Operating Manual
85 Pages
Preview
Page 1
System Operating Manuaf For use with List 11971-04
Abbott Laboratories ;g;h Chicago, IL 60064
430-95226-001 (Rev. 5/01)
Contents ‘.
SECTION 1
1-1 INTRODUCTION... 1.1 P RODUCT O VERVIEW...*... l-l 1.2 C ONVENTIONS... . l-2 l-2 Warnings, Cautions, and Notes... 1.3 D EFINITIONS... l-3
SECTION 2 DEVICE DESCRIPTION... . . 2-l 2.1 EATLJRES ... 2-l Therapies ... 2-l Line Programming Options ... 2-l PlumSet Capabilities ... 2-l Air Management ... 2-l Battery ... 2-2 Biomedical ... 2-2 Options ... 2-2 Other Features ... 2-2 2.2 U SER Q UALIFICATION ... 2-3 2.3 SYSTEM SELF-TE STS ... 2-3
SECTION 3 INSTRUCTIONS FOR USE ... 3- 1 3.1 SETUP ... 3-1 Unpacking ... 3-l Tandem Carrier Instructions ... 3-2 3.2 A DMINISTRATION S ETS ... 3-2 Preparing the Administration Set ... 3-3 Priming the Administration Set ... 3-4 Loading the Cassette ... 3-5 Preparing the Secondary Line ... 3-6 3.3 D ISCONTINUING E LECTRONIC F LOW C ONTROL & SE?TING G RAVITY F LOW ... .3-8 3.4 D ISCONTINUING F LUID ADMINISTRATION ... 3-8
...
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Contents
SECTION 4 BASIC OPERATION...4-l 4.1 GETTING STARTED ... 4-l System Self-Tests ... 4-l Data Retention ... ..‘~ ... 4-3 4.2 OPERATING KEYS ... ... 4-3 4.3 INDICATORS ... 4-5 4.4 REAR CASECONTROLS ... 4-5 4.5 POWER ON ... 4-7 4.6 SIMPLE DELIVERY ... 4-8 4-9 4.7 EXAMPLES OF AUTOMATIC CALCULATION ... 4.8 RTFL4TION ... 4-10 4.9 SIMPLE DELIVERY USING D RUG L IST ... .4-12 4.10 SIMPLE D ELIVERY USING D ELAYED START ... 4-14 4.11 PIGGYBACK D ELIVERY ... 4-15 4.12 P IGGYBACK WITH NURSE C ALLBACK ... 4-17 4.13 CONCURRENT DELIVERY ... .4-18 4.14 S ELECT O PTION - VOLUMES INFUSED , PRESSURE / POST INFUSION R ATE , AND L IGHTING /C• ... .4-20 4.15 S TOP AND S TART WITH ONLY 1 L INE P UMPING ... 4-23 4.16 S TOP AND S TART WITH B OTH L INES P UMPING ... 4-23 4.17 BACKPRIMING ... 4-25 4.18 C LEARING P ROGRAM SETI-INGS ... 4-25 4.19 POSSIBLE NON -DELIVERY PROGRAMMED ... 4-26
SECTION 5 THERAPIES (FOR ADVANCED USERS*) ... 5-l 5.1 D OSE C ALC (MCG/KC~MIN ON A) ... 5-l 5.2 D OSE C ALC (MG/HR OS B) ... ... 5-5 5.3 L OADING D OSE ... 5-9 5.4 MULTISTEP PROG~WX~MING ... 5-15
SECTION 6 ALARMS AND TROUBLESHOOTING... 6. -l 6.1 W ARNING ME.SSAGE~... 6. -l 6.2 R ESPONSE TO ALARMS... 6-2 . General Alarms...6-2 . . . . . . . . . . . . . . 6-3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Line A Alarms Line B Alarms...6-4 Malfunctions... 4-4
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Plum A+ Infusion Pump
Contents
SECTION 7 MAINTENANCE AND STORAGE ... 7-l 7.1 C LEANING , M AINTENANCE , AND STORAGE ... 7-l Cleaning and Sanitizing ... 7-l Battery Maintenance ... 7-2 Storage ... 7-2 Service ... 7-2
SECTION 8 ... 8-l PRECAUTIONS... 8.1 ARTIFACTS ... 8-1 8.2 HEALTHCARE PROFESSIONALS AND P ATIENT R ELATED ... 8-1 8.3 C ONCURRENT F LOW ... 8-2 ... 8-3 8.4 E PIDURAL A DMINISTRATION 8.5 BATTERY O PERATION ... 8-4 8.6 S ETS A N D ACCESSORIES ... 8-4 8.7 BACKPRIMING ... 8-5 8.8 G ENERAL ... 8-5
SECTION 9 SPECIFICATIONS ... 9-l PHYSICAL ... 9-l ELECTRICAL ... 9-l VTBI RANGE ... 9-l ENVIRONMENT ... 9-2 D ELIVERY RATE R ANGE ... 9-2 AIR-IN-L INE ALARM ... 9-2 OCCLUSION ALARM AND LIMITS ... 9-3 T IME TO D ETECT DOWNSTREAM O CCLUSIONS ... 9-3 BOLUS V OLUME R ELEASED AFTER D OWNSTREAM O CCLUSIONS ARE C ORRECTED ... 9-3 D ELIVERY ACCURACY ... 9-4 ~~LJM~ET CURVES ... 9-4
SECTION 10 SUPPLIES AND ACCESSORIES ... 10.1 ADMINISTRATION F~um ... Administration Fluids ... Enteral and High Viscosity Fluids ... Containers ... 10.2 ACCESSORIES ...
System Operating Manual
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Introduction
SECTION 1
8.
1 .l Product Overview The Plum A+TM Volumetric Infusion System is designed to meet the fluid delivery requirements of today’s
evolving healthcare environments. The Plum A+ is a cassette based, two lines in and one line out, multifunction infusion pump. The pump can be used for standard, piggyback. 05 concurrent delivery. Therapy modes include: . Standard Infusions l
Multistep Programming
Loading Dose l Dose Calculation l
The Plum A+ is designed to deliver parenteral and enteral or epidural infusions over a broad range of infusion rates from multiple fluid container types. The system includes a pumping module (hereafter called the pump) and an assortment of disposable IV sets (hereafter called a set), optional accessories, and this operator’s manual. The optional Barcode Reader allows drug name identification by scanning a provided list of drug names located on the Flash Tips & Barcode Directory. A computer data port is also provided to interface with a host computer. The Plum A+ is designed to be used in most areas of patient care, including, but not limited to:
General Floor MedicallSurgical ICU/CCU Pediatrics Neonatolgy
Laborj3etiverylPost Pattum ORfinesthesia Post OpDecovery Cardiac Cath Lab Emergency
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Burn Unit Hkmodialysis Oncology Mobile Intensive Cure Nutritional
430-95226-001 (Rev. 5/01)
Introduction
1.2 Conventions This section describes the conventions used throughout this manual, as follows: Convention
Application
Example
Italic
Reference to a section, figure, or table
(See Figure 3- 1, Priming Cassette)
Function or mode specific instructions
Primary On/y: Attach an empty container.
[ALL CAPS]
Keys or touchswitches on the device are described all caps in brackets
[START]
A [Italic]
Softkey Options
A [Choose]
Initial Caps lowercase
Screen displays and device labels (as appropriate)
Therapy
I
I
Dose Calculation . ..sets are supplied Sterile and are for...
Emphasis
Bold
‘.
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 INF-ORMATION TRAT COULD PRBVENT IRREVERSIBLE PRODUCT DAMAGE OR RARDWARE FAILURE. FAXLXJRE TO OBSERVE A CAUTION COULD RESULT M SERIOUS PATIENT OR USER INJURY. Note:
a
A Note highlights information that helps explain a concept or procedure.
This symbol directs the user to consult accompanying documents.
1.
Note: Figures are rendered as graphic representations to approximate the actual product. Therefore, figures may not exactly reflect the product.
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Plum A+ Infusion Pump
Definitions (General and Clinical)
1.3 Definitions (General and Clinical) Alarms Backprime Bolus Cassette Installed Concurrent Delivery Delfvery Together Delivery Rate Duration Error Flow Rate KVO (Keep Vein Open) Line A Line B Malfunction Pfgg ybac k PressurelPost Infusion Rate Units VTBI Warning
Any condition of the pump that requires operator.attentfon. These condftions will cause both audible and visible alarm indicators. Confirmation of the condition is usuallu reauired. Removal of air orfluid from the proximal line and cassette air trap. Nofluid is delivered distal to the cassette during backpriming. A single uninterrupted discrete volume of jlufd delivered in a discrete period of time. A recognized cassette type installed with the door closed. Simultaneous delivery of twofluids at
fndependentjlow rates.
Delivery option which allows lines A and B to deliver concurrently. The Delivery rate set by the operator. The time period used to deliver a VTBI at a delivery rate set by the operator. A condition resulting when an operator attempts a nonacceptable input, such as an invalid key press. The resulting rate of fluidflow. Delivery of fluid at a slow rate in or&r to prevent occluding the patient catheter. Cassette Inlet line on the top center of the cassette when looking at the cassette from the front of the Device. Cassette Inlet line on the top right of the cassette when looking at the cassette from the front of the Device. Failure of the device to pass internal integrity or performance tests. The mode where line B delivers first, followed by line A. Selected using A [OptfonslVol Inflt this mode is used to set KVO Rate and Dfstal Pressure Limit. It is also used to view Distal Pressure in real-time. A predetermined delivery quantity adopted as a standard of measure. Volume To Be Infused - The amount offlufd remaining to be delivered to the vatfent. An indication to advise the operator: a) Of a possibly hazardous condition such as a Low-Battery warning. b) That an attempt has been made to use a function in the wrong sequence, with the wrong values, or at the wrong time such as an Invalid Key Warning. c) That a function has been initiated in the proper manner such as a Valid Keu Warnfnq.
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SECTION 2
2.1 Features The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospitalwide, 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@ needleless protection systems makes the Plum A+ a convenient and cost-effective infusion system.
THERAPIES l
Dose Calculation
l
Loading Dose
l
Multistep Programming
LINE PROGRAMMIN G OPTIONS . Therapy Selection l Nurse Call Back l Delayed Start Setting l Drug Label Library . Concurrent delivery l Titration l Micro 0.1-99.9 mL/hr (in 0.1 mL increments) flow rate range for both lines l Macro loo-999 mL/hr (in 1 mL increments) flow rate range for both lines l Automated Secondary drug delivery (Piggyback) PLUMSET CAPABILITIES l Anti Free-Flow Protection l Direct Connection for syringe delivery AIR MANAGEMENT l Air Trap l Air Removal/Backpriming l Air Detection-Proximal l Air Detection-Distal
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Device Description BATTERY Battery Gauge l Six Hour Battery Recharge Time l Long battery life (6 hours) for emergency backup and l
tempprary portable operation
BIOMEDICAL l Serial Communication l Upgradability (Field) l Variable Rate Cap . Alarm History l Plug-in Bar Code Reader for drug identification (Optional) l Nurse Call Relay Connector
1
OPTIONS l Volumes Infused (A, B, Total Volume) l KVO at dose end (1.0 ml/hr or less depending on delivery rate) or Continue Rate (CR) to continue at the current rate l Variable Distal Pressure Settings OTHER FEATURES Nonpulsatile volumetric accuracy Microprocessor control Large liquid crystal display (LCD) screen Panel back illumination on mains power Lockout switch Standard fullfill, partfill, syringe and vial use Parenteral and nonparenteral (enteral) fluid delivery Blood and blood products delivery Wide range of Standard and Specialty administration sets
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Plum A+ Infusion Pump
User Qualification
2.2 User Qualification The Plum A+ is intended for use at the direction or under the supervision of licensed physicians or certified healthcare professionals who are trained in the use of the pump and the administration of parenteral, enteral, and epidural fluids and drugs and whole blood or red blood cell components. The training should emphasize preventing related IV complications, including appropriate precautions to prevent accidental infusion of air. The epidural route can be used to provide anesthesia or analgesia.
WARNING ADMINISTER ONLY ANESTHETICS/ANALGESICS APPROVED FOR EPIDURAL ADMINISTRATION (AS INDICATED OR ALLOWED BY THE DRUGS’ FDA APPROVEiD LABELING). EPIDURAL ADMINISTRATION OF DRUGS OTHER THAN THOSE INDICATED FOR EPIDURAL USE COULD RESULT IN SERIOUS INJURY TO THE PATIENT.
2.3 System Self-Tests The pump performs a suite of System Self-Tests when power is applied to con.fii readiness for use. Failure during the Self-Tests is reported as a Malfunction Condition.
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hstructions for Use
SECTION 3
‘.
This section explains the Plum A+ setup and administration set use.
3.1 Setup WARNING ARRANGE TUBING, CORDS, AND CABLES TO MINIMIZE THE RISK OF PATIENT STRANGULATION OR ENTANGLEMENT.
UNPACKING CAUTION: PR ODUCT D A MAGE MAY OCCUR UNLESS PROPER CARE IS EXBRCISED DURING UNPACXING AND INSTALLATION. Do NOT USE TRE PLJJM A+ IF IT APPEARS DAMAGED IN ANY WAY. TRE BATTERY MAY NOT BE CRARGED UPON RECEIPT. Inspect the Plum A+ packaging for possible shipping damage. If damage is found, contact the delivery company immediately. Use care when unpacking the Plum A+. Retain the packing slip and save all packing material in case the Plum A+ is damaged or fails the pump self-test and has to be returned to Abbott Laboratories. Inspect the Plum A+ thoroughly for damage. CAUTION:
IF T= PLUM A+ APPEARS TO BE DAMAGED, CONTACT
ABBOTT -ORATORIES.
To set up the Plum A+, connect the mains cord to a properly earthed mains receptacle, unless temporary battery operation is desired.
Note:
Use mains power whenever possible. Store the Plum A+ connected to mains to confirm a fully charged battery for emergencies.
Note:
If the quality of earth grounding source is in doubt, use battery power.
CAUTION: THE PLUM A+ SYSTEM IS DESIGNED TO OPERATE NORMALLY JN TRB PRESENCE OF MOST ENCOUNTERED ELECTROMAGNETIC INTERFERENCE (EMI) CONDITIONS. m TRE 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 BE D I SR UPT ED . O PE RA TION OF THE PUMP UND ER THESE CON D ITIONS SROULD BE AVOIDED.
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430-95226-001 (Rev. 5/01)
Instructions for Use 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# 12276-O 1) to the pole before attaching the pump(s) to the tandem carrier. Make sure tandem carrier clamp is attached firmly to pole. Make sure pumps are firmly attached to tandem carrier.
3.2 Administration Sets The Plum A+ is compatible with the wide range of LifeCare Plum series administration sets. Become familiar with the set components before preparing the administration set.
=Ei
Pnrnaty Line-
87
IK!B
Finger Grip
Flow Regulator
4 Pumping Chamber
-~
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Plum A+ Infusion Pump
Administration Sets PREPARING THE ADMINISTRATION SET Note:
For detailed instructions, see administration set packaging.
Use the aseptic technique to prepare the administration set for priming, th$n proceed as follows:
E
Make sure flow regulator is closed.
Insert piercing pin into container outlet with a twisting motion.
Fill drip chamber to about l/2 full or to score mark. Do not completely fill.
Note: To avoid getting Distal Air Alarms, confirm that the fluid bag is positioned higher than the pump. This should be set up prior to priming the cassette.
System Operating Manual
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430-95226-001 (Rev. 5101)
Instructions for Use PRIMING THE ADMINISTRATION SET To prime the administration set, proceed as follows:
1 Invert the cassette.
Turn the flow regulator counter-clockwise until a drop of fluid is seen in the pumping chamber.
Turn the cassette upright, then prime the remainder of the administration set.
Push in the flow regulator to close. Confirm there is no flow.
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Plum A+ Infusion Pump
Administration Sets LOADING THE CASSETTE To load the primed cassette into the Plum A+, proceed as follows:
k.
Open the cassette door by lifting up the handle.
.T,.
Note:
Insert cassette into door guides. Close the cassette door. Confirm there is no flow and no kinks appear in tubing.
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.
System Operating Manual
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430-95226-001 (Rev. 5101)
Instructions for Use PREPARING THE SECONDARY LINE CAUTION: C ONS UL T THE DRUG LABELING TO CO N F IR M DRUG COEXPATIBILITP, CONCE NTRA TION , DELIVERY RATES, AND VOLUMES ARE ALL SUITABLE FOR CONCURRENT DELIVERY OR PIGGYBACK DELIVERY (SECONDARY FOLLOWED AUTOMATICALLY BY PRIMARY) MODES.
,
The Plum A+ features concurrent or piggyback delivery modes when therapy requires administering more than one fluid. In addition to standard containers, the Plum A+ can use syringes or vials on the secondary port. The secondary line can be prepared without removing or repriming the cassette. Before preparing the secondary line, observe the following guidelines: l l
l
l l
l
’
Review the backpriming function Attach the secondary container using an 18- or 19- gauge, 31 mm (or shorter) needle, if the cassette secondary inlet port has a piercing reseal Attach syringe adapter (List 1198648) to syringes smaller than 10 cc. (Syringes 10 cc or larger can be attached directly to the secondary port of the cassette.) Syringes smaller than 3 cc should not be used. Attach a vial adapter (List 1188448) to the line
vial cap when using vials on the secondary
When using a syringe adapter, retract the plunger to draw approximately 1 into the syringe to clear air from the adapter filter.
mL of fluid
To prepare the secondary line, use aseptic technique and proceed as follows:
With cassette door closed: loosen and remove white cap, then discard. Add secondary tubing or syringe.
Open all proximal clamps before pressing [START].
Set up pump per operating instructions. (See Se&ions 4 and 5 of this manual.)
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Plum A+ Infusion Pump
Administration Sets Vial or Syringe: Secure the container to the cassette door using the optional container support arm (List 12095-04-01).
E Vial: Attach the vial adapter to the secondary
port. Backprime the air from the vial
adapter into the vial, if necessary.
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Instructions for Use
3.3 DISCONTINUING ELECTRONIC FLOW CONTROL & SETTING GRAVITY FLOW CAUTION:
B EFORE OPE N I N G DOOR , CLOSE CLAMP ON PRIMARY OR S~ONDARY SET OR R EMOVE SECONDARY CONTAINER FROM SECONDARY PORT TO PREVENT MIXING Op_PRIBlARY AND SECONDARY FLUIDS.
If electronic flow needs to be stopped, the precision flow regulator on the cassette can be used to manually set and maintain fluid flow in a gravity mode (see the following graphics).
@ SET GRAVITY RATE BY @ OPEN DOOR & REMOVE CASSETTE NOTE: FLOW REGULATOR CLOSES AUTOMATICALLY WHEN DOOR IS OPENED TO PREVENT ACCIDENTAL FREE FLOW
TURNING FLOW REGUIATOR COUNTER-CLOCKWISE NOTE: CASSElTE SHOULD BE
IN UPRIGHT POSITION
NOTE: IF DOOR OPEN ALARM OCCURS, TURN PUMP OFF
3.4 DISCONTINUING FLUID ADMINISTRATION @ PRESS STOP
@ CLOSE DOOR
0 OPEN DOOR, REMOVE CASSETTE
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DISCARD SET AND FLUID CONTAINER PER HOSPITAL PROCEDURE
Plum A+ Infusion Pump
Basic Operation
SECTION 4
Line A Flow Indicator
tine B Flow Indicator
Status Region ____)
Status Region
Working Region _I_)
Message Region e-b Softkeys Label Region j
+ LCD
Working Region
Messa! ge Region
xkIrlr I
AA
Start and Stop Keys - moom
Softkeys - Numeric Keys UP/LEFT e Selection Key
Charging/Line Indicator
DOWN/RIGHT k + Silence Key
ON/OFF Key ___)
- Decimal Point Key
Numeric Field Clear Key Y
Basic Layout of Front Panel Display and Keypad
4.1 GETTING STARTED This section details the Plum A+ instrument setup procedures.
SYSTEM SELF-TESTS CAUTION: Do NOT P L ACE TRE PLUM A+ IN SER VI CE IF IT FAILS THE S YSTEM S ELF -TES TS . Connect the mains cord to mains power, then confirm that the Charging/Line indicator illuminates (above the [ON/OFF] key on the front panel).
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Basic Operation A systematic self-testing of the processing, delivery, and safeiy systems is performed whenever the Plum A+ is turned on, to verify readiness for operation. Note:
If the quality of earth grounding source is in doubt, use battery power.
Press the [ON/OFF] key to turn the power on. Check screen display and listen for a beep to indicate the audio is working. Wait for the self-tests to complete. If successful, put a fully primed macro cassette into the cassette door and close the door. See L.oaciing 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.
q A
CAUTION: Do NOT OPERATE THE PLUM A+ ON PATIENTS WITH THE -BATTERY REMOVED. USE OF A PROPERLY MAINTAINBD AND CHARGED BATTERY HELPS CONFIRM PROPER OPERATION. To confirm battery is fully charged, connect the Plum A+ to AC power for a minimum of six hours while in the OFF mode. If an alarm occurs during the power on self-test, identify the alarm message, then take corrective action (see Section 6, Alarms and Troubleshooting). Start pump. If the self-test alarm recurs, remove the Plum A+ from service and contact the local Abbott Laboratories representative.
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Plum A+ Infusion Pump