ICU Medical 20677 PlumA + with MedNet Wireless Enabled Infuser User Manual Cover
Hospira, Inc. PlumA + with MedNet Wireless Enabled Infuser Cover
Contents
- 1. Installation Manual
- 2. Users Manual
- 3. Replacement Installation Guide
Users Manual
System Operating Manual e . for t ti with t ua N it For use with Lists: 12391, 20679-04, a a ONLY) and above and 11971-04 (-03u Options/ Back Ma lin Prime t a Vol Inf a in HOSPIRA, INC., LAKE FOREST, IL 60045, USA 430-95520-001 (Rev. 04/05) Change History Change History Title 430-95520-001 (Rev. 04/05) Description of Changes Pages Affected First Release All be n. to tio t ua N it a a M Cli t a ra in 430-95520-001 (Rev. 04/05) Contents Section 1, Descriptive Information . . . . . . . . . . . . . . . 1-1 PRODUCT DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 INDICATIONS FOR USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 user qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 CONVENTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 warnings, cautions, and notes . . . . . . . . . . . . . . . . . . . . . 1-3 PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 healthcare professionals and patient related . . . . . . . . . . 1-4 concurrent flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 epidural administration . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 battery operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8 sets and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9 backpriming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9 general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9 cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10 bolus related . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10 artifacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11 GUIDENCE ON EMC COMPATIBILITY . . . . . . . . . . . . . . . . . . . . . . 1-13 FCC INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14 Section 2, Principles of Operation . . . . . . . . . . . . . . . 2-1 FEATURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . line programming options . . . . . . . . . . . . . . . . . . . . . . . . . plumset capabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . air management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . biomedical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . other features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 2-1 2-1 2-2 2-2 2-2 2-2 2-2 2-2 2-3 Section 3, Equipment Description . . . . . . . . . . . . . . . 3-1 OPERATING KEYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 INDICATORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4 DISPLAY SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 430-95520-001 (Rev. 3/05) Contents REAR CASE CONTROLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 ADMINISTRATION SETS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7 PREPARING THE ADMINISTRATION SET . . . . . . . . . . . . . . . . . . . . 3-7 PRIMING THE ADMINISTRATION SET . . . . . . . . . . . . . . . . . . . . . . 3-8 LOADING THE CASSETTE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9 PREPARING THE SECONDARY LINE . . . . . . . . . . . . . . . . . . . . . 3-10 DISCONTINUING ELECTRONIC FLOW CONTROL & SETTING GRAVITY FLOW . . . . . . . . . . . . . . . . . . . 3-11 DISCONTINUING FLUID ADMINISTRATION . . . . . . . . . . . . . . . . . . 3-12 Section 4, Basic Operation . . . . . . . . . . . . . . . . . . . . . 4-1 GETTING STARTED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 tandem carrier instructions . . . . . . . . . . . . . . . . . . . . . . . . 4-2 system self-tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 data retention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 POWER ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 SIMPLE DELIVERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 TITRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 PIGGYBACK DELIVERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12 CONCURRENT DELIVERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15 STOP AND START WITH ONLY 1 LINE PUMPING . . . . . . . . . . . . . 4-18 STOP AND START WITH BOTH LINES PUMPING . . . . . . . . . . . . . 4-19 BACKPRIMING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20 CLEARING SETTINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21 UPDATING DRUG LIBRARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23 Section 5, Advanced Programs . . . . . . . . . . . . . . . . . . 5-1 DOSE CALC (MCG/KG/MIN ON A) . . . . . . . . . . . . . . . . . . . . . . . . 5-2 DOSE CALC (MG/MIN ON B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9 LOADING DOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15 MULTISTEP PROGRAMMING . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22 Section 6, Additional Features . . . . . . . . . . . . . . . . . . . 6-1 SIMPLE DELIVERY USING DELAYED START . . . . . . . . . . . . . . . . . 6-1 PIGGYBACK WITH NURSE CALLBACK . . . . . . . . . . . . . . . . . . . . . 6-2 POSSIBLE NON-DELIVERY PROGRAMMED . . . . . . . . . . . . . . . . . . 6-4 USING THE STANDBY FEATURE . . . . . . . . . . . . . . . . . . . . . . . . . 6-4 SELECT OPTION- VOLUMES INFUSED, PRESSURE/POST INFUSION 430-95520-001 (Rev. 3/05) RATE, AND LIGHTING/CONTRAST . . . . . . . . . . . . . . . . . . . . . . . . 6-6 VARIABLE RATE CAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10 EXAMPLES OF AUTOMATIC CALCULATION . . . . . . . . . . . . . . . . . 6-10 at startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10 while running (titration) . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10 at kvo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11 CHANGING CCA WHILE INFUSING . . . . . . . . . . . . . . . . . . . . . . 6-12 AUTO-PROGRAMMING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13 Section 7, Alarms and Troubleshooting . . . . . . . . . . . 7-1 WARNING MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RESPONSE TO ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . GENERAL ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LINE A ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LINE B ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . MALFUNCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . GENERAL MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 7-2 7-3 7-5 7-7 7-8 7-9 Section 8, Cleaning, Maintenance, and Storage . . . . 8-1 cleaning and sanitizing . . . . . . . . . . . . . . . . . . . . . . . . . . . battery maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 8-3 8-4 8-4 Section 9, Specifications . . . . . . . . . . . . . . . . . . . . . . 9-1 PHYSICAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ELECTRICAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . WIRELESS LAN DEVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VTBI RANGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ENVIRONMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DELIVERY RATE RANGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AIR-IN-LINE ALARM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . OCCLUSION ALARM AND LIMITS . . . . . . . . . . . . . . . . . . . . . . . . . TIME TO DETECT DOWNSTREAM OCCLUSIONS . . . . . . . . . . . . . . BOLUS VOLUME RELEASED AFTER DOWNSTREAM OCCLUSIONS ARECORRECTED . . . . . . . . . . . . . . . . . . . . . . . . . DELIVERY ACCURACY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ENTERAL & HIGH VISCOSITY FLUIDS EFFECTS . . . . . . . . . . . . . . TRUMPET CURVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1 9-1 9-2 9-2 9-3 9-3 9-3 9-4 9-5 9-5 9-6 9-6 9-7 430-95520-001 (Rev. 3/05) Contents example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7 Section 10, Supplies and Accessories . . . . . . . . . . . . 10-1 ADMINISTRATION FLUIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 administration fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 enteral and high viscosity fluids . . . . . . . . . . . . . . . . . . . 10-1 containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2 general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2 networked application . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2 Section 11, Warranty . . . . . . . . . . . . . . . . . . . . . . . . . 11-1 Section 12, Default Drug Library (DDL) . . . . . . . . . . . 12-1 430-95520-001 (Rev. 3/05) Plum A+ Infusion System SECTION 1 Descriptive Information The Plum A+ Volumetric Infusion System is designed to meet the fluid delivery requirements of today’s evolving healthcare environments. The infuser is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The infuser can be used for standard, piggyback, or concurrent delivery. Programming 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 Product Description The 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 430-95520-001 (Rev. 04/05) 1- 1 802.11b local area networking capabilities. This allows the Hospira MednetTM networked application software for drug library downloads and Auto-programming to the infuser. 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. 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 1- 2 Primary Only: Attach an empty container. 430-95520-001 (Rev. 04/05) Plum A+ Infusion System CONVENTION APPLICATION EXAMPLE [BRACKETED ALL CAPS] Keys or buttons on the device are displayed in [BRACKETED ALL CAPS] or with a graphic. [START] V [Italic] Softkey Options V [Choose] Initial Caps lowercase Screen displays and device labels (as appropriate) Program Bold Emphasis ...sets are supplied Sterile and are for.... 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. 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. 430-95520-001 (Rev. 04/05) 1- 3 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. • 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. 1- 4 430-95520-001 (Rev. 04/05) Plum A+ Infusion System • 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 result of normal outgassing of dissolved air in the fluid. This may occur if chilled solution is in use, if the infuser is mounted significantly above the patient, or when using certain fluids known to routinely outgas. In these cases, an air eliminating filter may be used. • Repeated opening and closing of the door may defeat the proximal air-in-line alarm and may cause a distal air-in-line alarm, requiring repriming. • 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. 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 2.0 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. 430-95520-001 (Rev. 04/05) 1- 5 • If the critical drug (with half-life less than 6 minutes) is to be infused at 2.0 to 5.0 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. 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 1- 6 430-95520-001 (Rev. 04/05) Plum A+ Infusion System CRITICAL DRUGS Examples of drugs with a short half-life (approximately 6 minutes or less when given IV) include: Dobutamine Lidocaine Dopamine Nitroglycerin Epinephrine Nitroprusside Epoprostenol Norepinephrine Esmolol Oxytocin Isoproterenol Procainamide For these drugs, the concurrent flow guidelines should be followed when the infusion rate of the drug will be 5 mL/hr or less. NOTE: This list of critical drugs is not intended to be allinclusive of critical drugs or drugs with a short half-life. The clinician should become familiar with the pharmacodynamics of any critical drug before administration. This information is presented to inform clinicians of a rare situation that could be misinterpreted if they are unfamiliar with this phenomenon. EPIDURAL ADMINISTRATION • Recommended use of the epidural route is to provide anesthesia or analgesia for periods up to 96 hours. • This device can be used to administer only those anesthetics/ analgesics approved for epidural administration (as indicated or allowed by the drugs’ FDA approved labeling). Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient. • For epidural administration, the use of Hospira catheters, Plum sets without Y-sites, and "epidural" stickers indicating ongoing epidural administration are recommended. 430-95520-001 (Rev. 04/05) 1- 7 • 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. • 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. 1- 8 430-95520-001 (Rev. 04/05) Plum A+ Infusion System 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 (5.0 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 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. • 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. 430-95520-001 (Rev. 04/05) 1- 9 • 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 fields maximum hard limit will be diplayed as dashes (-- -- --). The user must clear these fields using the [CLEAR] key prior to entering new values. 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 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 (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. 1- 10 430-95520-001 (Rev. 04/05) Plum A+ Infusion System • 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 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 430-95520-001 (Rev. 04/05) 1- 11 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. • This equipment has been tested and found to comply with the EMC limits for the Medical Device Directive 93/42/EEC (EN 55011 Class B and IEC/EN 60601-1-2:2001). These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. The equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference with other devices (radio or television reception), which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving device • Increase the separation between the equipment • Connect the equipment into an outlet on a circuit different from that to which the other device(s) is connected • Consult the manufacturer or field service technician for help • Portable and mobile RF communications equipment, such as cellular telephones, 2-way radios, Bluetooth devices, microwave ovens, in close proximity to this device may affect wireless and wired communications with the Infusion pump and/or the operation of the Infusion pump. Special precautions need to be exercised regarding EMC, These include: • Use of a shielded Ethernet cable (CAT5 STP or better) for plugging into the RJ45 Ethernet connector. Using an unshielded Ethernet cable may result in increased emissions. 1- 12 430-95520-001 (Rev. 04/05) Plum A+ Infusion System • Maintaining a minimum separation distance of 2 ½ ft between the Infusion pump system and portable/ mobile RF communications equipment • List Numbers 12391 and 11971 are compliant to IEC/EN 60601-1-2 (1993) List Number 20679 is compliant to IEC/EN 60601-1-2 (2001) and have been tested and found to comply with EMC limits for the Medical Device Directive 93/42/EEC (EN 55011 Class B and EN 60601-1-2:2001). Guidance on EMC Compatibility • There is a shared responsibility between manufacturers, customers and users to ensure that Medical Equipment and Systems are designed and operated as intended. Medical electrical equipment needs special precautions regarding electromagnetic compatibility and needs to be installed and used according to the electromagnetic compatibility information provided in this manual. • The device is suitable for use in all establishments, including domestic establishments. If extended operation during power mains interruption is needed, use battery power. • Always manage the electromagnetic environment. • The guidance included in this manual provides information needed to: • Determine the device’s suitability for use in the intended environment. • Manage the electromagnetic environment to permit the device to perform as intended without disturbing other equipment. • Separate the device from all other electronic equipment. If the device must be used near other electrical equipment, monitor the equipment to ensure there is no electromagnetic interference. • Devices should not be used adjacent to or stacked with other equipment. If the device must be used adjacent to or stacked 430-95520-001 (Rev. 04/05) 1- 13 with other equipment, monitor the devices to verify normal operation. • USE ONLY components specifically labeled for use with the Plum A+ Infusion System to help ensure the device operates as intended. • If you suspect external RF sources or other equipment are influencing device operation, contact the biomedical engineering department for additional guidelines concerning electromagnetic immunity. • Contact the biomedical engineering department for additional information in the technical service manual concerning operating devices near RF sources. FCC Information U.S. Pat. No. 5,681,285 FCC ID: STJ-20677 IC: 5627A-20677 US FCC (FEDERAL COMMUNICATIONS COMMISSION) STATEMENT • This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause interference, and (2) This device must accept any interference, including that may cause undesired operation of this device. FCC INTERFERENCE STATEMENT • This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy. If not installed and used in accordance with the instructions, it may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference 1- 14 430-95520-001 (Rev. 04/05) Plum A+ Infusion System to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try and correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the distance between the equipment and the receiver. • Connect the equipment to an outlet on a circuit different from that to which thereceiver is connected. • Consult the dealer or an experienced radio/TV technician for help. • Changes or modifications not expressly approved by Hospira could void the user's authority to operate the equipment. RADIO FREQUENCY EXPOSURE STATEMENT • The Wireless LAN radio device in the Connectivity Engine peripheral board with this infusion device has been evaluated and found compliant to the requirements of the following Radio Frequency exposure standards: • Federal Communications Commission, OET Bulletin 65 (Edition 97-01), Supplement C (Edition 01-01), Evaluating Compliance with FCC Guidelines for Human Exposure to Radio frequency Electromagnetic Fields, July 2001. • Industry Canada, Evaluation Procedure for Mobile and Portable Radio Transmitters with respect to Health Canada's Safety Code 6 for Exposure of Humans to Radio Frequency Fields, Radio Standards Specification RSS-102 Issue 1 (Provisional): September 1999. • Federal Communications Commission, OET Bulletin 65 (Edition 97-01), Supplement C (Edition 01-01), Evaluating Compliance with FCC Guidelines for Human Exposure to Radio frequency Electromagnetic Fields, July 2001. • The radiated output power of this Wireless LAN device is far below the FCC radio frequency exposure limits. The Wireless 430-95520-001 (Rev. 04/05) 1- 15 LAN device has been evaluated with zero inches separation of human body from the antenna and found to be compliant with FCC RF exposure limits. 1- 16 430-95520-001 (Rev. 04/05) Plum A+ Infusion System SECTION 2 Principles of Operation 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 its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/ surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield® and CLAVE® needleless protection systems, makes the Plum A+ a convenient and cost-effective infusion system. PROGRAMS • Standard Programming • Loading Dose • Multistep Programming LINE PROGRAMMING OPTIONS • Drug List • Nurse Call Back • Delayed Start/Standby 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) 430-95520-001 (Rev. 04/05) 2- 1 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 • Battery Gauge • Less than 8-Hour Battery Recharge Time • Long battery life (3 hours) for emergency backup and temporary portable operation BIOMEDICAL • Upgradability (Field) • 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 OTHER FEATURES • Nonpulsatile volumetric accuracy • Microprocessor control • Large liquid crystal display (LCD) screen 2- 2 430-95520-001 (Rev. 04/05) Plum A+ Infusion System • Panel back illumination on mains power • Lockout switch • Standard syringe use • Parenteral and nonparenteral (enteral) fluid delivery • Blood and blood products delivery • Wide range of Standard and Specialty administration sets • Password protected keypad lock COMMUNICATION • Networked Communication (Ethernet & Wireless) • Autoprogramming • Drug Library Download Definitions TERM DEFINITION Administration 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 administration to the patient. Alarm A condition requiring operator intervention that invokes both audible and visible alarm indicators. Confirmation of the condition usually is required. Alert While entering a program, a visual warning that informs the clinician of the violation of a hospital-defined rule set, e.g., a dose limit for a specific drug. 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. 430-95520-001 (Rev. 04/05) 2- 3 TERM DEFINITION Auto-Program A physician order sent to the infuser. Auto-Program (new) An auto-program is considered “new” if either of the following conditions are met: A) There is no program on the associated line. B) The drug and concentration in the auto-program is different from a currently-programmed drug and concentration. Auto-Program (titration) An auto-program is considered a “titration” if the drug and concentration in the auto-program match the currentlyprogrammed drug and concentration. Non-promotion titration programs include some subset of the following: Rate, Dose, Duration. Promotion titration programs include some subset of the following: Rate, Dose, Duration, Patient Weight, Dosing Units, Drug Amount, Drug Units, Diluent Amount. Awake CE The CE is considered awake when the infuser is powered on with battery power and the battery is above the low battery threshold or is plugged into AC. Backpressure Resistance to fluid flow on the Distal or output portion of the Administration Set, usually expressed as PSIG. Backprime Removal of air or fluid from the proximal tubing and Cassette air trap by rapid pumping of fluid from Line A to an output receptacle on Line B. No fluid delivered distal to the cassette during a Backprime. Basic Delivery A single-step delivery specifying rate, VTBI, and duration only. Drug name may or may not be specified. Biomed Mode The name for the non-delivery or service mode of Infuser operation. 2- 4 430-95520-001 (Rev. 04/05) Plum A+ Infusion System TERM DEFINITION 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. 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. Clinical Care Area (CCA) An area of the hospital for which authorized hospital staff has allowed use of up to 149 specific drugs, plus No Drug Selected. The clinician selects a CCA after turning on the Infuser. The hospital may create from one to eighteen CCA’s. 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”. 430-95520-001 (Rev. 04/05) 2- 5 TERM DEFINITION 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. Connectivity Engine (CE) A component of the infuser that controls ethernet and wireless communication between the MMU and Infuser processor. 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’. Does not contain Soft or Hard Limits. The DDL is a subset of Plum A+ Version 11.3 drug list. The Infuser functions initially with the DDL. Deliver Together A Biomed Delivery option setting, which selects default of Piggyback or Concurrent delivery mode. Delivery Mode The normal operational mode for the Infuser, either Concurrent or Piggyback, during which fluid delivery may occur. Delivery Rate The delivery rate (as Volume/Time) assigned by the operator or calculated from other delivery parameters. Device The Plum A+ IV Infusion Device (Infuser), not including the disposable administration sets. Diluent (Volume) The volume of fluid used with the Diluent Unit (e.g., 250 mL), which dilutes the drug to be infused. 2- 6 430-95520-001 (Rev. 04/05) Plum A+ Infusion System TERM DEFINITION Distal Downstream (output) from the Cassette portion of the Administration Set. Door The lever-operated, bottom-hinged, Cassette holder on the front of the Mechanism. Dose (Rate) Delivery rate times drug concentration. Dose 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. Drug Library Drug names available for use with the Infuser in the selected CCA, and each drug’s concentration, units of measure, and dose limits, as determined by authorized hospital staff. The Drug Library is based on hospital-defined best practices. The Drug Library is customized and downloaded into the Infuser by authorized hospital personnel using Hospira MedNet Networked software. 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. 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. 430-95520-001 (Rev. 04/05) 2- 7 TERM DEFINITION 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. Hard Limit The dosing amount (upper and/or lower amount) that when assigned to a drug cannot be overridden. Defined by the hospital for each drug in its Drug Library. The hard limits for a particular drug may vary across different CCAs. Infuser A Plum A+ device, not including the disposable administration 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 panels intended for user input via a pressing action. KVO (Keep Vein Open) Internally selected minimal delivery rate, the lesser of 1.0 mL/Hr or actual Rate, intended to provide sufficient fluid flow to decrease the potential for clotting at the IV infusion site. Line A Inlet tubing on the top center of Cassette when viewed after it has been loaded in Mechanism Door. 2- 8 430-95520-001 (Rev. 04/05) Plum A+ Infusion System TERM DEFINITION Line B Inlet connector on the top right of Cassette when viewed after it has been loaded in Mechanism Door. Loading Dose Allows programming of an initial infusion rate for a specific volume, followed automatically by a maintenance rate from the same container (e.g., a fluid challenge). If Dose Calc is used, the Loading Dose and Maintenance Dose are in the same unit of measure, over the same period of time (mcg/min), from the same container. Macro Cassette The Plum Cassette as part of an Administration Set whose attainable delivery performance is for general purpose uses. Malfunction One of a number of conditions that indicate a failure of the Infuser. These conditions usually require a repair action. Mechanism The provider of the physical activities of: 1) valve control for Line selection and inlet to or outlet from the Cassette; 2) Plunger extension and retraction for changing fluid volume of the Cassette pumping chamber. MedNet software Networked application software used to define and download the custom drug library to the Infuser. 430-95520-001 (Rev. 04/05) 2- 9 TERM DEFINITION Multistep Allows a sequential program to deliver up to 10 steps; fluid volumes and delivery rates may be programmed for each step. The program may be entered based on Rate and Volume or Volume and Time. If Dose Calc is used, the delivery steps are in the same unit of measure, over the same period of time, from the same container. MMS Medication Management Suite- a product suite that will be used to support safe and efficient caregiver administration of intravenous medications. MMU Medication Management Unit- the MMU is a product of the MMS and provides external communications with infusers and other systems supporting medication management. It supports drug library downloads and status/log updates to the infusers. MMU also delivers a variety of pre-built and custom reports related to the infuser activities. Network-Enabled Module The hardware that facilitates communication between the infuser and the network. Note A Note explains something new, gives tips on performing an activity, or provides a reminder of necessary preparations. Override The clinician acknowledges an Alert, confirms and proceeds with a program containing a parameter that falls outside the hospital-defined Soft Limits. Parenteral Delivery via other than an intestinal route, such as intravenous (IV) injection. 2- 10 430-95520-001 (Rev. 04/05) Plum A+ Infusion System TERM DEFINITION 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 Infuser without restriction, with an opened Door. POST Power On Self Tests. Startup initialization and test of critical hardware modules and software functions, to determine Infuser readiness for its Intended Use. Power On When the power is first applied to the Infuser processor. It occurs when Infuser is in the off condition and the AC power is applied or during battery operation when the ON/OFF key is pressed. Pressure The measured fluid pressure for Proximal Line A, Proximal Line B, or the Distal line when a fully primed administration set is loaded into a Mechanism with the Cassette Door closed. 430-95520-001 (Rev. 04/05) 2- 11 TERM DEFINITION Programs A Concentration-based extension to basic Volume/Rate delivery for Dose Rate applications. Softkey-selected types are: 1) Standard Program for single rate delivery; 2) Loading Dose for up to two steps of delivery at differing rates; 3) Multistep for up to ten steps of delivery at differing rates. Loading Dose and Multistep include the basic Delivery Rate option. Protocol In the medical field, hospital-approved procedures. For devices with an electronic communications interface, the format and content of messages being exchanged. Proximal Upstream (input, as Line A and/or B) with respect to the Cassette portion of the Administration Set. Rate See Delivery Rate Rounding To round-off to the closest whole number (e.g., 25.5 would round to 26, but 25.4 would round to 25). Rule Sets The compilation of Soft and Hard Limits associated with a drug entry. Screen That active portion of the LCD assigned to a delivery or other user interactive display operation. Softkey A front panel 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. 2- 12 430-95520-001 (Rev. 04/05) Plum A+ Infusion System TERM DEFINITION Soft Limit The dosing amount (upper and/or lower amount) that when assigned to a drug can be overridden based on confirmation. Defined by the hospital for each drug in its Drug Library. The soft limits for a particular drug entry may vary across CCAs. 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+ Infuser system with its associated accessories and Administration Sets. Tall-Man Lettering Tall-Man lettering uses upper-case letters in combination with lower-case letters to help clinicians differentiate among sound-alike or look-alike drug names. Certain Hospira Default Library drug names are displayed in Tall-Man lettering. 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. VTBI Volume To Be Infused – The volume of fluid or IV solution (remaining) for delivery by a program or Therapy step from a Line. 430-95520-001 (Rev. 04/05) 2- 13 TERM DEFINITION 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/. 2- 14 430-95520-001 (Rev. 04/05) Plum A+ Infusion System SECTION 3 Equipment Description Line B Flow Indicator Line A Flow Indicator u LCD be n. o ioBattery Working Working Region t t Charge Region o tu Indicator Message Region - Region Message a A aB Softkey Label Numeric Softkey Keys a lin Selector M C (Up/Left) Start and Selection Stopf Keys Key (Down/ D Charging/i Status Region Status Region Back Prime Options/ Vol Inf Right) Line Indicator Silence Key ON/OFF Key Numeric Field Clear Key Decimal Point Key Front Panel Display and Keypad 430-95520-001 (Rev. 04/05) 3- 1 Operating Keys 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 infuser, do not unplug until “double beep” is heard (approximately 5 seconds). If “double beep” is not heard, the infuser will turn itself back ON sensing the AC power was lost and revert to battery back-up power. be n. to tio t ua N it The [START] key is used to uabegin ca infusion. It brings upn the Confirmation screen. a If alllin informtion appears M correct, C select V [Yes] tot start program. Dr i 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. 3- 2 430-95520-001 (Rev. 04/05) Plum A+ Infusion System The [SILENCE] key is used to silence an audible alarm during actions to correct its cause. The [SELECT] key (or ) is used to move the highlighting cursor between the programming fields. be n. to tio t ua N it a a center The numeric keys are used to values for anya highlighted in field requiring numeric M data. f[CLEAR] a The key will cause a i numeric field to be D highlighted cleared in preparation for data entry. It is also used to clear the displayed dashes (-- -- --) that occur when entering values beyond the pre-programmed hard limits. It WILL NOT clear the entire program. The [DECIMAL POINT] key is used to manually enter numbers other than whole numbers (i.e., 1.2 mL). 430-95520-001 (Rev. 04/05) 3- 3 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. Indicators The Charge/Line Indicator is illuminated to indicate the battery is currently charging. Standby Enter Cancel/ Back e . NOTE: If the device is plugged into AC power, with a battery t ti installed, and the Charge t ua Indicator is not illuminated, N it contact technical support. The fluid drop symbol, when ua ica flashing, indicates ann active infusion on Line Aa and/or Line n B. M Cli t a a in 3- 4 430-95520-001 (Rev. 04/05) Plum A+ Infusion System Display Symbols Battery Capacity Symbol (located on right side of message region on display) indicates relative charge with number of white boxes from left to right. Cautionary Symbol is displayed to alert the user that the infuser is being operated without rule sets (soft or hard limits). Read the drug package insert for information on proper usage. be n. to tio t ua Soft Limit Override Symbol N it indicates the programmed soft limits upper (up arrow) orllower l S a a (down arrow) have u been overridden. a lin MThe infuser NOTE: Cfromwillthedisplay the rule set icon first step in a situation where a 2-step process is completed and the infuser is stopped after going to ra KVO.in The "Wireless Connection Available" icon is displayed when the device is receiving a wireless signal. The infuser will connect to the network if a wireless network access point is recognized. 430-95520-001 (Rev. 04/05) 3- 5 It may appear on any Main Delivery A STOPPED PUMPING B Screen whether pumping or stopped. It DOPamine Lidocaine Dose Calculation Dose Calculation also may appear regardless of AutoRate 26.3 30 mL/hr Programming. However, in a wireless Vol Inf 0.1 network environment, AutomL Dose Programming will not be successful if mcg/kg/min mg/min MedSurg the icon is not visible during the AutoOptions/ Program transfer. If wireless AutoB Vol Inf Programming is desired and the icon is not displayed on the Main Delivery Screen, try relocating the pump towards the wireless access point until the icon is displayed. The icon will not be displayed if the infuser is communicating via an ethernet connection. be n. to tio Rear Case ControlsNo tu The audio level rotary knob, a the al located on the back, adjusts alarm audio level. n M Cli t a a switch, Thertoggle located below incontrol, the activates D audio level the lockout function when the lever is placed in the “up” position, disabling all front panel keys except [STOP]. Password Protected Keypad Lock may also be used. It both locks and unlocks the keypad by pressing the decimal key, followed by 9, 6, & 3. 3- 6 430-95520-001 (Rev. 04/05) Plum A+ Infusion System 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. NOTE: If the lockout switch is put in the “Locked” position while the infuser 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. be n. The Ethernet port is used to connect to a local area connection. to tio t ua N it a a M Cli Administration Sets t a a TheiPlum n A+ is compatible with a wide range of LifeCare Plum series administration sets. Become familiar with the set components before preparing the administration set. Primary Line Secondary Inlet Port (Capped) Finger Grip Flow Regulator Patient Line Pumping Chamber Air Trap 430-95520-001 (Rev. 04/05) 3- 7 Preparing the Administration Set NOTE: For detailed instructions, see administration set packaging. WARNING ARRANGE TUBING, CORDS, AND CABLES TO MINIMIZE THE RISK OF PATIENT STRANGULATION OR ENTANGLEMENT. be n. Make sure flow regulator is closed. to tio t ua N it aoutlet with Insert piercing pin into container a twisting motion. M Cli t a ra in Use the aseptic technique to prepare the administration set for priming, then proceed as follows: 3 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 infuser. This should be set up prior to priming the cassette. 3- 8 430-95520-001 (Rev. 04/05) Plum A+ Infusion System Priming the Administration Set 1Invert the cassette. 2Turn the flow regulator counter-clockwise until a drop of fluid is seen in the pumping chamber. be n. o io 3 Turn the cassette upright, then primetthe remainder of the administration t set. o tu - l Si a a n to close. Confirm 4 Push in thea flow regulator there is Mno flow.Cli t a a in Loading the cassette To load the primed cassette into the plum A+, proceed as follows. 1 Open the cassette door by lifting up the handle. 430-95520-001 (Rev. 04/05) 3- 9 2Insert 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 administration set. NOTE: The administration set should be changed per CDC guidelines or healthcare provider policy. Discard after use. e . Preparing the Secondary o Line on t ti CAUTION: C t ua, , o N it a a c or piggyback delivery modes The Plum A+ features concurrent when programa requires administering more than one fluid. M Cli In addition containers, the Plum A+ can use t to standard syringes on the secondary port. The secondary line can be prepared without removing or repriming the cassette. ONSULT 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 Before preparing the secondary line, observe the following guidelines: • Review the backpriming function. • Attach the secondary container using an 18- or 19gauge, 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 3- 10 430-95520-001 (Rev. 04/05) Plum A+ Infusion System 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: 1 With cassette door closed: Loosen and e . 2 Open all proximal clamps before pressing b [START]. t ti t ua 3 Set up per operating instructions. (See Sections 4 - 6 of this manual.) N it a a c to the 4 Syringe: Secure the container a lin cassette door using the optional container support arm (List 12095-03). t a a in remove white cap, then discard. Add secondary tubing or syringe. 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 430-95520-001 (Rev. 04/05) 3- 11 maintain fluid flow in a gravity mode (see the following graphics). 1 PRESS STOP STOP be n. to tio t ua N it l Administration Discontinuing a Fluid u ica a lin STOP Dr i 2 OPEN DOOR & REMOVE CASSETTE NOTE: FLOW REGULATOR CLOSES AUTOMATICALLY WHEN DOOR IS OPENED TO PREVENT ACCIDENTAL FREE FLOW 3 SET GRAVITY RATE BY TURNING FLOW REGULATOR COUNTER-CLOCKWISE NOTE: CASSETTE SHOULD BE IN UPRIGHT POSITION NOTE: IF DOOR OPEN ALARM OCCURS, TURN PUMP OFF 1 PRESS STOP 3 CLOSE DOOR 2 OPEN DOOR, REMOVE CASSETTE 3- 12 DISCARD SET AND FLUID CONTAINER PER HOSPITAL PROCEDURE 430-95520-001 (Rev. 04/05) sec04.fm Page 1 Monday, April 11, 2005 8:34 AM Plum A+ Infusion System SECTION 4 Basic Operation Getting Started UNPACKING CAUTION: PRODUCT 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. be n. Inspect the Plum A+ packaging for possible o shipping iodamage. If damage is found, contact the deliverytcompany immediately. t uathe packing slip Use care when unpacking the o infuser. Retain t infuser is damaged or Nin caseithe and save all packing material fails the infuser self-test to be returned to Hospira. l and has Inspect thoroughly u for damage. ca CAUTION: a I Pn A+ M, I . Cli tset up,aconnect the AC (mains) cord to a properly grounded To ra receptacle, in unless temporary battery operation is desired. F THE OSPIRA LUM APPEARS TO BE DAMAGED CONTACT NC NOTE: Use AC (mains) power whenever possible. Store the infuser 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: 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 , CELLULAR TELEPHONES, OR 2-WAY RADIOS, IT IS POSSIBLE THAT THE NORMAL OPERATION OF A SENSOR OR MICROCOMPUTER MIGHT 430-95520-001 (Rev. 04/05) 4- 1 sec04.fm Page 2 Monday, April 11, 2005 8:34 AM BE DISRUPTED . O PERATION OF THE INFUSER UNDER THESE CONDITIONS SHOULD BE AVOIDED. TANDEM CARRIER INSTRUCTIONS 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 infuser(s) to the tandem carrier. e . Make sure infusers are firmly n io attached to tandem tocarrier. tdetailsutheaPlum A+ This section instrument setup procedures. N it l l SYSTEM SELF-TESTS ua suiteicof a The infuser performs System Self-Tests when power a readiness is applied to confirm for use. Failure during the Self-Tests is reported as a Malfunction Condition. a in A+ D CAUTION: D Make sure tandem carrier clamp is attached firmly to pole. O NOT PLACE THE THE LUM IN SERVICE IF IT FAILS SYSTEM SELF-TESTS. 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 panel). A systematic self-testing of the processing, delivery, and safety systems is performed whenever the Plum A+ is turned on, to verify readiness for operation. NOTE: If the quality of the earth grounding source is in doubt, use battery power. 4- 2 430-95520-001 (Rev. 04/05) sec04.fm Page 3 Monday, April 11, 2005 8:34 AM Plum A+ Infusion System 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. sP CAUTION: WHEN THE BATTERY IS REMOVED FROM THE LUM A+, DO NOT OPERATE ON PATIENTS . U SE OF A PROPERLY be n. To confirm battery is fully charged, connect the Plum otheA+OFFto AC towhile (mains) power for a minimum of six hours in mode. o tu If an alarm occurs during the power on self-test, identify the iaction - corrective alarm message, then l take (see Section 7, Alarms and Troubleshooting). u back caON. If the self-test alarm recurs, Turn infuser n OFF, then i n service and contact the local Hospira ainfuser from remove the M Cli representative. t aperforms a suite of System Self-Tests when power The infuser a is applied to confirm readiness for use. induring D Failure the Self-Tests is reported as a Malfunction MAINTAINED AND CHARGED BATTERY HELPS CONFIRM PROPER OPERATION. 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. 430-95520-001 (Rev. 04/05) 4- 3 sec04.fm Page 4 Monday, April 11, 2005 8:34 AM Power On Press to Power On the Plum A+ and the System SelfTests Screen is displayed. After self-testing successfully completes, the display will proceed to the next screen. HOSPIRA Plum A+ 13.X Jan 31 2005 12:30:30 Copyright Hospira, Inc. 2005 System Self Test In Progress Programming the infuser may ** be n. begin during the cassette o io ’ t ** check phase of the start-up testing. o tu NOTE: If battery is missinglor defective, a “Battery not installed” lbattery” prompt will appear message with a “Continue a without (AC power only). CAUTION: W M Cli A+, . U t . a ra in SCREENS SHOWN IN THIS MANUAL ARE EXAMPLES ONLY AND DON T NECESSARILY REFLECT ACTUAL CLINICAL PRACTICE HEN THE BATTERY IS REMOVED FROM THE LUM DO NOT OPERATE ON PATIENTS SE OF A PROPERLY MAINTAINED AND CHARGED BATTERY HELPS CONFIRM PROPER OPERATION 2D 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. If Infuser ID Entry screen appears, consult your hospital’s biomed personnel. 4- 4 430-95520-001 (Rev. 04/05) sec04.fm Page 5 Monday, April 11, 2005 8:34 AM Plum A+ Infusion System The Area Selection screen will appear if your system has been programmed with the Hospira MedNet accessory. Use to choose. If only one CCA has been entered, it becomes the default and this screen is skipped. Area Selection Any Hospital, USA MM/DD/YY XXYYZZ- 123456 ICU MedSurg OR Cardio Urology Psych Recov L&D 5 West Renal Neo ICU OB/GYN Oncol Ad ICU ER 7 South 3 North 4 North Select, then Enter Enter be n. o go straight If not using MedNet, the displaytwill io to the “Clear Settings ?” option. t N it Example of Clear Settings Screen a a 3 The on-screen message a lin “Clear M may Settings?” appear. Select f [Yes] toaclear all settings. inALL settings when Dr Clear NOTE: To change the CCA while infusing, see Section 6.8, Changing CCA While Infusing. SETUP Clear Settings? Yes clears ALL settings Yes No 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 bypassed. 430-95520-001 (Rev. 04/05) 4- 5 sec04.fm Page 6 Monday, April 11, 2005 8:34 AM Simple Delivery Example of MedNet Main Delivery Screen (with cleared settings). The selected area is displayed at the bottom. A STOPPED STOPPED B Rate mL/hr Vol Inf mL **SCREENS SHOWN IN THIS MANUAL ARE EXAMPLES ONLY AND DON’T MedSurg NECESSARILY REFLECT CURRENT ACTUAL PRACTICE** NOTE: For clarity, whole number font be n. sizes will appear larger than fractional number font sizes (numbers on the right-side io toof thetdecimal). t ua 1 To Program a delivery rate, select t[A]. - lS a usea 2 To enter deliveryurate, numeric keypad. M Cli 3 Usef t to move down to the 00:00 VTBI field. Dr i Back Prime Options/ Vol Inf PROGRAM MedSurg Rate mL/hr VTBI mL Duration hr : min Enter Value using keypad Program Options 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- 6 Drug List Cancel/ Back PROGRAM MedSurg Rate 5.5 VTBI Duration 00:00 mL/hr mL hr : min Enter value using keypad Program Options Drug List Cancel/ Back 430-95520-001 (Rev. 04/05) sec04.fm Page 7 Monday, April 11, 2005 8:34 AM Plum A+ Infusion System Use to move down to the DURATION field. If auto-calculated Duration is acceptable, skip to step 9. Use keypad to change/enter the hours part of duration if desired. PROGRAM 0. s NOTE: When all parameters are 00:05 displayed, changing any one b n. parameter will result in other o io parameters automatically being computed. To understand the Automatic Calculation feature,o see tu Section 6.7 Examples of Automatic Calculation. - lS uafrom ca 7 Use tonmove hours to minutes. a lin NOTE: MThe maximum C hours allowed is 99 and the maximum minutes is 59. Dr8 Usei keypad to enter minutes. MedSurg 5.5 Rate mL/hr 5 mL VTBI Duration hr : min Enter value using keypad Program Options Press Cancel/ Back Drug List PROGRAM MedSurg Delivery will be: CAUTION: VERIFY ALL BEFORE STARTING INFUSION. VALUES Drug Rate VTBI No Drug Selected 5.5 mL/hr 0.5 mL Program Confirmation screen will appear. If correct, press [Yes] to begin infusion. 430-95520-001 (Rev. 04/05) Confirm Program? Yes No 4- 7 sec04.fm Page 8 Monday, April 11, 2005 8:34 AM Example of Main Delivery Screen just after being programmed and started. A PUMPING STOPPED B 5.5 Rate mL/hr 0.1 Vol Inf mL NOTE: The Line A Fluid Flow Indicator also will flash to indicate pumping. MedSurg Options/ Vol Inf NOTE: VTBI (volume to be infused) values over 100 mL are displayed truncated. This means that the number displayed rounds-down to the last whole number (e.g., 105.7 would be displayed as 105). An example would be the Programming or Pumping screens. be n. io tomL aretdisplayed NOTE: VI (volume infused) values over 100 tdisplayed arounds-off to rounded. This means that the number the nearest number (e.g., 105.7N would be t idisplayed as 106, but 105.3 would be displayed as 105). AnS example would be the l l Program Options screen. u ica Titration a lin M C f Line a [A] (or [B]) at 1 a Select inDelivery Screen. Drthe Main A PUMPING PUMPING B 25 Rate mL/hr 50 41 Vol Inf mL 20 MedSurg 4- 8 Options/ Vol Inf 430-95520-001 (Rev. 04/05) sec04.fm Page 9 Monday, April 11, 2005 8:34 AM Plum A+ Infusion System 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 6.7 Examples of Automatic Calculation. PROGRAM MedSurg Rate 15 mL/hr VTBI 50 mL 03:20 Duration hr : min Enter Value using keypad Program Options Cancel/ Back Drug List be n. CAUTION: V ALL VALUES to tio t ua Program Confirmation screen N it will appear. If correct, press [Yes] to begin infusion. a a NOTE: During Titration, iinfuser n nprevious continuesa to deliver at parameters until new program is confirmed. M C fExampleaof Main Delivery r Screen in after being titrated. Press PROGRAM MedSurg Delivery will be: ERIFY BEFORE STARTING INFUSION No Drug Selected 15 mL/hr 50 mL Drug Rate VTBI Confirm Program? Yes No A PUMPING PUMPING B NOTE: Volume Infused is an incrementing value which is cleared in [Options/Vol Inf]. The following 3 screens are examples of changed values. 430-95520-001 (Rev. 04/05) 15 Rate mL/hr 50 41.6 Vol Inf mL 20 MedSurg Options/ Vol Inf 4- 9 sec04.fm Page 10 Monday, April 11, 2005 8:34 AM Example of changed rate. PROGRAM MedSurg From the Main Delivery Screen, select [A]. Rate 15 mL/hr VTBI 50 mL Duration Use keypad to change the RATE value. 03:20 hr : min Enter Value using keypad Program Options Drug List 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). be n. to tio 6 Press t ua N iappear. Program Confirmationlscreen will If correct, press [Yes] to begin infusion. a a cchange. Delivery is changed to the NOTE: [START] accepts the a lin and display returns to Main Delivery new RATE and DURATION Screen. Example of Changed VTBI Drvalue.i PROGRAM MedSurg Use field. to highlight the VTBI Rate 15 VTBI 100 Duration 06:40 mL/hr mL hr : min Enter Value using keypad Use the keypad to change the VTBI value. Program Options Drug List Cancel/ Back NOTE: When the VTBI is changed, the Duration is recomputed with respect to the current Rate. To understand the Automatic 4- 10 430-95520-001 (Rev. 04/05) sec04.fm Page 11 Monday, April 11, 2005 8:34 AM Plum A+ Infusion System Calculation feature, see Section 6.7 Examples of Automatic Calculation. Press Program Confirmation screen will appear. If correct, press [Yes] to begin infusion. NOTE: [START] accepts the change. Delivery is changed to the new VTBI and DURATION and the display brings up the Confirmation screen before returning to the Main Delivery Screen. be n. Example of changed to tio DURATION field. t ua 150 100 -the l S 10 Use to highlight a athe 00:40 Duration field, then use i value. keypad a to n change its NOTE: When DURATION is t RATE is automatically changed, a a recomputed using the current VTBI inTo understand the Automatic D value. PROGRAM MedSurg Rate mL/hr VTBI mL Duration hr : min Enter Value using keypad Program Options Drug List Cancel/ Back Calculation feature, see Section 6.7 Examples of Automatic Calculation. 11 Press CAUTION: VERIFY ALL VALUES BEFORE STARTING INFUSION. Program Confirmation screen will appear. If correct, press [Yes] to begin infusion. 430-95520-001 (Rev. 04/05) 4- 11 sec04.fm Page 12 Monday, April 11, 2005 8:34 AM NOTE: [START] accepts the change. Delivery is changed to the new DURATION and RATE and the display brings up the Confirmation screen before returning to the Main Delivery Screen. Piggyback Delivery PIGGYBACK DELIVERYInfusion will stop Line A and infuse Line B until VTBI completes. Line A will automatically restart. A PUMPING STOPPED B be n. o io 1 With Line A pumping, to o tu program a Piggyback delivery, select [B]. - l Si afield isa The Delivery Mode highlighted.an in NOTE: If an entry C was previously t a programmed, RATE is highlighted. If no previous entries, MODE is 00:00 Drhighlighted. 5.5 Rate mL/hr 20 Vol Inf mL MedSurg Options/ Vol Inf PROGRAM MedSurg Mode Piggyback Rate mL/hr VTBI mL Duration hr : min Change using Change Mode Program Change Options Mode Drug List Cancel/ Back If field reads “Concurrent”, select [Change Mode] to switch to “Piggyback”. 4- 12 430-95520-001 (Rev. 04/05) sec04.fm Page 13 Monday, April 11, 2005 8:34 AM Plum A+ Infusion System Select to highlight the RATE field. Mode Piggyback Rate To enter delivery rate, use numeric keypad. VTBI Duration 200 00:00 mL/hr mL hr : min Enter value using keypad Program Options PROGRAM MedSurg Cancel/ Back Drug List Use to move down to the VTBI field. be n. 6 To enter VTBI amount, use keypad. to tio t ua 200 NOTE: While the VTBI is being 100 N it entered, the duration is automatically 00:30 computed. If the computed is l value greater than 99:59,a dashes (- -) appear in placeu of hours.c To understand Automatic Calculation n6.7 Examples atheSection feature, see of M Calculation. Automatic t a a in PROGRAM MedSurg Mode Piggyback Rate mL/hr VTBI mL Duration hr : min Enter value using keypad Program Options 430-95520-001 (Rev. 04/05) Drug List Cancel/ Back 4- 13 sec04.fm Page 14 Monday, April 11, 2005 8:34 AM PROGRAM Use to move down to the DURATION field. MedSurg Mode Piggyback 133 100 00:45 Rate (Optional) Use keypad to change duration. VTBI Duration mL/hr mL hr : min Enter value using keypad When all parameters are displayed, changing any one parameter will result in other parameters automatically being computed. Program Options Drug List Cancel/ Back be n. o io 8 Press o tu CAUTION: V ALL VALUES l screenl will appear. If correct, Program Confirmation press [Yes] n to u begin iinfusion. ca a in NOTE: If M Line A has al Delay Start remaining or is stopped, a message will appear warning of a possible non-delivery (see f 6.4). a section inof Main Delivery DrExample ERIFY BEFORE STARTING INFUSION Screen just after being programmed and started. A DELAYED PUMPING B 5.5 Rate mL/hr 133 20 Vol Inf mL 0.1 MedSurg 4- 14 Options/ Vol Inf 430-95520-001 (Rev. 04/05) sec04.fm Page 15 Monday, April 11, 2005 8:34 AM Plum A+ Infusion System Concurrent Delivery CONCURRENT DELIVERYSimultaneous delivery of two fluids at independent flow rates. CAUTION: CONSULT DRUG LABELING TO CONFIRM DRUG C O MP AT I BI L IT Y , C O N CE NT R A TI O N , DELIVERY RATES, AND VOLUME ARE ALL SUITABLE FOR CONCURRENT AND PIGGYBACK DELIVERY MODES . S EE S ECTION 8 FOR INFORMATION ON CONCURRENT FLOW, SEE SECTION 9 FOR DELIVERY RATE RANGES. A PUMPING STOPPED B 5.5 Rate mL/hr 0.1 Vol Inf mL MedSurg be n. io one toalarm tconditions, NOTE: In concurrent mode with certain tmay continue a to deliver. line may stop while the other line N it 1 With pumping started on llineSA, to program a a rate, Concurrent delivery ca select [B]. a lin field is The M Delivery Mode highlighted. NOTE: If an entry was previously r i Options/ Vol Inf PROGRAM MedSurg Mode Piggyback mL/hr Rate programmed, RATE is highlighted. If no previous entries, MODE is highlighted. If field reads “Piggyback”, select [Change Mode] to switch to “Concurrent”. 430-95520-001 (Rev. 04/05) VTBI Duration 00:00 mL hr : min Change using Change Mode Program Change Options Mode Drug List Cancel/ Back 4- 15 sec04.fm Page 16 Monday, April 11, 2005 8:34 AM Verify change to “Concurrent” mode. PROGRAM MedSurg Mode Concurrent Rate Use to highlight Rate field. VTBI Duration 00:00 mL/hr mL hr : min Change using Change Mode Program Change Options Mode Drug List Cancel/ Back be10 n. NOTE: When Rate for Line A plus to tio Rate for Line B is greater than valid 00:00 rate ranges, a “Concurrency violation” o tu message will explain why second line did not start. See Section 9.3 for valid S delivery rate ranges. a c may not be displayed if unit is NOTE: “Concurrency violation” a Complete”. displaying “VTBI in The device will not start and an invalid keypress sound C will occur when [START] is pressed. r i To enter delivery rate, use numeric keypad. PROGRAM MedSurg Mode Concurrent Rate mL/hr VTBI mL Duration hr : min Enter value using keypad Program Options 4D Use Cancel/ Back PROGRAM to move down to the VTBI field. 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. To 4- 16 Drug List MedSurg Mode Concurrent Rate VTBI Duration 10 100 10:00 mL/hr mL hr : min Enter value using keypad Program Options Drug List Cancel/ Back 430-95520-001 (Rev. 04/05) sec04.fm Page 17 Monday, April 11, 2005 8:34 AM Plum A+ Infusion System understand the Automatic Calculation feature, see Section 6.7 Examples of Automatic Calculation. Use to move down to the DURATION field. (Optional) Enter values for desired hours and minutes. NOTE: When Duration is entered, Rate is automatically computed. e . 7 Press t ti CAUTION: V ALL VALUES o willtuappear. If correct, Program ConfirmationN screen i - infusion. press [Yes] to begin a a Example ofna concurrent delivery.a M Cli t a a in ERIFY BEFORE STARTING INFUSION A PUMPING PUMPING B 5.5 Rate mL/hr 10 20.4 Vol Inf mL MedSurg 430-95520-001 (Rev. 04/05) Options/ Vol Inf 4- 17 sec04.fm Page 18 Monday, April 11, 2005 8:34 AM Stop and Start with only 1 Line Pumping Press at the Main Delivery Screen. A PUMPING STOPPED B 100 Rate mL/hr 8.5 Vol Inf mL NOTE: If [A] (or [B]) is selected prior to pressing [STOP], the display will return to the programming screen. Select [Cancel/Back] to return to the Main Delivery screen. be n. o io Example of STOPPED o tu delivery. - l Si 2 To discontinue infusion, a press M Cli t secondary 3 Clamp a tubing if connected. Dr i MedSurg Back Prime Options/ Vol Inf A STOPPED STOPPED B 100 Rate mL/hr 8.5 Vol Inf mL MedSurg Back Prime Options/ Vol Inf Open door, remove set and close door. Or, press to resume infusion. 4- 18 430-95520-001 (Rev. 04/05) sec04.fm Page 19 Monday, April 11, 2005 8:34 AM Plum A+ Infusion System Stop and Start with Both Lines pumping Press at the Main Delivery Screen. A PUMPING PUMPING B 25 Rate mL/hr Vol Inf mL 50 20.4 be n. o io 2 Select [Stop A], [Stop B], t or [Stop All]. o tu - is selected NOTE: If [A] (or l [B]) prior to [STOP], thea display willl show the programming screen.c Select [Cancel/Back] to return to the Main Delivery screen. li M C t a a Example in of stopped infusion. MedSurg Options/ Vol Inf A PUMPING PUMPING B 25 Rate mL/hr 50 Vol Inf mL 20.4 MedSurg Choose line(s) to stop: Stop All Stop Stop Cancel A STOPPED STOPPED B NOTE: This is an example using [Stop All]. CAUTION: VERIFY ALL BEFORE STARTING INFUSION. 25 Rate mL/hr 50 Vol Inf mL 20.4 VALUES MedSurg Back Prime 430-95520-001 (Rev. 04/05) Options/ Vol Inf 4- 19 sec04.fm Page 20 Monday, April 11, 2005 8:34 AM To resume infusion, press A STOPPED STOPPED B 25 Rate mL/hr 50 Vol Inf mL 20.4 Select [Start A], [Start B], or [Start All]. Or, to discontinue infusion, press MedSurg Choose line(s) to start: Start All Start Start Cancel be n. to tio 6 Open door, remove set and close door. t ua N it Backpriming a a BACKPRIMING- Removal icair or n nofand fluid from the a proximal line cassette airtrap. M Cli t a 1 ra To initiate a backprime, select D [Backi Prime]. Clamp secondary tubing if connected. A STOPPED STOPPED B 5.5 Rate mL/hr 8.9 Vol Inf mL MedSurg NOTE: Backpriming is available only when all delivery is stopped. Secondary container is necessary to receive the air. 4- 20 Back Prime Options/ Vol Inf 430-95520-001 (Rev. 04/05) sec04.fm Page 21 Monday, April 11, 2005 8:34 AM Plum A+ Infusion System 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. BACKPRIMING 5.5 Rate mL/hr 8.9 Vol Inf mL MedSurg Release Backprime to Stop Back Prime NOTE: Fluid flow is at maximum rate possible. Options/ Vol Inf be n. to tiodelivery. Pressing will resume programmed t ua N it Clearing Settings a a Main 1 Press an at the in Delivery M Screen. a settings when fClear ALL i patients or multiple Dr changing Upon release of [Back Prime], the cassette test is performed to confirm readiness for pumping. A PUMPING STOPPED B 5.5 Rate mL/hr 0.1 Vol Inf mL MedSurg programming parameters. 430-95520-001 (Rev. 04/05) Options/ Vol Inf 4- 21 sec04.fm Page 22 Monday, April 11, 2005 8:34 AM Select Line [A] (or B if active) from the stopped Main Delivery Screen. NOTE: If Line A or B is programmed with a Therapy (i.e., 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]. A STOPPED STOPPED B 5.5 Rate mL/hr 8.9 Vol Inf mL MedSurg Back Prime Options/ Vol Inf be n. 3 Select [Yes]. to tio t ua Clear ALL settings when N it changing patients or multiple programming parameters. a a M Cli t screen Example a of “Cleared Settings”. Dr i PROGRAM Clear Line A Settings? Yes No PROGRAM MedSurg Rate Select [Cancel/Back] to return to the Main Delivery screen or program new settings. 4- 22 VTBI Duration mL/hr 00:00 mL hr : min Enter Value using keypad Program Options Drug List Cancel/ Back 430-95520-001 (Rev. 04/05) sec04.fm Page 23 Monday, April 11, 2005 8:34 AM Plum A+ Infusion System Updating Drug Library If a new Drug Library is available, the New Drug Library Install screen will be displayed. Library Install New Drug Library Available The Installation may take up to an hour. Select [Yes] to begin the installation (It may take up to an hour). Select [No] to skip the installation and continue using the current library. Ensure pump is connected to AC power. Install Now? be n. to tio Example screen of Library t Installing. N it a a M Cli t a a in Yes No Library Install Installing New Drug Library The Installation may take up to an hour. Ensure pump is connected to AC power. 430-95520-001 (Rev. 04/05) 4- 23 sec04.fm Page 24 Monday, April 11, 2005 8:34 AM NOTES be n. to tio t ua N it a a M Cli t a ra in 4- 24 430-95520-001 (Rev. 04/05) Plum A+ Infusion System SECTION 5 Advanced Programs Standard Program (Dose Calculation) Allows programming Dose Rates in alternative units of measure. Dose Calculation can be used in Simple Delivery, Loading Dose, and Multistep. be n. to tio Loading t ua Dose N it a a c program to deliver up to 10 Allows a sequential n volumes and delivery rates may be asteps;lifluid M programmed for each step. The program may be entered based on Rate and Volume or aVolume and Time. If Dose Calc is used, the Multistep steps are in the same unit of measure, Dr i delivery over the same period of time, from the same 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. container. NOTE: During programming, user must identify desired drug with softkey Drug List prior to setting program parameters. Use drug manufacturer recommendations for IV administration when using the Plum A+ infuser. 430-95520-001 (Rev. 04/05) 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 settings when changing patients or multiple programming parameters. The Area Selection screen will appear if your system has been programmed with the MedNet accessory. be n. to tio t ua Use to select CCA and bring you to the Main Delivery N it Screen. a a NOTE: To change the CCA while c CCA While Infusing. infusing, see Section 6.8, Changing M Cli t [A]aat the Main 1 Select Deliveryn Screen. Area Selection Any Hospital, USA MM/DD/YY XXYYZZ- 123456 ICU MedSurg OR Cardio Urology Psych Recov L&D 5 West Renal Neo ICU OB/GYN Oncol Ad ICU ER 7 South 3 North 4 North Select, then Enter Enter A STOPPED STOPPED B **SCREENS SHOWN IN THIS MANUAL ARE EXAMPLES ONLY AND DON’T NECESSARILY REFLECT CURRENT ACTUAL PRACTICE** 5- 2 Rate mL/hr Vol Inf mL MedSurg Back Prime Options/ Vol Inf 430-95520-001 (Rev. 04/05) Plum A+ Infusion System The Line A Programming screen appears. PROGRAM MedSurg Select [Drug List] for Dose Calculation programming. Rate mL/hr VTBI mL 00:00 Duration hr : min Enter Value using keypad Program Options The Drug List Screen appears, in mainly alphabetical order. Drug List be n. NOTE: Default entry is “No Drug Selected”. to tio t ua N it a a 3 Use atonhighlight desired in drugM name. Cl t adoes not contain When list a desired generic drug name or inname D group select Cancel/ Back MedSurg No Drug Selected 25 grams/500 mL Albumin 5% 2.6 mg/50 mL Aldesleukin 10 mg/250 mL Alfentanil 50 mg/50 mL Alteplase 100 mg/100 mL Alteplase 100 mL Amikacin 150 mg/100 mL Amiodarone Select, then Enter Page Up Page Down Enter Cancel/ Back MedSurg Antibiotic 250 mg/500 mL DOBUTamine 500 mg/500 mL DOBUTamine 100 mg/250 mL Docetaxel ___ ___/___ mL DOPamine 400 mg/250 mL DOPamine 800 mg/250 mL DOPamine 25,000 units/500 mL Heparin Select, then Enter [Page Down] (or [Page Up]) until it shows, then use Page Up Page Down Enter Cancel/ Back to highlight choice. Select [Enter] to indicate selection and advance to the Therapy selection screen. Based on this selection, assume the hospital has set the following rules for the Med/Surg Area: 430-95520-001 (Rev. 04/05) 5- 3 Soft upper limit of 8 mcg/kg/min Hard upper limit of 12 mcg/kg/min NOTE: The SOFT and HARD limits are not displayed. However, the limit is provided if a value is programmed outside the acceptable range. Typically, the pharmacy will set the limit. The Select Therapy screen for Line A appears. PROGRAM DOPamine be n. to tio t ua If selected drug has been programmed with established N it dosing units and concentration, skip to step 8. a a The Program n Dose Calc screen appears. M Cli t Cursoradefaults to package NOTE: insert (orn ra i hospital) recommended Standard Program Select [Choose] to select Standard Program (Dose Calc) and continue. Loading Dose Multistep Select, then Choose Choose Back Program Dose Calc DOPamine dose units associated with the selected drug. mL/hr mcg/kg/min mcg/kg/hr mcg/min mcg/hr mg/kg/hr Select, then Choose Page Up Select mg/min mg/hr grams/hr ng/kg/min mmol/min mmol/hr mEq/hr Page Down Choose Back [Choose] to continue. Or, use to change the units to use in the delivery. If desired, select measure. 5- 4 [Page Down] to see more units of 430-95520-001 (Rev. 04/05) Plum A+ Infusion System 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 DOPamine Drug Conc in Container mcg mg grams Select, then Choose Choose Back NOTE: Cursor defaults to package insert (or hospital) recommended concentration units associated with the selected drug. be n. 7 Select [Choose] to continue. t Or, use ti to change tunitsutoause in the the Container Concentration N it delivery. The next page of the Program a appears a to Dose Calc screen provide a for entry n of delivery program parameters. M C and Volume fThe Concentration fields are filled in per drug r i Program Dose Calc DOPamine Conc Weight 400 mg Dose VTBI Duration Rate 250 mL 70 kg 00: 00 mcg/kg/min mL hr : min mL/hr Enter value using keypad selection. Program Options Cancel/ Back Use keypad to enter desired values. Once each value is entered, use highlight the next programming field. to NOTE: The Concentration elements and weight value must be entered before the [SELECT] key allows access to remaining fields. 430-95520-001 (Rev. 04/05) 5- 5 9 Continue to enter values using the keypad, and advancing to the next field using Program Dose Calc DOPamine Conc Weight 400 mg 70 kg Dose VTBI Duration Rate NOTE: As the Dose value is entered, the Rate is automatically calculated. To understand the Automatic Calculation feature, see Section 6.7 Examples of Automatic Calculation. 10 00: 00 26.3 250 mL mcg/kg/min mL hr : min mL/hr Enter value using keypad Program Options Cancel/ Back 10 Use to scroll down to the be n. VTBI field. to tio t ua 11 Enter a value for VTBI using N it the keypad. a a NOTE: As the VTBIu value is entered or changes, Duration is automatically updated. M Cli t At thisapoint, programming is complete unless NOTE: are desired. See Section 6, Additional a[Program nforOptions] Features, more information. Program Dose Calc DOPamine Conc Weight Dose VTBI Duration Rate 400 mg 70 kg 10 250 09: 30 26.3 250 mL mcg/kg/min mL hr : min mL/hr Enter value using keypad Program Options 12 Press CAUTION: 5- 6 Cancel/ Back VERIFY ALL VALUES BEFORE STARTING INFUSION. 430-95520-001 (Rev. 04/05) Plum A+ Infusion System Because the Dose falls outside the soft limits, the infuser beeps three times (Invalid Key Warning), and generates the error message: “Dose > 8. Override?” Conc Weight 400 mg 70 kg Dose VTBI Duration Rate 10 250 09: 30 26.3 250 mL mcg/kg/min mL hr : min mL/hr Dose > 8. Override? Yes 13 Select Program Dose Calc DOPamine [Yes]. No e . This will bring up the PROGRAM t ti CONFIRMATION screen. t ua N &it 14 If Dose, Drug, Conc., Weight Rate appear correct, select [Yes] to beginu program.a NOTE: If a drug has been indosing M the selected pre-programmed with units and concentration, the concentration a or diluent volume cannot be changed whether fdrug amount r delivering i or stopped. The only way to change to a different NOTE: A SOFT limit override will be recorded in the History Events Log. Program Dose Calc MedSurg Delivery will be: Dose Drug Conc Weight Rate 10 mcg/kg/min DOPamine 400 mg 250 mL 70 kg 26.3 mL/hr Confirm Program? Yes No concentration is to clear the program. However, if selected drug has not been pre-programmed (or still operating with the DDL), the concentration can be changed for a program. 430-95520-001 (Rev. 04/05) 5- 7 The Main Delivery screen appears displaying the information just entered. NOTE: The Program Type and Drug are displayed as well as the Dose Rate and Dose Units. A PUMPING STOPPED B DOPamine Dose Calculation 10 Rate mL/hr Vol Inf mL Dose mcg/kg/min MedSurg 26.3 Options/ Vol Inf be n. to tio t ua N it a a M Cli t a ra in 5- 8 430-95520-001 (Rev. 04/05) Plum A+ Infusion System 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 settings when changing patients or multiple programming parameters. be n. to tio t ua N it a a n nic The LineaB Programming li screen Mappears. t a 2a Select [Drug List]. Select [B] at the Main Delivery Screen. A PUMPING STOPPED B DOPamine Dose Calculation 10 Rate mL/hr Vol Inf mL Dose mcg/kg/min MedSurg 26.3 Options/ Vol Inf PROGRAM MedSurg Mode Piggyback mL/hr Rate mL VTBI Duration 00:00 hr : min Change using Change Mode Program Change Options Mode 430-95520-001 (Rev. 04/05) Drug List Cancel/ Back 5- 9 The Drug List Screen appears, in mainly alphabetical order. NOTE: Default entry is “No Drug Selected”. MedSurg No Drug Selected 25 grams/500 mL Albumin 5% 2.6 mg/50 mL Aldesleukin 10 mg/250 mL Alfentanil 50 mg/50 mL Alteplase 100 mg/100 mL Alteplase 100 mL Amikacin 150 mg/100 mL Amiodarone Select, then Enter Page Up Page Down Enter Cancel/ Back be n. o io When list does not contain desired generic drug name or t o tu group name select [Page Down] (or [Page Up]) until itashows, l then use to highlight in choice. M 4 ra Select [Enter] to indicate selection and advance to i Selection screen. D the Program Use to highlight desired drug name. MedSurg Labetalol Lepirudin Lidocaine Lidocaine Lidocaine Liposyn 10% Liposyn 20% Milrinone 200 mg/200 mL 100 mg/250 mL 1 grams/250 mL 2 grams/500 mL 4 grams/500 mL 100 mL 500 mL 200 mcg/100 mL Select, then Enter Page Up The Select Program screen for Line B appears. Page Down Enter Cancel/ Back PROGRAM Lidocaine Standard Program Select [Choose] to continue. Loading Dose Multistep Select, then Choose Choose 5- 10 Back 430-95520-001 (Rev. 04/05) Plum A+ Infusion System If selected drug has been programmed with established dosing units and concentration, skip to step 8. The Program Dose Calc screen appears. NOTE: Cursor defaults to package insert (or hospital) recommended dose units associated with the selected drug. Program Dose Calc Lidocaine mL/hr mcg/kg/min mcg/kg/hr mcg/min mcg/hr mg/kg/hr mg/min mg/hr grams/hr ng/kg/min mmol/min mmol/hr mEq/hr 6 Select [Choose] to continue. be n. o io Or, use to change the unitst to use in the delivery. o tu i to see more units of [Page Down] If desired, select la al measure. The Container Concentration ascreen inappears Selection whenever the selected Dose fUnits areagram-based (e.g., in mg, mcg, or ng) Dr grams, Select, then Choose Page Up Page Down Choose Back Program Dose Calc Lidocaine Drug Conc in Container mcg mg grams otherwise this screen is skipped. Select, then Choose Choose Back NOTE: Cursor defaults to package insert recommended concentration units associated with the selected drug. Select [Choose] to continue. Or, use to change the Container Concentration units to use in the delivery. 430-95520-001 (Rev. 04/05) 5- 11 The next page of the Program Dose Calc screen appears to provide for entry of delivery program parameters. Use keypad to enter desired values. Once entered, use to highlight the next field. Program Dose Calc Lidocaine Conc Mode Dose VTBI Duration Rate 2 grams 500 mL Piggyback 00: 00 mg/min mL hr : min mL/hr Enter value using keypad Program Options Cancel/ Back be n. to tio t Mode adefault, 9 To change the Piggyback Delivery N , then itselect scroll down to Mode using l l [Change Mode]. a u ica NOTE: Delivery Option is available on Line B, its default n field aandMode is Piggyback, the Weight is gone. M C t a 10ra Continue nentering desired D values using the keypad. Use NOTE: If selected drug has established Rule Sets (e.g., nonblank concentration), the Mode field will be highlighted upon entry to this screen. Program Dose Calc Lidocaine Conc to advance to the next field. NOTE: When entering the RATE, with a VTBI value entered, the DOSE and DURATION fields are automatically updated. To understand the Automatic Calculation feature, see Section 6.7 Examples of Automatic Calculation. 5- 12 Mode Dose VTBI Duration Rate 2 grams 500 mL Concurrent 500 16 : 40 30 mg/min mL hr : min mL/hr Enter value using keypad Program Options Cancel/ Back 430-95520-001 (Rev. 04/05) Plum A+ Infusion System NOTE: The Duration field temporarily changes to dashes when the computed value is larger than what can be displayed. 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. be n. o io CAUTION: V ALL VALUES t No itu 12 To start the delivery,- press a a n upntheicPROGRAM This willa bring CONFIRMATION M Clscreen. t a a If Dose, r13 in Drug, Conc., Weight, & NOTE: At this point, programming is complete unless [Program Options] are desired. See Section 6, Additional Features, for more information. ERIFY BEFORE STARTING INFUSION. Program Dose Calc MedSurg Delivery will be: Dose Drug Conc Weight Rate 2 mg/min Lidocaine 2 grams 500 mL 70 kg 30 mL/hr Confirm Program? Yes No Rate appear correct, select [Yes] to begin program. NOTE: If the selected drug has been pre-programmed with dosing units and concentration, the concentration drug amount or diluent volume cannot be changed whether delivering or stopped. The only way to change to a different concentration is to clear the program. However, if selected drug has not been pre-programmed (or still operating with the DDL), the concentration can be changed for a program. 430-95520-001 (Rev. 04/05) 5- 13 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. A STOPPED PUMPING B DOPamine Dose Calculation Lidocaine Dose Calculation 26.3 Rate mL/hr 30 Vol Inf mL 0.1 mcg/kg/min Dose MedSurg mg/min Options/ Vol Inf be n. to tio t ua N it a a M Cli t a ra in 5- 14 430-95520-001 (Rev. 04/05) Plum A+ Infusion System 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 settings when changing patients ors multiple programming parameters. be n. The Area Selection screen will appear if your system has beento io programmed with the MedNet t ua accessory. N it Use to select CCA and a a cDelivery bring you to the Main Screen.a M Cli NOTE: t Toachange CCA while infusing, see Section 6.8, Changing CCA While Infusing. ra in Area Selection Any Hospital, USA MM/DD/YY XXYYZZ- 123456 ICU MedSurg OR Cardio Urology Psych Recov L&D 5 West Renal Neo ICU OB/GYN Oncol Ad ICU ER 7 South 3 North 4 North Select, then Enter Enter D1 Select [A] (or [B]) at the Main Delivery screen. A STOPPED STOPPED B Rate mL/hr Vol Inf mL MedSurg Back Prime 430-95520-001 (Rev. 04/05) Options/ Vol Inf 5- 15 The selected Line (A or B) Programming screen appears. Select PROGRAM MedSurg [Drug List]. Rate mL/hr VTBI mL 00:00 Duration hr : min Enter Value using keypad Program Options The Drug List Screen appears, in mainly alphabetical order. Drug List Cancel/ Back be n. NOTE: Default entry is “No Drug Selected”. This process will guide you to tio through a “fluid challenge”, so “No t ua Drug Selected” will be entered. o N it l lS 3 Select [Enter] to a indicate selection and advance u itocthe Program selection a liscreen. The Select Program C screen for Line (or B) appears. iThis example shows line A DrNOTE: being programmed. MedSurg No Drug Selected 25 grams/500 mL Albumin 5% 2.6 mg/50 mL Aldesleukin 10 mg/250 mL Alfentanil 50 mg/50 mL Alteplase 100 mg/100 mL Alteplase 100 mL Amikacin 150 mg/100 mL Amiodarone Select, then Enter Page Up Page Down Enter Cancel/ Back PROGRAM Standard Program Loading Dose Multistep Select, then Choose Choose 5- 16 Back 430-95520-001 (Rev. 04/05) Plum A+ Infusion System Use to scroll down to Loading Dose. PROGRAM Standard Program Loading Dose Select [Choose] to continue. Multistep Select, then Choose Choose Back be n. 6 Select [Choose] to continue.to io Or, use to change theo units u it to use in the delivery. l l If desired, select u i[Page Down] to see more a lin units of measure. The M LoadingCDose a screen appears. fProgramming r in The next page of the Program Loading Dose screen appears. A Program Loading Dose mg/min mg/hr grams/hr ng/kg/min mmol/min mmol/hr mEq/hr mL/hr mcg/kg/min mcg/kg/hr mcg/min mcg/hr mg/kg/hr Select, then Choose Page Up Page Down Choose Back A Program Loading Dose D7 The default field is Rate. Since a “Fluid Challenge” is being performed in this example, press to advance to the VTBI field. 430-95520-001 (Rev. 04/05) Rate mL/hr VTBI mL Duration hr : min 00 : 00 00 : 00 Enter value using keypad Program Options Cancel/ Back 5- 17 8 Enter value using keypad. A Program Loading Dose Rate mL/hr VTBI mL 250 Duration hr : min 00 : 00 00 : 00 Enter value using keypad Program Options Cancel/ Back e . 9 Use to highlight the next t ti field. t ua N it 10 Enter Duration using keypad. The Rate value is automatically a athe calculated. To understand Automatic Calculation feature, in of see Sectiona 6.7 Examples Automatic Calculation. i values for loading 11 the DrAfter dose Step-1 are entered, use A Program Loading Dose Rate mL/hr 500 VTBI mL 250 Duration hr : min 00 : 30 00 : 00 Enter value using keypad Program Options Cancel/ Back A Program Loading Dose to highlight the maintenance dose, Step-2. NOTE: The Loading Dose program 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. 5- 18 Rate mL/hr 500 75 VTBI mL 250 Duration hr : min 00 : 30 00 : 00 Enter value using keypad Program Options Cancel/ Back 430-95520-001 (Rev. 04/05) Plum A+ Infusion System 12 Enter the set of desired values A Program Loading Dose for Step-2 of the program. 13 Select [Program Options] to select a Delayed Start or Standby. Rate mL/hr 500 75 VTBI mL 250 750 Duration hr : min 00 : 30 10 : 00 Enter value using keypad Program Options Cancel/ Back NOTE: At this point, programming is complete unless [Program Options] are desired. See Section 6, Additional Features, for more information. be n. o io NOTE: Nurse Callback enables an t alarm when a change in the delivery o u on a line occurs such as completing Step-1 and starting Step-2.N Or on lineit -is completed B, a piggyback delivery aits delivery. and line A is starting ca M Cli t a a in r14 Enter a delay time (less than Program Options Loading Dose Delay Start for 00:00 hr:min Callback No Enter Value using keypad Standby 24 hours) using the keypad. NOTE: Not available if a delivery is taking place on the line. NOTE: Nurse Callback cannot be changed while a delivery is taking place on the line. Enter Cancel/ Back Program Options Loading Dose Delay Start for 00:05 hr:min Callback Yes Change using Yes/No Yes/No Enter Cancel/ Back 15 Select [Enter] to accept the changes and return to the Program Loading Dose screen. 430-95520-001 (Rev. 04/05) 5- 19 NOTE: [Cancel/Back] returns the fields to their original value and displays the previous screen. 16 To start the delivery, press This will bring up the PROGRAM CONFIRMATION screen. CAUTION: VERIFY ALL BEFORE STARTING INFUSION. VALUES Program Loading Dose MedSurg Delivery will be: No Drug Selected 500 mL/hr 250 mL Drug Rate VTBI 17 If Drug and Rate appear be n. correct, select [Yes] to begin program. to tio t ua The Main Delivery Screen o N it appears. a a NOTE: The words “DELAYED” and “Loading Dose” appear in the uppernindicatenthei options left corner. These li which have Mbeen selected. t a a in D After the programmed delay Confirm Program? Yes No A DELAYED STOPPED B Loading Dose 500 Rate mL/hr Vol Inf mL MedSurg period has expired, the Plum A+ starts “Pumping”. This is indicated where “Delayed” previously was displayed. Options/ Vol Inf A PUMPING STOPPED B Loading Dose 500 Rate mL/hr Vol Inf mL MedSurg 5- 20 Options/ Vol Inf 430-95520-001 (Rev. 04/05) Plum A+ Infusion System After the Step-1 has completed, the Main Delivery Screen changes to the second step. Maintenance Dose NOTE: A flashing “Callback Line A” message and the audio alarm sound indicates activation of that option. N105 Callback Line A A PUMPING STOPPED B 75 Rate mL/hr 250 Vol Inf mL MedSurg 18 The user should acknowledge Options/ Vol Inf be n. pressing o io Upon completion of delivery, t the screen shows a flashing o tu “Line A VTBI complete” - lalarm Si message and the audible a a sounds. NOTE: The KVO rate will nor lesschange to a1.0 mL/hr the rate of M on C depending delivery rate and “Pumping”a mode changes to “KVO”. If a Continue Rate option was selected, pumping continues at inrate. D original the Callback message and stop the audio alarm by STOPPED B KVO Maintenance Dose Rate mL/hr 1000 Vol Inf mL MedSurg N161 Line A VTBI complete 19 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. 430-95520-001 (Rev. 04/05) 5- 21 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. be n. The Area Selection screen will appear if your system has been to io programmed with the MedNet t accessory. N it Use to select CCA and a a bring you to the Main Delivery Screen. a M Cli NOTE: CCA while t To change infusing, see Section 6.8, Changing CCA While Infusing. ra in Clear ALL settings when changing patients or multiple programming parameters. Area Selection Any Hospital, USA MM/DD/YY XXYYZZ- 123456 ICU MedSurg OR Cardio Urology Psych Recov L&D 5 West Renal Neo ICU OB/GYN Oncol Ad ICU ER 7 South 3 North 4 North Select, then Enter Enter Select [A] at the Main Delivery screen. A STOPPED STOPPED B Rate mL/hr Vol Inf mL MedSurg Back Prime 5- 22 Options/ Vol Inf 430-95520-001 (Rev. 04/05) Plum A+ Infusion System The Line A Programming screen appears. Select PROGRAM MedSurg [Drug List]. Rate mL/hr VTBI mL 00:00 Duration hr : min Enter Value using keypad Program Options Cancel/ Back Drug List be n. o io NOTE: Default entry is “No Drug Selected”. o tu - l Si a a a lin desired 3 Use M to highlight drug name. When list does not contain i drug Dr desired name or drug The Drug List Screen appears, in mainly alphabetical order. MedSurg No Drug Selected 25 grams/500 mL Albumin 5% 2.6 mg/50 mL Aldesleukin 10 mg/250 mL Alfentanil 50 mg/50 mL Alteplase 100 mg/100 mL Alteplase 100 mL Amikacin 150 mg/100 mL Amiodarone Select, then Enter Page Up Page Down Cancel/ Back MedSurg Tirofiban Tobramycin Tobramycin Vancomycin VinCRIStine VinCRIStine class name, select [Page Down] (or [Page Up]) until it shows, then use Enter 5 mg/100 mL 40 mg/50 mL 80 mg/100 mL 500 mg/100mL 100 mL 50 mL Select, then Enter Page Up Page Down Enter Cancel/ Back to highlight choice. Select [Enter] to indicate selection and advance to the Program Selection screen. 430-95520-001 (Rev. 04/05) 5- 23 The Select Program screen for Line A (or B) appears. PROGRAM VinCRIStine Standard Program NOTE: This example shows line A being programmed. Loading Dose Multistep Select, then Choose Choose Back be n. 5 Use to scroll down to Multistep. to tio t ua 6 Select [Choose] to continue. N it l lS If selected drug hasabeen programmed with uestablished dosing unitsa and concentration, skip to step M 9. Cli tProgramaMultistep screen The appears. D NOTE: iCursor defaults to package PROGRAM VinCRIStine Standard Program Loading Dose Multistep Select, then Choose Choose Back Program Multistep VinCRIStine insert recommended dose units associated with the selected drug. mL/hr mcg/kg/min mcg/kg/hr mcg/min mcg/hr mg/kg/hr mg/min mg/hr grams/hr ng/kg/min mmol/min mmol/hr mEq/hr Select, then Choose Use key to highlight the units to use in the delivery. Select Page Down Choose Back [Choose] to continue. If desired, select 5- 24 Page Up [Page Down] to see more units of 430-95520-001 (Rev. 04/05) Plum A+ Infusion System measure. The Multistep Programming screen appears. Rate is the default field. Enter value using keypad. Program Multistep VinCRIStine Rate VTBI Duration mL/hr 50 mL hr : min 00 : 00 00 : 00 00 : 00 00 : 00 Enter value using keypad Program Options More Steps e . 10 Use to highlight the t ti Duration or VTBI field. t ua NOTE: The VTBI value is N it automatically computed-when theS l If VTBI l is Duration value is entered. entered, the Duration value is automaticallyn computed. M Cli t a ra in Cancel/ Back Program Multistep VinCRIStine Rate VTBI Duration mL/hr 50 mL 50 hr : min 01 : 00 00 : 00 00 : 00 00 : 00 Enter value using keypad Program Options D 11 Use to drop down to Step2, Rate field. 12 Enter the set of desired values for Step-2 of the program. Continue process for each additional Step. 430-95520-001 (Rev. 04/05) More Steps Cancel/ Back Program Multistep VinCRIStine Rate VTBI Duration mL/hr 50 100 mL 50 hr : min 01 : 00 00 : 00 00 : 00 00 : 00 Enter value using keypad Program Options More Steps Cancel/ Back 5- 25 NOTE: When Step-4 is programmed, using [SELECT] to advance will highlight another item on this screen. 13 When Step-4 is programmed, select [More Steps] to program up to 10 Steps. Program Multistep VinCRIStine Rate VTBI Duration mL/hr 50 100 75 50 mL 50 825 75 50 hr : min 01 : 00 08 : 15 01 : 00 01 : 00 Enter value using keypad Program Options Cancel/ Back More Steps NOTE: Using [SELECT] will not advance you to the additional steps. e . 14 To set up Steps 5 through 10, t ti enter desired values as t ua performed for Steps 1 through 4. N it l lS To see the previousasteps, select [Prev Steps]. u ica M Cli t the adelivery, press 15 To fstart a i.n Program Multistep VinCRIStine 10 Rate VTBI Duration mL/hr mL hr : min 00 : 00 00 : 00 00 : 00 00 : 00 00 : 00 00 : 00 Enter value using keypad Program Options Cancel/ Back Prev Steps Program Multistep MedSurg Delivery will be: Drug Rate VTBI This will bring up the Confirmation screen. CAUTION: VERIFY ALL BEFORE STARTING INFUSION. 5- 26 VinCRIStine 50 mL/hr 50 mL Confirm Program? VALUES Yes No 430-95520-001 (Rev. 04/05) Plum A+ Infusion System The Main Delivery Screen displays Step-1 in the upperleft corner. A PUMPING STOPPED B VinCRIStine Step 1 NOTE: In units other than mL/hr, the Dose rate and units also will be displayed. 50 Rate mL/hr 27.5 Vol Inf mL Example of Multistep Screen Pumping on Step-2. Options/ Vol Inf be n. 16 To change a program to tio parameter while pumping, t ua select [A]. N it a a NOTE: The “*” inlaiStep number field C is delivering or “d” indicates the step findicates a each completed step. Dr i A PUMPING STOPPED B VinCRIStine Step 2 100 Rate mL/hr 652 Vol Inf mL Options/ Vol Inf Program Multistep VinCRIStine 17 Enter a value using the Rate VTBI Duration mL/hr 50 100 75 50 mL 50 825 75 50 hr : min 01 : 00 08 : 15 01 : 00 01 : 00 keypad. Enter value using keypad Program Options 430-95520-001 (Rev. 04/05) More Steps Cancel/ Back 5- 27 If Rate value is changed, the Duration will automatically change. Program Multistep VinCRIStine NOTE: Only the current delivering step and future steps can be changed. Rate VTBI Duration mL/hr 50 125 75 50 mL 50 825 75 50 hr : min 01 : 00 06 : 36 01 : 00 01 : 00 Enter value using keypad Program Options 18 To start the delivery, press Cancel/ Back More Steps be n. o io This will bring up the Confirmation screen. o tu CAUTION: V ALL VALUES .S a al NOTE: The Values are now updated on the Main Delivery Screen. a lin The infuser reverts C to KVO when last Step a completes. rThe lastinstep can be restarted Program Multistep MedSurg Delivery will be: VinCRIStine 125 mL/hr 825 mL Drug Rate VTBI Confirm Program? ERIFY BEFORE STARTING INFUSION Yes No A PUMPING STOPPED B VinCRIStine Step 2 125 Rate mL/hr 658 Vol Inf mL by entering a new VTBI value. 5- 28 Options/ Vol Inf 430-95520-001 (Rev. 04/05) Plum A+ Infusion System SECTION 6 Additional Features Simple Delivery Using Delayed Start Before or after entering the simple delivery program, select [Program Options]. be n5 . o io250 NOTE: To program a Delayed Start t t 50:00 using an advanced program (i.e.,t o u Dose Calc) you must first select which line you want (A or B), next it - thenl S select [Drug List], and a If youaprogram [Program Options]. the Delayed Start first, itic will be cleared upon entry into Select Program Mmode.Cli t a The Default screen for a Program i Options appears. PROGRAM MedSurg Mode Concurrent Rate mL/hr VTBI mL Duration hr : min Change using Change Mode Program Change Options Mode Drug List Program Options Cancel/ Back Delay Start for 00:00 hr:min Callback No Enter Value using keypad Standby 430-95520-001 (Rev. 04/05) Enter Cancel/ Back 6- 1 2 Enter values for desired hours and/or minutes. Program Options Delay Start for 01:00 hr:min Select [Enter] to confirm delayed start. Callback No Enter Value using keypad CAUTION: VERIFY ALL VALUES BEFORE STARTING INFUSION. Standby Enter Cancel/ Back be n. o io Line B is delayed for the time entered. o tu NOTE: Delayed line drip indicator - lis Si solid, not flashing. It will begin flashing when actually a pumping.a M Cli t a ra in Press to confirm programming. A PUMPING DELAYED B 125 Rate mL/hr 850 Vol Inf mL MedSurg Options/ Vol Inf Piggyback with Nurse Callback After programming in desired values for both lines, select [Program Options]. NOTE: To set a nurse callback, the infuser must be stopped. This function can be selected either before or after entering the Piggyback delivery program. 6- 2 PROGRAM MedSurg Mode Rate VTBI Duration Piggyback 200 100 00:30 mL/hr mL hr : min Enter value using keypad Program Options Drug List Cancel/ Back 430-95520-001 (Rev. 04/05) Plum A+ Infusion System The default screen for Program Options appears. Program Options Delay Start for 00:00 hr:min Use to highlight “Callback” field and select [Yes/No], if necessary to obtain “Yes”, then select [Enter]. Callback Yes Change using Yes/No Yes/No Cancel/ Back Enter e . CAUTION: V ALL VALUES t ti t ua 2 Press to confirm o N to it program setting and return Main Delivery screen. 200 a a 100 00:30 M Cli t a a At iend n of Piggyback delivery, NOTE: Callback default of Yes or No is a biomedical setting and must be configured using the Hospira MedNet accessory. ERIFY BEFORE STARTING INFUSION. PROGRAM MedSurg Mode Piggyback Rate mL/hr VTBI mL Duration hr : min Enter value using keypad Program Options with Callback enabled for the line, Callback alarm is issued. Drug List A PUMPING STOPPED B 5.5 Rate mL/hr 200 0.3 Vol Inf mL 100 Press Cancel/ Back to clear alarm. MedSurg N104 Callback Line B 430-95520-001 (Rev. 04/05) Options/ Vol Inf 6- 3 Possible Non-Delivery Programmed NOTE: Whenever a valid [START] key is pressed, the device checks the delivery program(s) for non-delivery 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. PROGRAM Attention: Line A is stopped or delayed. Line B in piggyback mode gives no KVO or alarm at dose end. Continue anyway? 1 Select [Yes] to continue with be n. delivery. Or, select [No] to cancel. to tio t ua Using the Standby Feature N it Standby is a feature that ato a enables the clinician c23: program the infuser upito in of 59 minutes a in advance Starting. 1DrIf LineiA is infusing, select Yes No Program Dose Calc DOPamine Conc Weight Dose VTBI Duration Rate 400 mg 70 kg 10 250 09: 30 26.3 250 mL mcg/kg/min mL hr : min mL/hr Enter value using keypad [A] or [B] to access program screen of line to be placed on Standby. Select [Program Options]. Select [Standby]. 6- 4 Program Options Cancel/ Back 430-95520-001 (Rev. 04/05) Plum A+ Infusion System Confirm the information displayed is correct, then select [Yes] to place program on Standby mode. 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. Program Dose Calc MedSurg 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? Yes No be n. to tio t ua 5 Press to remove o it Standby and start the infusion. l l u ica M Cli t a a in A STANDBY STOPPED B DOPamine Dose Calculation 26.3 Rate mL/hr Vol Inf mL 10 mcg/kg/min MedSurg 430-95520-001 (Rev. 04/05) Options/ Vol Inf 6- 5 Select Option- Volumes Infused, Pressure/Post Infusion Rate, and Lighting/Contrast To select Options Screen, select [Options/Vol Inf]. A PUMPING STOPPED B DOPamine Dose Calculation 5.5 Rate mL/hr Vol Inf mL be n. to tio t ua N it 2 Use to highlightaanl option. u ica 3 Select [Choose] a ltoinselect the VolumesM Infused Cscreen. Dr i 393 MedSurg Options/ Vol Inf OPTIONS Release 13.x - xx/xx/xx Volumes Infused Pressure/Post Infusion Rate Lighting/Contrast Any Hospital, USA MM/DD/YY XXYYZZ-123456 Select, then Choose Change CCA This will bring up the Volumes Infused screen which defaults to Total Volume. Use to scroll to Line A or B. Choose Back OPTIONS DOPamine Dose Calculation Volumes Infused Line A Line B Total Vol 0 mL 0 mL 393 mL Press CLEAR to clear value Enter 6- 6 Cancel/ Back 430-95520-001 (Rev. 04/05) Plum A+ Infusion System To reset Line A (or B) Volume OPTIONS DOPamine Dose Calculation Infused,use and press to highlight To restore the cleared quantity, select [Cancel/Back]. Volumes Infused Line A Line B Total Vol 0 mL 0 mL 393 mL Press CLEAR to clear value Enter be n. to tio t ua Nselectit 8 To restore all quantities, [Cancel/Back] softkey. a a M Cli t a a in To reset all volumes, use to highlight Total Vol, then press Cancel/ Back OPTIONS DOPamine Dose Calculation Volumes Infused Line A Line B Total Vol 0 mL 0 mL 0 mL Press CLEAR to clear value Enter 430-95520-001 (Rev. 04/05) Cancel/ Back 6- 7 9 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. OPTIONS Release 13.x - xx/xx/xx Volumes Infused Pressure/Post Infusion Rate Lighting/Contrast 11 Use to highlight the Pressure/Post Infusion Rate option. Any Hospital, USA MM/DD/YY XXYYZZ-123456 be n. o io 12 Select [Choose] to continue. t o Infusion NOTE: Prior to changing Pressure/Post tu Rate, infuser must be stopped. - lS a a ic n n 13 Use to a highlight Continue li Limit Rate or M Distal Pressure field.t i Rate allows a choice 14 DrContinue Select, then Choose Change CCA Back Choose OPTIONS DOPamine Dose Calculation Pressure/Post Infusion Rate Continue Rate when VTBI is completed. Select [KVO/Rate]. KVO Distal Pressure Limit 6 psi Distal Pressure 0 psi Change using KVO/Rate KVO/ Rate Enter Cancel/ Back • KVO- The infuser will revert to a fixed KVO of 1 mL/hr or the last programmed Rate, whichever is less. • Rate- The infuser will continue at the Rate programmed. NOTE: Option will be for both line A and line B selections. 15 To change Distal Pressure Limit when highlighted, 6- 8 430-95520-001 (Rev. 04/05) Plum A+ Infusion System enter value between 1.0 and 15.0 psi. 16 Select [Enter] to keep changes and return to the Main Delivery screen, or [Cancel/Back] to restore original values and return to the Options screen. NOTE: Continue Rate default of KVO or Rate must be configured using the Hospira MedNet software. be n. to tio t ua 18 Use to highlight Lighting/ N it Contrast Option. a to continue. 19 Select [Choose] ca a lin 20 Press toC highlight Backlight or Display Contrast. ra Intensity 17 Select [Options/Vol Inf] from the Main Delivery screen to return to the Options screen. OPTIONS Release 13.x - xx/xx/xx Volumes Infused Pressure/Post Infusion Rate Lighting/Contrast Any Hospital, USA MM/DD/YY XXYYZZ-123456 Select, then Choose Change CCA Choose OPTIONS Back Lighting/Contrast 21 While viewing display for desired effect, select either [Increase Setting] or [Decrease Setting] to change level. Backlight Intensity Display Contrast Use Inc/Decrease Settings Decrease Increase Setting Setting Enter Cancel/ Back 22 Select [Enter] to keep change(s) and return to the Main Delivery screen, or [Cancel/Back] to restore previous settings and return to the Options screen. 430-95520-001 (Rev. 04/05) 6- 9 Variable Rate Cap NOTE: Variable Rate Cap is used to set the maximum rate values to be accepted by the device. The clinician cannot change it once it has been programmed. It must be configured using the Hospira MedNet software. Examples of Automatic Calculation AT STARTUP be n. to tio 1st Action 2nd Action t [AUTOCALC] enter RATE enter VTBI N i[DURATION] enter VTBI enter DURATION [RATE] l l [VTBI] enter RATE entera DURATION u ica WHILE RUNNING (TITRATION a lin ) ChangingM two parameters C after startup of the infusion will allow for the re-calculation of the third parameter. Dr i 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) 6- 10 430-95520-001 (Rev. 04/05) Plum A+ Infusion System NOTE: VTBI will not be re-calculated if the Rate and Duration are changed. VTBI must be cleared and then the new VTBI reentered. The new VTBI will automatically calculate a new Rate. 1st Action change RATE change RATE change VTBI change DURATION change VTBI change RATE 2nd Action [AUTOCALC] 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 enter VTBI enter DURATION change DURATION [DURATION] [RATE] [VTBI] be n. to tio t ua AT KVO N itwill need to re-set the Audible KVO alarm will sound, clinician appropriate settings. l a a c Action 1st Action 2nd [AUTOCALC] a lin enter VTBIM RATE [DURATION] C keep enter DURATION keep RATE [VTBI] enter VTBI [DURATION] a iRATE rchange DURATION D enter enter VTBI change RATE 430-95520-001 (Rev. 04/05) 6- 11 Changing CCA While Infusing Select [Options/Vol Inf] from the Main Delivery screen. A PUMPING STOPPED B DOPamine Dose Calculation 26.3 Rate mL/hr 0.2 10 Vol Inf mL Dose mcg/kg/min ER be n. 2 Select [Change CCA]. to tio t ua N it a a M Cli f t toahighlight desired 3 a Press then in select [Enter] to DrCCA, confirm the change. Options/ Vol Inf OPTIONS Release 13.x - xx/xx/xx Volumes Infused Pressure/Post Infusion Rate Lighting/Contrast Any Hospital, USA MM/DD/YY XXYYZZ-123456 Select, then Choose Change CCA Choose Back Area Selection Any Hospital, USA MM/DD/YY XXYYZZ- 123456 The delivery continues until VTBI equals zero, or you stop the program and clear the settings. 6- 12 ICU MedSurg OR Cardio Urology Psych Recov L&D 5 West Renal Neo ICU OB/GYN Oncol Ad ICU ER 7 South 3 North 4 North Select, then Enter Enter 430-95520-001 (Rev. 04/05) Plum A+ Infusion System The message bar informs the user of the changed CCA. A PUMPING STOPPED B DOPamine Dose Calculation 26.3 Rate mL/hr 0.3 10 Vol Inf mL Dose mcg/kg/min ICU Line A using prior CCA Options/ Vol Inf be n. to tio t ua key. N it a a Auto-Programming M Cli t a is a new feature for the Hospira Plum A+ Auto-Programming of infusion pumps. It can only be used if the feature has ra line ininstalled in conjunction with your Hospital Information been When VTBI reaches zero (infusion is competed), VTBI may no longer be incremented. To program, the user must first select [Back], then press the PROGRAM Press Back, then press STOP key. This program was started under a previous CCA. Back System (HIS) and Barcode Point-Of-Care (BPOC) Unit. It works by scanning barcode labels for the patient, pump, and IV bag using a BPOC Unit, such as a PDA. This information is then transferred to the pump utilizing either it’s wireless antenna or RJ-45 Ethernet connector. The feature reduces the number of steps needed to program an infusion. NOTE: If the physician’s order for an auto-program therapy exceeds the capabilities of the pump or is above a hospital defined hard drug limit, the infusion parameters for autoprogramming will be rejected and the order will need to be rechecked. 430-95520-001 (Rev. 04/05) 6- 13 NOTE: It is important that biomed personnel ensure that the barcode identification label affixed to each infuser corresponds to the correct Connectivity Engine Identification Number. This way the correct order will be sent to the appropriate infuser. Power On the pump as described in Section 4.2. A STOPPED STOPPED B After the CCA has been selected, the pump is ready for auto-programming. Rate mL/hr Vol Inf mL e . NOTE: The Auto-Program feature t ti must begin on the Main Delivery t ua Screen (with the desired line STOPPED). N it S activate your 3 Following your hospital’s procedure, a a BPOC Unit. a wristband in to pull up the patient’s 4 Scan theMpatient C Unit. task t list on the BPOC i IV bag. IV Task and documentation with 5DrScan the MedSurg Back Prime Options/ Vol Inf Order Details is displayed on the BPOC. NOTE: If the scanned medication does not exist in the Hospira MedNet Rx Rules medication library, that medication will display on the pump as “No Drug Selected”. Scan the barcode of the available pump channel that is not currently infusing (A or B). 6- 14 430-95520-001 (Rev. 04/05) Plum A+ Infusion System Programming screen is autofilled. Verify ALL parameters. If changes are desired, the infusion parameters can be manually changed using the keypad on the pump. Program Dose Calc DOPamine Conc Weight 400 mg 70 kg Dose VTBI Duration Rate 10 250 09: 30 26.3 250 mL mcg/kg/min mL hr : min mL/hr Enter value using keypad Program Options Cancel/ Back be n. 10 Select [Yes] to confirm to tio t ua programming and begin infusion. N it a a that The BPOC will reconfirm cmatch the pump parameters the order. M Cli t athe transaction on 11 Complete a theiBPOC n Unit or document Press to display the Confirmation screen. Program Dose Calc MedSurg Delivery will be: Dose Drug Conc Weight Rate 10 mcg/kg/min DOPamine 400 mg 250 mL 70 kg 26.3 mL/hr Confirm Program? Yes No the process per hospital procedure. 430-95520-001 (Rev. 04/05) 6- 15 NOTES be n. to tio t ua N it a a M Cli t a ra in 6- 16 430-95520-001 (Rev. 04/05) Plum A+ Infusion System SECTION 7 Alarms and Troubleshooting Warning Messages CORRECTIVE ACTION Stop all lines, then Stop delivery then turn Attempting to turn the sturn infuser off. u off infuser off while a delivery is in progress. bebattery.n. Replace Warning: Replace The battery current Battery charge is greater than o t tio 200 mA/hr. tis ua The battery voltage less than N the depletedit threshold and charge level is higher than the athreshold. low charge n Thencharging Warning: Chargera inot behaving ascircuitry is Silence key is pressed. Service M C expected (charge a voltage is not changing) and can reduce battery Dr i MESSAGE POSSIBLE CAUSE life. Warning: Low Battery Pump 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 settings, 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 warning message will be shown to explain the 430-95520-001 (Rev. 04/05) 7- 1 problem. All such messages will be cleared or replaced by another message upon the next valid input key press. 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. be n. 4 Correct Alarm condition (see following tables). to tio t ua 5 Press [START] to resume infusion. N it Salphanumeric code for NOTE: Alarm messages begin with an tracking purposes only.a If troubleshooting does not correct the aand contact problem, record theu code number technical support. M Cli t a a in 7- 2 430-95520-001 (Rev. 04/05) Plum A+ Infusion System 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 Pump programming incomplete. Press [START] or continue programming. low. See page 1-14 for detailed instructions for avoiding a bolus following a distal occlusion. Begin programming N102 Infuser Idle 2 Pump is ON without s or turn infuseru OFF. Minutes operator input. e all . Re-enter Standby time has programmedn data. elapsed. Re-enter N103 Memory Failure The infuser did not t t all programmed data. accept the previous odata. tu programmed i Check for clamps, or N230 Prox Air, When the total proximal containers on Backprime lexceeds the empty aairlimit.detected line A or B. Correct as necessary. Backprime a lin into line B tubing or M C syringe. Distal line kinked, IV site Check distal tubing, N180, f Distala check IV site, reset Occlusion clotted or positional, N181, rN186 i pressure limit. pressure limit set too N187 Neg Distal Occlusion Pump too high above patient or defective set. Lower infuser 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. 430-95520-001 (Rev. 04/05) 7- 3 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 infuser. be n. N252 Depleted Too much time on Plug into AC (mains) io Battery battery power. power. t ua N253 Hard lockout The use of the [STOP] tUnlock lockout switch. Violation key during delivery, or i -the door,lwhileS opening a is enabled. lockout Unlock lockout switch. N254 Hard lockout Pressing of any key Enabled a except [STOP] during l while any alarm M Cdelivery t a is active and lockout is enabled. a in DN255 Soft lockout The use of the [STOP] Unlock lockout by N256 7- 4 Violation key during delivery, or opening the door, while lockout is enabled. pressing the decimal key, followed by 9, 6, & 3 on the keypad. 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. 430-95520-001 (Rev. 04/05) Plum A+ Infusion System Line A Alarms MESSAGE POSSIBLE CAUSE N105 Callback Line A Alarm programmed by user. Change in delivery for Loading Dose to Maintenance Step or for any step in “Multistep” program provided the step is not the last step. Press [SILENCE]. VTBI complete on line A. Program new VTBI. be n. N185 Prox Occl A At Proximal line o Examineioline A for tor closed kinks Startup obstructed, line A t t ua clamps. If there are container (oro syringe) clamps, open disconnected or Nduring it closed the clamps. Then, obstructed nonS l l open and close door. delivery (startup). Continue programming. Replace a lin set if problem persists. M C If clamps are not t a opened prior to completion of cassette r i test, peak proximal N161 CORRECTIVE ACTION CODE Line A VTBI complete occlusion may recur. For syringe, select [Backprime]. 430-95520-001 (Rev. 04/05) 7- 5 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. be n. to tio t ua N it a a M Cli t a ra in 7- 6 430-95520-001 (Rev. 04/05) Plum A+ Infusion System Line B Alarms CODE MESSAGE POSSIBLE CAUSE N104 Callback Line Alarm programmed by user. Change in delivery for piggyback delivery, Loading Dose to Maintenance Step, or for any step in “Multistep” program provided the step is not the last step. CORRECTIVE ACTION Press [SILENCE]. e . N160 Line B VTBI VTBI complete on line oProgram new VTBI. t ti complete B. a line B for kinks Examine N183 Prox Occl B Proximal lineot clamps. If there At Startup obstructed, N(orlinesyringe) it orareclosed closed clamps, open container the clamps. Then, open disconnectedlor and close door. Continue obstructeda during nonu c(startup). programming. Replace delivery a lin set if problem persists. M C If clamps are not opened t a prior to completion of cassette test, peak r i proximal occlusion may recur. For syringe, select [Backprime]. 430-95520-001 (Rev. 04/05) 7- 7 CODE MESSAGE POSSIBLE CAUSE N182, N188, N189 Prox Occl B / Air Proximal line obstructed, line B container disconnected or obstructed. CORRECTIVE ACTION Examine line B for kinks, closed clamps, or air in cassette. Occlusion caused by empty container, backprime into line B tubing or syringe. be n. to tio t ua Malfunctions N it a a E300 or Malfunction n has occurred Record Malfunction a A ifailure error code. Pump must higher the infuser’s internal M Clinsystems. be turned OFF to clear malfunction. If alarm a in malfunction repeats, replace infuser. N231 ODE 7- 8 Prox Air B, Backprime ESSAGE When proximal air detected exceeds the limit for the line. OSSIBLE AUSE Check for clamps, or empty container. Correct as necessary. Backprime into line B tubing or syringe. ORRECTIVE CTION 430-95520-001 (Rev. 04/05) Plum A+ Infusion System General Messages MESSAGE POSSIBLE CAUSE Cannot Standby in Piggyback Selection of [Standby] when Line B is in Piggyback Mode. Cannot Standby with Delay Selection of [Standby] when Delay time was entered for program. Change Vol clears entries A program delivery which has been stopped and diluent value is selected. This is displayed before any screen or field message. CORRECTIVE ACTION Select [Cancel/ Back]. [Cancel/Back]. e . N/Ab Changing CCA clears Displays when other program than last-used Care Area is highlighted. t t uUser a can enter new Change Conc clears A program delivery t Concentration using entries which hasN been stopped keypad, or press andldrug amount value [CLEAR] then make new is selected. This is entry. displayed before any screen or field message. a lin User can select Change units clears program delivery C Awhich entriest has been stopped [Back] to exit, or and user highlights use [SELECT] arrows to a in another concentration highlight a new value. unit for the same line. 430-95520-001 (Rev. 04/05) User can enter new Concentration volume using keypad, or press [CLEAR] then make another entry. 7- 9 MESSAGE POSSIBLE CAUSE Concurrency alert Attempt to start a multistep or loading dose delivery whose later steps would exceed concurrent delivery limit if delivery proceeds. CORRECTIVE ACTION User can enter new values using number keypad, or use [SELECT] arrows to move to another field to change the entry. User can also press [CLEAR]. Concurrency violation Attempt to start a second User can enter new s values using number line with a delivery rate keypad, or e use that would exceed barrows [SELECT] to concurrent delivery upper limit immediately. o to another iofield to tmove change thetentry. User Or, concurrent delivery apress [CLEAR]. attempt and rate foro thet can also second line is less N than it concurrent-delivery S lowera limit. Takes l a“Rate precedence over be > n mL/hr” a must message. The l n delivery M Ccombined rate must fall within the range a of 1.0 mL/hr – 500 mL/hr or CCA-specific Dr i Maximum Volumetric Rate, with 0.5 mL/hr minimum per line. Decimal point not allowed 7- 10 Attempt to input Decimal point when either not used in field or a threedigit whole number already input. Press [CLEAR] Hardkey. 430-95520-001 (Rev. 04/05) Plum A+ Infusion System CORRECTIVE ACTION MESSAGE POSSIBLE CAUSE Dose > [X.xx]. Override? Attempt to start program with parameter that has caused the Dose (or Rate, if mL/hr program) to be greater than the upper soft limit [uuuuuuuu] for the selected drug and CCA. Also includes placing program in Standby, and re-starting a stopped program. May be overridden by selecting [Yes]. Cleared by pressing of [NUMERIC KEYS], [.], [SELECT], [CLEAR] or [STOP] hard keys, or [Yes/No] softkeys. Also cleared by the [ON/OFF] key when the line is stopped. been enabled, no Alarm is active, and any key besides Stop is pressed. switch located on the back of the device. (See Section 3) Attempt to select program other than Dose Calculation while a Basic program is delivering on this line. Select [Cancel/ Back] or press [CLEAR]. Pressing [CLEAR] invokes another message. be n. toMay betioverridden Dose < [X.xx]. Override? Attempt to start program thas uselecting a [Yes].by with parametero that caused the by pressing of NDose (or it Cleared Rate,-if mL/hr program) [NUMERIC KEYS], [.], to be less thanlthe lower [SELECT], [CLEAR] or a for the [STOP] hard keys, or limit [llllllll] u soft drug and CCA. [Yes/No] softkeys. Also nincludes a liselected Also placing by the [ON/OFF] M C program in Standby, and cleared key when the line is t a re-starting a stopped stopped. program. a in rHard Disable the Lockout Lockout Enabled The Lockout Switch has Illegal when Line Delivering 430-95520-001 (Rev. 04/05) 7- 11 CORRECTIVE ACTION MESSAGE POSSIBLE CAUSE Input digits > max allowed Attempt to input digit that would exceed the number of decimal places allowed for defined value except Dose and Rate. Press [CLEAR] hardkey. Input value > max allowed Attempt to input number that would cause field to exceed its defined limit. In the Drug amount, Diluent amount, VTBI, Duration, Patient Weight, Distal pressure, and Delayed Start time fields, the Software shall display ‘---‘, and the user must press the Clear hard key and input a valid value. Press [CLEAR] hardkey. be n. to tio t ua N it a a a in contrast/ User can select Maximum value reached Theldisplay M Cintensity reached its [Enter] or t a maximumhasvalue. [Cancel/Back]. r valueireached The display contrast/ User can select DMinimum intensity has reached its [Enter] or minimum value. [Cancel/Back]. No delivery programmed Delivery attempt at Main Delivery Screen when A and B have both Rate and VTBI equal to zero (no delivery programmed). Select a line to program, or [Options] or [Backprime]. Rate must be > 0 mL/hr Delivery attempt when VTBI is non-zero but rate is zero. Use number keypad to enter a value. 7- 12 430-95520-001 (Rev. 04/05) Plum A+ Infusion System MESSAGE POSSIBLE CAUSE Soft Lockout Enabled While the Soft Lockout is enabled and no Alarm is active, either 1) any key besides Stop is pressed during delivery, or 2) any key is pressed while stopped. CORRECTIVE ACTION Disable the Soft Lockout. (See Section 3) Use number keypad VTBI must be > 0 Delivery attempt when us to enter a value. rate is non-zero but VTBI is zero. e . n to Use number keypad Value is too high Attempt to move cursor from field whose input t enter a value. value is too high. t Use number keypad to Value is too low Attempt to move cursor u t enter a value. from fieldN requiring a i l value. non-default Weight change affects u Selecting the weight field Use number keypad to cwhile a weight- enter a value. Line A/B on line n program is M Clibased entered on other line. Minimum a Attempt to start program Use number keypad to f Dose X.xx enter a value. with Dose less than lower hard Dose limit Dr i n.nn. Maximum Dose X.xx Attempt to start program with Dose greater than upper hard Dose limit n.nn. Attempt to input a Dose greater than the upper Hard Limit. 430-95520-001 (Rev. 04/05) The Software will display ‘---‘, and the user must press the [CLEAR] hard key and input a valid value. 7- 13 CORRECTIVE ACTION MESSAGE POSSIBLE CAUSE Minimum Rate X mL/hr Attempt to start mL/hr program with Rate less than lower hard Dose limit nn.n. Use number keypad to enter a value. Maximum Rate X mL/hr Attempt to start mL/hr program with Rate greater than the upper Hard Limit or CCA Maximum Volumetric Rate n. The Software will display ‘---‘, and the user must press the [CLEAR] hard key and input a valid value. e . Attempt to input a Rate greater than the upper t ti Hard Limit or CCA t Maximum Volumetric N it Rate n. a a M Cli t a ra in 7- 14 430-95520-001 (Rev. 04/05) Plum A+ Infusion System SECTION 8 Cleaning, Maintenance, and Storage The cleaning, maintenance, and storage of the Plum A+ are described in this section. be n. tocleaningtitheoinfuser. To Establish a routine weekly schedule for t ua clean, proceed as follows: t switch • Turn the Plum A+ off using Nthe [ON/OFF] • Disconnect from ACl (mains) power a al The exposed surfaces ofc the Plum A+ may be cleaned with a lint-free cloth dampened by of the recommended cleaning n listone solutions in the following or mild, nonabrasive soapy water. M C t cassette door with a soft, lint-free cloth, dampened Clean thea n of the cleaning agents listed in the following table, or a ra with ione mild solution of soapy water. Use a small non-abrasive brush to CLEANING AND SANITIZING For proper maintenance of the Plum A+, observe the following cleaning and sanitizing guidelines. 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. 430-95520-001 (Rev. 04/05) 8- 1 CLEANING SOLUTION MANUFACTURER PREPARATION CoverageTMHBV Steris Corporation, A division of Calgon Vestal Laboratories Per manufacturer's recommendation Formula C TM Diversey Corporation Per manufacturer's recommendation Caltech Industries Per manufacturer's recommendation Dispatch be n. omanufacturer's io Caltech Industries tPer Precise t recommendation Household bleach Various procedures; N itdoPernothospital exceed one part bleach in ten parts water a a Calgon Vestal Per manufacturer's Manu-Klenz a Laboratories recommendation M Sporicidin C International Per manufacturer's Sporicidin t recommendation r Edisonitei S. M. Edison Co. Per manufacturer's DSuper recommendation ® ® ® ® ® 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. 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. 8- 2 430-95520-001 (Rev. 04/05) Plum A+ Infusion System CAUTION: TO AVOID MECHANICAL OR ELECTRONIC DAMAGE, DO NOT IMMERSE THE P LUM 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. USING ABRASIVE CLEANERS OR CLEANING SOLUTIONS NOT RECOMMENDED BY HOSPIRA MAY RESULT IN PRODUCT DAMAGE. D O NOT USE COMPOUNDS CONTAINING COMBINATIONS OF ISOPROPYL ALCOHOL AND DIMETHYL BENZYL AMMONIUM CHLORIDE. e . CAUTION: D (ETO), t ti t u, a CAUTION: T t .T; - lS . a a BATTERY Mn AINTENANCE CAUTION: M DCli. U t a CAUTION: i( ) I Dr AC CAUTION: NEVER USE SHARP OBJECTS SUCH AS FINGERNAILS, PAPER CLIPS, OR NEEDLES TO CLEAN ANY PART OF THE INFUSER. O NOT STERILIZE BY HEAT STEAM ETHYLENE OXIDE OR RADIATION O AVOID INFUSER DAMAGE CLEANING SOLUTIONS HE DISINFECTING SHOULD ONLY BE USED AS DIRECTED PROPERTIES OF CLEANING SOLUTIONS VARY CONSULT THE MANUFACTURER FOR SPECIFIC INFORMATION O NOT OPERATE THE INFUSER ON PATIENTS WITH THE SE OF A PROPERLY MAINTAINED AND BATTERY REMOVED CHARGED BATTERY HELPS CONFIRM PROPER OPERATION F THE LOW BATTERY ALARM SOUNDS CONNECT TO MAINS POWER IMMEDIATELY The Plum A+ is battery powered for emergency backup and temporary portable operation. A fully charged, new battery provides 3 hours of operation at 125 mL/hr, or delivers 250 mL total volume if pumping at a rate of 126 mL/hr or greater, whichever occurs first. NOTE: For optimum battery life, the Plum A+ should be operated on battery power for three continuous hours at least once every six months and then charged for a minimum of six hours. 430-95520-001 (Rev. 04/05) 8- 3 The battery charges whenever connected to AC (mains) power. If the infuser is switched OFF, recharge takes approximately six hours. Recharge takes longer if the infuser 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 infuser to AC (mains) power whenever possible. be n. to tio STORAGE t theufollowing a storage To prolong the life of the Plum A+, observe N it precautions: Scold, and humidity • Store the away from excessive heat, a apower • Store connected u to AC (mains) ic the [ON/OFF] key n OFFnusing • Switch the a infuser li SERVICE t a All servicing or adjustments to the Plum A+ should be referred ntechnical to qualified personnel. A technical service manual When the infuser is used without wireless, the operation times may be proportionally longer. may be ordered from the local Hospira sales office. 8- 4 430-95520-001 (Rev. 04/05) Plum A+ Infusion System SECTION 9 Specifications Physical Dimensions: Approximately 8” X 8” X 6”, excluding pole clamp protrusion and power cord storage. Weight: Approximately 9.5 lbs. with battery. Casing: High-impact plastic. Electrical Power Requirements: 120 V~, 50-60 Hz, 35 VA. Meets UL 60601-1. Fuses: F1, F2, 250V~, 0.5 A. (internal) Power Cord: Hospital-grade AC cord. 10 ft long, with transparent plug and retainer plate. Battery: One sealed, lead-acid, rechargeable 6 V battery, internal to device. Battery Life: With a new fully charged battery, the infuser operates for a minimum of three hours at 125 mL/ hr or less, or delivers 250 mL if > 126 mL/hr. (Time is measured from initial pumping to Depleted Battery Alarm) Recharge: The battery charges whenever the infuser is connected to AC power. The recharge time is approximately six hours with the device operating at 125 mL/hr on one line. Electrical Leakage: Meets IEC 60601-1 standard: Medical Electronic Equipment, Part 1: General Requirements for Safety. 430-95520-001 (Rev. 04/05) 9- 1 NURSE-CALL System: NURSE-CALL alarm is factory set for NormallyOpen (NO) Contact 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 Contact Rating- 3 Watts Max Wireless Lan Device Standards: IEEE802.11b Radio Technology: IEEE802.11b Direct Sequence Spread Spectrum Data Transfer Rate: 11, 5.5, 2, 1 Mbps (auto sense) FREQUENCY RANGE IEEE802.11b Channels: Transmit Power: Antenna: Certifications: 2412 - 2462 MHz 1-11 (FCC) 100mW (+20dBm) max Integrated surface mount antenna FCC Part 15.247 for US, IC VTBI Range VTBI Range: 0.1 to 99.9 mL (in 0.1 mL increments) 100 to 9999 mL (in 1 mL increments) 9- 2 430-95520-001 (Rev. 04/05) Plum A+ Infusion System Environment Operating Temperature: 5° to 40° C Storage Temperature: -20° to 60° C Atmospheric Pressure: 0 - 10,000 feet (0 - 3,000m) or equivalent pressure Relative Humidity: 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) Concurrent Delivery: 0.5 mL/hr minimum for each line 500 mL/hr cumulative (A+B) maximum PlumSet: KVO: 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 430-95520-001 (Rev. 04/05) 9- 3 Occlusion Alarm and Limits 9- 4 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 userselectable. Factory default setting is 6 psig. Maximum Infusion Pressure: 20 psig 430-95520-001 (Rev. 04/05) Plum A+ Infusion System Time To Detect Downstream Occlusions RATE 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 6 psig 17 minutes 22 minutes 15 psig 45 minutes 49 minutes 1 mL/hr * Baseline backpressure is 0 psig * Bolus Volume Released After Downstream Occlusions Are Corrected RATE 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 6 psig 0.24 mL 0.30 mL 15 psig 0.59 mL 0.70 mL 1 mL/hr * Baseline backpressure is 0 psig * 430-95520-001 (Rev. 04/05) 9- 5 Delivery Accuracy The Plum A+ Infuser 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 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 9- 6 430-95520-001 (Rev. 04/05) Plum A+ Infusion System 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 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, SubClause 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 infusers) 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 430-95520-001 (Rev. 04/05) 9- 7 the nominal rate. The average delivery rate error over the entire 2nd hour was +1.6% (D). For other time intervals look at other points at the horizontal axis and determine corresponding limits as above. 25 ML/HR, 0 mm Hg DELIVERY HEAD, START UP PERCENT ERROR (%) 15.0% 10.0% Max Positive Error over 5 Minute Interval = +2.8% 5.0% 0.0% C Max Negative Error over 5 Minute Interval = -0.5% -5.0% -10.0% Average Delivery Rate Error = +1.6% -15.0% 10 15 20 Observation Interval (minutes) Max Min 25 30 Mean A trained professional can use the resulting graphs to select a infuser 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 administered 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. 9- 8 430-95520-001 (Rev. 04/05) Plum A+ Infusion System 25 ML/HR, 0 mm Hg DELIVERY HEAD, START UP (Typical) 50 45 40 Rate (ml/hr) 35 30 25 20 15 10 -5 -10 10 20 30 40 50 60 70 80 90 100 110 120 Time (minutes) Actual Rate Programmed Rate 25 ML/HR, 0 mm Hg DELIVERY HEAD, START UP (Typical) Percent Error (%) 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -15.0% 10 15 20 25 30 Observation Interval (minutes) Max Min Mean 25 ML/HR, 0 mm Hg DELIVERY HEAD, START UP (Composite of 3 Pumps) Percent Error (%) 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -15.0% 10 15 20 25 30 Observation Interval (minutes) Max 430-95520-001 (Rev. 04/05) Min Mean 9- 9 25 ML/HR, 0 mm Hg DELIVERY HEAD , 96 HOURS (Typical) 50 45 Rate (ml/hr) 40 35 30 25 20 15 10 10 20 30 40 50 Time (minutes) Actual Rate Programmed Rate 25 ML/HR, 0 mm Hg DELIVERY HEAD, 96 HOURS (Typical) Percent Error (%) 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -15.0% 10 15 20 25 30 Observation Interval (minutes) Max Min Mean 25 ML/HR, 0 mm Hg DELIVERY HEAD, 96 HOURS (Composite of 3 Pumps) Percent Error (%) 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -15.0% 10 15 20 25 30 Observation Interval (minutes) Max 9- 10 Min Mean 430-95520-001 (Rev. 04/05) Plum A+ Infusion System Rate (ml/hr) 1 ML/HR, 0 mm Hg 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 10 20 30 40 50 60 70 80 90 100 110 120 Time (minutes) Actual Rate Programmed Rate 1 ML/HR, 0 mm Hg DELIVERY HEAD, START UP (Typical) Percent Error (%) 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -15.0% 10 15 20 25 30 Observation Interval (minutes) Max Min Mean 1 ML/HR, 0 mm Hg DELIVERY HEAD, STARTUP (Composite of 3 Pumps) Percent Error (%) 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -15.0% 10 15 20 25 30 Observation Interval (minutes) Max 430-95520-001 (Rev. 04/05) Min Mean 9- 11 Rate (ml/hr) 1 ML/HR, 0 mm Hg 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 10 20 30 40 50 Time (minutes) Actual Rate Programmed Rate 1 ML/HR, 0 mm Hg DELIVERY HEAD, 96 HOURS (Typical) Percent Error (%) 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -15.0% 10 15 20 25 30 Observation Interval (minutes) Max Min Mean 1 ML/HR, 0 mm Hg DELIVERY HEAD, 96 HOURS (Composite of 3 Pumps) Percent Error (%) 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -15.0% 10 15 20 25 30 Observation Interval (minutes) Max 9- 12 Min Mean 430-95520-001 (Rev. 04/05) Plum A+ Infusion System SECTION 10 Supplies and Accessories Administration Fluids ADMINISTRATION 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 ADDVantage • Part Fill Parenteral glass containers • Small Volume Parenterals • Syringes (may require special adapters) • Top Filled Enteral bags • Ready to hang Enteral solution containers 430-95520-001 (Rev. 04/05) 10- 1 Accessories GENERAL • Syringe Adapter- List# 11986-48 • Mini Pole- List# 12096-04 • Secondary Container Support- List# 12095-03 • Tandem Carrier- List# 12270-01 NETWORKED APPLICATION • Hospira MedNetTM Medication Management Server Suite (MMSS) List# 20676-04 • *Hospira MedNetTM Plug ‘n Play Module List# 20677 * = For use with Hospira Plum A+ Infusers Lists 11971-04-03 & above, 12391-04, & 20679-04 NOTE: Contact Technical Support Operations at 1-800-241-4002 for current listing of accessories. 10- 2 430-95520-001 (Rev. 04/05) Plum A+ Infusion System SECTION 11 Warranty Subject to the terms 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. be n. o io t option, the Purchaser's exclusive remedy shall be, at Hospira's o Intnouevent shall Hospira's repair or replacement of the product. i (whether such liability arising out of any cause whatsoever - negligence, cause be based in contract, strict liability, other tort, or otherwise) exceed the price of such product, and in no event a consequential, shall Hospira beu liable for incidental, special n nfori lost business, revenues, ororprofits. damagesa or losses or Warranty productlreturned to Hospira must be properly packaged t aand sent freight prepaid. n warranty shall be void in the event the product ra Theiforegoing 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 430-95520-001 (Rev. 04/05) 11- 1 replacement of accessory items such as batteries and detachable mains power cords. 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 an Hospira representative performing repair or service is not an authorized agent of Hospira. be n. to tio t ua N it a a M Cli t a ra in 11- 2 430-95520-001 (Rev. 04/05) Plum A+ Infusion System SECTION 12 Default Drug Library (DDL) NOTE: This list is only accurate if no custom drug library has been developed using the Hospira MedNetTM accessory. Once a custom drug library has been developed, this list will no longer be accessable. Only Hospira personnel can re-install the DDL. The information contained in this manual is current as of s11/01/ 02. User must assure themselves that drug prescribing information has not changed since the publication of this manual. be n. to for IVtiadministration Use drug manufacturer recommendations when using the Plum A+ infusiont infuser. a tu D lD S No Drug Selected n mL/hric N/A Abciximab mg/mL limcg/kg/min Acyclovir N/A t a mL/hr Albumin mL/hr N/A a in mL/hr N/A D Aldesleukin RUG AME EFAULT ATE OSE EFAULT ONCENTRATION Alfentanil mcg/kg/min mcg/mL Alteplase (rt-PA) mg/kg/hr mg/mL Amikacin mL/hr Aminophylline mg/hr mg/mL Amiodarone mg/min mg/mL Amphotericin B mL/hr N/A Ampicillin mL/hr N/A Atracurium mL/hr N/A Azithromycin mL/hr N/A 430-95520-001 (Rev. 04/05) N/A 12- 1 DRUG NAME DEFAULT DOSE RATE DEFAULT CONCENTRATION Bleomycin mL/hr N/A Blood Products mL/hr N/A Bretylium mg/min Carboplatin mL/hr N/A Cefazolin mL/hr Cefepime mL/hr CefoPERAZONE mL/hr Cytarabine mL/hr 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 mg/mL N/A N/A u N/A CefoTAXIME mL/hr e N/A. nN/A CefoTETAN mL/hr t ti N/A CefoXITIN mL/hr t ua CeftAZIDime mL/hr N/A N i CeftIZOXime mL/hr N/A Ceftriaxone mL/hr N/A Cefuroxime mL/hr N/A u ic Cimetidine N/A a mL/hrlin Ciprofloxacin M mL/hr N/A Cisplatin f N/A a mL/hr Clindamycin N/A r in mL/hr DCotrimoxazole mL/hr N/A 12- 2 N/A N/A mg/mL N/A 430-95520-001 (Rev. 04/05) Plum A+ Infusion System DRUG NAME DEFAULT DOSE RATE DEFAULT CONCENTRATION Erythromycin mL/hr Esmolol mcg/kg/min Etoposide mL/hr N/A Famotidine mL/hr N/A Fentanyl mL/hr Fluconazole mL/hr Flumazenil mL/hr N/A mg/mL N/A N/A Fluorouracil mL/hr e . Furosemide mL/hr t ti Gatifloxacin mL/hr t ua Gentamicin mL/hr Heparin units/kg/hrN it units/mL l l Hydromorphone mL/hr Ifosfamide u mL/hrica Insulin units/mL a liunits/hr Labetalol M mg/min mg/mL Lepirudin mg/mL a mg/kg/hr Leucovorinn mL/hr DrLevofloxacin mL/hr N/A N/A N/A N/A N/A N/A N/A N/A N/A Lidocaine mg/min Lorazepam mL/hr Magnesium grams/hr grams/mL Mannitol grams/hr grams/mL Mesna mL/hr N/A MethoHEXITAL mL/hr N/A MethoTREXATE mL/hr N/A Metoclopramide mL/hr N/A Metronidazole mL/hr N/A 430-95520-001 (Rev. 04/05) grams/mL N/A 12- 3 DRUG NAME DEFAULT DOSE RATE DEFAULT CONCENTRATION Midazolam mL/hr Milrinone mcg/kg/min mg/mL Morphine mg/hr mg/mL Nafcillin mL/hr NitroGLYCERIN mcg/min mg/mL NitroPRUSSIDE mcg/kg/min mg/mL Norepinephrine mcg/min mg/mL Propofol mcg/kg/min mg/mL Ranitidine mL/hr STREPTOkinase units/hr units/mL Theophylline mg/kg/hr mg/mL Ticar-clavulanate mL/hr Tirofiban mcg/kg/min Tobramycin mL/hr N/A UROkinase mL/hr N/A Vancomycin mL/hr N/A N/A N/A Ofloxacin mL/hr e N/A. nN/A Ondansetron mL/hr t ti N/A Oxacillin mL/hr t units/mL Oxytocin mUn/min N it Paclitaxel mL/hr N/A Pantoprazole mg/min mg/mL Penicillin mL/hr N/A u ic Pentobarbital N/A a mL/hrlin Phenylephrine M mcg/min mg/mL Piperacillin N/A a mL/hr Potassium mEq/mL r in mEq/hr DProcainamide mg/min grams/mL 12- 4 N/A N/A mg/mL 430-95520-001 (Rev. 04/05) Plum A+ Infusion System DRUG NAME DEFAULT DOSE RATE DEFAULT CONCENTRATION Verapamil mL/hr N/A VinCRIStine mL/hr N/A be n. to tio t ua N it a a M Cli t a ra in 430-95520-001 (Rev. 04/05) 12- 5 NOTES be n. to tio t ua N it a a M Cli t a ra in 12- 6 430-95520-001 (Rev. 04/05) Plum A+ Infusion System For customer service within the United States, contact: 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, contact Hospira, Inc. Technical Support Operations: 1-800-241-4002 To order parts using the online eCatalog, download 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 Support Operations 755 Jarvis Drive Morgan Hill, CA 95037 Outside the U.S., contact your local Hospira, Inc. sales office. 430-95520-001 (Rev. 04/05) CAUTION: FEDERAL (USA) LAW RESTRICTS THIS INFUSER TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR OTHER LICENSED PRACTITIONER. WARNING POSSIBLE EXPLOSION HAZARD EXISTS IF THE INFUSER IS USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS. Plum A+ Infusion Pump is a registered 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 ® US Protected against dripping water Mains supply equipment using protective earth UL 60601-1 CSA 601.1 MCN 160992 430-95520-001 (Rev. 04/05)
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