Operation Manual
116 Pages
Preview
Page 1
Medfusion®
Model 3500E Syringe Infusion Pump Operation Manual Software Version 3.0.6
This manual and its contents are valid for use with software version 3.0.6.
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Medfusion® 3500 Operation Manual
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Medfusion® 3500 Operation Manual
Table of Contents Important Safety Information
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Introduction
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Warnings.................................................................................... 1 Cautions..................................................................................... 2 Symbols...................................................................................... 3 Indications for use.................................................................... 4 Contraindications..................................................................... 4
About the pump
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Features and Controls.............................................................. 5 Keypad closeup................................................................... 6 Correct use of this pump......................................................... 8
Pump Programming
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Custom Configuration............................................................. 9 Programming an infusion....................................................... 9 Navigating the pump menus........................................... 10 Legend........................................................................... 10 Getting Started........................................................................ 11 Turn the pump on............................................................. 11 Turning the pump off.................................................. 12 Loading a syringe and syringe manufacturer/type setup............................................................................... 13 Unloading the syringe................................................. 18 Select delivery mode.............................................................. 19 Continuous mode: mL/hr............................................... 21 Mass modes....................................................................... 22 Body weight infusion deliveries...................................... 24 Volume / time.................................................................... 26 Intermittent volume / time ............................................. 28 Recall last settings............................................................. 30 Custom dilutions.................................................................... 31 Types of custom dilutions available................................ 31 Calculating dilutions........................................................ 31 Priming the system................................................................. 35
Guidelines for enhanced pump performance 37 Always use the smallest syringe for volume of fluid being delivered............................................................ 37 Use small internal diameter tubing...................................... 37
Options
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Bolus dosing............................................................................ 39 Set up bolus dosing .......................................................... 39 Delivering a bolus dose.................................................... 41 Bolus dose rate reduction................................................ 43 Loading doses......................................................................... 44 Set up loading dose........................................................... 44 Delivering a loading dose................................................ 46 Loading dose rate reduction............................................ 47 Volume limit .......................................................................... 48 Setting volume limit ........................................................ 48 Keep Vein Open (KVO) rate................................................. 50 Programming KVO rate.................................................. 50 Standby.................................................................................... 53 Programming standby..................................................... 53 Delayed start........................................................................... 55
Programming delayed start............................................. 55 Override and toggle features................................................. 57 Override occlusion limit ................................................. 57 Override alarm loudness................................................. 58 Disable/enable rapid occlusion detection...................... 59 Disable/enable near empty alarm tone.......................... 59 Disable/enable empty alarm tone................................... 60
Starting & stopping infusion delivery
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Occlusion trend graph during delivery
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Making changes during delivery
66
Total volume, program volume / dose delivered
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Keypad lock User defined libraries
72 73
Transferring libraries from pump to pump
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Alarms & remedies
78
Start delivery from pause....................................................... 61 Starting delivery from standby, delayed start or pause...... 61 Stopping delivery.............................................................. 62 FlowSentry™ (rapid occlusion detection)............................ 63 Post occlusion bolus reduction ............................................ 64 Time to occlusion................................................................... 65 Changing delivery rate........................................................... 66 Titrate Rate During Delivery.......................................... 66 Changing rate during delivery........................................ 67 Changing the rate when paused..................................... 67
Displaying “Program Volume Delivered” (PVD) / “Program Dose Delivered” (PDD) .......................... 69 Clearing total volume, program volume, or program dose delivered display................................................. 70
What are libraries?............................................................ 73 When are library programs used?.................................. 73 Who can use these library programs?............................ 73 Types of programmable libraries.................................... 73 Using “Standard” library categories..................................... 74 How to tell if E-Plates are enabled for use........................... 74 E-Plates is disabled........................................................... 74 E-Plates is enabled............................................................ 74 Using E-Plates......................................................................... 75 Enabling E-Plates & Standard Libraries.............................. 75 Creating library templates..................................................... 75 Saving a new template to a library....................................... 75 Libraries must be enabled................................................ 76 PharmGuard® Toolbox: Dosage Protocol Protection........ 77 Serial Communications......................................................... 77 Serial conversion box....................................................... 77 Cloning Block.................................................................... 77 Alarms / alerts......................................................................... 78 “Neglected Pump” alarm ...................................................... 79 “Syringe Near Empty” alarm during delivery.................... 79 “Syringe Empty” alarm during delivery............................. 79 “Syringe Empty − Manual” alarm during delivery............. 79 System Advisory - Maintenance is Recommended........... 80 General system alarms & alerts............................................ 81
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Medfusion® 3500 Operation Manual Battery, AC & external DC power operation
84
On screen display of internal battery power level gauge........................................... 85 Battery guidelines ............................................................ 85 External DC power option.................................................... 85
Poleclamp assembly & use
87
Technical specifications & other information
91
Software Safety Features
97
3000 series pump rotating/ detachable poleclamp (standard).............................. 87 Assembling the 3000 series pump rotating/detachable poleclamp................................... 88 3000 series pump stationary poleclamp.............................. 89 Assembling the 3000 series pump stationary poleclamp...................................................................... 90 Pump development standards.............................................. 91 Specifications.......................................................................... 95
Hardware-related Software Safety Features........................ 97 Program Memory - Check FLASH memory POST or BGND............................................................................ 97 RAM Memory Check - RAM BGND ........................... 97 Motor Circuit Check - pump motor phase A or B POST and Motor rate error during operation......... 97 Keyboard Encoder Check - Control key POST or BGND ........................................................................... 97 Data Handling Software Safety Features............................. 97 Data Stored in RAM - Critical data POST or BGND, RAM GND.................................................................... 97 Data Stored in EEPROM - Critical data POST or EEPROM timeout or Primary critical data corrupted....................................................................... 97 Data Used in Calculations - Critical data failure.......... 97 Timer Data Registers - Time base BGND, time of day clock POST, time of day clock timeout ............. 97 Syringe manufacturers & standard sizes............................. 98 Syringe flow rate & minimum volume by manufacturer & size..................................................... 99 Mass modes .......................................................................... 100 Body Weight modes............................................................. 100 Volume / time and intermittent modes............................. 101 Custom dilution algorithm................................................. 101 The results from the dilution calculation.................... 101 How the calculation is performed................................ 101 Goal of dilution calculation........................................... 102 Custom Configuration options........................................... 102 Flow Delivery Graphs.......................................................... 103 Serial communications ....................................................... 104 MRI room usage................................................................... 104 Proper placement of pump ........................................... 104 Pulse sequences for MRI when using the Medfusion® 3500 ...................................................... 104 EMC information for the Medfusion® 3500 pump.......... 104 Use of cables.................................................................... 105 Cleaning and care................................................................. 105 Maintenance & service........................................................ 106 Periodic maintenance..................................................... 106 Using Smiths Medical service assistance..................... 106 iv
Returning a pump for repair......................................... 107 Collect Separately................................................................. 107
Limited Warranty Index
108 109
Medfusion® 3500 Operation Manual
Important Safety Information WARNING: Read this entire manual before using the Medfusion® Model 3500 Syringe Infusion Pump (Medfusion® 3500 pump). Failure to follow the instructions and important information contained in this manual, or improper/inadequate troubleshooting can lead to death or serious injury. Warnings, cautions and other important safety information can be found in this section, and throughout the manual (they are contained within lines at top and bottom). See the Alarms and Remedies section for information on troubleshooting pump alarms. The term WARNING is used to indicate a hazard that has the potential to cause injury or death to a patient or user. The term CAUTION is used to indicate a hazard that has the potential to cause damage to the product or other property. Note: This manual supersedes all previous revisions.
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Warnings • •
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To avoid risk of explosion, never use pump in presence of flammable anesthetics, oxygen-enriched atmospheres, or explosive gases. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided. Portable and mobile Radio Frequency (RF) communications equipment can affect medical electrical equipment. Before using any Medfusion® 3500 pump, you must be thoroughly familiar with the contents of the operations manual, including all warnings, cautions, and instructions for use. This syringe infusion pump is intended for use only under the direction of trained medical professionals. Failure to strictly adhere to the Intended Use of this product can result in serious injury or death. Do not use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than negative 100mm Hg as the high negative pressures can result in uncontrolled fluid flow. The pump may be placed in static magnetic fields up to 150 Gauss when secured to a non-moveable object. (Tested using 1.5 Tesla 64 MHz shielded MRI system.) Placement of the pump in a magnetic fringe field greater than 150 gauss may present a projectile hazard to the patient or MRI user because of magnetic field interactions. In addition, the operation of the pump may be affected and/or the quality of the MR images may be altered or degraded. Confirm All Settings. Before starting any delivery, always confirm the accuracy of all infusion values
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to the original order. Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery rate. Always read manufacturer precautions and guidelines for medications, fluids, syringes and administration sets used with this pump. Medications or fluids may interact with the plastic components of the infusion syringe and sets. Only use syringe sizes and manufacturers listed in this manual, and always confirm that the syringe manufacturer and size displayed on the pump matches the manufacturer and size loaded into the pump. Use of other syringe sizes or manufacturers or mismatching syringes and sizes may cause improper instrument operation resulting in inaccurate fluid delivery or pressure sensing or other potential hazards. For detailed instructions and warnings pertaining to the syringe or administration set, please refer to the instructions for use supplied with the product for preparing the product for use. Verify that the plunger holders securely capture the syringe plunger. Make sure to capture the syringe barrel and flange and to thread the tubing through the holding clamps. Failure to properly secure the syringe and tubing could result in uncontrolled fluid flow to the patient. Always use the Prime function on the pump when loading a new syringe in order to remove any mechanical slack. Failure to prime correctly can delay infusion delivery and cause Total Volume Delivered to read higher than what is actually delivered to the patient. 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 infusion set is not clamped or turned off resulting in inappropriate delivery rate. Always 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 dilution formula. NEVER prime any syringe while connected to a patient infusion site, as this may cause over-infusion. To avoid air embolism, always purge all air from syringe and infusion lines before connecting to the patient. Periodically check the fluid pathway and all connections (including the catheter/administration set connection) for leaks. Leaks in the system may cause fluid loss resulting in under-delivery, as well as allowing an opening for contamination. Once the syringe and tubing system is connected to the patient, raising the system above the patient (even briefly) can cause significant bolusing due 1
Medfusion® 3500 Operation Manual
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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. This could cause improper instrument operation resulting in inaccurate fluid delivery. Use the smallest syringe size necessary to deliver the fluid or medication. Using a large syringe at very low rates may cause improper instrument operation, pressure sensing, or other potential hazards. When using E-Plates libraries, preset values are automatically inserted without pausing to verify each setting. You go directly to the Begin Infusion screen where all the infusion values are displayed at once. Be sure to verify their accuracy before starting the delivery. Certain data fields may be programmed blank (e.g. patient weight) and require data entry before the infusion will proceed. Never use a pump when it has signaled a system failure alarm. Withdraw it from use and send it to a trained biomedical technician for service. Electric Shock hazard. The only means of removing AC power is to disconnect the AC power cord. While the AC power cord is attached to the pump and plugged into an AC outlet, live mains voltage is present inside the pump. Any external power source connected to the DC jack must be IEC 60601-1 certified for medical equipment Type CF and meet Safety Class II requirements. Connecting any external power source to the Medfusion® 3500 pumps creates a medical system. Therefore, the user is responsible for compliance with IEC 60601-1 standards. Always operate this pump in a horizontal position to prevent fluid leakage into the pump. If you suspect fluid has leaked into it, remove pump from service until a trained biomedical technician can test it. Ensure that the ± 2% accuracy specification is taken into account when programming the pump and/or filling a syringe. Failure to do so may result in medication in the syringe becoming depleted sooner than expected. If the pump is being used to deliver critical or life sustaining medication, the interruption in the delivery of medication could result in patient injury or death. 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. This equipment should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the pump should be observed to verify normal operation in the configuration in which it will be used. To avoid electric shock, before cleaning, always switch electrically operated equipment off and dis-
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connect from AC power source. To avoid electric shock, only trained biomedical service personnel may service this pump. Service personnel should disconnect the AC power cord before servicing the pump. Always maintain this pump following manufacturer recommended instructions in the Service Manual. Improperly maintained pumps may cause either under-infusion or over-infusion to patient. To avoid electric shock, users should never open the pump case or battery compartment for any reason. Service personnel should always disconnect the AC power cord before servicing the pump. Never use a dropped or obviously damaged pump. Withdraw it from service until a trained biomedical technician can test it. There are potential health hazards associated with improper disposal of batteries, electronics, and contaminated (used) infusion sets and syringes. Dispose of used batteries, infusion sets, syringes, and other used accessories, or a pump that has reached the end of its useful life, in an environmentally safe manner, and according to any regulations that may apply.
Cautions • • • •
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ALWAYS verify that the software version of the pump and operations manuals are the same. Refer to this manual’s front page. NEVER use sharp objects to depress control buttons on the pump. This may damage the pump by rendering buttons inoperable. NEVER use organic solvents (e.g., acetone), quarternary ammonia compounds, strong acids, or bases to clean any portion of the pump. The pump is “spray resistant” from the top and sides but not “waterproof ”. NEVER spray cleaning or other fluids directly into openings on the bottom of the pump. The pump is not certified “waterproof ”. Never immerse the pump in water or other fluids. NEVER use light oil sprays (e.g., WD40™) to clean or lubricate pump. These oils contain chemicals that can damage the plastic of the pump. No useradded lubrication is necessary. NEVER sterilize the pump in a steam autoclave or gas sterilizer. Using autoclave or gas sterilization can seriously damage the pump and void the warranty.
Medfusion® 3500 Operation Manual
Symbols The following is a list of symbols which may appear on the pump (or on it’s labeling or accessories), as well as certain technical terms, along with an explanation of what they mean. > g
J K
J
6 <
ó P _ i
Ü Ö Ñ V~ IPX3
Serial number Attention, See instructions for use Type CF equipment (protection from electric shock) Class II Equipment in which protection against electric shock relies on double or reinforced insulation instead of basic insulation. Accessible metal components of pump enclosure use this higher level of insulation instead of safety grounding. Date of manufacture CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Catalog number UL Mark for Canada and the United States. Indicates the product was manufactured in accordance with the requirements of UL (Underwriter’s Laboratory). Temperature limitation
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Indicates the product was designed and manufactured in accordance with applicable standards/guidelines and may be sold in the EU (European Union). @ Authorized representative in the European Community Aus Australian representative Collect separately
Z
Infusion Class 4 An infusion pump that combines 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 rates For an explanation of the symbols that appear on the pump keypad, see “Keypad Closeup” and the tables that follow (page 6).
Humidity limitation Atmospheric pressure limitation Pins of connectors and other areas identified with this ESD Warning symbol should not be touched. Connections should only be made when ESD precautionary measures are used. External DC jack connection. Tip (negative sign) is for power ground and ring (positive sign) is for positive power connection. Symbol for infrared serial communications port on pump. Operating voltage range for alternating current (i.e. AC or mains) power source Equipment that is ingress protected from fluid spraying at vertical angle from above, and from angles to 60° on either side of vertical
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Medfusion® 3500 Operation Manual
Introduction The Medfusion® 3500 pump is a small, lightweight and portable syringe infusion pump. The pumps offer a variety of delivery modes ready for you to program to meet your specific patient care needs. The actual modes available in a given pump, and their location on a given screen, depend on the custom setup. Configuration can be performed either directly on the pump, or on a PC using the PharmGuard® Toolbox software. Libraries can also be created (see page 73 for discussion about libraries). The cloning feature allows you to program a single pump then use that pump to “teach” it’s program to other pumps.
Indications for use The Medfusion® 3500 syringe infusion pump is
designed for the administration of fluids requiring precisely controlled infusion rates. The Medfusion® 3500 syringe pump is indicated for use with the following delivery routes: • Arterial • Intravenous • Epidural • Spinal • Enteral • Subcutaneous for delivering the following fluids: • Intravenous solutions • Blood or blood products • Drug solutions • Enteral feedings
The Medfusion® 3500 pump imports and exports data to assist in patient data management. The pump only communicates using the IR port. The required communications adapter and cable are later in this manual.
and can be programmed using one or more of the following delivery modes:
The pumps also have the FlowSentry™ rapid occlusion detection feature, which is a comprehensive array of pressure-related safety features, including rapid alarm response and reduced false alarms. Pressure trending is shown in the pump display, allowing earlier opportunities for intervention, as well as a post-bolus reduction feature that decreases bolus on occlusion release to less than 0.3 mL without the use of expensive, dedicated infusion sets.
Contraindications
CAUTION: ALWAYS verify that the software version of the pump and operations manuals are the same. Refer to this manual’s front page.
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Continuous • Body weight Volume / Time • Custom dilution Mass Intermittent Volume / Time
The only people authorized to set up & monitor any infusion are nurses, physicians, or other healthcare professionals with training in infusion therapy and operation of the syringe pump. Use only syringe manufacturers and sizes listed in the Technical specifications section of this manual. WARNINGS: • Before using any Medfusion® 3500 pump, you must be thoroughly familiar with the contents of the operations manual, including all warnings, cautions, and instructions for use. • This syringe infusion pump is intended for use only under the direction of trained medical professionals.
Medfusion® 3500 Operation Manual
About the pump Features and Controls Following are several illustrations showing the various controls, connectors and features of the Medfusion® 3500 pump.
C
D
E
F
H
I
G*
B *G
J
1) 1
2 3 4 5 6 7
Display: all pump operating and status information appears on the display. The lower portion of the display corresponds with the 4 ‘softkeys’ (their function changes depending on where you are in a pump program) on the keypad. Tubing Holders: Thread infusion set tubing between holders to prevent kinking at syringe tip. Carrying Handle Syringe Barrel Clamp: The clamp holds the syringe barrel securely in place. Syringe Barrel Flange Clip: When loading a syringe, slide the syringe flange into the clip. Syringe Plunger Holders: Holds the syringe plunger securely in place. Syringe Plunger Driver: Once loaded and delivery is started, the driver pushes the plunger forward at a controlled, precise rate to deliver fluid.
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Syringe Plunger Release Lever: Squeeze the release lever to allow placement of the syringe plunger onto the holder during loading, or to remove it during unloading. AC Power Connection Port: Plug the AC power cord into connection port to allow pump to operate on AC (mains) power.
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Medfusion® 3500 Operation Manual
1!
10 Keypad: See Keypad closeup for identification of the individual keypad buttons and what they are used for. 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. 13 RS232 Connection Port: Plug RS232 connector into the port to allow upload of data from and download of data to a pump from a PC.
Keypad closeup
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Medfusion® 3500 Operation Manual Button
Stop (á)
Set number values or selects options. N/A
When pump is delivering Silences audible alarm. Allows operator to switch the display backlight from bright to dim or dim to bright. Push and release, then push and hold to turn pump off. Function is defined on the display. Reverts to a previous step or level if adjusting settings. Set number values or selects options. Stops delivery (pump remains on).
Starts delivery.
N/A
Bolus (è)
Begins priming after confirmation.
Begins delivery of programmed bolus after confirmation.
Alarm Silence (í) Power ë Menu buttons Back â Numbers & Decimal Start (É)
Indicator
ò - Alarm ô - AC Line õ - Battery ö - Lock
When pump is paused Silences audible alarm. Allows operator to switch the display backlight from bright to dim or dim to bright. Push and hold to turn pump off. Function is defined on the display. Reverts to a previous step or level.
What it means The Alarm indicators (yellow or red) are on whenever the pump is in an alarm condition. The specific details of each alarm are covered in the Alarm section later in this manual. The AC Line indicator (green) is on whenever the pump is connected to “mains” line power. It is off when the pump is not connected to an active AC line. The Battery indicator (green) blinks on & off whenever the pump is operating on internal battery power, and remains on when battery is charging. The Lock indicator tells you the pump has been locked into its current operational mode.
While this indicator is lighted, the keypad is locked and no changes can be made to settings. Attempting to stop or change an infusion while locked will result in an alarm and an advisory message. úù - Infusing The Infusing indicators are 3 green lights, which illuminate in sequence right to left when the pump is infusing. During intermittent delivery mode, a single Infusing indicator lights during the time between infusions. When the pump is off or stopped, the Infusing indicator is not lit.
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Medfusion® 3500 Operation Manual
Correct use of this pump The correct use of the Medfusion® 3500 pump should
be based on the following principles: 1. This syringe pump is intended for intravenous, subcutaneous, epidural, enteral, spinal, and arterial infusions of critical medications or fluids requiring precisely controlled infusion rates. 2. Use only syringe manufacturers and sizes listed in the technical specifications of this manual. 3. Ensure all medications or fluids are compatible with the syringe, catheters, tubing, and fittings used in the infusion setup. 4. Always ensure fluids are compatible with each other when infusing more than one fluid or medication through the same infusion site. If connecting more than one pump to the same infusion site, use one-way checkvalves to prevent pumps from interfering with each other. Verify that the pumps will operate together without alarming. 5. Keep a spare Medfusion® 3500 Syringe Infusion Pump available in situations where an interruption in infusion could be dangerous. System failures require you to remove the Medfusion® 3500 Syringe Infusion Pump from service immediately. 6. A “System Failure” alarm indicates that you cannot use the Medfusion® 3500 Syringe Infusion Pump until it is serviced by a trained biomedical service technician. IMMEDIATELY REMOVE FROM SERVICE any Medfusion® 3500 Syringe Infusion Pump that displays a “System Failure” alarm, even if silencing the alarm, turning the power off and back on clears the alarm. WARNINGS: • Failure to strictly adhere to the Intended Use of this product can result in serious injury or death. • ECMO use: Do not use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than negative100mm Hg as the high negative pressures can result in uncontrolled fluid flow. • The pump may be placed in static magnetic fields up to 150 Gauss when secured to a non-moveable object. (Tested using 1.5 Tesla 64 MHz shielded MRI system.) Placement of the pump in a magnetic fringe field greater than 150 gauss may present a projectile hazard to the patient or MRI user because of magnetic field interactions. In addition, the operation of the pump may be affected and/or the quality of the MR images may be altered or degraded.
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CAUTION: NEVER use sharp objects to depress control buttons on the pump. This may damage the pump by rendering buttons inoperable.
Medfusion® 3500 Operation Manual
Pump Programming Custom Configuration Depending on the settings and features chosen in customization, certain features may or may not be available when programming any specific pump. Each user is responsible to determine which features are present on the pump they are using and programming them accordingly.
WARNING: Always read manufacturer precautions and guidelines for medications, fluids, syringes and administration sets used with this pump. Medications or fluids may interact with the plastic components of the infusion syringe and sets. This interaction may result in serious injury or death.
For this reason, you will see the following warning throughout the steps for programming and delivering fluids throughout this 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 rate, which can result in serious injury or death.
Programming an infusion The Medfusion® 3500 infusion pumps have a variety
of delivery modes that 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. The modes and programming steps described in this chapter, and the steps given for programming them, are based on general setup parameters. Which of the features and functions are available on your pump, and how the screens associated with them appear, depends entirely on how the pump was customized. If the functions and screens on your pump look different than those shown here, it is due to this customization. For a better understanding of the enabled or disabled features of your pump, refer to the “Tables of default settings for Anesthesia, General and NICU” chapter in the Configuration Manual. The pumps are shipped with the standard default settings for “Anesthesia” units or departments. These may be unchanged in your pump. Or, they may have been used as a foundation for configuring your pump to meet the needs of a specific unit, department, organization or hospital.
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Medfusion® 3500 Operation 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 softkey buttons indicated. For example:
PRESS < START > TO BEGIN INFUSION
CONC WEIGHT
250 MG/ML 66.5 KG
150 MCG/KG/MIN
DOSE E-PLATES
B
CHG DOSE
C
PVD v limit
2.394 ml/hr
Rate OPTIONS
D
The screen shown above is an example of a “Start” screen. Pressing softkey “1” opens the E-Plates menu; pressing softkey “2” initiates the screens for changing the dose value; pressing softkey “3” opens the Options menu; pressing softkey “4” clears the infusion totals stored in pump memory. The softkeys change for different screens, and some screens will have only certain of the softkeys active, or even no active softkeys. Always look to the display to see what the softkeys are used for. When you are programming a value or want to enter a menu, in most cases you will use the number and decimal buttons on the right side of the keypad. (In many cases once you have entered a value, you will need to press a softkey to “Enter” or save the value or to open the menu.) Some menus are very large and there will be more items to choose from than can fit on a single display screen. In those cases one of the softkeys will be “More”, indicating there are more options available and you can press More to view them. On those sorts of menus, once you get to the end of the choices, the More button becomes Beginning, indicating you can press Beginning to go back to the first “page” of the menu.
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0.000 ML 60 ml
CLEAR TOTALS
E If you make a mistake in programming, or open a menu accidentally, you can press â. Pressing â will return you to a previous screen or menu. In certain situations in the Biomed menu, pressing â will cause the pump to confirm whether you want to save whatever it was you were changing with the following screen: SAVE CHANGES?
YES
NO
If you want to save the changes press Yes. If you want to back up to the previous screen or menu without saving any changes, press No. Legend In this manual, menu information that appears onscreen is shown in bold and small capitals (for instance, Select the Mode). Text associated with softkeys is shown as bold (for instance, Enter).
Medfusion® 3500 Operation Manual
Getting Started Turn the pump on Below is an illustration of a startup screen, and a list of basic steps for turning the infusion pump on. 1. Press and hold ë until the display turns dark. Verify the display shows all pixels on, then all pixels off.
2. The pump “beeps” twice, and then the Alarm, Infusing and Lock indicators flash as the self-test cycles. The pump ID, if it has one, appears in the upper left corner. (In this example, it is called “HOSPITAL”.) The pump serial number will appear at the middle right, if it has been set in the software. (In this example, it is “M01234”.) PERFORMING SELF-TEST HOSPITAL
64%
MEDFUSION 3500
VERSION: 3.0.6 CONFIG ID: 8E69 SECONDS REMAINING
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M01234 © 99–2002 MEDEX
3. You should now verify the display indicates successful completion of system startup self-tests. If the pump does not turn on with successful completion of self-tests, remove it from service and have it checked by a trained biomedical technician. 11
Medfusion® 3500 Operation Manual Neglected Pump Alarm: If you stop in the middle of a numerical entry, you will hear the “Neglected Pump” alarm. You can: • Press í to silence the alarm for another 30 seconds. • Finish numerical entries and reach the Begin Infusion screen with the normal alarm silence interval. Turning the pump off You can turn off the pump at any time, in any delivery mode, while the pump is running. Note: If there are any alarms sounding, you must first silence the alarm before you can turn the pump off. With the pump infusing: 1. Press and hold ë.
B–D CONC WEIGHT
60ml
250 MG/ML 66.5 KG
150 MCG/KG/MIN
DOSE E-PLATES
CHG DOSE
9.25 6
PVD V LIMIT
2.3
RATE TITRATE
The Shutdown screen appears. Infusion has not stopped at this point. PRESS < POWER > AGAIN TO SHUTDOWN CONC WEIGHT DOSE CONTINUE
2. Press and hold ë again to turn the pump off. To cancel press Continue or â. Infusion stops when you turn the pump off. With the pump stopped: 1. Press and hold ë. The pump turns off.
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150
250 MG/ML 66.5 KG
PDD V LIMIT
MCG/KG/MIN
RATE
9.27 ML N
60
2/394
ML
ML/HR
Medfusion® 3500 Operation Manual Loading a syringe and syringe manufacturer/type setup Once a Delivery Mode has been chosen you specify the syringe manufacturer and size, and load the syringe. Pumps can be customized to allow for use of a wide variety of syringe brands and sizes, or can limit to as few as a single syringe brand. If your pump has been customized to a single syringe brand, none of the following screens will appear. Syringe setup and loading is a multi-step process, based on your daily practice of infusing patients with medications or other fluids. Use your standard protocol for preparing your infusion. Fill the selected syringe, and attach an appropriate administration set (tubing) - it is recommended that you use small internal diameter tubing (see page 37). WARNING: Only use syringe sizes and manufacturers listed in this manual, and always confirm that the syringe manufacturer and size displayed on the pump matches the manufacturer and size loaded into the pump. Use of other syringe sizes or manufacturers or mismatching syringes and sizes may cause improper instrument operation resulting in inaccurate fluid delivery or pressure sensing or other potential hazards, which could result in serious injury or death. WARNING: For detailed instructions and warnings pertaining to the syringe or administration set, please refer to the instructions for use supplied with the product for preparing the product for use. 1. Press any number button to select the syringe manufacturer. SELECT SYRINGE MANUFACTURER/TYPE 1. B-D 2. MONOJECT 3. TERUMO
2. It is now time to load the syringe. (The arrows shown on screen indicate that the syringe sensors detect that the syringe is not loaded.) LOAD SYRINGE – PRESS ENTER WHEN READY
↓
B–D
← ↑ ENTER
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Medfusion® 3500 Operation Manual 3. Lift upward on the Syringe Barrel Clamp and turn it so it is out of the way.
4. 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® 3500 Operation Manual 5. Load the syringe onto the pump as illustrated, making sure the flange of the syringe barrel is pressed or rolled into the Flange Clip.
6. 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.
WARNING: Verify that the plunger holders securely capture the syringe plunger. Make sure to capture the syringe barrel and flange and to thread the tubing through the holding clamps. Failure to properly secure the syringe and tubing could result in uncontrolled fluid flow to the patient, which could result in serious injury or death.
15
Medfusion® 3500 Operation Manual 7. Turn and lower the Barrel Clamp onto the barrel of the syringe.
WARNINGS: • Verify that the plunger holders securely capture the syringe plunger. Make sure to capture the syringe barrel and flange and to thread the tubing through the holding clamps. Failure to properly secure the syringe and tubing could result in uncontrolled fluid flow to the patient, which could result in serious injury or death. • Always use the Prime function on the pump when loading a new syringe in order to remove any mechanical slack. Failure to prime correctly can delay infusion delivery and cause Total Volume Delivered to read higher than what is actually delivered to the patient. The size should now appear in the display. LOAD SYRINGE – PRESS ENTER WHEN READY
B–D
60ml ENTER
Note: If the syringe is incorrectly loaded, guide arrows appear on screen to identify the problem. LOAD SYRINGE – PRESS ENTER WHEN READY
B–D
↓ 60ml
← ↑ ENTER
Arrow pointing down “↓“ on screen means check syringe barrel clamp. Arrow pointing left “←“ on screen means check syringe plunger holders. Arrow pointing up “↑” on screen means check syringe flange clip.
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. 16
Medfusion® 3500 Operation Manual WARNING: Only use syringe sizes and manufacturers listed in this manual, and always confirm that the syringe manufacturer and size displayed on the pump matches the manufacturer and size loaded into the pump. Use of other syringe sizes or manufacturers or mismatching syringes and sizes may cause improper instrument operation resulting in inaccurate fluid delivery or pressure sensing or other potential hazards, which could result in serious injury or death. 9. Thread the tubing through the three Tubing Holders on the top left side of the pump.
10. Press Enter to confirm the syringe information. The pump will now automatically take you to the programming screens for the delivery mode you have chosen. Since it is impossible to know which mode you have chosen, or which functions within that mode have been enabled, what follows is an explanation of the programming steps required for each possible delivery mode.
17
Medfusion® 3500 Operation Manual Unloading the syringe You unload a syringe exactly the opposite way as you load it. Just use the following steps: 1. Press á to stop delivery. 2. Clamp or close infusion line from the syringe to patient. 3. Unthread the tubing from the Tubing Holders on the top left side of the pump. 4. Lift and swivel the syringe Barrel Clamp out of the way. 5. Squeeze the Plunger Release Lever on the syringe plunger and remove the syringe. WARNING: Turn off fluid flow. 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 infusion set is not clamped or turned off resulting in inappropriate delivery rate, and may cause serious injury and/or death.
18
Medfusion® 3500 Operation Manual
Select delivery mode Below are the steps for selecting a delivery mode for programming an infusion. After successfully completing its system startup selftests, the pump displays the delivery mode selection screen. PERFORMING SELF-TEST
MEDFUSION 3500
HOSPITAL
64% •
VERSION: 3.0.6 CONFIG ID: 8E69 SECONDS REMAINING
5
M01234 © 99–2002 MEDEX
The delivery modes available on this screen are dependent on how the pump was configured (performed by whomever is responsible for customizing the pump before it was delivered to your work area). The actual screen on your pump may look very different from the one shown here. PRESS THE NUMBER TO SELECT THE MODE 1. 2. 3. 4.
•
VOLUME / TIME MICROGMS / HR MICROGMS / MINUTE MG / HR E-PLATES
5. 6. 7. 8.
MG / MINUTE MILLIUNITS / HR MILLIUNITS / MINUTE UNITS / HR MORE
Also, if the pump has been configured with “E-Plates” enabled, the first screen is the Select the Library screen (libraries are discussed later on page 73). If the Select the Library Entry screen appears, press the Main Menu button to reach the Select the Mode screen. PRESS THE NUMBER TO SELECT THE LIBRARY ENTRY 1. URDRUGS-1 2. DOX-RX5 3. MEDIC8 MAIN MENU
MORE
1. Press any Number button to select the delivery mode you want to use. If you make a mistake, press â to return to the mode selection screen. 2. If you do not see the mode you need, press the More button to display the next page of delivery modes. You can either: a) Select an option by pressing its number, and continue. OR
19
Medfusion® 3500 Operation Manual b) Press Beginning to return to the beginning page of the mode selection screen. PRESS THE NUMBER TO SELECT THE MODE 1. 2. 3. 4.
RECALL LAST SETTINGS LIBRARY A LIBRARY B LIBRARY C E-PLATES
After selecting the mode the pump will prompt you for selecting the syringe manufacturer and size before programming the selected mode (see page 13).
20
5. CUSTOM PROGRAM 6. BIOMED
BEGINNING
Medfusion® 3500 Operation Manual Continuous mode: mL/hr Continuous infusion is programmed by setting a flow rate in mL/hr. Actual range limits for flow rate are determined by syringe size (see the table in Technical section of this manual) or by a custom configured maximum rate. If needed, a volume limit, loading dose, or bolus dose can also be programmed. To program a Continuous mode infusion, at the mode selection menu, choose ml/hr. Choose the syringe manufacturer and size, and load the syringe as instructed on page 13. 1. Use the number buttons and (if needed) the decimal point to set the flow rate. Press Clear to clear an entry. Press Backspace to erase a character. Press the Enter button to accept the setting. ENTER RATE – PRESS ENTER TO CONTINUE
MAX: MIN:
944 0.1
5.2 CLEAR
ML / HR BACKSPACE
ENTER
2. After all infusion values are set, the pump pauses at the Begin Infusion screen. PRESS < START > TO BEGIN INFUSION
0
PVD
5.2
RATE E-PLATES
CHG RATE
OPTIONS
ML
ML/HR
CLEAR TOTALS
E-Plates or Main Menu– Returns you to the beginning of setup. Chg Rate – allows modifying the set rate without starting from scratch. Options – lets you select from a list of variables (e.g., bolus, volume limit, etc.). Clear Totals – lets you clear total volume delivered, and PVD or PDD.
3. If desired, program a Bolus Dose, Loading Dose or Volume Limit (see Options, page 38). 4. Prior to beginning the infusion, press è to initiate the priming sequence (page 35). 5. You may now accept the settings and start the infusion, or use the four menu buttons to modify the settings. 6. When ready, press É 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 rate, which can result in serious injury or death.
21
Medfusion® 3500 Operation Manual Mass modes The following Mass Modes may be available on your pump: mg/min − mg/hr − mcg/min − mcg/hr − mU/min − mU/hr − u/min − u/hr: Mass Mode is a continuous infusion mode you program by setting: Drug concentration (i.e., mg/mL or U/mL) Dose rate in mass/hr (e.g., mg/hr or u/hr) You can also program volume limit, loading dose, or bolus dose (these options are only available if they have been enabled in the custom program) At the Select the Mode menu, choose the desired mass mode. Choose the syringe manufacturer and size, and load the syringe as instructed on page 13. • • •
1. Use the number buttons to set fluid concentration. Concentration is limited to 4 digits. Press Clear to clear an entry. Press Backspace to erase a character. Press the Enter button to accept the setting. ENTER CONCENTRATION – PRESS ENTER TO CONTINUE
MAX: MIN:
1000 0.0001
2
CLEAR
MG / ML BACKSPACE
ENTER
2. Use the number buttons to set dose rate. Range limits for dose rate are determined by syringe size. The high and low rate limits display on screen. When the dose is correct, press Enter. ENTER DOSE RATE – PRESS ENTER TO CONTINUE
MAX: MIN:
9999 3.334
175 CLEAR
MCG / MINUTE BACKSPACE
ENTER
4. At the Begin Infusion screen all values are set and the pump pauses. 5. You may now accept the settings and start the infusion, or use the four menu buttons shown below to modify the settings. PRESS < START > TO BEGIN INFUSION
CONC 2 MG/ML PVD 0.000 ML DOSE 175 MCG/MIN RATE 5.25 ML/HR E-PLATES
CHG DOSE
OPTIONS
CLEAR TOTALS
E-Plates or Main Menu – returns you to the beginning of setup. Chg Dose – allows modifying the set dosage without starting from scratch. Options – lets you select from a list of variables (e.g., bolus, volume limit, etc.). Clear Totals – lets you clear total volume delivered.
22
Medfusion® 3500 Operation Manual 6. Prior to beginning the infusion, press è to initiate the priming sequence (page 35). 7. If desired, program a Bolus Dose, Loading Dose or Volume Limit (see Options, page 38). 8. When all delivery settings are correct, press É to begin 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 rate, which can result in serious injury or death.
23
Medfusion® 3500 Operation Manual Body weight infusion deliveries The following Body Weight-based infusion delivery modes may be available on your pump: mcg/kg/min − mcg/kg/hr – mg/kg/min – mg/kg/hr – Units/kg/hr. The body weight rate calculation allows programming by: Drug concentration Patient’s weight Drug dosage You can also program volume limit, loading dose, or bolus dose (these options are only available if they have been enabled in the custom program) The pump calculates the correct flow rate in mL/hr to achieve the required drug dose. From the Select the Mode menu, choose the desired body weight delivery mode. Choose the syringe manufacturer and size, and load the syringe as instructed on page 13. • • • •
1. Press the number buttons to set medication concentration. Concentration is limited to 4 digits. Press Clear to clear an entry. Press Backspace to erase a character. Press Enter to accept the setting. ENTER CONCENTRATION – PRESS ENTER TO CONTINUE
MAX: MIN:
1000 0.0001
1.2
CLEAR
MG / ML BACKSPACE
ENTER
2. Press the number buttons to set the patient’s weight in kilograms. Weight is limited to the indicated range. Press Enter to accept the patient weight setting. ENTER PATIENT WEIGHT – PRESS ENTER TO CONTINUE
HIGH: LOW:
250 0.25
50.2
CLEAR
KG BACKSPACE
ENTER
3. At the Dose screen, press the number buttons to set the dose. Range limits here for dose are determined by installed syringe size. When the setting is correct press Enter to accept the dose. ENTER DOSE – PRESS ENTER TO CONTINUE
MAX: MIN:
376 0.04
2.5
CLEAR
24
MCG / KG / MINUTE BACKSPACE
ENTER
Medfusion® 3500 Operation Manual 4. If desired (and if they are enabled), program a Bolus Dose, Loading Dose or Volume Limit (see Options, page 38). 5. At the Begin Infusion screen all values are set and the pump pauses. 6. Prior to beginning the infusion, press è to initiate the priming sequence (page 35). 7. You may now accept the settings and start the infusion, or use the four menu buttons shown below to modify the settings. PRESS < START > TO BEGIN INFUSION CONC WEIGHT DOSE E-PLATES
1.2 MG/ML 50.2 KG 2.5 MCG/KG/MIN CHG DOSE
PVD RATE OPTIONS
0.000
ML
6.275 ML/HR CLEAR TOTALS
E-Plates or Main Menu – returns you to the beginning of setup. Chg Dose – allows modifying the set dosage without starting from scratch. Options – lets you select from a list of variables (e.g., bolus, volume limit, etc.). Clear Totals – lets you clear total volume delivered, and PVD or PDD.
8. When all delivery settings are correct, press É to begin 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 rate, which can result in serious injury or death.
25
Medfusion® 3500 Operation Manual Volume / time The volume over time rate calculation allows programming by: • 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 cannot be set in this mode. To program Volume / Time, choose it at the Select Delivery Mode menu. Choose the syringe manufacturer and size, and load the syringe as instructed on page 13. 1. Press the number buttons to program the volume to infuse. Volume is limited to the maximum fill volume for the syringe size – and minimum volume is 1/600th of the selected syringe size. When the Volume setting is correct, press Enter. ENTER VOLUME TO INFUSE – PRESS ENTER TO CONTINUE
MAX: MIN:
60 0.1
10.4
CLEAR
ML BACKSPACE
ENTER
2. Press the number buttons to set delivery time. Time is always limited by maximum and minimum rates for selected syringe size. When the delivery time is correct, press Enter. ENTER DELIVERY TIME
MAX: 24:00 MIN: 00:08
02:00 CLEAR
HR : MIN
BACKSPACE
ENTER
3. At the Begin Infusion screen all values are set and the pump pauses. 4. Prior to beginning the infusion, press è to initiate the priming sequence (page 35). 5. Confirm all settings are correct. You may now accept the settings and start the infusion, or use the three menu buttons to modify the settings. PRESS < START > TO BEGIN INFUSION PVD VOLUME 10.4 ML TIME 02:00:00 TIME REMAINING 02:00:00 RATE E-PLATES OPTIONS
6. When all delivery settings are correct, press É to begin infusion. 26
5.2
0 ML
ML/HR CLEAR TOTALS
Medfusion® 3500 Operation 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 rate, which can result in serious injury or death.
27
Medfusion® 3500 Operation Manual 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, pauses a set period, then infuses for a set period, and so on. The delivery stop interval equals “Time Between Starts” minus “Delivery Time.” • The pattern repeats at “Time Between Starts” interval. Below are the steps for programming an Intermittent Volume / Time infusion. Select Intermittent Volume / Time from the Select the Mode screen. Choose the syringe manufacturer and size, and load the syringe as instructed on page 13. •
1. Use the number buttons to set the volume. Volume is limited to the maximum fill volume for the syringe size, and minimum volume is 1/600th of syringe size. When the volume is correct, press Enter. ENTER VOLUME TO INFUSE – PRESS ENTER TO CONTINUE
MAX: MIN:
60 0.1
35
CLEAR
ML BACKSPACE
ENTER
2. Use the number buttons to set the delivery time. Maximum and minimum times are calculated for the syringe you are using. When ready, press Enter. ENTER DELIVERY TIME
MAX: 24:00 MIN: 00:08
02:00 CLEAR
HR : MIN
BACKSPACE
ENTER
3. Use the number buttons to set the time between starts value. Maximum and minimum times are calculated for the delivery time entered (minimum time must be at least one minute longer than the delivery time; the pump will not accept delivery times equal to or less than the delivery time). When ready, press Enter. ENTER TIME BETWEEN STARTS
MAX: 24:00 MIN: 00:10
02:00 CLEAR
28
HR : MIN
BACKSPACE
ENTER
Medfusion® 3500 Operation Manual 4. At the Begin Infusion screen all values are set and the pump pauses. 5. Prior to beginning the infusion, press è to initiate the priming sequence (page 35). 6. You may now accept the settings and start the infusion, or use the three menu buttons shown below to modify the settings. PRESS < START > TO BEGIN INFUSION VOLUME TIME TIME BETWEEN STARTS TIME REMAINING MAIN MENU
35 ML 02:00 02:00 02:00
PVD RATE OPTIONS
0.000 ML 25.5
ML/HR CLEAR TOTALS
7. When all delivery settings are correct, press É to begin 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 rate, which can result in serious injury or death.
29
Medfusion® 3500 Operation Manual Recall last settings
The Medfusion® 3500 will recall the settings used to run the last infusion. To reuse the same delivery settings to repeat an identical dosage of medication or fluids to a patient (choose the syringe manufacturer and size, and load the syringe as instructed on page 13): 1. Select Recall Last Settings from the Select The Mode screen. (If you don’t see it, press the More button and search for it.) In this example, you would press the number 7. PRESS THE NUMBER TO SELECT THE MODE 1. 2. 3. 4.
MICROGMS / KG / MINUTE MICROGMS / KG / HR MG / KG / MINUTE MG / KG / HR E-PLATES
5. ML / HR 6. CUSTOM DILUTION 7. RECALL LAST SETTINGS MORE
When selected, you must then press Enter 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 was configured and which features are enabled or disabled. After confirmation the Begin Infusion screen appears. PRESS < START > TO BEGIN INFUSION CONC WEIGHT DOSE E-PLATES
2. Prior to beginning the infusion, press è to initiate the priming sequence (page 35). 3. Press Clear Totals if you wish to clear TVD and PVD or PDD. 4. When all delivery settings are correct, press É to begin infusion. Be sure all pump settings are correct before starting 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 rate, which can result in serious injury or death. TVD and PVD/PDD Retention: The pump also retains TVD and PVD or PDD from the last infusion. If you do not want to use these values, you must manually clear them before beginning a new infusion. 30
6.363 MG/ML 100 KG
PVD
66.6 MCG/KG/MIN CHG DOSE
RATE OPTIONS
0.00 ML
62.80
ML/HR CLEAR TOTALS
Medfusion® 3500 Operation Manual
Custom dilutions Custom Dilution is a form of body weight delivery where you specify the target delivery rate and the pump calculates the custom drug dilution needed to meet that target. The settings required are: • • • •
Patient’s weight Initial (undiluted) drug concentration Target dose rate Target total volume (medication plus diluting fluid) From this data, the pump then calculates: • • •
Amount of fluid required to dilute the initial drug concentration Actual dose rate Actual total volume (as close to target rate and volume as possible by rounding dilution)
Notes: • Reasonable dilution range: You must use a volume of diluent 20 mL or larger to give reasonable range for dilutions. • Enable/disable Custom Dilutions: If you do not see Custom Dilution, or any of these listed on the Select The Infusion Units screen for Custom Dilution, you must enable them through custom configuration.
Types of custom dilutions available There are four different types of custom dilution infusion available in the Medfusion® 3500 infusion pump. Dilution mode Micrograms / Kilogram / Minute Micrograms / Kilogram / Hour Milligrams / Kilogram / Minute Milligrams / Kilogram / Hour
What the pump does Calculates micrograms of medication or fluid per kilogram of patient body weight per minute of infusion to determine the mixing formula. Calculates micrograms of medication or fluid per kilogram of patient body weight per hour of infusion to determine the mixing formula. Calculates milligrams of medication or fluid per kilogram of patient body weight per minute of infusion to determine the mixing formula. Calculates milligrams of medication or fluid per kilogram of patient body weight per hour of infusion to determine the mixing formula.
Calculating dilutions Custom Dilution allows the pump to calculate dilutions for: mcg/kg/min − mcg/kg/hr − mg/kg/min − mg/kg/hr.
31
Medfusion® 3500 Operation Manual Custom dilutions calculates a mixing formula for dilutions of drug to reach a target dose rate for a given volume of fluid to be delivered. 1. Select Custom Dilution from the Select The Mode screen. (If you don’t see it, press the More button and search for it.) In this example, you would press the number 6. PRESS THE NUMBER TO SELECT THE MODE 1. 2. 3. 4.
MICROGMS / KG / MINUTE MICROGMS / KG / HR MG / KG / MINUTE MG / KG / HR E-PLATES
5. ML / HR 6. CUSTOM DILUTION 7. RECALL LAST SETTINGS MORE
2. Use the number buttons to select the desired infusion units. PRESS THE NUMBER TO SELECT THE INFUSION UNITS 1. 2. 3. 4.
MICROGMS / KG / MINUTE MICROGMS / KG / HR MG / KG / MINUTE MG / KG / HR
3. Use the number buttons to set the desired target infusion rate. The target rate should be based on the desired volume that you wish to give the patient over a given time. Syringe size limits the range of infusion rates. When ready, press Enter. ENTER TARGET RATE – PRESS ENTER TO CONTINUE
MAX: MIN:
1130 0.001
200
CLEAR
ML / HR BACKSPACE
ENTER
4. Use the number buttons to set the value for initial or undiluted drug concentration. You are limited to 4 digits. When ready, press the Enter. ENTER INITIAL CONCENTRATION – PRESS ENTER TO CONTINUE
MAX: MIN:
1000 0.0001
100
CLEAR
MG / ML BACKSPACE
ENTER
5. Use the number buttons to set the patient weight in kilograms. Weight is limited to the range indicated. When ready, press Enter. ENTER PATIENT WEIGHT – PRESS ENTER TO CONTINUE
MAX: MIN:
250 0.25
66.6
CLEAR
32
KG BACKSPACE
ENTER
Medfusion® 3500 Operation Manual 6. Use the number buttons to select the desired target dose rate. Target dose rate is the desired rate for infusion of the diluted drug into the patient. When ready, press the Enter. ENTER DOSE RATE – PRESS ENTER TO CONTINUE
MAX: MIN:
9999 0.001
100
CLEAR
MCG/KG/MINUTE BACKSPACE
ENTER
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. When ready, press Enter. ENTER FINAL VOLUME – PRESS ENTER TO CONTINUE
MAX: MIN:
250 20
60
CLEAR
ML BACKSPACE
ENTER
8. The pump then calculates the formula for the Custom Dilution and displays it onscreen. PRESS CONTINUE WHEN READY
MIX: 1 ML OF DRUG WITH 59 ML OF DILUENT TO ACHIEVE A FINAL VOLUME OF
60
ML
CONTINUE
9. Using aseptic technique, prepare a syringe using the formula specified. Fill the syringe and attach an appropriate administration set. When ready, press Continue. WARNING: Fluids Compatibility. Always 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 dilution formula. 10. Choose the syringe manufacturer and size, and load the syringe as instructed on page 13. SELECT SYRINGE MANUFACTURER/TYPE 1. B-D 2. MONOJECT 3. TERUMO
11. At the Begin Infusion screen all values are set and the pump pauses.
33
Medfusion® 3500 Operation Manual 12. Prior to beginning the infusion, press è to initiate the priming sequence (page 35). 13. You may now accept the settings and start the infusion, or use the three menu buttons shown below to modify the settings. PRESS < START > TO BEGIN INFUSION CONC WEIGHT
1.666 MG/ML 66.6 KG
DOSE E-PLATES
100 MCG/KG/MIN
14. When all delivery settings are correct, press É to begin infusion.
34
CHG DOSE
PDD RATE OPTIONS
0.00 MG
239.8
ML/HR CLEAR TOTALS
Medfusion® 3500 Operation Manual
Priming the system Priming is accomplished as a secondary function of the è button. Always prime a new syringe after loading it onto the pump. This removes the mechanical slack in the pump and syringe, and significantly reduces start-up time. The priming sequence is extremely important to assure the accuracy of the delivery and reduce the start-up time. The priming sequence is performed after the infusion is programmed, and before the delivery is started. The message at the top of the Begin Infusion screen will alternate between “Press < START > To Begin Infusion”, and “Press <BOLUS> To Prime” to remind you of the prime sequence. WARNINGS: • NEVER prime any syringe while connected to a patient infusion site, as this may cause over-infusion which could result in serious injury or death. • To avoid air embolism, always purge all air from syringe and infusion lines before connecting to the patient. • Periodically check the fluid pathway and all connections (including the catheter/administration set connection) for leaks. Leaks in the system may cause fluid loss resulting in under-delivery, as well as allowing an opening for contamination. 1. Press è to initiate priming.
2. The priming screen opens. To prime a loaded syringe, press and hold è while observing for fluid movement at the patient end of the system. PRESS AND HOLD
< BOLUS > TO PRIME
PRESS EXIT WHEN PRIME IS COMPLETE PRIMING VOLUME
0.45
ML
EXIT
35
Medfusion® 3500 Operation Manual 3. For safety reasons there is a built-in priming cutoff at 15 seconds. To continue priming after cutoff, release è, then press & hold it again. Priming Volume Not Counted in TVD: The total priming volume accumulates on screen, but is NOT counted in the Total Volume Delivered display. This is because the prime should never be delivered to the patient. Priming infusion rate is 300 mL/hr, or the default maximum bolus rate for the syringe size being used, whichever is lower. Once the system is primed you can connect the tubing to the patient and begin infusion. 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. This could cause improper instrument operation resulting in inaccurate fluid delivery that could result in serious injury or death.
36
Medfusion® 3500 Operation Manual
Guidelines for enhanced pump performance The following are guidelines for enhanced syringe pump performance. Review occlusion time and flow delivery graphs (page 65). Because of the way syringe pumps operate, clinicians should use appropriate syringe size, tubing, and inline devices for expediting delivery of medication or fluid. Certain factors enhance syringe pump performance, where performance is defined as: a) Time to Detect Occlusion b) Continuity of Flow c) Startup Time
Always use the smallest syringe for volume of fluid being delivered It is all too easy to fall into a pattern of using the same syringe size, or sizes to infuse medications or fluids. It is recommended to always using the smallest syringe that can get the job done. This can help avoid a variety of problems. Friction and compliance of the syringe plunger tip affect delivery startup and flow continuity. The bigger the syringe, the greater the friction and compliance, the slower the startup. Use a smaller syringe when running at a lower rate. The tables below and to the right recommend minimum delivery rates by syringe size. When programming flow rates, a limited priority alarm will be activated with an advisory message on the screen if a rate that falls outside those recommended here is entered. When FlowSentry™ (rapid occlusion detection) is disabled: Syringe Size 60 mL 30 mL 20 mL 10 mL 5 mL 3 mL 1 mL
When FlowSentry™ is enabled: Syringe Size 60 mL 30 mL 20 mL 10 mL 5 mL 3 mL 1 mL
Lowest Recommended rate 0.6 mL/hr 0.3 mL/hr 0.2 mL/hr 0.1 mL/hr 0.05 mL/hr 0.03 mL/hr 0.03 mL/hr (FlowSentry™ is not available with 1 mL syringes)
WARNING: Use the smallest syringe size necessary to deliver the fluid or medication. Using a large syringe at very low rates may cause improper instrument operation or pressure sensing or other potential hazards.
Use small internal diameter tubing For the most consistently precise control of all fluids and medications, it is recommended always using small internal diameter tubing. Always minimize residual volumes between syringe and patient by reducing: a) Tubing length b) Size of in-line filters c) Number of stopcocks This makes the infusion setup less variable or compliant, which in turn reduces the start time for fluid to reach the patient – and reduces time required for detecting an occlusion.
Lowest Recommended rate 2 mL/hr 1 mL/hr 0.67 mL/hr 0.33 mL/hr 0.17 mL/hr 0.1 mL/hr 0.03 mL/hr
Note: This table is only a guideline as syringes and infusion setups vary. 37
Medfusion® 3500 Operation Manual
Options Options gives you access to program options that affect the current infusion only. The options available depend on the options that have been enabled. Any options in use 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. These options are available when the pump is at the Begin Infusion screen (prior to starting an infusion): • • • • • • • • • • • • • •
38
Standby Loading Dose Bolus Dose Volume Limit KVO Save to Library Toggle FlowSentry™ Override Occlusion Limit Override Alarm Loudness Toggle Empty Alarm Tone Toggle Near Empty Alarm Tone Toggle PVD / PDD Delayed Start Disable / Enable FlowSentry™
Medfusion® 3500 Operation Manual
Bolus dosing A Bolus dose is an optional parameter of some delivery modes which allows you specify a bolus volume to be delivered over a specified time. Enable / Disable Bolus: Bolus dose is enabled or disabled through pump custom configuration; if disabled it will not appear in the Options menu. You can temporarily disable bolus dosing through the Bolus Dose screen. It is also possible that Bolus Dose was configured to be “auto prompted”, and the bolus programming screens added whenever you program an infusion. Auto Prompt Bolus: It is possible to configure Bolus dosing as an “auto prompt”, so that the bolus dose programming screen is added whenever you program an infusion. If this is the case and you do not want to program a bolus dose, at the Enter Bolus Dose screen you can either press Disable to disable the feature or, with no value entered press Enter.
Set up bolus dosing Below are the steps for adding a bolus to an infusion you are about to begin, or to one you have paused to include a bolus: 1. Set the delivery mode parameters. When the pump is paused at the Begin Infusion screen, press Options. PRESS < START > TO BEGIN INFUSION CONC WEIGHT DOSE E-PLATES
150
250 MG/ML 66.6 KG
PVD V LIMIT
MCG/KG/MIN CHG DOSE
RATE OPTIONS
0.000 60
ML ML
2.397
ML/HR CLEAR TOTALS
2. Use the number buttons to choose Bolus Dose. (You may have to press More to see this option.) PRESS THE NUMBER TO SELECT THE PROGRAM OPTION 1. 2. 3. 4.
STANDBY LOADING DOSE BOLUS DOSE VOLUME LIMIT
5. SAVE TO LIBRARY
39
Medfusion® 3500 Operation Manual 3. Use the number buttons to set the bolus volume desired for this infusion. Volume is limited to the maximum fill volume of the current syringe size, and minimum volume is 1/600th the syringe size. If the initial infusion is programmed in one of the body weight modes (e.g. mcg/kg/min), the bolus “dose” will be programmed in the parameters of that dose mode (e.g. mcg/kg). When the bolus volume (or dose setting if in body weight or mass mode) is correct, press Enter. ENTER BOLUS DOSE – PRESS ENTER TO CONTINUE
MAX: MIN:
60 0.1
DISABLE
2.5 CLEAR
ML BACKSPACE
ENTER
Disable – turns Bolus off. Clear – deletes an entry. Backspace – erases a character.
If the Bolus Time feature has been enabled, you will be able to set the bolus delivery time at the Bolus Time screen. 4. 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. Maximum & minimum time is calculated from the maximum & minimum rate for the syringe size you are currently using. (If you are using a generic infusion and the Bolus Time feature has been disabled the pump will default to the maximum bolus rate.) When the bolus time is correct, press Enter. ENTER BOLUS TIME – PRESS ENTER TO CONTINUE
MAX: 15:00 MIN: 01:00
05:00 CLEAR
MIN : SEC
BACKSPACE
ENTER
5. After the bolus settings have been programmed, the pump pauses. The Bolus setting now appears on the Begin Infusion screen. If this is a new infusion, prior to starting press è to initiate the priming sequence (page 35). PRESS < START > TO BEGIN INFUSION
250 MG/ML PVD CONC WEIGHT 66.6 KG V LIMIT BOLUS DOSE 150 MCG/KG/MIN RATE E-PLATES CHG DOSE OPTIONS
40
0.000 ML 60 ML 2.5 MCG/KG 2.397 ML/HR
CLEAR TOTALS
Medfusion® 3500 Operation 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 rate, which can result in serious injury or death.
Delivering a bolus dose A bolus is a specified volume (or dose) to be delivered over a specified, usually short, period of time. You must have started a delivery before you can deliver a bolus dose. 1. With the pump infusing, press è. (A bolus delivery cannot be initiated until after you press É to begin a programmed delivery.)
2. The Bolus Delivery screen appears. Depending on which mode you are delivering in, the screen is slightly different. BEGIN BOLUS DELIVERY? BOLUS 2.5 ML TIME 00:10 MIN:SS RATE CHG BOLUS YES
900
ML/HR NO
BEGIN BOLUS DELIVERY? BOLUS 1000 MCG/KG VOLUME TIME 01:24 MIN:SS RATE CHG BOLUS YES CHG IN ML
7 300
ML
ML/HR NO
3. To begin delivering the bolus, press Yes. OR • Press No to skip the bolus and return to the normal Delivery screen. OR • Press Chg Bolus to change the bolus settings. OR • If the bolus settings have been programmed in body weight, the key labeled Chg In ml will allow the bolus to be changed in mL directly. 41
Medfusion® 3500 Operation Manual Note: If you don’t press ANY button for 30 seconds, the neglected pump alarm will call you back to the pump. 4. If you pressed Yes the Bolus Delivery screen appears. PRESS CANCEL TO STOP BOLUS DELIVERY DELIVERING 2.5 ML DELIVERED BOLUS 00:06 MIN:SS REMAINING RATE CANCEL
1.345 900
ML
ML/HR
CANCEL – stops the bolus and returns to the normal delivery rate and screen. STOP - halts all delivery and the pump pauses.
The bolus delivery continues at the bolus delivery rate until the bolus volume is delivered. On completion of bolus dosing the pump beeps, then resumes the programmed infusion delivery. The bolus volume delivered is automatically added to the Total Volume Delivered (TVD) as well as the Programmed Volume Delivered (PVD), or Programmed Dose Delivered (PDD) for that infusion.
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Medfusion® 3500 Operation 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 rate is automatically reduced. This is accomplishede by increasing the bolus time over the bolus volume. The bolus rate continues to be reduced until resistance is below the set occlusion limit. There could be a variety of reason for this to occur, including (but not limited to) the occlusion limit in use, fluid/ medication viscosity, the patient’s infusion site setup, etc. RESTRICTED FLOW - RATE REDUCED DELIVERING BOLUS 20 ML DELIVERED 07:16 MIN:SS REMAINING RATE CANCEL
3.345 300
ML
ML/HR
1. Press to silence the alarm. (Bolus delivery continues at the reduced rate.) The pump continues to monitor the infusion and may reduce the rate multiple times. However, the first alarm is the only one that produces an audible tone. If the first alarm is silenced, additional rate reductions will not cause an audible tone to sound, however the amber (yellow) LED and the alarm message will display which you can clear by pressing .
í
í
2. Press to silence the alarm. The normal infusion delivery is continued.
í
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Medfusion® 3500 Operation Manual
Loading doses 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. Enable / Disable Loading Dose: Loading dose is enabled or disabled through pump custom configuration (using the PharmGuard® Toolbox software); if disabled it will not appear in the Options menu. You can temporarily disable loading dose through the Loading Dose screen. Auto Prompt Loading Dose: It is possible to configure Loading Dose dosing as an “auto prompt”, so that the loading dose programming screen is added whenever you program an infusion. If this is the case and you do not want to program a loading dose, at the Enter Loading Dose screen you can either press Disable to disable the feature or, with no value entered press Enter.
Set up loading dose 1. Set the delivery mode parameters. When the pump is paused at the Begin Infusion screen, press Options. PRESS < START > TO BEGIN INFUSION
0.00 0.00
TVD PVD RATE E-PLATES CHG RATE OPTIONS
ML ML
25.5
ML/HR CLEAR TOTALS
2. Use the number buttons to choose Loading Dose. (You may have to press More to see this option.) PRESS THE NUMBER TO SELECT THE PROGRAM OPTION 1. 2. 3. 4.
STANDBY BOLUS DOSE LOADING DOSE VOLUME LIMIT
3. At the Enter Loading Dose screen, set the loading dose volume. Here, volume is limited to the maximum fill volume for the current syringe size, and minimum volume is 1/600th of syringe size. When the loading dose is correct, press Enter to accept the volume setting (or dose setting if in body weight or mass mode). ENTER LOADING DOSE – PRESS ENTER TO CONTINUE
MAX: MIN: DISABLE
60 0.1
6.6 CLEAR
ML BACKSPACE
ENTER
Disable – turns loading dose Off. Clear – deletes an entry. Backspace – erases a character.
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Medfusion® 3500 Operation Manual 4. Use the number buttons to set delivery time in minutes & seconds. The default value for loading (i.e., bolus) delivery rate is set in custom configuration. Maximum & minimum time is calculated from the maximum & minimum rate for the syringe size you are currently using. ENTER LOADING TIME – PRESS ENTER TO CONTINUE
MAX: 15:00 MIN: 01:20
01:20 CLEAR
MIN : SEC
BACKSPACE
ENTER
5. After the loading dose is set and accepted, the pump pauses. The Loading Dose setting now appears on the Begin Infusion screen. If this is a new infusion, prior to starting press è to initiate the priming sequence (page 35). PRESS < START > TO BEGIN INFUSION TVD PVD LOAD 6.6 ML RATE E-PLATES CHG RATE OPTIONS
0.00 0.00
ML ML
25.5
ML/HR CLEAR TOTALS
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 rate, which can result in serious injury or death.
45
Medfusion® 3500 Operation Manual Delivering a loading dose 1. When ready, press É.
2. The Begin Loading Dose screen appears. BEGIN LOADING DOSE DELIVERY? LOAD 6.6 ML 01:20 MM:SS TIME RATE CHG DOSE YES
297
ML/HR NO
3. To begin delivering the loading dose, press Yes. OR • Press No to skip the loading dose and return to the Normal Delivery screen. OR • Press Chg Dose to change the loading dose settings. • If the loading dose settings have been programmed in body weight, the key labeled Chg In ml will allow the dose to be changed in mL directly (if enabled). NOTE: If you don’t press ANY button for 30 seconds, the neglected pump alarm will call you back to the pump. 2. If you press Yes the Loading Dose Delivery screen appears and the infusion begins. PRESS CANCEL TO STOP LOADING DOSE DELIVERY DELIVERING LOAD 6.6 ML DELIVERED REMAINING 01:15 MIN:SS RATE CANCEL
0.619 297
ML
ML/HR
CANCEL – stops the bolus and returns to the normal delivery rate and screen. STOP - halts all delivery and the pump pauses.
The pump delivers the loading dose then automatically switches to normal delivery rate and screen. The loading dose volume delivered is automatically added to the Total Volume Delivered (TVD) as well as the Programmed Volume Delivered (PVD), or Programmed Dose Delivered (PDD) for that infusion.
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