Hospira Plum A+, Plum A+3 User manual

System Operating Manual

For Infusion Systems with v11.6 Software

For use with Lists: 12391-04, 12618-04, 12348-04, & 11971-04

Back		A			B		Options/
Prime							Vol Inf

430-95215-003 (Rev. 10/05)

Change History

Change History

	Description of	Pages
Title	Change	Affected
430-95215-001	First Release	All
(Rev. 04/05)
430-95215-002	Second Release	All
(Rev. 07/05)	Added IEC/EN 60601-1	Section 1
	Information
430-95215-003	Third Release	All
(Rev. 10/05)

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Contents

1) DESCRIPTIVE INFORMATION. . . . . . . . . . . . . . . . 1-1

1.1 PRODUCT DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . 1-2 1.2 INDICATIONS FOR USE . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 user qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 1.3 CONVENTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 warnings, cautions, and notes . . . . . . . . . . . . . . . . . . 1-5 1.4 PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 artifacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 guidance on emc compatibility . . . . . . . . . . . . . . . . . . 1-7 healthcare professionals and patient related . . . . . . . 1-7 concurrent flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10 epidural administration . . . . . . . . . . . . . . . . . . . . . . 1-11 battery operation . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12 sets and accessories . . . . . . . . . . . . . . . . . . . . . . . . 1-12 backpriming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13 general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13 cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13

2) PRINCIPLES OF OPERATION . . . . . . . . . . . . . . . . 2-1

2.1 FEATURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 line programming options . . . . . . . . . . . . . . . . . . . . . 2-1 plumset capabilities . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 air management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 biomedical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 other features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

2.2 DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

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Contents

3) EQUIPMENT DESCRIPTION . . . . . . . . . . . . . . . . . 3-1

3.1 OPERATING KEYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2

3.2 INDICATORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5

3.3 REAR CASE CONTROLS . . . . . . . . . . . . . . . . . . . . . . . . .3-6

3.4 ADMINISTRATION SETS . . . . . . . . . . . . . . . . . . . . . . . . .3-8

preparing the administration set . . . . . . . . . . . . . . . . .3-8

priming the administration set . . . . . . . . . . . . . . . . . . .3-9

loading the cassette . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

preparing the secondary line . . . . . . . . . . . . . . . . . . 3-10

3.5 DISCONTINUING ELECTRONIC FLOW CONTROL & SETTING

GRAVITY FLOW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

3.6 DISCONTINUING FLUID ADMINISTRATION . . . . . . . . . . . .3-13

4) BASIC OPERATION . . . . . . . . . . . . . . . . . . . . . . . 4-1

4.1 GETTING STARTED . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1

unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1

tandem carrier instructions . . . . . . . . . . . . . . . . . . . . .4-2

system self-tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2

data retention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4

4.2 POWER ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4

4.3 SIMPLE DELIVERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6

4.4 TITRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

4.5 PIGGYBACK DELIVERY . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

4.6 CONCURRENT DELIVERY . . . . . . . . . . . . . . . . . . . . . . . 4-14

4.7 STOP AND START WITH ONLY 1 LINE PUMPING . . . . . . .4-17

4.8 STOP AND START WITH BOTH LINES PUMPING . . . . . . .4-18

4.9 BACKPRIMING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

4.10 CLEARING PROGRAM SETTINGS . . . . . . . . . . . . . . . . . 4-21

5) THERAPIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

5.1 DOSE CALC (MCG/KG/MIN ON A) . . . . . . . . . . . . . . . . . .5-2

5.2 DOSE CALC (MG/MIN ON B) . . . . . . . . . . . . . . . . . . . . . . 5-8

5.3 LOADING DOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14

5.4 MULTISTEP PROGRAMMING . . . . . . . . . . . . . . . . . . . . . 5-21

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6) ADDITIONAL FEATURES . . . . . . . . . . . . . . . . . . . 6-1

6.1 SIMPLE DELIVERY USING DRUG LIST . . . . . . . . . . . . . . 6-1

6.2 SIMPLE DELIVERY USING DELAYED START . . . . . . . . . . 6-4

6.3 PIGGYBACK WITH NURSE CALLBACK . . . . . . . . . . . . . . . 6-5

6.4 POSSIBLE NON-DELIVERY PROGRAMMED . . . . . . . . . . . 6-7

6.5 USING THE STANDBY FEATURE . . . . . . . . . . . . . . . . . . . 6-7

6.6 SELECT OPTION- VOLUMES INFUSED, PRESSURE/POST

INFUSION RATE, AND LIGHTING/CONTRAST . . . . . . . . . . 6-9

6.7 VARIABLE RATE CAP . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13

6.8 EXAMPLES OF AUTOMATIC CALCULATION . . . . . . . . . . 6-13

at startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13

while running (titration) . . . . . . . . . . . . . . . . . . . . . . 6-13

at KVO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14

7) ALARMS AND TROUBLESHOOTING . . . . . . . . . 7-1

7.1 WARNING MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 7.2 RESPONSE TO ALARMS . . . . . . . . . . . . . . . . . . . . . . . . 7-2 general alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3 line a alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5 line b alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7 malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

8) MAINTENANCE AND STORAGE . . . . . . . . . . . . . 8-1

8.1 CLEANING, MAINTENANCE, AND STORAGE . . . . . . . . . . . 8-1 cleaning and sanitizing . . . . . . . . . . . . . . . . . . . . . . . 8-1 battery maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

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Contents

9) SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . 9-1 physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1 electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1 vtbi range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2 environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2 delivery rate range . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2 air-in-line alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-3 occlusion alarm and limits . . . . . . . . . . . . . . . . . . . . .9-3 time to detect downstream occlusions . . . . . . . . . . . .9-4 bolus volume released after downstream occlusions are corrected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-4 delivery accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-4 enteral & high viscosity fluids effects. . . . . . . . . . . . . .9-5 trumpet curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-6 example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-6

10) SUPPLIES AND ACCESSORIES . . . . . . . . . . . . 10-1

10.1 ADMINISTRATION FLUIDS . . . . . . . . . . . . . . . . . . . . . . 10-1 administration fluids . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 enteral and high viscosity fluids . . . . . . . . . . . . . . . . 10-1 containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 10.2 ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2

11) WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1 12) DRUG LIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1

© Hospira, Inc.

All Rights Reserved

This document and the subject matter disclosed herein are proprietary information. Hospira retains all the exclusive rights of dissemination, reproduction, manufacture and sale. Any party using this document accepts it in confidence, and agrees not to duplicate it in whole or in part nor disclose it to others without the written consent of Hospira.

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1)Descriptive Information

NOTE: In this manual, references to Plum A+ apply to both systems unless otherwise noted.

Plum A+®

Lists # 12391-04 and 11971-04

Plum A+®3 Lists # 12618-04 and 12348-04

CAUTION: T H I S

DEVICE IS TO BE USED

WITH AN IV POLE WITH

A 6-WHEEL BASE AND

A SHELF.

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The Plum A+ and Plum A+3 Volumetric Infusion Systems are designed to meet the fluid delivery requirements of today’s evolving healthcare environments. Both are cassette based multifunction infusion systems. The Plum A+ allows two lines in and one line out while the Plum A+3 allows six lines in and three lines out. Each pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include:

•Standard Infusions

•Multistep Programming

•Loading Dose

•Dose Calculation

The Plum A+ and Plum A+3 are designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types.

Both are designed to be used in most areas of patient care, including, but not limited to:

•General Floor	•Labor/Delivery/	•Burn Unit
	Post Partum
•Medical/Surgical	•OR/Anesthesia	•Hemodialysis
•ICU/CCU	•Post Op/	•Oncology
	Recovery
•Pediatrics	•Cardiac Cath	•Mobile Intensive
	Lab	Care
•Neonatolgy	•Emergency	•Nutritional

1.1 Product Description

Each system includes a pumping module (hereafter called the infuser) and an assortment of disposable IV sets (hereafter called a set), optional accessories, and this operator’s manual.

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A computer dataport is also provided to interface with a host computer.

Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC Standards (e.g. IEC 60950 for data processing equipment and IEC 60601-1 for Medical Equipment). Furthermore, all configurations shall comply with the system standard IEC 60601- 1-1. 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 the system Standard IEC 60601-1-1. If in doubt, consult the technical service department or your local representative.

NOTE: Do not connect dataport while infusing.

1.2 Indications for Use

USER QUALIFICATION

The Plum A+ is intended for use 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 fluids and drugs and whole blood or red blood cell components. The training should emphasize preventing related IV complications, including appropriate precautions to prevent accidental infusion of air. The epidural route can be used to provide anesthesia or analgesia.

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WARNING

ADMINISTER ONLY ANESTHETICS/ANALGESICS APPROVED FOR EPIDURAL ADMINISTRATION (AS INDICATED OR ALLOWED BY THE DRUGS’ FDA APPROVED LABELING). EPIDURAL ADMINISTRATION OF DRUGS OTHER THAN THOSE INDICATED FOR EPIDURAL USE COULD RESULT IN SERIOUS INJURY TO THE PATIENT.

1.3 Conventions

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

CONVENTION	APPLICATION	EXAMPLE
Italic	Reference to a	(See Figure 3-1,
	section, figure, or	Priming
	table	Cassette)
	Function or mode	Primary Only:
	specific instructions	Attach an empty
		container.
[BRACKETED	Keys or buttons on	[START]
ALL CAPS]	the device are	or
	displayed in
	[BRACKETED ALL
	CAPS] or with a
	graphic.
[Italic]	Softkey Options	[Choose]
Initial Caps	Screen displays and	Therapy
lowercase	device labels (as	Dose Calculation
	appropriate)

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CONVENTION	APPLICATION	EXAMPLE
Bold	Emphasis	...sets are
		supplied Sterile
		and are for....

WARNINGS, CAUTIONS, AND NOTES

Alert messages used throughout this manual are described below. Pay particular attention to these messages.

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 USUALLY APPEARS IN FRONT OF A PROCEDURE OR STATEMENT. IT CONTAINS INFORMATION THAT COULD PREVENT IRREVERSIBLE PRODUCT DAMAGE OR HARDWARE FAILURE. FAILURE TO OBSERVE A CAUTION COULD RESULT IN SERIOUS PATIENT OR USER INJURY.

NOTE: A Note highlights information that helps explain a concept or procedure.

This symbol directs the user to consult accompanying documents.

NOTE: Figures are rendered as graphic representations to approximate the actual product. Therefore, figures may not exactly reflect the product.

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1.4 Precautions

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

For safe operation of the Plum A+, observe the following precautions and hazards.

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 A+ system is designed to operate normally in the presence of most encountered electromagnetic interference (EMI) conditions. In the event of extreme levels of interference, such as encountered next to an electrosurgical generator, it is possible that the normal operation of a sensor or microcomputer might be

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disrupted. Even in this event, the outcome would likely be a false alarm or detected system malfunction and would not result in a hazard to patient or operator.

•Use of radio frequency emitting devices such as cellular telephones and 2-way radios in close proximity of this device may affect its operation.

HEALTHCARE PROFESSIONALS AND PATIENT

RELATED

•Setting the primary rate greater than the secondary rate will result in a more rapid infusion of any residual secondary drug remaining in the line and the cassette.

•Consult drug labeling to confirm drug compatibility, concentration, delivery rates, and volumes are all suitable for secondary, concurrent and piggyback delivery modes.

•Arrange tubing, cords, and cables to minimize the risk of patient strangulation or entanglement.

•Before opening the door, close clamp on the primary line or remove the secondary container from the secondary port to prevent mixing of primary and secondary fluids.

•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. Single fault failure of certain electronic/motor control components would result in no more than 5 mL of unexpected fluid delivery.

•A small amount of fluid is expelled from the set (less than 0.05 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 overmedication of the patient.

•Before disconnecting a syringe from the cassette, pull up the plunger slightly to avoid spilling the fluid. For rigid containers, close the upper slide clamp, open the cassette door, then remove and invert the cassette (ports down).

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•Air bubbles may form distal to the cassette as result of normal out-gassing of dissolved air in the fluid. This may occur if chilled solution is in use, if the infuser is mounted significantly above the patient, or when using certain fluids known to routinely outgas. In these cases, an air eliminating filter may be used.

•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.

•In vitro studies have suggested that packed red blood cells with unusually high hematocrit be diluted with bloodcompatible fluids, such as 0.9% sodium chloride injection, to decrease hemolysis and increase flow rate.

•The screen displays the VTBI (volume to be infused) in integers when value is above 99.9. Any fraction of a milliliter delivered is not displayed, but is retained in memory.

•For Plum A+3 users, be aware that changing the weight on one device does NOT change the weight on the other two devices. Patient weight must be changed on each device when delivering weight-based therapy dependent on medication requirements.

CONCURRENT FLOW

GUIDELINES

When delivering short half-life critical drugs (see Critical Drugs, this section) using the Plum A+ in the 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 to 5 mL/hr the other infusion

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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.

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1) Descriptive Information

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 (LESS
THAN 6 MINUTES) CRITICAL	MAXIMUM RATE OF
DRUG INFUSION RATE	ACCOMPANYING INFUSION
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

CRITICAL DRUGS

Examples of drugs with a short half-life (approximately 6 minutes or less when given IV) include:

Dobutamine	Lidocaine
Dopamine	Nitroglycerin
Epinephrine	Nitroprusside
Epoprostenol	Norepinephrine
Esmolol	Oxytocin
Isoproterenol	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: This list of critical drugs is not intended to be allinclusive 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.

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EPIDURAL ADMINISTRATION

•Recommended use of the epidural route is to provide anesthesia or analgesia for periods up to 96 hours.

•This device can be used to administer only those anesthetics/analgesics approved for epidural administration (as indicated or allowed by the drugs’ FDA approved labeling). Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient.

•For epidural administration, the use of Hospira catheters, Plum sets without Y-sites, and "epidural" stickers indicating ongoing epidural administration are recommended.

•Administration of drugs via the epidural route should be limited to personnel familiar with associated techniques and patient management problems. Proper epidural placement of the catheter is essential since catheter migration could result in intravascular or intrathecal administration. Facilities practicing epidural administration must be equipped with resuscitative equipment, oxygen, naloxone, and other resuscitative drugs. Adequate monitoring equipment (e.g., Oximetry) is recommended for continuous monitoring of the patient during epidural administration. Patients must be observed frequently for side effects in a fully-equipped and staffed environment for at least 24 hours following completion of drug administration by the epidural route. DELAYED RESPIRATORY DEPRESSION FOLLOWING CONTINUOUS EPIDURAL ADMINISTRATION OF PRESERVATIVE-FREE MORPHINE SULFATE HAS BEEN REPORTED.

•The epidural space has 58 openings through which fluid can exit. Pressure buildup during administration is transient. However, if a large volume of fluid is administered over a short time period, the pressure will take longer to return to normal. If overdelivery occurs during administration, observe the patient closely for

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1) Descriptive Information

signs of spinal cord compression (disorientation, headache, transient neuralgias) and drug overdose.

BATTERY OPERATION

•Do not operate the Plum A+ on patients when the battery is removed. Use of a properly maintained and charged battery helps confirm proper operation.

•The battery may not be fully charged upon receipt. Connect the infuser to AC power for at least six hours.

•Use AC power whenever possible. Connect to AC power during storage to ensure a fully charged battery for emergencies. If quality earth grounding source is in doubt, use battery power.

•If the low-battery alarm sounds, connect the infuser to AC power immediately.

SETS AND ACCESSORIES

•Only compatible LifeCare Plum Sets can be used with the Plum A+. See individual set instructions for additional information.

•Administration sets should be changed per CDC guidelines or healthcare provider policy. Discard after use.

•LifeCare IV 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.

•When infusing at low delivery rates (5 mL/hr or less) the use of thick-walled microbore Plum sets is recommended. This will reduce the amount of the fluid bolus that may be delivered when a distal line occlusion is released.

•Syringes must be larger than 3 cc. Use syringe adapter (List 11986-48) when using syringes smaller than 10cc. Some 10cc syringes may require use of a syringe

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adapter. Syringes larger than 10cc may be attached directly to the secondary port of the cassette. Use of a syringe adapter may decrease the occurrence of proximal occlusion alarms.

•Use a 19-gauge or larger needle or catheter at the venipuncture site for viscous fluids if operating at rates greater than 500 ml/hr.

See Section 10 for information on sets and accessories.

BACKPRIMING

•Backpriming is not recommended for reconstituting secondary containers containing dry powders.

•To avoid pressurization when backpriming into a syringe, the user must confirm there is sufficient empty space to accept the backprimed fluid.

GENERAL

•Possible explosion hazard exists if used in the presence of flammable anesthetics.

•Do not place Plum A+ in service if it fails the self-test.

•Do not operate the Plum A+ with the case opened.

•Keep the cassette door securely closed while the infuser is not in use, to avoid cassette door damage.

•The Plum A+3 is to be used with an IV pole with a 6- wheel base and a shelf.

CLEANING

For more information on cleaning the infuser, see Section 8.

•To avoid mechanical or electronic damage, do not immerse the Plum A+ 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.

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1) Descriptive Information

Using abrasive cleaners or cleaning solutions not recommended by Hospira may result in product damage. Do not use compounds containing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride.

•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.

Use the following procedure to avoid the administration of a bolus following a distal occlusion (i.e., a closed distal clamp):

•If a secondary container is in use, clamp proximal tubing before opening cassette door.

•Open cassette door and remove the cassette.

•Open the flow regulator briefly to dissipate the pressure and then close it.

•Eliminate the source of occlusion (closed clamp).

•Reinsert the cassette and close the cassette door.

•Open all clamps and resume infusion.

NOTE: When troubleshooting an occlusion where all clamps are in the OPEN position, use care to avoid delivery of a bolus by opening the flow regulator to release any built-up pressure. Close the clamp between the cassette and the patient before opening the flow regulator to relieve the pressure. See Section 7, Alarms and Troubleshooting, for more information.

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2)Principles of Operation

2.1 Features

The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With it’s primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/ surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield® and CLAVE® needleless protection systems, makes the Plum A+ a convenient and cost-effective infusion system.

PROGRAMS

•Dose Calculation

•Loading Dose

•Multistep Programming

LINE PROGRAMMING OPTIONS

•Drug List

•Nurse Call Back

•Delayed Start Setting

•Concurrent delivery

•Titration

•Micro 0.1-99.9 mL/hr (in 0.1 mL increments) flow rate range for both lines

•Macro 100-999 mL/hr (in 1 mL increments) flow rate range for both lines

•Automated Secondary drug delivery (Piggyback)

•Standby Setting

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2- 2	2) Principles of Operation

PLUMSET CAPABILITIES

•Anti Free-Flow Protection

•Direct Connection for syringe delivery

AIR MANAGEMENT

•Air Trap

•Air Removal/Backpriming

•Air Detection-Proximal

•Air Detection-Distal

BATTERY

NOTE: The Plum A+3 utilizes three batteries.

•Battery Gauge

•Six Hour Battery Recharge Time

•Long battery life (6 hours) for emergency backup and temporary portable operation

BIOMEDICAL

•Serial Communication

•Upgradability (Fieldfor List 12391 only)

•Variable Rate Cap

•Alarm History

•Nurse Call Relay Connector

OPTIONS

•Volumes Infused (A, B, Total Volume)

•KVO at dose end (1 ml/hr or less depending on delivery rate) or Continue Rate (CR) to continue at the current rate

•Variable Distal Pressure Settings

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2- 3

OTHER FEATURES

•Nonpulsatile volumetric accuracy

•Microprocessor control

•Large liquid crystal display (LCD) screen

•Panel back illumination on mains power

•Lockout switch

•Standard syringe use

•Parenteral and nonparenteral (enteral) fluid delivery

•Blood and blood products delivery

•Wide range of Standard and Specialty administration sets

•Password protected keypad lock

2.2Definitions

	TERM	DEFINITION
	Administration	The sterile, disposable assembly with
	Set	flexible tubing that connects to a
		source fluid container for input to the
		Cassette pumping chamber and to
		some output device for administration
		to the patient.
	Alarm	A condition requiring operator
		intervention that invokes both audible
		and visible alarm indicators.
		Confirmation of the condition usually
		is required.
	Alert	While entering a program, a visual
		warning that informs the clinician of
		the violation of a hospital-defined rule
		set, e.g., a dose limit for a specific
		drug.

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2- 4		2) Principles of Operation
	TERM	DEFINITION
	Alternate Units	Dose Rate units that may be selected.
		Alternate Units are any units other than
		mL/hr.
	Alternate Units	Drug Amount, Diluent, Patient Weight
	Parameters	(if applicable), and Dose Rate.
	Backpressure	Resistance to fluid flow on the Distal or
		output portion of the Administration
		Set, usually expressed as mmHg.
	Backprime	Removal of air or fluid from the
		proximal tubing and Cassette air trap
		by rapid pumping of fluid from Line A
		to an output receptacle on Line B. No
		fluid delivered distal to the cassette
		during a Backprime.
	Basic Delivery	A single-step delivery specifying rate,
		VTBI, and duration only. Drug name
		may or may not be specified.
	Biomed Mode	The name for the non-delivery or
		service mode of Infuser operation.
	Bolus	A single uninterrupted discrete volume
		of fluid delivered over a discrete period
		of time.
	Cassette	A Hospira standard Plum Macro
		Cassette that contains the actual
		pumping chamber with inlet and outlet
		valves. It also contains access ports to
		diaphragms for proximal and distal line
		pressure sensing and chambers for air
		trapping and air quantity
		measurement.
	Caution	Contains information which could
		prevent hardware failure, irreversible
		damage to equipment, or loss of data.
	Channel	Distal Line output to the patient.

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Plum A+ Infusion Systems			2- 5
	TERM	DEFINITION
	Cleared	Same as Cleared Settings, but
	Program	restricted to the program delivery
		settings for an individual line.
	Cleared	Programmed delivery settings for both
	Settings	lines and the general control
		parameters are at their default values.
	Concentration	For Dose Calculation based Line A or B
		delivery programming of premixed
		drugs, the concentration consists of
		Drug Amount (in micrograms [mcg],
		milligrams [mg], grams,
		milliequivalents [mEq], millimols
		[mmols], or units [USP Units]) and
		Diluent (Volume in milliliters [mL]).
		Abbreviated on screen displays as
		“Conc”.
	Concurrent	Simultaneous delivery of two fluids at
	Delivery	independent flow rates.
	Concurrent	The Line B control selection mode that
	Mode	allows either Line A or Line B (or both)
		of the Mechanism to be programmed
		for delivery that completes with KVO or
		CR. Line A operation is unaffected by
		Line B delivery.
	Continue Rate	An option used to provide fluid
	(CR)	delivery at the current fluid delivery
		rate when the VTBI becomes zero.
	Default Drug	A drug list of 99 drug names, default
	Library (DDL)	units and default concentrations, plus
		‘No Drug Selected’.
	Deliver	A Biomed Delivery option setting,
	Together	which selects default of Piggyback or
		Concurrent delivery mode.

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2- 6		2) Principles of Operation
	TERM	DEFINITION
	Delivery Mode	The normal operational mode for the
		Infuser, either Concurrent or
		Piggyback, during which fluid delivery
		may occur.
	Delivery Rate	The delivery rate (as Volume/Time)
		assigned by the operator or calculated
		from other delivery parameters.
	Device	The Plum A+ IV Infusion Device
		(Infuser), not including the disposable
		administration sets.
	Diluent	The volume of fluid used with the
	(Volume)	Diluent Unit (e.g., 250 mL), which
		dilutes the drug to be infused.
	Distal	Downstream (output) from the
		Cassette portion of the Administration
		Set.
	Door	The lever-operated, bottom-hinged,
		Cassette holder on the front of the
		Mechanism.
	Dose (Rate)	Delivery rate times drug concentration.
	Dose	Allows programming Dose Rates in
	Calculation	alternative units of measure. Dose
		Calculation can be used in Simple
		Delivery, Loading Dose, and Multistep.
	Drug Amount	The mass or quantity of the drug
		premixed with a Diluent to express the
		Concentration for the Line being
		programmed.
	Duration	The time period used to deliver a VTBI
		at an existing Delivery Rate or as set by
		the operator.
	Enteral	Delivery via an intestinal route.

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Plum A+ Infusion Systems			2- 7
	TERM	DEFINITION
	Error	A condition resulting in an audible
		warning and often an accompanying
		message, such as an invalid key press,
		resulting from an operator attempt to
		make an input that is not valid for the
		current operational context. Not a
		Malfunction.
	Filling Head	The gravity induced Proximal Line
	Height (FHH)	pressure due to fluid height in source
		container above the Distal Line output
		level.
	Flow Rate	The resulting rate of fluid flow. (See
		Rate and Dose.)
	Fluid Delivery	The time required, measured from the
	Begin	initial start of a keypad press, for a
		digit in the third decimal place of a
		scale measuring grams to change
		when pumping water, the delivery tube
		is fluid filled, and the end of the
		delivery tube is immersed.
	Infuser	A Plum A+ device, not including the
		disposable administration set.
	Initialized	The plunger is in the Plunger Park
	Position	Position, and each valve is in the Valve
		Home Position.
	Key	Any of the marked locations on the
		front panels intended for user input via
		a pressing action.
	KVO	(Keep Vein Open) Internally selected
		minimal delivery rate, the lesser of 1.0
		mL/Hr or actual Rate, intended to
		provide sufficient fluid flow to
		decrease the potential for clotting at
		the IV infusion site.

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2- 8		2) Principles of Operation
	TERM	DEFINITION
	Line A	Inlet tubing on the top center of
		Cassette when viewed after it has been
		loaded in Mechanism Door.
	Line B	Inlet connector on the top right of
		Cassette when viewed after it has been
		loaded in Mechanism Door.
	Loading Dose	Allows programming of an initial
		infusion rate for a specific volume,
		followed automatically by a
		maintenance rate from the same
		container (e.g., a fluid challenge). If
		Dose Calc is used, the Loading Dose
		and Maintenance Dose are in the same
		unit of measure, over the same period
		of time (mcg/min), from the same
		container.
	Macro Cassette	The Plum Cassette as part of an
		Administration Set whose attainable
		delivery performance is for general
		purpose uses.
	Malfunction	One of a number of conditions that
		indicate a failure of the Infuser. These
		conditions usually require a repair
		action.
	Mechanism	The provider of the physical activities
		of: 1) valve control for Line selection
		and inlet to or outlet from the Cassette;
		2) Plunger extension and retraction for
		changing fluid volume of the Cassette
		pumping chamber.

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Plum A+ Infusion Systems			2- 9
	TERM	DEFINITION
	Multistep	Allows a sequential program to deliver
		up to 10 steps; fluid volumes and
		delivery rates may be programmed for
		each step. The program may be
		entered based on Rate and Volume or
		Volume and Time. If Dose Calc is used,
		the delivery steps are in the same unit
		of measure, over the same period of
		time, from the same container.
	Note	A Note explains something new, gives
		tips on performing an activity, or
		provides a reminder of necessary
		preparations.
	Parenteral	Delivery via other than an intestinal
		route, such as intravenous (IV)
		injection.
	Patient Weight	The Alternate Units Parameter whose
		value entry is required with Dose rates
		(quantity/time) having the third
		parameter of weight, such as mcg/kg/
		min.
	Piggyback	Infusion will stop Line A and infuse
	Delivery	Line B until VTBI completes.
	Piggyback	The Line B control selection mode that
	Mode	requires Line A delivery suspension
		while Line B delivers and then its
		resumption when Line B VTBI
		completes. If Line A is not programmed
		and started, Line B delivery just stops
		when its VTBI completes. Line A
		operation is delayed for duration of its
		interruption by Line B.
	Plunger Park	The position of the pumping plunger
	Position	that allows the cassette to be
		withdrawn from the Infuser without
		restriction, with an opened Door.

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2- 10		2) Principles of Operation
	TERM	DEFINITION
	POST	Power On Self Tests. Startup
		initialization and test of critical
		hardware modules and software
		functions, to determine Infuser
		readiness for its Intended Use.
	Power On	When the power is first applied to the
		Infuser processor. It occurs when
		Infuser is in the off condition and the
		AC power is applied or during battery
		operation when the ON/OFF key is
		pressed.
	Pressure	The measured fluid pressure for
		Proximal Line A, Proximal Line B, or
		the Distal line when a fully primed
		administration set is loaded into a
		Mechanism with the Cassette Door
		closed.
	Programs	A Concentration-based extension to
		basic Volume/Rate delivery for Dose
		Rate applications. Softkey-selected
		types are: 1) Standard Program for
		single rate delivery; 2) Loading Dose
		for up to two steps of delivery at
		differing rates; 3) Multistep for up to
		ten steps of delivery at differing rates.
		Loading Dose and Multistep include
		the basic Delivery Rate option.
	Protocol	In the medical field, hospital-approved
		procedures. For devices with an
		electronic communications interface,
		the format and content of messages
		being exchanged.
	Proximal	Upstream (input, as Line A and/or B)
		with respect to the Cassette portion of
		the Administration Set.
	Rate	See Delivery Rate

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