Summary of Contents for Smiths Medical Medfusion 3500
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Medfusion Syringe Pump ® Model 3500 Operator’s Manual Software Version 6 This manual and its contents are valid for use with software Version 6 (V6)
When calling, please specify the pump’s software version. This information is located on the start-up screen. Our staff at Smiths Medical in the USA is available to help clinicians 24 hours a day with the programming ® and operation of the Medfusion Model 3500 pump Smiths Medical ASD, Inc.
Medfusion® Model 3500 pump V6 Operator’s Manual Table of Contents Continuous mode: mL/hr ..........38 Dose / Min and Dose / Hr ..........39 Dose / Day ................. 41 Important Safety Information Dose / Time ............... 43 Warnings ..................1 Body weight/surface area infusion deliveries ....45 Cautions ..................4 Volume / weight infusions ..........
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Maintenance & service ............140 gauge ................112 Periodic maintenance ............. 140 Battery guidelines ............112 Using Smiths Medical USA service assistance .... 141 Poleclamp use Returning a pump to the USA for repair ..... 142 Rotating/detachable poleclamp (standard) ....... 113 Collect Separately ..............
(including the risk of fire). Use ® 3, and included in the Medfusion Standard only Smiths Medical supplied service/replacement Configuration), or the models and sizes available parts, including the battery pack. Unauthorized ® as part of the PharmGuard...
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Medfusion® Model 3500 pump V6 Operator’s Manual the model and size loaded onto the pump. Use of delivery inaccuracies, or other potential hazards. unapproved syringes may cause improper pump Bolus Volume: Delivering a bolus volume less than operation resulting in inaccurate fluid delivery or the recommended bolus volume for the syringe occlusion sensing or other potential hazards.
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Medfusion® Model 3500 pump V6 Operator’s Manual • Use of cables other than as listed and with equipment other than those specified may result in increased EMC emissions or decreased immunity of the pump. • The pump should not be used adjacent to or stacked with other equipment.
Medfusion® Model 3500 pump V6 Operator’s Manual Cautions • The pump is not certified “waterproof”. Never immerse the pump in water or other fluids as this • Federal (USA) law restricts this device to sale by or can render the pump inoperable. on the order of a physician.
Medfusion® Model 3500 pump V6 Operator’s Manual Symbols The following is a list of symbols which may appear on UL Mark for Canada and the United States. the pump (or on its labeling or accessories), as well as Indicates the product was manufactured in certain technical terms, along with an explanation of accordance with the requirements of UL what they mean.
Medfusion® Model 3500 pump V6 Operator’s Manual Introduction • In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral CAUTION: ALWAYS verify that the software solutions and other therapeutic fluids. version of the pump (displayed on screen during •...
Medfusion® Model 3500 pump V6 Operator’s Manual Contraindications CAUTION: NEVER use sharp objects to depress keypad keys on the pump. This may damage the WARNING: ECMO use: Do not use on the inlet side pump by rendering keypad keys inoperable. of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than ®...
Medfusion® Model 3500 pump V6 Operator’s Manual About the pump Features and Controls Following are several illustrations showing the various ® controls, connectors and features of the Medfusion Model 3500 pump V6. * * ...
Medfusion® Model 3500 pump V6 Operator’s Manual 11 Optional Poleclamp Mount: If desired, attach the optional poleclamp here. 12 External DC Power Connector Port: Plug approved external DC power supply into port. Note: The DC Connector Port is functional only on pumps where the External DC Jack Connection symbol (Ö) appears on the pump serial number label (located on the bottom of the pump).
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Medfusion® Model 3500 pump V6 Operator’s Manual When pump is paused When pump is delivering Silences audible alarm. Allows operator Silences audible alarm. Allows operator to í Alarm Silence ( to switch the display backlight from switch the display backlight from bright to bright to dim or dim to bright.
Medfusion® Model 3500 pump V6 Operator’s Manual Pump Customization and General Programming Custom Configuration Generally speaking, pump customization is performed before a pump is used on a patient (see the diagram on page 12). ® Customization is accomplished using PharmGuard Toolbox 2.
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Medfusion® Model 3500 pump V6 Operator’s Manual ® Medfusion Model 3500 Pump V6 “Medfusion® Standard Configuration” includes manual delivery modes, some options and a variety of syringes. No Drug ® Medfusion Model 3500 Pump V6 Programs are available in the Standard With Custom Configuration Configuration PharmGuard®...
Medfusion® Model 3500 pump V6 Operator’s Manual General Programming The pump then prompts entry of a new value. Soft Limits - The normal range. Soft Limits show ® • The Medfusion Model 3500 pump V6 has a variety up as Low and High on the pump. They are the of delivery modes that are customizable by the user.
Medfusion® Model 3500 pump V6 Operator’s Manual User defined pump Types of programmable Library Configurations Categories ® There are two types of Library Categories in the This chapter describes the Medfusion Model 3500 ® Medfusion Model 3500 pump V6: pump V6 Configuration. Library What it does What are Configurations?
Medfusion® Model 3500 pump V6 Operator’s Manual Using a Custom Configuration ® PharmGuard Toolbox 2 allows a facility to create a custom Configuration and send it to the pump for use. If profiles are created in the Configuration, the pump displays the Profile Menu. If the desired profile isn’t displayed on the first screen press More for additional selections.
Using Quick Libraries (If there is only one profile on the pump, and a Quick Library is enabled, the drug programs in the Smiths Medical ships the infusion pump with the designated Quick Library will display on screen after ®...
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Medfusion® Model 3500 pump V6 Operator’s Manual 1. To use Quick Library programs from the PRESS NUMBER TO SELECT Select screen, use the number keys to roPoFoL L (or) select a drug program. ecUroniom dobUt L (or) amine For example: if “1” at right is selected, doPa 1600 L (or)
Medfusion® Model 3500 pump V6 Operator’s Manual PharmGuard® Safety Software: Dose Protocol Protection ® PharmGuard Medication Safety Software provides programmable Hard and Soft upper and lower limits ® for infusion parameters. Refer to the PharmGuard software limits in the Technical Specifications section of this manual (page 131) for a list of all parameters ®...
Medfusion® Model 3500 pump V6 Operator’s Manual Adjusted limits in reverse During set up, the pump determines absolute minimums and maximums based on the physical Reverse highlight abilities of the pump, such as syringe size (among PRESS < « > TO BEGIN INFUSION other things).
Toolbox 2, for use in creating Drug Programs. PSS Series 2 files must be ® added via PharmGuard Toolbox 2 when creating a custom Configuration. Contact Smiths Medical for ® a complete list of available PharmGuard Supported Syringes (PSS) Series 2.
Medfusion® Model 3500 pump V6 Operator’s Manual Navigating the pump menus There are some general rules for navigating pump menus. Most of the pump programming steps are accomplished by looking to the display screen, and pressing the softkeys indicated. For example: PRESS <...
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Medfusion® Model 3500 pump V6 Operator’s Manual Setup Prime Power On Program Con rm Select Drug Con rm Connect to Pause Infusion Program Settings Syringe Patient Settings Program Options Bolus Deliver Dose Start Infusion Complete Infuse Volume Limit Reached Loading Syringe Dose Flush...
Medfusion® Model 3500 pump V6 Operator’s Manual Guidelines for enhanced pump performance The following are guidelines for enhanced syringe programming flow rates, a limit priority alarm will pump performance. Review occlusion time and be activated, along with an advisory message on the flow delivery graphs (starting on page 93).
Supported Syringes (PSS) Series 2 (available from 60 mL 1 mL Smiths Medical). Smiths Medical also provides a variety of infusion sets that can be used with the pump. See www.smiths-medical.com for information regarding infusion sets available from Smiths Medical,...
Medfusion® Model 3500 pump V6 Operator’s Manual Programming an Infusion Turn the pump on Below right is an illustration of a startup screen, and a list of basic steps for turning the infusion pump on. ë 1. Press and hold until the display turns dark.
Medfusion® Model 3500 pump V6 Operator’s Manual Turning the pump off The pump can be turned off at any time, in any delivery mode, while the pump is running. Note: If there are any alarms sounding, you must first í silence the alarm by pressing before the pump can be turned off.
Medfusion® Model 3500 pump V6 Operator’s Manual Selecting a Delivery Mode and Programming an infusion Due to the customization capabilities of the ® Medfusion Model 3500 pump V6, the screen shown once power-up is complete depends entirely on what, if any, customization was performed. Typically a Custom Configuration will have been ®...
Medfusion® Model 3500 pump V6 Operator’s Manual General Infusion Programming Procedure Load desired syringe (may also be done when it comes up in the programming process) ® Custom Configuration: Medfusion Standard Configuration: Select a Profile PRESS THE NUMBER TO SELECT THE PROFILE aneStHeSia cardiac nicU...
Medfusion® Model 3500 pump V6 Operator’s Manual Selecting an Infusion Following are the steps for selecting an infusion type for programming an infusion. The Profiles, Categories or Delivery Modes, and drug programs available on a pump are dependent on how the pump was configured, and whether a custom ®...
Medfusion® Model 3500 pump V6 Operator’s Manual Select a Profile (Custom Configuration) After successfully completing its system startup self-tests, a pump with a Custom Configuration with multiple profiles defined will display Select The Profile. Pumps can be configured so that all or some of the profiles require a passcode to access them.
Medfusion® Model 3500 pump V6 Operator’s Manual Select a Category 4. Once inside a profile, select a category PRESS THE NUMBER TO SELECT generaL PedS by pressing its number. If a category GEN PEDS A - D GEN PEDS Q - Z GEN PEDS E - I cannot be found, press CHG Profile to Lood...
Medfusion® Model 3500 pump V6 Operator’s Manual The pump requires a confirmation for drug CONFIRM DRUG PROGRAM SELECTION? HEM/ONC program selections; press Yes to confirm the selection, or press No to return to the Select DEXA metHaSone screen. If “manual” modes are available in the custom CONFIRM MANUAL PROGRAMMING / DELIVERY MODE? Configuration and selected for an infusion, the pump prompts for a confirmation as well.
Medfusion® Model 3500 pump V6 Operator’s Manual Loading a syringe and syringe model setup Once a Drug Program or manual delivery mode has Note: Pharmacy labels placed on the syringe may been chosen, specify the syringe model and size, and interfere with the pump’s syringe sensors.
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Medfusion® Model 3500 pump V6 Operator’s Manual 4. Lift upward on the Syringe Barrel Clamp and turn it so it is out of the way. 5. Squeeze the Plunger Release Lever on the syringe plunger driver and pull gently to extend it all the way outward.
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Medfusion® Model 3500 pump V6 Operator’s Manual 7. Squeeze the Plunger Release Lever on the syringe plunger driver and push it toward the syringe plunger; once it is flush with the syringe plunger release the lever. Be sure both holders close around the syringe plunger.
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Medfusion® Model 3500 pump V6 Operator’s Manual Note: Some syringes may have similar outer SELECT THE SYRINGE dimensions, despite being different sizes (for ™ ® example, BD 1mL Luer Lok™ and 3mL syringes), or even different models. In these cases, the pump will display size options, requiring selection of the correct syringe size actually in use.
Medfusion® Model 3500 pump V6 Operator’s Manual for each possible delivery mode with all functions enabled. Unloading the syringe WARNING: Turn off fluid flow. Always turn off fluid flow to patient in tubing via clamp or stopcock before loading or unloading a syringe. Uncontrolled fluid flow can occur when infusion set is not clamped or turned off resulting in inappropriate delivery rate, and may cause serious...
Medfusion® Model 3500 pump V6 Operator’s Manual Programming Infusions Continuous mode: mL/hr Continuous infusion is programmed by setting a flow To program a Continuous mode infusion, at the rate in mL/hr. Actual range limits for flow rate are selection menu, choose ml/hr (or choose a drug determined by syringe model and size (see the table program that uses the continuous mode infusion in Technical section (page 129) of this manual and/...
Medfusion® Model 3500 pump V6 Operator’s Manual Dose / Min and Dose / Hr The Dose / Min and/or Dose / Hr modes may be • Volume limit, KVO, loading dose, or bolus dose may also be programmed (these options available on a pump.
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Medfusion® Model 3500 pump V6 Operator’s Manual 6. Confirm the settings and start the infusion, PRESS < « > TO BEGIN INFUSION or use the four menu softkeys shown at right CONC to modify the settings. 0.15 è MCG/MIN DOSE RATE 7.
Medfusion® Model 3500 pump V6 Operator’s Manual Dose / Day The Dose / Day mode may be available on a pump. • Volume limit, KVO, loading dose, or bolus dose may also be programmed (these options Program Dose / Day by setting: are only available if they have been enabled in Drug concentration units (i.e., g/mL, mg/mL, •...
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Medfusion® Model 3500 pump V6 Operator’s Manual 7. Prior to connecting to the patient, press è to initiate the priming sequence (page 58). 8. If desired, program a Bolus Dose, Loading Dose or Volume Limit (see Options, page 60 ). WARNING: Confirm All Settings.
Medfusion® Model 3500 pump V6 Operator’s Manual Dose / Time The Dose / Time mode may be available on a pump. • Dose rate Delivery Time • Program Dose / Time by setting: At the selection menu, choose Dose/Time (or choose Drug concentration units (i.e., g/mL, mg/mL, •...
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Medfusion® Model 3500 pump V6 Operator’s Manual 7. Confirm the settings and start the infusion, PRESS < « > TO BEGIN INFUSION or use the three menu softkeys shown at CONC right to modify the settings. DOSE 02:15:00 TIME 8. Prior to connecting to the patient, press 02:15:00 TIME REMAINING RATE...
Medfusion® Model 3500 pump V6 Operator’s Manual Body weight/surface area infusion deliveries • Volume limit, KVO, loading dose, or bolus The following Body weight/surface area -based dose may also be programmed (these options infusion delivery modes may be available on a pump: are only available if they have been enabled dose/kg/min (dose/m /min) −...
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Medfusion® Model 3500 pump V6 Operator’s Manual The pump may be customized with an RE-ENTER PATIENT WEIGHT - PRESS ENTER TO CONTINUE additional patient weight/body surface HIGH: area confirmation screen. If so, re-enter the LOW: 0.25 patient weight/body surface area, then press Enter to accept the setting.
Medfusion® Model 3500 pump V6 Operator’s Manual Volume / weight infusions The following volume/weight modes may be available The pump calculates the correct flow rate in mL/ on a pump: mL/kg/min and mL/kg/hr. hr to achieve the required drug dose. To program a volume/weight infusion, at the selection menu, Volume/weight infusion rate calculations allow choose either mL/Kg/Min or mL/Kg/Hr (or choose...
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Medfusion® Model 3500 pump V6 Operator’s Manual 6. Confirm the settings and start the infusion, PRESS < « > TO BEGIN INFUSION or use the four menu softkeys shown at right to modify the settings. WEIGHT DOSE RATE WARNING: Confirm All Settings. Before starting MAIN MENU CHG DOSE OPTIONS...
Medfusion® Model 3500 pump V6 Operator’s Manual Dose/kg/time (dose/m /time) The body weight/surface area infusion delivery mode • Patient’s weight/Body surface area will only be available on a pump through custom Dose • ® programming of a drug program via PharmGuard Delivery time •...
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Medfusion® Model 3500 pump V6 Operator’s Manual 4. The time setting screen appears. Press the ENTER DELIVERY TIME number keys to set the time in hours and HIGH: 00:30:00 00:00 minutes, then press Enter. LOW: 00:03:00 H R : M I N : S E C CLEAR BACKSPACE ENTER...
Medfusion® Model 3500 pump V6 Operator’s Manual Volume / weight / time The volume/weight/time delivery mode (mL/kg/ The pump calculates the correct flow rate in mL/ Time) may be available on a pump. hr to achieve the required drug dose. To program a volume/weight/time infusion, at the selection menu, Volume/weight/time infusion rate calculations allow choose mL/Kg/Time (or choose a drug program that...
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Medfusion® Model 3500 pump V6 Operator’s Manual 6. Confirm the settings and start the infusion, PRESS < « > TO BEGIN INFUSION or use the menu softkeys shown at right to WEIGHT VTBI modify the settings. 00:30:00 TIME: 00:30:00 TIME REMAINING RATE WARNING: Confirm All Settings.
Medfusion® Model 3500 pump V6 Operator’s Manual Volume / time The volume over time rate calculation allows To program Volume / Time, choose it at the selection programming by: menu (or choose a drug program that uses the volume/time mode infusion type). Choose the syringe Dose Volume •...
Medfusion® Model 3500 pump V6 Operator’s Manual Intermittent volume / time Intermittent Volume / Time mode allows specification Below are the steps for programming an Intermittent of a delivery volume for a specific delivery time, after Volume / Time infusion. Select Intermittent which the delivery stops for a programmed interval, Volume / Time from the selection menu (or choose then the pattern recycles.
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Medfusion® Model 3500 pump V6 Operator’s Manual 6. Confirm the settings and start the infusion, PRESS < « > TO BEGIN INFUSION or use the three menu softkeys shown at 0.000 VOLUME 00:55:00 TIME right to modify the settings. 05:00:00 TIME BETWEEN STARTS 65.5 00:55:00...
Medfusion® Model 3500 pump V6 Operator’s Manual Recall last settings ® The Medfusion Model 3500 pump V6 will recall the must be reprogrammed from the Options menu at the Begin Infusion screen. settings used to run the last infusion. Reuse the same delivery settings to repeat an identical Note: If a pump has a custom configuration (created dosage of medication or fluids to a patient (choose ®...
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Medfusion® Model 3500 pump V6 Operator’s Manual WARNING: Confirm All Settings. Before starting any delivery, always confirm the accuracy of all infusion values to the original order. Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery, which can result in serious injury or death.
Medfusion® Model 3500 pump V6 Operator’s Manual Priming the system WARNINGS: Priming is one of the functions of the Bolus key • NEVER prime any syringe while connected to è ). Always prime a new syringe after loading it a patient infusion site, as this may cause over- onto the pump and before connecting the tubing to infusion which could result in serious injury or the patient.
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Medfusion® Model 3500 pump V6 Operator’s Manual WARNING: Once the syringe and tubing system is connected to the patient, raising the system above the patient (even briefly) can cause significant bolusing due to changes in hydrostatic pressure. Lowering the system below the patient (even briefly) can cause significant interruptions in flow due to changes in hydrostatic pressure.
Medfusion® Model 3500 pump V6 Operator’s Manual Options Options gives access to program options that affect • Disable/Enable Near Empty Tone the current infusion only. The options available • Change to Dose/Change to Volume depend on the options that have been enabled for •...
Medfusion® Model 3500 pump V6 Operator’s Manual Bolus dosing A bolus may be programmed during the initial A Bolus dose is a separate delivery that pauses the infusion setup, at the Begin Infusion screen, or main infusion, delivers the bolus (often at a different, during an infusion without stopping medication higher rate), then returns to the main infusion when delivery.
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Medfusion® Model 3500 pump V6 Operator’s Manual Note: If Bolus Total Dose is enabled in the profile ® Toolbox 2), the Enter (using PharmGuard Bolus Dose screen will not display a default value, even if a default value was specified in Toolbox for dose/kg or dose/m 4.
Medfusion® Model 3500 pump V6 Operator’s Manual Bolus delivery è 1. Press (if necessary). 2. The Begin Bolus Delivery? screen BEGIN BOLUS DELIVERY? appears. To begin bolus delivery, press Yes. BOLUS MG/KG VOLUME 01:00 TIME MM:SS RATE If bolus delivery is not desired right now, totaL boLUS doSe press No.
Medfusion® Model 3500 pump V6 Operator’s Manual Continuing an interrupted bolus dose Should a High Priority alarm occur during bolus á or Cancel are pressed, the bolus delivery, or if stops. Either continue the bolus from where it left off, or cancel the bolus. í...
Medfusion® Model 3500 pump V6 Operator’s Manual Bolus dose rate reduction The increased delivery rate of a bolus dose may trigger an occlusion alarm (depending on the occlusion limit settings in the pump and the resistance in the line). If this occurs, the bolus time is automatically increased by 30%, thus reducing the bolus rate.
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Medfusion® Model 3500 pump V6 Operator’s Manual past the maximum bolus time, the bolus is RESTRICTED FLOW - BOLUS CANCELLED 12.763 CONC cancelled. WEIGHT í to silence the alarm. The KVO MAX boLUS mg/mL • Press DOSE RATE normal infusion delivery is continued. MAIN MENU CHG DOSE OPTIONS...
Medfusion® Model 3500 pump V6 Operator’s Manual Loading doses A loading dose may be programmed at the Begin A loading dose is a separate, specified volume (or Infusion screen by pressing Options. If Loading dose) of drug infused as a one-time-only bolus (often ®...
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Medfusion® Model 3500 pump V6 Operator’s Manual 5. Use the number keys to set delivery time ENTER LOADING TIME - PRESS ENTER TO CONTINUE in minutes & seconds. The default value 00:03:00 CURRENT SETTING HIGH: 00:59:00 for loading (i.e., bolus) delivery rate is 00:03: LOW: 00:03:00 set in custom configuration.
Medfusion® Model 3500 pump V6 Operator’s Manual Delivering a loading dose É 1. When ready, press 2. The Begin Loading Dose Delivery? BEGIN LOADING DOSE DELIVERY? screen appears. Depending on which mode LOAD MG/KG 03:00 TIME MM:SS RATE the pump is delivering in, the screen is totaL Loading doSe slightly different.
Medfusion® Model 3500 pump V6 Operator’s Manual Continuing an interrupted loading dose Should a High Priority alarm occur during loading á or Cancel are pressed, the dose delivery, or if dose stops. Either continue the dose from where it left off, or cancel the dose. í...
Medfusion® Model 3500 pump V6 Operator’s Manual Loading dose rate reduction The increased delivery rate of a loading dose may trigger an occlusion alarm (depending on the occlusion limit settings in the pump and the resistance in the line). If this occurs, the loading time is automatically increased by 30%, thus reducing the loading rate.
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Medfusion® Model 3500 pump V6 Operator’s Manual 2. If, however, the loading dose rate reduces RESTRICTED FLOW - LOADING CANCELLED minocaProic below the infusion rate, or the dose time 4.9690 LOAD DELIVERED increases past the maximum loading dose 08:28 99.3799 REMAINING MM:SS time, the loading dose is cancelled.
Medfusion® Model 3500 pump V6 Operator’s Manual Volume limit A Volume Limit is an Option available for continuous delivery modes. On reaching the preset volume limit, the pump stops – or changes to KVO if a keep vein open rate has been programmed. Volume limit is based on the amount of programmed volume that is delivered.
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Medfusion® Model 3500 pump V6 Operator’s Manual 4. The volume limit setting now appears on the PRESS < « > KEY TO BEGIN INFUSION display. Program Volume Delivered (PVD) 0.000 V LIMIT will appear on the screen directly above the V Limit.
Medfusion® Model 3500 pump V6 Operator’s Manual Keep Vein Open (KVO) rate Once the volume limit has been reached, The Keep Vein Open (KVO) rate is an Option the pump will begin infusing at either the available for continuous delivery modes. programmed KVO rate or the current infusion The keep vein open feature is intended for use when rate, which ever is less.
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Medfusion® Model 3500 pump V6 Operator’s Manual WARNING: Confirm All Settings. Before starting any delivery, always confirm the accuracy of all infusion values to the original order. Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery, which can result in serious injury or death.
Medfusion® Model 3500 pump V6 Operator’s Manual Standby Enable / Disable Standby: The Standby option can Standby is an Option that allows the pump to remain at the Begin Infusion screen without the User be enabled / disabled through custom configuration ®...
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Medfusion® Model 3500 pump V6 Operator’s Manual 6. When the counter reaches zero, the pump sounds an alarm as a reminder to begin the infusion. WARNING: Confirm All Settings. Before starting any delivery, always confirm the accuracy of all infusion values to the original order. Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery, which can result in serious injury or death.
Medfusion® Model 3500 pump V6 Operator’s Manual Delayed start Delayed Start is an Option that allows the pump to Enable / Disable Delayed Start: The Delayed Start remain at the Begin Infusion screen without the option can be enabled / disabled through custom ®...
Medfusion® Model 3500 pump V6 Operator’s Manual Periodic callback alarm The Periodic callback alarm is an Option that causes Enable / Disable Periodic Callback Alarm: The an alarm to be generated at a programmed period of Periodic Callback Alarm option can be enabled time.
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Medfusion® Model 3500 pump V6 Operator’s Manual É 5. When ready, press to begin infusion. Once the infusion starts, the Periodic Callback PERIODIC CALLBACK - SILENCE ALARM TO CONTINUE Alarm sounds a Medium priority alarm at the time 14.251 interval programmed. BOLUS V LIMIT KVO RATE...
Medfusion® Model 3500 pump V6 Operator’s Manual Override and toggle features When the pump is paused at the Begin Infusion screen (or, in some cases while infusing), pressing Options provides access to several override and toggle options that will affect the current infusion only. These Options will return to the default selection whenever the pump is turned off, or whenever the program is returned to the Main menu prior to...
Medfusion® Model 3500 pump V6 Operator’s Manual Override occlusion limit The pump’s programmed default occlusion setting can be overridden. This allows setting a higher or lower occlusion limit for a specific infusion. Note: When a 1mL syringe is entered into the programming, the occlusion pressure setting is fixed at very high (50psi), meaning there is no option of changing it.
Medfusion® Model 3500 pump V6 Operator’s Manual Override alarm loudness Occasionally it may be necessary to change the loudness of the audible alarm. For instance, if the infusion is taking place in an area with a lot of ambient room noise the loudest alarm setting may be wanted.
Medfusion® Model 3500 pump V6 Operator’s Manual Disable/enable FlowSentry™ pressure monitoring The pump has an internal program for rapid occlusion detection called FlowSentry™ pressure monitoring. The pump may have been configured to either turn this feature on or off. To change the default setting for a specific infusion, use this option.
Medfusion® Model 3500 pump V6 Operator’s Manual Disable/enable vol empty alarm tone The pump may be configured to have an alarm sound to indicate when the volume of medication in a syringe is near empty. (The calculation for when the alarm sounds is based on the syringe size used and the volume initially programmed.) Use this option to enable or disable this feature for this infusion.
Medfusion® Model 3500 pump V6 Operator’s Manual Infusion Delivery Starting & stopping infusion WARNING: Confirm All Settings. Before starting delivery any delivery, always confirm the accuracy of all infusion values to the original order. Programming An infusion delivery can be started at any time after the pump at a delivery rate other than that prescribed a delivery mode has been set up.
Medfusion® Model 3500 pump V6 Operator’s Manual Starting delivery from standby or delayed start Start the infusion at any time when the pump is on TIME UNTIL START OF INFUSION 00:59:50 standby or delayed start. It is unnecessary to either 0.000 cancel standby or wait until the standby period BOLUS...
Medfusion® Model 3500 pump V6 Operator’s Manual Flush feature Some medications and infusions may require enabled). This feature is only available if enabled for flushing the line to remove any residual medication intermittent (timed) infusions (for example, Dose/ ® or infusate. Using PharmGuard Toolbox 2, this kg/Time, Volume/Time, mL/Kg/Time, etc.), and is feature can be enabled for certain profiles, facilitating...
Medfusion® Model 3500 pump V6 Operator’s Manual Note: If no keys are pressed for 30 seconds, the User Callback alarm will sound. 7. When Confirm is pressed, the flush PRESS < > TO STOP FLUSH DELIVERY infusion begins delivering, with FLUSHING 0.140 FLUSH VOLUME...
Medfusion® Model 3500 pump V6 Operator’s Manual Volume and time 1. When the programmed infusion is INFUSION COMPLETE complete or the Syringe Empty alarm í activates and the pump alarms, press WEIGHT 00:03:00 TIME VTBI 00:00:00 TIME REMAINING RATE CHG DOSE CLEAR TVD MAIN MENU OPTIONS...
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Medfusion® Model 3500 pump V6 Operator’s Manual 8. To begin flush delivery, press Confirm. OR CONFIRM FLUSH SETTINGS? • Press Chg Vol to return to the Flush FLUSH VOLUME Volume screen and change the volume. 00:04:30 TIME RATE MAIN MENU CHG TIME CHG VOL CONFIRM...
Medfusion® Model 3500 pump V6 Operator’s Manual Time to occlusion The time for the pump to detect an occlusion is pumps were delivered to a work area. affected by three factors: Override the default Occlusion limit for a particular 1. Occlusion Pressure Setting – High (H), Normal infusion from the Options menu if that option is (N), Low (L), or Very Low (VL).
Medfusion® Model 3500 pump V6 Operator’s Manual ™ Note: FlowSentry pressure monitoring is disabled ™ FlowSentry maximum Syringe Size at rates greater than roughly ⅓ of the syringe size per infusion rate hour. See the table at right for more information. 60 mL 20 mL/hr 50 mL...
Medfusion® Model 3500 pump V6 Operator’s Manual Making changes during delivery At right is an illustration of a delivery screen. There are eight options available during any standard infusion. While running an infusion, you may: DOBUT PICU amine 0.005 • Lock/Unlock the keypad.
Medfusion® Model 3500 pump V6 Operator’s Manual Changing the rate when paused The dosage rate can be changed at any time the pump is paused: 1. With the pump paused at the Begin PRESS < « > TO BEGIN INFUSION Infusion screen, press Chg Rate (or Chg 0.429 BOLUS...
Medfusion® Model 3500 pump V6 Operator’s Manual Total volume, program volume / dose delivered ® The Medfusion Model 3500 pump V6 monitors and maintains the total quantity of fluids being delivered DOBUT 1000 NICU amine during any given session of infusions. Total Volume 1000 0.414 CONC...
Medfusion® Model 3500 pump V6 Operator’s Manual Clearing total volume, program volume, or program dose delivered Use the following steps to clear the total volume and program volume (or dose) and reset the counter to zero. á With the pump paused (press , if necessary): 1.
Medfusion® Model 3500 pump V6 Operator’s Manual Keypad lock The keypad can be locked during delivery. The lock feature is provided to make the delivery settings tamper resistant. Once the keypad is locked, a setting cannot be modified until the keypad is unlocked. The ®...
Medfusion® Model 3500 pump V6 Operator’s Manual Alarms & remedies ® The Medfusion Model 3500 pump V6 has numerous alarms built into it. These are triggered by situations as a means of warning or advising that something is not functioning within normal parameters. Pump alarms are logged into the pump’s Alarm History (viewable in the Biomed menu, and may be included in ®...
Medfusion® Model 3500 pump V6 Operator’s Manual Type Definition and Remedy A low-priority alarm indicates any condition not requiring immediate operator Low priority intervention. Low-priority alarms are announced with a continuous yellow indicator, a viewing screen backlight that oscillates between bright and dim and a non-repeating audible signal. í...
Medfusion® Model 3500 pump V6 Operator’s Manual Empty” alarm sounds, stopping the infusion. “User Callback” alarm The “Syringe Near Empty” alarm time may be set and The “User Callback” alarm is a Medium priority alarm is useful in allowing preparation time for the next that serves as a reminder to finish what you started.
Medfusion® Model 3500 pump V6 Operator’s Manual medication in the syringe; therefore the infusion continues. ® Monoject 1, 3, 12 and 35 mL: Because of ® variations in syringe manufacturing, the Monoject í 1, 3, 12 and 35 mL syringes may in some cases not 1.
Medfusion® Model 3500 pump V6 Operator’s Manual General system alarms & alerts This section contains a table of the general system alarms, listed alphabetically, which may be ® encountered while operating the Medfusion Model 3500 pump V6. This table identifies the alarm by message and type, and provides a definition and possible remedies.
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Medfusion® Model 3500 pump V6 Operator’s Manual Alarm Message Priority Remedy Sensor is active when syringe is not loaded correctly. Check the syringe High Check Syringe Plunger Sensor plunger holders. Ensure the syringe barrel clamp, flange holder, and plunger holders are properly engaged and the holders move freely. If they do not operate correctly or if the alarm persists, immediately remove the pump from service for repair by a trained biomedical service technician.
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Medfusion® Model 3500 pump V6 Operator’s Manual Alarm Message Priority Remedy The motor is not running, which may be due to an erroneous (possibly High Motor Not Running transient) sensor signal, or a mechanical and/or electrical failure. Press ë í .
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Medfusion® Model 3500 pump V6 Operator’s Manual Alarm Message Priority Remedy Bolus delivery was cancelled before completion. While the pump Medium Restricted Flow - Bolus Cancelled was delivering a bolus, the flow rate was restricted and initiated rate reduction, which eventually fell below the main infusion rate or extended past the maximum bolus time.
Medfusion® Model 3500 pump V6 Operator’s Manual Alarm Message Priority Remedy í High Syringe Plunger Not in Press . The syringe is not loaded correctly, or the sensor has failed. Place Make sure the syringe plunger head is properly inserted. Proceed with the infusion, if possible.
Medfusion® Model 3500 pump V6 Operator’s Manual System Failure Alarms Alarm Message Priority Remedy Either a key on the keypad has been pressed for longer than 7 seconds, System System Failure : ë Fault or the keypad needs to be replaced; fluid delivery stops. Press Control Key Switch BGND turn the pump off, then turn it back on.
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Medfusion® Model 3500 pump V6 Operator’s Manual Alarm Message Priority Remedy Infusion will continue using backup copy of xx data (where xx System Advisory : represents variable text indicating the specific data that is corrupted). As xx Data Corrupted soon as possible, remove pump from service for testing and checkout by a trained biomedical service technician.
Medfusion® Model 3500 pump V6 Operator’s Manual Battery and AC power operation The infusion pump is typically operated by AC (mains) power. The pump contains a rechargeable battery that is continually charged – as long as the pump is connected to AC power (see page 122 for battery life specification).
Medfusion® Model 3500 pump V6 Operator’s Manual On screen display of internal Battery guidelines battery power level gauge Power & Battery Limits When the “Battery Low” When to charge Whenever the pump is turned on, the internal battery message displays, plug the battery charge level briefly appears on the “battery shaped”...
Rotating/detachable 100-degree poleclamp poleclamp (standard) Smiths Medical offers two rotating poleclamps, one with a 90-degree angle anchor bracket (catalog number 22-1050-51), and one with a 100-degree angle anchor bracket (catalog number 22-1051-51) (older pumps may use poleclamp catalog number 3000RPC, which is no longer available).
Medfusion® Model 3500 pump V6 Operator’s Manual Assembling the rotating/detachable poleclamp 1. If necessary, slide the rotating poleclamp onto the poleclamp anchor at the rear of the pump until the retainer lock button audibly clicks into place. 2. Pull the round lock button at the top of the clamp assembly up and rotate the clamp to the desired angle.
Medfusion following cable: Model 3500 pump V6. Accessible pins of connectors • Smiths Medical G6000329 AC power cord identified with the ESD warning symbol near them (USA) should not be touched with the fingers or hand-...
Medfusion® Model 3500 pump V6 Operator’s Manual Technical specifications & other information Pump development standards Medical Electrical Equipment Safety Reference (Year) Title IEC 60601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety, Amendment 1 (1991), Amendment 2 (1995) IEC 60601-1-4 (2000) Medical electrical equipment -- Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems...
Medfusion® Model 3500 pump V6 Operator’s Manual Reference (Year) Title EN 55011 (2009) Industrial, scientific and medical (ISM) radio frequency equipment - Radio disturbance characteristics - Limits and methods of measurement. Amendment 1 (2010) CAN/CSA-C22.2 No. Medical electrical equipment - Part 1-2: General requirements for basic safety and 60601-1-2:08 essential performance CAN/CSA-C22.2 No.
Medfusion® Model 3500 pump V6 Operator’s Manual Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Medfusion® Syringe Pump Model 3500 V6 is intended for use in the electromagnetic environment specified below. The customer or the user of the Medfusion® Syringe Pump Model 3500 V6 should assure that it is used in such an environment.
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Medfusion® Model 3500 pump V6 Operator’s Manual Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Medfusion® Syringe Pump Model 3500 V6 is intended for use in the electromagnetic environment specified below. The customer or the user of the Medfusion® Syringe Pump Model 3500 V6 should assure that it is used in such an environment.
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Medfusion® Model 3500 pump V6 Operator’s Manual Guidance and manufacturer’s declaration – electromagnetic immunity The Medfusion® Syringe Pump Model 3500 V6 is intended for use in the electromagnetic environment specified below. The customer or the user of the Medfusion® Syringe Pump Model 3500 V6 should assure that it is used in such an environment.
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Medfusion® Model 3500 pump V6 Operator’s Manual Recommended separation distances between portable and mobile RF communications equipment and the Medfusion® Syringe Infusion Pump Model 3500 V6 The Medfusion® Syringe Pump Model 3500 V6 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Medfusion® Model 3500 pump V6 Operator’s Manual Technical specifications Specifications ® Below are the technical specifications of the Medfusion Model 3500 pump V6. Testing was performed using ® the syringes listed in the table on page 128 and the following Medfusion Administration Sets: 1) Model 536040 for low flow rates and 2) Model MX448HL60 for high flow rates.
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Medfusion® Model 3500 pump V6 Operator’s Manual Operating conditions Temperature: 5° to 40° C (41° to 104° F) Relative Humidity: 20% to 95% non-condensing Ambient Pressure: 70 kPa to 106 kPa (10.2 psia to 15.4 psia) Storage/transportation Temperature: -20° to 50°C (-4° to 122°F) conditions Relative Humidity: 20% to 95% non-condensing...
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Medfusion® Model 3500 pump V6 Operator’s Manual Occlusion Alarm For 1 mL Syringes, the occlusion limit is fixed at Very High. Very High (1 mL syringe only, not selectable): 50 psi (2585 mmHg) (345 kPa) For Syringes with a volume greater than 1 mL, the user can set the occlusion limit from Very Low to High.
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Medfusion® Standard Syringes (catalog number 67-2459-[current version]) Lockbox with Keys (22-1000-51) Infrared - RS232 Converter Box (3000RS232) (not RoHS [Restriction of Hazardous Substances] compliant and being phased out; contact Smiths Medical for availability) Infrared - USB Connector (22-1060-51) (RoHS [Restriction of Hazardous...
Medfusion® Model 3500 pump V6 Operator’s Manual Safety Features (Motor Drive Phase A/B POST, the ability for the watchdog to stop the motor (Motor Drive off POST). Safety Features and Fault Periodically during pump operations the software checks motor operation in background. Motor Detection background checks include the stopping of the motor when an infusion stops and the motor supply voltage...
Medfusion® Model 3500 pump V6 Operator’s Manual delivery of drug are performed redundantly. The two calculated values are then compared. If the two values do not match, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all drug delivery.
1/100th of the syringe size by volume. PharmGuard® Supported Syringes (PSS) Series 2 In order to offer customers a wide range of available syringe manufacturers and sizes, Smiths Medical has ® available PharmGuard Supported Syringes (PSS) ®...
Medfusion® Model 3500 pump V6 Operator’s Manual Flow rate & minimum volume by manufacturer & size - Standard syringes For flow rate and minimum volume information ® regarding syringes available in the PharmGuard Supported Syringes (PSS) Series 2, see the product literature provided with that product.
Medfusion® Model 3500 pump V6 Operator’s Manual Concentration and dosing units Drug Delivery Units Concentration Units Delivery Units /Time /Min /Day Millimoles • • • • Millimoles Milliequivalents • • • • Milliequivalents Units • • • • Units Milliunits •...
Medfusion® Model 3500 pump V6 Operator’s Manual PharmGuard® software limits Delivery Mode Parameter Limit Type Limit Range Concentration Hard and Soft User Defined Dose / Hr Dose / Min Dose Hard and Soft User Defined Dose / Day Concentration Hard and Soft User Defined Dose / Kg / Hr Dose / Kg / Min...
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Medfusion® Model 3500 pump V6 Operator’s Manual Auto Lock Time Defines the number of seconds the pump will wait before automatically locking the pump’s interface. Auto Lock Time is a numeric value in the range of 0 to 999 seconds. Setting this value to zero (0) or (none) will disable the Auto Lock feature.
Medfusion® Model 3500 pump V6 Operator’s Manual × 10 mL/hr = 50 mL/hr maximum bolus rate), or Syringe Size Max mL/hr (see the table on page 129). Maximum Flow Rate Defines the maximum flow rate allowed by the pump. Maximum Flow Rate is a numeric value in the range 0.1 to 1130 mL/hr, and is dependent on the syringe size being used.
Medfusion® Model 3500 pump V6 Operator’s Manual Prompt to Prime Defines if a pump user will be prompted to Prime as a last step in setting up an infusion. Select from two values—Enabled or Disabled. Re-enter Weight Defines if a pump user will be prompted to re-enter a patient’s weight to confirm the setting (a double check).
Medfusion® Model 3500 pump V6 Operator’s Manual Volume Limit Defines if a pump user will be able to enter a Volume Limit during infusion setup. This value cannot be set or changed while an infusion is running. The range is 0 to 500 mL. Device Setup Features The following items are set on a per pump basis in the Device Setup menu.
Medfusion® Model 3500 pump V6 Operator’s Manual Start-up curves over stabilization period Minimum rate (1 mL/hr) Intermediate rate (5 mL/hr) Flow rate immediately following startup Flow rate immediately following startup time [Min] time [Min] Trumpet curves over T2 period Minimum rate (1 mL/hr) 10.0 T (min) Epmax...
Medfusion® Model 3500 pump V6 Operator’s Manual Magnetic Resonance Imaging Image Distortion (MRI) Information Certain MRI receiver coils are sensitive to electronic emissions. Therefore, prior to patient examinations, ® The Medfusion Model 3500 pump V6 is MR MR image scans should be completed while operating Conditional according to the terminology specified in ®...
Medfusion® Model 3500 pump V6 Operator’s Manual • Avoid Oil Sprays: NEVER use light oil sprays Cleaning and care ® (e.g., WD40 ) to clean or lubricate pump. These Below are common methods and cautions relating to oils contain chemicals that can damage the cleaning and caring for the infusion pump.
• Dropped or Damaged Pumps: Never use a • Service Parts* dropped or obviously damaged pump. Withdraw Contact Smiths Medical for availability. it from service until a trained biomedical technician can test it. *Including replacement battery packs and power cords...
3. The service representative may “talk you through” to a solution if possible. Component parts such as the internal battery can be ordered from Smiths Medical Service and Repair. Note: If outside the USA, contact your local distributor for service assistance.
States Occupational Safety & Health Administration (OSHA) regulations. 3. Package the infusion pump carefully for shipment. 4. Smiths Medical will not accept returns for service without the assigned RA number clearly printed on the shipping package. Mark the RA number clearly on the outside of the shipping package used to return the pump.
(SVHC)) at a concentration above 0.10% by weight. any regulations that may apply. Smiths Medical’s declarations regarding SVHCs in This product contains electrical and electronic products can be found at: components (including batteries) that may contain www.smiths-medical.com/environment...
Medfusion® Model 3500 pump V6 Operator’s Manual Limited Warranty Smiths Medical ASD, Inc. (the “Manufacturer”) warrants to the offered by the Manufacturer. The following exclusions and Original Purchaser that the Medfusion® Syringe Pump Model limitations shall apply: 3500 V6 (the “Pump”), not including accessories, shall be free 1.
Medfusion® Model 3500 pump V6 Operator’s Manual Index General Use Diagram 22 AC power connection port 8, 111 Hard limits 13, 18, 131 Alarms & alerts 100 Hardware-related Software Safety Features 126 Troubleshooting 104 hyperbaric chamber use warning 1 Battery 111 Intermittent volume / time 54 Battery Alarms 108 guidelines 112...
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Medfusion® Model 3500 pump V6 Operator’s Manual Standard libraries 14 Using 15 Occlusion settings 93 Standby 77, 88 Post occlusion bolus reduction 94 Starting an infusion 87 Options 60, 135 from pause 87 Bolus dosing 61 from standby, delayed start 88 Delayed start 79, 88 Stopping an infusion 88 Disable/enable near empty alarm tone 85...
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Ashford, Kent, TN25 4BF, UK Tel: +44 (0)1233 722100 www.smiths-medical.com Medfusion, PharmGuard, FlowSentry, Medfusion design mark and Smiths Medical design mark are trademarks of Smiths Medical. ® The symbol indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. All other names and marks mentioned are the trade names, trademarks or service marks of their respective owners.