circuits via memory-mapped outputs BARPWR and COMPWR*. The barcode reader is isolated from the main system by an optical data path on the peripheral PWA and an isolated power supply.

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SECTION 4 THEORY OF OPERATION

4.2.1.20

DATAPORT INTERFACE

The CPU communicates with an external computer by way of a DataPort interface. The DataPort interface provides for remote monitoring of up to 15 infusers using a host computer with a modified RS-232-D serial interface. Infusers are either connected directly to the host or in a daisy chain configuration using junction boxes that provide a 5 bit hard ID via DIP switches on the junction box. The DIP switches are buffered (peripheral PWA U8) and read by the CPU via the memory-mapped input/output (MMIO) port.

The DataPort system conforms to the EIA-232-D standard, with the following exceptions:

- DataPort uses non-standard DB-15 and 6 pin modular connectors in addition to the standard DB-25 and DB-9 connectors

- With DataPort, more than one infuser is allowed on the line

- The minimum line impedance is 2 KΩ (EIA-232-D standard: 3 KΩ min.)

- The maximum line impedance is 30 KΩ (EIA-232-D standard: 7 KΩ max.)

- The maximum line capacitance is 13 nF (EIA-232-D standard: 2,500 pF)

The communications default is 1200 BAUD, no parity, 8 data bits and 1 stop bit. The BAUD rate is selectable (1200, 2400, 4800, and 9600). The data format on the serial port is a 10 bit frame with asynchronous start and stop. The CTS line is held high and the RTS line is disconnected.

The DataPort is isolated from the main system by an optical data path on the peripheral PWA and an isolated power supply.

4.2.1.21

POWER SUPPLY INTERFACE

The CPU subsystem interfaces the power supply subsystem by providing the MMIO signals needed for power control and battery management. Additionally, the CPU subsystem measures the battery terminal voltage and charge/discharge current via the ADC.

See Table 4-3 for CPU-power supply interface signals.

Table 4-3. CPU-Power Supply Interface

Signal Name Type Description

PWRHLD D, O Holds system power on

STRTUP A, I Startup pulse from the [ON/OFF] key

STRUPD* D, I Digital startup pulse, used as interrupt to the CPU

V3_3 P 3.3 V system power

V5_0/VANA P 5 V analog and interface power

VMOT P Raw, unregulated charger voltage or battery voltage

V2_7 P 2.7 V backup power for RTC and non-volatile SRAM

VSC P Full time 5 V supply, backed up by supercap

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4.2 ELECTRONIC SUBSYSTEM OVERVIEW

Table 4-3. CPU-Power Supply Interface

Signal Name Type Description

V12_0 P 12 V, low current supply for audio alarm

OVRVLT* D, I Signal that indicates overvoltage, regulation problem

on the power supply main regulator

BACON D, I Buffered AC on signal

IBATT A, I Voltage proportional to integration of battery

charge/discharge current

VBATT A, I Divided battery terminal voltage

CHG* D, O Battery charger enable

VFLOAT* D, O Set the main regulator voltage to battery float charge level

ITGRST D, O Reset the charge current integrator

Legend: P = Power; A = Analog; D = Digital; I = Input; O = Output

4.2.1.22

MECHANISM INTERFACE

The CPU subsystem provides the MMIO ports for interface to the mechanism subsystem, in addition to the analog interface mentioned in Section 4.2.1.11 and Section 4.2.1.12.

See Table 4-4 for CPU-mechanism interface signals.

Table 4-4. CPU-Mechanism Interface Signals

Signal Name Type Description

MI_STA A, O Motor current set for phase A

MI_STB A, O Motor current set for phase B

GDAC A, O Ground signal from chopper (for compensation)

M_PHA D, O Motor phase A

M_PHB D, O Motor phase B

M_SEL1, M_SEL0 D, O Motor select bits

FLCAME D, O I/O and L/S cam flag sensors enable

FLPINE D, O L/S pin motion detectors enable

FLPLE D, O Plunger motor sensor pair enable

FLLS_C D, I Flag, L/S valve cam sensor

FLIO_C D, I Flag, I/O valve cam sensor

FLLS_A D, I Flag, L/S valve A pin detector

FLLS_B D, I Flag, L/S valve B pin detector

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SECTION 4 THEORY OF OPERATION

Table 4-4. CPU-Mechanism Interface Signals

Signal Name Type Description

FLPLRO D, I Flag, plunger rotation sensor

FLPLTR D, I Flag, plunger translation sensor

PXPRE D,O Proximal pressure sensor enable

PXPRS A, I Proximal pressure sensor

DIPRE D, O Distal pressure sensor enable

DIPRS D, O Distal pressure sensor

PXARE D, O Proximal air sensor enable

PXAIR A, I Proximal air sensor

DIARE D, O Distal air sensor enable

DIAIR A, I Distal air sensor

CASPR* D, I Cassette present

CASS2*, CASS1*, CASSO* D, I Cassette type coding:

Macro (111), Micro (010); all others are invalid

SPCLK D, O SCP clock output

SPRXD D, I SCP receive data

SPTXD D, O SCP transmit data

CSSEP* D, O Chip select, EEPROM

V5_0 P 5 V supply for interface power

V3_3 P 3.3 V supply for logic power

GDIG P Digital ground

VANA P 5 V supply for analog power

GANA P Analog ground

VMOT, GMOT P Motor power is directly from power supply PWA

V2_5 A, I Reference voltage for ADC and DAC

Legend: P = Power; A = Analog; D = Digital; I = Input; O = Output

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4.2 ELECTRONIC SUBSYSTEM OVERVIEW

4.2.2

POWER SUPPLY SUBSYSTEM

The power supply subsystem provides DC power to system circuits and interface software controlled power and battery management.

The power supply subsystem provides for the following functions:

- Main switching regulator

-AC power detection

- Main regulator fault detection

- System power (secondary regulators)

- Auxiliary supplies

-Power control

- Battery charging circuitry

- Battery terminal voltage measurement

- Battery charge/discharge current measurement

4.2.2.1

MAIN SWITCHING REGULATOR

The main source of power for the infuser is the AC line. The main switching regulator is a pulse width modulated, AC-to-DC converter which provides the system an isolated DC voltage of 6.74 V preceded by: line fuses F1 and F2, surge suppressor VR1, and a line filter. The bridge rectifier U14 and capacitors C52 and C53 provide the DC voltage required for the switching circuit. Voltage regulator U13 provides the pulse width modulator (PWM) device U12 startup supply voltage. After startup, supply voltage for U12 is supplied by half wave rectifier circuitry CR14, R76, and C51.

The PWM oscillation frequency is approximately 40 kHz, determined by external resistor R72 and capacitor C45. U12 controls the power delivered by varying the duty cycle of the power metal-oxide-semiconductor field-effect transistor (MOSFET) Q9, which drives T2. A half-wave rectifier rectifies the transformer’s secondary voltage, which provides the raw DC voltage for the battery charger and system power. There are three feedback mechanisms that maintain control: a main loop for normal control, a secondary loop for overvoltage protection, and a current limit loop.

4.2.2.1.1

(or 7.35 VDC in battery charger boost mode). The main regulator is

Main Loop

The main loop uses an optical feedback path to regulate the charger voltage (BATPOS) at 6.9 V control of the VFLOAT* line). A shunt regulator and opto-isolator provide feedback to the PWM error amplifier.

Technical Service Manual 4 - 13 430-95150-007 (Rev. 01/06)

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Page 46

SECTION 4 THEORY OF OPERATION

4.2.2.1.2

Secondary Loop

Diode CR10 and opto-isolator U10 provide overvoltage protection. CR10 conducts and activates U10 when secondary voltage exceeds approximately 10 V

. The duty cycle of

U12 is reduced until the excessive voltage is removed.

4.2.2.1.3

Current Limit Loop

The current limit loop is activated when the primary current, sensed by R71, exceeds 3 A. Resistor R70 and capacitor C46 filter the voltage across R71 and feed it back to the current sense input (1.5 V

threshold) of U12. The duty cycle of U12 is reduced until the excessive

load is removed.

4.2.2.2

MAIN REGULATOR FAULT DETECTION

If the switching regulator’s main loop fails, the secondary voltage limit loop takes over. However, the battery charger and motors must be disabled, and an alarm must be generated. A comparator is used to monitor the raw DC (+BUSS) for overvoltage. A 3.3 V logic signal (OVRVLT*) is provided to the CPU subsystem.

4.2.2.3

SYSTEM POWER

Along with the unregulated VMOT supply, a secondary switching regulator provides system power. The secondary switching regulator includes IC U4, transformer T1, and transistors Q4 and Q5. The regulator is a triple output, wide supply range, fly-back converter that provides regulated 3.3 V transformer T1. The regulator operates over an input range of 4 to 10 V

, 5 VDC, and 12 VDC outputs from the five winding

and provides

output current limit as well as voltage overshoot limit. Primary feedback is metered through a bias arrangement on transistor Q3. A Schottky rectifier diode CR4 provides feedback in the event of V3_3 or V12_0 failure, and transistor Q10 provides feedback in the event of V5_0 failure. The positive terminal of the battery provides the raw DC voltage, VMOT, for the motors and backlight of the display.

4.2.2.4

AUXILIARY SUPPLIES

The power supply subsystem provides full time 5 VDC and 2.7 VDC supplies, which are active when battery or AC voltage is present. The full time 5 V low dropout voltage regulator U6, whose power source is directly from the battery and is backed up by a 0.1 F capacitor. VSC is used for the ON/OFF switch and a power failure alarm latch. The full time 2.7 V

supply (V2_7) is derived from VSC and is used to supply

the ultra-low current needed to power the real-time clock and non-volatile SRAM during shutdown.

supply (VSC) uses a linear

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4.2 ELECTRONIC SUBSYSTEM OVERVIEW

4.2.2.5

POWER CONTROL

The infuser will operate in one of three modes: normal, standby, or shutdown. During normal operation, the user interface is active and either on battery or AC line power. During standby mode the user interface is inactive while the CPU is still operating, servicing the battery management and waiting for a startup interrupt. Shutdown mode iswhen system power is off. Shutdown mode only occurs during battery operation; otherwise, +BUSS holds the system power on.

The infuser is activated when the [ON/OFF] key is pressed or the AC line is plugged in. The [ON/OFF] key activates the STRTUP signal, triggering a three second one-shot circuit (C3, R10, CR1, and Q1) that will temporarily turn the system power on. This three second one-shot period allows the CPU enough time to power up, initialize, and turn on the PWRHLD signal. The CPU monitors the STRTUP signal, via interrupt, to signal a user request for turning off the infuser.

Figure 4-2 illustrates the system startup/shutdown sequence while battery powered.

System power is always on while AC powered.

STRTUP

ONE-SHOT

V3_3, V5_0, V12V

PWRHLD

Figure 4-2. System Startup and Shutdown Timing, Battery Powered

3 SEC

98K01021

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SECTION 4 THEORY OF OPERATION

4.2.2.6

BATTERY VOLTAGE MEASUREMENT

The battery terminal voltage (BATPOS - BATNEG) is measured with a differential amplifier consisting of U1, R1, R2, R4, R7, and R8. It has a gain of 0.317 to generate a single ended VBATT signal. The VBATT signal is then provided to the CPU A/D converter as input for the battery management algorithms.

4.2.2.7

BATTERY CHARGE/DISCHARGE CURRENT MEASUREMENT

The battery management algorithms measure battery charge/discharge current for battery capacity estimation and charger control. The charge/discharge current is measured by integrating the voltage across current sense resistor R57. An operational amplifier (op-amp) integrator circuit, consisting of U2, C5, R12, R13, R19, and R20, provides a voltage proportional to the integration of battery current (IBATT) over a CPU controlled measurement period. The IBATT signal is fed to the CPU A/D converter, where it is sampled at the end of the measurement period. The battery management algorithm further accumulates the charge/discharge current for battery capacity estimation. The op-amp integrator is reset by the CPU system at the beginning of each measurement period by parallel analog switches U3, controlled by the CPU’s ITGRST signal. The battery management algorithm periodically calibrates the op-amp integrator.

4.2.2.8

BATTERY CHARGER

The software battery management algorithm controls the battery charger. The charging scheme is a current limit/two stage voltage limit charger. The charge current is limited to

1.3 A and the voltage is limited to either 6.74 V

The source of the charge current is power MOSFET transistor Q7 operating in the linear mode. Charge current passes through a current sense resistor R57, where it develops a feedback signal for the charger control amplifier consisting of U7, Q6, and associated parts. The feedback signal is compared against a 2.5 V protects against damage due to a short circuit. The battery management algorithm maintains on/off control of the charger by the charger enable signal CHG*. When set high, CHG* activates a comparator, which overrides the feedback signal and disables the charger. Excessive voltage on the BATNEG terminal indicates that there is a shorted battery cell, and will disable the charger through the same comparator.

or 7.35 VDC.

voltage reference U8. A 0.5 A fuse

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4.2 ELECTRONIC SUBSYSTEM OVERVIEW

4.2.3

MECHANISM SUBSYSTEM

The mechanism subsystem includes the electronics and electromechanical components that interface with the infuser pumping mechanism.

The mechanism subsystem provides the following functions:

- Chopper motor drive for three stepper motors (plunger, L/S valve, I/O valve)

- Four motor position sensors (flag detectors)

- Precision voltage reference

- Two air sensors (distal, proximal)

- Two pressure sensors (distal, proximal)

- Cassette presence and type detection

- Serial electrically erasable PROM (EEPROM)

See Table 4-4 for mechanism interface signals.

4.2.3.1

MOTORS/MOTOR DRIVE

The infuser uses three stepper motors for pumping: one for fluid displacement and two for cassette valve actuation. The stepper motors are driven, under step-by-step control from software, by a unipolar chopper drive.

4.2.3.1.1

Stepper Motors

Each motor is named by its function, as follows:

- Plunger motor for driving the plunger screw

- I/O valve motor for moving the input-output valve pins

- L/S valve motor for moving the line select valve pins A and B

All three motors are four phase stepper types. One electrical revolution is accomplished after four motor steps (phases) are completed. The step-angle (the number of steps per shaft revolution) resolutions are 3.6 and 7.5

The unipolar motor windings have a center tap connected on each of the two coils as shown in Figure 4-3. Unidirectional current enters the center tap and is steered to one end of the coil or the other end by the driver electronics, creating positive or negative flux lines in the motor coil. With two coils each with a choice of flux polarity, four electrical combinations or phases are possible.

° /step (48 steps/rev) for the I/O and L/S valve motors.

° /step (100 steps/rev) for the plunger motor,

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SECTION 4 THEORY OF OPERATION

ACOM

BCOM

B B

98K01020

Figure 4-3. Stepper Motor Coils

4.2.3.1.2

Chopper Motor Drive

The infuser stepper motor drive is a chopper drive, which is a pulse width modulation of the coil current in each motor winding. Current is switched on and off to maintain a predetermined coil current independent of supply voltage and motor speed. The motor winding inductance acts as a filter to smooth out the switching currents, slowing the current rise when turned on and storing a decaying current when turned off. Each motor coil is modulated independently, allowing different coil currents in the two motor windings. The coil current is sensed and compared to a reference input for each winding. Modulation circuits correct for any error between the sensed current and the reference. This reference input can be changed to set a different coil current.

4.2.3.2

MOTOR POSITION SENSORS

Motor position is estimated by counting the motor steps, relative to a position reference. Optical switches and flags serve as position references, which are used to find the motor home positions and to verify proper motion. Flag positions are anticipated by software.

Optical switch flag sensors are used for tracking the following:

- Plunger motor rotational position (coupler flag)

- Plunger translational (linear) position

- I/O valve motor rotational position (cam flag)

- L/S valve motor rotational position (cam flag)

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4.2 ELECTRONIC SUBSYSTEM OVERVIEW

Each optical switch consists of an infrared LED, which shines through a rectangular aperture, across a slot, to illuminate a photo-transistor. The photo-transistor is activated as long as the beam is on and not blocked (by a flag in the slot). The optical switches are distributed throughout the mechanism, near their associated flags. The motor rotational optical switches are mounted on the driver PWA along with the control circuitry. The plunger translational optical switch is mounted remotely on the switch PWA. The switches are used intermittently to save power.

There are two control signals that enable associated switch pairs, as follows:

- FLCAME flag valve motor cam sensor enable

- FLPLE flag plunger motor rotation and translation sensors enable

Each of these control signals enables a constant current source which turns on the associated switch’s infrared LEDs. The photo transistor states are sensed by Schmidt trigger inverters on the driver PWA, which provide a 3.3 V logic high when the optical path is blocked or a logic low when the optical path is clear. The Schmidt trigger output is high when the sensor is disabled.

The following output signals are provided to the CPU subsystem:

- FLIO_C flag I/O valve motor cam sensor

- FLLS_C flag L/S valve motor cam sensor

- FLPLRO flag plunger motor rotation sensor

- FLPLTR flag plunger motor transition sensor

4.2.3.3

V2_5 REFERENCE VOLTAGE

A precision 2.5 VDC reference voltage is generated on the APP PWA for use by the pressure sensor excitation circuits, the air sensor amplifier circuits, and the ADC and DAC reference voltage. The precision 2.5 V is V2_5.

4.2.3.4

reference is buffered by a voltage follower. The signal name

AIR SENSORS

The mechanism subsystem includes two air sensors, used to detect air passage into (proximal) or out of (distal) the cassette. Both sensors are piezoelectric crystal transmitter receiver pairs. Liquid between the transmitter and receiver will conduct the ultrasonic signal, while air will not (see Figure 4-4).

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SECTION 4 THEORY OF OPERATION

VSO

CPU

VCO/PLL

Figure 4-4. Air Sensor Block Diagram

4.2.3.4.1

Transmitter Circuitry

A/D

G_TX

OUTPUT

AMP

XTL TX

XTL RX

G_RX

PEAK

DETECTOR

98K01019

The transmitter circuitry consists of a voltage sweep oscillator (VSO), a voltage-controlled oscillator (VCO), and a transmitter amplifier, and are located on the APP PWA.

The voltage sweep oscillator circuit oscillates at approximately 12 kHz at 50 percent duty cycle. The output of the sweep oscillator is between +2 V

and +3 VDC, and is used to

sweep the VCO. The VCO sweeps through the sensor’s peak coupling frequency, which is between 3 MHz and 6 MHz. A resistor and capacitor are used to configure the VCO center frequency. The VCO is enabled when the CPU asserts either DIARE or PXARE control signals.

The transmitter amplifier consists of a push-pull, emitter-follower, complementary pair of transistors. The transmitter amplifier drives both proximal and distal sensors simultaneously.

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4.2 ELECTRONIC SUBSYSTEM OVERVIEW

4.2.3.4.2

Receiver Circuitry

When the cassette’s test port is filled with fluid, the transmitted signal will be coupled to an identical piezoelectric crystal, where it is amplified and detected by the receiver circuitry. The receiver circuitry consists of an amplifier, a peak detector, and an adjustable gain buffer stage. There is a separate, symmetrical receiver circuit for each channel (proximal and distal). Component references (called out in this design description) will be made to the distal channel only.

The first amplifier includes two, directly coupled common emitter stages, biased from the V2_5 supply. DIARE and PXARE are used to enable the distal and proximal sensors, respectively. The detector stage consists of an emitter follower, charging a 400 µsec time constant, refreshed every 40 microseconds (twice per VCO sweep).

The peak detector output is buffered by an op-amp configured as a basic non-inverting amplifier with a trimming potentiometer for gain adjustment. Each sensor has an independent gain adjustment. The two air sensor, gain-trimming potentiometers are accessible for calibration in an assembled mechanism.

The following final signals are read by the CPU subsystem via the ADC:

- PXAIR proximal air sensor output

- DIAIR distal air sensor output

4.2.3.5

PRESSURE SENSORS

The mechanism subsection contains two strain gauge-type pressure sensors, one at the proximal and the other at the distal cassette ports. Electrically, the strain gauge is a Wheatstone bridge made of four strain gauge resistors. When the bridge is electrically excited, the bridge will output a millivolt level signal proportional to the applied pressure. The output signal is amplified and offset adjusted before being read by the ADC. Each pressure sensor circuit includes an excitation voltage supply, sensor amplifiers, and a low pass filter.

The pressure sensor circuitry is on the APP PWA. Each of the two channels has an identical topology, but different gain and filter response. A block diagram of this circuit is shown in Figure 4-5.

 Note: Component references are made to the distal channel only.

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SECTION 4 THEORY OF OPERATION

PRESSURE

SENSOR

ENABLE

(FROM CPU)

BRIDGE

EXCITATION

3.75 V

REFERENCE

2.5 V

WHEATSTONE

BRIDGE

DIFFERENTIAL

AMPLIFIER

AND OFFSET

ADJUST

OUTPUT

AMPLIFIER

AND FILTER

PRESSURE SIGNAL OUTPUT (TO CPU)

05K01018

Figure 4-5. Pressure Sensor Excitation and Amplifier Block Diagram

4.2.3.5.1

Bridge Excitation Supply

The bridge excitation voltage is 3.75 VDC, and is derived from the 2.5 VDC reference signal (V2_5), gained 1.5 times by an amplifier. The CPU subsystem may independently enable power to each pressure sensor bridge.

The following enable signals are active high 3.3 V logic level inputs:

- PXPRE proximal pressure sensor enable

- DIPRE distal pressure sensor enable

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4.2 ELECTRONIC SUBSYSTEM OVERVIEW

4.2.3.5.2

Amplifier and Low Pass Filter

The pressure sensor amplifiers include a high gain differential pre-amplifier, followed by a second stage non-inverting amplifier with low gain. A trimming potentiometer is adjusted to minimize any offset in the impedance of the bridge.

A two-pole filter is used to filter the pressure signals. The first pole is formed by a capacitor (multiplied by 230 due to Miller effect) and a Thevenin resistance. The second pole is the RC filter at the ADC input, which is located on the CPU PWA.

The output signals to the A/D converter in the CPU PWA are, as follows:

- PXPRS proximal pressure signal

- DIPRS distal pressure signal

4.2.3.6

PRESSURE SENSOR CALIBRATION

Pressure sensors are calibrated for offset and gain during mechanism calibration. A trimming potentiometer is used to adjust the initial, zero pressure offset. The proximal and distal pressure sensors have independent offset adjustments. The final system gain (cassette pressure to corrected amplifier output) is adjusted in software. During mechanism calibration, each channel’s gain (amplifier output/cassette pressure) will be measured, and stored in the serial EEPROM on the driver PWA.

4.2.3.7

CASSETTE TYPE/PRESENCE SELECTION

The mechanism subsystem includes one force sensing resistor (FSR) switch, which is coupled to the cassette and is used for cassette present detection. The FSR is a polymer thick film device, which exhibits a decrease in resistance with any increase in force applied to the active surface. The FSR is arranged in a voltage divider configuration with a fixed resistor, followed by a comparator with hysteresis. The comparator circuits are located on the CPU PWA. The comparators are designed to trip as the FSR’s resistance falls below 120 KΩ.

4.2.3.8

SERIAL EEPROM

The driver PWA holds the 8 K x 8 bit, serial EEPROM, which is used to store event, alarm, malfunction, and calibration data specific to the pumping mechanism. It is accessed through a serial peripheral interface (SPI) compatible interface, which is a high-speed serial interface to the CPU. The CPU PWA accesses this device through its SCP serial interface. This interface is a subset of the SPI, and consists of clock (SPCLK), data in (SPRXD), and data out (SPTXD) pins. This device is in the driver PWA to allow the calibration data to stay with the mechanism.

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SECTION 4 THEORY OF OPERATION

4.3

PRINTED WIRING ASSEMBLIES

Infusion system electronics are packaged into six printed wiring assemblies (PWA) and

several remote mounted peripherals (see Section 4.4). The following sections provide a brief

description of the functional interfaces of each PWA.

4.3.1

POWER SUPPLY PWA

The power supply PWA (see Figure 9-10) contains the following functions of the power supply subsystem:

- Main switching regulator

-AC power detection

- Main regulator fault detection

-System power

The power supply PWA is a four layer board, with primarily surface mount technology (SMT) components. The board is fully testable from the bottom side. Insulating tape covers the back of the power supply PWA. Open system troubleshooting should be done under battery power. If connection to the AC line is required, an isolation transformer should be used since AC line potentials are present on the power supply PWA.

See Section 4.2.2 for a functional description, and see Table 4-5 for power supply PWA interface connections.

Table 4-5. Power Supply PWA Interface Connections

Connector Type Interface

P2 30 pin receptacle Board-to-board connection to CPU PWA

J16 4 pin header Motor power connection to driver PWA

J21 3 pin receptacle AC power cord connection

- Auxiliary supplies

-Power control

- Battery management

J22 2 pin header Battery cable connection

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4.3 PRINTED WIRING ASSEMBLIES

4.3.2

PERIPHERAL PWA

The peripheral PWA (see Figure 9-11) contains part of the CPU subsystem circuitry, including system program and data memories (PROM and SRAM), external communication interface circuits, and rear instrument user controls. The peripheral PWA is designed to be field replaceable, to facilitate software upgrades or additional external interfaces.

The peripheral PWA is a four layer board, including one ground plane, one power plane, and two signal layers. In its initial configuration, all of the components are mounted on the top side.

See Section 4.2.1 for a functional description, and see Table 4-6 for peripheral PWA interface connections.

Table 4-6. Peripheral PWA Interface Connections

Connector Type Interface

P1 96 pin receptacle Board-to-board connection to CPU PWA

J26 15 pin D-sub DataPort

J27 9 pin D-sub Barcode reader connection

J28 3 pin phone jack Nurse call jack

4.3.3

CPU PWA

The CPU PWA (see Figure 9-12) contains most of the CPU subsystem functions, with the exception of main memory and communications ports, which are located on the peripheral PWA. The CPU PWA also accommodates system interconnect.

The CPU PWA is an eight layer board, with one ground plane, one power plane, and six signal layers. The CPU PWA primarily contains SMT components. Most of the components are on the top side, while the bottom side holds wave-solder compatible SMT resistors and capacitors.

See Section 4.2.1 for a functional description, and see Table 4-7 for CPU PWA interface connections.

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Table 4-7. CPU PWA Interface Connections

Connector Type Interface

J7 96 pin header Connection to peripheral PWA

(CPU bus; rear panel I/O; communication ports)

J2 30 pin header Connection to power supply PWA

J3 50 pin SMT Ribbon cable connection to driver PWA (mechanism)

J4 21 pin header Front panel connector (keypad; LEDs; ON/OFF switch)

J5 14 pin SMT Flat flex cable to LCD panel

J6 4 pin header Lock box connector

J20 4 pin header CCFT backlight connector

J24 2 pin header Main audible alarm connector

4.3.4

DRIVER PWA

The driver PWA (see Figure 9-13) contains the mechanism subsystem’s motor drive circuitry, motor position sensors, and serial EEPROM. The driver PWA is mounted in the mechanism sub-chassis.

The driver PWA is a four layer board, with one ground plane, one power plane and two signal layers. The driver PWA primarily uses SMT components. Most of the components are located on the top side of the board, while the bottom side holds wave-solder compatible resistors and capacitors.

See Section 4.2.3 for a functional description, and see Table 4-8 for driver PWA interface connections.

Table 4-8. Driver PWA Interface Connections

Connector Typ e Interface

J7 6 pin header Plunger motor

J8 6 pin header Input/output motor

J9 6 pin header Line select motor

J10 20 pin SMT Flat flex cable to APP PWA

J11 50 pin header Ribbon cable to CPU PWA

J12 6 pin SMT FSR flex circuit

J13 4 pin header Motor power from power supply PWA

J14 8 pin SMT Flat flex cable to switch PWA

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4.4 REMOTE MOUNTED PERIPHERALS

4.3.5

SWITCH PWA

The switch PWA (see Figure 9-14) contains the plunger translation position sensor, which is one of six position sensors in the system. The switch PWA is located at the side of the mechanism sub-chassis, and connects to the driver PWA.

4.3.6

APP PWA

The APP (air, pressure, and pin) PWA (see Figure 9-15) is mounted in the mechanism sub-chassis. The APP PWA contains the following mechanism subsystem circuitry:

- Proximal and distal air sensors and circuitry

- Proximal and distal pressure sensor amplifiers and excitation

- V2_5 precision voltage reference

- Pin detector optical switch module

The APP PWA is a four layer board, with one ground plane, one power plane and two signal layers. The APP PWA uses SMT components, mounted on both sides of the board. The air sensors and the pin detector module are board mounted.

See Section 4.2.3 for a functional description, and see Table 4-9 for APP PWA interface connections.

Table 4-9. APP PWA Interface Connections

Connector Typ e Interface

J15 20 pin SMT Flat flex cable to driver PWA

J11 10 pin SMT Pressure sensor connector

4.4

REMOTE MOUNTED PERIPHERALS

The following sections describe the major remote mounted peripherals.

4.4.1

LCD

The infuser uses a graphic LCD module with a CCFT. The CCFT provides a backlight source for the LCD. The LCD requires a nominal -16 V is controlled by the CPU. The infuser’s graphic display data is shifted out to the LCD by the CPU LCD controller, which interfaces directly with the CPU (see Section 4.2.1.6). The display is configured as a 240 x 240 dot matrix with a viewing angle of approximately 60

° .

supply for contrast control, which

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SECTION 4 THEORY OF OPERATION

4.4.2

SEALED LEAD ACID BATTERY

The infuser uses a nominal 6 VDC rechargeable sealed lead acid battery with a 4 amp-hour capacity.

4.4.3

BARCODE READER WAND

 Note: The barcode reader feature will not be present on later versions of the Plum A+

The barcode reader wand connects to the BCR port on the peripheral PWA

(see Figure 9-11). The BCR wand interfaces through the infuser’s optically isolated, TTL

logic level, asynchronous interface. The BCR wand is also capable of interfacing at RS-232 levels. The infuser provides an isolated +5 V LED at the tip of the BCR wand is swiped across a barcode label, the reflected light is scanned and processed. After a successful scan, the data is sent over the communication interface to the CPU.

regulator to power the BCR wand. When the

4.5

MECHANICAL OVERVIEW

The principal mechanical elements of the infuser include the cassette and the mechanism assembly. When a cassette is locked into the operating position and the [ON/OFF] switch is pressed, the infuser performs a self test to verify the integrity of the internal systems. The operation of the mechanism assembly moves a plunger, causing a pumping action. A valve motor selects the A or B valve, depending on the command. An additional valve motor alternately opens and closes an inlet valve and outlet valve to control fluid flow through the cassette pumping chamber.

The following sections detail the cassette and the mechanism assembly.

4.5.1

CASSETTE

The cassette operates on a fluid displacement principle to volumetrically deliver fluid

(see Figure 4-6 and Figure 4-7). See the system operating manual for a description of the

major cassette functions.

The pumping cycle begins when the outlet valve is opened and the inlet valve is closed. The plunger extends to deflect the cassette diaphragm and expel fluid. At the end of the pumping stroke, the outlet valve is closed, the inlet opens, the appropriate A or B valve opens, and the plunger retracts to allow fluid to refill the pumping chamber. After the pumping chamber is filled, the inlet and outlet valves are reversed, the A and B valves are closed, and the cycle repeats.

The cassette contains two chambers: an upper air trap chamber and a pumping chamber. The two chambers are separated by an inlet valve and operate together to detect air. The air trap chamber receives fluid from the intravenous (IV) container through either the A or B valve. The air trap chamber collects air bubbles from the IV line and container to prevent them from entering the pumping chamber and can collect a substantial amount of air.

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4.5 MECHANICAL OVERVIEW

A proximal air-in-line sensor (bubble detector) is located between the A/B valves and the upper air-trap chamber. The proximal air-in-line sensor detects air entering the upper air-trap chamber and initiates an audible alarm if the predetermined air collection threshold is exceeded. Similarly, a second air-in-line sensor located distal to the pumping chamber initiates an audible alarm if a predetermined amount of air is detected.

The pumping chamber receives fluid from the upper air-trap chamber through an inlet valve. A pressure sensor located in the upper air-trap chamber monitors pressure on the proximal side of the cassette. When the diaphragm covering the pumping chamber is deflected by the plunger, the pumping chamber expels fluid through an outlet valve. A pressure sensor located distal to the pumping chamber monitors pressure on the distal side of the cassette.

A flow regulator is incorporated into the cassette distal end. This flow regulator is used to manually control flow when the cassette is not inserted in the infuser. When the cassette is properly inserted into the infuser and the door is closed, a mechanism opens the flow regulator to allow the infuser to control fluid flow. When the door is opened, the same mechanism closes the flow regulator to disable fluid flow.

SECONDARY PORT

PRESSURE SENSOR

RIGHT VIEW

(Y-RESEAL OR LOCKING CAP)

B VALVE

AIR-IN-LINE

SENSOR

(PROXIMAL)

AIR TRAP

CHAMBER

INLET VALVE

FROM PRIMARY

CONTAINER

REAR VIEW

PRECISION GRAVITY

(CONTROL NOT SHOWN)

A VALV E

AIR-IN-LINE

SENSOR (DISTAL)

PRESSURE SENSOR

(DISTAL)

OUTLET VALVE

PUMPING CHAMBER

FLOW REGULATOR

FINGER

GRIP

OUTLET

PATIENT

LEFT VIEW

98G01017

Figure 4-6. Major Elements of the Dual-Channel Cassette

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SECTION 4 THEORY OF OPERATION

LINE A

A VALV E

AIR TRAP CHAMBER

INLET VALVE

OUTLET VALVE

LINE B

B VALVE

AIR-IN-LINE SENSOR (PROXIMAL)

PRESSURE SENSOR (PROXIMAL)

PUMPING CHAMBER

PRESSURE SENSOR (DISTAL)

AIR-IN-LINE SENSOR (DISTAL)

PRECISION GRAVITY

FLOW REGULATOR (AND SHUT OFF)

98G01001

Figure 4-7. Fluid Path in the Cassette

4.5.2

MECHANISM ASSEMBLY

The mechanism assembly is a fully self-contained unit consisting of the motor and valve assemblies, A/B valve subsystem, inlet/outlet valve subsystem, plunger drive subsystem, air bubble (ultrasonic) sensor assemblies, cassette door, and pressure sensor assemblies. The motor and valve assemblies, A/B valve subsystem, inlet/outlet valve subsystem, and plunger drive subsystem are detailed in the following sections.

During infuser operation, the mechanism assembly plunger motor drives a lead screw that is coupled to the plunger. The motor action and lead screw move the plunger forward to cause the delivery of approximately 0.33 mL of fluid per cycle. The plunger motion is synchronized to the valve motors to provide controlled fluid delivery.

4.5.2.1

MOTOR AND VALVE ASSEMBLIES

The mechanism assembly pumping action is controlled by three stepper motors. The first stepper motor, in conjunction with an associated valve assembly, activates the A valve or B valve of the cassette, depending on the command. The second stepper motor alternately opens and closes the inlet and outlet valve to control fluid delivery through the cassette pumping chamber. A third stepper motor controls plunger movement.

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4.5 MECHANICAL OVERVIEW

4.5.2.2

A/B VALVE SUBSYSTEM

The A/B valve subsystem includes a motor designed to rotate a cam. When the cam is positioned at top-dead-center (home position), both valves are closed. Clockwise rotation (when viewed from the motor side) from the home position opens the A valve, while the B valve remains closed. Counterclockwise rotation opens the B valve, while the A valve remains closed (see Figure 4-8).

The A/B valve subsystem consists of a stepper motor with attached cam and integral cam flag, A and B rockers and valve pins, and a pin detector assembly. The cam flag passes through an interrupter module as it rotates with the cam. Valve home position is determined by this cam flag/interrupter module combination through predetermined factory calibration data. During operation, if the cam flag passes through the interrupter module at the incorrect time sequence, a motor phase loss is detected. The rocker is the connecting link between the cam and the valve pin.

A VALV E

REGULATOR ACTUATOR

AIR-IN-LINE SENSOR (DISTAL)

PRESSURE SENSOR (DISTAL)

CASSETTE LOCATOR

OUTLET VALVE

Figure 4-8. Mechanism Valve Pins and Sensor Locations

PLUNGER

INLET VALVE

B VALVE

AIR-IN-LINE SENSOR

(PROXIMAL)

PRESSURE SENSOR

(PROXIMAL)

FORCE SENSING

RESISTOR

02K01023

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4.5.2.3

INLET/OUTLET VALVE SUBSYSTEM

The inlet/outlet valve subsystem is similar in function and build to the A/B valve subsystem (see Section 4.5.2.2).

4.5.2.4

PLUNGER DRIVE SUBSYSTEM

The main components of the plunger drive subsystem are: plunger, lead screw and coupler, and stepper motor. When the infuser is turned on, the plunger moves from the retracted, PARK position to the HOME position. The cassette diaphragm is engaged. The stepper motor rotates approximately 1 2/3 revolutions per pump cycle to permit a 0.33 mL fluid displacement every pump cycle. The stepper motor then reverses and the plunger returns to HOME position. This cycle repeats for the duration of fluid administration.

The screw/coupler assembly links the motor and the plunger. This assembly includes a flag that passes through an interrupter module. This screw/coupler, flag/interrupter module combination is used in conjunction with predetermined factory calibration data to determine the plunger position. During operation, if the screw/coupler flag passes through the interrupter module at the incorrect time sequence, a motor phase loss is detected.

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Section 5

MAINTENANCE AND SERVICE TESTS

A complete maintenance program promotes infusion system longevity and trouble-free operation. Such a program should include routine maintenance, periodic maintenance inspection, and following any repair procedure, performance verification testing.

5.1

ROUTINE MAINTENANCE

Routine maintenance consists of basic inspection and cleaning procedures. As a minimum requirement, inspect and clean the infuser after each use. In addition, establish a regular cleaning schedule for the device.

5.1.1

CLEANING

Accumulation of dust or spilled fluids on the cassette door and housing can affect proper operation. The following cleaning procedures are designed to sustain longevity and promote trouble-free operation.

Follow hospital protocol for establishing the infuser cleaning schedule.

WARNING:

CAUTION: Do not immerse the infuser in liquids. Immersion could damage the device. Do not allow liquids to enter the electronics compartment. Do not spray cleaning solutions toward any openings in the device.

CAUTION: Certain cleaning and sanitizing compounds may slowly degrade components made from some plastic materials. Using abrasive cleaners or cleaning solutions not recommended by Hospira may result in product damage and, potentially, void the product warranty. Do not use compounds containing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride. Do not use solvents that are harmful to plastic.

CAUTION: To avoid damage to the device, cleaning solutions should be used only as directed in Table 5-1. The disinfecting properties of cleaning solutions vary; consult the manufacturer for specific information.

DISCONNECT THE INFUSER FROM AC POWER PRIOR TO CLEANING THE DEVICE. FAILURE TO COMPLY WITH THIS WARNING COULD RESULT IN ELECTRICAL SHOCK.

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SECTION 5 MAINTENANCE AND SERVICE TESTS

Table 5-1. Cleaning Solutions

Cleaning Solution Manufacturer Preparation

Coverage

Dispatch

Manu-Klenz

Precise

Sporicidin

Household bleach Various

1. Clean the exposed surfaces of the infusion system with a soft, lint-free cloth

2. Remove soap residue with clear water.

HB Steris Corporation

dampened with one of the cleaning solutions listed in Table 5-1, or a mild solution of soapy water.

Caltech Industries

Steris Corporation

Caltech Industries

Sporicidin International

Per manufacturer's recommendation

Per manufacturer’s recommendation

Per hospital procedures; do not exceed one part bleach in ten parts water

5.1.2

SANITIZING

Sanitize the external surfaces of the infuser using a cleaning solution listed in Table 5-1.

 Note: Not all cleaning solutions are sanitizers. Check product labeling.

CAUTION: Do not sterilize the infuser using heat, steam, ethylene oxide (ETO), or radiation. These methods may cause the device to malfunction.

5.2

PERFORMANCE VERIFICATION TEST

The performance verification test (PVT) consists of the tests described in the following sections. The PVT can be used for diagnostic purposes during the troubleshooting of a malfunctioning infuser. The PVT should be used for performance verification before an infuser is placed back in service after repair. If any malfunction is detected as a result of the PVT, see Table 6-3.

 Note: Perform the PVT exactly as described in this manual to assure effective

and reliable product evaluation information.

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5.2 PERFORMANCE VERIFICATION TEST

5.2.1

EQUIPMENT REQUIRED

The PVT requires the following equipment and materials, or equivalents:

- Graduated cylinder, 25 mL, with 0.2 mL graduations (Type A)

- Sterile water or tap water in an IV bag/container

- Digital pressure meter (DPM), 0 to 50 psi (Fluke

Biomedical DPM3)

- Three-way stopcock, latex-free (List No. 3233-01)

- IV Set (List No. 11419)

- 21-gauge butterfly needle, latex-free (List No. 4492-01), or 18-gauge blunt cannula

- Safety analyzer (Fluke

- Digital multimeter (DMM) (Fluke

Biomedical 232D)

187) (optional)

- Nurse call test cable (P/N 561-88416-001) (optional)

5.2.2

INSPECTION

Inspect the infusion system periodically for signs of defects such as worn accessories, broken connections, or damaged cables. In addition, inspect the infuser after repair or during cleaning. Replace any damaged or defective external parts.

Inspect the following areas for missing or damaged parts:

-Labels

- AC power cord, retainer, and strap

- Rubber foot pads

- Door assembly and handle

- Keypad and display

- External screws

- Pole clamp assembly

- Front and rear enclosures

- Battery door

- Peripheral assembly and components

-LEDs

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SECTION 5 MAINTENANCE AND SERVICE TESTS

5.2.3

TEST SETUP

WARNING:

To set up the infuser for the PVT, proceed as follows:

1. Confirm the infuser and appropriate accessories are assembled.

2. Hang two sterile water containers at a height of 18 inches ± 6 inches above the pumping chamber of the infuser.

3. Connect the infuser to AC power, and press [ON/OFF] to turn on the device.

4. Verify the infuser is in the unlocked mode. Toggling the [LOCKOUT] switch alternates between unlocked [DOWN] and locked [UP] modes.

5. Turn off the infuser.

A PATIENT SHOULD NEVER BE CONNECTED TO THE INFUSER DURING TESTING.

5.2.4

SELF TEST

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

 Note: Conduct all tests with the infuser connected to AC power unless otherwise

specified.

 Note: If an alarm condition occurs during the self test, cycle the power and repeat the

self test. If the alarm condition recurs, note the message and take corrective action

(see Section 6). Repeat the self test. If the alarm condition continues to recur, remove

the infuser from service and contact Hospira.

To perform the self test, see Figure 5-1, then proceed as follows:

1. Connect the AC power cord to a grounded AC outlet. Verify the charge/line indicator CHARGE illuminates and an alarm beep sounds.

2. Without a cassette installed, turn on the infuser.

3. The LCD screen briefly displays the SELF TEST screen (see Figure 5-1).

 Note: If the SELF TEST screen does not appear, contact Hospira.

4. After the self test is complete, the message “INSERT PLUM SET CLOSE LEVER” appears.

5. Verify the time and date. To set the time and date, see Section 1.8.3.

6. Open the cassette door and insert a primed cassette. Close the cassette door. The cassette test is complete when the “CASSETTE TEST IN PROGRESS” message disappears.

 Note: The message “MECHANISM INITIALIZATION IN PROGRESS” may briefly

appear prior to the “CASSETTE TEST IN PROGRESS” message.

7. A “NEW PATIENT?” message may appear. Press [YES], then turn off the infuser.

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5.2 PERFORMANCE VERIFICATION TEST

ON/OFF

LINE FLOW

INDICATORS

A B

HOSPIRA Plum A+

STATUS REGION

MESSAGE REGION

SOFTKEY LABEL REGION

CHARGE/LINE INDICATOR

Version X.XX MM/DD/YY

START

STOP

CHARGE

ON/OFF

2005

System Self Test

In Progress

1 4

2 5

CLEAR

3 6

WORKING

REGION

SOFTKEYS

SELECT

KEYPAD

SILENCE

05K01002

Figure 5-1. Display and Keypad

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SECTION 5 MAINTENANCE AND SERVICE TESTS

5.2.5

CASSETTE ALARM TEST

To perform the cassette alarm test, proceed as follows:

1. Verify the infuser is on. Insert an empty cassette and close the door.

 Note: The infuser may display a CCA screen. Choose an area and press

[ENTER].

2. Verify the “CASSETTE TEST FAIL” message is flashing on the display and the alarm sounds after the cassette test is complete.

3. Open the door and remove the cassette.

4. Turn off the infuser.

5.2.6

FREE FLOW TEST

To perform the free flow test, proceed as follows:

1. With a primed cassette installed, press [ON/OFF] to turn on the infuser.

 Note: The infuser may display a CCA screen. Choose an area and press

[ENTER].

2. A “NEW PATIENT?” message may appear. Press [YES].

3. Place the distal end of tubing into a collection container a minimum of 36 inches below the cassette.

4. With the cassette door closed, check the distal end of the tubing for fluid flow. Verify a minimal flow of fluid occurs (a few drops maximum).

5. Open the cassette door and check the distal end of the tubing for fluid flow. Verify a minimal flow of fluid occurs (a few drops maximum).

 Note: A small amount of fluid may be expelled from the cassette when opening

or closing the door.

6. Close the cassette door.

5.2.7

DISPLAY TEST

To perform the display test, see Figure 5-1, then proceed as follows:

1. Verify the LCD backlight is illuminated and the display is clearly legible at eye level from approximately 18 inches.

2. With the infuser in the DELIVERY screen, press the [OPTIONS/VOL INF] softkey to select the OPTIONS screen.

3. Select Lighting/Contrast, and press [CHOOSE].

4. Press the [DECREASE SETTING] and [INCREASE SETTING] softkeys to change backlight intensity. Verify backlight intensity decreases and increases.

5. Select Display Contrast.

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5.2 PERFORMANCE VERIFICATION TEST

6. Press [DECREASE SETTING] and [INCREASE SETTING] to change display contrast. Verify the display contrast decreases and increases.

7. Press the [CANCEL] softkey to return to the OPTIONS screen.

8. Press the [BACK] softkey to return to the DELIVERY screen.

5.2.8

KEYPAD VERIFICATION/FUNCTIONAL TEST

To perform the keypad verification/functional test, see Figure 5-1, then proceed as follows:

1. With the infuser in the DELIVERY screen, press the [A] softkey to select line A.

2. Verify the PROGRAM screen is displayed.

3. Enter a rate of 123 mL/hr and VTBI of 4567.

4. Press [START] and verify the “CONFIRM PROGRAM?” message is displayed. If rate and VTBI are correct, press [YES].

5. Verify fluid is pumping, the message “PUMPING” is displayed in the line A status bar, and the line A LED flashes.

6. Press [STOP], then press and hold the [BACKPRIME] softkey.

7. Verify the “BACKPRIMING” and “RELEASE BACKPRIME TO STOP” messages are displayed, and verify the infuser is actually backpriming.

8. Release the [BACKPRIME] softkey, press [START], and verify normal pumping operation.

9. Press the [B] softkey.

10. Verify PIGGYBACK is the displayed delivery mode. If necessary, change the delivery

mode by pressing the [CHANGE MODE] softkey.

11. Enter a rate of 890 mL/hr and VTBI of 2 mL.

12. Press [START] and verify the “CONFIRM PROGRAM?” message is displayed. If rate and VTBI are correct, press [YES].

13. Verify fluid is pumping. Verify the message “PUMPING” is displayed in the line B status bar, and the line B LED flashes.

14. After 20 seconds, verify pumping has switched to line A.

15. Press [STOP].

16. Press [OPTIONS/VOL INF]. Select Volume Infused and press [CHOOSE].

17. Select line A.

18. Press [CLEAR]. Verify the line A volume is 0 mL and press [ENTER].

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SECTION 5 MAINTENANCE AND SERVICE TESTS

5.2.9

ALARM LOUDNESS TEST

To perform the alarm loudness test, proceed as follows:

1. Press the [A] softkey to select line A.

2. Enter a rate of 400 mL/hr and VTBI of 1 mL.

3. Press [START] and verify the “CONFIRM PROGRAM?” message is displayed. If rate and VTBI are correct, press [YES].

4. Verify fluid is pumping, the message “PUMPING” is displayed in the line A status bar, and the line A LED flashes.

5. Verify the alarm sounds when the dose has been delivered.

6. Turn the volume control knob between HIGH and LOW (see Figure 5-2). Verify the alarm loudness changes.

7. Press the [SILENCE] key, and verify the alarm is silenced.

8. Press [STOP].

4-40 x 1/2 PAN HEAD SCREW (2)

VOLUME CONTROL KNOB

LOCKOUT SWITCH

NURSE CALL JACK

RECTANGLE SEAL

EQUIPOTENTIAL TERMINAL

DATAPORT CONNECTOR

ROUND SEAL (2)

6-32 x 2 1/2

PAN HEAD

SCREW

POLE CLAMP

ASSEMBLY

AC POWER CORD

6-32 x 3 1/4 PAN HEAD SCREW

Figure 5-2. Rear View

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05K01038

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5.2 PERFORMANCE VERIFICATION TEST

5.2.10

LOCKOUT SWITCH TEST

To perform the lockout switch test, proceed as follows:

1. Press the [A] softkey to select line A.

2. Enter a rate of 400 mL/hr and VTBI of 50 mL.

3. Press [START] and verify the “CONFIRM PROGRAM?” message is displayed. If rate and VTBI are correct, press [YES].

4. Verify fluid is pumping, the message “PUMPING” is displayed in the line A status bar, and the line A LED flashes.

5. Toggle the lockout alarm switch up (ON) to engage the alarm (see Figure 5-2).

6. Press any key except [STOP], and verify an alarm sounds and the “HARD LOCKOUT ENABLED” message is displayed. Verify the infuser continues to operate until [STOP] is pressed.

7. Press [STOP] and verify the “HARD LOCKOUT VIOLATION” message appears.

8. Toggle the lockout alarm switch down (OFF). Verify the “HARD LOCKOUT VIOLATION” message disappears and the alarm stops.

9. Press [START].

10. Open the door and verify the “DOOR OPEN WHILE PUMPING” message is displayed and the audio alarm activates.

11. Close the cassette door.

12. Press [NO] at the “NEW PATIENT?” prompt.

5.2.11

PROXIMAL OCCLUSION TEST

To perform the proximal occlusion test, proceed as follows:

1. Press the [A] softkey to select line A.

2. Enter a rate of 400 mL/hr and VTBI of 50 mL.

3. Press [START] and verify the “CONFIRM PROGRAM?” message is displayed. If rate and VTBI are correct, press [YES].

4. Verify fluid is pumping, the message “PUMPING” is displayed in the line A status bar, and the line A LED flashes.

5. After several pumping cycles, clamp line A tubing proximal to the cassette. Verify the “PROX OCCL A/AIR” message flashes and the alarm sounds before three pumping cycles are completed.

6. Press [SILENCE] and verify the alarm stops while the message on the display continues to flash.

7. Unclamp the proximal line and press [START]. Verify pumping resumes.

8. Press [STOP].

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SECTION 5 MAINTENANCE AND SERVICE TESTS

5.2.12

PROXIMAL AIR-IN-LINE TEST

To perform the proximal air-in-line test, see Figure 5-3, then proceed as follows:

1. Install the special cassette marked proximal, and close the cassette door.

 Note: Confirm the special cassette proximal bubble sensor tips are removed.

2. A “NEW PATIENT?” message may appear. Press [YES].

3. Press the [A] softkey to select line A.

4. Enter a rate of 400 mL/hr and VTBI of 50 mL.

5. Press [START] and verify the “CONFIRM PROGRAM?” message is displayed. If rate and VTBI are correct, press [YES].

6. Verify fluid is pumping, the message “PUMPING” is displayed in the line A status bar, and the line A LED flashes.

7. Before 1 mL of fluid is delivered, verify the alarm sounds and the “PROX AIR A. BACKPRIME” message is flashing on the display.

8. Open the door and remove the special cassette.

5.2.13

DISTAL AIR-IN-LINE TEST

To perform the distal air-in-line test, see Figure 5-3, then proceed as follows:

1. Install the special cassette marked distal, and close the cassette door.

 Note: Confirm the special cassette distal bubble sensor tips are removed.

2. A “NEW PATIENT?” message may appear. Press [YES].

3. Press the [A] softkey to select line A.

4. Enter a rate of 400 mL/hr and VTBI of 50 mL.

5. Press [START] and verify the “CONFIRM PROGRAM?” message is displayed. If rate and VTBI are correct, press [YES].

6. Verify fluid is pumping, the message “PUMPING” is displayed in the line A status bar, and the line A LED flashes.

7. Before 1 mL of fluid is delivered, verify the alarm sounds and the “DISTAL AIR A. BACKPRIME” message is flashing on the display.

8. Open the door and remove the special cassette.

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PROXIMAL BUBBLE SENSOR BULB TIPS (REMOVED FOR PROXIMAL-AIR-IN-LINE ALARM TEST)

5.2 PERFORMANCE VERIFICATION TEST

(REMOVED FOR DISTAL-AIR-IN-LINE ALARM TEST)

DISTAL BUBBLE SENSOR BULB TIPS

CASSETTE CENTERING DEVICE

98G01024

Figure 5-3. Special Cassettes with Bubble Sensor Tips Removed

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SECTION 5 MAINTENANCE AND SERVICE TESTS

5.2.14

DISTAL OCCLUSION TEST

To perform the distal occlusion test, see Figure 5-4, then proceed as follows:

1. Install the cassette and connect the distal tubing to the DPM through a three-way stopcock as illustrated in Figure 5-4. Close the cassette door.

 Note: A reflux valve may be attached between the stopcock and the DPM

to keep moisture out of the DPM.

 Note: The height of the DPM must be 0 ± 12 inches from the midline of the

pumping chamber.

2. Turn on the infuser.

3. A “NEW PATIENT?” message may appear. Press [YES].

4. Press [OPTIONS/VOL INF] to select the OPTIONS screen.

5. Select Pressure/Post Infusion Rate, and press [CHOOSE].

6. Verify the distal pressure limit is set at 6 psi. If the pressure limit is not 6 psi, enter 6, and press [ENTER].

7. Press the [A] softkey to select line A.

8. Enter a rate of 40 mL/hr and VTBI of 50 mL.

9. Open the three-way stopcock to air.

10. Press [START] and verify the “CONFIRM PROGRAM?” message is displayed. If rate and VTBI are correct, press [YES].

11. Verify fluid is pumping, the message “PUMPING” is displayed in the line A status bar, and the line A LED flashes.

12. Set the three-way stopcock to measure pressure.

13. Verify the distal occlusion audible alarm occurs at 6 psi ± 3 psi. Verify the DISTAL OCCLUSION message is flashing on the screen.

14. Open the three-way stopcock to air.

15. Open and close the door. Press [NO] at the “NEW PATIENT?” prompt.

16. Press [OPTIONS/VOL INF] to select the OPTIONS screen.

17. Select Pressure/Post Infusion Rate and press [CHOOSE].

18. Select Distal Pressure Limit. Enter 10 psi, and press [ENTER].

19. Set the three-way stopcock to measure pressure, then press [START].

20. Verify the distal occlusion audible alarm occurs at 10 psi ± 3 psi. Verify the DISTAL OCCLUSION message is flashing on the screen.

21. Open the door and remove the cassette.

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FROM FLUID CONTAINERS

5.2 PERFORMANCE VERIFICATION TEST

THREE-WAY

STOPCOCK

Figure 5-4. Distal Occlusion Test Setup

UNIVERSAL

PRESSURE METER

0.00

cm OF H O

mmHg

OFF

PRESSURE INPUT

INCHES OF H O

-13.5 TO 15

-13.5 TO 75

98K01041

DPM

PSI

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SECTION 5 MAINTENANCE AND SERVICE TESTS

5.2.15

DELIVERY ACCURACY TEST

 Note: Accuracy testing is for informational purposes only, and is not to be used

as a re-release test. If there is any concern as to infuser accuracy, contact Hospira.

CAUTION: Do not remove the protective cover from the 21-gauge needle.

To perform the delivery accuracy test, proceed as follows:

1. Open the cassette door and insert a primed cassette. Close the cassette door.

2. A “NEW PATIENT?” message may appear. Press [YES].

3. Install an 18-gauge blunt cannula or a 21-gauge needle to the distal end of the tubing. Verify the fluid container is 18 to 24 inches above the pumping chamber. Verify all lines are unclamped.

4. Place the distal output end of tubing into the graduated cylinder.

5. Press the [A] softkey to select line A.

6. Enter a rate of 200 mL/hr and VTBI of 10 mL.

7. Press [START] and verify the “CONFIRM PROGRAM?” message is displayed. If rate and VTBI are correct, press [YES].

8. Verify fluid is pumping, the message “PUMPING” is displayed in the line A status bar, and the line A LED flashes.

9. Press the [B] softkey to select line B.

10. Verify the infuser is in the PIGGYBACK delivery mode. If necessary, press

[CHANGE MODE] to change the delivery mode.

11. Enter a rate of 200 mL/hr and VTBI of 10 mL.

12. Press [START] and verify the “CONFIRM PROGRAM?” message is displayed. If rate and VTBI are correct, press [YES].

13. Verify fluid is pumping, the message “PUMPING” is displayed in the line B status bar, and the line B LED flashes.

14. Verify the “KVO” message flashes on the display and an audible alarm sounds when total delivery is complete on line A.

15. Press [STOP] and verify the volume delivered is 20 mL ± 1 mL.

5.2.16

NURSE CALL TEST

 Note: The nurse call test may be bypassed if the nurse call function is not used.

To perform the nurse call test, attach the nurse call test cable and proceed as follows:

1. Set the primary delivery rate to 400 mL/hr, and the primary dose limit to 1 mL.

2. Connect a DMM to the nurse call test cable.

3. Press [START] and verify pumping action.

4. After “DOSE END” and “KVO” appear on the display, observe a short circuit on the DMM (approximately 1 Ω on a scale of 0 to 100 Ω).

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5.3 PERIODIC MAINTENANCE INSPECTION

5.2.17

ELECTRICAL SAFETY TEST

To perform the electrical safety test, proceed as follows:

1. Connect the AC power cord to a safety analyzer.

2. Connect the safety analyzer ground lead to the ground test-point located on the rear of the infuser.

3. Check the leakage current with the safety analyzer. Leakage current (both open and closed ground) must not exceed 100 microamperes AC

4. Measure the resistance of the AC connector ground lug with the safety analyzer. Resistance should not exceed 0.1 Ω.

rms

5.2.18

END OF THE PVT

If all performance verification tests have been successful, proceed as follows:

1. Press [OPTIONS/VOL INF]. Select Volume Infused and press [CHOOSE].

2. Press [CLEAR] to clear the volume infused.

3. Press [ENTER].

4. Press the [A] softkey.

5. Press the [CLEAR PROGRAM] softkey.

6. Press [YES] at the “CLEAR LINE A SETTINGS?” prompt.

7. Press the [CANCEL/BACK] softkey to return to the delivery screen.

8. Press the [B] softkey.

9. Press the [CLEAR PROGRAM] softkey.

10. Press [YES] at the “CLEAR LINE B SETTINGS?” prompt.

11. Reset the infuser to the original configuration.

12. Turn off the infuser and return the device to service.

 Note: If any tests fail, see Section 6, or contact Hospira.

5.3

PERIODIC MAINTENANCE INSPECTION

Periodic maintenance inspections should be performed per hospital procedures for compliance to accreditation requirements. It is recommended that JCAHO and/or hospital protocol be followed for establishing a periodic maintenance inspection schedule. Product specifications for this inspection are listed in Section 8.

To perform the periodic maintenance inspection, complete the PVT in Section 5.2.

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SECTION 5 MAINTENANCE AND SERVICE TESTS

5.4

BATTERY OPERATION OVERVIEW

The infusion system is intended to operate on battery power on an exception basis only, such as emergency backup or temporary portable operation. Examples of emergency backup include AC power failure or inadvertent disconnection of the AC power cord. An instance of temporary portable operation includes patient transfer from one location to another.

The device should be connected to AC power whenever possible to allow the battery to remain fully charged. The line power indicator turns off when the infuser is operating on battery power. After five minutes of operation on battery power, the infuser switches its display backlight intensity to a low intensity mode.

Factors that most commonly affect battery life are the depth and frequency of discharge and the length of the recharge period. As a general rule, the more often the battery is discharged and recharged, the sooner it will need replacement. The primary cause of damage is leaving the battery in a less than fully charged state for any period of time. Battery damage can occur in a matter of hours and cause a permanent loss of battery capacity. The amount of lost capacity depends on the degree of discharge, the storage temperature, and the length of time the battery was stored in a discharged state.

 Note: A permanently damaged battery cannot be recharged to full capacity.

When the battery discharges below the acceptable level while the infuser is operating, the audio indicator is activated and the “WARNING: LOW BATTERY” message displays. Although it is not recommended to continue operating the infuser on battery power at this point, the battery continues providing power until it is depleted. When the battery is depleted, delivery stops, a continuous alarm tone sounds, and, after three minutes, the infuser automatically turns off.

CAUTION: As soon as the low battery alarm occurs, connect the infuser to AC power.

When the infuser detects that the battery has reduced capacity, it will register a Replace Battery condition. For the first two occurrences of a Replace Battery condition, the “WARNING: LOW BATTERY” message will appear and the audio indicator will activate. The message and audio indicator can be cleared only when the device is plugged in or turned off. For the third and subsequent occurrences, the “WARNING: REPLACE BATTERY” message will appear, and the audio indicator will activate and persist over power cycles. The message and audio indicator are cleared by replacing the battery, accessing the biomed settings screen, and pressing the [CHANGE BATTERY] softkey.

Recharging can occur any time the infuser is connected to AC power. It is recommended that the infuser be connected to AC power whenever practical to maximize available battery charge during transport or ambulation. The infuser does not have to be on for the battery to recharge.

 Note: The infuser should be operated on battery power for three continuous hours

at least once every six months for optimum battery performance and life.

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Infusion System

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Section 6

TROUBLESHOOTING

This section contains information on technical assistance, warning messages, alarm messages and error codes, and troubleshooting procedures for the Plum A+ infusion system.

6.1

TECHNICAL ASSISTANCE

For technical assistance, product return authorization, and to order parts, accessories, or manuals within the United States, contact Hospira Technical Support Operations.

1-800-241-4002

For additional technical assistance, technical training, and product information, visit the website at www.hospira.com.

Send all authorized, prepaid returns within the United States to the following address:

Hospira, Inc.

Technical Support Operations

755 Jarvis Drive

Morgan Hill, California 95037

For technical assistance, product return authorization, and to order parts, accessories, or manuals from outside the United States, contact the nearest Hospira sales office.

6.2

WARNING MESSAGES

Table 6-1 lists warning messages, possible causes, and corrective actions. These warning

messages are captured in the Error Log.

 Note: When the infuser detects that the battery has reduced capacity, it will register

a Replace Battery condition. For the first two occurrences of a Replace Battery condition, the “WARNING: LOW BATTERY” message will appear and the audio indicator will activate. The message and audio indicator can be cleared only when the device is plugged in or turned off. For the third and subsequent occurrences, the “WARNING: REPLACE BATTERY” message will appear, and the audio indicator will activate and persist over power cycles. The message and audio indicator are cleared by replacing the battery, accessing the biomed settings screen, and pressing the [CHANGE BATTERY] softkey.

 Note: If the device is not plugged in, and turned on with a previously depleted battery,

the infuser will display a “DEPLETED BATTERY” message for 16 seconds, then power off.

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SECTION 6 TROUBLESHOOTING

Message Possible Cause Corrective Action

Table 6-1. Warning Messages

Stop delivery, then turn off Attempting to turn off the

infuser while a delivery is in progress

Warning: Low Battery Battery is discharged so

that only approximately 30 minutes of battery life remains

Warning: Replace Battery Battery service needed

Battery voltage is less than the depleted threshold and the charge level is higher than the low charge threshold

Warning: Charger Service A hardware problem with

the battery charging circuit is detected

Charging circuitry is not behaving as expected

6.3

Stop all lines, then turn off the infuser

Plug into AC power

Replace the battery

Press [SILENCE]

ALARM MESSAGES AND ERROR CODES

Under most alarm conditions the infuser ceases normal operation, generates an audible alarm, and displays an alarm message or error code on the LCD screen.

There are two types of alarm conditions:

- alarm codes that can be cleared by the operator

- error codes that require qualified service personnel

6.3.1

OPERATIONAL ALARM MESSAGES

Table 6-2 lists infuser alarm codes that can be cleared by the operator. Also listed in Table 6-2 are the alarm messages, descriptions, possible causes, and corrective actions.

 Note: Operational alarm messages are displayed on the LCD screen. Associated error

codes are displayed in the alarms log (see Section 1.8.2).

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6.3 ALARM MESSAGES AND ERROR CODES

Table 6-2. Operational Alarm Messages and Corrective Actions

Alarm

Code

N100

(URC)

N101

(NAA)

N102

(RL)

N103

(SEEP

CRC)

N104

(NC2)

Alarm Description Possible Cause

Unrecognizable cassette

Incorrect cassette type

An incorrect cassette is inserted

No action No operator action

and no delivery for two minutes during

Interruption or a partial change to

a program delivery parameters entry

Infuser idle 2 minutes

NV RAM lost therapy data

Infuser in reset or idle for over two minutes

Programming set

without start for

two minutes

Therapy data is lost Infuser did not

complete the

non-volatile

memory write

successfully

Nurse callback B Delivery line B

has changed (if alarm is enabled)

End of delivery

step on line B

other than VTBI

complete while

callback is

enabled

Corrective

Action

Insert proper cassette

Complete programming of the infuser

Press [START]

Re-enter all programmed data

Press [SILENCE]

N105

(NC1)

N160

E160

(VTB2)

N161

E161

(VTB1)

N180

E180

(OD1)

N181

E181

(OD1)

Nurse callback A Delivery line A

has changed (if alarm is enabled)

Line B VTBI complete

Programmed volume to be infused completed on line B

Line A VTBI complete

Programmed volume to be infused completed on line A

Distal Occl Peak distal

occlusion, non-delivery

Distal Occl Negative distal

occlusion, non-delivery

End of delivery

step on line A

other than VTBI

complete while

callback is

enabled

VTBI is complete

on line B

VTBI is complete

on line A

Distal occlusion

detected during

non-delivery

Distal occlusion

detected during

non-delivery

Press [SILENCE]

Press [SILENCE] and replace IV bag, and restart line B

Press [SILENCE] and replace IV bag, and restart line A

Backprime the cassette and restart the infuser

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SECTION 6 TROUBLESHOOTING

Table 6-2. Operational Alarm Messages and Corrective Actions

Alarm

Code

N182

E182

(OP2)

N183

E183

(OP2)

N184

E184

(OP1)

Alarm Description Possible Cause

Prox. Occl B, Air or Prox. Occl B

Negative proximal occlusion B, non-delivery

Proximal occlusion detected on line B during non-delivery

Prox. Occl B, Air or Prox. Occl B

Peak proximal occlusion B, non-delivery

Proximal occlusion detected on line B during non-delivery

Prox. Occl A, Air or Prox. Occl A

Negative proximal occlusion A, non-delivery

Proximal occlusion detected on line A during non-delivery

Corrective

Action

Backprime the cassette and restart line B or Stop all lines, backprime the cassette, and restart all lines

Backprime the cassette and restart line A or Stop all lines, backprime the cassette, and restart all lines

N185

E185

(OP1)

N186

E186

(OD1)

N187

E187

(OD1)

N188

E188

(OP2)

Prox. Occl A, Air or Prox. Occl A

Peak proximal occlusion A, non-delivery

Distal Occl Peak distal

occlusion, delivery

Distal Occl Negative distal

occlusion, delivery

Prox. Occl B, Air Negative proximal

occlusion B, delivery

Proximal occlusion detected on line A during non-delivery

Distal occlusion detected during delivery

Proximal occlusion detected during delivery on line B

Backprime the cassette and restart line A or Stop all lines, backprime the cassette, and restart all lines

Fix occlusion, and restart the infuser

Fix occlusion, and restart line B or Stop all lines, fix occlusion, and restart the infuser

430-95150-007 (Rev. 01/06) 6 - 4 Plum A+

Infusion System

Page 85

6.3 ALARM MESSAGES AND ERROR CODES

Table 6-2. Operational Alarm Messages and Corrective Actions

Alarm

Code

N189

E189

(OP2)

N190

E190

(OP1)

N191

E191

(OP1)

Alarm Description Possible Cause

Prox. Occl B, Air Peak proximal

occlusion B, delivery

Proximal

occlusion

detected during

delivery on line B

Prox. Occl A, Air Negative proximal

occlusion A, delivery

Proximal

occlusion

detected during

delivery on line A

Prox. Occl A, Air Peak proximal

occlusion A, delivery

Proximal

occlusion

detected during

delivery on line A

Corrective

Action

Fix occlusion, and restart line B or Stop all lines, fix occlusion, and restart the infuser

Fix occlusion and restart line A or Stop all lines, fix occlusion, and restart the infuser

N230

E230

(APT)

N231

E231

(APB)

N232

E232

(APA)

Prox. Air Total Proximal

air-in-line total

Prox. Air on B, Backprime

Proximal air-in-line on line B

Prox. Air on A, Backprime

Proximal air-in-line on line A

500 µL of air

has entered

the cassette

500 µL of air

has entered

the cassette

on line B

500 µL of air

has entered

the cassette

on line A

Backprime the cassette and restart the infuser or Remove and manually reprime the cassette and restart the infuser

Backprime the cassette and restart line B or Remove and manually reprime the cassette and restart the infuser

Backprime the cassette and restart line A or Remove and manually reprime the cassette and restart the infuser

Technical Service Manual 6 - 5 430-95150-007 (Rev. 01/06)

Page 86

SECTION 6 TROUBLESHOOTING

Table 6-2. Operational Alarm Messages and Corrective Actions

Alarm

Code

N233

E233

(ADC)

N234

E234

(ADB)

N250

E250

(DCO1)

N251

E251

(CS1)

Alarm Description Possible Cause

Distal air cumulative

500 µL of air detected in the last 5.3 mL of fluid delivered

Distal air bolus Distal air bolus 100 µL bolus

of air detected at distal sensor

Door opened while pumping

Valve/cass test fail

Door opened while pumping

Valve/cassette test failure

Door opened while pumping

Valve/cassette fails the leak test

Corrective

Action

Remove and manually reprime the cassette and restart the infuser

Turn off the infuser or Insert the cassette and close the door

Replace cassette and retest or Backprime and retest

N252

E252

(BDP)

N253

E253

(LOV)

N254

E254

(FPL)

Depleted battery Low battery The battery

terminal voltage is less than 5.45 V

Lockout violation Hard lockout

violation

The use of the [STOP] key or an attempt to open the door while the lockout switch is locked

Lockout enabled Keypad locked Any action not

resulting in stopping of delivery while the lockout switch is locked

Connect the infuser to AC power or Recharge or replace the battery

Unlock the lockout switch

430-95150-007 (Rev. 01/06) 6 - 6 Plum A+

Infusion System

Page 87

6.3 ALARM MESSAGES AND ERROR CODES

Table 6-2. Operational Alarm Messages and Corrective Actions

Alarm

Code

N255

(SLV)

N256

(SLV)

Alarm Description Possible Cause

Lockout violation Soft lockout

violation

Lockout enabled Soft lockout

enabled

The use of the

[STOP] key or an

attempt to open

the door while the

lockout switch

is locked

Any action not

resulting in

stopping of

delivery while

the lockout

switch is locked

Corrective

Action

Unlock the software lockout switch

6.3.2

ERROR CODES REQUIRING TECHNICAL SERVICE

Table 6-3 lists infuser error codes that require technical service. Also listed in Table 6-3

are malfunction descriptions, possible causes, and corrective actions.

Table 6-3. Error Codes Requiring Technical Service

Error

Code Malfunction Possible Cause Corrective Action

E300 ADC failure Analog to digital

converter failure

E301 Audio alarm

failure

E302 Backlight failure Backlight (CCFT tube) is

Piezo is off but sensed on or Piezo is on but sensed off

not at the expected range

Replace CPU PWA

(see Section 7.2.12.4)

Reset time and date, if required

(see Section 1.8.3)

Turn power off, then on, to reset the infuser

Replace piezo alarm

(see Section 7.2.12.5)

Replace CPU PWA

(see Section 7.2.12.4)

Reset time and date, if required

(see Section 1.8.3)

Turn power off, then on, to reset the infuser

Replace display

(see Section 7.2.12.3)

Reset time and date, if required

(see Section 1.8.3)

Technical Service Manual 6 - 7 430-95150-007 (Rev. 01/06)

Page 88

SECTION 6 TROUBLESHOOTING

Table 6-3. Error Codes Requiring Technical Service

Error

Code

Malfunction Possible Cause Corrective Action

E320 Battery charge

current out of range

E321 Battery not

charging

E322 Battery current

calibration value out of range

E323 Battery trickle

charge current out of range

E324 Supply

overvoltage

E325 Battery

overvoltage

Battery charge current is out of range after 8 hours

Battery charging timed out Complete battery discharge

has occurred

Battery integrator calibration value is out of range

Battery trickle charge current is out of range

An overvoltage condition is detected in the charging circuit

An overvoltage condition is detected in the battery

Replace battery

(see Section 7.2.4)

Replace power supply PWA

(see Section 7.2.12.1)

Reset time and date, if required

(see Section 1.8.3)

Charge battery for additional 8 hours

Replace battery

(see Section 7.2.4)

Replace power supply PWA

(see Section 7.2.12.1)

Reset time and date, if required

(see Section 1.8.3)

E326 Battery

disconnected

E327 Brownout

condition

E340 Critical

instruction failure

E341 Critical data

memory failure

Battery disconnected while the infuser is on

Check for loose battery connections

Replace battery

(see Section 7.2.4)

Reset time and date, if required

(see Section 1.8.3)

Brownout condition detected Replace power supply PWA

(see Section 7.2.12.1)

Reset time and date, if required

(see Section 1.8.3)

Power-up CPU register test failed (no malfunction message displayed)

Replace CPU PWA

(see Section 7.2.12.4)

Reset time and date, if required

(see Section 1.8.3)

Critical data memory failure Replace mechanism

assembly

(see Section 7.2.12.6)

Reset time and date, if required

(see Section 1.8.3)

430-95150-007 (Rev. 01/06) 6 - 8 Plum A+

Infusion System

Page 89

6.3 ALARM MESSAGES AND ERROR CODES

Table 6-3. Error Codes Requiring Technical Service

Error

Code

Malfunction Possible Cause Corrective Action

E342 Display failure Defective display Replace display assembly

(see Section 7.2.12.3)

Reset time and date, if required

(see Section 1.8.3)

E343 Distal air sensor

failure 1

E344 Distal air sensor

failure 2

E345 Distal pressure

sensor failure 1

E346 Distal pressure

sensor failure 2

E347 Hardware

watchdog failure

E378 I/O valve

phase loss

With the cassette removed, the distal air sensor self test detects liquid

With the cassette inserted, the distal air sensor self test detects sensor out of range

Replace mechanism assembly

(see Section 7.2.12.6)

Reset time and date, if required

(see Section 1.8.3)

Distal pressure sensor failed while the infuser is off

Distal pressure sensor failed while the infuser is on

Hardware watchdog failure Replace CPU PWA

(see Section 7.2.12.4)

Reset time and date, if required

(see Section 1.8.3)

Generic I/O valve failure Turn power off, then on,

to reset the infuser Replace mechanism

assembly

(see Section 7.2.12.6)

Reset time and date, if required

(see Section 1.8.3)

E379 L/S valve

phase loss

E380 Plunger motor

phase loss

Generic L/S valve failure Turn power off, then on,

to reset the infuser

Generic plunger motor failure

Replace mechanism assembly

(see Section 7.2.12.6)

Reset time and date, if required

(see Section 1.8.3)

Technical Service Manual 6 - 9 430-95150-007 (Rev. 01/06)

Page 90

SECTION 6 TROUBLESHOOTING

Table 6-3. Error Codes Requiring Technical Service

Error

Code

Malfunction Possible Cause Corrective Action

E430 Proximal

air sensor failure 1

E431 Proximal

air sensor failure 2

E432 Proximal

pressure

Proximal air sensor ongoing test detects liquid with cassette removed

Proximal air sensor self test detects liquid with cassette removed

Proximal pressure sensor failed while the infuser is off

Replace mechanism assembly

(see Section 7.2.12.6)

Reset time and date, if required

(see Section 1.8.3)

sensor 1

E433 Proximal

pressure

Proximal pressure sensor failed while the infuser is on

sensor 2

E434 RAM failure RAM failure Turn power off, then on,

to reset the infuser Replace peripheral

assembly

(see Section 7.2.6)

Reset time and date, if required

(see Section 1.8.3)

E435 RTC failure Real-time clock failure Turn power off, then on,

to reset the infuser Replace CPU PWA

(see Section 7.2.12.4)

Reset time and date, if required

(see Section 1.8.3)

E436 ROM failure ROM checksum failure Turn power off, then on,

to reset the infuser Replace peripheral

assembly

(see Section 7.2.6)

Reset time and date, if required

(see Section 1.8.3)

E437 Software failure Generic software failure Turn power off, then on,

to reset the infuser

E438 Stack

out-of-range failure

Stack out-of-range failure

Replace CPU PWA

(see Section 7.2.12.4)

Reset time and date, if required

(see Section 1.8.3)

430-95150-007 (Rev. 01/06) 6 - 10 Plum A+

Infusion System

Page 91

Error

Code

6.3 ALARM MESSAGES AND ERROR CODES

Table 6-3. Error Codes Requiring Technical Service

Malfunction Possible Cause Corrective Action

E439 Stuck key A key is sensed as pressed

for over two minutes

E440 Power hold stuck Power hold signal stuck

Power cannot be turned off

Replace keypad

(see Section 7.2.12.2)

Reset time and date, if required

(see Section 1.8.3)

E443 LCD failure LCD bias is out of range Replace display assembly

(see Section 7.2.12.3)

Reset time and date, if required

(see Section 1.8.3)

E444 CPU timebase

inaccurate

CPU timer 2 and RTC measured times disagree

Turn power off, then on, to reset the infuser

Replace CPU PWA

(see Section 7.2.12.4)

Reset time and date, if required

(see Section 1.8.3)

E445 RTC memory

failure

Real-time clock memory is corrupt

Turn power off, then on, to reset the infuser

Reset time and date, if required

(see Section 1.8.3)

E446 CPU timer failure CPU timer 1 and timer 2

measured times disagree

E447 Battery ADC

reading failure

16 consecutive readings have been either all zero or the max value

E448 SEEP write

SEEP data write failed Replace mechanism

failure

E449 SEEP calibration

data corrupted

E450 MMIO port

Calibration data block corrupted

I/O port read/write failure Replace CPU PWA

read/write failure

Replace CPU PWA

(see Section 7.2.12.4)

Reset time and date, if required

(see Section 1.8.3)

assembly

(see Section 7.2.12.6)

Replace CPU PWA

(see Section 7.2.12.4)

Replace CPU/driver cable

(see Section 7.2.12.6)

Reset time and date, if required

(see Section 1.8.3)

(see Section 7.2.12.4)

Reset time and date, if required

(see Section 1.8.3)

Technical Service Manual 6 - 11 430-95150-007 (Rev. 01/06)

Page 92

SECTION 6 TROUBLESHOOTING

Table 6-3. Error Codes Requiring Technical Service

Error

Code

Malfunction Possible Cause Corrective Action

E451 Inaccurate

delivery

E452 Software failure Miscellaneous

E453 Two SEEP

CRC errors

E454 NVRAM over

capacity

E455 Invalid device

configuration

Over/under delivery detected Turn power off, then on,

software failures

NVRAM data block corrupted Replace mechanism

Software trying to write into non-existent NVRAM space

Incorrect flash memory on peripheral PWA

to reset the infuser Reset time and date,

if required

(see Section 1.8.3)

If error codes recur,

contact Hospira

assembly

(see Section 7.2.12.6)

Replace CPU PWA

(see Section 7.2.12.4)

Replace CPU/driver cable

(see Section 7.2.12.6)

Reset time and date, if required

(see Section 1.8.3)

Turn power off, then on, to reset the infuser

Replace peripheral assembly

(see Section 7.2.6)

E456 Invalid drug

library

E457 Drug library

corrupted

A drug library install was started but not completed successfully

CRC failure on drug library Reload the library

Attempt to reinstall the drug library

(see the system operating manual)

Replace peripheral assembly

(see Section 7.2.6)

(see the system operating manual)

 Note: The following error codes are not generated in the biomed service mode:

E320

E321

E322

E323

E324

E325

E326

E343

E345

E346

E371

E372

E373

E374

E375

E376

E377

E378

E379

E380

E430

E431

E432

E433

E441

E447

 Note: Some error codes include sub-ID codes. These sub-ID codes are intended for

Hospira internal use only, and should be included when contacting Hospira Technical

Support Operations (see Section 6.1).

430-95150-007 (Rev. 01/06) 6 - 12 Plum A+

Infusion System

Page 93

6.4 TROUBLESHOOTING PROCEDURES

6.4

TROUBLESHOOTING PROCEDURES

This section details recommended procedures for problems not associated with malfunction alarms. Before performing any troubleshooting procedure, turn the infuser off, then on.

Allow the self test to complete and proceed as follows:

1. If a malfunction exists, carefully inspect the infuser for damage as described in Section 5.2.2.

2. If an infuser inspection has not disclosed a malfunction, perform the PVT in Section 5.2. See Table 6-4 for section reference, probable cause, and corrective actions.

3. If, after completing step 1 and step 2, a malfunction has not been located, or if the infuser persistently fails, contact Hospira (see Section 6.1).

Table 6-4. Troubleshooting with the PVT

Test Failure Probable Cause Corrective Action

Self test

Section 5.2.4

Cassette alarm test

Section 5.2.5

Free flow test

Section 5.2.6

Display test

Section 5.2.7

Keypad verification/ functional test

Section 5.2.8

Cassette not properly installed

Defective CPU PWA Replace CPU PWA

Cassette not properly seated

Defective cassette Replace cassette

Cassette not properly seated

Defective cassette Replace cassette

Defective or dirty valve pins Clean valve pins

Defective display assembly Replace display assembly

Defective keypad Replace keypad

Reseat cassette

(see Section 7.2.12.4)

Reseat cassette

Replace mechanism assembly

(see Section 7.2.12.6)

(see Section 7.2.12.3)

(see Section 7.2.12.2)

Alarm loudness test

Section 5.2.9

Technical Service Manual 6 - 13 430-95150-007 (Rev. 01/06)

Defective CPU Replace CPU PWA

(see Section 7.2.12.4)

Defective peripheral PWA Replace peripheral assembly

(see Section 7.2.6)

Defective piezo alarm assembly

Replace piezo alarm assembly

(see Section 7.2.12.5)

Page 94

SECTION 6 TROUBLESHOOTING

Table 6-4. Troubleshooting with the PVT

Test Failure Probable Cause Corrective Action

Lockout switch test

Section 5.2.10

Proximal occlusion test

Section 5.2.11

Proximal air-in-line test

Section 5.2.12

Distal air-in-line test

Section 5.2.13

Defective peripheral PWA Replace peripheral assembly

(see Section 7.2.6)

Closed proximal clamp Open clamp

Cassette not

Re-prime cassette

properly primed

Defective cassette Replace cassette

Dirty sensor pin Clean sensor pin

Defective APP PWA Replace mechanism assembly

(see Section 7.2.12.6)

Defective special cassette Replace special cassette

Dirty sensors Clean sensors

Defective APP PWA Replace mechanism assembly

(see Section 7.2.12.6)

Defective special cassette Replace special cassette

Dirty sensors Clean sensors

Defective APP PWA Replace mechanism assembly

(see Section 7.2.12.6)

Distal occlusion test

Section 5.2.14

Delivery accuracy test

Section 5.2.15

Electrical safety test

Section 5.2.17

Cassette not

Re-prime cassette

properly primed

Defective cassette Replace cassette

Dirty sensor pin Clean sensor pin

Defective APP PWA Replace mechanism assembly

(see Section 7.2.12.6)

Set not properly primed Re-prime cassette

Damaged or faulty cassette Replace cassette

Defective mechanism assembly

Replace mechanism assembly

(see Section 7.2.12.6)

Defective AC power cord Replace AC power cord

(see Section 7.2.5)

430-95150-007 (Rev. 01/06) 6 - 14 Plum A+

Infusion System

Page 95

Section 7

REPLACEABLE PARTS AND REPAIRS

This section itemizes all parts and subassemblies of the infusion system that are repairable within the scope of this manual. In addition, this section details replacement procedures for all listed parts.

7.1

REPLACEABLE PARTS

Replaceable parts for the infuser are itemized in the spare parts price list and are identified in Figure 9-1. Table 9-2 identifies each part by an index number that correlates to Figure 9-1.

To request a copy of the current spare parts price list, contact Hospira Technical Support

Operations (see Section 6.1), or to view the catalog online, visit the website at:

www.hospiraparts.com

For convenient reference, insert a copy of the spare parts price list here.

Technical Service Manual 7 - 1 430-95150-007 (Rev. 01/06)

Page 96

SECTION 7 REPLACEABLE PARTS AND REPAIRS

This page intentionally left blank.

430-95150-007 (Rev. 01/06) 7 - 2 Plum A+

Infusion System

Page 97

7.2 REPLACEMENT PROCEDURES

7.2

REPLACEMENT PROCEDURES

This section contains safety and equipment precautions, required tools and materials, and step-by-step procedures for replacing parts in the infuser. Unless otherwise stated, always perform the PVT after a replacement procedure.

7.2.1

SAFETY AND EQUIPMENT PRECAUTIONS

Before opening the front enclosure of the infuser, take all necessary precautions for working on high-voltage equipment.

WARNING: POSSIBLE EXPLOSION HAZARD EXISTS IF THE INFUSER

WARNING: UNLESS OTHERWISE INDICATED, DISCONNECT THE INFUSER

CAUTION: Use proper ESD grounding techniques when handling components. Wear an antistatic wrist strap and use an ESD-protected workstation. Store PWAs in antistatic bags before placing them on any surface.

IS SERVICED IN THE PRESENCE OF FLAMMABLE ANESTHETICS.

FROM AC POWER BEFORE PERFORMING ADJUSTMENTS OR REPLACEMENT PROCEDURES.

7.2.2

REQUIRED TOOLS AND MATERIALS

The following tools and materials, or equivalents, are required for the replacement procedures in this section. In addition, the beginning of each procedure lists tools and materials recommended for that specific procedure.

- Set of flat blade screwdrivers

- Set of Phillips

- Set of standard and metric nutdrivers

screwdrivers

- Wide-head pliers

- Diagonal cutters

-X-acto

knife

- Metric 10 mm wrench

- Custom nutdriver (P/N 519-95056-001)

- Long needle nose pliers

Technical Service Manual 7 - 3 430-95150-007 (Rev. 01/06)

- Mild solvent

- Lint-free cloth

Page 98

SECTION 7 REPLACEABLE PARTS AND REPAIRS

7.2.3

RUBBER FOOT PAD REPLACEMENT

Recommended tools for this procedure are an X-acto knife, mild solvent, and lint-free cloth.

The replacement part for this procedure is:

Pad, Rubber Foot

To replace the rubber foot pad, see Figure 7-1, then proceed as follows:

1. Turn off the infuser, and disconnect the device from AC power.

2. Place the infuser on its side.

3. Using the X-acto knife, remove the rubber foot pad and scrape the enclosure recess to remove adhesive residue.

 Note: Each adhesive-backed rubber foot pad is bonded in its recess.

Do not damage the recess.

4. Using mild solvent and a lint-free cloth, clean any adhesive residue from the enclosure recess.

5. Remove the protective backing from the self-adhesive surface of the replacement foot pad and press the pad in place.

6. After approximately five minutes, verify the foot pad is secure.

Replacement of a rubber foot pad is routine maintenance and no verification procedure is normally required. However, if the infuser may have been damaged during a rubber foot pad replacement, perform the PVT in Section 5.2.

430-95150-007 (Rev. 01/06) 7 - 4 Plum A+

Infusion System

Page 99

BATTERY

DOOR COVER

7.2 REPLACEMENT PROCEDURES

FLEX TABS (REAR)

RUBBER FOOT PAD (5)

DOOR PIVOT

CAP

FLEX TABS

(FRONT)

HEX HEAD

SCREW

05K01026

Figure 7-1. Bottom View

Technical Service Manual 7 - 5 430-95150-007 (Rev. 01/06)

Page 100

SECTION 7 REPLACEABLE PARTS AND REPAIRS

7.2.4

BATTERY, BATTERY DOOR, AND DOOR PAD REPLACEMENT

Recommended tools for this procedure are a medium size flat blade screwdriver, mild solvent, and a lint-free cloth.

The replacement parts for this procedure are:

Assembly, Battery, with Wire Harness Door, Battery Pad, Door Gasket, Battery Screw, 6-32 x 3/8, Hex Head, Slotted, with Washer

To replace the battery, battery door, and door pad, see Figure 7-2, then proceed as follows:

1. Turn off the infuser, and disconnect the device from AC power.

2. Place the infuser on its side.

3. Using the flat blade screwdriver, remove the screw that attaches the battery door to the infuser, and remove the door.

4. Inspect the battery door, gasket, and door pad for damage. Replace the door, if required.

5. If the door pad is defective, remove it and clean the door with mild solvent. Dry the battery door thoroughly, and install the replacement pad onto the door.

6. Remove and inspect the gasket from the battery door. Remove the adhesive from the replacement gasket and install the gasket in the battery door.

 Note: The gasket may not be present on earlier versions of the Plum A+

7. Disconnect the battery harness from the charger circuit cable. Carefully pull the battery harness wires and connector outside the enclosure, and remove the battery.

8. Connect the replacement battery harness to the charger circuit cable, and insert the replacement battery into the enclosure.

 Note: The cable connectors are keyed so that cables cannot be connected

incorrectly.

 Note: Confirm the battery harness is not pinched between the battery and the

enclosure.

9. Replace the battery door using the screw that was removed in step 3.

10. Press [ON/OFF] with the infuser disconnected from AC power, and verify the front panel battery symbol illuminates.

11. Access the BIOMED SETTINGS screen and press [CHANGE BATTERY].

 Note: The [CHANGE BATTERY] softkey will not appear on earlier versions

of the Plum A+

Replacement of the battery, battery door, and door pad is routine maintenance and no verification procedure is normally required. However, if the infuser may have been damaged during these procedures, perform the PVT in Section 5.2.

430-95150-007 (Rev. 01/06) 7 - 6 Plum A+

Infusion System

Hospira EPS-95150-007 Console Operation & Maintenance Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

FIGURES

Tables

INTRODUCTION

SCOPE

CONVENTIONS

COMPONENT DESIGNATORS

ACRONYMS AND ABBREVIATIONS

USER QUALIFICATION

ARTIFACTS

INSTRUMENT INSTALLATION PROCEDURE

UNPACKING

INSPECTION

SELF TEST

BIOMED SETTINGS

IV PARAMETERS

COMMON IV PARAMETERS

DEFAULT UNITS/DRUG

MACRO IV PARAMETERS

ALARMS LOG

SETTING THE TIME AND DATE

WARRANTY

SYSTEM OPERATING MANUAL

THEORY OF OPERATION

GENERAL DESCRIPTION

ELECTRONIC SUBSYSTEM OVERVIEW

CPU SUBSYSTEM

SYSTEM MEMORY ADDRESS MAP

PROGRAMMABLE READ-ONLY MEMORY

STATIC RANDOM ACCESS MEMORY

CONTROL LOGIC

LCD CONTROLLER

LCD BACKLIGHT CONTROL

LCD CONTRAST CONTROL

REAL-TIME CLOCK

VOLTAGE MONITOR WATCHDOG TIMER

ANALOG-TO-DIGITAL CONVERTER

DIGITAL-TO-ANALOG CONVERTER

FRONT PANEL KEYPAD MATRIX

FRONT PANEL LED INDICATORS

KEYPAD LOCKOUT INTERFACE

NURSE CALL INTERFACE

AUDIBLE INDICATORS

BARCODE READER INTERFACE

DATAPORT INTERFACE

POWER SUPPLY INTERFACE

MECHANISM INTERFACE

POWER SUPPLY SUBSYSTEM

MAIN SWITCHING REGULATOR

Main Loop

Secondary Loop

Current Limit Loop

MAIN REGULATOR FAULT DETECTION

SYSTEM POWER

AUXILIARY SUPPLIES

POWER CONTROL

BATTERY VOLTAGE MEASUREMENT

BATTERY CHARGE/DISCHARGE CURRENT MEASUREMENT

BATTERY CHARGER

MECHANISM SUBSYSTEM

MOTORS/MOTOR DRIVE

Stepper Motors

Chopper Motor Drive

MOTOR POSITION SENSORS

V2_5 REFERENCE VOLTAGE

AIR SENSORS

Transmitter Circuitry

Receiver Circuitry

PRESSURE SENSORS

Bridge Excitation Supply

Amplifier and Low Pass Filter

PRESSURE SENSOR CALIBRATION

CASSETTE TYPE/PRESENCE SELECTION

SERIAL EEPROM

PRINTED WIRING ASSEMBLIES

POWER SUPPLY PWA