Plum 360 System Operating Manual Rev 01 Sept 2018

Notes

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Change History Part Number

Description of Change

430-98340-003 (A, 2017-09)

Updated entire manual to reflect new ICU Medical corporate identity. Added notes about compatible administration sets and applicable software /CE versions throughout the manual. Added content for the Radio Equipment Directive in Section 1. Updated “Responding to an Alarm” and information on restarts, and added notes in “Turning Power on” and “Turning Power Off” in Section 3. Added a new section called “To view and clear the volumes infused before a cassette is inserted” in Section 3. Updated “Priming the Syringe Adapter” in Section 4. Added a note in “Auto-Programming the Plum 360 Infuser” in section 6. Added note in “Time-Based Dose Calculation (for example, 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 updated information on accessories in Section 12. Updated the default drug library medication names in Section 14. Updated high voltage symbol information on the inside back cover.

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Part Number

Description of Change

430-98340-004 (01, 2018-09)

Updated the Australian Sponsor address on the front cover. Updated Section 1 for IEC 60601-1-2:2014 Edition 4 compliance. Updated support email addresses on the inside back cover. Updated the CE Mark definition on the back cover.

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Contents Section 1, Introduction... 1-1 Intended Use... 1-2 Training... 1-3 Conventions... 1-4 Illustrations, Screen Displays, and Software Messages... 1-5 Definitions... 1-6 Precautions... 1-11 Warnings, Cautions, and Guidelines... 1-11 General Warnings and Cautions... 1-12 Piggyback, Concurrent, and Secondary Delivery Guidelines... 1-13 Guidelines When Opening the Cassette Door... 1-16 Administration Sets and Accessories Guidelines... 1-16 Precautions to Avoid Unintended Bolus... 1-18 Guidelines to Avoid Air in the Patient Line... 1-19 Guidelines During Backpriming... 1-19 Battery Guidelines... 1-20 Guidelines During Cleaning... 1-20 Artifacts... 1-21 Interconnecting of Medical Equipment... 1-22 Electromagnetic Compatibility... 1-23 FCC Information... 1-26 US FCC (Federal Communications Commission) Statement (United States Only)... 1-26 FCC Interference Statement (United States Only)... 1-26 Canadian Department of Communications Industry Canada Notice (Canada Only)... 1-27 Radio Frequency Exposure Statement... 1-27 FCC Rules, Part 15/Industry Canada... 1-27 Radio Equipment Directive... 1-28 RoHS... 1-28 Taiwan NCC Warning Statement... 1-28 Suspected Cybersecurity Event or Threat... 1-29

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Section 2, Equipment Description...2-1 Keypad and Display...2-2 Alphanumeric Keypad...2-2 Numeric Keypad...2-3 Operating Keys...2-4 Indicators...2-7 Display Symbols...2-7 CE Module...2-10 Pole Clamp, Potential Equalization Terminal, and Power Cord...2-12 Plum Administration Sets...2-14 The Plum Cassette...2-15 Other Administration Set Features...2-18

Section 3, Basic Operations...3-1 Mounting the Infuser on an I.V. Pole...3-2 Mounting Multiple Infusers to an I.V. Pole...3-4 Attaching a Nurse Call Interface Cable...3-4 Opening the Cassette Door...3-4 Opening the Cassette Door Completely...3-6 Closing the Cassette Door...3-8 Turning Power On...3-9 Turning Power Off...3-10 Viewing the Display...3-11 Using the Keypad and Controls...3-11 Using the Keypad to Enter Program Information...3-11 Silencing the Keypad...3-12 Locking and Unlocking the Keypad...3-12 Using the Keypad to Search the Drug List...3-15 Working with Alarms...3-17 Test the Alarm System...3-17 Responding to an Alarm...3-18 Adjusting the Audio Alarm Volume...3-19 Programming a Callback Alarm...3-19 Restarting the Delivery Automatically After a Distal Occlusion Alarm...3-19

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Stopping and Restarting a Delivery... 3-21 Clearing a Line... 3-22 Setting the Post Infusion Rate... 3-23 Post Infusion Rate (Loading Dose Delivery and Multistep Delivery)... 3-25 Viewing and Clearing the Volumes Infused... 3-25 Adjusting Display Lighting and Contrast... 3-28 Viewing CCA and Infuser Settings... 3-29 CCA/Infuser Setting Descriptions... 3-31 Changing the Default Infuser Settings... 3-34 Setting the Distal Pressure Alarm Limit... 3-34 Changing the Default Line B Delivery Mode... 3-36

Section 4, Plum Administration Sets... 4-1 Priming a Primary Administration Set... 4-2 Loading a Cassette... 4-8 Preparing a Secondary Delivery from an Administration Set... 4-10 Connecting a Secondary Line or Syringe... 4-13 Connecting to a Clave Port... 4-14 Connecting to a Prepierced Port... 4-16 Connecting to a Capped Port... 4-18 Priming the Syringe Adapter... 4-19 Preparing a Secondary Delivery from a Syringe... 4-19 Backpriming... 4-21 Preparing to Backprime... 4-22 Backpriming Procedure... 4-23 Discontinuing Electronic Flow Control and Setting Gravity Flow... 4-25 Removing a Secondary Line or Syringe... 4-27 Discontinuing Fluid Administration... 4-28 Changing Administration Sets... 4-29 Resolving a Distal Air-in-Line Alarm... 4-30 Avoiding Unintended Bolus While Resolving a Distal Occlusion... 4-31

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Section 5, Programming...5-1 Programming Features Common to the Default Drug Library and Custom Drug Libraries...5-1 Auto-Calculations...5-1 Body Surface Area (BSA) Dosing Unit...5-1 Programming Line B...5-2 Clearing Line Settings...5-2 Programming with a Default Drug Library...5-3 Programming Without a Drug List...5-3 Programming with a Drug List...5-4 Programming with a Custom Drug Library...5-5 Hard Limits...5-6 Soft Limits...5-6 Programming Line B with Line A Programmed...5-7 Changing a CCA from the Drug List Screen...5-7 Delaying a Line...5-8 Putting a Line in Standby – A/B Delivery Screen...5-8 Putting a Line in Standby – Confirmation Screen...5-8 Putting a Line in Standby – Piggyback Mode...5-9 Canceling Standby – Piggyback Mode...5-9 Nurse Callback...5-9

Section 6, Auto-Programming...6-1 Auto-Programming the Plum 360 Infuser...6-2

Section 7, Additional Features...7-1 Delay a Line...7-1 Standby...7-1 Put 1 or 2 Lines in Standby from the Delivery Screen (Non-Piggyback)...7-2 Cancel Standby for 1 or 2 Lines from the Delivery Screen (Non-Piggyback)...7-2 Put Piggyback Mode in Standby...7-3 Cancel Piggyback Mode Standby...7-3 Examples of Automatic Calculation...7-4 mL/hr - Initial Programming...7-4

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mL/hr - After VTBI Complete Alarm... 7-4 Non-Time-Based Dose Calculation (for example, mL) Initial Programming... 7-5 Non-Time-Based Dose Calculation (for example, mL) After VTBI Complete Alarm... 7-5 Time-Based Dose Calculation (for example, mg/min) Initial Programming... 7-6 Time-Based Dose Calculation (for example, mg/min) After VTBI Complete Alarm... 7-7 Recalculation Alert When Titrating a Confirmed mL/hr or Non-Time-Based Dosing Unit... 7-7

Section 8, Delivery Options... 8-1 Programming a Bolus Dose... 8-1 Programming a Loading Dose... 8-4 Programming a Multistep Delivery... 8-6 Adding a Step to a Multistep Delivery... 8-8 Adding VTBI to Loading Dose or Multistep Program After VTBI Complete Alarm Activates... 8-9 Titration... 8-11 Loading Dose Delivery and Multistep Delivery... 8-11 Changing the CCA During Infusion... 8-11

Section 9, Alarms and Troubleshooting... 9-1 Alarm Priority Levels... 9-1 General Alarms... 9-2 High Priority Alarms... 9-2 Medium Priority Alarms... 9-6 Low Priority Alarms... 9-7 Line A Alarms... 9-9 High Priority Alarms... 9-9 Medium Priority Alarms... 9-11 Line B Alarms... 9-13 High Priority Alarms... 9-13 Medium Priority Alarms... 9-16

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Lines A and B Alarms...9-18 High Priority Alarms...9-18 Rejected Auto-Programs...9-24 Partially Programmed Line...9-28 Invalid Titration...9-28

Section 10, Cleaning, Maintenance, Storage, and Service...10-1 Cleaning the Infuser...10-1 Cleaning Procedure...10-2 Cleaning Supplies...10-3 Infuser Maintenance...10-4 Battery Maintenance...10-4 Storage...10-5 Service...10-6

Section 11, Specifications...11-1 Physical...11-1 Electrical...11-2 Connectivity Engine...11-4 VTBI Range...11-6 Delivery Rate Range and Duration...11-6 Air-in-Line Alarm...11-6 Occlusion Alarm and Limits...11-6 Time To Detect Downstream Occlusions...11-8 Maximum Unintended Bolus Volume Released After Distal Occlusion is Resolved...11-9 Delivery Accuracy...11-10 Bolus Delivery Accuracy...11-11 Enteral or High Viscosity Fluids Effects...11-11 Trumpet Curves...11-12 Example...11-13

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Section 12, Supplies and Accessories... 12-1 Administration Sets... 12-1 CE Marked Administration Sets... 12-1 Non-CE Marked Administration Sets... 12-3 Administration Fluids... 12-6 Containers... 12-6 Accessories... 12-7 Tandem Carrier... 12-7 Multiple Device Adapter... 12-9 I.V. Pole... 12-11 T-bar Accessory... 12-13 I.V. Mini-Pole... 12-15 ICU Medical MedNet Safety Software... 12-16 Loss of Communication... 12-17

Section 13, Warranty... 13-1 Section 14, CCAs and Drug Libraries... 14-1 DDL CCA and Drug List... 14-1 Custom Drug Library (CDL)... 14-9 Dosing Units and Allowable Ranges... 14-10 Patient Data Limits... 14-12

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Section 1

Introduction The Plum 360™ is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser 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. The Plum 360 infuser features an innovative design that automates many aspects of Concurrent, Secondary, and Piggyback infusions. A positive valving cassette allows two lines to be delivered at independent rates. The volume to be infused (VTBI) is delivered through one line to a patient. The two lines can be delivered in Concurrent mode (together) or Piggyback mode (one after another) without raising or lowering I.V. bags. The Plum 360 infuser also enables fluid pathway troubleshooting such as removing proximal air in line, without disconnecting the patient line.

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START

STOP

AC ON

ON OFF

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LOCK KEYPAD

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Plum 360 Infuser 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 drug libraries to support hospital defined protocols by clinical care area. In such a configuration, the Plum 360 infuser can communicate with systems on the network via Ethernet or state of the art wireless communication using an 802.11 a/b/g/n/, 2.4 GHz/5 GHz dual-band radio. The Plum 360 infuser and ICU Medical MedNet software interface with other hospital systems such as Electronic Health Records, Electronic Medication Administration Records, Bar Code Point of Care, Real Time Location Services, and other systems designed to create efficiency and consistency in managing patient information and clinical workflows. Each infuser includes a Connectivity Engine (CE) which provides both wired Ethernet and wireless 802.11 a/b/g/n networking capabilities. The Plum 360 infuser interfaces with ICU Medical MedNet application software to download drug library and infuser software updates and enable auto-programming of the infuser. The Plum 360 infuser is fully compatible with Plum™ Series administration sets and accessories, and the CLAVE™ needleless connection systems, providing a convenient and cost-effective infuser.

Intended Use The Plum 360 infuser is intended for parenteral, enteral, and epidural therapies and the administration of whole blood and blood products. The Plum 360 infuser is intended for use in clinical environments at the direction or under the supervision of licensed physicians or certified healthcare professionals who are trained in the use of the infuser and the administration of parenteral, enteral, and epidural therapies and the administration of whole blood and blood products.

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Training ICU Medical offers a complete range of training and education to help new users and experienced personnel acquire the knowledge and confidence to operate the Plum infuser properly and efficiently. Training is available at the time of infuser purchase. Supplemental training can be purchased throughout the infuser's service life. Training content is tailored to the needs of the medical facility and is presented by clinical personnel. ICU Medical works with hospital staff to identify training needs, including duration and frequency of training. Training is mandatory for new device installation. Contact your ICU Medical Representative for more information about available training programs.

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Conventions This section describes the conventions used throughout this manual, as follows: Convention

Application

Example

Italic

Function or mode specific instructions, or disclaimer

Primary Only: Attach an empty container.

Italic, bold, blue

Reference to a section, figure, or table

(See Adjusting the Audio Alarm Volume on page 3-19)

[BRACKETED ALL CAPS]

Keys on the device are displayed in [BRACKETED ALL CAPS] or with a graphic.

[START]

[Bracketed Blue]

Softkey Options

[Choose]

Initial Caps lowercase

Screen displays and device labels (as appropriate)

Program

Emphasis

...sets are supplied Sterile and are for...

Bold

or

Dose Calculation

WARNING A WARNING MESSAGE CONTAINS SPECIAL SAFETY EMPHASIS AND MUST BE OBSERVED AT ALL TIMES. FAILURE TO OBSERVE A WARNING MESSAGE IS POTENTIALLY LIFE-THREATENING.

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CAUTION A CAUTION CONTAINS INFORMATION THAT COULD PREVENT IRREVERSIBLE PRODUCT DAMAGE OR HARDWARE FAILURE . FAILURE TO OBSERVE A CAUTION COULD RESULT IN SERIOUS USER OR PATIENT INJURY.

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. PROHIBITION A Prohibition symbol highlights a safety notice describing a prohibited action. Failure to observe a Prohibition could impact user or patient safety. NOTE: A Note highlights information that helps explain a concept or procedure.

Illustrations, Screen Displays, and Software Messages There may be minor language differences between software messages shown in this manual and the infuser's user interface. These differences include alternate spelling and terminology for English-language infusers with list numbers ending in -27, -54, and -57. Illustrations and screen examples in this manual are graphic depictions, not exact representations of the product.

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Definitions Term

Definition

Administration Set

The cassette with flexible tubing assembly that connects a source fluid container to a patient access device for fluid administration.

Air Trap

A component of the cassette that allows trapping and removal of proximal air.

Alarm

A condition that invokes audible and/or visible alarm indicators requiring operator attention.

Alert

A visual signal that provides information to you or prompts further action.

Alternate Units

The Dose Rate units that may be selected. Alternate Units are any units other than mL/hr.

Alternate Units Parameters

Drug Amount, Diluent Amount, Patient Weight, Height for BSA (manually or calculated if applicable), and Dose Rate.

Auto-Program

Auto-programming refers to the ability to receive a remotely configured therapy from ICU Medical MedNet Software.

Backpressure

The resistance to fluid flow on the Distal or output portion of the Administration Set, usually expressed as pounds per square inch (PSI).

Backprime

The use of fluid in Line A to move proximal air or fluid into a receptacle attached to Line B. No fluid is delivered distal to the cassette during a backprime.

Biomed Mode

Name for the non-delivery mode of infuser operation for hospital technicians (Biomeds) who have access to technical information such as delivery parameter limits and displays default settings.

Bolus

A rapid infusion of a relatively large volume of fluid or dose of the drug currently being administered (same medication, concentration, and dosing unit) to enhance a therapeutic response. Also see Unintended Bolus on page 1-11.

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Plum 360 Infuser Term

Definition

BSA

Body Surface Area, in m2, for calculation of medication doses that require a patient’s height and weight.

CAIR™

Trade name of ICU Medical's enhanced performance roller clamp.

Cassette

A component of an administration set specifically designed to work with the Plum infuser that facilitates two lines in and one line out, allowing primary and secondary I.V. delivery rates to be controlled separately.

CCA

Clinical Care Area. The CCA is a defined physical or virtual area in the hospital for a specific patient population that comprises rules for infuser settings and which drugs can be used along with their associated delivery limits.

CDL

Custom Drug Library. A drug library that is based on hospital-defined practices and customized using the ICU Medical MedNet application.

CE

Connectivity Engine is a component of an infuser that allows communications with the device over wired or wireless networks.

Channel

The distal line of an administration set that connects to the patient.

Cleared Settings

When programmed delivery settings for an individual line or both lines are reset to their default settings.

Clinical Use

The clinical use attributed to a medication entry.

Composite Version String

The library-identifying string transmitted to the infuser by the ICU Medical MedNet application.

Concentration

Concentration refers to the ratio of Drug Amount (in mg, for example) to diluent (in mL).

Concurrent Delivery

Simultaneous delivery of fluids on Line A and Line B.

Concurrent Mode

A mode that enables the user to program Line B for Concurrent delivery.

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Plum 360 Infuser Term

Definition

DDL

Default Drug Library. A factory default non-customized drug library with a default set of infuser settings and drugs available for use and their associated concentration and dosing units. DDL has 1 to 17 pages.

Delay Start

A pending delivery program that will automatically start and not require operator action at the delay time programmed.

Device

The infuser, not including the disposable administration sets.

Diluent (Volume)

Volume of fluid in which a medication is diluted.

Distal

The portion of the Administration Set downstream from the Cassette’s pumping chamber.

Dose

A volume of medication to be delivered on a continuous basis.

Dosing Unit

Unit of measure for a drug to be delivered.

Drug Amount

The mass or quantity of medication to be delivered before being mixed with a diluent.

Duration

The time period required to deliver a programmed infusion.

Enteral

Delivery using an intestinal route.

Expected Service Life

The amount of time from the date of installation that the manufacturer will provide technical service to the device. Technical service involves repairs, technical support questions and troubleshooting, and replacement parts.

Filling Head Height (FHH)

The height difference between the source container and the distal line output.

Hard Limit

The upper- and lower-dosing limits associated with a drug, in the drug library, that cannot be overridden by the operator.

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Plum 360 Infuser Term

Definition

ICU Medical MedNet

ICU Medical MedNet provides healthcare professionals with the capability to send, receive, and store information from infusers. The bi-directional communication between the hospital medication safety software and infusers includes infusion parameters, infuser default configurations, infuser location, history, events, trending, alarms and status.

Infiltration

Unintentional fluid migration into the tissues surrounding a venipuncture site.

Infuser

See Device.

I.V. Push

The act of manually pushing on the syringe plunger to deliver the contents of medication through access at a Y-site of an administration set.

Key

Any of the marked locations on the front panel intended for user input via a pressing action.

KVO

Keep Vein Open. The Post Infusion Rate setting that provides a minimal delivery rate (1 mL/hr or the actual programmed rate when less than 1 mL/hr), intended to provide sufficient fluid flow to decrease the potential for clotting at the I.V. infusion site.

Line A

The proximal Primary tubing attached to the A port of the cassette.

Line B

The proximal secondary line/syringe attached to the secondary port of the cassette.

Loading Dose

Allows programming of an initial infusion rate/dose for a specific volume and duration, automatically followed by a maintenance rate/dose for a specific volume and duration from the same container (for example, a fluid challenge) using the same dosing unit.

Maintenance Dose

A pre-programmed rate/dose for a specific volume and duration from the same container that automatically follows the completion of a Loading Dose.

Malfunction

One of a number of alarm conditions that indicate a failure of the infuser.

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