Technical Manual
270 Pages
Preview
Page 1
TM
INFUS(5 Compatible with
TM
Software For use with the following list numbers: 30010 30011 30012 (Including English for Canada list numbers 30010-65, 30011-65, and 30012-65)
Technical Service Manual Hospira, Inc. 275 North Field Drive Lake Forest, IL 60045 USA
430-97316-003 (C, 2015-05)
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Plum 360 Infuser
Technical Service Manual
Change History Part Number
Description of Change
430-97316-003 (C, 2015-05)
Initial Release
Technical Service Manual
i
Plum 360 Infuser
CHANGE HISTORY
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Plum 360 Infuser
ii
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 INFORMATION... 1.8.1 CANADIAN DEPARTMENT OF COMMUNICATIONS INDUSTRY CANADA NOTICE (CANADA ONLY)... 1.8.2 FCC RULES, PART 15/INDUSTRY CANADA... 1.9 INSTRUMENT INSTALLATION PROCEDURE... 1.9.1 UNPACKING... 1.9.2 INSPECTION... 1.9.3 INFUSER OPERATION... 1.10 SELF TEST... 1.11 CONNECTIVITY CHECK... 1.12 BIOMED... 1.12.1 BIOMED ACCESS... 1.12.2 SOFTWARE UPDATES... 1.12.3 PREVENTIVE MAINTENANCE... 1.12.4 SET TIME AND DATE... 1.12.5 MANAGE LANGUAGES... 1.12.6 DISPLAY LOGS... 1.12.7 INFUSER SETTINGS... 1.12.7.1 INFUSER DEFAULTS... 1.12.7.2 DISPLAY DEFAULTS... 1.12.7.3 PROGRAMMING OPTIONS... 1.12.8 MANAGE NETWORK... 1.12.8.1 WIRELESS SETTINGS... 1.12.8.2 ETHERNET SETTINGS... 1.12.8.3 HOSPIRA MEDNET SETTINGS... 1.12.8.4 RESET NETWORK TO DEFAULT SETTINGS... 1.12.8.5 SHUTDOWN CE...
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1-1 1-1 1-2 1-3 1-3 1-5 1-5 1-6 1-6
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1-7 1-7 1-8 1-8 1-8 1-8 1-9 1-11 1-13 1-13 1-17 1-20 1-22 1-23 1-25 1-26 1-27 1-28 1-31 1-32 1-33 1-35 1-36 1-37 1-38
SECTION 2 WARRANTY .
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SYSTEM OPERATING MANUAL .
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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
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4-1 4-1 4-2 4-2 4-2 4-3
SECTION 3 SECTION 4
Technical Service Manual
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Plum 360 Infuser
CONTENTS
4.3
4.4
4.2.1.3 CONTROL LOGIC... 4.2.1.4 LCD CONTROLLER... 4.2.1.5 LCD BACKLIGHT CONTROL... 4.2.1.6 LCD CONTRAST CONTROL... 4.2.1.7 REAL-TIME CLOCK... 4.2.1.8 VOLTAGE MONITOR WATCHDOG TIMER . . . 4.2.1.9 ANALOG-TO-DIGITAL CONVERTER... 4.2.1.10 DIGITAL-TO-ANALOG CONVERTER... 4.2.1.11 FRONT PANEL KEYPAD MATRIX... 4.2.1.12 FRONT PANEL ON/OFF KEY... 4.2.1.13 FRONT PANEL LED INDICATORS... 4.2.1.14 NURSE CALL INTERFACE... 4.2.1.15 AUDIBLE INDICATORS... 4.2.1.16 POWER SUPPLY INTERFACE... 4.2.1.17 INFUSION MECHANISM INTERFACE... 4.2.2 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... 4.2.2.9 BATTERY... 4.2.3 INFUSION MECHANISM SUBSYSTEM... 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 PRESENCE SELECTION... 4.2.3.8 SERIAL EEPROM... 4.2.4 CONNECTIVITY ENGINE MODULE - REVISION 3.0 . . . 4.2.4.1 CE 3.0 COMMON AND PERIPHERAL INTERFACES 4.2.4.2 PLUM 360 CPU MEMORY... 4.2.4.3 WI-FI... 4.2.4.4 ETHERNET... 4.2.4.5 NURSE CALL... 4.2.4.6 PERIPHERAL POWER SUPPLY... 4.2.4.7 USB... 4.2.4.8 IMX534 APPLICATION PROCESSOR... 4.2.4.9 REAL-TIME CLOCK... 4.2.4.10 MAIN ALARM VOLUME CONTROL... PRINTED WIRING ASSEMBLIES... 4.3.1 POWER SUPPLY PWA... 4.3.2 PERIPHERAL ASSEMBLY... 4.3.3 COMMON PWA... 4.3.4 ANTENNA PWA... 4.3.5 CPU PWA... 4.3.6 DRIVER PWA... 4.3.7 SWITCH PWA... 4.3.8 APP PWA... LCD...
Technical Service Manual
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4-13 4-13 4-14 4-15 4-15 4-16 4-17 4-17 4-19 4-20 4-20 4-21 4-21 4-23 4-24 4-24 4-24 4-24 4-24 4-25 4-25 4-25 4-25 4-25 4-25 4-26 4-27 4-27 4-27 4-28 4-28 4-29 4-29
Plum 360 Infuser
CONTENTS
4.5
MECHANICAL OVERVIEW... 4.5.1 CASSETTE... 4.5.2 INFUSION 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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4-29 4-30 4-31 4-32 4-32 4-32 4-33
MAINTENANCE AND SERVICE TESTS... 5.1 CLEANING AND DISINFECTION... 5.2 CLEANING... 5.2.1 APPROVED CLEANING SOLUTIONS... 5.2.2 CLEANING SUPPLIES... 5.2.3 PREPARING THE INFUSER FOR CLEANING... 5.2.4 GENERAL CLEANING INSTRUCTIONS... 5.2.5 CLEANING EXTERIOR SURFACES... 5.2.6 CLEANING THE CASSETTE RECEPTACLE... 5.2.7 CLEANING THE POWER CORD VELCRO STRAP... 5.2.8 CLEANING INFUSER ACCESSORIES... 5.2.9 RINSING THE INFUSER... 5.2.10 DRYING THE INFUSER... 5.3 DISINFECTION... 5.3.1 APPROVED DISINFECTING SOLUTIONS... 5.3.2 DISINFECTING SUPPLIES... 5.3.3 PREPARING THE INFUSER FOR DISINFECTION... 5.3.4 GENERAL DISINFECTION INSTRUCTIONS... 5.3.5 DISINFECTING EXTERIOR SURFACES... 5.3.6 DISINFECTING THE CASSETTE DOOR AND RECEPTACLE. . 5.3.7 DISINFECTING THE POWER CORD VELCRO STRAP... 5.3.8 DISINFECTING ACCESSORIES... 5.3.9 RINSING THE INFUSER... 5.3.10 DRYING THE INFUSER... 5.4 PREVENTIVE MAINTENANCE... 5.4.1 LABELS INSPECTION... 5.4.2 AC POWER CORD, RETAINER, AND VELCRO STRAP INSPECTION... 5.4.3 FRONT ENCLOSURE, REAR ENCLOSURE, CASSETTE DOOR, AND DOOR LEVER INSPECTION AND TEST... 5.4.4 DOOR ROLLER INSPECTION AND TEST... 5.4.5 FLUID SHIELD INSPECTION... 5.4.6 DISTAL PRESSURE PIN INSPECTION... 5.4.7 PROXIMAL PRESSURE PIN INSPECTION... 5.4.8 RUBBER FOOT PAD INSPECTION... 5.4.9 POLE CLAMP INSPECTION AND TEST... 5.4.10 BATTERY REPLACEMENT... 5.4.11 KEYPAD INSPECTION... 5.4.12 DISPLAY AND INDICATORS INSPECTION... 5.4.13 PREVENTIVE MAINTENANCE CHECKLIST... 5.5 PERFORMANCE VERIFICATION TEST... 5.5.1 PVT EQUIPMENT LIST... 5.5.2 TEST SETUPS... 5.5.2.1 BASIC TEST SETUP... 5.5.2.2 PROXIMAL AIR-IN-LINE TEST SETUP... 5.5.2.3 DISTAL AIR-IN-LINE TEST SETUP... 5.5.2.4 PRIMING A RUN-IN CASSETTE ASSEMBLY...
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. 5-1 . 5-1 . 5-2 . 5-2 . 5-3 . 5-3 . 5-4 . 5-5 . 5-7 . 5-10 . 5-10 . 5-10 . 5-10 . 5-11 . 5-11 . 5-11 . 5-11 . 5-12 . 5-13 . 5-13 . 5-14 . 5-14 . 5-14 . 5-14 . 5-15 . 5-16
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5-19 5-20 5-21 5-23 5-24 5-25 5-26 5-28 5-30 5-31 5-33 5-34 5-35 5-35 5-36 5-46 5-47 5-48
Plum 360 Infuser
CONTENTS
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REPLACEABLE PARTS AND REPAIRS... 7.1 REPLACEABLE PARTS... 7.2 REPLACEMENT PROCEDURES... 7.2.1 SAFETY AND EQUIPMENT PRECAUTIONS... 7.2.2 REQUIRED TOOLS AND MATERIALS... 7.2.3 RUBBER FOOT PAD REPLACEMENT... 7.2.4 BATTERY, WIRE HARNESS, DOOR, AND DOOR PAD REPLACEMENT... 7.2.5 AC POWER CORD, RETAINER, AND VELCRO STRAP REPLACEMENT... 7.2.6 CE MODULE REPLACEMENT... 7.2.7 CE MODULE COMPONENT REPLACEMENT... 7.2.7.1 VOLUME CONTROL KNOB REPLACEMENT... 7.2.7.2 ANTENNA PWA REPLACEMENT... 7.2.7.3 CE MODULE COVER REPLACEMENT... 7.2.8 SEPARATING THE FRONT ENCLOSURE, REAR ENCLOSURE, AND MAIN CHASSIS... 7.2.9 FRONT ENCLOSURE, REAR ENCLOSURE, OR MAIN CHASSIS REPLACEMENT... 7.2.10 FRONT ENCLOSURE COMPONENT REPLACEMENT... 7.2.11 REAR ENCLOSURE COMPONENT REPLACEMENT... 7.2.11.1 POLE CLAMP ASSEMBLY, POLE CLAMP BRACKET, HANDLE BRACKET, AND INSULATOR REPLACEMENT...
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5.5.3 5.5.4 5.5.5 5.5.6 5.5.7 5.5.8 5.5.9 5.5.10 5.5.11 5.5.12 5.5.13 5.5.14 5.5.15 5.5.16 5.5.17
5.5.2.5 DISTAL OCCLUSION TEST SETUP . . . SELF TEST... CASSETTE ALARM TEST... UNRESTRICTED FLOW TEST... DISPLAY TEST... KEYPAD VERIFICATION/FUNCTIONAL TEST . . LOCKING AND UNLOCKING THE KEYPAD TEST . ALARM LOUDNESS TEST... PROXIMAL OCCLUSION TEST... PROXIMAL AIR-IN-LINE TEST... DISTAL AIR-IN-LINE TEST... DISTAL OCCLUSION TEST... DELIVERY ACCURACY TEST... NURSE CALL TEST... ELECTRICAL SAFETY TEST... END OF THE PVT...
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5-51 5-54 5-54 5-55 5-55 5-55 5-57 5-58 5-59 5-60 5-60 5-61 5-64 5-65 5-67 5-68
SECTION 6 TROUBLESHOOTING... 6.1 TECHNICAL ASSISTANCE... 6.2 ALARM MESSAGES AND ALARM CODES... 6.2.1 OPERATIONAL ALARM MESSAGES AND CODES . . 6.2.2 ALARM CODES REQUIRING TECHNICAL SERVICE . 6.3 TROUBLESHOOTING PROCEDURES... 6.3.1 UNRESTRICTED FLOW... 6.3.2 RESETTING THE NETWORK SETTINGS TO FACTORY DEFAULTS... 6.3.3 RESETTING THE INFUSER SETTINGS TO FACTORY DEFAULTS...
SECTION 7
Technical Service Manual
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Plum 360 Infuser
CONTENTS
7.2.11.2
7.2.12 7.2.13
POLE CLAMP SHAFT/KNOB ASSEMBLY AND SHAFT TIP REPLACEMENT... 7.2.11.3 REAR ENCLOSURE GASKET REPLACEMENT... MINIPOLE ASSEMBLY REPLACEMENT... MAIN CHASSIS ASSEMBLY COMPONENT REPLACEMENT . . . 7.2.13.1 POWER SUPPLY PWA REPLACEMENT... 7.2.13.2 KEYPAD REPLACEMENT... 7.2.13.3 DISPLAY ASSEMBLY REPLACEMENT... 7.2.13.4 CPU PWA REPLACEMENT... 7.2.13.5 PIEZO ALARM ASSEMBLY REPLACEMENT... 7.2.13.6 INFUSION MECHANISM ASSEMBLY REPLACEMENT . . 7.2.13.7 INFUSION MECHANISM CHASSIS GASKET TAPE INSTALLATION... 7.2.13.8 CASSETTE DOOR AND FLUID SHIELD REPLACEMENT . 7.2.13.9 DOOR HANDLE ASSEMBLY REPLACEMENT...
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SECTION 8 SPECIFICATIONS .
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9-1
SECTION 9 DRAWINGS
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APPENDIX .
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Plum 360 Infuser
CONTENTS
Figures Figure 1-1 Figure 1-2 Figure 1-3 Figure 1-4 Figure 1-5 Figure 1-6 Figure 1-7 Figure 1-8 Figure 1-9 Figure 1-10 Figure 1-11 Figure 1-12 Figure 1-13 Figure 1-14 Figure 1-15 Figure 1-16 Figure 1-17 Figure 1-18 Figure 1-19 Figure 1-20 Figure 1-21 Figure 1-22 Figure 1-23 Figure 1-24 Figure 1-25 Figure 1-26 Figure 1-27 Figure 1-28 Figure 1-29 Figure 1-30 Figure 1-31 Figure 1-32 Figure 1-33 Figure 1-34 Figure 1-35 Figure 1-36 Figure 1-37 Figure 1-38 Figure 1-39 Figure 1-40 Figure 1-41 Figure 1-42 Figure 1-43 Figure 1-44 Figure 1-45 Figure 1-46 Figure 1-47 Figure 1-48 Figure 1-49 Figure 1-50 Figure 1-51 Figure 1-52 Figure 1-53
Plum 360 Enabled Display and Keypad... Wireless Connection Available icon... Main Delivery Screen Connectivity Icons... Ethernet Connection Available Icon... Hospira MedNet is Active Symbol... WiFi Icon versus Ethernet Icon... Rear View of Plum 360 with CE Module... Plum 360 Infuser Display and Keypad... Plum 360 Charge Indicator Light... Plum 360 ON/OFF Button and Decimal Key... System Self Test Screen... Biomed Passcode Screen... Enter Passcode .963... Biomed Settings Menu... Software Request Softkey... Install Software Softkey... New Software Available Screen... New Software Installation in Progress... Device Log Shows Software Installed Successfully . . . Plum 360 Navigation Keys... Preventive Maintenance Menu Selection... PM Due Notification Screen... Change Battery Softkey... Clear Battery Warning Message... Set Time and Date Screen... Set Time and Date Screen Details... Manage Languages Menu Option... Language Settings Active Language... Change Language Activate Softkey... Confirm Language Screen... Display Logs Screen... Choose Log to View Screen... Alarm and Device Logs... Infuser Settings Menu Option... Infuser Settings Screen... Infuser Defaults Screen... Display Defaults Screen... Calibration Test Step 1 of 2 Screen... Calibration Test Step 2 of 2 Screen... Programming Options Screen... Manage Network Menu Option... Network Settings CE 3.0 Screen... Wireless Settings Menu Option... Wireless Settings Screen... Ethernet Settings Menu Option... Ethernet Settings Screen... Hospira MedNet Settings Menu Option... Hospira MedNet Settings Screen... Reset Network to Default Settings Menu Option... Reset Network Settings Screen... Shutdown CE Softkey on the Network Settings Screen . Confirm CE Shutdown Warning Screen... Wait for Shutdown Screen...
Technical Service Manual
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1-10 1-11 1-11 1-11 1-12 1-12 1-12 1-13 1-14 1-14 1-15 1-15 1-16 1-16 1-17 1-17 1-18 1-18 1-19 1-20 1-20 1-20 1-21 1-21 1-22 1-22 1-23 1-23 1-24 1-24 1-25 1-25 1-26 1-26 1-27 1-27 1-29 1-30 1-31 1-31 1-32 1-33 1-33 1-34 1-35 1-35 1-36 1-36 1-37 1-37 1-38 1-38 1-39
Plum 360 Infuser
CONTENTS
Figure 4-1 Figure 4-2 Figure 4-3 Figure 4-4 Figure 4-5 Figure 4-6 Figure 4-7 Figure 4-8 Figure 4-9 Figure 4-10 Figure 4-11 Figure 5-1 Figure 5-2 Figure 5-3 Figure 5-4 Figure 5-5 Figure 5-6 Figure 5-7 Figure 5-8 Figure 5-9 Figure 5-10 Figure 5-11 Figure 5-12 Figure 5-13 Figure 5-14 Figure 5-15 Figure 5-16 Figure 5-17 Figure 5-18 Figure 5-19 Figure 5-20 Figure 5-21 Figure 5-22 Figure 5-23 Figure 5-24 Figure 5-25 Figure 5-26 Figure 5-27 Figure 5-28 Figure 5-29 Figure 5-30 Figure 5-31 Figure 5-32 Figure 5-33 Figure 5-34 Figure 5-35 Figure 5-36 Figure 5-37 Figure 5-38 Figure 5-39 Figure 5-40 Figure 5-41 Figure 5-42 Figure 5-43 Figure 5-44 Figure 5-45
Serial Interface to ADC... System Startup and Shutdown Timing, Battery Powered... Stepper Motor Coils... Air Sensor Block Diagram... Pressure Sensor Excitation and Amplifier Block Diagram... Rear View of Plum 360 Infuser... Single Peripheral Assembly with CE 3.0 Subsystem... CE 3.0 Common PWA Block Diagram... Fluid path in the cassette... Major Elements of the Dual-Channel Cassette... Infusion Mechanism Valve Pins and Sensor Locations... Bottom View - Cleaning the Bottom of Infuser... Rear View - Cleaning the Back of Infuser... Front View - Cleaning the Keypad... Opening the Cassette Door... Cleaning the Cassette Receptacle Pins and Sensors... Plum 360 Infuser Labels... Plum 360 Power Cord, Retainer, and Velcro Strap... Front Enclosure, Rear Enclosure, Cassette Door, and Door Lever . . Door Roller Inspection... Releasing the Cassette Door... Inspecting the Fluid Shield with Feeler Gauge... Infusion Mechanism Valve Pins and Cassette Presence Diaphragm . Distal Pressure Pin... Proximal Pressure Pin... Rubber Foot Pads on Plum 360 Infuser... Pole Clamp and Extrusion on Plum 360 Infuser... Pole Clamp Assembly... Removing the Battery... Plum 360 Infuser Keypad... Plum 360 Infuser Display and Indicators... Basic Test Setup... Closing the Flow Regulator... Filter Vent Cover... Inserting the Piercing Pin... Squeezing the Drip Chamber... Secondary Port... Opening the Flow Regulator... Removing Air from the Administration Set... Closing the Flow Regulator... Opening the Cassette Door... Cassette Finger Grip... Cassette and Door Guide... Inserting the Piercing Pin... Squeezing the Drip Chamber... Opening the Roller Clamp... Closing the Roller Clamp... Option-Lok Collar and Clave Secondary Port... Capped Secondary Port... Complete Basic Test Setup... Preparing the Proximal Run-In Cassette... Preparing the Distal Run-In Cassette... Parts of a Run-In Cassette... Pulling Out the Flow Regulator... Pressing the Pumping Chamber... Preventing Air from Returning to the Pumping Chamber...
Technical Service Manual
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4-6 4-13 4-16 4-18 4-19 4-21 4-22 4-23 4-30 4-31 4-32 5-5 5-6 5-7 5-8 5-9 5-17 5-18 5-20 5-21 5-22 5-22 5-23 5-24 5-25 5-26 5-27 5-27 5-29 5-30 5-32 5-36 5-38 5-38 5-38 5-39 5-39 5-39 5-39 5-40 5-40 5-40 5-41 5-42 5-42 5-43 5-43 5-43 5-44 5-45 5-46 5-47 5-48 5-49 5-50 5-50
Plum 360 Infuser
CONTENTS
Figure 5-46 Figure 5-47 Figure 5-48 Figure 5-49 Figure 5-50 Figure 5-51 Figure 5-52 Figure 5-53 Figure 5-54 Figure 5-55 Figure 5-56 Figure 5-57 Figure 5-58 Figure 5-59 Figure 5-60 Figure 6-1 Figure 7-1 Figure 7-2 Figure 7-3 Figure 7-4 Figure 7-5 Figure 7-6 Figure 7-7 Figure 7-8 Figure 7-9 Figure 7-10 Figure 7-11 Figure 7-12 Figure 7-13 Figure 7-14 Figure 7-15 Figure 7-16 Figure 7-17 Figure 7-18 Figure 7-19 Figure 7-20 Figure 7-21 Figure 7-22 Figure 7-23 Figure 7-24 Figure 7-25 Figure 7-26 Figure 7-27 Figure 7-28 Figure 7-29 Figure 7-30 Figure 7-31 Figure 7-32 Figure 9-1 Figure 9-2 Figure 9-3 Figure 9-4 Figure 9-5
Distal Occlusion Test Setup... Three-Way Stopcock Ports... Attaching the Three-Way Stopcock to the DPM... Securing the Distal Tubing to the Three-Way Stopcock... DPM Connector Height... Passcode to Lock Keypad... Passcode to Unlock Keypad... Volume Control Knob... Positioning the Control Arm Over the DPM Connector... Positioning the Control Arm to Measure Pressure... Opening the Three-Way Stopcock to Air... Positioning the Control Arm Over the DPM Connector... Positioning the Control Arm to Measure Pressure... Delivery Accuracy Test Setup... Rear View Shows Nurse Call Interface Port... Regulator Closer... Bottom View Plum 360 Infuser... Battery Assembly... AC Power Cord Assembly... CE Module... CE Module... Rear View... Antenna PWA... Separating the Front Enclosure, Main Chassis, and Rear Enclosure . . . Front Enclosure Gaskets... Rear Enclosure Components... Minipole Assembly... Main Chassis Assembly Components... Keypad, Display, CPU PWA, and Piezo Alarm... Front and Rear View of CPU/Driver Cable Routed Through Main Chassis... CPU/Driver Cable Routed Through Main Chassis... Female Cable Connector on the CPU/Driver Cable... Male Receptacle Header Socket on the CPU PWA... Female Cable Connector on the CPU/Driver Cable Connected to the Male Receptacle Header Socket on the CPU PWA... Side View of the CPU/Driver Cable Female Connector Firmly Seated and Locked to the CPU PWA Male Connector... Infusion Mechanism in Front of Chassis... J11 Connector on the Infusion Mechanism Driver PWA... CPU/Driver Cable Connected to the Infusion Mechanism Driver PWA . Battery Power Cable Routed Toward Infusion Mechanism... Power Cable and Battery Cable Tie-wrapped... CPU PWA Replacement Assembly... Infusion Mechanism Assembly Replacement... Installing the Infusion Mechanism Chassis Gasket Tape... Fluid Shield Tab... Normal Fluid Shield Tab Before and After Assembly is Seated... Close-up Views of Normal (Left) and Bent (Right) Fluid Shield Tab . . Fluid Shield Replacement... Cassette Door and Door Handle Replacement... Illustrated Parts Breakdown... Front Enclosure, Rear Enclosure, Main Chassis, and CE Module... Front Enclosure Assembly... Rear Enclosure Assembly... CE Module...
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Plum 360 Infuser
CONTENTS
Figure 9-6 Figure 9-7 Figure 9-8 Figure 9-9 Figure 9-10 Figure 9-11
Main Chassis Assembly... AC Power Cord Assembly and Battery Assembly . Antenna PWA... CPU PWA and Main Chassis... Infusion Mechanism Assembly... Minipole Assembly...
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Plum 360 Infuser
CONTENTS
Tables Table 1-1 Table 1-2 Table 1-3 Table 1-4 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 4-10 Table 5-1 Table 5-2 Table 5-3 Table 5-4 Table 5-5 Table 5-6 Table 5-7 Table 6-1 Table 6-2 Table 6-3 Table 9-1 Table 9-2
Conventions... Infuser Default Settings... Display Default Parameters... Programming Option Parameters... Analog Inputs... Keypad Map... CPU-Power Supply Interface... CPU-Infusion mechanism Interface Signals . . . Power Supply PWA Interface Connections . . . Peripheral PWA Interface Connections... Common PWA Interface Connections... CPU PWA Interface Connections... Driver PWA Interface Connections... APP PWA Interface Connections... Cleaning Solution... Cleaning Methods... Time Intervals for Cleaning... Disinfecting Solutions... Disinfection Methods... Minimum Time Intervals for Disinfecting... Electrical Safety Measurements... Operational Alarm Messages and Corrective Actions Alarm Codes Requiring Technical Service... Troubleshooting with the PVT... Drawings... IPB for the Infuser...
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Plum 360 Infuser
Section 1
INTRODUCTION The Plum 360™ Infuser is an advanced medication management system designed to meet the growing demand for hospital wide and alternate site device standardization. Advanced clinical capabilities, auto-programming, networked communication, and a plug-and-play platform make the Plum 360 a convenient and cost-effective multipurpose, multimode, flexible infuser. The host device contains a Connectivity Engine (CE) that provides wired Ethernet and wireless 802.11 a/b/g/n local area networking capabilities. The Hospira MedNet™ networked application software is designed to allow a facility to customize and download a Drug Library for use with the infuser. Before using the software, see the Hospira MedNet Software Installation and Configuration Guide, and the Hospira MedNet Software User Guide. This Technical Service Manual is written for on site qualified and trained biomedical engineers and technicians. Instructions for operating the device are found in the Plum 360 Infuser System Operating Manual (see Section 3). For device configuration and compatible module list numbers, contact Hospira. If a problem in device operation cannot be resolved using the information in this manual, contact Hospira for technical assistance (see Section 6.1). Note: Servicing on the Plum 360 infuser is to be performed only by trained, authorized personnel.
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
The terms “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.
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Plum 360 Infuser
SECTION 1 INTRODUCTION
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 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. MANDATORY ACTION: A MANDATORY ACTION SYMBOL MEANS THE INSTRUCTIONS THAT FOLLOW DESCRIBE A REQUIRED ACTION. FAILURE TO OBSERVE A MANDATORY ACTION COULD IMPACT USER OR PATIENT SAFETY. Note: A note highlights information that helps explain a concept or procedure.
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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). 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 Connectivity 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
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Plum 360 Infuser
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 MCU Microcontroller unit 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
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Technical Service Manual
1.5 USER QUALIFICATION
SRAM Static random access memory 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 360 infuser 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 infuser and the administration of parenteral and enteral fluids and drugs, and whole blood or red blood cell components. Training should emphasize preventing related IV complications, including appropriate precautions to prevent accidental infusion of air. The epidural route can be used to provide anesthesia or analgesia.
1.6
ARTIFACTS Nonhazardous, low-level electrical potentials are commonly observed when fluids are administered using infusion devices. These potentials are well within accepted safety standards, but may create artifacts on voltage-sensing equipment such as ECG, EMG, and EEG machines. These artifacts vary at a rate that is associated with the infusion rate. If the monitoring machine is not operating correctly or has loose or defective connections to its sensing electrodes, these artifacts may be accentuated so as to simulate actual physiological signals. To determine if the abnormality in the monitoring equipment is caused by the infuser instead of some other source in the environment, set the device so that it is temporarily not delivering fluid. Disappearance of the abnormality indicates that it was probably caused by electronic noise generated by the infuser. Proper setup and maintenance of the monitoring equipment should eliminate the artifact. Refer to the appropriate monitoring system documentation for setup and maintenance instructions.
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Plum 360 Infuser
SECTION 1 INTRODUCTION
1.7
ELECTROMAGNETIC COMPATIBILITY The Plum 360 infuser (List Number 30010 with Module 30011 or 30012) has been tested to the requirements of IEC 60601-1-2:2007 and IEC 60601-2-24:2012. The infuser meets the EMC requirements of the Medical Device Directive 93/42/EEC with amendments by 2007/47/EC. Refer to the Appendix in this document for further details of the EMC testing procedures and compliance levels. Use a shielded Ethernet cable (CAT5 STP or better) for a wired connection of the infuser to the medical network. Using an unshielded Ethernet cable may result in increased emissions or reduced immunity. 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). 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 that there is no electromagnetic interference, and verify normal infuser operation.
1.8
FCC INFORMATION This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This 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 radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Re-orient or relocate the receiving antenna • Increase the separation between the equipment and receiver • Connect the equipment to an outlet on a circuit different from that to which the receiver is connected • Consult the dealer or an experienced radio/television technician for help This device and its antenna(s) must not be co-located or operated in conjunction with any other antenna or transmitter.
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Technical Service Manual