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1. Therefore j eb ce TT RATE 1 DB ML HR e Ifthe graph slopes upward from left to right then the pump is headed toward occlusion fe ce TT RATE 1 BB ML HR CLEAR TWD e Ifthe graph is level then backpressure is steady FlowSentry Rapid Occlusion Detection FlowSentry is an internal program unique to the 3500 that monitors and analyzes delivery pressure When activated FlowSentry will alert the clinician to the existence of an occlusion much more rapidly than conventional occlusion alert systems How do you know if FlowSentry has been activated 1 During startup and during the stabilization period following a rate change a pound sign will appear to the left of the pressure trend graph The presence of the indicates that FlowSentry is active and that the delivery pressure is stabilizing j e o amp Bn Two 1 68 ML PWD 1 55 mL H RATE 188 ML HR CHG RATE TITRATE CLEAR TWD 2 Once the delivery pressure has reached a stabile level the sign will be replaced by a horizontal arrow gt j e o 6o Two 4 38 ML FWD 4 98 HL RATE 188 ML HR CHG RATE TITRATE CLEAR TWD Medex Part G6000608 Revision 3 Operation Manual Page 48 MEDEX Medfusion 3500 If there is an increase in the delivery pressure the horizontal arrow will be replaced by a vertical arrow 7 E D HLT TwD 1 211 mL Fw 1 211 ML H T RATE 1 ML HR CHG RATE TITRATE CLEAR TWD In this way the c
2. Operation Manual Page 39 MEDEX Medfusion 3500 13 VOLUME LIMIT A Volume Limit is an Option available for most delivery modes except volume time and intermittent volume time On reaching the preset volume limit the pump stops or changes to K VO if a keep vein open rate has been programmed Volume limit is based on the quantity of programmed volume delivered Enable Disable Volume Limit If Volume Limit Dosing is not currently available as a dosing option you can enable it through custom pump configuration 0 Setting Volume Limit You can set a volume limit either before starting an infusion or by pausing the pump during an infusion Volume limit is found on the OPTIONS screen which you select from the BEGIN INFUSION screen START TO EEGIH INFUSION PD HHHH mL EOLUS aS ML wv LIMIT BE ML RATE 3 5 ML HR E FLATES CHG RATE OF TIONS CLEAR TOTALS 1 When pump is paused press the Options button to find the volume limit feature PRESS THE HUMEER TO SELECT THE PROGRAM OPTION 1 STANDE Y 5 SAVE TO LIERARY c LOADING DOZE J BOLUS DOSE d VOLUME LIMIT 2 Press the number button for volume limit to call the ENTER VOLUME LIMIT screen ENTER VOLUME LIMIT FRESS ENTER TO COHTIHUE CURRENT SETTING Max 6 HIH Fe eB ML BACKSFACE Disable turns Volume Limit OFF CLEAR deletes an entry Backspace erases a character 3 Use the number buttons to set the volume limit Volume is li
3. When using E Plates preset values are automatically inserted without pausing to verify each setting You go directly to the BEGIN INFUSION screen where all the infusion values Warning are displayed at once Be sure to verify their correctness before starting the delivery Confirm All Certain data fields may be programmed blank eg patient weight and require data entry before the infusion will proceed Settings Extra caution should be exercised when using E Plates It is recommended each organization unit or department maintain a written logbook of the contents of every E Plate and have this logbook available as a reference resource for personnel using E Plates in their daily operations The steps in this section are hypothetical The Medfusion 3500 infusion pumps are Displaying shipped with all the libraries both blank and disabled So the actual E Plates you have E Plate Options available depend entirely on whatever E Plates and standard library entries your system operator has programmed into your pump A Using Standard Libraries If a standard library enabled the pump displays this library selection under the Main menu 1 Ifyou don t see a library listing on the SELECT THE MODE screen press the More button to find it on another screen otherwise it is necessary to enable that library using the custom configuration PRESS THE HUMBER TO SELECT THE MODE 1 ML HE Ce WOLUME TIME BL MICROGHSZ Ku MIMUTE d RECAL
4. 3 Ensure all medications or fluids are compatible with the syringe catheters tubing and fittings used in the infusion setup 4 Always ensure fluids are compatible with each other when infusing more than one fluid or medication through the same infusion site If connecting more than one pump to the same infusion site use one way check valves to prevent pumps from interfering with each other Verify that the pumps will operate together without alarming Failure to strictly adhere to these principles of use can cause over infusion or under Tate L Warning infusion with possibility of serious injury or death Do not use on the inlet side of Extracorporeal Membrane Oxygenation ECMO systems where the negative pressure is greater than 100mm Hg as the high negative pressures can result in uncontrolled fluid flow Warning ECMO use Never use the pump in magnetic fields above 150 gauss Always secure the pump to a non moveable object In magnetic fields above 150 gauss the attraction of the pump Warning A Tele to the magnet may be a hazard Fields Above 150 Gauss This pump may be operated in static magnetic fields up to 150 gauss for specific MRI devices identified in Appendix 5 Medex Part G6000608 Revision 3 Operation Manual Page 3 MEDEX Medfusion 3500 Features amp Controls Below 1s an illustration of the pump in a front view with callouts identifying major elements F 2 LT A XC Z
5. Trademark Owner Manufacturer Omnifix and Perfusor B Braun Medical AG Medex Part G6000608 Revision 3 Operation Manual Page 9 MEDEX Medfusion 3500 5 OPERATION WARNINGS amp CAUTIONS This chapter contains vital information in the form of warnings and cautions that apply to operation of this infusion pump As an operator of this pump you are responsible for knowing and using this information Warnings Below is a table of warnings and conditions for operation of the Medfusion3500 infusion pump Other warnings are posted throughout this manual A Warning defines a potentially serious life safety hazard specific limitations for using this device imposed by the hazard and the steps for avoiding the hazard Operational Warnings Always purge all air from syringe and infusion lines before connecting to the patient Air infused Avoid Air Emboli into a patient may cause serious injury and or death Flammables Never use pump in presence of flammable anesthetics oxygen enriched atmospheres or explosive gases Always read manufacturer precautions and guidelines for medications or fluids infused with this pump Medications or fluids may interact with the plastic components of the infusion syringe and sets This interaction may result in serious injury and or death to the patient Manufacturer Guidelines Always use the Prime function on the pump when loading a new syringe in order to remove any mechanical slac
6. 3 Set Delayed Start time in hours amp minutes The maximum delayed start setting is 6 hours The default delayed start time is 1 00 Hr ENTER DELAYED START TIME FRESS EHTEK TO COHTIHUE Hza CURRENT SETTING Max BeBe 03 00 HIH BAHA HR MIH REhR EncksrFacE ENTER 4 Whenready press the Enter button to accept the Delayed Start setting and go to the BEGIN INFUSION screen OPTIONS CLEAR TOTALS 5 The Delayed Start timer then appears in the upper right corner onscreen counting down The Distracted user alarm is disabled for this interval Delayed Start continues until timer has counted to zero You can discontinue Delayed Start mode at any time by pressing the Start button or by setting Delayed Start to Zero 6 When the counter reaches zero the pump begins the infusion Medex Part G6000608 Revision 3 Operation Manual Page 45 MEDEX Medfusion 3500 17 OVERRIDE AND TOGGLE FEATURES IN THE INFUSION PROGRAM OPTIONS The OPTIONS key when the pump is paused at the BEGIN INFUSION screen will give access to override and toggle options that will effect the current infusion only The Option key will return to the default selection whenever the pump is turned off or whenever the program is returned to the main menu prior to beginning the next infusion The override and toggle features that will automatically return to their default settings at the conclusion of the current infusion are e Override Occ
7. Delivered On the display PVD or PDD accumulates as the volume or dose delivered to the patient while in the current programmed delivery This display totals the boluses loading dose and normal delivery volumes PRESS lt START gt TO EEGIH INFUSION CONE 1 2 MG ML FD A HL WEIGHT CH EG DOSE cab MCGEG MIH RATE 6 25 ML HR E FLATES cHG DosE oFTIOHS CLEAR TOTALS e Priming volume which should never be delivered to the patient does not accumulate on this display e Program volume or dose delivered Appears on screen during DELIVERY and while the pump pauses e Toggle between PVD or PDD Available through Options menu when paused provided this has been set e Program Dose Delivered Only available when concentration has been programmed PRESS THE HUMEER TO SELECT THE FROGRAM OFTIOW 1 STANDE Y c CHANGE TO TOTAL DOSE Medex Part G6000608 Revision 3 Operation Manual Page 54 MEDEX Medfusion 3500 Use the following steps to clear the total volume and program volume or dosage and reset the counter to zero 1 From the pause screen press the Clear Totals program key CLEAR TOTAL VOLUME DELIVERED e Confirmation is required to clear totals delivered e Press Yes to clear total volume delivered and program volume or dose delivered Or press NO to exit without clearing e The program volume or dose delivered is cleared automatically whenever the pump s delivery mode or syringe size is c
8. All users of this pump are responsible for knowing this information Before using any Medfusion 3500 you the operator must be thoroughly familiar with the T contents of the operations manual including all warnings cautions and instructions for use If you use this pump you are responsible for knowing these things This syringe infusion pump is intended for use only under direction of trained medical Warning professionals Caution United States Federal law restricts this device to sale by or on the order of a physician m This manual and its contents are valid for use with all software versions starting with 3 0 x for Usability example 3 0 0 3 0 1 etc O 1998 2003 by Medex Inc All Rights Reserved Manufacturer Medex Inc Carlsbad CA USA Tel 800 848 1757 C 0120 Authorized EU representative Medex Medical Ltd St Crispin Way Haslingden Rossendale Lancashire BB4 4PW Great Britain Tel 44 0 1706 233826 Medex Part G6000608 Revision 3 Operation Manual Page 1 MEDEX Medfusion 3500 2 INTRODUCTION The Medfusion 3500 syringe infusion pump is designed for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates Because of the pump s simplicity and ease of use this pump can also be used successfully in the non critical areas of a clinical setting The only people authorized to setup amp monitor any infusion are nurses physicians or other health care
9. Glass Medex Part G6000608 Revision 3 Operation Manual Page 70 MEDEX Medfusion 3500 27 APPENDIX 2 FLOW DELIVERY CALCULATIONS Rate calculations used by different delivery modes in the syringe infusion pump Here the maximum rate is limited by syringe size or the custom configured maximum rate limit The minimum rate 1s limited by the syringe size E NN 3 4 3 32 3 4 3 3 3 4 3 32 33 3 32 3 4 3 32 33 3 42 3 3 3 32 3 3 3 3 3 4 3 4 3 4 3 3 3 4 3 3 3 4 3 3 3 4 3 32 3 32 32 3 3 32 3 4 3 32 3 3 32 3 4 3 32 3 4 3 32 3 3 3 32 3 3 32 32 3 3 32 3 3 4 3 32 3 3 32 32 3 3 32 33 3 3 32 3 3 3 3 3 3 32 3 3 3 3 3 32 34 3 4 32 32 3 4 3 32 3 4 32 32 3 3 32 32 3 3 32 32 3 3 32 32 3 3 32 32 2 32 2 2 32 2 2 3 2 2 3 2 3 4 2 3 2 3 3 2 3 4 2 3 2 3 4 2 3 22 34 22 5 Mass modes Below is a table of mass modes and the formulae used to calculate them Type of Mode How it is Figured Rate is calculated as mass delivery rate microgram min times 60 min hr divided by incon concentration mg ml divided by 1000 Rate is calculated as mass delivery rate microgram hr divided by concentration mg ml mcg hr e divide by 1000 Rate is calculated as mass delivery rate milligram min times 60 min hr divided by mg min concentration mg ml mg hr Rate is calculated as mass delivery rate milligram hr divided by concentration mg ml PUDE Rate is calculated as mass delivery rate milliUnits min times 60 min hr divided by concentration U ml d
10. Press the Alarm Silence button AF to silence the alarm for another 30 seconds Alarm o e Finish numerical entries and reach the BEGIN INFUSION screen with the normal alarm silence interval 1 Use the number buttons to set flow rate and decimal point Press Clear to clear an entry Press Backspace to erase a character Press the Enter button to accept the setting ENTER RATE PRESS ENTER TO COHTIHUE BE MIH Fal ML HA M CLEAR EACESPACE EMTER 2 After all infusion values are set the pump pauses at the BEGIN INFUSION screen PRESS STRRT TO EEGIH IHFUSIOH FD 4 444 mL Ca ML HR E FLHTEZ CHG RATE OF TIOHS CLEAR TOTALS E PLATES or MAIN MENU returns you to the beginning of setup CHG RATE allows modifying the set rate without starting from scratch OPTIONS lets you select from a list of variables e g bolus or volume limit CLEAR TOTALsS lets you clear total volume delivered and PVD or PDD 3 You may now accept the settings and start the infusion or use the four menu buttons to modify the settings 4 Prior to beginning the infusion press lt BOLUS gt to initiate the priming sequence page 21 5 When ready press the Start button to begin infusion Medex Part G6000608 Revision 3 Operation Manual Page 26 MEDEX Medfusion 3500 Mass Modes Mass Modes mg min mg hr mcg min mcg hr mU min mU hr u min u hr This Mass Mode 1s a continuous infusion mode yo
11. Revision 3 Operation Manual Page 29 MEDEX Medfusion 3500 This Intermittent Volume Time Mode lets you specify a delivery volume for a specific delivery time after which the delivery stops for a programmed interval then the pattern recycles In other words the pump delivers for a set period then pauses a set period then infuses for a set period and so on e The delivery stop interval equals Time Between Starts minus Delivery Time e The pattern repeats at Time Between Starts interval Below are the steps for programming an Intermittent Volume Time infusion Select Intermittent Volume Time from the SELECT THE MODE screen This calls the VOLUME TO INFUSE screen ENTER VOLUME TO INFUSE FRESS ENTER TO COMTIHLE Max 6h HIM Gd 3o HE LS EACKSPACE 1 Use the number buttons to set the volume Volume here is limited to the maximum fill volume for the syringe size and minimum volume is 1 600 of syringe size 2 When ready press the Enter button to accept the Volume to Infuse setting and call the DELIVERY TIME screen 3 Use the number buttons to type in the Delivery Time setting Maximum and minimum times are calculated for the syringe you are using When ready press the Enter button to call the TIME BETWEEN STARTS screen ENTER DELIVERY TIME Max gdb MIH BAHS OZ 00 EACKSPACE 4 Use the number buttons to set the Time Between Starts value Time must be greater than delivery time and less
12. Small Internal Diameter Tube ra 17 8 SETUP EOADSYRINGES 2 etie O y 18 TUNN Onde PII odisse etn en ne eet A A 18 What the Pump Does Not TUMOR 18 Sclectine Delivery Md 19 Syringe Matnnfactuter ype daa 19 What if Only One Syringe Manufacturer is Setup 19 Loading ie 20 Primis ie 21 L ntoadie the yin a 22 9 STARTING amp STOPPING INFUSION DELIVERY cernerent entnehmen nnns 23 Sia Delon RTI T A 23 Strine Delivery TEOr Sa 23 Makins Changes D ring DeltVely3 iai a 24 NO 24 TUN Ohe PUN A A AAA AAA 24 10 PROGRAMMING DELIVERY MODES es o 25 Overview OF Pro Sram SA do 25 Medex Part G6000608 Revision 3 Operation Manual Page ii MEDEX Medfusion 3500 Apparently Missing or Different EPS ai 25 REDealed AN 3 25 Continuous Mode RA ia 26 E O UU M E E e nes 24 Body Weireht Infusion Deliveries od aon vM esM ol du io HA DU CAU A MUS 28 Volume Time ML IR e e E M oe DE oa 28 Intermittent VO O 30 RECAM O EE EE TTE 3 COSA era rena Mansi Cnet ete A E O epe OD LM o e Coe e LS CI Mui Sd 32 Types or Custom Ditl tton Ayala least oia et onn deti ota tia on dete uasa ata 32 Calculaune DIOS ois n t eee ONEA OE OON etu E EAE 32 Ll BOLUS DOSING A A oat dI d Eu O 35 Setup BOS DO Mal ata 35 Deliyem a BOS DOS he ee EID E 36 2 TOADNGDOSES A cadence seu Ee t e dra ED dda o d dede 38 Dei CAO AGI OOS 6 NR RR RR ERR 38 Delverme a Eogdinp IO 39 I3 VOLUME CMI ara AAA cat o tiw ee Ehre iS 40 40 Id KEEP VEINO
13. as volume ml divided by time hours minutes where time is rationalized volume time as hours plus minutes divided by 60 Rate is calculated as volume ml divided by time hours minutes where time is rationalized OS as hours plus minutes divided by 60 here there is a time between deliveries with no flow Below is a table of parameters needed to generate the custom dilution formula Parameter Units Abbreviation initial drug concentration mg ml IC target volumetric rate TVR target dose rate TDR Dose rate is chosen from list of mg kg min mg kg hr mcg kg min mcg kg hr THE RESULTS FROM THE DILUTION CALCULATION Result Unit Type Volume of drug ml VDR Medex Part G6000608 Revision 3 Operation Manual Page 72 MEDEX Medfusion 3500 HOW THE CALCULATION IS PERFORMED The custom dilution calculation performed is as follows l SUSO A a 9 Find target mass delivery rate TDR times W times 60 min hr result is in mg hr units Note for body weight modes in hr the times 60 min hr is omitted in the equation Find target concentration target mass delivery rate TVR result is in mg ml units Calculate dilution ratio target concentration IC Result is ratio unitless Calculate Volume of Drug VDR Dilution ratio FV Round result to nearest ml Calculate Volume of Diluent VDL FV VDR Result is in ml Calculate Final Concentration C VDR FV IC Re
14. for turning on the infusion pump FERFORMIHG SELF TEST JUEBEA MEDFUSION 3000 vERZIAOH SEH Mei 2s4 CONFIG Io SE69 ca 959 2002 5 SECONDS REMAINING MEDE 1 Press and hold the Power button until the dark screen appears Verify the screen shows all pixels on then all pixels off 2 The pump should beep twice and then the indicators flash for Alarm Infusing and Lock as the self test cycles The pump ID if it has one appears in the upper left corner In this case it is called Jobara The pump serial number will appear at the middle right if it has been set in the software In this case it 1s M01234 3 You should now verify the display indicates successful completion of system startup self tests WHAT IF THE PUMP Does NoT TURN ON If the pump does not turn ON with successful completion of self tests remove it from service and have it checked by a trained biomedical technician PRESS THE HUMEER TO SELECT THE MODE 1 VOLUME TIME E MG MIHUTE c MICROGMS HR E MILLIUMITS HR J MICKOGHS MIHUTE T MILLILIMITS MIMUTE d MG HR B UNITS HR E FLaTES SWART Medex Part G6000608 Revision 3 Operation Manual Page 18 u Selecting Delivery Mode Below are the steps for selecting a delivery mode for programming with infusion settings 1 After successfully completing its system startup self tests the pump displays the SELECT THE MODE screen e The delivery modes on this screen wer
15. on the ENTER KVO RATE screen K VO rates are calculated by syringe size and its minimum flow rate e The programmed KVO rate must be ess than the normal delivery rate and greater than or equal to minimum flow rate for the syringe Once the volume limit has been reached the pump will begin infusing at either the programmed KVO rate or the current infusion rate which ever is less Enable Disable KVO dosing KVO dosing can be enabled or disabled through custom configuration pump 1 You can set a KVO rate at the BEGIN INFUSION screen either before starting an infusion or by pausing the pump during an infusion You can find it by pressing the Options button on the BEGIN INFUSION screen 2 When pump is paused press the Options button to call the SELECT THE PROGRAM OPTION screen PRESS START TO BEGIN INFUSION FWD Ad HL LIMIT amp ML RATE 3 5 ML HRE E FLATES CHG RATE OF TIONS CLEAR TOTALS PRESS THE HUHEEK TO SELECT THE FROGRAM OFTIOW 1 STANDE Y D EYO c LOADING DOSE E SAVE TO LIERARY J BOLUS DOSE d VOLUME LIMIT rs es DISABLE BACK SPACE ENTER 3 Find the KVO option Press its number button call the ENTER KVO RATE screen Use the number buttons to set the KVO rate within the minimum and maximum rates onscreen 5 When ready press the Enter button After the K VO setting is complete the pump pauses The KVO setting now appears on the BEGIN INFUSION screen gt PRESS STRRT TO EEGIH INFUSION FD ALARM HL BOLUS c
16. professionals with training in infusion therapy and operation of the syringe pump The Medfusion 3500 syringe pump is indicated for use with the following delivery routes e Arterial e Spinal e Epidural e Subcutaneous e Intravenous The Medfusion 3500 syringe pump is indicated for delivering the following fluids e Intravenous solutions e Drug solutions e Blood or blood products The Medfusion 3500 syringe pump is indicated for use with the following delivery modes e Continuous e Body weight e Volume Time e Custom dilution e Mass e Intermittent Volume Time This syringe infusion pump is intended for use only under direction of trained medical WARNING professionals Pump Usage Before using any Medfusion 3500 you must be thoroughly familiar with this manual including all Warnings Cautions and instructions for use Medex Part G6000608 Revision 3 Operation Manual Page 2 MEDEX Medfusion 3500 3 INTENDED USE FEATURES amp CONTROLS This chapter defines basic use parameters features and control options of the Medfusion 3500 infusion pump The correct use of the Medfusion 3500 infusion pump should be based on the following principles 1 This syringe pump is intended for intravenous subcutaneous epidural spinal and arterial infusions of critical medications or fluids requiring precisely controlled infusion rates 2 Use only syringe manufacturers and sizes listed in the technical specifications of this manual
17. screen PRESS STRRT TO EEGIH IHFUSIOH FD 4 444 mL BOLUS Eso ML tw LIMIT BH HL Evo RATE M G HL HK RATE 3 5 ML HR DFTIONE CLEAR TOTALS 5 The standby timer then appears in the upper left corner onscreen counting down The Distracted user alarm is disabled for this interval Standby continues until timer has counted to zero You can discontinue standby mode at any time by pressing the Start button or by setting standby to zero 6 When the counter reaches zero the pump sounds an alarm reminding you to begin the infusion Medex Part G6000608 Revision 3 Operation Manual Page 44 MEDEX Medfusion 3500 16 DELAYED START DELAYED START is an Option that allows setting the pump for an infusion then delaying the start for a programmed interval of time e The pump will automatically start an infusion at the end of the standby Enable Disable The DELAYED START option can be enabled disabled through custom configuration Delayed Start Programming Delayed Start 1 When the pump is paused at the BEGIN INFUSION screen pres the Options button to find the DELAYED START utility PRESS lt START TO BEGIN INFUSION Fw FLARE HL EOLUS cac ML w LIMIT 6H mL Kw RATE 6 6 MLHA RATE 2 5 ML HR OPTIONS CLEAR TOTALS 2 Select Delayed Start mode by pressing its number button FRES THE HUMEER TO SELECT THE FROGRAM OFTIOH 1 DISAELE EMPTY TOHE Z DISAELE HEAR EMPTY TOHE J DELAYED START d STAHDEY
18. syringe in place Proceed with the infusion Syringe Flange Not in Place The syringe is not loaded correctly Make sure the syringe flange is properly inserted into the flange clip Proceed with the infusion The syringe is not loaded correctly Make sure the syringe plunger head is MES eere es ue Lees properly inserted Proceed with the infusion Syringe Does Not Match Limit Program the delivery for the type of syringe you are actually using Then Library Entry The pump has halted infusion at empty You may either Prepare and load another syringe then begin another infusion Press the Start button to override the empty alarm and deliver any Synge Empiy migi remaining fluid in the syringe Return to the SELECT THE MODE screen where no alarms sound Turn off the pump proceed with infusion setup and start it The pump has halted infusion after overriding empty alarm You may either Syringe Empty Manual High Prepare and load another syringe then begin another infusion Return to the SELECT THE MODE screen where no alarms sound Turn off the pump The pump is telling you the syringe will soon be empty Syringe Near Empty System Advisory Maintenance is Recommended System Advisory Set Time As soon as possible remove pump from service for testing and checkout by As soon as possible remove pump from service for testing and checkout by a trained biomedical service technician and Date a trained biomed
19. table to identify battery message status Medex Part G6000608 Revision 3 Operation Manual Page 64 The infusion pump can also be run by an optional external DC power supply The external DC power supply must supply Input 6 14 VDC 7 Watts This optional DC power supply is connected through a terminal on the rear of the pump The connection can be used for either an external battery or other low voltage DC input Use only Medex approved cabling and power supplies Refer to Service Manual and pump labeling for this information ny external power source connected to the jack must be 1 certified for Warnina A t ted to the DC jack t be IEC 601 1 certified f g medical equipment Type CF and meet Safety Class ll requirements Connecting any SaR external power source to the Medfusion 3500 pumps creates a medical system must be Therefore the user is responsible for compliance with IEC 601 1 standards Refer all IEC 601 1 questions to the Medex Technical Service Department Certified Medex Part G6000608 Revision 3 Operation Manual Page 65 MEDEX Medfusion 3500 24 CLEANING AND CARE Below are common methods and cautions relating to cleaning and caring for the infusion pump Before cleaning always switch electrically operated equipment off and disconnect Power Source from AC power source Follow your institution s guidelines for cleaning and disinfecting of devices The syringe pump can be safely clean
20. the alarm for another 30 seconds e Go to the BEGIN INFUSION screen There the alarm silence interval is at least 2 minutes or longer depending on custom configuration e Press the Start button to begin the infusion e You can cancel the infusion and return to the SELECT THE MODE screen where no alarms sound e You can press amp hold the Power button and turn off the pump NS GR GGUUS RR Gu Gu GG os gag a gei O Syringe Near Empty Alarm During Delivery Medex Part G6000608 Revision 3 Operation Manual Page 13 MEDEX Medfusion 3500 The Near Empty alarm 1s a low priority alarm during delivery telling you the syringe 1s just about empty The pump sound the low priority alarm tone displays the near empty alarm message appears on screen and does not stop delivery conc 1 2 MG HL FWD 13 51 mL WEIGHT SH ka EOLUS DOSE 28 MCG KG HIH RATE oB HL ZHR T EE CLEAR TWD 1 Press the Alarm Silence button 320 to clear the alarm message 2 Confirm how long you have before the infusion ends 3 Then be prepared to load a new syringe onto the pump if necessary and then start a new infusion Calculating Near empty status is calculated by checking the volume remaining in the syringe Near Empty against the near empty alarm time setting divided by current delivery rate Status Syringe Empty Alarm During Delivery The SYRINGE EMPTY alarm ls a high priority alarm advising the syringe is empty 1 The EMPTY
21. warranty Never use organic solvents to clean or disinfect the pump Refer to the CLEAN amp CARE section Avoid Strong Solvents ofthis manual Always ensure the software version of the pump and operations manuals agree Refer to this Use Correct Manuals manual s front page Never use sharp objects to depress control buttons on the pump They may damage the pump Avoid Sharp Objects by rendering buttons inoperable Always periodically check the fluid pathway and connections for leaks As with any infusion Check for Leaks system leaks may cause patient or infusate fluid loss l Follow your institution s procedures and applicable laws regarding the proper disposal or Correct Disposal recycling of device components Medex Part G6000608 Revision 3 Operation Manual Page 12 MEDEX Medfusion 3500 6 ALARMS amp REMEDIES The Medfusion3500 infusion pump has numerous alarms built into it These are triggered by situations as a means of warning or advising you something is not functioning within normal parameters Score eee EIE ee S y eee eee GUY GG YUESR S Kg G Y SERE Y y GGG EY GE Sg GGYE S Y GG ES RN EGGS ER GN GUESS E GN UE ES E NUES SR GER R SR Y UE R S ER GGG a SR Gg GEGSEE ER NGULSUES REGN ERES ER NUUS REGN ERES ER GNUUSR SR RS GaU ER GG US R EG GE EUER GRUSS E RN E SR ERG R SR RS GG EE ER NOUS SR EG E GER R NOUS E EV EGGS ER GNULSUU E S GN GG ER NOUS REN EG ER GNU SUUS ERG GE ES ER NOUS ER EGG G GE ER NOUS EN EGG EE ER GOUUS
22. weight in kilograms 2 2 lbs kg Weight is limited to the range indicated Press the Enter button to accept the value and go to the set target DOSE RATE screen ENTER DOSE RATE FRESS ENTER TO CONTINUE 11441 CURRENT SETTING Max 9999 MIN A AA 1 MCG KG MINUTE O E EA ENTER 6 Use the number buttons to enter the desired target dose rate The target dose rate is the desired rate for infusion of diluted drug into the patient Units for this dose rate were set in the SELECT THE INFUSION screen When ready press the Enter button to accept the value and go to the set FINAL VOLUME screen ENTER FIHHL LLIFIE PRESS ENTER TO COMTIHUIE iat CURRENT SETTING Max 256 HIH I1 60 ML UL ee sncksFhcE EE Medex Part G6000608 Revision 3 Operation Manual Page 33 MEDEX Medfusion 3500 7 Use the number buttons to set the Final Volume to be infused This can go to only one decimal place and final volume must be equal to or less than the maximum fill volume of the syringe being used 8 When ready press the Enter button The pump calculates the formula for the Custom Dilution and displays 1t onscreen PRESS CONTINUE WHEH READY MIx IM HL OF DRUG WITH ML OF DILUEHT TO ACHIEVE A FINAL VOLUME OF 15 mL AA 2 2 9 Using aseptic techniques prepare the dilution with this formula Fill the syringe Load syringe onto the infusion pump see Syringe Loading Warning Always confirm compatibility b
23. 33 12 33 33 312 33 33 3 1 33 3 3 33 33 3 3 33 33 3 3 13 33 3 33 12 33 33313 33 33313 33 33312 33 33312 33 33 12 33 33312 23 33 12 33 33312 33 33312 33 33312 33 33312 33 33312 32 323 12 32 32 2 2 3 2 2 2 3 2 3 2 3 4 2 32 3 2 2 32 3 3 2 32 32 2 32 32 2 32 32 2 32 32 2 32 3 2 22 2 23 7 A REPEATED WARNING You will see the following warning placed repeatedly throughout the steps for programming and starting all of the infusion delivery modes Warning Before starting ANY delivery ALWAYS confirm correctness of ALL infusion values you Confirm All just set Settings It 1s possible to fall into a pattern of expecting an infusion pump to function in a specific way But each pump can be configured to be programmed differently So a pump in one unit or department can be setup quite differently from one in the next unit or department or hospital You are responsible for always verifying the correctness of any infusion delivery you program and start Medex Part G6000608 Revision 3 Operation Manual Page 25 E MEDEX 1 1 0 Med iusion 5500 Continuous Mode ML HR Continuous infusion is programmed by setting a flow rate in ml hr Actual range limits for flow rate are determined by syringe size see table in Appendix or custom configured maximum rate If needed a volume limit loading dose or bolus dose can be set If you stop in the middle of a numerical entry you will hear the Neglected Pump alarm Neglected Pump vougan Z e
24. Actual total volume as close to target rate amp volume as possible by rounding dilution Reasonable Dilution You must use a volume of diluent 20 ml or larger to give reasonable range for Range dilutions If you do not see CUSTOM DILUTION or any of these listed on the SELECT THE Enable Disable INFUSION UNITS screen for Custom Dilution you must enable them through Custom Dilution custom configuration TYPES OF CUSTOM DILUTION AVAILABLE There are four different types of custom dilution infusion available in the Medfusion3500 infusion pump Dilution Mode What the Pump does Micrograms Kilogram Calculates micrograms of medication or fluid per kilogram of patient body weight per Minute minute of infusion to determine the mixing formula Calculates micrograms of medication or fluid per kilogram of patient body weight per Micrograms Kilogram Hour hour of infusion to determine the mixing formula Calculates milligrams of medication or fluid per kilogram of patient body weight per Milligrams Kilogram Minute minute of infusion to determine the mixing formula Calculates milligrams of medication or fluid per kilogram of patient body weight per Milligrams Kilogram Hour hour of infusion to determine the mixing formula Calculating Dilutions Calculating Dilutions for mcg kg min mcg kg hr mg kg min mg kg hr This custom dilution mode calculates a mixing formula for dilutions of drug to reach a targe
25. CO Medex Part G6000608 Revision 3 Operation Manual Page 61 MEDEX Medfusion 3500 HOIRIR3i343333 3303333333 33 33 333 1332 3331232 3331332 33 31233 33312 33 33 13 23 33 13 33 33 12 33 33313 33 33 13 33 33312 33 33313 33 33 12 32 33 12 33 33313 33 33 12 33 33 13 33 33 12 33 33313 33 33312 33 33 13 33 3 3312 33 33 32 3 3 3 3 32 33 3 3 32 33 3 3 33 32 33 13 33 3 3 3 33 33 3 33 3 3 33 33 3 33 13 33 3 33 32 32 3 43 33 32 3 3 33 32 333 13 33 3 3 12 33 3 33 12 33 3 3 33 32 333 3 33 3 3 33 32 33 33 33 3 3 33 32 333 13 32 3 33 1 33 333 13 33 3 3 33 32 3 33 13 33 3 3 33 33 3 3 13 33 33313 33 33313 33 33 12 33 33313 32 33 12 33 33 13 33 3 3 33 33 3 33 33 33 3 3 33 32 333 12 32 3 4 2 32 3 2 2 22 3 2 2 32 3 4 2 22 3 2 2 32 3 2 22 3 2 32 3 4 2 32 3 2 2 32 3 4 2 2 2 3 2 2 3 2 2 3 2 32 3 22 3 2 32 TEMPLATE NAMING CONVENTIONS Basically you can give any template any name you wish The name serves only to identify the template for future use Name the template following the naming convention established by your unit department organization or hospital If there is no naming convention Medex recommends you establish one The best approach is to name templates so you can readily identify its contents and function You should also create and maintain a logbook of all libraries and templates with a sheet for each template to describe its contents and function e There is a 15 character limit on naming templates e Use any combination of letters spaces symbol
26. E l B D 2 MOMOJECT J TERLIMO 3 Press any number button to select the syringe manufacturer If you make a mistake use the Back button to undo 1t A EE EEE EEE ZEEE ZZ EZ DE BE DB DEE EE DE EE ED DEB DEE BD BEB DEE DEE DE DE DEE DE DEB DE DEE BEDE BEE EEE DEE EE EE Ay WHAT IF ONLY ONE SYRINGE MANUFACTURER IS SETUP If only one syringe manufacturer has been setup for use by this pump through custom configuration then this entire level and its screen is skipped during infusion programming Medex Part G6000608 Revision 3 Operation Manual Page 19 MEDEX Medfusion 3500 Below are the steps for loading a syringe onto the infusion pump Warning Always turn OFF fluid flow to patient in tubing via clamp or stopcock before loading or unloading syringe onto the pump Uncontrolled fluid flow can occur when fluid set is not Always Turn clamped or turned off and may cause serious injury or death Off Fluid Flows After you set the syringe manufacturer information setup in the pump it is time to install the syringe itself Load the syringe using to the following steps 1 Using standard protocol prepare the syringe by filling it with medication or other fluid and attaching the tubing 2 Lift and swivel the syringe Barrel Clamp A out of the way 3 Squeeze Plunger Release Lever B on the syringe plunger driver and pull gently to extend it all the way 4 Load the syringe onto the pump as illustrated making sur
27. E CLAMP ASSEMBLY amp USE This appendix contains the instructions for assembling and using the Pole Clamp options available for the 3000 Series infusion pumps 8000 Series Pump Rotating Detachable Pole Clamp standard SSS With the Rotating Clamp you can align the pole clamp for mounting on any vertical or horizontal pole bed rail or similar solid structure small enough to fit within the clamp s jaws The light weight of the pump makes this convenient 1 Open the clamp jaws wide enough to easily slip around the pole 2 Tighten the clamp until it is securely fastened so the pump cannot be moved The 3000 Series rotating detachable pole clamp is packaged in two pieces that must be clipped together before it can be used e The L Bracket and clamp anchor with release lever is pre attached to the pump base with 2 flathead Screws e The Rotating pole clamp which must be slid onto the clamp anchor at the back of the pump Assembling the 3000 Series Pump Rotating Detachable Pole Clamp 1 Unpack the pump and pole clamp assembly from the shipping container 2 Slide the rotating pole clamp onto the pole clamp anchor at the rear of the pump until the retainer lock button audibly clicks into place 3 Pull the round lock button at the top of the clamp assembly up and rotate the clamp to fit either a vertical or horizontal pole 4 To remove the pump from the pole clamp pull the release lever toward the pump and slide the pump off the po
28. E PROGRAM OPTION 1 STANDE Y c BOLUS DOSE J LOADING DOSE d VOLUME LIMIT 2 Use the number buttons to call the ENTER LOADING DOSE screen ENTER LOADING DOSE PRESS ENTER TO CONTINUE Max 6h MIM Gl E META Disable turns loading dose OFF Clear deletes an entry Backspace erases a character 3 At the ENTER LOADING DOSE screen set the loading dose volume Here volume is limited to the maximum fill volume for the current syringe size and minimum volume is 1 600th of syringe size 4 When ready press the Enter button to accept the volume setting or dose setting if in body weight or mass mode 5 Use the number buttons to set delivery time in minutes amp seconds The default value for loading i e bolus delivery rate is set in custom configuration Maximum amp minimum time is calculated from the maximum amp minimum rate for the syringe size you are currently using ENTER LOADING TIME PRESS ENTER TO COMTIHLIE 41 24 CURRENT SETTING Maxi 15 00 MIN Bl 2 B1 yas MIH SEC ee E ee ENTER 6 After the loading dose is set and accepted the pump pauses at the BEGIN INFUSION screen The Loading Dose setting now appears onscreen j eb ce TT Two 8 68 ML PD HHA mL LOAD Bab HL RATE 5 5 HLZHK E FLATE CHG RATE OF TIOHS CLEAR TOTALS Medex Part G6000608 Revision 3 Operation Manual Page 38 MEDEX Medfusion 3500 ma Warning Before starting ANY delivery ALWAYS confirm correctness of ALL
29. ES E eee 2 Select bolus dose programming by pressing its number button This calls the ENTER BOLUS DOSE screen 3 Use the number buttons to set the bolus volume desired for this infusion Volume is limited to the maximum fill volume of the current syringe size and minimum volume is 1 600th the syringe size If the initial infusion 1s programmed in one of the body weight modes eg mcg Kg min the bolus dose will be programmed in the parameters of that dose mode eg mcg Kg ENTER BOLUS DOSE FRESS ENTER TO CONTINUE MIN 61 ML DISAELE WEA ENTER Disable turns Bolus OFF Clear deletes an entry Backspace erases a character 4 When ready press the Enter button to accept the volume setting or dose setting if in body weight or mass mode Medex Part G6000608 Revision 3 Operation Manual Page 35 MEDEX Medfusion 3500 5 Ifthe Bolus Time feature has been enabled you will be able to set the bolus delivery time at the BOLUS TIME screen use the number buttons to set bolus delivery time in minutes and seconds The default value for bolus delivery rate 1s set in custom configuration Maximum amp minimum time is calculated from the maximum amp minimum rate for the syringe size you are currently using Ifthe Bolus Time feature has been disabled the pump will default to the maximum bolus rate ENTER BOLUS TIME PRESS ENTER TO COHTIHUE 45 44 CURRENT SETTING Max 15 00 MIN BSG Da BOUES _ META 6 When
30. GHT screen press the number buttons to set the patient s weight in kilograms Weight 1s limited to the indicated range 4 Press the Enter button to accept the patient weight setting and go to the DOSE RATE screen ENTER DOSE RATE FRESS ENTER TO CONTINUE cam CURRENT SETTING HIH 4 44 Mig EG MINUTE UL EET sncksFhcE EE 5 At the DOSE RATE screen press the number buttons to set the dose rate Range limits here for dose rate are determined by installed syringe size 6 When ready press the Enter button to accept the dosage rate go to the BEGIN INFUSION screen Confirm all settings are correct 7 Prior to beginning the infusion press lt BOLUS gt to initiate the priming sequence page 21 8 You may now accept the settings and start the infusion or use the four menu buttons to modify the settings When ready press the Start button to begin the infusion TART TO BEGIN IHFLUZIGOH Cone 1 2 MG ML FWD Ej EIER mL WEIGHT SEL KG DISE 2 5 MOG EG mMIH RATE Bdr O ML HRE E FLATES CHG DOSE OFTIONS CLEAR TOTALS Volume Time ML HR The volume over time rate calculation allows programming by Medex Part G6000608 Revision 3 Operation Manual Page 28 MEDEX Medfusion 3500 e Dose Volume e Delivery Time The pump calculates the correct flow rate by dividing the volume by the delivery time Volume limit loading or bolus dose can not be set in this mode Find and select VOLUME TIME from the SELECT THE
31. L LAST SETTINGS UL HORE S 2 Selecta library from the menu For example If 3 below is selected then the LIBRARY C screen appears Libraries may be specifically named per facility preference such as NICU or Anesthesia or Antibiotics etc PRESS THE NUMBER TD SELECT THE MODE 1 LIERARY A 5 EIOMED Z LIERARY E 2 LIERAR Y C 4 CUSTOM PROGRAM METE O EE Select a LIBRARY ENTRY template by pressing its number PRESS THE HUMEER TO SELECT THE LIERHE Y ENTRY 1 URORUG 1 c Dax RXxD For example If you select template 1 you get the presets for infusing URDRUG I 3 You are next prompted to load a syringe then confirm amp accept each level of settings by pressing the Enter button Some data fields may require data input prior to proceeding eg Patient Weight 4 When all settings are confirmed you go to the BEGIN INFUSION screen Press Start to begin the infusion Medex Part G6000608 Revision 3 Operation Manual Page 58 MEDEX Medfusion 3500 Warning Before starting ANY delivery ALWAYS confirm correctness of ALL infusion values you Confirm All just set Settings Medex ships the infusion pump with all the libraries disabled Whether they are enabled on the pump you are using depends entirely on 1ts custom configuration What actual E Plates presets you have available depend on the configuration setup by the person responsible for custom configuration before the pumps were delivered to your w
32. MEDFUSION 3300 SYRINGE INFUSION PUMP Manufactured by Medex Inc Duluth Georgia 30096 USA Authorized EU Representative Medex Medical Ltd Haslingden Rossendale Lancashire England BB4 4PW Ss gt S pu lt b a E MEDEX Medfusion 3500 Table of Contents 1 IMPORTANT NOTCE S incom uictum dna e hea Ed 2 INTRODUCTION o EL AS M EM M essi cte 2 3 INTENDED USE FEATURES amp CONTROLS Ne 3 Correct Use Of This Putlp osec atr ibn mnia dd 3 Feites d 4 Keypad A FUNCIONS cio etx reiecit eden pine eene besote deni vo frere bona ottiene ee Pod tnnt asduleiiins 5 Using Front Panel Control On 5 es 6 AF ale Weel Be Ye Uhre 68 acl IE 6 4 TECHNICAL SPECIFICATIONS amp DEFINITIONS esce ener nnr nnns 7 METIA e 1 a coo nd ie pU tae ee at EE E UA I OUT 8 Syringe Manufacturers amp Standard ae 9 Ta 9 5 OPERATION WARNINGS amp CAUTIONS erect nnet ene nnstns tret tastes rasta sans ess sa sean 10 ban ce Pe ee nee 10 12 6 ALARMS SREMEDTE St odeur 13 NS NA A IS II Iu Eae e eri T 13 Neslected 13 Syringe Near Empty Alarm During Delivery 4 13 Syrnse Empty Alarm Durino Delivery sai iia ace o tan dpt ida dere et deen Sian UR odo fit 14 Syringe Empty Manual Alarm During DeliveTy 9 14 General SyYsEm ae 14 GUIDELINES FOR ENHANCED PUMP PERFORMANCE Ne 17 Always Use Smallest Syringe for Volume of Fluid Being Delivered pp 17 Use
33. MODE screen You may have to press the More button to find it 1 When ready press the Enter button to accept the syringe This calls the VOLUME TO INFUSE Screen EMHTEF LLIFE TO INFUSE FRESS ENTER TO COMTIHLE 14 4 CURRENT SETTING Max 6B HIM Bi i3 Pr META 2 Atthe VOLUME TO INFUSE screen press the number buttons to program the volume setting Volume is limited to the maximum fill volume for the syringe size and minimum volume is 1 600th of the selected syringe size 3 When ready press the Enter button to go to the DELIVERY TIME screen ENTER DELIVERY TIME 42 04 CURRENT SETTING Max 2488 62 00 MIM Bari HF MIH E EREKEFRIE ENTER 4 At the DELIVERY TIME screen press the number buttons to set delivery time Time is always limited by maximum and minimum rates for selected syringe size 5 When ready press the Enter button to accept the setting to go to the BEGIN INFUSION screen 35 START TO EEGIH INFUSION FD 4 544 HL TIME BZB TIME REMAINING Heidi RATE Da2 ML HR HST BO 2 TNI CLEAR TOTALS 6 All settings are made and the pump pauses at the BEGIN INFUSION screen Confirm all settings are correct You may now accept the settings and start the infusion or use the three menu buttons to modify the settings 7 Prior to beginning the infusion press lt BOLUS gt to initiate the priming sequence page 21 8 When ready press the Start button to begin the infusion Medex Part G6000608
34. MhIH MEHMU EN EE DNI FOR EXAMPLE If you select 1 above the pump loads the stored settings for URDRUG 1 infusion and pauses at the BEGIN INFUSION screen 3 Allthe infusion settings display on the BEGIN INFUSION screen Always check and verify their correctness You are responsible for ensuring the safety of any infusion you tell the pump to deliver UPDPRUG 1 two 18 592 ML CONC 54 MG ML PD FLARE mL WEIGHT 66 6 KG w LIMIT Bk ML EDLUS SHEA Hc6 KG DOSE 158 Mco EG mMIM RATE 2o97 HL HR ME E 4 When ready press the Start button to begin the infusion Depending on the configuration of your pump E Plates and libraries may or may not be readily available If you cannot find them as an option in your pump then they must be enabled through custom configuration e Refer to the Medfusion 3500 Syringe Infusion Pump Configuration Manual for setting E Plate libraries and templates e If you have authorization you may use custom configuration to enable the E Plates and or standard libraries If not ask the person responsible for custom configuration to make library changes for you All such standard dosage templates shall be setup according to the standards amp practices of your hospital unit or organization l l Even though you may select to enable the E Plates and standard libraries the pump Displaying display will not offer E Plates and or libraries until you actually create and save a E Plate Options template inside a lib
35. N EN EGG EE ER GUERRE ES EE ER GUERRE GE GE ER GOGH N SN EG NK GS ER GOULSR VEG ES EE ERN SEN EN GER ER OUS EG EE EG GUOGUSRUE NEUE REN SR ER SEE ER AUS EN ERN S EE ERR SEN ERR E GE ER SR EN ERU SR Nu Su Sg ga a ER Sa Sa Rug EE gE sa Su Suus E uu Alarms Alerts Below 1s a table of the alarms and alerts generated by the pump including definitions and remedies Definition and Remedy A high priority alarm is initiated by either any condition that halts an ongoing infusion or any pump system fault which effect infusion High priority alarms are signaled with a flashing red indicator a viewing screen backlight that oscillates between bright and dim and an audible signal Press the Alarm Silence button to return the viewing screen backlight to bright and silence the audible alarm for the High priority programmed alarm silence period If the front panel controls are locked when a high priority alarm occurs the pump controls do unlock A high priority alarm that stops delivery during loading dose or bolus will not return to the pause screen until the alarm is silenced allowing the user to record the bolus volume delivered A medium priority alarm indicates any condition requiring operator intervention but does not halt infusion Medium priority alarms are signaled with a flashing yellow indicator a viewing screen backlight that oscillates between bright and dim and an audible signal Pressing the Alarm Silence button will return the viewin
36. NEF SA IL Fr r Pc AS ANNE AN S NENNEN T TH AZ A Handle B Tubing Holders C Display D Syringe Barrel Clamp E Syringe Plunger Holders F Syringe Plunger Release Lever G Syringe Barrel Flange Clip H Syringe Plunger Driver Medex Part G6000608 Revision 3 Operation Manual Page 4 Mepx 0 1 1 AMed usion 3500 Keypad amp Functions Below is an illustration of the front panel of the Medfusion 3500 with tables below identifying functions and effects Control Button When Pump is Paused When Pump is Delivering Push and hold to turn OFF pump Push amp release then push amp hold to turn OFF Bolus Begins priming after confirmation Begins programmed bolus after confirmation Silences audible alarm Allows 25 Alarm Silence operator to switch the backlight from bright to dim or dim to bright Using Front Panel Control Buttons Silences audible alarm Allows operator to switch the backlight from bright to dim or dim to bright Below 1s a table of the Medfusion 3500 front panel buttons and their assigned functions Button Function Push and hold to turn the pump ON Push and hold to turn the pump OFF Pressing the power button while the pump is infusing results in a message asking you to press the power button a second time to turn OFF power Starts an infusion after settings are made Press this button to start infusing after all infusion parame
37. PEN KY RAT 42 Proprammine OR ii tdci densa 42 DEINEN aA OUe ca 43 E A AAA Aat a nee Om LAG ASTE E MEE 44 Probramimine Standby osse deiude t un reu lila 44 I6 JOBbAYEDSLDIAETxG A an Mu dU EE 45 Propsramni ng Delayed Siar eei iae uds tin Unete a dat de e 45 17 OVERRIDE AND TOGGLE FEATURES IN THE INFUSION PROGRAM OPTIONS 46 sad 47 erarme DEVE eim ui dt MM eee 47 Stoppin Delivety nace a nba Ms eom db Me 47 Occlusion rend Graph During Delivery a adu steht llo la eti Catal cenas 47 FlowSentry Rapid Occlusion Detection eese eene nn 48 Post Occlusion Bolus Reduction pp 49 Time to Occlusion ee 49 Fiow Delivery Orap i cesna E A AA 50 Flow Deliver Grap hS eein E amc E a ol e eLu 51 JO CHANGING DELVERSRATE 0 e e de o ed e 52 Bitrate Rite Drino DI aia 52 changin Rate Dunne DellyeEy zescas io ete i adelante un metuebat uiu tatunsua ue Mist raa aisle 53 Chann me Rate ne RE 53 20 TOTAL VOLUME PROGRAM VOLUME DOSE DELIVERED Ne 54 Displaying Program Volume Delivered Program Dose Delivered pp 54 Clearing Total Volume Program Volume or Program Dose Delivered Display 55 UESAC 56 Medex Part G6000608 Revision 3 Operation Manual Page iii MEDEX Medfusion 3500 20 JUSER DEFINED LIBRARIES errarcas coreanas dorso Grete EI C ICA EDDA DM ed Bares ers A ato 57 AS a A OOO RE UT eM 57 For What Are Libraries and Templates Used ooocccccccccncncnonnnnnnnnnnnnnnnnnnnnnn
38. R UHLOCE CLEAR TWD 3 Press the Unlock menu button to unlock the front panel If an Unlock Passcode has been set you will be instructed to supply the passcode before the front panel will unlock ENTER WAHLOCK FASSCODE PRESS ENTER TO COHTIHLE MIH E u LEnR EnckszrFacE ENTER 4 Any high priority alarm automatically unlocks the front panel Medex Part G6000608 Revision 3 Operation Manual Page 56 MEDEX Medfusion 3500 22 USER DEFINED LIBRARIES This chapter describes the Medfusion 3500 infusion pump user defined libraries tells you how to use them create and save them and enable or disable their availability E NN NN IZ IIYITIZIIZIIZ IIS IZ IIYITIZIIZITIZ IIS ITIZ IITITIZ IIS IIS IIS IIS IIYITIZIIZIZIZ IIS IZ IIYITIZ IIZITIZ IIS IZ IIYITIZIIZITIZ IIS IZ IIYIZIZ IIZIZIZ IIS IZ IIYITIZ II YITIZ IIT TIS IIZITIZIIZIIZIIZ IZ IIZITIZ IIYIIZ IIYITIZ IIS TIS IIS TIS IIS TIS IIS IZ II gi II II gig II gigi gigi gig is gigi egi gig ie gigi sie gigirrr gigi rir ri gi rrr rrgirrrrr gi rrrrr sr rrrrrrrrrrrrrrrrrerrrrrreno What Are Libraries The pumps have 4 libraries containing as many as 16 entries per library Each library is here defined as an electronic storage place for a group of preset infusion delivery values Each group of preset values is a user programmable template A template is defined here as a stored record of infusion settings that load from memory These templates are stored in memory
39. This is required before shipment by United States Occupational Safety amp Health Administration OSHA 3 Package the infusion pump carefully for shipment 4 Medex will not accept returns for service without the assigned RA number clearly printed on the shipping package Mark the Return Authorization RA number clearly on the outside of the shipping package used to return the pump 5 Ship the carefully packaged infusion pump to either of the addresses listed below United States Service European Service Medex Medex Medical Ltd 4350 River Green Parkway Suite 200 St Crispin Way Duluth Georgia 30096 USA Haslingden Rossendale Lancashire BB4 4PW Great Britain 770 623 9809 or 800 848 1757 44 0 1706 233826 Medex Part G6000608 Revision 3 Operation Manual Page 68 MEDEX Medfusion 3500 Medex Limited Warranty THIS WARRANTY IS GIVEN IN LIEU OF ANY EXPRESS OR IMPLIED WARRANTIES INCLUDING WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE Medex warrants to the purchaser that the Medfusion 3500 Syringe Infusion Pump shall be free from defects in material and workmanship for the period of one 1 year from the date of purchase Medex sole obligation with respect to any such defect is limited to the repair or at Medex option replacement of the Syringe Infusion Pump The Purchaser shall pay return freight charges This limited warranty is made on the condition that prompt notification of a defect is given
40. Tubing Holders D on the top left side of the pump 10 Then press the Enter button to confirm this information The syringe manufacturer amp size displayed onscreen must ALWAYS match the actual syringe you are loading Mismatching syringe manufacturer or size may cause either under infusion or over infusion to the patient with possible serious injury or death Warning Match Syringes Priming is accomplished as a secondary function of the Bolus button Always prime a new syringe after loading it onto the pump This removes the mechanical slack in the pump and syringe and significantly reduces start up time Warning NOTE l NEVER prime any syringe while connected to a patient infusion site as this may cause NOAA over infusion with possible serious injury or death Patient 1 Press the Bolus button to call the priming screen illustrated below FRES AND HOLD A BOLUS TO PRIME PRESS EXIT WHEN PRIME 13 COMPLETE PRIMING VOLUME 4 45 HL Le eee 2 To prime a loaded syringe press and hold the Bolus button while observing for fluid movement at the patient end of the system 3 For safety reasons there is a built in priming cutoff at 15 seconds To continue priming after cutoff release the Bolus button then press amp hold again The total priming volume accumulates onscreen but is NOT counted in the Total Volume Delivered display This is because the prime should never be delivered to the Priming Da
41. aaaaaaaaaaaaaaaaaaaaaaaaaaaoaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaasaaaaoaaaaaasaaaaaaaaaaaaasasaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaasasaaaaaaaaaaaaasaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaoaaaaaaaaaaaaaaaaaaoaaaaaaaaaaaat Another option is the Medex Serial Conversion Box which allows direct connection between the Series 3000 pumps and a PC running the PC Cloning software This software provides a full featured simulation of the functioning of the Series 3000 pumps This can be used as both a training tool and a configuration utility As a configuration utility the simulated pump can be setup exactly as a unit or department needs to use it Then these configuration settings may be transferred en masse from the PC to actual pumps Specific details on the serial interface protocol are provided with the conversion box P N 3000RS232 Medex Cloning Block 0000000000000 Two pumps can be interfaced without the use of the conversion box Depending on your working surface it may be difficult to perfectly align the infrared serial ports by hand Instead use an optional Medex Cloning Block P N G6000200 to physically align the two pumps This is a specially designed plastic plug which fits into the serial port notches on the backs of both pumps providing simple alignment for both pumps every time Medex Part G6000608 Revision 3 Operation Manual Page 74 MEDEX Medfusion 3500 29 APPENDIX 4 POL
42. ac ML tw LIMIT S HL EVO RATE B G ML HR RATE 3 5 ML HE E FLATES CHG RATE OF TIONS CLEAR TOTALS 6 When ready press the Start button to begin the infusion Warning Before starting ANY delivery ALWAYS confirm correctness of ALL infusion values you Confirm All just set Settings Medex Part G6000608 Revision 3 Operation Manual Page 42 MEDEX Medfusion 3500 The keep vein open feature is intended for use when you are delivering a series of infusions to a patient and wish to ensure the delivery site remains patent between the end of one infusion and the beginning of the next 1 Set the delivery mode you want to use for infusion Select and set the Volume Limit option Select and set the KVO option Press Start to begin an infusion Normal delivery ceases when the pump reaches the programmed volume limit The pump then begins to infuse at the preset keep vein open KVO delivery rate or the infusion rate at the time the volume limit is reached whichever 1s less 6 Here the pump triggers a KVO alarm informing you the infusion is complete amp the pump 1s infusing at KVO rate eal a I9 FYD SHES ML Kwv w LIMIT 5 ML H RATE 6 6 ML HR AAA AA 7 KVO delivery terminates when the syringe is empty or if you press the Stop button When the pump automatically stops keep vein open infusion it sounds a syringe empty alarm Stop KVO 0 infusi n You can stop a KVO infusion at any time by pressing th
43. alarm stops delivery immediately 799 2 Press the Alarm Silence button ZG to clear the alarm tone amp message 3 Unload the syringe 4 Either prepare and load another syringe return to the SELECT THE MODE screen where no alarms sound or turn off the pump Calculating Empty status is determined by measuring plunger position of syringe against the set Empty Status value for syringe size amp manufacturer Caution Because of variations in syringe manufacturing the Monoject 3ml syringe may in some Monoject 3ml ases not fully empty Here the empty alarm sounds with some fluid left in the syringe Syringe Empty Manual Alarm During Delivery It 1s possible to override a syringe empty alarm sounded during delivery There will be times when the pump calculates the syringe is empty and yet there remains a residual volume of medication or fluid in the syringes A common cause is variation In manufacturing of syringes 1 Press the Alarm Silence button The pump has stopped delivery and is at the BEGIN INFUSION screen 2 Ifyou do not wish to deliver this remaining fluid then a Unload the syringe b Either prepare and load another syringe return to the SELECT THE MODE screen where no alarms sound or turn off the pump 3 Ifyou do wish to deliver the remaining fluid then press the Start button 4 The pump begins delivery and continues until no fluid remains in the syringe 5 As soon as the pump senses an o
44. cclusion it halts delivery and displays the Syringe Empty Manual message onscreen 6 Press the Alarm Silence button The pump has stopped delivery and 1s at the BEGIN INFUSION screen 7 Either prepare and load another syringe return to the Select the Mode screen where no alarms sound or turn off the pump A This section contains a table of the general system alarms you may encounter while operating the Medfusion 3500 infusion pumps This table identifies the alarm by message and type and provides a definition and possible remedies Medex Part G6000608 Revision 3 Operation Manual Page 14 MEDEX Medfusion 3500 Alarm Message Priority Remedy The internal battery 1s not working The pump may be used on AC power Low on a conditional basis As soon as possible remove pump from service for repair by a trained biomedical service technician Battery Communication Timeout The internal battery is not charging The pump may be used on AC power Battery Not Charging Low on a conditional basis As soon as possible remove pump from service for repair by a trained biomedical service technician The internal battery is not working The pump may be used on AC power on a conditional basis As soon as possible remove pump from service for repair by a trained biomedical service technician Battery Not Working Medium Calculated Rate Out of The calculated rate is not valid Verify that all infusion parameters have Range High b
45. e press the Chg Rate or Chg Dose button ENTER RATE PRESS EHTEK TO COHTIHUE a CURRENT SETTING MIN Gl PIL 7 HR E EnckszrFacE E 3 Use the number buttons to change the delivery rate Rate 1s limited by the maximum and minimum delivery rate for syringe size ENTER RATE FEEZZ ENTER TO COHTIHUE aL CURRENT SETTIMG Max SHE HIH El 4 mem REESE META 4 When ready press the Enter button to accept the new setting a The delivery rate entry does not change until you press the Enter button b You may exit without changing the rate by pressing the Back button 5 The pump is paused at the BEGIN INFUSION screen When ready press the Start button to begin delivery Medex Part G6000608 Revision 3 Operation Manual Page 53 MEDEX Medfusion 3500 20 TOTAL VOLUME PROGRAM VOLUME DOSE DELIVERED The Medfusion 3500 infusion pumps monitor and maintain the total quantity of fluids being delivered during any given session of infusions Total Volume Delivered TVD is displayed at the top of the screen directly above the Program Volume Delivered PVD or Program Dose Delivered PDD The TVD 1s the total volume delivered to the patient and 1t will continue to accumulate until the Clear Totals program key 1s pressed or the pump 1s turned off Displaying Program Volume Delivered Program Dose Delivered In most delivery modes you have the option of viewing either Program Volume Delivered or Program Dosage
46. e A AS 71 Volume Time amp Intermittent modes ee 72 Custont Dilutiom 72 The Results from the Dilution Calculatton cessere nmm mnn 72 How the Calculation is Performed 4 73 Goal of This Dilution Calculation 3 ee onere de iste e e ros epe e tese deas 73 28 APPENDIX3 SERIAL COMMUNICATIONS ccccccccccccsccsccscssscsscssccsscssccsscssccsscsscssecsscssccscssccesessecsesseeaes 74 Serial Conversion ES OX TT O a waaamueaeaaeea 74 Medex Cloning lock 74 29 APPENDIX 4 POLE CLAMP ASSEMBLY USE errem enne nnsnn ns 75 3000 Series Pump Rotating Detachable Pole Clamp standard cccccccccnnnnnnnnononnnnnnnnnnnnnnnnnnninononoss 1D Assembling the 3000 Series Pump Rotating Detachable Pole Clamp pp T5 3000 Series Pump Stationary Pole Clan a 76 Assembling the 3000 Series Pump Stationary Pole Clamp pp TI 30 APPENDIX 5 MRI ROOM USAGE cccccccccccccscccscesccescsscssccsscesccsccssccsccssccescsscceccsccescssccsecsscsccasesseessecasessccaseesees 78 MRI Room Usage tor the Medfuston SU 78 Medex Part G6000608 Revision 3 Operation Manual Page iv MEDEX Medfusion 3500 9 Proper Placement Of Pin picts os A a 78 Pulse Sequences for MRI when using the Medfusion 3300 pp 78 Medex Part G6000608 Revision 3 Operation Manual Page v MEDEX Medfusion 3500 1 IMPORTANT NOTICES The notices In the table below contain important information you need to know and understand before beginning to use the Medfusion 3500 pump
47. e Stop button sae a You can silence the alarm by pressing 2 the Alarm Silence button Medex Part G6000608 Revision 3 Operation Manual Page 43 MEDEX Medfusion 3500 STANDBY is an Option that allows setting the pump for an infusion then delaying advisory alarms for a programmed interval of time e The pump does not automatically start an infusion at the end of the standby e Instead the pump triggers an alarm at the end of the standby period to tell you to either Start or Cancel the infusion Enable Disable The STANDBY option can be enabled disabled through custom configuration Standby RS RN are Programming Standby 1 When the pump is paused at the BEGIN INFUSION screen press the Options button to find the STANDBY utility FRESS START TO EEGIH INFUSION Fw HARE mL EOLUS cac HL wv LIMIT B HL EVO RATE HG MLAHA RATE 2 5 MLAHA OPTIONS CLEAR TOTALS 2 Select Standby mode by pressing its number button PRESS THE HUMEER TO SELECT THE PROGRAM OPTION 1 STANDE Y D EYO 2 LOADING DOZE D SAVE TO LIERARY J BOLUS DOSE d VOLUME LIMIT es ES 3 Set standby time in hours amp minutes The maximum Standby setting is 24 hours The default standby time is 1 00 Hr ENTER STANDEY TIME FRESS ENTER TO COHTIHUE 41 44 CURRENT SETTING Maxi 24 88 61 ao HIH HAHA JE ee EnckszrFacE ENTER 4 When ready press the Enter button to accept the standby setting and go to the BEGIN INFUSION
48. e setup by Custom Configuration which was completed by the person responsible for custom configuration before the pumps were delivered to your work area e Also if the pump has been configured with E Plates enabled the first screen is the SELECT THE LIBRARY ENTRY screen see User Programmable Libraries FRESS THE HUMBER TO SELECT THE LIERARY ENTRY 1 URDRUG 1 2 Ifthe SELECT THE LIBRARY ENTRY screen appears press the Main Menu button to call the SELECT THE MODE screen 3 Press any Number button to select the desired delivery mode If you make a mistake use the Back button to undo it 4 Ifyou do not see the mode you need press the More button to display the next page of delivery modes 5 At the next menu either a Select an option by pressing its number and continue b Or press the Beginning button to return to the beginning screen Below is an example for syringe manufacturer type setup for use with the Medfusion 3500 pump 1 Use your standard protocol for preparing your syringe amp tubing and filling the syringe 2 When delivery mode is chosen set the syringe information If more than one manufacturer is configured for the pump then the SELECT SYRINGE MANUFACTURER TYPE screen appears The syringe manufacturers on this screen were setup in Custom Configuration which was completed by the person responsible for custom configuration before the pumps were delivered to your work area SELECT SYRINGE MANUFACTURER TYF
49. e the flange of syringe barrel 1s pressed or rolled into Flange Clip C 5 Squeeze Plunger Release Lever B on the end of the syringe plunger driver and slip the end of the syringe plunger into place then release the lever to close it around the syringe Be sure both holders close around the syringe plunger Warning Verify the plunger holders securely capture the syringe plunger Failure to capture the AU iaa syringe plunger may result in siphoning the syringe 6 Turn and lower Barrel Clamp A onto the barrel of the syringe The size should appear in the display If the syringe is incorrectly loaded guide arrows appear onscreen to identify the problem Down arrow J onscreen means check syringe barrel clamp A Right arrow lt onscreen means check syringe plunger holders B Up arrow P onscreen means check syringe flange clip C LOAD YRIHGE PRESS ENTER WHEN READY 4 so E UL O SE Medex Part G6000608 Revision 3 Operation Manual Page 20 MEDEX Medfusion 3500 7 There are no arrows onscreen when the syringe is correctly loaded 8 Make sure the pump correctly recognizes the syringe size and the syringe manufacturer is correct If not verify that the manufacturer and size are listed in the technical specifications of this manual LOAD YRIMGE 7 PRESS ENTER WHEH READY ed lt T A O fs 9 Thread the tubing through the 3
50. each screen that applies for the last infusion This includes all settings and options The actual screens that appear depend on how your pump is configured and which features are enabled or disabled FREEZE ZTHET TO EEGIH IHFUZIGOH Conc 6 263 MG ML 4 44 mL WEIGHT 146 ko DOSE amp amp 5 MCG KG MIH RATE be ML HR E PLATES RA AO CLEAR TOTALS After reviewing these previously used settings the pump pauses If you wish to clear the TVD and PVD or PDD press the lt CLEAR Totals gt button Prior to beginning the infusion press lt BOLUS gt to initiate the priming sequence page 21 Be sure all pump settings are correct before starting infusion ae A TVD and PVD The pump also retains TVD and PVD or PDD from the last infusion If you do not want PDD Retention to use these values you must manually clear them before beginning a new infusion Medex Part G6000608 Revision 3 Operation Manual Page 31 MEDEX Medfusion 3500 Custom Dilution The Custom Dilution mode 1s a form of body weight delivery where you tell the pump a target delivery rate and the pump calculates the custom drug dilution to meet that target The settings required are a Patient s weight b Initial undiluted drug concentration c Target dose rate d Target total volume medication plus diluting fluid From this data the pump then calculates a Amount of fluid required to dilute the initial drug concentration b Actual dose rate C
51. eatures or screens do not appear when you program a delivery mode in your pump In an effort to simplify the use of this manual all features were not enabled for the writing of this operation manual What steps you actually pass through in programming a delivery depend entirely on which features have been either enabled or disabled in the custom configuration process So if you are programming and you find a step not included in these directions it is because the step describes an optional feature that has been enabled for your particular machine For a better understanding of the enabled or disabled features of your infusion pump refer to the Configuration Manual and to the chapter titled Tables of Default Settings for Anesthesia General and NICU All Medfusion 3500s are shipped with the standard default settings for Anesthesia units or departments These may be unchanged in your pump Or they may have been used as a foundation for configuring your pump to meet the specific needs of your unit department organization or hospital HIIRIRXi3 4343333033333 33133 333 33 12 3 33 31233 33 31233 3331333 33 312 33 33 312 33 33312 32 33 312 33 33 12 33 33 313 33 33 12 33 33 13 33 33 12 33 33 12 33 33 312 33 33 13 33 33312 33 33313 33 33 12 33 33 13 33 33 1 33 33 1 3 3 1 3 4 3 3 33 33312 33 33313 33 33312 33 33313 33 33312 33 33 13 33 33 12 33 33312 33 33 13 33 33 12 33 33312 33 3 32 1 4 3 3 3 3 3 3 3 3 33 33312 33 33313 33 33312 33 33312 33
52. ed to the patient raising the system above the patient Vertical even briefly can cause significant bolusing due to changes in hydrostatic pressure Lowering the Displacement system below the patient even briefly can cause significant interruptions in flow due to changes in hydrostatic pressure Use the smallest syringe size to deliver the fluid or medication Running a large syringe at very ITA ENT low rates may cause under delivery e g a long time to occlusion alarm See the section on size guidelines for enhanced performance and review startup curves and time to occlusion information when selecting a syringe Only use this pump under direction of trained medical professionals Before using this pump you Trained Users must become thoroughly familiar with this manual including warnings cautions and instructions for use MAMI Always turn OFF fluid flow to patient in tubing via clamp or stopcock before loading or unloading When Loading a syringe onto the pump Uncontrolled fluid flow can occur when fluid set is not clamped or turned Syringe off and may cause serious injury and or death Medex Part G6000608 Revision 3 Operation Manual Page 10 MEDEX Secure the Syringe Horizontal Operation Only External DC Power must be IEC 601 1 Certified AC Power 1ml Syringe Occlusion Pressure Pump Maintenance Manufacturer Recommended Maintenance Never open pump case System Failure Alarm Dropped or Damaged Pump
53. ed with the following agents Common bleach 10 solution diluted with water Mild detergent mixed with water Isopropyl alcohol 70 solution Surface disinfectants compatible with plastic materials Standard Cleaning of the Medfusion 3500 For best results Clean by spraying cleanser directly onto a soft cloth and then wiping surfaces dry Never use organic solvents e g acetone quarternary ammonia compounds strong acids or Avoid Using Solvents bases to clean any portion of the pump The pump is spray resistant from the top and sides but not water proof Spray Resistant NEVER spray cleaning or other fluids directly into openings on the bottom of the pump Not Waterproof The pump is not certified water proof Never immerse the pump in water or other fluids Never use light oil sprays e g WD40 to clean or lubricate pump These oils contain Avoid Oil Sprays chemicals that can damage the plastic of the pump No user added lubrication is necessary Never sterilize the pump in a steam autoclave or gas Using autoclave or gas sterilization can Never Autoclave seriously damage the infusion pump and void the warranty Medex Part G6000608 Revision 3 Operation Manual Page 66 MEDEX Medfusion 3500 25 MAINTENANCE amp SERVICE This chapter includes information relating to both standard maintenance and service Periodic Maintenance Trained biomedical service personnel should test the pu
54. een entered correctly Check Clutch Plunger Hich The syringe is not loaded correctly Check the plunger lever and ensure it is Lever 5 all the way up Sensor is active when syringe is not loaded Check the syringe flange holder Ensure the flange holder pulls back to the side of the case If holder does not operate correctly immediately remove the pump from service for repair Check ss Flange High ensor Sensor is active when syringe is not loaded Check the syringe plunger holders Ensure the holders move freely If they do not operate correctly immediately remove the pump from service for repair Completing System Initialization Limit Allow pump startup to complete self testing Either begin a new infusion return to the SELECT THE MODE screen where Infusion Complete High no alarms sound or turn off the pump Low Battery Each 1 drop in capacity following initial signal if power cord is not plugged in Low Battery Initial Signal Medium Plug in power cord and run pump on AC mains while recharging the battery KVO in Progress Medium nii LE that volume limit has been reached and KVO infusion is Advisory message in custom dilution program Consult syringe flow delivery tables in appendix to determine appropriate syringe size Check Syringe Plunger Sensor High Plug in the power cord and run pump on AC mains while recharging the Tam battery Invalid Rate for Syringe Size High Syringe size not recogni
55. en the pump and the patient does not involve any thermally conductive material there is no concern with respect to possible heating of this device during an MRI procedure Medex Part G6000608 Revision 3 Operation Manual Page 78
56. es See guidelines for pump performance on time to occlusion At lower rates smaller syringes have shorter occlusion times Medex Part G6000608 Revision 3 Operation Manual Page 49 MEDEX Medfusion 3500 30 BD 60 cc 4 BD 30 cc a v 20 E a E E E F 10 Rate ml hr Flow Rate ml hr BD 10 cc ho a Time mins e Time mins e 0 0 2 0 4 0 6 0 8 1 0 0 5 1 1 5 2 2 5 3 Rate ml hr Flow Rate ml hr uw T E E E E E 0 0 125 0 25 0 375 0 5 0 01 0 2 0 3 0 4 0 5 Rate ml hr Rate ml hr Medex Part G6000608 Revision 3 Operation Manual Page 50 MEDEX _ How Delivery Graphs Medfusion 3500 This section contains the flow delivery graphs for selected B D syringes Becton Dickinson 60cc at Zml hr 15 ae Ch flow ml hr Variation in flowrate 5s 30 60 30 120 time Min Startup graph for B D 60 ml Becton Dickinson G60cc at zml hr observation window min Trumpet curve for B D 60ml Becton Dickinson 30cc at 1mlihr flow mi Variation in flowrate 30 60 90 120 time Min Startup graph for B D 30 ml Becton Dickinson Sec at 0 17ml hr 0 285 flow miih Varlation in thowrate 5 0 085 30 e 50 120 time Min Startup graph for B D 5 ml Medex Part G6000608 Revision 3 Operation Manual Becton Dickinson 30cc at 1ml hr 9 13 17 21 25 29 observation window m
57. es in any of the 4 available libraries Your facility should establish a policy for controlling setup modification and recording of libraries TYPES OF PROGRAMMABLE LIBRARIES There are two types of libraries in the Medfusion 3500 infusion pumps Type of Library What it Does The 1 is the E Plates Library Like the standard libraries they contain templates with presets necessary for programming an infusion But they do not pause at each level for you to verify the settings Instead the entire set of values is programmed at one step including syringe manufacturer and size Then the pump pauses at the BEGIN DELIVERY E Plates Library Library D screen and displays all the infusion values At that point you merely have to press the Start button to begin delivery If the E Plates library is not desired it can be converted to the 4 Standard Library Library D by simply disabling E Plates and enabling library D in the custom program The last 3 are Standard Libraries and contain templates with presets necessary for Standard Libraries programming an infusion These libraries require you to step through and review each setting This allows modifying standard settings while stepping through preset values Medex Part G6000608 Revision 3 Operation Manual Page 57 MEDEX eee MMedfusion 3500 LIBRARY AND TEMPLATE WARNINGS amp CAUTIONS Before starting ANY delivery ALWAYS confirm correctness of ALL infusion values you just set
58. etween drug and diluent Verify that the actual dose amp Fluids delivery rates are acceptable settings Actual rate may differ from target rate because Compatibility of rounding of volumes in the dilution formula 10 When ready press the Continue button to call the SELECT SYRINGE MANUFACTURER screen Now you will complete setup of the pump and begin infusion SELECT S3YRINGE MANUFACTURER TYPE 1 E D 2 HOHO JECT J TERUMO PA PA EA PA 11 At the Select SYRINGE MANUFACTURER TYPE screen select the syringe you are using and then load the syringe Step through the remaining levels pressing the Enter button to verify each setting 12 After all values are confirmed the pump pauses at the BEGIN INFUSION screen PRESS lt START TO EEGIH INFUSION conc 1 666 MG HL ALB mu WEIGHT 66 6 KG DOSE LBB HcG KG MIHO RATE 2359 5 ML HR E FLATES cHG DOSE AO CLEAR TOTALS 13 Prior to beginning the infusion press lt BOLUS gt to initiate the priming sequence page 21 14 When ready press the Start button to begin infusion Medex Part G6000608 Revision 3 Operation Manual Page 34 MEDEX Medfusion 3500 11 BoLus DOSING A Bolus dose is an optional parameter of some delivery modes wherein you specify a bolus volume to be delivered over a specified time You may also configure bolus dose to be automatically prompted or called up in the programming steps Enable You can permanently disable Bolus programmin
59. f the display FERFORMIHG SELF TEST ERES MEDFUSION 3008 VERSION S EH Hai CONFIG Io SE69 ca 959 2002 E SECONDS REHMRIHIHG MEDEX When you begin running an infusion on internal battery this battery shaped gauge also appears briefly in the upper right corner of the display at the start of delivery j e rmf PD RATE HL HF CHG RATE TITRATE CLEAR TWD And you can briefly display this battery shaped gauge at any time while the pump is infusing on battery by pressing any number button BATTERY GUIDELINES Power amp Battery Limits When you see the Battery Low message you should plug the pump into a power outlet for recharging The battery indicator remains on continuously when When To Charge The Battery charging If the pump IS plugged into an outlet and fails to charge the battery withdraw the pump from service for testing by trained biomedical service personnel The internal battery in intended for allowing you to infuse medications and fluids when an external power outlet is not conveniently available or when the patient is being moved When You Can Run On Battery Alone When battery becomes fully depleted all infusion stops and a Battery Depleted alarm begins sounding For a fully depleted battery you must plug in the AC power cord turn OFF the pump to clear the alarm and then turn ON the pump When You Cannot Run On Battery See Alarm Priorities amp Messages
60. fic operating criteria indicated below The pump when correctly placed and operated within this 1 5 T 64 MHz MR environment will not present an additional hazard or risk to the patient or MR user or affect the image quality of the MRI examination MRI procedures using the pumps must only be performed according to the specific operating guidelines as follows Proper Placement of Pump The pump must be positioned in the MR environment of a 1 5 Tesla MRI system in a magnetic fringe field that does not to exceed 150 gauss Placement of the pump in a magnetic fringe field greater than 150 gauss may present a projectile hazard to the patient or MRI user because of magnetic field interactions In addition the operation of the pump may be affected and or degrade or alter the quality of the MR images that are obtained Warning The pump must be securely fastened to a non moveable object while positioned in the W arning MR environment Pulse Sequences for MRI when using the Medfusion 3500 With the pump operating in a proper position relative to the 1 5 Tesla MRI system 1 e a magnetic fringe field of 150 gauss or less the use of standard spin echo fast spin echo and gradient echo pulse sequences for MRI examinations has been determined to produce no substantial alteration in image quality The use of unconventional or non standard MRI techniques has not been assessed and must be avoided Note Since the interface betwe
61. g screen backlight to bright and silence the audible alarm for the Medium priority programmed alarm silence period If the front panel controls are locked when a medium priority alarm occurs the pump controls do not unlock A low priority alarm indicates any condition not requiring immediate operator intervention Low priority alarms are announced with a continuous yellow indicator a viewing screen backlight that E oscillates between bright and dim and an audible signal 2 Medex Bing Bongs or three international Low priority tones on 1 sec off 1 sec on 1 sec off 1 sec on 1 sec off signal If the front panel controls are locked when a low priority alarm occurs the pump controls do not unlock A limit priority alarm sounds a tone and displays an advisory message onscreen for 3 seconds Limit Priority If the front panel controls are locked when a low priority alarm occurs the pump controls do not unlock Neglected Pump Alarm The Neglected Pump alarm is a medium priority alert It is simply reminding you to finish what you started Once you begin programming any infusion delivery the pump expects you to continue until setup is complete If you forget and leave the pump paused too long 30 seconds on a data entry screen then the pump initiates a medium priority user callback alarm There are several basic resolutions e Press the Alarm Silence button XE or ANY button to silence
62. g through pump custom configuration or Disable Bolus temporarily through the BOLUS DOSE screen QOIRRRSXRs4RiRGgiTI343G3 3 I3G4I y I3 IG IIG3 T I3 4 IG 3301 03 3 G DD 9 00 D 5 G 3 2 3 3 3 0 22 3 3 30432 3 3 3 43 3 3 0 3 4 4 D 4 G BG S GG GGMG DS RS GG G GUERRE GE GGUSR S GGG SG S GgGGOD GR g G GULSER GG GOLSR GG GGOLSER GG GOLES G y GUOLSR SG Ru G SES RR GG GUERRE G GG OLSRR GR G OLS RR G GG OUS GS GG OLSR SG 3 GARS GG GULSY SG G GULSR E GG GUOLS E GG US RS GG GILSY S GG GULSR S GG GUGPSR GG GUUCSR S GG GUETYE GR GGULS RR GG GULSRR RR GGULS REG 3G ULS RR GG GUSLSTR GG GULS RR GG GULSRR GR GULS RR GG GULSER GR GULSYS GG GULS RS GG GULSR S GG GULS ER GGG ULSR S GG GU LS RS GR GUERRE GR GUULS ER GR G ULSES GR GULS RS GG GUERRE GR GUULS ER GR GUULSER GR GULS RR GR GUGULSTE RR G a GONE Ru G ug gs Gag rigidi irgrgisiriegiririrriririrririririirrrrrrirrirrrrrrrrrrririr Setup Bolus Dosing Below are the steps for adding a bolus doing to an infusion you are about to begin or to one you have paused to include a bolus PRESS STRRT TO EEGIH IHFUSIOH COHC c EI MG ML FD 4 444 mL WEIGHT 66 6 KG tw LIMIT BH HL EDLUS 2 5SH8 Har EG DOSE 158 MrG EG mHMIH RATE Sar HL HRE MES cua DosE EE cLEnk ToraLs 1 When paused at the BEGIN INFUSION screen press the Options menu button to find bolus dose programming PRESS THE HUMEER TO SELECT THE PROGRAM OPTION 1 STANDE Y D SAVE TO LIBERAR Y Z LOADING DOSE J BOLUS DOSE d VOLUME LIMIT E
63. hanged The Total Volume Delivered does not clear automatically 2 From any run screen press the Clear TVD program key e Confirmation is required to clear the Total Volume delivered e Press Yes to clear total volume delivered only Or press NO to exit without clearing e The program volume or dose delivered is cleared automatically whenever the pump s delivery mode or syringe size 1s changed The Total Volume Delivered does not clear automatically Recovering You can restore total volume delivered display after turning OFF the pump by using the TVD TDD Recall Settings selection from the Main menu If you have cleared the TVD then only the quantity infused since clearing will be stored in memory Information Medex Part G6000608 Revision 3 Operation Manual Page 55 MEDEX Medfusion 3500 21 KEYPAD LOCK The keypad can be locked during delivery The lock feature 1s provided to make the delivery settings tamper resistant Once the system is locked a setting cannot be modified until the system 1s unlocked The Medfusion 3500 offers a programmable unlock code option To set an unlock code refer to the Configuration Manual j eb 6af PD RATE 40 ML HR CLEAR TD Press the LOCK button to lock the front panel controls The LOCK indicator lights 2 If you press any front panel buttons other than the UNLOCK button a PUMP IS LOCKED message appears onscreen FIF IS LOCKED FD 4 424 mL RATE 49 ML H
64. he BEGIN INFUSION screen 3 Press the Options button This calls the SELECT THE PROGRAM OPTION screen USE ARROW KEYS THEM ENTER TO CHOOSE A CHARACTER BecOEFGHIJE LMHOFGRZTUM Wty 2 SPACE PRESS STOF TO A12345572839 SAVE AHD EXIT META 4 You need to find the SAVE TO LIBRARY option You may have to press the More button until it appears onscreen 5 When you find it press the number button for SAVE TO LIBRARY and call the SELECT THE LIBRARY screen Press the number button for the library you want to use This calls the SELECT THE LIBRARY ENTRY screen 7 You may save to either a used or unused template Make your choice and press its number button a PRESS THE HUMEER TO SELECT THE LIERARY ENTRY 1 URDRUG 1 D UNUSED ci DOX RXBD E UNUSED Ss UNUSED T a UNUSED d UNUSED ci UNUSED LL MORE o You are now at the CHOOSE A CHARACTER screen This is where you name the template 9 Use the gt and l keys to put the highlight on the character or symbol you wish to use Then press the Enter button to type the character onto the screen 10 Repeat step 9 until you have named the new template Use the Backspace key to make corrections a 11 When finished naming the new template press the Stop button to save and exit The new template 1s now stored permanently in the designated library And 1t now appears on the SELECT THE LIBRARY menu PRESS THE HUMBER TO SELECT THE LIERARY ENTRY 1 URORUG 1 Z Dax Rxb 2 MEDI
65. ical service technician Infusion will continue using backup copy of xx data As soon as possible remove pump from service for testing and checkout by a trained biomedical service technician System Advisory xx Data Corrupted service for repair by a trained biomedical service technician E Reminds user that the programmed rate is below that recommended for the Below Recommended Rate Limit syringe size no remedy required System Failure aa bb cc Press Power button to turn off pump Immediately remove pump from Medex Part G6000608 Revision 3 Operation Manual Page 16 MEDEX Medfusion 3500 7 GUIDELINES FOR ENHANCED PUMP PERFORMANCE The following are guidelines for enhanced syringe pump performance Review occlusion time and flow delivery graphs in Delivery section Because of the way syringe pumps operate clinicians should use appropriate syringe size tubing and inline devices for expediting delivery of medication or fluid Certain factors enhance syringe pump performance where performance is defined as a Time to Detect Occlusion b Continuity of Flow c Startup Time ALWAYS USE SMALLEST SYRINGE FOR VOLUME OF FLUID BEING DELIVERED It is all too easy to fall into a pattern of using the same syringe size or sizes to infuse medications or fluids It is recommended to always using the smallest syringe that can get the job done This can help avoid a variety of problems Friction and compliance of the syri
66. in Trumpet curve for B D 30 ml Becton Dickinson Sec at 0 17 ml hr 9 13 17 z1 zm 29 observation window min Trumpet curve for B D 5 ml Page 51 MEDEX Medfusion 3500 19 CHANGING DELIVERY RATE The Medfusion 3500 infusion pumps offer different ways of changing delivery rate either before beginning infusion during delivery or when paused You can change the infusion rate by titrating the dosage Up or Down during infusion Titration changes infusion rate by increasing or decreasing the current setting The increments of change depend on syringe size amp fluid concentration j Ep Baf TwD 16 186 ML PD Hse ML EOLUS cal HL Kwo w LIMIT Bk ML RATE 30 ML HR CHG RATE TITRATE CLEAR TWD 1 Press TITRATE button at DELIVERY screen This calls the ADJUST THE RATE screen Infusion does not stop ADJUST RATE PRESS ENTER TO COHTIHUE ab CURRENT SETTING Him Fl ME HR NENNEN A e 1 ENTER 2 Press the or Y menu buttons to increase or decrease the setting Or use the Back button to escape without titrating Increments of change are based on syringe size The smaller the syringe installed on Increments of the pump the smaller the available increments The larger the installed syringe the Change larger the increments 3 The delivery rate does not change until you press the Enter button If you change your mind press Back to return to DELIVERY screen without making a change Rate is limited by the
67. indefinitely over 10 years or until overwritten QUIsIRXG3 4343333033333 33 33 33333 12 3 33 31332 33 31333 33 313 33 33313 33 3331233 33 31 33 3331233 33 313 33 33 1333 33 312 13 33 312 33 33 13 33 33 1 33 33 1 13 33 1213 33 31 33 33 312 33 33 1 33 33 31 13 33 1 33 3331 33 33 313 33 33 13 33 33 13 33 33 31 33 33 313 33 33 31 33 33 13 33 33 12 33 33 31 33 33 1 33 33 1 13 33 13 13 33 31 13 33 31 13 33 1 13 33 1 13 33 31 13 33 31 13 33 33 33 33 31 13 33 31 33 33 33 33 33 31 12 33 31 13 33 31313 33 31 13 33 1 12 33 31 13 33 33 13 33 33 13 33 33 33 33 3 3 33 3 3 33 33 3 33 34 3 3 33 33 3 3 33 33 3 33 32 3 3 33 33 1 32 33 3 3 32 34 3 3 32 32 3 3 32 32 3 2 32 2 2 32 2 32 2 2 32 2 2 2 3 2 2 2 3 3 2 32 3 2 2 22 32 8 FOR WHAT ARE LIBRARIES AND TEMPLATES USED Every unit department organization or hospital has standard ways of delivering medications or fluids If you use the pump on a regular basis you will find yourself typing the same values again and again when preparing the pump for delivery By using the libraries and templates feature you can make these settings once and then save those settings to a permanent file or template These templates of stored presets are used for administering fluids or medications in standard infusions without your having to setup individual dosage values each time you need to begin an infusion So they are a means of automating the pump setup process Anyone who 1s authorized to use the infusion pump can use templat
68. infusion values you Confirm All just set Settings Delivering a Loading Dose 1 When ready press the Start button to begin infusion The BEGIN LOADING DOSE screen appears e Press Yes to confirm and begin loading dose delivery e Press Chg Dose button to change the loading dose settings e If the loading dose settings have been programmed in body weight the key labeled CHG IN ML will allow the dose to be changed in ML directly e Press No to skip the loading dose and return to the NORMAL DELIVERY screen e Ifyou don t press ANY button for 30 seconds the neglected pump alarm will call you back to the pump BEGIN LOADING DOSE DELIVERY LOAD 6 6 HL TIME Bl 28 MH 22 oor ML HR O E TES mo 2 Pressing Yes calls the LOADING DOSE DELIVERY screen and begins the infusion The pump automatically completes the Loading Dose then switches to normal delivery rate and screen The loading dose volume delivered is automatically added to the Total Volume Delivered TVD as well as the Programmed Volume Delivered PVD or Programmed Dose Delivered PDD for that infusion FRES CANCEL TO STOP L HDIHG DOSE DELIVERY LOAD 6 6 HL DELIVERED 4 61 HL REMAINING H1 115 mms ss RATE oor ML HR cancel Y poo oo S CANCEL stops the loading dose and returns to the normal delivery rate and screen STOP during a loading dose delivery immediately halts all delivery and the pump pauses Medex Part G6000608 Revision 3
69. ivided by 1000 Rate is calculated as mass delivery rate milliUnits hr divided by concentration U ml mU hr iu divided by 1000 A Rate is calculated as mass delivery rate Units min times 60 min hr divided by U min concentration U ml U hr Rate is calculated as mass delivery rate Units hr divided by concentration U ml Below ls a table of body weight modes and the formulae used to calculate them Type of Mode How it is Figured Rate is calculated as patient weight kg times dose delivery rate milligram kg min times soe Mee Krl 60 min hr divided by concentration mg ml Rate is calculated as patient weight kg times dose delivery rate milligram kg hr divided mg kg hr i by concentration mg ml ICE AIR Rate is calculated as patient weight kg times dose delivery rate microgram kg min g Kg times 60 min hr divided by concentration mg ml divided by 1000 ined kalbr Rate is calculated as patient weight kg times dose delivery rate microgram kg hr divide g Kg by concentration mg ml divided by 1000 Units Kg min Rate is calculated as patient weight kg times dose delivery rate Units kg hr divide by concentration Units ml Medex Part G6000608 Revision 3 Operation Manual Page 71 MEDEX 0 1 AMed usion 3500 Volume Time amp Intermittent modes Below is a table of volume time and intermittent modes and the formulae used to calculate them Type of Mode How it is Figured Rate is calculated
70. k Failure to prime correctly can delay infusion delivery and cause Total Volume Delivered to read higher than what is actually delivered to the patient Priming New Syringes Never operate the Prime function while pump is connected to the patient infusion site Using the pump in the Prime function may cause over infusion with possible serious injury or death to patient Don t Prime the Patient ANNE Before starting ANY delivery ALWAYS confirm correctness of ALL infusion values you just set Only use syringe sizes and manufacturers listed in this manual Use of other syringe Syringe Matching manufacturers or sizes may possibly cause an under infusion or over infusion to the patient that could result in serious injury and or death Always confirm syringe manufacturer and syringe size displayed on the pump match the ey ai amd EL manufacturer and syringe size loaded into the pump Mismatching syringe make or size may amp Size possibly cause an under infusion or over infusion to the patient that could result in serious injury and or death Never use the pump in magnetic fields above 150 gauss Always secure the pump to a non movable object In magnetic fields above 150 gauss the attraction of the pump to the magnet may be a hazard This pump may be operated in static magnetic fields up to 150 gauss for specific MRI devices identified in Appendix 5 Check Magnetic Fields Above 150 Gauss Once the syringe and tubing system 1s connect
71. le clamp Using the 3000 Series Pump Rotating Detachable Pole Clamp Pole Clamp Medex Part G6000608 Revision 3 Operation Manual Page 75 MEDEX Medfusion 3500 8000 Series Pump Stationary Pole Clamp With the L bracket you can align the pole clamp for mounting on any vertical or horizontal pole bed rail or similar solid structure small enough to fit within the clamp s jaws The light weight of the pump makes this convenient 1 Open the clamp jaws wide enough to easily slip around the pole 2 Tighten the clamp until it is securely fastened so the pump cannot be moved Clamp with L bracket aligned for vertical pole mounting Clamp with L bracket aligned for horizontal pole mounting The 3000 Series stationary pole clamp is packed in a bag in pieces which must be assembled before it can be used e The Pole Clamp assembly with 4 pan head screws amp 4 lock washers already inserted e The L Bracket which must be attached for mounting on either a vertical or horizontal pole e 2 flathead screws and 2 conical lock washers in a small plastic bag Medex Part G6000608 Revision 3 Operation Manual Page 76 MEDEX Medfusion 3500 Assembling the 3000 Series Pump Stationary Pole Clamp You need a Philips head screwdriver The steps for assembling the pole clamp are given below 1 Unpack the pole clamp assembly from the shi
72. led fluid flow can occur when fluid set is not clamped or turned off and may cause serious injury and or death Turn Off Fluid Flow Medex Part G6000608 Revision 3 Operation Manual Page 22 MEDEX Medfusion 3500 9 STARTING amp STOPPING INFUSION DELIVERY Y ou can start an infusion delivery at any time after you have setup a delivery mode You can start infusion from a pause standby or delayed start screen Whenever you begin an infusion setup and progress all the way through the setup levels the pump pauses at the BEGIN INFUSION screen FRESS lt TART gt TO EEGIH INFUSIOH CONC 25 H6 HL F vD AAW HL WEIGHT 66 5 KG tw LIMIT B HL DOSE 158 McG EG mMIH RATE eee ML HE E FLATES cHG DOSE a e CLEAR TOTALS 1 Program the delivery mode by setting its variables like rate volume limit and so on 2 When you finish setting the delivery mode the pump pauses at the BEGIN INFUSION screen 3 Press the Start button on the face of the pump 4 The pump begins the infusion A Starting Delivery from Standby Y ou can start the infusion at any time when the pump is on standby It is unnecessary to either cancel standby or wait until its period ends 4 44 mL 66 ML HE E FLATE CHG FATE OF TIOHS CLEAR TOTALS 1 To start infusion from standby delayed start or pause press the Start button 2 Before starting the infusion you may also a Return to the Main menu b Change the Rate c Change deli
73. lete the infusion Bolus changing Intermittent rate and titrating rate are not allowed in this delivery mode Volume Time You can stop infusion delivery at any time 1 Press the Stop button 2 The infusing indicators turn OFF and the pump pauses You may a Restart infusion at any time b Change settings and restart infusion c Cancel the infusion by returning to the Main menu screen d Turn off the pump Occlusion Trend Graph During Delivery The pump automatically monitors occlusion or syringe backpressure during any infusion This trend appears in a bar graph on the right side of the display during delivery The letter at the top of the graph indicates the configured occlusion alarm level Fixed for 1 ml syringe at very high 35 psi 248 kPa ips Si ips Cis Pressures in above table are only approximations This 1s because syringe friction affects the actual pressure level Occlusion limit default is set in the custom configurations see Configuration Manual Medex Part G6000608 Revision 3 Operation Manual Page 47 MEDEX Medfusion 3500 The operator may override the default Occlusion limit for a particular infusion from the lt OPTIONS gt menu if that option 1s enabled This bar graph indicates three pressure reading values 1 The right side of the bar is the current reading 2 The left side of the bar is the oldest reading 3 The update rate to the graphical readings depends on the flow delivery rate
74. linician can easily see a that FlowSentry is activated and b whether the delivery pressure is stabilizing steady or increasing In the event that the FlowSentry has not been activated there will be no or arrow signs to the left of the pressure trend graph RR RRE RRE Post Occlusion Bolus Reduction With large syringes Bolus can accumulate or be stored in the syringe tip when an occlusion happens This pump contains an algorithm for post occlusion bolus reduction Using post occlusion bolus reduction the pump withdraws the plunger a predetermined amount to reduce stored bolus in the syringe However this feature does not totally eliminate the occlusion bolus Occlusion bolus will vary greatly with infusion setup and the fluid infused The table below shows typical occlusion bolus volumes after bolus reduction for several syringes at different occlusion pressure settings Note for syringes smaller than 10 ml the occlusion bolus is very small M L N H Syringe Size Volume of Bolus ml Typical occlusion bolus volumes for Becton Dickinson 10 20 30 and 60 ml syringes The time for the pump to detect an occlusion is affected by three factors 1 Occlusion Pressure Setting High H Normal N Low L or Very Low VL 2 Flow Rate Setting 3 Syringe amp Tubing Compliance i e softness of syringe plunger tip or tubing Below are typical time to occlusion graphs for several syring
75. lusion Limit Override Alarm Loudness Disable Enable Rapid Occlusion Detection Disable Enable Near Empty Alarm Tone Disable Enable Empty Alarm Tone Medex Part G6000608 Revision 3 Operation Manual Page 46 MEDEX Medfusion 3500 In DELIVERY the pump infuses at the rate setting for the pump The infusing indicators are 1lluminated and the total volume delivered or total dose delivered accumulates aaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaasaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaemu Starting Delivery You can start the infusion at any time when the pump is on STANDBY or paused at BEGIN INFUSION screen 1 To start infusion from standby or pause press the Start button 2 While you are running an infusion you may a Lock the keypad b Change the Dosage Rate c Titrate the Rate d Clear TVD j ED f TWD 2 352 ML PD Ej ES mL EOLUS oS ML KWO w LIMIT BE ML RATE 3 9 ML HR CHG RATE TITRATE CLEAR TWD Volume Time DF In Volume Time Delivery and Intermittent Volume Time the screen indicates the effective delivery rate and time remaining to comp
76. maximum and minimum delivery rate for the syringe size 4 When ready press the Enter button to accept the new setting The new rate is not effective until you press the Enter button Titration TON E t at ui Titration is unavailable for either VOLUME TIME or INTERMITTENT modes Unavailable Medex Part G6000608 Revision 3 Operation Manual Page 52 MEDEX Medfusion 3500 Changing Rate During Delivery You can change the infusion rate during any delivery session except Volume Time or Intermittent modes l Tochange the rate during delivery press the Chg Rate or Chg Dose button dj Ep X amp aBm FVD 5 42 mL n ED Y LIMIT B HL H RATE 3 9 ML HR CLEAR TWD 2 Use the number buttons to set the dose rate Rate is limited by the maximum and minimum delivery rate for syringe size ENTER RATE PRESS ENTER TO COHTIHUE ab CURRENT SETTING MIN Gl DIEA HR NENNEN E ee NETTES 3 When ready press the Enter button to accept the new setting The pump delivery rate does not change until you press the Enter button If you change your mind press Back to return to DELIVERY screen without making a change You can change the dosage rate at any time the pump is paused 1 Ifthe pump isn t already paused then press the Stop button to pause the infusion FRESS START TO BEGIN INFUSION FWD 4423 ML BOLUS 2 5 ML V LIMIT 6H ML EVO RATE B G ML HR RATE 3 5 ML HRE OPTIONS CLEAR TOTALS 2 To change the rate during any paus
77. mited to the maximum fill volume for the current syringe size and minimum volume is 1 100th the syringe size 4 When ready press the Enter button to accept the settings and call the BEGIN INFUSION screen PRESS STRRT TO EEGIH INFUSION FD 4 444 mL BOLUS CaL ML tw LIMIT 6H HL RATE a b MLHR OPTIONS CLEAR TOTALS 5 With the volume limit set the pump pauses at the BEGIN INFUSION screen The volume limit setting now appears on the display Program Volume Delivered PVD will appear on the screen directly above the V LIMIT Medex Part G6000608 Revision 3 Operation Manual Page 40 MEDEX Medfusion 3500 6 If you are initiating a new infusion Prior to beginning the infusion press lt BOLUS gt to initiate the priming sequence page 21 7 When ready press Start to begin infusion The infusion will stop when it reaches the preset volume limit Warning T Before starting ANY delivery ALWAYS confirm correctness of ALL infusion values you Confirm All just set Settings Medex Part G6000608 Revision 3 Operation Manual Page 41 MEDEX Medfusion 3500 14 KEEP VEIN OPEN KVO RATE The Keep Vein Open KVO rate is an Option available for most delivery modes except volume time and intermittent volume time e You must have a volume limit programmed for KVO to work After a volume limit is reached a low rate K VO is set to maintain patency of the infusion site e The range of rates available appears
78. mp is running 1 Press and hold the Power button This calls the SHUTDOWN OR CONTINUE screen Infusion has not stopped at this point PRESS POWER AGAIN TO SHUTOOWH COHC 15 Mu HL POD der MG WEIGHT rH EG EOLUS DOSE 198 MCG KG MIH RATE 63 ML HR PO IE eee 2 Press and hold the Power button to turn OFF the pump To cancel press the Continue or Back buttons 3 Infusion stops when you turn OFF the pump Medex Part G6000608 Revision 3 Operation Manual Page 24 MEDEX Medfusion 3500 10 PROGRAMMING DELIVERY MODES The Medfusion 3500 infusion pumps come with a variety of delivery modes ready for you to program to meet your specific patient care needs In fact all modes are customizable by the user The actual modes available in a given pump and their location on a given screen depend on the custom setup performed by your in house technician or service representative The following modes described in this chapter and the steps given for programming them are based on general setup parameters Overview of Programming Steps This chapter describes the basic steps for programming the different delivery modes However there is a difficulty in describing these steps for an average user This is caused by the extensive customization available in the Medfusion 3500 infusion pumps _ APPARENTLY MISSING OR DIFFERENT STEPS As you learn to program infusion deliveries on your infusion pump you may find that certain f
79. mp periodically to ensure continued safe operation e This testing should be performed at least yearly or whenever the pump has been damaged or dropped e The occlusion and other sensors must be checked annually to ensure safe operation of the pump e Refer to the Service Manual for specific details The Medfusion 3500 Configuration Manual PN G6000609 provides information on customizing the settings and features of the pump which in turn affect the use and operation of the pump on a daily basis The 3000 Series Service Manual PN G6000278 provides technical information on this pump including e Circuit Diagrams e Theory of Operation e Calibration e Functional Descriptions e Diagnosis and Testing e Service Parts Service Warnings Only trained biomedical service personnel may service this pump Service personnel Pump Maintenance should disconnect the AC power cord before servicing the pump The only means of removing AC power is to disconnect the AC power cord While AC Power the AC power cord is attached to the pump and plugged into an AC outlet live main voltage is present within the pump Manufacturer Always maintain this pump following manufacturer recommended instructions in the Recommended Service Manual Improperly maintained pumps may cause either under infusion or Maintenance over infusion to patient Users should never open the pump case or battery compartment for any reason Never open pump case Service personnel should al
80. ng from right to left What Indicators Mean Below is a table of front panel indicators and what each of them means Indicator What it means GD Alarm Indicators The ALARM indicators yellow or red are on whenever the pump is in an alarm condition The specific details of each alarm are covered in the Alarm section later in this manual The AC LINE indicator green is ON whenever the pump is connected to mains line AC Line Indicator power It is OFF when the pump is not connected to an active AC line The BATTERY indicator green blinks ON amp OFF whenever the pump is operating on ED Battery Indicator internal battery power and remains ON when battery is charging The Lock indicator tells you the pump has been locked into its current operational mode CD Lock Indicator While this indicator is lighted the keypad is locked and no changes can be made to settings Attempting to stop or change an infusion while locked will result in an alarm and an advisory message The Infusing indicators are 3 green lights which illuminate in sequence right to left when the pump is infusing al Infusing Indicator During intermittent delivery mode a single Infusing indicator lights during the time between infusions Medex Part G6000608 Revision 3 Operation Manual Page 6 MEDEX Medfusion 3500 4 TECHNICAL SPECIFICATIONS amp DEFINITIONS Below are the technical specifications of the Medfusion 3500 infusi
81. nge plunger tip affect delivery startup and flow continuity The bigger the syringe the greater the friction and compliance the slower the startup Use a smaller syringe when running at a lower rate The table below recommends minimum delivery rates by syringe size when programming flow rates a limited priority alarm will be activated with an advisory message on the screen if a rate below those recommended here is entered Syringe size Lowest Recommended Rate 1 0 ml hr 0 67 ml hr 0 17 ml hr 0 10 ml hr 0 03 ml hr Note this table is only a guideline because syringes and infusion setups vary om 0 33 mir USE SMALL INTERNAL DIAMETER TUBING For the most consistently precise control of all fluids and medications it is recommended always using small internal diameter tubing Always minimize residual volumes between syringe and patient by reducing a Tubing length b Size of in line filters c Number of stopcocks This makes the infusion setup less variable or compliant which In turn reduces the start time for fluid to reach the patient and reduces time required for detecting an occlusion Medex Part G6000608 Revision 3 Operation Manual Page 17 MEDEX Medfusion 3500 8 SETUP amp LOAD SYRINGES Pump setup and syringe loading is a multi step process based on your daily practice of infusing patients with medication or other fluids Below are an illustration of the startup screen and a list of basic steps
82. nnnnnonnnnnnnnnnnnnnnnnanananess 57 Who Can Use These Libraries or Templates ia e pc Ebo HER n Vt dae 57 JI ypes ot Programinable ea 57 Library and Template Warnings amp Cautions esses nono non non non nn nn ronca conos 58 SS 58 How to Tell Whether E Plates Are Enabled For Use eee nnnm nnne 59 E Pates Diabeedi nocere atero itv de OO 59 ESPIAS e A e AD E 59 Usmo E Um 59 Enabline E Plates Standard LE o tut deo ats 60 C reaune librar la ti ta E 60 Saving a New Template T0 a LIL A A AA 61 Template Namina Conventos dad 62 Libraries Must Be Enabled to Use Ne 62 Transferring Libraries ron Pump to Pump io 63 23 BATTERY AC amp EXTERNAL DC POWER OPERATION Ne 64 Onscreen Display of Internal Battery Power Level Gauge 4 64 Batea ds 64 External DCPower Op OM scanne a enia eR SUR Venu mE Men aide Maie adis iia 65 24 XCLEANINGSANIDC ARE ettet tese ere ed 66 25 MAINTENANCE SERVICE eodeni A e Lo ode ae e e advo Ert Ioas 67 Periodic Maimtenatiee se eee e de t DEL EUR 67 sine Medex Service JNSSISUITICO e eret a o epe EH S tutu am ru iem E ur LH MEE 68 Returning a Medfusion 3500 Pump for Repair pp 68 Medex Limited WaS 69 26 APPENDIX 1 SYRINGE FLOW RATE BY MANUFACTURER amp SIZE eren 70 27 APPENDIX 2 FLOW DELIVERY CALCULATIONS onoooccncnnnnononnonnnonnnnnnnnnonnnonnonnnnnnonnoonnnonnnnnnnnonnnnnnnncnononnnnnos 71 AR A RI TO CO IR RD ARI RIA 71 Body Wer 010 0 886 i ane eee ee o
83. o be changed in ML directly 3 Pressing YES calls the BOLUS DELIVERY screen Medex Part G6000608 Revision 3 Operation Manual Page 36 MEDEX Medfusion 3500 CANCEL stops the bolus and returns to the normal delivery rate and screen STOP during a bolus delivery immediately halts all delivery and the pump pauses The bolus delivery continues at the bolus delivery rate until the bolus volume is delivered On completion of bolus dosing the pump beeps then resumes the programmed infusion delivery PRESS CANCEL TO STOP EOLUS DELIVERY DELIVERING BOLUS cab ML DELIVERED 1 345 mL REMAINING HEHEHE MHR Ss RATE J66 HL HR The bolus volume delivered is automatically added to the Total Volume Delivered TVD as well as the Programmed Volume Delivered PVD or Programmed Dose Delivered PDD for that infusion Medex Part G6000608 Revision 3 Operation Manual Page 37 MEDEX Medfusion 3500 12 LOADING DOSES A loading dose 1s a specified volume or dose of drug infused as a one time only bolus prior to the start of normal delivery You may also configure loading dose to be automatically prompted or called up in the programming steps Enable Disable Loading Dose You can permanently enable disable the Loading Dose option through custom pump configuration Setting a Loading Dose 1 When paused pressed the OPTIONS menu button to find the loading dose feature PRESS THE HUMEER TO SELECT TH
84. on pumps Category Specification 10 5 wide x 5 1 high x 5 5 deep 27 cm x 13 cm x 14 cm Weight pump only 3 8 lbs 1 7 kg Nominal 2 excluding syringe variations Accuracy for infusion back pressures of 100 mm Hg to 300 mm Hg BM S S 0 01 n hrto1130mlhr 3500 syringe size ml hr Body Weight Volume Time Custom Dilution Dimensions pump only Delivery modes user customized Mass Intermittent Volume Time KVO Rate Delayed Start Ve Standby Override Alarm Volume Delivery options user Bolus Dos Override Occlusion Limit Toggle PVD PVD customized Loading Dos Save to Library Toggle Empty Tone Toggle Rapid Occlusion Toggle Near Empty Tone Detection AC DOW er SOUTE 100 240 VAC 50 60 Hz 30VA P safety Class II Type CF External DC power source External DC Input 6 14 VDC 7 Watts Optional Safety Class II Type CF must meet IEC 601 1 Medical Equipment Standards IB i Bee attery Capacity at Rechargeable 10 hours at 5 0 ml hr with 60 ml syringe from fully charged battery Four libraries with 16 profiles per library User defined Delivery Libraries NE y One library option is E Plates for rapid setup Temperature 5 to 40 C 40 to 104 F Relative Humidity 15 to 95 non condensing Ambient Pressure 70 kPa to 106 kPa 10 2 psia to 15 4 psia Infusion Back Pressure 100 mmHg to 300 mmHg Normal Operating Conditions Medex Part G6000608 Revision 3 Operation Man
85. ork area You can tell whether E Plates is enabled for use by what you see onscreen when you start the pump or when you progress to the BEGIN INFUSION screen or when you return to the beginning screen E NN IIZITIZIIIIIIZIIZITIZIIIITIZIIZITIZIIIITIZIIIITIZIIIIIZIIZITIZIIIIIZIIZITIZIIIITIZIIIIIIS III TIS Ii s TII 4i gi 4G 43 3 2 7 3 D 3 3 3 3 o0 3 3 0 3400 E PLATES IS DISABLED Below is the rule of thumb for determining whether the E Plates library is disabled and not available for you to use When E PLATES is disabled or there is no stored template in the library the SELECT THE MODE menu is what you see onscreen after you turn on the pump and it completes its startup self check It will look something like the screen below E PLATES Is ENABLED The infusion pump gives you visual cues when the E Plates library is enabled Below are some rules for determining whether the E Plates library is enabled and ready for you to use Normally the SELECT THE MODE screen is the first thing you see on screen after you turn on the pump and it completes it startup self checks ENTRY menu is the first thing you see on screen after you turn on the pump and it completes its startup self checks PRESS THE HUMBER TO SELECT THE LIERARY ENTRY 1 URDRUG 1 ci DOX RXBD If you then press the Main Menu button from the above SELECT THE LIBRARY screen this toggles the SELECT THE MODE screen or menu Notice how E PLATES now ap
86. ovides programmable upper and lower limits for library dose rate parameters When attempting to enter or change a dose rate of a library selection the PharmGuard limits will be displayed on the screen between the MAX and MIN values as HIGH and LOW 3 Ifa value is entered that is outside the PharmGuard range an audible alarm will sound and the message OUTSIDE RANGE LIMIT SILENCE ALARM TO CONTINUE will appear 4 Once the alarm is silenced the message CONFIRM LIMIT OVERRIDE will appear 5 If this message is answered in the affirmative the rate will be accepted If the message is answered in the negative the rate entry screen will re appear Medex Part G6000608 Revision 3 Operation Manual Page 63 MEDEX Medfusion 3500 23 BATTERY AC EXTERNAL DC POWER OPERATION The infusion pump is normally operated by an AC power supply This pump may also be operated by an external DC power supply Each pump contains a rechargeable battery that is continually charged by the power supply as long as the pump is connected to AC or external DC power If the AC or external DC power is disconnected while the pump is turned ON the pump automatically begins drawing power from the internal battery _Onscreen Display of Internal Battery Power Level Gauge Whenever you turn ON the power the internal battery charge level briefly appears on the battery shaped gauge in the bottom left corner o
87. pears in the bottom left menu button If you press the E Plates button you return to the SELECT THE LIBRARY screen PRESS THE HUMBER TO SELECT THE MODE 1 MICROGHMS EG MIHUTE D ML HR Ce MICROGHMS KG HR Es CUSTOM DILUTIOH 2 MG EG MIHUTE T RECALL LAST SETTINGS d MG KG HK E FLRTES If you press the E Plates button on the above screen you return to the SELECT THE LIBRARY ENTRY screen RRA 2 2 3 2 2 3 4 3 32 3 4 2 3 4 2 32 5 2 20 EEN Using E Plates E Plates are much easier to use in fact than to describe how to use them If E Plates are enabled and there is at least one saved template in the library you just press a button to select it Medex Part G6000608 Revision 3 Operation Manual Page 59 MEDEX Medfusion 3500 The E Plate s preset values are loaded automatically into the pump provided that you have loaded a syringe of the manufacturer and size programmed for this library entry All you have to do then is press the Start button to begin the preset infusion after verifying infusion settings Some Data fields may be preset as blank and require data entry to proceed To determine enabled or disabled status see the previous section titled How to Tell Whether E Plates Are Enabled For Use 1 To use E PLATES from the SELECT THE LIBRARY screen 2 Use the number buttons to select the template you wish to use PRESS THE HUMEER TO SELECT THE LIERARY ENTRY 1 URORUG 1 c Dax RXxD _H
88. pping container 2 The L bracket attaches the pole clamp to the pump When you receive the pole clamp assembly 1t 18 configured for use with a vertical pole If you wish to change this assembly for use with a horizontal pole e g bed rail then you must reconfigure the L bracket using the following steps e Remove the 4 pan head screws and their lock washers from the rear of the pole clamp e Align the L bracket for horizontal mounting see previous page Install the 4 washers and pan head screws to mount the L bracket to the clamp Tighten them to at least 10 in lb 1 1 Nm torque 3 Use the small flathead screws and star lock washers to attach the pole clamp to the bottom of the pump Tighten them to at least 10 in lb 1 1 Nm torque Medex Part G6000608 Revision 3 Operation Manual Page 77 MEDEX Medfusion 3500 30 APPENDIX 5 MRI ROOM USAGE AN MRI Room Usage for the Medfusion 3500 The magnetic resonance imaging MRI room usage information for MRI procedures 1 e imaging angiography functional imaging and spectroscopy refers to the use of a shielded MRI system operating at a static magnetic field of 1 5 Tesla with radio frequency transmission and reception at 64 MHz The effects of using other MRI systems have not been determined for this infusion pump The Medfusion 3500 syringe infusion pumps have been determined to be acceptable for use in MRI rooms based upon the speci
89. rary The infusion pump comes with 4 blank libraries built into it There are 3 Standard Libraries and 1 E Plates Standard library Each library comes with 16 blank entries or templates These may be filled with presets through custom configuration e You are limited to creating 64 templates This is 16 templates each for the 4 libraries e Ifyou have authorization to reconfigure the pump settings you can delete the contents of library templates name amp rename the templates and save infusion presets in the templates All such standard dosage templates shall be setup according to standards amp practices of your hospital unit or organization Medex Part G6000608 Revision 3 Operation Manual Page 60 MEDEX Medfusion 3500 Any trained user of the Medfusion 3500 infusion pumps can save a group of presets to any library and template in the pump You can save presets to any library whether or not the library is enabled It is very easy In fact it is easier to USE ARROW KEYS THEN ENTER TO CHOOSE A CHARACTER AECOEFGHI Jk MEDICA LHHOPGRSTUY WXYZ ASPACE FRESS lt 5T0F gt TO a123456TB9 SAVE AND EXIT MITE ENTER 1 STAHDEY D SAVE TO LIBERAR Y Z LOADING DOSE Z EOLUS DOSE 4 VOLUME LIMIT UL IE 8 1 0 0 l1 eee do than to describe The steps are given below 1 Select and setup any infusion you want used as a standard delivery method Any group of settings can be saved to a template 2 Progress all the way to t
90. ready press the Enter button to accept the settings and go to the BEGIN INFUSION screen 7 After the bolus settings have been programmed the pump pauses The Bolus setting now appears on the BEGIN INFUSION screen PRESS START TO BEGIN IHFUZIGOH PD HHHH mL EOLUS c n ML 2 5 HL HK E FLATE CHG RATE OF TIOHS CLEAR TOTALS Warning RUN l Before starting ANY delivery ALWAYS confirm correctness of ALL infusion values you Confirm All just set Settings Delivering a Bolus Dose A bolus is a specified volume or dose to be delivered over a specified usually short period of time You must have started a delivery before you can deliver a bolus dose 1 Press the Bolus button the 44 button next to Start to call the BOLUS DELIVERY screen A bolus delivery cannot be initiated until after you press the Start button to begin a programmed delivery 2 Press Yes to begin bolus delivery e Or press No to skip the bolus and return to the NORMAL DELIVERY screen e Or press the Chg Bolus button to change the bolus settings e Ifyou don t press ANY button for 30 seconds the neglected pump alarm will call you back to the pump BEGIN BOLUS DELIVERY EOLUS 2 5 ML TIHE WeELTA MH ss SHH ML HR BEGIN BOLUS DELIVERY EDLUS JAB mc EG VOLUME T ML TIME H1l124 HH ss RATE SHA HL HR ee ee CHG EOLUS e Ifthe bolus settings have been programmed in body weight the key labeled CHG IN ML will allow the bolus t
91. rvice this pump Service personnel should disconnect the AC power cord before servicing the pump Always maintain this pump following manufacturer recommended instructions in the Service Manual Improperly maintained pumps may cause either under infusion or over infusion to patient Users should never open the pump case or battery compartment for any reason Service personnel should always disconnect the AC power cord before servicing the pump Never use a pump when it has signaled a system failure alarm Withdraw it from service and send it to a trained biomedical technician for service Never use a dropped or obviously damaged pump Withdraw it from service until a trained biomedical service technician can test it Page 11 MEDEX Medfusion 3500 Cautions Below ls a table of Cautions and conditions related to operation of the Medfusion3500 infusion pump Other cautions are posted throughout this manual An operational Caution defines any special care you must exercise for safe amp effective use of this device Operational Cautions Who Can Buy This United States of America Federal law restricts this device to sale by or on the order of a Pump physician Don t Dunk the Pump Never immerse the pump in water or other fluids This pump is not waterproof NEVER sterilize the pump in a steam autoclave or gas sterilizer Using autoclave or gas Never Autoclave sterilization can seriously damage the pump and void the
92. s Medex Part G6000608 Revision 3 Operation Manual Medfusion 3500 Always be sure to secure the syringe barrel flange and plunger with tubing threaded through holding clamp Failure to properly secure the syringe and tubing can result in uncontrolled fluid flow into a patient which can result in serious injury and or death Do Not use on the inlet side of Extracorporeal Membrane Oxygenation ECMO systems where the negative pressure is greater than 100 mm Hg as the high negative pressures can result in uncontrolled fluid flow Always operate this pump in horizontal position to prevent fluid leakage into the pump If you suspect fluid has leaked into it remove pump from service until a trained biomedical technician can test it Any external power source used with this pump must be IEC 601 1 certified for medical equipment Type CF and meet safety class II Connecting an external power source to the pump creates a medical system The user is responsible for complying with IEC 601 1 standards Refer all questions to Medex Technical Service Department The only means of removing AC power is to disconnect the AC power cord While the AC power cord is attached to the pump and plugged into an AC outlet live main voltage is present inside the pump When a 1 ml syringe is entered into the programming the occlusion pressure setting is fixed at very high 35psi Service Warnings Only trained biomedical service personnel may se
93. s and numbers you see on the naming screen e tis possible to give the same name to two or more templates within any library Avoid confusion by not doing this e With E plates it would be helpful to include syringe size like 30ml as part of the library name LIBRARIES MusT BE ENABLED TO USE It is possible to save a template to any of the 4 libraries whether they enabled or disabled But the library containing the template must be enabled before you use them to setup an infusion PRESS THE HUMEER TO SELECT THE LIERAR 1 E FLATES c LIERARY A S LIERARY E d LIBRARY C Medex Part G6000608 Revision 3 Operation Manual Page 62 MEDEX Medfusion 3500 Libraries and their stored presets can be copied electronically from one pump to another through the serial communications interface The process 1s called Library Cloning and involves one pump Teaching and the other pump Learning To learn how to do this refer to the Medfusion 3500 Syringe Infusion Pump Configuration Manual If you have authorization you may use custom configuration to clone libraries If not ask the person responsible for custom configuration to make library changes for you If you save to an existing template you write over its contents and the new template replaces the old If you reuse a template be sure to change its name to avoid confusion Reusing Templates PharmGuard Dosage Protocol Protection 1 PharmGuard pr
94. starting from scratch OPTIONS LETS YOU SELECT FROM A LIST OF VARIABLES E G BOLUS OR VOLUME LIMIT CLEAR TVD LETS YOU CLEAR TOTAL VOLUME DELIVERED 7 Prior to beginning the infusion press lt BOLUS gt to initiate the priming sequence page 21 8 When all delivery settings are correct press the Start button to begin infusion Medex Part G6000608 Revision 3 Operation Manual Page 27 MEDEX Medfusion 3500 Body Weight Infusion Deliveries mcg kg min mcg kg hr mg kg min mg kg hr Units K g Min The body weight rate calculation allows programming by e Drug Concentration e Patient s Weight e Drug Dosage The pump calculates the correct flow rate in ml hr to achieve the required drug dose If desired a volume limit loading dose or bolus dose can be set From the SELECT THE MODE screen select the desired Body Weight Delivery Mode These directions use select Micrograms Kg Minute as an example This calls the ENTER CONCENTRATION Screen 1 Press the number buttons to set medication concentration Concentration is limited to 4 digits ENTER COHCENTRATION FRESS ENTER TO CONTINUE 1 2 CURRENT SETTING Max Lae MIN 6 4461 Mia ML EncksFacE ENTER 2 Press the Enter button to accept the concentration setting and go to the PATIENT WEIGHT screen ENTER PATIENT WEIGHT PRESS ENTER TO CONTINUE CB CURRENT SETTING Max 25H HIH B25 28 iis BEEN EA sncksFacE 3 At the PATIENT WEI
95. sult is in mg ml Given that Target Dose Rate Final Delivery Dose Rate Calculate Final Volumetric Rate R Final Dose Rate W C Result is in ml hr GOAL OF THIS DILUTION CALCULATION The goal of this calculation is providing a dilution which makes the target dose rate the final dose rate while trying to stay as close as possible to the target volumetric rate In the result of the dilution calculation the final volumetric rate may be different from the target volumetric rate This is caused by the round to nearest ml occurring in step 4 above Medex Part G6000608 Revision 3 Operation Manual Page 73 MEDEX Medfusion 3500 28 APPENDIX 3 SERIAL COMMUNICATIONS This pump contains an optically isolated Infrared serial communications interface With an optional Medex conversion box this pump can be connected to a standard computer RS 232 serial interface This process 1s called Configuration Cloning and 1t allows pump setting information to be copied from one pump to another see Configuration Manual The interface provides capability for a remote computer to collect e Pump Settings e Pump Libraries e Current Delivery Information aaaaaaaaaaasaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaasaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaoaoaaaaoaaaaaaaaaaaaaaaaaaaaoaaaaaaaaaaaaaaaaaaaaa
96. t dose rate for a given volume of fluid to be delivered 1 Atthe SELECT THE INFUSION screen use the number buttons to select delivery mode Micrograms KG Minute Micrograms KG Hour Milligrams KG Minute or Milligrams Kg Hour This calls the TARGET RATE screen FRESS THE HUMEER T SELECT THE INFUSION WAITS 1 MICROGMS KG MINUTE Za MICKOGMS KG HR J MG EG 7 MIHUTE d MG KG HK Medex Part G6000608 Revision 3 Operation Manual Page 32 MEDEX Medfusion 3500 2 Use the number buttons to set the desired target infusion rate The target rate should be based from the desired volume that you wish to give the patient over a given time Syringe size limits the range of infusion rates ENTER TARGET RATE FRESS ENTER TO COHTIHUE HH CURRENT SETTING Max 1138 MIN 4 4411 ML HR EA ENTER 3 When ready press the Enter button to accept the target rate setting and go to INITIAL CONCENTRATION screen ENTER INITIAL COHCENTRATION FRE ENTER To COHTIHLE 144 CURRENT SETTING HIH Beam TIE TE qwLEnR EncksFRcE mnm 4 Atthe INITIAL CONCENTRATION screen set the value for initial or undiluted drug concentration You are limited to 4 digits When ready press the Enter button to accept this value and go to the PATIENT WEIGHT screen ENTER FHTIEHT WEIGHT FRESS ENTER TO CONTINUE 566 5 CURRENT SETTIHG Max 25H MIN AS 66 6 KG AA ee EHTER 5 Atthe PATIENT WEIGHT screen set the patient s
97. ta patient NOT counted in TVD Priming infusion rate is 300 mi hr or the default maximum Bolus rate for the syringe size being used whichever is lower The priming sequence is extremely important to assure the accuracy of the delivery and reduce the start up time The priming sequence is performed after the infusion 1s programmed and before the delivery is started The message at the top of the BEGIN INFUSION screen will alternate between Press lt START gt To Begin Infusion and Press lt BOLUS gt To Prime to remind the operator of the prime sequence Medex Part G6000608 Revision 3 Operation Manual Page 21 MEDEX Medfusion 3500 Unloading the Syringe You unload a syringe exactly the opposite way as you load it Just use the following steps 1 Press the Stop button to end delivery Clamp or close infusion line from the syringe to patient Unthread the tubing from the Tubing Holder D on the top left side of the pump Lift and swivel the syringe Barrel Clamp A out of the way Squeeze the Plunger Release Lever B on the syringe plunger and remove the syringe _ pou aa Warning Always turn OFF fluid flow to patient in tubing via clamp or stopcock before loading or unloading syringe onto the pump Uncontrol
98. ters have been set amp reviewed Starts bolus infusion or primes the pump Press Bolus button when the pump is paused to call up the PRIMING screen then press and hold this button to prime Press Bolus button when the pump is infusing to call up the BOLUS CONFIRM screen and then press the menu button to confirm the bolus dose and start the bolus delivery Silences an alarm for a programmed delay period The usual is 2 minutes Any new alarms Saul lence occurring within the delay period sound immediately When the delay period expires any audible portion of the highest priority alarm still present will sound Pressing this button exits the current data entry operation and reverts to previous operation screen The four buttons directly below the display are software defined buttons with assigned function varying from screen to screen The bottom line of the display defines the function for these buttons Menu Buttons Medex Part G6000608 Revision 3 Operation Manual Page 5 MEDEX Medfusion 3500 Understanding Front Panel Indicators Below ls a table of function indicators and their effects while using the pump Indicator Pump Off Pump Paused Pump Delivering AC Line Indicator ON when AC powered ON when AC powered ON when AC powered i l ON when charging ON when charging Battery Indicator ON when charging l l l Flashing when battery in use Flashing when battery in use AH Infusing Indicator Flashi
99. than or equal to 24 hours When ready press the Enter button to accept the setting go to the BEGIN INFUSION screen 5 All settings are made and the pump pauses at the BEGIN INFUSION screen Confirm all settings are correct You may now accept the settings and start the infusion or use the four menu buttons to modify the settings ENTER TIME EETWEEH STARTS 42 04 CURRENT SETTING Mars can MIH 4 14 62 08 HR s HIH PT cK SP ace ENTER E Prior to beginning the infusion press lt BOLUS gt to initiate the priming sequence page 21 7 After confirming all settings are correct press Start to begin intermittent volume time infusion Medex Part G6000608 Revision 3 Operation Manual Page 30 MEDEX Medfusion 3500 Recall Last Settings The Medfusion 3500 will remember the settings used to run the last infusion indefinitely or at least 10 years This means you can reuse the same delivery settings to repeat an identical dosage of medication or fluids to a patient 1 You may reuse the last settings by selecting RECALL LAST SETTINGS from the SELECT THE MODE screen If you don t see it press the More button and search for it PRESS THE HUMEER TO SELECT THE MODE 1 MICROGHS KG MIHUTE 5 amp ML HR c MICROGHMS KG HR Es CUSTOM BDILUTIOH J MG 7 EG MIHUTE T RECALL LAST SETTINGS d MG KG HK E FLATES amp RE When selected you must then press the Enter button to confirm data for
100. tive sign is for positive power connection See warning below Warnina Any external power source connected to the DC jack must be IEC 601 1 certified for g medical equipment Type CF and meet Safety Class Il Connecting any external External Power power source to the pump creates a medical system Therefore the user is must be responsible for compliance with IEC 601 1 standards Refer all questions to the IEC 601 1 Medex Technical Service Department Certified Medex Part G6000608 Revision 3 Operation Manual Page 8 MEDEX Medfusion 3500 Below 1s a table of syringe manufacturers for which the Medfusion or 3500 has been designed and the specific syringe sizes programmed into the pump database for use with the pump Manufacturer Syringe Sizes Omnifix 5 10 20 and 50 ml Luer Lock Perfusor 20 and 50ml Luer Lock t icki L Lok eb m l e E Becton Dickinson Luer Lo Lock B D 1ml Luer Lock and 1ml Tuberculin Becton Dickinson Glass 1 2 5 5 and 10 ml Luer Slip B Braun Monoilect 3 6 12 20 35 and 60 ml Luer Lock Iml Slip The critical volume for volume limit which could be infused in the event of a single Warning point positional failure in this infusion pump is 1 100 of the syringe fill volume ente MN At any rate the critical volume for rate in this infusion pump is 1 400 of the syringe fill volume TRADEMARK INFORMATION Below is a table of registered trademarks and the manufacturers owning them
101. to Medex within the warranty period and that Medex shall have the sole right to determine whether a defect exists This limited warranty does not apply to Syringe Infusion Pumps that have been partially or completely disassembled altered subjected to misuse negligence or accident or operated other than in accordance to the instructions provided within this manual While under this limited warranty Medex recommends that personnel other than Medex service personnel shall not open the pump Service by unauthorized personnel shall void this limited warranty This limited warranty represents the exclusive obligation of Medex and the exclusive remedy of the purchaser regarding defects in a Syringe Infusion Pump No person is authorized to modify in any manner Medex obligation as described above Medex reserves the right to make changes in or additions to pumps manufactured and or sold by Medex at any time without incurring any obligation to make the same or similar changes on pumps previously manufactured or sold by Medex Medex Part G6000608 Revision 3 Operation Manual Page 69 MEDEX Medfusion 3500 26 APPENDIX 1 SYRINGE FLOW RATE BY MANUFACTURER amp SIZE Manufacturer Size Min Rate Max Rate Manufacturer Size Min Rate Max Rate pr mm mb nm mm B Braun Luer Lock Sherwood Medical Luer Lock Lom oe Terumo Medical Luer Lock IS 550 Becton Dickinson Glass AstraZeneca Diprivan Prefilled
102. u program by setting e Drug concentration i e mg ml or U ml e Dose rate in mass hr e g mg hr or ug min e You can also set volume limit loading dose or bolus dose ENTER CONCENTRATI N FRESS ENTER TO COHTINUE z CURRENT gt ETTIHG maxi LEB MIN Bid 2 Z Mi HL E sncksFhrE ENTER CLEAR deletes an entry BACKSPACE deletes a character backward Use the number buttons to set the fluid concentration Concentration is limited to 4 digits When ready press the Enter button to accept the concentration value and go to the ENTER DOSE screen NO m ENTER DOSE RATE FRESS ENTER TO CONTINUE Max 2999 MIN 2 3 334 MCG MINUTE tEnk EA ENTER 3 Usethe number buttons to set dosage rate Range limits for dose rate are determined by syringe size The maximum and minimum rates display onscreen 4 Whenready press the Enter button to go to the BEGIN INFUSION screen At the BEGIN INFUSION screen all values are set and the pump pauses 6 Youmay now accept the settings and start the infusion or use the four menu buttons shown below to modify the settings Un PRESS lt START TO EEGIH IHFUSIOH E MG ML FD HARE mL DOSE 15 McG MIH RATE Laco HL HE E FLATES cHG DOSE E CLEAR TOTALS E PLATES OR MAIN MENU RETURNS YOU TO THE BEGINNING OF SETUP E PLATES When present indicates E Plates are enabled amp returns you to beginning of setup CHG DosE allows modifying the set dosage without
103. ual Page 7 MA Medfusiom 3500 Technical Definitions Below 1s a table of technical definitions as required per international standards Definition instead of basic insulation Accessible metal components of pump enclosure use this higher level of Oj OE Equipment in which protection against electrical shock relies on double or reinforced insulation insulation instead of safety grounding Equipment in which level of protection from electrical shock is defined by leakage current C T exposure and insulation by isolated or floating F metal of pump enclosure relative to earth ype A CF grounding Under normal conditions users are exposed to no more than 100 microamps when measured though the pump and patients to no more than 10 microamps when measured through IV path An infusion pump that combines the functions of continuous infusion flow intermittent flow and Infusion Class 4 discrete bolus delivery An infusion pump that functions as a profile pump providing a programmed sequence of delivery Infusion Class 5 rates Equipment that is ingress protected from fluid spraying at vertical angle from above and from angles IPX3 to 60 on either side of vertical Symbol for operating voltage range for alternating current 1 e AC or mains power source e Symbol for infrared serial communications port on pump B L Symbol for external DC jack connection Tip negative sign is for power ground and ring posi
104. very options such as volume limit or bolus dose d Clear Totals Medex Part G6000608 Revision 3 Operation Manual Page 23 MEDEX Medfusion 3500 Below is an illustration of a delivery screen There are six options available during any standard infusion While running an infusion you may e Lock the keypad Change the Dosage Rate Titrate the Rate Clear TVD Press the Bolus button to set change or deliver a bolus Press the Stop button to pause or end the infusion delivery fcc TT TWD 4 886 ML Po Ej Ell HL EOLUS c n ML Kw w LIMIT BE ML RATE 3 9 ML HR CHG RATE TITRATE CLEAR TWD aaaaaasaaasaasaaaaaaaaaaaaaaaaasaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaasaasaaasaasaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaasaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaasaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaanaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa eene Stopping Delivery You can stop infusion delivery at any time in any delivery mode 1 Press the Stop button 2 The infusing indicators turn OFF and the pump pauses You may restart infusion or change settings and restart Or turn OFF the pump You can turn off the pump at any time in any delivery mode while the pu
105. ways disconnect the AC power cord before servicing the pump Dropped or Damaged Never use a dropped or obviously damaged pump Withdraw it service until a trained Pumps biomedical technician can test it Medex Part G6000608 Revision 3 Operation Manual Page 67 MEDEX Medfusion 3500 Using Medex Service Assistance Use the following steps to make use of Medex technical service assistance 1 Contact Medex Technical Service Department at one of the following telephone numbers Toll free in continental United States Outside continental United States 800 848 1757 614 889 2220 Contact via Fax in United States In Europe contact Medex Medical Ltd England 770 497 0736 44 0 1706 233826 2 When calling any of these numbers please have the following ready Model name number of pump Pump serial number Purchase date if pump is within warranty period Description of problem in as much detail as possible 3 The service representative will talk you through to a solution if possible 2 Returning a Medfusion 3500 Pump for Repair When the service representative cannot solve your problem by talking you through it then 1t becomes necessary to return the infusion pump for service 1 Ifthe problem cannot be resolved through the assistance of the Technical Service Department then you will be assigned a Return Authorization RA number 2 Clean and decontaminate the pump and accessories prior to returning items to Medex
106. zed for the manufacturer selected Review syringe Is zen sizes in the technical specifications section Occlusion Check Infusion Check infusion line for blockage Clear or remedy any discovered Line occlusion Press the Start button to begin infusion Pressure Increasing Check Medium Check infusion line for blockage Clear or remedy any discovered Infusion Line occlusion The entered rate is outside of the library limits Press Alarm Silence button DE to continue You may then chose to override the range limit or change the value entered High Outside Range Limit Medium Keypad has been locked to prevent changes during infusion The alarm Pump is Locked Limit initiated by pressing any button except Power or Unlock Press Unlock if you need to make changes to delivery settings Or press Power button twice to end delivery If the bolus rate is high enough to trigger an occlusion alarm the 3500 software will reduce the bolus rate until the bolus is successfully delivered With each rate reduction this process repeats Once silenced the audible alarm tone will not reactivate even if the process repeats Medex Part G6000608 Revision 3 Operation Manual Page 15 Restricted Flow Bolus Rate Reduced bosim MEDEX Medfusion 3500 Alarm Message Priority Remedy The syringe is not loaded correctly Make sure the syringe barrel clamp is Syringe Barrel Not in Place High correctly positioned and is holding the

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