Transcription
Plum 360 System Operating ManualInfuserCompatible with:ICU Medical MedNet For use with the following list numbers30010-27,30010-54,30010-57Not CE Marked, notavailable in Europe30010-04,30010-10,30010-650086CE MarkedAustralian Sponsor:EC REP:ICU Medical B.V.Hofspoor 3, 3994 VZ Houten,The NetherlandsICU Medical Australia Pty LimitedUnit U, 10-16 South Street,Rydalmere, NSW 2116Australia430-98340-004 (01, 2018-09)ICU Medical, Inc.600 N. Field DriveLake Forest, Illinois, 60045USA
NotesiiSystem Operating Manual
Plum 360 InfuserChange HistoryPart NumberDescription of Change430-98340-003(A, 2017-09)Updated entire manual to reflect new ICU Medicalcorporate identity.Added notes about compatible administration setsand applicable software /CE versions throughout themanual.Added content for the Radio Equipment Directive inSection 1.Updated “Responding to an Alarm” and informationon restarts, and added notes in “Turning Power on”and “Turning Power Off” in Section 3.Added a new section called “To view and clear thevolumes infused before a cassette is inserted” inSection 3.Updated “Priming the Syringe Adapter” in Section 4.Added a note in “Auto-Programming the Plum 360Infuser” in section 6.Added note in “Time-Based Dose Calculation (forexample, mg/min) - Initial Programming” in Section 7.Updated information in the “Rejected Auto-Programs”and General Alarm tables in Section 9.Updated “Partially Programmed Line” in Section 9.Updated cleaning information in Section 10.Modified list of administration sets and updatedinformation on accessories in Section 12.Updated the default drug library medication names inSection 14.Updated high voltage symbol information on theinside back cover.System Operating Manualiii
Part NumberDescription of Change430-98340-004(01, 2018-09)Updated the Australian Sponsor address on the frontcover.Updated Section 1 for IEC 60601-1-2:2014 Edition 4compliance.Updated support email addresses on the inside backcover.Updated the CE Mark definition on the back cover.ivSystem Operating Manual
Plum 360 InfuserContentsSection 1, Introduction . . . . . . . . . . . . . . . . . . . . 1-1Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4Illustrations, Screen Displays, and SoftwareMessages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11Warnings, Cautions, and Guidelines . . . . . . . . . . . . . . . 1-11General Warnings and Cautions . . . . . . . . . . . . . . . . . . 1-12Piggyback, Concurrent, and Secondary DeliveryGuidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13Guidelines When Opening the Cassette Door . . . . . . . 1-16Administration Sets and Accessories Guidelines . . . . . 1-16Precautions to Avoid Unintended Bolus . . . . . . . . . . . . 1-18Guidelines to Avoid Air in the Patient Line . . . . . . . . . 1-19Guidelines During Backpriming . . . . . . . . . . . . . . . . . . . 1-19Battery Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20Guidelines During Cleaning . . . . . . . . . . . . . . . . . . . . . . 1-20Artifacts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21Interconnecting of Medical Equipment . . . . . . . . . . . . 1-22Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . 1-23FCC Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26US FCC (Federal Communications Commission)Statement (United States Only) . . . . . . . . . . . . . . . 1-26FCC Interference Statement (United States Only) . . . . 1-26Canadian Department of Communications IndustryCanada Notice (Canada Only). . . . . . . . . . . . . . . . . 1-27Radio Frequency Exposure Statement . . . . . . . . . . . . . 1-27FCC Rules, Part 15/Industry Canada . . . . . . . . . . . . . . . 1-27Radio Equipment Directive . . . . . . . . . . . . . . . . . . . . . . 1-28RoHS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28Taiwan NCC Warning Statement . . . . . . . . . . . . . . . . . 1-28Suspected Cybersecurity Event or Threat . . . . . . . . . . . . . . 1-29System Operating Manualv
Plum 360 InfuserSection 2, Equipment Description. . . . . . . . . . . . .2-1Keypad and Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2Alphanumeric Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2Numeric Keypad. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3Operating Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7Display Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7CE Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10Pole Clamp, Potential Equalization Terminal, andPower Cord. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12Plum Administration Sets . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14The Plum Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15Other Administration Set Features. . . . . . . . . . . . . . . . .2-18Section 3, Basic Operations . . . . . . . . . . . . . . . . .3-1Mounting the Infuser on an I.V. Pole . . . . . . . . . . . . . . . . . . .3-2Mounting Multiple Infusers to an I.V. Pole . . . . . . . . . . .3-4Attaching a Nurse Call Interface Cable . . . . . . . . . . . . . . . . .3-4Opening the Cassette Door . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4Opening the Cassette Door Completely . . . . . . . . . . . . . . . . .3-6Closing the Cassette Door . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8Turning Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9Turning Power Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10Viewing the Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11Using the Keypad and Controls . . . . . . . . . . . . . . . . . . . . . . .3-11Using the Keypad to Enter Program Information . . . . .3-11Silencing the Keypad. . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12Locking and Unlocking the Keypad . . . . . . . . . . . . . . . .3-12Using the Keypad to Search the Drug List . . . . . . . . . . .3-15Working with Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17Test the Alarm System. . . . . . . . . . . . . . . . . . . . . . . . . . .3-17Responding to an Alarm . . . . . . . . . . . . . . . . . . . . . . . . .3-18Adjusting the Audio Alarm Volume . . . . . . . . . . . . . . . .3-19Programming a Callback Alarm . . . . . . . . . . . . . . . . . . .3-19Restarting the Delivery Automatically After aDistal Occlusion Alarm . . . . . . . . . . . . . . . . . . . . . . .3-19viSystem Operating Manual
Plum 360 InfuserStopping and Restarting a Delivery . . . . . . . . . . . . . . . . . . .Clearing a Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Setting the Post Infusion Rate . . . . . . . . . . . . . . . . . . . . . . .Post Infusion Rate (Loading Dose Delivery andMultistep Delivery) . . . . . . . . . . . . . . . . . . . . . . . . .Viewing and Clearing the Volumes Infused. . . . . . . . . . . . .Adjusting Display Lighting and Contrast . . . . . . . . . . . . . . .Viewing CCA and Infuser Settings . . . . . . . . . . . . . . . . . . . .CCA/Infuser Setting Descriptions . . . . . . . . . . . . . . . . .Changing the Default Infuser Settings . . . . . . . . . . . . .Setting the Distal Pressure Alarm Limit. . . . . . . . . . . . . . . .Changing the Default Line B Delivery Mode . . . . . . . . . . . on 4, Plum Administration Sets . . . . . . . . . . 4-1Priming a Primary Administration Set . . . . . . . . . . . . . . . . . . 4-2Loading a Cassette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8Preparing a Secondary Delivery from anAdministration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10Connecting a Secondary Line or Syringe . . . . . . . . . . . . . . . 4-13Connecting to a Clave Port . . . . . . . . . . . . . . . . . . . . . . 4-14Connecting to a Prepierced Port . . . . . . . . . . . . . . . . . . 4-16Connecting to a Capped Port. . . . . . . . . . . . . . . . . . . . . 4-18Priming the Syringe Adapter . . . . . . . . . . . . . . . . . . . . . 4-19Preparing a Secondary Delivery from a Syringe . . . . . . . . . 4-19Backpriming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21Preparing to Backprime . . . . . . . . . . . . . . . . . . . . . . . . . 4-22Backpriming Procedure . . . . . . . . . . . . . . . . . . . . . . . . . 4-23Discontinuing Electronic Flow Control and SettingGravity Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25Removing a Secondary Line or Syringe . . . . . . . . . . . . . . . . 4-27Discontinuing Fluid Administration . . . . . . . . . . . . . . . . . . . 4-28Changing Administration Sets . . . . . . . . . . . . . . . . . . . . . . . 4-29Resolving a Distal Air-in-Line Alarm . . . . . . . . . . . . . . . . . . 4-30Avoiding Unintended Bolus While Resolving aDistal Occlusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31System Operating Manualvii
Plum 360 InfuserSection 5, Programming . . . . . . . . . . . . . . . . . . . .5-1Programming Features Common to the DefaultDrug Library and Custom Drug Libraries . . . . . . . . . . . . .5-1Auto-Calculations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1Body Surface Area (BSA) Dosing Unit . . . . . . . . . . . . . . .5-1Programming Line B . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2Clearing Line Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2Programming with a Default Drug Library . . . . . . . . . . . . . . .5-3Programming Without a Drug List . . . . . . . . . . . . . . . . . .5-3Programming with a Drug List. . . . . . . . . . . . . . . . . . . . . . . . .5-4Programming with a Custom Drug Library . . . . . . . . . . . . . . .5-5Hard Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6Soft Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6Programming Line B with Line A Programmed . . . . . . . .5-7Changing a CCA from the Drug List Screen. . . . . . . . . . .5-7Delaying a Line. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8Putting a Line in Standby – A/B Delivery Screen . . . . . .5-8Putting a Line in Standby – Confirmation Screen. . . . . .5-8Putting a Line in Standby – Piggyback Mode . . . . . . . . .5-9Canceling Standby – Piggyback Mode . . . . . . . . . . . . . . .5-9Nurse Callback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9Section 6, Auto-Programming . . . . . . . . . . . . . . .6-1Auto-Programming the Plum 360 Infuser . . . . . . . . . . . . . . .6-2Section 7, Additional Features . . . . . . . . . . . . . . .7-1Delay a Line. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1Standby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1Put 1 or 2 Lines in Standby from the DeliveryScreen (Non-Piggyback). . . . . . . . . . . . . . . . . . . . . . .7-2Cancel Standby for 1 or 2 Lines from the DeliveryScreen (Non-Piggyback). . . . . . . . . . . . . . . . . . . . . . .7-2Put Piggyback Mode in Standby. . . . . . . . . . . . . . . . . . . .7-3Cancel Piggyback Mode Standby . . . . . . . . . . . . . . . . . . .7-3Examples of Automatic Calculation . . . . . . . . . . . . . . . . . . . .7-4mL/hr - Initial Programming. . . . . . . . . . . . . . . . . . . . . . .7-4viiiSystem Operating Manual
Plum 360 InfusermL/hr - After VTBI Complete Alarm . . . . . . . . . . . . . . . .Non-Time-Based Dose Calculation (for example, mL) Initial Programming . . . . . . . . . . . . . . . . . . . . . . . . .Non-Time-Based Dose Calculation (for example, mL) After VTBI Complete Alarm. . . . . . . . . . . . . . . . . . . .Time-Based Dose Calculation (for example, mg/min) Initial Programming . . . . . . . . . . . . . . . . . . . . . . . . .Time-Based Dose Calculation (for example, mg/min) After VTBI Complete Alarm. . . . . . . . . . . . . . . . . . . .Recalculation Alert When Titrating a ConfirmedmL/hr or Non-Time-Based Dosing Unit . . . . . . . . . .7-47-57-57-67-77-7Section 8, Delivery Options . . . . . . . . . . . . . . . . . 8-1Programming a Bolus Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1Programming a Loading Dose. . . . . . . . . . . . . . . . . . . . . . . . . 8-4Programming a Multistep Delivery. . . . . . . . . . . . . . . . . . . . . 8-6Adding a Step to a Multistep Delivery . . . . . . . . . . . . . . . . . . 8-8Adding VTBI to Loading Dose or Multistep ProgramAfter VTBI Complete Alarm Activates . . . . . . . . . . . . . . . 8-9Titration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11Loading Dose Delivery and Multistep Delivery . . . . . . . 8-11Changing the CCA During Infusion . . . . . . . . . . . . . . . . . . . 8-11Section 9, Alarms and Troubleshooting . . . . . . . . 9-1Alarm Priority Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1General Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2High Priority Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2Medium Priority Alarms . . . . . . . . . . . . . . . . . . . . . . . . . 9-6Low Priority Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7Line A Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9High Priority Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9Medium Priority Alarms . . . . . . . . . . . . . . . . . . . . . . . . . 9-11Line B Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13High Priority Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13Medium Priority Alarms . . . . . . . . . . . . . . . . . . . . . . . . . 9-16System Operating Manualix
Plum 360 InfuserLines A and B Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-18High Priority Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-18Rejected Auto-Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-24Partially Programmed Line . . . . . . . . . . . . . . . . . . . . . . .9-28Invalid Titration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-28Section 10, Cleaning, Maintenance, Storage,and Service . . . . . . . . . . . . . . . . . . . . . . . . . .10-1Cleaning the Infuser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1Cleaning Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2Cleaning Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-3Infuser Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-4Battery Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-4Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-6Section 11, Specifications . . . . . . . . . . . . . . . . .11-1Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-1Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-2Connectivity Engine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-4VTBI Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6Delivery Rate Range and Duration . . . . . . . . . . . . . . . . . . . .11-6Air-in-Line Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6Occlusion Alarm and Limits . . . . . . . . . . . . . . . . . . . . . . . . . .11-6Time To Detect Downstream Occlusions. . . . . . . . . . . . . . . .11-8Maximum Unintended Bolus Volume Released AfterDistal Occlusion is Resolved . . . . . . . . . . . . . . . . . . . . . .11-9Delivery Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-10Bolus Delivery Accuracy . . . . . . . . . . . . . . . . . . . . . . . .11-11Enteral or High Viscosity Fluids Effects . . . . . . . . . . . .11-11Trumpet Curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-12Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-13xSystem Operating Manual
Plum 360 InfuserSection 12, Supplies and Accessories. . . . . . . . . 12-1Administration Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1CE Marked Administration Sets. . . . . . . . . . . . . . . . . . . 12-1Non-CE Marked Administration Sets . . . . . . . . . . . . . . 12-3Administration Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-6Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-6Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7Tandem Carrier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7Multiple Device Adapter . . . . . . . . . . . . . . . . . . . . . . . . 12-9I.V. Pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-11T-bar Accessory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13I.V. Mini-Pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15ICU Medical MedNet Safety Software . . . . . . . . . . . . . . . . 12-16Loss of Communication . . . . . . . . . . . . . . . . . . . . . . . . 12-17Section 13, Warranty . . . . . . . . . . . . . . . . . . . . 13-1Section 14, CCAs and Drug Libraries . . . . . . . . . 14-1DDL CCA and Drug List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1Custom Drug Library (CDL) . . . . . . . . . . . . . . . . . . . . . . . . . . 14-9Dosing Units and Allowable Ranges. . . . . . . . . . . . . . . . . . 14-10Patient Data Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-12System Operating Manualxi
Plum 360 InfuserNotesxiiSystem Operating Manual
Plum 360 InfuserSection 1IntroductionThe Plum 360 is a large volume infuser capable of delivering fluidsfor a variety of therapies such as parenteral, enteral, or epiduralinfusions. The Plum 360 infuser can deliver fluids over a broad rangeof infusion rates and is capable of Concurrent delivery from one ormore rigid or flexible fluid containers.The Plum 360 infuser features an innovative design that automatesmany aspects of Concurrent, Secondary, and Piggyback infusions.A positive valving cassette allows two lines to be deliveredat independent rates. The volume to be infused (VTBI) is deliveredthrough one line to a patient. The two lines can be deliveredin Concurrent mode (together) or Piggyback mode (one after another)without raising or lowering I.V. bags.The Plum 360 infuser also enables fluid pathway troubleshootingsuch as removing proximal air in line, without disconnecting thepatient line.AUDIO PAUSEDabcdefghijklmnopqrstuvwxyzSTARTSTOPAC ONON OFFSystem Operating ManualCLEARLOCK KEYPAD1-1
Plum 360 InfuserThe Plum 360 can act as a standalone infuser, or in conjunction withthe ICU Medical MedNet software to provide medication safetysoftware at the point of care, with customized drug libraries to supporthospital defined protocols by clinical care area. In such aconfiguration, the Plum 360 infuser can communicate with systemson the network via Ethernet or state of the art wireless communicationusing an 802.11 a/b/g/n/, 2.4 GHz/5 GHz dual-band radio.The Plum 360 infuser and ICU Medical MedNet software interfacewith other hospital systems such as Electronic Health Records,Electronic Medication Administration Records, Bar Code Point ofCare, Real Time Location Services, and other systems designed tocreate efficiency and consistency in managing patient information andclinical workflows.Each infuser includes a Connectivity Engine (CE) which providesboth wired Ethernet and wireless 802.11 a/b/g/n networkingcapabilities. The Plum 360 infuser interfaces with ICU MedicalMedNet application software to download drug library and infusersoftware updates and enable auto-programming of the infuser.The Plum 360 infuser is fully compatible with Plum Seriesadministration sets and accessories, and the CLAVE needlelessconnection systems, providing a convenient and cost-effectiveinfuser.Intended UseThe Plum 360 infuser is intended for parenteral, enteral, and epiduraltherapies and the administration of whole blood and blood products.The Plum 360 infuser is intended for use in clinical environments atthe direction or under the supervision of licensed physicians orcertified healthcare professionals who are trained in the use of theinfuser and the administration of parenteral, enteral, and epiduraltherapies and the administration of whole blood and blood products.1-2System Operating Manual
Plum 360 InfuserTrainingICU Medical offers a complete range of training and education to helpnew users and experienced personnel acquire the knowledge andconfidence to operate the Plum infuser properly and efficiently.Training is available at the time of infuser purchase. Supplementaltraining can be purchased throughout the infuser's service life.Training content is tailored to the needs of the medical facility andis presented by clinical personnel. ICU Medical works with hospitalstaff to identify training needs, including duration and frequency oftraining. Training is mandatory for new device installation.Contact your ICU Medical Representative for more information aboutavailable training programs.System Operating Manual1-3
Plum 360 InfuserConventionsThis section describes the conventions used throughout this manual,as follows:ConventionApplicationExampleItalicFunction or modespecific instructions,or disclaimerPrimary Only:Attach an emptycontainer.Italic, bold, blueReference to a section,figure, or table(See Adjustingthe Audio AlarmVolume onpage 3-19)[BRACKETEDALL CAPS]Keys on the device aredisplayed in[BRACKETED ALLCAPS] or with agraphic.[START] [Bracketed Blue]Softkey Options [Choose]Initial Caps lowercaseScreen displays anddevice labels (asappropriate)ProgramEmphasis.sets are suppliedSterile and arefor.BoldorDose CalculationWARNINGA WARNING MESSAGE CONTAINS SPECIAL SAFETY EMPHASISAND MUST BE OBSERVED AT ALL TIMES. FAILURE TO OBSERVEA WARNING MESSAGE IS POTENTIALLY LIFE-THREATENING.1-4System Operating Manual
Plum 360 InfuserCAUTIONA CAUTION CONTAINS INFORMATION THAT COULD PREVENTIRREVERSIBLE PRODUCT DAMAGE OR HARDWARE FAILURE .FAILURE TO OBSERVE A CAUTION COULD RESULT IN SERIOUS USEROR PATIENT INJURY.MANDATORY ACTIONA Mandatory Action symbol means the instructions that followdescribe a required action. Failure to observe a MandatoryAction could impact user or patient safety.PROHIBITIONA Prohibition symbol highlights a safety notice describinga prohibited action. Failure to observe a Prohibition couldimpact user or patient safety.NOTE: A Note highlights information that helps explain a conceptor procedure.Illustrations, Screen Displays, and Software MessagesThere may be minor language differences between softwaremessages shown in this manual and the infuser's user interface.These differences include alternate spelling and terminology forEnglish-language infusers with list numbers ending in -27, -54, and-57.Illustrations and screen examples in this manual are graphicdepictions, not exact representations of the product.System Operating Manual1-5
Plum 360 InfuserDefinitionsTermDefinitionAdministration SetThe cassette with flexible tubing assembly thatconnects a source fluid container to a patientaccess device for fluid administration.Air TrapA component of the cassette that allows trappingand removal of proximal air.AlarmA condition that invokes audible and/or visiblealarm indicators requiring operator attention.AlertA visual signal that provides information to youor prompts further action.Alternate UnitsThe Dose Rate units that may be selected.Alternate Units are any units other than mL/hr.Alternate UnitsParametersDrug Amount, Diluent Amount, Patient Weight,Height for BSA (manually or calculatedif applicable), and Dose Rate.Auto-ProgramAuto-programming refers to the ability to receivea remotely configured therapy from ICU MedicalMedNet Software.BackpressureThe resistance to fluid flow on the Distal or outputportion of the Administration Set, usuallyexpressed as pounds per square inch (PSI).BackprimeThe use of fluid in Line A to move proximal airor fluid into a receptacle attached to Line B.No fluid is delivered distal to the cassette duringa backprime.Biomed ModeName for the non-delivery mode of infuseroperation for hospital technicians (Biomeds)who have access to technical information suchas delivery parameter limits and displays defaultsettings.BolusA rapid infusion of a relatively large volume of fluidor dose of the drug currently being administered(same medication, concentration, and dosing unit)to enhance a therapeutic response. Also seeUnintended Bolus on page 1-11.1-6System Operating Manual
Plum 360 InfuserTermDefinitionBSABody Surface Area, in m2, for calculationof medication doses that require a patient’s heightand weight.CAIR Trade name of ICU Medical's enhancedperformance roller clamp.CassetteA component of an administration set specificallydesigned to work with the Plum infuser thatfacilitates two lines in and one line out, allowingprimary and secondary I.V. delivery rates to becontrolled separately.CCAClinical Care Area. The CCA is a defined physicalor virtual area in the hospital for a specific patientpopulation that comprises rules for infuser settingsand which drugs can be used along with theirassociated delivery limits.CDLCustom Drug Library. A drug library that is basedon hospital-defined practices and customizedusing the ICU Medical MedNet application.CEConnectivity Engine is a component of an infuserthat allows communications with the device overwired or wireless networks.ChannelThe distal line of an administration set thatconnects to the patient.Cleared SettingsWhen programmed delivery settings for anindividual line or both lines are reset to their defaultsettings.Clinical UseThe clinical use attributed to a medication entry.Composite VersionStringThe library-identifying string transmitted to theinfuser by the ICU Medical MedNet application.ConcentrationConcentration refers to the ratio of DrugAmount (in mg, for example) to diluent (in mL).ConcurrentDeliverySimultaneous delivery of fluids on Line Aand Line B.Concurrent ModeA mode that enables the user to program Line Bfor Concurrent delivery.System Operating Manual1-7
Plum 360 InfuserTermDefinitionDDLDefault Drug Library. A factory defaultnon-customized drug library with a default setof infuser settings and drugs available for useand their associated concentration and dosingunits. DDL has 1 to 17 pages.Delay StartA pending delivery program that will automaticallystart and not require operator action at the delaytime programmed.DeviceThe infuser, not including the disposableadministration sets.Diluent (Volume)Volume of fluid in which a medication is diluted.DistalThe portion of the Administration Setdownstream from the Cassette’s pumpingchamber.DoseA volume of medication to be deliveredon a continuous basis.Dosing UnitUnit of measure for a drug to be delivered.Drug AmountThe mass or quantity of medication to be deliveredbefore being mixed with a diluent.DurationThe time period required to deliver a programmedinfusion.EnteralDelivery using an intestinal route.ExpectedService LifeThe amount of time from the date of installationthat the manufacturer will provide technical serviceto the device. Technical service involves repairs,technical support questions and troubleshooting,and replacement parts.Filling Head Height(FHH)The height difference between the sourcecontainer and the distal line output.Hard LimitThe upper- and lower-dosing limits associated witha drug, in the drug library, that cannot beoverridden by the operator.1-8System Operating Manual
Plum 360 InfuserTermDefinitionICU MedicalMedNetICU Medical MedNet provides healthcareprofessionals with the capability to send,receive, and store information from infusers. Thebi-directional communication between the hospitalmedication safety software and infusers includesinfusion parameters, infuser default configurations,infuser location, history, events, trending, alarmsand status.InfiltrationUnintentional fluid migration into the tissuessurrounding a venipuncture site.InfuserSee Device.I.V. PushThe act of manually pushing on the syringeplunger to deliver the contents of medicationthrough access at a Y-site of an administration set.KeyAny of the marked locations on the front panelintended for user input via a pressing action.KVOKeep Vein Open. The Post Infusion Rate settingthat provides a minimal delivery rate (1 mL/hror the actual programmed rate when less than1 mL/hr), intended to provide sufficient fluid flowto decrease the potential for clotting at theI.V. infusion site.Line AThe proximal Primary tubing attached to the A portof the cassette.Line BThe proximal secondary line/syringe attachedto the secondary port of the cassette.Loading DoseAllows programming of an initial infusion rate/dosefor a specific
The Plum 360 can act as a standalone infuser, or in conjunction with the ICU Medical MedNet software to provide medication safety software at the point of care, with customized dr ug libraries to support hospital defined protocols by clinical care area. In such a configuration, the Plum 360 infuser can communicate with systems
