Plum 360™

Infuser System Operating Manual

For use with all configurations Compatible with:

of list number 30010 ICU Medical MedNet™

IFU0000140 (02, 2020-06)

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Notes

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Plum 360 Infuser

Change History
Part Number Description of Change
IFU0000140 Updated Sections 1, 4, and 12 to reflect that the use
(02, 2020-06) of a syringe adapter is required for syringes 3-10mL
to ensure delivery accuracy and reduce proximal
occlusion alarms.

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Notes

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Plum 360 Infuser

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

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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

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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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Plum 360 Infuser

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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Notes

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Plum 360 Infuser

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 Primary Only:

specific instructions, Attach an empty
or disclaimer container.

Italic, bold, blue Reference to a section, (See Adjusting

figure, or table the Audio Alarm
Volume on
page 3-20)

[BRACKETED Keys on the device are [START]

ALL CAPS] displayed in
[BRACKETED ALL or
CAPS] or with a
graphic.

[Bracketed Blue] Softkey Options [Choose]

Initial Caps lowercase Screen displays and Program

device labels (as
appropriate) Dose Calculation

Bold Emphasis ...sets are supplied

Sterile and are
for....

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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
Symbol Description Standards
Identifier
Manufacturer BS EN ISO 15223-1 Clause
5.1.1

EC REP
Authorized Representative in BS EN ISO 15223-1 Clause
the European Community 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
SN 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 BS EN ISO 15223-1 Clause

5.4.4

Equipotential Terminal (Ground) IEC 60417 Ref no.

5021

Nurse Call Interface IEC 60417 Ref no.

5035

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Symbol
Symbol Description Standards
Identifier
Dangerous Voltage IEC 60417 Ref no.
5036

Non-ionizing electromagnetic IEC 60417 Ref no.

radiation. To indicate generally 5140
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.
The administration set, which IEC 60417 Ref no.
comprises the infusion liquid 5335
pathway, is an applied part for
Type CF 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.
Wired Ethernet Interface Port IEC 60417 Ref no.
5988

Mains supply equipment using IEC 60601-1 Clause 6.2

protective earth
Volume IEC 60601-1 Clause
7.4.2

Protection against vertically IEC 60601-2-24 Clause

IPX2 falling water drops 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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Plum 360 Infuser

Symbol
Symbol Description Standards
Identifier
Warning ISO 7010 Ref no.
W001

Dangerous Voltage ISO 7010 Ref no.

W012

Federal (USA) law restricts this FDA 21 CFR 801.109 N/A

device to sale by or on the order
of a doctor or other licensed
practitioner
Complies with limits for Class B FCC 47 CFR 15.19
digital device established by
FCC Rules, Part 15
CE mark EU Medical Device N/A
2797

Directive/Regulation
Waste from Electrical and EN 50419 Clause 4
Electronic Equipment

Separate Collection for Batteries Battery Directive Annex II

with Lead 2006/66/EC
Pb
Regulatory Compliance Mark Australian Clause 3.2
Communications and
Media Authority (ACMA)
wireless regulatory
authority AS/NZS 4417.1
The ‘C’ and ‘US’ indicators CSA International N/A
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.

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Plum 360 Infuser

Symbol
Symbol Description Standards
Identifier
Complies with the Independent Electronic N/A
Communications Authority of Communications Act, Act
South Africa (ICASA) Electronic No 36 of 2005
Communications Act, Act No 36
of 2005
National Communications Radio Wave Regulatory Articles
Commission of Taiwan (NCC) 12 & 14
Wireless Registration
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 Drug Amount, Diluent Amount, Patient Weight,
Parameters 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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Term Definition
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 1-13.
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.

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Term Definition
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 The library-identifying string transmitted to the
String 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 Simultaneous delivery of fluids on Line A
Delivery and Line B.
Concurrent Mode A mode that enables the user to program Line B
for Concurrent delivery.
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.

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Term Definition
Enteral Delivery using an intestinal route.
Expected The amount of time from the date of
Service Life implementation 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 The height difference between the source
(FHH) container and the distal line output.
Flush A feature that enables the clinician to flush the
distal tubing volume of a piggyback therapy. The
programmed Flush volume is delivered from the
Line A container at the Piggyback therapy rate
after the Piggyback therapy completes.
Hard Limit The upper- and lower-dosing limits associated with
a drug, in the drug library, that cannot be
overridden by the operator.
ICU Medical ICU Medical MedNet provides healthcare
MedNet 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.

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Term Definition
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.
ME Equipment Medical Electrical equipment
Mode A type of secondary infusion, either Piggyback
or Concurrent.
Multistep A sequential program that can deliver up to
10 steps from one container at different rates,
doses, VTBIs and durations using the same
dosing unit.
Non-Time-Based A dosing unit that does not include a time
Dosing Unit component (for example, grams).
Outgassing The release of a gas that was dissolved, trapped,
frozen or absorbed in a material.
Override An action by a clinician that acknowledges
and confirms an alert and then proceeds with
a program containing a parameter that falls
outside the hospital-defined Soft Limits.
Parenteral Delivery via other than an intestinal route,
such as intravenous (I.V.) injection.
Piggybackable A drug setting in a custom drug library that
indicates whether a drug is allowed to be delivered
in Piggyback Mode.

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Plum 360 Infuser

Term Definition
Piggyback Mode The delivery mode that suspends Line A delivery
while Line B delivers. Line A resumes when Line
B delivery completes.
Prime The action of filling the Plum Administration
Set, Plum Cassette, and all connected tubing
with the fluid to be infused.
Proximal Upstream (input, as Line A and/or Line B)
with respect to the Cassette pumping chamber
portion of the Administration Set.
Rate The amount of fluid pumped to the patient over
a given period of time, expressed in mL/hr.
Rule Set The programmed Soft Limits and Hard Limits
associated with a drug entry from the CCA in the
drug library.
Service Mode A non-therapeutic mode used for configuring the
infuser and changing default settings.
Softkey A front panel key on the bottom portion of the
display screen that is assigned specific functions
within the operational context of a particular
screen.
Soft Limit The upper- and lower-dosing limits associated
with a drug, in the drug library, that can be
overridden by the operator.
Standby A pending delivery program that requires operator
action to begin the infusion.
Tall-Man Lettering Uses uppercase letters in combination with
lowercase letters to help clinicians differentiate
among sound-alike or look-alike drug names.
Time-Based A dosing unit that includes a time component
Dosing (for example, g/min).
Titration A change in Rate, Dose Duration, and/or VTBI
in a currently running or programmed infusion.
Unintended Bolus A single, unintended volume of fluid delivered.
Also see Bolus on page 1-9.

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Term Definition
Unit of Measure One of a variety of terms used to describe a drug
amount, such as grams, mg, or units.
VTBI Volume To Be Infused. The volume of fluid
or I.V. solution (remaining) for delivery
by a program or Therapy step from a Line.

Precautions
The Plum 360 infuser has been designed and manufactured
to be safe, reliable, and easy to use. This section details precautions
and possible hazards.

Warnings, Cautions, and Guidelines

For safe operation of the Plum 360 infuser, observe the Warnings,
Cautions, and recommendations in the following sections.

General Warnings and Cautions

WARNING
POSSIBLE EXPLOSION HAZARD EXISTS IF THE PLUM 360
INFUSER IS USED IN THE PRESENCE OF FLAMMABLE
SUBSTANCES, INCLUDING ANESTHETICS.

TO AVOID THE RISK OF ELECTRIC SHOCK, THE EQUIPMENT

MUST ONLY BE CONNECTED TO A SUPPLY MAINS WITH
PROTECTIVE EARTH.

TO AVOID THE RISK OF ELECTRIC SHOCK, DO NOT OPEN THE

CASE. REFER TO QUALIFIED SERVICE PERSONNEL.

NO MODIFICATION OF THIS EQUIPMENT IS ALLOWED.

NO ADDITIONAL DEVICES CAN BE CONNECTED TO THE INFUSER

THAT HAVE NOT BEEN SPECIFIED AS COMPATIBLE WITH THE
INFUSER BY ICU MEDICAL.

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Plum 360 Infuser

ARRANGE TUBING, CORDS, AND CABLES TO MINIMIZE THE RISK

OF PATIENT STRANGULATION OR ENTANGLEMENT.

DO NOT OPERATE THE PLUM 360 INFUSER WITH THE CASE

OPENED.

ADMINISTER ONLY ANESTHETICS/ANALGESICS APPROVED

FOR EPIDURAL ADMINISTRATION (AS INDICATED OR ALLOWED
BY THE DRUGS’ FDA APPROVED LABELLING OR HEALTH
CANADA APPROVED LABELLING). EPIDURAL ADMINISTRATION
OF DRUGS OTHER THAN THOSE INDICATED FOR EPIDURAL USE
COULD RESULT IN SERIOUS INJURY TO THE PATIENT.

DO NOT USE THE INFUSER IN A MRI ENVIRONMENT OR IN THE

PRESENCE OF STRONG MAGNETIC FIELDS. SERIOUS INJURY
OR DAMAGE TO EQUIPMENT MAY RESULT.

DO NOT USE THE INFUSER IN ANY HYPERBARIC OR OXYGEN-

R I C H EN V I R O N M E N T. S E RI O U S I N J U R Y OR D A M A G E
TO EQUIPMENT MAY RESULT.

DO NOT EXPOSE THE INFUSER DIRECTLY TO X-RAYS

OR ULTRASOUND; PERMANENT DAMAGE TO THE INFUSER’S
ELECTRONIC CIRCUITRY MAY OCCUR.

CONSULT THE PHARMACY TO CONFIRM DRUG COMPATIBILITY,

CONCENTRATION, DELIVERY RATES, AND VOLUMES ARE ALL
SUITABLE FOR SECONDARY, CONCURRENT AND PIGGYBACK
DELIVERY MODES.

CAUTION
EXERCISE CAUTION WHEN THE PATIENT IS AMBULATORY WHILE
CONNECTED TO THE INFUSER.

Important: Although unlikely, failure of certain robust mechanical

components such as the anti-free flow mechanism or valve control
springs could cause fluid delivery limited to the contents of the fluid
container.

Important: Single fault failure of certain electronic/motor control

components would result in no more than 5 mL of unexpected fluid
delivery.

Important: Do not place the infuser in service if it fails the self-test.

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Piggyback, Concurrent, and Secondary Delivery

Guidelines
Primary and secondary fluids are delivered to the patient through
a common cassette and distal line. Observe the following guidelines
during Piggyback, Concurrent, and Secondary deliveries.

WARNING
CLOSE ALL CLAMPS ON THE PRIMARY AND SECONDARY LINES,
OR REMOVE THE SECONDARY CONTAINER, BEFORE OPENING
THE CASSETTE DOOR TO PREVENT THE MIXTURE OF PRIMARY
AND SECONDARY FLUIDS AND TO PREVENT UNRESTRICTED
FLOW.

CAUTION
IF THE PRIMARY RATE IS SET HIGHER THAN THE SECONDARY RATE,
ANY DISTAL FLUID REMAINING FROM THE SECONDARY INFUSION WILL
BE INFUSED AT THE HIGHER PRIMARY RATE.

WHEN NOT USING THE AUTO-FLUSH FEATURE, IF THE PRIMARY RATE

IS SET LOWER THAN THE SECONDARY RATE, ANY DISTAL FLUID
REMAINING FROM THE SECONDARY INFUSION WILL BE INFUSED AT
THE LOWER PRIMARY RATE.

IF THE SECONDARY RATE IS SET HIGHER THAN THE PRIMARY RATE,

ANY DISTAL FLUID REMAINING FROM THE PRIMARY INFUSION WILL BE
INFUSED AT THE HIGHER SECONDARY RATE.

IF THE SECONDARY RATE IS SET LOWER THAN THE PRIMARY RATE,

ANY DISTAL FLUID REMAINING FROM THE PRIMARY INFUSION WILL BE
INFUSED AT THE LOWER SECONDARY RATE.

Concurrent Delivery of Critical Drugs

WARNING
ENSURE MEDICATIONS THAT ARE DELIVERED
CONCURRENTLY, OR IN PIGGYBACK, ARE COMPATIBLE.

CAUTION
AT RATES BELOW 0.4 mL/HR, PAUSES IN FLOW CONTINUITY
OF MORE THAN 20 SECONDS WILL OCCUR, WHICH MAY IMPACT THE
PHYSIOLOGIC RESPONSE TO DRUGS THAT HAVE A VERY SHORT
HALF-LIFE.

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When delivering short half-life critical drugs (see Critical Drug

Examples on page 1-18) using the Plum 360 infuser in Concurrent
mode, the following delivery rate guidelines should be observed:
• If the critical drug (with half-life less than 6 minutes) is to be infused
at less than 2 mL/hr, the other infusion should be no faster than
5 times the critical drug’s rate. Dopamine, for example, delivered
at 1.5 mL/hr should not be accompanied by an infusion
programmed any faster than 7.5 mL/hr.
• If the critical drug (with half-life less than 6 minutes) is to be infused
at 2 - 5 mL/hr the other infusion should be no faster than ten times
the critical drug’s rate. Dopamine, for example, delivered at 3.5 mL/
hr should not be accompanied by an infusion programmed any
faster than 35 mL/hr.
• If the critical drug (with half-life less than 6 minutes) is to be infused
at 5.1 mL/hr or greater, the other infusion can be programmed
at any desired rate.

NOTE: The total of the primary rate plus the secondary rate cannot
exceed 500 mL/hr.

These guidelines apply only when infusing short half-life critical drugs
in Concurrent mode. Individual patient responses may vary requiring
adjustment of delivery rates.

Delivery Rate Guidelines

Short Half-life
Maximum Rate
(less than 6 minutes)
of Accompanying Infusion
Critical Drug Infusion Rate

0.5 - 1.9 mL/hr 5 Times the Critical Drug Rate

2 - 5 mL/hr 10 Times the Critical Drug Rate

5.1 or Greater Any Desired Ratio

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Critical Drug Examples

Examples of drugs with a short half-life (approximately 6 minutes

or less when given intravenously) include:

Dobutamine Esmolol Nitroprusside

Dopamine Isoproterenol Norepinephrine

Epinephrine Lidocaine Oxytocin

Epoprostenol Nitroglycerin Procainamide

For these drugs, the Concurrent flow guidelines should be followed

when the infusion rate of the drug will be 5 mL/hr or less.

NOTE: The list of critical drugs on page 1-18 is not intended to be all-
inclusive of critical drugs or drugs with a short half-life.

The clinician should become familiar with the pharmacodynamics

of any critical drug before administration.
This information is presented to inform clinicians of a rare situation
that could be misinterpreted if they are unfamiliar with this
phenomenon.

Guidelines When Opening the Cassette Door

NOTE: Opening the cassette door will stop the infusion on one
or both lines.

• To prevent unrestricted flow and mixing fluids in lines A and B,

close all clamps, or remove the secondary container, before
opening the cassette door.
• A small amount of fluid is expelled from the set (less than or equal
to 0.1 mL) each time the door is opened or closed with a set
installed. If potent drugs are being used, take appropriate action
to guard against over-medication of the patient.
• Keep the cassette door securely closed while the infuser is not
in use to avoid cassette door damage.

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Plum 360 Infuser

Administration Sets and Accessories Guidelines

• Plum 360 infuser operation requires single-use Plum series
administration sets (PlumSets). See Administration Sets on
page 12-1 for a representative list of Plum administration sets.
• Use only compatible PlumSets with the Plum 360 infuser. See
individual set instructions for additional information.
• Administration sets should be changed at least every 96 hours.
Discard after use.
• I.V. infusion sets with integral nonblood filters are not for use in the
administration of blood, blood products, emulsions, suspensions, or
any medications not totally soluble in the solution being
administered. These medications may be administered through the
lower Y-injection site, below the filter.

WARNING
WHEN INFUSING AT LOW DELIVERY RATES (5 mL/HR OR LESS)
USE THICK-WALLED MICROBORE PLUMSETS. THIS WILL
REDUCE THE AMOUNT OF THE UNINTENDED FLUID BOLUS THAT
MAY BE DELIVERED WHEN A DISTAL OCCLUSION IS RELEASED.

• Microbore PlumSets are not recommended at flow rates above

100 mL/hr.

WARNING
USE OF MICROBORE SETS AT RATES GREATER THAN
100 ML/HR MAY INCREASE THE LIKELIHOOD OF DISTAL
OCCLUSIONS RESULTING IN DELAY OF THERAPY, AND REDUCE
SYSTEM ACCURACY AS STATED IN THE Delivery Accuracy
SECTION STARTING ON PAGE 11-10.

• When infusing at delivery rates of 0.1 to 999 mL/hr, macrobore

PlumSets may be used.
• When attaching a syringe to the primary port (Line A), use standard
clinical practices to ensure the syringe is secure in order to reduce
the chances of creating a proximal occlusion.
• Syringes must be between 3 mL (minimum) to 60 mL (maximum).
Syringes larger than 10 mL may be directly attached to the

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Plum 360 Infuser

secondary port of the cassette. Small volume syringes, i.e.,

3-10mL, require a vented syringe adapter to ensure delivery
accuracy and reduce proximal occlusion alarms. For syringe sets
on Line A, use a vented syringe adapter with all syringes from 3 mL
to 60 mL.
• Before disconnecting a syringe from the cassette, pull up the
plunger slightly to avoid spilling the fluid.
• Before disconnecting a rigid container from the cassette, close the
upper slide clamp or clamp proximal tubing, open the cassette door,
and then remove and invert the cassette (ports down) to avoid
spilling the fluid.

Precautions to Avoid Unintended Bolus

In addition to the following procedure, refer to Maximum Unintended
Bolus Volume Released After Distal Occlusion is Resolved on
page 11-9.
Use the following procedure to avoid the administration of an
unintended bolus following a distal occlusion:

1. If the administration set does not have a clamp distal to the

cassette, disconnect the tubing from the patient while eliminating
the distal occlusion.
If the administration set has a clamp on the distal line, ensure that
the clamp is closed (even if the closed clamp caused the distal
occlusion alarm).

2. Close all clamps on the primary and secondary lines.

3. Open the cassette door and remove the cassette.

4. Gently pull out the flow regulator on the cassette to dissipate the
pressure for a brief moment, and then push in on the flow
regulator to close it.

5. Eliminate the source of occlusion, unless it was caused by

a closed distal clamp. (The distal clamp must remain closed
until Step 8.)

6. If the distal line was removed, reattach it to the patient access

device.

7. Reinsert the cassette and close the cassette door.

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Plum 360 Infuser

8. Open all clamps and resume infusion.

For other conditions that may cause an unintended bolus to be

administered, see Guidelines When Opening the Cassette Door
on page 1-18 and Administration Sets and Accessories
Guidelines on page 1-19.

Guidelines to Avoid Air in the Patient Line

• Air bubbles may form distal to the cassette as the result of normal
outgassing of dissolved air in the fluid in one or more of the
following cases:
• Chilled solution is in use.
• Certain fluids known to routinely outgas are in use.
• The infuser is mounted significantly above the patient. Minimize
this differential (head height) when outgassing is a concern.
• The infuser is infusing at very low rates between 0.1 and 5 mL/hr.
In these cases, an air-eliminating filter may be used when clinically
appropriate.
• Repeated opening and closing of the door may defeat the proximal
air-in-line alarm and may cause a distal air-in-line alarm, requiring
repriming.
• When using a syringe adapter, retract the plunger to draw
approximately 1 mL of fluid into the syringe to clear air from the
adapter filter.

Guidelines During Backpriming

• Backpriming is not recommended for reconstituting secondary
containers containing dry powders.
• To avoid pressurization when backpriming into a syringe, confirm
that there is sufficient empty space to accept the backprimed fluid
before beginning a backprime.

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Plum 360 Infuser

• During a backprime, fluid is pumped from the container on Line A to

a line or syringe attached to the secondary port (Line B) at a rate of
approximately 1 mL every 5 seconds.
• To accept the backprimed air and/or fluid, a line with a container
or a syringe needs to be attached to the secondary port.

Battery Guidelines
Use AC (mains) power whenever possible. Connect to AC
(mains) power during storage to ensure a fully charged battery
for emergencies.

• Do not operate the Plum 360 infuser on patients when the battery is
removed. Use of a properly maintained and charged battery helps
to ensure proper operation.
• The battery may not be fully charged upon receipt. Connect the
infuser to AC (mains) power for at least eight hours.
• If the quality of the earth grounding source is in doubt, use battery
power.
• If the low-battery alarm sounds, connect the infuser to AC (mains)
power immediately.

Guidelines During Cleaning

• The infuser must be cleaned prior to first use on a patient.
• To avoid mechanical or electronic damage, do not immerse the
Plum 360 infuser in any fluids or cleaning solutions.
• Do not spray cleaning solutions toward any opening in the
instrument.
• Certain cleaning and sanitizing solutions may slowly degrade
components made from some plastic materials. Using abrasive
cleaners or cleaning solutions not recommended by ICU Medical
may result in product damage. Do not use compounds containing
combinations of isopropyl alcohol and dimethyl benzyl ammonium
chloride.

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Plum 360 Infuser

• Never use sharp objects such as fingernails, paper clips, or needles

to clean any part of the infuser.
• Do not sterilize by heat, steam, ethylene oxide (ETO), or radiation.
• To avoid infuser damage, cleaning solutions should only be used as
directed. The disinfecting properties of cleaning solutions vary;
consult the manufacturer for specific information.
For more information, see Cleaning the Infuser on page 10-1
and the Plum 360 Infuser Technical Service Manual.

Artifacts
Nonhazardous, low-level electrical potentials are commonly observed
when fluids are administered using infusion devices. These potentials
are well within accepted safety standards, but may create artifacts
on voltage-sensing equipment such as ECG, EMG, and EEG
machines. These artifacts vary at a rate that is associated with the
infusion rate. If the monitoring machine is not operating correctly
or has loose or defective connections to its sensing electrodes, these
artifacts may be accentuated so as to simulate actual physiological
signals.
To determine if the abnormality in the monitoring equipment is caused
by the infusion device instead of some other source in the
environment, set the infusion device so that it is temporarily not
delivering fluid. Disappearance of the abnormality indicates that
it was probably caused by the electronic noise generated by the
infusion device. Proper setup and maintenance of the monitoring
equipment should eliminate the artifact. Refer to the appropriate
monitoring equipment system documentation for setup and
maintenance instructions.
The Plum 360 infuser is designed to operate normally in the presence
of most encountered electromagnetic interference (EMI) conditions.
The Plum 360 has been tested for electromagnetic immunity
compliance in accordance with professional healthcare environment
immunity requirements of IEC/EN 60601-1-2 Edition 4 standard. This
device has also been tested for extended EMI immunity in the event
of extreme levels of interference encountered next to an
electrosurgical generator at a separate distance of ½ meter and found

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Plum 360 Infuser

to present no observable hazards in the presence of bipolar

electrosurgical generator up to 80W of RF power and unipolar
electrosurgical generator up to 300W of RF power at 490kHz +/-
5kHz and associated harmonics.
This equipment has been tested and found to comply with the EMC
limits for its classification of medical device. Those limits are designed
to provide reasonable protection against harmful interference in a
typical medical installation. The equipment generates, uses and can
radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to
other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment
does cause harmful interference with other devices, which can be
determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the
following measures:
• Reorient or relocate the receiving device
• Increase the separation between the equipment
• Connect the equipment into an outlet on a circuit different from that
to which the other device(s) is connected
• Consult the manufacturer or field service technician for help
CAUTION
PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT, SUCH
AS CELLULAR TELEPHONES , 2- WAY RADIOS , B LUETOOTH ™
DEVICES, MICROWAVE OVENS, IN CLOSE PROXIMITY TO THIS DEVICE
MAY AFFECT WIRELESS AND WIRED COMMUNICATIONS WITH THE
INFUSER AND/OR THE OPERATION OF THE INFUSER.

Special cautions need to be exercised regarding EMC. These include:

• Use of a shielded Ethernet cable (CAT5 STP or better) for plugging
into the RJ45 Ethernet connector. Using an unshielded Ethernet
cable may result in increased emissions or decreased immunity
performance.

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Plum 360 Infuser

• Maintaining a minimum separation distance of 2 ½ ft (77 cm)

between the infuser system and portable/mobile RF communica-
tions equipment.

Interconnecting of Medical Equipment

Accessory equipment connected to the analog and digital interfaces
must be certified according to the respective IEC Standards (for
example, IEC 60950 for data processing equipment and IEC 60601-1
for Medical Equipment). Any person who connects additional
equipment to the signal input or output part configures a medical
system, and is therefore responsible for ensuring that the system
complies with the requirements of Standard IEC/EN 60601-1.

Electromagnetic Compatibility
The Plum 360 infuser has been tested to the requirements of the
standards in the following table:

Pump Labeling Inventory

Standard Code
05/06 09/10 13/14
IEC/EN 60601-1-2:2007 Edition 3 X X X
IEC 60601-1-2:2014 Edition 4
X
EN 60601-1-2:2015 Edition 4
IEC 60601-1:2012
X X X
EN 60601-1:2013
IEC 60601-2-24:2012
X X X
EN 60601-2-24:1998

The Plum 360 device has been evaluated and tested for safety and
essential performance under the scope and requirements of IEC/
EN 60601-1-2 Edition 4 (as defined in the table above) under the
professional healthcare environment immunity category for following
electromagnetic tests and found to be compliant:
• Radiated and Conducted Emissions (CISPR 11 Group 1 Class B)

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Plum 360 Infuser

• Harmonic Current Emissions (IEC 61000-3-2)

• Voltage Fluctuation and Flicker (IEC 61000-3-3)
• ESD Immunity (IEC 61000-4-2)
• Radiated RF Field Immunity (IEC 61000-4-3)
• Proximity Fields from wireless transmitters (IEC 61000-4-3)
• Electrical Fast Transients (IEC 61000-4-4)
• Surge Immunity (IEC 61000-4-5)
• Conducted Immunity (IEC 61000-4-6)
• Conducted Immunity to ISM band (IEC 61000-4-6)
• Magnetic Field Immunity (IEC 61000-4-8)
• Voltage Dips and Interruptions (IEC 61000-4-11)
The infuser is suitable for use in clinical professional healthcare
environments in accordance with the provisions of IEC 60601-1-
2:2014 Edition 4/EN 60601-1-2:2015 Edition 4 Medical Electrical
equipment standard for basic safety and essential performance for
electromagnetic disturbances. The infuser is suitable for use in all
establishments, excluding domestic establishments. The infuser is
Group 1a Class Bb Medical Electrical equipment for electromagnetic
disturbance emissions purposes.

WARNING
THIS EQUIPMENT IS INTENDED FOR USE BY HEALTHCARE
PROFESSIONALS ONLY. THIS EQUIPMENT/SYSTEM MAY
CAUSE RADIO FREQUENCY INTERFERENCE OR MAY
DISRUPT THE OPERATION OF NEARBY EQUIPMENT,
DEVICES, OR SYSTEMS USING RF ELECTRICAL ENERGY FOR
THEIR OPERATION. THE USER MIGHT NEED TO TAKE
MITIGATION MEASURES, SUCH AS RELOCATING OR RE-
ORIENTING THE PLUM 360 EQUIPMENT OR SHIELDING THE
LOCATION.

a. Group 1 ME equipment includes:

- equipment that generates or uses RF energy only for its internal functioning, or
- equipment intended to deliver energy to the patient in a form other than RF
electromagnetic (such as infusion pumps).
b. Class B equipment is suitable for use in all establishments including domestic
surroundings.

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Plum 360 Infuser

The essential performance of a Plum 360 device consists of:

• Delivery accuracy
• Free flow avoidance under single-fault condition
• Alarm generations and conditions
If the essential performance of the infuser is affected due to an
electromagnetic disturbance event or if you suspect external RF
sources or other equipment are influencing device operation, stop
usage of the device and contact the biomedical engineering
department for additional guidelines concerning electromagnetic
immunity. Contact the biomedical engineering department for
additional information in the Plum 360 Infuser Technical Service
Manual concerning operating devices near RF sources or sources of
electromagnetic disturbance.
Refer to the Plum 360 Infuser Technical Service Manual for further
details of the EMC testing procedures and compliance levels. There
is a shared responsibility between manufacturers, customers and
users to ensure that Medical Equipment and Systems are designed
and operated as intended. Medical electrical equipment needs
special cautions regarding electromagnetic compatibility and needs to
be installed and used according to the electromagnetic compatibility
information provided in this manual.
Always manage the electromagnetic environment.
The guidance included in this manual provides information needed to:
• Determine the device’s suitability for use in the intended
environment.
• Manage the electromagnetic environment to permit the device
to perform as intended without disturbing other equipment.
Separate the device from all other electronic equipment. If the device
must be used near other electrical equipment, monitor the equipment
to ensure there is no electromagnetic interference.

WARNING
DEVICES SHOULD NOT BE USED ADJACENT TO OR STACKED
WITH OTHER EQUIPMENT. IF THE DEVICE MUST BE USED
ADJACENT TO OR STACKED WITH OTHER EQUIPMENT,
MONITOR THE DEVICES TO VERIFY NORMAL OPERATION.

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Plum 360 Infuser

WARNING
USE ONLY COMPONENTS AND ACCESSORIES SPECIFICALLY
LABELED FOR USE WITH THE PLUM 360 INFUSER TO HELP
ENSURE THE DEVICE OPERATES AS INTENDED. USE OF
UNAUTHORIZED ACCESSORIES, CABLES, TRANSDUCERS
AND EQUIPMENT MAY HAVE A RISK OF AFFECTING THE
EMISSIONS AND IMMUNITY COMPLIANCE REQUIREMENTS OF
THE PLUM 360 INFUSER.

FCC Information
US FCC (Federal Communications
Commission) Statement (United States Only)
The device has been tested and found to comply with the limits for
a Class B digital device, pursuant to Part 15C, 15E of the FCC rules.
These limits are designed to provide reasonable protection against
harmful interference.
Operation is subject to the following two conditions: (1) This device
may not cause interference, and (2) This device must accept any
interference, including that may cause undesired operation of these
devices.

FCC Interference Statement (United States Only)

This equipment has been tested and found to comply with the limits
for a Class B digital device, pursuant to Part 15 of the FCC rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment
generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the

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Plum 360 Infuser

equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
• Reorient or relocate the receiving antenna
• Increase the separation between the equipment and receiver
• Connect the equipment to an outlet on a circuit different from that
to which the receiver is connected
• Consult the dealer or an experienced radio/television technician for
help
This device and its antenna(s) must not be co-located or operated in
conjunction with any other antenna or transmitter.

Department of the Minister of Innovation, Science,

and Economic Development (Canada Only)
The Class B digital apparatus complies with Canadian ICES-003.

Radio Frequency Exposure Statement

The Wireless LAN radio device in the Connectivity Engine peripheral
assembly with this infusion device has been evaluated and found
compliant to the requirements of the following Radio Frequency
exposure standards.

FCC Rules, Part 15/Industry Canada

This device complies with Part 15 of FCC Rules and Industry Canada
license-exempt RSS standard(s). Operation is subject to the following
two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference, including interference
that may cause undesired operation of this device.
This equipment complies with FCC/IC radiation exposure limits set
forth for an uncontrolled environment and meets the FCC radio

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Plum 360 Infuser

frequency (RF) Exposure Guidelines in Supplement C to OET65 and

RSS-102 of the IC radio frequency (RF) Exposure rules.
Under Industry Canada regulations, this radio transmitter may only
operate using an antenna of a type and maximum (or lesser) gain
approved for the transmitter by Industry Canada. To reduce potential
radio interference to other users, the antenna type and its gain should
be so chosen that the equivalent isotropically radiated power (e.i.r.p.)
is not more than that necessary for successful communication.
This radio transmitter (identify the device by certification number,
or model number if Category II) has been approved by Industry
Canada to operate with the antenna types listed below with the
maximum permissible gain and required antenna impedance for each
antenna type indicated. Antenna types not included in this list, having
a gain greater than the maximum gain indicated for that type, are
strictly prohibited for use with this device.
For product available in the USA/Canada market, only channels 1-11
can be operated. Selection of other channels is not possible.
If this device is to be operated in the 5.15~5.25 GHz frequency range,
it is restricted to indoor environments only.

Antenna: Proprietary

Antenna Gain Information: Embedded Antenna:

4.2dBi (2.4 GHz), 5.1dBi (5 GHz)

Frequency Tolerance: ±20ppm

Radio Equipment Directive

Hereby, ICU Medical, Inc. declares that the radio equipment type
Wireless Local Area Network is in compliance with Directive 2014/53/
EU.
The full text of the EU declaration of conformity is available at the
following internet address:
http://www.icumed.com/about-us/qualityregulatory-certificates

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Plum 360 Infuser

RoHS
ICU Medical, hereby declares that this Plum Infusion Pump is in
compliance with Directive 2011/65/EU on the restriction of the use of
certain hazardous substances in electrical and electronic equipment
(RoHS).

Taiwan NCC Warning Statement

According to “Administrative Regulations on Low Power Radio Waves
Radiated Devices”
Without permission granted by the NCC, any company, enterprise, or
user is not allowed to change frequency, enhance transmitting power
or alter original characteristic as well as performance to an approved
low power radiofrequency devices. The low power radio-frequency
devices shall not influence aircraft security and interfere legal
communications; If found, the user shall cease operating immediately
until no interference is achieved. The said legal communications
means radio communications is operated in compliance with the
Telecommunications Act.
The low power radio-frequency devices must be susceptible with the
interference from legal communications or ISM radio wave radiated
devices. Device will avoid affecting the operation of the radar system
nearby. High-gain directivity antenna will only use for the stationary
point-to-point system.

經型式認證合格之低功率射頻電機，非經許可，公司、商號或使用者
均不得擅自變 更頻率、加大功率或變 更原設計之特性及功能。低功
率射頻電機之使用不得影響飛 航安全及干擾合法通信；經發現有干擾
現象時，應立即停用，並改善至無干擾時方 得繼續使用。前項合法通
信，指依電信法規定作業之無線電通信。低功率射頻電機 須忍受合法
通信或工業、科學及醫療用電波輻射性電機設備之干擾。避免影響附
近雷達系統之操作。高增益指向性天線只得應用於固定式點對點系統

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Plum 360 Infuser

Suspected Cybersecurity Event or Threat

The section contains information on the recommended procedure
upon detecting a suspected cybersecurity event or threat.

1. Contact hospital and/or follow hospital guidelines to report the

suspected cybersecurity event or threat.
Attempts to exploit a remote vulnerability on an infusion device
would require penetration of several layers of network security
enforced by the hospital, including firewalls. These measures
serve as the primary defense against tampering with a medical
device.

2. Contact ICU Medical to report the suspected cybersecurity

event or threat.

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Plum 360 Infuser

Section 2
Equipment Description
For a technical description of the Plum 360 infuser, see the Plum 360
Infuser Technical Service Manual.
The Plum 360 infuser includes the infuser (pumping module)
and attached Connectivity Engine peripheral module (CE module),
and this System Operating Manual. The CE module provides wired
Ethernet and wireless 802.11 a/b/g/n local area networking
capabilities. This allows the infuser to connect to the facility’s network
and communicate with the optional ICU Medical MedNet networked
application software to download software and drug libraries,
and to enable auto-programming features. Optional accessories are
also available.
Each infusion requires a disposable, single-use Plum administration
set to provide the fluid path between the fluid container and the
patient access device. Each administration set includes a proprietary
cassette that works with the pumping mechanism on the infuser
to provide accurate fluid delivery and air management.

AUDIO PAUSED

abc def
START

ghi jkl mno

STOP

pqrs tuv wxyz

AC ON

ON OFF CLEAR LOCK KEYPAD

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See Section 12 for a representative list of Plum administration sets

and optional accessories.
The following sections describe the Plum 360 infuser hardware and
Plum administration sets.

Keypad and Display

This manual covers Plum 360 infusers with an alphanumeric keypad
and Plum 360 infusers with a numeric keypad.
The screen examples used in this manual are representative of an
infuser with an alphanumeric keypad.

Alphanumeric Keypad
Audio Paused Key

Line A Flow Line B Flow

Indicator Indicator

AUDIO PAUSED
Line

Status A B
Region

Working
Region

0 Rate 0
Messages mL/hr
CCA
0 Vol Inf 0 Name
mL
Medical
Softkey ICU Medical
Label Select Line A/B to program MedNet
Back Settings / Connected
Prime
A B Vols / CCA

Softkey Battery
Capacity

abc def
Start START Wireless
and Signal
Stop Strength
Keys ghi jkl mno
STOP
AC ON Select Key
Indicator
pqrs tuv wxyz
AC ON

ON/OFF Lock Keypad

ON OFF CLEAR LOCK KEYPAD
Key Key

Clear Key Number/Letter Key Decimal Key

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Plum 360 Infuser

Numeric Keypad
Audio Paused Key

Line A Flow Line B Flow

Indicator Indicator

Line

Status A B
Region

Working
Region

0 Rate 0
Messages mL/hr
CCA
0 Vol Inf 0 Name
mL
Medical
Softkey ICU Medical
Label Select Line A/B to program MedNet
Back Settings / Connected
Prime
A B Vols / CCA

Softkey Battery
Capacity

Start Wireless
and Signal
Stop Strength
Keys

AC ON Select Key
Indicator

ON/OFF Lock Keypad

Key Key

Clear Key Number Key Comma Key

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Plum 360 Infuser

Operating Keys

[ON/OFF] - Infuser power on and off. See Turning Power

On and Turning Power Off for more information.

[START] - Is the first key to press to start a delivery.

For safety reasons, every delivery must be confirmed
by checking the programming and then pressing
an additional softkey, in response to a prompt.

[STOP] - Stops delivery.

If two lines are pumping when you press [STOP], you must
press one of the following softkeys: [Stop A], [Stop B],
or [Stop All] in response to a prompt to specify which
line(s) to stop (see page 2-6 for more information about
softkeys).

[SELECT] - Moves the cursor between fields on the display.

The top pair of arrows moves the cursor up or to the left.

The bottom pair of arrows moves the cursor down

or to the right.

[LOCK KEYPAD] - Pressing this key, followed by entering a

lock passcode, disables all keys on the keypad except
[STOP] until a valid unlock passcode is entered. See
Locking and Unlocking the Keypad for more information.

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[AUDIO PAUSED] - Has two functions, temporarily silencing

all audio output for any active alarms for two minutes
or temporarily silencing keypad input sound feedback for two
minutes if there are no active alarms. See Programming a
Callback Alarm and Silencing the Keypad for more
information.

[C] - Clears all values in the currently-highlighted field.

[C] also clears the dashes (-- -- --) that are displayed when
an entry is invalid or a drug delivery parameter is beyond the
pre-programmed hard limits.

NOTE: [C] will NOT clear an entire program.

Alphanumeric Keypad - [DECIMAL KEY] - Adds the

decimal point needed when entering numbers other than
whole numbers (1.2 mL, for example).

NOTE: On the infuser display, any digits after the decimal

point will be ¾ of the height of the whole number digits.

Numeric Keypad - [COMMA KEY] - Adds the comma

needed when entering numbers other than whole numbers
(1,2 ml, for example).

NOTE: On the infuser display, any digits after the comma

will be ¾ of the height of the whole number digits.

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Plum 360 Infuser

Alphanumeric Keypad -
Number keys - Have two
abc def functions, entering numbers
in any highlighted field and
navigating through the drug
ghi jkl mno
library.
See Using the Keypad to Enter
Program Information and
Using the Keypad to Search
pqrs tuv wxyz
the Drug List for more
information.

Numeric Keypad -
Number keys - To enter
numbers in any highlighted field.
See Using the Keypad to Enter
Program Information for more
information.

Loading Previous
Softkeys - Offer functions that
Delay Multistep Dose Screen are appropriate for the screen
currently being displayed.
The current function for each
softkey appears on the display;
you press the triangular key
below it to choose the function.
In this manual, softkeys are
represented by a triangle and the
name in brackets; [Delay],
for example.

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Indicators

Flow Indicator - Green LED that blinks while a delivery

is in progress, lights steadily when a delivery is in Standby
or is Delayed, Stopped, or Paused, and is off when a delivery
is not programmed for the line.
There are two flow indicators above the display. The one
on the left is for Line A, the one on the right is for Line B.

AC ON Indicator - Green LED that lights steadily when the

infuser is plugged into AC (mains) power. During this time,
the battery charges continuously when a battery is installed.
If the infuser is unplugged, the AC ON Indicator light goes off
within seconds, indicating that the infuser is operating on
battery power.

NOTE: If the device is plugged into AC (mains) power with a

battery installed, and the AC ON Indicator is not illuminated,
contact technical support.

Display Symbols
Caution - appears on the display to inform the clinician to
use CAUTION because the specified drug has been
programmed without rule sets (soft or hard limits), and may
have been programmed outside of specified safety limits for
that specific drug.

Upper Soft Limit Override - appears next to the drug name

when the dosage of the drug being infused is higher than the
upper soft limit set for the drug in the Custom Drug Library
(for systems with ICU Medical MedNet software only).

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Lower Soft Limit Override - appears next to the drug name

when the dosage of the drug being infused is less than the
lower soft limit set for the drug in the Custom Drug Library
(for systems with ICU Medical MedNet software only).

Wireless Signal Strength - appears when the infuser

is communicating with the network using a wireless
connection.
The number of bars indicate the strength of the wireless
connection. The following figure shows the signal strength
from highest on the left to lowest on the right.

If the signal strength is low, try relocating the infuser closer

to the access point.

Ethernet - appears when the infuser is communicating

with the network over a wired (Ethernet) connection.

ICU Medical MedNet Connected - appears when the

infuser is communicating with ICU Medical MedNet software
over either a wireless or Ethernet connection.

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Battery Capacity - shows the battery charge level when

a battery is installed in the infuser, or indicates that a battery
is not installed.
The following figure shows all possible appearances for this
symbol. From left to right, the symbols represent 100%, 75%
50%, and 25% charge levels, a fully-depleted battery,
and a battery not installed.

Alarm - appears when an alarm is currently active.

The following figure shows the two states for this symbol.
The appearance changes to the symbol on the right when
all audio output is temporarily silenced by pressing the
[AUDIO PAUSED] key.

!!! Alarm Priority - appears before each alarm message,

indicating the priority. This symbol has three possible states:

!!! - High priority alarm

!! - Medium priority alarm
! - Low priority alarm
The infuser also sounds the appropriate high, medium,
or low auditory alarm signal.

Lock - appears when the keypad is locked (see Locking

and Unlocking the Keypad on page 3-13).

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CE Module
Connection of the Plum 360 infuser to an IT network could result
in previously unidentified risks to patients, operators, or third parties.
The organization that makes those connections must identify and
control those risks.
The wireless CE (Connectivity Engine) Module attached to the back
of the infuser provides both wired Ethernet and wireless 802.11
networking capabilities for connection to ICU Medical MedNet
software on your facility’s network (see ICU Medical MedNet Safety
Software on page 12-16).
In addition to its communications features, the CE Module includes
these infuser controls:

Activity
Indicator
LEDs
I/O Port
Cover
Audio
Volume
Control
Ethernet
Port

Nurse Call
Interface
Port
Service
Port
(ICU Medical
Use Only)

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Activity Indicator LEDs – These LEDs show CE Module

activity.

CE Module Activity LED Color Indication

Powering up and performing Green On

self-check tests. Yellow On

Ready for operation. Green Blinking

Yellow Off

Communicating via Ethernet Green Blinking

or Wi-Fi. Yellow Blinking

Module is shut down* or there Green Off

is system failure. Yellow Off

* For information about CE shutdown, see the Plum 360 Infuser Technical Service
Manual.

Audio Volume Control – adjusts the sound level of the

audible alarm. Rotate the knob clockwise to increase the
volume. Rotate the knob counterclockwise to decrease the
volume.

Nurse Call Interface Connector– connects to the facility’s

Nurse Call System to provide remote notification for all
infuser alarms (see Attaching a Nurse Call Interface
Cable).

Ethernet port – accepts a shielded Ethernet cable

to connect to a local area network.

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Pole Clamp, Potential Equalization

Terminal, and Power Cord
Pole Clamp - adjusts to fit round I.V.
poles from 0.5 - 1.5 inches (1.2 cm to
3.8 cm) in diameter. See Mounting
the Infuser on an I.V. Pole on
page 3-3 for more information. When
the pole clamp is tight enough, a
ratcheting sound indicates that the
clamp is being over-tightened.

Power Cord - plugs into AC (mains)

power to provide power, charge the
battery, and ground the infuser
enclosure and chassis. The power
cord connection to the infuser is
protected by an enclosure to prevent
accidental disconnection. The power
cord can be replaced if damaged
(see the Plum 360 Infuser Technical
Service Manual).

INSPECT CORD BEFORE USE.

When plugging in, use straight
forward motion.

INSPECT CORD AFTER USE.

When unplugging, grasp plug and
pull straight out. Do not pull cable to
unplug.

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Potential Equalization Terminal -

is used to ensure that the infuser is
at the same electric potential (voltage)
as the other devices in the treatment
location. Ideally the electrical potential
is at zero volts, so that no current can
inadvertently flow from one device to
another through a patient.
When the infuser’s power cord
is connected to an AC (mains) outlet,
the grounding wire of the power cord
POTENTIAL
(48$/,=$7,21 forces the infuser enclosure and
TERMINAL chassis to be at zero volts. If the
infuser power cord is not connected
to the mains outlet, a separate
grounding cord should be connected
from the Potential Equalization
Terminal to a grounding terminal in the
treatment location.

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Plum 360 Infuser

Plum Administration Sets

Plum administration sets are available for a wide variety of uses,
including intravenous, blood, enteral, and epidural deliveries.
Intravenous, epidural, and blood sets are supplied sterile. Some sets
have additional features such as burettes, filters, or special tubing.
See Administration Sets on page 12-1 for a representative list of
Plum administration sets.

CONVERTIBLE PIERCING PIN

WITH DRIP CHAMBER

SLIDE CLAMP SECONDARY PORT

(Prepierced, capped, Clave
PRIMARY (Not for IV push delivery of medicine))
LINE

Y-SITE
(For IV push delivery
of medicine) DISTAL
(PATIENT)
FLOW LINE
REGULATOR CASSETTE
FINGER CAIR
GRIP (ROLLER)
CLAMP

LOCKING COLLAR
CONNECTOR
PROTECTIVE CAP
WITH FILTER
(Connect to patient access device)

The following sections describe the most common features.

See Section 4 for instructions on how to prepare and use Plum
administration sets. See set packaging for specific instructions.

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Plum 360 Infuser

The Plum Cassette

Each PlumSet includes a proprietary cassette that works with
the infuser’s pumping mechanism to provide fluid delivery,
air management, and occlusion detection.
The following figure shows the parts of the cassette.

(PROXIMAL)
PRIMARY
LINE (PROXIMAL)
SECONDARY
PORT

FLOW
REGULATOR FINGER
GRIP

PUMPING
CHAMBER
DISTAL
(PATIENT)
LINE
AIR-IN-LINE
SENSORS
AIR TRAP

The air trap allows 1 mL of air before the infuser sounds a cassette
alarm. To remove air bubbles from the air trap, perform Backpriming.

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Plum 360 Infuser

Most cassettes also include a secondary port for attaching a line

or syringe for Piggyback or Concurrent fluid delivery. The secondary
port has one of these connectors:

Clave secondary ports are compatible with

sets or syringes that employ male luer
adaptors for connection. Clave secondary
ports are incompatible with needles.
The Clave needle-less design provides
a mechanically- and microbiologically-closed
fluid path.

Capped secondary ports are also compatible

with secondary sets or syringes that employ
male luer adaptors for connection. Capped
ports are incompatible with needles.

Prepierced secondary ports accept

a locking blunt cannula attached to a
secondary line or syringe.

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Plum 360 Infuser

The cassette also has these features:

• A finger grip to assist placing the cassette in the correct position,
to guide and load it into the door tracks of the cassette door.
• A pumping chamber that works with the pumping mechanism
on the infuser to pump fluid to the patient.
• An air trap that collects air bubbles from the I.V. proximal A and B
lines. Air trap capacity is 2 mL of air that can be removed
by backpriming (see Backpriming on page 4-21).
• Air-in-line sensor bulbs that work with the proximal and distal air-
in-line detectors in the infuser to check for air bubbles that may
be entering or leaving the cassette.
• A flow regulator that can be used to manually control flow during
priming or when using gravity flow to deliver fluid. When you insert
the cassette into the infuser and close the cassette door,
a mechanism opens the flow regulator to allow the infuser to control
fluid flow. When you open the cassette door, the same mechanism
closes the flow regulator to prevent unrestricted flow from the distal
line.

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Other Administration Set Features

Most Plum administration sets have some combination of the
following features. For complete information about all the features
of a particular administration set, refer to the label on the
administration set packaging.

The convertible piercing pin spikes the seal

on the fluid container and secures the
administration set tubing to the container.
The piercing pin has a built-in filter vent that
allows use with flexible or rigid fluid containers,
and an integrated drip chamber with score mark
for monitoring fluid flow.
If using a rigid fluid container (glass bottle,
for example), open the filter vent cover above
the drip chamber. If using a flexible plastic
container, make sure this vent cover is closed.

Slide clamps can be placed anywhere on the

tubing. The shape of the cutout provides three
clamp positions:
• Open position, in the middle of the cutout,
OPEN
POSITION
allows fluid to flow and also allows the clamp
CLOSED to slide freely on the tubing.
POSITION
• Closed position, at the narrow end of the
cutout, clamps the line, preventing fluid flow.
The closed clamp stays in a fixed position
on the tubing.
PARKED
POSITION • Parked position, at the wide end of the
cutout, also allows fluid to flow, but keeps
the clamp in a fixed position on the tubing
to prevent movement.

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Plum 360 Infuser

Roller Clamps allow controlled fluid flow.

OPEN
POSITION • To gradually increase fluid flow, slide the roller
towards the fully Open position.

• Observe the fluid drops in the drip chamber.

• To gradually decrease and then stop fluid flow,

slide the roller towards the fully Closed
position.
CLOSED
POSITION

DISTAL (PATIENT)
The distal line (patient line) runs from the
LINE
cassette to the patient.
The connector that attaches the distal line
to the patient access device has a locking collar
LOCKING COLLAR
CONNECTOR that prevents accidental disconnection.
NOTE: The cap on the connector has a filter
that allows the set to be primed while the cap is
on as long as the cap stays dry. Cap is a sterile
fluid path barrier when in place.

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Plum 360 Infuser

Notes

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Plum 360 Infuser

Section 3
Basic Operations
The Plum 360 infuser does not require any special implementation.
Before placing the infuser into service for the first time, the only
preparation needed is to have a biomedical technician customize the
default settings according to the facility’s needs, clean the infuser,
and then fully charge the battery. See the Plum 360 Infuser
Technical Service Manual for more information.
If using ICU Medical MedNet safety software, the infuser must also
be connected to the facility’s network to download infuser
configuration, Clinical Care Area (CCA), and Custom Drug Library
(CDL) information before being placed into service.
Once these preparations are complete, follow these basic steps
to deliver fluids to the patient:

1. Mount the infuser on an I.V. pole (see Mounting the Infuser on

an I.V. Pole on page 3-3), or place the infuser on a stable
surface.

Do not place the infuser on an unstable surface.

WARNING
CONNECT THE AC (MAINS) CORD TO A PROPERLY
GROUNDED RECEPTACLE.

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Plum 360 Infuser

2. Connect the power cord to an AC (mains) power receptacle and

confirm that the green AC ON indicator lights.

Ensure that access to the mains plug is not blocked while

using the infuser so that the plug can be disconnected
from the mains power receptacle in the event of an
emergency.

INSPECT CORD BEFORE USE. When plugging in, use

straight forward motion.

INSPECT CORD AFTER USE. When unplugging, grasp

plug and pull straight out. Do not pull cable to unplug.

3. (Optional) Attach a Nurse Call Cable between the Nurse Call

Interface Port on the back of the infuser and your facility’s Nurse
Call system (see Attaching a Nurse Call Interface Cable on
page 3-4).

4. Prime and install a Plum administration set (see Priming a

Primary Administration Set on page 4-2). Confirm that the
cassette door is closed before attaching an administration set
to the patient access device.

5. Turn the infuser on and allow it to successfully complete the

Self Test (see Turning Power On on page 3-10).

6. Attach the administration set to the patient access device.

7. Program the delivery and start the infusion (Programming on

page 5-1 and Delivery Options on page 8-1).

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Plum 360 Infuser

Mounting the Infuser on an I.V. Pole

CAUTION
FOR STABILITY AND TO RESIST TIPPING, MOUNT INFUSER TO THE
I.V. POLE PER THE PROVIDED INSTRUCTIONS. VERIFY STABILITY
BEFORE USE.

The Plum infuser pole clamp is designed to be mounted on an I.V.

pole with a diameter from 0.5 - 1.5 inches (1.2 cm to 3.8 cm). To do
this:

1. Make sure the pole is assembled correctly, rests on a stable

surface, and is placed where infuser operations will not
be affected by other equipment.

CAUTION
IF THE PLUM INFUSER IS BEING USED NEXT TO OTHER ELECTRICAL/
ELECTRONIC EQUIPMENT, OBSERVE THE FUNCTIONING OF THE
INFUSER TO ENSURE THAT IT IS NOT BEING AFFECTED BY
ELECTROMAGNETIC INTERFERENCE FROM OTHER DEVICES BEING
USED IN THE VICINITY OF THE INFUSER.

2. Turn the pole clamp knob counterclockwise until the gap between
the pole clamp and the pole clamp screw is wide enough to fit the
I.V. pole.

3. Grasp the infuser by the handle and position the clamp around
the I.V. pole.

4. Rest the pole against the

infuser’s pole support. Refer
to Section 12, Accessories,
for proper mounting height.

5. With your other hand,

turn the pole clamp knob
clockwise to secure the
infuser to the pole.

NOTE: The Plum 360 infuser

pole clamp has a ratchet

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Plum 360 Infuser

mechanism that produces an audible click when properly

tightened. When the pole clamp is tight enough, a ratcheting
sound indicates that the clamp is being over-tightened.

CAUTION
MAKE SURE THE POLE CLAMP IS TIGHTENED PROPERLY AND THE
INFUSER IS SECURELY ATTACHED TO THE POLE, TO PREVENT
PERSONAL INJURY OR DAMAGE TO THE INFUSER.

6. Push down and pull up on the infuser to confirm that it is tightly

clamped to the I.V. pole, without vertical or rotational slippage.
If you detect slippage, loosen the pole clamp screw, realign the
pole clamp, tighten the pole clamp screw, and then check again.

Mounting Multiple Infusers to an I.V. Pole

If there is a need to mount multiple infusers on an I.V. pole, refer to
the I.V. Pole section on page 12-11 or the Multiple Device Adapter
section on page 12-9.

Attaching a Nurse Call Interface Cable

The Plum 360 infuser can connect to your facility’s Nurse Call system
through the Plum Nurse Call Interface cable (see Accessories on
page 12-7).

To connect the infuser to a Nurse Call system:

1. Attach the rectangular connector on the Nurse Call interface

cable to the Nurse Call interface connector that is built into the
CE unit on the back of the infuser.

2. Attach the other end of the cable to the Nurse Call System port
at the patient’s bedside.

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Plum 360 Infuser

Opening the Cassette Door

WARNING
CLOSE ALL CLAMPS ON THE PRIMARY AND SECONDARY
LINES, OR REMOVE THE SECONDARY CONTAINER, BEFORE
OPENING THE CASSETTE DOOR TO PREVENT THE MIXTURE OF
PRIMARY AND SECONDARY FLUIDS AND TO PREVENT
UNRESTRICTED FLOW.

TO CLOSE CLOSED
TO CLOSE CLOSED CAIR CLAMP POSITION
SLIDE CLAMP POSITION ROLLER

ROLLER

CAUTION
A SMALL AMOUNT OF FLUID IS EXPELLED FROM THE SET (LESS THAN
OR EQUAL TO 0.1 mL) EACH TIME THE CASSETTE DOOR IS OPENED
OR CLOSED WITH A SET INSTALLED. IF POTENT DRUGS ARE BEING
USED , T AKE APPROPRIAT E A CTIO N T O GUARD AGAI NST
OVERMEDICATION OF THE PATIENT.

Infuser components located behind the cassette door interact with the
cassette to control fluid flow, preventing primary and secondary fluids
from mixing, and allowing fluid to reach the patient only when the
infuser is pumping. The fluid regulator closes to prevent fluid flow
to a patient.
When you open the cassette door, infuser components are no longer
in contact with the cassette. Always close all clamps before you
open the cassette door so that fluid does not flow into drip
chambers.

To open the cassette door:

1. Make sure that all slide clamp and lower CAIR (roller) clamps are
closed before opening the cassette door.

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Plum 360 Infuser

2. Lift the cassette door lever as shown in the following illustration.

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Plum 360 Infuser

Opening the Cassette Door Completely

The cassette door can be opened flat if needed, for example,
to retrieve a dropped cap, remove a stuck cassette, or wipe a spill.

WARNING
CLOSE ALL CLAMPS ON THE PRIMARY AND SECONDARY
LINES, OR REMOVE THE SECONDARY CONTAINER, BEFORE
OPENING THE CASSETTE DOOR TO PREVENT THE MIXTURE OF
PRIMARY AND SECONDARY FLUIDS AND TO PREVENT
UNRESTRICTED FLOW.

To open the cassette door completely:

1. Close all slide clamp and lower CAIR (roller) clamps before
opening the cassette door.
TO CLOSE CLOSED
TO CLOSE CLOSED CAIR CLAMP POSITION
SLIDE CLAMP POSITION ROLLER

ROLLER

2. Lift the cassette door lever to open the cassette door.

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Plum 360 Infuser

3. Press the yellow door release tab on the lower part of the door
lever to disengage the cassette door from the door latch,
and then gently press the cassette door down until it opens
completely.

CLOSE
LEVER
WHEN
NOT
IN
USE

CLOSE LEVER WHEN

PR NOT IN USE
UN ESS
LA TA
TC B T
HD O
OO
R

NOTE: The precision pumping mechanism located behind the

cassette door includes pins and sensors that can be damaged
by rough handling.

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Plum 360 Infuser

Closing the Cassette Door

Keep the cassette door closed while not in use to avoid damage
to the cassette door.
To close the cassette door, press down on the cassette door lever.

BEFORE OPENING DOOR

WARNING: CLOSE ALL CLAMPS BEFORE OPENING DOOR
CLOSE
LEVER
WHEN
CLOSE
NOT LEVER
IN WHEN
NOT
USE IN
USE

OSE LEVER WHEN

NOT IN USE
ES
LA S TA
TC B
H D TO
OO
R

LEVER
CLOSED

If the infuser is turned on when you close the cassette door,

the cassette test begins automatically.

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Plum 360 Infuser

Turning Power On
Each time you turn the power on, the infuser performs a System Self
Test to check the operation of critical systems and alarms,
then prompts for a cassette, if one is not already installed. The infuser
then performs a cassette test that checks for air bubbles and verifies
the integrity of the cassette’s pumping components.

CAUTION
DO NOT USE THE INFUSER ON A PATIENT IF THE BATTERY IS
NOT INSTALLED.

Important: Do not use the infuser if the Self Test fails.

NOTE: A small amount of fluid may be expelled from the set

(less than or equal to 0.2 mL) when the infuser is powered on.
If potent drugs are being used, take appropriate action to guard
against over-medication of the patient.
Cassette test failure can be caused by improper cassette priming.
In that case, perform backpriming to resolve the problem. If the test
still fails, replace the administration set with a properly primed set.
If the failure persists, replace the infuser.

To turn power on:

1. Make sure the power cord is plugged into AC (mains) power and
that the infuser is mounted securely on an I.V. pole or located
on a stable surface.

Ensure that access to the mains plug is not blocked while

using the infuser so that the plug can be disconnected
from the mains power receptacle in the event
of an emergency.

INSPECT CORD BEFORE USE. When plugging in, use

straight forward motion.

INSPECT CORD AFTER USE. When unplugging, grasp

plug and pull straight out. Do not pull cable to unplug.

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Plum 360 Infuser

2. Press [ON/OFF] until you hear a beep and the Line A and Line B
flow indicators (drip symbols) briefly blink.
The infuser checks for a cassette and then begins the System
Self Test, followed by the cassette test.

NOTE: For software version 15.11 and later, while the self test
is in progress, the infuser displays the drug library version and
the infuser and CE software versions.

NOTE: The CE version will only display if the CE has

connected to the infuser at least once.
• If you see the prompt “Insert PLUM Set, Close Lever,” insert
a primed Plum cassette into the infuser to continue.
• With software version 15.11 and later, you can view and clear
volume infused totals while the Insert PLUM Set prompt
displays by pressing [Volumes Infused]. See Viewing and
Clearing the Volumes Infused on page 3-27.
• If you see the prompt “New Patient?” the infuser has a stored
program from the last delivery. To clear the programming, press
[Yes]; to keep it, press [No].

NOTE: If the cassette test fails while the New Patient? prompt
is displayed, press [Yes] or [No], as appropriate, and then
hold down [Back Prime] to clear air from the cassette.
See Backpriming on page 4-21 for more information.

NOTE: For software version 15.11 and later, if a Drug Library

issue is identified during the System Self Test, you will be
advised to return the infuser to the hospital biomedical staff.

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Plum 360 Infuser

Turning Power Off

NOTE: Always turn the infuser off when not in use, to reduce the
consumption of electrical energy.

You can only turn power off if the status is STOPPED or blank for
both lines.

To turn power off:

1. Stop all active deliveries (see Stopping and Restarting a

Delivery on page 3-22).

2. Press [ON/OFF] until you hear a beep.

NOTE: If the Plum 360 infuser has been turned off for longer than five
hours, all delivery settings are cleared and programming options are
restored to their default selections for next use.

NOTE: If a drug library is available for installation at power down,

based on the configuration either the user will be prompted to accept
it or it will install automatically.

Viewing the Display

When operating the infuser, position yourself at a distance of no more
than 39 inches (1 M) from the display.
Make sure you are directly in front of the display, or at an angle
of no more than 20 degrees off this position.

Using the Keypad and Controls

The alphanumeric keypad on the Plum 360 infuser has two functions,
entering information to program a delivery and searching through the
drug library.

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Plum 360 Infuser

Using the Keypad to Enter Program Information

When entering numbers in a Program screen (to program a delivery
rate or VTBI, for example), highlight the field and press the number
keys as needed.
• Use [Decimal] when entering numbers other than whole numbers
(1.2 mL, for example).
• Use [SELECT] to move the cursor between programming fields.
• Press the top pair of arrows to move up or to the left.
• Press the bottom pair of arrows to move down or to the right.
• Press [C] to clear all values in the currently-highlighted field
or to clear the dashes (-- -- --) that are displayed when an entry
is invalid or a drug delivery parameter is beyond the pre-
programmed hard limits.

NOTE: [C] will NOT clear an entire program.

Silencing the Keypad

To silence key press feedback sounds when there are no active
alarms, press [AUDIO PAUSED]. A message will display while key
press feedback is silenced.
Keypad sounds resume automatically after 2 minutes.
When the infuser enters an alarm state, silencing is deactivated
and keypad sounds automatically resume.

Locking and Unlocking the Keypad

A passcode is used to both lock and unlock the keypad. Please
contact ICU Medical or the hospital Biomedical staff for the code.
The same passcode is used to both lock and unlock the keypad.
The keypad can be locked to prevent unauthorized use. The keypad
lock disables all keys on the keypad except [STOP] until a valid
passcode is entered.

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Plum 360 Infuser

For safety reasons, [STOP] will stop an active delivery, even when the
keypad is locked. [Stop All], [Stop A], [Stop B], and [Cancel]
are all functional.
Pressing [STOP] or opening the cassette door during an infusion
while the keypad is locked activates an alarm that cannot be silenced
until a valid passcode is entered and the keypad is unlocked.
If an incorrect passcode is entered, the infuser displays an error
message.
• The number of unsuccessful attempts to unlock the keypad entered
is displayed in the passcode dialog box, so you can monitor the
infuser for attempts at unauthorized access.
• Each attempt is also recorded in the infuser log. Logs can be
retrieved by the Biomedical staff. See the Plum 360 Infuser
Technical Service Manual for more information.

To lock the keypad (Method #1):

1. Press the [LOCK KEYPAD] hard key.

2. The Passcode data entry

screen appears on the display.
A Passcode B

3. Enter the passcode using the Enter Passcode to Lock Keypad

numeric keypad.
Passcode ****
4. Press the [Enter] soft key.

Use keypad then press Enter

Enter Cancel

When the keypad is locked, the lock symbol appears in the

bottom right corner of the delivery screen.

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Plum 360 Infuser

To lock the keypad (Method #2):

1. At the main delivery screen, press the [Settings/Vols/CCA] soft

key.

2. The Settings/Vols/CCA screen

appears on the display.
A Settings/Vols/CCA B
Version 15.0.0.XX
Post Infusion Rate
Volumes Infused
Lighting/Contrast
CCA Settings
Pressure
Default Drug Library
DDL Version 02
DDL

Select then press Choose

Lock Choose Previous
Keypad Screen

3. Press the [Lock Keypad] soft key.

The Passcode data entry
screen appears on the display.
A Passcode B

4. Enter the passcode using the Enter Passcode to Lock Keypad

numeric keypad.
Passcode ****
5. Press the [Enter] soft key.

Use keypad then press Enter

Enter Cancel

When the keypad is locked, the lock symbol appears in the

bottom right corner of the delivery screen.

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Plum 360 Infuser

To unlock the keypad:

1. Press any key on the keypad to

display the Passcode data
A Passcode B
entry screen.
Enter Passcode to Unlock Keypad
2. Enter the passcode using the
numeric keypad. Passcode ****

3. Press the [Enter] soft key.

Use keypad then press Enter

Enter Cancel

NOTE: During infusion, pressing [STOP], or opening the cassette

door, activates an alarm that cannot be silenced until the keypad is
unlocked.

Using the Keypad to Search the Drug List

You can quickly locate a drug in the drug list by using the keypad
to spell up to the first three letters of the drug name.
The following figure shows how each number key matches up
to a letter. Since each key represents more than one letter, more than
one keypress may be required to enter the letter.

abc def

ghi jkl mno

pqrs tuv wxyz

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Plum 360 Infuser

To search the drug list and select a drug:

1. Display the drug list.

• For systems with ICU Medical MedNet software, the custom
drug list appears after you select a CCA and Line A or Line B.
• For systems without ICU Medical MedNet software, select Line
A or Line B and press [Drug List] to display the DDL.

2. Press the key that represents the first letter of the drug name.
If the letter you need is not in the first position on the key, repeat
the keypress quickly to enter the letter you need.
For example, press the 5 key once to enter J, or quickly press 5
twice to enter K, or quickly press 5 three times to enter L.
• To enter a number, quickly press the key an additional time.
For example, to enter 5, quickly press the 5 key four times.
• As you spell the name, the infuser sorts the drug list and
displays only the matching drugs.
• To sort further, wait for the screen to display “Press 0-9 to refine
sort”, and then use the keypad to enter the second letter.
Repeat, if needed, to enter the third letter of the drug name.

NOTE: To restart your search at any time, press [C].

3. Use [Page Down], [Page Up], and [SELECT] as needed

to select the drug from the sorted list, and then press [Choose].

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Plum 360 Infuser

Working with Alarms

Alarms on the Plum 360 infuser have two components, a message
that appears on the display and an audible signal. The infuser has an
intelligent alarm system that handles more than one alarm at a time.
There are different indicators for high, medium, and low priority
alarms, as shown in the following table.

Display
Alarm Priority Audio Indicator
Indicator

High !!! + message A series of tones in a 3-2-3-2

cadence, repeated every
2 seconds

Medium !! + message Double tone repeated every

2 seconds

Low ! + message Double tone repeated every

10 seconds

If a Nurse Call Interface cable is connected to the facility’s Nurse Call

system, the infuser also sends a signal to that system each time
an alarm is activated (see Attaching a Nurse Call Interface Cable
on page 3-4).
See Alarms and Troubleshooting on page 9-1 for descriptions
of alarms, their priorities, and how to resolve them.

Test the Alarm System

To test the alarm system before using on a patient:

1. Load a non-primed cassette in the infuser and power the infuser

on if it is not already on.

2. Verify the Cassette Test Failure alarm activates and the audible
alarm sounds.

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3. Verify the alarm volume is appropriate for the patient

environment.

4. Adjust the volume using the Volume Control knob on the back
of the infuser, if necessary.

5. Press the [AUDIO PAUSED] key, and verify that the alarm audio
is paused.

Responding to an Alarm
1. If the keypad is locked out, enter the unlock code on the keypad.

2. Press [AUDIO PAUSED] to silence the audible part of an alarm

for 2 minutes. The alarm symbol on the display changes:

The display also flashes and shows the alarm message until the
alarm condition is resolved.

NOTE: The Low Battery alarm is silenced for 15 minutes.

NOTE: For software versions 15.11 and later, the Replace

Battery alarm is silenced for 15 minutes.

NOTE: Alarm sounds resume after the silence period expires, but
can be paused again if resolving the alarm condition takes more
time.

3. Check the display for the alarm message.

4. Correct the alarm condition (see Alarms and Troubleshooting

on page 9-1).

5. Press [START] to resume infusion. If more than one line

is programmed, press [Start A], [Start B], or [Start All]
as needed.

NOTE: Each alarm puts an entry in the infuser logs.

If troubleshooting does not correct the problem, contact the

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Biomedical department, who can check the logs and further

isolate the problem.

A malfunction alarm alerts you to turn off the infuser and restart it.
If the alarm continues, replace the infuser.

Adjusting the Audio Alarm Volume

WARNING
CHECK THAT THE ALARM VOLUME LEVEL IS APPROPRIATE FOR
THE CURRENT PATIENT AND BACKGROUND NOISE LEVEL
BEFORE USE ON THE PATIENT.

The alarm volume control knob is located on the back of the infuser
(see CE Module on page 2-10).
• To increase the volume, turn the knob clockwise.
• To decrease the volume, turn the knob counterclockwise.

Programming a Callback Alarm

You can program a Callback Alarm to alert you to each interim step
of a Loading Dose or Multistep delivery, or to notify you that
a Piggyback or Bolus delivery has ended. See Delivery Options on
page 8-1 and Standby on page 7-1 for more information.
A Callback Alarm is a medium priority alarm that must be
acknowledged by the clinician. To turn off a Callback Alarm, press
[AUDIO PAUSED].
If a Nurse Call Interface cable is connected to the facility’s Nurse Call
system, the infuser also sends an alarm signal to that system.

Restarting the Delivery Automatically After a Distal

Occlusion Alarm
• When the infuser detects a distal occlusion, delivery stops
immediately and the infuser issues an alarm. The Plum 360 infuser
can restart the delivery automatically if the distal occlusion clears

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within 60 seconds. This gives time to resolve the occlusion without

the need to restart the delivery manually by pressing the [START]
key. During the 60 seconds, the infuser monitors the pressure,
the delivery screen displays the status PAUSED, and the infuser
issues a medium priority alarm. As soon as the pressure drops
below the Distal Occlusion Alarm Limit, the alarm clears and
delivery restarts immediately.
• If the occlusion is not resolved within 60 seconds, or the maximum
number of restarts is exceeded, the delivery status changes
to STOPPED. The alarm priority changes from medium to high.
The change in the audible alarm cadence alerts you that you must
intervene to resolve the alarm (see Working with Alarms on
page 3-18 for descriptions of the audible alarms).
• When two lines are delivering, if either line exceeds the maximum
number of restarts, the priority changes to high and the alarm must
be resolved manually by pressing the [START] key.
If ICU Medical MedNet software is installed, each CCA can be
configured to allow up to 10 restarts per infusion. For software version
15.11 and later, the allowed restarts are managed within a rolling 15-
minute window. Without ICU Medical MedNet software, the number of
restarts can be configured by the Biomedical staff for the default CCA
(DDL). To view the maximum number of restarts for the current CCA,
see Viewing CCA and Infuser Settings on page 3-31.

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Stopping and Restarting a Delivery

The following procedure describes how to stop and restart an active
delivery. Active deliveries include not only those that have the status
PUMPING, but also those that are in STANDBY, DELAYED,
or PENDING.
Where two lines are active, pressing [STOP] does not stop any lines.
You must choose to stop only one line or stop all or cancel the
attempt.

To stop a delivery:

1. Press [STOP].
• If only one line is active, pumping stops immediately.
• If both lines are active, the infuser prompts you to choose which
line to stop.

2. Press [Stop A] or [Stop B] to stop the individual line or press

[Stop All] to stop both at once.
To cancel the request and not stop any lines, press [Cancel].

NOTE: When two lines are active when you press [STOP], the infuser
will alarm after 15 seconds if you don’t press a softkey to choose the
line(s) to stop. Pressing the [STOP] hardkey does not stop infusion.

Opening the cassette door will stop the infusion on one or both lines.
If you are stopping the infusion entirely, see Discontinuing Fluid
Administration on page 4-28 for instructions on removing the
administration set from the patient. See Discontinuing Electronic
Flow Control and Setting Gravity Flow on page 4-25 for
instructions on removing the administration set from the infuser but
continuing fluid administration.

WARNING
CLOSE ALL CLAMPS BEFORE OPENING THE CASSETTE DOOR!

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To restart a delivery:

1. Press [START]. If only one line was pumping when delivery was
stopped, pumping resumes immediately.
• If the line was in DELAYED, the Delay countdown resumes
where it left off when the line was stopped.
• If the line was in STANDBY, pumping resumes when you press
[START]. To return the line to Standby, press [Standby].

2. If both lines are stopped, the infuser prompts you to choose

which line to start. Press [Start A] or [Start B] to start the
corresponding line, or press [Start All] to start both lines at
once. If either line is in DELAYED or STANDBY, the infuser
responds as described in Step 1.
To cancel the request to resume pumping, press [Cancel].
If no soft key is pressed within 15 seconds, an alarm will sound.

Clearing a Line
When you clear a line, all the programming is cleared for that line.
The Volume Infused reading for that line is not cleared. The Volume
Infused reading for the other line and the Total Volume reading are
not affected.
Each time you close the cassette door or turn the infuser on,
the infuser prompts “New Patient?” to give you the option to clear all
settings on both lines. This is a safety feature to ensure that a patient
does not get a stored delivery that was programmed for a different
patient. If you press [Yes], all programming and Volumes Infused
data are cleared and settings are returned to their defaults.

To clear a line:

1. If the line you want to clear is pumping, press [STOP].

2. Record the volume infused for the line, if needed (see Viewing
and Clearing the Volumes Infused on page 3-27).

3. Press [A] or [B] to choose the line to clear.

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4. In response to the prompt, press [Yes].

5. To cancel clearing a line and resume pumping, select [No],

[START], and then [Yes].

Setting the Post Infusion Rate

After the programmed VTBI is delivered, the infuser issues a VTBI
Complete alarm and begins delivering a Post Infusion Rate. The
default Post Infusion Rate setting is KVO, but the default setting can
be changed to Rate in ICU Medical MedNet custom drug libraries as
follows:
• For software versions 15.02 through 15.11, through a Master
Infuser setting
• For software versions 15.20 and later:
• For No Drug Selected and Label Only medications, through a
CCA setting
• For all other medications, through a rule set setting for the
medication
On infusers without ICU Medical MedNet software (using the default
drug library), the Post Infusion Rate default setting can be changed
by a biomedical technician.
You can change the default setting to one of the following:
• KVO - the infuser continues to deliver fluid at a Keep Vein Open
(KVO) rate of 1 mL/hr. If the delivery rate of the infusion that just
completed was less than 1 mL/hr, the KVO rate will continue at the
same delivery rate (for example, if the delivery rate was 0.5 mL/hr,
the KVO rate will be 0.5 mL/hr).
• Rate - the infuser continues to deliver fluid at the programmed rate,
maintaining the therapeutic rate until the VTBI Complete alarm can
be resolved.
For a Concurrent delivery, the Post Infusion Rate is set for both lines.
As each line completes its VTBI delivery, that line begins infusing
automatically at the Post Infusion Rate.

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For a Piggyback delivery, the Post Infusion Rate does not apply on
Line B. The infuser switches to Line A automatically when the
Piggyback Delivery is complete.
When Line A is no longer in a Pending state (STANDBY, DELAYED,
CLEAR, or STOPPED) and Piggyback delivery is complete, a “VTBI
Completed Line B! Add more VTBI OR Clear B” alarm is received.
For software versions 15.20 and later, the Post Infusion Rate setting
can only be changed for Line A if the line is programmed.
For software versions 15.20 and later, the Post Infusion Rate setting
can only be changed for Line B if the line is programmed with a
concurrent delivery.

To set the Post Infusion Rate:

1. If the infuser is running, stop the infusion.

2. On the delivery screen,

press [Settings/Vols/ A Settings/Vols/CCA B
CCA]. The Settings/Vols/ Version 15.0.0.XX
CCA screen appears, Post Infusion Rate
with Post Infusion Rate Volumes Infused
highlighted. Lighting/Contrast
CCA Settings
NOTE: For software Pressure
versions 15.20 and later, Default Drug Library
DDL Version 02
the Post Infusion Rate DDL
screen can only be
Select then press Choose
accessed if there is a
confirmed program on Lock Choose Previous
Keypad Screen
Line A or a confirmed
concurrent program on
Line B.

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3. Press [Choose].
The Post Infusion Rate A Post Infusion Rate B
screen appears, with No Drug Selected No Drug Selected
the current setting
highlighted.
Post Infusion Rate KVO
4. For software versions 15.11
and earlier, press
[KVO/Rate] to toggle the
setting between KVO and
Rate. Change using KVO/Rate.
Press Done to save and return.
KVO/ Previous
Done
Rate Screen

For software versions

15.20 and later, press A Post Infusion Rate B
[Change A] or No Drug Selected NoDrug
No Drug Selected
Selected
[Change B] (as available)
to toggle the setting for that Line A
line between KVO and Post Infusion Rate KVO
Rate. 1 mL/hr

Line B
Post Infusion Rate KVO
5. Press [Done] to save 1 mL/hr
your changes and return to Change Post Infusion Mode.
the Settings/Vols/CCA Press Done to save and return.
Change Change Previous
screen, and then press A B Screen
[Previous Screen]
to return to the delivery
screen.

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Post Infusion Rate (Loading Dose Delivery

and Multistep Delivery)
During a Loading Dose delivery or a Multistep Delivery, you can stop
the Post Infusion Rate and make changes (perform titration)
to the VTBI. For more information, see Adding VTBI to Loading
Dose or Multistep Program After VTBI Complete Alarm Activates
on page 8-9.

Viewing and Clearing the Volumes

Infused
The infuser records the volume infused during each delivery and
keeps separate records for Line A and Line B, and a cumulative total
for both lines. The recorded volume infused is retained for 5 hours
after the infuser is turned off.
The following procedure describes how to view the volume infused
records and clear them when necessary.

NOTE: All programming, including the volumes infused, is cleared

when you turn the infuser off, and then turn it on again, then answer
“Yes” to the “New Patient?” prompt, or when you select a new CCA.

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To view and clear the volumes infused before a cassette is

inserted (available with software version 15.11 and later):

1. Power on the infuser

without a cassette Setup
inserted.
Heparin Iocane
2. When the “Insert PLUM Insert PLUM Set
Set Close Lever” prompt Close Lever
displays, press
[Volumes Infused].
Volume Infused Line A 4 mL
The screen displays the Volume Infused Line B 5 mL
volumes infused on Line Total Volume Infused 9 mL
A, Line B, and the Total
Volume infused on both Clear A, Clear B or Clear Total?
lines since the last time Clear
Clear A Clear B
the values were cleared. Total

3. To continue without clearing any values, insert a set and close

the lever.

4. To clear the Volumes Infused data:

• Press [Clear A] to clear the Line A total only.
• Press [Clear B] to clear the Line B total only.
• Press [Clear Total] to clear all values, including
the Total Volume.
• To continue, insert a set and close the lever.

For software versions 15.02 and 15.20 and later, clearing the volume
infused totals on this screen also clears the associated volume
infused total(s) on the delivery screen.
For software versions 15.10 and 15.11, clearing the volume infused
totals on this screen does NOT clear the associated volume infused
total(s) on the delivery screen.

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To view and clear the volumes infused after a cassette has been
inserted:

1. On the main delivery screen (of a Plum 360 infuser with ICU
Medical MedNet software), press [Settings/Vols/CCA] to
display the Settings/Vols/CCA screen shown on page 3-25.

2. Use [SELECT] to highlight Volumes Infused and then press

[Choose].
The Volumes Infused screen
A Volumes Infused B
displays the volumes infused
Heparin Iocane
on Line A, Line B, and the Total 25,000 units 250 mL 500 mg 250 mL
Volume infused on both lines since Line A 4 mL
the last time the values were Line B 5 mL
cleared. Total Volume 9 mL

3. To return to the Settings/Vols/CCA

DDL
screen without clearing any
values, press [Previous Screen]. Clear A, Clear B or Clear Total?
Press [Previous Screen] again Clear A Clear B Clear
Total
Previous
Screen
to return to the delivery screen.
(The screen will automatically time out after 30 seconds and
return to the delivery screen if you do not press a softkey.)

4. To clear the Volumes Infused data:

• Press [Clear A] to clear the Line A total only.
• Press [Clear B] to clear the Line B total only.
• Press [Clear Total] to clear all values, including the Total
Volume, and return to the Settings/Vols/CCA screen.
• Press [Previous Screen] to return to the Settings/Vols/CCA
screen.
If you do not press a key in 30 seconds, the Delivery screen
automatically returns.
For software versions 15.02 and 15.20 and later, clearing the volume
infused totals on this screen also clears the associated volume
infused total(s) on the delivery screen.

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For software versions 15.10 and 15.11, clearing the volume infused
totals on this screen does NOT clear the associated volume infused
total(s) on the delivery screen.

Adjusting Display Lighting and Contrast

You can adjust the lighting and contrast on the infuser display screen
to ensure visibility and customize the level for the surrounding
environment.

To adjust display lighting and contrast:

1. On the main delivery screen, press [Settings/Vols/CCA]

to display the Settings/Vols/CCA screen shown on page 3-25.

2. Use [SELECT] to highlight

Lighting/Contrast and press A Light / Contrast B
[Choose]. The Light/
Contrast screen appears,
with Backlight Intensity Backlight Intensity
highlighted.
Display Contrast
3. Use [Increase Setting]
and [Decrease Setting]
to adjust the backlight
intensity. Use Increase / Decrease Settings.
Press Done to save and return.
4. Press [SELECT] to highlight Decrease Increase Previous
Done
Display Contrast. Setting Setting Screen

5. Use [Increase Setting] and [Decrease Setting] to adjust the

display contrast.

6. Press [Done] to save the current settings and return to the

Settings/Vols/CCA screen or press [Previous Screen] to leave
this screen without saving changes.
Press [Previous Screen] to return to the Settings/Vols/CCA
screen.

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Viewing CCA and Infuser Settings

CCA/Infuser settings set defaults and limits that are appropriate for
the patient population of each Clinical Care Area (CCA) or per facility
preference.
• For systems with ICU Medical MedNet software, CCA/Infuser
settings are configured through the ICU Medical MedNet software.
The settings are downloaded to all infusers over the network
through a wireless or Ethernet connection.
• For systems without ICU Medical MedNet software, CCA/Infuser
settings are configured for each infuser through a special Biomed
menu (see the Plum 360 Infuser Technical Service Manual).
To view CCA/Infuser settings when you select or change a CCA,
press [CCA Details] on the Select CCA screen. You can also view
the CCA settings for the current CCA from the Settings/Vols/CCA
menu. The following procedure describes how to do this.

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To view the current CCA and Infuser settings:

On an infuser with a DDL, the CCA is set by a biomed technician.
You cannot select a CCA on an infuser with a DDL.

1. On the delivery screen,

press [Settings/Vols/ CCA Settings
CCA] to display the
CCA settings: Medical ICU1
Settings/Vols/CCA menu Maximum Rate: 999 mL/hr
shown on page 3-25. Maximum VTBI: 9999 mL
Maximum Patient Weight: 500 kg
2. Select[CCA Settings] Minimum Patient Weight: 0.1 kg
and press [Choose]. Maximum Patient Height: 305 cm
The CCA Settings screen Minimum Patient Height: 7.5 cm
displays. Maximum Patient BSA: 7.07 m2
Minimum Patient BSA: 0.012 m2
3. Press[Page Down]
and [Page Up] to view Page Down / Up to view all
all the CCA and Infuser
Page Page Previous
settings. Up Down Screen
4. When you are finished,
press [Previous NOTE: Image represents software
Screen] to return to the version 15.20. For software versions
Settings/Vols/CCA 15.02 through 15.11, screen content
varies.
screen. Press
[Previous Screen]
again to return to the delivery screen.

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CCA/Infuser Setting Descriptions

CCA Settings Description

Maximum Rate The highest rate that you can program

for a single line or Piggyback delivery.
For Concurrent delivery, the total rate for
Line A + Line B must be <= 500 mL/hr.
If this exceeds the maximum rate per
line (for example, if the maximum rate
is set to 200 mL/hr), then the maximum
rate is enforced.

Maximum VTBI The largest VTBI that you can program

(software versions 15.20 and for a single line or Piggyback delivery.
later) The Maximum VTBI is defined in the
drug library.

Maximum Patient Weight Together, these display the allowable

Minimum Patient Weight patient weight range for the CCA when
you program a weight-based or BSA-
based delivery.
See Patient Data Limits on
page 14-12 for the increments that can
be programmed for different weight
ranges.

Maximum Patient Height Together, these display the allowable

Minimum Patient Height patient height range for the CCA when
you program a weight-based or BSA-
based delivery.
See Patient Data Limits on
page 14-12 for the increments that can
be programmed for different height
ranges.

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CCA Settings Description

Maximum Patient BSA Together, these display the allowable

Minimum Patient BSA patient BSA range for the CCA when
you program a BSA-based delivery.
See Patient Data Limits on
page 14-12 for the increments that
can be programmed for different BSA
ranges.

Default Distal Alarm Displays the normal Distal Alarm

Pressure Pressure Limit for the CCA. You can
change this value for a delivery, when
needed.
See Setting the Distal Pressure
Alarm Limit on page 3-37 for more
information.

Default End of Infusion Sets the rate of infusion after VTBI is

(software versions 15.20 and delivered to either KVO (Keep Vein
later) Open) or Rate.
See Setting the Post Infusion Rate
on page 3-24 for more information.

Default Line B Mode for No Sets the initial Line B delivery mode to
Drug Selected and Label Piggyback or Concurrent for No Drug
Only Medications Selected and Label Only Medications in
(software versions 15.20 and the CDL. Default is Piggyback. You can
later) change this mode any time you program
a delivery on Line B by selecting the
NOTE: This setting does not Post Infusion Rate option on the
display on the CCA Settings Settings/Vols/CCA screen.
screen.

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CCA Settings Description

Distal Alarm Resets Displays the number of times that the

infuser will restart delivery automatically
when a distal occlusion is resolved
within 60 seconds.
Set by a biomedical technician or the
CCA in the ICU Medical MedNet
software. Default setting is 0.
NOTE: This feature is disabled for the
CCA if Distal Alarm Resets = 0.

Allow Standby If Allow Standby = Yes, deliveries can

be put into Standby up to the configured
Maximum Standby Time which
is between 24 and 72 hours.
(Default is 72 hours.)
If Allow Standby = No, [Standby] will
not appear on the Program screen.

Allow Delayed Start If Allow Delayed Start = Yes, you can

program a Delayed Start of up to 23:59
hh:mm for deliveries.
If Allow Delayed Start = No, [Delay]
will not appear on the Program screen.

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Infuser Settings Description

Default End of Infusion Sets the rate of infusion after VTBI
(software versions 15.11 and is delivered to either KVO (Keep Vein
earlier) Open) or Rate.
See Setting the Post Infusion Rate
on page 3-24 for more information.
Default B Delivery Mode Sets the initial Line B delivery mode
(this setting applies only if the to Piggyback or Concurrent. Default is
DDL is being used in software Piggyback. You can change this mode
versions 15.20 and later) any time you program a delivery on
Line B by pressing [Change Mode].
Default Nurse Callback When Default Nurse Callback = Yes,
a medium priority alarm will be issued
automatically at the end of:
• any step but the last step of Multistep
delivery,
• a Loading Dose delivery,
• a Piggyback infusion, or
• a Bolus delivery.
The user can change the Callback
setting from the default setting of Yes.
When Default Nurse Callback = No,
a Callback Alarm must be set manually,
if needed, for each of these.
Maximum Standby Time This is the maximum time that a delivery
can remain in Standby before the infuser
issues a high priority Inactivity alarm.
The Maximum Standby Time is defined
in the drug library. The available range is
24 to 72 hours, with a default of 72
hours.

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Changing the Default Infuser Settings

CCA settings are set based on the patient population and cannot be
changed. Infuser settings that begin with “Default” can be adjusted for
a particular delivery, if clinically necessary.
• To change the Distal Alarm Pressure Limit from the preset Default
Distal Alarm Pressure, see Setting the Distal Pressure Alarm
Limit on page 3-37.
• To change the Post Infusion Rate from the value set by the Default
End of Infusion setting, see Setting the Post Infusion Rate on
page 3-24.
• To change the Line B delivery mode from the Default Line B
Delivery Mode setting, see Programming on page 5-1.
• To set a Nurse Callback Alarm for a Multistep, Loading Dose,
Piggyback delivery, or Bolus delivery, see Programming a
Callback Alarm on page 3-20.

Setting the Distal Pressure Alarm Limit

The distal pressure limit sets the threshold for the distal occlusion
alarm. When the infuser detects that the distal pressure in the
cassette sensor area is greater than the distal pressure limit you set,
± 3 psi, the infuser issues an alarm (see Restarting the Delivery
Automatically After a Distal Occlusion Alarm on page 3-20 for
more information).
The infuser checks the distal pressure and updates the reading every
second. You can view the distal pressure reading on the same screen
where you set the distal pressure limit.

WARNING
BEFORE STARTING A DELIVERY, VERIFY THE DISTAL
PRESSURE ALARM LIMIT OR SET THE APPROPRIATE LIMIT
FOR THE PATIENT, FLOW RATE AND ADMINISTRATION SET.

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To view the current distal pressure reading and set the distal
pressure limit:

1. On the main delivery

screen, press [Settings/ A Pressure B
Vols/CCA] to display the
Settings/Vols/CCA screen
shown on page 3-25.

2. Use [SELECT] to highlight Distal Pressure Alarm Limit 6 psi

Pressure and press
Current Distal Pressure 1.5 psi
[Choose] to view. Upon
completion, select [Done]
or [Previous Screen] to Enter value using keypad.
return to the Settings/Vols/ Press Done to save and return.
CCA screen; then press Done
Previous
Screen
[Previous Screen] to
return to the main delivery screen.

Check the Distal Occlusion alarm setting before each

patient use to ensure that the setting is correct for the
current patient.

To change the Distal Pressure Alarm Limit:

CAUTION
DO NOT SET THE DISTAL PRESSURE ALARM LEVEL LOWER THAN
3 PSI (155 MMHG) OR HIGHER THAN 12 PSI (624 MMHG). SETTING
THE ALARM OUTSIDE OF THAT RANGE MAY RESULT IN UNRELIABLE
ALARM FUNCTIONING.

1. If the infuser is running, stop the infusion.

2. Press [Settings/Vols/CCA] to display the Settings/Vols/CCA

screen.

3. Use [SELECT] to highlight Distal Pressure Alarm Limit and press

[Choose].

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4. Change the limit to the desired PSI value between 3 and 12

(between 155 and 634 mmHg).

5. Use the keypad to press [Done] to save your changes and

return to the Settings/Vols/CCA screen or press [Previous
Screen] to view the settings without making changes.

6. Press [Previous Screen] to return to the main delivery screen.

Changing the Default Line B Delivery

Mode
To change the default Line B delivery mode:

1. Press [B] to choose Line B. The Program screen appears,

displaying No Drug Selected.

2. Choose a drug and associated dosing units, if applicable.

3. Choose a dosing unit (the default is mL/hr) to display the

Program screen.

4. Navigate to the current Mode field (displaying Piggyback

or Concurrent), then [Change Mode].

5. Press [START] for confirmation when all program parameters

have been populated, then [Yes] to start delivery.

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Notes

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Plum 360 Infuser

Section 4
Plum Administration Sets
Plum 360 infuser operation requires single-use Plum series
administration sets (PlumSets). See Administration Sets on
page 12-1 for a representative list of Plum administration sets.
CAUTION
PLUM ADMINISTRATION SETS ARE NOT FOR USE WITH HIGH
PRESSURE INFUSION.

The following illustration shows the parts of a typical Plum primary

I.V. administration set.
CONVERTIBLE PIERCING PIN
WITH DRIP CHAMBER

SLIDE CLAMP SECONDARY PORT

(Prepierced, capped, Clave
PRIMARY (Not for IV push delivery of medicine))
LINE

Y-SITE
(For IV push delivery
of medicine) DISTAL
(PATIENT)
FLOW LINE
REGULATOR CASSETTE
FINGER CAIR
GRIP (ROLLER)
CLAMP

LOCKING COLLAR
CONNECTOR
PROTECTIVE CAP
WITH FILTER
(Connect to patient access device)

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Plum 360 Infuser

Plum administration sets have a 96-hour performance limit. Refer to

the set packaging or facility policy for guidelines on when to change
the set.
See Plum Administration Sets on page 2-14 for more information
about administration set features. See Administration Sets on
page 12-1 for a representative list of Plum administration sets.

Priming a Primary Administration Set

Priming fills the cassette, tubing, and any other special features of the
set with fluid, displacing air. Proper priming is an important part of air
management.
The following procedure gives the general steps for priming a Plum
administration set. Refer to the administration set packaging for
complete instructions on how to prime the set.

WARNING
DO NOT PRIME THE ADMINISTRATION SET WHILE IT IS
CONNECTED TO A PATIENT.

WARNING
DO NOT RESTERILIZE OR REUSE ADMINISTRATION SETS.
ADMINISTRATION SETS ARE SINGLE-USE ONLY.
RESTERILIZATION OR REUSE OF THE SETS MAY RESULT IN
INACCURATE DELIVERY, INFECTION, AND ALLERGIC
REACTION.

Sterile administration sets are indicated on the administration set

packaging. Refer to the packaging for the method of sterilization.
\

WARNING
USE ONLY ICU MEDICAL PLUM ADMINISTRATION SETS WITH
A CASSETTE SPECIFIED FOR USE WITH THE PLUM INFUSER.
USE OF NON-PLUM CASSETTES CAN RESULT IN IMPROPER
FUNCTIONING OF THE INFUSER OR INACCURATE DELIVERY.

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Plum 360 Infuser

WARNING
INSPECT THE ADMINISTRATION SET PACKAGING. IF THE
PACKAGING IS NOT INTACT, DISCARD IT AND USE A NEW SET.

Do NOT use a Plum administration set for longer than 96

continuous hours. Change sets per set package labeling or
facility policy. Administration sets are single-patient use only.

To prime a Plum administration set:

Use aseptic technique with all fluid path connections to prevent
contamination and infection. Remove caps when required and
secure all connections.

1. Attach the infuser to a compatible I.V. Pole (see Mounting the

Infuser on an I.V. Pole on page 3-3) or place the infuser
on a flat, stable surface.

2. Inspect the administration set packaging. If the packaging is not

intact, discard it and use a new set.

3. Open the package and remove the administration set.

4. Press the cassette flow regulator in to make sure it is closed and

confirm that there is no flow during priming.

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Plum 360 Infuser

CAUTION
BE CAREFUL WHEN PIERCING THE SOLUTION CONTAINER TO AVOID
PUNCTURING IT.

5. Insert the piercing pin into the outlet on the fluid container using
a twisting motion.

Do not insert the piercing pin while the container is hanging

above the infuser.

6. Suspend the container on an I.V. Pole.

CAUTION
CHECK THE CONTAINER FOR LEAKS. IF ANY PART OF THE
CONTAINER IS LEAKING, REPLACE IT.

7. Squeeze the drip chamber to the score mark. Do not completely

fill the drip chamber.

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Plum 360 Infuser

8. If using a rigid fluid container (glass bottle, for example), open the
filter vent cover above the drip chamber. If using a flexible plastic
container, make sure this vent cover is closed.

OPEN CLOSED

9. Invert the cassette so that the secondary port is pointing down.

10. Slowly open the flow regulator by turning it counter-clockwise

while holding the cassette in the inverted position, to allow the
fluid to flow into the cassette at a controlled rate.

NOTE: To quickly stop the flow at any time, push in on the flow
regulator.

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Plum 360 Infuser

11. When the first drop appears in the pumping chamber, turn the
cassette upright.

FIRST DROP

12. Continue to slowly prime the set until all air is removed from the
cassette and the remainder of the tubing.
• Tap the cassette and tubing to dislodge air bubbles.

NOTE: Invert and tap each Y-site to fill it with fluid, as shown
in the following figure, and then turn the Y-site upright.

FROM
CASSETTE

• If the filter at the distal (patient) end of the tubing gets wet, you
must temporarily remove the cap to continue priming.

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Plum 360 Infuser

13. Once priming is complete, push the flow regulator in to close it.

CAUTION
CHECK THE DRIP CHAMBER AND THE DISTAL END OF THE TUBING
TO CONFIRM THAT THERE IS NO FLOW AND THAT NO KINKS APPEAR
IN THE TUBING. IF YOU OBSERVE FLOW OR LEAKS, CLOSE ALL
CLAMPS AND REPLACE THE ADMINISTRATION SET.

The cassette is now ready to load into the infuser.

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Plum 360 Infuser

Loading a Cassette
To load a primed cassette into the infuser:

1. Lift the lever to open the cassette door.

2. Grasp the cassette by the finger grip.

FINGER
GRIP

3. Slide the cassette between the cassette door and the door
guides.

DOOR
GUIDES

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Plum 360 Infuser

4. Press the lever down to close the cassette door.

BEFORE OPENING DOOR

WARNING: CLOSE ALL CLAMPS BEFORE OPENING DOOR
CLOSE
LEVER
WHEN
CLOSE
NOT LEVER
IN WHEN
NOT
USE IN
USE

OSE LEVER WHEN

NOT IN USE
ES
LA S TA
TC B
H D TO
OO
R

LEVER
CLOSED

5. Insert the proximal line into the Line A tubing guide.

6. Open all clamps.

CAUTION
CHECK THE DRIP CHAMBER AND THE DISTAL END OF THE TUBING TO
CONFIRM THAT THERE IS NO FLOW AND THAT NO KINKS APPEAR IN
THE TUBING. IF YOU OBSERVE FLOW OR LEAKS, CLOSE ALL CLAMPS
AND REPLACE THE ADMINISTRATION SET.

7. Press [ON/OFF] to turn on the infuser.

8. After the infuser completes its startup sequence, insert the

connector on the distal tubing into the patient access device.
Move the locking collar over the connection. Turn the collar
clockwise to secure the tubing to the patient access device.

WARNING
ARRANGE ALL TUBING, CORDS, AND CABLES TO MINIMIZE
THE CHANCE OF PATIENT STRANGULATION OR
ENTANGLEMENT.

9. Program a delivery on Line A. See Programming on page 5-1

or Delivery Options on page 8-1 for instructions.

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Preparing a Secondary Delivery

from an Administration Set
The following procedure gives the general steps for preparing a
secondary administration set for a Piggyback or Concurrent delivery.
Refer to the set packaging for complete instructions on how to prime
the administration set you are about to use.

WARNING
ENSURE MEDICATIONS THAT ARE DELIVERED
CONCURRENTLY OR IN PIGGYBACK, ARE COMPATIBLE.

WARNING
USE ONLY ICU MEDICAL PLUM ADMINISTRATION SETS.

WARNING
DO NOT RESTERILIZE ADMINISTRATION SETS.

WARNING
DO NOT REUSE ADMINISTRATION SETS. REUSE MAY RESULT
IN INFECTIONS AND ALLERGIC REACTIONS. REUSE MAY
ALSO RESULT IN INACCURATE FLOW RATES.

Use aseptic technique with all fluid path connections to prevent

contamination. Remove caps when required and secure all
connections.

NOTE: You do not need to remove the primary administration set

from the infuser or detach it from the patient before attaching a
primed secondary administration set.

To prime a secondary administration set:

1. Inspect the set packaging. If the packaging is not intact, discard

it and use a new set.

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Plum 360 Infuser

2. Open the set packaging and remove the set. Make sure the roller
clamp on the set is in the closed position.

CLOSED
POSITION

CAUTION
BE CAREFUL WHEN PIERCING THE SOLUTION CONTAINER TO AVOID
PUNCTURING IT.

3. Insert the piercing pin into the secondary container outlet using
a twisting motion.

Do not insert the piercing pin while the container is hanging

above the infuser.

4. Suspend the container on an I.V. Pole.

CAUTION
CHECK THE SECONDARY CONTAINER FOR LEAKS. IF ANY PART OF
THE CONTAINER IS LEAKING, REPLACE IT.

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Plum 360 Infuser

5. Squeeze the drip chamber to fill it about 1/3 full or to the score
mark. Do not completely fill the drip chamber.

6. If using a rigid fluid container (glass bottle, for example), open the
filter vent cover above the drip chamber. If using a flexible plastic
container, make sure this vent cover is closed.

OPEN CLOSED

7. Slowly open the roller clamp to allow fluid to flow into the
secondary tubing at a controlled rate.

TO OPEN OPEN
CAIR CLAMP POSITION
ROLLER

ROLLER

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Plum 360 Infuser

8. After all air is removed, close the roller clamp.

TO CLOSE CLOSED
CAIR CLAMP POSITION
ROLLER

ROLLER

9. Attach the line to the secondary port (see Connecting a

Secondary Line or Syringe on page 4-13).
10. Insert the secondary line into the Line B tubing guide.

WARNING
ARRANGE ALL TUBING, CORDS, AND CABLES TO MINIMIZE THE
CHANCE OF PATIENT STRANGULATION OR ENTANGLEMENT.

11. Open all clamps. Check that no kinks appear in the tubing.

12. Program the delivery on Line B (see Programming Line B on

page 5-2).

Connecting a Secondary Line or Syringe

A primary PlumSet may have a Clave, prepierced, or capped
connector on the secondary port. The following sections describe
how to attach a secondary line or syringe to each secondary port
type.

Use aseptic technique with all fluid path connections to prevent

contamination. Remove caps when required and secure all
connections.

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Plum 360 Infuser

Connecting to a Clave Port

The Clave is a needle-free connector with an internal design that
prevents leakage from the top of the connector. The secondary line
or syringe can be attached directly to the port. Avoid twisting
or bending the port during attachment to prevent damage
or breakage.

To connect a line or syringe to a Clave secondary port:

1. Grasp the base of the Clave connector to support it, and then
insert the end of the secondary line or syringe into the Clave.

WARNING: CLOSE ALL OPENING DOOR

CLOSE
LEVER
WHEN
NOT
IN
USE

WARNING: CLOSE ALL OPENING DOOR

CLOSE
LEVER
WHEN
NOT
IN
USE

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Plum 360 Infuser

NOTE: Do not twist or bend the Clave when accessing the

secondary port.

2. Secure the connection:

• If attaching a secondary
line, continue to support
the Clave with one hand
as you move the locking
collar over the port with
the other hand and twist
the collar clockwise to
secure the line.

• If attaching a Luer-Lok
syringe or syringe
adapter, continue to
support the Clave
connector with one hand
as you twist the Luer-Lok
or adapter connector
clockwise with the other
hand to lock the
connection in place.

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Plum 360 Infuser

Connecting to a Prepierced Port

The prepierced port requires a locking blunt cannula to provide
needle-free access and a secure connection.

To connect a line or syringe to a prepierced port:

1. Remove the protective sleeve from the locking blunt cannula.

2. Insert the connector on the secondary line or syringe into the

locking blunt cannula, and then twist the locking collar on the
line to secure the connection.

NOTE: If using a syringe adapter, attach the adapter to the

syringe and then attach the locking blunt cannula to the adapter.

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Plum 360 Infuser

WARNING: CLOSE ALL OPENING DOOR

CLOSE
LEVER
WHEN
NOT
IN
USE

3. Center the cannula over the prepierced secondary port and push
until the cannula clicks into place.

CLOSE
LEVER
WHEN
NOT
IN
USE

4. Gently pull the connection between the secondary line or syringe

and the locking blunt cannula to confirm that all connections are
secure.

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Plum 360 Infuser

Connecting to a Capped Port

A secondary line or syringe attaches directly to the capped port.
To prevent leakage from the top of the connector during the following
procedure, you must ensure that the cassette door remains closed
or clamp the primary line (Line A) before opening the cassette door.

To connect a line or syringe to a capped port:

1. Confirm that the cassette door is closed, to prevent leakage.

2. Loosen, remove, and discard the cap.

WARNING
CLOSE THE CLAMP ON PROXIMAL LINE A TO PREVENT FLUID
FROM SPILLING IF YOU MUST OPEN THE CASSETTE DOOR
TO REMOVE THE CAP.

3. Insert the connector on the secondary line or syringe into the

secondary port.

4. Secure the connection:

• If attaching a secondary line, move the locking collar over the
port and twist the collar clockwise to secure the line.
• If attaching a Luer-Lok syringe or syringe adapter, twist the
Luer-Lok or adapter connector clockwise to lock it in place.

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Plum 360 Infuser

Priming the Syringe Adapter

To prime the syringe adapter:

1. Fill the syringe with solution.

2. Attach the vented syringe adapter onto syringe.

3. Press on the syringe plunger until the vented syringe adapter fills
up and fluid is seen at the open end of the syringe adapter.

4. Refill the syringe, if necessary.

Preparing a Secondary Delivery

from a Syringe
WARNING
ENSURE MEDICATIONS THAT ARE DELIVERED
CONCURRENTLY OR IN PIGGYBACK ARE COMPATIBLE.

NOTE: Access ports on the Plum cassette are NOT for I.V. push
delivery of medication. Ports are only for infuser-controlled delivery of
medication.

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Plum 360 Infuser

You can attach a syringe to the secondary port on a Plum cassette for
Piggyback or Concurrent delivery of a secondary fluid. Follow these
guidelines:

Syringe sizes 3 mL - 60 mL
accepted: Small volume syringes, i.e., 3-10 mL, require a
vented syringe adapter to ensure delivery
accuracy and reduce proximal occlusion
alarms.
Syringes larger than 10 mL do not require
a syringe adapter.

Attaching to a Clave Attach the syringe directly to the port. If using

or capped secondary a syringe adapter, attach the adapter to the
port: syringe and prime the adapter before attaching
the syringe/adapter assembly to the port
(see Connecting a Secondary Line or
Syringe on page 4-13).

Attaching Fit the syringe with a locking blunt cannula

to a prepierced before attaching to the port.
secondary port: If using a syringe adapter, attach the adapter
to the syringe and prime the adapter, and then
attach the locking blunt cannula to the adapter
before attaching the syringe/adapter/cannula
assembly to the port
(see Connecting to a Prepierced Port on
page 4-16).

You do not need to remove the primary administration set from the
infuser or the patient before attaching a syringe to the secondary port.

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Plum 360 Infuser

Backpriming
CAUTION
DURING BACKPRIMING, FLUIDS CAN BECOME MIXED AND DILUTED.

Backpriming should not be performed for reconstituting

secondary containers containing dry powders.

NOTE: A small amount of fluid may be expelled from the set

(less than or equal to 0.05 mL) after backpriming. If potent drugs are
being used, take appropriate action to guard against over-medication
of the patient.

Backpriming resolves proximal air-in-line alarms on Line A or Line B

without the need to disconnect the administration set from a patient.
Backpriming can also relieve built-up pressure in the cassette caused
by some occlusion conditions, resolving the occlusion alarms while
the patient is still connected to the set. However, backpriming is not
necessary to clear alarms. After an obstruction or occlusion
is resolved, pressing [START] clears an alarm. See Alarms and
Troubleshooting on page 9-1 for alarms that can be resolved
by backpriming.
During a backprime, fluid is pumped from the container on Line A to
a line or syringe attached to the secondary port (Line B) at a rate of
approximately 1 mL every 5 seconds. In the process, air is cleared
from the cassette air trap and proximal line(s). The infuser closes
valves to ensure that the backprimed fluid never reaches the patient.

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Plum 360 Infuser

Preparing to Backprime
To accept the backprimed air and/or fluid, a line with a container or
syringe must be attached to the secondary port. This attachment
prevents proximal occlusion alarms on the secondary line during the
backprime operation.

NOTE: If you are using a syringe adapter, you must open and close
the lever before you will be able to backprime.

Setup for Backpriming into a Secondary Line

If you already have a delivery set up for Line B, you can backprime
into the Line B fluid container. This setup will resolve a proximal air-in-
line alarm for either Line A or Line B.

NOTE: Since the Plum 360 infuser delivers the exact VTBI that
is programmed for a line, you may need to adjust the VTBI on Line B
to account for the extra volume from backprimed fluid.

The following illustration shows how the Line A fluid mixes with the
Line B fluid during a backprime. Notice that the fluid path from the
pumping chamber to the patient contains only Line A fluid.

LINE A LINE B

LINE A LINE B

DISTAL (PATIENT) LINE

PUMPING CHAMBER

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Plum 360 Infuser

Setup for Backpriming into a Syringe

If you do not have a delivery set up

on Line B, or you need to avoid
pumping air and fluid from Line A
into Line B, you can attach a syringe
to the secondary port to accept the
fluid and/or air from Line A and the
cassette when backpriming.

NOTE: Before you begin

a backprime, ensure that the syringe WARNING: CLOSE ALL OPENING DOOR

has enough free space to accept the CLOSE

LEVER
WHEN

backprimed fluid. Backpriming into

NOT
IN
USE

a full syringe will trigger a proximal

occlusion alarm.

The illustration shows the setup for

backpriming into a syringe.
For instruction on how to attach
a syringe to a secondary port on
the cassette, see Preparing a
Secondary Delivery from a
Syringe on page 4-19.

Backpriming Procedure
Before you begin a backprime, ensure that there is a line or syringe
on the secondary port and a secondary container to accept the
backprimed fluid and expelled air (see Preparing to Backprime on
page 4-22).

To backprime:

1. Press and hold [Back Prime] until fluid pumped from Line A to
Line B clears air from the cassette and from Line B (if present).
When you release [Back Prime] the infuser performs a cassette
test.

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Plum 360 Infuser

NOTE: If you press and hold the [Back Prime] key for two
minutes, a stuck key alarm sounds and the display screen shows
Power Off then On. Replace pump if alarm continues.

2. If the cassette test detects that there is still air in the line, repeat
Step 1 until the cassette test is successful.

3. Press [START] to restart the delivery. If two lines were pumping

when delivery stopped, press the appropriate softkey in response
to the prompt (see Stopping and Restarting a Delivery on
page 3-22).

If you do not see [Back Prime]:

[Back Prime] is available only on the delivery screen and only when
delivery is stopped. (Delivery stops automatically when there is an
alarm that can be resolved by backpriming.)
• If the cassette test fails while the New Patient? prompt
is displayed, press [Yes] or [No], as appropriate, and then
hold down [Back Prime] to clear air from the cassette.
• If the cassette test fails while the CCA Selection screen
is displayed, choose the correct CCA. The infuser displays the
delivery screen, where [Back Prime] is available.
• If the infuser alarms and stops while you are viewing a screen
other than the delivery screen (for example, Line A stops due
to an air-in-line alarm while you are programming Line B)
navigate to the delivery screen and then press [Back Prime].

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Plum 360 Infuser

Discontinuing Electronic Flow Control

and Setting Gravity Flow
CAUTION
CONSULT INDIVIDUAL ADMINISTRATION SET INSTRUCTIONS FOR
USE FOR ANY RESTRICTIONS REGARDING GRAVITY USE.

Gravity flow allows you to temporarily continue fluid delivery without

the Plum 360 infuser.

NOTE: Gravity flow is supported for only one line. When using gravity
flow to deliver fluid, only deliver from one fluid container at a time.

WARNING
CLOSE ALL CLAMPS BEFORE OPENING THE CASSETTE
DOOR.

To discontinue fluid flow and set gravity flow:

1. Press [STOP]. If two lines were pumping, press [Stop All].

2. Press [ON/OFF] to turn off the infuser.

3. Close all clamps.

4. Open the cassette door and remove the cassette.

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Plum 360 Infuser

5. If only 1 line was pumping, open all clamps.

If 2 lines were pumping, you must choose one line for gravity
flow. Open the clamps on that proximal line and on the distal line.
Make sure one proximal line stays clamped.

6. Holding the cassette upright, set gravity flow by turning the flow
regulator counter-clockwise.

NOTE: If the line is equipped with a roller clamp, you can use the
clamp to control the flow rate. To do this, close the roller clamp,
open the flow regulator completely, and then gradually open the
roller clamp to adjust the flow.

7. Check the drip chamber to measure the flow rate. Refer to the
administration set package for the number of drops/mL, or see
Administration Sets on page 12-1 for a representative list of
Plum administration sets with information on drops/mL.

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Plum 360 Infuser

To resume delivery in a replacement infuser:

1. Close all clamps.

2. Insert the cassette into the infuser and close the door.

3. Open all clamps.

4. Check the drip chamber to ensure that there is no flow.

If you see flow, close all clamps and replace the set. If you still
see flow from a replacement set, replace the infuser.

5. Turn on the infuser.

6. Program the delivery.

7. Start the delivery.

Removing a Secondary Line or Syringe

The following procedure describes how to disconnect a secondary
line or syringe from the Plum cassette.
• You do not need to disconnect the set from the patient during this
procedure.
• You also do not need to stop Line A.

To remove a secondary line or syringe during delivery:

Use aseptic technique with all fluid path connections to
prevent contamination. Remove caps when required and
secure all connections.

1. Press [STOP] and then press [Stop B].

2. Remove the syringe or line as follows:

• To remove a secondary line from a Clave or capped

secondary port - Clamp the line, twist counterclockwise
to release the locking collar, and then pull up to disconnect the
line. Aseptically cap a capped secondary port.

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Plum 360 Infuser

• To remove a syringe from a Clave or capped secondary

port - Pull up the plunger slightly to avoid spilling fluid. Twist
counterclockwise to disconnect a Luer-Lok or syringe adapter,
if present, and remove the syringe from the port. Aseptically
cap a capped secondary port.
• To remove a secondary line or syringe from a prepierced
secondary port - Pull up the plunger slightly to avoid spilling
fluid. Clamp the secondary line (if present), fully depress the
levers on the locking blunt cannula, and then pull upward.

3. Discard the secondary line or syringe (with fluid container,

if present) per hospital procedure.

Discontinuing Fluid Administration

The following procedure describes how to remove a primary
administration set from the patient, either to discontinue fluid delivery,
or to change the set.

Do NOT use a Plum administration set for longer than 96

continuous hours. Change sets per set package labeling or
facility policy. Administration sets are single-patient use only.

To discontinue fluid delivery:

1. Press [STOP]. If two lines are pumping, press [Stop All].

2. Press [ON/OFF] to turn off the infuser.

3. Close all clamps.

4. Detach the distal line from the patient access device.

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Plum 360 Infuser

5. Open the cassette door and remove the cassette.

6. Close the cassette door.

7. Discard the set and fluid container per hospital procedure.

Changing Administration Sets

Plum administration sets should be changed per facility policy
or every 96 hours, whichever is less.

Do NOT use a Plum administration set for longer than 96

continuous hours. Change sets per set package labeling or
facility policy. Administration sets are single-patient use only.

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Plum 360 Infuser

To change the administration set:

Use aseptic technique with all fluid path connections to prevent
contamination. Remove caps when required and secure all
connections.

1. Stop the infuser, close all clamps, and then remove and discard
the old set. See Discontinuing Fluid Administration on
page 4-28 for instructions.

2. Prepare and install a new administration set. See Priming a

Primary Administration Set on page 4-2 for instructions.

Resolving a Distal Air-in-Line Alarm

Use the following procedure to remove air from the distal (patient) line
following a distal air-in-line alarm.

To resolve a distal air-in-line alarm:

Use aseptic technique with all fluid path connections, to prevent
contamination, and secure all connections.

1. Close all clamps. If secondary line is attached, clamp the

proximal Line B to avoid the mixing of fluids.

2. Disconnect the administration set from the patient.

3. Open the cassette door and remove the cassette.

4. Unclamp the proximal tubing of the line you want to use to prime
the distal line.

5. Reprime the administration set to remove the distal air

(see Priming a Primary Administration Set on page 4-2).

6. Insert the cassette into the infuser, close the cassette door, and
then open all clamps (see Loading a Cassette on page 4-8).

7. Reattach the administration set to the patient and restart delivery.

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Avoiding Unintended Bolus While

Resolving a Distal Occlusion
When using critical drugs, care must be taken to avoid an unintended
bolus. Use the following procedure to avoid the administration of an
unintended bolus caused by the buildup of pressure in the cassette
caused by a distal occlusion (see Maximum Unintended Bolus
Volume Released After Distal Occlusion is Resolved on
page 11-9).

To resolve a distal occlusion when fluid volume is critical:

1. Close all clamps.

TO CLOSE CLOSED
SLIDE CLAMP POSITION

Roller

Roller

TO CLOSE CLOSED
CAIR (ROLLER) POSITION
CLAMP

2. Open the cassette door and remove the cassette.

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3. Gently pull out the flow regulator on the cassette to dissipate the
pressure for a brief moment, and then push in on the flow
regulator to close it.

4. Eliminate the source of occlusion.

5. Insert the cassette into the infuser and close the cassette door.

NOTE: A small amount of fluid is expelled from the set (less than
0.1 mL) each time the door is opened or closed with a set
installed. If potent drugs are being used, take appropriate action
to guard against over-medication of the patient.

6. Open all clamps and resume the infusion.

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Section 5
Programming

Programming Features Common

to the Default Drug Library
and Custom Drug Libraries
Auto-Calculations
There are three ways that the Plum 360 infuser performs auto-
calculations:
• In a time-based dosing unit such as mL/hr or mg/kg/hr, where
entering the dose calculates the rate and entering the VTBI
calculates the duration.
• In a non-time-based dosing unit such as mg/mL, where entering the
dose calculates the VTBI, and entering the rate calculates the
duration. Calculated VTBIs are rounded to the nearest 0.1 mL
resolution.
• In mL/hr, where there is no dose value entry.
Refer to Examples of Automatic Calculation on page 7-4 for
additional information on how the infuser performs auto-calculations.

Body Surface Area (BSA) Dosing Unit

A BSA dosing unit is indicated by m2, for example, mg/m2/day.
BSA can be entered manually or, if you enter a weight and height,
it will be automatically calculated.

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Programming Line B

WARNING
ENSURE MEDICATIONS THAT ARE DELIVERED
CONCURRENTLY, OR IN PIGGYBACK, ARE COMPATIBLE.

When you are programming Line B, you can select a delivery mode
of Piggyback or Concurrent as the delivery mode. If you are using a
custom drug library, there may be some restrictions.
The following rules apply when programming Line B.
• All software versions:
• When programming Line B with a non-Piggybackable drug (as
defined in the custom drug library), the delivery mode for Line
B defaults to Concurrent and cannot be changed.
• When programming Line B, if there is a confirmed program on
Line A with a drug that is non-interruptible, the delivery mode
for Line B will default to Concurrent and cannot be changed.
• If there is a confirmed program on Line A with a medication that
is interruptible, the medication on Line B is Piggybackable, and
the infusion would result in a concurrency violation, the Line B
delivery mode is set to Piggyback and cannot be changed.
• For software versions 15.02 - 15.11:
• If Line A is not programmed or if Line A is programmed with a
medication that is interruptible, the medication on Line B is
Piggybackable, and the infusion would not result in a
concurrency violation, Line B delivery mode is set based on the
Default B Delivery Mode setting and can be changed.
• For software versions 15.20 and later:
• If Line A is not programmed or Line A is programmed with a
medication that is interruptible, the medication on Line B is
Piggybackable, and the infusion would not result in a
concurrency violation, Line B delivery mode is set as follows
and can be changed:

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• If the infuser is using the default drug library, the Line B

delivery mode is set based on the Biomed Mode Default B
Delivery Mode infuser setting.
• If the infuser is using a custom drug library and No Drug
Selected has been selected, the Line B delivery mode is
set based on the drug library Default B Delivery Mode
infuser setting.
• If the infuser is using a custom drug library with a
medication other than No Drug Selected, the Line B
delivery mode is set based on the drug library Default
Line B Mode medication setting.
To change the delivery mode, highlight the current delivery mode on
the programming screen and press [Change Mode] to toggle the
delivery mode between Piggyback or Concurrent.
To program Line B in Concurrent delivery mode, the delivery rate of
Lines A and B must each be greater than or equal to 0.5 mL/hr and
the combined delivery rate of both lines must be less than or equal to
500 mL/hr.
If programming a Piggyback delivery on Line B, you can program
a Callback alarm to activate when the Piggyback VTBI is complete.
Anytime Line B is in Piggyback mode and Line A is not in a PENDING
state, the infuser will notify you that there is a potential for a period of
no delivery after the Piggyback VTBI is complete.

Programming a Flush for a Piggyback Delivery

The Flush feature enables the clinician to flush the distal tubing
volume after a piggyback therapy. The programmed Flush volume is
delivered from the Line A container at the Piggyback therapy rate
after the Piggyback therapy completes.
Flush programming is available in software versions 15.20 and later.
A flush can be programmed under the following conditions:
• Line A is programmed with a medication that is interruptible

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• Line A is programmed with a delivery mode other than Multistep or

Loading Dose
• Line A VTBI is greater than 0
• Line B delivery mode is Piggyback
• Line B is stopped
Flush duration and volume are not considered when the infuser is
checking for Hard Limit or Soft Limit violations for the Line A or Line B
programs.

To program a flush with a new Piggyback delivery under the

conditions listed above:

1. On the Line B Program

screen, press [Flush]. Program Piggyback B
ceFAZolin

Mode Piggyback
Rate 100 mL/hr
VTBI 100 mL
Duration 01 : 00 hr : min
DDL
START: Confirmation

Delay Add Flush Return to

Callback A/B

2. Enter a Flush Volume

between 5 mL and 30 mL. A Flush Volume
This is the only editable value IV Maint Fluid
on the screen.
If the entered Flush Volume is Rate 100 mL/hr
more than the current VTBI Flush Volume 0 mL

on Line A, you will be required Duration 00: 00 hr :min

to either increase the VTBI on Maximum Flush Volume 30 mL

Line A or decrease the Flush DDL
DDL
Volume before completing the Enter value using keypad
flush programming. Cancel

3. Press [START].

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4. Press [Yes] to confirm the

Confirm Piggyback B
Piggyback program with a
flush and start delivery on ceFAZolin
Line B.

Rate 100 mL/hr

VTBI 100 mL (15mL Flush)
Duration 01 : 00 hr : min

DDL
DDL Piggyback
Yes: Start delivery
No: Edit
Yes Standby No

The Delivery screen displays

with Line A PENDING state
and Line B PUMPING.

When the Piggyback VTBI

reaches 0, the flush will be
delivered from the Line A
container at the Line B
Piggyback delivery rate until
the flush has been delivered.
Line A will display FLUSH.

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To program a flush after the Piggyback therapy has started:

1. Press Line B.

2. Press [STOP].

3. Select Line B then follow steps above to program a flush.

When the flush completes, the volume of the delivered flush is
subtracted from the Line A VTBI (added to Volume Infused for Line A)
and Line A does one of the following:
• If Line A was infusing when the Piggyback delivery started, Line A
will resume delivery at its programmed rate.
• If Line A was stopped before the flush started, Line A will return to
the stopped state.
• If Line A had a Delayed Start, the Delayed Start countdown will
resume from when it was interrupted.
• If Line A was in Standby before the flush started, Line A will return
to Standby.

Cancelling a Flush

A flush will automatically be cancelled if one of the following occurs:

• The Line A VTBI is less than the flush volume at the time Line B
completes
• Line A has been cleared by the time Line B completes
The infuser will notify you when a flush is automatically cancelled.
The infuser will prompt you to cancel the flush if you try to titrate the
current program or enter a new program on Line B while Line A is
delivering the flush.
You can manually cancel a flush if Line B is stopped.

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To cancel the flush from Line A while the flush is delivering:

1. Press [Cancel Flush].
A FLUSH STOPPED B
IV Maint Fluid ceFAZolin

100 Rate 100

mL/hr
13.3 Vol Inf 74.4
mL
DDL
DDL Piggyback-F
Select Line A/B to program.
Select STOP key to Clear.
Cancel A B Settings/
Flush Vols/CCA

2. Press [Yes] to clear the flush

or press [No] to continue the A Cancel Flush
flush.
The Delivery screen displays.
Clear Flush?

DDL
Yes: Stop and clear Flush.
No: Return to previous screen.
Yes No

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To cancel the flush from Line B while the Piggyback delivery is

stopped:
1. Press [B].
A PUMPING STOPPED B
IV Maint Fluid ceFAZolin

100 Rate 100

mL/hr
16.8 Vol Inf 74.6
mL
DDL
DDL Piggyback-F
Select Line A/B to program.
Select STOP key to Clear.
Standby A B Settings/
Vols/CCA

2. Press [No].
Program B

Clear Line B Settings?

DDL
Yes: Clear
No: Program Screen
Yes No

3. Press [Cancel Flush].

Program Piggyback B
ceFAZolin

Mode Piggyback
Rate 100 mL/hr
VTBI 9.8 mL
Duration 00 : 06 hr : min
DDL
Enter value using keypad
Add Cancel Return to
Delay
Callback Flush A/B

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4. Press [Yes] to clear the flush

A Cancel Flush
or press [No] to keep the flush
programmed.
The Delivery screen displays with
Line B stopped.
Clear Flush?

DDL
Yes: Stop and clear Flush.
No: Return to previous screen.
Yes No

Clearing Line Settings

To clear line settings:

1. STOP either Line A or Line B to clear. The line must be stopped

before clearing settings.

2. Select the line that was stopped (either A or B).

3. The infuser display asks if you want to clear the line settings.
Select [Yes] to clear the line settings.
or,
Select [No] to advance to the program screen for the line
selected without clearing the settings.

NOTE: Clearing a line does not clear the volumes infused.

Programming with a Default Drug Library

The default drug library has 113 drugs, including No Drug Selected,
which is always listed first. After you select a drug, the assigned
default dosing unit is highlighted; however, you can change the
dosing unit.

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Programming Without a Drug List

To program without a drug list:

1. On the Delivery (A/B) Screen, select a line to program.

If you are programming a primary delivery, select Line A. If you
are programming a secondary delivery, select Line B.

CAUTION
BEFORE STARTING DELIVERY, VERIFY THE VALUES.

2. On the Program screen, enter the rate, VTBI, and duration.

Values can be entered in any order.

A on the Confirm Program screen alerts you that the

infuser is being operated without rule sets.

Programming with a Drug List

To program with a drug list:

1. On the Delivery (A/B) Screen, select a line to program.

If you are programming a primary delivery, select Line A. If you
are programming a secondary delivery, select Line B.

2. On the Program screen, select [Drug List].

3. In the drug list, select the drug.

4. Select the dosing unit.

5. Select the drug concentration in container as required for the

selected dosing units.

NOTE: The remainder of these steps is for a single-step standard

program. For information on Bolus Dose, Loading Dose, or
Multistep Programming, see Delivery Options on page 8-1.

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6. On the programming screen, enter the concentration, container

volume, weight or BSA information as applicable.
See Body Surface Area (BSA) Dosing Unit on page 5-1 for
information on entering/calculating the BSA.

7. Enter Rate and/or Dose, VTBI, and Duration as appropriate for

the displayed program parameters. These values can be entered
in any order.

CAUTION
BEFORE STARTING DELIVERY, VERIFY THE VALUES.

8. Press [START].
Confirm the program.

Press [Yes].

Programming with a Custom Drug

Library
To program with a custom drug library:

1. At power on, select a CCA.

NOTE: The CCA can be changed from the Drug List screen.
For more information, see Changing a CCA from the Drug List
Screen on page 5-13.

2. On the Delivery (A/B) Screen, select a line to program. If you are

programming a primary delivery, select Line A. If you are
programming a secondary delivery, select Line B.

3. In the drug list, select the drug.

4. Select a clinical use. If the selected drug has multiple defined

clinical uses, they will be displayed.

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5. Select the dosing units. If the selected drug has multiple, defined
dosing units, they will be displayed.

6. Select the drug concentration in container units.

If the selected dosing units require a drug concentration in
container units, the units will be displayed. In most custom drug
library entries, this is already defined and will not require manual
selection.
The remainder of these steps are for a single-step standard program.
For information on Loading Dose or Multistep Programming,
see Delivery Options on page 8-1.

NOTE: For software version 15.20 and later, if a clinical advisory

exists in the drug library for the selected medication, the clinical
advisory will display before the programming screen. Press the
[Continue] soft key to proceed to the programming screen.

7. On the programming screen, enter the concentration, container

volume, weight or BSA information as applicable. See Body
Surface Area (BSA) Dosing Unit on page 5-1 for information
on entering/calculating the BSA.

8. Enter the rate and/or dose, VTBI, and duration as appropriate for
the displayed program parameters. These values can be entered
in any order.

CAUTION
BEFORE STARTING DELIVERY, VERIFY THE VALUES.

9. Press [START].

Confirm the program.

Press [Yes].

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Hard Limits
If a maximum hard limit is exceeded, an alert appears. You cannot
proceed until the entry is cleared.
Press the [C] key to clear the entry and enter a new value.

Soft Limits
If a soft limit is exceeded, an alert appears when [START] is pressed
to confirm the program.
When the alert displays:
• Select [Yes] to override and continue to the confirmation
screen.
or,
• Select [No] to return to the program screen and edit the
value.

Changing a CCA from the Drug List Screen

The CCA can be changed from the Drug List screen where it is the
first highlighted selection on the screen.

To change the CCA:

1. On the Drug List screen, highlight [Change CCA] and select

[Choose].

The CCA Selection screen displays. The current CCA is indicated

by arrows before and after the CCA name.

2. Highlight the desired CCA and select [Choose].

The Drug List screen displays for the chosen CCA.

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Delaying a Line
To program a delayed start, first select a line and program the line
(see Programming on page 5-1).

1. On the Program screen, press [Delay].

2. Enter time in hours and minutes up to 23:59 hh:mm, and press

[Done].

3. Confirm the program.

The Confirmation screen displays the entered delay time.

The delivery screen shows DELAYED and the delay time

countdown.

4. To clear a delay, choose the line, press [Delay], then change

or clear the delay settings, then press [Done].

Putting a Line in Standby – A/B Delivery Screen

WARNING
ENSURE MEDICATIONS THAT ARE DELIVERED
CONCURRENTLY, OR IN PIGGYBACK, ARE COMPATIBLE.

1. On the delivery screen, press [Standby].

2. On the Confirm Standby screen, press [Yes] to put the

Piggyback therapy in standby mode and restart the line that is
infusing. To return to the Confirm Piggyback screen and program
the delivery, press [No].

Putting a Line in Standby – Confirmation Screen

To put a line in standby – confirmation screen:

1. Press [Standby], select the line to put in standby mode.

2. On the Confirm Standby screen, press [Standby].

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3. On the Confirm Standby screen, press [Yes] to put the delivery

in standby mode and restart the line that is infusing. To return to
the Confirm Piggyback screen and program the delivery, press
[No].

Putting a Line in Standby – Piggyback Mode

To put a line in standby – Piggyback mode:

1. Press [Standby] and confirm by pressing [Yes]. Line B will

stand by, line A will remain pending.

2. Press [Restart A] to restart line A.

Canceling Standby – Piggyback Mode

To cancel standby – Piggyback mode:

1. On the delivery screen, select the line that is in standby.

2. On the Cancel Standby screen, press [Yes] to resume infusion.

To keep the line in standby mode, press [No].

Nurse Callback
To add a nurse callback on programming screen, press [Add
Callback].
Callback is available for Piggyback, Loading Dose, Multistep, and
Bolus deliveries.

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Notes

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Section 6
Auto-Programming
Auto-programming is the ability to take an I.V. medication order from
the Bar Code Medication Administration (BCMA) system and
translate it into operational settings that can automatically populate
the infuser. Order taking is done by using the BCMA application and
its bar code scanner to scan the patient identification, the medication
container, and the infuser. Scanned information is transferred to the
infuser via either its wireless antenna or RJ-45 Ethernet connector
with a shielded Ethernet cable.

NOTE: The wireless icon does not appear when an Ethernet

cable is used to connect the infuser to the BCMA system.

The integration of ICU Medical MedNet software with a BCMA system

enables the system to incorporate pharmacy-validated orders into the
Five Rights verification process reducing the number of steps
to manually program the infuser.
After verifying that the order is within the allowed parameters, ICU
Medical MedNet software sends the program parameters to the
infuser. A clinician has the option of manually editing the program
or confirming and starting the infusion.
Auto-programming can only be used if this feature has been licensed
and in conjunction with the BCMA system.

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Auto-Programming the Plum 360 Infuser

Before you begin auto-programming, make sure that a cassette
is installed in the infuser. To perform auto-programming:

1. Press [ON/OFF]. The infuser begins its startup process. After two
minutes, the infuser is ready to accept an auto-programming
request.
The delivery screen appears.
A B
2. Choose a CCA.
To see the chosen CCA, press
[Change CCA]. The chosen
CCA is indicated by arrows 0 Rate 0
mL/hr
before and after the CCA name.
0 Vol Inf 0
3. Follow your hospital’s mL
Medical ICU1
procedure to activate your
Select Line A/B to program
BCMA device.
Back Settings /
Prime
A B Vols / CCA
4. Scan the patient wristband to
retrieve the patient’s task list on the device.

5. Scan the medication. The I.V. task and documentation with order
details are displayed on the device.

6. Scan the barcode on the infuser.

NOTE: If the scanned medication does not exist in the drug

library, no medication will be displayed on the infuser and “No
Drug Selected” will be shown on the subsequent Confirmation
and Main Delivery Screens.

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The programming screen

is automatically filled.
A Program
DOPamine(CARDIAC)
7. Verify ALL parameters. Conc 400 mg 250 mL
If changes are desired, Weight 60 kg
you can manually change the Dose 10 mcg/kg/min
infusion parameters using the Rate 22.5 mL/hr
VTBI 250 mL
keypad on the infuser. Duration 11 : 06 hr : min

Medical ICU1
Before starting delivery,
Enter value using keypad
press [START], then
Return to
confirm the program. Delay
A/B

8. When all values are completed, press [START] to confirm the

program with the received order.

9. Select [Yes] to start

delivery or [No] to edit A Confirm Program
the program. DOPamine(CARDIAC)
Conc 400 mg 250 mL
The BCMA will confirm the Weight 60 kg
program with the original
Dose 10 mcg/kg/min
order. Rate 22.5 mL/hr
VTBI 250 mL
10. Complete the transaction on Duration 11 : 06 hr : min
the BCMA unit or document
Medical ICU1
the process per hospital Yes: Start delivery
procedure. No: Edit
Yes Standby No

If your order is rejected, refer to Rejected Auto-Programs on

page 9-25.

NOTE: For software version 15.11 and later, when an auto-program is

confirmed for a new bag, the infuser will clear the volume infused
value displayed on the delivery screen.

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Notes

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Section 7
Additional Features

Delay a Line
To program a delayed start, first select a line and program the line
(see Programming on page 5-1).

1. On the Program screen, press [Delay].

2. Enter time in hours and minutes up to 23:59 hh:mm, and press

[Done].

3. Confirm the program.

The Confirmation screen displays the entered delay time.

The delivery screen shows DELAYED and the delay time

countdown.

4. To clear a delay, choose the line, press [Delay], then change

or clear the delay settings, then press [Done].

Standby
Standby is a feature that enables you to postpone starting delivery for
a period of 24 hours to 72 hours. The default setting is 72 hours.
The maximum standby time is configured by the Biomed if the infuser
is using the Default Drug Library. It is defined in the Custom Drug
Library per CCA if one is installed on the infuser. You can leave the
infuser in standby up to the configured maximum.
A line must be infusing to be put in Standby.
If a line is in standby and the configured maximum standby time
expires, the program on the line is cleared and the infuser alarms
2 minutes later when there has been no interaction with the infuser on
either line.

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The instructions below describe how to put one or both lines in

Standby from the Delivery screen. This can also be accomplished for
a single line from that line's Confirmation screen.

Put 1 or 2 Lines in Standby from the Delivery Screen

(Non-Piggyback)
1. On the Delivery screen, press [Standby].

If both lines are PUMPING, the infuser will give you the option to
select a line, select both lines, or cancel the request.

2. If the option is provided to standby a line or both lines, select the

appropriate softkey.

The Confirm Standby screen displays.

3. On the Confirm Standby screen:

• Press [Yes] to confirm the requested standby selection.
• Press [No] to cancel the standby request and return to the
Delivery (A/B) screen.

Cancel Standby for 1 or 2 Lines from the Delivery

Screen (Non-Piggyback)
1. Press [START].
The Cancel Standby screen displays. If both lines are in standby,
the infuser will give you the option to select a line, select both
lines, or cancel the request. If only one line is in standby, the
infuser will give you the option to cancel standby for the line or
cancel the request to cancel standby.

2. Select the appropriate softkey.

Delivery resumes on the selected line(s).

NOTE: A or B softkeys can be used to remove just one line from

standby. Even if both lines are in standby, this method of canceling
standby will only affect the line you selected the softkey for.

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Put Piggyback Mode in Standby

WARNING
ENSURE MEDICATIONS THAT ARE DELIVERED
CONCURRENTLY, OR IN PIGGYBACK, ARE COMPATIBLE.

1. While Line B is PUMPING and Line A is PENDING, press

[Standby].

2. On the Confirm Piggyback Therapy Standby screen:

• Press [Yes] to confirm the standby request. This will place
Line B in standby and leave Line A in PENDING.
• Press [Restart A] to confirm the standby request. This will
place Line B in standby and place Line A in PUMPING.
• Press [No] to cancel the standby request and return to the
Delivery (A/B) screen.

Cancel Piggyback Mode Standby

1. Press [START] or [B].

2. On the Cancel Piggyback Therapy Standby screen:

• Press [Yes] to confirm the cancel standby request. This will
return to the Piggyback therapy with Line A PENDING and Line
B PUMPING.
• Press [No] to cancel the cancel standby request and return
to the Delivery (A/B) screen leaving both lines in their current
states.

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Examples of Automatic Calculation

mL/hr - Initial Programming
Initial programming allows the clinician to enter two of the three
programming parameters (Rate, VTBI, or Duration) and the third is
automatically calculated. (Refer to the table below)

1st Action 2nd Action [AUTOCALC]

enter RATE enter VTBI [DURATION]

enter VTBI enter DURATION [RATE]

enter RATE enter DURATION [VTBI]

mL/hr - After VTBI Complete Alarm

1st Action 2nd Action [AUTOCALC]

enter VTBI keep RATE [DURATION]

enter VTBI change DURATION [RATE]

enter DURATION keep RATE [VTBI]

enter DURATION change VTBI [RATE]

change RATE enter VTBI [DURATION]

change RATE enter DURATION [VTBI]

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Non-Time-Based Dose Calculation (for example, mL)

- Initial Programming

1st Action [AUTOCALC] 2nd Action [AUTOCALC]

enter DOSE [VTBI] enter DURATION [RATE]

enter DOSE [VTBI] enter RATE [DURATION]

enter VTBI [DOSE] enter DURATION [RATE]

enter VTBI [DOSE] enter RATE [DURATION]

enter N/A enter DOSE [RATE], [VTBI]

DURATION

enter N/A enter RATE [DOSE], [VTBI]

DURATION

enter N/A enter VTBI [RATE], [DOSE]

DURATION

enter RATE N/A enter DOSE [DURATION],

[VTBI]

enter RATE N/A enter DURATION [DOSE], [VTBI]

enter RATE N/A enter VTBI [DURATION],

[DOSE]

Non-Time-Based Dose Calculation (for example, mL)

- After VTBI Complete Alarm
With the exception of the entry of the VTBI auto-calculating the Dose
and the entry of the Dose auto-calculating the VTBI, all auto-
calculation for a non-time-based program is the same as auto-
calculation for an mL/hr program after a VTBI Complete alarm.

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Time-Based Dose Calculation (for example, mg/min)

- Initial Programming

1st Action [AUTOCALC] 2nd Action [AUTOCALC]

enter DOSE [RATE] enter DURATION [VTBI]

enter DOSE [RATE] enter VTBI [DURATION]

enter RATE [DOSE] enter DURATION [VTBI]

enter RATE [DOSE] enter VTBI [DURATION]

enter VTBI N/A enter DOSE [RATE],

[DURATION]

enter VTBI N/A enter RATE [DOSE],

[DURATION]

enter N/A enter DOSE [RATE], [VTBI]

DURATION

enter N/A enter RATE [DOSE], [VTBI]

DURATION

enter N/A enter VTBI [RATE], [DOSE]

DURATION

Once the VTBI is > 0, then the Duration cannot be changed, even
during initial programming. This prevents the Dose/Rate from being
calculated or recalculated when the Duration is changed.

NOTE: If DURATION is entered first and a VTBI < 1 mL is entered

second, the DURATION value will be reset to 0 and either RATE or
DOSE will need to be entered.

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Time-Based Dose Calculation (for example, mg/min)

- After VTBI Complete Alarm

1st Action [AUTOCALC] 2nd Action [AUTOCALC]

enter [VTBI] keep DOSE keep RATE

DURATION
(if VTBI = 0)*

enter VTBI [DURATION] keep DOSE keep RATE

enter [VTBI] keep RATE keep DOSE

DURATION
(if VTBI = 0)*

enter VTBI [DURATION] keep RATE keep DOSE

*If VTBI is > 0, then the Duration cannot be changed.

Any changes except those listed in the above table will follow the
auto-calculation rules in the Time-Based Dose Calculation (for
example, mg/min) - Initial Programming on page 7-6.

Recalculation Alert When Titrating a Confirmed

mL/hr or Non-Time-Based Dosing Unit
If you change the Duration of a confirmed mL/hr or non-time-based
dosing unit program and press [START] to confirm the titration,
a Recalculation Alert will be displayed indicating that the rate has
been recalculated due to the duration change.
Press [Yes] to continue to the Confirmation screen.
Press [No] to return to the programming screen.
The Recalculation Alert will not occur for initial programming
or programming after a VTBI Complete alarm.

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Notes

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Section 8
Delivery Options
Programming a Bolus Dose
NOTE: Bolus dose functionality is available in software version 15.1
and later.
A Bolus delivery is defined as 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 magnify a
therapeutic response. A stand-alone bolus dose of a new medication
cannot be delivered.
Bolus can be delivered from either line A or line B (while in the
piggyback mode). Bolus delivery is available only when using a
Custom Drug Library with the ICU Medical MedNet application; it is
not available in the Default Drug Library. Those medications which
can be delivered by bolus will have dose, time, and bolus limits
defined in the drug library.
A Bolus can be completed only if the following conditions are present:
• the line on which the bolus is to be delivered is currently infusing,
• Bolus Dose is enabled within the medication’s selected profile,
• Rule Sets permit the medication to be delivered by bolus,
• there is adequate VTBI of the medication to complete the bolus
dose, and
• the device is in Piggyback mode (not Concurrent mode) if the
bolus is to be delivered on Line B (see Changing the Default
Line B Delivery Mode on page 3-39).

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To program a bolus on Line A:

A Program
1. Press [A] (the Line A softkey). NoDrug Selected

2. Press [Bolus] (the Bolus

Rate 25 mL/hr
softkey is available only if the
medication to be bolused is VTBI 1000 mL

enabled in the drug library and Duration 40 00 hr : min

is currently infusing).
CardioBolus

3. On the Bolus programming Enter value using keypad

screen, enter the dose and Delay Bolus
Return to
A/B
duration, rate and VTBI will be
calculated.

4. Optional: To add a Callback alarm when the Bolus delivery

completes, press [Add Callback]. When the Callback alarm
occurs, it must be manually cleared. If a Callback alarm is
configured on and you want to remove it; press [Remove
Callback].

5. Press [START] for confirmation.

6. Select [Yes] to start delivery or [No] to edit parameters.

NOTE: The Status Region will show BOLUS on Line A. Upon

completion, the infuser will resume the continuous infusion which
was previously infusing and the nurse callback alarm will activate
if programmed.

To program a bolus on Line B:

NOTE: Bolus is available on Line B only when in Piggyback

mode (see Changing the Default Line B Delivery Mode on
page 3-39) and when the medication to be bolused is enabled in
the drug library and is currently infusing.

1. Press [B] (the Line B softkey).

2. Press [Bolus],

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3. On the Bolus programming screen, enter the dose and duration,

rate and VTBI will be calculated.

4. Optional: To add a Callback alarm when the Bolus delivery

completes, press [Add Callback]. When the Callback alarm
occurs, it must be manually cleared. If a Callback alarm is
configured on and you want to remove it; press [Remove
Callback].

5. Press [START] for button for confirmation.

6. Select [Yes] to start delivery or [No] to edit parameters.

NOTE: The Status Region will show BOLUS on Line B. Upon

completion, the infuser will resume the piggyback which was
previously infusing and the nurse callback alarm will activate if
programmed. If Line A was previously in a PENDING state, it will
remain in PENDING until the bolus and the underlying piggyback
are complete.

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To stop or cancel a bolus:

1. To stop a bolus during infusion, press [STOP].

NOTE: After the bolus is stopped, selecting the channel the bolus
was infusing will display the softkeys [Cancel Bolus], [Add
Callback], [Resume Bolus], or [Return to A/B].

2. To cancel a bolus during infusion, press [Cancel Bolus].

NOTE: The following will appear in the working region of the

screen: Clear Line Bolus Settings? Yes to stop and Clear Bolus,
No to return to previous screen.

Programming a Loading Dose

A Loading Dose delivery is a sequential program that can deliver up
to 2 doses (Loading Dose and Maintenance Dose) from one
container at different rate/dose/VTBI and durations using the same
dosing unit.
A Loading Dose delivery is a two-step process that delivers an initial
dose of a medication fluids followed by a maintenance dose of the
same medication fluids.
Both steps must be programmed with the same dosing unit (mL/hr or
mg/kg/min, for example) and drug concentration. You can change the
dosage either by entering a different dose (the infuser calculates the
rate needed to deliver that dose) or by entering a new rate directly.
The following procedure describes how to program a Loading Dose
delivery. As an example, 4 mcg/mL solution of Dexmedetomidine is
delivered in a Loading Dose of 1 mcg/kg/hr for 10 minutes, followed
by a maintenance dose of 0.2 mcg/kg/hr for 2 hours.

NOTE: All drugs and associated dosages shown in this manual are
used solely for the purpose of demonstrating how to program the
Plum 360 infuser, and are not meant to represent actual clinical
practice.

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To program a Loading Dose delivery:

Start programming the line as defined in Programming on page 5-1
until you reach the step that directs you to this section for a Loading
Dose program.

1. Press [Loading Dose] before entering any values on the

programming screen.

NOTE: If you do not see [Loading Dose] in the softkey row,

press [Return to A/B] to start over again.

The Program Loading Dose screen appears.

2. On the programming screen, enter the concentration, container

volume, weight or BSA information as applicable. See Body
Surface Area (BSA) Dosing Unit on page 5-1 for information
on entering/calculating the BSA.

NOTE: On the Program Loading Dose screen, 1 represents the

Loading Dose and 2 represents the Maintenance Dose.

3. Enter Rate and/or Dose, VTBI, and Duration as appropriate

for the parameters displayed for 1 (Loading Dose). Navigate
between entry fields. See Auto-Calculations on page 5-1 for
additional information on auto-calculations performed by the
infuser.

4. After completely programming 1 (Loading Dose), navigate to 2

(Maintenance Dose) and program the maintenance dose
parameters.

5. Optional: To add a Callback alarm when the Loading Dose VTBI

completes, press [Add Callback]. When the Callback alarm
occurs, it must be manually cleared. If a Callback alarm is
configured on and you want to remove it, press [Remove
Callback].

NOTE: The infuser will issue a VTBI Complete alarm after the
Maintenance Dose VTBI is delivered.

6. When both 1 (loading dose) and 2 (maintenance dose) are

programmed, press [START]. The Confirm Loading Dose screen
appears.

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7. Confirm that all programming is correct, and then press [Yes]

to start delivery of 1 (loading dose).
The delivery screen displays the drug name (or No Drug
Selected, if applicable), the dosing units, what is currently being
delivered (Loading Dose or Maintenance), the dose (if
applicable), rate, and current volume infused for the delivery, and
if Callback is configured on.
When 2 (Maintenance Dose) is complete, the infuser issues
a VTBI Complete alarm and begins delivering the Post Infusion
Rate, unless delivering in Piggyback mode.

Programming a Multistep Delivery

Multistep delivery is a sequential program that can deliver up to
10 steps from one container at different rate/dose/VTBI and durations
using the same dosing unit and concentration.

To program a Multistep delivery:

1. Press [Multistep] before entering any values on the

programming screen.

NOTE: If you do not see [Multistep] in the softkey row, press

[Return to A/B] to start over again.

The Program Multistep screen appears.

2. On the programming screen, enter the concentration, container

volume, weight or BSA information as applicable. See Body
Surface Area (BSA) Dosing Unit on page 5-1 for information
on entering/calculating the BSA.

NOTE: On the Program Multistep screen, 1 represents Step 1,

2 represents Step 2, etc.

3. Enter Rate and/or Dose, VTBI, and Duration as appropriate for

the parameters displayed for Step 1. Navigate between entry
fields. See Auto-Calculations on page 5-1 for additional
information on auto-calculations performed by the infuser.

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4. After programming all values in 1 (Step 1), navigate to the 2

(Step 2), and program that step.

5. After programming all values in 2 (Step 2), continue with 3

(Step 3) if desired.

As soon as all values in Step 3 are populated, [To Steps 4-10]

appears in the softkey row.

6. Press [To Steps 4-10] to program additional steps, if needed.

7. Optional: To add a Callback alarm when each step, except the

last step, completes, press [Add Callback]. When the Callback
alarm occurs, it must be manually cleared. If a Callback alarm
is configured on and you want to remove it, press [Remove
Callback].

NOTE: The infuser will issue a VTBI Complete alarm after the last
step.

8. When all steps are programmed, press [START]. The Confirm

Multistep screen appears.

If no more than 3 steps are programmed, the Confirm Multistep

screen prompts you to start the delivery.
Otherwise, if more than 3 steps are programmed, confirm that the
programming for the first 3 steps is correct and then press
[To Steps 4-10]. The confirmation screen displays for the
additional steps and prompts you to start the delivery.

9. Confirm that all programming is correct, and then press

[Yes] to start the delivery for 1 (Step 1).

The delivery screen displays the drug name (or No Drug

Selected, if applicable), the dosing units, the step that is
currently being delivered out of how many steps that have
been programmed (for example, Step 1 of 4), and the information
for the step that is delivering.
When the last step is complete, the infuser issues a VTBI
Complete alarm and begins delivering the Post Infusion Rate,
unless delivering in Piggyback mode.

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Adding a Step to a Multistep Delivery

A step can be added to a running Multistep infusion only after
a running step or a step that has not yet started delivery.

NOTE: If the infusion is stopped, the softkey used to add a new step
changes to add or remove the Callback.

To add a step to a running Multistep infusion:

1. Select the line.

2. Select [Add New Step].

3. Enter the number of the step after which you want to add a new
step.

4. Select [Add Step].

5. Enter the Dose, Rate, VTBI, or Duration for the step as desired.

6. Press [START] and confirm the program as described

in Programming a Multistep Delivery on page 8-6.

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Adding VTBI to Loading Dose

or Multistep Program After VTBI
Complete Alarm Activates
The status of delivery steps is shown on the Program screens for Line
A and Line B.

Display Indicator Delivery Step Status

* Step is currently running.

d VTBI for step has completed.

Number Infusion for step not started yet OR VTBI

is complete and VTBI can be added to the step
as described below.

NOTE: When the last step has completed delivery and the post-
infusion rate has begun delivery, the last step display indicator returns
to the step number.

During a Loading Dose delivery or a Multistep delivery, after the VTBI

Complete alarm activates and post-infusion rate delivery has begun,
as long as the post-delivery rate infusion has not been stopped you
can add more VTBI to the last delivery step, if needed.
If you stop infusion after VTBI has completed, you can add more
VTBI, but you must add it to all delivery steps before restarting the
program.

To add more VTBI to the last step (Multistep) or maintenance

dose (Loading Dose) while post-infusion rate delivery continues:

1. Select the line.

2. Navigate to the VTBI for the last step. Step display indicators will
have returned to the step number, indicating it is editable.

3. Enter a VTBI.

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4. Press [START] and confirm the program as described in

Programming a Loading Dose on page 8-4 and Programming
a Multistep Delivery on page 8-6.

To stop the post-infusion rate and add more VTBI to all steps:

1. Stop the line running the program to which you want to add more
VTBI.

NOTE: When adding VTBI, you can also update other step
parameters if necessary.

2. Reselect the line.

3. In the Program screen, press [No] to edit the program. All step
display indicators will have returned to numbers, indicating they
are editable.

4. Enter the VTBI.

NOTE: You must add VTBI to all steps.

5. Press [START] and confirm the program as described in

Programming a Loading Dose on page 8-4 and Programming
a Multistep Delivery on page 8-6.

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Titration
Titration is a change in Dose/Rate, Duration, and/or VTBI in
a currently running or programmed infusion.

NOTE: Titration cannot be performed while a bolus dose is being

delivered.

Loading Dose Delivery and Multistep Delivery

In a Loading Dose delivery or Multistep delivery, during infusion and
before VTBI is completed, titration can be performed only on steps
where the display indicator is an * or a number.

To perform titration:

1. Select the line to titrate.

2. Navigate to any step where the display indicator is an *

or a number and change the Dose, Rate, VTBI, or Duration
for the step as desired.

3. Press [START] and confirm the program as described in

Programming a Loading Dose on page 8-4 and Programming
a Multistep Delivery on page 8-6.

Changing the CCA During Infusion

To change the CCA during infusion:

1. Press [Settings/Vols/CCA].

2. Press [Change CCA]. The current CCA is indicated by arrows

before and after the CCA name.

3. Choose a CCA.
When the Delivery screen displays, the infuser will inform
the user that line is delivering under a prior CCA. Until a VTBI
Complete alarm occurs for the line, you can still titrate the
infusion on that line under the old CCA.

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When a VTBI Complete alarm occurs on a line that is infusing

under a prior CCA:

1. Stop the line.

2. Clear the volume for the line, if desired.

3. Select the line.

4. Clear the line settings.

5. Reprogram the line under the current CCA.

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Section 9
Alarms and Troubleshooting

Alarm Priority Levels

The Plum 360 infuser has an intelligent alarm system that handles
more than one alarm at a time. Alarms are prioritized as high,
medium, or low. You can distinguish the priority by the number
of beeps:

Priority Number of Beeps

High 10

Medium 3

Low 2

The alarm sound pressure range is from 45 dB to 70 dB, depending

on the setting of the alarm loudness control located on the back of the
infuser.
The alarm sound pressure is measured in accordance with IEC
60601-1-8:2012.

WARNING
SETTING THE ALARM SOUND PRESSURE LEVEL LOWER THAN
THE AMBIENT SOUND PRESSURE LEVEL CAN IMPEDE
OPERATOR RECOGNITION OF ALARM CONDITIONS.

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General Alarms
High Priority Alarms

Alarm Message
Possible Cause Corrective Action
and Priority

Power Off then On. Malfunction. Power the infuser off,

Replace pump if alarm and then on. Replace
continues. infuser if this does not
High clear the alarm.
Various E### Alarms

Replace pump. Audio alarm is OFF Power off the infuser.

Audio alarm failure. but sensed ON, or
High ON but sensed
OFF.
E301

Replace pump. Backlight voltage Power off the infuser.

Backlight failure. out of range during
High operation.
E302

Line B VTBI complete Line B delivery is Stop the delivery

in prior CCA! complete, the line on Line B or open
Press STOP key. was programmed the cassette door.
High under a different
CCA than the CCA
N160
currently being
used, and Line B
has a Concurrent
delivery
programmed.

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Alarm Message
Possible Cause Corrective Action
and Priority

Distal OCCLUSION! Distal occlusion Examine the distal line

Resolve then detected while for kinks.
Backprime. attempting to Resolve the distal
High backprime or occlusion and then
during cassette either backprime
N180
check. or open and close
the cassette door.

Distal OCCLUSION! A distal occlusion Examine the distal line

Check IV line and site. is detected and for kinks and correct
High either the any found.
maximum auto- Restart the delivery.
N186
restarts have Note: (software
occurred for the versions 15.11 and
infusion or auto- earlier)
The alarm can also be
restart was set cleared by clearing the
to zero. confirmed programs on
OR any programmed line
or opening the
An N192 alarm has cassette door.
been active for 60 Note: (software
seconds without versions 15.20 and
the pressure later)
dropping below the The alarm can also be
cleared by pressing the
distal occlusion [A] or [B] softkey for
pressure threshold. any programmed line
or opening the cassette
door.
See Avoiding
Unintended Bolus
While Resolving a
Distal Occlusion on
page 4-31.

WARNING
THE PLUM 360 INFUSER DOES NOT HAVE CAPABILITY
TO DETECT INFILTRATION TO THE PATIENT

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Alarm Message
Possible Cause Corrective Action
and Priority

Pump too high above Distal occlusion Resolve the occlusion

patient. detected during by lowering the infuser
Lower Pump or replace delivery due on the pole to place it
closer to the level of
set. to too much the patient’s heart
High backpressure. (see Delivery
Accuracy on
N187 page 11-10) and then
press [START].
Note: The alarm can
also be cleared by
clearing the confirmed
programs on any
programmed line
or opening the
cassette door.

Data was cleared. Corruption of Acknowledge the alarm.

Re-enter all retained delivery
programming parameters is
detected. Autoclear
High of SEEP requires
N103 fresh delivery
setup.

Distal AIR! Disconnect / The single air bolus Open the cassette door.
reprime. or the cumulative See Resolving a
Press START. air detected at the Distal Air-in-Line
High distal sensor Alarm on page 4-30.
exceeds the air
N233 / N234
detection
threshold.

Door opened! Infusion The cassette door Close the cassette door
stopped! was opened during with the cassette
Close Door. a delivery. inserted.
High
N250

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Alarm Message
Possible Cause Corrective Action
and Priority

Cassette test failure! Faulty cassette, Resolve occlusion and

Check set. proximal occlusion, then open and close the
High or air was detected cassette door.
in the cassette Press [Back Prime].
N251
during the cassette Replace administration
test. set.

Depleted Battery! The infuser is Plug into an AC (mains)

Plug into AC now! running on battery power source.
High power and the
battery voltage is
N252
below the depleted
battery threshold.

Keypad locked. While the keypad Enter valid keypad

Enter code to disable. was locked, unlock code.
High someone pressed
[STOP] or opened
N255
the cassette door
during delivery.

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Medium Priority Alarms

Alarm Message
Possible Cause Corrective Action
and Priority

Door opened! The cassette door Close the cassette door

Delayed Start! was opened while with cassette inserted.
Close Door an infusion was
Medium in Delayed Start.
N108

Distal OCCLUSION - A distal occlusion Examine the distal line

Paused! was detected, auto- for kinks and correct
Attempting restart. reset is configured any found.
Medium on, and the No action is necessary
maximum number if the patient can
N192
of auto-resets have resolve the alarm
not occurred for the condition within 60
infusion. seconds of activation
(for example, moving
an arm to eliminate the
occlusion) before the
maximum retry number
is reached.
Open the cassette door.

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Low Priority Alarms

Alarm Message
Possible Cause Corrective Action
and Priority

Keep Plugged into AC! The battery or Power off the infuser.
Service battery / battery charge Replace the infuser
replace pump. circuitry needs as soon as possible,
Low servicing. so that it can be sent
for repair.
N56 / N57

Power Off then On. Battery voltage Power off the infuser.
Replace pump if alarm is greater than
continues. the expected limit.
Low
E325

Low Battery! The battery charge Plug into AC (mains)

Plug into AC power! level is low. power.
Low
N58

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Alarm Message
Possible Cause Corrective Action
and Priority

Programming not (software version Press any hardkey

complete! 15.1 and earlier) or softkey except the
Action required! No operator input [AUDIO PAUSED]
Low for 2 minutes after hardkey.
the infuser is
N102
powered on in
Clinical mode,
except for
situations that
trigger an N101.

(software version
15.11 and later)
No operator input
for 2 minutes after
the infuser is
powered on in
Clinical mode, with
a cassette installed
or a confirmed
program, except for
situations that
trigger an N101.

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Line A Alarms

High Priority Alarms

Alarm Message
Possible Cause Corrective Action
and Priority

No Action Alarm! (software versions Press any hardkey on

Start or Clear line A. 15.11 and earlier) the infuser except
High No operator action [AUDIO PAUSED].
for 2 minutes when Select Line A to
N101
Line A has been program or clear it.
stopped by the
user and is not
cleared or
restarted.
(software versions
15.20 and later)
No operator action
for 2 minutes when
Line B is not
programmed, and
Line A has been
stopped by the
user and is not
cleared or
restarted.
Note:
Will reassert if the
condition persists.

Line A VTBI complete Line A was Stop the delivery

in prior CCA! programmed under on Line A.
Press STOP key. a different CCA Open the cassette door.
High than is currently
being used and
N161
delivery is
complete.

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Alarm Message
Possible Cause Corrective Action
and Priority

VTBI Completed Line A! Line A delivery is Add VTBI on Line A.

Add more VTBI complete and line Stop Line A.
or Clear A. was programmed Open the cassette door.
High under the CCA that
is currently being
N161
used.

Proximal OCCLUSION Proximal occlusion Examine the proximal

A! or air detected on line for kinks and
Check Line A. Line A during correct any found.
High delivery. If the occlusion is
caused by a closed
N190 / N191
clamp, open the clamp.
If all clamps are open,
the alarm may be
caused by excessive air
that is creating
backpressure in the
cassette.
To remove the air,
see Backpriming on
page 4-21.
Check the syringe size.
See Administration
Sets and
Accessories
Guidelines on
page 1-19.
Restart Line A.
Note: The alarm can
also be cleared by
clearing the confirmed
programs on any
programmed line
or opening the
cassette door.

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Plum 360 Infuser

Alarm Message
Possible Cause Corrective Action
and Priority

Proximal AIR Line A! The single air bolus Press [Back Prime].
Backprime. detected at the See Backpriming on
High proximal sensor in page 4-21.
Line A exceeds the Check the syringe size.
N232
air detection See Administration
threshold. Sets and
Accessories
Guidelines on
page 1-19.

Medium Priority Alarms

Alarm Message
Possible Cause Corrective Action
and Priority

Callback to Line A! A Callback Alarm Press

Silence audio to clear. was programmed [AUDIO PAUSED].
Medium for Line A, and the
VTBI for Line A
N105
reaches 0 for a
Loading Dose or
any step in a
multistep therapy
except the last step.

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Plum 360 Infuser

Alarm Message
Possible Cause Corrective Action
and Priority

Proximal OCCLUSION Proximal occlusion Examine Line A

A! detected on Line A for kinks.
Resolve then during backprime. Resolve the occlusion.
Backprime. Either backprime or
Medium open and close the
cassette door.
N184
Check the syringe size.
See Administration
Sets and
Accessories
Guidelines on
page 1-19.

Bolus complete on Line Bolus delivery Press

A! completes on [AUDIO PAUSED].
Silence audio to clear. Line A and a Nurse
Medium Callback was
N107 configured.

(software version 15.1

and later)

Prox OCCLUSION A A proximal Examine Line A

Startup! occlusion was for kinks.
Open/close door detected on Line A Resolve the occlusion.
or Backprime. during the cassette Either backprime
Medium integrity test. or open and close
the cassette door.
N185
See Opening the
Cassette Door
Completely on
page 3-7.
Check the syringe size.
See Administration
Sets and
Accessories
Guidelines on
page 1-19.

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Plum 360 Infuser

Line B Alarms
High Priority Alarms

Alarm Message
Possible Cause Corrective Action
and Priority

No Action Alarm! (software versions Press any hardkey on

Start or Clear line B. 15.11 and earlier) the infuser except
High No operator action [AUDIO PAUSED].
for 2 minutes when Select Line B to
N101
Line B has been program or clear it.
stopped by the
user and is not
cleared or
restarted.
(software versions
15.20 and later)
No operator action
for 2 minutes when
Line A is not
programmed, and
Line B has been
stopped by the
user and is not
cleared or
restarted.
Note:
Will reassert if the
condition persists.

Line B VTBI complete A Line B Piggyback Clear the program

in prior CCA! delivery that was on Line B.
Clear line B. programmed under Open the cassette door.
High a different CCA is
complete, and
N160
no delivery is
programmed
on Line A.

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Plum 360 Infuser

Alarm Message
Possible Cause Corrective Action
and Priority

VTBI Completed Line B! A Piggyback Add VTBI on Line B.

Add more VTBI delivery on Line B Clear program
or Clear B. is complete and on Line B.
High the line was Open the cassette door.
programmed under
N160
the current CCA
and no delivery is
programmed to
deliver on Line A.
Note:
Piggyback with
a Line A delivery
will not alarm;
it will just transition
to Line A delivery.

VTBI Completed Line B! A Concurrent Add VTBI on Line B.

Add more VTBI delivery on Line B Stop the delivery on
or Clear B. is complete and Line B.
High the line was Open the cassette door.
programmed under
N160
the current CCA.

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Plum 360 Infuser

Alarm Message
Possible Cause Corrective Action
and Priority

Proximal OCCLUSION Proximal occlusion Examine line B

B! detected on Line B for kinks.
Resolve then during cassette Make sure a line or
Backprime. integrity test. syringe is attached to
High the secondary port and
that the line is
N183
unclamped or the
syringe has enough free
space to accept the
backprimed fluid. Either
backprime or open and
close the cassette door.
See Backpriming on
page 4-21 to remove
the air.
Check the syringe size.
See Administration
Sets and
Accessories
Guidelines on
page 1-19.

Proximal OCCLUSION Proximal occlusion Examine the proximal

B! detected on Line B line for kinks and
Check Line B. during delivery. correct any found,
High Restart Line B.
Note: The alarm can
N188 / N189 also be cleared by
clearing the confirmed
program or opening
the cassette door.

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Plum 360 Infuser

Alarm Message
Possible Cause Corrective Action
and Priority

Proximal AIR Line B! The single air bolus Press [Back Prime].
Backprime. detected at the See Backpriming on
High proximal sensor in page 4-21.
Line B exceeds the Check the syringe size.
N231
air detection See Administration
threshold. Sets and
Accessories
Guidelines on
page 1-19.

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Plum 360 Infuser

Medium Priority Alarms

Alarm Message
Possible Cause Corrective Action
and Priority

Callback to Line B! A Callback Alarm was Press [AUDIO

Silence audio to programmed for Line B, PAUSED].
clear. which is in Piggyback
mode, Line A is
Medium programmed to resume
when Line B completes,
N104 and the VTBI for Line B
reaches 0 for a Piggyback
therapy, Loading Dose,
Maintenance Dose or any
step in a multistep therapy.
OR
A Callback Alarm was
programmed for Line B,
which is in Piggyback
mode, Line A is not
programmed to resume
when Line B completes,
and the VTBI for Line B
reaches 0 for a Loading
Dose or any step in a
multistep therapy except
the last step.
OR
A Callback Alarm was
programmed for Line B,
which is in Concurrent
mode, and the VTBI for Line
B reaches 0 for a Loading
Dose or any step in a
multistep therapy except
the last step.

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Plum 360 Infuser

Alarm Message
Possible Cause Corrective Action
and Priority

Proximal Proximal occlusion detected Examine line B for

OCCLUSION B. on Line B during cassette kinks.
Resolve then integrity test. Make sure a line or
Backprime syringe is attached to
Medium the secondary port and
N183 that the line is
unclamped or the
syringe has enough
free space to accept
the backprimed fluid.
Either backprime or
open and close the
cassette door.
Check the syringe
size. See
Administration
Sets and
Accessories
Guidelines on
page 1-19.
Bolus complete on Bolus delivery completes on Press [AUDIO
Line B! Line B and a Nurse Callback PAUSED].
Silence audio to was configured.
clear.
Medium
N106
(software version
15.1 and later)

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Plum 360 Infuser

Lines A and B Alarms

High Priority Alarms

Alarm Message
Possible Cause Corrective Action
and Priority

No Action Alarm! Rate was Press a labeled softkey.

Acknowledge Alert. recalculated;
High operator has not
acknowledged the
N101
alert within
30 seconds.

Line not in STANDBY! No operator action Press [Standby All],

Choose line(s) for 15 seconds [Standby A],
to Standby: when the user has [Standby B],
High selected or [Cancel].
[Standby] when
N101
both lines are able
to be put in
standby, but has
not selected a line
(A, B or A & B)
or selected
[Cancel] to
complete the
action.

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Plum 360 Infuser

Alarm Message
Possible Cause Corrective Action
and Priority

Delivery was No operator action Press [Stop All],

not STOPPED! for 15 seconds [Stop A], [Stop B],
Choose line(s) to stop. when the user has or [Cancel].
High attempted to stop
a delivery where
N101
both lines are
delivering by
pressing [STOP],
but has not
selected a line
(A, B or A & B)
or selected
[Cancel]
to complete the
action.

Delivery was No operator action Press [Start All],

not STARTED! for 15 seconds [Start A], [Start B],
Choose line(s) to start. when the user has or [Cancel].
High attempted to start
a delivery where
N101
both lines are
confirmed by
pressing [START],
but has not
selected a line
(A, B or A & B)
or selected
[Cancel]
to complete
the action.

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Plum 360 Infuser

Alarm Message
Possible Cause Corrective Action
and Priority

(software version 15.1 Standby is not Press [Yes] to confirm

and earlier) possible and no the program or [No]
Yes: Start titration! operator action for to go back to the
No: Edit 30 seconds when Program screen.
(software version 15.11 a titrated program
and later) is waiting to be
Yes: Start program confirmed.
No: Edit
High
N101

No Action Alarm! Standby is possible Press [Yes] to confirm

Yes: Start No: Edit and no operator the program or [No]
action for 2 minutes to go back to the
High when a new Program screen, or
N101 program is waiting press [Standby].
to be confirmed or
Note: Standby is placed into
intentionally not Standby.
included in the
instruction text.

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Plum 360 Infuser

Alarm Message
Possible Cause Corrective Action
and Priority

(software version 15.1 Standby is possible Press [Yes] to confirm

and earlier) and no operator the program or [No]
Yes: Start titration! action for 30 to go back to the
seconds when a Program screen, or
No: Edit titrated program is press [Standby].
waiting to be
confirmed or
(software version 15.11
placed into
and later)
Standby.
Yes: Start program
No: Edit
High
N101

Note: Standby is
intentionally not
included in the
instruction text.

(software version 15.1 No operator action Press [START].

and earlier) for 30 seconds Press
No Action Alarm! when a line is [Return to A/B].
titrated during
START: Confirm infusion and the
titration. [START] hardkey
has not been
pressed for a
(software version 15.11
program that can
and later)
be started.
No Action Alarm! Note: A delivery
START: Confirm cannot be started
if it is in a
program concurrency
High violation. If it is
in a concurrency
N101 violation, an alarm
will occur.

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Plum 360 Infuser

Alarm Message
Possible Cause Corrective Action
and Priority

No Action Alarm! Soft limit override Press [Yes] to confirm

Yes: Override No: Edit and no operator the program or [No] to
High action for 2 minutes go back to the Program
when a new screen.
N101
program is waiting
to be confirmed.
OR
Soft limit override
and no operator
action for 30
seconds when
a titrated program
is waiting to be
confirmed.

No Action Alarm! No operator action Press any hardkey

Start or Clear lines. for 2 minutes when except [AUDIO
High both lines have PAUSED].
been stopped by
N101
the user and not
cleared or
restarted.
OR
(software version
15.1 and later)
No operator action
for 2 minutes after
a Bolus has been
cancelled (putting
both lines into a
stopped state).
Note: Will reassert
if the condition
persists.

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Plum 360 Infuser

Alarm Message
Possible Cause Corrective Action
and Priority

No Action Alarm! Standby is not Press [Yes]

Yes: Start No: Edit possible and there or [No].
High is no operator
N101 action for 2 minutes
when a new
program is waiting
to be confirmed.

Proximal AIR! The cumulative air Press [Back Prime].

Backprime. detected at the See Backpriming on
High proximal sensors in page 4-21.
Line A and Line B Check the syringe size.
N230
exceeds the air See Administration
detection Sets and
threshold.
Accessories
Guidelines on
page 1-19.

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Plum 360 Infuser

Rejected Auto-Programs
If a physician’s order for an automatically programmed therapy
(see Auto-Programming on page 6-1) exceeds the capabilities
of the infuser or is above a hospital-defined hard drug limit, the order
will be rejected. If your order is rejected, recheck the order.
The following table is a list of auto-program rejection messages and
operator actions to respond to rejections.

Message Action

The program was rejected because there is no Press [Reject], or

custom drug library installed. wait for this screen to
automatically dismiss.

The program was rejected because a CCA Press [Reject],

has not been selected. or wait for this screen
to automatically dismiss.
Select a CCA and
resubmit the program.

The program was rejected because the patient Press [Reject],

weight is different than the weight being used or wait for this screen
on the other line. to automatically dismiss.

The program was rejected because the patient Press [Reject],

height is different than the height being used or wait for this screen
on the other line. to automatically dismiss.

The program was rejected because required Press [Reject],

information was missing. or wait for this screen
to automatically dismiss.

The program was rejected because the patient Press [Reject], or

BSA is different than the BSA being used on wait for this screen to
the other line. automatically dismiss.

The program was rejected because it contains Press [Reject], or

invalid data. wait for this screen to
automatically dismiss.

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Plum 360 Infuser

Message Action

The program was rejected by ICU Medical Press [OK], or wait

MedNet due to drug library incompatibility. for this screen to
automatically dismiss.

The program was rejected because the line is Press [Reject],

in Standby. or wait for this screen
to automatically dismiss.
Clear this line and
resubmit the program.

The program was rejected because the line is Press [Reject],

in Delayed Start. or wait for this screen
to automatically dismiss.
Clear the line and
resubmit the program.

The program was rejected because the dosing Press [Reject], or

units do not match the medication units. wait for this screen to
automatically dismiss.

The program was rejected because line A Press [Reject],

cannot be interrupted. or wait for this screen
to automatically dismiss.

The program was rejected because the Press [Reject],

combined rate of line A and line B cannot or wait for this screen
exceed 500 mL/hr in concurrent mode. to automatically dismiss.

The program was rejected because the rate Press [Reject],

on each line must be greater than 0.5 mL/hr in or wait for this screen
concurrent mode. to automatically dismiss.

The program was rejected because there is no Press [Reject], or

confirmed program on this line. wait for this screen to
automatically dismiss.

The program was rejected because rate Press [Reject], or

change or titration is not allowed on “No Drug wait for this screen to
Selected”. automatically dismiss.

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Plum 360 Infuser

Message Action

The program was rejected because the Press [Reject], or

medication cannot be infused as a Piggyback. wait for this screen to
automatically dismiss.

(software version 15.1 and earlier) Press [Reject],

The program was rejected because the or wait for this screen
duration cannot be changed. to automatically dismiss.

The program was rejected because the Press [Reject], or

medication on line A cannot be interrupted. wait for this screen to
automatically dismiss.

The program was rejected because it is for a Press [Reject],

different medication / concentration than is or wait for this screen
currently infusing. to automatically dismiss.

(software version 15.11 and earlier) Press [Reject], or

The program was rejected because there is no wait for this screen to
remaining volume to be infused (VTBI). automatically dismiss.

The program was rejected because the line is Press [Reject], or

currently delivering. wait for this screen to
automatically dismiss.

The program was rejected because there is an Press [Reject],

unconfirmed program on the infuser. or wait for this screen
to automatically dismiss.
Resubmit the program.

The program was rejected because a change Press [Reject], or

to a non-rate-based infusion is not supported. wait for this screen to
automatically dismiss.

The program was rejected because there is a Press [Reject], or

Loading Dose or Multistep program on this wait for this screen to
line. automatically dismiss.

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Plum 360 Infuser

Message Action

The program was rejected because the infuser Press [Reject],

is alarming. or wait for this screen
to automatically dismiss.
Clear the alarm and
resubmit the program.

The program was rejected because the Unlock the keypad and
keypad is locked. resubmit the program.

The program was rejected because the New Press [Reject], or

Patient question must be answered. wait for this screen to
automatically dismiss.

(software version 15.11 and later) Press [Reject], or

The program was rejected because the line wait for this screen to
has a pending CCA change. automatically dismiss.

(software version 15.1 and later) Press [Reject], or

The program was rejected because the line is wait for this screen to
delivering a bolus. automatically dismiss.

(software version 15.1 and later) Press [Reject], or

The program was rejected because there is no wait for this screen to
cassette installed. automatically dismiss.

(software version 15.20 and later) Press [Reject], or

The program was rejected because the pump wait for this screen to
is in Flush mode. automatically dismiss.

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Plum 360 Infuser

Partially Programmed Line

For software version 15.1 and earlier, if an auto-program is received
for a partially-programmed line, the auto-program will be rejected.
For software version 15.11 and later, if an auto-program is received
for a partially-programmed line, the infuser will clear the partial
program and accept the auto-program.
A line is partially programmed when a drug is selected for the line and
the line program has not been cleared or confirmed.

Invalid Titration
In this case, an auto-program is rejected because auto-programming
is performed on a line in the PENDING or PUMPING state and the
Post Infusion Rate (KVO or RATE) is interpreted as not being
a titration.
An infuser with an installed cassette was started. The CCA was
selected. Line A was programmed and delivery was started.
A barcode was scanned and an order on line A was placed. The auto-
program for line A was sent to the infuser.
The infuser determines that the auto-program is a new delivery based
on titration rules and rejects the auto-program.

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Plum 360 Infuser

Notes

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Plum 360 Infuser

Section 10
Cleaning, Maintenance, Storage,
and Service

Cleaning the Infuser

The Plum 360 infuser should be cleaned and disinfected prior to first
patient use, between patient use, and prior to performing repairs and
preventive maintenance. For instructions, see the Plum 360 Infuser
Technical Service Manual.
The following sections describe how to clean spills that may occur
while preparing or operating the infuser at the patient site, and the
recommended cleaning supplies.

CAUTION
DO NOT SATURATE THE AIR-IN-LINE DETECTORS BEHIND THE
CASSETTE DOOR WITH CLEANING SOLUTIONS.

DO NOT STERILIZE THE INFUSER BY HEAT, STEAM, ETHYLENE OXIDE

(ETO), OR RADIATION.
DO NOT USE SHARP OBJECTS TO CLEAN ANY PART OF THE INFUSER.

To avoid mechanical or electronic damage, do not immerse the

infuser in any fluid.

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Plum 360 Infuser

Cleaning Procedure
The following procedure describes how to clean nonhazardous spills
or soil from the infuser during the course of patient care.
• Non-hazardous fluid spills should be wiped up as soon as
possible, and not allowed to dry on the infuser.
• Hazardous spills (such as blood or chemotherapy drugs) should be
processed per facility policy.

To clean non-hazardous spills or soil at the patient site:

1. Inspect the infuser enclosure, display, and keypad for visible

cracks or damage that may allow fluid to reach internal
components.

CAUTION
DO NOT USE THE INFUSER IF THE ENCLOSURE, KEYPAD, OR DISPLAY
IS DAMAGED OR CRACKED.

If damage or cracks are found, replace the infuser.

2. With gloves on, remove a wipe from the dispenser and unfold
it to expose the maximum surface area before wiping, or spray
an approved cleaning solution on a clean, lint-free cloth.

CAUTION
DO NOT SPRAY CLEANING SOLUTIONS TOWARD ANY OPENING IN THE
INFUSER.

See Cleaning Supplies on page 10-3 for approved cleaning

solutions.

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Plum 360 Infuser

3. Wipe up the spill.

• Use a spiral pattern when wiping, moving from the inner

to outer edges of each surface to avoid recontaminating the
areas you have already wiped.
• When part of the cleaning cloth or wipe becomes soiled
or saturated, start wiping with an unused part.
• Change cloths or wipes as needed to avoid spreading the spill
from one area of the infuser to another.
• Do not allow cleaning fluid to run into internal parts of the
infuser.
• When wiping behind the cassette door, take care to avoid
damaging the precision parts of the pumping mechanism.

NOTE: If sticky or high-viscosity fluids such as TPN are spilled behind

the cassette door, replace the infuser as soon as possible so it can be
thoroughly cleaned. Dried, built-up residue from these type of fluids
can damage the pumping mechanism.

Cleaning Supplies
To clean the infuser, use clean, soft, lint-free cloths moistened with an
approved cleaning solution or commercial wipes.

CAUTION
CERTAIN SOLUTIONS AND ABRASIVES MAY DAMAGE THE INFUSER.
DO NOT USE COMPOUNDS CONTAINING COMBINATIONS OF
ISOPROPYL ALCOHOL AND DIMETHYL BENZYL AMMONIUM CHLORIDE.

PREPARE CLEANING SOLUTIONS AS SPECIFIED BY THE

MANUFACTURER TO AVOID INFUSER DAMAGE.

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Plum 360 Infuser

NOTE: Disinfecting properties of cleaning solutions vary, and not all

cleaning solutions are sanitizers. Check product labeling or consult
the manufacturer for specific information.

Approved Cleaning Solutions

Class of Cleaning Solution Manufacturer Preparation
Enzymatic Detergent ASP Enzol™ Use per
ASP Cidezyme™ manufacturer’s
recommendations
and instructions
in this manual.

To obtain additional information on cleaning the infuser, contact ICU

Medical.

Infuser Maintenance
The Plum 360 infuser requires annual preventive maintenance that is
performed by qualified service personnel. There is no clinician-
required maintenance. See the Plum 360 Infuser Technical Service
Manual for instructions.

Battery Maintenance
WARNING
CONNECT THE AC (MAINS) CORD TO A PROPERLY GROUNDED
RECEPTACLE.

CAUTION
DO NOT OPERATE THE INFUSER ON PATIENTS WITH THE BATTERY
REMOVED. USE OF A PROPERLY MAINTAINED AND CHARGED
BATTERY HELPS CONFIRM PROPER OPERATION.

If the low-battery alarm sounds, connect to AC (mains) power

immediately.

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Plum 360 Infuser

NOTE: If spare parts other than ICU Medical-approved spare parts

are used for battery replacement, the warranty on the Plum 360
infuser shall be void.

The battery system requires annual preventive maintenance. See the

Plum 360 Infuser Technical Service Manual for instructions.
Additionally, there are specific storage conditions for the battery (see
notes starting on page 11-3). There is no clinician-required battery
maintenance.
The Plum 360 infuser is battery-powered for emergency backup and
temporary portable operation. The typical battery operating time with
a new and fully charged battery is 7 hours when infusing at 25 mL/hr,
and 4 hours at 999 mL/hr.
The battery charges whenever connected to AC (mains) power.
If the infuser is switched OFF, recharge takes approximately eight
hours. Recharge takes longer if the infuser is turned ON.
To maintain maximum battery charge and to prolong battery life,
connect the infuser to AC (mains) power whenever possible. Connect
to AC (mains) power to continually charge the battery for emergency
use.

Storage
WARNING
CONNECT THE AC (MAINS) CORD TO A PROPERLY
GROUNDED RECEPTACLE.

WARNING
TO PREVENT BATTERY LEAKAGE, REMOVE THE BATTERY
BEFORE STORING THE INFUSER FOR AN EXTENDED PERIOD
OF TIME.

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Plum 360 Infuser

Store the infuser connected to AC (mains) power, with the infuser

switched OFF using the [ON/OFF] key.

Ensure that access to the (mains) plug is not blocked

while using the infuser so that the plug can be
disconnected from the mains power receptacle in the
event of an emergency.

INSPECT CORD BEFORE USE. When plugging in, use

straight forward motion.

INSPECT CORD AFTER USE. When unplugging, grasp

plug and pull straight out. Do not pull cable to unplug.

For storage conditions, including extended storage conditions that

can affect battery life, see notes starting on page 11-3.

Service
The infuser has no user-serviceable parts. In addition:

• Servicing and adjustments must only be performed by ICU Medical

personnel or trained, authorized service representatives. Service
training is available from ICU Medical. Contact your ICU Medical
representative.
• Replacement of fuses, power cord, or other parts must only be
performed by ICU Medical personnel or trained, authorized service
representatives. See the Plum 360 Infuser Technical Service
Manual for repair and replacement procedures.
• Circuit diagrams and repair parts lists are available for trained,
authorized service representatives. See the Plum 360 Infuser
Technical Service Manual for more information.

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Plum 360 Infuser

• See the Plum 360 Infuser Technical Service Manual for more
information for all battery removal and storage information,
component part lists, descriptions, calibration instructions, and fuse
replacement.
• The Plum 360 infuser can be disconnected from the mains supply
by removing the power cord from the wall socket.

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Plum 360 Infuser

Notes

10-8 System Operating Manual

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Section 11
Specifications

Physical
Dimensions: Approximately 8” H x 8” W x 6” D
(20 cm H x 20 cm W x 15 cm D),
excluding pole clamp extrusion
and power cord storage.

Mass: Approximately 10 lbs. (4.5 kg) with battery.

Casing: High-impact plastic.

Expected Service Life: 10 years

NOTE: Expected Service Life is defined as

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

NOTE: At the end of the infuser’s serviceable life,

the infuser parts must be recycled by an
authorized electronic waste handler.
Inappropriate disposal of the device can result
into Hazards to the Environment.
Refer to the Plum 360 Infuser Technical
Service Manual or contact ICU Medical
Service Center for the current disposal
process or follow your facility procedure for
proper disposal of the device.

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Electrical
WARNING
AT THE END OF THE BATTERY’S SERVICE LIFE, DISPOSE OF THE
BATTERY BY DELIVERING IT TO AN AUTHORIZED LEAD-ACID
BATTERY RECYCLER.

Power Requirements: 100 - 120 VAC; 50-60 Hz; 50 VA

220 - 240 VAC; 50-60 Hz; 50 VA

Power Cord: Hospital-grade AC cord.

Fuses: Internal and non-replaceable
Electrical Leakage: Meets IEC 60601-1:2012: Medical Electronic
Equipment, Part 1: General Requirements
for Basic Safety and Essential Performance.
Battery: One sealed, lead-acid, rechargeable
6 V battery, internal to device.
Battery Operation: The typical battery operating time with a new
and fully charged battery is 7 hours when
infusing at 25 mL/hr, and 4 hours at 999 mL/hr.
Recharge: The battery charges whenever the infuser
is connected to AC (mains) power. The
recharge time is up to 8 hours with the device
operating at 125 mL/hr on one line.
Nurse Call Interface: The nurse call interface active state
is factory set for Normally-Open (NO).
Contact the Technical Services Center
to change the device from Normally-Open (NO)
to Normally-Closed (NC).
Nurse Call Voltage: 30 VDC
Circuitry Ratings:
Max current: 1 Amp

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Environment:
• Operating Temperature: 41°F to 104 °F (5°C to 40 °C)
See Notes 1 and 2.
• Storage Temperature: –5°F to 104°F (–20°C to 40°C)
See Notes 2 and 3.
• Atmospheric Pressure: 0 to 10,000 feet (0 to 3,000m)
or equivalent pressure
• Relative Humidity: 10% to 90% (maximum dew point of 30°C)
See Note 4
NOTES:
1. Batteries operate on electrochemical reaction, which converts chemical
energy to electric energy. The electrochemical reaction is reduced as
temperature lowers, thus, available discharge capacity is greatly reduced
at temperatures as low as –15°C.

2. Battery cycle life (number of cycles) of the battery is dependent on the

depth of discharge in each cycle. The deeper the discharge, the shorter
the cycle life (smaller number of cycles), providing the same discharge
current. The cycle life (number of cycles) of the battery is also related
to such factors as the ambient temperature and rest period between
charge and discharge. The expected life of the battery will decrease
by one-half with each rise in temperature of 10°C. In particular, the life
of the battery will shorten at about 40°C. Therefore, careful consideration
must be taken not to use or store the battery at high temperature.
A permanently damaged battery cannot be recharged to full capacity.

3. The ambient temperature range of storage shall be –15°C to 40°C.

For short-term storage (up to 2 weeks), the temperature range of –20°C
to 60°C is permissible. For long-term storage (up to 12 months),
the optimum temperature range is –15°C to 25°C. When it is unavoidable
to store the battery for 3 months or longer, periodically recharge the
battery at the intervals recommended in the following table, depending
on ambient temperature. Avoid storing the battery for more than 12
months either in the infuser or in spares inventory.

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Storage Temperature Refresh Charge Interval

–15°C to 25°C 6 months
25°C to 40°C 2 months
40°C to 60 °C 1 week

Do not store above 40°C for more than 2 weeks.

If any of the above conditions are not or cannot be met during storage,
replace the battery before use.
4. The optimal relative humidity for storage or operation is 25% to 85%.
For short durations (up to 2 weeks), operation or storage at a relative
humidity in the range of 10% to 90% is permissible.

Connectivity Engine
Wireless Standards: IEEE 802.11 a/b/g/n
Radio Technology: 802.11a: Orthogonal Frequency Division
Multiplex
802.11b: Direct Sequence Spread Spectrum
802.11g: Orthogonal Frequency Division
Multiplex
802.11n: Orthogonal Frequency Division
Multiplex
Data Transfer Rate: 802.11a: Up to 54 Mbps
802.11b: Up to 11 Mbps
802.11g: Up to 54 Mbps
802.11n: Up to 72.2 Mbps
(2.4 GHz Frequency Band)
802.11n: Up to 72.2 Mbps
(5.0 GHz Frequency Band, 20 MHz channel)
802.11n: Up to 150 Mbps
(5.0 GHz Frequency Band, 40 MHz channel)

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Frequency Band 802.11a: 5.0 GHz

IEEE 802.11b: 802.11b: 2.4 GHz
802.11g: 2.4 GHz
802.11n: 2.4 GHz, 5.0 GHz
Transmit Power: 802.11a: +16 dBm (max)
802.11b: +15 dBm (max)
802.11g: +15 dBm (max)
802.11n: +14.5 dBm (max) @ 2.4 GHz
+16dBm (max) @ 5 GHz
Antenna: PCB antenna mounted in infuser housing
Ethernet LAN: Shielded Ethernet cable plugged into an
RJ-45 connector
Ethernet Protocol: DHCP; assigned IP Address, Subnet Mask,
Gateway, and DNS
Certifications: FCC Part 15.247, 15.407
IC RSS-210, RSS-102
FCC ID: STJ-SDMAN
IC No: 5627A-SDMAN

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VTBI Range
VTBI Range: 0.1 to 99.9 mL (in 0.1 mL increments)
100 to 9999 mL (in 1 mL increments)

Delivery Rate Range and Duration

Lines A and B: 0.1 to 99.9 mL/hr (in 0.1 mL increments)
100 to 999 mL/hr (in 1 mL increments)
Concurrent Delivery: 0.5 mL/hr minimum for each line
PlumSet: 500 mL/hr cumulative (A+B) maximum
KVO: 1.0 mL/hr or the last delivery rate on the
associated line, whichever is less
Bolus Delivery 1 to 99.9 mL/hr (in 0.1 mL increments)
(software version 100 to 999 mL/hr (in 1 mL increments)
15.1 and later):
Maximum
Programmable 1500:00 hh:mm
Duration:

Air-in-Line Alarm
PlumSet (Distal): Air Bolus at 0.1 mL or larger
Cumulative 0.25 mL out of 4.9 mL

PlumSet (Proximal): Air Bolus at 0.5 mL

Cumulative 1.0 mL

Occlusion Alarm and Limits

Temperature and length of administration set affect the maximum
occlusion detection time.

Distal Occlusion: The DISTAL OCCLUSION alarm sounds after

the distal set tubing or set outlet fitting becomes
occluded or vacuum occurs.

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Proximal The PROXIMAL OCCLUSION alarm sounds if the

Occlusion: tubing proximal to the cassette becomes occluded
or pressurized.
Distal Pressure Maximum pressure limit: user-selectable.
Limit Factory default setting: 6 psi (310 mmHg)
(without alarm):
Selectable range: 1 to 15 psi (52 to 776 mmHg)
with display accuracy ±3 psi (±155 mmHg).
Maximum 20 psi (1034 mmHg)
Infusion
Pressure:

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Time To Detect Downstream Occlusions

Maximum Time
Distal
Flow Distal Pressure to Detect
Tubing
Rate Alarm Limit Setting Downstream
Type
Occlusion

.1 mL/hr 1 psi (52 mmHg) Microbore 27 minutes

.1 mL/hr 15 psi (776 mmHg) Microbore 3 hours
1 mL/hr 1 psi (52 mmHg) Microbore 2 minutes
1 mL/hr 15 psi (776 mmHg) Microbore 15 minutes
25 mL/hr 1 psi (52 mmHg) Microbore 5 seconds
25 mL/hr 15 psi (776 mmHg) Microbore 30 seconds
.1 mL/hr 1 psi (52 mmHg) Macrobore 27 minutes
.1 mL/hr 15 psi (776 mmHg) Macrobore 9 hours
1 mL/hr 1 psi (52 mmHg) Macrobore 3 minutes
1 mL/hr 15 psi (776 mmHg) Macrobore 45 minutes
25 mL/hr 1 psi (52 mmHg) Macrobore 5 seconds
25 mL/hr 15 psi (776 mmHg) Macrobore 90 seconds
* Baseline backpressure is 0 psi (0 mmHg)*

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Maximum Unintended Bolus Volume

Released After Distal Occlusion is
Resolved
Maximum Typical
Distal Pressure Distal Unintended Unintended
Flow
Alarm Limit Tubing Bolus Bolus
Rate
Setting Type Volume Volume
Released Released

1 mL/hr 1 psi (52 mmHg) Microbore 0.01 mL 0.00 mL

1 mL/hr 15 psi (776 mmHg) Microbore 0.17 mL 0.11 mL

25 mL/hr 1 psi (52 mmHg) Microbore 0.02 mL 0.00 mL

25 mL/hr 15 psi (776 mmHg) Microbore 0.17 mL 0.12 mL

1 mL/hr 1 psi (52 mmHg) Macrobore 0.02 mL 0.00 mL

1 mL/hr 15 psi (776 mmHg) Macrobore 0.67 mL 0.48 mL

25 mL/hr 1 psi (52 mmHg) Macrobore 0.03 mL 0.00 mL

25 mL/hr 15 psi (776 mmHg) Macrobore 0.57 mL 0.44 mL

* Baseline backpressure is 0 psi (0 mmHg)*

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Delivery Accuracy
This table defines the standard conditions for delivery accuracy.

Delivery Accuracy

0.1 to 0.9 mL/hr (in 0.1 mL increments) ±10%

1 to 999 mL/hr (in 1 mL increments) ±5%

Ambient and Fluid Temperature 22°C ± 5°C

Back Pressure 0 psi (0 mmHg)

I.V. Fluid Sterile water

Filling Head Height 12” to 24” (30.5 to 61 cm)

WARNING
DELIVERY ACCURACY MAY POTENTIALLY BE AFFECTED BY
SEVERAL USE CONDITIONS, INCLUDING ELEVATED INFUSER
HEIGHT, VENOUS HYPERTENSION, PRESENCE OF AIR IN THE
CASSETTE AIR TRAP, I.V. SOLUTION VISCOSITY, AND I.V.
SOLUTION TEMPERATURE.

Delivery accuracy testing was performed in accordance with IEC

60601-2-24:2012. Tests were performed using Administration Set List
Numbers 12538, 14009, 14022, and 14246.
See Trumpet Curves on page 11-12 for data on how certain factors
influence rate accuracy.

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Bolus Delivery Accuracy

NOTE: Bolus dose functionality is available in software version 15.1
and later.
Bolus delivery accuracy testing was performed in accordance with
IEC 60601-2-24:2012. Refer to this standard for detailed information.
Bolus Delivery Accuracy data was generated using a representative
sample of administration sets from the Plum set portfolio. Tests were
performed using Administration Set List Number 14251.

Bolus Delivery Accuracy

Calculated % Maximum % Maximum %

Average Positive Negative
Tested Tested Deviation Deviation Deviation
Bolus Bolus from Set from Set from Set
Rate Volume Bolus Bolus Bolus
(in mL/hr) (in mL) Volume Volume Volume

1 mL/hr 4 mL -1.40 % -0.79 % -3.41 %

25 mL/hr 100 mL -0.23 % 0.33 % -1.96 %

Enteral or High Viscosity Fluids Effects

System delivery accuracy limits for enteral or high viscosity fluids can
be degraded by up to 5%. System delivery accuracy for enteral fluids
is defined only for rates of 1 to 200 mL/hr, with no suspended air
in the solution, and using a Plum enteral set.

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Trumpet Curves
The Trumpet Curve graphs following the example show
representative maximum and minimum percent flow rate deviation
from the programmed rate over time. This information was developed
in accordance with IEC 60601-2-24:2012. Refer to this standard for
detailed information.
How to read a Trumpet Curve Graph (Refer to example on the
following page): The graphs following the Example plot flow rates
at 30 second intervals for the first 2 hours and for the 96th hour
of delivery. The graph plots mean delivery rate error for the 2nd hour
and the 96th hour as a straight line. The graph also presents
maximum and minimum average delivery rate error for this interval
plotted by averaging delivery errors over intervals of 2, 5, 11, 19, and
31 minutes (“Trumpet Curve”).
Trumpet Curve data was generated using a representative sample
of administration sets from the Plum set portfolio. Tests were
performed using Administration Set List Numbers 12538, 14009,
14022, and 14246.
Note that at extremely low flow rates (that is, 0.1–0.3 mL/hr) and at
non-standard negative back pressures (-1 psi or -52 mmHg), the
accuracy error rate can be up to ±25%.
Backpressure Effect – At 25 mL/hr flow rate, backpressures of
+/- 2 psi (103 mmHg) on the distal line do not affect system delivery
accuracy.
Filling Head Effect – At 25 mL/hr flow rate, filling head variations of
-15 and +35 inches (-38 and +89 cm) of water (such as container
height) do not affect system delivery accuracy.
Concurrent Delivery Effect – When both lines (A & B) are
delivering, the concentration deviation for the lower rate may
be affected by up to 2.5%.
When air of volume greater than 0.05 mL is present in the cassette air
trap, the total system flow rate accuracy may be affected by up
to 2.0%.

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When variations in container height are present, the concentration

deviation for the lower rate may be affected by up to 4.0% for up to 24
inches (61 cm) of container height differences.

Example
From the Trumpet Curve Graph sample that follows, find the 5 minute
interval (A) at the horizontal axis and read the corresponding points
(B) and (C) on the vertical axis. The values are approximately +2.8%
and –0.5%.
This means that at the rate of 25 mL/hr the average maximum flow
rate fluctuation for any 5 minute time interval during the 2nd hour
of operation was within the limits of +2.8% and –0.5% from the
nominal rate. The average delivery rate error over the entire 2nd hour
was +1.6% (D).
For other time intervals look at other points at the horizontal axis and
determine corresponding limits as above.

25 ML/HR, 0 mm Hg DELIVERY HEAD, START UP

A
15.0%
PERCENT ERROR (%)

10.0% Max Positive Error over 5

B
Minute Interval = +2.8%
5.0%

0.0% + + + + +
-5.0% C Max Negative Error over 5
Minute Interval = -0.5%
-10.0% Average Delivery
D
Rate Error = +1.6%
-15.0%
0 5 10 15 20 25 30
Observation Interval (minutes)
Max + Min Mean

A trained professional can use the resulting graphs to select

an infuser with the appropriate startup and flow characteristics
to suit the clinical application.
NOTE: As an example of how the trumpet curves can be used,
consider the maximum and minimum deviations at the 5 minute
average interval. The upper curve provides the maximum expected

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Plum 360 Infuser

delivery rate error over a 5 minute interval, the lower curve provides
the minimum expected delivery rate error over a 5 minute interval.
An example would be Dopamine administered at 5 µgm/kg/min.
At 5 minutes, the average drug delivery error would be within the
range of +2.8% and –0.5% of the expected nominal rate.

2
1.8 1 mL/hr, 0 mm Hg DELIVERY HEAD, START UP
1.6
1.4 (Typical)
Rate (mL/hr)

1.2
1
0.8
0.6
0.4
0.2
0
-0.2
-0.4
0 20 40 60 80 100 120
Time (minutes)
Actual Rate Programmed Rate

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Plum 360 Infuser

2
1.8 1 mL/hr, 0 mm Hg DELIVERY HEAD, 48 HOURS
1.6
1.4 (Typical)
Rate(mL/hr)

1.2
1
0.8
0.6
0.4
0.2
0
-0.2
-0.4
2820 2830 2840 2850 2860 2870 2880
Time (minutes)
Actual Rate Programmed Rate

15
1 mL/hr, 0 mm Hg DELIVERY HEAD,48 HOURS
10
(Typical)
Percent Error (%)

-5

-10

-15
0 5 10 15 20 25 30
KďƐĞƌǀĂƟŽŶ Interval (minutes)
Maximum (%) Minimum (%) Mean(%)

15
1 mL/hr, 0 mm Hg DELIVERY HEAD, 48 HOURS
10
(Composite of 18 Pumps)
Percent Error (%)

-5

-10

-15
0 5 10 15 20 25 30
KďƐĞƌǀĂƟŽŶ Interval (minutes)
Maximum (%) Minimum (%) Mean(%)

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50
45
40
25 mL/hr, 0 mm Hg DELIVERY HEAD, START UP
35 (Typical)
Rate (mL/hr)
30
25
20
15
10
5
0
-5
-10
0 20 40 60 80 100 120
Time (minutes)
Actual Rate Programmed Rate

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Notes

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Section 12
Supplies and Accessories
Administration Sets
The following is a representative list of administration sets that are
available for use with the Plum 360 infuser. Some administration sets
may not be available in your region. For information about additional
compatible administration sets, contact your local sales
representative.

CE Marked Administration Sets

Primary I.V. PlumSets

List
Description
Number

12193 Primary PlumSet™, 2 Clave™ Multiport Connector, 15 Micron

Filter, Clave Port, Clave Y-Site, PE Lined Light Resistant
Tubing, 20 drops/mL, 213 cm
12194 Primary PlumSet, 2 Clave Multiport Connector, 15 Micron
Filter, Clave Port, Clave Y-Site, PE Lined Tubing,
20 drops/mL, 213 cm
12195 Primary PlumSet, 4 Clave Multiport Connector, 15 Micron
Filter, Clave Port, Clave Y-Site, PE Lined Light Resistant
Tubing, 20 drops/mL, 216 cm
12196 Primary PlumSet, 4 Clave Multiport Connector, 15 Micron
Filter, Clave Port, Clave Y-Site, PE Lined Tubing,
20 drops/mL, 216 cm
14000 Primary PlumSet, 15 Micron Filter in Sight Chamber, Capped
Port, Prepierced Y-Site, 20 drops/mL, 272 cm
14001 Primary PlumSet, 15 Micron Filter in Sight Chamber, Clave
Port, Clave Y-Site, 20 drops/mL, 272 cm

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Plum 360 Infuser

List
Description
Number

14006 Primary PlumSet, 15 Micron Filter in Sight Chamber, Capped

Port, PE Lined Light Resistant Tubing, Distal Microbore
Tubing, 20 drops/mL, 272 cm

Secondary I.V. Set

List
Description
Number

14028 Secondary Set, 15 Micron Filter in Sight Chamber,

20 drops/mL, 86 cm

Burettes

List
Description
Number

14003 Plum 150 mL Burette Set, Prepierced Additive Port, 15

Micron Filter in Sight Chamber, Prepierced Secondary Port,
2 Prepierced Y-Sites, 20 drops/mL, 290 cm
12564 Plum 150 mL Burette Set, Clave Additive Port, 15 Micron
Filter in Sight Chamber, 2 Clave Y-Sites, 20 drops/mL,
290 cm

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Blood Sets

List
Description
Number

14211 Plum Blood Set, 200 Micron Filter, Prepierced Secondary

Port, 20 drops/mL, 279 cm
14212 Plum Blood Set Y-Type, 200 Micron Filter, Clave Secondary
Port, 20 drops/mL, 279 cm

Enteral Sets

List
Description
Number

14025 Enteral PlumSet, Integral Container, Enteral Catheter

Adapter, 20 drops/mL, 264 cm
14259 Primary Enteral PlumSet, 40mm Screw Cap, Enteral Catheter
Adapter, 20 drops/mL, 249 cm

Non-CE Marked Administration Sets

Primary I.V. PlumSets

List
Description
Number

14243 Primary PlumSet, Capped Port, 2 Clave Y-Sites,

15 drops/mL, 104 Inch
14247 Primary PlumSet, Capped Port, Clave Y-Site, Distal
Microbore Tubing, 15 drops/mL, 104 Inch
14254 Primary PlumSet, Clave Port, 2 Clave Y-Sites, 0.2 Micron
Filter, 15 drops/mL, 112 Inch
14687 Primary PlumSet, Clave Port, Clave Y-Site, 15 drops/mL,
103 inch

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Secondary I.V. Set

List
Description
Number

14230 Secondary Set, Macrobore, Extension Hook, 15 drops/mL,

34 Inch

Burettes

List
Description
Number

11948 Burette PlumSet, Capped Port, Microdrip 150 mL Burette,

Clave Additive Port, Capped Secondary Port, 2 Clave Y-sites,
60 drops/mL, 124 inch Clave
14271 Burette PlumSet, Microdrip 150 mL Burette, Clave Additive
Port, Clave Secondary Port, 0.2 Micron Filter, 3 Clave
Y-Sites, 60 drops/mL, 140 Inch
14272 Burette PlumSet, Microdrip 150 mL Burette, Prepierced
Additive Port, Prepierced Secondary Port, 2 Prepierced
Y-Sites, 60 drops/mL, 114 Inch

Blood Sets

List
Description
Number

14211 Primary Plum Blood Set, Clave Secondary Port, 200 Micron
Filter, Secure Lock, 110 Inch
14212 Plum Y-Type Blood Set, 200 Micron Filter, Clave Port,
20 drops/mL, 110 Inch
14220 Plum Y-Type Blood Set, 200 Micron Filter, Clave Port, Clave
Y-Site, 20 drops/mL, 110 Inch

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Enteral Sets

List
Description
Number

14257 Primary Enteral PlumSet, Enteral Adapter, 15 drops/mL,

98 Inch
14258 Primary Enteral PlumSet, 40 mm Screw Cap, Enteral
Adapter, 15 drops/mL, 98 Inch
14260 Primary Enteral PlumSet, Integral Container, Enteral Adapter,
15 drops/mL, 103 Inch

For Epidural Administration

List
Description
Number

14261 Primary PlumSet, Yellow Striped Tubing, Distal Microbore

Tubing, 15 drops/mL, 107 Inch

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Administration Fluids
The Plum 360 infuser is intended for parenteral, enteral, and epidural
therapies and the administration of whole blood and blood products.

Containers
The Plum 360 infuser and its compatible administration sets support
a wide variety of containers, including:
• Dual Chamber Parenteral flexible container (Nutrimix™)
• Large Volume Parenteral flexible plastic containers
• Large Volume Parenteral glass containers
• Part Fill Parenteral flexible plastic containers,
including ADD-Vantage™
• Part Fill Parenteral glass containers
• Small Volume Parenterals
• Syringes - minimum 3 mL, maximum 60 mL
(Small volume syringes, i.e., 3-10 mL, require a vented syringe
adapter to ensure delivery accuracy and reduce proximal
occlusion alarms.)
• Top Filled Enteral bags
• Ready-to-Hang Enteral solution containers

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Plum 360 Infuser

Accessories
The Plum 360 infuser is compatible with the types of accessories
presented in the table below and in the explanatory sections that
follow it.

NOTE: Contact your local ICU Medical representative for accessories

available in your area. Not all accessories are CE marked.

List Number Description

13852 Nurse Call Cable

13853 Mini Pole

Tandem Carrier
The Tandem Carrier has been tested for stability requirements
of IEC 60601-1:2012 using List Number 39001 I.V. Pole with locking
casters. The Tandem Carrier can be used in mobile and non-mobile
situations. Follow these directions to ensure stability in mobile use.

1. Obtain an I.V. Pole (six wheel type with six locking casters) to
mount the Tandem Carrier.

2. Rotate the carrier clamp wheel to open the clamp sufficiently

to be able to slide the carrier onto the I.V. Pole.

3. Prevent the I.V. Pole from moving while sliding the carrier onto
the I.V. Pole.

4. Choose a mounting position for the carrier that is NOT GREATER

than the maximum allowed mounting height as shown in the
picture.

5. Tighten the carrier clamp so that it grips the pole firmly.

6. Pull downward on the carrier. Confirm that the carrier does not
slide down the pole.

7. Attach an infuser to each arm of the carrier.

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Plum 360 Infuser

8. Check the I.V. Pole and Carrier assembly for stability and tight
mounting connections. If the assembly is NOT STABLE, check
the mounting height of the Tandem Carrier and the extension
height of the I.V. Pole. Adjust those settings until the
assembly is stable.

Do Not extend pole

greater than 68 Inches
(172 cm) from the
floor. Do Not mount bar
higher than 40 Inches
(102 cm) from the
floor.

The Tandem Carrier/I.V. Pole system was tested to a maximum

mobile load of 23.3 kilograms using 4 one-liter I.V. bags at a height
of 68 inches (172 cm) and the Carrier mounted 40 inches (102 cm)
above the floor. Those values represent the maximum settings
for the system to comply with the mobile stability requirements
of IEC 60601-1:2012.

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Plum 360 Infuser

Multiple Device Adapter

The Multi-device Adapter (MDA) has been tested for stability
according to the requirements of IEC 60601-1:2012 using List
Number 39001 I.V. Pole with locking casters. The MDA may only be
used in non-mobile situations. Follow these directions to ensure
stability in non-mobile use.

1. Obtain an I.V. Pole (six wheel type with six locking casters) to
mount the MDA.

2. For the upper and lower I.V. Pole clamp pieces: Loosen and
remove the two screws that hold the semi-circular clamp pieces
together. (Each screw has a lock washer. Use care to not lose
the lock washer.)

3. Prevent the I.V. Pole from moving while attaching each clamp
to the I.V. Pole shaft.

4. Mount the accessory as shown in the picture. Ensure that the

upper mounting block recess rests on the I.V. Pole clamp collar.

5. Tighten the MDA clamps so that they grip the pole firmly.

6. Pull downward on the MDA. Confirm that the MDA does not slide
down the pole.

7. Attach infusers to each arm of the MDA. Balance the loading

of infusers. For example, if mounting three infusers, do not
mount all three infusers on one side of the MDA, mount two
infusers on one side of the MDA and the remaining infuser
on the other side of the MDA.

8. Check the I.V. Pole and MDA/Infuser assembly for stability and
tight mounting connections. If the assembly is NOT STABLE,
check the infusers mounting position(s) on the MDA and
the extension height of the I.V. Pole. Adjust those settings
until the assembly is stable.

System Operating Manual 12-9

IFU0000140.book Page 10 Tuesday, April 28, 2020 3:13 PM

Plum 360 Infuser

Position top bracket

slot to fit around knob
and recess in upper
Do Not extend pole
mounting block to rest
greater than 72 Inches
on collar of IV Pole
(183 cm) from the
clamp.
floor.

The MDA/I.V. Pole system was tested to a maximum non-mobile load

of 49.5 kilograms using 6 Plum Infusers and 12 one-liter I.V. bags
at a height of 72 inches (183 cm) above the floor. Those values
represent the maximum settings for the system to comply with the
non-mobile stability requirements of IEC 60601-1:2012.

12-10 System Operating Manual

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Plum 360 Infuser

I.V. Pole
An I.V. Pole with locking casters has been tested for stability
according to the requirements of IEC 60601-1:2012. The I.V. Pole can
be used in mobile and non-mobile situations. Follow these directions
to ensure stability in mobile use.
• For Mobile Use, the I.V. Pole may not have more than three (3)
infusers mounted to the pole, may not be extended higher than
68 inches from the floor, and not have more than 2000 mL
of solution hanging from the I.V. Pole hangers. See the illustration
on page 12-12 for the allowable positions of the infusers.
• For Mobile Use, the I.V. Pole may also accept the Tandem
Carrier accessory. See Tandem Carrier on page 12-7.
• For Non-mobile Use, the I.V. Pole can accept the Multi Device
Adapter (MDA). See Multiple Device Adapter on page 12-9.
• After mounting infusers, check the I.V. Pole/infusers assembly for
stability and tight mounting connections. If the assembly is NOT
STABLE, check the mounting heights and the extension
height of the I.V. Pole. Adjust those settings until the
assembly is stable.

The Infuser/I.V. Pole system was tested to a maximum mobile load

of 24.0 kilograms using 2 one-liter I.V. bags at a height of 68 inches
(173 cm) and the infusers mounted at 50, 40, and 30 inches
(127, 102, and 76 cm) above the floor. Those values represent the
maximum settings for the system to comply with the mobile stability
requirements of IEC 60601-1:2012.

System Operating Manual 12-11

 ole with multiple infusers

12-12
Plum 360 Infuser

WARNING: CLOSE ALL CLAMPS BEFORE OPENING DOOR

AUDIO PAUSED

CLOSE
LEVER
WHEN
NOT
IN A B
USE

Infuser 3 0 Rate 0
68 Inches (173 cm)
mL/hr
0 Vol Inf 0
mL
DDL
Select Line A/B to program
Back Settings /
Prime
A B Vols / CCA
maximum
abc def
START

ghi jkl mno

STOP

pqrs tuv wxyz

AC ON

ON OFF CLEAR LOCK KEYPAD

Follow instructions for use. The System Operating Manual

contains proper use, warnings, and cautions.

WARNING: CLOSE ALL CLAMPS BEFORE OPENING DOOR WARNING: CLOSE ALL CLAMPS BEFORE OPENING DOOR WARNING: CLOSE ALL CLAMPS BEFORE OPENING DOOR
AUDIO PAUSED AUDIO PAUSED AUDIO PAUSED

CLOSE CLOSE CLOSE

LEVER LEVER LEVER
WHEN WHEN WHEN
NOT NOT NOT
IN A B IN A B IN A B
USE USE USE
Infuser 1 Infuser 1 Infuser 1
IFU0000140.book Page 12 Tuesday, April 28, 2020 3:13 PM

0 Rate 0 0 Rate 0 0 Rate 0

mL/hr mL/hr mL/hr
0 Vol Inf 0 0 Vol Inf 0 0 Vol Inf 0
mL mL mL
DDL DDL DDL
Select Line A/B to program Select Line A/B to program Select Line A/B to program
Back Settings / Back Settings / Back Settings /
Prime
A B Vols / CCA Prime
A B Vols / CCA Prime
A B Vols / CCA
50 Inches
abc def abc def abc def
START START START

ghi jkl mno ghi jkl mno ghi jkl mno

STOP STOP STOP
(127 cm) AC ON
pqrs tuv wxyz
AC ON
pqrs tuv wxyz
AC ON
pqrs tuv wxyz

ON OFF CLEAR LOCK KEYPAD ON OFF CLEAR LOCK KEYPAD ON OFF CLEAR LOCK KEYPAD

Follow instructions for use. The System Operating Manual Follow instructions for use. The System Operating Manual Follow instructions for use. The System Operating Manual
contains proper use, warnings, and cautions. contains proper use, warnings, and cautions. contains proper use, warnings, and cautions.

WARNING: CLOSE ALL CLAMPS BEFORE OPENING DOOR WARNING: CLOSE ALL CLAMPS BEFORE OPENING DOOR
AUDIO PAUSED AUDIO PAUSED

CLOSE CLOSE
LEVER LEVER
WHEN WHEN
NOT NOT
IN A B IN A B
USE USE

Infuser 2 0 Rate
mL/hr
0
Infuser 2 0 Rate
mL/hr
0
0 Vol Inf 0 0 Vol Inf 0
mL mL
DDL DDL
Select Line A/B to program Select Line A/B to program
Back Settings / Back Settings /
Prime
A B Vols / CCA Prime
A B Vols / CCA

40 Inches START
abc def
START
abc def

ghi jkl mno ghi jkl mno

STOP STOP

pqrs tuv wxyz pqrs tuv wxyz

AC ON AC ON
(102 cm) ON OFF CLEAR LOCK KEYPAD ON OFF CLEAR LOCK KEYPAD

Follow instructions for use. The System Operating Manual Follow instructions for use. The System Operating Manual
contains proper use, warnings, and cautions. contains proper use, warnings, and cautions.

30 Inches
(76 cm)

System Operating Manual

IFU0000140.book Page 13 Tuesday, April 28, 2020 3:13 PM

Plum 360 Infuser

T-bar Accessory
The T-bar Accessory (T-BA) can be mounted to an I.V. Pole as shown
in the diagram below. It can be used in mobile and non-mobile
situations.

1. Obtain an I.V. Pole (six wheel type with six locking casters) to
mount the T-BA.

2. Rotate the T-BA clamp wheel to open the clamp sufficiently

to be able to slide the T-BA onto the I.V. Pole.

3. Prevent the I.V. Pole from moving while sliding the T-BA onto
the I.V. Pole.

4. Choose a mounting position for the upper T-BA that is NOT

GREATER than the maximum allowed mounting height
as shown in the picture.

5. Tighten the T-BA clamp so that it grips the pole firmly.

6. Pull downward on the T-BA. Confirm that the T-BA does not slide
down the pole.

7. Attach the desired container or hanging style component

to the T-BA.

8. Check the I.V. Pole and T-BA for stability and tight mounting
connections.

9. Repeat the mounting steps for the lower T-BA. It can be mounted
anywhere below the upper T-BA.

System Operating Manual 12-13

IFU0000140.book Page 14 Tuesday, April 28, 2020 3:13 PM

Plum 360 Infuser

Maximum extension
height -72 Inches (183 cm)

Maximum mounting
height -0 Inches
(127 cm)

12-14 System Operating Manual

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Plum 360 Infuser

I.V. Mini-Pole
The I.V. Mini-Pole (MP) mounts to the rear pole clamp frame of the
Plum 360 infuser as shown in the diagram below. It can be used
in mobile and non-mobile situations.

1. Remove the Locking Clip from the pole shaft.

2. Slide the two shafts of the mini-pole into the two holes in the
infuser pole clamp.

3. Adjust the pole to the desired height.

4. Push the locking clip through the shaft hole.

5. Confirm that the Mini-Pole is secure in the infuser pole clamp.

To remove the MP:

1. Remove the locking clip.

2. Rotate the clutch handle to lessen the spring grip of the MP.

3. Pull up on the MP and pull it out of the pole clamp.

CLUTCH HOUSING

CLUTCH SPRING

BAG HANGER

POLE CLAMP
EXTRUSION

HAIRPIN CLIP

System Operating Manual 12-15

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Plum 360 Infuser

ICU Medical MedNet Safety Software

ICU Medical MedNet is a server-based safety software application
that manages infusion information across ICU Medical infusion
platforms including the Plum 360, Plum A+, and LifeCare PCA™
systems. ICU Medical MedNet software facilitates networked
communication between the server and ICU Medical MedNet-
compatible infusers.
ICU Medical MedNet safety software facilitates best practices
to streamline clinical workflows.
• Pharmacy-validated I.V. administration protocols are available
to clinicians at the point of care
• Upper and lower dosing limits help protect against infusion errors
• Hard and soft limits create a clinically acceptable range to guide
clinicians based on hospital and clinical care area practices
ICU Medical MedNet safety software delivers standard performance
reports that enable hospital staff to:
• Assess medication infusion practices in the hospital
• Track clinician drug library utilization or compliance
• Identify I.V. administration practices that can be improved
• Highlight medication use to simplify the drug library
• Identify management issues that can be altered to save costs
• Assess rule set (hard/soft limits) alignment with clinical practice
ICU Medical MedNet software is a modular system capable of
managing system users, infusers, drug libraries, clinical care areas,
I.V. medication rule sets, infuser software updates, as well as system
and infuser configurations.

12-16 System Operating Manual

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Plum 360 Infuser

ICU Medical MedNet software can also be integrated with third-party

applications to provide I.V. Clinical Integration, which connects
pharmacy validated medication orders with the I.V. infuser, the patient
and the patient's electronic medical record (EMR). Other third party
applications enable additional functions such as infuser asset
management and tracking, and infuser alarm forwarding.
Contact your ICU Medical sales representative for ordering and
implementation information.

Loss of Communication
If the Plum 360 infuser loses communication with ICU Medical
MedNet software, it will continue to infuse without interruption.
However, log content and status will not be sent and auto-programs
and software/drug library updates will not be received until
communication is restored.

System Operating Manual 12-17

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Plum 360 Infuser

Notes

12-18 System Operating Manual

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Plum 360 Infuser

Section 13
Warranty
Subject to the terms and conditions herein, ICU Medical, Inc., herein
referred to as ICU Medical, warrants that (a) the product shall
conform to ICU Medical's standard specifications and be free from
defects in material and workmanship under normal use and service
for a period of one year after purchase, and (b) the replaceable
battery shall be free from defects in material and workmanship under
normal use and service for a period of 90 days after purchase. ICU
Medical makes no other warranties, express or implied, as to
merchantability, fitness for a particular purpose, or any other matter.
Purchaser's exclusive remedy shall be, at ICU Medical's option, the
repair or replacement of the product. In no event shall ICU Medical's
liability arising out of any cause whatsoever (whether such cause be
based in contract, negligence, strict liability, other tort, or otherwise)
exceed the price of such product, and in no event shall ICU Medical
be liable for incidental, consequential, or special damages or losses
or for lost business, revenues, or profits. Warranty product returned to
ICU Medical must be properly packaged and sent freight prepaid.
The foregoing warranty shall be void in the event the product has
been misused, damaged, altered, or used other than in accordance
with product manuals so as, in ICU Medical's judgment, to affect its
stability or reliability, or in the event the serial number or lot number
has been altered, effaced, or removed.
The foregoing warranty shall also be void in the event any person,
including the Purchaser, performs or attempts to perform any major
repair or other service on the product without having been trained by
an authorized representative of ICU Medical and using ICU Medical
documentation and approved spare parts. For purposes of the
preceding sentence, “major repair or other service” means any repair
or service other than the replacement of accessory items such as
batteries and detachable mains power cords.

System Operating Manual 13-1

IFU0000140.book Page 2 Tuesday, April 28, 2020 3:13 PM

Plum 360 Infuser

However, the foregoing warranty also shall be voided if any person,

including the Purchaser, uses other than ICU Medical-approved
spare parts for replacement of batteries.
In providing any parts for repair or service of the product, ICU Medical
shall have no responsibility or liability for the actions or inactions of
the person performing such repair or service, regardless of whether
such person has been trained to perform such repair or service. It is
understood and acknowledged that any person other than an ICU
Medical representative performing repair or service is not an
authorized agent of ICU Medical.

13-2 System Operating Manual

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Plum 360 Infuser

Section 14
CCAs and Drug Libraries
Plum 360 infuser programming is based on the concepts of a Clinical
Care Area (CCA) with a Drug Library and infuser settings that support
the needs of the CCAs patient population.
When ICU Medical MedNet software is installed, the infuser can
download multiple CCAs, each with its own Custom Drug Library
(CDL) and infuser settings.
When the Plum 360 infuser is used without ICU Medical MedNet
software, the infuser has a single default CCA with associated infuser
settings and a drug library. The CCA and the drug library are both
called the DDL (Default Drug Library).
This section describes how the DDL and Custom Drug Libraries work.
It also lists the Dosing Units that are available when programming
a delivery, the allowable input ranges for each dosing unit, and the
upper and lower limits that are enforced by the infuser when you
enter patient data while programming a delivery.

DDL CCA and Drug List

The DDL CCA includes an extensive list of commonly-infused drugs,
and a group of default infuser settings. It is only available if no custom
drug library has been installed on the infuser using ICU Medical
MedNet software.
If an infuser does not have ICU Medical MedNet software installed,
the DDL offers you the capability of programming the infuser without
using the drug list. You can program mL/hr dosing units in single step
(single rate) delivery. Alternatively, two delivery options – Loading
Dose and Multistep – offer multiple step (multiple rate) delivery.
These options enable you to program multiple steps and multiple
delivery rates, including mL/hr delivery, with a named drug.

System Operating Manual 14-1

IFU0000140.book Page 2 Tuesday, April 28, 2020 3:13 PM

Plum 360 Infuser

NOTE: Once a custom drug library has been installed, the DDL CCA
and its default drug list will no longer be available. To restore the
DDL, see the Plum 360 Infuser Technical Service Manual.

When you select a drug from the DDL during programming,

the selected drug appears on the delivery screen, allowing the clinical
team to see what drug is being delivered. In addition, you must select
a drug from the DDL to program any delivery type other than mL/hr.

Default Dosing Unit and Concentration

Each drug in the DDL has a preselected Default Dosing Unit based
on the manufacturer’s recommendations. This dosing unit is provided
for convenience and can be changed when you program a delivery.
In addition, if the drug is formulated as a concentration dissolved in
a diluent (mg/mL, for example), the DDL information includes
a Default Concentration, which can also be changed during
programming.

DDL Drug List

The following table lists the 113 drugs, including No Drug Selected,
in the DDL, with their assigned Default Dose Rate and Dose
Concentration. Use drug manufacturer recommendations for I.V.
administration when using the Plum 360 infuser.

NOTE: Capitalization and tall man lettering in Drug Names will differ
for software versions 15.1 and earlier.

14-2 System Operating Manual

IFU0000140.book Page 3 Tuesday, April 28, 2020 3:13 PM

Plum 360 Infuser

Default
Drug Name Dosing Units
Concentration

No Drug Selected mL/hr N/A

abciximab mcg/kg/min mg/mL
acetaminophen mg/hr mg/mL
acyclovir mL/hr N/A
albumin mL/hr N/A
aldesleukin mL/hr N/A
alteplase (rt-PA) mg/kg/hr mg/mL
aminophylline mg/hr mg/mL
amiodarone mg/min mg/mL
amiodarone-BOLUS mL/hr N/A
amphotericin B mg/kg/hr mg/mL
ampicillin mg/hr mg/mL
argatroban mcg/kg/min mg/mL
azithromycin mL/hr N/A
bevacizumab mg/kg mg/mL
bivalirudin mg/hr mg/mL
bleomycin mL/hr N/A
Blood Products mL/hr N/A
calcium gluconate mL/hr gms/mL
CARBOplatin mL/hr N/A
carmustine mg/m2 mg/mL

ceFAZolin mL/hr N/A

cefepime mL/hr N/A
cefoperazone mL/hr N/A

System Operating Manual 14-3

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Plum 360 Infuser

Default
Drug Name Dosing Units
Concentration

cefotaxime mL/hr N/A

cefTAZidime mL/hr N/A
cefTRIAXone mL/hr N/A
cetuximab 2
mg/m /hr mg/mL

ciprofloxacin mL/hr N/A

CISplatin mL/hr N/A
clindamycin mL/hr N/A
cyclophosphamide mL/hr N/A
cytarabine mL/hr N/A
dacarbazine mg/m2/min mg

dexamethasone mg/hr mg/mL

dexmedetomidine mcg/kg/hr mcg/mL
dilTIAZem mg/hr mg/mL
DOBUTamine mcg/kg/min mg/mL
DOCEtaxel mL/hr N/A
DOPamine mcg/kg/min mg/mL
DOXOrubicin mL/hr N/A
EPINEPHrine mcg/min mg/mL
epiRUBicin mg/m2/min mg/mL

epoprostenol ng/kg/min mg/mL

eptifibatide mcg/kg/min mg/mL
esmolol mcg/kg/min mg/mL
etoposide mL/hr N/A
famotidine mL/hr N/A
fentaNYL mL/hr N/A
fluconazole mL/hr N/A

14-4 System Operating Manual

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Plum 360 Infuser

Default
Drug Name Dosing Units
Concentration

flumazenil mL/hr N/A

folinic acid mg/m2 mg/mL

fosphenytoin mL/hr mg/mL

furosemide mL/hr N/A
gemcitabine mg/m2/min mg/mL

gentamicin mL/hr N/A

heparin units/hr units/mL
heparin wt-based units/kg/hr units/mL
HYDROmorphone mL/hr N/A
ifosfamide mL/hr N/A
immune globulin mL/hr N/A
InFLIXimab mL/hr mg/mL
insulin units/hr units/mL
irinotecan HCI mg/m2/min mg/mL

IV Maint Fluid mL/hr N/A

IV Maint Fluid w/KCl mL/hr N/A
labetalol mg/min mg/mL
lepirudin mg/kg/hr mg/mL
leucovorin mL/hr N/A
levETIRAcetam mL/hr mg/mL
levoFLOXacin mL/hr N/A
lidocaine mg/min grams/mL
LORazepam mL/hr N/A
magnesium grams/hr grams/mL
mannitol grams/hr grams/mL
mesna mL/hr N/A

System Operating Manual 14-5

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Plum 360 Infuser

Default
Drug Name Dosing Units
Concentration

methotrexate mL/hr N/A

methylPREDNISolone mg/kg/hr mg/mL
metoclopramide mL/hr N/A
metroNIDAZOLE mL/hr N/A
midazolam mL/hr N/A
milrinone mcg/kg/min mg/mL
mitoMYcin mg/m2 mg/mL

morphine mg/hr mg/mL

nafcillin mL/hr N/A
nitroglycerin mcg/min mg/mL
nitroprusside mcg/kg/min mg/mL
norepinephrine mcg/min mg/mL
ondansetron mL/hr N/A
oxacillin mL/hr N/A
oxaliplatin mg/m2/hr mg/mL

oxytocin mUn/min units/mL

PACLitaxel mL/hr N/A
pantoprazole mg/min mg/mL
penicillin mL/hr N/A
phenylephrine mcg/min mg/mL
piperacillin- mL/hr grams/mL
tazobactam
potassium mEq/hr mEq/mL
procainamide mg/min grams/mL
propofol mcg/kg/min mg/mL
raltitrexed mg/m2/min mg/mL

14-6 System Operating Manual

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Plum 360 Infuser

Default
Drug Name Dosing Units
Concentration

raNITIdine mL/hr N/A

riTUXimab mg/hr mg/mL
tobramycin mL/hr N/A
TPN mL/hr N/A
trastuzumab mg/kg mg/mL
urokinase mL/hr N/A
valproate sodium mL/hr mg/mL
vancomycin mL/hr N/A
vasopressin units/min units/mL
verapamil mL/hr N/A
vinBLAStine mg/m2 mg/mL

vinCRIStine mL/hr N/A

System Operating Manual 14-7

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Plum 360 Infuser

DDL CCA and Infuser Settings

When the infuser is operating under the DDL CCA, it has the
following CCA and infuser settings:

CCA Settings:
Maximum Rate: 999 mL/hr
Maximum VTBI (software versions 9999 mL
15.20 and later):
Maximum Patient Weight: 500 kg
Minimum Patient Weight: 0.1 kg
Maximum Patient Height: 305 cm
Minimum Patient Height: 7.5 cm
Maximum Patient BSA: 7.07 m2
Minimum Patient BSA: 0.012 m2
Default Distal Alarm Pressure: 6 psi (310 mmHg)
Distal Alarm Resets: 0
Allow Standby: Yes
Allow Delayed Start: Yes
Default End of Infusion: KVO
NOTE: For software version 15.11
and earlier, Default End of Infusion is
an Infuser Setting.

Infuser Settings:
Default B Delivery Mode: Piggyback
Default Nurse Callback: No
Maximum Standby Time: 72 hours

See Viewing CCA and Infuser Settings on page 3-31 for

descriptions of these settings.

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Plum 360 Infuser

Custom Drug Library (CDL)

ICU Medical MedNet safety software enables your facility to build
a custom list of CCAs. Each CCA has its own CDL, to incorporate
pharmacy-validated I.V. administration practices for each CCA’s
patient population.
Every drug in a CDL is assigned upper and lower dosing limits to help
protect against infusion errors. These dosing limits can be specified
as hard and soft limits, to create a clinically acceptable range for each
drug based on hospital and CCA practices.
• Soft limits trigger an alarm that can be overridden during
programming. When a soft limit is overridden, the delivery screen
displays one of these symbols next to the drug during delivery:

Upper Soft Limit Override

Lower Soft Limit Override

• A custom drug library may contain up to the following:

Clinical Care Areas (CCAs) 40

Medications per CCA 400

Total Medications 2,500a

a. Each drug counts only once, even when used in multiple CCAs

The hard and soft limits together comprise a Rule Set.

For software version 15.20 and later, a clinical advisory for a
medication may be defined in the drug library. This advisory will
display when the associated medication is selected while manually
programming the infuser and must be acknowledged before
programming can continue.
See the ICU Medical MedNet Meds Software User Guide for more
information about custom drug libraries and how to build them.

System Operating Manual 14-9

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Plum 360 Infuser

Dosing Units and Allowable Ranges

The following table lists the dosing units available with the Plum 360
infuser, the allowable input ranges, and the increment values for each
range.
When the infuser is operating under the DDL, the entire range
is available within each dosing unit, for every drug. When a custom
drug library is installed, the input ranges are determined by the hard
and soft limits assigned to each drug.

NOTE: Dosing units shown in bold italics are applicable to software

version 15.1 and later.

Category Dosing Units Range Increment

grams mcg, mg, g, mcg/min, mcg/hr, 0.001-9.999 0.001
mcg/day, mcg/kg, mcg/kg/min, 10.00-99.99 0.01
mcg/kg/hr, mcg/kg/day,
100-9999 1
mcg/m2, mcg/m2/min,
mcg/m2/hr, mcg/m2/day,
mg/min, mg/hr, mg/day,
mg/kg, mg/kg/min, mg/kg/hr, mg/
kg/day, mg/m2, mg/m2/min,
mg/m2/hr, mg/m2/day,
grams/min, grams/hr,
grams/day, grams/kg,
grams/kg/min, grams/kg/hr,
grams/kg/day, grams/m2, grams/
m2/hr, grams/m2/day,
grams/m2/min,
nanog, nanog/min, nanog/hr,
nanog/day, nanog/kg,
nanog/kg/min, nanog/kg/hr,
nanog/kg/day, nanog/m2,
nanog/m2/min,
nanog/m2/hr, nanog/m2/day

14-10 System Operating Manual

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Plum 360 Infuser

Category Dosing Units Range Increment

Liters 2 2
liters/m /day, liters/m /hr, 0.001-9.999 0.001
liters/m2/min 10.00-99.99 0.01
100-9999 1
mEq mEq, mEq/min, mEq/hr, 0.001-0.999 0.001
mEq/day, mEq/kg, mEq/kg/min, 1.00-9.99 0.01
mEq/kg/hr, mEq/kg/day,
10.0-99.9 0.1
mEq/m2, mEq/m2/min,
mEq/m2/hr, mEq/m2/day 100-9999 1

mL mL/hr 0.1-99.9 0.1

100-999 1
mL, mL/min, mL/kg, 0.001-9.999 0.001
mL/kg/min, mL/kg/hr, 10.00-99.99 0.01
mL/kg/day, mL/m2, mL/m2/hr,
100-9999 1
mL/m2/min, mL/m2/day
mmol mmol, mmol/min, mmol/hr, 0.001-0.999 0.001
mmol/day, mmol/kg, 1.00-9.99 0.01
mmol/kg/min, mmol/kg/hr, mmol/
10.0-99.9 0.1
kg/day, mmol/m2,
mmol/m2/min, mmol/m2/hr, 100-999 1
mmol/m2/day
Units milliUnits, milliUnits/min, 0.001-0.999 0.001
milliUnits/hr, milliUnits/day, 1.00-9.99 0.01
milliUnits/kg, milliUnits/kg/min,
milliUnits/kg/hr, 10.0-99.9 0.1
milliUnits/kg/day, 100- 1
milliUnits/m2, milliUnits/m2/min, 99999999
milliUnits/m2/hr,
milliUnits/m2/day
units, units/min, units/hr,
units/day, units/kg,
units/kg/min, units/kg/hr,
units/kg/day, units/m2,
units/m2/min, units/m2/hr,
units/m2/day

System Operating Manual 14-11

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Plum 360 Infuser

Category Dosing Units Range Increment

Million Million Units, Million Units/kg, 0.001-0.999 0.001
Units Million Units/kg/min, 1.00-9.99 0.01
Million Units/kg/hr,
Million Units/min, 10.0-99.9 0.1
Million Units/hr, 100-999 1
Million Units/m2,
Million Units/m2/min,
Million Units/m2/hr

Patient Data Limits

When you program a delivery for a weight-based dosage (mg/kg/hr,
for example), you must enter the patient’s weight.
When programming a BSA (Body Surface Area)-based delivery
(grams/m2/min, for example), you must enter either the patient’s
height and weight, or enter the BSA directly.

NOTE: If you enter the height and weight, the BSA is computed using
the DuBois method.

The following table shows the valid ranges for patient weight, height,
and BSA, and the increments for each range.

Patient Data Range Increment

Weight (kg) 0.100 to 9.999 0.001
10.00 to 99.99 0.01
100.0 to 500.0 0.1
Height (cm) 7.5 to 305.0 0.1
BSA (m2) 0.012 to 0.999 0.001
1.00 to 7.07 0.01

For more information about dose calculations, see Programming on

page 5-1.

For more information about BSA-based deliveries, see Body Surface

Area (BSA) Dosing Unit on page 5-1.

14-12 System Operating Manual

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United States
For customer service, contact:
1-877-946-7747
For technical assistance, product return authorization, and to order parts or
manuals, contact ICU Medical Technical Support Center:
1-800-241-4002
Parts orders can be submitted by email:
TSC.Parts@icumed.com
or by fax:
1-408-284-7130
To review replacement parts lists, technical service manuals, and alternative
cleaning agents, or for additional technical resources, operating manuals, and
technical training courses, visit:
www.icumed.com
For inquiries on reprocessing (cleaning/disinfecting), email
Tech Support Client Solution Specialists at:
TSC.Support@icumed.com

Canada
For customer service, contact the Pump Repair Center:
1-866-488-6088
or by email:
canadapumpsupport@icumed.com
To order parts, contact Spare Parts Customer Service:
1-866-488-6088
or by email:
pumppartsservices@icumed.com

All Other Countries

For technical assistance, contact your local ICU Medical sales office.

CAUTION
FEDERAL (USA) LAW RESTRICTS THIS INFUSER TO SALE BY OR ON
THE ORDER OF A PHYSICIAN OR OTHER LICENSED PRACTITIONER.

WARNING
POSSIBLE EXPLOSION HAZARD EXISTS IF THE INFUSER IS USED
IN THE PRESENCE OF FLAMMABLE SUBSTANCES, INCLUDING
ANESTHETICS.
IFU0000140.book Page 2 Tuesday, April 28, 2020 3:13 PM

2797

ICU Medical B.V. ICU Medical, Inc.

EC REP 600 N. Field Drive
Hofspoor 3, 3994 VZ Houten,
Lake Forest, Illinois, 60045
The Netherlands USA

Australian Sponsor: ICU Medical Australia Pty Limited

Unit U, 10-16 South Street,
Rydalmere, NSW 2116
Australia