Abbott Plum A+ Operators Manual 1s3r1y

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System Operating Manual

3 For Infusion Systems with v11.6 Software For use with Lists: 12391-04,12618-04, 12348-04, & 11971-04

Back Prime

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Options/ Vol Inf

430-95215-003 (A, 08/08)

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Change History

Change History Description of Change

Pages Affected

430-95215-001 (Rev. 04/05)

First Release

All

430-95215-002 (Rev. 07/05)

Second Release Added IEC/EN 60601-1 Information

All Section 1

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

Third Release

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Title

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Plum A+ Infusion Systems

i

Contents 1) DESCRIPTIVE INFORMATION. . . . . . . . . . . . . . . . 1-1 1.1 PRODUCT DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . 1-2 1.2 INDICATIONS FOR USE . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 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 istration . . . . . . . . . . . . . . . . . . . . . . 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . line programming options . . . . . . . . . . . . . . . . . . . . . plumset capabilities . . . . . . . . . . . . . . . . . . . . . . . . . . air management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . biomedical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . other features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2 DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-1 2-1 2-1 2-2 2-2 2-2 2-2 2-2 2-3 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 ISTRATION SETS . . . . . . . . . . . . . . . . . . . . . . . . . 3-8 preparing the istration set . . . . . . . . . . . . . . . . . 3-8 priming the istration 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 ISTRATION . . . . . . . . . . . . 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 . . . . . . . . . . . . . . . . . . . . . . . . . . 7.2 RESPONSE TO ALARMS . . . . . . . . . . . . . . . . . . . . . . . . general alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . line a alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . line b alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7-1 7-2 7-3 7-5 7-7 7-8

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

8-1 8-1 8-3 8-4 8-4

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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 ISTRATION FLUIDS . . . . . . . . . . . . . . . . . . . . . . 10-1 istration 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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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: THIS DEVICE IS TO BE USED WITH AN IV POLE WITH A 6-WHEEL BASE AND A SHELF.

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1) Descriptive Information

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/ Post Partum

•Burn Unit

•Medical/Surgical

•OR/Anesthesia

•Hemodialysis

•ICU/CCU

•Post Op/ Recovery

•Oncology

•Pediatrics

•Cardiac Cath Lab

•Mobile Intensive Care

•Neonatolgy

•Emergency

•Nutritional

1.1 Product Description Each system includes a pumping module (hereafter called the inf) 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 606011-1. 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 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 inf and the istration 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 ISTER ONLY ANESTHETICS/ANALGESICS APPROVED FOR EPIDURAL ISTRATION (AS INDICATED OR ALLOWED BY THE DRUGS’ FDA APPROVED LABELING). EPIDURAL ISTRATION 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 section, figure, or table

(See Figure 3-1, Priming Cassette)

Function or mode specific instructions

Primary Only: Attach an empty container.

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

[START]

[BRACKETED ALL CAPS]

[Italic] Initial Caps lowercase

Softkey Options Screen displays and device labels (as appropriate)

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or

[Choose] Therapy Dose Calculation



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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 INJURY. NOTE: A Note highlights information that helps explain a concept or procedure. This symbol directs the 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 istered 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 inf 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-inline 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 s, 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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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 DRUG INFUSION RATE

MAXIMUM RATE OF 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 Dopamine Epinephrine Epoprostenol Esmolol Isoproterenol

Lidocaine Nitroglycerin Nitroprusside Norepinephrine Oxytocin 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 istration. 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 ISTRATION •

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

•

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

•

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

•

istration 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 istration. Facilities practicing epidural istration 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 istration. Patients must be observed frequently for side effects in a fully-equipped and staffed environment for at least 24 hours following completion of drug istration by the epidural route. DELAYED RESPIRATORY DEPRESSION FOLLOWING CONTINUOUS EPIDURAL ISTRATION OF PRESERVATIVE-FREE MORPHINE SULFATE HAS BEEN REPORTED.

•

The epidural space has 58 openings through which fluid can exit. Pressure buildup during istration is transient. However, if a large volume of fluid is istered over a short time period, the pressure will take longer to return to normal. If overdelivery occurs during istration, 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 inf 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 inf 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.

•

istration 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 istration of blood, blood products, emulsions, suspensions, or any medications not totally soluble in the solution being istered. These medications may be istered through the lower Yinjection 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 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 inf is not in use, to avoid cassette door damage.

•

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

CLEANING For more information on cleaning the inf, 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 inf.

•

Do not sterilize by heat, steam, ethylene oxide (ETO), or radiation.

•

To avoid inf 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 istration 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)

2- 1

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 istration 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) 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 (Field- for 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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OTHER FEATURES •

Nonpulsatile volumetric accuracy

•

Microprocessor control

•

Large liquid crystal display (LCD) screen

•

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 istration sets

•

protected keypad lock

2.2 Definitions TERM

DEFINITION

istration Set

The sterile, disposable assembly with flexible tubing that connects to a source fluid container for input to the Cassette pumping chamber and to some output device for istration 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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TERM

DEFINITION

Alternate Units

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

Alternate Units Parameters

Drug Amount, Diluent, Patient Weight (if applicable), and Dose Rate.

Backpressure

Resistance to fluid flow on the Distal or output portion of the istration 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 Inf 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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TERM

DEFINITION

Cleared Program

Same as Cleared Settings, but restricted to the program delivery settings for an individual line.

Cleared Settings

Programmed delivery settings for both 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 Delivery

Simultaneous delivery of two fluids at independent flow rates.

Concurrent Mode

The Line B control selection mode that 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 (CR)

An option used to provide fluid delivery at the current fluid delivery rate when the VTBI becomes zero.

Default Drug Library (DDL)

A drug list of 99 drug names, default units and default concentrations, plus ‘No Drug Selected’.

Deliver Together

A Biomed Delivery option setting, which selects default of Piggyback or Concurrent delivery mode.

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TERM

DEFINITION

Delivery Mode

The normal operational mode for the Inf, 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 (Inf), not including the disposable istration sets.

Diluent (Volume)

The volume of fluid used with the Diluent Unit (e.g., 250 mL), which dilutes the drug to be infused.

Distal

Downstream (output) from the Cassette portion of the istration Set.

Door

The lever-operated, bottom-hinged, Cassette holder on the front of the Mechanism.

Dose (Rate)

Delivery rate times drug concentration.

Dose Calculation

Allows programming Dose Rates in 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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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 Height (FHH)

The gravity induced Proximal Line 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 Begin

The time required, measured from the 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.

Inf

A Plum A+ device, not including the disposable istration set.

Initialized Position

The plunger is in the Plunger Park Position, and each valve is in the Valve Home Position.

Key

Any of the marked locations on the front s intended for 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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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 istration Set whose attainable delivery performance is for general purpose uses.

Malfunction

One of a number of conditions that indicate a failure of the Inf. 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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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 Delivery

Infusion will stop Line A and infuse Line B until VTBI completes.

Piggyback Mode

The Line B control selection mode that 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 Position

The position of the pumping plunger that allows the cassette to be withdrawn from the Inf without restriction, with an opened Door.

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TERM

DEFINITION

POST

Power On Self Tests. Startup initialization and test of critical hardware modules and software functions, to determine Inf readiness for its Intended Use.

Power On

When the power is first applied to the Inf processor. It occurs when Inf 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 istration 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 istration Set.

Rate

See Delivery Rate

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TERM

DEFINITION

Rounding

To round-off to the closest whole number (e.g., 25.5 would round to 26, but 25.4 would round to 25).

Screen

That active portion of the LCD assigned to a delivery or other interactive display operation.

Softkey

A front key whose function label is on the bottom portion of the display screen just above its location, so that label may be changed to indicate differing key functions within the operational context of the defined screens.

Standard Programming

(see Basic Delivery)

Standby

A delivery program state that resembles a delayed start for a line in all respects, but status display of STANDBY instead of DELAYED. A press of the START key (and a Start Softkey if necessary) will begin the programmed delivery.

System

The Plum A+ Inf system with its associated accessories and istration Sets.

Truncate

To round-down to the last whole number (e.g., 103.7 would be 103).

Units

A Drug Amount (without a quantity of mass referent) adopted as the United States Pharmacopoeia (USP) standard of measure for use in a Concentration.

VI

Volume Infused.

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TERM

DEFINITION

VTBI

Volume To Be Infused – The volume of fluid or IV solution (remaining) for delivery by a program or Therapy step from a Line.

Warning

Audible indication at the defined Warning sound level, often accompanied by a brief message, to advise operator that: 1. Input was attempt to use a function in wrong sequence, with wrong values, or at wrong time (resulting in an Invalid Key Warning); 2. Input was properly related to a function (resulting in a Valid Key Warning). (The Low Battery Warning is an exception, using the Alarm Indication sound level.)

Weight

The Alternate Units Parameter whose value entry is required with Alternate Units for Dose that include /kg/.

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3)

3- 1

Equipment Description Line B Flow Indicator

Line A Flow Indicator

LCD

Status Region

Status Region

Working Region

Working Region

Message Region Softkey Label Softkey Selector Start and Stop Keys Charging/ Line Indicator

Battery Charge Indicator

Message Region Back Prime

A

B

Options/ Vol Inf

Numeric Keys (Up/Left) Direction Keys (Down/ Right) Silence Key

ON/OFF Key Numeric Field Clear Key

Decimal Key

Basic Layout of Front Display and Keypad

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3- 2

3) Equipment Description

3.1 Operating Keys NOTE: For Plum A+3, all three pumps act as individual Plum A+’s.

The [ON/OFF] key is used to control the power of the Plum A+. NOTE: All deliveries must be stopped in order to turn the power off. NOTE: To confirm proper shutdown of inf, do not unplug until “double beep” is heard (approximately 5 seconds). If “double beep” is not heard, the inf will turn itself back ON sensing the AC power was lost and revert to battery back-up power.

The [START] key is used to begin infusion and as final confirmation of programming.

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3- 3

The [STOP] key is used to stop the current delivery on one line; used in conjunction with soft keys to stop delivery on both lines. The [SILENCE] key is used to silence an audible alarm during actions to correct its cause.

The [SELECT] keys (or ) are used to move the highlighting cursor between the programming fields.

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sec03.fm Page 4 Tuesday, September 9, 2008 10:37 AM

3- 4


The numeric keys are used to enter values for any highlighted field requiring numeric data. The [CLEAR] key will cause a highlighted numeric field to be cleared in preparation for data entry.

.

The [Decimal] key is used to manually enter numbers other than whole numbers (i.e., 1.2 mL). Softkeys are located at the bottom of the main display and serve a variety of functions. What each key does is indicated by the text in the display above the actual softkey.

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

Drug List

Standby

Enter

Cancel/ Back



3- 5

3.2 Indicators The Charge/Line Indicator is illuminated to indicate the battery is currently charging. NOTE: If the device is plugged into AC power, with a battery installed, and the Charge Indicator is not illuminated, technical .

The fluid drop symbol, when flashing, indicates an active infusion on Line A and/or Line B.

Battery Capacity Symbol (located on right side of message region on display) indicates relative charge with number of white boxes from left to right.

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3.3 Rear Case Controls NOTE: For Plum A+3, each control applies to all three pumps

The audio level rotary knob, located on the back, adjusts the alarm audio level.

The toggle switch, located below the audio level control, activates the lockout function when the lever is placed in the “up” position, disabling all front keys except [STOP]. Protected Keypad Lock may also be used. It both locks and unlocks the keypad by pressing the Decimal key, followed by 9, 6, & 3.

.

NOTE: For Plum A+3, keypad lock applies to individual pump in use. NOTE: Pressing of a key while lockout is active results in the display of the lockout enabled message. This action is recommended to confirm each lockout activation.

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3- 7

NOTE: If the lockout switch is put in the “Locked” position while the inf is off, the [ON/OFF] key allows the unit to turn on.

The connector located below the lockout switch is the Nurse Call Relay Connector, for providing remote notification of a nurse call event. The RS-232 DataPort is used to interface with a host computer.

NOTE: Do not connect dataport while infusing.

The Equipotential Post (located on the back of Plum A+3) is a terminal for connection of an equipotential conductor.

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3.4 istration Sets The Plum A+ is compatible with a wide range of LifeCare Plum series istration sets. Become familiar with the set components before preparing the istration set. Primary Line

Secondary Inlet Port (Capped) Finger Grip

Flow Regulator Patient Line Pumping Chamber Air Trap

PREPARING THE ISTRATION SET NOTE: For detailed instructions, see istration set packaging.

WARNING ARRANGE TUBING, CORDS, AND CABLES TO MINIMIZE THE RISK OF PATIENT STRANGULATION OR ENTANGLEMENT. Use the aseptic technique to prepare the istration set for priming, then proceed as follows: Make sure flow regulator is closed.

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3- 9

Insert piercing pin into container outlet with a twisting motion.

Fill Drip chamber to about 1/2 full or to the score mark. Do not completely fill. NOTE: To avoid getting Distal Air Alarms, confirm the fluid bag is positioned higher than the inf. This should be set up prior to priming the cassette.

PRIMING THE ISTRATION SET Invert the cassette.

Turn the flow regulator counter-clockwise until a drop of fluid is seen in the pumping chamber.

Turn the cassette upright, then prime the remainder of the istration set.

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3) Equipment Description Push in the flow regulator to close. Confirm there is no flow.

LOADING THE CASSETTE To load the primed cassette into the plum A+, proceed as follows. Open the cassette door by lifting up the handle.

Insert cassette into door guides. Close the cassette door. Confirm there is no flow and no kinks appear in tubing. NOTE: If flow is observed, close the tubing clamps and replace the istration set. NOTE: The istration set should be changed per CDC guidelines or healthcare provider policy. Discard after use.

PREPARING THE SECONDARY LINE CAUTION: CONSULT THE DRUG LABELING TO CONFIRM DRUG COMPATIBILITY, CONCENTRATION, DELIVERY RATES, AND VOLUMES ARE ALL SUITABLE FOR CONCURRENT DELIVERY OR PIGGYBACK DELIVERY (SECONDARY FOLLOWED AUTOMATICALLY BY PRIMARY) MODES. The Plum A+ features concurrent or piggyback delivery modes when therapy requires istering more than one fluid.

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In addition to standard containers, the Plum A+ can use syringes on the secondary port. The secondary line can be prepared without removing or repriming the cassette. Before preparing the secondary line, observe the following guidelines: •

Review the backpriming function.

•

Attach the secondary container using an 18or 19- gauge, 31 mm (or shorter) needle, if the cassette secondary inlet port has a piercing reseal.

•

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 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.

•

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.

To prepare the secondary line, use aseptic technique and proceed as follows: With cassette door closed: Loosen and remove white cap, then discard. Add secondary tubing or syringe. Open all proximal clamps before pressing [START].

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3) Equipment Description Set up per operating instructions. (See Sections 4 - 6 of this manual.)

Syringe: Secure the container to the cassette door using the optional container arm (List 12095-03).

3.5 Discontinuing Electronic Flow Control & Setting Gravity Flow CAUTION: BEFORE OPENING DOOR, CLOSE CLAMP ON PRIMARY OR SECONDARY SET OR REMOVE SECONDARY CONTAINER FROM SECONDARY PORT TO PREVENT MIXING OF PRIMARY AND SECONDARY FLUIDS. If electronic flow needs to be stopped, the precision flow regulator on the cassette can be used to manually set and maintain fluid flow in a gravity mode (see the following graphics). 1 PRESS STOP

STOP

2 OPEN DOOR & REMOVE CASSETTE NOTE: FLOW REGULATOR CLOSES AUTOMATICALLY WHEN DOOR IS OPENED TO PREVENT ACCIDENTAL FREE FLOW NOTE: IF DOOR OPEN ALARM OCCURS, TURN PUMP OFF

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3 SET GRAVITY RATE BY TURNING FLOW REGULATOR COUNTER-CLOCKWISE NOTE: CASSETTE SHOULD BE IN UPRIGHT POSITION



3- 13

3.6 Discontinuing Fluid istration 1 PRESS STOP

STOP

3 CLOSE DOOR

4 2 OPEN DOOR, REMOVE CASSETTE

DISCARD SET AND FLUID CONTAINER PER HOSPITAL PROCEDURE

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NOTES

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4)

4- 1

Basic Operation 4.1 Getting Started

UNPACKING CAUTION: P RODUCT DAMAGE MAY OCCUR UNLESS PROPER CARE IS EXERCISED DURING UNPACKING AND INSTALLATION. DO NOT USE THE PLUM A+ IF IT APPEARS DAMAGED IN ANY WAY. THE BATTERY MAY NOT BE CHARGED UPON RECEIPT. Inspect the Plum A+ packaging for possible shipping damage. If damage is found, the delivery company immediately. Use care when unpacking the inf. Retain the packing slip and save all packing material in case the inf is damaged or fails the inf self-test and has to be returned to Hospira. Inspect thoroughly for damage. CAUTION: IF THE PLUM A+ APPEARS TO BE DAMAGED, HOSPIRA.

To set up, connect the AC (mains) cord to a properly grounded receptacle, unless temporary battery operation is desired. NOTE: Use AC (mains) power whenever possible. Store the inf connected to AC (mains) to confirm a fully charged battery for emergencies. NOTE: If the quality of the earth grounding source is in doubt, use battery power. CAUTION:

T HE P LUM A+ SYSTEM IS DESIGNED TO O PE R A T E N O R M A L L Y I N T H E P R E S EN C E O F M O S T ENCOUNTERED ELECTROMAGNETIC INTERFERENCE (EMI) CONDITIONS . I N THE EVENT OF EXTREME LEVELS OF

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4) Basic Operation

INTERFERENCE , SUCH AS ENCOUNTERED NEXT TO AN ELECTROSURGICAL GENERATOR, CELLULAR TELEPHONES, OR 2-WAY RADIOS, IT IS POSSIBLE THAT THE NORMAL OPERATION OF A SENSOR OR MICROCOMPUTER MIGHT BE DISRUPTED. OPERATION OF THE INF UNDER THESE CONDITIONS SHOULD BE AVOIDED.

TANDEM CARRIER INSTRUCTIONS NOTE: The Plum A+3 is NOT to be used with the tandem carrier. It is only to be used with the Plum A+ and other single-channel devices. The Plum A+ may be safely and conveniently mounted on an IV stand or on a tandem carrier mounted on an IV stand. Always mount the tandem carrier (List# 12270-01) to the pole before attaching the inf(s) to the tandem carrier. Make sure tandem carrier clamp is attached firmly to pole. Make sure infs are firmly attached to tandem carrier. This section details the Plum A+ instrument setup procedures.

SYSTEM SELF-TESTS The inf performs a suite of System Self-Tests when power is applied to confirm readiness for use. Failure during the Self-Tests is reported as a Malfunction Condition. CAUTION: DO NOT PLACE THE PLUM A+ IN SERVICE IF IT FAILS THE SYSTEM SELF-TESTS.

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4- 3

Connect the AC power (mains) cord to an AC power receptacle, then confirm that the Charging/Line indicator illuminates (above the [ON/OFF] key on the front ). A systematic self-testing of the processing, delivery, and safety systems is performed whenever the Plum A+ is turned on, to readiness for operation. NOTE: If the quality of earth grounding source is in doubt, use battery power. Press the [ON/OFF] key to turn the power on. Check screen display and listen for a beep to indicate the audio is working. Wait for the self-tests to complete. If successful, put a fully primed macro cassette into the cassette door and close the door. See Loading Cassette in Section 3 for details of correct procedure. When the Charging/Line indicator is off and the battery symbol on the display is flashing, this indicates that the Plum A+ is operating on low battery power and should be recharged. CAUTION:

DO NOT OPERATE THE PLUM A+ ON PATIENTS WITH THE BATTERY REMOVED . U SE OF A PROPERLY MAINTAINED AND CHARGED BATTERY HELPS CONFIRM PROPER OPERATION.

To confirm battery is fully charged, connect the Plum A+ to AC (mains) power for a minimum of six hours while in the OFF mode. If an alarm occurs during the power on self-test, identify the alarm message, then take corrective action (see Section 7, Alarms and Troubleshooting). Turn inf OFF, then back ON. If the self-test alarm recurs, remove the inf from service and the local Hospira representative. The inf performs a suite of System Self-Tests when power is applied to confirm readiness for use.

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4) Basic Operation

Failure during the Self-Tests is reported as a Malfunction Condition.

DATA RETENTION Delivery program settings and programming option selections are retained in non-volatile memory. If the Plum A+ has been turned off for longer than four hours, all delivery settings are cleared and programming option selections are restored to their default selections for next use.

4.2 Power On 1)

Press to turn on the Plum A+ and you will see the System Self-Tests screen.

HOSPIRA Plum A+ Release XX.XX Copyright Hospira 2005 System Self Test In Progress

CAUTION: THE INF MUST BE INITIALLY STARTED ON AC POWER, OTHERWISE THE DATAPORT MAY NOT OPERATE PROPERLY.

After self-testing **SCREENS SHOWN IN THIS MANUAL ARE EXAMPLES ONLY AND DON’T successfully completes, NECESSARILY REFLECT ACTUAL the display will proceed to CLINICAL PRACTICE** the next screen. Programming the inf may begin during the cassette check phase of the start-up testing. NOTE: If battery is missing or defective, a “Battery not installed” message with a “Continue without battery” prompt will appear (AC power only).

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CAUTION: DO NOT OPERATE THE PLUM A+ ON PATIENTS WITH THE BATTERY REMOVED . U SE OF A PROPERLY MAINTAINED AND CHARGED BATTERY HELPS CONFIRM PROPER OPERATION.

2)

To set up the Plum A+, insert selected Plum Set and close cassette holder door lever.

SETUP

Insert PLUM Set Close Lever

NOTE: If cassette is already inserted, this screen is skipped.

Example of Clear Settings Screen 3)

The on-screen message “Clear Settings?” may appear. Select [YES] to clear all settings.

A

SETUP

B

Clear Settings?

Yes clears ALL settings Yes

No

Clear ALL settings when changing patients or multiple programming parameters. NOTE: This clears all delivery parameters, such as Rate and VTBI on both lines, as well as setting items, such as the KVO and Nurse Callback options, to their default values. NOTE: If no settings currently exist or all settings are zero, this screen will be byed.

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4) Basic Operation

4.3 Simple Delivery Example of Main Delivery screen (with cleared settings).

**SCREENS SHOWN IN THIS MANUAL ARE EXAMPLES ONLY AND DON’T NECESSARILY REFLECT ACTUAL CLINICAL PRACTICE**

A STOPPED STOPPED B

0

Rate mL/hr

0

0

Vol Inf mL

0

Back Prime

A

B

Options/ Vol Inf

NOTE: For clarity, whole number font sizes will appear larger than partial number font sizes (numbers on the right-side of the comma).

1)

To Program a delivery rate, select

2)

To enter delivery rate, use numeric keypad.

3)

Use key to move down to the VTBI field.

A

[A].

PROGRAM

Rate

0

mL/hr

VTBI

0

mL

Duration

00:00

hr : min

Enter Value using keypad Program Options

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

Therapy

Cancel/ Back


Plum A+ Infusion Systems 4)

To enter VTBI amount, use keypad. NOTE: While the VTBI is being entered, the duration is automatically computed. If the computed value is greater than 99:59, dashes (- -) appear in place of hours.

4- 7 A

VTBI

0 00:00

mL/hr mL hr : min

Enter Value using keypad

6)

Use keypad to change the hours part of duration if desired.

Use

5.5

Program Options

Use key to move down to the DURATION field.

7)

Rate

Duration

5)

NOTE: When all parameters are displayed, changing any one parameter will result in other parameters automatically being computed. To understand the Automatic Calculation feature, see Section 6.8 Examples of Automatic Calculation.

PROGRAM

A

Therapy

Cancel/ Back

PROGRAM

Rate

5.5

mL/hr

VTBI

0.5

mL

Duration

00:05

hr : min


Therapy

Cancel/ Back

to move from hours to minutes.

NOTE: The maximum hours allowed is 99 and the maximum minutes is 59.

8)

Use keypad to change minutes. CAUTION:

ALL VALUES BEFORE STARTING

INFUSION.

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


4- 8 9)

4) Basic Operation Press infusion.

to begin

Example of Main Delivery Screen just after being programmed and started. NOTE: The Line A Fluid Flow Indicator also will flash to indicate pumping.

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

A PUMPING STOPPED B

5.5

Rate mL/hr

0

0.1

Vol Inf mL

0

A

B

Options/ Vol Inf



4- 9

4.4 Titration 1)

Select Line [A] (or [B]) at the Main Delivery Screen.

A PUMPING PUMPING B

25

Rate mL/hr

50

41

Vol Inf mL

20

2)

Enter the desired Rate using the keypad. NOTE: When Rate is changed, the duration is automatically recomputed using the current VTBI. To understand the Automatic Calculation feature, see Section 6.8 Examples of Automatic Calculation. CAUTION:

A

Options/ Vol Inf

B

A

PROGRAM

Rate

15

mL/hr

VTBI

50

mL

03:20

Duration

hr : min


Therapy

Cancel/ Back


INFUSION.

3)

After any change, press to initiate new Rate and return to the Main Delivery Screen. NOTE: Volume Infused is an incrementing value which is cleared in [OPTIONS/VOL INF].

A PUMPING PUMPING B

15

Rate mL/hr

50

41.6

Vol Inf mL

20

A

B

Options/ Vol Inf

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


4- 10

4) Basic Operation

The following 3 screens are examples of changed values. Example of changed rate. 4)

5)

From the Main Delivery Screen, select [A]. Use keypad to change the RATE value.

A

PROGRAM

Rate

15

mL/hr

VTBI

50

mL

Duration

03:20

hr : min


Therapy

Cancel/ Back

NOTE: The display time is only accurate to ± one minute. As shown in this example, the delivery shows 3 hours and 20 minutes (not 3 minutes and 20 seconds). NOTE: [START] accepts the change. Delivery is changed to the new RATE and DURATION and display returns to Main Delivery Screen.

Example of Changed VTBI value. 6)

Use key to highlight the VTBI field.

A

PROGRAM

Rate

15

VTBI

100

Duration

06:40

mL/hr mL hr : min


7)

Use the keypad to change the VTBI value.

Program Options

Therapy

Cancel/ Back

NOTE: When the VTBI is changed, the Duration is recomputed with respect to the current Rate. To understand the Automatic Calculation feature, see Section 6.8 Examples of Automatic Calculation. NOTE: [START] accepts the change. Delivery is changed to the new VTBI and DURATION and display returns to Main Delivery Screen.

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


Plum A+ Infusion Systems Example of changed DURATION field. 8)

4- 11 A

Use to highlight the Duration field, then use the keypad to change it’s value.

PROGRAM

Rate

15

VTBI

100 00:40

Duration

mL/hr mL hr : min


Therapy

Cancel/ Back

NOTE: When DURATION is changed, RATE is automatically recomputed using the current VTBI value. To understand the Automatic Calculation feature, see Section 6.8 Examples of Automatic Calculation. NOTE: [START] accepts the change. Delivery is changed to the new DURATION and RATE and display returns to Main Delivery Screen. CAUTION:


INFUSION.

4.5 Piggyback Delivery PIGGYBACK DELIVERYInfusion will stop Line A and infuse Line B until VTBI completes. Line A will automatically restart. 1)

With Line A pumping, to program a Piggyback delivery, select [B].

A PUMPING STOPPED B

5.5

Rate mL/hr

5

20

Vol Inf mL

0

A

B

Options/ Vol Inf

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


4- 12

4) Basic Operation

The Delivery Mode field is highlighted. Mode

NOTE: If an entry was previously programmed, RATE is highlighted. If no previous entries, MODE is highlighted.

2)

If field reads “Concurrent”, select [CHANGE MODE] to switch to “Piggyback”.

3)

Select to highlight the RATE field.

Piggyback

Rate VTBI Duration


0 0 00:00

mL/hr mL hr : min

Change using Change Mode Program Change Therapy Options Mode

Cancel/ Back

B

PROGRAM Mode

4)

B

PROGRAM

Piggyback

Rate VTBI Duration

200 0 00:00

mL/hr mL hr : min

Enter value using keypad

5)

Use key to move down to the VTBI field.

6)

To enter VTBI amount, use keypad.

Program Options

Therapy

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

B

PROGRAM Mode

NOTE: While the VTBI is being entered, the duration is automatically computed. If the computed value is greater than 99:59, dashes (- -) appear in place of hours. To understand the Automatic Calculation feature, see Section 6.8 Examples of Automatic Calculation.

Cancel/ Back

Rate VTBI Duration

Piggyback

200 100 00:30

mL/hr mL hr : min

Enter value using keypad Program Options

Therapy

Cancel/ Back



4- 13

Use key to move down to the DURATION field. (Optional) Use keypad to change duration. When all parameters are displayed, changing any one parameter will result in other parameters automatically being computed. CAUTION:

B

PROGRAM Mode

Piggyback

133 100 00:45

Rate VTBI Duration

mL/hr mL hr : min


Therapy

Cancel/ Back


INFUSION.

8)

Press

to begin infusion.

NOTE: If Line A has a Delay Start remaining, a message will appear warning of a possible non-delivery (see section 6.4).

9) Select

[YES] to continue.

Example of Main Delivery Screen just after being programmed and started.

A DELAYED PUMPING B

5.5

Rate mL/hr

133

20

Vol Inf mL

0.1

A

B

Options/ Vol Inf

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


4- 14

4) Basic Operation

4.6 Concurrent Delivery CONCURRENT DELIVERYSimultaneous delivery of two fluids at independent flow rates. CAUTION: CONSULT DRUG LABELING TO CONFIRM DRUG COMPATIBILITY , CONCENTRATION , DELIVERY RATES, AND VOLUME ARE ALL SUITABLE FOR CONCURRENT AND PIGGYBACK DELIVERY MODES. SEE SECTION 8 FOR INFORMATION ON CONCURRENT FLOW, SEE SECTION 9 FOR DELIVERY RATE RANGES.

A PUMPING STOPPED B

5.5

Rate mL/hr

0

0.1

Vol Inf mL

0

A

B

Options/ Vol Inf

NOTE: In concurrent mode with certain alarm conditions, one line may stop while the other line may continue to deliver.

1)

With pumping started on line A, to program a Concurrent delivery rate, select [B]. The Delivery Mode field is highlighted. Mode

NOTE: If an entry was previously programmed, RATE is highlighted. If no previous entries, MODE is highlighted.

If field reads “Piggyback”, select [CHANGE MODE] to switch to “Concurrent”.

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

B

PROGRAM

Rate VTBI Duration

Piggyback

0 0 00:00

mL/hr mL hr : min


Cancel/ Back



4- 15

change to “Concurrent” mode.

B

PROGRAM Mode Concurrent

2)

Use field.

to highlight Rate

Rate VTBI Duration

0 0 00:00

mL/hr mL hr : min


3)


Cancel/ Back

B


NOTE: When Rate for Line A plus Rate for Line B is greater than valid rate ranges, a “Concurrency violation” message will explain why second line did not start. See Section 9.3 for valid delivery rate ranges.

Rate VTBI Duration

10 0 00:00

mL/hr mL hr : min


Therapy

Cancel/ Back

NOTE: “Concurrency violation” may not be displayed if unit is displaying “VTBI Complete”. The device will not start and an invalid keypress sound will occur when START is pressed.

4)

Use

key to move down to the VTBI field.

5)

To enter VTBI amount, use keypad.

B


NOTE: While the VTBI is being entered, the duration is automatically computed. While the computed value is greater than 99:59, dashes (- -) appear in place of hours. To understand the

Rate VTBI Duration

10 100 10:00

mL/hr mL hr : min


Therapy

Cancel/ Back

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


4- 16

4) Basic Operation

Automatic Calculation feature, see Section 6.8 Examples of Automatic Calculation.

6)

Use field.

key to move down to the DURATION

(Optional) Enter values for desired hours and minutes. NOTE: When Duration is entered, Rate is automatically computed. CAUTION:


INFUSION.

7)

Press to begin infusion and return to the Main Delivery screen. Example of a concurrent delivery.

A PUMPING PUMPING B

5.5

Rate mL/hr

10

20.4

Vol Inf mL

1

A

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

B

Options/ Vol Inf



4- 17

4.7 Stop and Start with only 1 Line Pumping 1)

Press at the Main Delivery Screen. NOTE: If [A] (or [B]) is selected prior to [STOP], the line is stopped, the display will show the programming screen. Select [CANCEL/BACK] to return to the Main Delivery screen.

Example of STOPPED delivery. 2)

To discontinue infusion, press .

3)

Clamp secondary tubing if connected.

4)

Open door, remove set and close door. Or, press infusion.

A PUMPING STOPPED B

100

Rate mL/hr

0

8.5

Vol Inf mL

0

Back Prime

B

A

Options/ Vol Inf

A STOPPED STOPPED B

100

Rate mL/hr

0

8.5

Vol Inf mL

0

Back Prime

A

B

Options/ Vol Inf

to resume

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


4- 18

4) Basic Operation

4.8 Stop and Start with Both Lines pumping 1)

Press at the Main Delivery screen.

A PUMPING PUMPING B

25

Rate mL/hr

50

3

Vol Inf mL

20.4

B

A

2)

Select [STOP A], [STOP B], or [STOP ALL]. NOTE: If [A] (or [B]) is selected prior to [STOP], the display will show the programming screen. Select [CANCEL/BACK] to return to the Main Delivery screen.

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

Options/ Vol Inf

A PUMPING PUMPING B

25

Rate mL/hr

50

3

Vol Inf mL

20.4

Choose line(s) to stop: Stop All

Stop A

Stop B

Cancel


Plum A+ Infusion Systems Example of stopped infusion.

4- 19 A STOPPED STOPPED B

NOTE: This is an example using [STOP ALL].

25

Rate mL/hr

50

3

Vol Inf mL

20.4

Back Prime

A

B

Options/ Vol Inf

CAUTION:

ALL VALUES BEFORE STARTING INFUSION.

3)

4)

To resume infusion, press . Select [START A], [START B], or [START ALL]. Or, to discontinue infusion, press .

A STOPPED STOPPED B

25

Rate mL/hr

50

3

Vol Inf mL

20.4

Choose line(s) to start: Start All

Start A

Start B

5)

Clamp secondary tubing if connected.

6)

Open door, remove set and close door.

Cancel

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


4- 20

4) Basic Operation

4.9 Backpriming BACKPRIMING- Removal of air or fluid from the proximal line and cassette airtrap.

1)

To initiate a backprime, select [BACK PRIME]. NOTE: Backpriming is available only when all delivery is stopped. Secondary container is necessary to receive the air.

2)

A STOPPED STOPPED B

Select and hold [BACK PRIME] until fluid pumped from line A to line B has expelled the air from cassette air trap into Secondary container.

5.5

Rate mL/hr

0

8.9

Vol Inf mL

0

Back Prime

A

A

B

Options/ Vol Inf

B

BACKPRIMING

5.5

Rate mL/hr

0

8.9

Vol Inf mL

0

Release Backprime to Stop

NOTE: Fluid flow is at maximum rate possible.

3)

Back Prime

A

B

Options/ Vol Inf

Upon release of [BACK PRIME], the cassette test is performed to confirm readiness for pumping. Pressing will resume programmed delivery.

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



4- 21

4.10 Clearing Program Settings 1)

Press at the Main Delivery Screen.

A PUMPING STOPPED B

Clear ALL settings when changing patients or multiple programming parameters.

5.5

Rate mL/hr

0

0.1

Vol Inf mL

0

A

B

Options/ Vol Inf

Use [CLEAR PROGRAM] when changing ONLY Line A or B. 2)

3)

Select Line A (or B if active) from the stopped Main Delivery Screen. Select [CLEAR PROGRAM].

A

PROGRAM

Rate

5.5

mL/hr

VTBI

22

mL

Duration

03:20

hr : min


NOTE: If Line A or B is programmed with Dose Calculation, Rate, VTBI and Duration will not display values. The values to be cleared may be viewed in applicable programming screen under [DRUG LIST].

Program Clear Therapy Options Program

Cancel/ Back

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


4- 22 4)

Select

4) Basic Operation [YES].

A

PROGRAM

Clear ALL settings when changing patients or multiple programming parameters.

Clear Line A Settings?

Yes

Use [CLEAR PROGRAM] when changing ONLY Line A or B. Example screen of “Cleared Program”. 5)

Select [CANCEL/BACK] to return to the Main Delivery screen or program new settings.

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

A

No

PROGRAM

Rate

0

mL/hr

VTBI

0

mL

Duration

00:00

hr : min


Therapy

Cancel/ Back



5) Dose Calculation

Loading Dose

Multistep

5- 1

Therapies Allows programming Dose Rates in alternative units of measure. Dose Calculation can be used in Simple Delivery, Loading Dose, and Multistep. 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. 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: During programming, must identify desired drug with softkey drug list prior to setting program parameters. Use drug manufacturer recommendations for IV istration when using the Plum A+ inf.

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


5- 2

5) Therapies

5.1 Dose Calc (mcg/kg/min on A) DOSE CALCULATION- Allows programming Dose Rates in alternative units of measure. Dose Calculation can be used in Simple Delivery, Loading Dose, and Multistep. Clear ALL values when changing patients or multiple programming parameters. Use [CLEAR PROGRAM] when changing ONLY Line A or B. 1)

Select [A] at the Main Delivery screen.

A STOPPED STOPPED B

**SCREENS SHOWN IN THIS MANUAL ARE EXAMPLES ONLY AND DON’T NECESSARILY REFLECT ACTUAL CLINICAL PRACTICE**

The Line A Programming screen appears. 2)

Select [THERAPY] for Dose Calculation programming.

0

Rate mL/hr

0

0

Vol Inf mL

0

Back Prime

A

A

B

Options/ Vol Inf

PROGRAM

Rate

0

mL/hr

VTBI

0

mL

Duration

00:00

hr : min


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

Therapy

Cancel/ Back


Plum A+ Infusion Systems The Drug List screen appears, in mainly alphabetical order. NOTE: Default entry is “No Drug Selected”. This selection may be used later to remove an incorrect or unwanted drug name from the display.

3)

Use to highlight desired drug name. When list does not contain desired generic drug name or group name select [PAGE DOWN] (or [PAGE UP]) until it shows, then use choice.

4)

A

Program Drug List No Drug Selected Abciximab Acyclovir Albumin Aldesleukin Alfentanil Alteplase (rt-PA) Amikacin

Select, then Enter Page Up

Page Down

A

Enter

Cancel/ Back

Program Drug List Dexmedetomidine HCI Diltiazem Dobutamine Docetaxel Dopamine Doxorubicin Epinephrine Epoprostenol


Page Down

Enter

Cancel/ Back

to highlight

Select [ENTER] to indicate selection and advance to the Program Selection screen. The Program Selection screen for Line A appears.

5)

5- 3

Select [CHOOSE] to select Dose Calculation and continue.

A

PROGRAM

Dopamine

Dose Calculation Loading Dose Multistep Select, then Choose Choose

Back

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


5- 4

5) Therapies

The Program Dose Calc screen appears. NOTE: Cursor defaults to package insert recommended dose units associated with the selected drug.

Program Dose Calc

A Dopamine

mL/hr mcg/kg/min mcg/kg/hr mcg/min mcg/hr mg/kg/hr mg/min mg/hr

grams/hr ng/kg/min units/kg/hr units/min units/hr mUn/min mEq/hr

Select, then Choose

6)

Select

[CHOOSE] to

Choose

Back

continue. Or, use to change the units to use in the delivery. The Container Concentration Selection screen appears whenever the selected Dose Units are gram-based (e.g., grams, mg, mcg, or ng) otherwise this screen is skipped.

Program Dose Calc

A Dopamine

Drug Conc in Container mcg mg grams Select, then Choose Choose

Back

NOTE: Cursor defaults to package insert recommended concentration units associated with the selected drug.

7)

Select [CHOOSE] to continue. Or, use to change the Container Concentration units to use in the delivery.

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


Plum A+ Infusion Systems The next page of the Program Dose Calc screen appears to provide for entry of delivery program parameters. 8)

Use keypad to enter desired values. Once each value is entered, use to highlight the next programming field.

5- 5 A

Program Dose Calc

Dopamine

400 mg

Conc Weight

250 mL

70 kg

Dose VTBI Duration Rate

0 0 00: 00 0

mcg/kg/min mL hr : min mL/hr


Cancel/ Back

NOTE: The Concentration elements and weight value must be entered before the [SELECT] keys allow access to remaining fields.

9)

Continue to enter values using the keypad, and advancing to the next field using . NOTE: As the Dose value is entered, the Rate is automatically calculated. To understand the Automatic Calculation feature, see Section 6.8 Examples of Automatic Calculation.

A

Program Dose Calc

Dopamine

Conc Weight Dose VTBI Duration Rate

400 mg 70 kg 10 0 00: 00 26.3

250 mL



Cancel/ Back

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


5- 6 10) Use to scroll down to the VTBI field. 11) Enter a value for VTBI using the keypad. NOTE: As the VTBI value is entered or changes, Duration is automatically updated.

5) Therapies A

Program Dose Calc

Dopamine

Conc Weight

400 mg 70 kg

Dose VTBI Duration Rate

10 250 09: 30 26.3

250 mL



Cancel/ Back

NOTE: At this point, programming is complete unless [PROGRAM OPTIONS] are desired. See Section 6, Additional Features, for more information.

12) After entering the desired VTBI value and any desired [PROGRAM OPTIONS], press to begin program. This will bring up the PROGRAM CONFIRMATION screen which appears for all units of measure except mL/hr. ALL VALUES BEFORE SELECTING [YES] AND STARTING INFUSION.

A

Program Dose Calc Delivery will be:

Dose 10 mcg/kg/min Dopamine Drug Conc 400 mg 250 mL Weight 70 kg Confirm Program?

CAUTION:

Yes

NOTE: The Concentration drug amount or Diluent volume cannot be changed while a delivery is in progress.

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

No


Plum A+ Infusion Systems The Main Delivery screen appears displaying the information just entered. NOTE: The Therapy Type and Drug are displayed as well as the Dose Rate and Dose Units.

5- 7 A PUMPING STOPPED B Dopamine Dose Calculation

26.3

Rate mL/hr

0

0

Vol Inf mL

0

10 mcg/kg/min

A

B

Options/ Vol Inf

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


5- 8

5) Therapies

5.2 Dose Calc (mg/min on B) DOSE CALCULATION- Allows programming Dose Rates in alternative units of measure. Dose Calculation can be used in Simple Delivery, Loading Dose, and Multistep. Clear ALL values when changing patients or multiple programming parameters. Use [CLEAR PROGRAM] when changing ONLY Line A or B. 1)

Select [B] at the Main Delivery screen.

A PUMPING STOPPED B Dopamine Dose Calculation

26.3

Rate mL/hr

0

0

Vol Inf mL

0

10 mcg/kg/min

A

The Line B Programming screen appears. Select

[THERAPY].

Options/ Vol Inf

B

PROGRAM Mode

2)

B

Rate VTBI Duration

Piggyback

0 0 00:00

mL/hr mL hr : min


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

Cancel/ Back


Plum A+ Infusion Systems The Drug List screen appears, in mainly alphabetical order.

5- 9 Program Drug List

B

No Drug Selected Abciximab Acyclovir Albumin Aldesleukin Alfentanil Alteplase (rt-PA) Amikacin Select, then Enter Page Up

3)


4)

Cancel/ Back

Enter

Program Drug List

B

Leucovorin Levofloxacin Lidocaine Lipids Lorazepam Magnesium Infusion Mannitol Mesna Select, then Enter Page Up

Page Down

Cancel/ Back

Enter

to highlight

Select [ENTER] to indicate selection and advance to the Therapy Selection screen. The Program Select screen for Line B appears.

5)

Page Down

Select [CHOOSE] to continue.

PROGRAM

B Lidocaine


Back

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


5- 10

5) Therapies

The Program Dose Calc screen appears. NOTE: Cursor defaults to manufacturer package insert recommended dose units associated with the selected drug.

Program Dose Calc mL/hr mcg/kg/min mcg/kg/hr mcg/min mcg/hr mg/kg/hr mg/min mg/hr


Select, then Choose Choose

6)

Select

B

Lidocaine

Back

[CHOOSE] to

continue. Or, use to change the units to use in the delivery. The Container Concentration Selection screen appears whenever the selected Dose Units are gram-based (e.g., grams, mg, mcg, or ng) otherwise this screen is skipped.

Program Dose Calc

B

Lidocaine

Drug Conc in Container mcg mg grams Select, then Choose Choose

Back

NOTE: Cursor defaults to manufacturer package insert recommended concentration units associated with the selected drug.

7)

Select [CHOOSE] to continue. Or, use to change the Container Concentration units to use in the delivery.

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


Plum A+ Infusion Systems The next page of the Program Dose Calc screen appears to provide for entry of delivery program parameters.

5- 11 Program Dose Calc

B

Lidocaine

Conc Mode Dose VTBI Duration Rate

0 grams 0 mL Piggyback 0 0 00: 00 0

mg/min mL hr : min mL/hr


8)

Use keypad to enter desired values. Once entered, use to highlight the next field.

9)

To override the Piggyback Delivery Mode default, scroll down to Mode using , then select [CHANGE MODE].

Program Options

Cancel/ Back

NOTE: Delivery Mode option is available on Line B and its default is Piggyback. The weight field is independent of Line A unless Line A selected drug is weight-based. In that scenario, the Line A weight information applies to Line B.

10) Continue entering desired values using the keypad. Use to advance to the next field.

Program Dose Calc

B

Lidocaine

Conc Mode Dose VTBI Duration Rate

2 grams 500 mL Concurrent 2 500 16 : 40 30

mg/min mL hr : min mL/hr

NOTE: When entering the RATE, Enter value using keypad with a VTBI value entered, the Program Cancel/ DOSE and DURATION fields are Options Back automatically updated. To understand the Automatic Calculation feature, see Section 6.8 Examples of Automatic Calculation. NOTE: The Duration field temporarily changes to dashes when the computed value is larger than what can be displayed.

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


5- 12

5) Therapies

11) Continue entering the RATE value, if desired. NOTE: As Rate is entered, the Duration and Dose are automatically adjusted as individual numbers are entered. NOTE: If the Duration value is changed, the Rate and Dose are automatically adjusted. NOTE: At this point, programming is complete unless [Program Options] are desired. See Section 6, Additional Features, for more information.

12) Press program.

to begin

This will bring up the PROGRAM CONFIRMATION screen which appears for all units of measure except mL/hr.

Program Dose Calc

Dose 2 mg/min Lidocaine Drug Conc 2 grams 500 mL Weight 70 kg Confirm Program?

Yes

CAUTION:

ALL VALUES BEFORE SELECTING [YES] AND STARTING INFUSION. NOTE: The Concentration drug amount or Diluent volume cannot be changed while a delivery is in progress.

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

B

Delivery will be:

No


Plum A+ Infusion Systems Upon , the Main Delivery screen shows delivery status for both A and B lines. NOTE: See Delivery Rate Range in Section 9. The ratio of concurrent rates has recommendations specified in Section 1.4.

5- 13 A STOPPED PUMPING B Dopamine Dose Calculation

Lidocaine Dose Calculation

26.3

Rate mL/hr

30

1

Vol Inf mL

0.1 2

Dose

mcg/kg/min

A

mg/min

B

Options/ Vol Inf

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


5- 14

5) Therapies

5.3 Loading Dose 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. Clear ALL values when changing patients or multiple programming parameters. Use [CLEAR PROGRAM] when changing ONLY Line A or B. 1)

Select [A] (or [B]) at the Main Delivery screen.

A STOPPED STOPPED B

0

Rate mL/hr

0

0

Vol Inf mL

0

Back Prime

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

A

B

Options/ Vol Inf


Plum A+ Infusion Systems The selected Line (A or B) Programming screen appears. 2)

Select

[THERAPY].

5- 15 A

PROGRAM

Rate

0

mL/hr

VTBI

0

mL

00:00

Duration

hr : min


The Drug List Screen appears, in mainly alphabetical order. NOTE: Default entry is “No Drug Selected”. This process will guide you through a “fluid challenge”, so “No Drug Selected” will be entered.

3)

A

Therapy

Cancel/ Back



Page Down

Enter

Cancel/ Back

Select [ENTER] to indicate selection and advance to the Therapy selection screen. The Select Therapy screen for Line A (or B) appears. NOTE: This example shows line A being programmed.

A

PROGRAM


Back

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


5- 16 4)

Use to scroll down to Loading Dose.

5)


5) Therapies A

PROGRAM


The next page of the Program Loading Dose screen appears. 6)

Select [CHOOSE] to continue. Or, use to change the units to use in the delivery. The Loading Dose Programming screen appears.

7)

The default field is Rate. Since a “fluid Challenge” is being performed in this example, press to advance to the VTBI field.

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

Back

A Program Loading Dose grams/hr ng/kg/min units/kg/hr units/min units/hr mUn/min mEq/hr

mL/hr mcg/kg/min mcg/kg/hr mcg/min mcg/hr mg/kg/hr mg/min mg/hr Select, then Choose

Choose

Back

A Program Loading Dose

1 2

Rate mL/hr 0 0

VTBI mL 0 0

Duration hr : min 00 : 00 00 : 00


Cancel/ Back



Enter value using keypad.

5- 17 A Program Loading Dose

1 2

Rate mL/hr 0 0

VTBI mL 250 0

Duration hr : min 00 : 00 00 : 00


9)

Use to highlight the next field.

10) Enter Duration using keypad. The Rate value is automatically calculated. To understand the Automatic Calculation feature, see Section 6.8 Examples of Automatic Calculation. 11) After the values for loading dose Step-1 are entered, use to highlight the maintenance dose, Step-2. NOTE: The Loading Dose therapy has two steps. The first is the loading dose followed by the maintenance dose. These words will appear on the main screen as each step is delivered.

Cancel/ Back


1 2

Rate mL/hr 500 0

VTBI mL 250 0

Duration hr : min 00 : 30 00 : 00


Cancel/ Back


1 2

Rate mL/hr 500 75

VTBI mL 250 0

Duration hr : min 00 : 30 00 : 00


Cancel/ Back

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


5- 18

5) Therapies

12) Enter the set of desired values for Step-2 of the program. 13) Select [PROGRAM OPTIONS] to select a Delayed Start or Standby.


1 2

Rate mL/hr 500 75

VTBI mL 250 750

Duration hr : min 00 : 30 10 : 00


Cancel/ Back

NOTE: At this point, programming is complete unless [Program Options] are desired. See Section 6, Additional Features, for more information. NOTE: Nurse Callback enables an alarm when a change in the delivery on a line occurs such as completing Step-1 and starting Step-2. Or on line B, a piggyback delivery is completed and line A is starting its delivery.

A

Program Options

Delay Start for 00:00 hr:min Callback

No

Enter Value using keypad Standby

14) Enter a delay time (less than or equal to 24 hours) using the keypad.

A

Enter

Cancel/ Back

Program Options

Delay Start for 00:05 hr:min

NOTE: Not available if a delivery is taking place on the line.

Callback

Yes

Change using Yes/No

NOTE: Nurse Callback cannot be changed while a delivery is taking place on the line.

15) Select

Yes/No

Enter

Cancel/ Back

[ENTER] to accept the changes and

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



5- 19

return to the Program Loading Dose screen. NOTE: [CANCEL/BACK] returns the fields to their original value and displays the previous screen. CAUTION: INFUSION.

16) Press


to begin program.

The Main Delivery Screen appears. NOTE: The words “DELAYED” and “Loading Dose” appear in the upper-left corner. These indicate the options which have been selected.

After the programmed delay period has expired, the Plum A+ starts “Pumping”. This is indicated where “Delayed” previously was displayed.

A DELAYED STOPPED B Loading Dose

500

Rate mL/hr

0

0

Vol Inf mL

0

B

A

Options/ Vol Inf

A PUMPING STOPPED B Loading Dose

500

Rate mL/hr

0

0

Vol Inf mL

0

A

B

Options/ Vol Inf

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


5- 20

5) Therapies

After the Step-1 has completed, the Main Delivery screen changes to the second step. NOTE: A flashing “Callback Line A” message and the audio alarm sound indicates activation of that option.

A PUMPING STOPPED B Maintenance Dose

75

Rate mL/hr

0

250

Vol Inf mL

0

N105 Callback Line A

B

A

Options/ Vol Inf

17) The should acknowledge the Callback message and stop the audio alarm by pressing . Upon completion of delivery, the screen shows a flashing “Line A VTBI complete” message and the audible alarm sounds.

A

STOPPED B

KVO

Maintenance Dose

1

Rate mL/hr

0

1000

Vol Inf mL

0

N161 Line A VTBI complete NOTE: The KVO rate will change to the rate of 1 mL/hr or less B A depending on delivery rate and “Pumping” mode changes to “KVO”. If Continue Rate option was selected, pumping continues at original rate.

18) Press

Options/ Vol Inf

to stop alarm sound.

NOTE: Warning message continues to flash and audio alarm will return after a two minute period of silence, unless delivery is stopped or VTBI of last line is changed.

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



5- 21

5.4 Multistep Programming 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. Clear ALL values when changing patients or multiple programming parameters. Use [CLEAR PROGRAM] when changing ONLY Line A or B. 1)

Select [A] at the Main Delivery screen.

A STOPPED STOPPED B

0

Rate mL/hr

0

0

Vol Inf mL

0

Back Prime

A

B

Options/ Vol Inf

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


5- 22

5) Therapies


Select

[THERAPY].

A

PROGRAM

Rate

0

mL/hr

VTBI

0

mL

Duration

00:00

hr : min


The Drug List Screen appears, in mainly alphabetical order.

A

Therapy

Cancel/ Back



3)

Use to highlight desired drug name. When list does not contain desired generic drug name or group name, select [PAGE DOWN] (or [PAGE UP]) until it shows, then use choice.

4)

A

Page Down

Enter

Program Drug List Ticar-clavulanate Tirofiban Tobramycin TPN Urokinase Vancomycin Vecuronium Verapamil


Page Down

Enter

to highlight

Select [ENTER] to indicate selection and advance to the Therapy selection screen.

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

Cancel/ Back

Cancel/ Back


Plum A+ Infusion Systems The Select Therapy screen for Line A (or B) appears.

5- 23 A

PROGRAM

TPN

Dose Calculation

NOTE: This example shows line A being programmed.

Loading Dose Multistep Select, then Choose Choose

5)

Use to scroll down to Multistep.

A

Back

PROGRAM

TPN

Dose Calculation

6)


Loading Dose Multistep Select, then Choose Choose

The Program Multistep screen appears. NOTE: Cursor defaults to package insert recommended dose units associated with the selected drug.

A

Back

Program Multistep

TPN

mL/hr mcg/kg/min mcg/kg/hr mcg/min mcg/hr mg/kg/hr mg/min mg/hr


Select, then Choose

7)

Use key to highlight the units to use in the delivery.

8)


Choose

Back

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


5- 24 The Multistep Programming screen appears. 9)

Rate is the default field. Enter value using keypad.

5) Therapies Program Multistep

A TPN

1 2 3 4

Rate

VTBI

Duration

mL/hr 50 0 0 0

mL 0 0 0 0

hr : min 00 : 00 00 : 00 00 : 00 00 : 00


10) Use to highlight the Duration or VTBI field. NOTE: The VTBI value is automatically computed when the Duration value is entered. If VTBI is entered, the Duration value is automatically computed.

11) Use to drop down to Step-2, Rate field. 12) Enter the set of desired values for Step-2 of the program. Continue process for each additional Step.

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

More Steps

Cancel/ Back

Program Multistep

A TPN

1 2 3 4

Rate

VTBI

Duration

mL/hr 50 0 0 0

mL 50 0 0 0

hr : min 01 : 00 00 : 00 00 : 00 00 : 00


More Steps

Cancel/ Back

Program Multistep

A TPN

1 2 3 4

Rate

VTBI

Duration

mL/hr 50 100 0 0

mL 50 0 0 0

hr : min 01 : 00 00 : 00 00 : 00 00 : 00


More Steps

Cancel/ Back


Plum A+ Infusion Systems NOTE: When Step-4 is programmed, using the [SELECT] keys to advance will highlight another item on this screen.

13) When Step-4 is programmed, select [MORE STEPS] to program up to 10 Steps.

5- 25 Program Multistep

A TPN

1 2 3 4

Rate

VTBI

Duration

mL/hr 50 100 75 50

mL 50 825 75 50

hr : min 01 : 00 08 : 15 01 : 00 01 : 00


More Steps

Cancel/ Back

NOTE: Using the [SELECT] keys will not advance you to the additional steps.

14) To set up Steps 5 through 10, enter desired values as performed for Steps 1 through 4. To see the previous steps, select [PREV STEPS].

Program Multistep

A TPN

5 6 7 8 9 10

Rate

VTBI

Duration

mL/hr 0 0 0 0 0 0

mL 0 0 0 0 0 0

hr : min 00 : 00 00 : 00 00 : 00 00 : 00 00 : 00 00 : 00


Prev Steps

Cancel/ Back

NOTE: Confirmation screen will appear ONLY if using weightbased program. CAUTION: INFUSION.

15) Press


to begin program.

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


5- 26 The Main Delivery screen displays Step-1 in the upper-left corner.

5) Therapies A PUMPING STOPPED B TPN Step 1

NOTE: In units other than mL/hr, the Dose rate and units also will be displayed.

50

Rate mL/hr

0

27.5

Vol Inf mL

0

Example of Multistep Screen Pumping on Step-2.

A PUMPING STOPPED B TPN Step 2

16) To change a program parameter while pumping, select [A].

100

Rate mL/hr

0

652

Vol Inf mL

0

17) Enter a value using the keypad.

Program Multistep

A TPN

d 3 4

Rate

VTBI

Duration

mL/hr 50 100 75 50

mL 50 825 75 50

hr : min 01 : 00 08 : 15 01 : 00 01 : 00


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

Options/ Vol Inf

B

A

NOTE: The “*” in a Step number field indicates the step is delivering or “d” indicates each completed step.

Options/ Vol Inf

B

A

More Steps

Cancel/ Back


Plum A+ Infusion Systems If Rate value is changed, the Duration will automatically change.

5- 27 Program Multistep

A TPN

d

Rate

VTBI

Duration

mL/hr 50 125 75 50

mL 50 825 75 50

hr : min 01 : 00 06 : 36 01 : 00 01 : 00

NOTE: Only the current delivering step and future steps can be changed.


CAUTION:

Program Options

ALL VALUES BEFORE STARTING INFUSION. NOTE: The Values are now updated on the Main Delivery Screen.

The inf reverts to KVO when last Step completes. The last step can be restarted by entering a new VTBI value.

3 4

More Steps

Cancel/ Back

A PUMPING STOPPED B TPN Step 2

125

Rate mL/hr

0

658

Vol Inf mL

0

A

B

Options/ Vol Inf

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


5- 28

5) Therapies

NOTES

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



6)

6- 1

Additional Features 6.1 Simple Delivery Using Drug List

1)

Select Line [A] (or [B]) at the Main Delivery screen.

A STOPPED STOPPED B

0

Rate mL/hr

0

0

Vol Inf mL

0

**SCREENS SHOWN IN THIS MANUAL ARE EXAMPLES ONLY AND DON’T Back Prime

NECESSARILY REFLECT ACTUAL CLINICAL PRACTICE**


Select [PROGRAM OPTIONS].

A

Options/ Vol Inf

B

A

PROGRAM

Rate

0

mL/hr

VTBI

0

mL

Duration

00:00

hr : min


The default screen for Program Options appears. 3) Select

[DRUG LIST].

A

Therapy

Cancel/ Back

Program Options


No

Enter Value using keypad Drug List

Standby

Enter

Cancel/ Back

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


6- 2

6) Additional Features

The Drug List Screen appears, in mainly alphabetical order.

A



4)


5)

A

Enter

Cancel/ Back

Program Drug List Dexmedetomidine HCI Diltiazem Dobutamine Docetaxel Dopamine Doxorubicin Epinephrine Epoprostenol


Page Down

Enter

Cancel/ Back

to highlight

Select [ENTER] to indicate selection and return to the Program Options screen. Or, select [CANCEL/BACK] if no choice is acceptable. Drug name is now visible in the upper-left corner.

6)

Page Down

Select [ENTER] or [CANCEL/BACK] to return to the Line Programming screen. CAUTION:


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

A

Program Options

Dopamine


No


Standby

Enter

Cancel/ Back


Plum A+ Infusion Systems Notice the drug name remains in the upper-left corner. 7)

6- 3 A

PROGRAM

Dopamine

Enter a RATE using the keypad.

Rate

5

VTBI

250 50:00

Duration

mL/hr mL hr : min


8)

Use to highlight the VTBI field and enter a value. The DURATION will be automatically calculated.

9)

Press to begin program and return to the Main Delivery screen. Notice the drug name remains in the upper-left corner.

Therapy

Cancel/ Back

A PUMPING STOPPED B Dopamine

5

Rate mL/hr

0

0.1

Vol Inf mL

0

A

B

Options/ Vol Inf

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


6- 4


6.2 Simple Delivery Using Delayed Start 1)

Before or after entering the simple delivery program, select [PROGRAM OPTIONS].

Mode Concurrent Rate VTBI

NOTE: To program a Delayed Start using a Therapy (i.e., Dose Calc) you must first select which line you want (A or B), next select [DRUG LIST], and then [PROGRAM OPTIONS]. If you program the Delayed Start first, it will be cleared upon entry into Program mode.

The Default screen for Program Options appears.

B

PROGRAM

Duration

5 250 50:00

mL/hr mL hr : min


Program Options

Cancel/ Back

B


No


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

Standby

Enter

Cancel/ Back



Enter values for desired hours and/or minutes.

3)

Select [ENTER] to confirm delayed start. CAUTION:


4)

6- 5 Program Options

B


No


Standby

Enter

Cancel/ Back

Press to begin program. Line B is delayed for the time entered. NOTE: Delayed line drip indicator is solid, not flashing. It will begin flashing when actually pumping.

A PUMPING DELAYED B

125

Rate mL/hr

5.0

850

Vol Inf mL

0.0

A

B

Options/ Vol Inf

6.3 Piggyback with Nurse Callback 1)

After programming in desired values for both lines, select [PROGRAM OPTIONS].

Mode Rate VTBI

NOTE: To set a nurse callback, the inf must be stopped. This function can be selected either before or after entering the Piggyback delivery program.

B

PROGRAM

Duration

Piggyback

200 100 00:30

mL/hr mL hr : min


Therapy

Cancel/ Back

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


6- 6


The default screen for Program Options appears. Use to highlight “Callback” field and select [YES/NO], if necessary to obtain “Yes”, then select [ENTER].

Program Options

B


Yes

Change using Yes/No Drug List

Yes/No

Enter

Cancel/ Back

NOTE: Callback default of Yes or No is a biomedical setting and must be configured as described in the Technical Service Manual. CAUTION: INFUSION.

2)


Press to begin program and return to Main Delivery screen.

B

PROGRAM Mode

Piggyback

200 100 00:30

Rate VTBI Duration

mL/hr mL hr : min


At end of Piggyback delivery, with Callback enabled for the line, Callback alarm is issued. 3)

Press

to clear alarm.

Therapy

A PUMPING STOPPED B

5.5

Rate mL/hr

200

0.3

Vol Inf mL

100

Callback Line B

A

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

Cancel/ Back

B

Options/ Vol Inf



6- 7

6.4 Possible Non-Delivery Programmed NOTE: Whenever a valid [START] key is pressed, the device checks the delivery program(s) for nondelivery conditions (such as Line B Piggyback without Line A or delayed start) that could permit a period of non-delivery. If so, the display presents this warning screen.

1)

B

PROGRAM Attention: Line A is stopped or

delayed. Line B in piggyback mode gives no KVO or alarm at dose end.

Continue anyway?

Yes

No

Select [YES] to continue with delivery. Or, select [NO] to cancel.

6.5 Using the Standby Feature Standby is a feature that enables the clinician to program the inf up to 23: 59 minutes in advance of Starting.

A

Program Dose Calc

Dopamine

Conc Weight Dose VTBI Duration Rate

400 mg 70 kg 10 250 09: 30 26.3

250 mL



1)

If Line A is infusing/ programmed, select [A] (or [B])to access program screen of line to be placed on Standby.

2)

Select

[PROGRAM OPTIONS].

3)

Select

[STANDBY].

Program Options

Cancel/ Back

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


6- 8 4)

6) Additional Features Confirm the information displayed is correct, then select [YES] to place program on Standby mode.

Program Dose Calc

A

Delivery will be: Dose Drug Conc Weight Rate

10 mcg/kg/min Dopamine 400 mg 250 mL 70 kg 26.3 mL/hr

Put delivery in Standby?

NOTE: This example screen shows a Dose Calculation Program with a Standby. It looks similar to the Program Confirmation screen with the substitution of “Put delivery in Standby” replacing “Confirm Program”. Selecting [YES] confirms both the Program and the Standby.

5)

Press to remove Standby and start the program.

Yes

No

A STANDBY STOPPED B Dopamine Dose Calculation

26.3

Rate mL/hr

0

0

Vol Inf mL

0

10 mcg/kg/min

A

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

B

Options/ Vol Inf



6- 9

6.6 Select Option- Volumes Infused, Pressure/Post Infusion Rate, and Lighting/ Contrast 1)

To select the Options screen, select [OPTIONS/VOL INF].

A PUMPING STOPPED B

5.5

Rate mL/hr

0

393

Vol Inf mL

0

B

Options/ Vol Inf

OPTIONS

B

A

2)

Use option.

to highlight an

A

Release 11.x - xx/xx/xx Volumes Infused

3)

Select [CHOOSE] to select the Volumes Infused screen.

Pressure/Post Infusion Rate Lighting/Contrast Select, then Choose Choose

This will bring up the Volumes Infused screen which defaults to Total Volume. 4)

Use A or B.

to scroll to Line

A

Back

B

OPTIONS

Volumes Infused Line A Line B Total Vol

0 mL 0 mL 393 mL

Press CLEAR to clear value Enter

Cancel/ Back

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


6- 10 5)


To reset Line A (or B) Volume Infused, use press

6)

7)

A

to highlight and


.

To restore the cleared quantity, select [CANCEL/BACK]. To reset all volumes, use

B

OPTIONS

0 mL 0 mL 393 mL


A

Cancel/ Back

B

OPTIONS

to highlight Total Vol, then press 8)

.

To restore all quantities, [CANCEL/BACK] select softkey.

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


0 mL 0 mL 0 mL


Cancel/ Back



6- 11

When clearing of quantities is completed, select [ENTER] to return to the Main Delivery screen.

10) Select [OPTIONS/VOL INF] from the Main Delivery screen to return to the Options screen. 11) Use to highlight the Pressure/Post Infusion Rate option. 12) Select

A

B

OPTIONS Release 11.x - xx/xx/xx Volumes Infused

Pressure/Post Infusion Rate Lighting/Contrast Select, then Choose Choose

Back

[CHOOSE] to continue.

NOTE: Prior to changing Pressure/Post Infusion Rate, inf must be stopped.

13) Use to highlight Continue Rate or Distal Pressure Limit field.

A

Pressure/Post Infusion Rate Continue Rate

14) Continue Rate allows a choice when VTBI is completed. Select [KVO/RATE].

B

OPTIONS

KVO

Distal Pressure Limit

6

psi

Distal Pressure

0

psi

Change using KVO/Rate KVO/ Rate

Enter

Cancel/ Back

•

KVO- The inf will revert to a fixed KVO of 1 mL/hr or the last programmed Rate, whichever is less.

•

Rate- The inf will continue at the Rate programmed.

NOTE: Option will be for both line A and line B selections.

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


6- 12


15) To change Distal Pressure Limit when highlighted, enter value between 1 and 15 psi. 16) Select [ENTER] to keep changes and return to the Main Delivery screen, or [CANCEL/ BACK] to restore original values Options screen. NOTE: Continue Rate default of KVO or Rate is a biomedical setting and must be configured as described in the Technical Service Manual.

17) Select [OPTIONS/VOL INF] from the Main Delivery screen to return to the Options screen.

A

B

OPTIONS Release 11.x - xx/xx/xx Volumes Infused

Pressure/Post Infusion Rate Lighting/Contrast

18) Use key to highlight Lighting/Contrast Option.

Select, then Choose Choose

Back

19) Select [CHOOSE] to continue. 20) Press key to highlight Backlight Intensity or Display Contrast. 21) While viewing display for desired effect, select either [INCREASE SETTING] or [DECREASE SETTING] to change level.

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

A

OPTIONS

B

Lighting/Contrast Backlight Intensity Display Contrast

Use Inc/Decrease Settings Decrease Increase Setting Setting

Enter

Cancel/ Back



6- 13

22) Select [ENTER] to keep change(s) and return to the Main Delivery screen, or [CANCEL/ BACK] to restore previous values and return to the Options screen.

6.7 Variable Rate Cap Variable Rate Cap is a biomed programmable item to set the maximum rate values to be accepted by the device. The clinician cannot change it once biomed has programmed it.

6.8 Examples of Automatic Calculation AT STARTUP 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 table below)

1st Action enter RATE enter VTBI enter RATE

2nd Action enter VTBI enter DURATION enter DURATION

[AUTOCALC] [DURATION] [RATE] [VTBI]

WHILE RUNNING (TITRATION) Changing two parameters after startup of the infusion will allow for the re-calculation of the third parameter.

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


6- 14


NOTE: VTBI will not be re-calculated if the Rate and Duration are changed. VTBI must be cleared and then the new VTBI re-entered. The new VTBI will automatically calculate a new Rate.

1st Action

2nd Action

[AUTOCALC]

change RATE change RATE change VTBI change DURATION change VTBI change RATE

keep VTBI change VTBI keep RATE keep VTBI change DURATION change DURATION

[DURATION] [DURATION] [DURATION] [RATE] [RATE] Recalculates [RATE] based on previous VTBI and new DURATION

AT KVO Audible KVO alarm will sound, clinician will need to re-set the appropriate settings.

1st Action enter VTBI enter DURATION change RATE enter DURATION enter VTBI change RATE

2nd Action keep RATE keep RATE enter VTBI enter VTBI enter DURATION change DURATION

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

[AUTOCALC] [DURATION] [VTBI] [DURATION] [DURATION] [RATE] [VTBI]



7- 1

7) Alarms and Troubleshooting 7.1 Warning Messages

CORRECTIVE ACTION

MESSAGE

POSSIBLE CAUSE

Stop delivery then turn off

Attempting to turn the inf off while a delivery is in progress.

Stop all lines, then turn inf off.

Warning: Replace Battery

The battery current charge is greater than 200 mA/hr.

Battery needs to be replaced.

The battery voltage is less than the depleted threshold and charge level is higher than the low charge threshold. Warning: Charger Service

The charging circuitry is not behaving as expected (charge voltage is not changing) and can reduce battery life.

Silence key is pressed.

Warning: Low Battery

Inf not plugged in to AC power.

Plug into AC power, only about 30 minutes of battery life remains.

NOTE: Other error and warning messages will occur when appropriate for the current selection context. For instance, when a change to a required parameter would result in clearing some delivery values, the warning message will appear when that field is selected. When an input error has just been made, the three quick beeps of an Invalid Key Warning will sound and an appropriate

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


7- 2

7) Alarms and Troubleshooting

warning message will be shown to explain the problem. All such messages will be cleared or replaced by another message upon the next valid input key press.

7.2 Response to Alarms 1. Disable Lockout by confirming back switch is in the down position or press the decimal key followed by 9, 6, & 3 on the keypad. 2. Press [SILENCE] key. 3. Identify/Observe Alarm condition. 4. Correct Alarm condition (see following tables). 5. Press [START] to resume infusion. NOTE: Alarm messages begin with an alphanumeric code for tracking purposes only. If troubleshooting does not correct the problem, record the code number and technical .

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



7- 3

GENERAL ALARMS

CODE

MESSAGE

POSSIBLE CAUSE

CORRECTIVE ACTION

N100

Unrecognized cassette

Attempting to use unrecognized cassette.

Turn off or insert recognized cassette.

N101

No Action Alarm

Inf programming incomplete.

Press [START] or continue programming.

N102

Inf Idle 2 Minutes

Pump is ON without operator input.

Begin programming or turn inf OFF.

Standby time has elapsed.

Re-enter all programmed data.

N103

Memory Failure

The inf did not accept the previous programmed data.

Re-enter all programmed data.

N230

Prox Air, Backprime

When the total proximal air detected exceeds the limit.

Check for clamps, or empty containers on line A or B. Correct as necessary. Backprime into line B tubing or syringe.

N180, N181, N186

Distal Occlusion

Distal line kinked, IV site clotted or positional, pressure limit set too low.

Check distal tubing, check IV site, reset pressure limit. See page 1-17 for detailed instructions for avoiding a bolus following a distal occlusion.

N187

Neg Distal Occlusion

Pump too high above patient or defective set.

Lower inf or replace set.

N233, N234

Distal Air

When air is detected at the distal sensor and exceeds the limit.

Remove and reprime cassette using standard technique.

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


7- 4


CODE

MESSAGE

POSSIBLE CAUSE

CORRECTIVE ACTION

N250

Door open while pumping

Pump door opened while operating.

Close door with cassette inserted.

N251

Cassette Test Failure

Faulty cassette, proximal or distal occlusion or air in cassette detected at start up.

Check clamps, manually reprime set, close door. Backprime into line B tubing or syringe if appropriate. If alarm recurs on retest, replace set. If alarm repeats, replace inf.

N252

Depleted Battery

Too much time on battery power.

Plug into AC (mains) power.

N253

Hard lockout Violation

The use of the [STOP] key during delivery, or opening the door, while lockout is enabled.

Unlock lockout switch.

N254

Hard lockout Enabled

Pressing of any key except [STOP] during delivery while any alarm is active and lockout is enabled.

Unlock lockout switch.

N255

Soft lockout Violation

The use of the [STOP] key during delivery, or opening the door, while lockout is enabled.

Unlock lockout by pressing the decimal key, followed by 9, 6, & 3 on the keypad.

N256

Soft lockout Enabled

Pressing of any key except [STOP] during delivery while any alarm is active and lockout is enabled.

Unlock lockout by pressing the decimal key, followed by 9, 6, & 3 on the keypad.

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



7- 5

LINE A ALARMS CORRECTIVE ACTION

CODE

MESSAGE

POSSIBLE CAUSE

N105

Callback Line A

Alarm programmed by . Change in delivery for Loading Dose to Maintenance Step or for any step in “Multistep” therapy provided the step is not the last step.

Press [SILENCE].

N161

Line A VTBI complete

VTBI complete on line A.

Program new VTBI.

N185

Prox Occl A At Startup

Proximal line obstructed, line A container (or syringe) disconnected or obstructed during nondelivery (startup).

Examine line A for kinks or closed clamps. If there are closed clamps, open the clamps. Then, open and close door. Continue programming. Replace set if problem persists. If clamps are not opened prior to completion of cassette test, peak proximal occlusion may recur. For syringe, select [Backprime].

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


7- 6

7) Alarms and Troubleshooting CORRECTIVE ACTION

CODE

MESSAGE

POSSIBLE CAUSE

N184, N190, N191

Prox Occl A / Air

Proximal line obstructed, line A container disconnect or obstruction.

Examine line A for kinks, closed clamps, or air in cassette.

N232

Prox Air A, Backprime

When proximal air detected exceeds the limit for the line.

Check for clamps, or empty container. Correct as necessary. Backprime into line B tubing or syringe.

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7- 7

LINE B ALARMS POSSIBLE CAUSE

CORRECTIVE ACTION

Callback Line B

Alarm programmed by . Change in delivery for piggyback delivery, Loading Dose to Maintenance Step, or for any step in “Multistep” therapy provided the step is not the last step.

Press [SILENCE].

N160

Line B VTBI complete

VTBI complete on line B.

Program new VTBI.

N183

Prox Occl B At Startup

Proximal line obstructed, line B container (or syringe) disconnected or obstructed during non-delivery (startup).

Examine line B for kinks or closed clamps. If there are closed clamps, open the clamps. Then, open and close door. Continue programming. Replace set if problem persists.

CODE

MESSAGE

N104

If clamps are not opened prior to completion of cassette test, peak proximal occlusion may recur. For syringe, select [Backprime].

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


7- 8


CODE

MESSAGE

N182, N188, N189

Prox Occl B / Air

N231

Prox Air B, Backprime

POSSIBLE CAUSE

CORRECTIVE ACTION

Proximal line obstructed, line B container disconnected or obstructed.

Examine line B for kinks, closed clamps, or air in cassette.

When proximal air detected exceeds the limit for the line.

Check for clamps, or empty container. Correct as necessary. Backprime into line B tubing or syringe.

Occlusion caused by empty container, backprime into line B tubing or syringe.

MALFUNCTIONS

CODE

MESSAGE

E300 or higher

Malfunction

POSSIBLE CAUSE

CORRECTIVE ACTION

A failure has occurred in the inf’s internal systems.

Record Malfunction error code. Pump must be turned OFF to clear malfunction. If alarm malfunction repeats, replace inf.

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



8)

8- 1

Maintenance and Storage

8.1 Cleaning, Maintenance, and Storage The cleaning, maintenance, and storage of the Plum A+ are described in this section.

CLEANING AND SANITIZING For proper maintenance of the Plum A+, observe the following cleaning and sanitizing guidelines. Establish a routine weekly schedule for cleaning the inf. To clean, proceed as follows: •

Turn the Plum A+ off using the [ON/OFF] switch

•

Disconnect from AC (mains) power

The exposed surfaces of the Plum A+ may be cleaned with a lintfree cloth dampened by one of the recommended cleaning solutions in the following list or mild, nonabrasive soapy water. Clean the cassette door with a soft, lint-free cloth, dampened with one of the cleaning agents listed in the following table, or a mild solution of soapy water. Use a small non-abrasive brush to aid in cleaning the infusion system housing and subsystem chassis components. To thoroughly clean the cassette receptacle, disengage the cassette door from the door latch by pressing the door release tab. CAUTION:

DO NOT ALLOW CLEANING SOLUTIONS TO SATURATE THE AIR-IN-LINE DETECTORS OR ENTER THE DEVICE WHEN CLEANING THE AIR-IN-LINE DETECTORS.

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


8- 2

CLEANING SOLUTION

8) Maintenance and Storage

MANUFACTURER

PREPARATION

CoverageTMHBV

Steris Corporation, A division of Calgon Vestal Laboratories

Per manufacturer's recommendation

Formula CTM

Diversey Corporation


Dispatch®

Caltech Industries


Precise®

Caltech Industries


Household bleach

Various

Per hospital procedures; do not exceed one part bleach in ten parts water

Manu-Klenz®

Calgon Vestal Laboratories


Sporicidin®

Sporicidin International


Super Edisonite®

S. M. Edison Co.


The rubber pad on the Plum A+3 pole clamp, as well as the IV poles for both instruments, may be cleaned using isopropyl alcohol. On a routine basis, clean all of the elements behind the cassette door using cotton-tipped swabs saturated with cleaning solution. The cassette door may be unlatched from the door handle to facilitate cleaning.

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



8- 3

To unlatch the cassette door from its handle, tilt the device back, open the cassette door, then push the door release tab to open the door fully. CAUTION: T O AVOID MECHANICAL OR ELECTRONIC DAMAGE, DO NOT IMMERSE THE PLUM A+ IN ANY FLUIDS OR CLEANING SOLUTIONS. CAUTION: DO NOT SPRAY CLEANING SOLUTIONS TOWARD ANY OPENING IN THE INSTRUMENT. CAUTION:

CERTAIN CLEANING AND SANITIZING SOLUTIONS MAY SLOWLY DEGRADE COMPONENTS MADE FROM SOME PLASTIC MATERIALS . U SING 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. CAUTION:

N EVER USE SHARP OBJECTS SUCH AS FINGERNAILS, PAPER CLIPS, OR NEEDLES TO CLEAN ANY PART OF THE INF. CAUTION: DO NOT STERILIZE BY HEAT, STEAM, ETHYLENE (ETO), OR RADIATION.

OXIDE

CAUTION: T O AVOID INF DAMAGE , CLEANING SOLUTIONS SHOULD ONLY BE USED AS DIRECTED. THE DISINFECTING PROPERTIES OF CLEANING SOLUTIONS VARY; CONSULT THE MANUFACTURER FOR SPECIFIC INFORMATION.

BATTERY MAINTENANCE CAUTION: DO NOT OPERATE THE INF ON PATIENTS WITH THE BATTERY REMOVED . U SE OF A PROPERLY MAINTAINED AND CHARGED BATTERY HELPS CONFIRM PROPER OPERATION. CAUTION: CONNECT TO

I F THE LOW - BATTERY ALARM SOUNDS , AC (MAINS) POWER IMMEDIATELY.

The Plum A+ is battery powered for emergency backup and temporary portable operation. A fully charged, new battery provides six hours of operation at 125 ml/hr or 500 ml total volume delivered, whichever occurs first.

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


8- 4

8) Maintenance and Storage

NOTE: For optimum battery life, the Plum A+ should be operated on battery power for six continuous hours at least once every six months and then charged for a minimum of eight hours. The battery charges whenever connected to AC (mains) power. If the inf is switched OFF, recharge takes approximately six hours. Recharge takes longer if the inf is turned ON. As a general rule, the more often the battery is partially discharged and recharged, the sooner it will need to be replaced. Consult a qualified biomedical technician for battery replacement if necessary. To maintain maximum battery charge and to prolong battery life, connect the inf to AC (mains) power whenever possible.

STORAGE To prolong the life of the Plum A+, observe the following storage precautions: •

Store the away from excessive heat, cold, and humidity

•

Store connected to AC (mains) power

•

Switch the inf OFF using the [ON/OFF] key

SERVICE All servicing or adjustments to the Plum A+ should be referred to qualified technical personnel. A technical service manual may be ordered from the local Hospira sales office.

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

sec09.fm Page 1 Tuesday, September 9, 2008 10:11 AM


9)

9- 1

Specifications

NOTE: Specification information applies to both systems (Plum A+ & Plum A+3) unless otherwise noted.

PHYSICAL DimensionsPlum A+: Plum A+3: Weight- Plum A+: Plum A+3: Casing:

Approximately 8” X 8” X 6”, excluding pole clamp protrusion and power cord storage. Approximately 19” X 15” X 14”, including pole clamp, barcode wand holder, and power cord. Approximately 9.5 lbs. with battery. Approximately 28 ibs. with (3) batteries. High-impact plastic.

ELECTRICAL Power RequirementsPlum A+:

120 V~, 50-60 Hz, 50 VA.

Plum A+3:

120 V~, 50-60 Hz, 150 VA.

Fuses: Power Cord: Battery- Plum A+: Plum A+3: Battery Life:

F1, F2, 250V~, 0.5 A. (internal) Hospital-grade AC cord. 10 ft long, with transparent plug and retainer plate. One sealed, lead-acid, rechargeable 6 V battery, internal to device. Three sealed, lead-acid, rechargeable 6 V batteries, internal to device. With a new fully charged battery, the inf shall operate for a minimum of six hours at 125 mL/hr or less, or deliver 500 mL at 126 mL/hr or greater on one line.

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


9- 2

9) Specifications Recharge:

Electrical Leakage: NURSE-CALL System:

The battery charges whenever the inf(s) is connected to AC power. The recharge time is approximately six hours with the device operating at 125 mL/hr on one line. Meets ANSI/AAMI ES1-1993 standard: Safe Current Limits for Electro-medical Apparatus. NURSE-CALL alarm is factory set for NormallyOpen (NO) the Technical Services Center to make an internal adjustment to change the device from Normally-Open (NO) to Normally Closed (NC) system.

Circuitry Ratings:

Voltage-30 VDC Max Current- 0.25 Amps Max Rating- 3 Watts Max

VTBI RANGE VTBI Range:

0.1 to 99.9 mL (in 0.1 mL increments) 100 to 9999 mL (in 1 mL increments)

ENVIRONMENT Operating Temperature: Storage Temperature: Atmospheric Pressure: Relative Humidity:

5° to 40° C -20° to 60° C 0 - 10,000 feet (0 - 3,000m) or equivalent pressure 10 - 90% (40° C Max)

DELIVERY RATE RANGE Lines A and B:

0.1 - 99.9 mL/hr (in 0.1 mL increments) 100 - 999 mL/hr (in 1 mL increments)

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


Plum A+ Infusion Systems Concurrent Delivery: PlumSet: KVO:

9- 3

0.5 mL/hr minimum for each line 500 mL/hr cumulative (A+B) maximum 1.0 mL/hr or the last primary delivery rate, whichever is less

AIR-IN-LINE ALARM PlumSet (Distal):

Bolus 0.1 mL (100 microliters) or larger for delivery rates less than 500 mL/hr. Bolus 0.5 mL (500 microliters) or larger for delivery rates equal to or greater than 500 mL/hr. Cumulative 0.25 mL out of 2.6 mL for delivery rates less than 500 mL/hr. Cumulative 0.50 mL out of 5.3 mL for delivery rates equal to or greater than 500 mL/hr.

PlumSet (Proximal):

Bolus at 0.5 mL, Total 1.0 mL

OCCLUSION ALARM AND LIMITS Distal Occlusion:

The DISTAL OCCLUSION alarm sounds after the distal set tubing or set outlet fitting becomes occluded.

Proximal Occlusion:

The PROXIMAL OCCLUSION alarm sounds if the tubing proximal to the cassette becomes occluded.

Distal Pressure Limit (without alarm):

1 to 15 psig. The maximum pressure is -selectable. Factory default setting is 6 psig.

Maximum Infusion Pressure:

20 psig

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


9- 4

9) Specifications

TIME TO DETECT DOWNSTREAM OCCLUSIONS OCCLUSION ALARM PRESSURE SETTING

TYPICAL TIME TO ALARM (MACRO)

MAXIMUM TIME TO ALARM (MACRO)

25 mL/ hr

6 psig

38 seconds

47 seconds

15 psig

98 seconds

106 seconds

1 mL/hr

6 psig

17 minutes

22 minutes

15 psig

45 minutes

49 minutes

RATE

* Baseline backpressure is 0 psig *

BOLUS VOLUME RELEASED AFTER DOWNSTREAM OCCLUSIONS ARE CORRECTED OCCLUSION ALARM PRESSURE SETTING

TYPICAL BOLUS VOLUME (MACRO)

MAXIMUM BOLUS VOLUME (MACRO)

25 mL/ hr

6 psig

0.23 mL

0.28 mL

15 psig

0.55 mL

0.63 mL

1 mL/hr

6 psig

0.24 mL

0.30 mL

15 psig

0.59 mL

0.70 mL

RATE

* Baseline backpressure is 0 psig *

DELIVERY ACCURACY The Plum A+ Inf was designed and manufactured to maintain a volumetric delivery rate error of the total fluid delivered of less than or equal to ± 5% over the course of 48 hours at a programmed rate of 1 to 999 mL/hr during normal operating conditions. For use of the device at rates below 1 mL/hr, the delivery rate error is less than or equal to ± 10%. Backpressure Effect- Positive backpressure on the distal line may affect delivery accuracy by no more than 0.5% per psig (2% per

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



9- 5

psig for rates between 0.1 and 0.9 mL/hr) for backpressures up to 15 psig. A typical deviation under these conditions is 0.3%. Negative backpressure may affect delivery accuracy no more than 2% for pressures up to -2 psig (56 inches of water). A typical deviation under these conditions is 0.3%. Filling Head Effect- Variations in filling head (such as container height) may affect delivery accuracy by no more than 2% for variations in the range -15 to +28 inches. A typical deviation under these conditions is 0.5%. Concurrent Delivery Effect- When both lines (A & B) are delivering, the ratio of delivery for the fluid with the lowest rate may be affected by as much as 5% for ratios up to 9 to 1. For higher ratios, the absolute percentage of delivery for the lowest rate may be affected by no more than 0.5%. When air is present in the bubble trap, the absolute percentage of delivery for the lowest rate may be affected by up to 2.0%. When variations in container height are present, the absolute percentage of delivery for the lowest rate may be affected by up to 2.5% for up to 24 inches of container height differences.

ENTERAL & HIGH VISCOSITY FLUIDS EFFECTS System delivery accuracy limits for each Enteral and High Viscosity Fluid, such as those listed in the following table, can be degraded by an additional maximum of 5%. System accuracy for Enteral Fluids is defined only for rates of 1 to 200 mL/hr, with no suspended air in the solution, and using an Hospira Plum enteral set.

ENTERAL/HIGH VISCOSITY FLUIDS Dextrose 20% to 50% concentration Isomil Powder Similac Powder Ensure Plus HN Twocal HN Jevity

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


9- 6

9) Specifications

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: 1998, Sub-Clause 50.102. 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 (Average of 3 infs) 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”).

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).

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



9- 7

For other time intervals look at other points at the horizontal axis and determine corresponding limits as above. 25 ML/HR, 0 mmHg DELIVERY HEAD, START UP

A PERCENT ERROR (%)

15% 10%

B

Max Positive Error over 5 Minute Interval = +2.8%

5%

+

+

0%

+

+

+ C Max Negative Error over 5 Minute Interval = -0.5%

-5% -10%

D

Average Delivery Rate Error = +1.6%

-15% 0

5

10 15 20 Observation Interval (minutes) Max

+

Min

25

30

Mean

A trained professional can use the resulting graphs to select an inf 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 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 istered 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.

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


9- 8

9) Specifications 25 ML/HR, 0 mmHg DELIVERY HEAD, START UP (Typical) 50 45 40

Rate (ml/hr)

35 30 25 20 15 10 5 0 -5 -10 0

10

20

30

40

50

60

70

80

90

100

110

Time (minutes) Actual Rate

Programmed Rate

25 ML/HR, 0 mmHg DELIVERY HEAD, START UP (Typical)

Percent Error (%)

15% 10% 5% 0% -5%

-10% -15% 0

5

10

15

20

25

30

Observation Interval (minutes) Max

Min

Mean

25 ML/HR, 0 mmHg DELIVERY HEAD, START UP (Composite of 3 Pumps)

Percent Error (%)

15% 10% 5% 0% -5% -10% -15% 0

5

10

15

20


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

Min

Mean

25

30

120



9- 9

25 ML/HR, 0 mmHg DELIVERY HEAD , 96 HOURS (Typical) 50 45

Rate (ml/hr)

40 35 30 25 20 15 10 5 0 0

10

20

30

40

50


Programmed Rate

25 ML/HR, 0 mmHg DELIVERY HEAD, 96 HOURS (Typical) Percent Error (%)

15% 10% 5% 0% -5% -10% -15% 0

5

10

15

20

25

30


Min

Mean

25 ML/HR, 0 mmHg DELIVERY HEAD, 96 HOURS (Composite of 3 Pumps)

Percent Error (%)

15% 10% 5% 0% -5% -10% -15% 0

5

10

15

20

25

30


Min

Mean

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


9- 10

9) Specifications

Rate (ml/hr)

1 ML/HR, 0 mmHg DELIVERY HEAD, START UP (Typical) 2.0 1.8 1.6 1.4 1.2 1.0 0.8 0.6 0.4 0.2 0.0 -0.2 -0.4 0

10

20

30

40

50

60

70

80

90

100

110


Programmed Rate

1 ML/HR, 0 mmHg DELIVERY HEAD, START UP (Typical)

Percent Error (%)

15% 10% 5% 0% -5%

-10% -15% 0

5

10

15

20

25

30


Min

Mean

1 ML/HR, 0 mmHg DELIVERY HEAD, STARTUP (Composite of 3 Pumps)

Percent Error (%)

15% 10% 5% 0% -5% -10% -15% 0

5

10

15

20


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

Min

Mean

25

30

120



9- 11

Rate (ml/hr)

1 ML/HR, 0 mmHg DELIVERY HEAD, 96 HOURS (Typical) 2.0 1.8 1.6 1.4 1.2 1.0 0.8 0.6 0.4 0.2 0.0 0

10

20

30

40

50


Programmed Rate

1 ML/HR, 0 mmHg DELIVERY HEAD, 96 HOURS (Typical)

10% 5% 0% -5% -10% -15% 0

5

10

15

20

25

30


Min

Mean

1 ML/HR, 0 mmHg DELIVERY HEAD, 96 HOURS (Composite of 3 Pumps) 15%

Percent Error (%)

Percent Error (%)

15%

10% 5% 0% -5% -10% -15% 0

5

10

15

20

25

30


Min

Mean

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


9- 12

9) Specifications

NOTES

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



10- 1

10) Supplies and Accessories 10.1 istration Fluids ISTRATION FLUIDS •

All parenteral fluids

•

Whole Blood

•

Blood fractions

ENTERAL AND HIGH VISCOSITY FLUIDS •

Dextrose 20% to 50% concentration

•

Isomil Powder

•

Similac Powder

•

Ensure plus HN

•

TwoCal HN

•

Packed red cells

CONTAINERS •

Dual Chamber Parenteral flexible container (Nutrimix)

•

Large Volume Parenteral flexible plastic containers, including premixed

•

Large Volume Parenteral glass containers, including premixed and nutritional

•

Part Fill Parenteral flexible plastic containers, including ADD-Vantage

•

Part Fill Parenteral glass containers

•

Small Volume Parenterals

•

Syringes (may require special adapters)

•

Top Filled Enteral bags

•

Ready to hang Enteral solution containers

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


10- 2

10) Supplies and Accessories

10.2 Accessories •

Syringe Adaptor- List# 11986-48

•

Mini Pole- List# 12096-04

•

Secondary Container - List# 12095-03

•

Tandem Carrier- List# 12270-01

•

Plum A+3 IV Pole (upright)- 12577-04-01

•

Plum A+3 IV Pole (base)- 12576-04-01

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



11)

11- 1

Warranty

Subject to the and conditions herein, Hospira, Inc., herein referred to as Hospira, warrants that (a) the product shall conform to Hospira’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. Hospira 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 Hospira’s option, the repair or replacement of the product. In no event shall Hospira’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 Hospira be liable for incidental, consequential, or special damages or losses or for lost business, revenues, or profits. Warranty product returned to Hospira 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 Hospira’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 Hospira and using Hospira 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.

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


11- 2

11) Warranty

In providing any parts for repair or service of the product, Hospira 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 a Hospira representative performing repair or service is not an authorized agent of Hospira.

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



12)

12- 1

Drug List

Use drug manufacturer recommendations for IV istration when using the Plum A+ inf.

DRUG NAME

DEFAULT DOSE RATE

DEFAULT CONCENTRATION

No Drug Selected

mL/hr

Abciximab

mcg/kg/min

Acyclovir

mL/hr

N/A

Albumin

mL/hr

N/A

Aldesleukin

mL/hr

N/A

Alfentanil

mcg/kg/min

mcg/mL

Alteplase (rt-PA)

mg/kg/hr

mg/mL

Amikacin

mL/hr

Aminocaproic Acid

grams/hr

grams/mL

Aminophylline

mg/hr

mg/mL

Amiodarone

mg/min

mg/mL

Amphotericin B

mL/hr

N/A

Ampicillin-sublactam

mL/hr

N/A

Analgesic

mL/hr

N/A

Antibiotic

mL/hr

N/A

Atracurium

mL/hr

N/A

Azithromycin

mL/hr

N/A

Bleomycin

mL/hr

N/A

Blood Products

mL/hr

N/A

Bretylium

mg/min

Carboplatin

mL/hr

N/A

Cefazolin

mL/hr

N/A

Cefapime

mL/hr

N/A

N/A mg/mL

N/A

mg/mL

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


12- 2

12) Drug List

DRUG NAME

DEFAULT DOSE RATE

Cefoperazone

mL/hr

N/A

Cefotaxime

mL/hr

N/A

Cefotetan

mL/hr

N/A

Cefoxitin

mL/hr

N/A

Ceftazidime

mL/hr

N/A

Ceftizoxime

mL/hr

N/A

Ceftriaxone

mL/hr

N/A

Cefuroxime

mL/hr

N/A

Chemotherapy

mL/hr

N/A

Cimetidine

mL/hr

N/A

Ciprofloxacin

mL/hr

N/A

Cisplatin

mL/hr

N/A

Clindamycin

mL/hr

N/A

Co-trimoxazole

mL/hr

N/A

Cyclophosphamide

mL/hr

N/A

Cyclosporine

mL/hr

N/A

Cytarabine

mL/hr

N/A

Dexmedetomidine HCl

mcg/kg/hr

mcg/mL

Diltiazem

mg/hr

mg/mL

Dobutamine

mcg/kg/min

mg/mL

Docetaxel

mL/hr

Dopamine

mcg/kg/min

Doxorubicin

mL/hr

Epinephrine

mcg/min

mg/mL

Epoprostenol

ng/kg/min

mg/mL

Eptifibatide

mcg/kg/min

mg/mL

Erythromycin

mL/hr

Esmolol

mcg/kg/min

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


N/A mg/mL N/A

N/A mg/mL



12- 3

DRUG NAME

DEFAULT DOSE RATE


Etomidate

mL/hr

N/A

Etoposide

mL/hr

N/A

Famotidine

mL/hr

N/A

Fentanyl

mL/hr

N/A

Fluconazole

mL/hr

N/A

Flumazenil

mL/hr

N/A

Fluorouracil

mL/hr

N/A

Furosemide

mL/hr

N/A

Gatifloxacin

mL/hr

N/A

Gentamicin

mL/hr

N/A

Heparin

units/kg/hr

Hetastarch/NaCl

mL/hr

N/A

Hextend

mL/hr

N/A

Hydromorphone

mL/hr

N/A

Ifosfamide

mL/hr

N/A

Imipenem Cilastatin

mL/hr

N/A

Immune Globulin IV

mL/hr

N/A

Insulin

units/hr

Isoproterenol HCl

mL/hr

Labetalol

mg/min

mg/mL

Lepirudin

mg/kg/hr

mg/mL

Leucovorin

mL/hr

N/A

Levofloxacin

mL/hr

N/A

Lidocaine

mg/min

Lipids

mL/hr

N/A

Lorazepam

mL/hr

N/A

Magnesium Infusion

grams/hr

grams/mL

Mannitol

grams/hr

grams/mL

units/mL

units/mL N/A

grams/mL

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


12- 4

12) Drug List

DRUG NAME

DEFAULT DOSE RATE

Mesna

mL/hr

N/A

Methohexital

mL/hr

N/A

Methotrexate

mL/hr

N/A

Methylprednisolone

mL/hr

N/A

Metoclopramide

mL/hr

N/A

Metronidazole

mL/hr

N/A

Midazolam

mL/hr

N/A

Milrinone

mcg/kg/min

mg/mL

Morphine

mg/hr

mg/mL

Nafcillin

mL/hr

N/A

Naloxone

mL/hr

N/A

Nitroglycerin

mcg/min

mg/mL

Nitroprusside

mcg/kg/min

mg/mL

Norepinephrine

mcg/min

mg/mL

Ofloxacin

mL/hr

N/A

Ondansetron

mL/hr

N/A

Oxacillin

mL/hr

N/A

Oxytocin

mUn/min

Paclitaxel

mL/hr

Pancuronium

mg/kg/hr

mg/mL

Pantoprazole

mg/min

mg/mL

Penicillin

mL/hr

N/A

Pentobarbital

mL/hr

N/A

Phenylephrine

mcg/min

Piperacillin-bactam

mL/hr

Potassium Infusion

mEq/hr

mEq/mL

Procainamide

mg/min

grams/mL

Propofol

mcg/kg/min

mg/mL

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


units/mL N/A

mg/mL N/A



12- 5

DRUG NAME

DEFAULT DOSE RATE


Quinolone

mL/hr

N/A

Ranitidine

mL/hr

N/A

Streptokinase

units/hr

Teniposide

mL/hr

Theophylline

mg/kg/hr

Ticar-calvulanate

mL/hr

Tirofiban

mcg/kg/min

Tobramycin

mL/hr

N/A

TPN

mL/hr

N/A

Urokinase

mL/hr

N/A

Vancomycin

mL/hr

N/A

Vecuronium

mL/hr

N/A

Verapamil

mL/hr

N/A

Vincristine

mL/hr

N/A

units/mL N/A mg/mL N/A mg/mL

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


12- 6

12) Drug List

NOTES

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


Plum A+ Infusion Systems For customer service within the United States, : 1-877-9-HOSPIRA (1-877-946-7747) For technical assistance, product return authorization, and to order parts, accessories, or manuals within the United States, Hospira, Inc. Technical Operations: 1-800-241-4002 To order parts using the online eCatalog, technical publications, technical training courses, and additional services, visit the website at: www.hospiraparts.com After authorization, ship prepaid product returns to the following address: Hospira, Inc. Technical Operations 755 Jarvis Drive Morgan Hill, CA 95037 Outside the U.S., your local Hospira, Inc. sales office.

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


CAUTION: FEDERAL (USA) LAW RESTRICTS THIS INF TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR OTHER LICENSED PRACTITIONER.

WARNING POSSIBLE EXPLOSION HAZARD EXISTS IF THE INF IS USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS.

Plum A+ Infusion Pump is a ed trademark of Hospira, Inc. Hospira MedNet, LifeShield, and E.L.I. are trademarks of Hospira Incorporated. CLAVE, Teflon, Formula C, Manu-Klenz, Super Edisonite, Coverage, Sporicidin, Dispatch, and Precise are not trademarks of Hospira.

Equipment providing adequate degree of protection against electrical shock and suitable for application to patient

Type CF

IPX1

Drip Proof Medical Equipment

Class 1 ® C

US

Protected against dripping water

Mains supply equipment using protective earth

UL 60601-1 CSA 601.1 MCN 160992

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

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