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EDEX

Medfusion 3500

Medex Operation Manual

Artwork GD000608 Revision 5

Page 7

4. T

ECHNICAL

PECIFICATIONS

EFINITIONS

Below are the technical specifications of the

Medfusion 3500

infusion pumps:

Category

Specification

Dimensions (pump only)

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)

Accuracy

Nominal ± 2% excluding syringe variations
(for infusion back pressures of -100 mm Hg to +300 mm Hg)

Flow Rate Range (depends on
syringe size)

0.01 ml/hr to 1130 ml/hr 3500

Delivery modes (user
customized)

ml/hr
Volume / Time
Mass

Body Weight
Custom Dilution
Intermittent Volume / Time

Delivery options (user
customized)

Volume Limit
Bolus Dose
Loading Dose

KVO Rate
Standby
Override Occlusion Limit
Save to Library
Toggle Rapid Occlusion
Detection

Delayed Start
Override Alarm Volume
Toggle PVD/PVD
Toggle Empty Tone
Toggle Near Empty Tone

AC power source

100-240 VAC, 50/60 Hz, 30VA
Safety Class II – Type CF

External DC power source
(Optional)

External DC Input 6 – 14 VDC, 7 Watts
Safety Class II – Type CF (must meet IEC 601-1 Medical Equipment Standards)

Internal Battery Capacity (at
25

Rechargeable. 10 hours at 5.0 ml/hr with 60 ml syringe

−

(from fully charged battery)

User-defined Delivery Libraries

Four libraries with 16 profiles per library
One library option is “E-Plates” for rapid setup

Normal Operating Conditions

Temperature: 5

to 40

C (40

to 104

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

Содержание MEDFUSION 3500

Страница 1: ...US S SI I IO O ON N N 3 3 35 5 50 0 00 0 0 S S SY Y YR R RI I IN N NG G GE E E I I IN N NF F FU U US S SI I IO O ON N N P P PU U UM M MP P P Manufactured by Medex Inc Carlsbad CA 92008 USA Authorized...

Страница 2: ...ng Delivery 13 Syringe Empty Alarm During Delivery 14 Syringe Empty Manual Alarm During Delivery 14 General System Alarms Alerts 14 7 GUIDELINES FOR ENHANCED PUMP PERFORMANCE 17 Always Use Smallest Sy...

Страница 3: ...VO RATE 42 Programming KVO Rate 42 Delivery at KVO Rate 43 15 STANDBY 44 Programming Standby 44 16 DELAYED START 45 Programming Delayed Start 45 17 OVERRIDE AND TOGGLE FEATURES IN THE INFUSION PROGRAM...

Страница 4: ...ery guidelines 64 External DC Power Option 65 24 CLEANING AND CARE 66 25 MAINTENANCE SERVICE 67 Periodic Maintenance 67 Using Medex Service Assistance 68 Returning a Medfusion 3500 Pump for Repair 68...

Страница 5: ...MEDEX Medfusion 3500 Medex Operation Manual Artwork GD000608 Revision 5 Page v Proper Placement of Pump 78 Pulse Sequences for MRI when using the Medfusion 3500 78...

Страница 6: ...instructions for use If you use this pump you are responsible for knowing these things Warning This syringe infusion pump is intended for use only under direction of trained medical professionals Cau...

Страница 7: ...on of the syringe pump The Medfusion 3500 syringe pump is indicated for use with the following delivery routes Arterial Epidural Enteral Intravenous Spinal Subcutaneous The Medfusion 3500 syringe pump...

Страница 8: ...r 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 w...

Страница 9: ...ontrols 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 Syringe Plu...

Страница 10: ...ion Power 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 t...

Страница 11: ...m condition The specific details of each alarm are covered in the Alarm section later in this manual AC Line Indicator The AC LINE indicator green is ON whenever the pump is connected to mains line po...

Страница 12: ...s Dose Loading Dose KVO Rate Standby Override Occlusion Limit Save to Library Toggle Rapid Occlusion Detection Delayed Start Override Alarm Volume Toggle PVD PVD Toggle Empty Tone Toggle Near Empty To...

Страница 13: ...the functions of continuous infusion flow intermittent flow and discrete bolus delivery Infusion Class 5 An infusion pump that functions as a profile pump providing a programmed sequence of delivery r...

Страница 14: ...5 and 10 ml Luer Slip Monoject 3 6 12 20 35 and 60 ml Luer Lock 1ml Slip Terumo 3 5 10 20 30 and 60 ml Luer Lock 1ml Slip AstraZeneca 50 ml pre filled Diprivan Luer Lock Warning Critical Volume The c...

Страница 15: ...ng Only use syringe sizes and manufacturers listed in this manual Use of other syringe manufacturers or sizes may possibly cause an under infusion or over infusion to the patient that could result in...

Страница 16: ...s Refer all questions to Medex Technical Service Department AC Power 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...

Страница 17: ...in a steam autoclave or gas sterilizer Using autoclave or gas sterilization can seriously damage the pump and void the warranty Avoid Strong Solvents Never use organic solvents to clean or disinfect t...

Страница 18: ...ight and silence the audible alarm for the programmed alarm silence period If the front panel controls are locked when a medium priority alarm occurs the pump controls do not unlock Low priority A low...

Страница 19: ...the Monoject 3ml syringe may in some cases not fully empty Here the empty alarm sounds with some fluid left in the syringe Syringe Empty Manual Alarm During Delivery It is possible to override a syrin...

Страница 20: ...new infusion return to the SELECT THE MODE screen where 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 Limit Plug in...

Страница 21: ...ringe Return to the SELECT THE MODE screen where no alarms sound Turn off the pump Syringe Empty Manual High The pump has halted infusion after overriding empty alarm You may either Prepare and load a...

Страница 22: ...ect 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 recomm...

Страница 23: ...reen 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 upp...

Страница 24: ...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 Sy...

Страница 25: ...eze 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 sure the flange of syringe barrel is pressed o...

Страница 26: ...r Prime the Patient NEVER prime any syringe while connected to a patient infusion site as this may cause over infusion with possible serious injury or death 1 Press the Bolus button to call the primin...

Страница 27: ...thread the tubing from the Tubing Holder D on the top left side of the pump 4 Lift and swivel the syringe Barrel Clamp A out of the way 5 Squeeze the Plunger Release Lever B on the syringe plunger and...

Страница 28: ...ry 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 p...

Страница 29: ...usion delivery 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...

Страница 30: ...ing 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...

Страница 31: ...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 s...

Страница 32: ...ts for dose rate are determined by syringe size The maximum and minimum rates display onscreen 4 When ready press the Enter button to go to the BEGIN INFUSION screen 5 At the BEGIN INFUSION screen all...

Страница 33: ...Press the Enter button to accept the concentration setting and go to the PATIENT WEIGHT screen 3 At the PATIENT WEIGHT screen press the number buttons to set the patient s weight in kilograms Weight...

Страница 34: ...aximum 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 4 At the DELIVERY TIME screen p...

Страница 35: ...the syringe size and minimum volume is 1 600th 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...

Страница 36: ...ss the Enter button to confirm data for 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 w...

Страница 37: ...different types of custom dilution infusion available in the Medfusion3500 infusion pump Dilution Mode What the Pump does Micrograms Kilogram Minute Calculates micrograms of medication or fluid per ki...

Страница 38: ...ial 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 5 At the PATIENT WEIGHT screen set the patien...

Страница 39: ...confirm compatibility between drug and diluent Verify that the actual dose delivery rates are acceptable settings Actual rate may differ from target rate because of rounding of volumes in the dilutio...

Страница 40: ...you have paused to include a bolus 1 When paused at the BEGIN INFUSION screen press the Options menu button to find bolus dose programming 2 Select bolus dose programming by pressing its number butto...

Страница 41: ...creen Warning Confirm All Settings Before starting ANY delivery ALWAYS confirm correctness of ALL infusion values you just set Delivering a Bolus Dose A bolus is a specified volume or dose to be deliv...

Страница 42: ...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 the pump beeps then resumes the programmed...

Страница 43: ...ING DOSE screen 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...

Страница 44: ...to be changed in ML directly Press No to skip the loading dose and return to the NORMAL DELIVERY screen If you don t press ANY button for 30 seconds the neglected pump alarm will call you back to the...

Страница 45: ...the pump during an infusion Volume limit is found on the OPTIONS screen which you select from the BEGIN INFUSION screen 1 When pump is paused press the Options button to find the volume limit feature...

Страница 46: ...ion 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 Warni...

Страница 47: ...e current infusion rate which ever is less Enable Disable KVO dosing KVO dosing can be enabled or disabled through custom configuration pump Programming KVO Rate 1 You can set a KVO rate at the BEGIN...

Страница 48: ...5 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 lim...

Страница 49: ...mp is paused at the BEGIN INFUSION screen press the Options button to find the STANDBY utility 2 Select Standby mode by pressing its number button 3 Set standby time in hours minutes The maximum Stand...

Страница 50: ...on to find the DELAYED START utility 2 Select Delayed Start mode by pressing its number button 3 Set Delayed Start time in hours minutes The maximum delayed start setting is 6 hours The default delaye...

Страница 51: ...ent 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 over...

Страница 52: ...not allowed in this delivery mode Stopping Delivery 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...

Страница 53: ...usion If the 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 acti...

Страница 54: ...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 re...

Страница 55: ...MEDEX Medfusion 3500 Medex Operation Manual Artwork GD000608 Revision 5 Page 50...

Страница 56: ...5 Page 51 Flow Delivery Graphs This section contains the flow delivery graphs for selected B D syringes Startup graph for B D 60 ml Trumpet curve for B D 60ml Startup graph for B D 30 ml Trumpet curv...

Страница 57: ...sion does not stop 2 Press the or menu buttons to increase or decrease the setting Or use the Back button to escape without titrating Increments of Change Increments of change are based on syringe siz...

Страница 58: ...our mind press Back to return to DELIVERY screen without making a change Changing Rate When Paused You can change the dosage rate at any time the pump is paused 1 If the pump isn t already paused then...

Страница 59: ...p is 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 Delivered On the disp...

Страница 60: ...ever the pump s delivery mode or syringe size is changed The Total Volume Delivered does not clear automatically 2 From any run screen press the Clear TVD program key Confirmation is required to clear...

Страница 61: ...a programmable unlock code option To set an unlock code refer to the Configuration Manual 1 Press the LOCK button to lock the front panel controls The LOCK indicator lights 2 If you press any front p...

Страница 62: ...aving to setup individual dosage values each time you need to begin an infusion So they are a means of automating the pump setup process WHO CAN USE THESE LIBRARIES OF TEMPLATES Anyone who is authoriz...

Страница 63: ...0 infusion pumps are shipped with all the libraries both blank and disabled So the actual E Plates you have available depend entirely on whatever E Plates and standard library entries your system oper...

Страница 64: ...r 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 ena...

Страница 65: ...annot 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 an...

Страница 66: ...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 6 Press the number button for the...

Страница 67: ...also create and maintain a logbook of all libraries and templates with a sheet for each template to describe its contents and function There is a 15 character limit on naming templates Use any combina...

Страница 68: ...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 PharmGuard Dosage Protocol Protection 1 Pharm...

Страница 69: ...splay at the start of delivery 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 Battery Li...

Страница 70: ...l 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 Warning External Power must be IEC 601 1 Certi...

Страница 71: ...results Clean by spraying cleanser directly onto a soft cloth and then wiping surfaces dry Avoid Using Solvents Never use organic solvents e g acetone quarternary ammonia compounds strong acids or bas...

Страница 72: ...luding Circuit Diagrams Functional Descriptions Theory of Operation Diagnosis and Testing Calibration Service Parts Service Warnings Pump Maintenance Only trained biomedical service personnel may serv...

Страница 73: ...t solve your problem by talking you through it then it becomes necessary to return the infusion pump for service 1 If the problem cannot be resolved through the assistance of the Technical Service Dep...

Страница 74: ...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...

Страница 75: ...ml 0 030 207 0 12 ml 0 07 325 0 10 ml 0 07 338 0 20 ml 0 10 536 0 20 ml 0 10 537 0 35 ml 0 10 735 0 50 ml 0 10 1042 60 ml 0 10 944 0 Becton Dickinson Luer Lock Terumo Medical Luer Lock WWD 1 ml 0 01 3...

Страница 76: ...s 60 min hr divided by concentration U ml divided by 1000 mU hr Rate is calculated as mass delivery rate milliUnits hr divided by concentration U ml divided by 1000 U min Rate is calculated as mass de...

Страница 77: ...where time is rationalized as hours plus minutes divided by 60 here there is a time between deliveries with no flow Custom Dilution Algorithm Below is a table of parameters needed to generate the cus...

Страница 78: ...olume of Drug VDR Dilution ratio FV Round result to nearest ml 6 Calculate Volume of Diluent VDL FV VDR Result is in ml 7 Calculate Final Concentration C VDR FV IC Result is in mg ml 8 Given that Targ...

Страница 79: ...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 configu...

Страница 80: ...es rotating detachable pole clamp is packaged in two pieces that must be clipped together before it can be used The L Bracket and clamp anchor with release lever is pre attached to the pump base with...

Страница 81: ...ugh 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 fo...

Страница 82: ...or 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 Remove the 4 pan head scre...

Страница 83: ...t 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 Warning Placement of the pump in a magnetic fringe fi...

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