Medfusion Model 3500 Operations Manual sw ver 6

Medfusion® Model 3500 pump V6 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 Pump Model 3500 Version 6 (Medfusion® Model 3500 pump V6), please call the appropriate number given below. When calling, please specify the pump’s software version. This information is located on the start-up screen. Our staff at Smiths Medical in the USA is available to help clinicians 24 hours a day with the programming and operation of the Medfusion® Model 3500 pump V6. 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 3500 pump V6 Operator’s Manual

Table of Contents Important Safety Information

1

Introduction

5

About the pump

7

Warnings... 1 Cautions... 3 Symbols... 4 Indications for use... 5 Contraindications... 6 Features and Controls... 7 Keypad closeup... 8

Pump Customization and General Programming

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Custom Configuration... 10 General Programming... 12 Exceeding limits... 12 How pump settings and limits are prioritized... 12 User defined pump Configurations... 13 What are Configurations?... 13 When are Drug Programs used?... 13 Who can use these Drug Programs?... 13 Types of programmable Library Categories... 13 Using a Custom Configuration... 14 Using Quick Libraries... 15 PharmGuard® Safety Software: Dose Protocol Protection... 17 Soft limits... 17 Hard limits... 17 Adjusted limits in reverse... 18 Overridden limits in reverse... 18 Invalid infusion parameter combination... 18 PharmGuard® Supported Syringes (PSS) Series 2... 19 Navigating the pump menus... 20 The Workflow Process... 20

Guidelines for enhanced pump performance 22 Always use the smallest syringe for volume of fluid being delivered... 22 Bolus Volume... 23 Use appropriate internal diameter tubing... 23

Programming an Infusion

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Turn the pump on... 24 Turning the pump off... 25 Selecting a Delivery Mode and Programming an infusion... 26 General Infusion Programming Procedure... 27 Selecting an Infusion... 28 Select a Profile (Custom Configuration)... 29 Select a Category... 30 Select a Drug Program... 30 Select a Delivery Mode (Medfusion® Standard Configuration)... 31 Loading a syringe and syringe model setup... 32 Unloading the syringe... 36 Programming Infusions... 37

Continuous mode: mL/hr... 37 Dose / Min and Dose / Hr... 38 Dose / Day... 40 Dose / Time... 42 Body weight/surface area infusion deliveries... 44 Volume / weight infusions... 46 Dose/kg/time (dose/m2/time)... 48 Volume / weight / time... 50 Volume / time... 52 Intermittent volume / time ... 53 Recall last settings... 55 Priming the system... 57

Options

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Infusion Delivery

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Bolus dosing... 60 Bolus programming... 60 Bolus delivery... 62 Continuing an interrupted bolus dose... 63 Bolus dose rate reduction... 64 Loading doses... 66 Set up loading dose... 66 Delivering a loading dose... 68 Continuing an interrupted loading dose... 69 Loading dose rate reduction... 70 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™ pressure monitoring... 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 Time to occlusion... 92 Occlusion trend graph during delivery... 92 FlowSentry™ pressure monitoring (rapid occlusion detection)... 92 Post occlusion bolus reduction ... 93 Making changes during delivery... 94 Changing delivery rate... 94

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Medfusion® Model 3500 pump V6 Operator’s Manual 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

Battery and AC power operation

110

Poleclamp use

112

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 On screen display of internal battery power level gauge... 111 Battery guidelines ... 111 Rotating/detachable poleclamp (standard)... 112 Assembling the rotating/detachable poleclamp... 113 EMC information for the Medfusion® Model 3500 pump V6... 114 Use of cables... 114 Stacked equipment... 114

Technical specifications & other information 115 Pump development standards... 115 Medical Electrical Equipment Safety... 115 Electromagnetic Compatibility... 115 Miscellaneous Standards... 116 Compliance using:... 118 Technical specifications... 122 Specifications... 122

Safety Features

126

Safety Features and Fault Detection... 126 Hardware Safety Features... 126 Software Safety Features... 126 Hardware-related Software Safety Features... 126 Program Memory - Check FLASH memory POST or BGND... 126 RAM Memory Check - RAM BGND ... 126 Motor Circuit Check - pump motor phase A or B POST and Motor rate error during operation... 126 Keyboard Encoder Check - Control key POST or BGND ... 126 Data Handling Software Safety Features... 126 iv

Data Stored in EEPROM - Critical data POST or EEPROM timeout or Primary/Secondary critical data corrupted... 126 Data Used in Calculations - Critical data failure... 126 Timer Data Registers - Time base BGND, time of day clock POST, time of day clock timeout... 127

Additional Technical Information

128

Limited Warranty Index

144 145

Medfusion® Standard Syringes... 128 PharmGuard® Supported Syringes (PSS) Series 2... 128 Flow rate & minimum volume by manufacturer & size - Standard syringes... 129 Concentration and dosing units ... 131 PharmGuard® software limits... 131 Configuration options... 132 General Options... 132 Auto Prompt Options... 134 Program Options... 135 Device Setup Features... 136 Flow Delivery Graphs... 136 Start-up curves over stabilization period... 137 Trumpet curves over T2 period... 137 Magnetic Resonance Imaging (MRI) Information... 138 MRI Related Testing... 138 Image Distortion... 138 Cleaning and care... 139 Maintenance & service... 140 Periodic maintenance... 140 Using Smiths Medical USA service assistance... 141 Returning a pump to the USA for repair... 142 Collect Separately... 143

Medfusion® Model 3500 pump V6 Operator’s Manual

Important Safety Information WARNING: Read this entire manual before using the Medfusion® Model 3500 pump V6. 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.

Warnings •

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To avoid risk of explosion, never use the pump in the presence of flammable anesthetics, oxygenenriched 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/system is intended for use by healthcare professionals only. 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

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Warranty. Before using any Medfusion® Model 3500 pump V6, users must be thoroughly familiar with the contents of the 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. 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. 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 must be positioned in an MR environment such that it is secured to a nonmoveable object and the magnetic fringe field does not exceed 150 gauss. Exposing the Medfusion® Model 3500 pump V6 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 Series 2 (supplied with PharmGuard® Toolbox 2, Version 3, and included in the Medfusion® Standard Configuration), or the models and sizes available as part of the PharmGuard® Supported Syringes 1

Medfusion® Model 3500 pump V6 Operator’s Manual

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(PSS) Series 2, and always confirm that the syringe model and size displayed on the pump matches the model and size loaded onto 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 the amount 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 in inappropriate delivery rate. NEVER prime any syringe while connected to a patient infusion site, as this may cause overinfusion. 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

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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 than 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 and send it to a trained biomedical technician for service. 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® Model 3500 pump V6 creates a medical device system. Therefore, the user is responsible for compliance with IEC 60601-1 standards (see Technical Specifications section for DC power requirements). 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

Medfusion® Model 3500 pump V6 Operator’s Manual

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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. 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. 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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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

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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 any other position (including vertical), 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) before 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. DO NOT USE cleaning solutions containing: acetone, ammonia, ammonium chloride (including Hyamine 1622), aromatic solvents (such as paint thinner, toluene, methylbenzene), chlorinated solvents (such as methyl ethyl ketone (MEK), trichloroethane), ether (such as ethylene glycol monobutyl ether, diethylene glycol butyl ether) or oxidizing acids (such as phosphoric acid, sulfuric acid or accelerated hydrogen peroxide). Use of the solutions or solvents listed as DO NOT USE could damage plastic parts and cause premature failure or device malfunction. Use only the recommended cleaning/disinfecting agents and method. Use of cleaning/disinfecting agents and method other than those listed may cause damage to the pump and will void the warranty. 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. 3

Medfusion® Model 3500 pump V6 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.

f Caution 7 <

> 8 J H

nol

6

Do not reuse Catalog number Serial number Use by Date of manufacture Manufacturer Not made with natural rubber latex CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Temperature limitation

P _ Humidity limitation i Atmospheric pressure limitation J

Z K

Ö

Ñ

4

Type CF equipment (protection from electric shock) Collect Separately 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. UL Mark for Canada and the United States. Indicates the product was manufactured in accordance with the requirements of UL (Underwriter’s Laboratory). 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

V~ IPX3

î

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 Non-ionizing radiation

 Pins of connectors and other areas with this ESD Warning symbol Ü identified should not be touched. Connections should MR (Magnetic Resonance) Conditional

only be made when ESD precautionary measures are used.

For an explanation of the symbols that appear on the pump keypad, see “Keypad Closeup” and the tables that follow (page 8).

Medfusion® Model 3500 pump V6 Operator’s Manual

Introduction

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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.

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The Medfusion® Model 3500 pump V6 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 on 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 3500 pump V6 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, Version 3 software (PharmGuard® Toolbox 2), 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 13 for discussion about libraries). The Medfusion® Model 3500 pump V6 imports and exports data to assist in history data management. The pump communicates via the IR port on the rear of the pump. Pump Configurations and firmware can be updated, and infusion settings and events history downloaded in combination with the PharmGuard® Toolbox 2 software application. The pump also has the FlowSentry™ pressure monitor (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.

Indications for use The Medfusion® Model 3500 pump V6 is indicated

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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 surface area, 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: • This equipment/system is intended for use by healthcare professionals only. • Before using any Medfusion® Model 3500 pump V6, users must be thoroughly familiar with the contents of the 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. • 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 nonmoveable object and the magnetic fringe field does not exceed 150 gauss. Exposing the Medfusion® Model 3500 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.

for the following uses:

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Medfusion® Model 3500 pump V6 Operator’s Manual 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 Series 2 (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 19), 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.

Medfusion® Model 3500 pump V6 Operator’s Manual

About the pump Features and Controls Following are several illustrations showing the various controls, connectors and features of the Medfusion® Model 3500 pump V6.

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PRIME / BOLUS

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2

3 4 5 6

Display: 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. 8 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. 9 Keypad: See Keypad closeup (page 8) for identification of the individual keypad keys and what they are used for. 10 AC Power Connection Port: Plug the AC power cord into connection port to allow pump to operate on AC (mains) power. 7

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Medfusion® Model 3500 pump V6 Operator’s Manual

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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 Infrared RS232 Connection Port: Align RS232 converter box with port to allow upload of data from and download of data to a pump from a PC.

Keypad closeup

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Medfusion® Model 3500 pump V6 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 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. When the pump is off or stopped, the Infusing indicator is not lit.

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Medfusion® Model 3500 pump V6 Operator’s Manual

Pump Customization and General Programming Custom Configuration Generally speaking, pump customization is performed before a pump is used on a patient (see the diagram on page 11). Customization is accomplished using PharmGuard® Toolbox 2. Once the custom Configuration is created and validated, PharmGuard® Toolbox 2 is used to send it to the pump. 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 3500 pump V6 Operator’s Manual ®

Medfusion Model 3500 Pump V6 “Medfusion® Standard Configuration” includes manual delivery modes, some options and a variety of syringes. No Drug Programs are available in the Standard Configuration

PharmGuard® Toolbox 2 Create a custom Configuration (settings and Drug Programs), validate Configuration, then send to pump using PharmGuard® Toolbox 2 (see the product literature supplied with the product for more information)

®

Medfusion Model 3500 Pump V6 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 3500 pump V6 Operator’s Manual

General Programming The Medfusion® Model 3500 pump V6 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 17 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, a prompt to enter an ID or a passcode is displayed 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. •

Hard Limits – Values that cannot be exceeded under any conditions. Hard limits show up as Max and Min on the pump. If an attempt is made 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

12

CLEAR

BACKSPACE

ENTER

The pump then prompts entry of a new value. •

Soft Limits - The normal range. Soft Limits show up as Low and High on the pump. They are the normal upper and lower limits. A value above or below the Low or High limit can be entered (so long as it does not exceed the Min or Max). If the soft limits are exceeded, the pump prompts 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, a prompt to enter an ID is displayed. “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 3500 pump V6 Operator’s Manual

User defined pump Configurations

Types of programmable Library Categories

This chapter describes the Medfusion® Model 3500 pump V6 Configuration.

There are two types of library categories in the Medfusion® Model 3500 pump V6:

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 the use of 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 stepping through and reviewing 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 entry of 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, 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 3500 pump V6 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. 13

Medfusion® Model 3500 pump V6 Operator’s Manual

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

a custom Configuration and send it to the pump for use. If profiles are created in the Configuration, the pump displays the Profile Menu. If the desired profile isn’t displayed on the first screen press More for additional selections. 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 30 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. 14

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

PREV

NEXT

Medfusion® Model 3500 pump V6 Operator’s Manual

Using Quick Libraries Smiths Medical ships the infusion pump with the Medfusion® Standard Configuration that does not include a Quick Library. The profiles, categories and custom drug programs available on a pump depend on the configuration set up by the person responsible for custom configuration. Quick Libraries is an option that can be set-up in custom configuration. This option designates a category in a profile as a Quick Library. A profile with Quick Library enabled displays a list of custom drug programs. PRESS NUMBER TO SELECT

1/1

1 Propofol 10 mg/mL 2 Vecuroniom 1 mg/mL (OR) 3 DOBUTamine 200 mcg/mL (OR) 4 DOPAmine 1600 mcg/mL (OR) MAIN MENU

Rather than the CHG Profile key displayed on standard library category screens, the Quick Library will have Main Menu on the far left. When Main Menu is pressed, another selection screen is displayed, with the additional categories and delivery modes for the selected profile. PRESS THE NUMBER TO SELECT 1 Anesthesia A-D 2 Anesthesia E-I 3 Anesthesia J-M 4 Anesthesia N-P QUICK LIBRARY

(If there is only one profile on the pump, and a Quick library is enabled, the drug programs in the designated Quick Library will display on screen after the pump is turned on and completes its self tests.) The drug programs in a Quick Library have been customized with default values for infusion parameters that may include: syringe model and size, dose, volume, weight, delivery time, etc. Setting default values in the custom program allows the user to proceed from the drug program selection screen to the final confirmation screen (provided the loaded syringe matches the default syringe in the drug program). The Quick Library program’s preset values are loaded automatically into the pump provided that you have loaded a syringe of the manufacturer and size programmed for this library entry. Press É to begin the preset infusion after verifying infusion settings and using the Prime feature. Some data fields may be blank and require data entry to proceed.

ANESTHESIA

5 Anesthesia Q-Z

CHG PROFILE

MORE

The softkey on the far left of this screen reflects the name of the Quick library (the above is an example only). Press this key to re-enter the Quick library. The Quick library is exited when Main Menu is pressed. The CHG Profile key responds the same here as with all others.

15

Medfusion® Model 3500 pump V6 Operator’s Manual 1. To use Quick Library programs from the Select screen, use the number keys to select a drug program. For example: if “1” at right is selected, the pump loads the stored settings for Propofol 10 mg/ml infusion and pauses at the Begin Infusion screen. 2. All the infusion settings display on the Begin Infusion screen. You have the option to change the default settings for weight and dose using the softkeys displayed. All settings should be confirmed to ensure they are correct. Always check the infusion settings’ accuracy. You are responsible for ensuring the safety of any infusion the pump is programmed to deliver. 3. Use the Prime feature, then press É to begin the infusion.

16

1/1

PRESS NUMBER TO SELECT

1 Propofol 10 mg/mL 2 Vecuroniom 1 mg/mL (OR) 3 DOBUTamine 200 mcg/mL (OR) 4 DOPAmine 1600 mcg/mL (OR) MAIN MENU

Propofol 10 mg/mL

CONC 10 mg/mL TVD WEIGHT 75 KG LOAD 2000 MCG/KG DOSE 75 MCG/KG/MIN CHG DOSE QUICK LIBRARY

ANESTHESIA 0 mL RATE OPTIONS

33.8 mL/hr CHG WEIGHT