Technical Service Manual
185 Pages
Preview
Page 1
TM
INFUSION SYSTEM with
TM
For use with the following list numbers: 11971-04 12391-04 20679-04 20792-04
Technical Service Manual
Hospira, Inc. 275 North Field Drive Lake Forest, IL 60045 USA
430-95551-008 (B, 2012-11)
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Plum A+3 with Hospira MedNet Software
Technical Service Manual
Change History Part Number
Description of Change
430-95551-001 (Rev. 06/05)
Original issue
430-95551-002 (Rev. 02/06)
Second Issue Update Section 1, Section 6, Section 7, and Section 9 Added Appendix Added IEC paragraph Update/add battery warnings Update graphics throughout
430-95551-003 (Rev. 09/06)
Third Issue Add list number Update Warranty Update Section 5 and Section 7 Update graphics throughout
430-95551-004 (Rev. 03/07)
Fourth Issue Update references to wireless module 802.11 a/b/g
430-95551-005 (Rev. 08/09)
Fifth Issue Update Section 5.2.17 Update Table 6-2 Update Section 7.2.4, Section 7.2.6, Section 7.2.6.1, and Section 7.2.11 Update Section 9, Illustrated Parts Breakdown
430-95551-006 (Rev. 09/09)
Sixth Issue Update Section 5.2.14
430-95551-007 (Rev. 03/10)
Seventh Issue Update Section 1.9.3 Update Section 5.2.17 Update Table 6-2
Technical Service Manual
Plum A+ with Hospira MedNet Software
CHANGE HISTORY
430-95551-008 (B, 2012-11)
Eighth Issue Update cover art and add Hospira address on front cover Global - add symbols to Warnings and Cautions, change ® to ™, use ™ after the first or most prominent occurrence of a Hospira or a third-party product name, delete ©Hospira, Inc., and delete copyright and trademark statements Update graphics in Sections 1, 5, and 7 Update distal air-in-line test procedure in Section 5 Delete Morgan Hill return address information, add replace CPU PWA corrective actions, and add unrestricted flow procedure with unrestricted flow warning and regulator closer caution (Section 6.4.1) in Section 6 Update front enclosure replacement procedure, and update fluid shield procedure with regulator closer and unrestricted flow steps, warnings, and cautions in Section 7 Update air-in-line Air in Line Alarm for single air bolus and cumulative air bolus in Section 8 Update item 23 in Table 9-2 Update IEC symbols/descriptions and add “All Rights Reserved” on back page
Plum A+ with Hospira MedNet Software
Technical Service Manual
Contents Section 1 INTRODUCTION... 1.1 SCOPE... 1.2 CONVENTIONS... 1.3 COMPONENT DESIGNATORS... 1.4 ACRONYMS AND ABBREVIATIONS... 1.5 USER QUALIFICATION... 1.6 ARTIFACTS... 1.7 ELECTROMAGNETIC COMPATIBILITY . . . 1.8 FCC... 1.9 INSTRUMENT INSTALLATION PROCEDURE . 1.9.1 UNPACKING... 1.9.2 INSPECTION... 1.9.3 SELF TEST... 1.10 BIOMED SETTINGS... 1.10.1 ALARMS LOG... 1.10.2 SETTING THE TIME AND DATE . . . 1.11 CONNECTIVITY CHECK...
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. 1-1 . 1-1 . 1-2 . 1-3 . 1-3 . 1-5 . 1-5 . 1-6 . 1-6 . 1-7 . 1-7 . 1-7 . 1-8 . 1-10 . 1-11 . 1-12 . 1-13
Section 2 WARRANTY .
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2-1
SYSTEM OPERATING MANUAL
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3-1
THEORY OF OPERATION... 4.1 GENERAL DESCRIPTION... 4.2 ELECTRONIC SUBSYSTEM OVERVIEW... 4.2.1 CPU SUBSYSTEM... 4.2.1.1 CPU... 4.2.1.2 SYSTEM MEMORY ADDRESS MAP... 4.2.1.3 PROGRAMMABLE READ-ONLY MEMORY . 4.2.1.4 STATIC RANDOM ACCESS MEMORY . . . CONTROL LOGIC... 4.2.1.5 4.2.1.6 LCD CONTROLLER... 4.2.1.7 LCD BACKLIGHT CONTROL... 4.2.1.8 LCD CONTRAST CONTROL... 4.2.1.9 REAL-TIME CLOCK... 4.2.1.10 VOLTAGE MONITOR WATCHDOG TIMER . 4.2.1.11 ANALOG-TO-DIGITAL CONVERTER . . . 4.2.1.12 DIGITAL-TO-ANALOG CONVERTER . . . 4.2.1.13 FRONT PANEL KEYPAD MATRIX... 4.2.1.14 FRONT PANEL [ON/OFF] KEY... 4.2.1.15 FRONT PANEL LED INDICATORS... 4.2.1.16 KEYPAD LOCKOUT INTERFACE... 4.2.1.17 NURSE CALL INTERFACE... 4.2.1.18 AUDIBLE INDICATORS... 4.2.1.19 POWER SUPPLY INTERFACE... 4.2.1.20 MECHANISM INTERFACE...
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. . 4-1 . . 4-1 . . 4-2 . . 4-2 . . 4-2 . . 4-3 . . 4-3 . . 4-3 . . 4-3 . . 4-4 . . 4-4 . . 4-4 . . 4-5 . . 4-5 . . 4-6 . . 4-8 . . 4-8 . . 4-8 . . 4-8 . . 4-9 . . 4-9 . . 4-9 . . 4-9 . . 4-11
Section 3 Section 4
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CONTENTS
4.2.2
4.3
4.4
4.5
POWER SUPPLY SUBSYSTEM... 4.2.2.1 MAIN SWITCHING REGULATOR... 4.2.2.2 MAIN REGULATOR FAULT DETECTION . . 4.2.2.3 SYSTEM POWER... 4.2.2.4 AUXILIARY SUPPLIES... 4.2.2.5 POWER CONTROL... 4.2.2.6 BATTERY VOLTAGE MEASUREMENT . . . 4.2.2.7 BATTERY CHARGE/DISCHARGE CURRENT MEASUREMENT... 4.2.2.8 BATTERY CHARGER... MECHANISM SUBSYSTEM... 4.2.3 4.2.3.1 MOTORS/MOTOR DRIVE... 4.2.3.2 MOTOR POSITION SENSORS... 4.2.3.3 V2_5 REFERENCE VOLTAGE... 4.2.3.4 AIR SENSORS... 4.2.3.5 PRESSURE SENSORS... 4.2.3.6 PRESSURE SENSOR CALIBRATION... 4.2.3.7 CASSETTE TYPE/PRESENCE SELECTION . . 4.2.3.8 SERIAL EEPROM... 4.2.4 COMMUNICATION ENGINE... 4.2.4.1 ETHERNET... 4.2.4.2 WIRELESS MODULE... PRINTED WIRING ASSEMBLIES... 4.3.1 POWER SUPPLY PWA... 4.3.2 PERIPHERAL PWA... 4.3.3 ANTENNA PWA... 4.3.4 CPU PWA... 4.3.5 DRIVER PWA... 4.3.6 SWITCH PWA... 4.3.7 APP PWA... REMOTE MOUNTED PERIPHERALS... 4.4.1 LCD... 4.4.2 SEALED LEAD ACID BATTERY... MECHANICAL OVERVIEW... 4.5.1 CASSETTE... 4.5.2 MECHANISM ASSEMBLY... 4.5.2.1 MOTOR AND VALVE ASSEMBLIES... 4.5.2.2 A/B VALVE SUBSYSTEM... 4.5.2.3 INLET/OUTLET VALVE SUBSYSTEM . . . 4.5.2.4 PLUNGER DRIVE SUBSYSTEM...
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4-12 4-13 4-13 4-14 4-14 4-14 4-15
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4-15 4-16 4-16 4-16 4-18 4-18 4-19 4-20 4-22 4-22 4-22 4-22 4-23 4-24 4-24 4-24 4-25 4-25 4-25 4-26 4-27 4-27 4-27 4-27 4-27 4-28 4-28 4-30 4-30 4-30 4-31 4-31
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5-1 5-1 5-1 5-2 5-3 5-3 5-4 5-4 5-6 5-6 5-6 5-7 5-8 5-9
Section 5 MAINTENANCE AND SERVICE TESTS... 5.1 ROUTINE MAINTENANCE... 5.1.1 CLEANING AND SANITIZING... 5.2 PERFORMANCE VERIFICATION TEST... 5.2.1 EQUIPMENT REQUIRED... 5.2.2 INSPECTION... 5.2.3 TEST SETUP... 5.2.4 SELF TEST... 5.2.5 CASSETTE ALARM TEST... 5.2.6 FREE FLOW TEST... 5.2.7 DISPLAY TEST... 5.2.8 KEYPAD VERIFICATION/FUNCTIONAL TEST 5.2.9 ALARM LOUDNESS TEST... 5.2.10 LOCKOUT SWITCH TEST...
Plum A+ with Hospira MedNet Software
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Technical Service Manual
CONTENTS
5.3 5.4
5.2.11 PROXIMAL OCCLUSION TEST . 5.2.12 PROXIMAL AIR-IN-LINE TEST . 5.2.13 DISTAL AIR-IN-LINE TEST . . . 5.2.14 DISTAL OCCLUSION TEST . . . 5.2.15 DELIVERY ACCURACY TEST . . 5.2.16 NURSE CALL TEST... 5.2.17 ELECTRICAL SAFETY TEST . . . 5.2.18 END OF THE PVT... PERIODIC MAINTENANCE INSPECTION BATTERY OPERATION OVERVIEW . .
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5-9 5-10 5-10 5-12 5-14 5-15 5-15 5-16 5-16 5-17
Section 6 TROUBLESHOOTING... 6.1 TECHNICAL ASSISTANCE... 6.2 WARNING MESSAGES... 6.3 ALARM MESSAGES AND ERROR CODES... 6.3.1 OPERATIONAL ALARM MESSAGES... 6.3.2 ERROR CODES REQUIRING TECHNICAL SERVICE... 6.4 TROUBLESHOOTING PROCEDURES... 6.4.1 UNRESTRICTED FLOW... 6.4.2 RESETTING THE ETHERNET IP ADDRESS AND SUBNET MASK.
. 6-1 . 6-1 . 6-1 . 6-2 . 6-2 . 6-7 . 6-12 . 6-14 . 6-15
Section7 REPLACEABLE PARTS AND REPAIRS... 7-1 7.1 REPLACEABLE PARTS... 7-1 7.2 REPLACEMENT PROCEDURES... 7-1 7.2.1 SAFETY AND EQUIPMENT PRECAUTIONS... 7-1 7.2.2 REQUIRED TOOLS AND MATERIALS... 7-2 7.2.3 RUBBER FOOT PAD REPLACEMENT... 7-2 7.2.4 BATTERY, WIRE HARNESS, DOOR, AND DOOR PAD REPLACEMENT... 7-4 7.2.5 AC POWER CORD, RETAINER, AND VELCRO STRAP REPLACEMENT... 7-6 7.2.6 CE MODULE REPLACEMENT... 7-8 7.2.6.1 USB ADAPTOR... 7-11 7.2.7 CE MODULE COMPONENT REPLACEMENT... 7-12 7.2.7.1 VOLUME CONTROL KNOB REPLACEMENT... 7-15 7.2.7.2 ETHERNET QUICK RELEASE LATCH REPLACEMENT . . 7-16 7.2.7.3 ANTENNA PWA REPLACEMENT... 7-17 7.2.7.4 CE MODULE COVER REPLACEMENT... 7-18 7.2.8 SEPARATING THE FRONT ENCLOSURE, REAR ENCLOSURE, AND MAIN CHASSIS... 7-19 7.2.9 FRONT ENCLOSURE, REAR ENCLOSURE, OR MAIN CHASSIS REPLACEMENT... 7-21 7.2.9.1 SHOE GASKET REPLACEMENT... 7-23 7.2.9.2 FRONT/REAR ENCLOSURE GASKET REPLACEMENT . . 7-24 7.2.10 REAR ENCLOSURE COMPONENT REPLACEMENT . . . 7-26 7.2.10.1 POLE CLAMP EXTRUSION, BACKING PLATE, AND INSULATOR REPLACEMENT... 7-27 7.2.10.2 POLE CLAMP SHAFT/KNOB ASSEMBLY AND SHAFT TIP REPLACEMENT... 7-28 7.2.10.3 REAR ENCLOSURE AND HANDLE GASKETS REPLACEMENT... 7-29 7.2.11 MINIPOLE ASSEMBLY REPLACEMENT... 7-29
Technical Service Manual
v
Plum A+ with Hospira MedNet Software
FIGURES
7.2.12
MAIN CHASSIS ASSEMBLY COMPONENT REPLACEMENT . . 7.2.12.1 POWER SUPPLY PWA REPLACEMENT... 7.2.12.2 KEYPAD AND GROUND GASKET REPLACEMENT . . 7.2.12.3 DISPLAY ASSEMBLY REPLACEMENT... 7.2.12.4 CPU PWA REPLACEMENT... 7.2.12.5 PIEZO ALARM ASSEMBLY REPLACEMENT... 7.2.12.6 MECHANISM ASSEMBLY REPLACEMENT... 7.2.12.7 CASSETTE DOOR AND FLUID SHIELD REPLACEMENT 7.2.12.8 OPENER HANDLE ASSEMBLY REPLACEMENT . . .
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7-31 7-32 7-33 7-34 7-36 7-38 7-39 7-41 7-46
Section 8 SPECIFICATIONS .
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8-1
Section 9 DRAWINGS .
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9-1
Appendix .
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A-1
Index .
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I-1
Figure 1-1. Display and Keypad... Figure 1-2. Biomed Settings... Figure 1-3. Alarms Log... Figure 1-4. Setting the Time and Date... Figure 1-5. Main Delivery Screen... Figure 1-6. Rear View... Figure 4-1. Serial Interface to ADC... Figure 4-2. System Startup and Shutdown Timing, Battery Powered... Figure 4-3. Stepper Motor Coils... Figure 4-4. Air Sensor Block Diagram... Figure 4-5. Pressure Sensor Excitation and Amplifier Block Diagram... Figure 4-6. CE Module Block Diagram... Figure 4-7. Major Elements of the Dual-Channel Cassette... Figure 4-8. Fluid Path in the Cassette... Figure 4-9. Mechanism Valve Pins and Sensor Locations... Figure 5-1. Display and Keypad... Figure 5-2. Rear View... Figure 5-3. Special Cassettes with Bubble Sensor Tips Removed... Figure 5-4. Distal Occlusion Test Setup... Figure 6-1. Regulator Closer... Figure 6-2. Reset Button... Figure 7-1. Bottom View... Figure 7-2. Battery Assembly... Figure 7-3. AC Power Cord Assembly... Figure 7-4. CE Module with USB Adaptor... Figure 7-5. CE Module without USB Adaptor... Figure 7-6. CE Module Components... Figure 7-7. Rear View... Figure 7-8. Antenna PWA and Ethernet Quick Release Latch Replacement . . Figure 7-9. Separating the Front Enclosure, Main Chassis, and Rear Enclosure . Figure 7-10. Main Chassis Conductive Gaskets... Figure 7-11. Front Enclosure Gaskets...
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1-9 1-11 1-11 1-12 1-13 1-14 4-7 4-15 4-17 4-19 4-21 4-23 4-29 4-29 4-31 5-5 5-8 5-11 5-13 6-14 6-15 7-3 7-5 7-7 7-9 7-10 7-12 7-13 7-14 7-20 7-22 7-25
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Figures
Plum A+ with Hospira MedNet Software
vi
Technical Service Manual
FIGURES
Figure 7-12. Rear Enclosure Components... Figure 7-13. Minipole Assembly... Figure 7-14. Main Chassis Assembly Components... Figure 7-15. Keypad, Display, CPU PWA, and Piezo Alarm... Figure 7-16. CPU PWA Replacement... Figure 7-17. Mechanism Assembly Replacement... Figure 7-18. Fluid Shield Tab... Figure 7-19. Normal Fluid Shield Tab Before and After Assembly is Seated . . Figure 7-20. Close-up Views of Normal (left) and Bent (right) Fluid Shield Tab . Figure 7-21. Fluid Shield Replacement... Figure 7-22. Cassette Door and Opener Handle Replacement... Figure 9-1. Illustrated Parts Breakdown (1 of 2)... Figure 9-1. Illustrated Parts Breakdown (2 of 2)... Figure 9-2. Front Enclosure, Rear Enclosure, Main Chassis, and CE Module . . Figure 9-3. Front Enclosure Assembly... Figure 9-4. Rear Enclosure Assembly... Figure 9-5. CE Module... Figure 9-6. Main Chassis Assembly (1 of 2)... Figure 9-6. Main Chassis Assembly (2 of 2)... Figure 9-7. AC Power Cord Assembly and Battery Assembly... Figure 9-8. Antenna PWA and Ethernet Quick Release Latch... Figure 9-9. CPU PWA and Main Chassis... Figure 9-10. Mechanism Assembly...
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. 7-26 . 7-30 . 7-31 . 7-35 . 7-37 . 7-40 . 7-42 . 7-43 . 7-43 . 7-44 . 7-45 . 9-7 . 9-9 . 9-11 . 9-13 . 9-15 . 9-17 . 9-19 . 9-21 . 9-23 . 9-25 . 9-27 . 9-29
Conventions... System Configuration Data... Analog Inputs... Keypad Map... CPU-Power Supply Interface... CPU-Mechanism Interface Signals... Power Supply PWA Interface Connections... Peripheral PWA Interface Connections... CPU PWA Interface Connections... Driver PWA Interface Connections... APP PWA Interface Connections... Cleaning Solutions... Electrical Safety Measurements... Warning Messages... Operational Alarm Messages and Corrective Actions... Error Codes Requiring Technical Service... Troubleshooting with the PVT... Drawings... IPB for the Infuser... Guidance and Manufacturerʹs Declaration - Electromagnetic Emissions . Guidance and Manufacturerʹs Declaration - Electromagnetic Immunity . Guidance and Manufacturerʹs Declaration - Electromagnetic Immunity for Life-Supporting Equipment and Systems... Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Infusion System...
. 1-2 . 1-10 . 4-7 . 4-8 . 4-10 . 4-11 . 4-24 . 4-25 . 4-26 . 4-26 . 4-27 . 5-2 . 5-15 . 6-2 . 6-3 . 6-7 . 6-12 . 9-1 . 9-2 . A-1 . A-2
Tables Table 1-1. Table 1-2. Table 4-1. Table 4-2. Table 4-3. Table 4-4. Table 4-5. Table 4-6. Table 4-7. Table 4-8. Table 4-9. Table 5-1. Table 5-2. Table 6-1. Table 6-2. Table 6-3. Table 6-4. Table 9-1. Table 9-2. Table A-1. Table A-2. Table A-3. Table A-4.
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. A-3 . A-5
Plum A+ with Hospira MedNet Software
CONTENTS
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Technical Service Manual
Section 1
INTRODUCTION The Plum A+™ with Hospira MedNet™ Software is an advanced medication management system designed to meet the growing demand for hospital wide, alternate site, and home healthcare device standardization. Advanced clinical capabilities, autoprogramming, networked communication, and a plug-and-play platform make the Plum A+ with Hospira MedNet Software a convenient and cost-effective multipurpose, multimode, flexible infusion system. The host device contains a Communication Engine (CE) that provides wired Ethernet and wireless 802.11 a/b/g local area networking capabilities. Hospira MedNet networked application software is designed to allow a facility to customize and download a Drug Library for use with the infusion system. Before using the software, see the Hospira MedNet Software Installation and Configuration Guide, and the Hospira MedNet Software User Guide.
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
If a problem in device operation cannot be resolved using the information in this manual, contact Hospira (see Section 6.1).
Technical Service Manual
1-1
Plum A+ with Hospira MedNet Software
SECTION 1 INTRODUCTION
Specific instructions for operating the device are contained in the Plum A+ and Plum A+3 Infusion System for use with Hospira MedNet Software System Operating Manual. For device configuration and compatible module list numbers, contact Hospira. The terms “infusion system”, “infuser”, and “device” are used interchangeably throughout the manual. Figures are rendered as graphic representations to approximate actual product. Therefore, figures may not exactly reflect the product. Screen representations are examples only, and do not necessarily reflect the most current configuration.
1.2
CONVENTIONS The conventions listed in Table 1.1 are used throughout this manual. Table 1-1. Convention
Conventions
Application
Example
Italic
Reference to a section, figure, table, website, or publication
(see Section 6.1)
[ALL CAPS]
[START]
ALL CAPS
In-text references to keys, touchswitches, and display messages
Bold
Emphasis
CAUTION: Use proper ESD grounding techniques when handling components.
Screen displays
Select Set Time and Date.
CASSETTE TEST IN PROGRESS
Throughout this manual, warnings, cautions, and notes are used to emphasize important information as follows: WARNING: A WARNING CONTAINS SPECIAL SAFETY EMPHASIS AND MUST BE OBSERVED AT ALL TIMES. FAILURE TO OBSERVE A WARNING MAY RESULT IN PATIENT INJURY AND BE LIFE-THREATENING. CAUTION: A CAUTION usually appears in front of a procedure or statement. It contains information that could prevent hardware failure, irreversible damage to equipment, or loss of data.
d Note: A note highlights information that helps explain a concept or procedure.
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1-2
Technical Service Manual
1.3
COMPONENT DESIGNATORS
1.3
COMPONENT DESIGNATORS Components are indicated by alphanumeric designators, as follows: Battery
BT
Diode
D
Resistor
R
Capacitor
C
Fuse
F
Switch
SW
Crystal
Y
Integrated Circuit
U
Transistor
Q
The number following the letter is a unique value for each type of component (e.g., R1, R2).
d Note: Alphanumeric designators may be followed by a dash (-) number that indicates a pin number for that component. For example, U15-13 is pin 13 of the encoder chip [U15] on the interface PWA.
1.4
ACRONYMS AND ABBREVIATIONS Acronyms and abbreviations used in this manual are as follows: A Ampere AC Alternating current A/D Analog-to-digital ADC Analog-to-digital converter APP Air, pressure, and pin CCA Clinical care area CCFT Cold cathode fluorescent tube CE Communication engine CMOS Complementary metal-oxide semiconductor CPU Central processing unit DAC Digital-to-analog converter DC Direct current DMA Direct memory access DMM Digital multimeter DPM Digital pressure meter ECG Electrocardiogram EEG Electroencephalogram EEPROM Electrically erasable programmable read-only memory EMC Electromagnetic compatibility EMG Electromyogram EMI Electromagnetic interference ESD Electrostatic discharge ETO Ethylene oxide FPGA Field programmable gate array
Technical Service Manual
1-3
Plum A+ with Hospira MedNet Software
SECTION 1 INTRODUCTION
FSR Force sensing resistor hr Hour Hz Hertz ID Identification I/O Input/output IPB Illustrated parts breakdown IV Intravenous KB Kilobyte Kg Kilogram kHz Kilohertz KVO Keep vein open LCD Liquid crystal display LED Light emitting diode L/S Line select mA Milliampere MAC Media access control MB Megabyte mcg Microgram MHz Megahertz min Minute mL Milliliter mmHg Millimeter of mercury MMIO Memory-mapped input/output MOSFET Metal-oxide semiconductor field-effect transistor ms Millisecond ng Nanogram PROM Programmable read-only memory PVT Performance verification test PWA Printed wiring assembly PWM Pulse width modulator RAM Random access memory rms Root-mean-square RTC Real-time clock SCC Serial communication controller SCP Serial communication port SLA Sealed lead acid SMT Surface mount technology SPI Serial peripheral interface SRAM Static random access memory
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Technical Service Manual
1.5 USER QUALIFICATION
TQFP Thin quad flat pack V Volt VAC Volts AC VCC Collector supply voltage VCO Voltage-controlled oscillator VDC Volts DC Vrms Volts root mean square VSC 5 VDC supply circuitry VSO Voltage sweep oscillator VTBI Volume to be infused WDI Watchdog input WiFi Wireless fidelity
A Microampere L Microliter V Microvolt sec Microsecond
1.5
USER QUALIFICATION The Plum A+ must be used at the direction of or under the supervision of licensed physicians or certified healthcare professionals who are trained in the use of the infusion system and the administration of parenteral and enteral fluids and drugs, and whole blood or red blood cell components. Training should emphasize preventing related IV complications, including appropriate precautions to prevent accidental infusion of air. The epidural route can be used to provide anesthesia or analgesia.
1.6
ARTIFACTS Nonhazardous, low-level electrical potentials are commonly observed when fluids are administered using infusion devices. These potentials are well within accepted safety standards, but may create artifacts on voltage-sensing equipment such as ECG, EMG, and EEG machines. These artifacts vary at a rate that is associated with the infusion rate. If the monitoring machine is not operating correctly or has loose or defective connections to its sensing electrodes, these artifacts may be accentuated so as to simulate actual physiological signals. To determine if the abnormality in the monitoring equipment is caused by the infuser instead of some other source in the environment, set the device so that it is temporarily not delivering fluid. Disappearance of the abnormality indicates that it was probably caused by electronic noise generated by the infuser. Proper setup and maintenance of the monitoring equipment should eliminate the artifact. Refer to the appropriate monitoring system documentation for setup and maintenance instructions.
Technical Service Manual
1-5
Plum A+ with Hospira MedNet Software
SECTION 1 INTRODUCTION
1.7
ELECTROMAGNETIC COMPATIBILITY List numbers 20679 and 20792 are compliant with IEC/EN 60601-1-2 (2001), and have 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). List numbers 11971 and 12391 are compliant with IEC/EN 60601-1-2 (1993). The equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity (see the System Operating Manual). CAUTION: Portable and mobile RF communications equipment, such as cellular telephones, two-way radios, BluetoothTM devices, and microwave ovens in close proximity to the infusion system may affect wireless and wired communications and degrade performance of the system. Operation of the infusion system 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 infusion system to perform as intended without disturbing other equipment. The infusion system 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 that there is no electromagnetic interference, and verify normal infuser operation. Use of a shielded Ethernet cable (CAT5 STP or better) for plugging into the RJ-45 connector is required. Using an unshielded Ethernet cable may result in increased emissions. Indicates International Electrotechnical Commission (IEC) compliance.
1.8
FCC The device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15C, 15E of the FCC rules. These limits are designed to provide reasonable protection against harmful interference. The wireless LAN device in the CE has been evaluated and found to be compliant with the requirements of FCC radio frequency exposure standards.
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1.9
INSTRUMENT INSTALLATION PROCEDURE
1.9
INSTRUMENT INSTALLATION PROCEDURE CAUTION: Infusion system damage may occur unless proper care is exercised during product unpacking and installation. Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g., IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Any person who connects additional equipment to the signal input or output part is configuring a medical system, and is therefore responsible for assuring that the system complies with the requirements of IEC 60601-1-1. If in doubt, contact Hospira.
1.9.1
UNPACKING Inspect the shipping container, and, if any damage is found, contact the delivering carrier immediately. Use care when unpacking the infusion system. Retain the packing slip and save all packing material in the event it is necessary to return the infusion system to the factory. Verify the shipping container contains a copy of the System Operating Manual.
1.9.2
INSPECTION CAUTION: Inspect the infuser for evidence of damage. Do not use the device if it appears to be damaged. Should damage be found, contact Hospira. Inspect the infusion system periodically for signs of defects such as worn accessories, broken connections, or damaged cable assemblies. Replace any damaged or defective external parts. Inspect the infuser after repair or during cleaning.
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SECTION 1 INTRODUCTION
1.9.3
SELF TEST CAUTION:
Do not place the infuser in service if the self test fails.
If an alarm condition occurs during the self test, cycle the power and repeat the self test. If the alarm condition recurs, note the message and take corrective action (see Section 6). Repeat the self test. If the alarm condition continues to recur, remove the infuser from service and contact Hospira.
d Note: Do not place the infuser in service if the battery is not fully charged.
To make certain the battery is fully charged, connect the infuser to AC power for six hours.
d Note: Records prior to the date the infuser is received may be from
the manufacturing process. Disregard any events from dates prior to receipt of the infuser.
d Note: When plugging the device into an AC power outlet, grasp the AC power
cord plug and use a forward motion into the socket. Do not use a sideways motion. When unplugging the device, grasp the AC power cord plug and pull straight out. Do not pull out using the power cord cable and do not pull out at an angle.
To perform the self test, see Figure 1-1, then proceed as follows: 1. Connect the AC power cord to a grounded AC outlet. Verify the Charge/Line indicator CHARGE illuminates and an alarm tone sounds. 2. Without a cassette installed, press [ON/OFF] to turn on the infuser. 3. The LCD screen briefly displays the SELF TEST screen (see Figure 1-1). If the SELF TEST screen does not appear, contact Hospira.
d Note: The device may display a clinical care area (CCA) selection screen. . Choose a CCA and press [ENTER]
4. After the self test is complete, the message INSERT PLUM SET CLOSE LEVER appears. 5. Verify the time and date. To set the time and date, see Section 1.10.2. 6. Open the cassette door and insert a primed cassette. Close the cassette door. The cassette test is complete when the CASSETTE TEST IN PROGRESS message disappears.
d Note: The message may briefly appear prior to the
MECHANISM INITIALIZATION IN PROGRESS CASSETTE TEST IN PROGRESS message.
7. A NEW PATIENT? message may appear. Press [YES]. 8. Press [ON/OFF] to turn off the infuser.
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Technical Service Manual
1.9
INSTRUMENT INSTALLATION PROCEDURE
LINE FLOW INDICATORS A B
HOSPIRA Plum A+ 9HUsion X.XX - MM/DD/YY 2009
STATUS REGION
System Self Test In Progress
WORKING REGION
MESSAGE REGION SOFTKEY LABEL REGION
START STOP CHARGE
LINE INDICATOR
ON / OFF
CLEAR
Figure 1-1.
Technical Service Manual
2 5 8 0
1 4 7
3 6 9
SOFT KEYS
SELECT KEYPAD
.
SILENCE
Display and Keypad
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SECTION 1 INTRODUCTION
1.10
BIOMED SETTINGS The BIOMED SETTINGS screens contain the following options that can be changed or reviewed by qualified personnel: - Alarms Log - Set Time and Date All infusers (new or refurbished) are shipped with factory settings (see Table 1-2). Biomed screens do not time out for the Infuser Idle alarm or No Action alarm. The battery will not be detected in Biomed mode. Upon entry to Biomed mode, any Drug Library waiting for installation will be installed, and the infuser will power off at completion. To access the Biomed settings, proceed as follows: 1. Open the door and turn on the device. The infusion system will perform a self test. 2. After the self test is complete, the message INSERT PLUM SET CLOSE LEVER appears. Press the decimal [.] key, then [START], and verify the BIOMED SETTINGS screen is displayed (see Figure 1-2).
d Note: The. device may display a CCA screen. Choose a CCA and press [ENTER]
Table 1-2.
System Configuration Data
Data
Options Range
Factory Setting
Maximum macro IV mode delivery rate
0.1 - 99.9 mL/hr and 100 - 999 mL/hr
999 mL/hr
Macro Distal Occlusion alarm (pressure level)
1 to 15 psi
6 psi
Deliver Together enable
Concurrent or Piggyback
Piggyback
Delayed Start/Standby enable
Yes or No
Yes
Continue Rate
Rate or KVO
KVO
Nurse Callback default
Yes or No
No
Time
(24 hr) 00:00 - 23:59 in one minute increments
Factory time
Date
1/1/2002 - 12/31/2098
Factory date
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