Model 3500 Operations Manual Rev 5

Medfusion 3500

MEDEX

Table of Contents 1.

IMPORTANT NOTICES...1

2.

INTRODUCTION...2

3.

INTENDED USE, FEATURES & CONTROLS...3 Correct Use of This Pump ... 3 Features & Controls... 4 Keypad & Functions... 5 Using Front Panel Control Buttons ... 5 Understanding Front Panel Indicators ... 6 What Indicators Mean ... 6

4.

TECHNICAL SPECIFICATIONS & DEFINITIONS...7 Technical Definitions ... 8 Syringe Manufacturers & Standard Sizes... 9 Trademark Information ... 9

5.

OPERATION WARNINGS & CAUTIONS... 10 Warnings... 10 Cautions... 12

6.

ALARMS & REMEDIES... 13 Alarms / Alerts ... 13 “Neglected Pump” Alarm... 13 “Syringe Near Empty” Alarm During Delivery ... 13 “Syringe Empty” Alarm During Delivery ... 14 “Syringe Empty − Manual” Alarm During Delivery... 14 General System Alarms & Alerts ... 14

7.

GUIDELINES FOR ENHANCED PUMP PERFORMANCE ... 17 Always Use Smallest Syringe for Volume of Fluid Being Delivered ... 17 Use Small Internal Diameter Tubing... 17

8.

SETUP & LOAD SYRINGES ... 18 Turning on the Pump ... 18 What if the Pump Does Not Turn On? ... 18 Selecting Delivery Mode ... 19 Syringe Manufacturer/Type Setup... 19 What if Only One Syringe Manufacturer is Setup?... 19 Loading the Syringe onto the Pump ... 20 Priming the System... 21 Unloading the Syringe ... 22

9.

STARTING & STOPPING INFUSION DELIVERY... 23 Start Delivery from Pause... 23 Starting Delivery from Standby... 23 Making Changes During Delivery... 24 Stopping Delivery... 24 Turning Off the Pump ... 24

10.

PROGRAMMING DELIVERY MODES ... 25 Overview of Programming Steps ... 25

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Apparently Missing or Different Steps ... 25 A Repeated Warning ... 25 Continuous Mode: ML/HR ... 26 Mass Modes... 27 Body Weight Infusion Deliveries ... 28 Volume / Time – ML/HR ... 28 Intermittent Volume / Time... 30 Recall Last Settings ... 31 Custom Dilution ... 32 Types of Custom Dilution Available... 32 Calculating Dilutions... 32 11.

BOLUS DOSING... 35 Setup Bolus Dosing ... 35 Delivering a Bolus Dose... 36

12.

LOADING DOSES... 38 Setting a Loading Dose ... 38 Delivering a Loading Dose... 39

13.

VOLUME LIMIT... 40 Setting Volume Limit ... 40

14.

KEEP VEIN OPEN (KVO) RATE... 42 Programming KVO Rate ... 42 Delivery at KVO Rate ... 43

15.

STANDBY... 44 Programming Standby ... 44

16.

DELAYED START ... 45 Programming Delayed Start ... 45

17.

OVERRIDE AND TOGGLE FEATURES IN THE INFUSION PROGRAM OPTIONS... 46

18.

DELIVERY ... 47 Starting Delivery ... 47 Stopping Delivery... 47 Occlusion Trend Graph During Delivery ... 47 FlowSentry (Rapid Occlusion Detection)... 48 Post Occlusion Bolus Reduction ... 49 Time to Occlusion ... 49 Flow Delivery Graphs ... 50 Flow Delivery Graphs ... 51

19.

CHANGING DELIVERY RATE... 52 Titrate Rate During Delivery ... 52 Changing Rate During Delivery ... 53 Changing Rate When Paused ... 53

20.

TOTAL VOLUME, PROGRAM VOLUME / DOSE DELIVERED ... 54 Displaying Program Volume Delivered / Program Dose Delivered... 54 Clearing Total Volume, Program Volume, or Program Dose Delivered Display ... 55

21.

KEYPAD LOCK ... 56

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USER DEFINED LIBRARIES ... 57 What Are Libraries? ... 57 For What Are Libraries and Templates Used? ... 57 Who Can Use These Libraries of Templates?... 57 Types of Programmable Libraries ... 57 Library and Template Warnings & Cautions ... 58 Using “Standard” Libraries ... 58 How to Tell Whether E-Plates Are Enabled For Use ... 59 E-Plates is Disabled... 59 E-Plates Is Enabled... 59 Using E-Plates ... 59 Enabling E-Plates & Standard Libraries... 60 Creating Library Templates... 60 Saving a New Template to a Library... 61 Template Naming Conventions... 62 Libraries Must Be Enabled to Use ... 62 Transferring Libraries from Pump to Pump ... 63

23.

BATTERY, AC & EXTERNAL DC POWER OPERATION ... 64 Onscreen Display of Internal Battery Power Level Gauge ... 64 Battery guidelines... 64 External DC Power Option... 65

24.

CLEANING AND CARE... 66

25.

MAINTENANCE & SERVICE... 67 Periodic Maintenance ... 67 Using Medex Service Assistance ... 68 Returning a Medfusion 3500 Pump for Repair ... 68 Medex Limited Warranty ... 69

26.

APPENDIX 1: SYRINGE FLOW RATE BY MANUFACTURER & SIZE... 70

27.

APPENDIX 2: FLOW DELIVERY CALCULATIONS... 71 Mass modes ... 71 Body Weight modes ... 71 Volume / Time & Intermittent modes ... 72 Custom Dilution Algorithm... 72 The Results from the Dilution Calculation... 72 How the Calculation is Performed ... 73 Goal of This Dilution Calculation ... 73

28.

APPENDIX 3: SERIAL COMMUNICATIONS... 74 Serial Conversion Box... 74 Medex Cloning Block... 74

29.

APPENDIX 4: POLE CLAMP ASSEMBLY & USE... 75 3000 Series Pump Rotating/Detachable Pole Clamp (standard) ... 75 Assembling the 3000 Series Pump Rotating/Detachable Pole Clamp... 75 3000 Series Pump Stationary Pole Clamp ... 76 Assembling the 3000 Series Pump Stationary Pole Clamp ... 77

30.

APPENDIX 5: MRI ROOM USAGE ... 78 MRI Room Usage for the Medfusion 3500 ... 78

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Proper Placement of Pump ... 78 Pulse Sequences for MRI when using the Medfusion 3500 ... 78

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MEDEX

1. IMPORTANT NOTICES The notices in the table below contain important information you need to know and understand before beginning to use the Medfusion 3500 pump. All users of this pump are responsible for knowing this information.

!

Before using any Medfusion 3500, you the operator must be thoroughly familiar with the contents of the operations manual, including all warnings, cautions, and instructions for use. If you use this pump, you are responsible for knowing these things.

Warning!

This syringe infusion pump is intended for use only under direction of trained medical professionals.

Caution

United States Federal law restricts this device to sale by or on the order of a physician.

Usability

This manual and its contents are valid for use with all software versions starting with 3.0.x; for example, 3.0.0, 3.0.1, etc.

© 1998 − 2004 by Medex Inc. All Rights Reserved. Manufacturer: Medex Inc., Carlsbad, CA, USA Tel: 800-848-1757 Authorized EU representative: Medex Medical Ltd., St. Crispin Way, Haslingden Rossendale, Lancashire, BB4 4PW Great Britain Tel: +44 (0) 1706-233826

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2. INTRODUCTION The Medfusion 3500 syringe infusion pump is designed for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. Because of the pump’s simplicity and ease of use, this pump can also be used successfully in the non-critical areas of a clinical setting. The only people authorized to setup & monitor any infusion are nurses, physicians, or other health-care professionals with training in infusion therapy and operation of the syringe pump. The Medfusion 3500 syringe pump is indicated for use with the following delivery routes: • Arterial • Spinal • Epidural • Subcutaneous • Enteral • Intravenous The Medfusion 3500 syringe pump is indicated for delivering the following fluids: • Intravenous solutions • Drug solutions • Blood or blood products • Enteral feedings The Medfusion 3500 syringe pump is indicated for use with the following delivery modes • Continuous • Body weight • Volume / Time • Custom dilution • Mass • Intermittent Volume / Time

WARNING! Pump Usage

Medex Operation Manual

This syringe infusion pump is intended for use only under direction of trained medical professionals. Before using any Medfusion 3500, you must be thoroughly familiar with this manual, including all Warnings, Cautions, and instructions for use.

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MEDEX

3. INTENDED USE, FEATURES & CONTROLS This chapter defines basic use parameters, features, and control options of the Medfusion 3500 infusion pump.

Correct Use of This Pump The correct use of the Medfusion 3500 infusion pump should be based on the following principles: 1. This syringe pump is intended for intravenous, subcutaneous, epidural, enteral, spinal, and arterial infusions of critical medications or fluids requiring precisely controlled infusion rates. 2. Use only syringe manufacturers and sizes listed in the technical specifications of this manual. 3. Ensure all medications or fluids are compatible with the syringe, catheters, tubing, and fittings used in the infusion setup. 4. Always ensure fluids are compatible with each other when infusing more than one fluid or medication through the same infusion site. If connecting more than one pump to the same infusion site, use one-way check valves to prevent pumps from interfering with each other. Verify that the pumps will operate together without alarming.

Warning!

Failure to strictly adhere to these principles of use can cause over infusion or under infusion, with possibility of serious injury or death.

Warning!

Do not use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than –100mm Hg as the high negative pressures can result in uncontrolled fluid flow.

ECMO use

Warning! Check Magnetic Fields Above 150 Gauss

Medex Operation Manual

Never use the pump in magnetic fields above 150 gauss. Always secure the pump to a non-moveable object. In magnetic fields above 150 gauss, the attraction of the pump to the magnet may be a hazard. This pump may be operated in static magnetic fields up to 150 gauss for specific MRI devices identified in Appendix 5.

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Medfusion 3500

MEDEX Features & Controls

Below is an illustration of the pump in a front view, with callouts identifying major elements:

A

B

D

C

E

G

F

H

A − Handle

B − Tubing Holders

C − Display

D − Syringe Barrel Clamp

E − Syringe Plunger Holders

F − Syringe Plunger Release Lever

G − Syringe Barrel Flange Clip

H − Syringe Plunger Driver

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MEDEX Keypad & Functions

Below is an illustration of the front panel of the Medfusion 3500, with tables below identifying functions and effects: Control Button

When Pump is Paused

When Pump is Delivering

Power

Push and hold to turn OFF pump.

Push & release, then push & hold to turn OFF.

Start

Starts delivery.

N/A

Stop

N/A

Stops delivery.

Bolus

Begins priming after confirmation.

Begins programmed bolus after confirmation.

 – Alarm Silence

Silences audible alarm. Allows operator to switch the backlight from bright to dim, or dim to bright

Silences audible alarm. Allows operator to switch the backlight from bright to dim, or dim to bright

N/A

Indicates pump controls are locked.

Set number values or selects options.

Set number values or selects option.

Reverts to previous step or level.

Reverts to previous level or step if adjusting settings.

Function defined on screen.

Function defined on screen.

±– Lock Numerals & Decimal Back “Menu Buttons 1-4”

Using Front Panel Control Buttons Below is a table of the Medfusion 3500 front panel buttons and their assigned functions: Button

Function Push and hold to turn the pump ON. Push and hold to turn the pump OFF.

Power

Pressing the power button while the pump is infusing results in a message asking you to press the power button a second time to turn OFF power.

Start

Starts an infusion after settings are made. Press this button to start infusing after all infusion parameters have been set & reviewed.

Stop

Stops an infusion. All delivery (including Keep-Vein-Open) pauses. Starts bolus infusion or primes the pump.

Bolus

• •

Press Bolus button when the pump is paused to call up the PRIMING screen, then press and hold this button to prime. Press Bolus button when the pump is infusing to call up the BOLUS CONFIRM screen, and then press the menu button to confirm the bolus dose and start the bolus delivery.

Alarm Silence 

Silences an alarm for a programmed delay period. The usual is 2 minutes. Any new alarms occurring within the delay period sound immediately. When the delay period expires, any audible portion of the highest priority alarm still present will sound.

Back

Pressing this button exits the current data entry operation and reverts to previous operation screen.

Menu Buttons

The four buttons directly below the display are software-defined buttons, with assigned function varying from screen to screen. The bottom line of the display defines the function for these buttons.

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MEDEX Understanding Front Panel Indicators Below is a table of function indicators and their effects while using the pump. Indicator

Pump Off

Pump Paused

Pump Delivering

ON when AC powered.

ON when AC powered.

ON when charging.

ON when charging.

Flashing when battery in use.

Flashing when battery in use.

− AC Line Indicator

ON when AC powered.

– Battery Indicator

ON when charging.

– Lock Indicator

OFF

OFF

ON when keypad is locked.

− Infusing Indicator

OFF

OFF

Flashing from right to left.

What Indicators Mean Below is a table of front panel indicators and what each of them means: Indicator

What it means

− Alarm Indicators

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.

- AC Line Indicator

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.

– Battery Indicator

The BATTERY indicator (green) blinks ON&OFF whenever the pump is operating on internal battery power, and remains ON when battery is charging. The LOCK indicator (±) tells you the pump has been locked into its current operational mode.

– Lock Indicator

− Infusing Indicator

Medex Operation Manual

While this indicator is lighted, the keypad is locked and no changes can be made to settings. Attempting to stop or change an infusion while locked will result in an alarm and an advisory message. The Infusing indicators are 3 green lights, which illuminate in sequence right to left when the pump is infusing. During intermittent delivery mode, a single Infusing indicator lights during the time between infusions.

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Medfusion 3500

MEDEX

4. TECHNICAL SPECIFICATIONS & DEFINITIONS Below are the technical specifications of the Medfusion 3500 infusion pumps: Category

Specification

Dimensions (pump only)

10.5” wide x 5.1” high x 5.5” deep (27 cm x 13 cm x 14 cm)

Weight (pump only)

3.8 lbs. (1.7 kg)

Accuracy

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

Flow Rate Range (depends on syringe size)

0.01 ml/hr to 1130 ml/hr 3500

Delivery modes (user customized)

ml/hr Volume / Time Mass

Delivery options (user customized)

AC power source

Body Weight Custom Dilution Intermittent Volume / Time KVO Rate Delayed Start Standby Override Alarm Volume Volume Limit Override Occlusion Limit Toggle PVD/PVD Bolus Dose Save to Library Toggle Empty Tone Loading Dose Toggle Near Empty Tone Toggle Rapid Occlusion Detection 100-240 VAC, 50/60 Hz, 30VA Safety Class II – Type CF

External DC power source (Optional)

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

Internal Battery Capacity (at 25°C)

Rechargeable. 10 hours at 5.0 ml/hr with 60 ml syringe − (from fully charged battery)

User-defined Delivery Libraries

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

Normal Operating Conditions

Temperature:

5° to 40° C (40° to 104° F)

Relative Humidity:

15 to 95% non-condensing

Ambient Pressure:

70 kPa to 106 kPa (10.2 psia to 15.4 psia)

Infusion Back Pressure: -100 mmHg to 300 mmHg

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MEDEX Technical Definitions Below is a table of technical definitions as required per international standards: Term

Definition

Class II

Equipment in which protection against electrical 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.

Type CF

Equipment in which level of protection from electrical shock is defined by leakage current (C) exposure and insulation by isolated or floating (F) metal of pump enclosure relative to earth grounding. Under normal conditions, users are exposed to no more than 100 microamps – when measured though the pump, and patients to no more than 10 microamps – when measured through IV path.

Infusion Class 4

An infusion pump that combines the functions of continuous infusion flow, intermittent flow, and discrete bolus delivery.

Infusion Class 5

An infusion pump that functions as a profile pump, providing a programmed sequence of delivery rates.

IPX3

Equipment that is ingress protected from fluid spraying at vertical angle from above, and from angles to 60° on either side of vertical.

V~

Symbol for operating voltage range for alternating current (i.e. AC or mains) power source. Symbol for infrared serial communications port on pump. Symbol for external DC jack connection. Tip (negative sign) is for power ground and ring (positive sign) is for positive power connection. [See warning below.]

Warning! External Power must be IEC 601-1 Certified

Medex Operation Manual

Any external power source connected to the DC jack must be IEC 601-1 certified for medical equipment Type CF and meet Safety Class II. Connecting any external power source to the pump creates a medical system. Therefore, the user is responsible for compliance with IEC 601-1 standards. Refer all questions to the Medex Technical Service Department.

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MEDEX Syringe Manufacturers & Standard Sizes

Below is a table of syringe manufacturers for which the Medfusion/or 3500 has been designed, and the specific syringe sizes programmed into the pump database for use with the pump. Manufacturer

Syringe Sizes ®

Omnifix 5, 10, 20, and 50 ml Luer Lock

B. Braun

Perfusor® 20 and 50ml Luer Lock

Becton-Dickinson Luer Lok® Becton-Dickinson Glass

B-D 1ml Luer Lock, and 1ml Tuberculin 1, 2.5, 5 and 10 ml Luer Slip 3, 6, 12, 20, 35, and 60 ml Luer Lock

Monoject®

1ml Slip 3, 5, 10, 20, 30, and 60 ml Luer Lock

Terumo®

1ml Slip ®

AstraZeneca

Warning! Critical Volume

B-D 3, 5, 10, 20, 30, and 60 ml Luer Lock

50 ml pre-filled Diprivan® Luer Lock

The critical volume (for volume limit) which could be infused in the event of a single point positional failure in this infusion pump is 1/100th of the syringe fill volume. At any rate the critical volume (for rate) in this infusion pump is 1/400th of the syringe fill volume.

TRADEMARK INFORMATION Below is a table of registered trademarks and the manufacturers owning them: Trademark “Omnifix” and “Perfusor” “B-D”

Owner / Manufacturer B.Braun Medical AG Becton Dickinson and Co

“Monoject”

Sherwood Medical

“Diprivan”

AstraZeneca Pharmaceutical

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5. OPERATION WARNINGS & CAUTIONS This chapter contains vital information in the form of warnings and cautions that apply to operation of this infusion pump. As an operator of this pump, you are responsible for knowing and using this information.

Warnings Below is a table of warnings and conditions for operation of the Medfusion3500 infusion pump. Other warnings are posted throughout this manual. A Warning defines a potentially serious life-safety hazard, specific limitations for using this device imposed by the hazard, and the steps for avoiding the hazard. Operational Warnings Avoid Air Emboli Flammables

Always purge all air from syringe and infusion lines before connecting to the patient. Air infused into a patient may cause serious injury and/or death. Never use pump in presence of flammable anesthetics, oxygen-enriched atmospheres, or explosive gases.

Manufacturer Guidelines

Always read manufacturer precautions and guidelines for medications or fluids infused 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 and/or death to the patient.

Priming New Syringes

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.

Don’t Prime the Patient

Never operate the Prime function while pump is connected to the patient infusion site. Using the pump in the Prime function may cause over-infusion, with possible serious injury or death to patient.

Confirm All Settings

Before starting ANY delivery, ALWAYS confirm correctness of ALL infusion values you just set.

Syringe Matching

Only use syringe sizes and manufacturers listed in this manual. Use of other syringe manufacturers or sizes may possibly cause an under-infusion or over-infusion to the patient that could result in serious injury and/or death.

Verify Syringe Make & Size

Always confirm syringe manufacturer and syringe size displayed on the pump match the manufacturer and syringe size loaded into the pump. Mismatching syringe make or size may possibly cause an under-infusion or over-infusion to the patient that could result in serious injury and/or death.

Check Magnetic Fields Above 150 Gauss

Never use the pump in magnetic fields above 150 gauss. Always secure the pump to a nonmovable object. In magnetic fields above 150 gauss, the attraction of the pump to the magnet may be a hazard. This pump may be operated in static magnetic fields up to 150 gauss for specific MRI devices identified in Appendix 5.

Vertical Displacement

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.

Select right syringe size

Use the smallest syringe size to deliver the fluid or medication. Running a large syringe at very low rates may cause under-delivery, e.g. a long time to occlusion alarm. See the section on guidelines for enhanced performance and review startup curves and time to occlusion information when selecting a syringe.

Trained Users

Only use this pump under direction of trained medical professionals. Before using this pump, you must become thoroughly familiar with this manual, including warnings, cautions, and instructions for use.

Turn Off Fluid Flow When Loading a Syringe

Always turn OFF fluid flow to patient in tubing via clamp or stopcock before loading or unloading syringe onto the pump. Uncontrolled fluid flow can occur when fluid set is not clamped or turned off, and may cause serious injury and/or death.

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Medfusion 3500

MEDEX Secure the Syringe

Always be sure to secure the syringe barrel, flange and plunger, with tubing threaded through holding clamp. Failure to properly secure the syringe and tubing can result in uncontrolled fluid flow into a patient, which can result in serious injury and/or death.

ECMO Use

Do Not use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than –100 mm Hg as the high negative pressures can result in uncontrolled fluid flow.

Horizontal Operation Only

Always operate this pump in horizontal position to prevent fluid leakage into the pump. If you suspect fluid has leaked into it, remove pump from service until a trained biomedical technician can test it.

External DC Power must be IEC 601-1 Certified

Any external power source used with this pump must be IEC 601-1 certified for medical equipment Type CF and meet safety class II. Connecting an external power source to the pump creates a medical system. The user is responsible for complying with IEC 601-1 standards. Refer all questions to Medex Technical Service Department.

AC Power

The only means of removing AC power is to disconnect the AC power cord. While the AC power cord is attached to the pump and plugged into an AC outlet, live main voltage is present inside the pump.

1ml Syringe Occlusion Pressure

When a 1ml syringe is entered into the programming the occlusion pressure setting is fixed at very high - 35psi

Service Warnings Pump Maintenance

Only trained biomedical service personnel may service this pump. Service personnel should disconnect the AC power cord before servicing the pump.

Manufacturer Recommended Maintenance

Always maintain this pump following manufacturer recommended instructions in the Service Manual. Improperly maintained pumps may cause either under-infusion or overinfusion to patient.

Never open pump case

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.

System Failure Alarm

Never use a pump when it has signaled a system failure alarm. Withdraw it from service and send it to a trained biomedical technician for service.

Dropped or Damaged Pumps

Medex Operation Manual

Never use a dropped or obviously damaged pump. Withdraw it from service until a trained biomedical service technician can test it.

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Medfusion 3500

MEDEX Cautions

Below is a table of Cautions and conditions related to operation of the Medfusion3500 infusion pump. Other cautions are posted throughout this manual. An operational Caution defines any special care you must exercise for safe & effective use of this device. Operational Cautions Who Can Buy This Pump

United States of America Federal law restricts this device to sale by or on the order of a physician.

Don’t Dunk the Pump

Never immerse the pump in water or other fluids. This pump is not waterproof.

Never Autoclave

NEVER sterilize the pump in a steam autoclave or gas sterilizer. Using autoclave or gas sterilization can seriously damage the pump and void the warranty.

Avoid Strong Solvents

Never use organic solvents to clean or disinfect the pump. Refer to the CLEAN & CARE section of this manual.

Use Correct Manuals

Always ensure the software version of the pump and operations manuals agree. Refer to this manual’s front page.

Avoid Sharp Objects

Never use sharp objects to depress control buttons on the pump. They may damage the pump by rendering buttons inoperable.

Check for Leaks

Always periodically check the fluid pathway and connections for leaks. As with any infusion system, leaks may cause patient or infusate fluid loss.

Correct Disposal

Follow your institution’s procedures and applicable laws regarding the proper disposal or recycling of device components.

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MEDEX

6. ALARMS & REMEDIES The Medfusion3500 infusion pump has numerous alarms built into it. These are triggered by situations, as a means of warning or advising you something is not functioning within normal parameters.

Alarms / Alerts Below is a table of the alarms and alerts generated by the pump, including definitions and remedies: Type

Definition and Remedy

High-priority

A high-priority alarm is initiated by either any condition that halts an ongoing infusion, or any pump system fault, which effect infusion. High-priority alarms are signaled with a flashing red indicator, a viewing screen backlight that oscillates between bright and dim, and an audible signal. Press the Alarm Silence button to return the viewing screen backlight to bright, and silence the audible alarm for the programmed alarm silence period. If the front panel controls are locked when a high-priority alarm occurs, the pump controls do unlock. A high-priority alarm that stops delivery during loading dose or bolus will not return to the pause screen until the alarm is silenced – allowing the user to record the bolus volume delivered

Medium-priority

A medium-priority alarm indicates any condition requiring operator intervention but does not halt infusion. Medium-priority alarms are signaled with a flashing yellow indicator, a viewing screen backlight that oscillates between bright and dim, and an audible signal. Pressing the Alarm Silence button will return the viewing screen backlight to bright, and silence the audible alarm for the programmed alarm silence period. If the front panel controls are locked when a medium-priority alarm occurs, the pump controls do not unlock. A low-priority alarm indicates any condition not requiring immediate operator intervention.

Low-priority

Low-priority alarms are announced with a continuous yellow indicator, a viewing screen backlight that oscillates between bright and dim and an audible signal – 2 Medex “Bing-Bongs”, or three international tones (on 1 sec – off 1 sec, on 1 sec – off 1 sec, on 1 sec – off) signal If the front panel controls are locked when a low-priority alarm occurs, the pump controls do not unlock. A limit-priority alarm sounds a tone and displays an advisory message onscreen for 3 seconds.

Limit Priority

If the front panel controls are locked when a low-priority alarm occurs, the pump controls do not unlock.

“Neglected Pump” Alarm The “Neglected Pump” alarm is a medium priority alert. It is simply reminding you to finish what you started. Once you begin programming any infusion delivery, the pump expects you to continue until setup is complete. If you “forget” and leave the pump paused too long (30 seconds) on a data entry screen, then the pump initiates a medium-priority “user callback” alarm. There are several basic resolutions: • Press the Alarm Silence button “” or ANY button to silence the alarm for another 30 seconds. •

Go to the BEGIN INFUSION screen. There the alarm silence interval is at least 2 minutes or longer − depending on custom configuration.

•

Press the Start button to begin the infusion.

•

You can cancel the infusion and return to the SELECT THE MODE screen, where no alarms sound.

•

You can press & hold the Power button and turn off the pump.

“Syringe Near Empty” Alarm During Delivery Medex Operation Manual

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MEDEX

The “Near Empty” alarm is a low-priority alarm during delivery telling you the syringe is “just about” empty. The pump sound the low priority alarm tone, displays the near empty alarm message appears on screen, and does not stop delivery.

1. 2. 3.

Press the Alarm Silence button “” to clear the alarm message. Confirm how long you have before the infusion ends. Then be prepared to load a new syringe onto the pump if necessary, and then start a new infusion.

Calculating Near Empty Status

Near empty status is calculated by checking the volume remaining in the syringe against the near empty alarm time setting divided by current delivery rate.

“Syringe Empty” Alarm During Delivery The SYRINGE EMPTY alarm is a high priority alarm advising the syringe is empty. 1. The EMPTY alarm stops delivery immediately. 2. Press the Alarm Silence button “” to clear the alarm tone & message. 3. Unload the syringe. 4. Either prepare and load another syringe, return to the SELECT THE MODE screen, where no alarms sound or turn off the pump. Calculating Empty Status

Empty status is determined by measuring plunger position of syringe against the set value for syringe size & manufacturer.

Caution Monoject 3ml

Because of variations in syringe manufacturing, the Monoject 3ml syringe may in some cases not fully empty. Here, the empty alarm sounds with some fluid left in the syringe.

“Syringe Empty − Manual” Alarm During Delivery It is possible to override a “syringe empty” alarm sounded during delivery. There will be times when the pump calculates the syringe is empty and yet there remains a residual volume of medication or fluid in the syringes. A common cause is variation in manufacturing of syringes. 1. Press the Alarm Silence button. The pump has stopped delivery and is at the BEGIN INFUSION screen. 2. If you do not wish to deliver this remaining fluid, then: a) Unload the syringe. b) Either prepare and load another syringe, return to the SELECT THE MODE screen, where no alarms sound or turn off the pump. 3. If you do wish to deliver the remaining fluid, then press the Start button. 4. The pump begins delivery, and continues until no fluid remains in the syringe. 5. As soon as the pump senses an occlusion, it halts delivery and displays the “Syringe Empty − Manual” message onscreen. 6. Press the Alarm Silence button. The pump has stopped delivery and is at the BEGIN INFUSION screen. 7. Either prepare and load another syringe, return to the Select the Mode screen, where no alarms sound or turn off the pump.

General System Alarms & Alerts This section contains a table of the general system alarms you may encounter while operating the Medfusion 3500 infusion pumps. This table identifies the alarm by message and type, and provides a definition and possible remedies. Medex Operation Manual

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Medfusion 3500

MEDEX Alarm Message

Priority

Remedy

Battery Communication Timeout

Low

The internal battery is not working. The pump may be used on AC power on a conditional basis. As soon as possible, remove pump from service for repair by a trained biomedical service technician.

Battery Not Charging

Low

The internal battery is not charging. The pump may be used on AC power on a conditional basis. As soon as possible, remove pump from service for repair by a trained biomedical service technician.

Battery Not Working

Medium

The internal battery is not working. The pump may be used on AC power on a conditional basis. As soon as possible, remove pump from service for repair by a trained biomedical service technician.

Calculated Rate Out of Range

High

The calculated rate is not valid. Verify that all infusion parameters have been entered correctly.

Check Clutch / Plunger Lever

High

The syringe is not loaded correctly. Check the plunger lever and ensure it is all the way up.

Check Syringe Flange Sensor

High

Sensor is active when syringe is not loaded. Check the syringe flange holder. Ensure the flange holder pulls back to the side of the case. If holder does not operate correctly, immediately remove the pump from service for repair.

Check Syringe Plunger Sensor

High

Sensor is active when syringe is not loaded. Check the syringe plunger holders. Ensure the holders move freely. If they do not operate correctly, immediately remove the pump from service for repair.

Completing System Initialization

Limit

Allow pump startup to complete self-testing.

Infusion Complete

High

Either begin a new infusion, return to the SELECT THE MODE screen, where no alarms sound or turn off the pump.

Low Battery (Each 1% drop in capacity following initial signal if power cord is not plugged in)

Limit

Plug in the power cord and run pump on AC mains while recharging the battery.

Low Battery (Initial Signal)

Medium

Plug in power cord and run pump on AC mains while recharging the battery

KVO in Progress

Medium

Advisory message that volume limit has been reached and KVO infusion is in progress.

Invalid Rate for Syringe Size

High

Advisory message in custom dilution program. Consult syringe flow delivery tables in appendix to determine appropriate syringe size.

Invalid Syringe Size

High

Syringe size not recognized for the manufacturer selected. Review syringe sizes in the technical specifications section.

Occlusion − Check Infusion Line

High

Check infusion line for blockage. Clear or remedy any discovered occlusion. Press the Start button to begin infusion.

Pressure Increasing − Check Infusion Line

Medium

Check infusion line for blockage. Clear or remedy any discovered occlusion.

Outside Range Limit

Medium

The entered rate is outside of the library limits. Press Alarm Silence button “” to continue. You may then chose to override the range limit or change the value entered.

Limit

Keypad has been locked to prevent changes during infusion. The alarm initiated by pressing any button except Power or Unlock. Press Unlock if you need to make changes to delivery settings. Or press Power button twice to end delivery.

Medium

If the bolus rate is high enough to trigger an occlusion alarm, the 3500 software will reduce the bolus rate until the bolus is successfully delivered. With each rate reduction, this process repeats. Once silenced, the audible alarm tone will not reactivate, even if the process repeats.

Pump is Locked

Restricted Flow – Bolus Rate Reduced

Medex Operation Manual

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