BioConsole 560 Operator and Reference Manual

2011/JAN/19 at 10:09 a.m. Doc number: M937416A001 Rev. 1.0 [Uni]

BIO-CONSOLE® 560Extracorporeal Blood Pumping Console

Operator and Reference Manual

Caution: Federal law (USA) restricts this device to sale by or on the orderof a physician.


Bio-Console® is a trademark of Medtronic, Inc.Bio-Probe® is a trademark of Medtronic, Inc.Bio-Pump® is a trademark of Medtronic, Inc.Medtronic® is a trademark of Medtronic, Inc.


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Explanation of Symbols on Product or PackagingRefer to the appropriate product to see symbols that apply. Handling and Using the Product

Do Not Subject to Impact or Rough Handling

Do Not Use if Package Damaged

Open Here

Pressure Port 1Pressure Port 2Dangerous Voltage

Caution, Consult Accompanying Documents

High Voltage

Do not dispose of this product in the unsorted municipal waste stream. Dispose of thisproduct according to local regulations. See http://recycling.medtronic.com forinstructions on proper disposal of this product.China RoHS Standard (SJ/T11364-2006) Electronic Information Products PollutionControl Symbol. The number represents the years the device can be used before it mustbe recycled (environmental protection use period).

Pneumatic Pressure Range

Warning, Crushing Hazard: Finger

Consult Instructions for Use


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General Product Information

Date of Manufacture

Manufacturer

Use By

Catalog Number

Lot Number

Serial Number

Quantity

Fuse

Alternating CurrentTemperature Limitation

Humidity Limitation

This Way Up

Fragile, Handle with Care

Atmospheric Limitation


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User Interface Screen Display Symbols

Stopwatch/Timer

Pressure Measurement

Large Patient

Pediatric Patient

Normal Patient

Screen Contrast

Settings Screen Button/Screen Exit Button

Mute Button

Lower Limit Setting

Upper Limit Setting

Loudspeaker

Battery Status

Activity Indicator

Play Timer

Reset Timer

Pause Timer

Zero Button

AC Power

Service Log

No AC Power


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Count Up

Count Down

Upper Level Sensor

Lower Level Sensor

Open Clamp

Closed Clamp

Bubble Detector

Bubble Detector, Status Error

Upper Level Sensor, Status Error

Lower Level Sensor, Status Error

AutoClamp, Status Error


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Agencies

Classified by Underwriters Laboratories, Inc. according to U.S. and Canadian safetystandards (UL60601-1 and CAN/CSA C22.2 No. 601.1).For US Audiences Only

Conformité Européenne (European Conformity). This symbol means that the device fullycomplies with European Council Directive 93/42/EEC.Type CF Applied Part


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Table of ContentsAbout This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1 Bio-Console 560 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2 General Description and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Base Unit Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Base Unit Display Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Base Unit Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Factory Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Electromagnetic Emissions and Immunity Declarations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Connecting the Bio-Console Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Turning On the Bio-Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26Setting Up the User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Checking Battery Charge Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

4 Case Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33System Status Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Alerts and Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Installing the Bio-Pump Centrifugal Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Attaching the Pressure Monitoring Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Zeroing the Pressure Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Setting the Pressure Alert Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Attaching Insert to Flow Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Priming the Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40Zeroing the Flow Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40Correcting a Negative Flow Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Setting the Flow Bar Graph Display Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Setting Low and High Flow Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Establishing the Target Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Timers Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46Adjusting Screen Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

5 On-Pump Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49Adjusting Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49Monitoring Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50Using Timers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Volume Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Alert and Alarm Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Service Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53


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Activity Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Monitoring Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53AC Power Status Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Battery Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Stopping Flow: Taking A Patient Off Cardiopulmonary Bypass . . . . . . . . . . . . . . . . . . . . . . . 55Removing the Bio-Pump Centrifugal Blood Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Data Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

6 Safety Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Level Sensing System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Bubble Detection System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66Bio-Pump Coast/Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71AutoClamp System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

7 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85Cleaning the Flow Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85Cleaning the Bio-Console and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85Servicing the Pump Motor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85Servicing the Bio-Console and AutoClamp Interface Module . . . . . . . . . . . . . . . . . . . . . . . . . 85Maintaining and Charging the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86Checking Battery Charge Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86Battery Service and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87Checking the Handcrank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87End of Life Disposition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

8 Emergency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89Blood Pump Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89Electrical Power Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90Bio-Console System Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90Emergency Use of the Handcrank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90Emergency Use of a Roller Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

9 Use of Base Unit Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95Using the Base Unit Display Instead of the User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

Appendix A Checklist and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99Quick Start Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99AC Power and External Motor Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100Bio-Pump Centrifugal Blood Pump Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101Flow Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101RPM Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102Battery Power Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103Digital Output Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103Safety Systems Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103Alert and Alarm Message Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104Appendix B Hydraulics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107Viscosity and Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107Determining the Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107


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Appendix C Battery Longevity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109Variable Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109Battery Life Estimates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109Appendix D Digital Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111Selecting the Appropriate Transmission Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111Selecting the Appropriate Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111RS 232 Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112Data Output Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115RS 232 Hardware Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124Appendix E Warranties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125Equipment Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125Equipment Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126Equipment Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127Equipment Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128Appendix F Preventative Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129Index


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Operator and Reference Manual English 1

About This ManualThis Operator's Manual is to be used with Bio-Console 560 User Interface software versionUI 2.U02. The software version can be found by pressing the Service Log button (wrench icon)found at the bottom right corner of the Main Screen.

Chapter 1 Bio-Console 560 OverviewDescribes the general use of the Model 560 Bio-Console, the components of a Bio-Consoleextracorporeal blood pumping system, and precautions and warnings.

Chapter 2 General Description and SpecificationsProvides a brief description of the Model 560 Bio-Console and lists product specifications.

Chapter 3 SetupIncludes one-time setup and general procedures for the Bio-Console, such as attaching the UserInterface, connecting the pump motor, attaching pressure and flow transducers, turning on theBase Unit, configuring the User Interface, and checking the backup battery status.

Chapter 4 Case PreparationProvides setup procedures and system information relevant to case preparation, such asinstalling a centrifugal blood pump, zeroing the pressure and flow transducers, setting pressureand flow alert limits, establishing target flow rate, and timers setup.

Chapter 5 On-Pump OperationIncludes procedures necessary for operating the Bio-Console, such as adjusting and monitoringflow rate, using the timers, handling alerts and alarms, and attaching an optional digital computerinterface.

Chapter 6 Safety SystemsIncludes overview, setup and operating instructions for the level sensing system, bubbledetection system, AutoClamp system and Bio-Pump coast/stop.

Chapter 7 MaintenanceDescribes procedures for cleaning and maintaining the Bio-Console and accessories.

Chapter 8 EmergencyDescribes alternative power sources to use if AC power fails or the pump motor stops functioning.

Chapter 9 Use of Base Unit DisplayDescribes use of the Base Unit display if the User Interface stops functioning.

Appendix A: Checklist and TroubleshootingProvides a brief list of the procedures that must be completed before using the Bio-Console. Italso includes a troubleshooting checklist describing situations that may occur and steps forresolution.


2 Operator and Reference Manual English

Appendix B: HydraulicsDescribes the relationship between the RPM, pressure, and flow for the centrifugal blood pump.

Appendix C: Battery LongevityDescribes how RPM, flow, blood temperature, and hematocrit affect the longevity of fully chargedbatteries.

Appendix D: Digital OutputDescribes the information that is sent to a data output device and describes the computercommands for changing the format for a data output device and for changing the transmissioninterval.

Appendix E: WarrantiesContains product warranties.

Appendix F: Preventative Maintenance LogTracks maintenance activities performed by a Medtronic service technician.


Bio-Console 560 Overview


Bio-Console 560 Overview 1The operator must read this manual before using the Bio-Console Extracorporeal Blood PumpingConsole Model 560, hereafter referred to as the Bio-Console.

DescriptionThe Bio-Console 560 Extracorporeal Blood Pumping Console is an EN 60601-1 Class Iequipment for continuous operation, Type CF Applied Part.The equipment is not suitable for use in the presence of a flammable anaesthetic mixture withair or with oxygen or nitrous oxide.The Medtronic blood pumping system consists of the following components:

■ Model 560 Bio-Console with a User Interface that can be mounted on the Base Unit or in aremote location

■ Model 540T pump motor

■ Bio-Pump disposable centrifugal pump for either adult patients (Model BPX-80, CBBPX-80,or BPX-80T) or pediatric patients (Model BP-50 or CBBP-50)

■ Bio-Probe blood flow monitoring transducer for either adult patients (Model TX-50) orpediatric patients (Model TX-50P)

■ Disposable flow monitoring insert for either adult patients (Model DP-38) or pediatric patients(Model DP-38P)

■ Handcrank, Model 150

■ A data transfer cable is available for digital output

■ Safety systems (optional). Refer to Chapter 6.

15003000

45000

Model 150Handcrank

540T Pump MotorBio-Console 560

Bio-Pump BPX-80 Bio-Probe TX-50 and DP-38

Figure 1. Components of the Bio-Console Blood Pumping System


Chapter 1


Indications for UseThe Medtronic centrifugal blood pumping system is intended to pump blood through theextracorporeal bypass circuit for extracorporeal support for periods appropriate tocardiopulmonary bypass procedures (up to 6 hours).

ContraindicationsThe Medtronic centrifugal blood pumping system is contraindicated as a cardiotomy suctiondevice.

Warnings and PrecautionsRead all Warnings, Precautions, and Instructions for Use carefully prior to use. Failure to readand follow all instructions, or failure to observe all stated warnings, could cause seriousinjury or death to the patient.

WarningsThe Bio-Console Extracorporeal Blood Pumping Console Model 560 is designed to be operatedonly with the Bio-Pump centrifugal pump. There are no safety or performance data that establishcompatibility of any other manufacturer’s device or components with the Medtronic system.Using the Bio-Pump centrifugal pump beyond the labeled recommendations may result in failureof the centrifugal pump, reduced pumping capacity, leaks, excessive blood trauma, ordegradation or corrosion of blood contact materials, which may pass through the blood to thepatient.Massive air entry into the pump will cause the pump to deprime and blood flow to stop. As aresult, gaseous emboli may be introduced into the patient; gaseous emboli could result in deathor severe injury. To prevent this, stop the pump, clamp the arterial line, and remove air prior toresuming circulation. Reprime the centrifugal pump as described in the instructions included withthe Bio-Pump centrifugal pump.To prevent backflow of the patient’s blood when the centrifugal pump outlet tubing is open,establish and maintain a minimum centrifugal pump speed that overcomes line and patientresistance. Not maintaining a positive flow could allow retrograde flow and exsanguinate thepatient if the line is not clamped. If for any reason the centrifugal pump has stopped, the arterialline must be clamped, either manually or by use of the AutoClamp system.When working with the sterile fluid pathways of the centrifugal blood pumping system, use steriletechnique.The Bio-Pump centrifugal pump and the disposable insert of the Bio-Probe blood flow monitoringsystem are packaged as sterile products and are designed for single use only. Do not reuse orresterilize as this could result in severe patient injury or death.A handcrank must always be available for emergency use. Instructions for using the handcrankare in Chapter 8.Do not place level sensors below the minimum operating level recommended by the reservoirmanufacturer.


Bio-Console 560 Overview


Never place fingers inside remote tube clamp closing mechanism. Serious injury may occur iffingers are caught in the remote tube clamp when it closes.Establish pump RPM before unclamping the arterial line. Failure to do so could cause retrogradeflow.Proper positioning of the bubble detector is the responsibility of the user. Bubble detectors mustbe positioned to allow sufficient time for the user to respond to detected bubbles.Never occlude the inlet to the centrifugal pump because negative pressures will be created withinthat portion of the circuit.To avoid an electrical shock, the Bio-Console must be disconnected from the AC power sourceduring servicing or cleaning.Do not adjust, modify, repair, or touch the internal circuitry. These actions could cause operatorinjury or cause faulty operation of the Bio-Console or AutoClamp interface module.

PrecautionsInspect each package and device visually and functionally prior to use. If the equipment appearsdamaged, consult with a qualified Medtronic service technician.A standby Bio-Console should be available during cardiopulmonary bypass procedures. If theBio-Console must be replaced during a procedure, follow the instructions in Chapter 8.This system must be operated and monitored continuously by a trained and qualified medicalprofessional.The flow display may be inaccurate and/or the User Interface displays may blink when anelectrocautery unit is in operation.Before using the Bio-Console, determine that the system is in proper operating condition, asdescribed in this manual. Ensure that the system and its components are used according toaccepted medical practice and the manufacturer’s instructions. To ensure that the system willoperate properly, use only Medtronic accessories.Only operate a Bio-Pump centrifugal pump that is primed according to the procedures describedin the Bio-Pump manual. Operating the centrifugal pump without being primed may damage theinternal seal on the centrifugal pump.Connect the power cord only to an AC power source that is properly inspected and certified forbiomedical equipment.Do not expose the Bio-Pump centrifugal pump to chemical agents as they may affect the integrityof this device. Anesthesia solutions such as FORANE® are known to degrade polycarbonateplastics. Avoid contact of these solutions with the Bio-Pump centrifugal pump.1

To avoid damage to the equipment, all electrical connections to the Base Unit should be attachedbefore the Bio-Console is turned ON.For United States and Canada users: connect only to a UL/c-UL listed ITE computer or equivalent.For customers outside the United States and Canada: connect only to an ITE computer evaluatedto IEC 60950-1 or equivalent.Installing a centrifugal pump with the motor revolving may harm the centrifugal pump.The performance of the safety systems must be verified before each use.

1 FORANE® is a registered trademark of Total Petrochemicals USA, Inc.


Chapter 1


Tubing must be firmly seated in the bubble detector for it to detect bubbles properly.Loss of air pressure or an air pressure below 379 kPa (55 psi) will cause the AutoClamp to close.Air pressure greater than 689 kPa (100 psi) may damage the internal components of the interfacemodule.Do not immerse the Base Unit or accessories, nor allow water to run into the interior of the BaseUnit or accessories. Do not use alcohol or alcohol-based cleaning solutions. Do not spray fluidinto electrical connectors or onto the User Interface screen.The batteries may be damaged if they are not recharged after use.


General Description and Specifications


General Description and Specifications 2

General DescriptionThe Bio-Console consists of four (4) parts:

■ Base Unit Front Panel

■ Base Unit Display Screen

■ Base Unit Rear Panel

■ User Interface

Base Unit Front PanelThe front of the Base Unit has a mount for the User Interface, a backup display screen, and thePower On/Standby switch.

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1. The Power On/Standby Switch islocated in the center of the Base Unit frontpanel and is a rocker-type switch thatactivates the Base Unit and User Interfacedisplays.

2. The Display Screen at the upper-frontarea of the Base Unit serves as a backupif the main User Interface malfunctions.The screen also contains the criticalinformation to continue the surgicalprocedure.

3. The User Interface Mounting Postallows the User Interface to be mounteddirectly to the Base Unit.

Figure 2. Base Unit Front Panel

Base Unit Display ScreenThe Base Unit display area presents basic information of extracorporeal flow rate and centrifugalpump speed. In the event that the touch screen User Interface should stop functioning, the casecan be managed with the controls from separate screens of the Base Unit display.


Chapter 2


Bio-Console® 560

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Figure 3. Base Unit Display Screen

1. Graphic/character display.2. AC power indicator and battery charging status LED.3. Alarm mute key.4. Enter key.5. Up/down menu selection keys.6. Left/right value selection keys.

Base Unit Rear Panel

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Figure 4. Base Unit Rear Panel

1. External Pump Drive Motor Connector for the Bio-Pump centrifugal blood pump.2. Two (2) Pressure Transducer Luer Ports that require a sterile, disposable fluid barrier

between the internal pressure transducer (in the Base Unit) and the pressure line.




3. Bio-Probe Flow Connector for the Bio-Probe blood monitoring system containing a flowtransducer that is either Model TX-50 or Model TX-50P.

4. Service Port Cover to connections for service representatives to analyze systemproblems and perform system upgrades.

5. User Interface Cable Connector for the cable from the rear side of the User Interface.6. System Indicator LED Lights (green and red) that indicate system performance (for

service personnel).7. Unit Label contains the serial number and AC power information.8. Fuse Access to service the AC power switch fuse.9. AC Power Switch activates AC power to the Base Unit.10. Power Cord Connector for the connection of the Base Unit to a grounded, 3-wire, AC

power source. The power cord receptacle is an IEC 320 plug receptacle.Caution: Only connect the power cord to an AC power source that is properly inspectedand certified.

11. Unit Cooling Fans maintain Base Unit cooling.Note: If a safety board has been installed for the optional safety systems, the back ofthe Base Unit will have additional connectors not shown in Figure 4. Referto Chapter 6 for additional information.

User InterfaceThe User Interface display is a touch screen that is controlled by lightly touching the variousscreen buttons (Figure 5). The User Interface attaches to the mounting post on the Base Unit orto a bracket remote from the Base Unit. See Chapter 3, Chapter 4, and Chapter 5 for details onsetting up and using the User Interface.

Back SideFront Side

Figure 5. User Interface

1. A speaker for the alert/alarms.


Chapter 2


2. The RPM knob maintains the desired blood flow rate.3. The touch screen allows the input of primary Bio-Console commands.4. The connector for the User Interface cable allows for the connection of the Base Unit

and User Interface.5. The locking/release handle allows for User Interface articulation.6. The connector for the data output device (typically a computer).

User Interface Screen SequenceThe User Interface display progresses through the screen sequence as shown in Figure 6.

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Figure 6. User Interface Screen Sequence

1. Opening Screen.2. Opening Screen with Setup Screen button.3. Main Screen.4. Settings Screen.5. Setup Screen.

Opening ScreenThe Opening Screen (Figure 7) appears for several seconds while the Bio-Console completesits internal software self test.




Figure 7. Opening Screen

Opening Screen with Setup Screen ButtonAfter the Bio-Console completes its internal software self test, the Setup Screen button will displayon the Opening Screen (Figure 8). The user has approximately 4 seconds to press the SetupScreen button in order to access the Setup Screen (Figure 9). If the Setup Screen button is notpressed, the Main Screen will be displayed (Figure 10). If the user wishes to access the SetupScreen but misses pressing the Setup Screen button, the user must reboot the Bio-Console.

Figure 8. Opening Screen with Setup Screen Button

Setup ScreenIf the user presses the System Setup button, the Setup Screen (Figure 9) will appear. The SetupScreen allows the user to select interface profiles.


Chapter 2


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Figure 9. Setup Screen Information and User Functions

1. The Alarm/Alert Sound Selection Buttons allow the user to select between 3 distinctivealarm/alert sounds.

2. The Alarm/Alert Sound and Volume Test Buttons allow the user to test the alarm/alertsound and volume.

3. The Alarm/Alert Volume Control allows the user to adjust the alarm/alert sound volume.4. The Data Refresh Rate Selection Button allows the user to select the refresh rate of

data sent to a separate data output device.5. The Data Format Selection Buttons allow the user to choose either the Model 550 or

the Model 560 data output format.6. The Serial Port Baud Rate Selection Button allows the user to select the Serial Port baud

rate.7. The Data Exchange Handshake Buttons allow the user to select the mode of data

exchange.8. The Language Selection Button allows the user to select a language.9. The Versions Button, when pressed, displays the current operating software version.10. The Screen Exit Button accepts and stores the latest settings entered and sends the

user to the Main Screen.

Main ScreenThe Main Screen (Figure 10) displays information about:

■ alert and alarm status

■ blood flow and pump speed




■ line pressure

■ user configurable timers

■ safety systems (if installed)

■ power status

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Figure 10. Main Screen Elements

1. The Activity Indicator rotates when the screen is displaying current information.2. The Low Flow and High Flow Limit Setting Indicators display the low flow and high

flow limits as set from the Settings Screen.3. The Target Flow Indicator displays the target flow rate as calculated from the Target

Flow section in the Settings Screen.4. The measured Cardiac Index value changes as the measured flow changes.5. The System Status Indicator displays either red (alarm), yellow (alert), or green (ok).6. The System Status Message Box displays information about the highest priority

alert/alarm.7. The Bar Graph and Digital Display for Flow display the blood flow in liters per minute

(L/min) in two ways, using a bar graph as well as a digital display.8. The Bar Graph and Digital Display for Pump RPM display the motor speed in

revolutions per minute (RPM) in two ways, using a bar graph as well as a digital display.The bar graph shows a maximum speed of 5000 RPM. The maximum motor speed is4500 RPM.


Chapter 2


9. The Pressure Monitor Displays (2) display the pressure(s) within the extracorporealcircuit (in mm Hg). This requires using a pressure-monitoring line that is connectedbetween the circuit and the pressure transducer ports on the back of the Bio-Console.

10. The Battery Status Indicator conveys the charge status of the internal backup batteries.11. The AC Power Status Button appears as a plain power cord when AC power is applied,

and as a power cord with an X through it when battery backup is in use.12. The Settings Screen Button switches from the Main Screen to the Settings Screen.13. When pressed, the Mute Button mutes the alert/alarm tones for 60 seconds. The mute

button only appears when an alert or alarm has been activated.14. The Volume Control sets the alarm/alert volume.15. The Service Log Button, when pressed, displays a log of internal system errors stored

since the last time the Bio-Console was placed in standby mode. A “call service” messagemay display, if appropriate.

16. The Timer Displays (3) with Buttons for Start, Pause, and Reset display the hours,minutes and seconds since the timer was started or the time remaining from a set time.

17. The Coast Speed Setting Indicator displays the speed set for Coast Mode as set fromthe Settings Screen.

Settings ScreenThe Settings Screen (Figure 11) provides the capability to set the following parameters:

■ blood flow range and upper/lower alert/alarm limits

■ target blood flow rate with cardiac index and height/weight calculator

■ pressure transducer zeroing and upper/lower alert/alarm limits

■ three timer presets

■ screen backlight intensity

The Settings Screen does not provide system alert or alarm status information. However, if analert or alarm occurs when the Settings Screen is displayed, the system automatically switchesback to the Main Screen.




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Figure 11. Settings Screen1. The Flow Bar Graph Display Scale Selector Buttons allow the user to select the scale

for the flow bar graph display on the Main Screen.2. The Flow Monitor displays the current digital flow rate from the Main Screen.3. The Flow Monitor Zero Button calibrates the flow sensor for zero offset.4. The High Flow and Low Flow Limits Set Buttons with Displays allow the user to

modify the flow alert limits.5. This section calculates the Target Flow Rate needed to achieve a desired Cardiac

Index. The user selects a BSA (Body Surface Area) algorithm —BSA(m2)—, the desiredcardiac index, patient height, and patient weight.

6. The Pressure Monitor Displays (2) display the current pressure values from the MainScreen.

7. The Pressure Monitor Zero Buttons calibrate the pressure sensors for zero offset.8. The High and Low Pressure Limits Set Buttons with Displays allow the user to modify

the pressure alert limits.9. The Timer Mode Selection Buttons allow the user to select the timers to display either

elapsed time (Count Up) or set time (Count Down).10. The Timer Set Buttons with Displays allow the user to modify the timer presets (if timer

mode is set to Count Down).11. The Time Unit Selection Buttons allow the user to select the timer display units (hours,

minutes, or seconds).


Chapter 2


12. The Screen Exit Button switches from the Settings Screen to the Main Screen.13. The Screen Contrast Button allows the user to select the light intensity of the screen.14. The Coast Speed Buttons allow the user to select the speed (RPM) that the pump

maintains during a Coast event.

Specifications

AC Power100-240 VAC, 50-60 Hz, 3.25 amps

External Pump Drive Motor Brushless DC (non-arcing)

Internal BatteriesType Two, series connected, 12 VDC lead-acid gel; rechargeableDischarge Time Refer to Appendix CRecharge Time 18 hours to 90% capacity; 24 hours to 100% capacity

Dimensions: Base UnitSize 31.88 cm (12.55 in) high by 22.83 cm (8.99 in) wide by 43.02 cm (16.9 in)

longWeight 17.19 kg (37.9 lb)

Dimensions: User InterfaceOverall Size 22.18 cm (8.7 in) wide by 34.5 cm (13.6 in) longScreen Size 26.41 cm (10.4 in) diagonalWeight 4.26 kg (9.4 lb)

System LimitsFlow –9.99 to +9.99 L/min ± (5% + 50 mL)RPM 0 to 4500 revolutions per minute (RPM)Pressure –300 to +999 mm Hg ± (5% + 5 mm Hg)

Operating LimitsTemperature +18 to +33°C (+64 to +92°F)Humidity 10% - 95%, non-condensing

Storage LimitsTemperature –40 to +66°C (–40 to +150°F)Humidity 10% - 95%, non-condensingPressure 700 hPa to 1063 hPa

Output SignalDigital RS 232 Interface: flow, RPM, pressure, alarm statusBaud Rate 1200 to 19200




ResolutionPressure 1 mm HgFlow 10 mLRPM 10

AutoClamp System (Optional)Type PneumaticClamp Force 14.5 Kg (32 lb)Pressure 379-689 kPa (55-100 psi)Gas Air or nitrogenTubing (adult) 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in) PVCTubing (pediatric) 6.35 mm (1/4 in) ID x 0.8 mm (1/32 in) PVC

Bubble Detector System (Optional)Bubble Size 1/2 the diameter of the tubing I.D. Adult: 0.5 mL Pediatric: 0.2 mLTubing (adult) 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in) PVCTubing (pediatric) 6.35 mm (1/4 in) ID x 0.8 mm (1/32 in) PVC

Level Sensor System (Optional)Type CapacitiveReservoir Medtronic hardshellNumber of Sensors 2

Factory Default Settings

Digital OutputFormat 560 formatCable 9-pin PC compatible cableTransmission Interval 10 secondsBaud Rate 9600Language English

Electromagnetic Emissions and Immunity Declarations

IEC 60601-1-2 Table 201, Guidance and manufacturer's declaration — electromagnetic emissionsThe Bio-Console 560 is intended for use in the electromagnetic environment specified below. The customer or the userof the Bio-Console 560 should assure that it is used in such an environment.Emissions test Compliance Electromagnetic environment – guidanceRF Emissions, CISPR 11 Group 1 The Bio-Console 560 uses RF energy only for its internal

function. Therefore, its RF emissions are very low and arenot likely to cause any interference in nearby electronicequipment.

RF Emissions, CISPR 11 Class A Class A equipment is equipment suitable for use in allestablishments other than domestic and those directly con-nected to the public low-voltage power supply network thatsupplies buildings used for domestic purposes.

Harmonic emissionsIEC 61000-3-2

Class A

Voltage fluctuations/flicker emis-sions, IEC 61000-3-3

Complies


Chapter 2


IEC 60601-1-2 Table 202, Guidance and manufacturer's declaration — electromagnetic immunityThe Bio-Console 560 is intended for use in the electromagnetic environment specified below. The customer or the userof the Bio-Console 560 should assure that it is used in such an environment.Immunity test IEC 60601 test level Compliance level Electromagnetic environment — guidanceElectrostatic dis-charge (ESD)IEC 61000-4-2

±6 kV contact±8 kV air

±6 kV contact±8 kV air

Floors should be wood, concrete or ceramictile. If floors are covered with synthetic material,the relative humidity should be at least 30%.

Electrical fast transi-ent/burstIEC 61000-4-4

±2 kV for power sup-ply lines±1 kV for input/outputlines

±2 kV for power supplylines±1 kV for input/outputlines

Mains power quality should be that of a typicalcommercial or hospital environment.

Surge IEC 61000-4-5 ±1 kV line(s) to line(s)±2 kV line(s) to earth

±1 kV differential mode±2 kV common mode

Voltage dips, shortinterruptions and volt-age variations onpower supply inputlines IEC 61000-4-11

<5% UT (>95% dip inUT) for 0.5 cycle40% UT (60% dip inUT) for 5 cycles70% UT (30% dip inUT) for 25 cycles<5% UT (>95% dip inUT) for 5 sec<5% UT (>95% dip inUT) for 0.5 cycle

<5% UT (>95% dip inUT) for 0.5 cycle40% UT (60% dip in UT)for 5 cycles70% UT (30% dip in UT)for 25 cycles<5% UT (>95% dip inUT) for 5 sec<5% UT (>95% dip inUT) for 0.5 cycle

Power frequency(50/60 Hz) magneticfield IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be atlevels characteristic of a typical location in atypical commercial or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level.




IEC 60601-1-2: 2001 Table 203, Guidance and manufacturer's declaration — electromagnetic immunityThe Bio-Console 560 is intended for use in the electromagnetic environment specified below. The customer or the userof the Bio-Console 560 should assure that it is used in such an environment.Immunity test IEC/EN 60601 test

levelCompliance level Electromagnetic environment — guidance

Portable and mobile RF communicationsequipment should be used no closer to any partof the Bio-Console 560, including cables, thanthe recommended separation distance calcu-lated from the equation applicable to the fre-quency of the transmitter.Recommended separation distance:

Conducted RFIEC/EN 61000-4-6

3 Vrms

150 kHz to 80 MHzoutside ISM bands1

1 Vrms d = 3.5√ P

10 Vrms

150 kHz to 80 MHz inISM bands1

1 Vrms d = 12√ P

Radiated RFIEC/EN 61000-4-3

10 V/m80 MHz to 2.5 GHz

10 V/m d = 1.2√ P 80 MHz to 800 MHzd = 2.3√ P 800 MHz to 2.5 GHzwhere P is the maximum output power rating ofthe transmitter in watts (W) according to thetransmitter manufacturer and d is the recom-mended separation distance in meters (m).2

Field strengths from fixed RF transmitters, asdetermined by an electromagnetic site survey,should be less than the compliance level ineach frequency range.3, 4

Interference may occur in the vicinity of equip-ment marked with the following symbol:

Note: At 80 MHz and 800 MHz, the higher frequency range applies.Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption andreflection from structures, objects and people.

1 The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are: 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz;26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

2 The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended todecrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.

3 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AMand FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due tofixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Bio-Con-sole 560 is used exceeds the applicable RF compliance level above, the Bio-Console 560 should be observed to verify normal operation. If abnormalperformance is observed, additional measures may be necessary, such as reorienting or relocating the Bio-Console 560.

4 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.


Chapter 2


IEC 60601-1-2: 2001 Table 205, Recommended separation distances between portable and mobile RF commu-nications equipment and the Bio-Console 560The Bio-Console 560 is intended for use in an electromagnetic environment in which radiated RF disturbances arecontrolled. The customer or the user of the Bio-Console 560 can help prevent electromagnetic interference by main-taining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Bio-Console 560 as recommended below, according to the maximum output power of the communications equipment.

Rated maximumoutput power oftransmitter W

Separation distance according to frequency of transmitterRated maximum output power m

150 kHz to 80 MHzOutside ISM bands

d = 3.5√ P

150 kHz to 80 MHz InISM bandsd = 12√ P

80 MHz to 800 MHzd = 1.2√ P

800 MHz to 2.5 GHzd = 2.3√ P

0.01 0.35 1.2 0.12 0.230.1 1.1 3.8 0.38 0.731 3.5 12 1.2 2.310 11 38 3.8 7.3100 35 120 12 23For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum outputpower rating of the transmitter in watts (W) according to the transmitter manufacturer.Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.Note: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are: 6.765 MHz to 6.795 MHz;13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.Note: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in theISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease thelikelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought intopatient areas.Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption andreflection from structures, objects and people.Cautions:

■ Do not use non-Medtronic components with Medtronic in-line-powered external devices. The use of non-Medtroniccomponents may result in damage to Medtronic components, increased emissions, or decreased electromagneticimmunity of the Medtronic devices or systems.

■ Do not use Medtronic in-line-powered external devices adjacent to, or stacked with, other electronic devices. UsingMedtronic devices in these configurations may result in decreased electromagnetic immunity of the Medtronicdevices or systems.


Setup


Setup 3

Connecting the Bio-Console ComponentsRefer to Figure 4 for identification of the various ports on the back panel of the Base Unit.Caution: To avoid damage to the equipment, all electrical connections to the Base Unit shouldbe attached before the Bio-Console is turned ON.

Connecting the User InterfaceThe User Interface can attach to the Bio-Console via the mounting post on the Base Unit or to abracket remote from the Base Unit.

Connection to the Base Unit1. Position the User Interface on the User Interface Mounting Post (Figure 12).

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Figure 12. Secure User Interface to Base Unit

2. Tighten the knob.3. Connect the User Interface cable to the back side of the User Interface and the receptacle

on the back panel of the Base Unit (Figure 13). Insert the connecting pins firmly and rotatethe cable collar to lock in place. Either end of the cable can connect to the User Interface orto the Base Unit.


Chapter 3


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Figure 13. Connect User Interface Cable to Base Unit

Connection to an Optional Pole Mount1. Position the mount on the pole and secure by tightening the knob (Figure 14).

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Figure 14. Attach Remote Bracket to Pole

2. Adjust the support arm to the desired angle and secure by tightening the knob (Figure 14).3. Position the User Interface on the bracket post (Figure 15).


Setup


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Figure 15. Secure User Interface to Bracket Post

4. Firmly secure the attachment with the knob.5. Connect the User Interface cable on the back side of the User Interface and the receptacle

on the back panel of the Base Unit (Figure 13). Insert the connecting pins firmly and rotatethe cable collar to lock in place. Either end of the cable can connect to the User Interface orto the Base Unit.

Connecting the Pump MotorTo connect the pump motor, remove the cap on the pump motor port on the back of the BaseUnit and attach the pump motor cable (Figure 16).


Chapter 3


Figure 16. Connect Pump Motor Cable to Base Unit

Connecting the Flow TransducerThe flow transducer is part of the Bio-Probe blood flow monitoring system.Plug the flow transducer cable (1) into the flow connector on the back panel of the Base Unit(Figure 17).


Setup


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Figure 17. Attach Flow Transducer Cable to Base Unit

Mounting the Flow TransducerThe transducer mount (Figure 18) is used to attach the flow transducer to a pole. This may beuseful when operating the Bio-Console or when storing the transducer.

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Figure 18. Attach Flow Transducer to Pole

1. Push and hold the button on the transducer mount.2. Insert the exposed pin into the recess at the bottom of the transducer and release the button.


Chapter 3


3. Place the transducer mount on a sturdy pole and turn the knob until the transducer mount issecure.

4. Loosen the knob to extend or retract the bar on which the transducer is mounted. Retightenthe knob.

Connecting Optional Safety SystemsFor information on setting up and operating the optional safety systems, refer to Chapter 6.

Turning On the Bio-ConsoleCaution: To avoid damage to the equipment, all electrical connections to the Base Unit shouldbe attached before the Bio-Console is turned ON.

1. Ensure that the AC power source is properly inspected and certified for biomedicalequipment. Connect the Bio-Console to the hospital facility power source. Alternating current(AC) main voltage must be 100-240 VAC (50-60 Hz).

2. Connect the AC power cord into the connector (1) on the back panel of the Base Unit(Figure 19) and into an electrical outlet. Turn the AC power switch (2) to the ON position.

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Figure 19. AC Power Cord Connection

3. Make sure the RPM knob is turned to zero to the clicked-OFF position (Figure 20). The blackrelease button on the knob serves as the pointer to the RPM settings. As the knob is turnedto zero, slight pressure can be felt and a click will be heard. A mechanical stop is located atthe 2000 RPM setting to prevent accidental RPM reduction below that point. Depress theblack release button to release the knob from the mechanical stop in order to rotate it to theOFF position.Note: If the knob is not at zero when the Bio-Console is turned on, the centrifugal pump willnot spin. To reset the motor controller, turn the knob to 0 RPM for a minimum ofone (1) second.


Setup


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1. Black detent release button and RPMlevel indicator.

2. Mechanical stop at 2000 RPM.3. Clicked OFF position.

Figure 20. RPM Knob Turned to the Zero Position4. Press the Power On/Standby switch to the ON position (Figure 21). (The ON position is

achieved by pressing the right side of the switch.)Note: The battery is automatically charged when the Base Unit is plugged into AC powerand the AC power switch on the back panel is turned ON. The Power On/Standby switchposition does not affect battery charging.

5. When the power switch on the front panel is turned ON, the Base Unit performs a power onself-test during which a one second audible beep is heard, and the Base Unit Screen 1appears with zero values for flow and RPM.Note: Once the Base Unit self test is completed, the RPM knob can be used to control thepump. The User Interface does not need to be fully running, it can be in self-test, in order tocontrol the pump.


Chapter 3


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Figure 21. Power On/Standby Switch Location

Setting Up the User InterfaceWhen the user presses the Setup Screen button from the Opening Screen, the Setup Screen willappear (see Figure 22).

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Figure 22. User Interface Screen Sequence for System Setup

1. Opening Screen.2. Opening Screen with Setup Screen button.3. Setup Screen.


Setup


4. Main Screen.The Setup Screen is divided into five areas:

■ Alarm/Alert sound selection

■ Digital Output settings

■ Serial Port settings

■ Language selection

■ Software version

Selecting the LanguageThe Bio-Console allows the user to choose from a list of available languages.

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Figure 23. Language Selection

1. Enter the Setup Screen.2. Press the Language Selection button (default is English) to display the available language

settings. Press the desired language and the screen will immediately display in that language.

Selecting Alarm/Alert SoundsThe Bio-Console has distinct alarm/alert sounds to inform the user when alarm or alert conditionsare present.An alarm sound is a repeating sequence of long and short beeps. An alarm condition is moreserious than an alert condition and requires a corrective action by the user.An alert sound is a steady paced beep.


Chapter 3


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Figure 24. Alarm and Alert Sound Selection

1. While in the Setup Screen, press the Alarm/Alert Sound Selection buttons for the desiredalarm and alert sound.

2. Press the Test buttons to hear the selected sounds.3. Press the volume up/down arrows and Test buttons to determine adequate volume.

Entering Data Output Refresh Rate and FormatThe Bio-Console allows the user to program the data output refresh rate and format fortransmission to a data management system.

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Figure 25. Entering Data Output Refresh Rate and Format


Setup


1. While in the Setup Screen, press the up/down arrows on the Rate Selection button to set thedesired refresh rate (in seconds) of data transmission.

2. Select either the 550 Bio-Console or 560 Bio-Console button, depending on desired dataoutput format.

For additional information on data output formats, refer to Appendix D.

Setting Serial Port ParametersThe following steps allow the user to configure the serial port.

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Figure 26. Setting the Serial Port Parameters

1. While in the Setup Screen, press the up/down arrows on the Baud Rate Selection button toset the appropriate rate. The rate ranges from 1200 to 19200.

2. Select either the Hardware or XON/XOFF button for the handshake, depending on therequirements of the data management system.

Saving Selections

When you complete your selections in the Setup Screen, press the Screen Exit button toaccept all the settings and proceed to the Main Screen.Note: If the Screen Exit button is not pressed and the device is turned OFF, the user-selectedsettings will not be entered and the device will revert back to the previous settings. If you wantto change the settings after you have gone to the Main Screen, you must restart the machineand return to the Setup Screen.

Checking Battery Charge StatusThe green battery indicator on the lower portion of the Main Screen indicates the charge statusof the Bio-Console batteries (see Figure 10).


Chapter 3


Refer to page 86 in Chapter 7 for instructions to ensure the batteries are fully charged.


Case Preparation


Case Preparation 4

System Status IndicatorsAt the top of the User Interface, there are three colored lights that are associated with the operation statusof the system. These lights serve as a visual cue for assessing system status.

2 31

Figure 27. System Status Indicator

1. When the green light is illuminated, all systems are functioning normally and (asapplicable) safety devices are enabled. No action required.

2. When the yellow light is illuminated, an alert condition exists.3. When the red light is illuminated, an alarm condition exists.

The System Status Message Box displays information about the highest priority alert or alarm.

Alerts and AlarmsThe Bio-Console has distinct alert/alarm sounds to inform the user when alert/alarm conditionsare present:

■ An alert indicates a condition that requires attention. An alert notification consists of a steadypaced beep and illumination of the yellow system status indicator.

■ An alarm indicates a condition that requires immediate corrective action. An alarmnotification consists of a repeating sequence of long and short beeps and illumination of thered system status indicator.

In addition, the System Status Message Box displays information about the highest priority alertor alarm. Refer to page 104 in Appendix A.An alert or alarm can be temporarily silenced by the mute button on the Main Screen, but it willresume after 60 seconds if the situation is not resolved immediately or if a new alert or alarmcondition occurs. The mute button only appears when an alert or alarm condition exists.


Chapter 4


The alert/alarm sounds are selected from the upper area of the Setup Screen. Referto page 29 in Chapter 3.Note: The audible alerts/alarms are inactivated when the RPM knob is turned completelycounterclockwise to the clicked OFF position.Note: Specific alerts/alarms may display additional unique yellow/red identifiers to aid the userin identifying the source of the condition.

Installing the Bio-Pump Centrifugal PumpThe Bio-Console Extracorporeal Blood Pumping Console Model 560 is designed to be operatedonly with the Bio-Pump Centrifugal Pump. There are no safety or performance data that establishcompatibility of any other manufacturer's device or components with the Medtronic system.Warning: Use of the Bio-Pump centrifugal pump beyond the labeled recommendations mayresult in failure of the centrifugal pump, reduced pumping capacity, leaks, excessive bloodtrauma, or degradation or corrosion of blood contact materials, which may pass through the bloodto the patient.

1. Caution: Ensure the Bio-Pump centrifugal pump is primed according to the proceduresdescribed in the Bio-Pump manual. Operating the centrifugal pump without being primed maydamage the internal seal on the centrifugal pump.

2. Make sure the RPM knob is turned to zero to the clicked-OFF position (Figure 28). The blackbutton on the knob serves as the pointer to the RPM settings. As the knob is turned to zero,slight pressure can be felt and a click will be heard.Caution: Installing a centrifugal pump with the motor revolving may harm the centrifugalpump.

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1. Black detent release button and RPM levelindicator.


Figure 28. RPM Knob Turned to the Zero Position3. Remove the red protective cover and slide the centrifugal pump into the pump motor

receptacle with the outlet positioned away from the top center (Figure 29). Make sure thelocking pin engages.


Case Preparation


Figure 29. Installing the Centrifugal Pump

Note: Although the pump motor receptacle will accept the centrifugal pump at any angle,make sure that the outlet is away from the top center (12 o'clock) position. This will helpprevent bubble migration to the pump outlet when flow has stopped.

Attaching the Pressure Monitoring CircuitThe pressure monitoring system is an optional component to the Bio-Console system. Itmeasures up to two pressures in the extracorporeal blood circuit. If the pressure monitoringsystem is used, a fluid barrier device is required to protect the internal circuitry.Note: Do not use this connection to measure pressure in other circuits or the Base Unit may bedamaged.

1. Connect a pressure-monitoring line with a 3-way stopcock and a fluid barrier to the male luerlock pressure port on the back panel of the Base Unit (Figure 30). The fluid barrier protectsthe pressure transducer in the Bio-Console.

2. Prime the pressure line from the circuit to the fluid barrier, removing all air.

Note: The top port corresponds to on the User Interface and the bottom port corresponds to on the User Interface.


Chapter 4


P2

P1

Figure 30. Attaching the Pressure-Monitoring Line

Zeroing the Pressure TransducerThe pressure value on the Main Screen will flash until the pressure transducer has beensuccessfully zeroed.To zero the pressure transducer:1. Turn the 3-way stopcock so that the pressure transducer is open to atmospheric pressure

(Figure 31).

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Figure 31. Atmospheric Pressure Opened to Transducer


Case Preparation


2. Press the Settings Screen button to open the Settings Screen.

3. Press the zero buttons for one or both ( and ) pressure monitors (Figure 32).4. After successful zeroing, the Main Screen will display a pressure value of 000 mm Hg and

will stop flashing.Note: Pressure values must be within ± 20 mm Hg of 0 in order to be zeroed.

3

Figure 32. Zero Pressure Transducer Values

Setting the Pressure Alert LimitsAlerts are activated when pressure sensed by a pressure monitor drops below the low pressurelimit or exceeds the high pressure limit.To set low and high pressure limits, go to the Settings Screen and press the up/down arrows forthe lower ( ) and upper ( ) limits for and pressure monitors (Figure 33).Note: If an alert occurs when in the Settings Screen, the system automatically Exits to the MainScreen.


Chapter 4


1

Figure 33. Setting Pressure Alert Limits

If a low or high pressure alert is active a yellow down or up arrow icon will flash next to the pressuremonitor value on the Main Screen (Figure 34). For additional information, refer to page 33in Chapter 4.


Case Preparation


Figure 34. High Pressure Alert

Note: If the patient is on bypass and the pressure display is not functioning, the pressure can beapproximated by referring to Appendix B. Immediately after the procedure, contact a qualifiedMedtronic service technician and report that the pressure display is not working.

Attaching Insert to Flow TransducerThe disposable insert (Model DP38 or DP38P) is part of the Bio-Probe blood flow monitoringsystem and should be attached to the flow transducer as follows:1. Position the transducer distal to the Bio-Pump.2. Install the insert in the flow transducer.

Note: Ensure the insert is the appropriate size for the flow transducer used:

■ adult Model DP-38 (TX-50)

■ pediatric Model DP-38P (TX-50P)3. Align the arrow on the cover of the flow transducer with the direction of the fluid flow.4. Close the flow transducer cover securely.


Chapter 4


Figure 35. Attaching an Insert to a Flow Transducer

Priming the CircuitPrime the centrifugal pump, insert, and tubing. Refer to the instructions included with the Bio-Pump centrifugal pump for priming details.

Zeroing the Flow TransducerThe flow transducer cannot be zeroed until:

■ the perfusion circuit is primed. (Refer to the instructions included with the Bio-Pumpcentrifugal pump for priming details.)

■ the Bio-Probe blood flow monitoring system is connected to the Base Unit.

The flow value on the Main Screen will flash until the flow transducer has been successfullyzeroed.To zero the flow transducer:1. Place a tubing clamp distal to the transducer so fluid is not flowing through the transducer

(Figure 36).2. Press the Settings Screen button to open the Settings Screen.


Case Preparation


Figure 36. Stop Fluid Movement Through the Flow Transducer

3. Press the Flow Transducer zero button (Figure 37).4. After successful zeroing, the Main Screen will display a rate of 0.00 L/min and will stop

flashing.5. Note: The flow rate must be within ± 0.1 L/min of 0 in order to be zeroed. Refer

to page 101 in Appendix A.


Chapter 4


3

Figure 37. Zeroing the Flow Transducer

6. Remove the tubing clamp.

Correcting a Negative Flow ReadingIf the transducer was placed backwards in the flow circuit, a negative flow reading will bedisplayed. To correct the flow reading:1. Open the transducer cover.2. Turn the transducer 180°.3. Close the transducer cover until the latch engages.4. Proceed according to whether or not the patient is on bypass.

a. Before bypass: Rezero the transducer.b. On bypass: Do not rezero the transducer; the flow reading will provide a relative

value from which to work.Note: If the transducer is not rezeroed, a 0.1 L/min maximum offset may be reflected in the flowvalue.

Setting the Flow Bar Graph Display ScaleThe Flow Bar Graph Display Scale Selector buttons on the Settings Screen allow you to changethe scale of the flow bar graph displayed on the Main Screen. Three ranges are displayed on the


Case Preparation


Settings Screen: 0-10 (L/min), 0-7 (L/min), and 0-2 (L/min), symbolized by large adult, normaladult, and pediatric icons, respectively (Figure 38).To set the flow bar graph display scale:

1. Press the Settings Screen button ( ) to open the Settings Screen.2. On the Settings Screen, press the appropriate Flow Bar Graph Display Scale Selector button

in the Flow section at the top of the screen.

2

Figure 38. Setting Flow Bar Graph Display Scale

3. Press the Screen Exit button ( ) to accept settings and return to the Main Screen.

Setting Low and High Flow AlertsThe Bio-Console allows the user to set lower and upper flow alert settings. The settings aredisplayed on the Main Screen as two triangular markers on the Flow Bar Graph (Figure 10). Alertswill activate when flow goes below the low flow limit or above the high flow limit.To set low and high flow limits:1. Go to the Settings Screen.

2. Press the up/down arrows for the lower ( ) and upper ( ) flow monitor limits (Figure 39).


Chapter 4


2

Figure 39. Setting Flow Alert Limits

If a low or high flow alert is active, a yellow down or up arrow icon will flash next to the flow monitorvalue (Figure 40). For additional information, refer to page 33.


Case Preparation


Figure 40. Low Flow Alert

Establishing the Target Flow RateTarget Flow is the nominal rate of flow needed to achieve a desired Cardiac Index for a specificpatient. It is displayed on the Main Screen as a vertical green marker on the Flow Bar Graph(Figure 10).The Bio-Console will calculate the Target Flow value based on inputs entered in the Target Flowsection of the Settings Screen (Figure 41):

1. Select desired Cardiac Index value.2. Select the desired BSA (Body Surface Area) algorithm. The three BSA algorithms are:

■ DuBois (m2) = 0.007184 x height (cm)0.725 x weight (kg)0.425

■ Boyd (m2) = 0.0003207 x height (cm)0.3 x weight (gm)[0.7285 - (0.0188 x Log (gm)]

■ Infant (m2) = 0.024265 x height (cm)0.3964 x weight (kg)0.5378

3. Enter patient height and weight.


Chapter 4


1

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Figure 41. Calculating Target Flow

Note: Patient height and weight must be entered for every case. If they are not entered, theTarget Flow Rate and the measured Cardiac Index value will not display on the Main Screen.

Timers SetupThere are three timers, which are independent of each other (Figure 42). Each timer displaystime in hours, minutes and seconds. Timers are configured on the Settings Screen and controlledfrom the Main Screen.


Case Preparation


31

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Figure 42. Timer Settings on the Settings Screen

1. The Count Up/Count Down Selection Buttons designate whether each timer counts upfrom zero or counts down from a set amount of time entered by the user.Note: The arrow to the left of the timer symbol indicates whether a timer is in Count Up orCount Down mode.

2. If Count Down is selected, a display will appear allowing the user to designate the initial countdown value for that timer.Note: When the Count Down timer is used, the timer beeps five times and the display flashesat 00:00:00. The flashing will continue until the timer is reset.

3. Press either the HH, MM or SS Buttons to select the unit of time to be changed using theup/down arrows.

4. Use the up/down arrows to enter the desired Count Down time.

Adjusting Screen ContrastFrom the Settings Screen, press the up/down arrows (1) to adjust the light intensity of the screen(Figure 43).


Chapter 4


1

Figure 43. Adjust Light Intensity of Screen


On-Pump Operation


On-Pump Operation 5Before beginning this section:

■ Complete the procedures described in Chapter 3 and Chapter 4.

■ Caution: Ensure that a standby Bio-Console and handcrank are available during cardiopulmonarybypass procedures. If the Bio-Console must be replaced during a procedure, follow the instructionsin Chapter 8.

■ Caution: Determine that the system is in proper operating condition, as described in this manual.Ensure that the system and its components are used according to accepted medical practice andthe manufacturer's instructions. To ensure that the system will operate properly, use only Medtronicaccessories.

Adjusting Flow RateThe RPM speed is used to maintain positive flow and pressure to the centrifugal pump outlet sideof the perfusion circuit. The blood flow rate is dependent upon pump RPM, circuit resistance andpatient vascular resistance. Resistance factors include, but are not limited to:

■ length of tubing and size of the cannula

■ blood temperature and viscosity

■ patient's systemic vascular resistance

Refer to Appendix B for detailed information on the relationship between RPM, resistance andblood flow.To adjust the flow rate:1. Rotate the RPM knob on the User Interface.2. Continue rotating until the desired flow rate is achieved.Note: If the knob is not at zero when the Bio-Console is turned on, the centrifugal pump will notspin. To reset the motor controller, turn the knob to 0 RPM for a minimum of one (1) second.

2000 RPM Mechanical StopThe black detent release button on the RPM knob is connected to a mechanical stop that preventsan unintentional RPM reduction below 2000 (Figure 44).


Chapter 5


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1. Black detent release button and RPM levelindicator.


Figure 44. RPM Knob with a Mechanical Stop at 2000 RPM

1. To reduce the centrifugal pump speed and blood flow, turn the RPM knob counterclockwise.2. To reduce the RPM below the 2000 mechanical stop, press down on the black detent release

button while simultaneously turning the RPM knob.3. To reduce the flow without reducing the RPM, partially restrict the outlet tubing from the

centrifugal pump until the appropriate flow is reached.

Monitoring Flow RateFlow is displayed in three ways (Figure 45):1. Measured flow value (digital display in L/min).2. Measured cardiac index (digital display in L/min/m2).3. Flow bar graph.


On-Pump Operation


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Figure 45. Measured Flow Displays

In addition to the flow value, the flow bar graph also displays the target flow and the low/high flowalert settings. Refer to page 43 in Chapter 4 for instructions on how to set these values and onsetting the flow bar graph display scale.If a low or high flow alert is active, a yellow down or up arrow will flash next to the flow monitorvalue (Figure 40).If the RPM knob is set above zero, the Bio-Console backflow alarm will activate when flow goesbelow –100 mL/min. If a backflow alarm is active, a red down arrow will flash next to the flowmonitor value (Figure 77). For additional information, refer to page 33 in Chapter 4.Note: To configure the optional AutoClamp system to close in response to backflow alarms, referto Chapter 6.If flow values are flashing, the accuracy of the flow values may be compromised. Additionalinformation will be displayed in the System Status Message Box.Flashing dashes in place of a flow value indicates that the flow transducer has not been connectedproperly or is malfunctioning. Flashing values indicates that the flow transducer has not beenzeroed or that accuracy may have been compromised due to system malfunction or electricalinterference. Refer to page 40 in Chapter 4 for instructions on how to zero the flow transducer.Caution: The flow display may be inaccurate and/or the User Interface displays may blink whenan electrocautery unit is in operation.

Warning: When initiating flow, establish pump RPM before unclamping the arterial line. Failureto do so could cause retrograde flow.

Warning: To prevent backflow of the patient's blood when the centrifugal pump outlet tubing isopen, establish and maintain a minimum centrifugal pump speed that overcomes line and patient


Chapter 5


resistance. Not maintaining a positive flow could allow retrograde flow and exsanguinate thepatient if the line is not clamped. If for any reason the centrifugal pump has stopped, the arterialline must be clamped, either manually or by use of the AutoClamp system.

Monitoring Flow from the Base UnitThe Base Unit display presents basic information including the flow rate and pump speed. In theevent that the touch screen user interface should stop functioning the case can be managed withthe controls from the base unit display. Refer to Chapter 9.

Using TimersThe Bio-Console has three independent timers that can be configured for Count Up or CountDown operation. The arrow to the left of the timer symbol indicates whether a timer is in CountUp or Count Down mode. Each timer displays time in hours, minutes and seconds. Timers areconfigured in the Settings Screen and controlled from the Main Screen. For configuring timers,refer to page 46 in Chapter 4.From the Main Screen, the timers are controlled as follows:

1. To start a timer, press the start button

2. To pause a timer, press the pause button

3. To reset a timer, press the reset button

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Figure 46. Controlling Timers from the Main Screen


On-Pump Operation


Resetting a Count Up timer sets the timer value to 00:00:00. Resetting a Count Down timer setsthe timer to the initial Count down value designated in the Settings Screen (refer to page 46in Chapter 4). A timer may only be reset while it is paused.When the Count Down timer is used, the timer beeps five times and the display flashes at00:00:00. The flashing will continue until the timer is reset.

Volume ControlTo adjust the alert/alarm volume, press the up/down arrows on the Main Screen (Figure 10).

Alert and Alarm HandlingThe Bio-Console has distinct alert/alarm sounds to inform the user when alert/alarm conditionsare present.Refer to page 33 in Chapter 4 for information about handling alerts and alarms.

Service LogThe Service Log button, when pressed, displays a log of internal system errors (Figure 10). A“call service” message may display, if appropriate.Note: Internal system errors are stored until the next time the Bio-Console is placed in standbymode.

Activity IndicatorThe Activity Indicator rotates when the screen is displaying current information (see Figure 10).If the Activity Indicator is not rotating, data on the User Interface is not refreshing. If necessary,the case can be managed using the controls from the Base Unit display (refer to Chapter 9).

Monitoring PressurePressure values are displayed in mm Hg and range from –300 to +999.If a low or high pressure alert is active a yellow down or up arrow will display next to the pressuremonitor value (Figure 34). Refer to Figure 33 in Chapter 4 for setting low and high pressure alertlimits.If pressure values are flashing, the accuracy of the pressure values may be compromised.Additional information will be displayed in the System Status Message Box.Flashing dashes in place of a pressure value indicates that the pressure transducer ismalfunctioning. Flashing values indicates that the pressure transducer has not been zeroed.Refer to page 36 in Chapter 4.

AC Power Status AlertIf AC power is disconnected or turned off, an alert will sound indicating the loss of AC power. TheBio-Console will automatically switch to battery backup due to the loss of AC power.


Chapter 5


Pressing the AC Power Status button will silence the audible alert for 10 minutes. The visual alertwill remain until AC power is restored (Figure 47).

Figure 47. AC Power Status Button

Battery AlarmThe audible and visual battery alarms activate when approximately 5 minutes of battery chargeremains under normal operating conditions and cannot be adjusted (Figure 48). Recharging thebatteries to 90% capacity takes approximately 18 hours and a full charge requires approximately24 hours.


On-Pump Operation


Figure 48. Low Battery Alarm Activated

Stopping Flow: Taking A Patient Off Cardiopulmonary BypassWhen ending bypass or greatly reducing flow, occlude the arterial line before dropping below theminimum flow rate (<100 mL/min).When stopping the flow, the centrifugal pump outlet tubing and the patient venous tubing mustbe occluded to prevent exsanguination of the patient. Partially occluding the outlet tubing for longperiods of time may cause blood damage.When an arterial line is occluded, the centrifugal pump may continue revolving without excesspressure build-up in the circuit.Warning: Never occlude the inlet to the centrifugal pump because negative pressures will becreated within that portion of the circuit.To stop flow:1. Occlude the centrifugal pump outlet tubing.2. Reduce the RPM to approximately 2000 (to the knob detent position).3. Press the black detent release button on the knob and turn the RPM knob counterclockwise

below zero until it clicks OFF.Warning: If flow to the patient stops, occlude the outlet tubing from the centrifugal pump toprevent retrograde flow. Keep the outlet tubing occluded until flow is ready to be reestablished.Failure to occlude the outlet tubing will cause retrograde flow and may exsanguinate the patient.


Chapter 5


Removing the Bio-Pump Centrifugal Blood PumpRemove and discard the pump after each procedure. Discard the pump according to local andhospital procedures.1. Push the pump motor locking pin to release the centrifugal pump.2. Slide the centrifugal pump out of the pump motor receptacle.

Figure 49. Removing the Centrifugal Pump

3. Place the red cover on the pump motor receptacle. This helps prevent damage to themagnetic coupler and prevents the collection of metal objects.

4. Return the Bio-Console to standby mode and leave it connected to an AC power source. Thiswill ensure the battery remains charged.

Data OutputNote: For United States and Canada users: connect only to a UL/c-UL Listed ITE computer orequivalent.Note: For customers outside the United States and Canada: connect only to an ITE computerevaluated to IEC 60950-1 or equivalent.The RPM, flow, alarm conditions, and pressure measurements may be sent to a computer orother data output devices through a digital connector. Bio-Console data are sent to a data outputdevice when the Bio-Console is turned ON and the device is connected to the User Interface.

Attaching a Digital Output ConnectorBio-Console data may be sent to a computer through the 9-pin, RS 232 connector on the backof the User Interface (Figure 50).Note: Transmission of data begins as soon as the Bio-Console is turned ON and the cable isattached to both a data output device and the User Interface.


On-Pump Operation


If the cable does not work or if a different connector is needed, contact a qualified Medtronicservice technician.

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1. Connector for the User Interface cable whichallows for remote location of the UserInterface.

2. Connector for the data output device (typicallya computer).

3. RS 232 cable from User Interface connector toremote data output device.

Figure 50. Connecting Data Acquisition Device to the RS 232 Interface

Refer to Appendix D for additional information on changing data output format.


Chapter 5



Safety Systems


Safety Systems 6The optional safety systems used with the Bio-Console 560 function in two ways: to detect potentialhazards and to respond to those conditions. Safety systems used to detect potential hazards include thelevel sensing system and the bubble detection system. Safety systems used to respond to potentialhazards include the AutoClamp system and Bio-Pump coast/stop. These safety systems are discussedin detail in the following sections.Note: Use of the optional safety systems requires installation of a safety board in the Base Unit.Associated with the safety board are three additional connectors for plugging in the three safety systems(Figure 51):1. Level Sensing system2. Bubble Detection system3. AutoClamp systemCaution: The performance of the safety systems must be verified before each use.

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Figure 51. Safety Connectors on Back of Base Unit

Level Sensing SystemOverviewThe level sensing system is used to detect blood and fluid levels in a reservoir. It incorporates apair of color-coded sensors that are attached to the outside of the reservoir using double-sidedadhesive tape. One sensor is designated as the upper level sensor (yellow); the other sensor isdesignated as the lower level sensor (red). Each level sensor is configured independently. If thefluid in the reservoir level drops below the position of a level sensor, it will trigger a system alertor alarm and optionally may be configured to slow or stop the pump.Note: The level sensing system is designed to be used with a Medtronic hardshell reservoir.The level sensing system consists of the following components:


Chapter 6


■ Level sensor, Model LS100

■ Level sensor tape, Model LST

Connecting the Level SensorsThe level sensors detect the presence of fluid within the diameter of the “target” symbol on thelevel sensor. When fluid is detected, the red light on the level sensor is lit.To connect the level sensors:1. Attach the level sensor cable to the back panel of the Base Unit (Figure 52).

Figure 52. Attach Level Sensor Cable to Base Unit

2. Attach the level sensor tape to the outside surface of the reservoir:a. Remove one side of the protective strip on the adhesive tape.b. Adhere tape to reservoir surface at the desired level.c. Remove the outer protective strip on the adhesive tape.

3. Apply the upper and lower level sensors firmly to the adhesive tape with the cross-line targetat the desired level (Figure 53).


Safety Systems


Figure 53. Apply Level Sensors to Reservoir

Warning: Do not place level sensors below the minimum operating level recommended by thereservoir manufacturer.

Configuring the Level SensorsWhen the level sensors are connected to the Bio-Console, two level sensor buttons will appearon the lower portion of the Main Screen. These buttons indicate the level sensor status and allowthe user to configure the desired response to low fluid levels.


Chapter 6


Figure 54. Unconfigured Level Sensor Buttons

Note: When the level sensors are not plugged into the Base Unit, no level sensor buttons willappear.Pressing either of the level sensor buttons will cause the level sensor configuration window toappear (Figure 55). This window is divided into two sections:


Safety Systems


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Figure 55. Level Sensor Configuration Window

1. Level Sensor Enable/Disable — These buttons select whether the level sensor is enabledor not. If set to ON, the level sensing system will respond as configured (see below) if a lowfluid level is detected. If set to OFF, the level sensing system will not monitor the reservoir.Note: The level sensor enable/disable buttons will always default to OFF after the Bio-Console is switched to standby.

2. Level Sensor Configuration — These buttons select how the level sensing system willrespond if a low fluid level is detected. The configuration setting is indicated with text underthe level sensor button. The configuration choices are as follows:a. Alert Only (upper level sensor)/Alarm Only (lower level sensor) — If a low fluid level is

detected, a system alert or alarm will be generated and the button will changeappearance and color (yellow for alerts, red for alarms) (Figure 56).


Chapter 6


Figure 56. Upper Level Sensor Alert

b. Coast — If a low fluid level is detected, the pump will temporarily decelerate to the coastset speed until the sensor detects fluid. In addition, an alert or alarm will be generated.For more information on Coast, refer to page 71.Note: Coast will not engage if the pump speed is already less than the coast set speed.

c. Stop — If a low fluid level is detected, the pump will stop and, in addition, generate analarm. To restart the pump, the user must turn the RPM knob counterclockwise, past thedetent, to 0 RPM for a minimum of one second.Warning: If for any reason the centrifugal pump has stopped, the arterial line must beclamped either manually or by use of the AutoClamp system.Note: When the RPM knob is turned counterclockwise to 0 after a stop event (manualcontrol), the safety system that is overridden is the sensor that is not in its normaloperating condition when the RPM knob is at 0. The applicable safety system icon colorwill indicate its operating condition (Table 1).For example, if the reservoir does not fill up to an “OK” status level for the upper levelsensor, then the upper level sensor alert function will be ignored; and its icon will showgray (disabled) after the RPM knob is turned clockwise from 0.However, a lower level sensor event or a bubble detector event will trigger an alarm ifthose sensors are in their normal operating condition.

Note: Optionally, the clamp may be configured to close when the pump stops. Referto page 75.


Safety Systems


Note: The level sensing system will retain its configuration settings after the Bio-Console isswitched to standby.Once a selection is made in a level sensor window, the selected item will blink and the windowwill close. To close the window without making a selection, either press the level sensor buttonagain, press another safety system button, or wait 5 seconds and the window will close.

Level Sensor StatusThe graphics on the level sensor buttons change to represent the current level sensor status.Refer to Table 1 for a complete description of level sensor status indicators.

Table 1. Level Sensor Status Indicators

Icon Status

Upper Level Sensor, status OK.

Upper Level Sensor, status alert.

Upper Level Sensor, status disabled.

Upper Level Sensor, status error.

Lower Level Sensor, status OK.

Lower Level Sensor, status alarm.

Lower Level Sensor, status disabled.

Lower Level Sensor, status error.

Verifying the Level Sensing SystemTo verify that the level sensors are functioning properly:1. Ensure the level sensors are enabled.2. Manipulate the fluid levels in the reservoir in order to activate the upper and lower level

sensors.3. Verify the system responds appropriately for each sensor.

Removing Level Sensors from ReservoirTo remove the level sensors from the reservoir, pull on the finger grip portion of the level sensor(Figure 57).Caution: To avoid damage to the level sensor, do not pull on the cable when removing the levelsensor from the reservoir.


Chapter 6


Figure 57. Removing Level Sensors from Reservoir

Bubble Detection SystemOverviewThe bubble detection system is used to detect macro air bubbles in the circuit tubing. If air isdetected in the circuit tubing, it will trigger a system alarm and optionally may be configured toslow or stop the pump.The bubble detection system consists of the following components:

■ Bubble detector cable for adult patients, Model BD38

■ Bubble detector cable for pediatric patients, Model BD14

The bubble detector must be selected for tubing size compatibility with either adult patients orpediatric patients.

Connecting the Bubble Detector1. Attach the bubble detector cable to the back panel of the Base Unit (Figure 58).


Safety Systems


Figure 58. Attach Bubble Detector Cable to Base Unit

2. Press the bubble detector onto the circuit tubing at an appropriate location (Figure 59).

Figure 59. Press Bubble Detector onto Circuit Tubing

Caution: Tubing must be firmly seated in the bubble detector for it to detect bubbles properly.Warning: Proper positioning of the bubble detector is the responsibility of the user. Bubbledetectors must be positioned to allow sufficient time for the user to respond to detected bubbles.

Configuring the Bubble DetectorWhen the bubble detector is connected to the Bio-Console, a bubble detector button will appearon the lower portion of the Main Screen (Figure 60). This button indicates the bubble detectorstatus and allows the user to configure the desired response to the presence of bubbles in thecircuit tubing.


Chapter 6


Figure 60. Unconfigured Bubble Detector Button

Note: When the bubble detector is not plugged into the Base Unit, no bubble detector button willappear.Pressing the bubble detector button will cause the bubble detector configuration window toappear (Figure 61). This window is divided into two sections:


Safety Systems


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Figure 61. Bubble Detector Configuration Window

1. Bubble Detector Enable/Disable — These buttons select whether the bubble detector isenabled or not. If set to ON, the bubble detection system will respond as configured(Figure 62) if a bubble is detected. If set to OFF, the bubble detection system will not monitorthe circuit tubing.Note: The bubble detector enable/disable buttons will always default to OFF after the Bio-Console is switched to standby.

2. Bubble Detector Configuration — These buttons select how the bubble detection systemwill respond if a bubble is detected. The configuration setting is indicated with text under thebubble detector button. The configuration choices are as follows:a. Alarm Only — If a bubble is detected, a system alarm will be generated and the button

will change appearance and color (red).


Chapter 6


Figure 62. Bubble Detector Alarm

b. Coast — If a bubble is detected, the pump will temporarily decelerate to the coast setspeed until manually reset by the user. In addition, an alarm will be generated. For moreinformation on Coast, refer to page 71.Note: Coast will not engage if the pump speed is already less than the coast set speed.

c. Stop — If a bubble is detected, the pump will stop and, in addition, generate an alarm.To restart the pump, the user must turn the RPM knob counterclockwise, past the detent,to 0 RPM for a minimum of one second.Warning: If for any reason the centrifugal pump has stopped, the arterial line must beclamped either manually or by use of the AutoClamp system.Note: Optionally, the clamp may be configured to close when the pump stops. Referto page 75.Warning: Do not open the clamp after automatic closure until all air from the circuit hasbeen evacuated.

Note: The bubble detection system will retain its configuration settings after the Bio-Console isswitched to standby.Once a selection is made in the bubble detector window, the selected item will blink and thewindow will close. To close the window without making a selection, either press the bubbledetector button again, press another safety system button, or wait 5 seconds and the window willclose.


Safety Systems


Bubble Detector StatusThe graphics on the bubble detector button change to represent the current bubble detectorstatus. Refer to Table 2 for a complete description of bubble detection status indicators.

Table 2. Bubble Detector Status IndicatorsIcon Status

Bubble Detector, status OK.

Bubble Detector, status alarm.

Bubble Detector, status disabled.

Bubble Detector, status error.

Clearing a Bubble Detector AlarmAfter a bubble is detected, the bubble detector alarm must be cleared by pressing the bubbledetector button (Figure 65).Note: If the AutoClamp is closed, the Open Clamp button will not appear until the bubble detectoralarm is cleared.

Verifying the Bubble Detection SystemTo verify that the bubble detector is functioning properly:1. Ensure the bubble detector is enabled.2. Remove the tubing from the bubble detector.3. Verify the system responds with a bubble detector alarm.4. Reinsert the tubing into the bubble detector.5. Ensure the tubing is fully primed with no air bubbles.6. Clear the bubble detector alarm by pressing the bubble detector button.7. Verify that the alarm is cleared.

Bio-Pump Coast/StopCoastCoast is an automatic response that causes the Bio-Pump speed to be reduced to a user-selectedRPM of either 1500, 1750, or 2000 RPM.Note: The default setting for Coast with every new system is 2000 RPM.Warning: Before changing the Coast setting, be aware that varying conditions of patientresistance (eg, the patient’s Mean Arterial Pressure, or MAP) and hydrostatic pressure gradientbetween the patient and the venous reservoir affects the direction of fluid flow.Warning: User-selected Coast settings of 1500 RPM or 1750 RPM may not generate sufficientBio-Pump pressure to prevent arterial backflow.


Chapter 6


Note: The system backflow alarm will activate when the flow goes below -100 mL/min.To select a Coast speed:1. Enter the Settings Screen (Figure 63).2. Press the UP or DOWN arrows until the desired Coast RPM is selected.

3. Press to return to the Main Screen.

Figure 63. Setting Screen Coast Speed (RPM)

The system can be configured to have the Bio-Pump enter the Coast mode in response to eithera level sensing or bubble detection event. While the Bio-Pump is in the Coast mode, the followingchanges will occur on the screen (Figure 64):1. The button for the safety system that initiated Coast will change appearance and display in

either yellow or red, depending on severity.2. A (yellow) system alert will be generated and the event causing the pump to coast will display

in the System Status Message Box. Refer to Chapter 4.Note: The coast message may be preempted if a higher priority alert or alarm is active.

3. A yellow box will enclose the user-selected RPM value and “Coast” will be displayed.4. The RPM bar graph will split into two horizontal bars. The upper bar is black and displays

the speed setting of the RPM knob. The lower bar is yellow and displays the actual speed ofthe pump.

5. The yellow coast speed indicator will mark the speed set on the Settings Screen for the coastmode.


Safety Systems


The pump will remain at the user-selected Coast speed until the event is cleared or the safetysystem is disabled. The pump speed will then automatically ramp up its speed to the previouslevel.Warning: If the Bio-Pump enters the Coast mode in response to arterial air detection, the pumpwill remain at the user-selected Coast speed. It will not automatically ramp up after the air is nolonger detected by the bubble detector, or even after the bubble detector is turned OFF.

2

4

3 5

1

Figure 64. Coast Mode Activated

Note: Coast will disengage if the pump speed is manually reduced below the coast set speed.If Coast is engaged due to low fluid level detection from a level sensor, and the fluid level returnsabove the detector the following occurs:

■ Alert tone stops

■ Display “Reservoir Low” clears from the system status message bar on the screen

■ Bio-Pump RPMs ramp up to the speed that the RPM knob is set at

To manually disengage Coast, turn the RPM knob counterclockwise until the speed of the RPMknob (displayed by the black bar) is equal or less than the actual pump speed (displayed by theyellow bar).


Chapter 6


StopStop is an automated response, which reduces the pump speed to 0 RPM. The Bio-Console maybe configured to stop in response to either a low fluid level or bubble detection event. While thepump is stopped, the following changes will occur on the screen (Figure 65):1. The button for the safety system that stopped the pump will change appearance and display

in red.2. A (red) system alarm will be generated and the event causing the pump to stop will display

in the System Status Message Box. Refer to Chapter 4.

2

1

Figure 65. Pump Stop from Bubble Detected

Note: The stop message may be preempted if a higher priority alarm is active.Note: When the RPM knob is turned counterclockwise to 0 after a stop event, the bubbledetector or level sensor will be disabled if it is not in the normal operating condition.However, it may be necessary to enable each safety system again.

If air is detected, the pump will stop and, in addition, generate an alarm. In order to restart thepump, the user must turn the RPM knob counterclockwise, past the detent, to 0 RPM for aminimum of one second.


Safety Systems


AutoClamp SystemOverviewThe AutoClamp system is used to prevent retrograde flow. It may be configured to close inresponse to a pump stoppage or a flow rate of less than –100 mL/min. If the AutoClamp is closed,it must be opened by the user via a button press on the Main Screen.The AutoClamp system consists of the following components:

■ AutoClamp interface module, Model ACM100

■ AutoClamp interface module pole mount, Model ACMPM

■ Remote tube clamp, Model RTC100

■ Remote tube clamp mount adapter, Model RTCMA

■ Remote tube clamp pole mount TX50, Model RTC200

■ AutoClamp interface cable, Model ACM200

■ AutoClamp air supply line, Model ACM300

Note: The AutoClamp can be manually opened at any time (page 82).

Connecting the AutoClamp1. Secure the interface module pole mount to a pole (Figure 66).

2

1

Figure 66. Secure Interface Module to Pole

2. Attach the interface module to the pole mount (Figure 66).


Chapter 6


3. Attach the interface cable to the back panel of the Base Unit (Figure 67).

Figure 67. Attach AutoClamp Interface Cable to Back of Base Unit

4. Attach the other end of the interface cable to the left side of the interface module(Figure 68).

4

Figure 68. Attach Console-Module Cable to Interface Module

5. Attach the compressed air T-adaptor to the air inlet gas fitting of the oxygen-air blender(Figure 69).


Safety Systems


6

5

Figure 69. T-adaptor/Blender Connections

6. Attach the gas supply line to the T-adaptor (Figure 69).7. Attach the other end of the gas supply line to the air inlet connector on the interface module

(Figure 70).

7

Figure 70. Attach Gas Supply Line to Interface Module

Caution: Loss of air pressure or air pressure below 379 kPa (55 psi) will cause theAutoClamp to close.Caution: Air pressure greater than 689 kPa (100 psi) may damage the internal componentsof the interface module.

8. Slide the remote tube clamp onto the mount adapter and tighten the setscrew on the adapter(Figure 71).


Chapter 6


9

10

8

10

Figure 71. Remote Tube Clamp Attachment to Pole

9. Secure the remote tube clamp pole mount to a pole (Figure 71).10. Attach the remote tube clamp with mount adapter to the pole mount by pushing and holding

the button on the pin and sliding it through the aligned holes (Figure 71).11. Connect the remote tube clamp air supply line to the interface module (Figure 72).

12

11

Figure 72. Attach Air Supply Line and Communication Cable to Interface Module

12. Connect the remote tube clamp communication cable to the interface module (Figure 72).

Case SetupAfter priming the circuit, install a primed segment of the arterial circuit tubing into the remote tubeclamp (Figure 73):1. Loosen the knob to open the security latch.2. Insert the tubing.


Safety Systems


3. Close the security latch and tighten the knob.

1 2 3

Figure 73. Install Circuit Tubing into Remote Tube Clamp

Warning: Never place fingers inside remote tube clamp. Serious injury may occur if fingers arecaught in the remote tube clamp when it closes.

Configuring the AutoClampWhen the AutoClamp is connected to the Bio-Console, an AutoClamp button will appear on thelower portion of the Main Screen (Figure 74). This button indicates the AutoClamp status andallows the user to configure the desired response to pump stoppage or a flow rate less than–100 mL/min.

Figure 74. Unconfigured AutoClamp Button

Note: When the AutoClamp is not plugged into the Base Unit, no AutoClamp button will appear.


Chapter 6


Pressing the AutoClamp button will cause the AutoClamp configuration window to appear(Figure 75). This window is divided into two sections:

1 2

Figure 75. AutoClamp Configuration Window

1. AutoClamp Enable/Disable — These buttons select whether the AutoClamp is enabled ornot. If set to ON, the AutoClamp system will clamp the circuit tubing in response to pumpstoppage or low flow rate (Figure 76). If set to OFF, the AutoClamp system will not clamp thecircuit tubing (Figure 76).Note: The AutoClamp enable/disable buttons will always default to OFF after the Bio-Console is switched to standby.Note: Regardless of the enable/disable setting, the AutoClamp will only be activated after aflow of >250 mL/min has been achieved.

2. AutoClamp Configuration — These buttons select which events the AutoClamp willrespond to. The configuration setting is indicated with text under the AutoClamp button. Theconfiguration choices are as follows:a. Pump Stop — If the pump stops for any reason, the AutoClamp will close. A system

alarm will be generated and the button will change appearance and color (red)(Figure 65).

b. Backflow — If the measured flow rate is less than –100 mL/min, the AutoClamp willclose. A system alarm will be generated and the button will change appearance and color(red) (Figure 76).


Safety Systems


Figure 76. Pump Stop from Backflow

c. Both — If the pump stops or the measured flow rate is less than –100 mL/min, theAutoClamp will close. A system alarm will be generated and the button will changeappearance and color (red).

Note: The AutoClamp system will retain its configuration settings after the Bio-Console isswitched to standby.Once a selection is made in the AutoClamp configuration window, the selected item will blink andthe window will close. To close the window without making a selection, either press theAutoClamp button again, press another safety system button, or wait 5 seconds and the windowwill close.

Opening the AutoClampIf the AutoClamp closes for any reason, an Open Clamp button appears. Once the user hasdetermined it is safe to resume patient flow, the AutoClamp may be opened as follows:1. Turn RPM knob to 0 and then up to a speed greater than the coast set speed.2. Press the Open Clamp button.Warning: Reestablish pump RPM before unclamping the arterial line. Failure to do so couldcause retrograde flow.Note: In order to gradually reintroduce flow, it is recommended to use a hemostat in combinationwith opening the AutoClamp.


Chapter 6


Manually Opening the AutoClampIf for any reason you need to override the AutoClamp system, the AutoClamp can be manuallyopened as follows (Figure 73):1. Loosen the remote tube clamp knob to open the security latch.2. Remove the tubing.

AutoClamp StatusThe graphics on the AutoClamp button change to represent the current AutoClamp status. Referto Table 3 for a complete description of AutoClamp status indicators.

Table 3. AutoClamp Status IndicatorsIcon Status

AutoClamp, status OK.

AutoClamp, status alarm.

AutoClamp, status disabled.

AutoClamp, status error.

Verifying the AutoClamp SystemTo verify that the AutoClamp is functioning properly:1. Ensure the AutoClamp is enabled and the system is properly connected.2. Turn the RPM knob to a value >1000 RPM.3. Turn the RPM knob to zero.4. Verify the AutoClamp closes and the tubing is fully occluded.5. Confirm that the RPM knob is at zero then turn to >2000 RPM.6. Press the Open Clamp button.7. Verify the AutoClamp releases.

Backflow AlarmIf the RPM knob is set above zero, the Bio-Console backflow alarm will activate when flow goesbelow –100 mL/min. If a backflow alarm is active, a red down arrow will flash next to the flowmonitor value (Figure 77). For additional information, refer to Chapter 4.


Safety Systems


Figure 77. Backflow Alarm


Chapter 6



Maintenance


Maintenance 7

Cleaning the Flow TransducerTo clean the flow transducer, refer to the instructions included with the Bio-Probe blood flowmonitoring system.

Cleaning the Bio-Console and Accessories1. Make sure the AC power switch on the back panel is turned OFF.2. Unplug the electrical cord of the Base Unit from the AC outlet.

Warning: To avoid an electrical shock, the Bio-Console must be disconnected from the ACpower source during servicing or cleaning.

3. Use a mild detergent to clean the Base Unit and accessories with a sponge or a soft clothmoistened with water.

4. Use a mild detergent to clean the User Interface with a sponge or a soft cloth moistened withwater.Caution: Do not immerse the Base Unit or accessories, nor allow water to run into the interiorof the Base Unit or accessories. Do not use alcohol or alcohol-based cleaning solutions. Donot spray fluid into electrical connectors or onto the User Interface screen.

Servicing the Pump MotorThe moving parts of the pump motor are lubricated at the factory and require no further lubrication.The pump motor is a DC brushless motor, which requires infrequent maintenance. Schedule anannual preventative maintenance check with a Medtronic service technician. The inspection andmaintenance may be done either on site or at the factory. A Preventative Maintenance Log formis included in Appendix F.To prevent damage while the pump motor is not in use, utilize the red protective cover.

Servicing the Bio-Console and AutoClamp Interface ModuleNote: Do not attempt to service the Bio-Console or AutoClamp interface module; doing so willvoid the warranty.Schedule an annual preventative maintenance check with a Medtronic service technician. Theinspection and maintenance may be done either on site or at the factory. A PreventativeMaintenance Log form is included in Appendix F.If the Bio-Console or AutoClamp interface module appear to be malfunctioning, referto Appendix A or consult with a Medtronic service technician.Warning: Do not adjust, modify, repair, or touch the internal circuitry. These actions could causeoperator injury or cause faulty operation of the Bio-Console or AutoClamp interface module.


Chapter 7


Medtronic employs highly trained representatives and engineers located throughout the world toserve their customers. Upon request, training about Medtronic products is provided to qualifiedhospital personnel. In addition, Medtronic maintains a professional staff of consultants to providetechnical consultation to product users. For supplemental information, contact your localMedtronic representative at the address or telephone number listed on the back cover.

Maintaining and Charging the BatteriesThe Base Unit has two batteries that must be charged:

■ after being used as a backup electrical power source

■ before the first procedure with the device

■ when the battery charge is low

■ after extended storage

If the battery charge is low, recharging to 90% capacity takes approximately 18 hours and a fullcharge requires approximately 24 hours. To determine how long the batteries will provide energy,refer to Appendix C. Battery life depends upon both the RPM and the flow rate.Caution: The batteries may be damaged if they are not recharged after use.

To charge the batteries:

1

2

1. AC Power Switch2. Power Cord Port

Figure 78. AC Power Switch

1. Plug one end of the AC power cord into the connector at the back of the Base Unit and theother end of the cord into an electrical outlet.

2. Push the AC power switch to the ON position and allow it to remain turned on for 24 hours.

Checking Battery Charge StatusBattery charge status is indicated by the Battery Charge Status Indicator icon on the UserInterface Screen, on the Base Unit Console Screen and an LED Indicator. If you wish to checkbattery charge status further, you may follow this procedure:


Maintenance


1. Turn OFF the AC power switch on the back panel of the Base Unit. An alert will soundindicating the loss of AC power. (Press the AC Power Status button to silence the Alert for10 minutes.) The Bio-Console will automatically switch to battery backup due to the loss ofAC power.

2. Make sure a primed centrifugal pump is properly placed in the pump motor receptacle.3. Turn the RPM knob to the highest RPM setting for 10 seconds. During this time, make sure

the battery status indicator remains green.If the battery status indicator on the Main Screen changes to yellow or red, the batteries arenot fully charged. (Recharging the batteries to 90% capacity takes approximately 18 hoursand a full charge requires approximately 24 hours.) Ensure the availability of another Bio-Console during the procedure.

4. Turn the RPM knob below zero to the clicked OFF position.5. Turn ON the AC power switch.

Figure 79. Battery Status Indicator

Note: When AC power is initiated, the battery icon may momentarily display yellow beforeshowing actual battery status.

Battery Service and DisposalTo determine if the batteries need to be replaced, consult with a Medtronic service technician.When discarding batteries, discard according to local and hospital procedures. See page 88.

Checking the HandcrankTo ensure that the handcrank is accurate and operational, inspect the handcrank visually andfunctionally every month.

Visual Inspection1. Remove the red cover over the pump receptacle and visually inspect the magnet for damage.2. Slide the protective cover over the receptacle and make sure the locking pin secures the

cover.3. Visually inspect the handle for any damage.4. If the magnet or handle appears damaged, consult with a qualified Medtronic service

technician.

Functional Inspection1. Place a Bio-Pump centrifugal blood pump that is attached to a primed circuit into the pump

receptacle of the handcrank.2. Turn the handcrank handle to ensure that the magnets couple.3. Turn the handle and ensure that the RPM display is functioning. Refer to Table 4, Properties

of the Handcrank Model 150.


Chapter 7


4. If the magnet does not couple or if the RPM display is not functioning, consult with a qualifiedMedtronic service technician.

End of Life DispositionDo not dispose of this product in the unsorted municipal waste stream. Dispose ofthis product according to local regulations. See http://recycling.medtronic.com forinstructions on proper disposal of this product.


Emergency


Emergency 8This section describes the necessary emergency actions if:

■ the pump motor stops functioning

■ AC power fails

■ battery backup fails

Blood Pump FailureIf the centrifugal blood pump does not spin:1. Reset the motor controller by turning the RPM knob to zero.2. Hold for a minimum of one (1) second.If the centrifugal blood pump stops spinning and cannot be restarted:

1. Clamp the arterial and venous lines to prevent retrograde flow (Figure 80).2. Refer to page 90 in this section.

Figure 80. Prevent Retrograde Flow


Chapter 8


Electrical Power FailureAC Power FailureIf hospital AC power fails, the internal batteries in the Base Unit will immediately provide backuppower to the system. Battery backup will last for one half hour to allow for appropriate surgicaldecision-making.Ensure that the AC power cord is plugged into the back panel of the Base Unit and into the walloutlet, and ensure that the AC power switch on the back panel is turned ON. This will allow theBio-Console to immediately return to normal electrical operation when AC power is restored.Note: To silence the audible alert, press the AC Power Status button on the Main Screen.

Battery Backup FailureIn the unlikely event that hospital power and emergency generation power are lost and batterybackup fails, the handcrank must be used to maintain extracorporeal blood flow. Refer to“Emergency Use of the Handcrank” for information on using a handcrank.

Battery Life Estimates

Under operating conditions of 4 L/min and 400 mm Hg differential pressure, the batteries willfunction for approximately 1/2 hour.These time durations are based on new, fully-charged batteries. Instructions for ensuring that thebatteries have a full charge are described in page 86.

Bio-Console System FailureIf there is a Bio-Console System failure (as opposed to an electrical power failure), the Bio-Pumpmust be attached to a standby Bio-Console. However, if a standby Bio-Console is not available,a roller pump must be used. Refer to page 94 for information on using a roller pump.

Emergency Use of a Standby Bio-Console1. After clamping the arterial and venous lines, attach a handcrank as described in Figure 82

to maintain blood flow during the transfer to the standby console.2. Follow the procedures in Chapter 3 and Chapter 4 to configure the standby Bio-Console

system.3. Follow the procedures for the appropriate case settings.After resuming the RPM necessary to overcome the system resistance, unclamp the arterial andvenous lines.

Emergency Use of the HandcrankThe Model 150 Handcrank connects to a Model BP-50 or Model BPX-80 Bio-Pump centrifugalblood pump and provides manual power should the AC power or battery power fail. Manual powerto the pump is achieved by turning the handle.


Emergency


The handcrank has an LED display calibrated for the centrifugal pump speed to indicate the RPMof the centrifugal blood pump. The centrifugal pump speed does not directly correlate to flow rate.The Model 150 Handcrank may be operated from either the right or left side by turning themounting adapter 180°. Turn the handle in the direction of the arrows.Note: If the handle is turned in the opposite direction of the arrows, the centrifugal pump stillpumps fluid through the outlet, but the efficiency is reduced and the LED display does notilluminate.

Table 4. Properties of Handcrank Model 150Feature Model 150OperatorHandle Turning Left or Right SideMount Heart Lung Machine PoleRPMDisplay Range 1000 to 3250 RPMGear Ratio 1 handcrank RPM: 25 centrifugal pump RPM

88 handcrank RPM: 2200 centrifugal pump RPMDisplay Light Emitting Diode (LED)Weight 3.2 kg (approximately 7 lb)


Chapter 8


Components of the Model 150 Handcrank

1

2

3

Figure 81. Handcrank Components

1. Pump Receptacle.2. RPM Display.3. Handle.


Emergency


Attaching and Using the Model 150 Handcrank

4

7

8

10

Figure 82. Attaching and Using the Model 150 Handcrank

Note: Due to the effort required to maintain an appropriate RPM rate, it is recommended to haveadditional personnel available to operate the handcrank.1. Inspect the handcrank visually and functionally.2. Clamp the arterial and venous lines.3. Attach the handcrank to the pole mount adapter.4. Place the pole mount adapter with the handcrank attached on the pole.5. Turn the securing knob to ensure a snug fit on the pole.6. Remove the red cover on the handcrank pump receptacle.7. Remove the centrifugal blood pump from the pump motor.8. Attach the centrifugal blood pump to the handcrank receptacle so that the outlet is positioned

away from the top center.9. Pull out the gripping bar so that it is perpendicular to the handle.10. Turn the handle in the direction of the arrow on the handcrank.

Note: If the handle is turned in the opposite direction of the arrows, the centrifugal pump stillpumps fluid through the outlet, but the efficiency is reduced and the LED does not illuminate.

11. After resuming an RPM that overcomes the system resistance, unclamp the arterial andvenous lines and maintain an appropriate handle rotation speed, as viewed on the handcrank


Chapter 8


display. Rotating the handcrank 1 RPM is equivalent to 25 centrifugal pump RPM. (Example:Rotating the handle 88 RPM is equivalent to 2200 centrifugal blood pump RPM.)

Emergency Use of a Roller PumpIf a standby Bio-Console is not available, a roller pump must be used.1. After the arterial and venous lines are clamped, make sure a sufficient portion of arterial

tubing is on the inlet side of the centrifugal blood pump.2. Place a portion of the arterial pump inlet tubing into a properly occluded roller pump head,

release the clamps, and begin forward flow. (The centrifugal blood pump may remain as partof the circuit.)


Use of Base Unit Display


Use of Base Unit Display 9

Using the Base Unit Display Instead of the User InterfaceThe Base Unit display area (Figure 83) presents basic information of extracorporeal flow rate andcentrifugal pump speed. In the event that the touch screen User Interface should stop functioning,the case can be managed with the controls from separate screens of the Base Unit display. Theup/down selection keys scroll through the different screens.

■ Base Unit Screen 1: System Status

■ Base Unit Screen 2: Zeroing Flow Rate

■ Base Unit Screen 3: Set High Flow Rate Alarm

■ Base Unit Screen 4: Set Low Flow Rate Alarm

■ Base Unit Screen 5: Error Status

After several seconds of no activity on a particular screen, Base Unit Screen 1 will reappear.

Note: The RPM control knob on the User Interface operates independently of the User Interfaceand will continue its functionality even if the touch screen fails.

Bio-Console® 560

21

4

3

5

6

Figure 83. Bio-Console Base Unit Display

1. Graphic/character display.2. “AC Power connected” LED (flashes when battery is charging).3. Alarm mute key.4. Enter key (applies selected values).5. Up/Down Menu Selection keys.6. Left/Right Value Selection keys.

Note: Depress key for 5+ seconds to increase values faster.

Base Unit Display Startup ScreenWhen the power switch on the front panel is turned ON, the Base Unit will perform a self test.


Chapter 9


Base Unit Screen 1 — System StatusDuring the case, Base Unit Screen 1 displays the current flow and RPM settings and is the defaultdisplay.

L/min

RPM

Figure 84. Base Unit Screen 1

1. Flow Rate (L/min)2. Centrifugal Pump Speed3. Battery Charge Level4. Rotating clock hand represents Bio-Console operation.

Press the Down Main Menu Selection Key to view the next Base Unit Screen.

Base Unit Screen 2 — Zeroing Flow Rate

L/min L/minFlow ZeroFlow Zero

Yes No


1. Screen identifier.2. Press left/right selection keys to highlight Yes or No.

3. Press Enter .4. If the flow rate is higher than 0.10 L/min, the Yes/No options will not appear.

Press the Down Main Menu Selection Key to view the next Base Unit Screen.


Use of Base Unit Display


Base Unit Screen 3 — Set High Flow Rate Alarm

L/min

L/min

High Flow Alarm


1. Screen identifier.2. Press the left/right selection keys to set the high flow rate alarm.

3. Press Enter .Press the Down Main Menu Selection Key to view the next Base Unit Screen.

Base Unit Screen 4 — Set Low Flow Rate Alarm

L/min

L/min

Low Flow Alarm


1. Screen identifier2. Press the left/right selection keys to set the low flow rate alarm.

3. Press Enter .Press the Down Main Menu Selection Key to view the next Base Unit Screen.


Chapter 9


Base Unit Screen 5 — Error Status

L/min

Error 77


1. Displays error code to report for servicing. Use left/right arrows to scroll error list.Note: If no errors have occurred, “No Error” will be displayed in this field.


Checklist and Troubleshooting


Checklist and Troubleshooting AThis section describes common situations that may occur when using the Bio-Console and correctiveactions that may resolve these situations. If the actions recommended in this section have been followedand the situation is not resolved, consult a Medtronic service technician.

Quick Start GuideThis is a short summary of steps detailed in Chapters 3 through 5 of this manual.

Item Activity1. Be sure the Bio-Console

is turned OFF beforeattaching components tothe back panel.

■ Turn the Power On/Standby switch to OFF.

2. Connect the componentsto the back panel of theBase Unit.

■ Connect the User Interface cable to the User Interface and the BaseUnit.

■ Attach the pump motor cable to the back of the Bio-Console.

■ Lock the centrifugal blood pump into the external pump receptaclewith the outlet positioned away from the top center.

■ Connect the flow transducer cable to the FLOW connector on theback of the Bio-Console.

■ Connect a 3-way stopcock and a fluid barrier to the male luer lockPRESSURE connector on the back panel of the Base Unit.

■ Attach optional safety systems, if desired.

■ If desired, attach a computer cable to the RS 232 digital output inter-face on the back of the User Interface.

3. Check the internal batter-ies.

■ Turn the Power On/Standby switch to ON.

■ Turn OFF the AC power switch on the back panel.

■ With a primed Bio-Probe blood flow monitoring system attached toa centrifugal pump, turn the RPM to the highest setting for 10 sec-onds.

■ Make sure the battery status indicator remains green.

■ Turn ON the AC power switch on the back panel.4. Check the functionality of

the pump drive motor.■ Turn the RPM knob to MAX RPM and back to the clicked OFF posi-

tion. While doing this, make sure the PUMP SPEED and RPM displayand graph show appropriate values.


Appendix A


Item Activity5. Connect, prime, and zero

the pressure transducer.■ Attach the pressure tubing with a fluid barrier and a 3-way stopcock

to the PRESSURE connector on the back of the console.

■ Prime the pressure tubing.

■ Turn the 3-way stopcock so that the pressure transducer is exposedto air.

■ Press the Pressure Zero button on the User Interface SettingsScreen until 0 mm Hg is displayed.

6. Assemble the Bio-Probeblood flow monitoringsystem.

■ Attach the arterial tubing to one side of the insert and the centrifugalpump outlet tubing to the other side.Note: Make sure an adult insert (DP-38) is used with an adult trans-ducer (TX-50); similarly, use a pediatric insert (DP-38P) with a pedia-tric transducer (TX-50P).

■ Align the insert (under the transducer cover) according to the fluidpath direction shown on the transducer cover.

■ Prime the centrifugal pump, insert, and tubing as described in theinstructions included with the Bio-Pump centrifugal pump.

7. Zero the flow transducer. ■ Clamp the tubing on the outlet of the centrifugal blood pump.

■ Press the Flow Zero button on the User Interface Settings Screenuntil 0.00 L/min is displayed.

8. Check the flow range andflow alarm.

■ Press the appropriate Flow Range Display button on the User Inter-face Settings Screen.

■ Press the upper and lower Flow Alarm Limit buttons on the UserInterface Settings Screen until the desired limits are displayed.

THE CONSOLE IS READY FOR USE

AC Power and External Motor Troubleshooting

Situation Checklist for Resolution1. No AC power to the Bio-

Console.■ Verify AC power cord is plugged into an electrical outlet.

■ Verify AC power cord is plugged into the back panel of the Base Unit.

■ Verify both the AC power switch on the back panel and PowerOn/Standby switch on the front panel are turned ON.

If pump motor function is not restored, use a Model 150 handcrank ortransfer the centrifugal blood pump to a standby Bio-Console.

2. The pump motor does notspin.

■ Turn the knob to zero for a minimum of one (1) second, then turn theknob to the desired RPM value.

■ Verify the pump motor cable is properly connected to the back panelof the Base Unit.

If power to the Bio-Console is not restored, use a replacement pump drive,Model 150 handcrank, or transfer the centrifugal blood pump to a standbyconsole.




Bio-Pump Centrifugal Blood Pump Troubleshooting

Situation Checklist for Resolution1. The disposable pump

rotates but flow is not indi-cated.

■ Verify flow transducer is installed with proper flow orientation and isplugged into the Bio-Console.

■ Verify the centrifugal blood pump is primed.

■ Verify all clamps are removed from flow circuit.

■ Verify RPM is sufficient to overcome the outlet resistance.

■ Verify flow circuit is free of occlusions.

■ Verify flow transducer is zeroed. (Flow value will flash if transduceris not zeroed.)

If the flow display still does not function, use a standby flow transducer.2. The disposable pump

vibrates when the RPM isincreased.

■ Verify the centrifugal blood pump is placed securely in the remotedrive receptacle.

■ Verify there are no foreign objects on the centrifugal blood pump ordrive magnets.

If the centrifugal blood pump still vibrates, replace it.

Flow Troubleshooting

Situation Checklist for Resolution1. The flow value is flashing

dashes.■ Verify the flow transducer cable is properly connected to the Bio-

Console.

If the flow display is still flashing dashes, use a standby transducer.2. The flow value is flashing. ■ Verify the flow transducer has been zeroed.

■ Verify the insert is placed correctly into the transducer.

■ Verify the insert pins are dry.

■ Verify the transducer cover is latched securely.

■ Is the system primed with either a balanced electrolyte solution ornormal saline solution (not 5% Dextrose in Water [D5W] or sterilewater)?

■ Verify there is no intermittent electrical interference present. Wheninterference stops, the flow value will stop flashing.

If the flow value is still flashing, use a standby transducer.3. The flow value flashed for

a moment.This is normal operation. (The flow changed abruptly, eg, the RPM knobwas turned very quickly or a clamp was placed or removed quickly.)


Appendix A


Situation Checklist for Resolution4. The centrifugal pump is

revolving but a flow valueis not displayed.

■ Verify the flow transducer is installed with proper flow orientation andplugged into the Bio-Console.

■ Verify the centrifugal blood pump is primed.

■ Verify all clamps are removed from the flow circuit.

■ Verify the RPM is sufficient to overcome outlet resistance.

■ Verify the flow circuit is free of occlusions.

■ Verify flow transducer is zeroed. (Flow value will flash if transduceris not zeroed.)

If the flow value is still not displayed, use the standby transducer or plotthe RPM and difference in pressure between the inlet and outlet of thecentrifugal blood pump on the charts in Appendix B.

5. The centrifugal pump isrevolving but a negativeflow value is displayed.

■ Verify the fluid flow direction is aligned with the arrow on the trans-ducer.

■ Verify the RPM is adequate to achieve positive flow.6. The flow transducer will

not zero.■ Verify the circuit tubing is clamped and the flow is zero.

■ Verify no electrical interference is present.

■ Verify no system errors are present.

■ Verify the transducer cover is securely closed.

■ Verify the insert pins (inside the flow transducer) are dry.

If the transducer will still not zero, use the standby transducer.7. The displayed flow differs

from the expected values.■ Verify there are no flow circuit occlusions. Flow resistance affects the

flow rate.

■ Verify the transducer is zeroed correctly.

RPM Troubleshooting

Situation Checklist for Resolution1. The RPM display is flash-

ing.Minor User Interface malfunction, but the RPM value is valid. Call a Med-tronic service technician.

2. The RPM display is flash-ing dashes.

■ Verify the pump motor is connected.

If the pump motor is connected, there is a system failure. Use a backupBio-Console. Call a Medtronic service technician.

3. The RPM display indi-cates zero.

Turn the knob clockwise.If the RPM is still displayed as zero, use a standby console.

4. The RPM knob will notturn below 2,000.

Normal operation for the RPM knob. To reduce the RPM below 2,000,press the black button on the RPM knob while turning the knob.

5. When using the batteries,RPM is insufficient.

The battery charge is low. Prepare to use a standby Bio-Console or ahandcrank.




Battery Power Troubleshooting

Situation Checklist for Resolution1. The internal batteries are

not charged.■ Verify the AC power switch is turned ON.

■ Verify the charger LED on the Console face panel is flashing.Note: Battery charging requires 18-24 hours.

If batteries are not charged after 24 hours, call a Medtronic service tech-nician.

Digital Output TroubleshootingRefer to Appendix D in this manual for complete instructions.

Situation Checklist for Resolution1. The computer does not

receive data.■ Verify the cable is connected to the RS 232 interface on the back of

the User Interface and to the computer.

■ Verify the baud rate and handshake method are appropriate for thedevice.

Safety Systems Troubleshooting

Situation Checklist for Resolution1. Cannot get green light

status on the System Sta-tus Indicator when safetysystems are connected.

■ Verify no system errors are present.

■ Verify all safety systems are enabled and configured.Note: All safety systems that are plugged in must be enabled andconfigured to achieve green light status except for the upper levelsensor.

2. The level sensor reportslow fluid level when fluidlevel is normal.

■ Verify sensor is firmly fixed to reservoir.

■ Verify target on sensor is at or below the fluid level.

■ Verify red light on sensor is lit (red light is lit when fluid is presentwithin sensor target).

If sensor is properly applied and fluid is present, replace sensor cable.3. The level sensor reports

adequate fluid level whenfluid level is low.

■ Verify sensor is positioned correctly.

■ Verify red light on sensor is not lit (red light is lit when fluid is presentwithin sensor target).

■ Remove sensor from reservoir and verify it does not detect fluid.

If fluid is detected when sensor is not attached to reservoir, replace sensorcable.


Appendix A


Situation Checklist for Resolution4. The bubble detector

reports bubbles when nobubbles are present.

■ Verify tubing is properly seated in bubble detector.

■ Verify tubing size is compatible with bubble detector.

■ Reposition bubble detector to a known bubble-free section of tubing.

If bubbles are still falsely detected, disable or replace bubble detector.5. The bubble detector fails

to report bubbles whenpresent.

■ Verify bubble detector reports bubble when removed from tubing.

■ Reposition bubble detector.

■ Verify tubing size is compatible with bubble detector.

If bubbles are still not detected, disable or replace bubble detector.6. AutoClamp will not open

when Open Clamp buttonis pressed.

■ Verify RPM is >2000 when Open Clamp is pressed.

■ Verify air pressure is adequate.

■ Verify AutoClamp cables are securely attached to interface module.

If AutoClamp still does not open, manually open the clamp to remove thetubing and replace clamp.

7. AutoClamp will not close. ■ Verify AutoClamp is enabled and configured.

■ Verify bubble detector and level sensors are configured to stop thepump and are enabled.Note: The AutoClamp will close for pump stop or backflow or bothconditions, depending on the configuration.

8. AutoClamp malfunctionerror message appears.

■ Verify air pressure is adequate.

■ Verify AutoClamp cables are securely attached to interface module.

If clamp malfunction error remains, manually open the clamp to removethe tubing and replace clamp.

Alert and Alarm Message Priority

Priority Text-line 1 Text-line 2 Color

1 Communication to Base Unit Lost Call Service Red2 Bubble Detected Press Bubble Detector Button To

AcknowledgeRed

3 Motor Disconnected Red4 Reservoir Low (Lower Sensor) Bio-Pump Stopped — Clamp Closed Red5 Reservoir Low (Upper Sensor) Bio-Pump Stopped — Clamp Closed Red6 Reservoir Low (Lower Sensor) Bio-Pump Stopped Red7 Reservoir Low (Upper Sensor) Bio-Pump Stopped Red8 Biopump Stopped — Clamp Closed Turn Knob To 0 To Restart Red9 Biopump Stopped Turn Knob To 0 To Restart Red10 Backflow — Clamp Closed Press “Open Clamp” Button To Open Red11 Clamp Closed Low Clamp Air Pressure Red12 Clamp Closed Press “Open Clamp” Button To Open Red13 Backflow Red14 Reservoir Low (Lower Sensor) Bio-Pump Coasting Red




15 Reservoir Low (Lower Sensor) Red16 Bio-Pump Coasting Lower Knob Speed To Disengage Red17 Low Battery Red18 Flow Transducer Disconnected Red19 Reservoir Low (Upper Sensor) Bio-Pump Coasting Yellow20 Reservoir Low (Upper Sensor) Yellow21 High Flow Yellow22 Low Flow Yellow23 P1/2 High Pressure Yellow24 P1/2 Low Pressure Yellow25 AC Power Failure Press AC Power Failure Button To Clear

AlertYellow

26 Low Clamp Air Pressure Yellow27 Flow System Interference Detected Yellow28 Motor Controller Malfunction Press Service (Wrench) Button to

AcknowledgeYellow

29 Flow System Malfunction Press Service (Wrench) Button toAcknowledge

Yellow

30 Pressure Monitor 1/2 Malfunction Press Service (Wrench) Button toAcknowledge

Yellow


Yellow

32 Clamp Malfunction Press Service (Wrench) Button toAcknowledge

Yellow

33 Bubble Detector Malfunction Press Service (Wrench) Button toAcknowledge

Yellow

34 UL/LL Sensor Malfunction Press Service (Wrench) Button toAcknowledge

Yellow

35 Servo System Malfunction Press Service (Wrench) Button toAcknowledge

Yellow

36 Safety System Malfunction Press Service (Wrench) Button toAcknowledge

Yellow

37 UPS Malfunction Press Service (Wrench) Button toAcknowledge

Yellow

38 Motor Controller Malfunction Press Service (Wrench) Button toAcknowledge

Yellow

39 Flow System Malfunction Press Service (Wrench) Button toAcknowledge

Yellow


Yellow


Yellow

42 Clamp Malfunction Press Service (Wrench) Button toAcknowledge

Yellow

43 Bubble Detector Malfunction Press Service (Wrench) Button toAcknowledge

Yellow

44 UL/LL Sensor Malfunction Press Service (Wrench) Button toAcknowledge

Yellow


Appendix A


45 Servo System Malfunction Press Service (Wrench) Button toAcknowledge

Yellow

46 Safety System Malfunction Press Service (Wrench) Button toAcknowledge

Yellow

47 UPS Malfunction Press Service (Wrench) Button toAcknowledge

Yellow

48 Clamp Disabled Yellow49 Bubble Detector Disabled Yellow50 LL Sensor Disabled Yellow51 Medtronic Bio-Console 560 Green


Hydraulics


Hydraulics B

Viscosity and Flow RateThe following charts show the relationship between RPM, pressure, and flow. The flow ratesreflect a fluid viscosity of 2.1 mPa·s. This viscosity is similar to the combination of blood andbalanced electrolyte solution, which occurs during a cardiopulmonary bypass procedure.The same viscosity was used for the BPX-80 and BP-50 models of the Bio-Pump centrifugalblood pumps.

Determining the FlowThe following charts are useful if a flow display malfunctions. To determine the flow, plot the RPMand difference in pressure between the inlet and outlet of the centrifugal blood pump on the chart.If pressure is not measured at the outlet of the centrifugal blood pump, add the pressure dropacross the devices in the line.

BPX8030% Hct Bovine Blood

Differential Pressure (mm Hg)

RPM

Flow (L/min)

Figure 89. Model BPX-80 Centrifugal Pump Flow Rate


Appendix B


Differencein

Pressure(mm Hg)from the

Inletto theOutlet

BP-50 Flow Curve

4000 RPM

3000 RPM

2000 RPM

1000 RPM

0.25 0.5 0.750 1 1.25 1.5 1.75 2

Figure 90. Model BP-50 Centrifugal Pump Flow Rate


Battery Longevity


Battery Longevity C

Variable FactorsMany variables affect the length of time a battery will operate. The three main factors are:

■ the RPM at which the centrifugal blood pump is revolving

■ the blood flow through the centrifugal blood pump

■ the age and charge status of the battery

Battery Life EstimatesUnder operating conditions of 4 L/min and 400 mm Hg differential pressure, the batteries willfunction for approximately 1/2 hour.These time durations are based on new, fully-charged batteries. Instructions for ensuring that thebatteries have a full charge are described in Chapter 7.


Appendix C



Digital Output


Digital Output D

OverviewThis section describes the protocol of the Bio-Console 560 (560) RS 232 interface to facilitatethe connection of an external computer or data output device. The Bio-Console 560 RS 232interface has two operating modes and data format protocols that provide support for the legacyBio-Console 550 (550) in addition to the Bio-Console 560.

Selecting the Appropriate Transmission ModeThe Bio-Console 560 RS 232 interface supports two basic modes to determine the intervalbetween data transmissions, periodic transmission, and on-request transmission.

Periodic TransmissionDuring periodic transmission, data are automatically sent at a predefined interval as specified bythe Setup Screen or through the “DR” command “rate” parameter.Periodic transmission of data is applicable when no custom data output applications are available.With the periodic transmission mode, a standard terminal emulator program (such asHyperTerminal which comes with most PCs) can be used to capture the data that can then beformatted and manipulated using standard PC tools.

On-Request TransmissionDuring on-request transmission, data are only sent in response to a DR command.On-request transmission of data is preferred for data output applications because the applicationcan request data when required. This allows the custom application to enable/disable data outputand determine the transfer rate.

Selecting the Appropriate ProtocolThe RS 232 protocol refers to the specific data transmitted periodically or in response to a DRcommand. The 550 protocol is a subset of the 560 protocol; therefore the 560 protocol is preferredfor most applications.The 550 protocol is provided to support applications where a custom data output application hasalready been developed and it is undesirable to modify the application for the 560 protocol.For those applications where both the 550 and the 560 Bio-Consoles must be supported, thefollowing options are available:

■ Utilize the 550 protocol on the 560 to support both instruments.

■ Utilize the 560 protocol and modify the data output application to use the “ID” command todetermine the appropriate protocol. This would allow both the 550 and 560 Bio-Consoles tobe supported for data output without compromising the transmitted data.

Once the desired protocol has been determined, the protocol may be selected using the SetupScreen or through the DR command “format” parameter.


Appendix D


RS 232 CommandsThis section defines the 560 RS 232 interface commands.

Command SyntaxAn external data output device can request data from the 560 by sending a command string. Acommand string consists of a series of ASCII characters that comprise the command, parameters(if required), and a checksum value. The command is terminated with an ASCII “CR” (0x0D)character.Once the command has been received, the 560 will respond with an ASCII string as defined bythe specific command or an error as defined under “Command Errors.”Note: Items enclosed in “{}” are optional. Items enclosed in “<>” are mandatory. Items enclosedin “(..)” may be repeated as required.Commands are defined utilizing the following syntax:<CMD>{(<SEP><DATA>…)}<Checksum><CR> where:

<CMD> ASCII characters used to define a command.<SEP> Separator, used to separate data fields. The space character (0x20) is used

as the separator.<DATA> Data field, used to provide data required by the command.<Checksum> Used to check validity of data. It is the sum of ASCII values of all the char-

acters in the command excluding the checksum. This total is representedby a 4 digit ASCII hexadecimal number with leading zeros as required. Thechecksum value must be in upper case characters.

<CR> Carriage Return (0x0D), used to specify the end of the command string.

Command ErrorsThe error response is sent from the Bio-Console to the PC/data output device in response to aninvalid message received. The format of this response is:<ER><SEP><Error Code><SEP><Checksum><CR>

ER: Indicates an error response.Error code Code A 2-character value which specifies the error condition detected. The

error codes are defined as:

■ 00 — Unknown command for processor

■ 01 — Wrong number of parameters

■ 02 — Parameter out of range

■ 03 — Unexpected ErrorExample:

Field Characters<Command><SEP> E R <Error Code><SEP> 0 1 <checksum><CR> 0 1 3 8


Digital Output


Example of data output as displayed in terminal emulator application (HyperTerminal):ER 01 0138

DR, Set Data RateThe DR command is sent from the terminal to the Bio-Console 560 to select the periodic rate inwhich the data output commands will be sent. After receiving this command, the User Interfacewill begin sending the data output (DA) command at the specified rate. If the rate parameter isset to zero or is not provided (default), then the data is sent immediately only once.<Command><SEP>{<Rate>}<SEP>{<Format>}<Checksum><CR>

Command A 2-character constant value (“D” 0x44 “R” 0x52).Rate The number of seconds between sending the data output commands.

Range0–32767 seconds. (default = 0)

Format It is the desired output format.0 — Use 550 format1 — Use 560 format

Note: The format parameter defaults to the last specified format from the Setup Screen or DRcommand.The response for the DR command is the “DA” response as described in Data Output Format.Example to set date rate to 15 seconds in 550 format.

Field Characters<Command><SEP> D R <Rate><SEP> 1 5 <checksum><CR> 0 1 3 C

Example of command as displayed in terminal emulator application (HyperTerminal):DR 15 013C

ET, Request Elapsed TimeThe elapsed time command provides the instrument’s operating time since turned ON (SystemElapsed Time) and the total elapsed time since manufacturing (Total Elapsed Time).ET Command:<Command><SEP><Checksum><CR>Example:

Field Characters<Command><SEP> E T <checksum><CR> 0 0 B 9

As displayed in terminal emulator application (HyperTerminal): ET 00B9ET Response:<Command><SEP><System Elapsed Time><SEP><Total ElapsedTime><SEP><Checksum><CR>Command is a 2-character constant value (“E” 0x45 “T” 0x54).


Appendix D


System Elapsed Time and Total Elapsed Time are 7-character values with leading zeros andno decimal point. The assumed precision is the hundredths. System Elapsed Time is the elapsedtime since the console was turned ON. Total Elapsed time is the elapsed time the console hasbeen used since manufacturing.Example: Elapsed time = 1.47 hours, Total elapsed time = 132.05 hoursET 0000147 0013205 0390

ID, Identification CommandThe ID command provides the ability for an external data output system to identify the type ofBio-Console connected. The command will respond in accordance with the type of protocolselected through the User Interface or DR command (550 or 560).ID Command:<Command><SEP><Checksum><CR>Command is a 2-character constant value (“I” 0x49 “D” 0x44).Example Command:

Field Characters<Command><SEP> I D <checksum><CR> 0 0 A D

As displayed in terminal emulator application (HyperTerminal): ID 00ADID Response, 560 Protocol<Command><SEP><Model Number><SEP><Software Version><SEP><Checksum><CR>

Command A 2-character constant value (“I” 0x49 “D” 0x44).Model Number A 3-character constant value identifying the 560. “560”Software Version A 10-character value representing the version of the User Interface software.

Leading zeroes are used.Example 560 Response

Field Characters<Command><SEP> I D <Model Number><SEP> 5 6 0 <SW Version><SEP> 0 1 . 0 0 0 . 0 1 1 <checksum><CR> 0 3 4 7

As displayed in terminal emulator application (HyperTerminal): ID 560 01.000.011 0347ID Response, 550 Protocol<Command><SEP><Model Number><SEP><550 SW Version><Checksum><CR>

Command A 2-character constant value (“I” 0x49 “D” 0x44).Model Number A 5-character constant value identifying the emulated instrument. “540-D”Example 550 Response


Digital Output


Field Characters<Command><SEP> I D <Model Number><SEP> 5 4 0 - D <550 SW Version><SEP> 0 1 1 <checksum><CR> 0 2 E 9

As displayed in terminal emulator application (HyperTerminal): ID 540-D 011 02E9

Data Output FormatThe data are sent from the Bio-Console 560 to the terminal/DAQ device at the specified intervalor in response to the DR command. To be compatible with older Bio-Console systems, there aretwo formats of this command. The user can select which format is to be sent with the DRcommand format parameter or through the Setup Screen on the User Interface.All data are formatted as a series of ASCII characters separated by a space character(ASCII 0x20) and terminated with a carriage return (ASCII 0x0D).

550 Data Output FormatIf the 550 compatible output format is selected, the fields will be output in the following sequence:<Command><SEP><FS, Flow><SEP><PM, Pressure 1><SEP><MC, RPM><SEP><Flow, High Alarm><SEP><Flow, Low Alarm><SEP><Low RPM Alarm><SEP><UPS, AC Power Failure Alarm><SEP><UPS Low Battery Alarm><SEP><checksum><CR>The following table shows the 550 compatible data output format in terms of parameters andsome example ASCII characters.

Field Characters<Command><SEP> D A <FS, Flow><SEP> + 0 4 0 0 <PM, Pressure 1><SEP> + 2 1 0 <MC, RPM><SEP> 2 0 1 0 <Flow, High Alarm><SEP> 0 <Flow, Low Alarm><SEP> 1 <Low RPM Alarm><SEP> 1 <UPS, AC Power Failure Alarm><SEP> 0 <UPS Low Battery Alarm><SEP> 0 <checksum><CR> 0 4 8 6

Example of data output as displayed in terminal emulator application (HyperTerminal):DA +0400 +210 2010 0 1 1 0 0 0486


Appendix D


560 Data Output FormatIf the 560 compatible output format is selected, the fields will be output in the following sequence:<Command><SEP><Message Size><SEP><UPS, Status><SEP><UPS, Battery Capacity><SEP><UPS, Low Battery Alarm><SEP><UPS, AC Power Failure Alarm><SEP><UPS, System Error Code><SEP><MC, Status><SEP><MC, Low RPM Disable><SEP><MC, Motor Detect><SEP><MC, RPM><SEP><PM, Status 1><SEP><PM, Pressure 1><SEP><PM, Pressure 1, High Alert Limit><SEP><PM, Pressure 1, High Alert><SEP><PM, Pressure 1, Low Alert Limit><SEP><PM, Pressure 1, Low Alert><SEP><PM, Pressure 1 Zero><SEP><PM, Status 2><SEP><PM, Pressure 2><SEP><PM, Pressure 2, High Alert Limit><SEP><PM, Pressure 2, High Alert><SEP><PM, Pressure 2, Low Alert Limit><SEP><PM, Pressure 2, Low Alert><SEP><PM, Pressure 2 Zero><SEP><FS Status><SEP><FS, TX Detected><SEP><FS, Interference Detected><SEP><FS, Flow><SEP><FS, High Alert Limit><SEP><Flow, High Alert><SEP><FS, Low Alert Limit><SEP><Flow, Low Alert><SEP><FS, Flow Zero><SEP><SS, Status><SEP>


Digital Output


<SS, Motor State><SEP><Servo, Status><SEP><Clamp, Enable><SEP><Clamp, Config><SEP><Clamp, Status><SEP><Clamp, State><SEP><Clamp, Air Pressure><SEP><Bubble Detector, Enable><SEP><Bubble Detector, Config><SEP><Bubble Detector, Status><SEP><Bubble Detector, State><SEP><Upper Level Sensor, Enable><SEP><Upper Level Sensor, Config><SEP><Upper Level Sensor, Status><SEP><Upper Level Sensor, State><SEP><Lower Level Sensor, Enable><SEP><Lower Level Sensor, Config><SEP><Lower Level Sensor, Status><SEP><Lower Level Sensor, State><SEP><checksum><CR>The following table shows the 560 data output format in terms of parameters and some exampleASCII characters.


Appendix D


Parameter Characters<Command><SEP> D A <Message Size><SEP> 1 6 0 <UPS, Status><SEP> 0 <UPS, Battery Capacity><SEP> 0 9 <UPS, Low Battery Alarm><SEP> 0 <UPS, AC Power Failure Alarm><SEP> 0 <UPS, System Error Code><SEP> 0 0 0 <MC, Status><SEP> 0 <MC, Low RPM Disable><SEP> 0 <MC, Motor Detect><SEP> 1 <MC, RPM><SEP> 2 4 0 0 <PM, Status 1><SEP> 0 <PM, Pressure 1><SEP> + 0 4 0 0<PM, Pressure 1, High Alert Limit><SEP> + 0 5 0 0<PM, Pressure 1, High Alert><SEP> 0 <PM, Pressure 1, Low Alert Limit><SEP> + 0 2 3 0<PM, Pressure 1, Low Alert><SEP> 0 <PM, Pressure 1 Zero><SEP> 0 <PM, Status 2><SEP> 0 <PM, Pressure 2><SEP> + 0 1 5 0<PM, Pressure 2, High Alert Limit><SEP> + 0 1 0 0<PM, Pressure 2, High Alert><SEP> 1 <PM, Pressure 2, Low Alert Limit><SEP> + 0 0 5 0<PM, Pressure 2, Low Alert><SEP> 0 <PM, Pressure 2 Zero><SEP> 0 <FS Status><SEP> 0 <FS, TX Detected><SEP> 1 <FS, Interference Detected><SEP> 0


Digital Output


Parameter Characters<FS, Flow><SEP> + 0 4 0 5<FS, High Alert Limit><SEP> + 0 4 5 0<Flow, High Alert><SEP> 0 <FS, Low Alert Limit><SEP> + 0 3 0 0<Flow, Low Alert><SEP> 0 <FS, Flow Zero><SEP> 0 <SS, Status><SEP> 0 <SS, Motor State><SEP> 0 <Servo, Status><SEP> 0 <Clamp, Enable><SEP> 1 <Clamp, Config><SEP> 2 <Clamp, Status><SEP> 0 <Clamp, State><SEP> 0 <Clamp, Air Pressure><SEP> 0 <Bubble Detector, Enable><SEP> 1 <Bubble Detector, Config><SEP> 2 <Bubble Detector, Status><SEP> 0 <Bubble Detector, State><SEP> 0 <Upper Level Sensor, Enable><SEP> 1 <Upper Level Sensor, Config><SEP> 1 <Upper Level Sensor, Status><SEP> 0 <Upper Level Sensor, State><SEP> 0 <Lower Level Sensor, Enable><SEP> 1 <Lower Level Sensor, Config><SEP> 2 <Lower Level Sensor, Status><SEP> 0 <Lower Level Sensor, State><SEP> 0 <checksum><CR> 1 0 A E

Data Output Parameter Format

Parameter Description/ASCII FormatCommand Command parameter indicates the type of response. Formatted as DA (ASCII 0x44 0x41).Message Size Number of ASCII characters in the message. Going forward, any additions to the “560” pro-

tocol will be appended at the end of the message — therefore, parsers may be written tocheck the message length, compute the checksum, and then only parse the portions ofthe message it understands (recently added fields at the end of the message may beignored).

UPS, Status UPS status. This field indicates the error status of the UPS module within the instrument.UPS status is a 1-character field representing error status of the UPS module.The UPS status is defined as follows:0 — Normal operation, no errors1 — Soft error occurring, minor issue2 — Hard error occurring, major issue

UPS, BatteryCapacity

Battery charge capacity. This field indicates the relative charge of the batteries.Battery capacity is a 2-character field representing charge status of the system batteries.The battery capacity scale ranges from 0 to 10 with 0 being fully discharged and 10 beingfully charged.


Appendix D


Parameter Description/ASCII FormatUPS, Low Bat-tery Alarm

Low battery alarm.The low battery alarm is a 1-character field representing the alarm status for the batteries.An ASCII 0 indicates the alarm is not active.An ASCII 1 indicates the alarm is active.

UPS, ACPower FailureAlarm

AC power failure alarm.The AC power failure alarm is a 1-character field representing the status of the AC mainssupply.An ASCII 0 indicates the alarm is not active.An ASCII 1 indicates the alarm is active.

UPS, SystemError Code

The system error is a 3-character field representing the current system error code.Error code 0 indicates that no errors are occurring. Contact an authorized field servicerepresentative for a list of all system errors.

MC, Status Motor controller status. This field indicates the error status of the Motor controller withinthe instrument.MC status is a 1-character field representing error status of the motor controller.The MC status is defined as follows:0 — Normal operation, no errors1 — Soft error occurring, minor issue2 — Hard error occurring, major issue

MC, Low RPMDisable

Low RPM disable status bit. This field indicates the state of the low RPM disable controlbit from the motor controller.An ASCII 0 indicates motor is running.An ASCII 1 indicates the motor is stopped.

MC, MotorDetect

Motor detect status bit.An ASCII 0 indicates the motor is connected.An ASCII 1 indicates the motor is not connected.

MC, RPM Motor speed measurement (RPM).RPM is a 4-character field representing the current motor speed. Leading zeros are used.For example, a speed of 1900 RPM would be transmitted as 1900 (ASCII0x31 0x39 0x30 0x30).

PM, Status 1PM, Status 2

Pressure monitor status for channels 1 and 2. This field indicates the error status of thepressure monitor within the instrument.PM status is a 1-character field representing error status of the pressure monitor.The PM status is defined as follows:0 — Normal operation, no errors1 — Soft error occurring, minor issue2 — Hard error occurring, major issue


Digital Output


Parameter Description/ASCII FormatPM, Pressure1PM, Pressure2PM, Pressure1, High AlertLimitPM, Pressure1, Low AlertLimitPM, Pressure2, High AlertLimitPM, Pressure2, Low AlertLimit

Pressure channel measurements and alarm set-points.The first character is the sign and is either “+” or “–” (0x2B or 0x2D).The next 3 characters are the ASCII digits of the pressure value. Leading zeros are used.(For 550 mode — only 3 characters are used for digits.)For example, a pressure of 80 mmHg in “560 mode” would be transmitted as+0080 (ASCII 0x2B 0x30 0x30 0x38 0x30).

PM, Pressure1, High AlertPM, Pressure1, Low AlertPM, Pressure2, High AlertPM, Pressure2, Low Alert

High/Low pressure alert.The AC high/low pressure alert is a 1-character field representing the status of the asso-ciated pressure alert.An ASCII 0 indicates the alert is not active.An ASCII 1 indicates the alert is active.

PM, Pressure1 ZeroPM, Pressure2 Zero

Pressure channel zeroed indicator. This field indicates the status of the pressure zerofunction.An ASCII 0 indicates that the pressure channel has been zeroed.An ASCII 1 indicates that the pressure channel has not been zeroed.

FS, Status Flow system status. This field indicates the error status of the flow system within theinstrument.FS status is a 1-character field representing error status of the flow system. The FS statusis defined as follows:0 — Normal operation, no errors1 — Soft error occurring, minor issue2 — Hard error occurring, major issue

FS, TX Detec-ted

Flow transducer detection status bit.An ASCII 0 indicates the flow transducer has not been detected.An ASCII 1 indicates the flow transducer has been detected.

FS, Interfer-ence Detected

Flow system interference detection status bit.An ASCII 0 indicates that no RF interference has been detected.An ASCII 1 indicates that RF interference has been detected.


Appendix D


Parameter Description/ASCII FormatFS, FlowFS, High AlertLimitFS, Low AlertLimit

Flow rate measurement and alarm limitsThe first character is the sign and is either “+” or “–” (ASCII 0x2B or 0x2D).The next 5 characters are the ASCII digits of the flow value. Leading zeros are used. Nodecimal point is transmitted. The decimal point is assumed to be in the hundredth place.(For 550 mode — only 4 characters are used for digits.)For example a flow of 3.54 L/min in “560 mode” would be transmitted as +00354 (ASCII0x2B 0x30 0x30 0x33 0x35 0x34).

Flow, HighAlertFlow, Low Alert

High/low flow alert.The AC high/low flow alert is a 1-character field representing the status of the associatedflow alert.An ASCII 0 indicates the alert is not active.An ASCII 1 indicates the alert is active.

FS, Flow Zero Flow zeroed indicator. This field indicates the status of the flow zero function.An ASCII 0 indicates that the flow system has been zeroed.An ASCII 1 indicates that the flow system has not been zeroed.

Low RPMAlarm

Alarm status bits are each 1-character fields which represent the values of the associatedalarms.An ASCII 0 indicates the alarm is not active.An ASCII 1 indicates the alarm is active.

SS, Status Safety systems status. This field indicates the error status of the safety system within theinstrument.SS status is a 1-character field representing error status of the safety system.The SS status is defined as follows:0 — Normal operation, no errors1 — Soft error occurring, minor issue2 — Hard error occurring, major issue3 — Board not present/ready

SS, MotorState

Motor state. This field indicates the motor state.Motor state is a 1-character field representing the motor state.The motor state is defined as follows:0 — Normal operation, manual mode following knob setting1 — Coasting2 — Stopped

Servo, Status Servo systems status. This field indicates the error status of the servo system within theinstrument.Servo status is a 1-character field representing error status of the servo system.The servo status is defined as follows:0 — Normal operation, no errors1 — Soft error occurring, minor issue2 — Hard error occurring, major issue


Digital Output


Parameter Description/ASCII FormatClamp, StatusBubble Detec-tor, StatusUpper LevelSensor, StatusLower LevelSensor, Status

Safety device status. These fields indicate the error status of the safety accessories.Each status is a 1-character field representing error status of the device.The status is defined as follows:0 — Normal operation, no errors1 — Soft error occurring, minor issue2 — Hard error occurring, major issue3 — Device not present (disconnected)

Bubble Detec-tor, ConfigUpper LevelSensor, ConfigLower LevelSensor, Config

Safety device config. These fields indicate the error status of the safety accessories.Each config is a 1-character field representing config status of the device.The status is defined as follows:0 — Alert/alarm only1 — Coast2 — Stop

Clamp, Config Clamp config. These fields indicate the error status of the clamp.Config is a 1-character field representing config status of the clamp.The status is defined as follows:0 — Clamp on pump stop1 — Clamp on backflow2 — Clamp on either pump stop or backflow

Clamp, AirPressure

Clamp air pressure. This field indicates the air pressure status of the clamp.Air pressure is a 1-character field representing air pressure status of the clamp.The status is defined as follows:0 — Sufficient air pressure1 — Insufficient air pressure

Clamp, State Clamp state. This field indicates the state of the clamp.State is a 1-character field representing state of the clamp.The state is defined as follows:0 — Clamp open1 — Clamp closed

Bubble Detec-tor, State

Bubble detector state. This field indicates the state of the bubble detector.State is a 1-character field representing state of the bubble detector.The state is defined as follows:0 — Fluid detected1 — Bubble detected

Upper LevelSensor, StateLower LevelSensor, State

Level sensor states. These fields indicate the states of the level sensors.State is a 1-character field representing state of the level sensor.The state is defined as follows:0 — Fluid Detected1 — Air detected


Appendix D


Parameter Description/ASCII FormatClamp, EnableBubble Detec-tor, EnableUpper LevelSensor, Ena-bleLower LevelSensor, Ena-ble

Safety Device Enable. These fields indicate the enable status of the safety accessories.Each enable is a 1-character field representing enable status of the device.The status is defined as follows:0 — Disabled1 — Enabled

Checksum Used to check validity of transmitted data. It is the sum of the ASCII values of all thecharacters in the packet not including the checksum. This total is represented by a 4-digitASCII hexadecimal number with leading zeros, if necessary.

RS 232 Hardware Interface

RS 232 Interface Pin AssignmentsPin Number Signal Name Function/Direction2 RX Receive Data/Input3 TX Transmit Data/Output4 RTS Ready-To-Send/Output5 GND Ground8 CTS Clear-To-Send/Input


Warranties


Warranties E

Equipment Limited Warranty1

The following LIMITED WARRANTY Applies to United States Customers Only:

A. This LIMITED WARRANTY provides the following assurance to the purchaser of theMedtronic Bio-Console, Model 560 Extracorporeal Blood Pumping Console, hereafterreferred to as the “Bio-Console”:(1) Should the Bio-Console fail to function within normal tolerances due to a defect in

materials or workmanship within a period of one (1) year, commencing with the deliveryof the Bio-Console to the purchaser, Medtronic will at its option: (a) repair or replace anypart or parts of the Bio-Console; (b) issue a credit to the purchaser equal to the PurchasePrice, as defined in Subsection A(2), against the purchase of the replacement Bio-Console; or (c) provide a functionally comparable replacement Bio-Console at no charge.

(2) As used herein, Purchase Price shall mean the lesser of the net invoiced price of theoriginal, or current functionally comparable, or replacement Bio-Console.

B. To qualify for the repair, replacement or credit set forth in Section A, the following conditionsmust be met:(1) The Bio-Console must be returned to Medtronic within thirty (30) days after discovery of

the defect (Medtronic may, at its option, repair the Bio-Console on the Customer’s site).(2) The Bio-Console must not have been repaired or altered either (i) outside of Medtronic's

factory or (ii) by any person not authorized by Medtronic to repair the Bio-Console in anyway which, in the judgment of Medtronic, affects its stability and reliability. The Bio-Console must not have been subjected to misuse, abuse or accident.

C. This LIMITED WARRANTY is limited to its express terms. In particular:(1) Except as expressly provided by this LIMITED WARRANTY, MEDTRONIC IS NOT

RESPONSIBLE FOR ANY INDIRECT, INCIDENTAL OR CONSEQUENTIALDAMAGES BASED ON ANY DEFECT, FAILURE OR MALFUNCTION OF THE BIO-CONSOLE, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORTOR OTHERWISE.

(2) This LIMITED WARRANTY is made only to the purchaser of the Bio-Console. EXCEPTAS SET FORTH IN THIS LIMITED WARRANTY, MEDTRONIC MAKES NOWARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANYIMPLIED WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A PARTICULARPURPOSE WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM OROTHERWISE. NO EXPRESS OR IMPLIED WARRANTY SHALL EXTEND BEYONDTHE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THEEXCLUSIVE REMEDY AVAILABLE TO THE CUSTOMER.

(3) The exclusions and limitations set out above are not intended to, and should not beconstrued so as to, contravene mandatory provisions of applicable law. If any part or

1 This LIMITED WARRANTY is provided by Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604. It applies only in the UnitedStates. Areas outside the United States should contact a local Medtronic representative for exact terms of the LIMITED WARRANTY.


Appendix E


term of this LIMITED WARRANTY is held to be illegal, unenforceable or in conflict withapplicable law by a court of competent jurisdiction, the validity of the remaining portionsof the LIMITED WARRANTY shall not be affected, and all rights and obligations shall beconstrued and enforced as if this LIMITED WARRANTY did not contain the particularpart or term held to be invalid. This LIMITED WARRANTY gives the purchaser specificlegal rights. The purchaser may also have other rights which vary from state to state.

(4) No person has any authority to bind Medtronic to any representation, condition orwarranty with respect to the Bio-Console other than as set forth in this LIMITEDWARRANTY.


(FOR REPAIRABLE EXTERNAL EQUIPMENT/OUTSIDE THE UNITED STATES)

The following Limited Warranty Applies to Customers Outside the United States:

A. This LIMITED WARRANTY provides the following assurance to the purchaser of theMedtronic Bio-Console, Model 560 Extracorporeal Blood Pumping Console, hereafterreferred to as the “Bio-Console,” that should the Bio-Console fail to function within normaltolerances due to a defect in materials or workmanship within a period of one (1) year,commencing with the delivery of the Bio-Console to the purchaser, Medtronic will at its option:(a) repair or replace any defective part or parts of the Bio-Console; (b) issue a credit equalto the original Bio-Console purchase price (but not to exceed the value of the replacementBio-Console), against the purchase of replacement Bio-Console; or (c) provide functionallycomparable replacement Bio-Console at no charge.

B. To qualify for this repair, replacement or credit, the following conditions must be met:(1) The Bio-Console must be returned to Medtronic within sixty (60) days after discovery of

the defect (Medtronic may, at its option, repair the Bio-Console on site).(2) The Bio-Console must not have been repaired or altered by someone other than

Medtronic in any way which, in the judgment of Medtronic, affects its stability andreliability.

(3) The Bio-Console must not have been subjected to misuse, abuse or accident.C. This LIMITED WARRANTY is limited to its express terms. In particular, Medtronic is not

responsible for any incidental or consequential damages based on any use, defect or failureof the Bio-Console, whether the claim is based on warranty, contract, tort or otherwise.

D. The exclusions and limitations set out above are not intended to, and should not be construedso as to, contravene mandatory provisions of applicable law. If any part or term of thisLIMITED WARRANTY is held by any court of competent jurisdiction to be illegal,unenforceable or in conflict with applicable law, the validity of the remaining portion of theLIMITED WARRANTY shall not be affected, and all rights and obligations shall be construedand enforced as if this LIMITED WARRANTY did not contain the particular part or term heldto be invalid.

2 This LIMITED WARRANTY is provided by Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604. Areas outside the UnitedStates should contact a local Medtronic representative for exact terms of the LIMITED WARRANTY.


Warranties



The following LIMITED WARRANTY Applies to United States Customers Only:

A. This LIMITED WARRANTY provides the following assurance to the purchaser of theMedtronic Emergency Handcrank, Model 150, hereafter referred to as the “Equipment”:(1) Should the Equipment fail to function within normal tolerances due to a defect in materials

or workmanship within a period of one (1) year, commencing with the delivery of theEquipment to the purchaser, Medtronic will at its option: (a) repair or replace any part orparts of the Equipment; (b) issue a credit to the purchaser equal to the Purchase Price,as defined in Subsection A(2), against the purchase of the replacement Equipment; or(c) provide a functionally comparable replacement Equipment at no charge.

(2) As used herein, Purchase Price shall mean the lesser of the net invoiced price of theoriginal, or current functionally comparable, or replacement Equipment.

B. To qualify for the repair, replacement or credit set forth in Section A, the following conditionsmust be met:(1) The Equipment must be returned to Medtronic within thirty (30) days after discovery of

the defect (Medtronic may, at its option, repair the Equipment on site).(2) The Equipment must not have been repaired or altered outside of Medtronic’s factory in

any way which, in the judgment of Medtronic, affects its stability and reliability. TheEquipment must not have been subjected to misuse, abuse or accident.

C. This LIMITED WARRANTY is limited to its express terms. In particular:(1) Except as expressly provided by this LIMITED WARRANTY, MEDTRONIC IS NOT

RESPONSIBLE FOR ANY INDIRECT, INCIDENTAL OR CONSEQUENTIALDAMAGES BASED ON ANY DEFECT, FAILURE OR MALFUNCTION OF THEEQUIPMENT, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORTOR OTHERWISE.

(2) This LIMITED WARRANTY is made only to the purchaser of the Equipment. AS TO ALLOTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED,INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OFMERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE WHETHERARISING FROM STATUTE, COMMON LAW, CUSTOM OR OTHERWISE. NOEXPRESS OR IMPLIED WARRANTY TO THE PATIENT SHALL EXTEND BEYONDTHE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THEEXCLUSIVE REMEDY AVAILABLE TO ANY PERSON.

(3) The exclusions and limitations set out above are not intended to, and should not beconstrued so as to contravene mandatory provisions of applicable law. If any part or termof this LIMITED WARRANTY is held to be illegal, unenforceable or in conflict withapplicable law by a court of competent jurisdiction, the validity of the remaining portionsof the LIMITED WARRANTY shall not be affected, and all rights and obligations shall beconstrued and enforced as if this LIMITED WARRANTY did not contain the particular

3 This LIMITED WARRANTY is provided by Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604. It applies only in the UnitedStates. Areas outside the United States should contact a local Medtronic representative for exact terms of the LIMITED WARRANTY.


Appendix E


part or term held to be invalid. This LIMITED WARRANTY gives the purchaser specificlegal rights. The purchaser may also have other rights which vary from state to state.

(4) No person has any authority to bind Medtronic to any representation, condition orwarranty except this LIMITED WARRANTY.


(FOR REPAIRABLE EXTERNAL EQUIPMENT/OUTSIDE THE UNITED STATES)

The following Limited Warranty Applies to Customers Outside the United States:

A. This LIMITED WARRANTY provides the following assurance to the purchaser of theMedtronic Emergency Handcrank Model 150, hereafter referred to as the “Equipment,” thatshould the Equipment fail to function within normal tolerances due to a defect in materials orworkmanship within a period of one (1) year, commencing with the delivery of the Equipmentto the purchaser, Medtronic will at its option: (a) repair or replace any defective part or partsof the Equipment; (b) issue a credit equal to the original Equipment purchase price (but notto exceed the value of the replacement Equipment), against the purchase of replacementEquipment; or (c) provide functionally comparable replacement Equipment at no charge.

B. To qualify for this repair, replacement or credit, the following conditions must be met:(1) The Equipment must be returned to Medtronic within sixty (60) days after discovery of

the defect (Medtronic may, at its option, repair the Equipment on site).(2) The Equipment must not have been repaired or altered by someone other than Medtronic

in any way which, in the judgment of Medtronic, affects its stability and reliability.(3) The Equipment must not have been subjected to misuse, abuse or accident.

C. This LIMITED WARRANTY is limited to its express terms. In particular, Medtronic is notresponsible for any incidental or consequential damages based on any use, defect or failureof the Equipment, whether the claim is based on warranty, contract, tort or otherwise.

D. The exclusions and limitations set out above are not intended to, and should not be construedso as to, contravene mandatory provisions of applicable law. If any part or term of thisLIMITED WARRANTY is held by any court of competent jurisdiction to be illegal,unenforceable or in conflict with applicable law, the validity of the remaining portion of theLIMITED WARRANTY shall not be affected, and all rights and obligations shall be construedand enforced as if this LIMITED WARRANTY did not contain the particular part or term heldto be invalid.

4 This LIMITED WARRANTY is provided by Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604. Areas outside the UnitedStates should contact a local Medtronic representative for exact terms of the LIMITED WARRANTY.


Preventative Maintenance Log


Preventative Maintenance Log FBio-Console Extracorporeal Blood Pumping Console Model 560Serial Number _____________________________________________________Date Bio-Console received ___________________________________________The Bio-Console should be checked annually.

Date Comments Initials of Person Com-pleting the Check


Appendix F



i

Index

AAC Power 100

Caution 8Failure 90Status Alert 53Troubleshooting 100Warning 85

AC Power Cord 85, 90, 100Connection 26

AC Power Status Button 12, 90Pressing to Silence Audible Alert 53

AC Power Switch 8, 26, 86, 90, 100, 103Activity Indicator 13

Description 53Alarm/Alert

Description 33Mute Button 13Selecting Sounds 29Sound Selection Buttons 11Speaker 9Test Buttons 11, 30Volume Control from the Main Screen 13, 53Volume Control from the Setup

Screen 11, 29AutoClamp

Air Pressure Minimum/Maximum 75Backflow Configuration 79Both (Stop and Backflow) Configuration 79Case Setup 78Configuration 79Connecting Components 75Opening from User Interface 81Opening Manually 82Service 85Status Icons 82Stop Configuration 79

AutoClamp SystemComponents 75Overview 75Verifying Function 82

BBackflow Alarm 82Backflow

Prevention of 51Base Unit 3

Cable Connector for User Interface 8Caution 85Cleaning 85Dimensions 16Display Screen 8Front Panel 7Mounting Post for User Interface 7, 21Rear Panel 8Using the Base Unit Display Instead of the

User Interface 95Base Unit Display

Error Status 98Screen List 95Set High Flow Rate Alarm 97Set Low Flow Rate Alarm 97System Status 96Zeroing Flow Rate 96

BatteriesBattery Alarm 54Battery Charging 26Battery Service and Disposal 87Battery Status Indicator 13, 86Checking Charge Status 31, 86Life Estimates 90, 109Maintaining and Charging the Batteries 86Troubleshooting 103Variable Factors 109

Battery Backup 13, 90Battery Backup Failure 90


ii

Baud RateRange 31

Bio-Console 3Cleaning 85Components 3General Description 7Service 85Standby Bio-Console 90System Failure 90Turning On 26

Bio-Probe 3Bio-Pump 3

Failure 89Priming the Circuit 40Removal After Procedure 56Troubleshooting 101

BSA AlgorithmEquations 45Selection 14

Bubble Detection SystemBubble Size Detected 66Components 66Verifying Function 71

Bubble DetectorClearing an Alarm 71Coast Configuration 67Configuring 67Connecting to Base Unit 66Placement on Circuit Tubing 66Status Icons 71Stop Configuration 67

CCardiac Index

Entered Value 14Measured Value 14

Centrifugal Pump Speed 95, 96Coast Mode

Disengaging 73Screen Changes Resulting From 72

Coast Speed Button 14Coast Speed Setting Indicator 13Components of the Bio-Console 3

Connecting the Bio-Console Components 21Contraindications 4DData Exchange Handshake Buttons 11Data Format Selection Buttons 11Data Output

Attaching a Digital Output Connector 56Data Refresh Rate Selection Button 11Data Transfer Cable 3Digital Output 3, 99

Data Output Format 115, 116, 119Overview 111RS 232 Commands 112, 113, 114RS 232 Hardware Interface 124Selecting the Appropriate Protocol 111Selecting the Appropriate Transmission

Mode 111Troubleshooting 103

EElectrical Power Failure 90

AC Power Failure 90Battery Backup Failure 90

ElectrocauteryInterference with User Interface Displays 51

Electromagnetic Emissions and ImmunityDeclarations 17

FFactory Default Settings 17Flow Alert Limits 14Flow Bar Graph 13Flow Connector 8Flow Digital Display 13Flow

Determining the Flow 107Monitoring from the Base Unit 52Troubleshooting 101


iii

Flow Insert 3Flow Limit Setting Indicators 13Flow Limits

Setting Flow Alert Limits 43Flow Limits Set Buttons 14Flow Monitor Zero Button 14Flow Range 99Flow Rate 96, 107

Adjusting 49Dependencies 49Flashing Dashes 50Flashing Values 50How Displayed 50Minimum Allowed 50Monitoring 50

Flow TransducerAdult Model 39Attaching Insert 39Connecting to the Base Unit 24Correcting a Negative Flow Reading 42Mounting to a Pole 25Pediatric Model 39Zeroing 40

Fuse Access 8HHandcrank 3

Attaching and Using the Handcrank 93Checking the Handcrank 87Components 92Emergency Use of 90Properties 91

IIndications for Use 4Interface Module

Connecting to Base Unit 75Mounting to Pole 75

LLanguage Selection Button 11Language Selection 29

Level Sensing SystemComponents 60Verifying Function 65

Level SensorsAlarm Only Configuration 63Alert Only Configuration 63Attaching to Reservoir 60Coast Configuration 63Configuring 61Connecting to Base Unit 60Removing from Reservoir 65Status Icons 65Stop Configuration 63

MMain Screen

Overview 12Settings Screen Button 12

NNegative Flow 101PPower Cord Connector 9Power On/Standby Switch 7Pressure Alert Limits 14

Setting Pressure Alert Limits 37Pressure Limits Set Buttons 14Pressure Monitor Displays 13Pressure Monitoring Circuit

3-way Stopcock 35Attaching to Base Unit 35Fluid Barrier 35

Pressure Monitor Zero Buttons 14Pressure

Flashing Dashes 53Flashing Values 53Monitoring 53

Pressure Transducer Ports 8Pressure Transducer

Zeroing 36


iv

Pressure ValuesRange 53

Pump Motor Connector 8Pump Motor 3, 100

Connecting to the Base Unit 23Servicing the Pump Motor 85

Pump StopRestarting the Pump 74Screen Changes Resulting From 74

QQuick Start Guide 99RRemote Tube Clamp

Connecting to Interface Module 75Mounting to Pole 75

Retrograde Flow 89Roller Pump 90

Emergency Use of 94RPM Bar Graph 13RPM Digital Display 13RPM Knob 9

Components 34Independent Function 95Mechanical Stop 49

RPMTroubleshooting 102

SSafety Systems Board 9Safety Systems 3

Coast/Stop 71Overview 59Troubleshooting 103

Screen Contrast Button 14Screen Contrast

Adjusting 47Serial Port Baud Rate Selection Button 11Serial Port

Setting Parameters 31Service Log Button 13

Service LogFunction of 53

Service Port Cover 8Settings Screen

Flow Monitor 14Overview 14Pressure Monitor 14Screen Exit Button 14

Setup ScreenOverview 11Saving Selections 31Screen Exit Button 11

Specifications 16Stopping Flow

Taking A Patient Off Bypass 55System Indicator LED Lights 8System Status Indicators 33

Green Light 33Red Light 33Yellow Light 33

System Status Indicator 13System Status Message Box 13TT-adaptor/Blender Connections 75Target Flow Indicator 13Target Flow Rate Calculation 14

Patient Height 14Patient Weight 14

Target FlowDefinition 45Establishing Rate 45

Timer Displays 14Timer Mode Selection Buttons 14Timer Set Buttons 14Timers

Count Down Mode 46Count Up Mode 46Pause Button 52Reset Button 52


v

Setup 46Start Button 52Using 52

Time Unit Selection Buttons 14Transducers

Cleaning the Flow Transducer 85UUnit Cooling Fans 8Unit Label 8User Interface 3, 9

Cable Connector 9Connection to a Pole Mount 22Connection to the Base Unit 21Data Output Connector 9Dimensions 16Locking/Release Handle 9Remote Mounting Bracket 21Screen Sequence 10, 11, 13, 14Setting Up 28Touch Screen 9

VVersions Button 11Viscosity 107WWarnings and Precautions 4Warranties 125




EuropeEurope/Africa/Middle East HeadquartersMedtronic International Trading SàrlRoute du Molliau 31Case Postale 84CH - 1131 TolochenazSwitzerlandInternet: www.medtronic.co.ukTel. 41-21-802-7000Fax 41-21-802-7900Authorized Representative in the European CommunityMedtronic B.V.Earl Bakkenstraat 106422 PJ HeerlenThe NetherlandsTel. 31-45-566-8000Fax 31-45-566-8668

Asia-PacificJapanMedtronic JapanComodio Shiodome 5F2-14-1 Higashi-Shimbashi, Minato-kuTokyo 105-0021JapanTel. 81-3-6430-2011Fax 81-3-6430-7140AustraliaMedtronic Australasia Pty. Ltd.97 Waterloo RoadNorth Ryde NSW 2113AustraliaTel. 61-2-9857-9000Fax 61-2-9878-5100AsiaMedtronic International Ltd.Suite 1602 16/F, Manulife PlazaThe Lee Gardens, 33 Hysan AvenueCauseway BayHong KongTel. 852-2891-4068Fax 852-2591-0313

AmericasLatin AmericaMedtronic Latin America3750 NW 87th AvenueSuite 700Miami, FL 33178USATel. 305-500-9328Fax 786-709-4244CanadaMedtronic of Canada Ltd.99 Hereford StreetBrampton, Ontario L6Y 0R3CanadaTel. 905-460-3800Fax 905-826-6620Toll-free: 1-800-268-5346United StatesManufacturer:Medtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432USAInternet: www.medtronic.comTel. 763-514-4000Fax 763-391-9100Toll-free: 1-800-328-2518(24-hour consultation service)Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428USATel. 763-391-9000Fax 763-391-9100Customer Service and Product OrdersToll-free: 1-800-854-3570Visit Medtronic atwww.perfusionsystems.com

*M937416A001*

© 2008, 2011 MedtronicM937416A001 Rev. 1.0