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System Operating Manual

1. m 6 14 ALARMS AND TROUBLESHOOTING 7 1 7 1 WARNING MESSAGES 7 1 7 2 RESPONSE TO ALARMS 7 2 general alarms 7 3 line a alatms Stir eras aes acer x 7 5 linebalarms 7 7 malfunctions 7 8 MAINTENANCE AND STORAGE 8 1 8 1 CLEANING MAINTENANCE AND STORAGE 8 1 cleaning and sanitizing 8 1 battery maintenance 8 3 511914510 ERE RE 8 4 SEVICE queso edad 8 4 430 95215 003 Rev 10 05 iv Contents 9 SPECIFICATIONS 9 1 physical 9 1 electrical du ads aei a Moe 9 1 VIDI Tange ee uma Sines 9 2 enVIFOnmient reae RO ecc e ds 9 2 delivery rate range 9 2 air in line 9 3 occlusion alarm and limits 9 3 time to detect downstream occlusions 9 4 bolus volume released after downstream occlusions are COME CTO sso eiae LOAD ee 9 4 delivery accuracy 9 4 enteral amp high viscosity fluids 9 5 trumpet curves 9 6 example
2. 4 4 4 2 POWER ON tk EE ELE 4 4 4 3 SIMPLE DELIVERY 4 6 TITRATION puente Aire oa esc Da EX Mes 4 9 4 5 PIGGYBACK DELIVERY 4 11 4 6 CONCURRENT DELIVERY 4 14 4 7 STOP AND START WITH ONLY 1 LINE PUMPING 4 17 4 8 STOP AND START WITH BOTH LINES PUMPING 4 18 4 9 BACKPRIMING 4 20 4 10 CLEARING PROGRAM SETTINGS 4 21 THERAPIES 5 5 52 zu aaa xxm rw 5 1 5 1 DOSE CALC MCG KG MIN ON 5 2 5 2 DOSE CALC MG MIN 5 8 5 3 LOADING DOSE 5 14 5 4 MULTISTEP PROGRAMMING 5 21 430 95215 003 Rev 10 05 Plum Infusion Systems fii 6 7 8 ADDITIONAL FEATURES 6 1 6 1 SIMPLE DELIVERY USING DRUG LIST 6 1 6 2 SIMPLE DELIVERY USING DELAYED START 6 4 6 3 PIGGYBACK WITH NURSE CALLBACK 6 5 6 4 POSSIBLE NON DELIVERY PROGRAMMED 6 7 6 5 USING THE STANDBY FEATURE 6 7 6 6 SELECT OPTION VOLUMES INFUSED PRESSURE POST INFUSION RATE AND LIGHTING CONTRAST 6 9 6 7 VARIABLE RATE 6 13 6 8 EXAMPLES OF AUTOMATIC CALCULATION 6 13 at startup iud done eR dp EE Re 6 13 while running titration 6 13 Lig
3. A CANCEL BACK to return No to the Line Programming screen D Cancel List Standby Enter BO CAUTION VERIFY ALL VALUES ZEE BEFORE STARTING INFUSION Enter Value using keypad 430 95215 003 Rev 10 05 Plum A Infusion Systems 6 3 7 8 9 Notice the drug name remains in the upper left Dopamine corner Rate 5 VTBI mL a d RATE using the Duration 50 00 hr min Enter Value using keypad Puch Therap Cancel Use W to highlight the pA VTBI field and enter a value The DURATION will be automatically calculated Press m to begin EA poner sroreco 8 program and return to the Dopamine Main Delivery screen 22 404 Vol Inf DUE NO Notice the drug name remains in the upper left corner A Options Vol Inf A A 430 95215 003 Rev 10 05 6 4 1 430 95215 003 Rev 10 05 Before or after entering the simple delivery program select A PROGRAM OPTIONS 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 DRUG and then A PROGRAM OPTIONS If you program the Delayed Start first it will be cleared upon entry into Program mode The Default screen for Program Options appears 6 Additional Features 6 2 Simple Delivery Using Delayed Start PROGRAM Mode Rate 5 mL hr VTBI 250 mL Duration
4. Press SILENCE N160 Line B VTBI complete VTBI complete on line B Program new VTBI Prox Occl B At Startup N183 Proximal line obstructed line B container or syringe disconnected or obstructed during non delivery startup Examine line B for kinks or closed clamps If there are closed clamps open the clamps Then open and close door Continue programming Replace set if problem persists If clamps are not opened prior to completion of cassette test peak proximal occlusion may recur For syringe select A Backprime 430 95215 003 Rev 10 05 1 4 MESSAGE 7 Alarms and Troubleshooting POSSIBLE CAUSE CORRECTIVE ACTION N182 Prox OcclB Proximal line Examine line B for N188 Air obstructed line B kinks closed clamps N189 container or air in cassette disconnected or Occlusion caused by obstructed empty container backprime into line B tubing or syringe N231 Prox Air B When proximal air Check for clamps or Backprime detected exceeds the empty container limit for the line Correct as necessary Backprime into line B tubing or syringe MALFUNCTIONS POSSIBLE CORRECTIVE CopE 55 CAUSE ACTION E300 or Malfunction A failure has occurred Record Malfunction higher in the infuser s error code Pump internal systems must be turned OFF to clear malfunction If alarm malfunct
5. 23 59 minutes in advance 10 meg kg min mL of Starting Duration 08 80 Rate 1 If Line A is infusing Enter value using keypad Pro gram zn programmed select CONI or B to access program screen of line to be placed on Standby 2 Select 4 PROGRAM OPTIONS 3 Select 4 STANDBY 430 95215 003 Rev 10 05 6 8 6 Additional Features 4 Confirm the information displayed is correct then Delivery will be select 4 YEs to place 555 D makanin program on Standby Cone mode Rate 263 Put delivery in Standby NOTE This example screen shows a Dose Calculation Program with a Standby It looks similar to the Program Confirmation screen with the substitution of Put delivery in Standby replacing Confirm Program Selecting A Yes confirms both the Program and the Standby 5 Press toremove z smwevTereres s Standby and start the program dms NN Vol Inf 0 mL 10 mcg kg min T 1 Options A Vol Inf A 430 95215 003 Rev 10 05 Plum A Infusion Systems 6 9 6 6 Select Option Volumes Infused Pressure Post Infusion Rate and Lighting Contrast 1 To select the Options Pomena 5 B screen select A OPTIONS VOL INF ako 393 Vol Inf 0 mL Options A Vol Inf A 2 Use to highlight option Release 11 x 3 Select CHoosE to Pressure P
6. T T 0 2 0 4 0 10 20 30 40 50 60 70 80 90 100 110 120 Time minutes Actual Rate Programmed Rate 1 ML HR 0 mmHg DELIVERY HEAD START UP Typical 1596 2210 29 55 t N i 5 NM S RE Q10 d 15 0 5 10 15 20 25 30 Observation Interval minutes Min Mean 1 ML HR 0 mmHg DELIVERY HEAD STARTUP Composite of 3 Pumps 1596 38 10 5 5 o 8 n Hi Ps 4 5 10 p 15 lt lt 0 5 10 15 20 25 30 Observation Interval minutes Max Min Mean 430 95215 003 Rev 10 05 Plum Infusion Systems 9 11 1 ML HR 0 mmHg DELIVERY HEAD 96 HOURS Typical 2 0 1 8 4 164 144 12 104 seti H 5 06 04 4 02 4 0 0 0 10 20 30 40 50 Time minutes Actual Rate Programmed Rate 1 ML HR 0 mmHg DELIVERY HEAD 96 HOURS Typical 15 58 10 5 0 a a d 4 8 5 M SZ uu 10 15 0 5 10 15 20 25 30 Observation Interval minutes Min Mean 1 ML HR 0 mmHg DELIVERY HEAD 96 HOURS Composite of 3 Pumps 15 T 10 5 5 _ POMMES H 8 1 aa ee 15 d 0 5 10 15 20 25 30 Observation Interval minutes Max Min Mean 430
7. A user Change in delivery for Loading Dose to Maintenance Step or for any step in Multistep therapy provided the step is not the last step N161 Line A VTBI VTBI complete on line Program new VTBI complete A N185 ProxOcclAAt Proximal line Examine line A for Startup obstructed line A kinks or closed clamps If there are closed clamps open the clamps Then open and close door Continue programming Replace set if problem persists If clamps are not opened prior to completion of cassette test peak proximal occlusion may recur For syringe select A Backprime 430 95215 003 Rev 10 05 7 6 7 Alarms and Troubleshooting CORRECTIVE MESSAGE POSSIBLE CAUSE ACTION Prox Occl A Proximal line Examine line A for N190 Air obstructed line A kinks closed clamps N191 container disconnect or air in cassette or obstruction N232 Prox Air A When proximal air Check for clamps or Backprime detected exceeds the empty container limit for the line Correct as necessary Backprime into line B tubing or syringe 430 95215 003 Rev 10 05 Plum A Infusion Systems LINE B ALARMS MESSAGE Callback Line B 1 4 N104 POSSIBLE CAUSE 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 CORRECTIVE
8. accurate to 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 Example of Changed VTBI __ __ _ value Rate 15 mL hr 6 Use WF key to highlight VTBI mL the VTBI field Duration 06 40 hr min Enter Value using keypad 7 Usethe keypad to change Therapy Cancel Back the VTBI value AIA NOTE When the VTBI is changed the Duration is recomputed with respect to the current Rate To understand the Automatic Calculation feature see Section 6 8 Examples of Automatic Calculation NOTE START accepts the change Delivery is changed to the new VTBI and DURATION and display returns to Main Delivery Screen 430 95215 003 Rev 10 05 Plum A Infusion Systems 4 11 Example of changed DURATION field Rate 15 mL hr 8 Use W to highlight the VTBI 100 mL Duration field then use Duration 00 nr the keypad to change it s Enter Value using keypad value Program Options NOTE When DURATION is 4 4 changed RATE is automatically recomputed using the current VTBI value To understand the Automatic Calculation feature see Section 6 8 Examples of Automatic Calculation NOTE START accepts the change Delivery is changed to the new DURATION and RATE and display returns to M
9. 2 2 2 Principles of Operation PLUMSET CAPABILITIES Anti Free Flow Protection e Direct Connection for syringe delivery AIR MANAGEMENT e Air Trap e Removal Backpriming e Air Detection Proximal e Air Detection Distal BATTERY NOTE The Plum A 8 utilizes three batteries e Battery Gauge e Six Hour Battery Recharge Time Long battery life 6 hours for emergency backup and temporary portable operation BIOMEDICAL e Serial Communication e Upgradability Field for List 12391 only e Variable Rate Cap Alarm History e Nurse Call Relay Connector OPTIONS e Volumes Infused A B Total Volume e KVO at dose 1 ml hr or less depending on delivery rate or Continue Rate CR to continue at the current rate e Variable Distal Pressure Settings 430 95215 003 Rev 10 05 Plum A Infusion Systems 2 3 OTHER FEATURES Nonpulsatile volumetric accuracy Microprocessor control Large liquid crystal display LCD screen Panel back illumination on mains power Lockout switch Standard syringe use Parenteral and nonparenteral enteral fluid delivery Blood and blood products delivery Wide range of Standard and Specialty administration sets Password protected keypad lock 2 2 Definitions TERM DEFINITION Administration The sterile disposable assembly with Set flexible tubing that connects to a source fluid container for input to the Cassette pumping chambe
10. The Program Select screen PROGRAM B for Line B appears 5 Select A CHOOSE to continue Multistep Select then Choose Choose Back A A 430 95215 003 Rev 10 05 5 10 5 Therapies 6 7 The Program Dose Calc program Dose Cale screen appears Lidocaine mL hr grams hr mcg kg min ng kg min mcg kg hr nits kg hr NOTE Cursor defaults to ee manufacturer package insert mog hr units hr mg kg hr mUn min recommended dose units mEq hr associated with the selected drug Select then Choose Choose Back Select 4 CHOOSE to continue use AW to change the units to use in the delivery The Container selection 28 8 Concentration Selection screen appears whenever Drug Conc in Container the selected Dose Units meg m are gram based e g grams mg mcg or ng otherwise this screen is skipped Choose A NOTE Cursor defaults to manufacturer package insert recommended concentration units associated with the selected drug Select CHOOSE to continue Or use AW to change the Container Concentration units to use in the delivery 430 95215 003 Rev 10 05 Plum Infusion Systems 5 11 8 9 The next page of the Program DoseCalc 8 Program Dose Calc screen appears to provide for entry of delivery program Conc Mode Piggyback Dose 0 mg min p
11. 5 8 5 Therapies 5 2 Dose Calc mg min on B DOSE CALCULATION Allows programming Dose Rates in alternative units of measure Dose Calculation can be used in Simple Delivery Loading Dose and Multistep Clear ALL values when changing patients or multiple programming parameters Use A CLEAR PROGRAM when changing ONLY Line A or B 1 Select 4 B at the Main TA PuMPING STOPPED B Delivery screen Dopamine Dose Calculation Rate 26 3 IUE 0 Vol Inf Que DEUS 10 mcg kg min rm Options A Vol Inf A A The Line B Programming PROGRAM B screen appears Mode 2 Select THERAPY Rate 0 VTBI 0 mL Duration 00 00 hr min Change using Change Mode Program Change Cancel Options Mode Therapy Back A A A A 430 95215 003 Rev 10 05 Plum A Infusion Systems 5 9 522 Program Drug 8 appears in mainly alphabetical order Abciximab Acyclovir Albumin Aldesleukin Alfentanil Alteplase rt PA Amikacin Select then Enter Page Page Enter Up Down A A A 3 Use to highlight desired drug name Leucovorin Levofloxacin When list does not contain 8 Magnesium Infusion desired generic drug name Mannitol or group name select Select then m A PAGE Down or Enter pede agn own aci A PAGE UP until it shows uas then use AW to highlight choice 4 Select ENTER to indicate selection and advance to the Therapy Selection screen
12. o Ls Minute Interval 2 8 5 0 Negative Error over 5 5 Minute Interval 0 5 PERCENT ERROR 10 Average Delivery Rate Error 1 6 15 0 5 10 15 20 25 30 Observation Interval minutes A trained professional can use the resulting graphs to select an infuser with the appropriate startup and flow characteristics to suit the clinical application NOTE As an example of how the trumpet curves can be used consider the maximum and minimum deviations at the 5 minute average interval The upper curve provides the maximum expected delivery rate error over a 5 minute interval the lower curve provides the minimum expected delivery rate error over a 5 minute interval An example would be Dopamine administered at 5 ugm kg min At 5 minutes the average drug delivery error would be within the range of 2 8 and 0 5 of the expected nominal rate 430 95215 003 Rev 10 05 9 Specifications 25 ML HR 0 mmHg DELIVERY HEAD START UP Typical Rate ml hr 8 25 NMA yy Nes Ss SS MA e Ae INN s es e AMAN 20 40 50 60 70 80 90 100 110 120 Time minutes Actual Rate Programmed Rate 25 ML HR 0 mmHg DELIVERY HEAD START UP Typical 15 gt 10 5 5 E 0 2 E 4 a 8 5 0 10 15 4 0 5 10 15 20 25 30 Observat
13. A A A PROGRAM Rate mL hr VTBI 0 mL 00 00 hr min Duration Enter Value using keypad Program Cancel Options A A A Plum A Infusion Systems 5 3 appears mainly alphabetical order qnx Albumin NOTE Default entry is Drug prend Selected This selection may be Alteplase rt PA Amikacin used later to remove an incorrect or unwanted drug name from the Page Enter coe display 3 Use to highlight desired drug name Dexmedetomidine HCI Diltiazem Dobutamine When list does not contain Doxorubicin desired generic drug name Eie p select Select then 4 Down or A PAGE pase ener own aci UP until it shows then use AW to highlight choice 4 Select ENTER to indicate selection and advance to the Program Selection screen The Program Selection screen for Line A appears 5 Select CHOOSE to Roading Dose select Dose Calculation Multistep and continue Select then Choose Choose Back A 430 95215 003 Rev 10 05 5 4 6 7 The Program Dose Calc screen appears NOTE Cursor defaults to package insert recommended dose units associated with the selected drug Select 4 CHOOSE to continue Or use AW to change the units to use in the delivery The Container Concentration
14. Vol Inf A Use A CLEAR PROGRAM when changing ONLY Line A or B 2 Select Line A or B if active from the stopped Main Delivery Screen Rate mL hr VTBI 22 mL 3 Select Duration 09 20 hr min A CLEAR PROGRAM Enter Value using keypad 5 NOTE If Line A or B is Options Program Back programmed with Dose Calculation Rate VTBI and Duration will not display values The values to be cleared may be viewed in applicable programming screen under 4 DRUG LIST 430 95215 003 Rev 10 05 4 22 4 5 430 95215 003 Rev 10 05 Select 4 YES Clear ALL settings when changing patients or multiple programming parameters Use A CLEAR PROGRAM when changing ONLY Line A or B Example screen of Cleared Program Select 4 CANCEL BACK to return to the Main Delivery screen or program new settings 4 Basic Operation Clear Line A Settings PROGRAM Rate mL hr VTBI 0 mL Duration 00 00 hr min Enter Value using keypad Program Try Options Therapy A A Plum A Infusion Systems 5 1 5 Therapies Allows programming Dose Rates in alternative units of measure Dose Dose Calculation can be used in Simple Delivery OTTIENE Loading Dose and Multistep Allows programming of an initial infusion rate for a specific volume followed automatically by a maintenance rate from 5 the same container e g fluid chal
15. hie a d Eee 9 6 10 SUPPLIES AND ACCESSORIES 10 1 10 1 ADMINISTRATION FLUIDS 10 1 administration fluids 10 1 enteral and high viscosity fluids 10 1 containers uie eie VOLES dcs dag 10 1 10 2 ACCESSORIES 10 2 11 WARRANTY 11 1 12 DRUG LIST s 25 9 red 12 1 Hospira Inc All Rights Reserved This document and the subject matter disclosed herein are proprietary information Hospira retains all the exclusive rights of dissemination reproduction manufacture and sale Any party using this document accepts it in confidence and agrees not to duplicate it in whole or in part nor disclose it to others without the written consent of Hospira 430 95215 003 Rev 10 05 Plum A Infusion Systems 1 1 1 Descriptive Information NOTE In this manual references to Plum A apply to both systems unless otherwise noted Plum A Lists 4 12391 04 and 11971 04 Plum A493 Lists 4 12618 04 and 12348 04 CAUTION THIS DEVICE IS TO BE USED WITH AN IV POLE WITH A 6 WHEEL BASE AND A SHELF 430 95215 003 Rev 10 05 1 2 1 Descriptive Information The Plum A and Plum A 3 Volumetric Infusion Systems are designed to meet the fluid delivery requirements of today s evolving healthcare environments Both are cassette based multi function in
16. selected T 7 Options A Vol Inf A PN After the programmed FA PumPING STOPPED B delay period has expired Loading Dose the Plum A starts 500 Pumping This is indicated where Delayed mb previously was displayed E 430 95215 003 Rev 10 05 5 20 5 Therapies After the Step 1 has 5 completed the Main Maintenance Dose Delivery screen changes to 75 Pe 0 the second step aie Vol Inf 250 NOTE A flashing Callback Line A message and the audio alarm sound indicates activation of that ol In option A R 17 The user should acknowledge the Callback message and stop the audio alarm by pressing Upon completion of delivery the screen shows MIU a flashing Line A VTBI 4 Rate complete message and eo the audible alarm sounds 190 m NOTE The KVO rate will change to the rate of 1 mL hr or less A depending on delivery rate and R A Pumping mode changes to KVO If Continue Rate option was selected pumping continues at original rate 18 Press to stop alarm sound NOTE Warning message continues to flash and audio alarm will return after a two minute period of silence unless delivery is stopped or VTBI of last line is changed 430 95215 003 Rev 10 05 Plum A Infusion Systems 5 21 5 4 Multistep Programming MULTISTEP Allows a sequential program to deliver
17. Precautions The Plum has been designed and manufactured to be safe reliable and easy to use This section details precautions and possible hazards For safe operation of the Plum A observe the following precautions and hazards ARTIFACTS Nonhazardous low level electrical potentials are commonly observed when fluids are administered using infusion devices These potentials are well within accepted safety standards but may create artifacts on 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 conditi
18. Selection screen appears whenever the selected Dose Units are gram based e g grams mg mcg or ng otherwise this screen is skipped NOTE Cursor defaults to package insert recommended concentration units associated with the selected drug 5 Therapies Program Dose Calc Dopamine mL hr grams hr ng kg min mcg kg hr units kg hr mcg min units min mcg hr units hr mg kg hr mUn min mg min mEq hr mg hr Select then Choose Choose Back A Program Dose Calc Dopamine Drug Conc in Container mcg grams Select then Choose Choose Back A Select 4 CHOOSE to continue Or use AV to change the Container Concentration units to use in the delivery 430 95215 003 Rev 10 05 Plum A Infusion Systems 5 5 The next page of the Program Dose Calc screen v 400 mg 250 mL appears to provide for Weight ZI entry of delivery program Dose mog kgin parameters Duration 00 00 hr min 8 Use keypad to enter 777 E un ca desired values Once Options Back each value is entered use W to highlight the next programming field NOTE The Concentration elements and weight value must be entered before the SELECT keys allow access to remaining fields 9 Continue to enter values using the keypad and Dopamine advancing to the next ca oe field using W pose xeon Duration 00 00 hr min Rate 26 3 mL hr NOTE As the Dose value is entered the Rate is auto
19. being programmed and started NOTE The Line A Fluid Flow Indicator also will flash to indicate pumping 430 95215 003 Rev 10 05 4 Basic Operation EA roues erorres 8 Rate 515 TUI 0 Vol Inf 0 1 ai 0 T 7 Options A Vol Inf A Plum A Infusion Systems 4 9 1 2 3 4 4 Titration Select Line A PUMPING PUMPING or 4 B at the Main E z Delivery Screen R g Vol Inf SA 20 Vol Inf Enter the desired Rate PROGRAM using the keypad Rate mL hr NOTE When Rate is changed the 2222 VTBI 50 mL duration is automatically recomputed using the current Duration 03 20 hr min VTBI To understand the Automatic SER SRR Calculation feature see Section prm x Cancel 6 8 Examples of Automatic Options A Calculation A CAUTION VERIFY ALL VALUES BEFORE STARTING INFUSION FA Foe eue press to initiate new Rate and return to the io 50 Main Delivery Screen 416 Volinf 20 mL NOTE Volume Infused is an incrementing value which is cleared OPTIONS VOL INF m A A 430 95215 003 Rev 10 05 4 10 4 Basic Operation The following 3 screens are examples of changed values Example of changed rate 4 From the Main Delivery Rate mL hr Screen select A NE 50 mL Duration 09 20 hr min 5 Usekeypad to change the us RATE value Enter Value using keypad Cour NOTE The display time is only A
20. connect dataport while infusing The Equipotential Post located on the back of Plum A 3 is a terminal for connection of an equipotential conductor 430 95215 003 Rev 10 05 3 8 3 Equipment Description 3 4 Administration Sets The Plum is compatible with a wide range of LifeCare Plum series administration sets Become familiar with the set components before preparing the administration set Secondary Inlet Port Capped Finger Grip Patient Line Air Trap PREPARING THE ADMINISTRATION SET NOTE For detailed instructions see administration set packaging WARNING ARRANGE TUBING CORDS AND CABLES TO MINIMIZE THE RISK OF PATIENT STRANGULATION OR ENTANGLEMENT Use the aseptic technique to prepare the administration set for priming then proceed as follows Make sure flow regulator is closed 430 95215 003 Rev 10 05 Plum A Infusion Systems 3 9 Insert piercing pin into container outlet with a twisting motion Fill Drip chamber to about 1 2 full or to the score mark Do not completely fill NOTE To avoid getting Distal Air Alarms confirm the fluid bag is positioned higher than the infuser This should be set up prior to priming the cassette PRIMING THE ADMINISTRATION SET Invert the cassette Turn the flow regulator counter clockwise od until a drop of fluid is seen in the pumping i chamber Turn the cassette upright then prime the remainder of the ad
21. control components would result in no more than 5 mL of unexpected fluid delivery A small amount of fluid is expelled from the set less than 0 05 ml each time the door is opened or closed with a set installed If potent drugs are being used take appropriate action to guard against overmedication of the patient Before disconnecting a syringe from the cassette pull up the plunger slightly to avoid spilling the fluid For rigid containers close the upper slide clamp open the cassette door then remove and invert the cassette ports down 430 95215 003 Rev 10 05 1 8 1 Descriptive Information 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 infuser is mounted significantly above the patient or when using certain fluids known to routinely outgas these cases an air eliminating filter may be used Repeated opening and closing of the door may defeat the proximal air in line alarm and may cause a distal air in line alarm requiring repriming In vitro studies have suggested that packed red blood cells with unusually high hematocrit be diluted with blood compatible fluids such as 0 9 sodium chloride injection to decrease hemolysis and increase flow rate 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
22. expected charge voltage is not changing and can reduce battery life Silence key is pressed Warning Low Battery Infuser not plugged in to AC power Plug into AC power only about 30 minutes of battery life remains NOTE Other error and warning messages will occur when appropriate for the current selection context For instance when a change to a required parameter would result in clearing some delivery values 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 430 95215 003 Rev 10 05 7 2 7 Alarms and Troubleshooting o BON warning message will be shown to explain the problem All such messages will be cleared or replaced by another message upon the next valid input key press 7 2 Response to Alarms Disable Lockout by confirming back switch is in the down position or press the decimal key followed by 9 6 amp 3 on the keypad Press SILENCE key Identify Observe Alarm condition Correct Alarm condition see following tables Press START to resume infusion 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 430 95215 003 Rev 10 05 Plum Infusion Systems GENERAL ALARMS CoDE MESSAGE POSSIBLE CAUSE
23. retained in memory For Plum A 3 users be aware that changing the weight on one device does NOT change the weight on the other two devices Patient weight must be changed on each device when delivering weight based therapy dependent on medication requirements CONCURRENT FLOW GUIDELINES When delivering short half life critical drugs see Critical Drugs this section using the Plum A in the Concurrent mode the following delivery rate guidelines should be observed If the critical drug with half life less than 6 minutes is to be infused at less than 2 mL hr the other infusion should be no faster than 5 times the critical drug s rate Dopamine for example delivered at 1 5 mL hr should not be accompanied by an infusion programmed any faster than 7 5 mL hr If the critical drug with half life less than 6 minutes is to be infused at 2 to 5 mL hr the other infusion 430 95215 003 Rev 10 05 Plum A Infusion Systems 1 9 should be no faster than ten times the critical drug s rate Dopamine for example delivered at 3 5 ml hr should not be accompanied by an infusion programmed any faster than 35 mL hr Ifthe 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 430 95215 003 Rev 10 05 1 10 1 Descriptive Information These guid
24. see the following graphics e Q SET GRAVITY RATE BY TURNING FLOW REGULATOR OPEN DOOR amp REMOVE CASSETTE NOTE CASSETTE SHOULD BE NOTE FLOW REGULATOR CLOSES IN UPRIGHT POSITION AUTOMATICALLY WHEN DOOR IS OPENED TO PREVENT ACCIDENTAL FREE FLOW NOTE IF DOOR OPEN ALARM OCCURS TURN PUMP OFF 430 95215 003 Rev 10 05 Plum A Infusion Systems 3 13 3 6 Discontinuing Fluid Administration PRESS STOP oPEN DOO DISCARD SET AND FLUID CONTAINER PER HOSPITAL R REMOVE CASSETTE PROCEDURE 430 95215 003 Rev 10 05 3 14 3 Equipment Description NOTES 430 95215 003 Rev 10 05 Plum A Infusion Systems 4 1 4 Basic Operation 4 1 Getting Started UNPACKING CAUTION PRODUCT DAMAGE MAY OCCUR UNLESS PROPER CARE IS EXERCISED DURING UNPACKING AND INSTALLATION DO NOT USE THE PLUM IF IT APPEARS DAMAGED IN ANY WAY THE BATTERY MAY NOT BE CHARGED 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 infuser Retain the packing slip and save all packing material in case the infuser is damaged or fails the infuser self test and has to be returned to Hospira Inspect thoroughly for damage CAUTION IF THE PLUM A APPEARS TO BE DAMAGED CONTACT HOSPIRA To set up connect the AC mains cord to a properly grounded receptacle unl
25. six hours Recharge takes longer if the infuser is turned ON As a general rule the more often the battery is partially discharged and recharged the sooner it will need to be replaced Consult a qualified biomedical technician for battery replacement if necessary To maintain maximum battery charge and to prolong battery life connect the infuser to AC mains power whenever possible STORAGE To prolong the life of the Plum A observe the following storage precautions e Store the away from excessive heat cold and humidity e Store connected to AC mains power e Switch the infuser OFF using the ON OFF key SERVICE All servicing or adjustments to the Plum should be referred to qualified technical personnel A technical service manual may be ordered from the local Hospira sales office 430 95215 003 Rev 10 05 Plum Infusion Systems 9 1 9 Specifications NOTE Specification information applies to both systems Plum A amp Plum A 3 unless otherwise noted PHYSICAL Dimensions Plum A Approximately 8 X 8 6 excluding pole clamp protrusion and power cord storage Plum A 3 Approximately 19 X 15 X 14 including pole clamp barcode wand holder and power cord Weight Plum A Approximately 9 5 lbs with battery Plum A 3 Approximately 28 ibs with 3 batteries Casing High impact plastic ELECTRICAL Power Requirements Plum A 120 V 50 60 Hz 35 VA Plum A 3 12
26. troubleshooting an occlusion where all clamps are in the OPEN position use care to avoid delivery of a bolus by opening the flow regulator to release any built up pressure Close the clamp between the cassette and the patient before opening the flow regulator to relieve the pressure See Section 7 Alarms and Troubleshooting for more information 430 95215 003 Rev 10 05 Plum A Infusion Systems 2 1 2 Principles of Operation 2 1 Features The Plum is a dual line volumetric infusion system designed to meet the growing demand for hospital wide as well as alternate site and home healthcare standardization With it s primary line secondary line and piggyback fluid delivery capability the Plum is suited for a wide range of medical surgical and critical care applications Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield and CLAVE needleless protection systems makes the Plum A a convenient and cost effective infusion system PROGRAMS Dose Calculation e Loading Dose e Multistep Programming LINE PROGRAMMING OPTIONS e Drug List e Nurse Call Back e Delayed Start Setting e Concurrent delivery e Titration e Micro 0 1 99 9 mL hr 0 1 mL increments flow rate range for both lines e Macro 100 999 mL hr in 1 mL increments flow rate range for both lines e Automated Secondary drug delivery Piggyback Standby Setting 430 95215 003 Rev 10 05
27. without having been trained by an authorized representative of Hospira and using Hospira documentation and approved spare parts For purposes of the preceding sentence major repair or other Service means any repair or service other than the replacement of accessory items such as batteries and detachable mains power cords 430 95215 003 Rev 10 05 11 2 11 Warranty In providing any parts for repair or service of the product Hospira shall have no responsibility or liability for the actions or inactions of the person performing such repair or service regardless of whether such person has been trained to perform such repair or service It is understood and acknowledged that any person other than a Hospira representative performing repair or service is not an authorized agent of Hospira 430 95215 003 Rev 10 05 Plum Infusion Systems 12 1 12 Drug List Use drug manufacturer recommendations for IV administration when using the Plum A infuser DEFAULT DOSE DEFAULT DRUG NAME RATE CONCENTRATION No Drug Selected mL hr N A Abciximab mcg kg min mg mL Acyclovir mL hr N A Albumin mL hr N A Aldesleukin mL hr N A Alfentanil mceg kg min mcg mL Alteplase rt PA mg kg hr mg mL Amikacin mL hr N A Aminocaproic Acid grams hr grams mL Aminophylline mg hr mg mL Amiodarone mg min mg mL Amphotericin B mL hr N A Ampicillin sublactam mL hr N A Analgesic mL hr N A Anti
28. 0 V 50 60 Hz 120 VA Fuses F1 22 250V 0 5 A internal Power Cord Hospital grade AC cord 10 ft long with transparent plug and retainer plate Battery Plum A One sealed lead acid rechargeable 6 V battery internal to device Plum A 3 Three sealed lead acid rechargeable 6 V batteries internal to device Battery Life With a new fully charged battery the infuser shall operate for a minimum of six hours at 125 mL hr or less or deliver 500 mL at 126 mL hr or greater on one line 430 95215 003 Rev 10 05 Recharge Electrical Leakage NURSE CALL System Circuitry Ratings VTBI RANGE 9 Specifications The battery charges whenever the infuser s is connected to AC power The recharge time is approximately six hours with the device operating at 125 mL hr on one line Meets ANSI AAMI ES1 1993 standard Safe Current Limits for Electro medical Apparatus NURSE CALL alarm is factory set for Normally Open NO Contact the Technical Services Center to make an internal adjustment to change the device from Normally Open NO to Normally Closed NC system Voltage 30 VDC Max Current 0 25 Amps Max Contact Rating 3 Watts Max VTBI Range 0 110 99 9 mL in 0 1 mL increments ENVIRONMENT 100 to 9999 mL in 1 mL increments Operating 5 to 40 C Temperature Storage Temperature 20 to 60 Atmospheric 0 10 000 feet 0 3 000m or equivalent Pressure pressure Relative Hum
29. 10 05 Plum A Infusion Systems 12 5 DEFAULT DosE DEFAULT DRUG NAME RATE CONCENTRATION Quinolone mL hr N A Ranitidine mL hr N A Streptokinase units hr units mL Teniposide mL hr N A Theophylline mg kg hr mg mL Ticar calvulanate mL hr N A Tirofiban meg kg min mg mL Tobramycin mL hr N A TPN mL hr N A Urokinase mL hr N A Vancomycin mL hr N A Vecuronium mL hr N A Verapamil mL hr N A Vincristine mL hr N A 430 95215 003 Rev 10 05 12 6 12 Drug List NOTES 430 95215 003 Rev 10 05 Plum Infusion Systems For customer service within the United States contact 1 877 9 HOSPIRA 1 877 946 7747 For technical assistance product return authorization and to order parts accessories or manuals within the United States contact Hospira Inc Technical Support Operations 1 800 241 4002 To order parts using the online eCatalog download technical publications technical training courses and additional services visit the website at www hospiraparts com After authorization ship prepaid product returns to the following address Hospira Inc Technical Support Operations 755 Jarvis Drive Morgan Hill CA 95037 Outside the U S contact your local Hospira Inc sales office 430 95215 003 Rev 10 05 CAUTION FEDERAL USA LAW RESTRICTS THIS INFUSER TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR OTHER LICENSED PRACTITIONER WARNING POSSIBLE EX
30. 12 Select 4 CHOOSE to continue NOTE Prior to changing Pressure Post Infusion Rate infuser must be stopped 13 Use AW to highlight lA options Continue Rate or Distal Pressure Limit field Pressure Post Infusion Rate Continue Rate 5 Distal Pressure Limit 6 psi 14 Continue Rate allows a Distal Pressure 0 psi choice when VTBI is Change using KVO Rate completed Select KVO Enter Cancel Rate Back A KVO RATE PIE We e KVO The infuser will revert to a fixed KVO of 1 mL hr or the last programmed Rate whichever is less e Rate The infuser will continue at the Rate pro grammed NOTE Option will be for both line A and line B selections 430 95215 003 Rev 10 05 6 12 6 Additional Features 15 To change Distal Pressure Limit when highlighted enter value between 1 and 15 psi 16 Select 4 ENTER to keep changes and return 17 18 19 20 21 to the Main Delivery screen or 4 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 Select 4 OPTIONS VOL INF orons 8 from the Main Delivery screen to return to the Options screen Release 11 x xx xx xx Volumes Infused Pressure Post Infusion Rate Use to highlight Select then Choose Lighting Contrast Option uem A A Select 4 CHOOSE to con
31. 2 22 xar pe EMI Ee kae i 2 1 programs 4 cuca tee Sot EE rua 2 1 line programming options 2 1 plumset capabilities 2 2 air 2 2 esce ae ae EP BR eds 2 2 biomedical 2 2 OPONSE spi leere Pewee RE USE eds 2 2 other features 2 3 2 2 DEFINITIONS Bho Renae bees cae Ede ean 2 3 430 95215 003 Rev 10 05 ii 3 4 5 Contents EQUIPMENT DESCRIPTION 3 1 3 1 OPERATING KEYS 3 2 3 2 INDICATORS rore tees stet t tk E tace 3 5 3 3 REAR CASE CONTROLS 3 6 3 4 ADMINISTRATION SETS 3 8 preparing the administration set 3 8 priming the administration set 3 9 loading the cassette 3 10 preparing the secondary line 3 10 3 5 DISCONTINUING ELECTRONIC FLOW CONTROL amp SETTING GRAVITY 3 12 3 6 DISCONTINUING FLUID ADMINISTRATION 3 13 BASIC OPERATION 4 1 4 1 GETTING STARTED 4 1 npackirig ere te IURE 4 1 tandem carrier instructions 4 2 system 4 2 data retention
32. 50 00 hr min Change using Change Mode Program Change I Options Mode A A PN A Program Options B Delay Start 00 fff min Callback No Enter Value using keypad ed Standby Enter coe A A A Plum A Infusion Systems 6 5 2 Enter values for desired cpio hours and or minutes 3 Select A ENTER to Delay Start for 0 fff min confirm delayed start Ne CAUTION VERIFY ALL VALUES VERSER BEFORE STARTING INFUSION Drug Cancel List Standby Enter Back 4 Press to begin program Line B is delayed for the DELAYED B Rate jose ee b NOTE Delayed line drip indicator SCIRE is solid not flashing It will begin 850 TL 00 flashing when actually pumping Options A Vol inf A A 6 3 Piggyback with Nurse Callback 1 After programming in PROGRAM desired values for both lines select PRoGRAM Mode Piggyback OPTIONS Rate 200 VTBI mL NOTE To set a nurse callback the Duration 00 30 min infuser must be stopped This Enter value using keypad function can be selected either program Therapy Cancel before or after entering the ee A A Piggyback delivery program 430 95215 003 Rev 10 05 6 6 6 Additional Features 2 3 The default screen for mr Program Options appears Delay Start for 00 00 hr min Use to highlight Callback field and
33. 95215 003 Rev 10 05 9 12 9 Specifications NOTES 430 95215 003 Rev 10 05 Plum Infusion Systems 10 1 10 Supplies and Accessories 10 1 Administration Fluids ADMINISTRATION FLUIDS All parenteral fluids e Whole Blood Blood fractions ENTERAL AND HIGH VISCOSITY FLUIDS e Dextrose 20 to 50 concentration e somil Powder Similac Powder e Ensure plus HN e TwoCal HN e Packed red cells CONTAINERS e Dual Chamber Parenteral flexible container Nutrimix Large Volume Parenteral flexible plastic containers including premixed e Large Volume Parenteral glass containers including premixed and nutritional Part Fill Parenteral flexible plastic containers including ADD Vantage Part Fill Parenteral glass containers e Small Volume Parenterals e Syringes may require special adapters Filled Enteral bags e Ready to hang Enteral solution containers 430 95215 003 Rev 10 05 10 2 10 Supplies and Accessories 10 2 Accessories e Syringe Adaptor List 11986 48 e Mini Pole List 12096 04 e Secondary Container Support List 12095 03 e Tandem Carrier List 12270 01 Plum A 3 IV Pole upright 12577 04 01 e Plum A 3 IV Pole base 12576 04 01 430 95215 003 Rev 10 05 Plum Infusion Systems 11 1 11 Warranty Subject to the terms and conditions herein Hospira Inc herein referred to as Hospira warrants that a the product shall conform t
34. CORRECTIVE ACTION N100 Unrecognized Attempting to use Turn off or insert cassette unrecognized cassette recognized cassette N101 No Action Infuser programming Press START or Alarm incomplete continue programming N102 Infuser Idle 2 Pump is ON without Begin programming Minutes operator input or turn infuser OFF Standby time has Re enter all elapsed programmed data N103 Memory The infuser did not Re enter all Failure accept the previous programmed data programmed data N230 Prox Air When the total Check for clamps or Backprime proximal air detected empty containers on exceeds the limit line A or B Correct as necessary Backprime into line B tubing or syringe 180 Distal Distal line kinked IV Check distal tubing N181 Occlusion site clotted or check IV site reset N186 positional pressure pressure limit limit set too low See page 1 17 for detailed instructions for avoiding a bolus following a distal occlusion N187 Neg Distal Pump too high above Lower infuser or Occlusion patient or defective replace set set N233 Distal Air When air is detected at Remove and reprime N234 the distal sensor and cassette using exceeds the limit standard technique 430 95215 003 Rev 10 05 CopE MESSAGE N250 Door open 7 Alarms and Troubleshooting POSSIBLE CAUSE Pump door opened CORRECTIVE Close door with whi
35. MATERIALS USING ABRASIVE CLEANERS OR CLEANING SOLUTIONS NOT RECOMMENDED BY HOSPIRA MAY RESULT IN PRODUCT DAMAGE DO NOT USE COMPOUNDS CONTAINING COMBINATIONS OF ISOPROPYL ALCOHOL AND DIMETHYL BENZYL AMMONIUM CHLORIDE CAUTION NEVER USE SHARP OBJECTS SUCH AS FINGERNAILS PAPER CLIPS OR NEEDLES TO CLEAN ANY PART OF THE INFUSER CAUTION Do NOT STERILIZE BY HEAT STEAM ETHYLENE OXIDE ETO OR RADIATION CAUTION TO AVOID INFUSER DAMAGE CLEANING SOLUTIONS SHOULD ONLY BE USED AS DIRECTED THE DISINFECTING PROPERTIES OF CLEANING SOLUTIONS VARY CONSULT THE MANUFACTURER FOR SPECIFIC INFORMATION BATTERY MAINTENANCE CAUTION Do NOT OPERATE THE INFUSER ON PATIENTS WITH THE BATTERY REMOVED USE OF A PROPERLY MAINTAINED AND CHARGED BATTERY HELPS CONFIRM PROPER OPERATION CAUTION THE LOW BATTERY ALARM SOUNDS CONNECT TO AC MAINS 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 430 95215 003 Rev 10 05 8 4 8 Maintenance and Storage NOTE For optimum battery life the Plum should be operated on battery power for six continuous hours at least once every six months and then charged for a minimum of eight hours The battery charges whenever connected to AC mains power If the infuser is switched OFF recharge takes approximately
36. PLOSION HAZARD EXISTS IF THE INFUSER IS USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS Plum A Infusion Pump is a registered trademark of Hospira Inc Hospira MedNet LifeShield and E L I are trademarks of Hospira Incorporated CLAVE Teflon Formula C Manu Klenz Super Edisonite Coverage Sporicidin Dispatch and Precise are not trademarks of Hospira Equipment providing adequate degree of protection against electrical shock and suitable for application to patient Type CF Drip Proof X Medical Equipment Protected against dripping water Clas S 1 Mains supply equipment using protective earth indicator includes products eligible to bear the NRTL indicator NRTL i e National Recognized Testing Laboratory is a designation granted by the U S Occupational Safety and Health Administration OSHA to laboratories which have been recognized to perform certification to U S Standards The C and US indicators adjacent to the CSA Mark signify that the product has been evaluated to SP ped the applicable CSA and ANSI UL Standards for use in Canada and the U S respectively This US MCN 160992 05 430 95215 003 Rev 10 05
37. RMATION ON A A CONCURRENT FLOW SEE SECTION 9 FOR DELIVERY RATE RANGES NOTE In concurrent mode with certain alarm conditions one line may stop while the other line may continue to deliver With pumping started on line A to program a Concurrent delivery rate select 4 B The Delivery Mode field is PROocRMAM highlighted Mode NOTE If an entry was previously Rate 0 mL hr programmed RATE is highlighted VTBI 0 mL If no previous entries MODE is Duration 00 00 hr min highlighted Change using Change Mode Program Change Therapy H Options Mode Back If field reads Piggyback ERR select 4 CHANGE MODE to switch to Concurrent 430 95215 003 Rev 10 05 Plum A Infusion Systems 4 15 Verify change to PROGRAM Concurrent mode Mode Rate 0 mL hr 2 Use W to highlight Rate _ field Duration 00 00 hr min Change using Change Mode Program Change Cancel Options Mode A A A 3 enter delivery rate use PROGRAM 8 numeric keypad Mode Concurrent NOTE When Rate for Line A plus Rate mL hr Rate for Line B is greater than valid VTBI 0 mL rate ranges a Concurrency Duration 00 00 hr min violation message will explain Why second line did not start See Progam Therapy Cancel Section 9 3 for valid delivery rate Options ranges a NOTE Concurrency violation may not be dis
38. System Operating Manual For Infusion Systems with v11 6 Software For use with Lists 12391 04 12618 04 12348 04 amp 11971 04 Options Vol Inf A Hospira 430 95215 003 Rev 10 05 Change History Change History Description of Pages Title Change Affected 430 95215 001 First Release All Rev 04 05 430 95215 002 Second Release All Rev 07 05 Added IEC EN 60601 1 Section 1 Information 430 95215 003 Third Release All Rev 10 05 430 95215 003 Rev 10 05 Plum A Infusion Systems i Contents 1 DESCRIPTIVE INFORMATION 1 1 1 1 PRODUCT DESCRIPTION 1 2 1 2 INDICATIONS FOR USE 1 3 user qualification 1 3 T S CONVENTIONS EHE 1 4 warnings cautions and notes 1 5 T 4 PRECAUTIONS d en e tab bd rte rry e alat 1 6 artifacts ee roger ex We 1 6 guidance on compatibility 1 7 healthcare professionals and patient related 1 7 concurrent 1 10 epidural administration 1 11 battery operation 1 12 sets and accessories 1 12 backpriming 1 13 general ec eee Ce evi eR rmm 1 13 cleaning 1 13 2 PRINCIPLES OF OPERATION 2 1 221 FEATURES
39. Up Dawn Enter A A A A 4 Select ENTER to indicate selection and advance to the Therapy selection screen 430 95215 003 Rev 10 05 Plum Infusion Systems 5 6 7 8 The Select Therapy screen for Line A or B appears NOTE This example shows line A being programmed Use W to scroll down to Multistep Select 4 CHOOSE to continue The Program Multistep screen appears NOTE Cursor defaults to package insert recommended dose units associated with the selected drug Use AW key to highlight the units to use in the delivery Select 4 CHOOSE to continue 5 23 PROGRAM Dose Calculation Loading Dose Multistep Select then Choose Choose Back A Dose Calculation Loading Dose Multistep Select then Choose Choose Back A A Program Multistep TPN grams hr mcg kg min ng kg min mcg kg hr units kg hr mocg min units min mog hr units hr mg kg hr mUn min mg min mEg hr mg hr Select then Choose Choose Back A A 430 95215 003 Rev 10 05 5 24 5 Therapies The Multistep Programming screen appears Duration 9 Rate is the default field Enter value using keypad Enter value using keypad Program More Cancel Options Steps Back A A A 10 Use W to highlight the Duration or VTBI field Duration NOTE The VTBI value is automatically computed when the Duration value is entered If VTBI is entered the Duration value is Ent
40. Volume or Volume and Time If Dose Calc is used the delivery steps are in the same unit of measure over the same period of time from the same container Note A Note explains something new gives tips on performing an activity or provides a reminder of necessary preparations Parenteral Delivery via other than an intestinal route such as intravenous IV injection Patient Weight The Alternate Units Parameter whose value entry is required with Dose rates quantity time having the third parameter of weight such as mcg kg min Piggyback Infusion will stop Line A and infuse Delivery Line B until VTBI completes Piggyback The Line B control selection mode that Mode requires Line A delivery suspension while Line B delivers and then its resumption when Line B VTBI completes If Line A is not programmed and started Line B delivery just stops when its VTBI completes Line A operation is delayed for duration of its interruption by Line B Plunger Park The position of the pumping plunger Position that allows the cassette to be withdrawn from the Infuser without restriction with an opened Door 430 95215 003 Rev 10 05 2 10 2 Principles of Operation TERM DEFINITION POST Power On Self Tests Startup initialization and test of critical hardware modules and software functions to determine Infuser readiness for its Intended Use Power On When the power is firs
41. ain Delivery Screen CAUTION VERIFY ALL VALUES BEFORE STARTING INFUSION 4 5 Piggyback Delivery PIGGYBACK DELIVERY STOPPED B Infusion will stop Line A and infuse Line B until 52 568 VTBI completes Line A will NETS 20 0 automatically restart me 1 With Line A pumping to program a Piggyback delivery select 4 rom Options A Vol Inf A A 430 95215 003 Rev 10 05 4 12 The Delivery Mode field is highlighted NOTE If an entry was previously programmed RATE is highlighted If no previous entries MODE is highlighted 2 If field reads Concurrent select A CHANGE to switch to Piggyback 3 Select W to highlight the RATE field 4 Toenter delivery rate use numeric keypad 5 Use W key to move down to the VTBI field 6 Toenter VTBI amount use keypad NOTE While the VTBI is being entered the duration is automatically computed If the computed value is greater than 99 59 dashes appear in place of hours To understand the Automatic Calculation feature see Section 6 8 Examples of Automatic Calculation 430 95215 003 Rev 10 05 4 Basic Operation PROGRAM __ Rate 0 mL hr VTBI 0 mL Duration 00 00 hr min Change using Change Mode Program Change Cancel Options Mode A A A A PROGRAM Mode Piggyback Rate mL hr VTBI 0 mL Duration 00 00 hr min Enter value using key
42. am a delivery rate select A A 2 Toenter delivery rate use numeric keypad Rate mL hr 3 Use W key to move VTBI 0 mL down to the VTBI field Duration 00 00 hr min Enter Value using keypad Program Cancel Options A 430 95215 003 Rev 10 05 Plum A Infusion Systems 4 7 4 5 6 7 8 To enter VTBI amount use keypad Rate 5 5 mL hr NOTE While the VTBI is being entered the duration is NEU automatically computed If the Duration 00 00 hr min value is greater than Enter Value using keypad 99 59 dashes appear in place ET of hours Options Therapy 25208 Use W key to move down to the DURATION field Use keypad to change the hours part of duration if desired Rate 5 5 mL hr VTBI 0 5 mL Duration 8 05 min NOTE When all parameters are displayed changing any one parameter will result in other Enter Value using parameters automatically being Pregam Therapy Cancel computed To understand the Automatic Calculation feature see AJLA Section 6 8 Examples of Automatic Calculation Use W to move from hours to minutes NOTE The maximum hours allowed is 99 and the maximum minutes is 59 Use keypad to change minutes CAUTION VERIFY ALL VALUES BEFORE STARTING INFUSION 430 95215 003 Rev 10 05 4 8 9 Press to begin infusion Example of Main Delivery Screen just after
43. arameters ene 00 52 M min Rate 0 Use keypad to enter ore ina MUN 1 desired values Once Options Back A A entered use W to highlight the next field To override the Piggyback Delivery Mode default scroll down to Mode using W then select 4 CHANGE MODE NOTE Delivery Mode option is available on Line B and its default is Piggyback The weight field is independent of Line A unless Line A selected drug is weight based In that scenario the Line A weight information applies to Line B 10 Continue entering Tecganbececas El desired values using the Conc 2 grams keypad Use v to Mode Se advance to the next field Dose 2 mg min VTBI 500 mL Duration 16 40 hr min NOTE When entering the RATE as BEES Uv with a VTBI value entered the DOSE and DURATION fields sm automatically updated understand the Automatic Calculation feature see Section 6 8 Examples of Automatic Calculation NOTE The Duration field temporarily changes to dashes when the computed value is larger than what can be displayed 430 95215 003 Rev 10 05 5 12 5 Therapies 11 Continue entering the RATE value if desired NOTE As Rate is entered the Duration and Dose are automatically adjusted as individual numbers are entered NOTE If the Duration value is changed the Rate and Dose are automatically adjusted NOTE At this point programming is complete unless A Program Opt
44. ber with inlet and outlet valves It also contains access ports to diaphragms for proximal and distal line pressure sensing and chambers for air trapping and air quantity measurement Caution Contains information which could prevent hardware failure irreversible damage to equipment or loss of data Channel Distal Line output to the patient 430 95215 003 Rev 10 05 Plum A Infusion Systems 2 5 TERM DEFINITION Cleared Same as Cleared Settings but Program restricted to the program delivery settings for an individual line Cleared Programmed delivery settings for both Settings lines and the general control parameters are at their default values Concentration For Dose Calculation based Line A or B delivery programming of premixed drugs the concentration consists of Drug Amount in micrograms mcg milligrams mg grams milliequivalents mEq millimols mmols or units USP Units and Diluent Volume in milliliters mL Abbreviated on screen displays as Conc Concurrent Simultaneous delivery of two fluids at Delivery independent flow rates Concurrent The Line B control selection mode that Mode allows either Line A or Line B or both of the Mechanism to be programmed for delivery that completes with KVO or CR Line A operation is unaffected by Line B delivery Continue Rate An option used to provide fluid CR delivery at the current fluid deli
45. biotic mL hr N A Atracurium mL hr N A Azithromycin mL hr N A Bleomycin mL hr N A Blood Products mL hr N A Bretylium mg min mg mL Carboplatin mL hr N A Cefazolin mL hr N A Cefapime mL hr N A 430 95215 003 Rev 10 05 12 2 12 Drug List DEFAULT DosE DEFAULT DRUG NAME RATE CONCENTRATION Cefoperazone mL hr N A Cefotaxime mL hr N A Cefotetan mL hr N A Cefoxitin mL hr N A Ceftazidime mL hr N A Ceftizoxime mL hr N A Ceftriaxone mL hr N A Cefuroxime mL hr N A Chemotherapy mL hr N A Cimetidine mL hr N A Ciprofloxacin mL hr N A Cisplatin mL hr N A Clindamycin mL hr N A Co trimoxazole mL hr N A Cyclophosphamide mL hr N A Cyclosporine mL hr N A Cytarabine mL hr N A Dexmedetomidine mcg kg hr mcg mL Diltiazem mg hr mg mL Dobutamine mcg kg min mg mL Docetaxel mL hr N A Dopamine mcg kg min mg mL Doxorubicin mL hr N A Epinephrine mcg min mg mL Epoprostenol ng kg min mg mL Eptifibatide mcg kg min mg mL Erythromycin mL hr N A Esmolol mcg kg min mg mL 430 95215 003 Rev 10 05 Plum A Infusion Systems 12 3 DEFAULT DosE DEFAULT DRUG NAME RATE CONCENTRATION Etomidate mL hr N A Etoposide mL hr N A Famotidine mL hr N A Fentanyl mL hr N A Fluconazole mL hr N A Flumazenil mL hr N A Fluorouracil mL hr N A Furosemide
46. confirm readiness for use Failure during the Self Tests is reported as a Malfunction Condition CAUTION DO NOT PLACE THE PLUM A IN SERVICE IF IT FAILS THE SYSTEM SELF TESTS 430 95215 003 Rev 10 05 Plum A Infusion Systems 4 3 Connect the AC power mains cord to an AC power receptacle then confirm that the Charging Line indicator illuminates above the ON OFF key on the front panel A systematic self testing of the processing delivery and safety systems is performed whenever the Plum 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 Loading Cassette in Section 3 for details of correct procedure When the Charging Line indicator is off and the battery symbol on the display is flashing this indicates that the Plum A is operating on low battery power and should be recharged CAUTION DO NOT OPERATE THE PLUM A ON PATIENTS WITH THE BATTERY REMOVED USE OF A PROPERLY MAINTAINED AND CHARGED BATTERY HELPS CONFIRM PROPER OPERATION To confirm battery is fully charged connect the Plum to AC mains power for a minimum of six hours while in the OFF mode If an alarm occurs during th
47. ct A A or B at STOPPED STOPPED B the Main Delivery screen 0 Rate 0 mL hr Vol Inf 0 Em 0 T Options Prime Vol Inf 5 A A 430 95215 003 Rev 10 05 Plum A Infusion Systems 5 15 The selected Line A or B Programming screen appears Rate ENS VTBI 0 mL 2 Select 4 THERAPY Duration 00 00 hr min Enter Value using keypad Program cen Options Therapy Back A A appears TH mainly alphabetical order Abciximab Acyclovir Albumin Aldesleukin NOTE Default entry is Drug Alfentanil Selected This process will guide AGREES GERA Amikacin you through a fluid challenge No Drug Selected will be entered Up Down Back 3 Select 4 ENTER to indicate selection and advance to the Therapy selection screen The Select Therapy screen for Line A or B appears NOTE This example shows line A Loading D being programmed Multistep Select then Choose Choose Back A A 430 95215 003 Rev 10 05 5 16 4 Use W to scroll down to Loading Dose 5 Select CHOOSE to continue The next page of the 6 7 Program Loading Dose screen appears Select CHOOSE to continue Or use W to change the units to use in the delivery The Loading Dose Programming screen appears The default field is Rate Since a fluid Challenge is being perfor
48. e information on cleaning the infuser see Section 8 To avoid mechanical or electronic damage do not immerse the Plum A in any fluids or cleaning solutions Do not spray cleaning solutions toward any opening in the instrument Certain cleaning and sanitizing solutions may slowly degrade components made from some plastic materials 430 95215 003 Rev 10 05 1 Descriptive Information Using abrasive cleaners or cleaning solutions not recommended by Hospira may result in product damage Do not use compounds containing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride Never use sharp objects such as fingernails paper clips or needles to clean any part of the infuser Do not sterilize by heat steam ethylene oxide ETO or radiation To avoid infuser damage cleaning solutions should only be used as directed The disinfecting properties of cleaning solutions vary consult the manufacturer for specific information Use the following procedure to avoid the administration of a bolus following a distal occlusion i e a closed distal clamp If a secondary container is in use clamp proximal tubing before opening cassette door Open cassette door and remove the cassette Open the flow regulator briefly to dissipate the pressure and then close it Eliminate the source of occlusion closed clamp Reinsert the cassette and close the cassette door Open all clamps and resume infusion NOTE When
49. e power on self test identify the alarm message then take corrective action see Section 7 Alarms and Troubleshooting Turn infuser OFF then back ON If the self test alarm recurs remove the infuser from service and contact the local Hospira representative The infuser performs a suite of System Self Tests when power is applied to confirm readiness for use 430 95215 003 Rev 10 05 4 4 4 Basic Operation Failure during the Self Tests is reported as a Malfunction Condition DATA RETENTION Delivery program settings and programming option selections are retained in non volatile memory If the Plum A has been turned off for longer than four hours all delivery settings are cleared and programming option selections are restored to their default selections for next use 4 2 Power On 1 Press to turn on the Plum and you will see the System Self Tests Coprig ose screen System Self Test In Progress CAUTION THE INFUSER MUST INITIALLY STARTED ON AC POWER OTHERWISE THE DATAPORT MAY NOT OPERATE PROPERLY After self testing SCREENS SHOWN IN THIS MANUAL successfully completes ARE EXAMPLES ONLY AND DON T NECESSARILY REFLECT ACTUAL the display will proceed to CLINICAL PRAE TIGE the next screen Programming the infuser may begin during the cassette check phase of the start up testing NOTE If battery is missing or defective a Battery not installed message with a Contin
50. elines apply only when infusing short half life critical drugs in Concurrent mode Individual patient responses may vary requiring adjustment of delivery rates DELIVERY RATE GUIDELINES SHORT HALF LIFE LESS THAN 6 MINUTES CRITICAL MAXIMUM RATE OF DRUG INFUSION RATE ACCOMPANYING INFUSION 0 5 1 9 mL hr 5 Times the Critical Drug Rate 2 5 mL hr 10 Times the Critical Drug Rate 5 1 or Greater Any Desired Ratio CRITICAL DRUGS Examples of drugs with a short half life approximately 6 minutes or less when given IV include Dobutamine Lidocaine Dopamine Nitroglycerin Epinephrine Nitroprusside Epoprostenol Norepinephrine Esmolol Oxytocin Isoproterenol Procainamide For these drugs the concurrent flow guidelines should be followed when the infusion rate of the drug will be 5 mL hr or less NOTE This list of critical drugs is not intended to be 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 430 95215 003 Rev 10 05 Plum Infusion Systems 1 11 EPIDURAL ADMINISTRATION Recommended use of the epidural route is to provide anesthesia or analgesia for periods up to 96 hours This device can be used to administer only those anes
51. elivery Rate or as set by the operator Enteral Delivery via an intestinal route 430 95215 003 Rev 10 05 Plum A Infusion Systems 2 7 TERM DEFINITION Error A condition resulting in an audible warning and often an accompanying message such as an invalid key press resulting from an operator attempt to make an input that is not valid for the current operational context Not a Malfunction Filling Head Height FHH The gravity induced Proximal Line pressure due to fluid height in source container above the Distal Line output level Flow Rate The resulting rate of fluid flow See Rate and Dose Fluid Delivery Begin The time required measured from the initial start of a keypad press for a digit in the third decimal place of a scale measuring grams to change when pumping water the delivery tube is fluid filled and the end of the delivery tube is immersed Infuser A Plum A device not including the disposable administration set Initialized Position The plunger is in the Plunger Park Position and each valve is in the Valve Home Position Key Any of the marked locations on the front panels intended for user input via a pressing action KVO Keep Vein Open Internally selected minimal delivery rate the lesser of 1 0 mL Hr or actual Rate intended to provide sufficient fluid flow to decrease the potential for clotting at the IV infusi
52. er value using keypad automatically computed Program More Cancel Options Steps Back A A A 11 Use to drop down to Step 2 Rate field Rate VTBI Duration mL i 50 12 Enter the set of desired values for Step 2 of the program Continue Enter value using keypad process for each Program More Cancel additional Step Emm Se A A A 430 95215 003 Rev 10 05 Plum A Infusion Systems 5 25 NOTE When Step 4 is programmed using the SELECT keys to advance will highlight another item on this screen Program Multistep Duration 13 When Step 4 is programmed select Enter value using keypad A STEPS to Program More Cancel program up to 10 Steps Pea S NOTE Using the SELECT keys will not advance you to the additional steps 14 To set up Steps 5 through 10 enter desired values as performed for Steps 1 VTBI Duration through 4 To see the previous steps select A PREV STEPS Enter value using keypad Program Prev m Options Steps Back NOTE Confirmation screen will A appear ONLY if using weight based program CAUTION VERIFY ALL VALUES BEFORE STARTING INFUSION 15 Press to begin program 430 95215 003 Rev 10 05 5 26 5 Therapies The Main Delivery screen TA PUMPING STOPPED 5 displays Step 1 in the TEN Step 1 upper left corner 50 fate Vol Inf 27 5 PAL 0 NOTE In units other than mL hr the Dose rate and units also will be disp
53. ess temporary battery operation is desired NOTE Use AC mains power whenever possible Store the infuser connected to AC mains to confirm a fully charged battery for emergencies NOTE If the quality of the earth grounding source is in doubt use battery power CAUTION THE PLUM A SYSTEM IS DESIGNED TO OPERATE NORMALLY IN THE PRESENCE OF MOST ENCOUNTERED ELECTROMAGNETIC INTERFERENCE EMI CONDITIONS THE EVENT OF EXTREME LEVELS OF 430 95215 003 Rev 10 05 4 2 4 Basic Operation 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 DISRUPTED OPERATION OF THE INFUSER UNDER THESE CONDITIONS SHOULD BE AVOIDED TANDEM CARRIER INSTRUCTIONS NOTE The Plum A 3 is NOT to be used with the tandem carrier It is only to be used with the Plum A and other single channel devices The Plum A may be safely and conveniently mounted on an IV stand or on a tandem carrier mounted on an IV stand Always mount the tandem carrier List 12270 01 to the pole before attaching the infuser s to the tandem carrier Make sure tandem carrier clamp is attached firmly to pole Make sure infusers are firmly attached to tandem carrier This section details the Plum A instrument setup procedures SYSTEM SELF TESTS The infuser performs a suite of System Self Tests when power is applied to
54. fusion and as final confirmation of programming 430 95215 003 Rev 10 05 Plum A Infusion Systems 3 3 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 LE NC E its cause The SELECT keys or AW are used to move the highlighting cursor between the programming fields SELECT wv 430 95215 003 Rev 10 05 3 4 3 Equipment Description The numeric keys are used to enter values for any 2 3 highlighted field requiring numeric data 4 5 6 The CLEAR key will cause a highlighted numeric field to be cleared 7 8 9 in preparation for data entry CLEAR 0 The Decimal key is used to manually enter numbers other than whole numbers i e 1 2 mL Softkeys are located at the bottom af 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 430 95215 003 Rev 10 05 Plum A Infusion Systems 3 5 3 2 Indicators The Charge Line Indicator is illuminated to indicate the battery is currently charging NOTE If the device is plugged into AC power with a battery installed and the Charge Indicator is not illuminated contact technical support The fluid drop symbol when flashing indicates an active inf
55. fusion systems The Plum A allows two lines in and one line out while the Plum 3 allows six lines in and three lines out Each pump can be used for standard piggyback or concurrent delivery Therapy modes include Standard Infusions e Multistep Programming Loading Dose e Dose Calculation The Plum and Plum A 3 are designed to deliver parenteral enteral or epidural infusions over a broad range of infusion rates from multiple fluid container types Both are designed to be used in most areas of patient care including but not limited to General Floor Labor Delivery X Burn Unit Post Partum eMedical Surgical OR Anesthesia eHemodialysis eICU CCU Post Op Oncology Recovery Pediatrics Cardiac Cath eMobile Intensive Lab Care Neonatolgy Emergency Nutritional 1 1 Product Description Each system includes a pumping module hereafter called the infuser and an assortment of disposable IV sets hereafter called a set optional accessories and this operator s manual 430 95215 003 Rev 10 05 Plum A Infusion Systems 1 3 A computer dataport is also provided to interface with a host computer Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC Standards e g IEC 60950 for data processing equipment and IEC 60601 1 for Medical Equipment Furthermore all configurations shall comply with the system standard IEC 60601 1 1 Any pe
56. g is an exception using the Alarm Indication sound level Weight The Alternate Units Parameter whose value entry is required with Alternate Units for Dose that include kg 430 95215 003 Rev 10 05 Plum Infusion Systems 3 1 3 Equipment Description Line A Flow Line B Flow Indicator Pd Indicator Statue Status Region EG Region Nd Working Region gt Working Region Battery Charge Message d Indicator Region Message Region Options Softkey Label Vol Inf Numeric Softkey I Keys Selector Up Left La Start and 1 2 3 47 Direction Stop Keys Keys e 4 5 6 m Down Charging re 7 68 9 vw Right Indicator 0 d SILENCE i ON OFF uem y Key Numeric Field Decimal Key Clear Key Basic Layout of Front Panel Display and Keypad 430 95215 003 Rev 10 05 3 2 3 Equipment Description 3 1 Operating Keys NOTE For Plum 3 all three pumps act as individual Plum A s The ON OFF key is used to control the power of the Plum A NOTE All deliveries must be stopped in order to turn the power off NOTE To confirm proper shutdown of infuser do not unplug until double beep is heard approximately 5 seconds If double beep is not heard the infuser will turn itself back ON sensing the AC power was lost and revert to battery back up power The START key is used to begin in
57. how the programming screen Select rmm A CANCEL BACK to return to the A Options Main Delivery screen ain Delivery scree PEE of STOPPED FA 5 5 delivery 8 5 Vol Inf 0 mL Rate 100 mL hr Vol Inf as ian Oo 2 To discontinue infusion press i 3 Clamp secondary tubing NES if connected u Vol In 4 Open door remove set and close door Or press to resume infusion 430 95215 003 Rev 10 05 4 18 4 Basic Operation 4 8 Stop and Start with Both Lines pumping 1 Press at the Main A PumPine PUMPING B Delivery screen Rate 25 mL hr 50 Vol Inf 3 rail 20 4 Options A Vol Inf A A 2 Select A STOP A PUMPING PUMPING A STOP B or E B A STOP ALL ED Vol Inf 3 mt 202 NOTE If 4 A or 4 B is selected prior to STOP the display will show the programming E screen Select 4 CANCEL BACK stop stop Stop to return to the Main Delivery Screen 430 95215 003 Rev 10 05 Plum A Infusion Systems 4 19 3 4 5 6 Example of stopped 5 5 infusion NOTE This is an example using A STOP ALL CAUTION VERIFY ALL VALUES Back A Options Prime Vol Inf A A BEFORE STARTING INFUSION To resume infusion 5 B pres
58. idity 10 90 40 C Max DELIVERY RATE RANGE Lines A B 0 1 99 9 mL hr in 0 1 mL increments 100 999 mL hr in 1 mL increments 430 95215 003 Rev 10 05 Plum A Infusion Systems 9 3 Concurrent Delivery 0 5 mL hr minimum for each line PlumSet 500 mL hr cumulative maximum KVO 1 0 mL hr or the last primary delivery rate whichever is less AIR IN LINE ALARM PlumSet Distal Bolus 0 1 mL 100 microliters or larger for delivery rates less than 500 mL hr Bolus 0 5 mL 500 microliters or larger for delivery rates equal to or greater than 500 mL hr Cumulative 0 25 mL out of 2 6 mL for delivery rates less than 500 mL hr Cumulative 0 50 mL out of 5 3 mL for delivery rates equal to or greater than 500 mL hr PlumSet Proximal Bolus at 0 5 mL Total 1 0 mL OCCLUSION ALARM AND LIMITS Distal Occlusion DISTAL OCCLUSION alarm sounds after the distal set tubing or set outlet fitting becomes occluded Proximal Occlusion PROXIMAL OCCLUSION alarm sounds if the tubing proximal to the cassette becomes occluded Distal Pressure Limit 1 to 15 psig The maximum pressure is without alarm user selectable Factory default setting is 6 psig Maximum Infusion 20 psig Pressure 430 95215 003 Rev 10 05 9 4 9 Specifications TIME DETECT DOWNSTREAM OCCLUSIONS OCCLUSION ALARM TYPICAL TIME MAXIMUM TIME PRESSURE TO ALARM TO ALARM SETTING Macro MAcRO 25mL 6 5 38
59. ion repeats replace infuser 430 95215 003 Rev 10 05 Plum A Infusion Systems 8 1 8 Maintenance and Storage 8 1 Cleaning Maintenance and Storage The cleaning maintenance and storage of the Plum A described in this section CLEANING AND SANITIZING For proper maintenance of the Plum A observe the following cleaning and sanitizing guidelines Establish a routine weekly schedule for cleaning the infuser To clean proceed as follows Turn the Plum A off using the ON OFF switch e Disconnect from AC mains power The exposed surfaces of the Plum A4 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 Clean the cassette door with a soft lint free cloth dampened with one of the cleaning agents listed in the following table or a mild solution of soapy water Use a small non abrasive brush to aid in cleaning the infusion system housing and subsystem chassis components To thoroughly clean the cassette receptacle disengage the cassette door from the door latch by pressing the door release tab CAUTION Do NOT ALLOW CLEANING SOLUTIONS TO SATURATE THE AIR IN LINE DETECTORS OR ENTER THE DEVICE WHEN CLEANING THE AIR IN LINE DETECTORS 430 95215 003 Rev 10 05 8 Maintenance and Storage CLEANING SOLUTION MANUFACTURER PREPARATION Coverage HBV Steris Corporation A Per manufacturer
60. ion Interval minutes Max Mean 25 ML HR 0 mmHg DELIVERY HEAD START UP Composite of 3 Pumps 1596 1096 ES X 5 o 7 5 Z TE t 8 5 10 15 10 15 20 25 30 Observation Interval minutes Min Mean 430 95215 003 Rev 10 05 Plum Infusion Systems 25 ML HR 0 mmHg DELIVERY HEAD 96 HOURS Typical 50 45 40 4 35 304 25 4 See CREAN INI PSI PS IN NS Pt 20 154 10 5 0 10 20 30 40 50 Time minutes Actual Rate Programmed Rate 25 ML HR 0 mmHg DELIVERY HEAD 96 HOURS Typical 15 55 10 5 5 i 0 t 8 5 Q 10 15 0 5 10 15 20 25 30 Observation Interval minutes Max Min Mean 25 ML HR 0 mmHg DELIVERY HEAD 96 HOURS Composite of 3 Pumps 15 10 4 X 5 g x 0 T 8 5 2 15 0 5 10 15 20 25 30 Observation Interval minutes Max Min Mean 430 95215 003 Rev 10 05 9 10 9 Specifications 1 ML HR 0 mmHg DELIVERY HEAD START UP Typical 2 0 1 8 4 1 6 4 144 12 104 0 8 06 044 0 02 0 0 T T
61. ions are desired See Section 6 Additional Features for more information 12 Press sur to begin Program Dose 6 program Delivery will be Dose 2 mg min Drug Lidocaine This will bring up the aene Sam PROGRAM CONFIRMATION o 5 e screen which appears for i all units of measure except mL hr CAUTION VERIFY ALL VALUES BEFORE SELECTING 44 YES AND STARTING INFUSION NOTE The Concentration drug amount or Diluent volume cannot be changed while a delivery is in progress 430 95215 003 Rev 10 05 Plum A Infusion Systems 5 13 Upon sia the Main Fa sroeeeo uua 8 Delivery screen shows Bose Celestion EEE delivery status for both A 26 Fm a and B lines 4 Volinf gy mL meg kg min Dose mo NOTE See Delivery Rate Range in Section 9 The ratio of concurrent rates has Options A Vol Inf recommendations specified in A N Section 1 4 430 95215 003 Rev 10 05 5 14 5 Therapies 5 3 Loading Dose LOADING DOSE Allows programming of an initial infusion rate for a specific volume followed automatically by a maintenance rate from the same container e g a fluid challenge If Dose Calc is used the Loading Dose and Maintenance Dose are in the same unit of measure over the same period of time mcg min from the same container Clear ALL values when changing patients or multiple programming parameters Use A CLEAR PROGRAM when changing ONLY Line A or B 1 Sele
62. ivery rates b mL hr or less the use of thick walled microbore Plum sets is recommended This will reduce the amount of the fluid bolus that may be delivered when a distal line occlusion is released Syringes must be larger than 3 cc Use syringe adapter List 11986 48 when using syringes smaller than 10cc Some 10cc syringes may require use of a syringe 430 95215 003 Rev 10 05 Plum A Infusion Systems 1 13 adapter Syringes larger than 10cc may be attached directly to the secondary port of the cassette Use of a syringe adapter may decrease the occurrence of proximal occlusion alarms Use a 19 gauge or larger needle or catheter at the venipuncture site for viscous fluids if operating at rates greater than 500 ml hr See Section 10 for information on sets and accessories BACKPRIMING Backpriming is not recommended for reconstituting secondary containers containing dry powders To avoid pressurization when backpriming into a syringe the user must confirm there is sufficient empty space to accept the backprimed fluid GENERAL Possible explosion hazard exists if used in the presence of flammable anesthetics Do not place Plum A in service if it fails the self test Do not operate the Plum A with the case opened Keep the cassette door securely closed while the infuser is not in use to avoid cassette door damage The Plum A 3 is to be used with an IV pole with a 6 wheel base and a shelf CLEANING For mor
63. layed rm Options A Vol Inf A A Example of Multistep FA Pumpine Screen Pumping on Step 2 16 To change a program parameter while pumping select A NOTE The in a Step number field indicates the step is delivering or d indicates each completed T step D 17 Enter a value using the keypad Enter value using keypad Program More Cancel Options Steps Back A 430 95215 003 Rev 10 05 Plum Infusion Systems If Rate value is changed the Duration will automatically change NOTE Only the current delivering step and future steps can be changed CAUTION VERIFY ALL VALUES BEFORE STARTING INFUSION NOTE The Values are now updated on the Main Delivery Screen The infuser reverts to KVO when last Step completes The last step can be restarted by entering a new VTBI value 5 27 Program Multistep Rate VTBI mL hr mL 50 75 50 Duration 50 Enter value using keypad More Steps Cancel Back 5 A A Program Options a roues eroeres 8 TPN Step 2 125 Rate mL hr Vol Inf mL 0 7 Options A Vol Inf A A 658 430 95215 003 Rev 10 05 5 28 5 Therapies NOTES 430 95215 003 Rev 10 05 Plum A Infusion Systems 6 1 6 Additional Features 6 1 Simple Delivery Using Drug List 1 dn Ling a A or 4 STOPPED STOPPED B at the Main Delivery LA sroePED storen screen
64. le pumping while operating cassette inserted N251 Cassette Test Faulty cassette Check clamps Failure proximal or distal manually reprime set occlusion or air in close door cassette detected at Backprime into line B start up tubing or syringe if appropriate If alarm recurs on retest replace set If alarm repeats replace infuser N252 Depleted Too much time on Plug into AC mains Battery battery power power N253 Hard lockout The use of the STOP Unlock lockout Violation key during delivery or switch opening the door while lockout is enabled N254 Hard lockout Pressing of any key Unlock lockout Enabled except STOP during switch delivery while any alarm is active and lockout is enabled N255 Soft lockout The use of the STOP Unlock lockout by Violation key during delivery or pressing the decimal opening the door key followed by 9 6 while lockout is amp 3 on the keypad enabled N256 Soft lockout Pressing of any key Unlock lockout by Enabled except STOP during delivery while any alarm is active and lockout is enabled pressing the decimal key followed by 9 6 amp 3 on the keypad 430 95215 003 Rev 10 05 Plum Infusion Systems LINE A ALARMS MESSAGE Callback Line POSSIBLE CAUSE Alarm programmed by CORRECTIVE ACTION Press SILENCE container or syringe disconnected or obstructed during non delivery startup
65. lenge If Dose Calc is used the Loading Dose and Dose Maintenance Dose are in the same unit of measure over the same period of time mcg min from the same container Allows a sequential program to deliver up to 10 steps fluid volumes and delivery rates may be programmed for each step The program may be entered based on Rate and Volume or Volume and Time If Dose Calc is used the delivery steps are in the same unit of measure over the same period of time from the same container NOTE During programming user must identify desired drug with softkey drug list prior to setting program parameters Use drug manufacturer recommendations for IV administration when using the Plum A infuser 430 95215 003 Rev 10 05 5 Therapies 5 1 Dose Calc mcg kg min on A DOSE CALCULATION Allows programming Dose Rates in alternative units of measure Dose Calculation can be used in Simple Delivery Loading Dose and Multistep Clear ALL values when changing patients or multiple programming parameters Use A CLEAR PROGRAM when changing ONLY Line A or B 1 Select 4 A at the Main Delivery screen SCREENS SHOWN IN THIS MANUAL ARE EXAMPLES ONLY AND DON T NECESSARILY REFLECT ACTUAL CLINICAL PRACTICE The Line A Programming screen appears 2 Select 4 THERAPY for Dose Calculation programming 430 95215 003 Rev 10 05 EA ereere srrreo 8 Back A Options Prime Vol Inf
66. mL hr N A Gatifloxacin mL hr N A Gentamicin mL hr N A Heparin units kg hr units mL Hetastarch NaCl mL hr N A Hextend mL hr N A Hydromorphone mL hr N A Ifosfamide mL hr N A Imipenem Cilastatin mL hr N A Immune Globulin IV mL hr N A Insulin units hr units mL Isoproterenol mL hr N A Labetalol mg min mg mL Lepirudin mg kg hr mg mL Leucovorin mL hr N A Levofloxacin mL hr N A Lidocaine mg min grams mL Lipids mL hr N A Lorazepam mL hr N A Magnesium Infusion grams hr grams mL Mannitol grams hr grams mL 430 95215 003 Rev 10 05 12 4 12 Drug List DEFAULT DosE DEFAULT DRUG NAME RATE CONCENTRATION Mesna mL hr N A Methohexital mL hr N A Methotrexate mL hr N A Methylprednisolone mL hr N A Metoclopramide mL hr N A Metronidazole mL hr N A Midazolam mL hr N A Milrinone mcg kg min mg mL Morphine mg hr mg mL Nafcillin mL hr N A Naloxone mL hr N A Nitroglycerin mcg min mg mL Nitroprusside mcg kg min mg mL Norepinephrine mcg min mg mL Ofloxacin mL hr N A Ondansetron mL hr N A Oxacillin mL hr N A Oxytocin mUn min units mL Paclitaxel mL hr N A Pancuronium mg kg hr mg mL Pantoprazole mg min mg mL Penicillin mL hr N A Pentobarbital mL hr N A Phenylephrine mcg min mg mL Piperacillin bactam mL hr N A Potassium Infusion mEq hr mEq mL Procainamide mg min grams mL Propofol mcg kg min mg mL 430 95215 003 Rev
67. matically calculated To understand the E pg Automatic Calculation feature see A A Section 6 8 Examples of Automatic Calculation 430 95215 003 Rev 10 05 5 6 5 Therapies 10 Use W to scroll down to the VTBI field CON EE Weight 70 kg 11 Enter a value for VTBI d oe using the keypad Rate 4 NOTE As the VTBI value is susce enean M entered or changes Duration is automatically updated A A NOTE At this point programming is complete unless A PROGRAM OPTIONS are desired See Section 6 Additional Features for more information 12 After entering the desired VTBI value and any desired 4 PROGRAM OPTIONS press to begin program This will bring up the PROGRAM CONFIRMATION Delivery will be screen which appears for ema all units of measure except 099 Popamine Conc 400 mg 250 mL hr Weight 70 kg Confirm Program CAUTION VERIFY ALL VALUES BEFORE SELECTING 44 YES AND STARTING INFUSION NOTE The Concentration drug amount or Diluent volume cannot be changed while a delivery is in progress 430 95215 003 Rev 10 05 Plum A Infusion Systems 5 7 The Main Delivery screen FA PUMPING STOPPED B appears displaying the Dopamine information just entered NE 0 Vol Inf 0 NOTE The Therapy Type and mL Drug are displayed as well as the Dose Rate and Dose Units Options Vol inf A A 430 95215 003 Rev 10 05
68. med in this example press W to advance to the VTBI field 430 95215 003 Rev 10 05 5 Therapies Dose Calculation Loading Dose Multistep Select then Choose Choose Back A A Program Loading Dose mL hr mcg kg min mcg kg hr mcg min mcg hr mg kg hr mg min mg hr grams hr ng kg min units kg hr units min units hr mUn min mEq hr Choose Back A A Program Loading Dose Select then Choose VTBI Duration Enter value using keypad Program Options Plum A Infusion Systems 5 17 8 Enter value using keypad VTBI Duration Enter value using keypad Program Cancel Options Back A 9 Use W to highlight the next field 10 Enter Duration using keypad The Rate value is automatically calculated PERRO UU To understand the pum Automatic Calculation Sci feature see Section 6 8 Examples of Automatic Calculation 11 After the values for loading dose Step 1 are entered use W to highlight the maintenance dose Step 2 VTBI Duration NOTE The Loading Dose therapy ad euius has two steps The first is the Options loading dose followed by the A maintenance dose These words will appear on the main screen as each step is delivered 430 95215 003 Rev 10 05 5 18 5 Therapies 12 Enter the set of desired values for Step 2 of the program VTBI Duration 00 30 13 Select 4 PRoGRAM 10 00 OPTIONS to select a M Delayed Start or Standb
69. ministration set 1n 2 430 95215 003 Rev 10 05 3 10 3 Equipment Description Push in the flow regulator to close Confirm there is no flow LOADING THE CASSETTE To load the primed cassette into the plum A proceed as follows Open the cassette door by lifting up the handle Insert cassette into door guides Close the cassette door Confirm there is no flow and no kinks appear in tubing NOTE If flow is observed close the tubing clamps and replace the administration set NOTE The administration set should be changed per CDC guidelines or healthcare provider policy Discard after use PREPARING THE SECONDARY LINE CAUTION CONSULT THE DRUG LABELING TO CONFIRM DRUG COMPATIBILITY CONCENTRATION DELIVERY RATES AND VOLUMES ARE ALL SUITABLE FOR CONCURRENT DELIVERY OR PIGGYBACK DELIVERY SECONDARY FOLLOWED AUTOMATICALLY BY PRIMARY MODES The Plum A features concurrent or piggyback delivery modes when therapy requires administering more than one fluid 430 95215 003 Rev 10 05 Plum Infusion Systems 3 11 In addition to standard containers the Plum can use syringes 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 e Review the backpriming function Attach the secondary container using an 18 or 19 gauge 31 mm or shorter needle if the cassette secondary inlet po
70. o Vol Inf mL 0 Back A Options Prime Vol Inf A A A The Line A Programming screen appears Rate mL hr 2 Select VTBI 0 mL A PROGRAM OPTIONS Duration 00 00 hr min SCREENS SHOWN IN THIS MANUAL ARE EXAMPLES ONLY AND DON T NECESSARILY REFLECT ACTUAL CLINICAL PRACTICE Enter Value using keypad Program en Options Therapy A A The default screen for Program Options appears 3 Select 4 DRUG LIST Delay Start for 9 00 fW min Callback No Enter Value using keypad Drug Cancel List Standby Enter Back A A A A 430 95215 003 Rev 10 05 6 2 6 Additional Features ditio a appears in mainly alphabetical order Abciximab Acyclovir Albumin Aldesleukin Alfentanil Alteplase rt PA Amikacin Select then Enter Page Page Enter coma Up Down A A A 4 Use AW to highlight desired drug name Dexmedetomidine Diltiazem Dobutamine When list does not contain Doxorubicin desired generic drug name pid select Select then Um ERES 4 Down or A PAGE Pace Pese gner own ac UP until it shows then use AW to highlight choice 5 Select ENTER to indicate selection and return to the Program Options screen Or select 4 CANCEL BACK if no choice is acceptable Drug name is now visible in the upper left corner Dopamine 6 Select 4 ENTER or Delay Start 9 00
71. o Hospira s standard specifications and be free from defects in material and workmanship under normal use and service for a period of one year after purchase and b the replaceable battery shall be free from defects in material and workmanship under normal use and service for a period of 90 days after purchase Hospira makes no other warranties express or implied as to merchantability fitness for a particular purpose or any other matter Purchaser s exclusive remedy shall be at Hospira s option the repair or replacement of the product In no event shall Hospira s liability arising out of any cause whatsoever whether such cause be based in contract negligence strict liability other tort or otherwise exceed the price of such product and in no event shall Hospira be liable for incidental consequential or special damages or losses or for lost business revenues or profits Warranty product returned to Hospira must be properly packaged and sent freight prepaid The foregoing warranty shall be void in the event the product has been misused damaged altered or used other than in accordance with product manuals so as in Hospira s judgment to affect its stability or reliability or in the event the serial number or lot number has been altered effaced or removed The foregoing warranty shall also be void in the event any person including the Purchaser performs or attempts to perform any major repair or other service on the product
72. on site 430 95215 003 Rev 10 05 2 8 2 Principles of Operation TERM DEFINITION Line A Inlet tubing on the top center of Cassette when viewed after it has been loaded in Mechanism Door Line B Inlet connector on the top right of Cassette when viewed after it has been loaded in Mechanism Door Loading Dose Allows programming of an initial infusion rate for a specific volume followed automatically by a maintenance rate from the same container e g a fluid challenge If Dose Calc is used the Loading Dose and Maintenance Dose are in the same unit of measure over the same period of time mcg min from the same container Macro Cassette The Plum Cassette as part of an Administration Set whose attainable delivery performance is for general purpose uses Malfunction One of a number of conditions that indicate a failure of the Infuser These conditions usually require a repair action Mechanism The provider of the physical activities of 1 valve control for Line selection and inlet to or outlet from the Cassette 2 Plunger extension and retraction for changing fluid volume of the Cassette pumping chamber 430 95215 003 Rev 10 05 Plum A Infusion Systems 2 9 TERM DEFINITION Multistep Allows a sequential program to deliver up to 10 steps fluid volumes and delivery rates may be programmed for each step The program may be entered based on Rate and
73. on the bottom portion of the display screen just above its location so that label may be changed to indicate differing key functions within the operational context of the defined screens Standard Programming see Basic Delivery Standby A delivery program state that resembles a delayed start for a line in all respects but status display of STANDBY instead of DELAYED A press of the START key and a Start Softkey if necessary will begin the programmed delivery System The Plum A Infuser system with its associated accessories and Administration Sets Truncate To round down to the last whole number e g 103 7 would be 103 Units A Drug Amount without a quantity of mass referent adopted as the United States Pharmacopoeia USP standard of measure for use in a Concentration VI Volume Infused 430 95215 003 Rev 10 05 2 12 2 Principles of Operation TERM DEFINITION VTBI Volume To Be Infused The volume of fluid or IV solution remaining for delivery by a program or Therapy step from a Line Warning Audible indication at the defined Warning sound level often accompanied by a brief message to advise operator that 1 Input was attempt to use a function in wrong sequence with wrong values or at wrong time resulting in an Invalid Key Warning 2 Input was properly related to a function resulting in a Valid Key Warning The Low Battery Warnin
74. ons 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 430 95215 003 Rev 10 05 Plum A Infusion Systems 1 7 disrupted Even this event the outcome would likely be a false alarm or detected system malfunction and would not result in a hazard to patient or operator Use of radio frequency emitting devices such as cellular telephones and 2 way radios in close proximity of this device may affect its operation HEALTHCARE PROFESSIONALS AND PATIENT RELATED Setting the primary rate greater than the secondary rate will result in a more rapid infusion of any residual secondary drug remaining in the line and the cassette Consult drug labeling to confirm drug compatibility concentration delivery rates and volumes are all suitable for secondary concurrent and piggyback delivery modes Arrange tubing cords and cables to minimize the risk of patient strangulation or entanglement Before opening the door close clamp on the primary line or remove the secondary container from the secondary port to prevent mixing of primary and secondary fluids 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
75. ost Infusion Rate select the Volumes Lighting Contrast Infused Screen Select then Choose Choose Back This will bring up the options B Volumes Infused screen which defaults to Total Volumes Infused Volume Line A 0 mL Line B 0 mL Total Vol mL 4 Use AV to scroll to Line Press CLEAR to clear value A or B Enter Cancel Back PN A 430 95215 003 Rev 10 05 6 10 5 ToresetLine A or B Volume Infused use to highlight and press 6 Torestore the cleared quantity select A CANCEL BACK 7 Toresetall volumes use AW to highlight Total Vol then press 7 8 Torestore all quantities select 4 CANCEL BACK softkey 430 95215 003 Rev 10 05 6 Additional Features A options Volumes Infused Line A Line B Total Vol 393 mL Press CLEAR to clear value Cancel Enter A A A options Volumes Infused Line A 0 mL Line B 0 mL Total Vol BEEN Press CLEAR to clear value Cancel Ent mee Back A A Plum Infusion Systems 6 11 9 When clearing of quantities is completed select ENTER to return to the Main Delivery screen Bee a ornons 8 A OPTIONS VOL INF from the Main Delivery screen olumes Infused to return to the Options Release 11 x xx xx xx screen Lighting Contrast 5 Select then Choose 11 Use W to highlight the Pressure Post Infusion ES Rate option
76. pad Program Cancel Options A A A PROGRAM Mode Piggyback Rate 200 mL hr VTBI mL Duration 00 30 hr min Enter value using keypad Program Cancel Options A A A Plum A Infusion Systems 4 13 7 Use W move down to the DURATION field Mode Piggyback Rate 133 mL hr VTBI 100 mL Optional Use keypad to Duration 0008 nr change duration Enter value using keypad Program Options Iberapy md When all parameters are m PW IE displayed changing any one parameter will result in other parameters automatically being computed CAUTION VERIFY ALL VALUES BEFORE STARTING INFUSION 8 Press to begin infusion NOTE If Line A has a Delay Start remaining a message will appear warning of a possible non delivery see section 6 4 9 Select A YES to continue Example of Main Delivery DELAYED PUMPING Screen just after being programmed and started T 7 Options A Vol Inf PN A 430 95215 003 Rev 10 05 4 14 4 Basic Operation 1 4 6 Concurrent Delivery CONCURRENT DELIVERY pumpina B Simultaneous delivery of two fluids at independent flow rates Rate g mL hr CAUTION CONSULT DRUG LABELING TO CONFIRM DRUG COMPATIBILITY CONCENTRATION DELIVERY RATES AND VOLUME ARE ALL SUITABLE FOR CONCURRENT AND PIGGYBACK DELIVERY MODES SEE A Vol Inf SECTION 8 FOR INFO
77. played if unit is displaying VTBI Complete The device will not start and an invalid keypress sound will occur when START is pressed 4 Use W key to move down to the VTBI field 5b Toenter VTBI amount PROGRAM use keypad Mode Concurrent NOTE While the VTBI is being Rate 10 mL hr entered the duration is VTBI 100 mL automatically computed While the Duration 0 computed value is greater than Enter value using keypad 99 59 dashes appear in place Program Therapy Cancel of hours To understand the Options Back A 430 95215 003 Rev 10 05 4 16 4 Basic Operation Automatic Calculation feature see Section 6 8 Examples of Automatic Calculation 6 Use W key to move down to the DURATION field Optional Enter values for desired hours and minutes NOTE When Duration is entered Rate is automatically computed CAUTION VERIFY ALL VALUES BEFORE STARTING INFUSION 7 Press to begin infusion and return to the Main Delivery screen Example of a concurrent delivery Rate 55 IUE 10 Vol Inf 20 4 irl 1 Options A Vol nt 430 95215 003 Rev 10 05 Plum A Infusion Systems 4 17 4 7 Stop and Start with only 1 Line Pumping 1 Press atthe A runena store 6 Delivery Screen 100 Rate mL hr NOTE If 4 A or 4 B is selected prior to STOP the line is stopped the display will s
78. r and to some output device for administration to the patient Alarm A condition requiring operator intervention that invokes both audible and visible alarm indicators Confirmation of the condition usually is required Alert While entering a program a visual warning that informs the clinician of the violation of a hospital defined rule set e g a dose limit for a specific drug 430 95215 003 Rev 10 05 2 4 2 Principles of Operation TERM DEFINITION Alternate Units Dose Rate units that may be selected Alternate Units are any units other than mL hr Alternate Units Drug Amount Diluent Patient Weight Parameters if applicable and Dose Rate Backpressure Resistance to fluid flow on the Distal or output portion of the Administration Set usually expressed as mmHg Backprime Removal of air or fluid from the proximal tubing and Cassette air trap by rapid pumping of fluid from Line A to an output receptacle on Line B No fluid delivered distal to the cassette during a Backprime Basic Delivery A single step delivery specifying rate VTBI and duration only Drug name may or may not be specified Biomed Mode The name for the non delivery or service mode of Infuser operation Bolus A single uninterrupted discrete volume of fluid delivered over a discrete period of time Cassette A Hospira standard Plum Macro Cassette that contains the actual pumping cham
79. ration are changed VTBI must be cleared and then the new VTBI re entered The new VTBI will automatically calculate a new Rate 1st Action 2nd Action AUTOCALC change RATE keep VTBI DURATION change RATE change VTBI DURATION change VTBI keep RATE DURATION change DURATION keep VTBI RATE change VTBI change DURATION RATE change RATE change DURATION Recalculates RATE based on previous VTBI and new DURATION AT KVO Audible KVO alarm will sound clinician will need to re set the appropriate settings 1st Action 2nd Action AUTOCALC enter VTBI keep RATE DURATION enter DURATION keep RATE VTBI change RATE enter VTBI DURATION enter DURATION enter VTBI DURATION enter VTBI enter DURATION RATE change RATE change DURATION VTBI 430 95215 003 Rev 10 05 Plum Infusion Systems 7 1 7 Alarms and Troubleshooting 7 4 Warning Messages MESSAGE POSSIBLE CAUSE CORRECTIVE ACTION Stop delivery then turn off Attempting to turn the infuser off while a delivery is in progress Stop all lines then turn infuser off Warning Replace Battery The battery current charge is greater than 200 mA hr The battery voltage is less than the depleted threshold and charge level is higher than the low charge threshold Battery needs to be replaced Warning Charger Service The charging circuitry is not behaving as
80. red over a short time period the pressure will take longer to return to normal If overdelivery occurs during administration observe the patient closely for 430 95215 003 Rev 10 05 1 Descriptive Information signs of spinal cord compression disorientation headache transient neuralgias and drug overdose BATTERY OPERATION Do not operate the Plum on patients when the battery is removed Use of a properly maintained and charged battery helps confirm proper operation The battery may not be fully charged upon receipt Connect the infuser to AC power for at least six hours Use AC power whenever possible Connect to AC power during storage to ensure a fully charged battery for emergencies If quality earth grounding source is in doubt use battery power If the low battery alarm sounds connect the infuser to AC power immediately SETS AND ACCESSORIES Only compatible LifeCare Plum Sets can be used with the Plum See individual set instructions for additional information Administration sets should be changed per CDC guidelines or healthcare provider policy Discard after use LifeCare IV infusion sets with integral nonblood filters are not for use in the administration of blood blood products emulsions suspensions or any medications not totally soluble in the solution being administered These medications may be administered through the lower Y injection site below the filter When infusing at low del
81. riming table Cassette Function or mode Primary Only specific instructions Attach an empty container BRACKETED Keys or buttons on START ALL CAPS the device are displayed in or BRACKETED ALL CAPS or with a graphic A Italic Softkey Options A Choose Initial Caps Screen displays and Therapy lowercase device labels as appropriate Dose Calculation 430 95215 003 Rev 10 05 Plum A Infusion Systems 1 5 CONVENTION APPLICATION EXAMPLE Bold Emphasis Sets supplied Sterile and for WARNINGS CAUTIONS AND NOTES Alert messages used throughout this manual are described below Pay particular attention to these messages WARNINGH_ A WARNING MESSAGE CONTAINS SPECIAL SAFETY EMPHASIS AND MUST BE OBSERVED AT ALL TIMES FAILURE TO OBSERVE A WARNING MESSAGE IS POTENTIALLY LIFE THREATENING CAUTION A CAUTION USUALLY APPEARS IN FRONT OF A PROCEDURE OR STATEMENT IT CONTAINS INFORMATION THAT COULD PREVENT IRREVERSIBLE PRODUCT DAMAGE OR HARDWARE FAILURE FAILURE TO OBSERVE A CAUTION COULD RESULT IN SERIOUS PATIENT OR USER INJURY NOTE A Note highlights information that helps explain a concept or procedure This symbol directs the user to consult accompanying N documents NOTE Figures are rendered as graphic representations to approximate the actual product Therefore figures may not exactly reflect the product 430 95215 003 Rev 10 05 1 Descriptive Information 1 4
82. rson who connects additional equipment to the signal input or output part configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of the system Standard IEC 60601 1 1 If in doubt consult the technical service department or your local representative NOTE Do not connect dataport while infusing 1 2 Indications for Use USER QUALIFICATION The Plum A is intended for use at the direction or under the supervision of licensed physicians or certified healthcare professionals who are trained in the use of the infuser and the administration of parenteral enteral and epidural fluids and drugs and whole blood or red blood cell components The training should emphasize preventing related IV complications including appropriate precautions to prevent accidental infusion of air The epidural route can be used to provide anesthesia or analgesia 430 95215 003 Rev 10 05 1 4 WARNING 1 Descriptive Information ADMINISTER ONLY ANESTHETICS ANALGESICS APPROVED FOR EPIDURAL ADMINISTRATION AS INDICATED ALLOWED BY THE DRUGS FDA APPROVED LABELING EPIDURAL ADMINISTRATION OF DRUGS OTHER THAN THOSE INDICATED FOR EPIDURAL USE COULD RESULT IN SERIOUS INJURY TO THE PATIENT 1 3 Conventions This section describes the conventions used throughout this manual as follows CONVENTION APPLICATION EXAMPLE Italic Reference to a See Figure 3 1 section figure or P
83. rt has a piercing reseal e Syringes must be larger than 3 cc Use syringe adapter List 11986 48 when using syringes smaller than 10cc Some 10cc syringes may require use of a syringe adapter Syringes larger than 10cc may be attached directly to the secondary port of the cassette Use of a syringe adapter may decrease the occurrence of proximal occlusion alarms e When using a syringe adapter retract the plunger to draw approximately 1 mL of fluid into the syringe to clear air from the adapter filter To prepare the secondary line use aseptic technique and proceed as follows With cassette door closed Loosen and remove white cap then discard Add secondary tubing or syringe Open all proximal clamps before pressing START 430 95215 003 Rev 10 05 3 12 3 Equipment Description Syringe Secure the container to the lt cassette door using the optional container support arm List 12095 03 Set up per operating instructions See Sections 4 6 of this manual 3 5 Discontinuing Electronic Flow Control amp Setting Gravity Flow CAUTION BEFORE OPENING DOOR CLOSE CLAMP ON PRIMARY OR SECONDARY SET OR REMOVE SECONDARY CONTAINER FROM SECONDARY PORT TO PREVENT MIXING OF PRIMARY AND SECONDARY FLUIDS If electronic flow needs to be stopped the precision flow regulator on the cassette can be used to manually set and maintain fluid flow in a gravity mode
84. s Sram Select 4 START A A START or A START ALL Or to discontinue Choose line s to start t ancel A Start Start Start B infusion press EO es Clamp secondary tubing if connected Open door remove set and close door 430 95215 003 Rev 10 05 4 20 4 Basic Operation 1 2 3 4 9 Backpriming BACKPRIMING Removal of air Ma STOPPED STOPPED B or fluid from the proximal line and cassette airtrap 5 Rate 0 5 mL hr c 8 9 Vol Inf 0 To initiate a backprime i mL select 4 BACK PRIME NOTE Backpriming is available P MA only when all delivery is stopped up Secondary container is necessary to receive the air Select and hold T8 A BACK PRIME until fluid pumped from line A to 55 Rate g mL hr Vol Inf D line B has expelled the air from cassette air trap into Secondary container Release Backprime to Stop NOTE Fluid flow is at maximum vu rate possible Upon release of 4 BACK PRIME the cassette test is performed to confirm readiness for pumping Pressing will resume programmed delivery 430 95215 003 Rev 10 05 Plum A Infusion Systems 4 21 4 10 Clearing Program Settings 1 Press at the Main pumpina B Delivery Screen Rate mL hr Clear ALL settings when changing patients or multiple programming
85. s division of Calgon recommendation Vestal Laboratories Formula Diversey Corporation Per manufacturer s recommendation Dispatch Caltech Industries Per manufacturer s recommendation Precise Caltech Industries Per manufacturer s recommendation Household bleach Various Per hospital procedures do not exceed one part bleach in ten parts water Manu Klenz Calgon Vestal Per manufacturer s Laboratories recommendation Sporicidin Sporicidin International Per manufacturer s recommendation Super Edisonite S M Edison Co Per manufacturer s recommendation The rubber pad on the Plum A 3 pole clamp as well as the IV poles for both instruments may be cleaned using isopropyl alcohol 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 430 95215 003 Rev 10 05 Plum A Infusion Systems 8 3 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 CAUTION AVOID MECHANICAL OR ELECTRONIC DAMAGE DO NOT IMMERSE THE PLUM A IN ANY FLUIDS OR CLEANING SOLUTIONS CAUTION Do NOT SPRAY CLEANING SOLUTIONS TOWARD ANY OPENING IN THE INSTRUMENT CAUTION CERTAIN CLEANING AND SANITIZING SOLUTIONS MAY SLOWLY DEGRADE COMPONENTS MADE FROM SOME PLASTIC
86. seconds 47 seconds hr 15 psig 98 seconds 106 seconds 1mL hr 6psig 17 minutes 22 minutes 15 psig 45 minutes 49 minutes Baseline backpressure is 0 psig BOLUS VOLUME RELEASED AFTER DOWNSTREAM OCCLUSIONS ARE CORRECTED ALARM BOLUS MAXIMUM BOLUS PRESSURE VOLUME VOLUME SETTING Macro 25mL 6 psig 0 23 mL 0 28 mL hr 15 psig 0 55 mL 0 63 mL 1mL hr 6 psig 0 24 mL 0 30 mL 15 psig 0 59 mL 0 70 mL Baseline backpressure is 0 psig DELIVERY ACCURACY The Plum A Infuser was designed and manufactured to maintain volumetric delivery rate error of the total fluid delivered of less than or equal to 5 over the course of 48 hours at a programmed rate of 1 to 999 mL hr during normal operating conditions For use of the device at rates below 1 mL hr the delivery rate error is less than or equal to 1096 Backpressure Effect Positive backpressure on the distal line may affect delivery accuracy by no more than 0 5 per psig 2 per 430 95215 003 Rev 10 05 Plum A Infusion Systems 9 5 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 0 396 Filling Head Effect Variations in filling head such as container height may affect delivery acc
87. select A YES NO if necessary to mm KS obtain Yes 7 then select A ENTER ae Yes No Enter Back NOTE Callback default of Yes or No is a biomedical setting and must be configured as described in the Technical Service Manual Callback Yes CAUTION VERIFY ALL VALUES BEFORE STARTING INFUSION Press ai to begin program and return to Main Delivery screen Mode Piggyback Rate 200 mL hr VTBI mL Duration 00 30 hr min Enter value using keypad Program Options Were Back A At end of Piggyback delivery with Callback enabled the line 55 Rate 200 Callback alarm is issued Vol Inf Press to clear alarm Vol Inf 430 95215 003 Rev 10 05 Plum A Infusion Systems 6 7 6 4 Possible Non Delivery Programmed NOTE Whenever a valid START PROGRAM key is pressed the device checks the delivery program s for non Attention Line A is stopped or delivery conditions such as Line B delayed Line B in piggyback mode gives no KVO or alarm at dose end Piggyback without Line A or delayed start that could permit a Continue anyway period of non delivery If so the display presents this warning Screen 1 Select 4 YES to continue with delivery Or select a No to cancel 6 5 Using the Standby Feature Standby is a feature that enables the clinician to m program the infuser up o
88. t applied to the Infuser processor It occurs when Infuser is in the off condition and the AC power is applied or during battery operation when the ON OFF key is pressed Pressure The measured fluid pressure for Proximal Line A Proximal Line B or the Distal line when a fully primed administration set is loaded into a Mechanism with the Cassette Door closed Programs A Concentration based extension to basic Volume Rate delivery for Dose Rate applications Softkey selected types are 1 Standard Program for single rate delivery 2 Loading Dose for up to two steps of delivery at differing rates 3 Multistep for up to ten steps of delivery at differing rates Loading Dose and Multistep include the basic Delivery Rate option Protocol In the medical field hospital approved procedures For devices with an electronic communications interface the format and content of messages being exchanged Proximal Upstream input as Line A and or B with respect to the Cassette portion of the Administration Set Rate See Delivery Rate 430 95215 003 Rev 10 05 Plum Infusion Systems 2 11 TERM Rounding DEFINITION To round off to the closest whole number e g 25 5 would round to 26 but 25 4 would round to 25 Screen That active portion of the LCD assigned to a delivery or other user interactive display operation Softkey A front panel key whose function label is
89. thetics analgesics approved for epidural administration as indicated or allowed by the drugs FDA approved labeling Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient For epidural administration the use of Hospira catheters Plum sets without Y sites and epidural stickers indicating ongoing epidural administration are recommended Administration of drugs via the epidural route should be limited to personnel familiar with associated techniques and patient management problems Proper epidural placement of the catheter is essential since catheter migration could result in intravascular or intrathecal administration Facilities practicing epidural administration must be equipped with resuscitative equipment oxygen naloxone and other resuscitative drugs Adequate monitoring equipment e g Oximetry is recommended for continuous monitoring of the patient during epidural administration Patients must be observed frequently for side effects in a fully equipped and staffed environment for at least 24 hours following completion of drug administration by the epidural route DELAYED RESPIRATORY DEPRESSION FOLLOWING CONTINUOUS EPIDURAL ADMINISTRATION OF PRESERVATIVE FREE MORPHINE SULFATE HAS BEEN REPORTED The epidural space has 58 openings through which fluid can exit Pressure buildup during administration is transient However if a large volume of fluid is administe
90. tinue Press AW key to fa options highlight Backlight u Intensity or Display Lighting Contrast Backlight Intensity ht Intensity Contrast WEE uem While viewing display for desired effect select Use Inc Decrease Settings Setting Setting Back A A A A SETTING or DECREASE either INCREASE SETTING to change level 430 95215 003 Rev 10 05 Plum A Infusion Systems 6 13 22 Select ENTER to keep change s and return to the Main Delivery screen or 4 CANCEL BAck to restore previous values and return to the Options screen 6 7 Variable Rate Cap Variable Rate Cap is a biomed programmable item to set the maximum rate values to be accepted by the device The clinician cannot change it once biomed has programmed it 6 8 Examples of Automatic Calculation AT STARTUP Initial programming allows the clinician to enter two of the three programming parameters Rate VTBI or Duration and the third is automatically calculated Refer to table below 1st Action 2nd Action AUTOCALC enter RATE enter VTBI DURATION enter VTBI enter DURATION RATE enter RATE enter DURATION VTBI WHILE RUNNING TITRATION Changing two parameters after startup of the infusion will allow for the re calculation of the third parameter 430 95215 003 Rev 10 05 6 14 6 Additional Features NOTE VTBI will not be re calculated if the Rate and Du
91. tion 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 How to read a Trumpet Curve Graph Refer to example on the following page The graphs following the Example plot flow rates at 30 second intervals for the first 2 hours and for the 96th hour of delivery The graph plots mean delivery rate error Average of 3 infusers for the 2nd hour and the 96th hour as a straight line The graph also presents maximum and minimum average delivery rate error for this interval plotted by averaging delivery errors over intervals of 2 5 11 19 and 31 minutes Trumpet Curve EXAMPLE From the Trumpet Curve Graph sample that follows find the 5 minute interval A at the horizontal axis and read the corresponding points B and C on the vertical axis The values are approximately 2 8 and 0 5 This means that at the rate of 25 mL hr the average maximum flow rate fluctuation for any 5 minute time interval during the 2nd hour of operation was within the limits of 2 8 and 0 5 from the nominal rate The average delivery rate error over the entire 2nd hour was 1 6 D 430 95215 003 Rev 10 05 Plum A Infusion Systems 9 7 For other time intervals look at other points at the horizontal axis and determine corresponding limits as above 25 ML HR 0 mmHg DELIVERY HEAD START UP 15 Max Positive Error over 5
92. ue without battery prompt will appear AC power only 430 95215 003 Rev 10 05 Plum A Infusion Systems 4 5 2 3 CAUTION DO NOT OPERATE THE PLUM A ON PATIENTS WITH THE BATTERY REMOVED USE OF A PROPERLY MAINTAINED AND CHARGED BATTERY HELPS CONFIRM PROPER OPERATION To set up the Plum insert selected Plum Set and close cassette holder door lever NOTE If cassette is already inserted this screen is skipped Example of Clear Settings Screen The on screen message Clear Settings Clear Settings may appear Select 4 YEs to clear all settings Yes clears ALL settings Clear ALL settings when IONS changing patients or multiple programming parameters NOTE This clears all delivery parameters such as Rate and VTBI on both lines as well as setting items such as the KVO and Nurse Callback options to their default values NOTE If no settings currently exist or all settings are zero this screen will be bypassed 430 95215 003 Rev 10 05 4 6 4 Basic Operation 4 3 Simple Delivery Example of Main Delivery srorPEp sroPPED B screen with cleared settings SCREENS SHOWN IN THIS MANUAL ARE EXAMPLES ONLY AND DON T NECESSARILY REFLECT ACTUAL CLINICAL PRACTICE Back A Options Prime Vol Inf A A A NOTE For clarity whole number font sizes will appear larger than partial number font sizes numbers on the right side of the comma 1 To Progr
93. up to 10 steps fluid volumes and delivery rates may be programmed for each step The program may be entered based on Rate and Volume or Volume and Time If Dose Calc is used the delivery steps are in the same unit of measure over the same period of time from the same container Clear ALL values when changing patients or multiple programming parameters Use A CLEAR PROGRAM when changing ONLY Line A or B 1 Select A A at the Main 5 B Delivery screen Rate 0 mL hr 0 Vol Inf 0 DES umi Back A Options Prime Vol Inf A A A 430 95215 003 Rev 10 05 5 22 The Line A Programming screen appears 2 Select THERAPY The Drug List Screen appears in mainly alphabetical order 3 Use AW to highlight desired drug name When list does not contain desired generic drug name or group name select A PAGE DowN or A PAGE UP until it shows then use to highlight choice 5 Therapies PROGRAM Rate mL hr VTBI 0 mL 00 00 hr min Duration Enter Value using keypad Program cen Options Therapy Back A A Program Drug List No Drug Selected Abciximab Acyclovir Albumin Aldesleukin Alfentanil Alteplase rt PA Amikacin Select then Enter Page Page Enter coma Up Down A A A A Program Drug List Ticar clavulanate Tirofiban Tobramycin Urokinase Vancomycin Vecuronium Verapamil Select then Enter Page Page c3
94. uracy by no more than 2 for variations in the range 15 to 28 inches A typical deviation under these conditions is 0 596 Concurrent Delivery Effect When both lines A amp B are delivering the ratio of delivery for the fluid with the lowest rate may be affected by as much as 5 for ratios up to 9 to 1 For higher ratios the absolute percentage of delivery for the lowest rate may be affected by no more than 0 5 When air is present in the bubble trap the absolute percentage of delivery for the lowest rate may be affected by up to 2 0 When variations in container height are present the absolute percentage of delivery for the lowest rate may be affected by up to 2 5 for up to 24 inches of container height differences ENTERAL amp HIGH VISCOSITY FLUIDS EFFECTS System delivery accuracy limits for each Enteral and High Viscosity Fluid such as those listed in the following table can be degraded by an additional maximum of 596 System accuracy for Enteral Fluids is defined only for rates of 1 to 200 mL hr with no suspended air in the solution and using an Hospira Plum enteral set ENTERAL HIGH VISCOSITY FLUIDS Dextrose 20 to 50 concentration Isomil Powder Similac Powder Ensure Plus HN Twocal HN Jevity 430 95215 003 Rev 10 05 9 6 9 Specifications TRUMPET CURVES The Trumpet Curve Graphs following the Example show representative maximum and minimum percent flow rate devia
95. usion 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 430 95215 003 Rev 10 05 3 6 3 Equipment Description 3 3 Rear Case Controls NOTE For Plum 3 each control applies to all three pumps The audio level rotary knob located on the back adjusts the alarm audio level Loud Quiet The toggle switch located Locked 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 Unlocked Password Protected Keypad Lock may also be used It both locks and 9 6 3 unlocks the keypad by pressing the Decimal key followed by 9 6 amp 3 NOTE For Plum A43 keypad lock applies to individual pump in use NOTE Pressing of a key while lockout is active results in the display of the lockout enabled message This action is recommended to confirm each lockout activation 430 95215 003 Rev 10 05 Plum A Infusion Systems 3 7 NOTE If the lockout switch is put in the Locked position while the infuser is off the ON OFF key allows the unit to turn on The connector located below the lockout switch is the Nurse Call Relay Connector for providing remote notification of a nurse call event The RS 232 DataPort is used to interface with a host computer NOTE Do not
96. very rate when the VTBI becomes zero Default Drug A drug list of 99 drug names default Library DDL units and default concentrations plus No Drug Selected Deliver A Biomed Delivery option setting Together which selects default of Piggyback or Concurrent delivery mode 430 95215 003 Rev 10 05 2 6 2 Principles of Operation TERM DEFINITION Delivery Mode The normal operational mode for the Infuser either Concurrent or Piggyback during which fluid delivery may occur Delivery Rate The delivery rate as Volume Time assigned by the operator or calculated from other delivery parameters Device The Plum A IV Infusion Device Infuser not including the disposable administration sets Diluent The volume of fluid used with the Volume Diluent Unit e g 250 mL which dilutes the drug to be infused Distal Downstream output from the Cassette portion of the Administration Set Door The lever operated bottom hinged Cassette holder on the front of the Mechanism Dose Rate Delivery rate times drug concentration Dose Allows programming Dose Rates in Calculation alternative units of measure Dose Calculation can be used in Simple Delivery Loading Dose and Multistep Drug Amount The mass or quantity of the drug premixed with a Diluent to express the Concentration for the Line being programmed Duration The time period used to deliver a VTBI atan existing D
97. y Program Cancel Options Back NOTE Atthis point programming A A is complete unless 4 Program Options are desired See Section 6 Additional Features for more information NOTE Nurse Callback enables an alarm when a change in the Program Options delivery on a line occurs such as completing Step 1 and starting Delay Start for 00 ff min Step 2 Or on line B a piggyback delivery is completed and line A is starting its delivery Callback No Enter Value using keypad Cancel Standby Enter Back A PN PN 14 Enter a delay time less than or equal to 24 hours using the keypad Delay Start for 00 05 hr min NOTE Not available if a delivery is Callback Yes taking place on the line Change using Yes No Cancel Back NOTE Nurse Callback cannot be changed while a delivery is taking place on the line Yes No Enter 15 Select ENTER to accept the changes and 430 95215 003 Rev 10 05 Plum A Infusion Systems 5 19 return to the Program Loading Dose screen NOTE 4 CANCEL BACK returns the fields to their original value and displays the previous screen CAUTION VERIFY ALL VALUES BEFORE STARTING INFUSION 16 Press to begin program The Main Delivery Screen sroeeeo 8 appears Loading Dose Rate 500 0 Vol Inf 0 E 0 NOTE The words DELAYED and Loading Dose appear in the upper left corner These indicate the options which have been

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