PLUM A+ and PLUM A+3 System Operating Manual Rev A June 2015

For Systems With Hospira MedNet Software

Change History Title

Description of Changes

Section

430-95597-001 (Rev. 06/05)

First Release

All

430-95597-002 (Rev. 02/06)

Second Release

All

430-95597-003 (Rev. 01/07)

Third Release

All

430-95597-004 (Rev. 02/07)

Fourth Release

All

430-95597-005 (Rev. 2012-11)

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

Updated fuses information

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430-95597-009 (A, 2014-11)

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Plum A+ Infusion Systems Title

Description of Changes

Section

430-95597-010 (A, 2015-06)

Deleted "All Rights Reserved"

TOC

Revised power requirements and added low flow rate delivery accuracy statement

9

Deleted list number 20676

10

Updated "Technical Support Operations" to "Advanced Knowledge Center"

10 and inside back cover

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NOTES

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Plum A+ Infusion Systems

Contents Section 1, Descriptive Information... 1 PRODUCT DESCRIPTION... 2 INDICATIONS FOR USE... 3 USER QUALIFICATION... 3 CONVENTIONS... 4 WARNINGS, CAUTIONS, AND NOTES... 4 PRECAUTIONS... 5 HEALTHCARE PROFESSIONALS AND PATIENT RELATED... 5 CONCURRENT FLOW... 7 EPIDURAL ADMINISTRATION... 8 BATTERY OPERATION... 9 SETS AND ACCESSORIES... 10 BACKPRIMING... 10 GENERAL... 11 CLEANING... 11 BOLUS RELATED... 12 ARTIFACTS... 12 INTERCONNECTING OF MEDICAL EQUIPMENT... 14 GUIDANCE ON EMC COMPATIBILITY... 15 FCC INFORMATION... 16 US FCC (FEDERAL COMMUNICATIONS COMMISSION) STATEMENT... 16 FCC INTERFERENCE STATEMENT... 16 RADIO FREQUENCY EXPOSURE STATEMENT... 17 WIRELESS DEVICE PRECAUTION... 17

Section 2, Principles of Operation... 19 FEATURES... 19 PROGRAMS... 19 LINE PROGRAMMING OPTIONS... 19 PLUMSET CAPABILITIES... 20 AIR MANAGEMENT... 20 BATTERY... 20

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For Systems With Hospira MedNet Software BIOMEDICAL...20 OPTIONS...20 OTHER FEATURES...21 COMMUNICATION...21 DEFINITIONS...21

Section 3, Equipment Description... 33 OPERATING KEYS...34 INDICATORS...36 DISPLAY SYMBOLS...37 REAR CASE CONTROLS...38 ADMINISTRATION SETS...40 PREPARING THE ADMINISTRATION SET...41 PRIMING THE ADMINISTRATION SET...42 LOADING THE CASSETTE...42 PREPARING THE SECONDARY LINE...43 DISCONTINUING ELECTRONIC FLOW CONTROL & SETTING GRAVITY FLOW...45 DISCONTINUING FLUID ADMINISTRATION...46

Section 4, Basic Operation... 47 GETTING STARTED...47 UNPACKING...47 TANDEM CARRIER INSTRUCTIONS...48 SYSTEM SELF-TESTS...48 DATA RETENTION...49 POWER ON...50 SIMPLE DELIVERY...52 TITRATION...54 PIGGYBACK DELIVERY...58 CONCURRENT DELIVERY...61 STOP AND START WITH ONLY 1 LINE PUMPING...64 STOP AND START WITH BOTH LINES PUMPING...65 BACKPRIMING...66 CLEARING SETTINGS...67 UPDATING DRUG LIBRARY...69

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Plum A+ Infusion Systems Section 5, Advanced Programs... 71 DOSE CALC (MCG/KG/MIN ON A)... 72 DOSE CALC (MG/MIN ON B)... 79 LOADING DOSE... 85 MULTISTEP PROGRAMMING... 92

Section 6, Additional Features... 99 SIMPLE DELIVERY USING DELAYED START... 99 PIGGYBACK WITH NURSE CALLBACK... 100 POSSIBLE NON-DELIVERY PROGRAMMED... 102 USING THE STANDBY FEATURE... 102 SELECT OPTION- VOLUMES INFUSED, PRESSURE/ POST INFUSION RATE, AND LIGHTING/CONTRAST... 104 VARIABLE RATE CAP... 108 EXAMPLES OF AUTOMATIC CALCULATION... 108 AT STARTUP... 108 WHILE RUNNING (TITRATION)... 108 AT KVO... 109 CHANGING CCA WHILE INFUSING... 110 AUTO-PROGRAMMING... 111

Section 7, Alarms and Troubleshooting... 115 WARNING MESSAGES... 115 RESPONSE TO ALARMS... 116 GENERAL ALARMS... 117 LINE A ALARMS... 119 LINE B ALARMS... 121 MALFUNCTIONS... 122 GENERAL MESSAGES... 123

Section 8, Cleaning, Maintenance, and Storage... 129 CLEANING AND SANITIZING... 129 BATTERY MAINTENANCE... 131 STORAGE... 132 SERVICE... 132

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For Systems With Hospira MedNet Software Section 9, Specifications... 133 PHYSICAL...133 ELECTRICAL...133 WIRELESS LAN UPGRADE MODULE...134 VTBI RANGE...135 ENVIRONMENT...135 DELIVERY RATE RANGE...135 AIR-IN-LINE ALARM...135 OCCLUSION ALARM AND LIMITS...136 TIME TO DETECT DOWNSTREAM OCCLUSIONS...137 BOLUS VOLUME RELEASED AFTER DOWNSTREAM OCCLUSIONS ARE CORRECTED...137 DELIVERY ACCURACY...138 ENTERAL & HIGH VISCOSITY FLUIDS EFFECTS...138 TRUMPET CURVES...139 EXAMPLE...139

Section 10, Supplies and Accessories... 145 ADMINISTRATION FLUIDS...145 ADMINISTRATION FLUIDS...145 ENTERAL AND HIGH VISCOSITY FLUIDS...145 CONTAINERS...145 ACCESSORIES...146 GENERAL...146 NETWORKED APPLICATION...146

Section 11, Warranty... 147 Section 12, Default Drug Library (DDL)... 149

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Plum A+ Infusion Systems SECTION 1

Descriptive Information NOTE: In this manual, references to Plum A+ Infusion System apply to both the Plum A+ Infuser and Plum A+3 Infuser unless otherwise noted.

Plum A+ Infuser List # 20679/2079204 NOTE: This operating manual may also be used with Device List # 12391-04 & 11971-04 when used with Module List # 20677-04.

Plum A+3 Infuser List # 20678-04 CAUTION: THIS DEVICE IS TO BE USED WITH AN IV POLE WITH A 6- WHEEL BASE AND A SHELF.

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For Systems With Hospira MedNet Software 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 multi-function 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. Delivery modes include: • Standard Infusions

• Loading Dose

• Multistep Programming

• 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

• Neonatology

• Emergency

• Nutritional

Product Description Each system includes a pumping module (hereafter called the infuser) and an assortment of disposable IV sets (hereafter called a set), optional accessories, and this operator’s manual. The Plum A+ host device contains a Connectivity Engine peripheral module that provides wired Ethernet and wireless 802.11 a/b/g local area networking capabilities. This allows the Hospira Mednet networked application software to download drug libraries to the infuser and enable the auto-programming feature.

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Plum A+ Infusion Systems Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC Standards (e.g. IEC 60950 for data processing equipment and IEC 60601-1 for Medical Equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Any person who connects additional equipment to the signal input or output part configures a medical system, and is therefore responsible for ensuring that the system complies with the requirements of the system Standard IEC 60601-1-1. If in doubt, consult the technical service department or your local representative.

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

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.

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For Systems With Hospira MedNet Software

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)

Program

Bold

Emphasis

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

[BRACKETED ALL CAPS]

or

Dose Calculation

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.

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Plum A+ Infusion Systems 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.

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.

HEALTHCARE PROFESSIONALS AND PATIENT RELATED • 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. • 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.

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For Systems With Hospira MedNet Software • 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 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 the result of normal outgassing of dissolved air in the fluid in one or more of the following cases: • Chilled solution is in use • Certain fluids known to routinely outgas are in use • The infuser is mounted significantly above the patient • 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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Plum A+ Infusion Systems • For Plum A+3 users, be aware that changing the weight on one device does NOT change the weight on the other two devices. Patient weight must be changed on each device when delivering weight-based therapy dependent on medication requirements.

CONCURRENT FLOW GUIDELINES When delivering short half-life critical drugs (see Critical Drugs, this section) using the Plum A+ in the Concurrent mode, the following delivery rate guidelines should be observed: • If the critical drug (with half-life less than 6 minutes) is to be infused at less than 2 mL/hr, the other infusion should be no faster than 5 times the critical drug’s rate. Dopamine, for example, delivered at 1.5 mL/hr should not be accompanied by an infusion programmed any faster than 7.5 mL/hr. • If the critical drug (with half-life less than 6 minutes) is to be infused at 2 - 5 mL/hr the other infusion should be no faster than ten times the critical drug’s rate. Dopamine, for example, delivered at 3.5 mL/hr should not be accompanied by an infusion programmed any faster than 35 mL/hr. • If the critical drug (with half-life less than 6 minutes) is to be infused at 5.1 mL/hr or greater, the other infusion can be programmed at any desired rate. NOTE: The total of the primary rate plus the secondary rate cannot exceed 500 mL/hr. These guidelines apply only when infusing short half-life critical drugs in Concurrent mode. Individual patient responses may vary requiring adjustment of delivery rates.

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For Systems With Hospira MedNet Software

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 2 - 5 mL/hr 5.1 or Greater

5 Times the Critical Drug Rate 10 Times the Critical Drug Rate 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 administration. 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

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Plum A+ Infusion Systems or allowed by the drugs’ FDA approved labeling). Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient. • For epidural administration, the use of Hospira catheters, Plum sets without Y-sites, and "epidural" stickers indicating ongoing epidural administration are recommended. • Administration of drugs via the epidural route should be limited to personnel familiar with associated techniques and patient management problems. Proper epidural placement of the catheter is essential since catheter migration could result in intravascular or intrathecal administration. Facilities practicing epidural administration must be equipped with resuscitative equipment, oxygen, naloxone, and other resuscitative drugs. Adequate monitoring equipment (e.g., Oximetry) is recommended for continuous monitoring of the patient during epidural administration. Patients must be observed frequently for side effects in a fully-equipped and staffed environment for at least 24 hours following completion of drug administration by the epidural route. DELAYED RESPIRATORY DEPRESSION FOLLOWING CONTINUOUS EPIDURAL ADMINISTRATION OF PRESERVATIVE-FREE MORPHINE SULFATE HAS BEEN REPORTED. • The epidural space has 58 openings through which fluid can exit. Pressure buildup during administration is transient. However, if a large volume of fluid is administered over a short time period, the pressure will take longer to return to normal. If overdelivery occurs during administration, observe the patient closely for signs of spinal cord compression (disorientation, headache, transient neuralgias) and drug overdose.

BATTERY OPERATION • When the battery is removed from the Plum A+, do not operate on patients. Use of a properly maintained and charged battery helps confirm proper operation. • The battery may not be fully charged upon receipt. Connect the infuser to AC power for at least six hours.

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For Systems With Hospira MedNet Software • 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 infuser to AC power immediately.

SETS AND ACCESSORIES • Only compatible LifeCare PlumSets™ can be used with the Plum A+. See individual set instructions for additional information. • Administration sets should be changed per CDC guidelines or healthcare provider policy. Discard after use. • LifeCare™ IV infusion sets with integral nonblood filters are not for use in the administration of blood, blood products, emulsions, suspensions, or any medications not totally soluble in the solution being administered. These medications may be administered through the lower Yinjection 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 syringe adapter (List 11986-48) when using syringes smaller than 10 cc. Some 10 cc 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.

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

GENERAL • Possible explosion hazard exists if used in the presence of flammable anesthetics. • Do not place Plum A+ in service if it fails the self-test. • Do not operate the Plum A+ with the case opened. • Keep the cassette door securely closed while the infuser is not in use, to avoid cassette door damage. • Values beyond a field’s maximum hard limit will be displayed as dashes (-- -- --). The user must clear these fields using the [CLEAR] key prior to entering new values. • The Plum A+3 is to be used with an IV pole with a 6-wheel base and a shelf.

CLEANING For more information on cleaning the infuser, see Section 8. • To avoid mechanical or electronic damage, do not immerse the Plum A+ in any fluids or cleaning solutions. • Do not spray cleaning solutions toward any opening in the instrument. • Certain cleaning and sanitizing solutions may slowly degrade components made from some plastic materials. Using abrasive cleaners or cleaning solutions not recommended by Hospira may result in product damage. Do not use compounds containing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride. • Never use sharp objects such as fingernails, paper clips, or needles to clean any part of the infuser. • Do not sterilize by heat, steam, ethylene oxide (ETO), or radiation. • To avoid infuser damage, cleaning solutions should only be used as directed. The disinfecting properties of cleaning

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For Systems With Hospira MedNet Software 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 cassette door. • To prevent unrestricted flow, close all slide or CAIR clamps before opening the 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.

ARTIFACTS • Nonhazardous, low-level electrical potentials are commonly observed when fluids are administered using infusion devices. These potentials are well within accepted safety standards, but may create artifacts on voltage-sensing equipment such as ECG, EMG, and EEG machines. These artifacts vary at a rate that is associated with the infusion rate. If the monitoring machine is not operating correctly or has loose or defective connections to its sensing electrodes, these artifacts may be accentuated so as to simulate actual physiological signals. To determine if the abnormality in the monitoring equipment is caused by the infusion device instead of some other source in the environment, set the

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