Plum 360 System Operating Manual Rev 02 June 2020

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Notes

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Change History Part Number

Description of Change

IFU0000140 (02, 2020-06)

Updated Sections 1, 4, and 12 to reflect that the use of a syringe adapter is required for syringes 3-10mL to ensure delivery accuracy and reduce proximal occlusion alarms.

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Contents Section 1, Introduction... 1-1 Reporting Serious Incidents... 1-2 Intended Use... 1-2 Training... 1-2 Conventions... 1-3 Illustrations, Screen Displays, and Software Messages . 1-4 Labeling Symbols Glossary... 1-5 Definitions... 1-8 Precautions... 1-14 Warnings, Cautions, and Guidelines... 1-14 General Warnings and Cautions... 1-14 Piggyback, Concurrent, and Secondary Delivery Guidelines... 1-16 Guidelines When Opening the Cassette Door... 1-18 Administration Sets and Accessories Guidelines... 1-19 Precautions to Avoid Unintended Bolus... 1-20 Guidelines to Avoid Air in the Patient Line... 1-21 Guidelines During Backpriming... 1-21 Battery Guidelines... 1-22 Guidelines During Cleaning... 1-22 Artifacts... 1-23 Interconnecting of Medical Equipment... 1-25 Electromagnetic Compatibility... 1-25 FCC Information... 1-28 US FCC (Federal Communications Commission) Statement (United States Only)... 1-28 FCC Interference Statement (United States Only)... 1-28 Department of the Minister of Innovation, Science, and Economic Development (Canada Only)... 1-29 Radio Frequency Exposure Statement... 1-29 FCC Rules, Part 15/Industry Canada... 1-29 Radio Equipment Directive... 1-30 RoHS... 1-31 Taiwan NCC Warning Statement... 1-31 System Operating Manual

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Suspected Cybersecurity Event or Threat...1-32

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...3-3 Mounting Multiple Infusers to an I.V. Pole...3-4 Attaching a Nurse Call Interface Cable...3-4 Opening the Cassette Door...3-5 Opening the Cassette Door Completely...3-7 Closing the Cassette Door...3-9 Turning Power On...3-10 Turning Power Off...3-12 Viewing the Display...3-12 Using the Keypad and Controls...3-12 Using the Keypad to Enter Program Information...3-13 Silencing the Keypad...3-13 Locking and Unlocking the Keypad...3-13 Using the Keypad to Search the Drug List...3-16 Working with Alarms...3-18 Test the Alarm System...3-18 Responding to an Alarm...3-19 Adjusting the Audio Alarm Volume...3-20 Programming a Callback Alarm...3-20 Restarting the Delivery Automatically After a vi

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Distal Occlusion Alarm... 3-20 Stopping and Restarting a Delivery... 3-22 Clearing a Line... 3-23 Setting the Post Infusion Rate... 3-24 Post Infusion Rate (Loading Dose Delivery and Multistep Delivery)... 3-27 Viewing and Clearing the Volumes Infused... 3-27 Adjusting Display Lighting and Contrast... 3-30 Viewing CCA and Infuser Settings... 3-31 CCA/Infuser Setting Descriptions... 3-33 Changing the Default Infuser Settings... 3-37 Setting the Distal Pressure Alarm Limit... 3-37 Changing the Default Line B Delivery Mode... 3-39

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...5-9 Programming with a Default Drug Library...5-9 Programming Without a Drug List...5-10 Programming with a Drug List...5-10 Programming with a Custom Drug Library...5-11 Hard Limits...5-13 Soft Limits...5-13 Changing a CCA from the Drug List Screen...5-13 Delaying a Line...5-14 Putting a Line in Standby – A/B Delivery Screen...5-14 Putting a Line in Standby – Confirmation Screen...5-14 Putting a Line in Standby – Piggyback Mode...5-15 Canceling Standby – Piggyback Mode...5-15 Nurse Callback...5-15

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 mL/hr - After VTBI Complete Alarm...7-4

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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... 9-17 Lines A and B Alarms... 9-19 High Priority Alarms... 9-19

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Rejected Auto-Programs...9-25 Partially Programmed Line...9-29 Invalid Titration...9-29

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

Section 12, Supplies and Accessories...12-1 Administration Sets...12-1 CE Marked Administration Sets...12-1 Non-CE Marked Administration Sets...12-3

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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 and prevents free flow conditions. 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 infuser also allows the clinician to program a bolus dose from either line. The infuser has an IPX2 rating and includes a ratcheting pole clamp to prevent over-tightening, proximal tubing guides to help prevent tubing kinks that can lead to proximal occlusions, and a tilted display for improved readability. The Plum 360 infuser also enables fluid pathway troubleshooting such as removing proximal air in line, without disconnecting the patient line. 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

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Plum 360 Infuser 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.

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).

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.

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.

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Plum 360 Infuser 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 implementation. Contact your ICU Medical Representative for more information about available training programs.

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 3-20)

[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

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or

Dose Calculation

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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.

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. Important: An Important message highlights information on the proper use of the product, user expectations, error situations, and actions related to these.

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 infusers that use British English. Illustrations and screen examples in this manual are graphic depictions, not exact representations of the product.

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Labeling Symbols Glossary This section describes the symbols used in the labeling for the Plum 360 infuser. Symbol

EC REP

SN

Description

Standards

Symbol Identifier

Manufacturer

BS EN ISO 15223-1

Clause 5.1.1

Authorized Representative in the European Community

BS EN ISO 15223-1

Clause 5.1.2

Date of manufacture

BS EN ISO 15223-1

Clause 5.1.3

Catalogue Number

BS EN ISO 15223-1

Clause 5.1.6

Serial Number

BS EN ISO 15223-1

Clause 5.1.7

Fragile, Handle with Care

BS EN ISO 15223-1

Clause 5.3.1

Keep Dry

BS EN ISO 15223-1

Clause 5.3.4

Temperature Limitation

BS EN ISO 15223-1

Clause 5.3.7

Humidity Limitation

BS EN ISO 15223-1

Clause 5.3.8

Atmospheric Pressure Limitation BS EN ISO 15223-1

Clause 5.3.9

Caution

Clause 5.4.4

BS EN ISO 15223-1

Equipotential Terminal (Ground) IEC 60417

Ref no. 5021

Nurse Call Interface

Ref no. 5035

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IEC 60417

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Symbol

Description Dangerous Voltage

Type CF

IPX2

1-6

Standards

Symbol Identifier

IEC 60417

Ref no. 5036

Non-ionizing electromagnetic IEC 60417 radiation. To indicate generally elevated, potentially hazardous levels of non-ionizing radiation, or to indicate equipment or systems in the medical electrical area that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment.

Ref no. 5140

The administration set, which comprises the infusion liquid pathway, is an applied part for the Plum infuser. The administration set is a Type CF Applied Part complying with the higher degree of protection against electric shock. Type CF Applied Parts are those parts suitable for direct cardiac application.

IEC 60417

Ref no. 5335

Wired Ethernet Interface Port

IEC 60417

Ref no. 5988

Mains supply equipment using protective earth

IEC 60601-1

Clause 6.2

Volume

IEC 60601-1

Clause 7.4.2

Protection against vertically falling water drops

IEC 60601-2-24

Clause 201.11.6.5

This Way Up

ISO 7000

Ref no. 0623

Mandatory Action

ISO 7010

Ref no. M001

Follow Instructions for Use

ISO 7010

Ref no. M002

Prohibition

ISO 7010

Ref no. P001

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2797

Symbol

Description

Standards

Symbol Identifier

Warning

ISO 7010

Ref no. W001

Dangerous Voltage

ISO 7010

Ref no. W012

Federal (USA) law restricts this device to sale by or on the order of a doctor or other licensed practitioner

FDA 21 CFR 801.109

N/A

Complies with limits for Class B digital device established by FCC Rules, Part 15

FCC 47 CFR

15.19

CE mark

EU Medical Device Directive/Regulation

N/A

Waste from Electrical and Electronic Equipment

EN 50419

Clause 4

Separate Collection for Batteries Battery Directive with Lead 2006/66/EC

Annex II

Regulatory Compliance Mark

Clause 3.2

Pb

Australian Communications and Media Authority (ACMA) wireless regulatory authority AS/NZS 4417.1

The ‘C’ and ‘US’ indicators CSA International adjacent to the CSA Mark signify that the product has been evaluated to the applicable CSA and ANSI/UL Standards, for use in Canada and the U.S., respectively. This ‘US’ indicator includes products eligible to bear the ‘NRTL’ indicator. NRTL (National Recognized Testing Laboratory), is a designation granted by the U.S. Occupational Safety and Health Administration (OSHA) to laboratories which have been recognized to perform certification to U.S. Standards.

System Operating Manual

N/A

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Symbol

Symbol Identifier

Description

Standards

Complies with the Independent Communications Authority of South Africa (ICASA) Electronic Communications Act, Act No 36 of 2005

Electronic Communications Act, Act No 36 of 2005

N/A

National Communications Commission of Taiwan (NCC) Wireless Registration

Radio Wave Regulatory

Articles 12 & 14

Medical Device

N/A

N/A

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.

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