Plum XL™ 3 Micro/Macro with DataPort
Contents
1. Minipole Attachment m Pole Clamp DataPort Lockout Switch Equipotential Post Audio Switch Power Cord System Operating Manual 4 1 Control Dial Settings SET VTBI SET RATE q OFF CHARGE HOLD RESET CLEAR VOL OFF CHARGE stops all active functions The battery charges in any dial setting whenthe Plum XL3 Micro Macro with DataPort is connected to AC power Store the Plum XL3 Micro Macro with DataPort in the OFF CHARGE setting and plugged into AC power SET RATE sets the delivery rate for the Daun or secondary line using the gt or key The rate range is 0 1 to 99 9 mL hr in 0 1 mL increments then 100 to 999 mL hr in 1 mL hr increments Note Use the QUICKSET key to quickly raise the rate to the next higher entry in this sequence 0 5 0 25 0 50 0 75 0 100 125 150 200 500 999 SET VTBI sets the volume to be infused delivered VTBI from the primary or secondary line using the gt r key The VTBI range is 0 1 to 99 9 mL in 0 1 mL increments then 100 to 9999 mL in 1 mL increments Note Use the QUICKSET key to quickly raise the VTBI to the next higher entry in this sequence 0 10 0 25 0 50 0 100 150 250 500 1000 2000 3000 4000 9999 8 Plum XL3 Micro Macro with DataPort E 5 y UN 4 2 Operating Ke2. 28 68 Lockout 29 7 0 TROUBLESHOOTING 30 TA Alarms ohne 30 7 2 Malfunctions 33 7 3 Technical Assistance 34 8 0 PRECAUTIONS 35 8 1 Artifacts ton ewe ALS oos 5 8 2 Healthcare Professional and Patient Related 35 83 Battery Operation 36 84 Sets and Accessories 36 8 5 Backpriming 37 8 6 General uoo we ee x99 C97 9 0 CLEANING MAINTENANCE AND STORAGE 39 9 1 Cleaning and Sanitizing 39 9 2 Battery Maintenance 42 933 Storage 2 2 7 42 94 Service 43 10 0 SYSTEM ACCESSORIES 44 11 0 SPECIFICATIONS 45 120 WARRANTY 47 Copyright 2004 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 Plum XL3 Micro Macro with DataPort 1 0 CONVENTIONS This section describes the conventions used throughout this manual as follows Convention Application Example Italic Reference toa See Figure 3 1 section figure or table Priming Cassette Function or mode Primary Only At
3. 1 G n H I e TOTAL VOLUME ML HR DELIVERED LOCKED Optional Set the panel lockout switch to locked to prevent unauthorized SECONDARY tampering of the device see Section 6 8 Lockout RATE 1 0 n H e TOTAL VOLUME ML HR DELIVERED 6 3 Piggyback Delivery To program the Plum XL3 Micro Macro with DataPort for piggyback delivery proceed as follows Turn the control dial to SET RATE System Operating Manual 23 PRIMARY SET RATE Oo e TOTAL VOLUME ML HR DELIVERED PRIMARY SET RATE g C fo TOTAL VOLUME ML HR DELIVERED PRIMARY 1080 Go TOTAL VOLUME DELIVERED SECONDARY PRIMARY SET Un ML HR Ua TOTAL VOLUME DELIVERED Press the PRI SEC key to select the primary line if it is not already selected Press the lt gt or gt key or the QUICKSET key to set the primary rate Turn the control dial to SET VTBI Press the lt gt or key or the QUICKSET key to set the volume to be delivered Turn the control dial to SET RATE Press the PRI SEC key to select the secondary line 24 Plum XL3 Micro Macro with DataPort SECONDARY SET TOTAL VOLUME ML HR DELIVERED SECONDARY VTBI it TOTAL VOLUME PIGGYBACK ML DELIVERED SECONDARY TOTAL VOLUME PIGGYBACK ML HR DELIVERED LOCKED SECONDARY TOTAL VOLUME PIGGYBACK ML HR DELIVERED System Operating Manual Press the lt or key or the QUICKSET key to set the secondary r
4. Note Accessories are updated without notice Contact a Hospira representative for current listings You can order these accessories by contacting Customer Service at 800 241 4002 DataPort Accessories List Number 9 pin PC to Junction Box Cable 11431 03 25 pin PC to Junction Box Cable 11431 04 Junction Box to Junction Box Cable 11431 07 Junction Box 12074 04 DataPort Programmer s Guide 11859 04 44 Plum XL3 Micro Macro with DataPort 11 0 SPECIFICATIONS PHYSICAL Dimensions Approximately 13 75H x 12 2W x 7 5D inches excluding pole clamp Weight Approximately 20 lbs with battery Casing High impact plastic ELECTRICAL Power Requirements 100 130 VAC 47 63 Hz less than 60 W Power Cord Hospital grade AC cord 10 ft long Fuses 1 0 A 250 V Slow Blowing Battery Rechargeable and sealed lead acid 8 V battery which is internal to the device Accessible for ease of field replacement with leads and a polarized connector Battery Life The Plum XL3 Micro Macro with DataPort is battery powered for emergency backup and temporary portable operation It should be operated on battery power until full discharge at least once every six months for optimum battery performance and life While DataPort is disabled during battery operation a fully charged new battery will provide operating time of approximately four hours when all pumping units operate simultaneously at a rate of 125 mL hr or a cumulat
5. RATE OFF CHARGE HOLD RESET service System Operating Manual 33 Record the error number displayed on the screen Hes Turn the control dial to OFF CHARGE E Turn the control dial to its previously set setting to retest the device If the malfunction recurs remove the Plum XL3 Micro Macro with DataPort from 7 3 Technical Assistance For technical assistance technical training information or to order parts accessories or manuals contact Hospira Technical Support Operations The telephone number for Technical Support Operations is 1 800 241 4002 Do not return the Plum XL3 Micro Macro with DataPort without prior approval from Hospira Technical Support Operations For technical assistance from outside the U S contact the nearest Hospira representative 34 Plum XL3 Micro Macro with DataPort 8 0 8 1 8 2 PRECAUTIONS For optimum operation of the Plum XL3 Micro Macro with DataPort observe the following precautions 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 th
6. The Plum XL3 Micro Macro with DataPort may be safely and conveniently mounted on an IV stand CAUTION The XL3 system is designed to operate normally in the presence of most encountered EMF conditions In the event of extreme levels of interference such as encountered next to an electrosurgical generator cellular telephones or two way radios it is possible that the normal operation of a sensor or microcomputer might be disrupted Operation of the infusion device under such conditions should be avoided Cassettes The Plum XL3 Micro Macro with DataPort is compatible with the wide range of PlumSets administration sets Become familiar with the components illustrated in the following figure before preparing the cassette System Operating Manual 11 Secondary Inlet Port Capped Primary Line Flow Finger Grip Regulator Pumping Air Trap Chamber 5 2 1 PREPARING THE CASSETTE Use aseptic technique to prepare the cassette for priming then proceed as follows Close the upper clamp on the N c3 administration set Push in the flow regulator to close it 12 Plum XL3 Micro Macro with DataPort System Operating Manual Expose the outlet of the IV container then insert the piercing pin into the outlet with a twisting motion Fill the drip chamber to the score mark Open the upper clamp 5 2 2 PRIMING THE CASSETTE To prime the cassette proceed as
7. accept the backprimed fluid General Possible explosion hazard exists if used in the presence of flammable anesthetics Product damage may occur unless proper care is exercised during unpacking and installation Do not use the Plum XL3 Micro Macro with DataPort if it appears damaged in any way Do not place Plum XL3 Micro Macro with DataPort in service if it fails the self test see Section 3 2 Self Test for detailed information System Operating Manual 37 The XL3 system is designed to operate normally in the presence of most encountered EMF conditions In the event of extreme levels of interference such as encountered next to an electrosurgical generator cellular telephones or two way radios it is possible that the normal operation of a sensor or microcomputer might be disrupted Operation of the infusion device under such conditions should be avoided The screen displays VTBI in 0 1 mL increments from 0 1 to 99 9 mL 100 to 9999 mL are displayed in 1 mL increments Any fraction of a milliliter delivered is not displayed but is retained in memory Keep the cassette door securely closed while the Plum XL3 Micro Macro with DataPort is not in use to avoid cassette door damage To avoid mechanical or electronic damage do not immerse the Plum XL3 Micro Macro with DataPort in any cleaning fluids or cleaning solutions Certain cleaning and sanitizing compounds may slowly degrade components made from some plastic materials Us
8. and pull straight out Do not pull out using the power cord cable and do not pull out at an angle Connect the AC power cord to AC power then confirm the AC power indicators illuminate next to the OFF CHARGE setting Place a primed administration set into the cassette door of a pumping unit see Section 5 0 INSTRUCTIONS FOR USE Close the cassette door After the cassette door is closed turn the control dial to SET RATE System Operating Manual 5 AIR IN LINE LOCKED LOW BATTERY KVO VTBI COMPLETE DOOR CASSETTE TURN TO RUN CHECK SETTINGS OCCLUSION SECONDARY PRIMARY BACKPRIMING s 0 A ABg ees PIGGYBACK ML HR MICRO DELIVERED q q q q aaa The LCD screen displays all the symbols briefly Verify that the screen display exactly matches the illustration shown at the left If the LCD screen does not match the illustration remove the Plum XL3 Micro Macro with DataPort from service and contact the hospital repair facility or Hospira Technical Support Operations After the general LCD self test the LCD screen displays duplicated segments of the numeric display Verify that the screen display alternates exactly as shown in the illustrations at the left If the display does not match the illustrations remove the Plum XL3 Micro Macro with DataPort from service and contact the hospital repair facility or Hospira Technical Support Operations After the Plum XL3 Micro Macro with DataPort completes self testing disconnect it fr
9. 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 Plum XL3 Micro Macro with DataPort Do not sterilize by heat steam ethylene oxide ETO or radiation To avoid device damage cleaning solutions should be used only as directed in the following table The disinfecting properties of cleaning solutions vary consult the manufacturer for specific information System Operating Manual 39 Establish a routine weekly schedule for cleaning the Plum XL3 Micro Macro with DataPort To clean the Plum XL3 Micro Macro with DataPort proceed as follows Turn the control dial to OFF CHARGE RUN SET VTBI aed then disconnect the Plum XL3 SERRATE i Micro Macro with DataPort from AC V emare power The exposed surfaces of the Plum XL3 Micro Macro with DataPort may be cleaned with a lint free cloth dampened with one of the recommended cleaning solutions listed as follows or a mild nonabrasive soapy water 40 Plum XL3 Micro Macro with DataPort Cleaning Solution Manufacturer Preparation Super Edisonite S M Edison Co Per manufacturer s recommendation Vesphene II se Calgon Vestal Laboratories Per manufacturer s recommendation Manu Klenz Calgon Vestal Laboratories Per manufacturer s recommendation Formula C Diversey Corporation Per manufacturer s rec
10. following delivery mode from each pumping unit A B or C o Primary only delivery o Secondary only delivery o Piggyback delivery When a rate and a VTBI are entered for the primary line and no settings are entered for the secondary line the Plum XL3 Micro Macro with DataPort will deliver primary only Likewise when a rate and a VTBI are entered for the secondary line and no settings are entered for the primary line the Plum XL3 Micro Macro with DataPort delivers secondary only When a rate and a VTBI are entered for the primary and secondary lines piggyback delivery the Plum XL3 Micro Macro with DataPort completes secondary delivery before it begins primary delivery Note The Plum XL3 Micro Macro with DataPort retains all previous therapy settings and fluid delivery data in its memory until the settings are cleared by the user Check the primary and secondary settings during the initial setup to confirm that all settings are correct Confirm the proper clearing of the total volume delivered before use Primary Only Delivery To program the Plum XL3 Micro Macro with DataPort for primary only delivery proceed as follows 20 Plum XL3 Micro Macro with DataPort PRIMARY SET RATE fo TOTAL VOLUME ML HR DELIVERED PRIMARY SET RATE 0 No TOTAL VOLUME ML HR DELIVERED PRIMARY 1900 PRIMARY dp ML HR System Operating Manual Ua TOTAL VOLUME DELIVERED D TOTAL VOLUME DELIV
11. follows Invert the cassette Turn the flow regulator until a drop of fluid is seen in the pumping chamber Turn the cassette upright then prime the remainder of the administration set Push in the flow regulator to close it Confirm that there is no flow 14 Plum XL3 Micro Macro with DataPort 5 2 3 LOADING THE CASSETTE To load the primed cassette into one of the three pumping units proceed as follows Open the cassette door by lifting the door handle Holding the primed cassette by its fingergrip slide it into the cassette door guides until it firmly seats in the door Close the cassette door Confirm that there is no flow 5 2 4 SECURING THE TUBING WARNING ARRANGE TUBING CORDS AND CABLES TO MINIMIZE THE RISK OF PATIENT STRANGULATION OR ENTANGLEMENT Press the tubing from the cassette into the grooves between the pumping units or into the grooves at the far sides of the platform under the pump modules refer to the following illustrations System Operating Manual 15 5 2 5 PREPARING THE SECONDARY LINE CAUTION Consult the drug container labeling to confirm drug compatibility concentration delivery rates and volumes are all suitable for intermittent or continuous secondary or piggyback delivery mode The Plum XL3 Micro Macro with DataPort features a secondary or piggyback delivery mode when patient
12. houses three independent pumping units each having a primary line secondary line and piggyback fluid delivery capability The Plum XL3 Micro Macro with DataPort is suited for a wide range of medical surgical and critical care applications Full compatibility with LifeCare PlumSets administration sets and accessories and the LifeShield needleless protection systems makes the Plum XL3 Micro Macro with DataPort a convenient and cost effective infusion system The following features are included in the Plum XL3 Micro Macro with DataPort o Nonpulsatile volumetric accuracy Micro Macro 0 1 999 mL hr flow rate range Convenient Quickset M Programming allows clinician to quickly increase rate and volume o Microprocessor control Large LCD screen Panel back illumination on AC power Lockout Switch Wide range of standard and specialty administration sets Standard fullfill partfill syringe and vial use Parenteral blood and nonparenteral enteral fluid delivery Anti free flow protection Backpriming Titration DataPort KVO at dose end 1 0 mL hr or less depending on delivery rate Oo e 00000 coo oc 0c o Long battery life for emergency backup and temporary portable operation System Operating Manual 3 2 1 User Qualification The Plum XL3 Micro Macro with DataPort infusion system is for use at the direction or under the supervision of licensed physicians or by licensed or certified healthcare professionals who are t
13. to the next higher entry in this sequence 0 10 0 25 0 50 0 100 150 250 500 1000 2000 3000 4000 9999 BACKPRIME clears any air accumulated in the cassette Press the BACKPRIME key when the control dial is in HOLD RESET to pump fluid from the primary line and expel the air into the secondary line Backpriming is also used to reprime empty secondary tubing SILENCE temporarily mutes audible alarms The alarm display and the LCD screen continue to flash The audible alarm resumes after two minutes if the alarm condition is not corrected To silence a Low Battery alarm refer to the alarm tips in Section 7 0 TROUBLESHOOTING 4 3 Additional Features AUDIO SWITCH located on the rear panel has two sound level settings high and low LOCKOUT SWITCH located on the rear panel may be used to prevent unauthorized changes to the Plum XL3 Micro Macro with DataPort settings 10 Plum XL3 Micro Macro with DataPort 5 0 5 1 5 2 INSTRUCTIONS FOR USE This section describes the Plum XL3 Micro Macro with DataPort setup and cassette use Setup To set up the Plum XL3 Micro Macro with DataPort plug the power cord into an AC power outlet unless temporary battery operation is desired Note Use AC power whenever possible Store the Plum XL3 Micro Macro with DataPort connected to AC power to ensure a fully charged battery for emergency use Set the audio switch to the desired volume level HIGH or LOW
14. DataPort are in two categories alarms and malfunctions 7 1 Alarms During an alarm condition associated with one of the pumping units the screen backlight and the alarm message flash while an alarm sounds To clear an alarm condition proceed as follows Press the SILENCE key Observe the SILENCE alarm message that displays RUN Turn the control dial to HOLD RESET SET VTBI HOLD RESET y At Correct the alarm condition CHARGE RUN Turn the control dial to RUN SET VTBI HOLD RESET SET RATE CLEAR VOL Q offer 30 Plum XL3 Micro Macro with DataPort The following tips help correct the alarm conditions that may occur CORRECTIVE MESSAGE POSSIBLE CAUSE ACTION AIR IN LINE Air detected distal to Remove and reprime cassette cassette AIR IN LINE Air detected proximal Backprime to expel all air BACKPRIMING to cassette CHECK SETTINGS Container empty Rate or VTBI not set Change container and backprime to expel air Turn to SET RATE or SET VTBI to check setting or enter values DOOR Cassette door open Turn to OFF CHARGE close cassette door then restart CASSETTE Cassette improperly Turn to OFF CHARGE loaded reload cassette then restart Cassette improperly Turn to OFF CHARGE primed reprime cassette then restart Cassette failed valve Turnto OFF CHARGE open leak test and close cassette door then restart If condition recurs replace PlumSet LOCKED Control dial turned Set lockout switch
15. E setting If the LOW BATTERY alarm sounds connect to AC power immediately Sets and Accessories Only PlumSets administration sets can be used with this device 36 Plum XL3 Micro Macro with DataPort 8 5 8 6 Sets should be changed in accordance with current recognized guidelines of IV therapy Discard sets per hospital procedures 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 delivery rates 5 0 mL hr or less the use of thick walled microbore Plumsets is recommended This will reduce the amount of the fluid bolus that may be delivered when a distal line occlusion is released Use the syringe adapter when using syringes 10 cc or smaller on the secondary line syringes must be larger than 3 cc Use 19 gauge or larger needle or catheter for viscous fluids if operating at rates greater than 500 mL hr Use a cassette with a capped secondary port when delivering viscous fluids on the secondary line Backpriming Backpriming is not recommended for reconstituting secondary containers containing dry powders To avoid pressurization when backpriming into a syringe or a vial the user mustensure that these containers have sufficient empty space to
16. ERED Turn the control dial to SET RATE Press the PRI SEC key to select the primary line if it is not already selected Press the lt gt or key or the QUICKSET key to set the primary rate Turn the control dial to SET VTBI Press the lt gt or key or the QUICKSET key to set the volume to be delivered Turn the control dial to RUN Primary only delivery begins 21 LOCKED PRIMARY TOTAL VOLUME ML HR DELIVERED Optional Set the panel lockout switch to locked to prevent unauthorized tampering of the device see Section 6 8 Lockout 6 2 Secondary Only Delivery To program the Plum XL3 Micro Macro with DataPort for secondary only delivery proceed as follows Note Confirm that the primary rate and the VTBI are set to 0 zero before programming secondary only delivery SECONDARY PRIMARY RATE Hn D TOTAL VOLUME ML HR DELIVERED SECONDARY SET 5o TOTAL VOLUME ML HR DELIVERED Turn the control dial to SET RATE Press the PRI SEC key to select the secondary line if it is not already selected Press the or key or the QUICKSET key to set secondary rate 22 Plum XL3 Micro Macro with DataPort Turn the control dial to SET VTBI Press the gt or key or the QUICKSET key to set the volume to be SECONDARY delivered SET VTBI TOTAL VOLUME ML DELIVERED Turn the control dial to RUN Secondary only delivery begins SECONDARY RATE
17. Edisonite are not trademarks of Hospira Inc NRTL C SA R CSA 22 2 No 125 UL 544 System Operating Manual CSA is a registered trademark of the Canadian Standards Association The use of NRTL C adjacent to the CSA mark indicates that the product has been certified by CSA to U S and Canadian standards CSA has been accredited by the U S Occupational Safety and Health Administration OSHA as a Nationally Recognized Test Laboratory NRTL 51 Hospira Inc Lake Forest IL 60045 USA
18. System Operating Manual With DataPort Hospira 430 9461 1 002 Rev 09 10 CHANGE HISTORY Revised Part Number Description of Change Pages 430 94611 001 Rev 3 98 Original release 430 94611 A01 Rev 09 04 Changed Abbott to Hospira Verbiage Front and Back Covers Change History iii 2 5 6 8 thru 11 15 19 30 34 38 thru 41 43 44 47 49 51 430 94611 002 Rev 09 10 Second release Note Change page manuals assembled by Hospira Inc include a change page identifier in the part number on the cover page and on the bottom of each changed page This change page manual is identified as 430 9461 1 002 i Plum XL3 Micro Macro with DataPort CONTENTS 1 0 2 0 3 0 4 0 5 0 6 0 CONVENTIONS 131 Warnings Cautions and Notes FEATURES 2 1 User Qualification GETTING STARTED 3 1 Unpacking 3 2 Self Test COMPONENTS 4 1 Control Dial Settings 4 2 Operating Keys 4 3 Additional Features INSTRUCTIONS FOR USE 5 1 Setup 5 2 Cassettes 2 5 2 1 Preparing the Cassette 5 2 2 Priming the Cassette 5 2 8 Loading the Cassette 5 2 4 Securing the Tubing 5 2 5 Preparing the Secondary Line 5 3 Using the DataPort 5 3 1 Attaching DataPort Accessories PROGRAMMING 6 1 Primary Only Delivery 6 2 Secondary Only Delivery 6 3 Piggyback Delivery 6 4 Backpriming 6 5 Changing Containers 6 6 Titration iiu System Operating Manual ii 6 7 Clear Volume
19. and b the replaceable batteries 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 watranties 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 or lot number has been altered effaced or removed The foregoing warranty shall also be void in the event any person including the Purchaser performs or attempts to perform any major repair or other service on the product without having been trained by an authorized representative of Hospira and using Hospira documentation and approved spare parts For purposes of the precedin
20. ate Turn the control dial to SET VTBI Press the gt or key to set the volume to be delivered PIGGYBACK displays on the screen when the volume to be delivered is entered Turn the control dial to RUN Piggyback delivery begins When secondary delivery completes Plum XL3 Micro Macro with DataPorts with software revisions 1 02 and earlier beep five times and begin primary delivery Optional Set the panel lockout switch to locked to prevent unauthorized tampering of the device see Section 6 8 Lockout 25 6 4 Backpriming Backpriming is typically used to clear accumulated air from the cassette or to clear air from the secondary line without disconnecting the administration set from the patient AIR IN LINE and BACKPRIMING display on the screen and an alarm sounds when air is detected in the cassette Fluid is backprimed from the primary line up through the secondary inlet port to expel the air To expel air from the cassette when using primary delivery secondary inlet port is capped or resealed or when using piggyback delivery proceed as follows Turn the control dial to HOLD RESET the alarm is silenced Primary only Attach an empty container or syringe to the secondary inlet port syringe shown Primary only Press and hold the BACK BACKPRIME key until enough fluid PRIME from the primary line expels the trapped air into the secondary container Piggyback P
21. e clamp of the set before removing the container to minimize spilling of fluid during replacement of the container 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 USP to decrease hemolysis and increase flow rate A small amount of fluid is expelled from the set less than 0 1 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 opening a cassette door close the clamp on the secondary set or remove the secondary container from the secondary port of that pumping unit to prevent mixing of primary and secondary fluids Repeated opening and closing of a cassette door may defeat the proximal AIR IN LINE alarm and may cause an AIR IN LINE alarm requiring cassette repriming Repeated opening and closing of a door may also cause the drip chamber to fill Battery Operation CAUTION Do not operate the Plum XL3 Micro Macro with DataPort with the battery removed The use of a properly maintained and charged battery ensures proper operation As always in the event of an AC power interruption or failure verify infusion pump settings The battery may not be fully charged upon receipt Connect the Plum XL3 Micro Macro with DataPort to AC power for at least six hours with the control dial in the OFF CHARG
22. ese 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 Healthcare Professional and Patient Related Product checkout should be performed by qualified personnel only Arrange tubing cords and cables to minimize the risk of patient strangulation or entanglement Consult the drug container labeling to confirm drug compatibility concentration delivery rates and volumes are all suitable for intermittent or continuous secondary or piggyback delivery mode 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 System Operating Manual 35 8 3 8 4 Before disconnecting a syringe from the cassette pull up the plunger slightly to avoid spilling the fluid For rigid containers e g vials open the cassette door remove and invert the cassette ports down Close the upper slid
23. g sentence major repair or other service means any repair or service other than the replacement of accessory items such as batteries and detachable AC power cords In providing any parts for repair or service of the product Hospira shall have no responsibility or liability for the actions or inactions of the person performing such repair or service regardless of whether such person has been trained to perform such repair or service It is understood and acknowledged that any person other than a Hospira representative performing repair or service is not an authorized agent of Hospira System Operating Manual 47 Notes 48 Plum XL3 Micro Macro with DataPort Notes System Operating Manual 49 Notes 50 Plum XL3 Micro Macro with DataPort For customer service within the United States contact 1 877 9HOSPIRA For technical assistance and product return authorization within the United States call 1 800 241 4002 Note Outside the U S contact your local Hospira sales office CAUTION Federal USA law restricts this device to sale by or on the order of a physician or other licensed practitioner WARNING A POSSIBLE EXPLOSION HAZARD EXISTS IF THE DEVICE IS USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS Patents Pending Plum PlumSets LifeShield and LifeCare are registered trademarks of Hospira Inc Plum XL3 and Quickset are trademarks of Hospira Inc Formula C Manu Klenz Vesphene II se and Super
24. imary or secondary is in progress To titrate fluid delivery hold down the TITRATE key and press the lt gt or 6 7 Clear Volume key to increase or decrease the delivery rate CLEAR VOL erases the total volume delivered from memory RUN SET VTBI HOLD RESET SET RATE CLEAR VOL n OFF CHARGE Note The total volume delivered is the total amount of fluid both primary and secondary delivered to the patient Toclear the total volume turn the control 28 Plum XL3 Micro Macro with DataPort dial to CLEAR VOL Four beeps sound before the total volume is cleared Note Tocancel the clear total volume function turn the control dial away from the CLEAR VOL setting before the fourth beep sounds e g turn the control dial to HOLD RESET 6 8 Lockout To avoid unauthorized tampering of the Plum XL3 Micro Macro with DataPort set the panel LOCKOUT switch to on When the lockout switch is on the word LOCKED appears on the LCD screen and the keys are inactive If the control dial is moved the LOCKED alarm will sound To clear the alarm set the LOCKOUT switch to off System Operating Manual 29 7 0 TROUBLESHOOTING This section contains solutions to routine clinical conditions that may occur while using the Plum XL3 Micro Macro with DataPort that do not require assistance from hospital or Hospira Technical Support Operations personnel Problems that may occur in the Plum XL3 Micro Macro with
25. infusion therapy requires administering more than one drug through a single patient line In addition to standard containers the Plum XL3 Micro Macro with DataPort uses syringes or vials on the secondary port for piggyback or secondary delivery The secondary line can be prepared without removing or repriming the cassette 16 Plum XL3 Micro Macro with DataPort Before preparing the secondary line observe the following guidelines o Review the backpriming function see Section 6 4 Backpriming Use sets with an appropriate secondary port Attach the secondary line syringe or vial to the appropriate secondary cassette inlet using an 18 or 19 gauge 1 1 4 inch or shorter needle blunt cannula or male adapter Syringes Attach the syringe adapter to syringes 10 cc or smaller syringes must be larger than 3 cc Vials Attach the vial adapter to the secondary line vial To prepare the secondary line use aseptic technique and proceed as follows Confirm that the cassette air trap is full of fluid If air is present use the backpriming function to expel the air Remove the cap from the secondary inlet m lt port unless a reseal port is used System Operating Manual c f 5 3 Using the DataPort Syringe Invert the syringe and expel the air syringe adapte
26. ing 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 Plum XL3 Micro Macro with DataPort Do not sterilize by heat steam ethylene oxide ETO or radiation To avoid device damage cleaning solutions should be used only as directed in Section 9 1 Cleaning and Sanitizing The disinfecting properties of cleaning solutions vary consult the manufacturer for specific information 38 Plum XL3 Micro Macro with DataPort 9 0 9 1 CLEANING MAINTENANCE AND STORAGE The cleaning maintenance and storage of the Plum XL3 Micro Macro are described in this section Cleaning and Sanitizing For proper maintenance of the Plum XL3 Micro Macro with DataPort observe the following cleaning and sanitizing guidelines CAUTIONS To avoid mechanical or electronic damage do not immerse the Plum XL3 Micro Macro with DataPort in any cleaning fluids or cleaning solutions Do not spray cleaning solutions toward any openings in the device or directly on the device Certain cleaning and sanitizing compounds may slowly degrade components made from some plastic materials Using abrasive cleaners or cleaning solutions not recommended by Hospira may result in product damage Do not use compounds containing
27. ive delivery of 1 000 mL at any combination of rates and pumping units While DataPort is enabled under the same conditions operating time will be approximately 2 hours Recharge The single battery charges whenever the Plum XL3 Micro Macro with DataPort is connected to AC power If the device pumping units are turned to System Operating Manual 45 ENVIRONMENT Operating Temperature TRANSPORT AND STORAGE ENVIRONMENT Temperature Relative Humidity Atmospheric Pressure DELIVERY RATE RANGE Primary Secondary Mode KVO DOSE LIMIT RANGE Primary Secondary Mode OCCLUSION RANGE Distal OFF CHARGE recharge takes approximately six hours Recharge takes longer if the pumping units are turned on 10 to 40 C 10 to 90 relative humidity 20 to 60 C 10 to 90 0 10 000 feet 0 3 000m or equivalent pressure 0 1 to 99 9 mL hr in 0 1 mL increments 100 to 999 mL hr in 1 mL increments The lower of 1 0 mL hr or the last rate delivered 0 1 to 99 9 mL in 0 1 mL increments 100 to 9999 mL in 1 mL increments 10 psig 5 2 psig 46 Plum XL3 Micro Macro with DataPort 12 0 WARRANTY Subject to the terms and conditions herein Hospira Inc herein referred to as Hospira warrants that a the product shall conform to Hospira s standard specifications and be free from defects in material and workmanship under normal use and service for a period of one year after purchase
28. off Set flashing while lockout switch is unit for desired operation on System Operating Manual 31 Set lockout switch on MESSAGE POSSIBLE CAUSE CORRECTIVE ACTION LOW BATTERY Approximately 30 minutes of battery power remains Connect to AC power Note Pressing the SILENCE key mutes the audible alarm for 15 minutes from the time the LOW BATTERY alarm occurred Note When the battery discharges pumping stops and the alarm sounds continuously for one minute before the device shuts down completely OCCLUSION Clamp closed Open clamps Tubing kinked Unkink tubing Possible clotted Check IV site catheter TURN TO RUN Control dial is not in Turn control dial to RUN OFF CHARGE or RUN setting and no key is pressed for five minutes OFF CHARGE or HOLD RESET 32 Plum XL3 Micro Macro with DataPort MESSAGE POSSIBLE CAUSE CORRECTIVE ACTION VTBI COMPLETE Secondary Only or Primary Only Programmed VTBI completed Piggyback Primary VTBI completed Note KVO also displays on the screen indicating the KVO rate is in progress Discontinue infusion or change container and program new VTBI setting 7 2 Malfunctions During a malfunction associated with one of the pumping units an Er and an error number display on the screen and the audible alarm sounds To verify the malfunction proceed as follows Ti q 1 SET VTBI SET
29. om AC power and confirm that BATTERY displays on the screen indicating battery power is in use Repeat the procedure above for the remaining two pumping units CAUTION Do not operate the Plum XL3 Micro Macro with DataPort with the battery removed The use of a properly maintained and charged battery ensures proper operation As always in the event of an AC power interruption or failure verify infusion pump settings To ensure the battery is fully charged remove the administration set then reconnect the Plum XL3 Micro Macro with DataPort to AC power for a minimum of six hours in the OFF CHARGE setting Note Ifan alarm occurs during the self test note the message then take the appropriate corrective action see Section 7 0 TROUBLESHOOTING Repeat the self test If the alarm recurs remove the Plum XL3 Micro Macro with DataPort from service and contact Hospira Technical Support Operations 6 Plum XL3 Micro Macro with DataPort 4 0 COMPONENTS The front and back of the Plum XL3 Micro Macro with DataPort components are illustrated below ain ia Door Handle A puy me Cassette Door LCD Screen Control Dial X 41 AC Power Indicator LH Pump Operating Indicator
30. ommendation Household bleach Various Per hospital procedures do not exceed one part bleach in ten parts water On aroutine basis clean all of the elements behind the cassette doors using cotton tipped swabs saturated with cleaning solution The cassette doors may be unlatched from their door handles to facilitate cleaning System Operating Manual 41 To unlatch a cassette door from its handle tilt the device back open the cassette door then push the door release tab to open the door fully 9 2 9 3 Battery Maintenance CAUTION Do not operate the Plum XL3 Micro Macro with DataPort with the battery removed The use of a properly maintained and charged battery ensures proper operation As always in the event of an AC power interruption or failure verify infusion pump settings CAUTION Ifthe LOW BATTERY alarm sounds connect the Plum XL3 Micro Macro with DataPort to AC power immediately The Plum XL3 Micro Macro with DataPort is battery powered for emergency backup and temporary portable operation It should be operated on battery power until full discharge at least once every six months for optimum battery performance and life While DataPort is disabled a fully charged new battery will provide operating time of approximately four hours when all pumping units operate simultaneously at a rate of 125 mL hr or a cumulative delivery of 1 000 mL at any combination of rates and pumping units While DataP
31. ort is enabled under the same conditions operating time will be approximately 2 hours The battery charges whenever Plum XL3 Micro Macro with DataPort is connected to AC power If all Plum XL3 Micro Macro with DataPort pumping units are turned to OFF CHARGE recharge takes approximately six hours Recharge takes longer if the pumping units are 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 hospital biomedical technician for battery replacement if necessary To maintain maximum battery charge and to prolong battery life keep the line cord connected to AC power whenever possible Storage To prolong the life of the Plum XL3 Micro Macro with DataPort observe the following guidelines o Turn the control dial to the OFF CHARGE setting o Store the Plum XL3 Micro Macro with DataPort away from excessive heat cold and humidity 42 Plum XL3 Micro Macro with DataPort o Store the Plum XL3 Micro Macro with DataPort connected to AC power 9 4 Service All servicing or adjustments to the Plum XL3 Micro Macro with DataPort should be referred to qualified technical personnel A Technical Service Manual may be ordered from Hospira Technical Support Operations System Operating Manual 43 10 0 SYSTEM ACCESSORIES Plum XL3 Micro Macro with DataPort is compatible with all Plum accessories and all PlumSets administration sets
32. r with blunt cannula is shown Attach the secondary container to the secondary inlet port capped port shown on the left prepierced port on the right Syringe When using a 3 to 5 cc syringe retract the plunger to draw approximately 1 mL of air into the syringe to clear fluid from the adapter filter Vial or Syringe Secure the container to the cassette door using the optional container support arm Vial Attach the vial adapter to the secondary port Backprime the air from the vial adapter into the vial if necessary The Plum XL3 Micro Macro with DataPort Infuser can utilize optional communications accessories to establish a link between one or several infusers and a host computer see Accessories Section 10 18 Plum XL3 Micro Macro with DataPort When the infuser is linked to a properly equipped host computer infuser status can be monitored from a remote location Note The communications link between the infuser and the host PC is monitor only The infuser cannot be controlled from a remote location 5 3 1 ATTACHING DATAPORT ACCESSORIES Note For instructions on using the DataPort see the documentation packaged with the Junction Box and other DataPort accessories listed in Section 10 Note Attaching or removing accessories from the DataPort while the device is pumping will not affect infuser operation System Operating Manual 19 6 0 6 1 PROGRAMMING The Plum XL3 Micro Macro with DataPort has the
33. rained in the use of the Plum XL3 Micro Macro with DataPort and the administration of parenteral or enteral fluids and drugs 4 Plum XL3 Micro Macro with DataPort 3 0 3 1 3 2 GETTING STARTED This section describes the instrument installation procedures for the Plum XL3 Micro Macro with DataPort Unpacking CAUTION Product damage may occur unless proper care is exercised during unpacking and installation Do not use the Plum XL3 Micro Macro with DataPort if it appears damaged in any way The battery may not be charged upon receipt Inspect the Plum XL3 Micro Macro with DataPort packaging for visible shipping damage If any damage is found contact the delivering carrier immediately Carefully remove the Plum XL3 Micro Macro with DataPort from the shipping carton Retain the packing slip and save all packing material in case the Plum XL3 Micro Macro with DataPort is damaged or fails the self test and has to be returned to the manufacturer Inspect the Plum XL3 Micro Macro with DataPort thoroughly for damage CAUTION Ifthe Plum XL3 Micro Macro with DataPort appears to be damaged contact Hospira Self Test CAUTION Do not place the Plum XL3 Micro Macro with DataPort in service if it fails the self test Note When plugging the device into an AC power outlet grasp the AC power cord plug and use a forward motion into the socket Do not use a sideways motion When unplugging the device grasp the AC power cord plug
34. ress and hold the BACKPRIME key until enough fluid from the primary line expels the trapped air into the secondary line syringe or container BACK PRIME Ee E Note The fluid backprimed from the primary line is not added to the total volume delivered or subtracted from the 26 Plum XL3 Micro Macro with DataPort VTBI Backpriming cannot be used for clearing air in the line distal to the cassette Primary only Remove the container attached to the secondary inlet port then cap the port if appropriate RUN To resume delivery turn the control dial SET VTBI HOLD RESET to RUN SET RATE CLEAR VOL 3 offer 6 5 Changing Containers To change a container use aseptic technique and proceed as follows Ri Turn the control dial to HOLD RESET UN SET VTBI HOLD RESET SET RATE CLEAR VOL Q olor System Operating Manual 27 RUN SET VTBI HOLD RESET SET RATE CLEAR VOL j 0E CHARGE RUN SET VTBI HOLD RESET SET RATE CLEAR VoL V1 cific 6 6 Titration With the cassette door closed spike the new container Note If opening the cassette door close the primary and secondary clamps before removing containers to prevent mixing Turn the control dial to SET VTBI then set the volume to be delivered To resume delivery turn the control dial to RUN Titrationis the incremental adjustment of the fluid delivery rate while pumping pr
35. tach specific instructions an empty container ALL CAPS Keys or touchswitches OFF CHARGE on the device are described all caps in brackets ALL CAPS Screen displays and TURN TO RUN Initial Caps device labels as lowercase appropriate Bold Emphasis Sets are supplied Sterile and are for 1 1 Warnings Cautions and Notes Alert messages used throughout this manual are described below Pay particular attention to these messages WARNING A WARNING MESSAGE CONTAINS SPECIAL SAFETY EMPHASIS AND MUST BE OBSERVED AT ALL TIMES FAILURE TO OBSERVE A WARNING MESSAGE IS POTENTIALLY LIFE THREATENING System Operating Manual 1 CAUTION A CAUTION usually appears in front of a procedure or statement It contains information that could prevent irreversible product damage or hardware failure Neglecting to pay attention toa CAUTION could result in serious patient or user injury Note A Note highlights information that helps explain a concept or procedure N This symbol directs the user to consult accompanying documents Note Figures are rendered as graphic representations to approximate the actual product therefore figures may not exactly reflect the product 2 Plum XL3 Micro Macro with DataPort 2 0 FEATURES The Plum XL3 Micro Macro with DataPort is a multi line volumetric infusion system designed to meet the growing demand for hospital wide standardization The Plum XL3 Micro Macro with DataPort
36. ys QUICKSET TITRATE QUICKSET TITRATE System Operating Manual RUN starts fluid delivery at the rate set by the user RUN is the only setting that delivers fluid The pump operating indicator light on the front panel flashes during pumping HOLD RESET stops fluid delivery Fluid containers can be changed in this setting If the pumping unitis in an alarm condition HOLD RESET silences the audible alarm Alarm messages are retained until control dial is returned to the RUN setting CLEAR VOL clears the total volume delivered To avoid unintentional erasure of volumes an alert sounds to allow the user to change the setting before the volumes are cleared see Section 6 7 Clear Volume PRI SEC selects the fluid line to program Press the PRI SEC key when the control dial is in SET RATE or SET VTBI to toggle between the primary and secondary line TITRATE adjusts the fluid delivery rate up or down while pumping is in progress Hold the TITRATE key while pressing the or key to increase or decrease the delivery rate QUICKSET changes the rate to change in preprogrammed increments With the Plum XL3 Micro Macro with DataPort in SET RATE mode pressing the QUICKSET key causes the rate to BACK PRIME SILENCE change to the next higher entry in this sequence 0 5 0 25 0 50 0 75 0 100 125 150 200 500 999 With the instrument in VTBI mode pressing the QUICKSET key causes VTBI to change
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