Hospira Plum 360 User manual

430-98340-001 (B, 2016-12)
For use with the following list numbers :
System Operating Manual
CE Marked 30010-27, 30011-27, 30012-27,
30010-54, 30011-54, 30012-54,
30010-57, 30011-57, 30012-57
Not CE Marked, not
available in Europe
30010-04, 30011-04, 30012-04,
30010-10, 30011-10, 30012-10,
30010-65, 30011-65, 30012-65
Australian Sponsor: Hospira Pty Ltd,
Melbourne VIC,
Australia,
Telephone: [phone]
TM
INFUS(5
T
M
Compatible with
Software
0086
EC REP
Hospira UK Limited
Horizon, Honey Lane
Hurley, Maidenhead, SL6 6RJ, UK
Hospira Inc.
275 N. Field Drive
Lake Forest, Illinois, 60045
USA

ii System Operating Manual
Notes

Plum 360 Infuser
System Operating Manual iii
Change History
Part Number Description of Change
430-98340-001
(A, 2016-10)
Initial Release
430-98340-001
(B, 2016-12)
Added “Expected Service Life” definition to
glossary in Section 1.
Updated “Battery Maintenance” in Section 10.
Updated “Battery Operation” and “Expected
Service Life” specifications in Section 11.

iv System Operating Manual
Notes

Plum 360 Infuser
System Operating Manual v
Contents
Section 1, Introduction . . . . . . . . . . . . . . . . . . . . 1-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
User Qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Illustrations, Screen Displays, and Software
Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Warnings, Cautions, and Guidelines . . . . . . . . . . . . . . . 1-11
General Warnings and Cautions . . . . . . . . . . . . . . . . . . 1-12
Piggyback, Concurrent, and Secondary Delivery
Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Guidelines When Opening the Cassette Door . . . . . . . 1-16
Administration Sets and Accessories Guidelines . . . . . 1-16
Precautions to Avoid Unintended Bolus . . . . . . . . . . . . 1-18
Guidelines to Avoid Air in the Patient Line . . . . . . . . . 1-19
Guidelines During Backpriming . . . . . . . . . . . . . . . . . . . 1-19
Battery Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
Guidelines During Cleaning . . . . . . . . . . . . . . . . . . . . . . 1-20
Artifacts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Interconnecting of Medical Equipment . . . . . . . . . . . . 1-22
Guidance on EMC Compatibility . . . . . . . . . . . . . . . . . . . . . 1-23
FCC Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
US FCC (Federal Communications Commission)
Statement (United States Only) . . . . . . . . . . . . . . . 1-24
FCC Interference Statement (United States Only) . . . . 1-24
Canadian Department of Communications Industry
Canada Notice (Canada Only). . . . . . . . . . . . . . . . . 1-25
Radio Frequency Exposure Statement . . . . . . . . . . . . . 1-25
FCC Rules, Part 15/Industry Canada . . . . . . . . . . . . . . . 1-25
R&TTE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26
RoHS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27

Includes Systems Compatible with Hospira MedNet
vi System Operating Manual
Taiwan NCC Warning Statement . . . . . . . . . . . . . . . . . .1-27
Suspected Cybersecurity Event or Threat . . . . . . . . . . . . . . .1-28
Section 2, Equipment Description. . . . . . . . . . . . .2-1
Keypad and Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Alphanumeric Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Numeric Keypad. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Operating Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
Display Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
CE Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
Pole Clamp, Potential Equalization Terminal, and
Power Cord. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Plum Administration Sets . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
The Plum Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Other Administration Set Features. . . . . . . . . . . . . . . . .2-18
Section 3, Basic Operations . . . . . . . . . . . . . . . . .3-1
Mounting the Infuser on an I.V. Pole . . . . . . . . . . . . . . . . . . .3-2
Mounting Multiple Infusers to an I.V. Pole . . . . . . . . . . .3-4
Attaching a Nurse Call Interface Cable . . . . . . . . . . . . . . . . .3-6
Opening the Cassette Door . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
Opening the Cassette Door Completely . . . . . . . . . . . . . . . . .3-8
Closing the Cassette Door . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10
Turning Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11
Turning Power Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12
Viewing the Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12
Using the Keypad and Controls . . . . . . . . . . . . . . . . . . . . . . .3-13
Using the Keypad to Enter Program Information . . . . .3-13
Silencing the Keypad. . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13
Locking and Unlocking the Keypad . . . . . . . . . . . . . . . .3-14
Using the Keypad to Search the Drug List. . . . . . . . . . .3-17
Working with Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18
Test the Alarm System. . . . . . . . . . . . . . . . . . . . . . . . . . .3-19
Responding to an Alarm . . . . . . . . . . . . . . . . . . . . . . . . .3-19
Adjusting the Audio Alarm Volume . . . . . . . . . . . . . . . .3-20

Plum 360 Infuser
System Operating Manual vii
Programming a Callback Alarm. . . . . . . . . . . . . . . . . . . 3-21
Restarting the Delivery Automatically After a Distal
Occlusion Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Stopping and Restarting a Delivery . . . . . . . . . . . . . . . . . . . 3-22
Clearing a Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24
Setting the Post Infusion Rate . . . . . . . . . . . . . . . . . . . . . . . 3-24
Post Infusion Rate (Loading Dose Delivery and
Multistep Delivery) . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
Viewing and Clearing the Volumes Infused. . . . . . . . . . . . . 3-26
Adjusting Display Lighting and Contrast . . . . . . . . . . . . . . . 3-28
Viewing CCA and Infuser Settings . . . . . . . . . . . . . . . . . . . . 3-29
CCA/Infuser Setting Descriptions . . . . . . . . . . . . . . . . . 3-31
Changing the Default Infuser Settings . . . . . . . . . . . . . 3-34
Setting the Distal Pressure Alarm Limit. . . . . . . . . . . . . . . . 3-34
Changing the Default Line B Delivery Mode . . . . . . . . . . . . 3-36
Section 4, Plum Administration Sets . . . . . . . . . . 4-1
Priming a Primary Administration Set . . . . . . . . . . . . . . . . . . 4-2
Loading a Cassette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Preparing a Secondary Delivery
from an Administration Set . . . . . . . . . . . . . . . . . . . . . . 4-10
Connecting a Secondary Line or Syringe . . . . . . . . . . . . . . . 4-13
Connecting to a Clave Port . . . . . . . . . . . . . . . . . . . . . . 4-14
Connecting to a Prepierced Port . . . . . . . . . . . . . . . . . . 4-16
Connecting to a Capped Port. . . . . . . . . . . . . . . . . . . . . 4-18
Priming the Syringe Adapter . . . . . . . . . . . . . . . . . . . . . 4-19
Preparing a Secondary Delivery
from a Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Backpriming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Preparing to Backprime . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
Backpriming Procedure . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
Discontinuing Electronic Flow Control and Setting
Gravity Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
Removing a Secondary Line or Syringe . . . . . . . . . . . . . . . . 4-27
Discontinuing Fluid Administration . . . . . . . . . . . . . . . . . . . 4-28
Changing Administration Sets . . . . . . . . . . . . . . . . . . . . . . . 4-29
Resolving a Distal Air-in-Line Alarm . . . . . . . . . . . . . . . . . . 4-30

Includes Systems Compatible with Hospira MedNet
viii System Operating Manual
Avoiding Unintended Bolus While Resolving a Distal
Occlusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-31
Section 5, Programming . . . . . . . . . . . . . . . . . . . .5-1
Programming Features Common
to the Default Drug Library
and Custom Drug Libraries . . . . . . . . . . . . . . . . . . . . . . . .5-1
Auto-Calculations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
Body Surface Area (BSA) Dosing Unit . . . . . . . . . . . . . . .5-1
Programming Line B . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Clearing Line Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Programming with a Default Drug Library . . . . . . . . . . . . . . .5-3
Programming Without a Drug List . . . . . . . . . . . . . . . . . .5-3
Programming with a Drug List. . . . . . . . . . . . . . . . . . . . . . . . .5-4
Programming with a Custom Drug Library . . . . . . . . . . . . . . .5-5
Hard Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
Soft Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
Programming Line B with Line A Programmed . . . . . . . .5-7
Changing a CCA from the Drug List Screen. . . . . . . . . . .5-7
Delaying a Line. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8
Putting a Line in Standby – A/B Delivery Screen . . . . . .5-8
Putting a Line in Standby – Confirmation Screen. . . . . .5-8
Putting a Line in Standby – Piggyback Mode . . . . . . . . .5-9
Canceling Standby – Piggyback Mode. . . . . . . . . . . . . . .5-9
Nurse Callback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9
Section 6, Auto-Programming . . . . . . . . . . . . . . .6-1
Auto-Programming the Plum 360 Infuser . . . . . . . . . . . . . . .6-2
Section 7, Additional Features . . . . . . . . . . . . . . .7-1
Delay a Line. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
Standby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
Put 1 or 2 Lines in Standby from the Delivery
Screen (Non-Piggyback). . . . . . . . . . . . . . . . . . . . . . .7-2
Cancel Standby for 1 or 2 Lines from the Delivery
Screen (Non-Piggyback) . . . . . . . . . . . . . . . . . . . . . .7-2

Plum 360 Infuser
System Operating Manual ix
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
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 . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Low Priority Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Line A Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
High Priority Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Medium Priority Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9

Includes Systems Compatible with Hospira MedNet
x System Operating Manual
Line B Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-11
High Priority Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-11
Medium Priority Alarms . . . . . . . . . . . . . . . . . . . . . . . . .9-14
Lines A and B Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-16
High Priority Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-16
Rejected Auto-Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-20
Partially Programmed Line . . . . . . . . . . . . . . . . . . . . . . .9-24
Invalid Titration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-24
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-5
VTBI Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6
Delivery Rate Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6
Air-in-Line Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6
Occlusion Alarm and Limits . . . . . . . . . . . . . . . . . . . . . . . . . .11-7
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