Abbott Gemstar Service Manual

Page 1
For use with the following list numbers:
13000, 13100, 13150
All codes
®
Technical Service Manual
430-600203-003, A (Rev. 05/2007)
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.
430-600203-003 (Rev. 07/05) GemStar
®
Page 3
Change History
Part Number Description of Change
430-600203-001 (Rev. 04/00)
430-600203-002 (Rev. 12/02)
430-600203-A02 (Rev. 08/03)
430-600203-003 (Rev. 06/05)
Original issue
Second issue
Change Page issue
Updated cover and copyright pages
Updated change history
Updated equipment needed for Operation Test in Section 5
Third issue
Incorporated Hospira name change and updated to current style
Updated cover, copyright, and back page
Updated Section 1 and Section 4
Updated to include EMC/IEC requirements
Added Appendix
Remove and Destroy Pages
cover
i to ii
5-19 to 5-20
Insert Change Pages
cover
i to ii
5-19 to 5-20
Technical Service Manual i 430-600203-003 (Rev. 07/05)
Page 4
CHANGE HISTORY
This page intentionally left blank.
430-600203-003 (Rev. 07/05) ii GemStar
®
Page 5

Contents

Section 1
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.1 SCOPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.2 CONVENTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.3 ACRONYMS AND ABBREVIATIONS . . . . . . . . . . . . . . . . . . . . 1-2
1.4 USER QUALIFICATION. . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.5 ARTIFACTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.6 ELECTROMAGNETIC COMPATIBILITY . . . . . . . . . . . . . . . . . . . 1-5
1.7 INSTRUMENT INSTALLATION PROCEDURE . . . . . . . . . . . . . . . . 1-5
1.7.1 UNPACKING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.7.2 INSPECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1.7.3 SELF TEST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1.8 OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
1.8.1 THERAPIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
1.8.2 CONFIGURATION DIFFERENCES . . . . . . . . . . . . . . . . . . . 1-7
1.8.3 SAFETY FEATURES . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1.8.4 POWER SOURCES . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1.8.5 OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Section 2
WARRANTY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Section 3
SYSTEM OPERATING MANUAL . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Section 4
THEORY OF OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.1 ELECTRO-MECHANICAL SYSTEMS . . . . . . . . . . . . . . . . . . . . . 4-1
4.1.1 CPU SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.1.1.1 CPU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.1.1.2 MEMORY . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
4.1.1.3 FPGA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
4.1.2 CPU SUPERVISORY FUNCTIONS . . . . . . . . . . . . . . . . . . . 4-4
4.1.2.1 SUPPLY MONITORING . . . . . . . . . . . . . . . . . . . . 4-4
4.1.2.2 POWER-ON RESET . . . . . . . . . . . . . . . . . . . . . . 4-5
4.1.2.3 MEMORY AND TIME RETENTION . . . . . . . . . . . . . . . 4-5
4.1.2.4 WATCHDOG FUNCTION . . . . . . . . . . . . . . . . . . . 4-5
4.1.2.5 CPU ERROR CHECKING/WATCHDOG CIRCUITRY . . . . . . . 4-5
4.1.2.6 WDT PIC/BEEPER PIC/BEEPER DRIVER. . . . . . . . . . . . . 4-6
4.1.3 DISPLAY MODULE/BACKLIGHT . . . . . . . . . . . . . . . . . . . 4-6
4.1.4 KEYPAD/LEDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
4.1.5 BOLUS SWITCHES . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
4.1.6 TIME-OF-DAY CLOCK . . . . . . . . . . . . . . . . . . . . . . . . 4-7
4.1.7 POWER INPUT SENSING/SELECTION CIRCUITRY . . . . . . . . . . . 4-8
4.1.8 INTERNAL POWER SUPPLIES. . . . . . . . . . . . . . . . . . . . 4-10
4.1.9 INFUSER ON/OFF CONTROL . . . . . . . . . . . . . . . . . . . . 4-10
4.1.9.1 POWER ON . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
4.1.9.2 POWER OFF. . . . . . . . . . . . . . . . . . . . . . . . . 4-12
4.1.10 MOTOR DRIVE CIRCUITS . . . . . . . . . . . . . . . . . . . . . 4-12
4.1.10.1 SPEED CONTROL . . . . . . . . . . . . . . . . . . . . . . 4-14
4.1.10.2 POWER CONSERVATION . . . . . . . . . . . . . . . . . . 4-15
Technical Service Manual iii 430-600203-003 (Rev. 07/05)
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CONTENTS
4.1.10.3 MOTOR . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
4.1.10.4 TACHOMETER . . . . . . . . . . . . . . . . . . . . . . . . 4-15
4.1.10.5 REDUNDANT MOTOR CONTROL. . . . . . . . . . . . . . . 4-15
4.1.11 MOTOR TACHOMETER POWER CONSERVATION . . . . . . . . . . 4-16
4.1.12 OUTPUT SHAFT ENCODER . . . . . . . . . . . . . . . . . . . . . 4-16
4.1.13 AIR-IN-LINE SENSING. . . . . . . . . . . . . . . . . . . . . . . . 4-17
4.1.14 PROXIMAL PRESSURE MEASUREMENT . . . . . . . . . . . . . . . 4-17
4.1.15 DISTAL PRESSURE MEASUREMENT . . . . . . . . . . . . . . . . . 4-18
4.1.16 RS-232 INTERFACE SYSTEM . . . . . . . . . . . . . . . . . . . . . 4-18
4.2 CASSETTE SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
4.2.1 BODY AND TOP . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
4.2.2 DIAPHRAGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
4.2.3 FLOW STOP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Section 5
MAINTENANCE AND SERVICE TESTS . . . . . . . . . . . . . . . . . . . . . . 5-1
5.1 ROUTINE MAINTENANCE. . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.1.1 CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.1.1.1 SANITIZING . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
5.1.1.2 CLEANING THE CASSETTE POCKET
AND TUBING CHANNEL . . . . . . . . . . . . . . . . . . . 5-3
5.1.2 INSPECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
5.1.2.1 MATERIALS REQUIRED . . . . . . . . . . . . . . . . . . . 5-4
5.1.2.2 LABEL INSPECTION . . . . . . . . . . . . . . . . . . . . . 5-4
5.1.2.3 LATCH MECHANISM INSPECTION . . . . . . . . . . . . . . 5-6
5.1.2.4 AIR SENSOR INSPECTION . . . . . . . . . . . . . . . . . . 5-7
5.1.2.5 PLUNGER AND PRESSURE SENSOR INSPECTION . . . . . . . 5-8
5.1.2.6 TOP CAP INSPECTION . . . . . . . . . . . . . . . . . . . . 5-9
5.1.2.7 BOTTOM CAP INSPECTION . . . . . . . . . . . . . . . . . 5-10
5.1.2.8 BEZEL, GRIP, AND KEYPAD INSPECTION . . . . . . . . . . . 5-11
5.1.2.9 BATTERY DOOR AND COMPARTMENT INSPECTION . . . . . 5-12
5.1.2.10 POWER-ON TEST. . . . . . . . . . . . . . . . . . . . . . . 5-15
5.1.2.11 RECHARGEABLE BATTERY PACK (OPTIONAL) . . . . . . . . 5-16
5.1.2.12 DOCKING STATION (OPTIONAL) . . . . . . . . . . . . . . 5-17
5.1.2.13 AC ADAPTOR (OPTIONAL) . . . . . . . . . . . . . . . . . . 5-19
5.1.2.14 REMOTE BOLUS CORD AND SWITCH (OPTIONAL) . . . . . . 5-20
5.2 OPERATION TEST. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
5.2.1 EQUIPMENT REQUIRED . . . . . . . . . . . . . . . . . . . . . . . 5-21
5.2.2 TEST SETUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
5.2.3 PERFORMING THE OPERATION TEST . . . . . . . . . . . . . . . . 5-21
5.2.3.1 POWER TEST. . . . . . . . . . . . . . . . . . . . . . . . . 5-22
5.2.3.2 KEYPAD TEST . . . . . . . . . . . . . . . . . . . . . . . . 5-22
5.2.3.3 DISPLAY TEST . . . . . . . . . . . . . . . . . . . . . . . . 5-22
5.2.3.4 LED TEST . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
5.2.3.5 VOLUME ACCURACY TEST. . . . . . . . . . . . . . . . . . 5-23
5.2.3.6 DISTAL OCCLUSION TEST . . . . . . . . . . . . . . . . . . 5-23
5.2.3.7 PROXIMAL OCCLUSION TEST . . . . . . . . . . . . . . . . 5-23
5.2.3.8 AIR-IN-LINE TEST . . . . . . . . . . . . . . . . . . . . . . 5-24
5.2.4 PRINTING THE TEST RESULTS. . . . . . . . . . . . . . . . . . . . 5-24
5.2.5 OPERATION TEST CHECKLIST. . . . . . . . . . . . . . . . . . . . 5-26
5.2.6 RESTORING THE INFUSER FOR USE . . . . . . . . . . . . . . . . . 5-27
5.3 PERIODIC MAINTENANCE INSPECTION. . . . . . . . . . . . . . . . . . 5-27
430-600203-003 (Rev. 07/05) iv GemStar
®
Page 7
FIGURES
Section 6
TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.1 TECHNICAL ASSISTANCE . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2 TROUBLESHOOTING REFERENCES. . . . . . . . . . . . . . . . . . . . . 6-1
6.2.1 TROUBLESHOOTING TOOLS . . . . . . . . . . . . . . . . . . . . . 6-2
6.2.2 ALERT/ALARM MESSAGE INDEX . . . . . . . . . . . . . . . . . . . 6-2
6.2.3 PRINTING DEVICE HISTORY . . . . . . . . . . . . . . . . . . . . . 6-4
6.3 SERVICE ALARM CODES . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
6.3.1 SERVICE ALARM CODES - QUICK REFERENCE . . . . . . . . . . . . 6-4
6.3.2 SERVICE ALARM CODES - DETAILS . . . . . . . . . . . . . . . . . 6-8
6.4 OPERATIONAL ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . 6-37
Section 7
REPLACEABLE PARTS AND REPAIRS . . . . . . . . . . . . . . . . . . . . . . . 7-1
Section 8
SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Section 9
DRAWINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1
Technical Service Manual v 430-600203-003 (Rev. 07/05)
Page 8

TABLES

Figures

Figure 1-1. Illustration of the Infuser . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Figure 4-1. GemStar Block Diagram . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Figure 4-2. Board Connector References. . . . . . . . . . . . . . . . . . . . . . . 4-3
Figure 4-3. Power Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Figure 4-4. Power On/Off Circuitry . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Figure 4-5. Motor Control Circuit. . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Figure 4-6. Detail of Motor Circuit . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Figure 5-1. Cassette Pocket and Tubing Channel . . . . . . . . . . . . . . . . . . . 5-3
Figure 5-2. Label Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Figure 5-3. Cassette Retention and Ejection . . . . . . . . . . . . . . . . . . . . . 5-6
Figure 5-4. Air Sensor Inspection. . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Figure 5-5. Plunger and Pressure Sensor Inspection . . . . . . . . . . . . . . . . . 5-8
Figure 5-6. Top Cap Inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Figure 5-7. Bottom Cap Inspection . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Figure 5-8. Bezel, Grip, and Keypad Inspection . . . . . . . . . . . . . . . . . . . 5-11
Figure 5-9. Battery Door Engagement . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Figure 5-10. Battery Door Inspection. . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Figure 5-11. Battery Compartment Inspection. . . . . . . . . . . . . . . . . . . . . 5-14
Figure 5-12. Power-On Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Figure 5-13. Rechargeable Battery Pack . . . . . . . . . . . . . . . . . . . . . . . 5-16
Figure 5-14. Docking Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Figure 5-15. AC Adaptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
Figure 5-16. Remote Bolus Cord and Switch . . . . . . . . . . . . . . . . . . . . . 5-20
Figure 5-17. Sample Test Result Printout . . . . . . . . . . . . . . . . . . . . . . . 5-25
Figure 7-1. GemStar Infuser Exploded View. . . . . . . . . . . . . . . . . . . . . 7-1
Figure 9-1. GemStar Boards . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Figure 9-2. GemStar Top Board . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Figure 9-3. GemStar Middle Board . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Figure 9-4. GemStar Bottom Board . . . . . . . . . . . . . . . . . . . . . . . . . 9-15
Tables
Table 1-1. Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Table 1-2. Configuration List Numbers. . . . . . . . . . . . . . . . . . . . . . . 1-7
Table 1-3. Safety Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Table 5-1. Cleaning Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Table 5-2. GemStar Operation Test Checklist . . . . . . . . . . . . . . . . . . . . 5-26
Table 6-1. Troubleshooting Tools . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Table 6-2. Alert/Alarm Message Index . . . . . . . . . . . . . . . . . . . . . . . 6-2
Table 6-3. Service Alarm Codes - Quick Reference. . . . . . . . . . . . . . . . . . 6-4
Table 6-4. Service Alarm Codes - Details . . . . . . . . . . . . . . . . . . . . . . 6-8
Table 6-5. Operational Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37
Table 9-1. Drawings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Table A-1. Guidance and Manufacturer’s Declaration - Electromagnetic Emissions . . . A-1 Table A-2. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity . . . A-2 Table A-3. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
for Life-Supporting Equipment and Systems . . . . . . . . . . . . . . . A-3
Table A-4. Recommended Separation Distances Between Portable and Mobile RF
Communications Equipment and the GemStar . . . . . . . . . . . . . . A-6
430-600203-003 (Rev. 07/05) vi GemStar
®
Page 9
Section 1

INTRODUCTION

The GemStar® is a single-channel infuser designed for use in home care and hospital settings.
The infuser kit contains the following components:
-GemStar
- Two AA disposable batteries
- System Operating Manual
®
infuser
Note: Some international configurations contain a table-top 220 V
with a separate power cord.
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 Repairs
Section 8 Specifications
Section 9 Drawings
Appendix
Index
Technical Service Bulletins
mains adaptor
AC
If a problem in device operation cannot be resolved using the information in this manual,
contact Hospira (see Section 6.1, Technical Assistance).
Specific instructions for operating the device are contained in the GemStar Operating Manual. Provision is made for the inclusion of the system operating manual in Section 3 of this manual.
®
System
Note: The terms “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.
Technical Service Manual 1 - 1 430-600203-003 (Rev. 07/05)
Page 10
SECTION 1 INTRODUCTION
1.2

CONVENTIONS

The conventions listed in Table 1-1 are used throughout this manual.
Table 1-1. Conventions
Convention Use Example
Italic Reference to a section, figure,
table, or publication
[ALL CAPS] Keys Press [YES/ENTER]
ALL CAPS Display messages The infuser displays
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, Technical Assistance)
to continue.
END OF INFUSION
techniques when handling components.
Note: A note highlights information that helps explain a concept or procedure.
1.3

ACRONYMS AND ABBREVIATIONS

This section contains the acronyms and abbreviations that appear in the text of this manual.
A Ampere
AC Alternating current
A/D Analog-to-digital
ADC Analog-to-digital converter
CPU Central processing unit
CRC Cyclic redundancy check
DC Direct current
430-600203-003 (Rev. 07/05) 1 - 2 GemStar
®
Page 11
1.3 ACRONYMS AND ABBREVIATIONS
DMM Digital multimeter
ECG Electrocardiogram
EEG Electroencephalogram
EEPROM Electrically erasable programmable read-only memory
EL Electroluminescent
EMC Electromagnetic compatibility
EMG Electromyogram
EMI Electromagnetic interference
ESD Electrostatic discharge
ETO Ethylene oxide
FET Field effect transistor
FPGA Field programmable gate array
hr hour
Hz Hertz
IC Integrated circuit
IO Input/output
IV Intravenous
kHz Kilohertz
LCD Liquid crystal display
LED Light emitting diode
mA Milliampere
mcg Microgram
mg Milligram
MHz Megahertz
mL Milliliter
ms Millisecond
mV Millivolt
PFI Power fail input
PIC Programmable integrated circuit
PWA Printed wiring assembly
PWM Pulse width modulator
RAM Random access memory
ROM Read-only memory
RPM Revolutions per minute
TPN Total parenteral nutrition
UART Universal asynchronous receiver/transmitter
Technical Service Manual 1 - 3 430-600203-003 (Rev. 07/05)
Page 12
SECTION 1 INTRODUCTION
V Volts
Volts alternating current
V
AC
V
Collector voltage supply
CC
V
Volts direct current
DC
V
VTBI Volume to be infused
Primary power source
PWR
V
Volts root mean squared
rms
µA Microampere
µs Microsecond
1.4

USER QUALIFICATION

The infuser is intended for use at the direction or under the supervision of licensed physicians or certified healthcare professionals who are trained in the use of the infuser and the administration of parenteral fluids or drugs. Training should emphasize preventing related IV complications, including appropriate precautions to prevent accidental infusion of air.
1.5

ARTIFACTS

Non-hazardous, low level electrical potentials are commonly observed when fluids are administered using infusion devices. These potentials are well within accepted safety standards, but may create artifacts on voltage-sensing equipment such as ECG, EMG, and EEG machines. These artifacts vary at a rate that is associated with the infusion rate. If the monitoring machine is not operating correctly or has loose or defective connections to its sensing electrodes, these artifacts may be accentuated so as to simulate actual physiological signals. To determine if the abnormality in the monitoring equipment is caused by the infuser instead of some other source in the environment, set the device so that it is temporarily not delivering fluid. Disappearance of the abnormality indicates that it was probably caused by the electronic noise generated by the infuser. Proper setup and maintenance of the monitoring equipment should eliminate the artifact. Refer to the appropriate monitoring system documentation for setup and maintenance instructions.
430-600203-003 (Rev. 07/05) 1 - 4 GemStar
®
Page 13
1.6 ELECTROMAGNETIC COMPATIBILITY
1.6

ELECTROMAGNETIC COMPATIBILITY

The GemStar® is compliant with IEC/EN 60601-1-2 (2001), and has been tested and found to comply with electromagnetic compatibility (EMC) limits for the Medical Device Directive 93/42/EEC (EN 55011 Class B and EN 60601-1-2:2001). These limits are designed to provide reasonable protection against harmful interference in a typical medical installation (see the system operating manual).
CAUTION: Portable and mobile RF communications equipment, such as cellular telephones, two-way radios, Bluetooth proximity to the infuser may affect or degrade performance of the device. Operation of the infuser under such conditions should be avoided.
There is a shared responsibility between manufacturers, customers, and users to assure that medical equipment and systems are designed and operated as intended. Medical electrical equipment requires special precautions regarding electromagnetic compatibility.
The electromagnetic environment should be managed to permit the infuser to perform as intended without disturbing other equipment. The infuser should not be used adjacent to or stacked with other equipment. If the device must be used adjacent to or stacked with other equipment, monitor the equipment to assure there is no electromagnetic interference, and verify normal infuser operation.
®
devices, and microwave ovens in close
1.7

INSTRUMENT INSTALLATION PROCEDURE

CAUTION: Infuser damage may occur unless proper care is exercised during unpacking and installation.
CAUTION: Do not place the infuser in service if it fails the self test.
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 infuser. Retain the packing slip and save all packing material in the event it is necessary to return the infuser to the factory. Verify the shipping container contains a copy of the system operating manual.
Technical Service Manual 1 - 5 430-600203-003 (Rev. 07/05)
Page 14
SECTION 1 INTRODUCTION
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, Technical Assistance).
Inspect the infuser periodically for signs of defects. Also inspect the infuser after repair or during cleaning. Replace any damaged or defective external parts.
1.7.3

SELF TEST

CAUTION: Do not place the infuser in service if the self test fails.
At power-on, the infuser immediately enters an initialization mode and performs the following self tests:
-RAM test
- ROM checksum calculation
- Motor control test
- Stuck key test
- PIC watchdog test
- CONFIG register test
- Battery voltage test
- Power loss completion test
- CRC verifications on all RAM areas protected by CRCs
- CRC on calibration data stored in the EEPROM
- Calibration data verification
The initialization mode completes in approximately 30 seconds. During this time the infuser displays a message that the self tests are being performed. If any test fails, the infuser alarms.
Note: The device does not infuse during the initialization mode.
After successful completion of the initialization mode, if there is not a current program in the infuser, the device enters programming mode so the user can enter a new program.
If a program is already in the infuser, the user may:
- Use the current program. The infuser enters stop mode after the program is reviewed.
- Enter a new program. The infuser enters programming mode, then enters stop mode after the program is reviewed.
Note: If the infuser has been powered-off for less than five minutes, a program
review is not required.
See Figure 1-1 for an illustration of the infuser.
430-600203-003 (Rev. 07/05) 1 - 6 GemStar
®
Page 15
1.8 OVERVIEW
1.8

OVERVIEW

The following sections describe therapy options, differences between therapies, safety features, power sources, and basic operation of the infuser.
1.8.1

THERAPIES

The GemStar® offers the following seven types of therapy:
- Pain Management
- Total Parenteral Nutrition (TPN)
- Intermittent
-Weight Dosed
-Continuous
- mL/hr Only
-Variable Time
Note: The availability of these programs may vary, depending upon the configuration
of the infuser in use.
1.8.2

CONFIGURATION DIFFERENCES

The infuser is shipped from the factory with one of the configurations described in Table 1-2. The infuser configuration is easily identified by the end cap color.
Table 1-2. Configuration List Numbers
Therapies 13000 (Blue) 13100 (Gray) 13150 (Yellow)
Pain Management
TPN
Intermittent
Weight Dosed
Continuous





mL/hr Only
Variable Time
Technical Service Manual 1 - 7 430-600203-003 (Rev. 07/05)


Page 16
SECTION 1 INTRODUCTION
1.8.3

SAFETY FEATURES

Table 1-3 describes the special safety features of the GemStar®.
Table 1-3. Safety Features
Safety Feature Description
Proximal occlusion detection Strain gauge
Distal occlusion detection Strain gauge
Settings: low, medium, and high sensitivity
Air-in-line detection Ultrasonic settings: 0.5 mL, 2 mL, and Off
Motor monitoring circuit Redundant and independent monitoring
systems
Motor parameter monitoring Motor encoder and camshaft flag monitored
by optical sensor
Self tests Initialization and self test at power-on
Continuous self tests during operation
1.8.4

POWER SOURCES

The infuser can be powered by two internal AA disposable batteries, an external rechargeable battery pack, AC mains adaptor, or docking station. External supply voltage must not exceed 3.3 V
Install two fresh, disposable AA batteries for backup power when using an external power source. The infuser will continue to operate on backup power if the external power source fails.
CAUTION: To assure proper operation when using internal batteries, always replace both batteries with fresh, disposable AA batteries when a change is required. Use of rechargeable batteries in the battery compartment is not recommended.
CAUTION: Always connect to a grounded AC outlet when using the AC adaptor. Use only an AC adaptor specifically labeled for use with the GemStar battery pack. During charging, if the battery pack becomes hot to the touch, immediately disconnect from AC power and contact Hospira Technical Support Operations.
CAUTION: Do not touch exposed connectors on the bottom of the infuser. Exposed connectors are susceptible to electrostatic discharge (ESD) damage.
DC
.
®
to charge the
430-600203-003 (Rev. 07/05) 1 - 8 GemStar
®
Page 17
1.8 OVERVIEW
1.8.5

OPERATION

The infuser is microprocessor-based and is programmed using a 23-key keypad on the front of the device (see Figure 1-1). The 16-character-by-4-line backlight display indicates the status of the infuser.
The infuser has up to seven therapies available, depending on its configuration. Delivery rates and bolus dosage amounts are programmed in one of three units of measure: milliliters (mL), milligrams (mg), or micrograms (mcg). A loading dose is programmable for immediate delivery or delayed delivery. Bolus doses can be programmed to begin delivery on-demand.
To program the infuser, the operator selects the following:
- Therapy type
- Delivery type: volume delivery (mL) or mass delivery (mg or mcg)
- Concentration (only if mass delivery is selected)
- Delivery rate
- Loading dose, if desired
- Bolus dose, if desired
- Total amount to be delivered: volume to be infused (VTBI)
If mass delivery is selected, the infuser automatically converts mg or mcg to the closest number of tenths-of-mL. The amount of fluid delivered is shown on the display. When a bolus is programmed, a minimum lockout time between boluses must also be programmed. In addition to the lockout time, the operator can also program the maximum total volume that can be delivered in a selected period.
The infuser contains a time-of-day clock and event history storage capability. The program settings, significant events that take place while a protocol is running, and the associated time and date, can be reviewed on the display. The event history can be printed to a compatible printer or downloaded as an ASCII text file to a computer with the use of the GemStar
For specific instructions regarding infuser operation and optional system components, refer to the system operating manual.
®
serial printer cable.
Technical Service Manual 1 - 9 430-600203-003 (Rev. 07/05)
Page 18
SECTION 1 INTRODUCTION
BOLUS (BUTTON)
TOP CAP
GRIP
KEYPAD
SILENCE
1
4 7
PURGE
TOP VIEW
START
STOP
2 5
3
6 89 0
NOHELP
POWER
ON/OFF
BACK-UP
CHANGE
OPTIONS
YES
ENTER
CASSETTE EJECT
BUTTON
TOP CAP
BEZEL DISPLAY WINDOW
BEZEL ASSEMBLY
BOTTOM CAP
FRONT VIEW
BATTERY DOOR RECESS
BATTERY DOOR VOID LABEL
BATTERY DOOR
BATTERY PACK CONNECTOR
3 VDC BOLUS
BOTTOM VIEW
AC POWER CONNECTOR
DATAPORT CONNECTOR
BOLUS CONNECTOR
CONNECTOR LABEL
BOTTOM CAP
04K02001
Figure 1-1. Illustration of the Infuser
430-600203-003 (Rev. 07/05) 1 - 10 GemStar
®
Page 19
Section 2

WARRANTY

Subject to the terms and conditions herein, Hospira, Inc., herein referred to as Hospira, warrants that 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. 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.
Technical Service Manual 2 - 1 430-600203-003 (Rev. 07/05)
Page 20
SECTION 2 WARRANTY
This page intentionally left blank.
430-600203-003 (Rev. 07/05) 2 - 2 GemStar
®
Page 21
Section 3

SYSTEM OPERATING MANUAL

A copy of the system operating manual is included with every GemStar® infuser. Insert a copy here for convenient reference. If a copy of the system operating manual is not available, contact Hospira (see Section 6.1, Technical Assistance).
Technical Service Manual 3 - 1 430-600203-003 (Rev. 07/05)
Page 22
SECTION 3 SYSTEM OPERATING MANUAL
This page intentionally left blank.
430-600203-003 (Rev. 07/05) 3 - 2 GemStar
®
Page 23
Section 4

THEORY OF OPERATION

This section describes the theory of operation for the GemStar®. The theory of operation details the electro-mechanical and cassette systems. Related drawings are provided in Section 9.
4.1

ELECTRO-MECHANICAL SYSTEMS

The following sections describe the functions and electronic circuitry of the infuser.
4.1.1

CPU SYSTEM

The central processing unit (CPU) system consists of the following components:
CPU: controls infuser operation
Memory
- RAM: stores temporary therapy program data; stores ROM program during software updates
- ROM: stores the operating program
Field programmable gate array (FPGA): provides auxiliary logic functions to operate
the infuser
®
See Figure 4-1, GemStar
4.1.1.1
Block Diagram, and Figure 4-2, Board Connector References.
CPU
The CPU (U2) is a Motorola MC68L11K1 8-bit processor powered by 3.3 VDC. It operates at 2 MHz using a self-contained buffer and crystal Y1. The clock is divided by four to provide a 500 kHz bus clock (E-clock). Capacitors C9 and C11 provide the proper loading of the crystal.
The CPU provides the following:
- Separate data, address, and extended address lines
- On-chip 8-channel, 8-bit analog-to-digital converter
- On-chip EEPROM for non-volatile configuration status
- Serial UART port
- Serial peripheral port
- 4-channel, 8-bit pulse-width modulated output
- Non-maskable and maskable interrupt inputs
Technical Service Manual 4 - 1 430-600203-003 (Rev. 07/05)
- General purpose input and output lines (I/O)
Page 24
SECTION 4 THEORY OF OPERATION
Audio
Driver
Backup Power
U7
ROM
512K x 8
(29BV040)
FLASH MEM
D
XA
CS
A
R/W
U8
32K x 8
D
CS
SRAM
A
LED
LED
(Red)
Alarm
Power
(Yellow)
Bolus Jack
Interface
U9
FPGA
A
D
CS / IRQCS/IRQ
R/WR/W
Keypad
LED Drive
/Shaft IRQ
Encoder Signal
Digital Port I/O
CS
E-CLK
Bolus Switch
/TOD IRQ
/RST/RST
U10
DRIVER
BACKLIGHT
CS
IRQ
/TOD
CLOCK
D
CS
A
EL Backlight
CS
DISPLAY
D
E-CLK
A0
/RST
R/W
Backup Power
U3
XA
TIME-OF-DAY
Y2
Address Bus
Data Bus
XA(13..18) Bus Ext Addr
Digital Ports
Y201
U105
U201
+5V
+5V
DC-DC
PIC
BEEPER
Power Select
12C508
WD Fault
U202
WDT PIC
+3.3V
U108
Switch
12C508
WDTri
-5V
-5V
DC-DC
To motor drive
Y1
/RST
SUPERVISOR
+3.3V
VPWR
Backup Power
WDTri
g
Backup Battery
RAMCS
/XIRQ
RAMCS1
U1
MICRO-P
g
+5V
VPWR
+3.3V
PWM3
/XIRQ
RAMCS1
Ext-Addr
CS Flash
g
WDTri
U2
68L11K1
SDI
Microcontroller
E-CLK
A/D Input
A/D Input Ports
Digital Ports
U109
+3.3V
DC-DC
BT201
Battery
Lithium
Air
Ultrasonic
Piezo
Air Transmit
Circuit
U101, U102,
U103, U104
AA
Internal
Batteries
Power Sensing
Proximal
Pressure
Pressure
Proximal
Circuit
Sensor
Distal
Circuit
Pressure
MOTOR DRIVE
Motor
Addr
Digital I/O
and
CIRCUIT
Data
PW1
D/C-D/C
CONVERTER
WD Fault
Motor
/Shaft IRQ
SCI
Encoder
Motor Encoder Signals
Output Shaft Encoder Signals
RS232
INTERFACE
LT1331
Connector
Distal
Ext
Power
Signal
Ext_Pwr
Sensor
Pressure
Piezo
Air Receive
Drive
Mechanics
Output
Shaft
Encoder
Serial Data
Figure 4-1. GemStar® Block Diagram
430-600203-003 (Rev. 07/05) 4 - 2 GemStar
04K02010
®
Page 25
000
TOP BOARD
CPU, MEMORY, RTC, SERIAL PORT
4.1 ELECTRO-MECHANICAL SYSTEMS
J1
DISPLAY
CHASSIS GROUND
CONTACT
BATTERY SPRING
BATTERY CONTACT
MOTOR
J101
J104
J108
J106
J2
J102
J105
J3
J103
100
MIDDLE BOARD
MOTOR CONTROL,
POWER CONVERSION
J4
J110
J109
J107
PUMP BOTTOM
EXTERNAL CONNECTOR
KEYPAD
AIR
RECEIVER
AIR
TRANSMITTER
J203
J204
J205
200
BOTTOM BOARD
J207
J206
AUDIBLE BEEPER
PRESSURE SENSOR, AIR SENSOR
PROXIMAL
PRESSURE
DISTAL
PRESSURE
J201
J202
04K02002
Figure 4-2. Board Connector References
Technical Service Manual 4 - 3 430-600203-003 (Rev. 07/05)
Page 26
SECTION 4 THEORY OF OPERATION
4.1.1.2
MEMORY
The operating program is stored in a 512K x 8 flash ROM (U7) that can be reprogrammed with software updates.
Note: The program cannot be modified without special tools and protocols.
A 32K x 8 low-power static RAM (U8) is used to store the following data:
- Specific patient delivery protocols
-User options
- History records
- Operating program during Flash ROM programming
When the infuser is powered off, an on-board lithium battery provides power to the RAM chip.
4.1.1.3
FPGA
The FPGA (U9) is a specially programmed IC that incorporates auxiliary logic for the infuser. The FPGA provides the following:
-Input/output mapping
- Keypad interface
- Buffering and control of interrupt signals
- Additional logic interfaces for the infuser
- Motor encoder logic
The FPGA interfaces to the CPU through the address and data bus.
4.1.2

CPU SUPERVISORY FUNCTIONS

A MAX793R supervisory IC (U1) provides a secondary check for proper CPU functioning and monitors the following:
- Primary power source (V
- 3.3 volt power supply (V
- Battery backup switch over
- Power-on and brownout reset
4.1.2.1
SUPPLY MONITORING
PWR
CC
)
)
Whenever the 3.3 V power supply (VCC) drops below a safe system operating voltage of 2.6 V watchdog circuitry to sound an alarm. U1 also monitors the primary power (V provides early detection of loss of primary power to the infuser. If V power fail input (PFI) voltage of approximately 1.3 V be expected. When this happens, U1 interrupts program execution with a non-maskable interrupt via signal /PFO. This interrupt signals the microprocessor to execute a power-down routine that gracefully stops the motor, saves current data, and powers off the infuser.
430-600203-003 (Rev. 07/05) 4 - 4 GemStar
, U1 generates a system reset (/RST) that stops the computer and forces the
DC
drops below the
, imminent loss of 3.3 VCC power can
DC
PWR
PWR
) and
®
Page 27
4.1 ELECTRO-MECHANICAL SYSTEMS
4.1.2.2
POWER-ON RESET
During power-on or other reset conditions, the supervisory circuit holds the system in reset for 140 ms after V starting normal operation. During reset conditions, the reset signal interfaces with all circuitry to assure conditions are held in a safe operational state (e.g., motor stopped).
4.1.2.3
reaches 2.6 VDC to assure the system has stable power prior to
CC
MEMORY AND TIME RETENTION
Whenever all power sources are disconnected from the infuser, an internal 3.0 V lithium battery (BT201) provides power to retain memory and real-time clock operation. The lithium battery provides approximately three years of backup power from the time of infuser assembly. U1 monitors power, and whenever the supervisory circuit detects that the logic power is low (approximately 2.6 V appropriate circuits. A series 100 Ω resistor (R227) is used to measure the lithium current during off conditions. Voltage across R227 is normally less than 0.6 V
4.1.2.4
), it switches the lithium battery power to the
DC
(6 µA).
DC
WATCHDOG FUNCTION
U1 has a built-in secondary watchdog detection circuit (WDT) that provides a secondary check for proper CPU operation. The primary watchdog circuit is implemented using two programmable integrated circuit (PIC) microcontrollers on the bottom board
(see Section 4.1.2.6, WDT PIC/Beeper PIC/Beeper Driver).
During normal operation, the CPU provides a one-second timing signal (WDTRIG) to the supervisory circuit indicating proper operation. If the WDTRIG signal is greater than approximately 1.6 seconds, the supervisory circuit will generate a system reset and stop all infuser operations.
Each of the following signals are driven low during system reset:
- Motor on (MOTORON)
- Motor drive enable (MOTDRVEN)
- Motor speed control (MOTSPCTL)
4.1.2.5
CPU ERROR CHECKING/WATCHDOG CIRCUITRY
The CPU is the primary error detection and checking component. When error conditions exist, the CPU generates an alarm, warning, or other action appropriate to the conditions. For example, it stops delivery when out-of-tolerance conditions are sensed.
The watchdog (U202) PIC has been designed to monitor the CPU for error-free operation. The CPU toggles the logic state of the watchdog trigger (WDTRIG). If the CPU becomes unstable, this signal will either not be generated or will have incorrect timing. The PIC processors monitor the WDTRIG signal for the correct timing. Whenever this signal is out of tolerance (1 sec ± 25%), U202 stops the motor (using the WDFLT signal) and sounds an alarm independent of the CPU.
Technical Service Manual 4 - 5 430-600203-003 (Rev. 07/05)
Page 28
SECTION 4 THEORY OF OPERATION
4.1.2.6
WDT PIC/BEEPER PIC/BEEPER DRIVER
The watchdog WDT PIC (U202) is clocked from an external 32 kHz oscillator and crystal Y201 independent of the CPU clock. It monitors the WDTRIG signal for correct timing (change of state once a second). If either clock is in error or if the WDTRIG from the CPU is incorrect, the watchdog fault signal (WDFLT) goes low. This causes the beeper PIC (U201) to generate an audible alarm and the motor servo switching current source (U102) to stop the motor. When the infuser is turned off during normal power-down, the power-on (POWERON) signal from the CPU inhibits a WDTRIG fault while the power supply supercap discharges.
The beeper PIC (U201) can sound the beeper from the following two independent sources:
- Watchdog fault (WDFLT) signal from the WDT PIC (U202)
- Beeper control signal (BEEPCTL) from the CPU (U2)
When there is a watchdog fault, the WDFLT signal is activated and has the highest priority. When this happens, the motor turns off and the infuser stops. This causes the beeper PIC to produce an audible tone every five seconds.
The beeper PIC uses an internal 4 MHz oscillator and generates a predefined frequency and duty cycle for WDFLT faults. The CPU sends the BEEPCTL signal to generate audio output, such as audible operator alarms or keypad feedback. The beeper PIC passes the BEEPCTL signal frequency and duty cycle to the beeper. This allows different tones, duration, and volumes.
If the 3.3 V CPUs are reset. R201, R202, R203, D204, and Q203 (brownout detector) provide a reset-generator, which nominally trips at 2.1 V
When power losses occur, such as an accidental disconnection of the AC adapter with no battery backup, two .047 F capacitors (supercaps) maintain the 3.3 V supply for approximately 10 seconds. This allows the CPU to execute an orderly shutdown, and provides enough power to the watchdog circuit to sound an audible alarm every five seconds after power loss (at least three audible beeps).
supply drops below the minimum PIC operating level of 2.5 VDC, the PIC
CC
.
DC
4.1.3

DISPLAY MODULE/BACKLIGHT

The display module is a 64-by-128 dot matrix LCD array with control and memory circuitry. The CPU and FPGA generate the display control signals. Since the display consumes only 1 mA, it is powered from a logic gate (U4A) that goes low when powered off. This allows the display to clear within seconds after power-off.
Note: Display contrast can be factory adjusted.
An electroluminescent (EL) backlight illuminates the display. The CPU turns on the backlight drive circuit (U10) when a key is pressed or when AC mains power is applied.
430-600203-003 (Rev. 07/05) 4 - 6 GemStar
®
Page 29
4.1 ELECTRO-MECHANICAL SYSTEMS
4.1.4

KEYPAD/LEDS

A 23-key keypad receives operator input. One of these keys is used for power on/off
(see Section 4.1.9, Infuser On/Off Control). Each of the other keys is at a distinct junction
of an array of four columns and six rows, strobed by the FPGA approximately every 30 milliseconds. Pressing a key connects a row to a column. As the FPGA energizes each row, the columns are monitored and the FPGA determines which key has been pressed. A software routine eliminates noise (debounce) when the keys are pressed.
Two signal LEDs are mounted on the keypad and driven under software control, via FPGA outputs. The yellow LED illuminates when AC mains power is connected to the infuser. The red LED illuminates during an alarm condition, and is accompanied by an audible alarm and a display message, when applicable.
4.1.5

BOLUS SWITCHES

Patients can request a bolus dose for pain management and variable time protocols. The bolus switch (SW101) is located on the top of the infuser and is protected by a rubber end cap. The bolus switch signal (logic low) is buffered, inverted (U4C), and passed to the FPGA (U9-11) as the bolus request (BOLUSREQ) signal. The bolus request is latched by the FPGA and passed to the CPU as an interrupt.
An external (remote) bolus pendant can be connected to the bolus connector on the bottom of the infuser. The remote bolus pendant is wired in parallel with SW101. There is no distinction between the infuser bolus switch and the remote bolus switch. The buffering provided for the bolus request signal (U4C) allows for electrostatic discharge (ESD) rejection.
4.1.6

TIME-OF-DAY CLOCK

The infuser has a separate time-of-day clock (U3). The time is displayed at power-on and can be reset by the operator. This clock is used to provide the following:
- Schedule deliveries
- Record infuser history and event timing
- Generate a precise one-second CPU interrupt for timing functions
The internal lithium battery (BT201) powers the clock when no other power source is present.
Technical Service Manual 4 - 7 430-600203-003 (Rev. 07/05)
Page 30
SECTION 4 THEORY OF OPERATION
4.1.7

POWER INPUT SENSING/SELECTION CIRCUITRY

The infuser can be powered by two internal disposable AA batteries, or an external power source connected to the 3.3 V connector on the bottom of the infuser (see Figure 4-3,
Power Input). Power is applied to the internal voltage-power (V
or disconnected when the infuser is powered on or off (see Section 4.1.9).
) line, which is connected
PWR
Battery power connects to V
through a fuse (F101) and a field effect transistor (FET)
PWR
switch (Q110 A and B) controlled by comparator U110. The FET switch has an intrinsic forward diode, which allows sufficient battery current for the infuser to power-on when only batteries are present.
External power (EXTPWR) connects to V
through an isolation diode D106. Comparator
PWR
U110 senses the external voltage and automatically switches to external power when the external voltage (EXTPWR) is greater than approximately 1.8 V. When this happens, transistors Q106 and Q104 turn off the FET switch (Q110 A and B) to disconnect the internal batteries. The MAX965 (U110) has its own internal reference voltage at U110-6 of 1.235 V, which it uses to measure the switching point.
The external supply source may be from a DC supply connected to AC mains power or from an external battery. If the source is derived from AC mains power, a separate signal line is pulled high (to 3 volts). On external battery power, the signal line is low. The CPU monitors this signal line through the multiplexer (U106-4) and the A/D converter. The CPU uses this information when monitoring the external voltage to display appropriate messages (e.g., ON BATTERIES; LOW BATTERIES) or to turn on the power LED. The CPU monitors power source voltages. The internal (battery) and external voltages are connected to the CPU A/D input port through the multiplexer, MUX U106 (U106-13 and U106-15).
430-600203-003 (Rev. 07/05) 4 - 8 GemStar
®
Page 31
EXT PWR IN
ALK
F101
4.1 ELECTRO-MECHANICAL SYSTEMS
D106
VPWR
Q110A Q110B
Vcc
EXT PWR IN
ALK
3.3V
100K
R152
Vcc
47.5K Q106
R115 100K
U110
VREF (1.2V)
INPUT SOURCE POWER SWITCHING
R156
499K
R155
4.99K
R157
4.99K
SOURCES FOR SUPPLYING Vcc TO U110
Figure 4-3. Power Input
Q104
499K
47.5K
-5V
D108B
VPWR
D107B
D108A
02K02009
Technical Service Manual 4 - 9 430-600203-003 (Rev. 07/05)
Page 32
SECTION 4 THEORY OF OPERATION
4.1.8

INTERNAL POWER SUPPLIES

The input power at V
is converted to three operating voltages: +3.3 V, +5 V, and –5 V.
PWR
The 3.3 V supply is U109, a ML4875-3 outputting 3.3 V on pin 5. This switch-mode regulator has internal FETs that ground inductor L103 and direct flyback current to the output capacitor (C140). The value of coil L103 is chosen to optimize input power to achieve
3.3 V
output power during high loads, such as high motor torque, sensors on,
CC
or backlight activated.
The +5 V supply is U105, a ML4875-5. This circuit is similar to the 3.3 V regulator, except for the output voltage. Both regulators have a tolerance of ± 3%.
The –5 V supply is U108, a MAX828 switched capacitor, +5 V to –5 V supply for high efficiency at low currents. The –5 V is required at various points to allow FETs to turn on with minimum resistance, which results in high efficiency and maximum battery life. A separate –5 V supply is used in the motor drive servo amplifier circuitry. U101, a second MAX828, provides –5 V to U103 A and B, and Q101.
The display backlight is an electroluminescent (EL) lamp that requires a symmetric,
®
low-frequency alternating voltage. This voltage is generated by U10, a Durel
D353 lamp
driver IC. This IC uses inductor L1 in switch mode inverter circuit to drive the EL lamp.
4.1.9

INFUSER ON/OFF CONTROL

Electronic hardware and software, in conjunction with a dedicated ON/OFF button on the keypad, power the infuser on and off (see Figure 4-4, Power On/Off Circuitry). Flip-flop U107A, and the 3.3 V and 5 V supplies (U109 and U105), form the core of the electronic hardware. Pressing the keypad ON/OFF button grounds the on/off signal going to the on-off control circuit. The following two other control lines are also used:
- Shutdown signal (SHUTDOWN): a signal from the ON/OFF hardware to the CPU
- Power switch off signal (PWRSWOFF): a signal from the CPU to the ON/OFF circuit
These signals allow power to be turned on and off while preserving all data and assuring voltages are changed without damaging circuitry.
430-600203-003 (Rev. 07/05) 4 - 10 GemStar
®
Page 33
VPWR
4.1 ELECTRO-MECHANICAL SYSTEMS
ON
OFF
R123
47.5K
R122
47.5K
R136
47.5K
FROM
CPU
TO
CPU
U109
2
SHDN
4
DET RESET
PWRSWOFF
SHUTDOWN
U105
2
SHDN
4
DET
RESET
5V OUT
3.3V OUT
Q109
Vcc
5
D
3
CLK
1
Q
2
Q
POWER OFF
POWER ON
U107A
R137
47.5K
02G02011
Figure 4-4. Power On/Off Circuitry
Technical Service Manual 4 - 11 430-600203-003 (Rev. 07/05)
Page 34
SECTION 4 THEORY OF OPERATION
4.1.9.1
POWER ON
When power is first applied to the infuser, there is a voltage at V and 5 V supplies are held in a shutdown mode. The voltage at V
. However, the 3.3 V
PWR
is applied through
PWR
resistor R136 to the shutdown inputs (U105-2 and U109-2). Meanwhile, the voltage at pin 4 of U105 and U109 (ON/OFF) is held at one-half V
by resistor-divider R122 and
PWR
R123. When the ON/OFF key is pressed, the on/off signal line is pulled low, which causes a comparator in U105-7 to go low and removes the shutdown signal on U105-4 and U109-4. These switching regulators rapidly change their outputs (VOUT on pin 5) to 5 V and 3.3 V respectively. This supplies power to flip-flop U107A where the clock is held low by the reset output of U109-7. When the ON/OFF switch is released, the ON/OFF line returns to one-half V
and the reset lines on U105-7 and U109-7 return high. This clock
PWR
flip-flops U107A. The Q-Bar output (U107-2) toggles high, switching the signal line power-on (POWERON) high. It also turns on transistor Q109, which removes the shutdown signal from power supplies U105-2 and U109-2. Simultaneously, the Q output (U107-1) toggles low, switching POWEROFF low. As a result, power is established and maintained.
4.1.9.2
POWER OFF
Power is removed from the infuser under CPU control. When the ON/OFF switch is pressed, it pulls pin 4 of the 3.3 V supply (U109-4) to ground. This causes the reset pin (U109-7) to pull low and puts a low on the signal line SHUTDOWN\ to the CPU. When this signal is received, the CPU begins its power-down sequence. First, it assures that power-down is a viable choice. For example, if the infuser is in the delivery (RUN) mode, the device will not power-off and a warning message will display. If power-down is a viable choice, the CPU gracefully shuts down by saving data, history, and other required housekeeping. When this is complete, the CPU changes the PWRSWOFF signal high. The ON/O F F swi t ch mu s t be p r esse d and h e ld du r ing t h is pr o cess , whic h may t a ke up t o thr e e seconds. After the PWRSWOFF signal is switched high, releasing the power switch will change the signal ON/OFF and U109-4 back to one-half V U109-7 and at the clock input of U107-A-3. The high on PWRSWOFF at the flip-flop data input U107A-5 will be clocked to the Q output, and the Q output will go high. At the same time, Q-bar (U107-2) will go low and Q109 will shut down both U109 and U105. This removes power from the circuits.
. This will raise the signal at
PWR
4.1.10

MOTOR DRIVE CIRCUITS

A high efficiency moving coil permanent magnet DC motor operates a plunger to deliver fluid. The motor includes a 27:1 speed reduction transmission and an integral, dual-channel, quadrature-encoded tachometer. The speed of the motor is set by the CPU. A hardware servo control circuit maintains the selected speed while compensating for variations in load torque, motor losses, and power source voltage. The CPU monitors the servo circuit by reading the motor voltage, motor current, and motor turns (encoder counts). The CPU also monitors the activation of the cassette (via output shaft encoder) to verify that motor turns are correctly converted into fluid delivery actions. See Figure 4-5, Motor Control Circuit, and Figure 4-6, Detail of Motor Circuit.
430-600203-003 (Rev. 07/05) 4 - 12 GemStar
®
Page 35
MOTCNTRL
R106 100K
1.24V
REFERENCE
Figure 4-5. Motor Control Circuit
R105 301K
+
AMPLIFIER
-
4.1 ELECTRO-MECHANICAL SYSTEMS
U102, Q101, Q102
Q103, Q108, D101
MOT+
02K02013
MOT DREN
MOT+
MOTOR
R125
1
W
MOT SPCTL
R105
R121
57.6K
R120
1M
+
-
+5
-5
R112 150K
R111
U103A
-5V
+
-
R114
R110
200K
U103B
R106
TO U102-3
02K02005
Figure 4-6. Detail of Motor Circuit
Technical Service Manual 4 - 13 430-600203-003 (Rev. 07/05)
Page 36
SECTION 4 THEORY OF OPERATION
4.1.10.1
SPEED CONTROL
The CPU sets a desired speed. A summing amplifier (U103B) combines this speed setting, the motor speed (voltage across the motor), and the motor load (current through the motor) to establish a motor drive set point. This is converted into a drive voltage using a step-up DC-DC controller (U102). The CPU sets the motor speed as a pulse-width (duty-cycle) modulated signal (MOTSPCTL). Zero pulse width indicates a speed of zero, while full pulse width (100% duty cycle) is maximum speed resulting in approximately 1150 mL/hr delivery rate. A two pole RC filter (R117, C119, R118, C120) converts the duty cycle into a DC voltage (MSPEED). This voltage is fed to the summing amplifier U103B. Other inputs to this amplifier represent motor current and an offset reference current to assure the motor is off when the CPU sets a zero speed.
The motor current is sensed as the voltage across R125, amplified by U103A (gain approximately 18.4), and input to U103B via resistor R111. The motor current is sensed by the CPU A/D converter by monitoring the voltage at the output of U103A through R119 (MOTCUR).
The motor voltage and current range from approximately 1.5 V to 6.0 V, and 15 mA to 150 mA depending upon speed and load torque. This wide range of power must be delivered over the full range of input voltage (V the motor servo output is a switch-mode up/down (buck/boost) voltage regulator (U102; Q108B; Q102 A and B; L102; D101; and D102). It receives a DC signal (MOTCNTRL) from the summing amplifier U103B and converts this to the required rate of current pulses to equal the necessary output power to the motor.
) of 1.3 V to 3.2 V. To accomplish this,
PWR
U102 is a step-up DC-DC controller that adjusts the output pulses at pin 1 to maintain a constant voltage of 1.24 V at the feedback pin 3. IC U102 and its associated switching circuitry may be considered part of high gain op-amp circuit with input resistor R106 and feedback resistor R105. The junction of R105 and R106, and U102-3 is a current summing point maintained by U102. The ratio of R105 to R106 sets the gain at –3. As the motor control signal (MOTCNTRL) at U103B-7 ranges from 1.65 V to –1.24 V, the motor voltage, MOT+, will range from zero to 8.68 V. If the voltage MOT+ at the right side of R105 begins to dip, U102-3 will dip, causing the output, U102-1, to output more control pulses. These are amplified, and become higher output DC after filtering. Individual components have been selected to make the servo circuit operate properly. U102 does not provide enough current, or the required negative voltage, to drive Q108B efficiently, so Q103 and Q101 are used in the classic complementary CMOS output configuration. The low side of this totem pole combination is tied to minus 5 V (MD-5V). This reduces the switching time of the FETs and hence minimizes current consumption. L101 has been selected to deliver approximately 1 V at the maximum frequency of output pulses from U102.
Peak current in L101 (22 _H) must be limited, or coil saturation may adversely affect efficiency. Based on the voltage drop across R103 (0.05 Ω), U102 automatically terminates the coil charging ramps at 1.6 amperes.
430-600203-003 (Rev. 07/05) 4 - 14 GemStar
®
Page 37
4.1 ELECTRO-MECHANICAL SYSTEMS
4.1.10.2
POWER CONSERVATION
To conserve power, the 5 V supply is disconnected when the motor circuit is not operating. To activate the motor circuitry, the CPU switches the motor drive on signal (MOTDRVON) high. This is inverted by U104A, turns transistor Q105A on, and connects 5 V to the motor drive 5 V line (MD5V). When positive 5 V is available on MD5V, U101, a MAX828 voltage inverter, generates a -5 V (MD5V) for the negative rail of the op-amps and for FET switching.
4.1.10.3
MOTOR
The drive motor is a combined gear motor with integral quadrature tachometer. The gearbox following the motor divides the motor speed by 27.0. The motor speed constant is chosen such that with the maximum voltage available from the servo, the motor output shaft will turn at a speed sufficient to provide approximately 1000 mL/hr. The motor speed constant is 0.75 V revolutions to in-out strokes for the cassette. One revolution equals one stroke to cassette.
The motor resistance is 15 Ω +/- 8% (16.2 Ω maximum). At 120 mA, the motor voltage loss may be as high as 15.1 x 0.12 = 1.81 V adjusted for by the servo to keep the motor speed constant. The servo adds this lost voltage to the applied voltage to the motor. A 1 Ω resistor in series with the low side of the motor provides for the required motor current sensing.
per 1000 RPM. The mechanism converts rotary
DC
. This internal motor drop is automatically
DC
To get 1000 mL/hr requires 220 RPM at the output shaft. With a 27:1 gearbox, the motor is turning 6000 RPM. At 0.75 V/1000 RPM, the basic drive voltage is 4.5 V. The total maximum required drive voltage is then: 4.50 + 1.81 + 0.12 = 6.43 V.
4.1.10.4
TACHOMETER
A digital tachometer keeps precise track of motor rotations. The tachometer is integrally mounted on the motor, and has a two-channel output (PHASE A, PHASE B). Each channel uses a Hall-effect sensor to generate a digital square wave of 16 pulses for each revolution. The pulses on one channel follow the other by a one-fourth pulse. This quadrature phase shift allows the direction of motor movement to be detected. Counting the pulses is an indication of motor movement and is converted into volume delivered. Play in the mechanism may result in backward motor movement. The tachometer allows the CPU to keep track of this and correct for reverse motion.
4.1.10.5
REDUNDANT MOTOR CONTROL
Note that when the microcontroller detects an error or out of tolerance condition, it can inhibit motor motion with any one of three commands. A logic low on MOTORON, MOTDRVEN, or MOTSPCTL will stop the motor. All three being a logic low adds triple redundancy for overdelivery protection.
Technical Service Manual 4 - 15 430-600203-003 (Rev. 07/05)
Page 38
SECTION 4 THEORY OF OPERATION
4.1.11

MOTOR TACHOMETER POWER CONSERVATION

The motor tachometer is used to monitor motor speed. To minimize power consumption, the motor tachometer (encoder) is turned off whenever the motor is not running. In addition, when the motor is running, the tachometer is strobed. This means that at fixed intervals, the tachometer output is read into the computer. When it is not being read, it uses less power.
The tachometer is turned on just before the motor is turned on and remains on a short time after the motor turns off. It is switched on by the motor enable control signal (MOTENCON) from the CPU which turns on transistor Q108A to supply power to the tachometer on the motor (TACHVCC). The tachometer uses Hall-effect devices that switch on rapidly. A second line from the CPU, motor enable strobe (MOTENSTB), is buffered by U104E to become the tachometer strobe signal (STRB). This enables the Hall-effect devices to output the PHASE A and PHASE B signals. The strobe sampling rate is 31.25 kHz. This is fast enough to assure that no tachometer signals are missed, yet slow enough to conserve power. There are 16 tachometer pulses generated on each channel when the motor makes one revolution. The motor gear box has a gear ratio of twenty seven to one (27:1). This makes the output shaft turn once for every 27 motor turns. The drive shaft operates the pumping plunger once per revolution. As a result, there are 432 (16 x 27) tachometer pulses per pumping stroke.
The tach operates at 5 V (TACHVCC). To reduce the output signals to the 3.3 V levels required by the CPU system, resistors R145, R146, R107, and R108 divide the PHASE A and PHASE B signals.
4.1.12

OUTPUT SHAFT ENCODER

The motor output shaft turns the drive mechanism which drives the pumping plunger. A flag is attached to the end of the drive mechanism. Monitoring this flag allows the three following functions:
- A positive indication that the mechanism is operating when the motor is operating
- An indicator when the pumping plunger is in the home (fully retracted) position
- An indication of pumping speed
The flag is monitored using a reflective optical encoder (U208). The encoder LED emits an infrared beam of light. When the encoder flag enters the beam, it reflects light back to a photo detector which generates an output signal (SHFTSIGNAL). This signal is squared up by two inverters (U4D and E) before being input to the FPGA (U9-57) as shaft encoder check (SHFTENCH).
When the signal transitions low to high, this event is latched by the FPGA, which presents it to the CPU as an interrupt. In responding to this interrupt, the CPU polls a memory-mapped location in the FPGA to determine which external event caused the interrupt.
To assure correct motor operation, the shaft encoder looks for the flag every 8.2 ms whenever the infuser is on. This assures that the motor is only running when it should be. Any unauthorized motor movement or missing motor movement will be detected. To minimize power consumption, the shaft encoder is enabled for only 140 µs for a 2 % duty cycle. The shaft-on (SHFT-ON) control signal is generated at the FPGA (U9-30), passes through connectors J3, J103, J105, and J205 to R224 and U208.
430-600203-003 (Rev. 07/05) 4 - 16 GemStar
®
Page 39
4.1 ELECTRO-MECHANICAL SYSTEMS
4.1.13

AIR-IN-LINE SENSING

The GemStar® uses an ultrasonic air detection system. The mechanism holds a pulse generator on one side of the IV tubing and a receiver on the opposite side. If there is fluid inside the tubing, the sound pulse is conducted to the receiver and a strong signal results. Air in the tubing gives only a weak signal. The pulse generator (transmitter) and the receiver are made of piezo-electric crystals. These convert electrical energy into mechanical motion or mechanical motion into an electric signal. Sending an electrical pulse to a transmitting crystal generates an ultrasonic pulse. When the pulse is transmitted to the receiving crystal, the pulse energy acting on the crystal generates an electrical output signal. This signal is amplified, filtered, and converted into a digital signal for processing by the CPU.
When the cassette is inserted into the infuser, the transmit and receive crystals are clamped to opposite sides of the IV tubing. The transmit crystal is driven by U207 and connected to J204. The receive crystal is connected to amplifier U206 through J203. To check for air, the CPU first applies power to the ultrasonic circuits (AIRON) by turning Q204 on. This activates power to the ultrasonic transmitter and receiver. After the U5V supply is stable (about 10 µs), and before transmitting, the CPU measures the receive signal to establish background noise levels. Next, a signal is transmitted. The signal toggle air (TOGLAIR) switches from low to high. This is buffered by U207D and causes one side of the transmit piezo to receive an out-of-phase signal from the other. The piezo deflects, and rings slightly to generate approximately a 700 kHz burst. Approximately 12 ms later, TOGLAIR returns to low. This causes the crystal to transmit a second signal. The CPU measures the AIR reading immediately after this transmitted pulse.
The receiver is a differential amplifier, U206, which rejects low frequency interference, such as 50-60 Hz, and triples the received signal. Inter-stage capacitor C219 is a high-pass filter that rejects frequencies up to approximately 100 kHz. The second-stage amplifier is Q205 with an AC gain of approximately 14. L20 and C215 tune the amplifier frequency response to optimize only the range of piezo ringing frequencies. Total AC gain is approximately 45. The amplified output is rectified and filtered by D201 and C206 and converted to a digital value by the CPU’s A/D. The CPU records the signal value and the baseline values to determine whether air is present.
4.1.14

PROXIMAL PRESSURE MEASUREMENT

Proximal and distal pressures in the set are obtained by using strain gauges to measure forces on pins that contact the cassette diaphragm. The proximal pressure sensor pin contacts the cassette diaphragm at the inlet chamber. When proximal pressure decreases, the chamber deflates slightly and as a result, the pressure pin moves with the chamber wall. A resistive strain gauge connected to the pin deflects and changes its electrical output in proportion to the applied pressure. The signal from the strain gauge (J202) is filtered (R240; R241; C226; C227; C228) and then amplified by instrumentation amplifier U204 with a gain of 1000. Gain is established via gain resistor R211. The resultant signal, proximal pressure (PROXPRES), is converted to a digital signal by the analog-to-digital converter in the CPU (U2-48). The result is a signal with a range of 0 to 255. The normal proximal pressure range is from 2 psi to –8 psi. This pressure range results in a strain gauge signal change of approximately 1.75 mV has full range reference voltage of 3.3 V (i.e., 3.3 V = 255 counts). As a result, the proximal pressure gauge has a range change of 135 counts (1.75 mV x 1000 x 255 counts/3.3 V).
. The gain of U204 is 1000 and the ADC
DC
Initial offset voltages of the strain gauge circuit are adjusted to zero during production test and calibration. During calibration, the CPU adjusts a digital potentiometer (U203) to cancel the offset voltage. The setting is stored as calibration data in the battery-backed-up RAM. The offset adjustment can be 6.75 mV.
Technical Service Manual 4 - 17 430-600203-003 (Rev. 07/05)
Page 40
SECTION 4 THEORY OF OPERATION
4.1.15

DISTAL PRESSURE MEASUREMENT

The distal pressure measurement is very similar to the proximal. Rather than the pressure pin contacting the diaphragm directly, however, it contacts the cassette at the flow stop. The flow stop makes direct contact with the diaphragm. The opposite end of the pin contacts the strain gauge. The strain gauge connects at jack J201 and is filtered and amplified by U204 and the associated circuitry. Distal pressures are higher than proximal pressures (-5 to 40 psi). As a result, output voltages are larger (up to 6.75 mV) so the amplifier gain (U205) is smaller. Gain is set at 301 via gain resistor R212. The distal pressure gauge has a range change of 157 ADC counts (6.75 mV x 301 x 255 counts/3.3 V).
The distal pressure amplifier uses the same offset potentiometer that is used for proximal measurements. The CPU selects the appropriate value before taking a pressure reading. Because they share the same offset resistor, distal and proximal pressures cannot be measured at the same time.
To conserve power, the pressure measurement circuits are turned off between readings. The control signal from the CPU is called pressure sense on (PRSENSON). Transistors Q201 and Q202 connect + 5 V (5V-B) to the sensors (P5V) while transistors Q207 and Q208 connect - 5 V (-5 V-B) to the sensors (P-5V).
4.1.16

RS-232 INTERFACE SYSTEM

The infuser has an RS-232 interface to allow connection to a multiple of RS-232 devices. This allows printing reports, downloading new software, remote monitoring, and modem interfacing. The circuitry uses an RS-232 transceiver/receiver (U5) to buffer the signals. To input data, U5 receives the RS-232 logic level signals, serial data in [SDATIN] and serial control in [SCTLIN], converts them to 3.3 V UART serial port. For output, U5 receives 3.3 V serial data out (SDATOUT), and serial data control out (SCTLOUT) and converts them to RS-232 logic levels for external transmission from the infuser at J109.
U5 provides ohmic isolation between the infuser circuitry, and the RS-232 inputs and outputs. This isolation is good to several thousand volts, giving the infuser the ability to withstand electrostatic discharges on th e seri a l por t pins . When t he se r ial p o rt is n ot be i n g used, the IC is switched to a low-power mode. The logic line serial-on (SERIALON) (U9-29) connects to U5-13, disables the charge pump, and switches the outputs to high-impedance output states.
logic level signals, and connects to the CPU
DC
logic level signals from the CPU UART
DC
4.2

CASSETTE SYSTEM

The GemStar® cassette is a small, low cost, sterile pumping chamber that snaps into the infuser to deliver fluid to the patient. The cassette snaps and locks into the infuser without the need for a separate door. When the cassette release button on the top of the infuser is depressed, the cassette is released. When released, the cassette is automatically protected against fluid free-flow. By opening the flow stop rocker, the cassette may be gravity primed. The cassette has an infusion range from 0.1 mL/hr to 1000 mL/hr. Air is ultrasonically detected by the infuser in the tubing as fluid exits from the cassette.
430-600203-003 (Rev. 07/05) 4 - 18 GemStar
®
Page 41
4.2 CASSETTE SYSTEM
A pumping chamber forms the heart of the cassette. It interfaces to a plunger in the infuser. When the plunger is depressed, fluid in the chamber is exhausted through a one-way outlet valve to a small outlet chamber. When the plunger is retracted, the outlet valve closes and a one-way inlet valve opens to let fluid in from a small inlet chamber. The volume pumped for each pumping cycle is approximately 75 microliters (about 13 strokes per mL). The inlet and outlet chambers connect to strain gauges in the infuser to monitor proximal and distal tubing pressures. A latching flow stop contacts the outlet chamber. When it is latched open, the outlet valve is free to open and close. When latched closed, it causes the outlet valve to remain in the closed position, preventing fluid flow when the cassette is outside of the infuser.
The cassette consists of four parts: body, top, diaphragm, and flow stop.
4.2.1

BODY AND TOP

The body and top enclose the silicone diaphragm to form the inlet, pumping, and outlet chambers. The flexible diaphragm mates to the body to enclose the chambers and form the one-way valves. The pump plunger presses on the diaphragm to empty the pumping chamber and when the plunger retracts, the spring force of the diaphragm refills the pumping chamber.
4.2.2

DIAPHRAGM

Fluid enters the cassette at the inlet port to fill the inlet chamber. The top of this chamber is part of the diaphragm. A pin from the infuser contacts the top of this chamber to detect any deflection. If pressure drops in this chamber (evidence of a proximal occlusion), the top of the chamber will deflect, which the infuser can sense. The infuser analyzes this deflection to determine if there is a proximal occlusion.
When the pump plunger retracts, fluid is drawn from the inlet chamber to the pumping chamber through the one-way flapper valve. When the plunger completes the retracting stroke, it reverses direction. The flapper valve to the inlet chamber closes. As the plunger advances, pressure builds in the pumping chamber and opens the outlet valve. Fluid moves to the outlet chamber and the outlet port to the patient.
Like the inlet chamber, the outlet chamber top is part of the flexible diaphragm. The flow stop contacts the diaphragm and a pin from the infuser contacts the flow stop. If pressure builds up in the outlet chamber (evidence of a distal occlusion), the top of the chamber will deflect, which the infuser can sense. The infuser analyzes this deflection to determine if there is a distal occlusion.
4.2.3

FLOW STOP

The flow stop is a rocker that latches either open or closed. When closed, it will deflect the top of the outlet chamber to press the outlet valve closed. The flow stop pressure is sufficient to prevent free-flow to about a nine-foot head height. After priming, a caregiver should close the flow stop prior to installing the cassette in the infuser. However, when the cassette is installed into the infuser, the flow stop is switched to the closed position automatically. As the plunger engages the chamber, it relaxes the outlet valve and reduces the valve cracking pressure. When the cassette is removed from the infuser, the flow stop remains in the closed position and requires manual opening for priming.
Technical Service Manual 4 - 19 430-600203-003 (Rev. 07/05)
Page 42
SECTION 4 THEORY OF OPERATION
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430-600203-003 (Rev. 07/05) 4 - 20 GemStar
®
Page 43
Section 5

MAINTENANCE AND SERVICE TESTS

A complete maintenance program promotes longevity and trouble-free instrument operation. Such a program should include routine maintenance, operation testing, and periodic maintenance inspection.
This section details routine maintenance procedures and the operation test.
Note: Store the infuser in a cool, dry place. Remove the disposable batteries or optional
battery pack before storing the infuser.
Note: Program and Event History are protected in memory for at least one year when
power is removed from the infuser.
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: DISCONNECT THE INFUSER FROM AC POWER AND REMOVE THE
BATTERIES OR BATTERY PACK PRIOR TO CLEANING. FAILURE TO COMPLY WITH THIS WARNING COULD RESULT IN ELECTRICAL SHOCK.
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.
Technical Service Manual 5 - 1 430-600203-003 (Rev. 07/05)
Page 44
SECTION 5 MAINTENANCE AND SERVICE TESTS
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.
CAUTION: Clean the exposed surfaces of the infuser with a soft, lint-free cloth dampened with one of the cleaning solutions listed in Table 5-1, or a mild solution of soapy water. Remove soap residue with clear water. Do not use solvents that are harmful to plastic. Do not use abrasive cleaners.
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.
Table 5-1. Cleaning Solutions
Cleaning Solution Manufacturer Preparation
Coverage
TM
HB Steris Corporation Per manufacturer's
recommendation
Dispatch
TM
Caltech Industries Per manufacturer's
recommendation
Manu-Klenz
®
Steris Corporation Per manufacturer's
recommendation
Precise
TM
Caltech Industries Per manufacturer's
recommendation
Sporicidin
®
Sporicidin International Per manufacturer’s
recommendation
Household bleach Various Per hospital procedures;
do not exceed one part bleach in ten parts water
5.1.1.1
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 instrument to malfunction.
430-600203-003 (Rev. 07/05) 5 - 2 GemStar
®
Page 45
5.1 ROUTINE MAINTENANCE
5.1.1.2
CLEANING THE CASSETTE POCKET AND TUBING CHANNEL
Clean the cassette pocket and the tubing channel on a regular basis. The ultrasonic sensors are located in the cassette pocket.
CAUTION: Do not damage the silicone seals around the sensor bodies.
See Figure 5-1, Cassette Pocket and Tubing Channel, and complete the following steps:
1. Remove the cassette.
2. Using a cotton swab moistened with a recommended cleaning solution, clean the sensor faces (A), tubing channel (B), plunger tip (C), and sensor pins (D).
3. Dry the sensor faces and tubing channel and confirm that the sensor faces are free of detergent film and/or debris.
Note: Removing excess cleaning solution from the infuser helps prevent detergent
buildup, which could adversely affect performance.
A
D
C
B
02G02003
Figure 5-1. Cassette Pocket and Tubing Channel
Technical Service Manual 5 - 3 430-600203-003 (Rev. 07/05)
Page 46
SECTION 5 MAINTENANCE AND SERVICE TESTS
5.1.2

INSPECTION

Inspect the infuser periodically for signs of defects, such as worn accessories or damaged cables. Also, inspect the infuser after repair or during cleaning. Replace any damaged or defective external parts.
The following sections detail infuser inspection procedures.
5.1.2.1
MATERIALS REQUIRED
Infuser inspection requires the following materials:
-Cotton swab
- Cleaning solution
- Infuser administration set
- Small flashlight
- Two fresh AA disposable batteries
-3 V
- Digital multimeter (DMM) (Optional)
AC adaptor (optional)
DC
5.1.2.2
LABEL INSPECTION
See Figure 5-2, Label Inspection, and verify the following labels are present and in good condition:
1 Hospira void label
2 Configuration letter label
3 System kit label
4 Serial number label
5 GemStar
6 Operating instructions label
7 Battery door void label
8 3 V
9 Battery insertion label (not shown; located inside the battery compartment)
®
logo void label
/printer/bolus connector label
DC
430-600203-003 (Rev. 07/05) 5 - 4 GemStar
®
Page 47
5.1 ROUTINE MAINTENANCE
4
1
2
7 8
3
4
5
6
02G0201
Figure 5-2. Label Inspection
Technical Service Manual 5 - 5 430-600203-003 (Rev. 07/05)
Page 48
SECTION 5 MAINTENANCE AND SERVICE TESTS
5.1.2.3
LATCH MECHANISM INSPECTION
See Figure 5-3, Cassette Retention and Ejection, and complete the following steps:
1. Verify the four cassette latches are present.
2. Load a cassette into the chassis pocket and push the cassette until all four cassette latches securely hold the cassette in place.
3. Gently pull on the distal and proximal tubing to verify that the latches secure the cassette.
4. Push the cassette release button until the cassette snaps free from the service position.
5. Gently pull on the distal or proximal tubing to verify the cassette can be removed from the chassis with minimum resistance.
1
1
02K02021
Figure 5-3. Cassette Retention and Ejection
430-600203-003 (Rev. 07/05) 5 - 6 GemStar
®
Page 49
5.1 ROUTINE MAINTENANCE
5.1.2.4
AIR SENSOR INSPECTION
See Figure 5-4, Air Sensor Inspection, and complete the following steps:
1. Verify the two air sensor anvils are present and in good condition.
2. Apply gentle pressure to each anvil face with a cotton swab to verify the sensors retract and re-position.
3. Load the set into the chassis, nest the tubing between the air sensor anvils, and verify that both anvils engage the distal set tubing.
4. Verify the two sensor seals are present and in good condition. Each seal should be free of tears and nest snugly around the sensor. The seals should not interfere with contact between the anvil face and the set tubing.
5. Verify the sensor seal pockets and sensor anvils are free of debris and contamination.
2
5
1
3
4
02K02022
Figure 5-4. Air Sensor Inspection
Technical Service Manual 5 - 7 430-600203-003 (Rev. 07/05)
Page 50
SECTION 5 MAINTENANCE AND SERVICE TESTS
5.1.2.5
PLUNGER AND PRESSURE SENSOR INSPECTION
CAUTION: DO NOT apply excessive force to pressure sensor pins. Excessive force may damage sensor pins or internal beams.
See Figure 5-5, Plunger and Pressure Sensor Inspection, and complete the following steps:
1. Verify the plunger seal is present and in good condition.
2. Apply gentle pressure to the plunger to verify transmission compliance. There should be no significant free-play or reversing of the plunger position.
3. Verify the two pressure sensor pins are present and in good condition.
4. Using one finger, apply gentle pressure to each pressure sensor pin to verify proper beam deflection. The pin should retract slightly then re-position after pressure is removed.
1
3
Figure 5-5. Plunger and Pressure Sensor Inspection
2
4
02K02023
430-600203-003 (Rev. 07/05) 5 - 8 GemStar
®
Page 51
5.1 ROUTINE MAINTENANCE
5.1.2.6
TOP CAP INSPECTION
See Figure 5-6, Top Cap Inspection, and complete the following steps:
1. Verify the top cap is free of cracks, holes, and evidence of fluid ingress.
2. Verify the seal between the top cap and the bezel/extrusion is present and in good condition.
3. Verify the condition of the pole clamp retainer.
2
1
3
2
Figure 5-6. Top Cap Inspection
02K02024
Technical Service Manual 5 - 9 430-600203-003 (Rev. 07/05)
Page 52
SECTION 5 MAINTENANCE AND SERVICE TESTS
5.1.2.7
BOTTOM CAP INSPECTION
See Figure 5-7, Bottom Cap Inspection, and complete the following steps:
1. Verify the bottom cap is flush with the extrusion and bezel.
2. Verify the bottom cap is free of cracks and holes.
3. Verify all three hole plugs are present.
Note: Steps 4 through 6 apply to the GemStar
component interface.
4. Verify each port is free of foreign material and contamination.
5. Verify that each port retention and keying features are free from damage.
6. Verify that each gold contact is clearly visible, intact, and free of contamination.
®
with the optional system
PURGE
0
OPTIONS
NOHELP
YES
ENTER
1
1
3
Figure 5-7. Bottom Cap Inspection
2
02K02025
430-600203-003 (Rev. 07/05) 5 - 10 GemStar
®
Page 53
5.1 ROUTINE MAINTENANCE
5.1.2.8
BEZEL, GRIP, AND KEYPAD INSPECTION
See Figure 5-8, Bezel, Grip, and Keypad Inspection, and complete the following steps:
1. Verify the bezel face is in good condition.
2. Verify the seal of the bezel face to the grip.
3. Verify the bezel tail is in good condition.
4. Verify the seal of the bezel tail to the grip.
5. Verify the seal of the bezel face edge to extrusion.
6. Verify the keypad is free of damage and that each key provides tactile feedback when pressed.
1 3
4
7
2 6
5
5
02G02026
Figure 5-8. Bezel, Grip, and Keypad Inspection
Technical Service Manual 5 - 11 430-600203-003 (Rev. 07/05)
Page 54
SECTION 5 MAINTENANCE AND SERVICE TESTS
5.1.2.9
BATTERY DOOR AND COMPARTMENT INSPECTION
The following sections describe battery door and battery compartment inspection.
5.1.2.9.1
Battery Door Engagement
See Figure 5-9, Battery Door Engagement, and complete the following steps:
1. Flip the door latch to the open position, then to the closed position, then to the open position again. The door latch should snap positively in both positions with no free-play.
2. Verify the door retainer is present and in good condition.
3. Gently rotate the battery door latch counterclockwise to the open position, then clockwise to the closed position to verify proper engagement. The door is properly engaged when the door is secured by the door retainer.
2
1
Figure 5-9. Battery Door Engagement
3
04K02027
430-600203-003 (Rev. 07/05) 5 - 12 GemStar
®
Page 55
5.1 ROUTINE MAINTENANCE
5.1.2.9.2
Battery Door Inspection
See Figure 5-10, Battery Door Inspection, and complete the following steps:
1. Remove the battery door from the infuser.
2. Verify the o-ring is present and in good condition.
3. Verify the door latch and plunger hinges are free of fractures.
4. Verify the spring is secure with no wobble or excessive collapse.
5. Verify the wiper contact is free of contamination, corrosion, and excessive deformation.
2
4
5
3
02G02028
Figure 5-10. Battery Door Inspection
Technical Service Manual 5 - 13 430-600203-003 (Rev. 07/05)
Page 56
SECTION 5 MAINTENANCE AND SERVICE TESTS
5.1.2.9.3
Battery Compartment Inspection
See Figure 5-11, Battery Compartment Inspection, and complete the following steps:
1. Remove the battery door.
2. Verify the circuit board wiper contact is present and free of contamination, corrosion, and excessive deformation.
3. Verify the battery cap is present and free of contamination and corrosion.
2
3
02G02029
Figure 5-11. Battery Compartment Inspection
430-600203-003 (Rev. 07/05) 5 - 14 GemStar
®
Page 57
5.1 ROUTINE MAINTENANCE
POWER
BACK-UP
CHANGE
OPTIONS
YES
ENTER
ON/OFF
5.1.2.10
POWER-ON TEST
See Figure 5-12, Power-On Test, and complete the following steps:
1. Install two fresh, disposable AA batteries in the infuser.
2. Press [ON/OFF]. Verify the infuser powers on and UNIT SELF-TEST displays, along with the time and date.
3. Verify the audible alarm sounds at power-on.
4. Verify USING BATTERIES displays, and press [YES/ENTER].
5. Connect the AC adaptor to the 3 volt connector on the bottom of the infuser, and verify the green power LED illuminates.
6. Disconnect the AC adaptor, and verify the green power LED is not illuminated.
7. Remove the battery door. Verify the red LED illuminates, the beeper sounds, and POWER LOSS displays.
7
5
6
SILENCE
1
4 7
STOP
2 5 89 0
1
PURGE
START
3 6
NOHELP
POWER
ON/OFF
BACK-UP
CHANGE
OPTIONS
YES
ENTER
2
3
4
04K02030
Figure 5-12. Power-On Test
Technical Service Manual 5 - 15 430-600203-003 (Rev. 07/05)
Page 58
SECTION 5 MAINTENANCE AND SERVICE TESTS
5.1.2.11
RECHARGEABLE BATTERY PACK (OPTIONAL)
See Figure 5-13, Rechargeable Battery Pack, and complete the following steps:
1. Verify the 3 V
/printer/bolus port connector contacts are present and in good
DC
condition.
2. Verify the 3 V
/printer/bolus pass-through port connector contacts are present
DC
and in good condition.
CAUTION: Do not touch exposed connectors on the bottom of the infuser. Exposed connectors are susceptible to electrostatic discharge (ESD) damage.
3. Connect the infuser, without batteries, to the battery pack, and verify the battery pack slides into place and locks firmly.
4. Press [ON/OFF], and verify the infuser powers on and the green LED on the infuser flashes slowly.
5. Press the release buttons, and verify the latch mechanism releases.
6. Connect the battery pack to the battery pack charger, and verify the battery pack LED illuminates.
1
TOP VIEW
2
BOTTOM VIEW
5
6
FRONT VIEW
05K02031
Figure 5-13. Rechargeable Battery Pack
430-600203-003 (Rev. 07/05) 5 - 16 GemStar
®
Page 59
5.1 ROUTINE MAINTENANCE
5.1.2.12
DOCKING STATION (OPTIONAL)
See Figure 5-14, Docking Station, and complete the following steps:
1. Verify the dovetail is in good condition.
2. Press the release button, and verify the detent retracts.
3. Verify the 3 V condition.
CAUTION: Do not touch exposed connectors on the bottom of the infuser. Exposed connectors are susceptible to electrostatic discharge (ESD) damage.
4. Remove the connector cap and verify the bolus and printer pass-through port connector contacts are present and in good condition.
5. Verify the pole clamp is securely attached to the docking station body.
6. Verify the docking station is free of contamination, cracks, and other physical damage.
7. Verify the AC mains power cord lanyard and retention features are present.
8. Verify the AC mains power cord, plug, and prongs are in good condition.
9. Connect the docking station to AC mains power, and verify the docking station LED illuminates.
10. Slide the infuser, without batteries, into the docking station, and verify the device locks firmly into place.
11. Press [ON/OFF], and verify the infuser powers on and initiates the self test.
12. Remove the infuser, disconnect power, and perform a continuity test between the corresponding top and bottom pins to verify bolus pass-through functionality.
/printer/bolus port connector contacts are present and in good
DC
Technical Service Manual 5 - 17 430-600203-003 (Rev. 07/05)
Page 60
SECTION 5 MAINTENANCE AND SERVICE TESTS
2
7
1
8
FRONT VIEW
5
9
6
4
12
12
3
BACK VIEW TOP VIEW
02G02015
Figure 5-14. Docking Station
430-600203-003 (Rev. 07/05) 5 - 18 GemStar
®
Page 61
5.1 ROUTINE MAINTENANCE
5.1.2.13
AC ADAPTOR (OPTIONAL)
CAUTION: Do not use the AC adaptor if the cord is frayed or torn insulation is found, or if any prong is missing from the plug.
See Figure 5-15, AC Adaptor, and complete the following steps:
1. Using a multimeter and probes, verify the AC adaptor output is 3 V
2. Verify the cord is in good condition.
3. Verify the transformer and 3-prong plug are in good condition.
4. Verify the infuser plug adaptor pins are present and in good condition.
5. Connect the AC adaptor to the adaptor port on the bottom of the infuser. Verify the AC plug is properly engaged/retained.
6. Remove the batteries.
7. Press [ON/OFF], and verify the infuser powers on.
± 5 %.
DC
3
12
1
3
4
2
4
02K02032
Figure 5-15. AC Adaptor
Technical Service Manual 5 - 19 430-600203-003 (Rev. 07/05)
Page 62
SECTION 5 MAINTENANCE AND SERVICE TESTS
5.1.2.14
REMOTE BOLUS CORD AND SWITCH (OPTIONAL)
See Figure 5-16, Remote Bolus Cord and Switch, and complete the following steps:
1. Verify the bolus cord is free from fraying and torn insulation.
2. Verify the switch body is free of damage and evidence of fluid ingress.
3. Verify the bolus port connector pins are present and in good condition.
4. Press the bolus switch, and verify the bolus continuity across pins 1 and 2.
5. Connect the bolus cord to the bolus port on the bottom of the infuser. Verify the bolus cord plug is properly engaged/retained.
2
3
1
Figure 5-16. Remote Bolus Cord and Switch
4
1
2
3
02K02033
430-600203-003 (Rev. 07/05) 5 - 20 GemStar
®
Page 63
5.2 OPERATION TEST
5.2

OPERATION TEST

The operation test is designed to assure the infuser is operating properly. Hospira recommends performing this test a minimum of once every 12 months. Refer to facility requirements to determine additional testing needs.
The test can be performed when the infuser is in the STOP mode and requires approximately 15 minutes to complete. Each section of the test must be run in sequence. The infuser automatically sets the delivery rate when required during the operation test.
Note: This test is available only when the infuser is UNLOCKED.
WARNING: A PATIENT SHOULD NEVER BE CONNECTED TO THE INFUSER
DURING TESTING.
5.2.1

EQUIPMENT REQUIRED

The operation test requires the following equipment, or equivalents:
-GemStar
- Reservoir, with at least 50 mL of water
- Graduated cylinder, 25 mL or larger, graduated in 0.1 mL
- Two fresh, disposable AA batteries
- Hospira-approved AC adaptor
- Serial printer cable, List Number 13078-01
®
non-filter, straight ambulatory set, List Number 13273-01
5.2.2

TEST SETUP

1. Connect the external power source and install two fresh, disposable AA batteries.
2. Power on the infuser, and press [OPTIONS].
3. Select HISTORIES from the Options menu.
4. Select OPERATION TEST from the Histories menu, and follow the instructions on the display.
5.2.3

PERFORMING THE OPERATION TEST

The infuser display provides step-by-step guidance through each section of the test.
Note: The infuser clears any program and shift totals stored in memory before
starting the operation test.
Use the checklist provided in Section 5.2.5 to record test results (see Table 5-2, GemStar
Operation Test Checklist).
Technical Service Manual 5 - 21 430-600203-003 (Rev. 07/05)
Page 64
SECTION 5 MAINTENANCE AND SERVICE TESTS
5.2.3.1
POWER TEST
1. The display indicates an external power source and batteries are connected
(see Figure 5-12).
2. Remove the disposable AA batteries and press [ external power is connected. Press [
3. Install the batteries.
4. Disconnect the external power source and press [
5. The display indicates that only batteries are connected and displays the test results. Press [
6. If the test fails, reconnect the external power source and press [ test, or press [YES/ENTER] to confirm failure.
5.2.3.2
].
].
]. The display indicates that only
].
] to rerun the
KEYPAD TEST
1. Press each key, including the bolus button. Press [YES/ENTER] last.
2. Enter one of the following results:
- If each key makes an audible tone, press [YES/ENTER].
- If any key does not make an audible tone, press [NO].
5.2.3.3
DISPLAY TEST
1. Press [YES/ENTER] when prompted. The display fills with solid boxes for approximately ten seconds. To view the solid boxes for another ten seconds after the display times out, press [
2. Enter one of the following results:
- If the display fills with solid boxes, press [YES/ENTER].
- If the display does not fill with solid boxes, press [NO].
5.2.3.4
].
LED TEST
1. Verify the green power LED and red alarm LED illuminate (see Figure 5-12).
2. Enter one of the following results:
- If both LEDs illuminate, press [YES/ENTER].
- If either of the LEDs does not illuminate, press [NO].
430-600203-003 (Rev. 07/05) 5 - 22 GemStar
®
Page 65
5.2 OPERATION TEST
5.2.3.5
VOLUME ACCURACY TEST
To pass the volume accuracy test, the infuser must deliver between 19 and 21 mL within approximately three minutes.
1. Load a primed infuser set into the device, and press [
2. Place the proximal end in the reservoir of water, and press [
3. Place the distal end in a 20 mL graduated cylinder, and press [
4. Press [START].
5. Enter one of the following results:
- If the infuser delivers between 19 and 21 mL, press [YES/ENTER].
- If the infuser does not deliver between 19 and 21 mL, press [NO].
5.2.3.6
].
].
].
DISTAL OCCLUSION TEST
To pass the distal occlusion test, the occlusion must occur within approximately 30 seconds.
1. Clamp the set 10 to 12 inches (25.4 to 30.5 cm) below the cassette.
2. Press [START].
3. One of the following test results displays. Release the clamp and press [
- If the test has passed, the infuser advances to the next test.
- If the test has failed, clean the sensors and press [ [YES/ENTER] to confirm failure.
] to rerun the test, or press
].
5.2.3.7
PROXIMAL OCCLUSION TEST
To pass the proximal occlusion test, the occlusion must occur within approximately 30 seconds.
1. Clamp the infuser set above the cassette.
2. Press [START].
3. One of the following test results displays. Release the clamp and press [
- If the test has passed, the infuser advances to the next test.
- If the test has failed, clean the sensors and press [ [YES/ENTER] to confirm failure.
] to rerun the test, or press
].
Note: Clean the sensor pins before repeating the proximal occlusion test
(see Section 5.1.1.2).
Technical Service Manual 5 - 23 430-600203-003 (Rev. 07/05)
Page 66
SECTION 5 MAINTENANCE AND SERVICE TESTS
5.2.3.8
AIR-IN-LINE TEST
To pass the air-in-line test, the alarm must occur within approximately one minute.
1. Release the clamp.
2. Remove the proximal end of the set from the reservoir, and press [
3. Press [START].
4. One of the following test results displays. Press [
- If the test has passed, the infuser advances to the next test.
- If the test has failed, clean the sensors and press [ [YES/ENTER] to confirm the failure.
].
] to rerun the test, or press
].
5.2.4

PRINTING THE TEST RESULTS

When the test is complete, the infuser displays an option to print the test results. Follow Steps 1 through 3 to print the test results (see Figure 5-17, Sample Test Results
Printout).
Note: For maximum battery life, the infuser should be operated on AC mains power
when connected to a printer or computer.
1. Connect the serial printer cable to the infuser. Refer to the system operating manual for more information.
2. Press [YES/ENTER] to print the test results.
3. After the results have been transmitted to the printer, or if [NO] is pressed, the infuser automatically proceeds to the main programming menu.
430-600203-003 (Rev. 07/05) 5 - 24 GemStar
®
Page 67
5.2 OPERATION TEST
****************************************** *
*
*
GemStar
OPERATION TEST
RESULTS
*
*
*
******************************************
PUMP SERIAL NUMBER: XXXXXXXXX
10:54AM JAN 4, 05
VERSION n.n.n
1. Case Inspection PASS
2. Cassette Pocket & Latch PASS
3. Power Check PASS
4. Keypad Test PASS
5. Display Test FAIL
6. LED Test PASS
7. Volume PASS
8. Distal Occlusion Test PASS
9. Proximal Occlusion Test PASS
10. Air-in-line Test PASS
******************************************
**
VERIFIED BY:
******************************************
******************************************
*
*
*
******************************************
1234567890123456789012345678901234567890
END OF
OPERATION TEST
RESULTS
*
*
*
04K02039
Figure 5-17. Sample Test Result Printout
Technical Service Manual 5 - 25 430-600203-003 (Rev. 07/05)
Page 68
SECTION 5 MAINTENANCE AND SERVICE TESTS
5.2.5

OPERATION TEST CHECKLIST

Use the checklist provided in Table 5-2 to record operation test results.
Table 5-2. GemStar Operation Test Checklist
Pass Fail
Power Test ❏❏
Keypad Test ❏❏
Display Test ❏❏
LED Test ❏❏
Volume Accuracy Test ❏❏
Distal Occlusion Test ❏❏
Proximal Occlusion Test ❏❏
Air-in-Line Test ❏❏
Printed Test Results ❏❏
Restoring the Infuser for Use ❏❏
Serial Number:
Verified By: Date:
430-600203-003 (Rev. 07/05) 5 - 26 GemStar
®
Page 69
5.3 PERIODIC MAINTENANCE INSPECTION
5.2.6

RESTORING THE INFUSER FOR USE

Before returning the infuser for use, it must be initialized. Initializing the infuser automatically performs the following functions:
- Resets the configuration registers
- Performs a power-on test
- Clears the error log
- Resets RAM variables
- Sets the default beeper level
- Clears user history
To initialize the infuser for use, complete the following steps:
1. Power on the infuser with a 3.0 V
2. At the power status display, press and hold [OPTIONS] until ENTER ACCESS CODE displays. Ignore the stuck key alarm that will sound while [OPTIONS] is pressed.
3. Enter access code 72255. Asterisks display as the numbers are entered.
AC adaptor only (no internal batteries).
DC
Note: Press [CHANGE} to clear an entry and enter a new code. An invalid code causes
the infuser to return to the power-on self test.
4. Press [0][2] to select INT PUMP.
5. Turn off the infuser when initialization is complete.
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, Specifications.
To perform the periodic maintenance inspection, complete the operation test in Section 5.2.
Technical Service Manual 5 - 27 430-600203-003 (Rev. 07/05)
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SECTION 5 MAINTENANCE AND SERVICE TESTS
This page intentionally left blank.
430-600203-003 (Rev. 07/05) 5 - 28 GemStar
®
Page 71
Section 6

TROUBLESHOOTING

This section contains information on technical assistance, troubleshooting references, service alarms, and operational alarms for the GemStar
®
infuser.
6.1

TECHNICAL ASSISTANCE

For technical assistance and 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

TROUBLESHOOTING REFERENCES

The following information is provided to assist in troubleshooting the GemStar®.
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.
Troubleshooting should always start with a basic infuser inspection to isolate and eliminate common infuser/cassette interface problems and user errors. Most problems can be easily resolved through non-invasive recovery procedures.
Technical Service Manual 6 - 1 430-600203-003 (Rev. 07/05)
Page 72
SECTION 6 TROUBLESHOOTING
6.2.1

TROUBLESHOOTING TOOLS

Table 6-1, Troubleshooting Tools, describes the tools available to help isolate and resolve
many infuser problems.
Table 6-1. Troubleshooting Tools
Section Description Purpose
6.2.2 Alert/alarm message
6.2.3 Printing device history Provides significant events, in chronological
5.1.2 Inspection Provides information for inspecting the physical
5.2 Operation test Verifies infuser operation, including
index Provides the appropriate reference for a specific
error type
order, such as programming and infuser performance history
and functional parameters of the infuser to assure optimal performance
programmability, pressure and air sensitivity, and volume accuracy
6.2.2

ALERT/ALARM MESSAGE INDEX

Table 6-2, Alert/Alarm Message Index, describes error types, display messages,
descriptions, and references.
Table 6-2. Alert/Alarm Message Index
Error Type Display/Description Reference
Alert message ALMOST EMPTY
CHECK PRINTER
EMPTY CONTAINER
FLASHING DISPLAY
PROGRAM INCOMPLETE
START
Sensor alarm AIR-IN-LINE
DISTAL OCCLUSION
PROXIMAL OCCLUSION
Alarm message CHANGE BATTERIES
CHECK CASSETTE
LOW BATTERIES
POWER LOSS
USING BATTERIES
430-600203-003 (Rev. 07/05) 6 - 2 GemStar
System operating manual
®
Page 73
6.2 TROUBLESHOOTING REFERENCES
Table 6-2. Alert/Alarm Message Index
Error Type Display/Description Reference
Service alarm CALL 1-800-241-4002
CODE: NN/MMM/TTT
Section 6.1, Technical Assistance
Section 6.3, Service Alarm Codes
Other display messages KEYPAD LOCKED System operating manual
NOT ALLOWED DURING INFUSION PROCESS
PRESS STOP TO HALT DELIVERY
ROUNDING
DOSE IN PROGRESS
NEW CONTAINER NOT ALLOWED
CANNOT CHANGE CLOCK WHILE THE BASE DELIVERY IS IN PROGRESS
PROGRAM EXCEEDS MAX CONTAINER SIZE
CHANGE PROGRAM VALUES
THIS OPTION IS NOT AVAILABLE WHILE PROGRAMMING THE PUMP
No display No power or sign
of functionality
Locked up Infuser is powered on
but is not responding
Section 6.1
Section 5.2.6
Technical Service Manual 6 - 3 430-600203-003 (Rev. 07/05)
Page 74
SECTION 6 TROUBLESHOOTING
6.2.3

PRINTING DEVICE HISTORY

1. Power on the infuser.
2. Wait for the self test to complete, then press [YES/ENTER].
3. Connect the printer to the infuser.
4. Press [OPTIONS].
5. Select HISTORIES from the Options Menu.
6. Select HISTORY from the Histories menu to begin printing.
Note: Refer to the system operating manual for additional printing instructions and
configuration settings.
6.3

SERVICE ALARM CODES

Service alarms indicate maintenance or repair of the infuser is required to restore proper infuser performance. Service alarm codes are displayed in the following format:
Primary Supplemental Type
NN MMM TTT
The following sections provide an explanation of service alarm codes, quick references, and service alarm code details.
6.3.1

SERVICE ALARM CODES - QUICK REFERENCE

Table 6-3, Service Alarm Codes - Quick Reference, lists error codes and descriptions.
Table 6-3. Service Alarm Codes - Quick Reference
Error Description
01/000 CONFIG register contents are not what is expected
02/000 Stack error
03/000 Invalid interrupt
03/001 Interrupt overlap
03/002 Invalid IRQ interrupt
04/000 RAM Test error
05/000 EEPROM write error – data read back does not match data written
05/001 EEPROM write error – invalid EEPROM address
06/000 Pump configuration CRC error
430-600203-003 (Rev. 07/05) 6 - 4 GemStar
®
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Table 6-3. Service Alarm Codes - Quick Reference
Error Description
06/001 Infusion data CRC error
06/002 Pump data CRC error
06/003 Program data CRC error
06/004 Speed protocol CRC error
06/005 ROM CRC error
06/006 Protected variable error
06/007 Dose data CRC error
06/008 Air calibration CRC error
06/009 Pressure calibration CRC error
06/010 Motor calibration CRC error
06/011 Settings CRC error
6.3 SERVICE ALARM CODES
07/000 High air sensor value
07/001 Negative volume sampled
07/002 Bad air sensor state
07/003 Bad air sensor event
07/004 Air sensor not calibrated
07/005 Excessive volume sampled
08/005 Bad pressure sensor event
08/006 Bad pressure sensor state
08/007 Distal pressure is out of range
08/008 Proximal pressure is out of range
09/000 Short term overdelivery
09/001 Backward motor movement
09/002 Motor not calibrated
09/006 Power on motor test
09/007 Motor not turning when it should be turning
09/008 Bad motor state
09/009 Bad motor event
09/010 Bad motor rate
09/011 Motor stack error
09/012 Motor step overlap
09/013 Motor control error
Technical Service Manual 6 - 5 430-600203-003 (Rev. 07/05)
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SECTION 6 TROUBLESHOOTING
Table 6-3. Service Alarm Codes - Quick Reference
Error Description
09/014 Bad motor step number
09/015 Motor overshot IPRF step
09/016 Motor encoder overflow
09/017 Bad restart command
09/018 Motor overdelivery
09/019 Motor underdelivery
09/020 Motor runaway
10/000 Beeper error
11/000 More than 5.5 volts measured on the 5 V line
11/001 Less than 4.5 volts measured on the 5 V line
11/002 More than 3.2 volts measured on the AA battery voltage input
11/003 More than 3.6 volts measured on the external voltage input
11/004 Less than 2.0 volts measured on the lithium battery input
12/000 Stuck key
13/000 IRQ test of oscillator – timing error
13/001 RTI test of one second interrupt – timing error
14/001 Watchdog timeout – motor was turning when it should not be turning
14/003 Watchdog error – task not responding
15/000 Power down error
16/001 Air-in-line was active when it should not be active
16/002 Key event timeout
16/003 Invalid alarm semaphore
16/004 Invalid alarm message
16/005 Invalid alarm type
16/006 Invalid alarm callback
16/007 Invalid sound type
16/008 IQUEUE full
16/009 Infusion safety task received an invalid message type
16/010 Infusion safety task received a null message type
16/011 Infusion safety task received an invalid pressure message
16/012 Infusion safety task did not receive the expected queue information
16/013 Infusion safety task received an invalid semaphore value
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6.3 SERVICE ALARM CODES
Table 6-3. Service Alarm Codes - Quick Reference
Error Description
16/014 Infusion safety task received an invalid air message
16/015 Infusion safety task received an invalid check cassette message
16/016 Infusion safety task received a resume without an initial start
16/017 Infusion safety task detects a rate mismatch
16/018 Infusion safety task detects a mode mismatch
16/019 IED has message conflict
16/020 Remote queue out full
16/021 Remote queue out empty
16/022 Remote queue out bad state
16/023 ISA bad rate
18/000 History pointer error while inserting a new record into the history log
18/001 History pointer error while traversing to bottom of history
18/002 History pointer error while traversing to top of history
21/000 Remote communication input buffer error
21/001 Keypad queue error
21/002 Remote communication input message error
Technical Service Manual 6 - 7 430-600203-003 (Rev. 07/05)
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SECTION 6 TROUBLESHOOTING
6.3.2

SERVICE ALARM CODES - DETAILS

Table 6-4, Service Alarm Codes - Details, lists primary errors, supplemental errors, types,
error detection methods, error descriptions, and possible causes.
Table 6-4. Service Alarm Codes - Details
Error
Primary
Error
(NN)
01
CPU_ERROR
02
STACK_
ERROR
03
INTERRUPT_
ERROR
Supplemental
Error
(MMM)
000
CONFIG_REG
000 Stack #
000
INVALID_
INTERRUPT
Error
Typ e
(TTT)
CONFIG register contents At power on, the
0 = RTXC stack 1 = SCI_INPUT stack 2 = SCI_OUTPUT stack 3 = IED stack 4 = UI stack 5 = DISPMGR stack 6 = INFUSION stack 7 = ISAFETY stack 8 = ALARM stack
9 = NISAFETY stack 10 = HISTORY stack 11 = REMOTE OUT stack 12 = STACKMAX
Interrupt #
1 = SPI_INTERRUPT
2 = PAIE_INTERRUPT 11 = TIC2_INTERRUPT 12 = TIC1_INTERRUPT 18 = NOCOP_
INTERRUPT
19 = CME_INTERRUPT
Detection
Method
contents of the CONFIG register is tested for the expected value.
If the contents are invalid, a service alarm occurs.
Each stack is initialized during power on.
Once per second, these values are checked for corruption.
If a guard byte has been overwritten, a service alarm occurs.
All unsupported ISRs, when called, are trapped in a service alarm
Description
and
Possible Cause
The CONFIG register does not contain the expected value due to:
CPU failure EEPROM failure
Stack overflowed due to:
CPU failure Flash RAM
failure RAM chip
failure Bus failure
An unsupported interrupt has been called due to:
Flash RAM failure
Bus failure CPU failure RAM chip
failure
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Primary
Error
(NN)
03
INTERRUPT_
ERROR
04
RAM_ERROR
Table 6-4. Service Alarm Codes - Details
Supplemental
Error
(MMM)
001
INTERRUPT_
OVERLAP
002
INVALID_IRQ_
INTERRUPT
000
INTERNAL_
TEST
6.3 SERVICE ALARM CODES
Error
Typ e
(TTT)
Interrupt #
0 = SCI_INTERRUPT serial port
3 = PAO_INTERRUPT motor forward counts = 256
4 = TO_INTERRUPT timer overflow; general purpose timing
5 = TOC5_INTERRUPT air monitoring
6 = TOC4_INTERRUPT keypad scanning
7 = TOC3_INTERRUPT pressure monitoring
8 = TOC2_INTERRUPT motor control
9 = TOC1_INTERRUPT output shaft sensor scanning
10 = TIC3_INTERRUPT motor backward ticks
13 = RTI_INTERRUPT system clock; watchdog servicing; stack checking)
14 = IRQ_INTERRUPT real-time clock chip interrupt
15 = XIRQ_INTERRUPT power loss
IRQ status byte Upon entry into the
Test #
0 = Power on test 1 = Background test
Detection
Method
Each interrupt service routine has a unique activity flag associated with it.
The flag is set upon entry into the ISR and cleared upon exit.
If, on entry, the flag is already set, a service alarm occurs.
ISR, a processing flag is set to FAILURE.
As the individual bits are processed, the flag is set to SUCCESS.
If no flags are processed, a service alarm occurs.
At power on and continuously during operation, all RAM locations are tested by writing patterns of 0XAA and 0X55 and by address count up.
Error
Description
and
Possible Cause
An interrupt was called again before the last execution completed due to:
Flash RAM failure
Bus failure CPU overload
The IRQ interrupt was called but no interrupts were processed due to:
CPU failure FPGA failure timer chip failure output shaft
sensor failure
Read/write test to internal RAM failed due to:
CPU failure
Technical Service Manual 6 - 9 430-600203-003 (Rev. 07/05)
Page 80
SECTION 6 TROUBLESHOOTING
Table 6-4. Service Alarm Codes - Details
Primary
Error
(NN)
05
EEPROM_
WR_ERROR
06
CRC_
CHKSUM_
ERROR
Supplemental
Error
(MMM)
000 N/A All writes to CPU
001 N/A All writes to CPU
000
PUMP_
CONFIG_CRC
Error
Typ e
(TTT)
N/A The configuration
Detection
Method
EEPROM are processed via a common function which reads back the EEPROM contents following a write.
If the data read back following the write does not match the data written, a service alarm occurs.
EEPROM are processed via a common function.
If the function receives an invalid EEPROM address, a service alarm occurs.
data integrity is verified:
before viewing before printing before using
in rate-lock change function
before using in menu function
at power on whenever any
dose is started or restarted
If the CRC stored with the configuration data does not match the calculated value, a service alarm occurs.
Error
Description
and
Possible Cause
Unable to write to EEPROM in the 68HC11 chip due to:
CPU EEPROM failure
CPU failure
Unable to write to EEPROM in the 68HC11 chip due to:
RAM chip failure Bus failure
The computed configuration CRC value does not match the stored value due to:
CPU EEPROM failure
CRC calculation error
430-600203-003 (Rev. 07/05) 6 - 10 GemStar
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Primary
Error
(NN)
06
CRC_
CHKSUM_
ERROR
Table 6-4. Service Alarm Codes - Details
Supplemental
Error
(MMM)
001
INFUSION_ DATA_CRC
002
PUMP_DATA_
CRC
003
PROGRAM_
CRC
6.3 SERVICE ALARM CODES
Error
Error
Typ e
(TTT)
N/A The infusion data
N/A The infuser data
N/A The infuser
Detection
Method
integrity is verified at power on and once per second while the infusion task is running.
If an invalid infusion data pointer is found or if the CRC stored with the infusion data does not match the calculated value, a service alarm occurs.
integrity is verified at power on and once per second while the infusion task is running.
If the CRC stored with the infuser data does not match the calculated value, a service alarm occurs.
program data integrity is verified:
entering stop mode
entering run mode
when a new program is sent to infusion
whenever any dose starts or restarts
If the CRC stored with the infuser program data does not match the calculated value, a service alarm occurs.
Description
and
Possible Cause
The computed infusion data CRC does not match the stored value due to:
RAM chip failure Bus failure CRC calculation
error
The computed infuser data CRC does not match the stored value due to:
RAM chip failure Bus failure CRC calculation
error
The computed infuser program CRC does not match the stored value due to:
RAM chip failure Bus failure CRC calculation
error
Technical Service Manual 6 - 11 430-600203-003 (Rev. 07/05)
Page 82
SECTION 6 TROUBLESHOOTING
Table 6-4. Service Alarm Codes - Details
Primary
Error
(NN)
06
CRC_
CHKSUM_
ERROR
Supplemental
Error
(MMM)
004
SPEED_
PROTOCOL_
CRC
005
ROM_CRC
006
PROTECTED_
VAR
Error
Typ e
(TTT)
Speed protocol # The speed protocol
N/A The Flash RAM
Variable type
003 = Air state 004 = Pressure state 006 = Distal pressure
threshold 007 = Proximal pressure
threshold
Detection
Method
data integrity is verified:
before printing a speed protocol
before viewing a speed protocol
before assigning a speed protocol
before deleting a speed protocol
before retrieving a speed protocol
If the CRC stored with the speed protocol data does not match the calculated value, a service alarm occurs.
data integrity is verified at power on and once every hour.
If the checksum stored in the Flash RAM does not match the calculated value, a service alarm occurs.
Critical data used in air and pressure sensing is mirrored in RAM when written.
When read back, the data and its mirrored value is compared to verify data integrity.
If the data value cannot be verified, a service alarm occurs.
Error
Description
and
Possible Cause
The computed speed protocol CRC does not match the stored value due to:
RAM chip failure CRC calculation
error
The computed FLASH RAM checksum does not match the stored value
The protected variable value is corrupted due to:
RAM chip failure Bus failure CPU failure
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Primary
Error
(NN)
06
CRC_
CHKSUM_
ERROR
Table 6-4. Service Alarm Codes - Details
Supplemental
Error
(MMM)
007
DOSE_DATA_
CRC
008
AIR_CAL_CRC
009
PRESS_CAL_
CRC
010
MOTOR_CAL_
CRC
6.3 SERVICE ALARM CODES
Error
Typ e
(TTT)
Dose type The dose data
N/A The air calibration
N/A The pressure
N/A The motor
Detection
Method
integrity is verified at power on, once every second and at the start of a new dose.
If the CRC stored with the dose data does not match the calculated value, a service alarm occurs.
data integrity is verified at power on and in the background.
If the CRC stored with the air calibration data does not match the calculated value, a service alarm occurs.
calibration data integrity is verified at power on and in the background.
If the CRC stored with the pressure calibration data does not match the calculated value, a service alarm occurs.
calibration data integrity is verified at power on and every time a start delivery command is sent to infusion safety.
If the CRC stored with the motor calibration data does not match the calculated value, a service alarm occurs.
Error
Description
and
Possible Cause
The computed dose data CRC does not match the stored value due to:
RAM chip failure CRC calculation
error
The computed air calibration data CRC does not match the stored value due to:
CPU EEPROM failure
CRC calculation error
The computed pressure calibration data CRC does not match the stored value due to:
CPU EEPROM failure
CRC calculation error
The computed motor calibration data CRC does not match the stored value due to:
CPU EEPROM failure
CRC calculation error
Technical Service Manual 6 - 13 430-600203-003 (Rev. 07/05)
Page 84
SECTION 6 TROUBLESHOOTING
Table 6-4. Service Alarm Codes - Details
Primary
Error
(NN)
06
CRC_
CHKSUM_
ERROR
07
AIR_
SENSOR_
ERROR
Supplemental
Error
(MMM)
011
SETTINGS_
CRC
000
HIGH_VALUE
001
AIR_NEGATIVE
_VOLUME
002
AIR_BAD_
STATE
003
AIR_BAD_
EVENT
004
AIR_NOT_
CALIBRATED
Error
Typ e
(TTT)
0 = Error when entering
a function that will alter the infuser settings
1 = Error when entering a function that displays the current lock levels
Measured value When evaluating
N/A The volume
State # The state variable
Event # If an event code
0 The AIR MAX PRE
Detection
Method
Verifies the settings data is correct when:
displaying the lock levels
entering Run mode or Stop mode
changing the PM rate, PM bolus dose, or occlusion setting
the air sensor state, the measured pre-trigger value is compared with the level set during calibration.
If the measured value is greater than the calibration value, a service alarm occurs.
delivered between checkpoints is calculated each checkpoint.
If the volume is negative and more than one stroke has been delivered, a service alarm occurs.
was not one of the recognized states for the pressure software.
is received that is not one of the recognized events for the air software, a service alarm occurs.
LEVEL is checked to see that it is not zero at power on
If it is zero, a service alarm occurs.
Error
Description
and
Possible Cause
One of the following is corrupted:
lock level occlusion setting default occlusion
setting PM rate lock
ranges
Air sensor returning too high a value due to:
calibration error air sensor
receiver fault
Negative volume sampled due to:
RAM chip failure 180 degree
miscalibration of the output shaft encoder
The air sensor was in an invalid state due to:
RAM chip failure
The air sensor received an invalid event due to:
RAM chip failure
The air sensor calibration values are not within the expected ranges due to:
calibration error EEPROM failure
430-600203-003 (Rev. 07/05) 6 - 14 GemStar
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Primary
Error
(NN)
07
AIR_
SENSOR_
ERROR
08
PRESSURE_
SENSOR_
ERROR
Table 6-4. Service Alarm Codes - Details
Supplemental
Error
(MMM)
005
AIR_
EXCESSIVE_
VOLUME
005
PRESS_BAD_
EVENT
006
PRESS_BAD_
STATE
007
PRESS_ DISTAL_
RANGE
008
PRESS_
PROX_
RANGE
6.3 SERVICE ALARM CODES
Error
Typ e
(TTT)
N/A The volume
Bad event # Pressure sensor
State # If processing is not
N/A When delivery is
N/A When delivery
Detection
Method
delivered between checkpoints is calculated each checkpoint.
If the volume exceeds 100 a service alarm occurs.
software checks events it receives against a list of valid events.
If a received event is not in the list, a service alarm occurs.
defined for a state value, a service alarm occurs.
started and after the plunger passes home, the distal threshold is recomputed.
If it is not in the 0–255 range, a service alarm occurs.
is started, the proximal occlusion threshold is recomputed.
If it is not in the 0–255 range, a service alarm occurs.
µL,
Error
Description
and
Possible Cause
Excessive volume sampled due to:
RAM chip failure 180 degree
miscalibration of the output shaft encoder
CPU overload
The pressure sensor received an invalid event due to:
RAM chip failure Bus failure
The pressure sensor state variable was invalid due to:
RAM chip failure Bus failure
The distal pressure is out of range due to:
corruption of calibration data used to compute pressure
computation error in hardware or software
RAM error
The proximal pressure is out of range due to:
corruption of calibration data used to compute pressure
computation error in hardware or software
RAM error
Technical Service Manual 6 - 15 430-600203-003 (Rev. 07/05)
Page 86
SECTION 6 TROUBLESHOOTING
Table 6-4. Service Alarm Codes - Details
Primary
Error
(NN)
09
MOTOR_
ERROR
Supplemental
Error
(MMM)
000
MOTOR_IPRF_
ENC_OS_SYNC
Typ e
(TTT)
Step where problem occurred
Error
Detection
Method
IPRF steps, in general, are expected to begin on the pump side of the stroke.
If the microprocessor misses motor encoder counts, the plunger will advance further than it should, resulting in a short-term overdelivery.
Before beginning to deliver the next step, the software tests the output shaft flag position to detect that it is still on the pump side of the stroke.
There are several exceptions:
Step 0 of any delivery
Step 7 of an 8-step delivery
Steps 13, 14, and 15 of a 16-step delivery
Error
Description
and
Possible Cause
Microprocessor misses motor encoder counts
This error will never be reported for single step IPRF (30.1 mL/hr to 125 mL/hr).
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Primary
Error
(NN)
09
MOTOR_
ERROR
Table 6-4. Service Alarm Codes - Details
Supplemental
Error
(MMM)
000
MOTOR_IPRF_
ENC_OS_SYNC
Typ e
(TTT)
Step where problem occurred
6.3 SERVICE ALARM CODES
Error
Detection
Method
The last step of a stroke frequently overshoots its stopping position, near full extension, so Step 0 often starts on the fill side.
If the output shaft has the maximum positive offset (+10), all other steps can be expected to start on the output shaft flag.
If the output shaft has the maximum negative offset (-30), any step beginning at a position under 186 should be expected to start on the output shaft flag.
The steps that may not start on the flag is this case are:
Step 7 of an 8-step delivery
Steps 13, 14, and 15 of a 16-step delivery
Error
Description
and
Possible Cause
Microprocessor misses motor encoder counts
This error will never be reported for single step IPRF (30.1 mL/hr to 125 mL/hr).
Technical Service Manual 6 - 17 430-600203-003 (Rev. 07/05)
Page 88
SECTION 6 TROUBLESHOOTING
Table 6-4. Service Alarm Codes - Details
Primary
Error
(NN)
09
MOTOR_
ERROR
Supplemental
Error
(MMM)
001
MOTOR_
BACKWARD_
MOVEMENT
Typ e
(TTT)
Type 1:
single rollback greater than 40 counts
number of backward encoder counts
Type 2:
excessive accumulation of rollbacks greater than 16 counts
accumulated backward counts in excess of 16
Error log data, Type 1 only:
26/000/sss 26/fff/bbb 26/ppp/aaa
Where:
sss = iprf step number fff = forward count register
(*PACNT) bbb = total back ticks
this stroke ppp = distal pressure
(ADC) aaa = distal alarm flag
(1 = alarm) For each rollback greater
than 16 counts, error log contains:
29/ppp/rrr 29/ccc/nnn
Where: ppp = distal pressure
(ADC)
rrr = rollback amount, ticks ccc = count of large
rollbacks within this 16-stroke window
nnn = net position (forward–back counts) at start of this step
Error
Detection
Method
Type 1: The motor encoder
backward count accumulator tests the number of counts each time a count is accumulated.
If the backward count exceeds the limit (40), a service alarm occurs.
Type 2: Each time the
motor is started, if the number of backward counts in the previous rollback is greater than 16, the amount in excess of 16 is accumulated.
This accumulation is cleared every 16 strokes.
If the accumulation exceeds 40 counts, a service alarm occurs.
Error
Description
and
Possible Cause
Excessive motor backward movement due to:
high distal pressure
motor clutch failure
motor gearbox failure
430-600203-003 (Rev. 07/05) 6 - 18 GemStar
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Page 89
Primary
Error
(NN)
09
MOTOR_
ERROR
Table 6-4. Service Alarm Codes - Details
Supplemental
Error
(MMM)
002
MOTOR_NOT_
CALIBRATED
006
NO_MOTOR_
CONTROL
Typ e
(TTT)
Error type
0 = Invalid PWM 1 = Stroke volume 2 = Motor slope 4 = Output shaft offset
Error type
1 = Shorted switch FET 2 = Backward movement 3 = Motor does not turn 4 = Motor runs too fast 5 = Motor runs backward
Error log data for 09/006/003:
24/000/iii 24/fff/ppp
Where:
iii = motor current (ADC) fff = forward count register
(*PACNT) ppp = distal pressure
(ADC)
6.3 SERVICE ALARM CODES
Error
Detection
Method
The motor calibration values are tested at power on to verify they are within expected ranges.
If a value is out of range, a service alarm occurs.
For each new rate, a PWM is calculated.
If the calculated value is less than the minimum set during calibration, a service alarm occurs.
At power on, a motor test is performed to verify that, with other motor controls set, the motor does not turn when the motor switch FET is off and that the motor does turn when the motor switch FET is on.
If a test fails, a service alarm occurs.
Error
Description
and
Possible Cause
The motor calibration values are not within the expected ranges due to:
calibration error EEPROM failure
The power on motor control test failed
independent motor switch FET failed
motor wiring error
motor encoder strobe failure
motor encoder failure
PIC became active (003)
PIC failure (003)
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SECTION 6 TROUBLESHOOTING
Table 6-4. Service Alarm Codes - Details
Primary
Error
(NN)
09
MOTOR_
ERROR
Supplemental
Error
(MMM)
007
MOTOR_NOT_
PUMPING
Typ e
(TTT)
State #; Event # The type field is displayed
as xy, where x is the state # and y is the event #.
No movement while:
016 = Homing 036 = Stepping 046 = Continuous 066 = Ramping up
Error log data:
25/fff/bbb 25/vvv/iii 25/sss/000 25/ppp/aaa 25/nnn/ttt 25/ooo/eee 25/ddd/ccc 25/aal/prx
Where: fff = forward count register
(*PACNT) bbb = mticks_
back_stroke
iii = motor current (ADC) vvv = motor voltage (ADC) sss = motor speed (pwm) ppp = distal pressure
(ADC) aaa = distal alarm
local flag (1= alarm) nnn = motor encoder
enable (1 = on) ttt = motor encoder
strobe (1 = on) ooo = motor drive on
(1 = on) eee = motor drive
enable (1 = on) ddd = distal occlusion
alarm condition (1 = on) ccc = check cassette
alarm condition (1 = on) aal = air alarm condition
(1 = on) prx = proximal occlusion
alarm condition (1 = on)
Error
Detection
Method
Motor movement is tested during ramp up, IPRF homing, IPRF stepping, and continuous delivery.
If the PWM value to the motor reaches 200 and no movement is detected, a service alarm occurs.
Error
Description
and
Possible Cause
No encoder counts detected when the motor is supposed to be running due to:
motor drive failure
motor encoder strobe failure
motor encoder failure
PIC became active
The motor was off when it should not be due to:
independent motor switch FET fails off
V+ regulator shorted to ground
motor circuit open
The motor has stalled, due to:
motor drivetrain failure (high torque)
high backpressure
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Primary
Error
(NN)
09
MOTOR_
ERROR
Table 6-4. Service Alarm Codes - Details
Supplemental
Error
(MMM)
008
MOTOR_BAD_
STATE
009
MOTOR_BAD_
EVENT
010
MOTOR_BAD_
RATE
011
MOTOR_
STACK_
ERROR
012
MOTOR_
STEP_
OVERLAP
6.3 SERVICE ALARM CODES
Error
Typ e
(TTT)
State # If the motor state
State #; Event # The type field is displayed
as xy, where x is the state # and y is the event #.
Error #
000 = IPRF rate: 0.1 mL/hr 001 = Continuous rate:
1000 mL/hr
002 = Taper time is zero 003 = Taper dose is zero 004 = Taper starting rate:
400 mL/hr 005 = Taper ending up
rate: 400 mL/hr 006 = Taper down starting
rate is zero 007 = Taper down dose
cannot be delivered with the given starting rate and taper time
Error #
001 = Stack full 002 = Stack empty 003 = Invalid stack pointer
detected when pushing onto the stack
004 = Invalid stack pointer detected when popping from the stack
State #; Event #
15 = While homing 35 = While stepping
Detection
Method
variable is out of range, a service alarm occurs.
If event processing is not allowed within the current state, a service alarm occurs.
When a start command is received from the infusion task, the rate is verified to be within the acceptable range of values.
The stack is checked for space available before a state is added to the stack and for no data present before a state is removed from the stack.
If a stack request cannot be processed, a service alarm occurs.
A timer is used to control IPRF motor steps.
If the motor is homing or stepping when the timer expires, a service alarm occurs.
Error
Description
and
Possible Cause
The motor state variable was invalid due to:
RAM chip failure
The motor received an invalid event due to:
RAM chip failure
The motor received an invalid rate due to:
RAM chip failure Bus failure
An error was detected in processing the motor stack due to:
RAM chip failure Bus failure
A motor step did not complete before the next step was requested due to:
motor encoder strobe failure
motor encoder failure
motor encoder output failure
motor clutch failure (high torque)
Technical Service Manual 6 - 21 430-600203-003 (Rev. 07/05)
Page 92
SECTION 6 TROUBLESHOOTING
Table 6-4. Service Alarm Codes - Details
Primary
Error
(NN)
09
MOTOR_
ERROR
Supplemental
Error
(MMM)
013
MOTOR_RATE_
CONTROL_
ERROR
014
MOTOR_BAD_
STEP_NUM
015
MOTOR_
OVERSHOT
Error
Typ e
(TTT)
Error #
001 = Initial calculation 002 = Normal operation 003 = Rate adjustment
Error log data:
27/aaa/bbb
Where:
aaa = counts steps (1 = on) bbb = step #
Step # At the end of each
Step # of the second (last) step that overshot
Error log data:
23/000/sss 23/mmm/nnn 23/kkk/lll 23/ggg/hhh
Where:
sss = motor PWM mmm/nnn = NetBad2 =
(mmm*100) + nnn NetBad2 reports the net
counts (FINE_POS) as of the second consecutive overshot step reported in the
09/015 alarm kkk/lll = NetBad1 =
(kkk * 100) + lll NetBad1 reports the
net counts (FINE_POS) as of the step before the one reported in the 09/015 alarm
ggg/hhh = NetGood = (ggg * 100) + hhh
NetGood reports the net counts (FINE_POS) of the last step that was within tolerance (two steps before the one reported in the 09/015 alarm)
Detection
Method
The PWM_LOW_ COUNTER value must always be between 0 and 10.
When tested, if PWM_LOW_ COUNTER is ever greater than 10, the service alarm results.
IPRF motor step, the step number is incremented and confirmed to be within the expected range for that delivery rate.
After each IPRF step, the software checks the actual stopping position.
If two consecutive steps overshoot the stopping position by two points or more, a service alarm occurs.
Error
Description
and
Possible Cause
Error due to:
RAM chip failure Bus failure
The motor was performing an invalid step due to:
RAM chip failure Bus failure
The motor overshot the stopping position, due to:
software control error
motor encoder strobe failure
motor encoder failure
motor servo failure
430-600203-003 (Rev. 07/05) 6 - 22 GemStar
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Page 93
Primary
Error
(NN)
09
MOTOR_
ERROR
Table 6-4. Service Alarm Codes - Details
Supplemental
Error
(MMM)
016
MOTOR_ ENCODER_ OVERFLOW
Typ e
(TTT)
Type 1: Pulse accumulator
back counts in previous stroke
Type 2: Output shaft scan
pulse accumulator value
Error log data, Type 1:
22/aaa/bbb 22/ccc/ddd 22/eee/fff
Where:
aaa = IPRF step bbb = total turns (low byte) ccc/ddd = overflow ticks
as 256 * ccc + ddd eee/fff = net counts
forward minus backward as 256 * aaa + bbb
Error log data, Type 2:
28/aaa/bbb 28/ccc/ddd 28/eee/fff 28/ggg/hhh 28/iii/jjj
Where:
aaa = number of overflows bbb = whether pulse
accumulator has overflowed since previous pulse accumulator interrupt
ccc/ddd = forward limit, as 256 * ccc + ddd
eee/fff = total forward counts, as 256 * eee + fff
ggg/hhh = forward counts on previous turn
iii/jjj = total turns since starting infuser
6.3 SERVICE ALARM CODES
Error
Detection
Method
For purposes of this alarm, the maximum allowed number of forward motor counts per output shaft revolution is 432 + 80 + 8*N, where N is the number of times the motor stopped on the previous revolution.
If the forward counts are found to exceed this value, a service alarm occurs.
Error
Description
and
Possible Cause
The motor encoder overflow count was not cleared due to:
output shaft sensor strobe failure
output shaft sensor failure
output shaft encoder levels out of spec., possibly due to sensor positioning; reflectivity of parts; component variations; supply voltage variations; open/short in OSE subsystem; flag mismounted
stripped coupling gearbox failure other
transmission failure
Technical Service Manual 6 - 23 430-600203-003 (Rev. 07/05)
Page 94
SECTION 6 TROUBLESHOOTING
Table 6-4. Service Alarm Codes - Details
Primary
Error
(NN)
09
MOTOR_
ERROR
Supplemental
Error
(MMM)
017
MOTOR_BAD_
RESTART
018
MOTOR_
OVER_
DELIVERY
Error
Typ e
(TTT)
N/A The motor ISR
Error
1 = Too fast 2 = Turns exceeded dose
Error log data, if error = 1:
19/aaa/bbb 19/ccc/ddd
Where:
aaa = turns observed bbb = turns max ccc = window duration,
seconds ddd = dose count Error log data, if error = 2:
19/000/aaa 19/bbb/ccc 19/ddd/eee 19/fff/ggg 19/hhh/iii
Where:
aaa = dose count bbb/ccc/ddd/eee =
output shaft turns limit, as:
bbb * 256 ^ 3 + ccc * 256 ^ 2 + ddd * 256 ^ 1+ eee * 256 ^ 0
(i.e., high byte to low byte, and ^ is exponentiation)
fff/ggg/hhh/iii = total observed output shaft turns, expressed high byte to low byte as above
Detection
Method
verifies that the current rate is not zero when it receives a restart command from the infusion task.
Every five seconds, the infusion safety task tests the number of output shaft turns.
If the calculated number of turns is more than 25% above the expected number of turns, a service alarm occurs.
If this code appears, print out the error log from diagnostic mode.
Error
Description
and
Possible Cause
The motor received an invalid restart command due to:
RAM chip failure Bus failure
For 09/018/001 The infuser is
delivering at too high a rate due to:
V+ regulator fails high
motor servo failure
software control fault
180 degree miscalibration of the output shaft encoder
The indicated rate is above actual rate, due to:
spurious transitions on output shaft
encoder For 09/018/002 Extra turns were
detected, possibly due to:
spurious
transitions on
output shaft
encoder
software failure
to stop motor
at end of dose
motor start
without
permission
430-600203-003 (Rev. 07/05) 6 - 24 GemStar
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Page 95
Primary
Error
(NN)
09
MOTOR_
ERROR
Table 6-4. Service Alarm Codes - Details
Supplemental
Error
(MMM)
019
MOTOR_
UNDER_
DELIVERY
Typ e
(TTT)
Error
1 = Too fast 2 = Turns exceeded dose
Error log data, if error = 1:
19/pa1/pa2 19/000/sho 19/aaa/bbb 19/ccc/ddd
Where: pa1 = PACNT_
EXTENDED (high) pa2 = PACNT_
EXTENDED (low)
sho = short turns 000 = always zero aaa = turns observed bbb = turns max ccc = window duration,
seconds ddd = dose count Error log data, if error = 2:
19/pa1/pa2 19/sho/aaa 19/bbb/ccc 19/ddd/eee 19/fff/ggg 19/hhh/iii
Where: pa1 = PACNT_
EXTENDED (high) pa2 = PACNT_
EXTENDED (low)
sho = short rev count aaa = dose count bbb/ccc/ddd/eee =
output shaft turns limit, as:
bbb * 256 ^ 3 + ccc * 256 ^ 2 + ddd * 256 ^ 1+ eee * 256 ^ 0
(i.e., high byte to low byte, and ^ is exponentiation)
fff/ggg/hhh/iii = total observed output shaft turns, expressed high byte to low byte as above
6.3 SERVICE ALARM CODES
Error
Detection
Method
Every five seconds, the infusion safety task tests the number of output shaft turns.
If the calculated number of turns is more than 25% below the expected number of turns, a service alarm occurs.
If this code appears, print out the error log from diagnostic mode.
Error
Description
and
Possible Cause
The infuser is delivering at too low a rate due to:
V+ regulator fails low
motor servo failure
software control fault
Technical Service Manual 6 - 25 430-600203-003 (Rev. 07/05)
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SECTION 6 TROUBLESHOOTING
Table 6-4. Service Alarm Codes - Details
Primary
Error
(NN)
09
MOTOR_
ERROR
10
BEEPER_
ERROR
11
POWER_
SENSING_
ERROR
Supplemental
Error
(MMM)
020
MOTOR_
TAKEOFF
000 0 indicates digital signal
000
OVERVOLT_
5V
001
UNDERVOLT_
5V
Error
Typ e
(TTT)
Count of doses begun since the infuser was powered on
Error log data:
19/pa1/pa2 19/obs/sho
Where: pa1 = PACNT_
EXTENDED (high) pa2 = PACNT_
EXTENDED (low) obs = observed turns
(low) sho = short revs The infuser counts each
rate change as a new dose, except when resuming delivery after a purge, and during TPN ramping.
was low and should have been high.
1 indicates digital signal was high and should have been low.
ADC 5 V input reading The 5V line is
ADC 5 V input reading The 5 V line is
Detection
Method
Every two seconds while the delivery is not in progress, the number of output shaft turns is compared with a limit value which is set whenever a dose stops (the current number of turns plus three).
If the number of turns measured exceeds this limit, a service alarm occurs.
At power on, when non-infusion safety task is initiated, a check is performed to determine if the beeper is emitting sound.
If the signal is high when the beeper should be off or low; or when the beeper should be on, a service alarm is activated.
tested at power on and once each second.
If the voltage is greater than expected, a service alarm occurs.
tested at power on and once each second.
If the voltage is less than expected a service alarm occurs.
Error
Description
and
Possible Cause
Indicated rate is above actual rate due to:
spurious
transitions on
output shaft
encoder Motor fails to stop
when expected, due to:
software control
error
An incorrect digital signal could indicate that the beeper is not functioning properly or that the circuitry designed to check the beeper is malfunctioning.
More than 5.5 volts measured on the 5 V line due to:
5 V regulator
failure
power sensing
circuitry failure
Less than 4.5 volts measured on the 5 V line due to:
5 V regulator
failure
power sensing
circuitry failure
430-600203-003 (Rev. 07/05) 6 - 26 GemStar
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Page 97
Primary
Error
(NN)
11
POWER_
SENSING_
ERROR
12
STUCK_KEY
Table 6-4. Service Alarm Codes - Details
Supplemental
Error
(MMM)
002
OVERVOLT_
ALK
003
OVERVOLT_
EXT
004
NO_LITHIUM
N/A Key value At power on the
ADC battery compartment input reading
ADC external power input reading
ADC lithium input reading The lithium battery
Typ e
(TTT)
The AA battery input line is tested at power on and once each second.
If the voltage is greater than expected, a service alarm occurs.
The external power input line is tested at power on and once each second.
If the voltage is greater than expected, a service alarm occurs.
input line is tested at power on and once each second.
If the voltage is less than expected, a service alarm occurs.
keypad is scanned. If a key is active, an error message is displayed.
If the key continues to be active for more than one minute, a service alarm occurs.
The keypad ISR scans for key presses and tests each read against the previous one.
If a key is active continuously for more than one minute, a service alarm occurs.
6.3 SERVICE ALARM CODES
Error
Detection
Method
Error
Description
and
Possible Cause
More than 3.2 volts measured on the battery voltage input due to:
improper type of batteries installed
More than 3.6 volts measured on the external input due to:
power sensing circuitry failure
Less than 2 volts measured on the lithium battery input due to:
lithium battery discharged
lithium battery output shorted
A stuck key press was detected due to:
keypad failure
Technical Service Manual 6 - 27 430-600203-003 (Rev. 07/05)
Page 98
SECTION 6 TROUBLESHOOTING
Table 6-4. Service Alarm Codes - Details
Primary
Error
(NN)
13
TIME_BASE_
ERROR
Supplemental
Error
(MMM)
000 Number of RTIs counted The number
001 Number of RTIs counted The number
Typ e
(TTT)
Error
Detection
Method
of elapsed RTIs is tested once each second.
If the number is within the expected range, the count is zeroed.
If the number is not within the expected range, a service alarm occurs.
of elapsed RTIs is incremented and tested once each RTI.
If the number exceeds the upper limit value since the last one second interrupt, a service alarm occurs.
Error
Description
and
Possible Cause
Timing error due to:
oscillator failure
RTI failure
Timing error due to:
oscillator failure
clock chip failure
IRQ interrupt
failure
430-600203-003 (Rev. 07/05) 6 - 28 GemStar
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Page 99
Primary
Error
(NN)
14
WATCHDOG_
ERROR
Table 6-4. Service Alarm Codes - Details
Supplemental
Error
(MMM)
001 Reading of PACNT At power on,
003 Task number
1 = Infusion safety 2 = Non-infusion safety 3 = Pressure 4 = Motor 5 = Display manager 6 = Not used 7 = Keypad 8 = Infusion
Typ e
(TTT)
6.3 SERVICE ALARM CODES
Error
Detection
Method
the watchdog PIC is tested by overstrobing it while trying to run the motor.
If the motor moves more than 20 counts, a service alarm occurs.
Various periodic tasks update progress counters to indicate that they are still running.
Other periodic tasks check those counters and count the number of checks that have gone by without a change in the counter.
When the number of checks without change exceeds 20, a service alarm occurs.
Error
Description
and
Possible Cause
Watchdog PIC circuit is not functioning, due to:
PIC being in its disabled mode
PIC failure fault in
connection between PIC and motor power regulator SHDN pin
motor is being moved by pushing on plunger during PIC test
A periodic task has stopped updating its counter, due to:
RAM corruption or error
task deadlock programming
error
Technical Service Manual 6 - 29 430-600203-003 (Rev. 07/05)
Page 100
SECTION 6 TROUBLESHOOTING
Table 6-4. Service Alarm Codes - Details
Primary
Error
(NN)
15
POWER_
DOWN_ ERROR
16
SOFTWARE_
ERROR
Supplemental
Error
(MMM)
N/A System state
001
INVALID_
STATE
002
KEY_EVENT_
TIMEOUT
003
INVALID_
ALARM_
SEMAPHORE
Error
Typ e
(TTT)
0 = Power on 1 = Normal operation 3 = Service alarm 4 = Power off 5 = Power down started
0 The infusion safety
Task ID The callback
Semaphore value The alarm task
Detection
Method
At power on the system state is tested.
If power down processing is completed, power on processing continues.
If the system began power down processing, but did not complete it, a service alarm message is logged to the history and processing is allowed to continue.
If the power down processing did not start, a service alarm occurs.
task tests the air-in-line alarm status when it receives a start or restart command.
If the alarm is already active, a service alarm occurs.
functions failed to send an acknowledgement message to the IED task within 6 seconds after receiving a key-event.
verifies semaphore values when received.
If processing is not defined for a semaphore value, a service alarm occurs.
Error
Description
and
Possible Cause
The infuser did not perform normal power down processing due to:
hardware reset
The air-in-line was active when it should not be due to:
RAM chip failure
Bus failure
Tasks are in deadlock condition
The alarm task received an invalid alarm semaphore value due to:
RAM chip failure
Bus failure
430-600203-003 (Rev. 07/05) 6 - 30 GemStar
®
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