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Manufactured by: Medex Inc. Carlsbad, CA 92008 USA Authorized EU Representative: Medex Medical Ltd., Haslingden, Rossendale, Lancashire, England BB4 4PW...
Medfusion 3500 EDEX Table of Contents IMPORTANT NOTICES..............................1 INTRODUCTION................................2 INTENDED USE, FEATURES & CONTROLS......................3 Correct Use of This Pump ........................3 Features & Controls..........................4 Keypad & Functions..........................5 Using Front Panel Control Buttons ......................5 Understanding Front Panel Indicators ..................... 6 What Indicators Mean ..........................
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Medfusion 3500 EDEX Apparently Missing or Different Steps .................... 25 A Repeated Warning ........................25 Continuous Mode: ........................26 Mass Modes............................27 Body Weight Infusion Deliveries ......................28 Volume / Time – ........................28 Intermittent Volume / Time........................30 Recall Last Settings ..........................31 Custom Dilution ............................
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MAINTENANCE & SERVICE..........................67 Periodic Maintenance ..........................67 Using Medex Service Assistance ......................68 Returning a Medfusion 3500 Pump for Repair ..................68 Medex Limited Warranty ........................69 APPENDIX 1: SYRINGE FLOW RATE BY MANUFACTURER & SIZE........... 70 APPENDIX 2: FLOW DELIVERY CALCULATIONS..................71 Mass modes ............................
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Medfusion 3500 EDEX ♦ ........................ 78 Proper Placement of Pump ♦ ..............78 Pulse Sequences for MRI when using the Medfusion 3500 Medex Operation Manual Artwork GD000608 Revision 5 Page v...
The notices in the table below contain important information you need to know and understand before beginning to use the Medfusion 3500 pump. 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 contents of the operations manual, including all warnings, cautions, and instructions for use.
2. I NTRODUCTION 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.
NTENDED EATURES ONTROLS This chapter defines basic use parameters, features, and control options of the Medfusion 3500 infusion pump. Correct Use of This Pump The correct use of the Medfusion 3500 infusion pump should be based on the following principles: 1.
Medfusion 3500 EDEX Features & Controls Below is an illustration of the pump in a front view, with callouts identifying major elements: A − Handle B − Tubing Holders C − Display D − Syringe Barrel Clamp E − Syringe Plunger Holders F −...
Medfusion 3500 EDEX Keypad & 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 Power Push and hold to turn OFF pump.
Medfusion 3500 EDEX Understanding Front Panel Indicators Below is 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.
EDEX 4. T & D ECHNICAL PECIFICATIONS EFINITIONS Below are the technical specifications of the Medfusion 3500 infusion pumps: Category Specification 10.5” wide x 5.1” high x 5.5” deep Dimensions (pump only) (27 cm x 13 cm x 14 cm) Weight (pump only) 3.8 lbs.
Therefore, the user is External Power responsible for compliance with IEC 601-1 standards. Refer all questions to the must be Medex Technical Service Department. IEC 601-1 Certified Medex Operation Manual Artwork GD000608 Revision 5...
Medfusion 3500 EDEX Syringe Manufacturers & Standard Sizes Below is 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 ®...
Medfusion 3500 EDEX 5. O & C PERATION ARNINGS AUTIONS 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.
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The user is responsible for complying with IEC 601-1 standards. Refer Certified 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...
Medfusion 3500 EDEX Cautions Below is 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 & effective use of this device.
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 oscillates between bright and dim and an audible signal – 2 Medex “Bing-Bongs”, or three international Low-priority tones (on 1 sec –...
General System Alarms & Alerts 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.
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Medfusion 3500 EDEX Alarm Message Priority Remedy The internal battery is not working. The pump may be used on AC power Battery Communication on a conditional basis. As soon as possible, remove pump from service for Timeout repair by a trained biomedical service technician.
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Medfusion 3500 EDEX 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 syringe in place. Proceed with the infusion. The syringe is not loaded correctly. Make sure the syringe flange is...
Medfusion 3500 EDEX 7. G UIDELINES FOR NHANCED ERFORMANCE 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.
Medfusion 3500 EDEX 8. S & L ETUP YRINGES Pump setup and syringe loading is a multi-step process, based on your daily practice of infusing patients with medication or other fluids. Turning on the Pump Below are an illustration of the startup screen, and a list of basic steps for turning on the infusion pump.
Or press the Beginning button to return to the beginning screen. Syringe Manufacturer/Type Setup 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 & tubing and filling the syringe.
Medfusion 3500 EDEX Loading the Syringe onto the Pump 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.
Medfusion 3500 EDEX 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.
Medfusion 3500 EDEX 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. 2. Clamp or close infusion line from the syringe to patient.
Medfusion 3500 EDEX 9. S & S TARTING TOPPING NFUSION ELIVERY You 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. Start Delivery from Pause Whenever you begin an infusion setup and progress all the way through the setup levels, the pump pauses at the screen.
Medfusion 3500 EDEX Making Changes During Delivery Below is an illustration of a delivery screen. There are six options available during any standard infusion. While running an infusion, you may: • Lock the keypad. • Change the Dosage Rate. •...
ELIVERY 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.
Medfusion 3500 EDEX Continuous Mode: 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.
Medfusion 3500 EDEX Mass Modes Mass Modes: mg/min − mg/hr − mcg/min − mcg/hr − mU/min − mU/hr − u/min − u/hr: This Mass Mode is a continuous infusion mode you program by setting: • Drug concentration (i.e., mg/ml or U/ml).
Medfusion 3500 EDEX Body Weight Infusion Deliveries Body Weight Infusion Deliveries: mcg/kg/min − mcg/kg/hr − mg/kg/min − mg/kg/hr – Units/Kg/Min The body weight rate calculation allows programming by: • Drug Concentration • Patient’s Weight • 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.
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Medfusion 3500 EDEX • Dose Volume • 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 V from the S screen.
Medfusion 3500 EDEX Intermittent Volume / Time 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.
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.
Medfusion 3500 EDEX Custom Dilution The Custom Dilution mode is 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...
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Medfusion 3500 EDEX 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.
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Medfusion 3500 EDEX 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 it onscreen.
Medfusion 3500 EDEX 11. B OLUS OSING 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.
Medfusion 3500 EDEX 5. If the Bolus Time feature has been enabled, you will be able to set the bolus delivery time at the B OLUS screen, use the number buttons to set bolus delivery time in minutes and seconds. The default value for bolus delivery rate is set in custom configuration.
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Medfusion 3500 EDEX – stops the bolus and returns to the normal delivery rate and screen. ANCEL – during a bolus delivery immediately halts all delivery and the pump pauses. 4. The bolus delivery continues at the bolus delivery rate until the bolus volume is delivered. On completion of bolus dosing …...
Medfusion 3500 EDEX 12. L OADING OSES A loading dose is 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.
Medfusion 3500 EDEX Warning Before starting ANY delivery, ALWAYS confirm correctness of ALL infusion values you Confirm All just set. Settings Delivering a Loading Dose 1. When ready, press the Start button to begin infusion. The B screen appears. EGIN OADING •...
Medfusion 3500 EDEX 13. V OLUME IMIT 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 KVO if a keep vein open rate has been programmed.
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Medfusion 3500 EDEX 6. If you are initiating a new infusion, Prior to beginning the infusion, press <BOLUS> 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.
Medfusion 3500 EDEX 14. K (KVO) R The Keep Vein Open (KVO) rate is an Option available for most delivery modes (except volume/time and intermittent volume/time). • You must have a volume limit programmed for KVO to work. After a volume limit is reached, a low rate (KVO) is set to maintain patency of the infusion site.
Medfusion 3500 EDEX Delivery at KVO Rate 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.
Medfusion 3500 EDEX 15. S TANDBY is an Option that allows setting the pump for an infusion, then delaying advisory alarms for a programmed TANDBY interval of time. • The pump does not automatically start an infusion at the end of the standby.
Medfusion 3500 EDEX 16. D ELAYED TART is an Option that allows setting the pump for an infusion, then delaying the start for a programmed ELAYED TART interval of time. • The pump will automatically start an infusion at the end of the standby.
Medfusion 3500 EDEX 17. O VERRIDE AND OGGLE EATURES IN THE NFUSION ROGRAM PTIONS The OPTIONS key, when the pump is paused at the B screen, will give access to override and toggle EGIN NFUSION 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.
Medfusion 3500 EDEX 18. D ELIVERY In D , the pump infuses at the rate setting for the pump. The infusing indicators are illuminated, and the total ELIVERY volume delivered (or total dose delivered) accumulates. Starting Delivery You can start the infusion at any time when the pump is on S or paused at B screen.
Medfusion 3500 EDEX The operator may override the default Occlusion limit for a particular infusion from the <OPTIONS> menu if that option is enabled. This bar graph indicates three pressure-reading values: 1. The right side of the bar is the current reading.
Medfusion 3500 EDEX If there is an increase in the delivery pressure the horizontal arrow will be replaced by a vertical arrow (↑). In this way the clinician can easily see a) that FlowSentry is activated, and b) whether the delivery pressure is stabilizing, steady, or increasing.
19. C HANGING ELIVERY The Medfusion 3500 infusion pumps offer different ways of changing delivery rate, either before beginning infusion, during delivery, or when paused. Titrate Rate During Delivery 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.
Medfusion 3500 EDEX Changing Rate During Delivery You can change the infusion rate during any delivery session, except Volume/Time or Intermittent modes. 1. To change the rate during delivery, press the Chg Rate (or Chg Dose) button. 2. Use the number buttons to set the dose rate. Rate is limited by the maximum and minimum delivery rate for syringe size.
OLUME ELIVERED 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 is the total volume delivered to the patient and it will continue to accumulate until the Clear Totals program key is pressed or the pump is turned off.
Medfusion 3500 EDEX Clearing Total Volume, Program Volume, or Program Dose Delivered Display 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.
The keypad can be locked during delivery. The lock feature is provided to make the delivery settings tamper resistant. Once the system is locked, a setting cannot be modified until the system is unlocked. The Medfusion 3500 offers a programmable unlock code option. To set an unlock code, refer to the Configuration Manual.
22. U EFINED IBRARIES 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. 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.
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 shipped with all the libraries both blank and disabled. So the actual E-Plates you have...
Settings How to Tell Whether E-Plates Are Enabled For Use Medex ships the infusion pump with all the libraries disabled. Whether they are enabled on the pump you are using depends entirely on its 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 work area.
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. • Refer to the Medfusion 3500 Syringe Infusion Pump Configuration Manual for setting E-Plate libraries and templates. •...
Saving a New Template to a Library 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 do than to describe.
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.
The process is 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.
Medfusion 3500 EDEX 23. B , AC & E DC P ATTERY XTERNAL OWER PERATION 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.
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.
Mild detergent mixed with water. Standard Cleaning • Isopropyl alcohol 70% solution. of the Medfusion 3500 • Surface disinfectants compatible with plastic materials. 2. For best results: Clean by spraying cleanser directly onto a soft cloth and then wiping surfaces dry.
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.
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.
(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.
Medfusion 3500 EDEX 27. A 2: F PPENDIX ELIVERY ALCULATIONS 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 is limited by the syringe size.
Medfusion 3500 EDEX Volume / Time & 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 as volume (ml) divided by time (hours:minutes) where time is rationalized volume / time as hours plus minutes divided by 60.
Medfusion 3500 EDEX OW THE ALCULATION IS ERFORMED The custom dilution calculation performed is as follows: 1. Find target mass delivery rate = TDR times W times 60 min/hr; result is in mg/hr units. 2. [Note: for body weight modes in “/hr”, the “times 60 min/hr” is omitted in the equation].
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.
Medfusion 3500 EDEX 29. A 4: P & U PPENDIX LAMP SSEMBLY This appendix contains the instructions for assembling and using the Pole Clamp options available for the 3000 Series infusion pumps. 3000 Series Pump Rotating/Detachable Pole Clamp (standard) 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.
Medfusion 3500 EDEX 3000 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.
Medfusion 3500 EDEX 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 shipping container. 2. The “L” bracket attaches the pole clamp to the pump. When you receive the pole clamp assembly, it is configured for use with a vertical pole.
The Medfusion 3500 syringe infusion pumps have been determined to be acceptable for use in MRI rooms based upon the specific 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.
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