Plum A+ System Operating Manual Rev A Feb 2013

ii

Change History

Change History Description of Changes

Section

430-95491-003 (Rev. 03/06)

Third Release

All

430-95491-005 (Rev. 2013-02)

Replaced ® with ™, removed copyright and trademark statements, updated regulatory symbols

All

Added precaution to prevent unrestricted flow

1 and 2

Rewrote air bubble precaution and air filter recommendation. Added low flow rate range

1

Updated alarm volume instructions

3

Added administration set graphic and warning to prevent unrestricted flow

4

Added instructions for closing clamps

4 and 5

Updated air in line alarm distal and cumulative bolus amounts

9

Title

System Operating Manual

Plum A+ Infusion System

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Contents 1) DESCRIPTIVE INFORMATION... 1-1 1.1 PRODUCT DESCRIPTION... 1-2 1.2 INDICATIONS FOR USE... 1-2 USER QUALIFICATION... 1-2

1.3 CONVENTIONS... 1-3 WARNINGS, CAUTIONS, AND NOTES... 1-4

1.4 PRECAUTIONS... 1-5 ARTIFACTS... 1-5 HEALTHCARE PROFESSIONALS AND PATIENT RELATED . 1-6 CONCURRENT FLOW... 1-8 EPIDURAL ADMINISTRATION... 1-9 BATTERY OPERATION... 1-11 SETS AND ACCESSORIES... 1-11 BACKPRIMING... 1-12 GENERAL... 1-12 CLEANING... 1-13 BOLUS RELATED... 1-13

2) PRINCIPLES OF OPERATION... 2-1 2.1 FEATURES... 2-1 THERAPIES... 2-1 LINE PROGRAMMING OPTIONS... 2-1 PLUMSET CAPABILITIES... 2-2 AIR MANAGEMENT... 2-2 BATTERY... 2-2 BIOMEDICAL... 2-2 OPTIONS... 2-2 OTHER FEATURES... 2-3

2.2 DEFINITIONS... 2-3

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Contents

3) EQUIPMENT DESCRIPTION... 3-1 3.1 OPERATING KEYS... 3-2 3.2 INDICATORS... 3-5 3.3 DISPLAY SYMBOLS... 3-6 3.4 REAR CASE CONTROLS... 3-7 3.5 ADMINISTRATION SETS... 3-9 PREPARING THE ADMINISTRATION SET... 3-10 PRIMING THE ADMINISTRATION SET... 3-11 LOADING THE CASSETTE... 3-11 PREPARING THE SECONDARY LINE... 3-12

3.6 DISCONTINUING ELECTRONIC FLOW CONTROL AND SETTING GRAVITY FLOW... 3-14 3.7 DISCONTINUING FLUID ADMINISTRATION... 3-15 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... 4-10 4.5 PIGGYBACK DELIVERY... 4-14 4.6 CONCURRENT DELIVERY... 4-17 4.7 STOP AND START WITH ONLY 1 LINE PUMPING . . 4-20 4.8 STOP AND START WITH BOTH LINES PUMPING . . 4-21 4.9 BACKPRIMING... 4-23 4.10 CLEARING SETTINGS... 4-24 5) THERAPIES... 5-1 5.1 DOSE CALC (MCG/KG/MIN ON A)... 5-2 5.2 DOSE CALC (MG/MIN ON B)... 5-9 5.3 LOADING DOSE... 5-15 5.4 MULTISTEP PROGRAMMING... 5-23

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6) ADDITIONAL FEATURES... 6-1 6.1 SIMPLE DELIVERY USING DELAYED START... 6-1 6.2 PIGGYBACK WITH NURSE CALLBACK... 6-3 6.3 POSSIBLE NON-DELIVERY PROGRAMMED... 6-4 6.4 USING THE STANDBY FEATURE... 6-5 6.5 SELECT OPTION- VOLUMES INFUSED, PRESSURE/POST INFUSION RATE, AND LIGHTING/CONTRAST... 6-6 6.6 VARIABLE RATE CAP... 6-10 6.7 EXAMPLES OF AUTOMATIC CALCULATION... 6-10 AT STARTUP... 6-10 WHILE RUNNING (TITRATION)... 6-10 AT KVO... 6-11

7) ALARMS AND TROUBLESHOOTING... 7-1 7.1 WARNING MESSAGES... 7-1 7.2 RESPONSE TO ALARMS... 7-2 GENERAL ALARMS... 7-3 LINE A ALARMS... 7-5 LINE B ALARMS... 7-7 MALFUNCTIONS... 7-8

7.3 GENERAL MESSAGES... 7-9 8) CLEANING, MAINTENANCE, AND STORAGE... 8-1 CLEANING AND SANITIZING... 8-1 BATTERY MAINTENANCE... 8-3 STORAGE... 8-4 SERVICE... 8-4

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Contents

9) SPECIFICATIONS... 9-1 PHYSICAL... 9-1 ELECTRICAL... 9-1 VTBI RANGE... 9-2 ENVIRONMENT... 9-2 DELIVERY RATE RANGE... 9-2 AIR-IN-LINE ALARM... 9-3 OCCLUSION ALARM AND LIMITS... 9-3 TIME TO DETECT DOWNSTREAM OCCLUSIONS... 9-3 BOLUS VOLUME RELEASED AFTER DOWNSTREAM OCCLUSIONS ARE CORRECTED... 9-4 DELIVERY ACCURACY... 9-4 ENTERAL AND HIGH VISCOSITY FLUIDS EFFECTS... 9-5 TRUMPET CURVES... 9-6 EXAMPLE... 9-6

10) SUPPLIES AND ACCESSORIES... 10-1 10.1 ADMINISTRATION FLUIDS... 10-1 ADMINISTRATION FLUIDS... 10-1 ENTERAL AND HIGH VISCOSITY FLUIDS... 10-1 CONTAINERS... 10-1

10.2 ACCESSORIES... 10-2 GENERAL... 10-2 PC BASED APPLICATION... 10-2

11) WARRANTY... 11-1 12) DEFAULT DRUG LIBRARY... 12-1

All Rights Reserved

System Operating Manual

Plum A+ Infusion System

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Descriptive Information

The Plum A+TM Volumetric Infusion System is designed to meet the fluid delivery requirements of today’s evolving healthcare environments. The pump is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: •

Standard Infusions

•

Multistep Programming

•

Loading Dose

•

Dose Calculation

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

•Neonatology

•Emergency

•Nutritional

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1) Descriptive Information

1.1 Product Description The system includes a pumping module (hereafter called the pump) and an assortment of disposable IV sets (hereafter called a set), optional accessories, and this operator’s manual. Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC Standards (for example, IEC 60950 for data processing equipment and IEC 60601-1 for Medical Equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Any person who connects additional equipment to the signal input or output part configures a medical system, and is therefore responsible for ensuring that the system complies with the requirements of the system Standard IEC 60601-1-1. If in doubt, consult the technical service department or your local representative. NOTE: Do not connect to Dataport while infusing.

1.2 Indications for Use USER QUALIFICATION The Plum A+ is intended for use at the direction or under the supervision of licensed physicians or certified healthcare professionals who are trained in the use of the pump and the administration of parenteral, enteral, and epidural fluids and drugs and whole blood or red blood cell components. The training should emphasize preventing related IV complications, including appropriate precautions to prevent accidental infusion of air. The epidural route can be used to provide anesthesia or analgesia.

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

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

APPLICATION

EXAMPLE

Italic

Reference to a 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]

 [Italic]

Softkey Options

 [Choose]

Initial Caps lowercase

Screen displays and device labels (as appropriate)

Therapy

[BRACKETED ALL CAPS]

System Operating Manual

or

Dose Calculation

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1) Descriptive Information

CONVENTION

APPLICATION

EXAMPLE

Bold

Emphasis

...sets are supplied Sterile and are for...

WARNINGS, CAUTIONS, AND NOTES Alert messages used throughout this manual are described below. Pay particular attention to these messages.

WARNING A WARNING MESSAGE CONTAINS SPECIAL SAFETY EMPHASIS AND MUST BE OBSERVED AT ALL TIMES. FAILURE TO OBSERVE A WARNING MESSAGE IS POTENTIALLY LIFE THREATENING. CAUTION:

A CAUTION USUALLY APPEARS IN FRONT OF A PROCEDURE OR STATEMENT. IT CONTAINS INFORMATION THAT COULD PREVENT IRREVERSIBLE PRODUCT DAMAGE OR HARDWARE FAILURE. FAILURE TO OBSERVE A CAUTION COULD RESULT IN SERIOUS PATIENT OR USER INJURY. NOTE: A Note highlights information that helps explain a concept or procedure. This symbol directs the user to consult accompanying documents. When visible on the display, this symbol informs the user to use CAUTION because the specified drug has NOT been programmed with specified safety limits. NOTE: Figures are rendered as graphic representations to approximate the actual product. Therefore, figures may not exactly reflect the product.

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1.4 Precautions The Plum A+ has been designed and manufactured to be safe, reliable, and easy to use. This section details precautions and possible hazards. For safe operation of the Plum A+, observe the following precautions and hazards.

ARTIFACTS •

Nonhazardous, low-level electrical potentials are commonly observed when fluids are administered using infusion devices. These potentials are well within accepted safety standards, but may create artifacts on voltagesensing 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

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1) Descriptive Information 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 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 •

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

•

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.

•

To prevent unrestricted flow, close all slide or CAIR™ clamps before opening the cassette door.

•

Although unlikely, failure of certain robust mechanical components such as the anti-free

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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).

•

Air bubbles may form distal to the cassette as a result of normal outgassing of dissolved air in the fluid in one or more of the following cases: • Chilled solution is in use • Certain fluids known to routinely outgas are in use • The infuser is mounted significantly above the patient • The infuser is infusing at very low rates between 0.1– 5 mL/hr In these cases an air-eliminating filter may be used when clinically appropriate.

•

Repeated opening and closing of the door may defeat the proximal air-in-line alarm and may cause a distal air-in-line alarm, requiring repriming.

•

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.

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1) Descriptive Information

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 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

2.0 - 5.0 mL/hr

10 Times the Critical Drug Rate

5.1 or Greater

Any Desired Ratio

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

Lidocaine

Dopamine

Nitroglycerin

Epinephrine

Nitroprusside

Epoprostenol

Norepinephrine

Esmolol

Oxytocin

Isoproterenol

Procainamide

For these drugs, the concurrent flow guidelines should be followed when the infusion rate of the drug will be 5 mL/hr or less. NOTE: This list of critical drugs is not intended to be allinclusive of critical drugs or drugs with a short half-life. The clinician should become familiar with the pharmacodynamics of any critical drug before administration.

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1) Descriptive Information

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

EPIDURAL ADMINISTRATION •

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

•

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

•

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

•

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

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PRESERVATIVE-FREE MORPHINE SULFATE HAS BEEN REPORTED. •

The epidural space has 58 openings through which fluid can exit. Pressure buildup during administration is transient. However, if a large volume of fluid is administered over a short time period, the pressure will take longer to return to normal. If overdelivery occurs during administration, observe the patient closely for signs of spinal cord compression (disorientation, headache, transient neuralgias) and drug overdose.

BATTERY OPERATION •

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

•

The battery may not be fully charged upon receipt. Connect the pump 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 the quality of the earth grounding source is in doubt, use battery power.

•

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

SETS AND ACCESSORIES •

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

•

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

•

LifeCareTM IV infusion sets with integral nonblood filters are not for use in the

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1) Descriptive Information administration of blood, blood products, emulsions, suspensions, or any medications not totally soluble in the solution being administered. These medications may be administered through the lower Y-injection site, below the filter.

•

When infusing at low delivery rates (5 mL/hr or less) the use of thick-walled microbore PlumSets 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 a syringe adapter (List 11986-48) when using syringes smaller than 10 cc. Some 10cc syringes may require use of a syringe adapter. Syringes larger than 10 cc may be attached directly to the secondary port of the cassette. Use of a syringe adapter may decrease the occurrence of proximal occlusion alarms.

•

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

See Section 10 for information on sets and accessories.

BACKPRIMING •

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

•

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

GENERAL •

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

•

Do not place Plum A+ in service if it fails the selftest.

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•

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

•

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

•

The Hospira MedNet Plug ‘n Play module is not compatible with custom Dataport software previously written for the Plum A+ Infuser. Use ONLY Hospira MedNet software with infusers using the Hospira MedNet Plug ‘n Play module.

•

Values beyond a fields maximum hard limit will be displayed as dashes (-- -- --). The user must clear these fields using the [CLEAR] key prior to entering new values.

CLEANING For more information on cleaning the pump, see Section 8, Cleaning, Maintenance, and Storage. •

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. 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 pump.

•

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

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1) Descriptive Information To avoid pump damage, cleaning solutions should only be used as directed. The disinfecting properties of cleaning solutions vary; consult the manufacturer for specific information.

BOLUS RELATED Use the following procedure to avoid the administration of a bolus following a distal occlusion (that is, a closed distal clamp): •

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

•

To prevent unrestricted flow, close all slide or CAIR clamps before opening the cassette door.

•

Open the 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.

System Operating Manual