Medfusion Model 4000 Operators Manual sw V1.1 Sept 2011

Medfusion® Model 4000 pump Operator’s Manual Technical Assistance The issue date of this manual is included on the back cover. If your manual is a year or more old, contact Smiths Medical to see if a newer manual is available. If you have comments or questions concerning the operation of the Medfusion® Syringe Infusion Pump Model 4000 (Medfusion® Model 4000 pump), please call the appropriate number given below. When calling, please specify your pump’s software version. This information is located on the start-up screen. Our staff at Smiths Medical in the USA is available to help clinicians 24 hours a day with the programming and operation of the Medfusion® Model 4000 pump. Smiths Medical ASD, Inc. 1265 Grey Fox Road St. Paul, MN 55112 USA 1 800.258.5361 (USA), +1 214.618.0218 www.smiths-medical.com

A printed copy of this manual is available upon request.

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Medfusion® Model 4000 pump Operator’s Manual

Table of Contents Important Safety Information

1

Introduction

6

About the pump

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Network Connections

11

Warnings... 1 Cautions... 4 Symbols... 5 Indications for use... 6 Contraindications... 7 Features and Controls... 8 Keypad closeup... 9

Ethernet State... 11 Wireless State... 11 Connected to Toolbox... 11 Network Configuration... 11 Attaching the Pump to the Network... 11 Network status... 11

Pump Customization and General Programming

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Custom Configuration... 12 General Programming... 14 Exceeding limits... 14 How pump settings and limits are prioritized... 14 User defined pump Configurations... 15 What are Configurations?... 15 When are Drug Programs used?... 15 Who can use these Drug Programs?... 15 Types of programmable Library Categories... 15 Using a Custom Configuration... 16 Using Quick Libraries... 17 PharmGuard™ Safety Software: Dose Protocol Protection... 19 Soft limits... 19 Hard limits... 19 Adjusted limits in reverse... 20 Overridden limits in reverse... 20 Invalid infusion parameter combination... 20 PharmGuard™ Supported Syringes (PSS) Series 2... 21 Navigating the pump menus... 22 The Workflow Process... 22

Guidelines for enhanced pump performance 24 Always use the smallest syringe for volume of fluid being delivered... 24 Bolus Volume... 25 Use appropriate internal diameter tubing... 25

Programming an Infusion

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Turn the pump on... 26 Turning the pump off... 27 Selecting a Delivery Mode and Programming an infusion... 28 General Infusion Programming Procedure... 29 Selecting an Infusion... 30 Select a Profile (Custom Configuration)... 31

Select a Category... 32 Select a Drug Program... 32 Select a Delivery Mode (Medfusion™ Standard Configuration)... 33 Loading a syringe and syringe model setup... 34 Unloading the syringe... 38 Programming Infusions... 39 Continuous mode: mL/hr... 39 Dose / Min and Dose / Hr... 40 Dose / Day... 42 Dose / Time... 44 Body weight/surface area infusion deliveries... 46 Volume / weight infusions... 48 Dose/kg/time (dose/m2/time)... 50 Volume / weight / time... 52 Volume / time... 54 Intermittent volume / time ... 55 Recall last settings... 57 Priming the system... 59

Options

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Infusion Delivery

86

Bolus dosing... 62 Bolus programming... 62 Bolus delivery... 64 Continuing an interrupted bolus dose... 65 Bolus dose rate reduction... 66 Loading doses... 67 Set up loading dose... 67 Delivering a loading dose... 69 Continuing an interrupted loading dose... 70 Loading dose rate reduction... 71 Volume limit ... 72 Setting volume limit ... 72 Keep Vein Open (KVO) rate... 74 Programming KVO rate... 74 Standby... 76 Programming standby... 76 Delayed start... 78 Programming delayed start... 78 Periodic callback alarm... 79 Programming periodic callback alarm... 79 Override and toggle features... 81 Change to Dose / Change to Volume ... 81 Override occlusion limit ... 82 Override alarm loudness... 83 Disable/enable FlowSentry™... 84 Disable/enable near empty alarm tone... 84 Disable/enable vol empty alarm tone... 85 Starting & stopping infusion delivery... 86 Start delivery from pause... 86 Starting delivery from standby or delayed start... 87 Stopping delivery... 87 Continuing interrupted delivery... 87 Flush feature... 88 Volume only... 88 Continuing an interrupted flush infusion... 89 Volume and time... 90

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Medfusion® Model 4000 pump Operator’s Manual Time to occlusion... 92 Occlusion trend graph during delivery... 92 FlowSentry™ (rapid occlusion detection)... 92 Post occlusion bolus reduction ... 93 Making changes during delivery... 94 Changing delivery rate... 94 Changing rate during delivery... 94 Changing the rate when paused... 95 Total volume, program volume / dose delivered... 96 Displaying “Program Volume Delivered” (PVD) / “Program Dose Delivered” (PDD) ... 96 Clearing total volume, program volume, or program dose delivered... 97 Keypad lock ... 98

Alarms & remedies

99

Alarms / alerts types... 99 Re-displaying an alarm message... 100 “User Callback” alarm ... 101 Syringe Empty Alarm Process... 101 “Syringe Near Empty” alarm... 101 “Syringe Volume Near Empty” alarm... 101 “Syringe Empty” alarm... 102 System Advisory - Maintenance is Recommended... 102 System Failures... 102 General system alarms & alerts... 103 System Failure and Advisory Alarms... 107 Battery Alarms... 107 System Failure Alarms... 108 System Advisory Alarms... 108 Update(s) Available Notification... 110

Battery and AC power operation

111

Poleclamp assembly & use

113

On screen display of internal battery power level gauge... 112 Battery guidelines ... 112 Rotating/detachable poleclamp (standard)... 113 Assembling the rotating/detachable poleclamp... 114 Assembling the stationary poleclamp... 115 EMC information for the Medfusion® Model 4000 pump... 116 Use of cables... 116 Stacked equipment... 116

Technical specifications & other information 117 Pump development standards... 117 Medical Electrical Equipment Safety... 117 Electromagnetic Compatibility... 117 Miscellaneous Standards... 119 Compliance using:... 120 IEEE 802.11 b,g Radio for Auxiliary Communication... 123 Technical specifications... 124 Specifications... 124

Safety Features

128

Safety Features and Fault Detection... 128 Hardware Safety Features... 128 iv

Software Safety Features... 128 Hardware-related Software Safety Features... 128 Program Memory - Check FLASH memory POST or BGND... 128 RAM Memory Check - RAM BGND ... 128 Motor Circuit Check - pump motor phase A or B POST and Motor rate error during operation... 128 Keyboard Encoder Check - Control key POST or BGND ... 128 Data Handling Software Safety Features... 128 Data Stored in EEPROM - Critical data POST or EEPROM timeout or Primary/Secondary critical data corrupted... 128 Data Used in Calculations - Critical data failure... 128 Timer Data Registers - Time base BGND, time of day clock POST, time of day clock timeout ... 129

Additional Technical Information

130

Limited Warranty Index

146 147

Medfusion™ Standard Syringes... 130 PharmGuard™ Supported Syringes (PSS) Series 2... 130 Flow rate & minimum volume by manufacturer & size - Standard syringes... 131 Concentration and dosing units ... 133 PharmGuard™ software limits... 133 Configuration options... 134 General Options... 134 Program Options... 136 Auto Prompt Options... 137 Device Setup Features... 138 Flow Delivery Graphs... 138 Start-up curves over stabilization period... 139 Trumpet curves over T2 period... 139 Communications ... 140 Magnetic Resonance Imaging (MRI) Information... 140 MRI Related Testing... 140 Image Distortion... 140 Cleaning and care... 141 Maintenance & service... 142 Periodic maintenance... 142 Using Smiths Medical USA service assistance... 143 Returning a pump to the USA for repair... 144 Collect Separately... 145

Medfusion® Model 4000 pump Operator's Manual

Important Safety Information WARNING: Read this entire manual before using the Medfusion® Syringe Infusion Pump, Model 4000 (Medfusion® Model 4000 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 above and below in the main part of the manual). See the Alarms and Remedies section for information on troubleshooting pump alarms. The term WARNING is used in this manual 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.

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To avoid risk of explosion, never use pump in presence of flammable anesthetics, oxygen-enriched atmospheres, or explosive gases. Due to risk of explosion, never use this pump inside a hyperbaric chamber. If the patient is placed in a hyperbaric chamber while connected to a pump located outside the chamber, delivery accuracy can be affected. Due to pressure changes on the IV tubing, under-delivery can occur during compression, and over-delivery can occur during decompression. 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. This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the operator's manual, may cause

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harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. This equipment/system is intended for use by healthcare professionals only. The equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the Medfusion® Model 4000 pump or shield the location. The unauthorized modification of this product may constitute a safety hazard, which could lead to patient injury or death, as well as the potential for property damage (including the risk of fire). Use only Smiths Medical supplied service/replacement parts, including the battery pack. Unauthorized modification and/or the use of unauthorized service/replacement parts will also void the Limited Warranty. This device contains an RF transmitter which may interfere with aircraft systems. Before using any Medfusion® Model 4000 pump, users must be thoroughly familiar with the contents of the operator's 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. 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 user should ensure that the performance offered by the pump is fit for the intended use and that the pump is not used in any way or for any purpose other than its intended purpose. This pump is not to be used in any intra-articular space infusion. The pump must be positioned in an MR environment such that it is secured to a non-moveable object and the magnetic fringe field does not exceed 1

Medfusion® Model 4000 pump Operator's Manual

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150 gauss. Exposing the Medfusion® Model 4000 pump to magnetic fields that exceed 150 gauss presents a risk of becoming a projectile hazard and can lead to possible patient injury or death. Irreversible damage to the pump can also occur, rendering it inoperable. 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. 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 the Medfusion™ Standard Syringes (supplied with PharmGuard® Toolbox 2, and included in the Medfusion™ Standard Configuration), or the models and sizes available as part of the PharmGuard™ Supported Syringes (PSS) Series 2, and always confirm that the syringe model and size displayed on the pump matches the model and size loaded into the pump. Use of unapproved syringes may cause improper pump operation resulting in inaccurate fluid delivery or occlusion sensing or other potential hazards. Verify that the plunger holders securely capture the syringe plunger. Make sure to capture the syringe barrel and flange. Failure to properly secure the syringe 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. 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. Always turn off fluid flow to patient in tubing via clamp or stopcock before loading or unloading a syringe. Uncontrolled fluid flow can occur when infusion set is not clamped or turned off resulting

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in inappropriate delivery rate. 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. 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 pump operation resulting in inaccurate fluid delivery. Place the pump as close to the patient's infusion site as possible. Use the smallest syringe size necessary to deliver the fluid or medication. Using a large syringe at very low rates (below Minimum Recommended Rate for the syringe) may cause improper pump operation, delayed occlusion sensing, larger post occlusion bolus at higher occlusion limit settings, delivery inaccuracies, or other potential hazards. Bolus Volume: Delivering a bolus volume less then the recommended bolus volume for the syringe used may result in delivery inaccuracies. Use an infusion set with the smallest diameter tubing available that does not result in excessive back pressure at the desired flow rate. Consider priming, loading, bolus, and flush rates when selecting an infusion set. Larger size syringes at occlusion setting HIGH may produce a post occlusion bolus larger than 0.3 mL due to excessive syringe plunger tip compliance. When using Quick libraries, preset values are automatically inserted without pausing to verify each setting. The Begin Infusion screen displays immediately after selecting/confirming the drug program. Verify the infusion parameters before starting the delivery. Certain data fields may not be programmed (e.g. patient weight) and require data entry before the infusion will proceed. If a system failure alarm occurs and cannot be cleared by powering the pump down then back up, the pump cannot be used. Remove it from use

Medfusion® Model 4000 pump Operator's Manual

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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. Ensure that the ± 2% accuracy specification (± syringe accuracy) is taken into account when programming the pump and/or filling a syringe. If accuracy is of prime concern, use only syringes that meet the ± 2% requirement of the ISO 7886-2 Standard. Failure to do so may result in medication in the syringe becoming depleted sooner or later than expected. 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. It is recommended that when connecting the pump to a network using an Ethernet cable, the network equipment should conform to EN/IEC 60950. The pump should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the user should verify normal operation of the pump in the configuration in which it is to be used. To avoid electric shock, before cleaning, always switch electrically operated equipment off and disconnect 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 Technical 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.

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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.

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Medfusion® Model 4000 pump Operator's Manual

Cautions • •

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Federal (USA) law restricts this device to sale by or on the order of a physician. ALWAYS verify that the software version of the pump (displayed on screen during power-up) and Operator's Manual are the same. Refer to this manual’s front page. NEVER use sharp objects to depress keypad keys on the pump. This may damage the pump by rendering keypad keys inoperable. This pump is designed to be used in a horizontal position. If the pump is operated in a vertical position, there is an increased potential for fluid leaking into the pump. If fluid leakage into a pump is suspected, remove it from use until a trained biomedical technician can test it. Always verify the stability of the object to which the pump is mounted (for instance, an IV pole) using the poleclamp. Failure to verify the stability could cause the object to tip, with the possibility of causing damage to the pump and other equipment If the poleclamp is not adequately tightened, it could cause the pump to fall. NEVER use organic solvents (e.g., acetone), quarternary ammonia compounds, strong acids, or bases to clean any portion of the pump as these compounds may damage the pump. The pump is “spray resistant” from the top and sides but not “water proof ”. NEVER spray cleaning or other fluids directly into openings on the bottom of the pump as pump damage may occur. The pump is not certified “waterproof ”. Never immerse the pump in water or other fluids as this can render the pump inoperable. 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 will void the warranty.

Medfusion® Model 4000 pump Operator's Manual

Symbols The following is a list of symbols which may appear on the pump (or on its labeling or accessories), as well as certain technical terms, along with an explanation of what they mean.

>

Serial number

J

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 Latex free

f Caution K

J

6 <

nol 7 8

î Non-ionizing radiation

 Australian c-tick mark. Indicates that the complies with the applicable stanCCK product dard and establishes a traceable link beMR (Magnetic Resonance) Conditional

Ü Z

tween the equipment and the manufacturer, importer or their agent responsible for compliance and for placing it on the Australian or New Zealand market. 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. Collect Separately

For an explanation of the symbols that appear on the pump keypad, see “Keypad Closeup” and the tables that follow (page 9).

Do not reuse Use by 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

P _ Humidity limitation i Atmospheric pressure limitation ED

WD V~ IPX3

E=Wired Connection, D=Device Server Connection W=Wireless connection, D=Device Server Connection Operating voltage range for alternating current (i.e. AC or mains) power source Equipment that is ingress protected from fluid spraying at a vertical angle from above, and from angles to 60° on either side of vertical 5

Medfusion® Model 4000 pump Operator's Manual

Introduction CAUTION: ALWAYS verify that the software version of the pump (displayed on screen during power-up) and Operator's Manual are the same. Refer to this manual’s front page. The Medfusion® Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs. The actual modes available in a given pump, and their location on a given screen, depend on the custom setup. Fluids can be delivered from a variety of syringe sizes (1-60 mL) and syringe manufacturers in various delivery modes. The Medfusion® Model 4000 pump is equipped with PharmGuard® Medication Safety Software, an intuitive system designed to enhance safety while maintaining simplicity, which can allow streamlined implementation and improved work flow. A pump Configuration is created on a PC using the PharmGuard® Toolbox 2 software, and then the Configuration is sent to the pump. The Configuration may contain global settings, Profile definitions, library definitions, Drug Programs and syringe definitions (see page 15 for discussion about libraries). The Medfusion® Model 4000 pump imports and exports data to assist in history data management. The pump communicates with the PharmGuard® Server using Wireless and Ethernet interfaces. With its wired or wireless Ethernet connection, bi-directional communication of Configuration and infusion data is possible to and from the Medfusion® Model 4000 pump via your institution’s network. Pump Configurations and firmware can be updated, and infusion settings and events history downloaded in combination with the PharmGuard® Toolbox 2 software application and the PharmGuard® Server. The pump also has 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-occlusion bolus reduction feature.

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Indications for use The Medfusion® Model 4000 Syringe Infusion Pump is indicated for the following uses: •

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In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus. In critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician. Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

WARNINGS: • Before using any Medfusion® Model 4000 pump, users must be thoroughly familiar with the contents of this Operator’s Manual, including all warnings, cautions, and instructions for use. • The user should ensure that the performance offered by the pump is fit for the intended use and that the pump is not used in any way or for any purpose other than its intended purpose. • This pump is not to be used in any intra-articular space infusion. • This syringe infusion pump is intended for use only under the direction of trained medical professionals. • If the pump is used to deliver life-sustaining medications, an additional pump must be available for situations where an interruption in infusion could be dangerous. • The pump must be positioned in an MR environment such that it is secured to a non-moveable object and the magnetic fringe field does not exceed 150 gauss. Exposing the Medfusion® Model 4000 pump to magnetic fields that exceed 150 gauss presents a risk of becoming a projectile hazard and can lead to possible

Medfusion® Model 4000 pump Operator's Manual patient injury or death. Irreversible damage to the pump can also occur, rendering it inoperable. CAUTION: NEVER use sharp objects to depress keypad keys on the pump. This may damage the pump by rendering keypad keys inoperable. •

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Only the Medfusion™ Standard Syringes (supplied with PharmGuard® Toolbox 2, and included in the Medfusion® Standard Configuration), or the additional syringe models and sizes available as part of the PharmGuard™ Supported Syringes (PSS) Series 2 (see page 21), may be used on the pump. Ensure all medications or fluids are compatible with the syringe, catheters, tubing, and fittings used in the infusion setup. 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.

Contraindications WARNING: ECMO use: 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.

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Medfusion® Model 4000 pump Operator's Manual

About the pump Features and Controls Following are several illustrations showing the various controls, connectors and features of the Medfusion® Model 4000 pump.

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 * 



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*

PRIME / BOLUS

 1

2 3 4 5 6 7

8

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 the pump programming being accomplished) 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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9

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. Keypad: See Keypad closeup (next page) for identification of the individual keypad keys and what they are used for.

Medfusion® Model 4000 pump Operator's Manual

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10 AC Power Connection Port: Plug the AC power cord into connection port to allow pump to operate on AC (mains) power. 11 Ethernet Port: Plug an Ethernet network cable into the port to receive and send Configurations and data. 12 Optional Poleclamp Mount: If desired, attach the optional poleclamp here. 13 Pump Base / Bottom

Keypad closeup PRIME / BOLUS

G6000912 Rev 0

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Medfusion® Model 4000 pump Operator's Manual Key

í)

Alarm Silence (

ë)

Power (

Menu keys (softkeys) Back (â)

Numbers & Decimal

á) Start (É) Stop (

è)

Prime / Bolus (

Indicator ò - Alarm

ô - AC Line õ - Battery ö - Lock

ù - Infusing

When pump is paused Silences audible alarm. Allows operator to switch the display backlight from bright to dim or dim to bright. Allows redisplay of the text for the last active alarm. Silence certain active alarms. Push and hold to turn pump off. Function is defined on the display. Reverts to a previous step or level.

Set number values or selects menu items. N/A

When pump is delivering Silences audible alarm. Allows operator to switch the display backlight from bright to dim or dim to bright. Silence certain active alarms (some alarms must be silenced with before will function). 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. Briefly displays the battery life indicator, network connection type, data server status and PDD/PVD. Set number values or selects menu items.

í

ë

Stops delivery (pump remains on).

Starts delivery.

N/A

Begins priming after confirmation.

Displays the programmed bolus programming or confirmation/Begin Delivery screen.

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 indicates the pump has been locked into its current operational mode. While this indicator is lit, 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 informational message. The Infusing indicators are 3 green lights, which illuminate in sequence right to left when the pump is infusing. During intermittent volume over time delivery mode, a single Infusing indicator lights during the time between infusions.

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When the pump is off or stopped, the Infusing indicator is not lit. The Communicating indicator (blue) is on whenever the pump is communicating with - Communicating the PharmGuard® Server using wireless or wired interface. There is no audible tone associated with communications. During normal network operations the light may periodically turn on and off. The Communicating indicator has no affect on clinical operations of the pump.

Medfusion® Model 4000 pump Operator's Manual

Network Connections The pump can be connected to the PharmGuard® Server and/or to the PharmGuard® Toolbox 2 Software. When the pump is connected to the network, there are two connectivity states: Wireless and Ethernet. Ethernet (wired connection): When the pump is connected to Ethernet, it automatically defaults to communicating over Ethernet. Wireless: When an Ethernet connection is not present (and the Wireless Interface is enabled), the pump communicates via Wireless.

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The blue “Communicating” light is on whenever the pump is communicating with the PharmGuard® Server using wireless or wired interface. Note: To set up a network configuration, see the procedure provided in the Medfusion® Model 4000 Network Settings Manual (“Network Configuration”), the instructions provided with the PharmGuard® Server, and work with your IT personnel as needed.

through a simple command line interface from a telnet client program. The pump accepts incoming connections from the network using telnet. The telnet configuration interface supports a user definable telnet password. The pump must have External Commands enabled in biomed mode to use telnet.

Attaching the Pump to the Network See the Medfusion® Model 4000 Network Settings

Manual for instructions in how to attach the pump to the network.

Network status Briefly display the network status at any time while the pump is infusing by pressing â.

Example of communications state icon

Ethernet State The pump displays the ‘ED’ icon when the pump is connected to the PharmGuard® Server using the Ethernet connection. First an ‘E’ icon is displayed when the Ethernet connection is established, then an ‘ED’ icon when the connection to the PharmGuard® Server is also established.

B-D

100%

60ml

E

PVD

0.55 mL N

RATE

10 mL/hr

LOCK

CHG RATE

OPTIONS

CLEAR TVD

Wireless State The pump displays the icon ‘WD’ when the pump is connected to PharmGuard® Server using a Wireless connection. First a ‘W’ icon is displayed when the Wireless connection is established, then a ‘WD’ icon when the connection to the PharmGuard® Server is also established.

Connected to Toolbox When External Commands are enabled in Biomed mode, the pump can be connected to PharmGuard® Toolbox 2.

Network Configuration

The Medfusion® Model 4000 pump provides a telnet server to enable performance of configuration tasks 11

Medfusion® Model 4000 pump Operator's Manual

Pump Customization and General Programming Custom Configuration Generally speaking, pump customization is performed before a pump is used on a patient (see the graph on page 13). Customization is accomplished using PharmGuard® Toolbox 2. Once the custom Configuration is created and validated, PharmGuard® Toolbox 2 or the PharmGuard® Server is used to send it to one or more pumps. When sending Configurations using the PharmGuard® Server, all Medfusion® Model 4000 pumps configured to communicate with the PharmGuard® Server will receive the 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 to program them accordingly. For this reason, the following warning is included 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, which can result in serious injury or death.

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Medfusion® Model 4000 pump Operator's Manual ®

Medfusion 4000 Infusion Pump “Medfusion™ Standard Configuration” includes manual delivery modes and a variety of syringes. No Drug Programs or Options are available in the Standard Configuration

PharmGuard® Toolbox V2 Create a custom Configuration (settings and Drug Programs), validate Configuration, then send to pump using PharmGuard® Toolbox or PharmGuard® Server (see the product literature supplied with these products for more information)

®

Medfusion Model 4000 Pump With Custom Configuration

Send Configuration

Types of Delivery Modes Possible Dose / Day Dose / Hour Dose / Kg / Day Dose / Kg / Hr Dose / Kg/ Min Dose / m2 / Day Dose / m2 / Hr

Dose / m2 / Min Dose / Min Dose / Time Intermit Volume / Time mL / Hr mL / Kg / Hr mL / Kg / Min

mL / Kg / Time Volume Over Time Dose / Kg / Time Dose / M2 / Time Other mode: Recall Last Settings

These are the types of infusion modes possible. Some are manual (in that they can be used in Drug Programs or can be menu items on their own), while others can only be used in the creation of Drug Programs (such as Dose / Kg / Time and Dose / M2 / Time)

Flush feature may be used in some modes

Possible Options

The Customization Process

Bolus Dose Delayed Start KVO Loading Dose Override Alarm Loudness Override Occlusion Limit Periodic Callback Alarm Standby Toggle Empty Tone Toggle FlowSentry Toggle Near Empty Tone Toggle PVD / PDD Volume Limit Not all options are available in all delivery modes or Drug Programs

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Medfusion® Model 4000 pump Operator's Manual

General Programming The Medfusion® Model 4000 pump has a variety of

delivery modes that are customizable by the user. The actual modes available on a given pump, and their location on a given screen, depend on the custom setup performed. All customization is accomplished using the PharmGuard® Toolbox 2 software, including which syringes and features are available on the pump, as well as hard and soft limits on values (see below and page 19 for discussion about hard and soft limits). 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 a specific pump, and how the screens associated with them appear, depends entirely on how the pump was customized. If the functions and screens on a pump look different than those shown here, it is due to this customization. It is possible that a pump is customized so that an infusion cannot be programmed without first entering a user ID, or so that certain profiles cannot be accessed without first entering a passcode. If that is the case, you will be prompted to enter an ID or a passcode when attempting to program an infusion. 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.

Exceeding limits The pump has two types of programmed infusion limits, Hard limits and Soft limits. •

14

Hard Limits – Values that cannot be exceeded under any conditions. Hard limits show up as Max and Min on the pump. If you try to exceed a hard limit, a screen similar to the following figure displays.

INPUT OUT OF RANGE - GREATER THAN MAX VALUE MAX: 59 HIGH: 50 LOW: 10 mL MIN: 1

62

DISABLE

CLEAR

BACKSPACE

ENTER

The pump then prompts you to enter a new value. •

Soft Limits - The normal range. Soft Limits show up as High and Low on the pump. They are the normal upper and lower limits. You can enter a value above or below the High or Low limit (so long as it does not exceed the Min or Max). If the soft limits are exceeded, the pump prompts you to first silence an alarm, then confirm or cancel the override condition, as shown in the following screen. CONFIRM LIMIT OVERRIDE? MAX: HIGH: LOW: MIN:

59 50 10 1

55 OVERRIDE

mL

NO

It is possible that a pump is customized so that limits cannot be exceeded unless a user ID is entered. If that is the case you will be prompted to enter an ID. “Limit” style alerts are advisories that occur for various reasons (usually during programming). A non-repeating audio alarm sounds and a message is displayed for 3 seconds. To re-display the alert message, press í. The pump records exceeded limits and attempts to exceed limits.

How pump settings and limits are prioritized There can be a number of limits imposed on pump settings, for instance the rate is limited by the syringe size being used, as well as any hard and/or soft limits imposed in the drug program. The most restrictive limit takes priority. Additionally, available Options for delivery can be set for profiles as well as individual drug programs. In these cases, the settings for the drug program take priority over profile settings. For example, the Bolus option may be enabled for a profile, but a drug program within that profile may have the bolus option disabled.

Medfusion® Model 4000 pump Operator's Manual

User defined pump Configurations

Types of programmable Library Categories

This chapter describes the Medfusion® Model 4000 pump Configuration.

There are two types of library categories in the Medfusion® Model 4000 pumps:

What are Configurations?

Library Category Type Standard

A Configuration is a database of pump settings organized into Profiles, Categories and Drug Programs. The Configuration has global settings that are applicable to the pump operations. The Configuration may have up to 16 Profiles. Each Profile has a set of Profile-level settings and also up to 8 Categories. Each Category may contain up to 36 Drug Programs. There is a special category called a Quick Library. A Quick Library contains Drug Programs that have all infusion parameters pre-specified to allow quick start of an infusion. A Configuration is defined here as a stored record of infusion settings that load from memory. These programs are stored in memory indefinitely (over 10 years) or until overwritten. The Configuration is set up using PharmGuard® Toolbox 2. When it is completed it should be validated by the person responsible for custom configuration before the pumps are delivered to a work area.

When are Drug Programs used? Every unit, department, organization, or hospital has standard ways of delivering medications or fluids. The custom setup enables you to use programs of stored presets. Using the PharmGuard® Toolbox 2 Software, the PharmGuard® Toolbox 2 Administrator will establish the pump Configuration that implements the standard infusions for the unit, department, organization, or hospital. This process is described in the PharmGuard® Toolbox 2 User’s Manual.

Who can use these Drug Programs? Anyone who is authorized to use the infusion pump can use programs from the available libraries.

Quick

What it does

Standard library categories contain programs with parameters that are applied when programming an infusion. These libraries require you to step through and review each setting. This allows modifying standard settings while stepping through preset values. A quick category contains drug programs with the presets necessary for programming an infusion. However, they do not pause at each level for you to enter the settings. Instead, the entire set of values is programmed at one step including syringe model and size. The Begin Infusion screen, where all infusion values are shown, displays at once. At that point, you confirm all the settings are correct, then press to begin delivery.

É

WARNINGS: Confirm All Settings. Before starting any delivery, always confirm the accuracy of all infusion values to the original order. Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery, which can result in serious injury or death. When using Quick libraries, preset values are automatically inserted without pausing to verify each setting. The Begin Infusion screen displays immediately after selecting/confirming the drug program. Verify the infusion parameters before starting the delivery. Certain data fields may not be programmed (e.g. patient weight) and require data entry before the infusion will proceed. Displaying Quick library Options: The steps in this section are hypothetical. The Medfusion® Model 4000 pump is shipped with a Medfusion™ Standard Configuration, and without any Profiles, Categories and Drug Programs. So the actual Quick libraries available depend entirely on the custom Configuration sent to the pump. 15

Medfusion® Model 4000 pump Operator's Manual

Using a Custom Configuration PharmGuard® Toolbox 2 allows a facility to create

a custom Configuration and send it to the pump for use. If profiles are created in the Configuration, the pump displays the Profile Menu. If the desired profile isn't displayed on the first screen press More for additional selections. 1. If a profile listing isn't displayed on the Select the Profile menu, press More to find it on another screen; otherwise it is necessary to create that profile using PharmGuard® Toolbox 2. For example, if “4” at right is selected, the General Peds profile opens (profiles names are customized per facility preference, so will not be the same as those shown in the following screens). 2. Library categories in the profile are displayed. Select a category from the menu. For example: if “1” at right is selected, then the drug program category Gen Peds A - D opens. 3. Custom drug programs are displayed on the Drug Program screen. To use a drug program, use the number keys to select the desired drug program (see page 32 for a full explanation of this screen). For example: if entry “2” is selected, the preset infusion parameters for Abelcet 2 mg/mL is chosen. 4. You are next prompted to load a syringe, then confirm & accept each level of settings by pressing Enter. Some data fields may require data input prior to proceeding (e.g. Patient Weight). WARNING: Confirm All Settings. Before starting any delivery, always confirm the accuracy of all infusion values to the original order. Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery, which can result in serious injury or death. 5. When all settings are confirmed, the Begin Infusion screen is displayed. Use the Prime feature, then press É to begin the infusion. 16

PRESS THE NUMBER TO SELECT THE PROFILE

1 ANESTHESIA 2 NICU 3 PICU 4 GENERAL PEDS

5 CARDIAC 6 HEM/ONC 7 TICU 8 ED MORE

PRESS THE NUMBER TO SELECT

GENERAL PEDS 5 GEN PEDS Q - Z 6 Blood Products 7 Enteral FEEDS

1 GEN PEDS A - D 2 GEN PEDS E - I 3 GEN PEDS J - M 4 GEN PEDS N - P

CHG PROFILE 1/8

MORE

PRESS NUMBER TO SELECT

1 3% Saline mL/kg/time 2 Abelcet 2 mg/mL 3 Acyclovir (Zovirax)(kg dosing) 4 Ambisome 2 mg/mL PAGE

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