Abbott Plum A+
Abbott Plum A+
Abbott Plum A+
Contents
SECTION 1
.
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1 P RODUCT O VERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...*............................................................... 1.2 C ONVENTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . Warnings, Cautions, and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.3 D EFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......
1-1
SECTION 2
DEVICE DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . 2.1 EATLJRES ................................................................................................................................... Therapies ............................................................................................................................... Line Programming Options .................................................................................................. PlumSet Capabilities .............................................................................................................. Air Management ................................................................................................................... Battery ................................................................................................................................... Biomedical ............................................................................................................................ Options .................................................................................................................................. Other Features ....................................................................................................................... 2.2 U SER Q UALIFICATION ................................................................................................................ 2.3 SYSTEM SELF-TE STS .................................................................................................................. 2-l 2-l 2-l 2-l 2-l 2-l 2-2 2-2 2-2 2-2 2-3 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
111
...
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
. -l ALARMS AND TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 . -l 6.1 W ARNING ME.SSAGE~ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 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
iv
Contents
SECTION 7
MAINTENANCE AND STORAGE ............................................................................................................ 7.1 C LEANING , M AINTENANCE , AND STORAGE ................................................................................ Cleaning and Sanitizing ......................................................................................................... Battery Maintenance .............................................................................................................. Storage .................................................................................................................................. Service .................................................................................................................................. 7-l 7-l 7-l 7-2 7-2 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 ........................................................................................................................... 10-l 10-l 10-l 10-l 10-l 10-l
SECTION 1
Introduction
8.
1 .l Product Overview
The Plum A+TM Volumetric Infusion System is designed to meet the fluid delivery requirements of todays
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 l l
Multistep Programming
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 operators 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:
l- 1
Introduction
1.2 Conventions
This section describes the conventions used throughout this manual, as follows:
Convention Application Example .
Italic
(See Figure 3- 1, Priming Cassette) Primary On/y: Attach an empty container. [START] A [Choose] Therapy
I
Emphasis
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 Note highlights information that helps explain a concept or procedure.
a
1 .
Note: Figures are rendered as graphic representations to approximate the actual product. Therefore, figures may not exactly reflect the product.
l- 2
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.
l- 3
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 l l
Dose Calculation
Loading Dose
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
2- 1
Battery Gauge Six Hour Battery Recharge Time Long battery life (6 hours) for emergency backup and
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
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
2- 2
User Qualification
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
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:
Note:
Use mains power whenever possible. Store the Plum A+ connected to mains to confirm a fully charged battery for emergencies. 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.
3- 1
Pnrnaty Line-
87
Flow Regulator
=Ei
IK!B Finger Grip
4
Pumping Chamber
-~
3- 2
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:
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.
3- 3
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.
3- 4
Administration Sets
LOADING THE CASSETTE To load the primed cassette into the Plum A+, proceed as follows:
. k
.T,.
Note: If flow
Insert cassette into door guides. Close the cassette door. Confirm there is no flow and no kinks appear in tubing.
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.
3- 5
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
When using a syringe adapter, retract the plunger to draw approximately 1 into the syringe to clear air from the adapter filter.
To prepare the secondary line, use aseptic technique and proceed as follows:
With cassette door closed: loosen and remove white cap, then discard. Add secondary tubing or syringe.
3- 6
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
3- 7
CAUTION:
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).
IN UPRIGHT POSITION
@ CLOSE DOOR
3- 8
SECTION 4
Basic Operation
Status Region
Working Region
+ LCD
Messa! ge Region
Start and Stop Keys - moom Charging/Line Indicator ON/OFF Key ___) Numeric Field Clear Key Y
xkIrlr
I
AA
A+
IN
SER VI CE
IF
IT
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).
4- 1
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.
4- 2
Operating Keys
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.
The [START] key is used to begin infusion and as final confirmation of programming.
The [STOP] key is used to stop the current delivery on one line; used in conjunction with soft keys to stop delivery on both lines.
The [SILENCE] key is used to silence an audible alarm during actions to correct its cause.
4- 3
Basic Operation
The [SELECT] key is used to move the highlighting cursor between the programming fields.
The numeric keys are used to enter values for any highlighted field requiring numeric data. The [CLEAR] key will cause a highlighted numeric field to be cleared in preparation for data entry. The [DECIMAL POINT] key is used to manually enter numbers other than whole numbers (i.e., 1.2 mL). Softkeys are located at the bottom of the main display and serve a variety of functions. What each key does is indicated by the text in the display above the actual softkey.
4- 4
lqdicators
4.3 Indicators
CHARGE
The fluid drop symbol, when flashing, indicates an active infusion on Line A and/or Line B.
Battery Capacity Symbol (located on right side of message region on display) indicates relative charge with number of white boxes from left to right.
The toggle switch, located below the audio level control, activates the lockout function when the lever is placed in the up position, disabling all front panel keys except [STOP].
Note: Pressing of a key while lockout is active results in the display of the lockout enabled message. This action is recommended to car&m each lockout activation.
Note: If the lockout switch is put in the Locked position while the pump is off, the [ON/OFF] key allows the unit to turn on.
4- 5
0 0
The connector located below the lockout switch is the Nurse Call Relay Connector, for providing remote notification of a nurse call event.
<
Barcode Wand (optional) is used to scan desired drug names from provided list. It plugs into the Barcode Wand Port, located in the back of the pump.
4- 6
Power On
4.5 Power On
1. Press [ON/OFF] to turn on the Plum A+ and you will see the System Self-Tests screen. c
CAUTION: THE PUMP MUST BE INITIALLY STARTED ON AC POWER, OTHERWISE THE DATAPORT MAY NOT OPERATE PROPERLY.
After self-testing successfully completes, the display will proceed to the next screen.
Note: If battery is missing or defective, a Battery not installed message with a Continue without battery prompt will appear (AC power only). CAUTION: Do NOT OPERATE THB PLIRI A+ ON PATIENTS WITH THE BATTERY REMOVED. USE OF A PROPERLY MAINTAINED AND CHARGED BATTERY HELPS CONFIRM PROPER OPERATION.
2. To set up the Plum A+, insert selected Plum Set and close cassette holder door lever.
Note: If cassette is already inserted, this screen is skipped.
3. The on-screen message Clear Settings? may appear. Press A [Yes]to clear all settings.
Clear ALL settings when changing patients or multiple programming parameters. Use A [c&f or B.
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.
4- 7
Basic Operation
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- 8
PRESSING
mLlhr
lbte 0.0
A A A A,
%z
Note:
pumping.
L
A
A T S TARTUP
1st Action Enter RATE Enter VTBI Enter RATE 2nd Action
AT KVO
\rrBl=O.O DUFUUION=OO:OO 1 st Action Enter VTBI Enter DURATION 2nd Action
1 st Action
2nd Action
[AUTOCALC] ) [DURATION]
[AUTOCALC]
1 Enter VTBI
Enter DURATION Enter DURATION
1 Kee0 RATE
Keep RATE
I DURAT/ONl
Change RATE Change VTBI [DURATION] Change VTBI Keep RATE Keep VTBI
Change RATE
Enter DURATION Enter VTBI
Enter VTBI
Enter VTBI Enter DURATION
Change DURATION I
4- 9
Basic Operation
4.8 Titration
R
A
I
2. Enter the desired Rate using the keypad.
Note: When Rate is changed, the duration is automatically recomputed using the current VTBI. To understand the Automatic Calculation feature, see Section 4.7 Examples of Automatic
,AlAlAlA]
Duration 03:20 h
Calculation,
PRESSING
AND DURATION
BEFORE
3. After any change, press [START] to initiate new Rate and return to the Main Delivery Screen.
Note: Volume Infused is an incrementing value which is cleared in A [Options/V01 Inn.
\A A A A,
%z
THE FOLLOWING 3 SCREENS ARE EXAMPLES OF CHANGED VALUES. EXAMPLE OF CHANGED RATE.
Duration 03:20 hrmin
4. From the Main Delivery Screen, press A [A]. 5. Use keypad to change the RATE value.
Note: The display time is only accurate to f one minute. As shown in this example, the delivery shows 3 hours and 20 minutes (not 3 minutes and 20 seconds).
Note: [START] accepts the change. Delivery is changed to the new RATE and DURATION and display returns to Main Delivery Screen.
4- 10
Titration
EXAMPLE OF CHANGED VTBI VALUE. 6. Use [SELECT] key to highlight the VTBI field.
Duration 06:40 hrzmin
When the VTBI is changed, the Duration is recomputed with respect to the current Rate. To understand the Automatic Calculation feature, see Section 4.7 Examples of Automatic Calculation,
Note: [STAKE?] accepts the change. Delivery is changed to the new VTBI and DURATION and display returns to Main Delivery Screen.
EXAMPLE OF CHANGED DURATION FIELD. 8. Use [SELECT] to highlight the Duration field, then use the keypad to change its value.
Duration DO:mhnmin
When DURATION is changed, RATE is automatically recomputed using the current VTBI value. To understand the Automatic Calculation feature, see Section 4.7JZxampIes OfAutomatic
Note:
Calculation,
Note:
[SIART] accepts the change. Delivery is changed to the new DURATION and RATE and display returns to Main Delivery Screen.
AND DURATION
BEFORE
PRESSING
4- 11
Basic Operation
0.0 0.0
2. Enter a RATE using the keypad. 3. Use [SELECT] to highlight the VTBl field and enter a value. The Duration will be automatically calculated.
4. Before or after entering the simple delivery program, press A [Program Options].
VTBI
WmL
A1
5. Press A
[Drug List].
Callback
No
4- 12
Simple Delivery using Drug List The Drug List Screen appears, in mainly alphabetical order.
Note: Default entry is No Drug Selected. This selection may be used later to remove an incorrect or unwanted drug name from the display.
6. Use [SELECT] to highlight desireddrug name. 7. When list does not contain desired generic drug name or group name press A [Page Down] (or A [Page Up]) until it shows, then use [SELECT] to highlight choice. 8. Press A [Enter]to indicate selection and return to the Program Options screen. Or, press A [Cancel/Back] if no choice is acceptable.
aopamm
A1
10. Press [START] to confirm the programming, begin the delivery, and return to the Main delivery screen.
A 1 PUMPING 1 STOPPED 1 B Dc+mlwd
5.0 0.1
r&k,
6.0
VZ: 0.0
4- 13
Basic Operation
5.0 mL/hr I
BmL
Note: To program a Delayed Start using a Therapy (i.e., Dose Calc) you must first select which line you want (A or B), next select A [Therapy], and then A F'rogrcun Options]. If you program the Delayed Start first, it will be cleared upon entry into Therapy mode.
A1
AND
DURATION BEFORE
t A I DELAYED I STOPPED I B 1
5.0
mt%r
Vdnf mL
O-O
0.0
O-O
4- 14
Piggyback Delivery
PIGGYBACK DELIVERY - Infusion will stop Line A and infuse Line until VTBI completes. Line A will automatically restart.
5.5 20.0
L
A
[Change Mode]to
Options].
4.
4- 15
Basic Operation
7. Use
When all parameters are displayed, changing any one parameter will result in other parameters automatically being computed.
CAUTION: V E RI PRESSING [START].
FY
BEFO
RE
10. Press
A i DELAYED 1 PUMPING 1 B 1
A /Yes] to continue.
Example of Main Delivery Screen just after being programmed and started.
5.5 20.0
m%,,
133
,: 0.1
4- 16
(B
1
VT31
2. Use [SELECT] to highlight Callback field and press A [Yes/No], if necessary to obtain Yes, then press A [Enter].
Note: Callback default ofYes or No is a biomedical setting and must be configured as described in the Technical Service Manual.
PROGRAM wmdA0.r.m
1B
PRESSING
AND DURATION
BEFORE
3. Press [START] to confirm program setting and return to Main Delivery screen.
At end of Piggyback delivery, with Callback enabled for the line, Callback alarm is issued. 4. Press [SILENCE] to clear alarm.
4- 17
Basic Operation
-PUMPING/
5.5
0.1
E,
O-0
CAUTION:
II
nl: 0.0
\rIAlAlAj
m
w*
Note:
In concurrent mode with ceitain alarm conditions, one line may stop while the other line may continue to deliver.
1. With pumping started on line A, to program a Concurrent delivery rate, press A [f3J
PROGRAM (B
The Delivery Mode field is highlighted. Note: If an entry was previously programmed, RATE is highlighted. If no previous entries, MODE is highlighted.
[Change Mode]to
Upon entry to this screen, and to alI lower screens from here, the Barcode Reader (BCR) is enabled as indicated by Wand Active when attached to the Plum A+. To use the BCR. swipe tip of BCR wand across entire barcode, from dot to dot, on the Abbott supplied drug list card. The drug name also can be selected using A fProgram
OptionsJ
4- 18
Concurrent Deliverv
PROGRAM
Wrnd Aati
1B
Note: Concurrency violation may not be displayed if unit is displaying VTBI Complete. The device will not start and an invalid keypress sound will occur when START is pressed.
5. Use [SELECT] key to move down to the VTBI field. 6. To enter VTBI amount, use keypad.
Mode Concurrent Note: While theVTB1 is being entered, the duration is automatically computed. While the computed value is greater than 99:59, dashes (- -) appear in place of hours. To understand the Automatic Calculation feature, see Section 4.7 Examples of Automatic
calculation,
7. Use [SELECT] key to move down to the DURATION field. 8. (Optional) Enter values for desired hours and minutes.
Note:
9. Press [START] to begin infusion and return to the Main Delivery screen.
Example of a concurrent delivery.
4- 19
430-95226-001 (Rev.
5101)
Basic Operation
4.14 Select Option- Volumes Infused, Pressure/Post Infusion Rate, and Lighting/Contrast
1. To select Options Screen, press
A,[OptionsNol In@
A [Choose] to
IAl
OPTIONS
Volumes Infused
IBl
This will bring up the Volumes Infused screen which defaults to Total Volume.
5. To reset Line A (or B) Volume Infused, use [SELECT] to highlight and press [CLEAR]. 6. To restore the,cleared quantity, press A [Cancel
Back-
4- 20
7. To reset all valumes, use [SELECT] to highlight Total Vol, then press [CLEAR].
Volumes Infused
[Cancel/Back]
softkey.
A [Enter]
10. Select A [Options/l/o/ lng from t;he Main Delivery screen to return to the Options screen.
Lighting/Contrast
L
A
be stopped.
13. Use [SELECT] to highlight Continue Rate or Distal Pressure Limit field. 14. Continue Rate allows a choice when VTBI is completed. Press A [KVO/Rate]
KVO- The pump will revert to a fixed KVO of 1 mL/hr or the last programmed Rate, whichever is less. Rate- The pump @ll continue at the Rate programmed.
Pressure/Post Infusion Rate Canlinw Rate m 6.0 psi D&l Presrwe Limit
Dii Pressus 0.0 psi
Note: Option will be for both line A and line B selections. 15. To change Distal Pressure Limit when highlighted, enter
value between 1.0 and 15.0 psi. 16. Press A [Enter] to keep changes and return to the Main Delivery screen, or A [Cancel/Back] to restore original values Options screen.
Note:
Continue Rate default of KVO or Rate is a biomedical setting and must be configured as described in the Technical Service Manual.
4- 21
Basic Operation
\I
OPTIONS
IB
17. Select A [Options/Vo/ lnfl from the Main Delivery screen to return to the Options screen.
18. Use [SELECT] key to highlight Cighting/Contrast Option.
19. Press
A [Choose]
to continue.
[Al
OPTIONS Lighting/Contrast
20. Press [SELECT] key to highlightBacklight Intensity or Display Contrast. 21. While viewing display for desired effect, press either A [Increase Setting] or A [Decrease Setting] to change level. 22. Press A [Enter]to keep change(s) and return to the Main Delivery screen, or A [Cancel/Back]to restore previous settings and return to the Options screen.
Display Contrast m
4- 22
to return
<A A A
A,
Example of STOPPED delivery.
2. To discontinue infusion, press [ON/OFF]. 3. Clamp secondary tubing if connected. 4. Open door, remove set and close door. Or, press [START] to resume infusion.
Basic Operation
rAISX)PPED
25.0 my;;, 50.0 3.0 y 20.4
AND
DURATION BEFORE
3. To resume infusion, press [START]. 4. Select A [Start A], A [Start B], or A [Stati All]. Or, to discontinue infusion, press [ON/OFF]. 5. Clamp secondary tubing if connected. 6. Open door, remove set and close door.
4- 24
Backpriming
4.17 Backpriming
A) STOPPED 1 STOPPED 1 B 5.5 :;tr 0.0
BACKPRIMING Removal of air or fluid from the proximal line and cassette airtrap.
8.9 Z: 0.0
Bsck A prime
R%z
AA
A, 2. Press and hold A [Back Prime] until fluid pumped from line A to line B has expelled the air from cassette air trap into Secondary container.
Note: Fluid flow is at maximum rate possible.
3. Upon release of A [Back Prime], the cassette test is performed to confirm readiness for pumping. Pressing [START] will resume programmed delivery.
I 61
4- 25
Basic Operation
Al Rate
PROGRAM m mUhr
2. Select Line A (or B if active) from the stopped Main Delivery Screen. 3. Select A [C/ear Program].
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 A [Therapy].
VTBI
22.0 mL
4. Select A [Yes].
Clear Line
Settings?
Clear ALL settings when changing patients or multiple programming parameters. Use A [C/ear Programlwhen changing ONLY Line A or B.
Rate VTBI
m ml/hr 0.0 mL
5. Press A [CanceVBack]to return to the Main Delivery screen or program new settings.
to cancel.
4- 26
SECTION 5
Multistep-
2. Press A [Therapy].
5- 1
Therapies (For Advanced Users*) The Select Therapy screen for Line A appears.
Note: Dose Calculation is the only available option if Line A is infusing.
Loading Dose Multistep
IAI
The Program Dose Calc screen appears. Note: Screen defaults to the mcg/kg/min option or the previously
selected option.
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. Note: Default choice for possible gram-based Container
Concentration Unit is mg or the previously selected option.
Use [SELECT] key to highlight the Container Concentration units to use in the delivery.
6.
3. Use keypad to enter desired values. Once each value is entered, use [SELECT] to highlight the next programming ield.
Note: The Concentration elements and weight value must be entered before the (SELECT] key allows access to remaining fields.
5- 2
9. Continue to enter values using the keypad and advancing to the next field using [SELECT].
Note: As the Dose value is entered, the Rate is automatically calculated. To understand the Automatic Calculation feature, see
rA I
-
E
A I Program Dose Calc WMdccnc
Weight KY 0watkel bs
mmg
70.0 kg
250 rnL
12. After entering the desired VTBI value and any desired A
[Program Options],,press [START] to begin infusion.
Therapies (For Advanced Users*) The Main Delivery Screen appears, to display the information just entered. Note: The Therapy Type is displayed as well as the Dose Rate and
Dose Units. %, I
4 1 PUMPING 1 STOPPED ~ZZL4&C4 7.9 0.1 1M mql*phnin z;;, 0.0 Vi: 0.0
Dose
5- 4
5.5 O
m?ehr
Vol Inf mL
9-o
0.0
D OSE C ALCULATION - 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. Use A [C/ear Programlwhen changing ONLY Line A 1 or B.
2. Press A [Therapy].
Duration 0O:OO hr:min
The Select Therapy screen for Line B appears. The screen defaults to Dose Calculation or the previously selected option.
Note: Dose Calculation is the only available therapy while Line B is running.
5- 5
4. Continue to scroll using [SELECT] key until desired field is highlighted. 5. When desired field (mg/hr in this sample) is highlighted, _ press A [Choose].
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.
Note: Default choice for possible gram-based Container Concentration Unit is mg or the previously selected option.
,A
xA
A,
9. To override the Piggyback Delivery Mode default, scroll down to Mode using [SELECT], then press A [Change
Mode].
Note: Delivery Mode Option is available on Line B, its default is Piggyback, and the Weight field is gone.
5- 6
10. Continue entering desired values using the keypad. Use [SELECT] to advance to the next field.
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 4.7
Note:
The Duration field temporarily than es to dashes when the computed value is larger than what can be /?isplayed.
IB
mL
PRESSING
PUMPING 1 PUMPING
1.0 5.0
mLI hr
Upon [START], the Main Delivery Screen shows delivery status for both A and B lines.
Note:
n&e
mL
Vol Inf
See
14. To update and identify the infusing drug, enter the drug name by using either the BCR or via A [Program Options] then A [Drug List] with an entry for a selection.
The drug name will appear in the upper-right corner. If a drug name was previously entered and confiied by pressing [START], it cannot be changed while line is infusing. The line must be stopped and the Dose Calc screen entered before it can be changed. Note:
5- 7
0.2 s,
15. Press [START] to confirm entries and return to the Main I. Delivery screen.
Dose
5- 8
Loading Dose
:;tr 0.0
y: 0.0
AIIOWS 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.
L OADING D OSE -
Clear ALL settings when changing patients or multiple programming parameters. Use A [C/ear Program]when changing ONLY Line A or B.
2. Press A [Therapy].
Duration 0O:OO hnmin
Al
PROGRAM
Al
Therapies (For Advanced Users*) The Program Loading Dose screen appears.
Note: The screen defaults to the mL/hr option or the previously selected option.
<AA AA
1
2
mm
0.0
2.k
mL 0.0
0.0
pgp
0o.m
WE00
7. Enter a rate using the keypad from 0.1 to 999 mL/hr depending on delivery mode.
8. After the desired value has been entered, use [SELECT] to highlight the next field.
5- 10
Loading Dose
9. Enter Volume To Be Infused (VTBI) from 0.1 to 9999 mL using the keypad.
Note:
1
2
mUhr
;FmT
MO
0.0
&
0.0
w:c6
lYJ:W
After a Rate and VTBI value are entered, the Duration is automatically computed. Manually changing the Duration field will automatically recompute the Rate. To understand the Automatic Calculation feature, see Section 4.7 Exaniples of Automatic
Calculation,
10. After the values for the loading dose Step-l are entered, use [SELECT] to highlight the maintenance dose Step-2.
Note: The loading dose therapy has two steps. The first is the loading dose followed by the maintenance dose. These words will appear on the Main Screen as each step is delivered.
Rate mm 1
VTBI ml 0.0
wo 55.0
w:oo
Al Program Loadzdse 1
Rate miAw 1 2
v-ml mL
h% C&X w:w
5- 11
14. Press A [Program Options] to enable setting a Delayed Start or to enable the Nurse Callback.option.
/Program A1
Optioiow
Note:
Nurse Callback enables an alarm when a change in the delivery on a line occurs such as completing Step- 1 and starting Step-2. Or on line B, a piggyback delivery is completed and line A is starting its delivery.
15. Enter a delay time (less than or equal to 24 hours) using the keypad.
Delay Start
Note:
16. After selecting a desired value, use [SELECT] to highlight the callback feature.
5- 12
Loadina Dose
A)
Delay
Callback
Note: Nurse Callback cannot be changed while a delivery is taking place on the line.
PRESSING
A 1 DELAYED 1 STOPPED 1 B
0.0 $ 0.0
I A I PUMPING
-Do-
STOPPED I B I
500
0.5
mL/hr
Iwe 0.0
After the programmed delay period has expired, the Plum A+ starts Pumping. This is indicated where Delayed previously was displayed.
$ 0.0
Therapies (For Advanced Users*) After the first step has completed, the Main Delivery Screen changes to the second step.
Note:
A flashing Callback Line A message and the audio alarm sound indicates activation of that option.
Upon completion of delivery, the screen shows a flashing Line A VTBI complete message and the audible alarm sounds.
Note: The KVO rate will change to the rate of 1.0 mL/hr or less depending on delivery rate and Pumping mode changes to KVO. If Continue Rate option was selected, pumping continues at original rate.
5- 14
Multistep Programming
2. Press A [Therapy].
VTBI
0.0 mL
Al
PROGRAM
whnd&WO
Al
Program Multistep
AI
Program Multistep
5. Use [SELECT] to highlight the desired setting. This example is using mcg/hr. 6. Press A [Choose]to go to the second page of the Program Multistep screen.
AI
Program Multistep
Drug Cone in Container
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.
Note: Default choice for possible gram-based Container Concentration Unit is mg or the previously selected option.
Back
7. Press A [Choose]to continue, or use [SELECT] to highlight another option. 8. When desired field is highlighted, press A [Choose]. 9. The default field is the concentration field (Cone). Enter value using keypad.
The user must enter the concentration drug amount and diluent volume before any other entries. Note:
Ax.A
AI
1
s
z
O.oW IE
?%?
OOZW oo:W zt
z!ir 0.0
Multistep Programming
A)
cow
Program Multistep
WMd*aMI 50.0 mg m rnL
10. Use [SELECT] to highlight the next programming field (Diluent-Amount). 11. Enter value using keypad.
: 3 i
mgmr
%z olxa 0.030
_.
12. Use [SELECT] to highlight the next field. 13. Enter Dose using keypad.
Note: The Rate value is automatically computed. To understand the Automatic Calculation feature, see Section 4.7 Exa~npZes ofAutomatic
Calculatfon,
6.
AI
ceix 50.0
AI caw
If Rate is changed, Dose and Duration (or VTBI) are automatically re-computed, depending on the prog ramming order.
5- 17
16. Use [SELECT] to scroll past the Rate. The cursor will drop down to Step-2 Dose field. 17. Enter the set of desired values for Step-2 of the program. Continue process for each additionaf.Step.
Note: When Step-4 is programmed;:using [SELECT] to advance will highlight another item on this screen.
19. To set up Steps 5 through 10, enter desired values as for Steps 1 through 4. 20. To see the previous steps, press A [Prev Steps].
AI
21. To program a Delay Start Time or set up a Nurse Callback for this program, press A [Program Options]. 22. Enter a value using the keypad.
You can choose Drug Name, Callback, or Delay Start as previously shown.
5- 18
Multistep Programming
CAUTION:
VERIFY PRESSING [START].
A 1 PUMPING 1 STOPPED 1 B 8-3 2.5 37.5 250 Dose -1 mzehr 0.0 v,: 0.0
AI Program
ME2 1
Note: The ** in a Step number field indicates the step is delivering or d indicates each completed step.
AI cone
If Dose value is changed, the Duration and Rate will automatically change.
Note: Only the current delivering step and future steps can be changed.
5- 19
DURATION
BEFORE
27. Press [START] to begin infusion with the changed program and return to the Main Deljvery Screen. .
Note: The
The pump reverts to KVO when last Step completes. The last step can be restarted by entering a new VTBI value.
5- 20
SECTION 6
Alarms
and Troubleshooting
while a delivery is in progress. Pressinganykeywhfledelfverfng (exceptSTOP)whenLockoutswftch is enabled. The battery capacity is greater than 200 mAjw. The battery voltage is less than the depleted threshold and charge level is higher than the low charge threshold. The charging circuitry is not behaving as expected (charge voltage is not changing) and can reduce battery life. Pump not plugged in to AC power.
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 messa e will be shown to explain the %y another message upon the next problem. All such messages will be cleared or replaced valid input key press.
6- 1
Press [SILENCE] key. 3. Identify/Observe Alarm condition. 4. Correct Alarm condition (see chart below).
5.
Note: Alarm messages begin with an alphanumeric code for tracking purposes only. If troubleshooting does not correct the problem, record the code number and contact technical support. GENERAL ALARMS
El 00 El01 El 02
El 03
Unrecognized cassette No Action Alarm Infuser Idle 2 Mf nutes Memory Failure Prox Air, Backprime Distal Occlusion
E230
Attempting to use unrecognized cassette Pump programming incomplete. Pump is ON without operator input. The pump did not accept the previous programmed data. When the total proximal air detected exceeds the limit. Distal line kinked. Nsfte clotted or positional, pressure limit set too low.
Turn off or insert recognfzed cassette. Press [STAwrl or continue programming. Beginprogramming or turn pump OFF. Reenter all programmed data. Check for clamps, or empty containers on lineA or B. Correct as necessary. Backprime into line B tubing or syringe Check distal tubing, check IV site, reset pressure limit.
Note: See Section 8.8 for detailed instructions for avoiding a bolus
El87
El 83, El 85
Pump too high above patient or defective set. Proximal line obstructed, lineA (or B) container disconnected or obstructed during nondelivery (startup).
When air is detected at the distal sensor and exceeds the limit. Pump door opened while operating.
Remove and reprime cassette using standard technique. Close door with cassette inserted.
6- 2
Resnonse to Alarms
Failure
Too much time on battery power. Unlock lockout switch. The use of the [STOP) key dur f ng . &lfvery,oropenfngthedoor,whfle lockout is enabled. PressfngofanykeyexceptlSTOP] Unlock lockout switch. durfngdelfverywhfleanyalarmfs active and lockout is enabled.
set, close door. Backprime into line B tubing or syringe if appropffate. If alarm recurs on retest, replace set. If alarm repeats, replace pump. Plug into AC power.
LINE A ALARMS
Callback Line A
a
Proximal line obstructed, lineA When proximal af r detected exceeds the limit for the line.
Prox Af r A, Backprime
Alarm programmed by user. Change in delivery for Loading Dose to Maintenance Step orfor any step in Multistep therapy provided the step is not the last SteD.
Program new VTBI. Examine line A for kinks or closed clamps. Check for clamps, or empty container. Correct as necessary. Backprime into line B tubing or syringe
El60
El 82,
El 88, El89
Alarm programmed by user. Change in delivery for piggyback delivery, Loading Dose to Maintenance Step, or for any step in Multistep therapy provided the step is not the last step. VTBI complete on line B. Proximal line obstructed, 1fneB container disconnected or obstructed.
Press [SILENCE).
E23 1
When proximal air detected exceeds the limit for the line.
a 13
Check for clamps, or empty container. Correct as necessary. Backprime into line B tubing or 1 syringe.
MALFUNCTIONS
SECTION 7
The cleaning, maintenance, and storage of the Plum A+ are described in this section.
Establish a routine weekly schedule for cleaning the Plum A+. To clean the Plum A+, proceed as follows:
Turn the Plum A+ off with the [ON/OFF] switch, then disconnect the Plum A+ from mains power. The exposed surfaces of the Plum A+ may be cleaned with a lint-free cloth dampened by one of the recommended cleaning solutions in the following list or mild, nonabrasive soapy water.
Per manufacturers recommendation Per manufacturers recommendation Per manufacturers recommendation Per hospital procedures: do not exceed one part bleach in ten parts water
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.
7- 1
CAUTION: CERTAIN CLEANING AND MTIZING SOLUTIONS M AY SLOWLY DEGRADE COM PONENTS MADE FROM SOME PLASTIC MATERIALS. USING ABRASIVE CLEANERS OR CLEANING SOLUTIONS NOT RECOMMENDED BY ABBOTT LABORATORIES MAY RESULT IN PRODUCT DAMAGE. Do NOT USE COMPOUNDS
CONTAINING COMBINATIONS OF ISOPROPYL ALCOHOL AND CAUTION: N EVER USE SHARP ANY PART OF THE PLUM A+. OBJECTS SUCH DIMETWL BEti? AMMONIUM CHLORIDE. N A I L S,
PAPER
AS FINGER
CL&S,
OR
NE
EDL
ES
TO
CLEAN
CAUTION:
CAUTION: To AVOID PUMP DAMAGE, CLBANING SOLUTIONS SHOULD ONLY BE USED As DIRECTED. TI3B DISINFECTING PROPERTIES OF CLEANING SOLUTIONS VARY: CONSULT THE .$4ANUFAcTuRBR FOR SPECIFIC INFORMATION.
BATTERY MAINTENANCE
CAUTION: Do NOT OPERATE THE PLUM A+ ON PATIENTS WITa THE BATTERY REMOVED. USE OF A PROPERLY MAINTAINED AND CHARGED BATTERY HELPS CONFIRM PROPER OPERATION. CAUTION: IF THE LOW-BATTERY ALARM SOUNDS. CONNECT TRE PLUM A+ TO b%AINS POWER IMMEDIATELY. The Plum A+ is battery powered for emergency backup and temporary portable operation. A fully charged, new battery provides six hours of operation at 125 ml/hr or 500 ml total volume delivered, whichever occurs first. Note: For optimum battery life, the Plum A+ should be operated on battery power for six continuous hours at least once every six months and then charged for a minimum of six hours. The battery charges whenever the Plum A+ is connected to mains power. If the Plum A+ is switched off, recharge takes approximately six hours. Recharge takes longer if the Plum A+ 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 Plum A+ to mains power whenever possible.
STORAGE
To prolong the life of the Plum A+, observe the following storage precautions:
l l l
Store the Plum A+ away from excessive heat, cold, and humidity Store the Plum A+ connected to mains power Switch the Plum A+ off using the [ON/OFF] key
SERVICE
All servicing or adjustments to the Plum A+ should be referred to qualified technical personnel. A technical service manual may be ordered from the local Abbott Laboratories sales office.
7- 2
SECTION 8
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.
8.1 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 or microcomputer might be disrupted. Even in this event, the outcome would likely be a false alarm or detected system malfunction and would not result in a hazard to patient or operator. Use of radio frequency emitting devices such as cellular telephones and a-way radios in close proximity of this device may affect its operation.
E:
Consult drug labeling to co&ii drug compatibility, concentration, delivery rates, and volumes are suitable for secondary, concurrent and piggyback delivery modes.
all
8- 1
Precautions
Connecting more than one pump Into one patient line may significantly affect the infusion rate of at least one of the pumps. 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 sebondary container from the secondary port to prevent mixing of primary and secondary fluids. Although unlikely, failure of certain robust mechanical components such as the anti-free flow mechanism or valve control springs could cause fluid delivery limited to the contents of the fluid container. Single fault failure of certain electronic/motor control components would result in no more than 5 mL of unexpected fluid delivery. A small amount of fluid is expelled from the set (less than 0.05 ml) each time the door is opened or closed with a set installed. If potent drugs are being used, take appropriate action to guard against overmedication of the patient. Before disconnecting a syringe from the cassette, pull up the plunger slightly to avoid spilling the fluid. For rigid containers (for example, vials), 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 out-gassing of dissolved air in the fluid. This may occur if chilled solution is in use, if the pump 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 andmay 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.
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:
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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 drugs rate. Dopamine, for example, delivered at 1.5 mL/br should not be accompanied by an infusion programmed any faster than 7.5 mL/hr. If the critical drug (with half-life less than 6 minutes) is to be infused at 2.0 to 5.0 mL/hr the other infusion should be no faster than ten times the critical drugs rate. Dopamine, for example, delivered at 3.5 ml/hr should not be accompanied by an infusion programmed any faster than 35 mL/hr. If the critical drug (with half-life less than 6 minutes) is to be infused at 5.1 mL/hr or greater, the other infusion can be programmed at any desired rate.
Note:The total of the primary rate plus the secondary rate cannot exceed 500 mL/hr.
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Epidural Administration
NoteThese guidelines apply only when Infusing short half-1iJe critical drugs in Concurrent mode. patient responses may vary requiring adjustment of delivery rates. Delivery Rate Guidelines Short Half-life (less than 6 minutes) Critical Drug Infusion Rate 0.5 - 1.9 mL/hr 2.0 - 5.0 mL/hr 5.1 or Greater CRITICAL D RUGS Examples of drugs with a short half-life (approximately 6 minutes or less when given IV) Include: l Dobutamine Maximum Rate of Accompanying Infusion , - I . 5 Times the Critical Drug Rate 10 Times the Critical Drug Rate Any Desired Ratio Individual
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l Esmolol l Lidocaine
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l 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 all-inclusive 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.
E:
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Precautions
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., Orrimetry) is recommended for continuous monitoring of the patient during epidural administration. Patients must be observed frequently for side effects in a fullyequipped 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.
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Backpriming
8.7 Backpriming
Backpriming is not recommended for reconstituting secondary containers containing dry powders. To avoid pressurization when backpriming Into a syringe or a vial, the user must confirm that these containers have sufficient empty space to accept the backprimed fluid.
8.8 General
Possible explosion hazard exists if used in the presence of flammable anesthetics. Do not place Plum A+ in service if it fails the self-test. Do not operate the Plum A+ with the case opened. Keep the cassette door securely closed while the Plum A+ is not in use, to avoid cassette door damage. Use the following procedure to avoid the administration of a bolus following a distal occlusion:
If a secondary container is in use. clamp proximal tubing before opening cassette door Open cassette door and remove the cassette Open the flow regulator briefly to dissipate the pressure and then close it Eliminate the source of occlusion Reinsert the cassette and close the cassette door Open all clamps and resume infusion
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SECTION 9
Specifications
PHYSICAL
Dimensions: Weight: Casing: Approximately 8 X 8 X 6, excluding pole clamp protrusion and power cord storage. Approximately 9.5 Ibs. with battery. High-impact plastic
ELECTRICAL
Power Requirements: Fuses: Power Cord: Battery:
Battery Life:
120 V-, 50-60 Hz, 35 VA. Fl, F2,25OV-, 0.5 A. (internal) Hospital-grade AC cord. 10 ft long, with transparent plug and retainer plate. One sealed, lead-acid, rechargeable 6 V battery, internal to device. With a new fully charged battery, the infuser shall operate for a minimum of six hours at 125 mIJhr or less, or deliver 500 mL at 126 mL/hr or greater on one line. The battery charges whenever the Plum A+ is connected to AC power. The recharge time is approximately six hours with the device operating at 125 mIJhr on one line. Risk current limits meet AAMI/ANSI SCL (ungrounded) 12/78 standard. NURSE-CALL alarm is factory set for Normally- Open (NO) Note: Contact the Technical Services Center to make an internal adjustment to change the device from NorrnallyOpen (NO) to Normally Closed (NC) system. Voltage-30 VDC Max Current- 0.25 Amps Max Contact Rating- 3 Watts Max
Recharge:
Circuitry Ratings:
VTBI RANGE
VTBI Range: 0.1 to 99.9 mL (in 0.1 mL. increments) 100 to 9999 mL (in 1 mL increments)
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Specifications ENVIRONMENT
Operating Temperature: Storage Temperature: Atmospheric Pressure: Relative Humidity: 5 to 40 C -20 to 60 C 0 - 10,000 feet (0 - 3,000m) or equivalent pressure 10 - 90% (40 C Max)
AIR-IN-LINE ALARM
PlumSet (Distal): PlumSet (Proximal): Bolus 0.1 mL or larger Cumulative 0.26 rnL out of 2.5 mL Bolus at 0.5 mL, Total 1.0 mL
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The DISTAL OCCLUSION alamr sounds after the distal set tubing or set outlet fitting becomes occluded. The PROXIMAL OCCLUSION alarm sounds if the tubing proximal to the cassette becomes occluded.
1 to 15 psig. The maximum pressure k user-selectable. Factory default setting is 6 psig.
20 psig
Occlusion Alarm
Pressure Setting 6 ~51~ 15 PQE 6 pslg I5 pslg
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DELIVERY ACCURACY The Plum A+ Infusion pump was designed and manufactured to maintain a volumetric delivery rate error of the total fluid delivered of less than or equal to 2 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 rnL/hr, the delivery rate error is less than or equal to f 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) majr 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. TRUMPET CURVES The Trumpet Curve Graphs following the Example show representative maximum and minimum percent flow rate deviation from the programmed rate over time. This information was developed in accordance with IEC 60601-2-24: 1998, Sub-Clause 50.102. Refer to this standard for detailed information. wi Hog p& W T : 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 pumps) 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 3 1 minutes (Trumpet Curve).
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SECTION IO
10.2 Accessories
Syringe Adaptor- List# 11986-48 Vial Adaptor- List# 1188448 Mini Pole- List# 12096-04-91 Secondary Container Support- List# 12095-04-61 Bar Code Reader (Available as a Field-Installed Infuser Option)Tandem Carrier- List# 12270-O 1 List# 11972-04-01
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