Duo TSM PLM0004294 (PN IFU0000500)

Technical Service Manual IFU0000500 (0 7 , 202 5 - 0 2) LifeShield™ Infusion Safety Software Suite Compatible with: For use with list number 40002 Software Version 1.2 Plum Duo ™ Precision IV Pump Plum Duo Infusion Pump Technical Service Manual Technical Service Manual i Plum Duo Infusion Pump CHANGE HISTORY Part Number Description of Change IFU0000500 (05, 2024-06) Initial Release IFU0000500 (06, 2024-12) Administration of enteral fluids removed as an intended use. Intended level of disinfection note added to Disinfection section. Air detection thresholds added to Downstream Air Detection Alarm. Specifications section updated. EMC information updated. IFU0000500 (07, 2025-02) Added note to the Pump Settings section on CDL overriding settings. Edited Battery Status section to clarify the difference between Battery Status and Live Readings. Added clarifying notes to various PM and PVT checklists, as well as PVT tests. CHANGE HISTORY Plum Duo Infusion Pump ii Technical Service Manual This page intentionally left blank. Technical Service Manual iii Plum Duo Infusion Pump CONTENTS SECTION 1 INTRODUCTION 1-1 1.1 REPORTING SERIOUS INCIDENTS . 1-2 1.2 SCOPE 1-2 1.3 CONVENTIONS 1-3 1.3.1 ILLUSTRATIONS, SCREEN DISPLAYS, AND SOFTWARE MESSAGES . 1-3 1.4 LABELING SYMBOLS GLOSSARY 1-4 1.5 ACRONYMS AND ABBREVIATIONS . 1-7 1.6 USER QUALIFICATION/INTENDED USE 1-9 1.7 ARTIFACTS 1-9 1.8 ELECTROMAGNETIC COMPATIBILITY . . 1-10 1.9 IEC 60601-2-24: 2012 (ADMINISTRATION SETS COMPLIANCE). . 1-12 SECTION 2 DEVICE IMPLEMENTATION 2-1 2.1 UNPACKING 2-1 2.2 INSPECTION 2-1 2.3 BATTERY 2-2 2.4 INFUSION PUMP OPERATION 2-3 2.5 SELF TEST . 2-4 2.6 CONNECTIVITY TEST 2-7 2.7 LIFESHIELD™ INFUSION SAFETY SOFTWARE SUITE 2-7 2.7.1 LOSS OF COMMUNICATION 2-7 2.8 DRUG LIBRARY/SETTINGS UPDATE 2-8 2.8.1 DRUG LIBRARY/SETTINGS UPDATE FAILURE 2-8 2.9 SOFTWARE UPDATE 2-9 2.9.1 SOFTWARE UPDATE FAILURE 2-9 2.10 NOTIFICATION SCREEN 2-9 2.11 ACCESS TO TOUCHSCREEN. . 2-12 2.11.1 SCREEN LOCK / AUTO-LOCK FUNCTIONALITY . 2-12 2.11.2 PASSCODE LOCK/UNLOCK FUNCTIONALITY (PASSCODE PROTECTION) . 2-13 2.11.2.1 PASSCODE LOCKING . 2-13 2.11.2.2 PASSCODE UNLOCKING . 2-14 SECTION 3 BIOMED MODE 3-1 3.1 BIOMED ACCESS FROM CLINICAL MODE 3-1 3.1.1 BIOMED MODE - ALTERNATE ACCESS . 3-5 3.2 PUMP SETTINGS SCREEN 3-8 3.2.1 PUMP DEFAULTS . 3-9 3.2.1.1 HOW TO CHANGE THE INFUSION PUMP’S DEFAULT SETTINGS 3-9 3.2.2 DEVICE SETTINGS . 3-10 3.2.2.1 HOW TO ADJUST THE DEVICE SETTINGS . 3-10 3.2.3 PROGRAMMING OPTIONS . . 3-12 3.2.4 ABOUT DEVICE. . 3-13 3.2.4.1 HOW TO SET THE MAXIMUM DELIVERY RATE . . 3-13 3.2.4.2 HOW TO UPDATE THE DRUG LIBRARY . 3-14 3.2.4.3 RESETTING PUMP INFUSION SETTINGS TO DEFAULT SETTINGS . 3-16 3.3 DATE, TIME AND REGION SCREEN . 3-17 3.3.1 HOW TO SET UP THE DATE, TIME AND REGION. . 3-19 CONTENTS Plum Duo Infusion Pump iv Technical Service Manual 3.4 MANAGE NETWORK SCREEN . 3-21 3.4.1 RESETTING NETWORK TO DEFAULT SETTINGS 3-26 3.4.2 TURNING WEBCONFIG ON/OFF . 3-27 3.4.3 TURNING CE POWER OFF/ON 3-28 3.5 BATTERY MAINTENANCE SCREEN 3-31 3.5.1 PERFORMING A BATTERY RECONDITIONING . 3-33 3.6 DISPLAY LOGS SCREEN . 3-35 3.6.1 ALARM LOG VIEW 3-35 3.6.1.1 ACCESSING THE ALARM LOGS 3-36 3.6.2 DEVICE LOG VIEW 3-36 3.6.2.1 ACCESSING THE DEVICE LOGS 3-37 3.7 FACTORY DEFAULTS SCREEN 3-37 3.7.1 RESETTING TO FACTORY DEFAULTS. 3-39 3.7.2 HARD FACTORY RESET 3-40 3.8 SOFTWARE UPDATES SCREEN 3-42 3.8.1 HOW TO PERFORM SOFTWARE UPDATES . 3-42 SECTION 4 CONNECTIVITY ENGINE (CE) CONFIGURATION .4-1 4.1 SCOPE. 4-1 4.2 ASSUMPTIONS . 4-2 4.3 GENERAL . 4-2 4.4 WEBCONFIG ACCESS 4-2 4.5 WEB CONFIGURATION TOOL SCREENS 4-3 4.5.1 LOGIN PAGE .4-4 4.5.2 CHALLENGE .4-4 4.5.3 STATUS . .4-5 4.5.4 WIRELESS PROPERTIES . .4-7 4.5.5 WIRELESS SECURITY PROPERTIES .4-9 4.5.6 CERTIFICATE PROPERTIES . 4-11 4.5.7 FILE UPLOAD . 4-13 4.5.8 INFUSION SAFETY MANAGEMENT SOFTWARE (ISMS) PROPERTIES 4-13 4.5.9 SERVICE PROPERTIES 4-14 4.5.10 ADMINISTRATION PROPERTIES 4-15 4.5.11 CONFIGURATION RESULTS . 4-16 4.6 CYBERSECURITY 4-16 4.6.1 CYBERSECURITY CONTROLS IN PLUM DUO 4-16 4.6.2 CYBERSECURITY BEST PRACTICES 4-17 4.6.3 CYBERSECURITY CONTROLS AT HOSPITALS . 4-17 4.6.4 EXTERNAL NETWORK INTERFACES AVAILABLE AND NETWORK PORTS OPEN IN PLUM DUO . 4-18 4.6.5 SUSPECTED CYBERSECURITY EVENT OR THREAT . 4-19 4.7 TROUBLESHOOTING . 4-20 4.8 INFUSION PUMP DATA DECOMMISSIONING 4-20 SECTION 5 MAINTENANCE AND SERVICE TESTS .5-1 5.1 CLEANING AND DISINFECTION 5-1 5.2 CLEANING 5-2 5.2.1 APPROVED CLEANING SOLUTIONS .5-2 5.2.2 CLEANING SUPPLIES .5-3 5.2.3 PREPARING THE INFUSION PUMP FOR CLEANING .5-3 5.2.4 GENERAL CLEANING INSTRUCTIONS. .5-4 5.2.5 CLEANING THE INFUSION PUMP .5-5 5.3 DISINFECTION 5-8 CONTENTS Technical Service Manual v Plum Duo Infusion Pump 5.3.1 APPROVED DISINFECTING SOLUTIONS 5-8 5.3.2 DISINFECTING SUPPLIES 5-8 5.3.3 PREPARING THE INFUSION PUMP FOR DISINFECTION 5-9 5.3.4 GENERAL DISINFECTION INSTRUCTIONS . 5-9 5.3.5 DISINFECTING THE INFUSION PUMP . 5-10 5.4 PREPARATION FOR MAINTENANCE AND TESTING . 5-11 5.4.1 TESTING EQUIPMENT LIST . . 5-11 5.4.2 TEST SETUPS . 5-12 5.4.2.1 BASIC TEST SETUP . . 5-12 5.4.2.2 DOWNSTREAM OCCLUSION TEST SETUP . 5-21 5.4.2.3 UPSTREAM AIR-IN-LINE TEST SETUP . . 5-24 5.4.2.4 DOWNSTREAM AIR-IN-LINE TEST SETUP. . 5-24 5.4.2.5 PRIMING A RUN-IN CASSETTE ASSEMBLY . 5-25 5.4.3 PROGRAMMING A “NO DRUG SELECTED DELIVERY- BASIC - ML/HR” . 5-29 5.5 PREVENTIVE MAINTENANCE (PM) AND PERFORMANCE VERIFICATION TEST (PVT) . 5-32 5.5.1 PREVENTIVE MAINTENANCE . . 5-34 5.5.2 PREVENTIVE MAINTENANCE CHECKLIST . . 5-35 5.5.3 PERFORMANCE VERIFICATION TEST (PVT) . 5-36 5.5.4 PERFORMANCE VERIFICATION TEST CHECKLIST . . 5-37 5.6 INSPECTIONS AND TESTS . 5-38 5.6.1 LABELS INSPECTION. . 5-38 5.6.2 AC (MAINS) POWER CORD, RETAINER, AND STRAP INSPECTION. . 5-39 5.6.3 FRONT HOUSING, REAR HOUSING, BOTTOM HOUSING, RUBBER PADS, AND BATTERY COVER INSPECTION AND TEST . 5-40 5.6.4 CASSETTE DOOR, DOOR LEVER, AND DOOR ROLLER INSPECTION AND TEST . 5-42 5.6.5 FLUID SHIELD INSPECTION . 5-44 5.6.6 DOWNSTREAM PRESSURE PIN INSPECTION . 5-48 5.6.7 UPSTREAM PRESSURE PIN INSPECTION . . 5-49 5.6.8 POLE CLAMP INSPECTION AND TEST . . 5-50 5.6.9 DISPLAY AND INDICATORS INSPECTION AND TEST . 5-52 5.6.10 CONNECTIVITY TEST. . 5-55 5.6.11 ALARM AND GENERAL VOLUME LOUDNESS TEST . . 5-55 BEGINNING OF MANUAL PERFORMANCE VERIFICATION TEST (PVT) (PREVENTIVE MAINTENANCE CONTINUES) . 5-59 5.6.12 TOUCHSCREEN TEST . 5-59 5.6.13 DISPLAY BACKLIGHT LEVEL AND AUTO-BRIGHTNESS TESTS . . 5-61 5.6.14 TOUCH FEEDBACK TEST . 5-62 5.6.15 PIEZO TEST . . 5-62 5.6.16 CASSETTE ALARM TEST . 5-63 5.6.17 DOWNSTREAM OCCLUSION TEST . 5-64 5.6.18 UNRESTRICTED FLOW TEST . 5-75 5.6.19 UPSTREAM OCCLUSION TEST . 5-76 5.6.20 DOWNSTREAM AIR-IN-LINE TEST . 5-78 5.6.21 UPSTREAM AIR-IN-LINE TEST . . 5-83 5.6.22 DELIVERY ACCURACY TEST . 5-88 5.6.23 ELECTRICAL SAFETY TEST . 5-96 END OF MANUAL PERFORMANCE VERIFICATION TEST (PVT) . . 5-96 5.6.24 BATTERY RECONDITIONING PROCESS . 5-97 5.6.25 END OF MANUAL MAINTENANCE AND SERVICE TESTS . 5-97 BEGINNING OF GUIDED PERFORMANCE VERIFICATION TEST (PVT) (PREVENTIVE MAINTENANCE CONTINUES) . 5-98 5.6.26 PERFORMANCE VERIFICATION TEST MODE SCREEN (GUIDED PVT) . 5-98 5.6.27 TOUCHSCREEN TEST (GUIDED) . 5-100 5.6.28 BACKLIGHT LEVEL AND AUTO-BRIGHTNESS TEST (GUIDED) 5-102 CONTENTS Plum Duo Infusion Pump vi Technical Service Manual 5.6.29 TOUCH FEEDBACK TEST (GUIDED) . 5-104 5.6.30 PIEZO TEST (GUIDED) . . 5-105 5.6.31 CASSETTE ALARM TEST (GUIDED) . 5-106 5.6.32 DOWNSTREAM OCCLUSION TEST (GUIDED) . 5-107 5.6.33 UNRESTRICTED FLOW TEST (GUIDED) . 5-113 5.6.34 UPSTREAM OCCLUSION TEST (GUIDED) . 5-115 5.6.35 DOWNSTREAM AIR-IN-LINE TEST (GUIDED) . 5-117 5.6.36 UPSTREAM AIR-IN-LINE TEST (GUIDED) . . 5-119 5.6.37 DELIVERY ACCURACY TEST (GUIDED) . 5-121 5.6.38 ELECTRICAL SAFETY TEST (GUIDED). . 5-124 END OF GUIDED PERFORMANCE VERIFICATION TEST (PVT) . . 5-125 5.6.39 BATTERY RECONDITIONING PROCESS . . 5-126 5.6.40 END OF GUIDED MAINTENANCE AND SERVICE TESTS . . 5-126 SECTION 6 TROUBLESHOOTING .6-1 6.1 TECHNICAL ASSISTANCE 6-1 6.2 ALARM MESSAGES AND ALARM CODES 6-1 6.2.1 OPERATIONAL ALARM MESSAGES AND CODES .6-2 6.2.2 ALARM CODES REQUIRING TECHNICAL SERVICE 6-16 6.2.3 ALERT MESSAGES AND CODES 6-26 6.3 TROUBLESHOOTING PROCEDURES. 6-30 6.3.1 UNRESTRICTED FLOW. 6-32 6.3.2 RESETTING THE NETWORK SETTINGS TO FACTORY DEFAULTS 6-33 6.3.3 RESETTING THE INFUSION PUMP SETTINGS TO FACTORY DEFAULTS . 6-33 SECTION 7 REPLACEABLE PARTS AND REPAIRS .7-1 7.1 REPLACEABLE PARTS 7-1 7.2 REPLACEMENT PROCEDURES 7-8 7.2.1 SAFETY AND EQUIPMENT PRECAUTIONS .7-8 7.2.2 REQUIRED TOOLS AND MATERIALS .7-8 7.2.3 AC POWER CORD, AC POWER CORD LABEL, AC POWER CORD RETAINER, AND CORD RETENTION STRAP REPLACEMENT .7-9 7.2.4 DISASSEMBLING THE BATTERY COMPARTMENT . 7-11 7.2.5 BATTERY ASSEMBLY, BATTERY COVER, BATTERY INNER HOUSING AND BATTERY COVER GASKET REPLACEMENT 7-13 7.2.6 DISASSEMBLING THE BOTTOM HOUSING, TUBING GUIDE, AND SIDE TRIM . 7-15 7.2.7 REPLACING THE BOTTOM HOUSING, TUBING GUIDE, TUBING GUIDE LABEL(S), AND SIDE TRIM 7-17 7.2.8 INFUSION MECHANISM ASSEMBLY COMPONENTS REPLACEMENT 7-18 7.2.8.1 MECHANISM ASSEMBLY, MECHANISM RETENTION BRACKET, MECHANISM CABLE, AND MECHANISM CHASSIS BUMPER REPLACEMENT 7-18 7.2.8.2 CASSETTE DOOR ASSEMBLY, DOOR COVER, DOOR COVER HOLDER, DOOR PIVOT, AND INNER DOOR ASSEMBLY REPLACEMENT . 7-21 7.2.8.3 FLUID SHIELD ASSEMBLY REPLACEMENT 7-24 7.2.8.4 DOOR HANDLE/LEVER, DOOR LINK, LEVER COVER ASSEMBLY, PLASTIC RIVET, . 188 X .025 RETAINING RING AND 1 EXTENSION SPRING REPLACEMENT 7-29 7.2.9 REPLACING THE CHASSIS AND CHASSIS SEAL 7-32 7.2.10 REAR HOUSING COMPONENT REPLACEMENT 7-36 CONTENTS Technical Service Manual vii Plum Duo Infusion Pump 7.2.10.1 POWER SUBSYSTEM REPLACEMENT . . 7-36 7.2.10.2 HOUSING GASKET, PUMP HANDLE CENTER, .926 I.D. O-RING, PUMP HANDLE SHELL, AND ΜUSB CABLE REPLACEMENTS . . 7-39 7.2.10.3 POLE CLAMP ASSEMBLY, POLE CLAMP EXTRUSION, POLE CLAMP BRACKET, AND POLE CLAMP INSULATOR REPLACEMENT . 7-41 7.2.10.4 REAR HOUSING AND PRODUCT RATING LABEL REPLACEMENT . 7-43 7.2.10.5 POLE CLAMP KNOB ASSEMBLY AND POLE CLAMP SHAFT TIP REPLACEMENT . 7-44 7.2.11 FRONT HOUSING ASSEMBLY COMPONENTS REPLACEMENT . . 7-46 7.2.11.1 CPU PWA REPLACEMENT . . 7-48 7.2.11.2 PIEZO ALARM ASSEMBLY REPLACEMENT . 7-49 7.2.11.3 SPEAKER ASSEMBLY, SPEAKER BRACKET AND SPEAKER SEAL REPLACEMENT . 7-50 7.2.11.4 POWER BUTTON ASSEMBLY REPLACEMENT . 7-51 7.2.11.5 ANTENNA REPLACEMENT . . 7-52 7.2.11.6 AC MAINS GROMMET, BRIDGE FLEX CABLE, AND HAPTIC VIBRATOR REPLACEMENT . 7-53 7.2.11.7 FRONT HOUSING SUB-ASSEMBLY REPLACEMENT . 7-54 7.2.12 RUBBER PAD REPLACEMENT . . 7-55 SECTION 8 SPECIFICATIONS . 8-1 APPENDIX . A-1 CONTENTS Plum Duo Infusion Pump viii Technical Service Manual This page intentionally left blank. CONTENTS Technical Service Manual ix Plum Duo Infusion Pump Figures Figure 2-1 Plum Duo AC ON LED 2-4 Figure 2-2 System Self Test Screen . 2-4 Figure 2-3 Select Clinical Care Area 2-5 Figure 2-4 Insert Cassette to Program . 2-5 Figure 2-5 Cassette Testing in Progress 2-5 Figure 2-6 Plum Duo Infusion Pump - Primary and Secondary Lines 2-6 Figure 2-7 Wireless Signal Strength Icon . 2-7 Figure 2-8 LifeShield/Wireless Connectivity Icon - Clinical Mode . 2-8 Figure 2-9 Settings Icon - Notifications . 2-10 Figure 2-10 Settings Screen 2-10 Figure 2-11 Settings - Notification Button 2-11 Figure 2-12 Settings - Notification Button - Software Update . 2-11 Figure 2-13 Notification Screen 2-11 Figure 2-14 Lock Screen Icon - Locked 2-12 Figure 2-15 Screen Unlock Feature 2-12 Figure 2-16 Lock Screen Icon- Open . 2-13 Figure 2-17 Lock Passcode 2-13 Figure 2-18 Lock Screen Icon - Locked 2-14 Figure 2-19 Unlock Passcode . 2-14 Figure 3-1 Settings Icon 3-1 Figure 3-2 Settings Screen 3-2 Figure 3-3 Settings Screen - Launch Biomed 3-2 Figure 3-4 Settings Screen - Launch Biomed Confirmation . 3-2 Figure 3-5 Unable to Launch Biomed 3-3 Figure 3-6 Biomed Mode Authentication 3-3 Figure 3-7 Biomed Mode Settings Menu 3-4 Figure 3-8 Biomed Mode Access . 3-5 Figure 3-9 Pending Update Cancelled . 3-6 Figure 3-10 Biomed Mode Authentication 3-6 Figure 3-11 Biomed Mode Settings Menu 3-7 Figure 3-12 Infusion Pump Settings Screen 3-8 Figure 3-13 Pump Default Settings Section 3-9 Figure 3-14 Device Settings Screen 3-10 Figure 3-15 Programming Options Section 3-12 Figure 3-16 Programming Options Section - Edit Button 3-13 Figure 3-17 Set Maximum Delivery Rate 3-13 Figure 3-18 About Device Section - Update Button 3-14 Figure 3-19 New Drug Library Update 3-14 Figure 3-20 Library Update in Progress . 3-15 Figure 3-21 Successful Drug Library Update 3-15 Figure 3-22 Reset to Defaults Button . 3-16 Figure 3-23 Reset to Defaults Pop-Up 3-17 Figure 3-24 Date, Time and Region Screen 3-18 Figure 3-25 Set Time Screen Details . 3-19 Figure 3-26 Manage Network Screen . 3-21 Figure 3-27 Reset Network to Default Settings 3-26 Figure 3-28 Remote Access - WebConfig On/Off 3-27 Figure 3-29 Remote Access - CE Power Off 3-28 Figure 3-30 Remote Access - Confirm CE Shut Down 3-28 Figure 3-31 CE Shutdown Progress 3-29 Figure 3-32 Remote Access - CE Shutdown 3-29 Figure 3-33 Remote Access - CE OFF 3-30 Figure 3-34 Remote Access - CE ON . 3-30 Figure 3-35 Remote Access - CE Starting Up 3-30 Figure 3-36 Battery Maintenance Screen 3-31 CONTENTS Plum Duo Infusion Pump x Technical Service Manual Figure 3-37 Battery Reconditioning . 3-33 Figure 3-38 Battery Reconditioning - Progress Bars 3-34 Figure 3-39 Battery Reconditioning - Complete 3-34 Figure 3-40 Alarm Log View . 3-35 Figure 3-41 Alarm Log View . 3-36 Figure 3-42 Factory Defaults Screen 3-38 Figure 3-43 Factory Defaults - Factory Reset 3-39 Figure 3-44 Factory Reset - Confirmation Pop-Up 3-39 Figure 3-45 Hard Factory Reset - Touch Points 3-40 Figure 3-46 Hard Factory Reset - Touch Points 3-41 Figure 3-47 Hard Factory Reset - Touch Points 3-41 Figure 3-48 New Software Available Screen 3-42 Figure 3-49 New Software Installation in Progress 3-43 Figure 3-50 Successful Software Installation 3-44 Figure 5-1 Hard-to-Reach Areas 5-5 Figure 5-2 Opening the Cassette Door 5-6 Figure 5-3 Cleaning the Pins and Sensors 5-7 Figure 5-4 Basic Test Setup 5-12 Figure 5-5 Closing the Flow Regulator 5-13 Figure 5-6 Filter Vent Cover 5-13 Figure 5-7 Inserting the Piercing Pin 5-14 Figure 5-8 Squeezing the Drip Chamber 5-14 Figure 5-9 Secondary Port . 5-14 Figure 5-10 Opening the Flow Regulator . 5-14 Figure 5-11 Removing Air from the Administration Set 5-15 Figure 5-12 Closing the Flow Regulator 5-15 Figure 5-13 Opening the Cassette Door 5-16 Figure 5-14 Cassette Finger Grip . 5-16 Figure 5-15 Cassette and Door Guide . 5-17 Figure 5-16 Inserting the Piercing Pin 5-18 Figure 5-17 Squeezing the Drip Chamber 5-18 Figure 5-18 Opening the Roller Clamp 5-18 Figure 5-19 Closing the Roller Clamp 5-19 Figure 5-20 Option-Lok Collar and Clave Secondary Port 5-19 Figure 5-21 Capped Secondary Port 5-19 Figure 5-22 Complete Basic Test Setup 5-20 Figure 5-23 Downstream Occlusion Test Setup 5-21 Figure 5-24 Three-Way Stopcock Ports 5-22 Figure 5-25 Attaching the Three-Way Stopcock to the DPM 5-22 Figure 5-26 Securing the Downstream Tubing to the Three-Way Stopcock 5-23 Figure 5-27 DPM Connector Height . 5-23 Figure 5-28 Preparing the Upstream Run-In Cassette . 5-24 Figure 5-29 Preparing the Downstream Run-In Cassette 5-25 Figure 5-30 Parts of a Run-In Cassette 5-26 Figure 5-31 Pulling Out the Flow Regulator . 5-27 Figure 5-32 Pressing the Pumping Chamber 5-28 Figure 5-33 Preventing Air from Returning to the Pumping Chamber . 5-28 Figure 5-34 Line Selection - Tap to Program 5-29 Figure 5-35 Touchscreen Keypad - Type in to Filter 5-30 Figure 5-36 Basic Mode - No Drug Selected 5-30 Figure 5-37 Program Primary Line R/L1 - Select Option . 5-30 Figure 5-38 Program Primary Line R/L1 - Program Primary Infusion Button 5-31 Figure 5-39 Enable Numeric Keypad 5-31 Figure 5-40 Plum Duo Infusion Pump Labels 5-38 Figure 5-41 Plum Duo Power Cord, Retainer, and Strap . 5-39 Figure 5-42 Front and Rear Housings . 5-41 Figure 5-43 Bottom Housing, Rubber Pads, and Battery Cover 5-41 Figure 5-44 Cassette Door and Door Lever . 5-42 CONTENTS Technical Service Manual xi Plum Duo Infusion Pump Figure 5-45 Door Roller Inspection . 5-43 Figure 5-46 Releasing the Cassette Door 5-44 Figure 5-47 Door Fully Open 5-45 Figure 5-48 Inspecting the Fluid Shield with Feeler Gauge 5-46 Figure 5-49 Infusion Mechanism Control Pins and Sensors 5-47 Figure 5-50 Downstream Pressure Pin 5-48 Figure 5-51 Upstream Pressure Pin 5-49 Figure 5-52 Pole Clamp and Extrusion on Plum Duo Infusion Pump . 5-50 Figure 5-53 Pole Clamp Assembly . 5-51 Figure 5-54 Plum Duo AC ON LED 5-52 Figure 5-55 Power Button and AC ON LED 5-53 Figure 5-56 Self Test 5-53 Figure 5-57 Self Test - ICU Medical Connections Logo . 5-54 Figure 5-58 Plum Duo Infusion Pump Display and Indicators 5-54 Figure 5-59 Plum Duo Infusion Pump Settings Icon 5-55 Figure 5-60 Settings Screen 5-55 Figure 5-61 Pump Settings - Audio . 5-56 Figure 5-62 Audio Screen 5-56 Figure 5-63 Audio Screen - Alarm Volume . 5-57 Figure 5-64 Audio Screen - General Volume 5-57 Figure 5-65 Keypress Sounds Off 5-58 Figure 5-66 Swipe to Program without Cassette 5-59 Figure 5-67 No Left/Right Cassette Pop-Up 5-60 Figure 5-68 Select Clinical Care Area 5-60 Figure 5-69 Plum Duo Infusion Pump Touchscreen Keypad . 5-60 Figure 5-70 Pump Settings- Backlight Level 5-61 Figure 5-71 Ambient Light Sensor Hidden Position 5-61 Figure 5-72 Pump Settings- Touch Feedback 5-62 Figure 5-73 Cassette Testing in Progress 5-63 Figure 5-74 New Patient? - YES . 5-64 Figure 5-75 Rate and VTBI - Downstream Occlusion Test . 5-65 Figure 5-76 Off/Closed Position to the DPM 5-65 Figure 5-77 Review Primary Line R/L1 5-66 Figure 5-78 Plum Duo Infusion Pump - Pumping Status 5-66 Figure 5-79 Clinical Settings 5-67 Figure 5-80 Downstream Pressure Screen 5-67 Figure 5-81 Clinical Settings - Downstream Pressure - 6 psi . 5-68 Figure 5-82 Unsaved Changes Pop-Up . 5-68 Figure 5-83 Off/Closed Position to the Open Port 5-69 Figure 5-84 High Alarm Downstream Occlusion Pop-Up 5-69 Figure 5-85 Alarm Icon and Screen Blinks Red 5-70 Figure 5-86 Off/Closed Position to the Downstream Tubing 5-70 Figure 5-87 Off/Closed Position to the DPM 5-71 Figure 5-88 Clinical Settings - Downstream Pressure - 10 psi 5-71 Figure 5-89 Downstream Occlusion Test - Pumping Status 5-72 Figure 5-90 Off/Closed Position to the Open Port 5-72 Figure 5-91 High Alarm Downstream Occlusion Pop-Up 5-73 Figure 5-92 Alarm Icon and Screen Blinks Red 5-73 Figure 5-93 Off/Closed Position to the Downstream Tubing 5-74 Figure 5-94 Off/Closed Position to the DPM. 5-74 Figure 5-95 Edit or Clear 5-75 Figure 5-96 New Patient? - NO 5-75 Figure 5-97 Rate and VTBI - Upstream Occlusion Test . 5-76 Figure 5-98 Review Primary Line R/L1 5-77 Figure 5-99 Upstream Occlusion Test - Pumping Status 5-77 Figure 5-100 Upstream Occlusion Alarm . 5-78 Figure 5-101 Confirm Stop Pop-Up 5-78 Figure 5-102 Line Selection - Tap to Program. . 5-79 CONTENTS Plum Duo Infusion Pump xii Technical Service Manual Figure 5-103 Pump Settings 5-79 Figure 5-104 Clinical Settings - Volume Infused 5-80 Figure 5-105 Clinical Settings - Volume Infused Screen 5-80 Figure 5-106 Clear Volume Infused 5-81 Figure 5-107 Rate and VTBI - Downstream Air-In-Line Test . 5-81 Figure 5-108 Review Primary Line R/L1 5-82 Figure 5-109 Downstream Air-In-Line Test - Pumping Status 5-82 Figure 5-110 Downstream Air-In-Line Alarm . 5-83 Figure 5-111 Line Selection - Tap to Program. 5-84 Figure 5-112 Clinical Settings - Volume Infused Screen 5-84 Figure 5-113 Clear Volume Infused 5-85 Figure 5-114 Rate and VTBI - Upstream Air-In-Line Test 5-85 Figure 5-115 Review Primary Line R/L1 5-86 Figure 5-116 Upstream Air-In-Line Test - Pumping Status 5-86 Figure 5-117 Upstream Air Alarm 5-87 Figure 5-118 Delivery Accuracy Test Setup 5-88 Figure 5-119 Rate and VTBI - Delivery Accuracy Test 5-89 Figure 5-120 Review Primary Line R/L1 Screen 5-89 Figure 5-121 Options Button -When VTBI Complete Alarms Field 5-90 Figure 5-122 Delivery Accuracy Test - Pumping 5-90 Figure 5-123 Program Secondary Line R/L2 . 5-91 Figure 5-124 Program Secondary Line R/L2 - No Drug Selected 5-91 Figure 5-125 Program Secondary Line 2 R/L - Program Piggyback Infusion 5-92 Figure 5-126 Program Secondary Line R/L2 - Piggyback . 5-92 Figure 5-127 Review Primary Line R/L1 5-93 Figure 5-128 Delivery Accuracy Test - Pumping R/L2 5-93 Figure 5-129 Callback 5-94 Figure 5-130 VTBI Complete Line R/L2 . 5-94 Figure 5-131 VTBI Completed 5-95 Figure 5-132 PVT Mode Screen One . 5-98 Figure 5-133 PVT Mode Screen Two . 5-99 Figure 5-134 Enter PVT Mode 5-99 Figure 5-135 Touchscreen Test Screen . . 5-100 Figure 5-136 Touchscreen Test Partially Completed . . 5-101 Figure 5-137 Backlight and Auto-Brightness Test Screen . . 5-102 Figure 5-138 First Display Brightness Confirmation . 5-102 Figure 5-139 Second Display Brightness Confirmation . . 5-103 Figure 5-140 Ambient Light Sensor Location . . 5-103 Figure 5-141 Touch Feedback Test Instructions . 5-104 Figure 5-142 Touch Feedback Confirmation . . 5-104 Figure 5-143 Piezo Test Screen . 5-105 Figure 5-144 Piezo Sound Confirmation . 5-105 Figure 5-145 Cassette Alarm Test Screen . . 5-106 Figure 5-146 Insert Empty Cassette . 5-106 Figure 5-147 Downstream Occlusion Test Screen . 5-107 Figure 5-148 Off/Closed Position to the DPM . 5-108 Figure 5-149 Downstream Occlusion Infusion Status . 5-108 Figure 5-150 Off/Closed Position to the Open Port . 5-109 Figure 5-151 Enter DPM Pressure Reading . 5-109 Figure 5-152 Off/Closed Position to the Downstream Tubing . 5-110 Figure 5-153 Off/Closed Position to the DPM. . 5-110 Figure 5-154 Off/Closed Position to the Open Port . 5-111 Figure 5-155 Enter DPM Pressure Reading . 5-112 Figure 5-156 Unrestricted Flow Test Screen . . 5-113 Figure 5-157 First Stopped Fluid Flow Confirmation . . 5-113 Figure 5-158 Second Stopped Fluid Flow Confirmation . 5-114 Figure 5-159 Upstream Occlusion Test Screen . . 5-115 Figure 5-160 Line Clamped Confirmation . 5-115 CONTENTS Technical Service Manual xiii Plum Duo Infusion Pump Figure 5-161 Line Unclamped Confirmation . 5-116 Figure 5-162 Downstream Air-in-Line Test Screen 5-117 Figure 5-163 Insert Downstream Air-in-Line Test Cassette . 5-118 Figure 5-164 Upstream Air-in-Line Test Screen 5-119 Figure 5-165 Insert Upstream Air-in-Line Test Cassette 5-120 Figure 5-166 Delivery Accuracy Test Screen 5-121 Figure 5-167 Delivery Accuracy Test Setup . 5-122 Figure 5-168 Enter Volume Delivered 5-123 Figure 5-169 Electrical Safety Test Screen 5-124 Figure 5-170 Enter Recorded Values 5-125 Figure 6-1 Regulator Closer . 6-32 Figure 7-1 Illustrated Parts Breakdown (Sheet 1 of 4) . 7-4 Figure 7-2 Illustrated Parts Breakdown (Sheet 2 of 4) . 7-5 Figure 7-3 Illustrated Parts Breakdown (Sheet 3 of 4) . 7-6 Figure 7-4 Illustrated Parts Breakdown (Sheet 4 of 4) . 7-7 Figure 7-5 AC (Mains) Power Cord Assembly 7-10 Figure 7-6 Battery Assembly 7-12 Figure 7-7 Battery Power 7-14 Figure 7-8 Battery Serial Number . 7-14 Figure 7-9 Disassembling The Bottom Housing, Tubing Guide, and Side Trim 7-16 Figure 7-10 Main Chassis Assembly Component 7-20 Figure 7-11 Releasing the Inner Door Assembly 7-22 Figure 7-12 Cassette Door Assembly Component . 7-23 Figure 7-13 Flex Cable and Connector 7-25 Figure 7-14 Fluid Shield Tab 7-26 Figure 7-15 Normal Fluid Shield Tab Before and After Assembly is Seated 7-26 Figure 7-16 Close-up Views of Normal (Left) and Bent (Right) Fluid Shield Tab 7-27 Figure 7-17 Fluid Shield Replacement 7-28 Figure 7-18 Door Handle/Lever Components . 7-31 Figure 7-19 Separating the Front Housing Assembly, and Rear Housing Assembly . 7-33 Figure 7-20 Chassis and Chassis Seal 7-34 Figure 7-21 Cable Connections 7-35 Figure 7-22 Power Subsystem 7-38 Figure 7-23 Rear Housing Assembly Components 7-40 Figure 7-24 Pole Clamp Knob Assembly, Extrusion and Shaft Tip 7-45 Figure 7-25 Front Housing Assembly Components Replacement . 7-46 Figure 7-26 CPU PWA Replacement . 7-47 Figure 7-27 Rubber Pad Replacement 7-56 CONTENTS Plum Duo Infusion Pump xiv Technical Service Manual This page intentionally left blank. CONTENTS Technical Service Manual xv Plum Duo Infusion Pump Tables Table 1-1 Conventions 1-3 Table 1-2 Standards 1-10 Table 3-1 Pump Default Settings 3-9 Table 3-2 Default Parameters of the Device Settings 3-11 Table 3-3 Programming Option Parameters 3-12 Table 3-4 Infusion Pump Default Settings . 3-19 Table 3-5 Wireless Settings 3-22 Table 3-6 ISMS Settings 3-24 Table 3-7 Certificate Information 3-24 Table 3-8 Remote Access 3-25 Table 3-9 Battery Status 3-31 Table 3-10 Live Readings 3-32 Table 4-1 Screens 4-3 Table 4-2 Login Page 4-4 Table 4-3 Challenge 4-4 Table 4-4 Status 4-5 Table 4-5 Wireless Properties 4-7 Table 4-6 Wireless Security Properties 4-9 Table 4-7 Certificate Properties . 4-11 Table 4-8 File Upload 4-13 Table 4-9 Infusion Safety Management Software (ISMS) Properties 4-13 Table 4-10 Service Properties . 4-14 Table 4-11 Administration Properties 4-15 Table 4-12 Configuration Results . 4-16 Table 4-13 External Network Interfaces Available in Plum Duo 4-18 Table 4-14 Network Ports Open in Plum Duo 4-18 Table 4-15 Troubleshooting 4-20 Table 5-1 Cleaning Solution 5-2 Table 5-2 Cleaning Methods . 5-4 Table 5-3 Recommended Time Execution for Cleaning 5-5 Table 5-4 Disinfecting Solutions . 5-8 Table 5-5 Disinfection Methods . 5-9 Table 5-6 Recommended Time Execution for Disinfecting 5-10 Table 5-7 PM/PVT Inspections and Tests . 5-33 Table 5-8 Electrical Safety Measurements (PM) . 5-96 Table 6-1 Operational Alarm Messages and Corrective Actions . 6-2 Table 6-2 Alarm Codes Requiring Technical Service 6-16 Table 6-3 Alert Messages and Corrective Actions 6-26 Table 6-4 Troubleshooting with the PVT 6-30 Table 7-1 Illustrated Part Breakdown (IPB) for the Infusion Pump 7-1 Table A-1 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions (IEC 60601-1-2:2014+A1:2020 Edition 4.1 Compliance) A-1 Table A-2 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2:2014+A1:2020 Edition 4.1 and IEC 60601-4-2:2016 Edition 1 Compliance) A-2 Table A-3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity for Life- Supporting Equipment and Systems (60601-1-2:2014+A1:2020 Edition 4.1 and IEC 60601-4-2:2016 Edition 1 Compliance) A-3 Table A-4 Guidance for Wireless Power Transfer and 5G Cellular Range 1 A-4 Table A-5 Guidance for 5G Cellular Range 2 . A-6 Table A-6 Nearby Wi-Fi (LTE) Transmitter A-7 Table A-7 Data Traffic Estimates by Number of Infusion Pumps . A-8 CONTENTS Plum Duo Infusion Pump xvi Technical Service Manual This page intentionally left blank. Technical Service Manual 1 - 1 Plum Duo Infusion Pump Section 1 INTRODUCTION Plum Duo™ Precision IV Pump is a large volume infusion pump intended for administration of parenteral fluids, medications, and whole blood and blood products through the following routes of administration: intravenous, intra-arterial, and subcutaneous. The Plum Duo™ Precision IV Pump is intended for use in clinical environments in the hospital and other outpatient healthcare facilities by licensed healthcare professionals. These healthcare professionals are trained in the use of the infusion pump and the administration of therapies consistent with the intended use. The Plum Duo™ Precision IV Pump is intended for adults, pediatric (including infants and children), and neonatal patient populations. The Plum Duo™ Precision IV Pump (also known as Plum Duo Infusion System or Plum Duo infusion pump) can deliver fluids over a broad range of infusion rates and is capable of concurrent delivery from one or more rigid or flexible fluid containers. Plum Duo is a member of the Plum Device family, featuring an innovative design that automates many aspects of concurrent and piggyback infusions. The unique proprietary design of the cassette allows up to two lines to be delivered at independent rates and prevents free flow conditions. As the Plum Duo can accommodate two cassettes, one pump can support up to four lines. The infusion pump does not require a hanger to lower the primary line to deliver a secondary infusion. With piggyback mode functionality, the secondary line draws medication directly from the secondary container and is not dependent on head height. The flush feature enables the clinician to flush the downstream tubing volume of a piggyback therapy. The programmed flush volume is delivered from the Primary Line container at the piggyback therapy rate after the piggyback therapy completes. Also, the infusion pump allows the clinician to program loading dose and bolus on the primary or secondary line. The Plum Duo infusion pump also enables fluid pathway troubleshooting, such as removing upstream air in line, without disconnecting the patient line. The Plum Duo infusion pump is fully compatible with Plum™ Series administration sets and accessories, and the Clave™ needleless connection systems, providing a convenient and cost-effective infusion pump. The Plum Duo can act as a standalone infusion pump, or in conjunction with ICU LifeShield™ Infusion Software Suite to provide medication safety software at the point of care, with customized drug libraries to support hospital defined protocols by clinical care area. LifeShield™ Infusion Safety Software Suite connectivity is optional. For the list of features available with the version of LifeShield™ Infusion Safety Software Suite installed at your facility, contact your local representative. 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 Duo Infusion Pump System Operating Manual If a problem in device operation cannot be resolved using the information in this manual, Contact ICU Medical for technical assistance. WARNING: SERVICING ON THE PLUM DUO INFUSION PUMP IS TO BE PERFORMED ONLY BY TRAINED, AUTHORIZED PERSONNEL. SECTION 1 INTRODUCTION Plum Duo Infusion Pump 1 - 2 Technical Service Manual 1.1 REPORTING SERIOUS INCIDENTS Serious incidents associated with the use of this product should be reported to: - ICU Medical using the “Contact Us” link at www.icumed.com, and - the relevant regulatory/competent authority of the country in which the user and/or patient is established (where required). 1.2 SCOPE This manual is organized into the following sections: - Section 1 Introduction - Section 2 Device Implementation - Section 3 Biomed Mode - Section 4 Connectivity Engine (CE) Configuration - Section 5 Maintenance and Service Tests - Section 6 Troubleshooting - Section 7 Replaceable Parts and Repairs - Section 8 Specifications - Appendix The terms “infusion pump” and “device” are used interchangeably throughout the manual.