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

BIO-CONSOLE® 560 Extracorporeal Blood Pumping Console

Operator and Reference Manual Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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

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.

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

Explanation of Symbols on Product or Packaging Refer 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 1 Pressure Port 2 Dangerous Voltage Caution, Consult Accompanying Documents High Voltage Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product. China RoHS Standard (SJ/T11364-2006) Electronic Information Products Pollution Control Symbol. The number represents the years the device can be used before it must be 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 Current Temperature 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 safety standards (UL60601-1 and CAN/CSA C22.2 No. 601.1). For US Audiences Only Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Council Directive 93/42/EEC. Type CF Applied Part

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Table of Contents About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 Bio-Console 560 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2 General Description and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Base Unit Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Base Unit Display Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Base Unit Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Factory Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Electromagnetic Emissions and Immunity Declarations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Connecting the Bio-Console Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Turning On the Bio-Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Setting Up the User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Checking Battery Charge Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 4 Case Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 System Status Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Alerts and Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Installing the Bio-Pump Centrifugal Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Attaching the Pressure Monitoring Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Zeroing the Pressure Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Setting the Pressure Alert Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Attaching Insert to Flow Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Priming the Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Zeroing the Flow Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Correcting a Negative Flow Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Setting the Flow Bar Graph Display Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Setting Low and High Flow Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Establishing the Target Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Timers Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Adjusting Screen Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 5 On-Pump Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Adjusting Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Monitoring Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Using Timers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Volume Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Alert and Alarm Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Service Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 vii

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8

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Activity Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Monitoring Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AC Power Status Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Battery Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Stopping Flow: Taking A Patient Off Cardiopulmonary Bypass . . . . . . . . . . . . . . . . . . . . . . . Removing the Bio-Pump Centrifugal Blood Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Data Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Safety Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Level Sensing System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bubble Detection System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bio-Pump Coast/Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AutoClamp System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cleaning the Flow Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cleaning the Bio-Console and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Servicing the Pump Motor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Servicing the Bio-Console and AutoClamp Interface Module . . . . . . . . . . . . . . . . . . . . . . . . . Maintaining and Charging the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Checking Battery Charge Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Battery Service and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Checking the Handcrank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . End of Life Disposition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Emergency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Pump Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrical Power Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bio-Console System Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Emergency Use of the Handcrank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Emergency Use of a Roller Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Use of Base Unit Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Using the Base Unit Display Instead of the User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . .

53 53 53 54 55 56 56 59 59 66 71 75 85 85 85 85 85 86 86 87 87 88 89 89 90 90 90 94 95 95

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

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Appendix C Battery Longevity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Variable Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Battery Life Estimates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix D Digital Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Selecting the Appropriate Transmission Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Selecting the Appropriate Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RS 232 Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Data Output Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RS 232 Hardware Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix E Warranties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Equipment Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Equipment Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Equipment Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Equipment Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix F Preventative Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index

109 109 109 111 111 111 111 112 115 124 125 125 126 127 128 129

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About This Manual This Operator's Manual is to be used with Bio-Console 560 User Interface software version UI 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 Overview Describes the general use of the Model 560 Bio-Console, the components of a Bio-Console extracorporeal blood pumping system, and precautions and warnings. Chapter 2 General Description and Specifications Provides a brief description of the Model 560 Bio-Console and lists product specifications. Chapter 3 Setup Includes one-time setup and general procedures for the Bio-Console, such as attaching the User Interface, connecting the pump motor, attaching pressure and flow transducers, turning on the Base Unit, configuring the User Interface, and checking the backup battery status. Chapter 4 Case Preparation Provides setup procedures and system information relevant to case preparation, such as installing a centrifugal blood pump, zeroing the pressure and flow transducers, setting pressure and flow alert limits, establishing target flow rate, and timers setup. Chapter 5 On-Pump Operation Includes procedures necessary for operating the Bio-Console, such as adjusting and monitoring flow rate, using the timers, handling alerts and alarms, and attaching an optional digital computer interface. Chapter 6 Safety Systems Includes overview, setup and operating instructions for the level sensing system, bubble detection system, AutoClamp system and Bio-Pump coast/stop. Chapter 7 Maintenance Describes procedures for cleaning and maintaining the Bio-Console and accessories. Chapter 8 Emergency Describes alternative power sources to use if AC power fails or the pump motor stops functioning. Chapter 9 Use of Base Unit Display Describes use of the Base Unit display if the User Interface stops functioning. Appendix A: Checklist and Troubleshooting Provides a brief list of the procedures that must be completed before using the Bio-Console. It also includes a troubleshooting checklist describing situations that may occur and steps for resolution.

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Appendix B: Hydraulics Describes the relationship between the RPM, pressure, and flow for the centrifugal blood pump. Appendix C: Battery Longevity Describes how RPM, flow, blood temperature, and hematocrit affect the longevity of fully charged batteries. Appendix D: Digital Output Describes the information that is sent to a data output device and describes the computer commands for changing the format for a data output device and for changing the transmission interval. Appendix E: Warranties Contains product warranties. Appendix F: Preventative Maintenance Log Tracks maintenance activities performed by a Medtronic service technician.

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Bio-Console 560 Overview

Bio-Console 560 Overview

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

Description The Bio-Console 560 Extracorporeal Blood Pumping Console is an EN 60601-1 Class I equipment for continuous operation, Type CF Applied Part. The equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air 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 a remote location

■

Model 540T pump motor

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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)

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

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

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Handcrank, Model 150

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A data transfer cable is available for digital output

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Safety systems (optional). Refer to Chapter 6. Bio-Console 560

1500

Model 150 Handcrank

540T Pump Motor

3000

0

4500

Bio-Pump BPX-80

Bio-Probe TX-50 and DP-38

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

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Chapter 1

Indications for Use The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).

Contraindications The Medtronic centrifugal blood pumping system is contraindicated as a cardiotomy suction device.

Warnings and Precautions Read all Warnings, Precautions, and Instructions for Use carefully prior to use. Failure to read and follow all instructions, or failure to observe all stated warnings, could cause serious injury or death to the patient. Warnings The Bio-Console Extracorporeal Blood Pumping Console Model 560 is designed to be operated only with the Bio-Pump centrifugal pump. There are no safety or performance data that establish compatibility 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 failure of the centrifugal pump, reduced pumping capacity, leaks, excessive blood trauma, or degradation or corrosion of blood contact materials, which may pass through the blood to the patient. Massive air entry into the pump will cause the pump to deprime and blood flow to stop. As a result, gaseous emboli may be introduced into the patient; gaseous emboli could result in death or severe injury. To prevent this, stop the pump, clamp the arterial line, and remove air prior to resuming circulation. Reprime the centrifugal pump as described in the instructions included with the 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 patient resistance. Not maintaining a positive flow could allow retrograde flow and exsanguinate the patient if the line is not clamped. If for any reason the centrifugal pump has stopped, the arterial line 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 sterile technique. The Bio-Pump centrifugal pump and the disposable insert of the Bio-Probe blood flow monitoring system are packaged as sterile products and are designed for single use only. Do not reuse or resterilize as this could result in severe patient injury or death. A handcrank must always be available for emergency use. Instructions for using the handcrank are in Chapter 8. Do not place level sensors below the minimum operating level recommended by the reservoir manufacturer. 4

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Bio-Console 560 Overview Never place fingers inside remote tube clamp closing mechanism. Serious injury may occur if fingers are caught in the remote tube clamp when it closes. Establish pump RPM before unclamping the arterial line. Failure to do so could cause retrograde flow. Proper positioning of the bubble detector is the responsibility of the user. Bubble detectors must be 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 within that portion of the circuit. To avoid an electrical shock, the Bio-Console must be disconnected from the AC power source during servicing or cleaning. Do not adjust, modify, repair, or touch the internal circuitry. These actions could cause operator injury or cause faulty operation of the Bio-Console or AutoClamp interface module. Precautions Inspect each package and device visually and functionally prior to use. If the equipment appears damaged, consult with a qualified Medtronic service technician. A standby Bio-Console should be available during cardiopulmonary bypass procedures. If the Bio-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 medical professional. The flow display may be inaccurate and/or the User Interface displays may blink when an electrocautery unit is in operation. Before using the Bio-Console, 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 and the manufacturer’s instructions. To ensure that the system will operate properly, use only Medtronic accessories. Only operate a Bio-Pump centrifugal pump that is primed according to the procedures described in the Bio-Pump manual. Operating the centrifugal pump without being primed may damage the internal seal on the centrifugal pump. Connect the power cord only to an AC power source that is properly inspected and certified for biomedical equipment. Do not expose the Bio-Pump centrifugal pump to chemical agents as they may affect the integrity of this device. Anesthesia solutions such as FORANE® are known to degrade polycarbonate plastics. 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 attached before 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 evaluated to 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.

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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 interface module. Do not immerse the Base Unit or accessories, nor allow water to run into the interior of the Base Unit or accessories. Do not use alcohol or alcohol-based cleaning solutions. Do not spray fluid into electrical connectors or onto the User Interface screen. The batteries may be damaged if they are not recharged after use.

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General Description and Specifications

General Description and Specifications

2

General Description The Bio-Console consists of four (4) parts: ■

Base Unit Front Panel

■

Base Unit Display Screen

■

Base Unit Rear Panel

■

User Interface

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

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1

3

1. The Power On/Standby Switch is located in the center of the Base Unit front panel and is a rocker-type switch that activates the Base Unit and User Interface displays. 2. The Display Screen at the upper-front area of the Base Unit serves as a backup if the main User Interface malfunctions. The screen also contains the critical information to continue the surgical procedure. 3. The User Interface Mounting Post allows the User Interface to be mounted directly to the Base Unit.

Figure 2. Base Unit Front Panel

Base Unit Display Screen The Base Unit display area presents basic information of extracorporeal flow rate and centrifugal 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.

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Chapter 2

Bio-Console® 560 1

2 6

4 3

5

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 2 1 5

6

3

7 4

8

9 11

10

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. 8

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General Description and Specifications 3. Bio-Probe Flow Connector for the Bio-Probe blood monitoring system containing a flow transducer that is either Model TX-50 or Model TX-50P. 4. Service Port Cover to connections for service representatives to analyze system problems 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 inspected and certified. 11. Unit Cooling Fans maintain Base Unit cooling. Note: If a safety board has been installed for the optional safety systems, the back of the Base Unit will have additional connectors not shown in Figure 4. Refer to Chapter 6 for additional information.

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

Front Side

Back Side

Figure 5. User Interface 1. A speaker for the alert/alarms. Operator and Reference Manual

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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 Sequence The User Interface display progresses through the screen sequence as shown in Figure 6. 1

2

3

4

5

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

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General Description and Specifications

Figure 7. Opening Screen Opening Screen with Setup Screen Button After the Bio-Console completes its internal software self test, the Setup Screen button will display on the Opening Screen (Figure 8). The user has approximately 4 seconds to press the Setup Screen button in order to access the Setup Screen (Figure 9). If the Setup Screen button is not pressed, the Main Screen will be displayed (Figure 10). If the user wishes to access the Setup Screen but misses pressing the Setup Screen button, the user must reboot the Bio-Console.

Figure 8. Opening Screen with Setup Screen Button Setup Screen If the user presses the System Setup button, the Setup Screen (Figure 9) will appear. The Setup Screen allows the user to select interface profiles.

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Chapter 2

2 1

3 4 5 6

7 8 9 10

Figure 9. Setup Screen Information and User Functions 1. The Alarm/Alert Sound Selection Buttons allow the user to select between 3 distinctive alarm/alert sounds. 2. The Alarm/Alert Sound and Volume Test Buttons allow the user to test the alarm/alert sound 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 Screen The Main Screen (Figure 10) displays information about:

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alert and alarm status

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blood flow and pump speed

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General Description and Specifications ■

line pressure

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user configurable timers

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safety systems (if installed)

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power status 5 1 13

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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 is 4500 RPM. Operator and Reference Manual

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Chapter 2 9. The Pressure Monitor Displays (2) display the pressure(s) within the extracorporeal circuit (in mm Hg). This requires using a pressure-monitoring line that is connected between 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” message may 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 from the Settings Screen. Settings Screen The 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 an alert or alarm occurs when the Settings Screen is displayed, the system automatically switches back to the Main Screen.

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General Description and Specifications 3

1

2 4

5 7 6 8

9

10 11

12

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13

Figure 11. Settings Screen 1. 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 desired cardiac index, patient height, and patient weight. 6. The Pressure Monitor Displays (2) display the current pressure values from the Main Screen. 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). Operator and Reference Manual

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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 Power 100-240 VAC, 50-60 Hz, 3.25 amps External Pump Drive Motor Brushless DC (non-arcing) Internal Batteries Type Discharge Time Recharge Time

Two, series connected, 12 VDC lead-acid gel; rechargeable Refer to Appendix C 18 hours to 90% capacity; 24 hours to 100% capacity

Dimensions: Base Unit Size

16

Weight

31.88 cm (12.55 in) high by 22.83 cm (8.99 in) wide by 43.02 cm (16.9 in) long 17.19 kg (37.9 lb)

Dimensions: User Interface Overall Size Screen Size Weight

22.18 cm (8.7 in) wide by 34.5 cm (13.6 in) long 26.41 cm (10.4 in) diagonal 4.26 kg (9.4 lb)

System Limits Flow RPM Pressure

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

Operating Limits Temperature Humidity

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

Storage Limits Temperature Humidity Pressure

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

Output Signal Digital Baud Rate

RS 232 Interface: flow, RPM, pressure, alarm status 1200 to 19200

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General Description and Specifications Resolution Pressure Flow RPM

1 mm Hg 10 mL 10

AutoClamp System (Optional) Type Pneumatic Clamp Force 14.5 Kg (32 lb) Pressure 379-689 kPa (55-100 psi) Gas Air or nitrogen Tubing (adult) 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in) PVC Tubing (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 mL Tubing (adult) 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in) PVC Tubing (pediatric) 6.35 mm (1/4 in) ID x 0.8 mm (1/32 in) PVC Level Sensor System (Optional) Type Capacitive Reservoir Medtronic hardshell Number of Sensors 2

Factory Default Settings Digital Output Format Cable Transmission Interval Baud Rate Language

560 format 9-pin PC compatible cable 10 seconds 9600 English

Electromagnetic Emissions and Immunity Declarations IEC 60601-1-2 Table 201, Guidance and manufacturer's declaration — electromagnetic emissions The Bio-Console 560 is intended for use in the electromagnetic environment specified below. The customer or the user of the Bio-Console 560 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF 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 are not likely to cause any interference in nearby electronic equipment. RF Emissions, CISPR 11 Class A Class A equipment is equipment suitable for use in all establishments other than domestic and those directly conHarmonic emissions Class A nected to the public low-voltage power supply network that IEC 61000-3-2 supplies buildings used for domestic purposes. Voltage fluctuations/flicker emis- Complies sions, IEC 61000-3-3

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Chapter 2 IEC 60601-1-2 Table 202, Guidance and manufacturer's declaration — electromagnetic immunity The Bio-Console 560 is intended for use in the electromagnetic environment specified below. The customer or the user of the Bio-Console 560 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment — guidance Electrostatic dis±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic charge (ESD) tile. If floors are covered with synthetic material, ±8 kV air ±8 kV air IEC 61000-4-2 the relative humidity should be at least 30%. Electrical fast transi- ±2 kV for power sup- ±2 kV for power supply Mains power quality should be that of a typical ent/burst ply lines lines commercial or hospital environment. IEC 61000-4-4 ±1 kV for input/output ±1 kV for input/output lines lines Surge IEC 61000-4-5 ±1 kV line(s) to line(s) ±1 kV differential mode ±2 kV line(s) to earth ±2 kV common mode Voltage dips, short 95% dip in 95% dip in interruptions and volt- UT) for 0.5 cycle UT) for 0.5 cycle age variations on 40% UT (60% dip in UT) 40% UT (60% dip in power supply input UT) for 5 cycles for 5 cycles lines IEC 61000-4-11 70% UT (30% dip in UT) 70% UT (30% dip in for 25 cycles UT) for 25 cycles 95% dip in 95% dip in UT) for 5 sec UT) for 5 sec 95% dip in 95% dip in UT) for 0.5 cycle UT) for 0.5 cycle 3 A/m 3 A/m

Power frequency Power frequency magnetic fields should be at levels characteristic of a typical location in a (50/60 Hz) magnetic field IEC 61000-4-8 typical commercial or hospital environment. Note: UT is the a.c. mains voltage prior to application of the test level.

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General Description and Specifications IEC 60601-1-2: 2001 Table 203, Guidance and manufacturer's declaration — electromagnetic immunity The Bio-Console 560 is intended for use in the electromagnetic environment specified below. The customer or the user of the Bio-Console 560 should assure that it is used in such an environment. Immunity test IEC/EN 60601 test Compliance level Electromagnetic environment — guidance level Portable and mobile RF communications equipment should be used no closer to any part of the Bio-Console 560, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: 1 Vrms d = 3.5√ P Conducted RF 3 Vrms IEC/EN 61000-4-6 150 kHz to 80 MHz outside ISM bands1 10 Vrms

Radiated RF IEC/EN 61000-4-3

1 Vrms

150 kHz to 80 MHz in ISM bands1 10 V/m 10 V/m 80 MHz to 2.5 GHz

d = 12√ P

d = 1.2√ P 80 MHz to 800 MHz d = 2.3√ P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).2 Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.3, 4 Interference may occur in the vicinity of equipment 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 and reflection 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 to decrease 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, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Bio-Console 560 is used exceeds the applicable RF compliance level above, the Bio-Console 560 should be observed to verify normal operation. If abnormal performance 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.

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Chapter 2 IEC 60601-1-2: 2001 Table 205, Recommended separation distances between portable and mobile RF communications equipment and the Bio-Console 560 The Bio-Console 560 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Bio-Console 560 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BioConsole 560 as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter Rated maximum output power m Rated maximum 150 kHz to 80 MHz 150 kHz to 80 MHz In output power of transmitter W Outside ISM bands ISM bands 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 3.5√ P d = 12√ P d = 1.2√ P d = 2.3√ P 0.01 0.35 1.2 0.12 0.23 0.1 1.1 3.8 0.38 0.73 1 3.5 12 1.2 2.3 10 11 38 3.8 7.3 100 35 120 12 23 For 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 output power 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 the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Cautions:

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

■

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

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Setup

Setup

3

Connecting the Bio-Console Components Refer 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 should be attached before the Bio-Console is turned ON. Connecting the User Interface The User Interface can attach to the Bio-Console via the mounting post on the Base Unit or to a bracket remote from the Base Unit. Connection to the Base Unit 1. 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 rotate the cable collar to lock in place. Either end of the cable can connect to the User Interface or to the Base Unit.

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Chapter 3

3

3

Figure 13. Connect User Interface Cable to Base Unit Connection to an Optional Pole Mount 1. Position the mount on the pole and secure by tightening the knob (Figure 14). 1 2

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). 22

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Setup

4

3

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 rotate the cable collar to lock in place. Either end of the cable can connect to the User Interface or to the Base Unit. Connecting the Pump Motor To connect the pump motor, remove the cap on the pump motor port on the back of the Base Unit and attach the pump motor cable (Figure 16).

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Chapter 3

Figure 16. Connect Pump Motor Cable to Base Unit Connecting the Flow Transducer The 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).

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Setup

1

Figure 17. Attach Flow Transducer Cable to Base Unit Mounting the Flow Transducer The transducer mount (Figure 18) is used to attach the flow transducer to a pole. This may be useful when operating the Bio-Console or when storing the transducer.

4

2

1 3

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. Operator and Reference Manual

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Chapter 3 3. Place the transducer mount on a sturdy pole and turn the knob until the transducer mount is secure. 4. Loosen the knob to extend or retract the bar on which the transducer is mounted. Retighten the knob. Connecting Optional Safety Systems For information on setting up and operating the optional safety systems, refer to Chapter 6.

Turning On the Bio-Console Caution: To avoid damage to the equipment, all electrical connections to the Base Unit should be attached before the Bio-Console is turned ON. 1. Ensure that the AC power source is properly inspected and certified for biomedical equipment. 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.

2 1

Figure 19. AC Power Cord Connection 3. Make sure the RPM knob is turned to zero to the clicked-OFF position (Figure 20). The black release button 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. A mechanical stop is located at the 2000 RPM setting to prevent accidental RPM reduction below that point. Depress the black release button to release the knob from the mechanical stop in order to rotate it to the OFF position. Note: If the knob is not at zero when the Bio-Console is turned on, the centrifugal pump will not spin. To reset the motor controller, turn the knob to 0 RPM for a minimum of one (1) second.

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Figure 20. RPM Knob Turned to the Zero Position 4. 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 power and the AC power switch on the back panel is turned ON. The Power On/Standby switch position does not affect battery charging. 5. When the power switch on the front panel is turned ON, the Base Unit performs a power on self-test during which a one second audible beep is heard, and the Base Unit Screen 1 appears with zero values for flow and RPM. Note: Once the Base Unit self test is completed, the RPM knob can be used to control the pump. The User Interface does not need to be fully running, it can be in self-test, in order to control the pump.

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Figure 21. Power On/Standby Switch Location

Setting Up the User Interface When the user presses the Setup Screen button from the Opening Screen, the Setup Screen will appear (see Figure 22). 1

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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. 28

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

Alarm/Alert sound selection

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Digital Output settings

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Serial Port settings

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Language selection

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Software version

Selecting the Language The 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 Sounds The Bio-Console has distinct alarm/alert sounds to inform the user when alarm or alert conditions are present. An alarm sound is a repeating sequence of long and short beeps. An alarm condition is more serious than an alert condition and requires a corrective action by the user. An alert sound is a steady paced beep.

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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 desired alarm 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 Format The Bio-Console allows the user to program the data output refresh rate and format for transmission to a data management system.

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Figure 25. Entering Data Output Refresh Rate and Format

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Setup 1. While in the Setup Screen, press the up/down arrows on the Rate Selection button to set the desired refresh rate (in seconds) of data transmission. 2. Select either the 550 Bio-Console or 560 Bio-Console button, depending on desired data output format. For additional information on data output formats, refer to Appendix D. Setting Serial Port Parameters The 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 to set the appropriate rate. The rate ranges from 1200 to 19200. 2. Select either the Hardware or XON/XOFF button for the handshake, depending on the requirements of the data management system. Saving Selections When you complete your selections in the Setup Screen, press the Screen Exit button to accept 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-selected settings will not be entered and the device will revert back to the previous settings. If you want to change the settings after you have gone to the Main Screen, you must restart the machine and return to the Setup Screen.

Checking Battery Charge Status The green battery indicator on the lower portion of the Main Screen indicates the charge status of the Bio-Console batteries (see Figure 10). Operator and Reference Manual

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Chapter 3 Refer to page 86 in Chapter 7 for instructions to ensure the batteries are fully charged.

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Case Preparation

Case Preparation

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System Status Indicators At the top of the User Interface, there are three colored lights that are associated with the operation status of the system. These lights serve as a visual cue for assessing system status. 1

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Figure 27. System Status Indicator 1. When the green light is illuminated, all systems are functioning normally and (as applicable) 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 Alarms The Bio-Console has distinct alert/alarm sounds to inform the user when alert/alarm conditions are present: ■

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

■

An alarm indicates a condition that requires immediate corrective action. An alarm notification consists of a repeating sequence of long and short beeps and illumination of the red system status indicator.

In addition, the System Status Message Box displays information about the highest priority alert or 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 will resume after 60 seconds if the situation is not resolved immediately or if a new alert or alarm condition occurs. The mute button only appears when an alert or alarm condition exists. Operator and Reference Manual

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Chapter 4 The alert/alarm sounds are selected from the upper area of the Setup Screen. Refer to page 29 in Chapter 3. Note: The audible alerts/alarms are inactivated when the RPM knob is turned completely counterclockwise to the clicked OFF position. Note: Specific alerts/alarms may display additional unique yellow/red identifiers to aid the user in identifying the source of the condition.

Installing the Bio-Pump Centrifugal Pump The Bio-Console Extracorporeal Blood Pumping Console Model 560 is designed to be operated only with the Bio-Pump Centrifugal Pump. There are no safety or performance data that establish compatibility of any other manufacturer's device or components with the Medtronic system. Warning: Use of the Bio-Pump centrifugal pump beyond the labeled recommendations may result in failure of the centrifugal pump, reduced pumping capacity, leaks, excessive blood trauma, or degradation or corrosion of blood contact materials, which may pass through the blood to the patient. 1. Caution: Ensure the Bio-Pump centrifugal pump is primed according to the procedures described in the Bio-Pump manual. Operating the centrifugal pump without being primed may damage 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 black button 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 centrifugal pump. 1. Black detent release button and RPM level indicator. 2. Mechanical stop at 2000 RPM. 3. Clicked OFF position. 1500 3000

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Figure 28. RPM Knob Turned to the Zero Position 3. 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 the locking pin engages.

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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 help prevent bubble migration to the pump outlet when flow has stopped.

Attaching the Pressure Monitoring Circuit The pressure monitoring system is an optional component to the Bio-Console system. It measures up to two pressures in the extracorporeal blood circuit. If the pressure monitoring system 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 be damaged. 1. Connect a pressure-monitoring line with a 3-way stopcock and a fluid barrier to the male luer lock pressure port on the back panel of the Base Unit (Figure 30). The fluid barrier protects the 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.

on the User Interface and the bottom port corresponds to

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Chapter 4 P1

P2

Figure 30. Attaching the Pressure-Monitoring Line

Zeroing the Pressure Transducer The pressure value on the Main Screen will flash until the pressure transducer has been successfully 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 36

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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.

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Figure 32. Zero Pressure Transducer Values

Setting the Pressure Alert Limits Alerts are activated when pressure sensed by a pressure monitor drops below the low pressure limit or exceeds the high pressure limit. To set low and high pressure limits, go to the Settings Screen and press the up/down arrows for the 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 Main Screen.

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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 pressure monitor value on the Main Screen (Figure 34). For additional information, refer to page 33 in Chapter 4.

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Figure 34. High Pressure Alert Note: If the patient is on bypass and the pressure display is not functioning, the pressure can be approximated by referring to Appendix B. Immediately after the procedure, contact a qualified Medtronic service technician and report that the pressure display is not working.

Attaching Insert to Flow Transducer The disposable insert (Model DP38 or DP38P) is part of the Bio-Probe blood flow monitoring system 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.

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Figure 35. Attaching an Insert to a Flow Transducer

Priming the Circuit Prime the centrifugal pump, insert, and tubing. Refer to the instructions included with the BioPump centrifugal pump for priming details.

Zeroing the Flow Transducer The flow transducer cannot be zeroed until: ■

the perfusion circuit is primed. (Refer to the instructions included with the Bio-Pump centrifugal 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 successfully zeroed. 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.

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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.

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Figure 37. Zeroing the Flow Transducer 6. Remove the tubing clamp.

Correcting a Negative Flow Reading If the transducer was placed backwards in the flow circuit, a negative flow reading will be displayed. 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 flow value.

Setting the Flow Bar Graph Display Scale The Flow Bar Graph Display Scale Selector buttons on the Settings Screen allow you to change the scale of the flow bar graph displayed on the Main Screen. Three ranges are displayed on the 42

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Case Preparation Settings Screen: 0-10 (L/min), 0-7 (L/min), and 0-2 (L/min), symbolized by large adult, normal adult, 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 Alerts The Bio-Console allows the user to set lower and upper flow alert settings. The settings are displayed on the Main Screen as two triangular markers on the Flow Bar Graph (Figure 10). Alerts will 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).

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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 monitor value (Figure 40). For additional information, refer to page 33.

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Figure 40. Low Flow Alert

Establishing the Target Flow Rate Target Flow is the nominal rate of flow needed to achieve a desired Cardiac Index for a specific patient. 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 Flow section 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.

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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, the Target Flow Rate and the measured Cardiac Index value will not display on the Main Screen.

Timers Setup There are three timers, which are independent of each other (Figure 42). Each timer displays time in hours, minutes and seconds. Timers are configured on the Settings Screen and controlled from the Main Screen.

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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 up from 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 or Count Down mode. 2. If Count Down is selected, a display will appear allowing the user to designate the initial count down value for that timer. Note: When the Count Down timer is used, the timer beeps five times and the display flashes at 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 the up/down arrows. 4. Use the up/down arrows to enter the desired Count Down time.

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

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Figure 43. Adjust Light Intensity of Screen

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On-Pump Operation

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Before 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 cardiopulmonary bypass procedures. If the Bio-Console must be replaced during a procedure, follow the instructions in 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 and the manufacturer's instructions. To ensure that the system will operate properly, use only Medtronic accessories.

Adjusting Flow Rate The RPM speed is used to maintain positive flow and pressure to the centrifugal pump outlet side of the perfusion circuit. The blood flow rate is dependent upon pump RPM, circuit resistance and patient 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 and blood 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 not spin. To reset the motor controller, turn the knob to 0 RPM for a minimum of one (1) second. 2000 RPM Mechanical Stop The black detent release button on the RPM knob is connected to a mechanical stop that prevents an unintentional RPM reduction below 2000 (Figure 44).

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Chapter 5 1. Black detent release button and RPM level indicator. 2. Mechanical stop at 2000 RPM. 3. Clicked OFF position. 1500 3000

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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 Rate Flow 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.

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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 flow alert settings. Refer to page 43 in Chapter 4 for instructions on how to set these values and on setting 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 monitor value (Figure 40). If the RPM knob is set above zero, the Bio-Console backflow alarm will activate when flow goes below –100 mL/min. If a backflow alarm is active, a red down arrow will flash next to the flow monitor 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, refer to Chapter 6. If flow values are flashing, the accuracy of the flow values may be compromised. Additional information 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 connected properly or is malfunctioning. Flashing values indicates that the flow transducer has not been zeroed or that accuracy may have been compromised due to system malfunction or electrical interference. 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 when an electrocautery unit is in operation. Warning: When initiating flow, establish pump RPM before unclamping the arterial line. Failure to do so could cause retrograde flow. Warning: 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 patient Operator and Reference Manual

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Chapter 5 resistance. Not maintaining a positive flow could allow retrograde flow and exsanguinate the patient if the line is not clamped. If for any reason the centrifugal pump has stopped, the arterial line must be clamped, either manually or by use of the AutoClamp system. Monitoring Flow from the Base Unit The Base Unit display presents basic information including the flow rate and pump speed. In the event that the touch screen user interface should stop functioning the case can be managed with the controls from the base unit display. Refer to Chapter 9.

Using Timers The Bio-Console has three independent timers that can be configured for Count Up or Count Down operation. The arrow to the left of the timer symbol indicates whether a timer is in Count Up or Count Down mode. Each timer displays time in hours, minutes and seconds. Timers are configured 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

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On-Pump Operation Resetting a Count Up timer sets the timer value to 00:00:00. Resetting a Count Down timer sets the timer to the initial Count down value designated in the Settings Screen (refer to page 46 in 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 at 00:00:00. The flashing will continue until the timer is reset.

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

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

Service Log The 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 standby mode.

Activity Indicator The 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 Pressure Pressure 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 pressure monitor value (Figure 34). Refer to Figure 33 in Chapter 4 for setting low and high pressure alert limits. 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 is malfunctioning. Flashing values indicates that the pressure transducer has not been zeroed. Refer to page 36 in Chapter 4.

AC Power Status Alert If AC power is disconnected or turned off, an alert will sound indicating the loss of AC power. The Bio-Console will automatically switch to battery backup due to the loss of AC power. Operator and Reference Manual

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Chapter 5 Pressing the AC Power Status button will silence the audible alert for 10 minutes. The visual alert will remain until AC power is restored (Figure 47).

Figure 47. AC Power Status Button

Battery Alarm The audible and visual battery alarms activate when approximately 5 minutes of battery charge remains under normal operating conditions and cannot be adjusted (Figure 48). Recharging the batteries to 90% capacity takes approximately 18 hours and a full charge requires approximately 24 hours.

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Figure 48. Low Battery Alarm Activated

Stopping Flow: Taking A Patient Off Cardiopulmonary Bypass When ending bypass or greatly reducing flow, occlude the arterial line before dropping below the minimum flow rate (250 mL/min has been achieved. 2. AutoClamp Configuration — These buttons select which events the AutoClamp will respond to. The configuration setting is indicated with text under the AutoClamp button. The configuration 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 will close. A system alarm will be generated and the button will change appearance and color (red) (Figure 76).

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Figure 76. Pump Stop from Backflow c.

Both — If the pump stops or the measured flow rate is less than –100 mL/min, the AutoClamp will close. A system alarm will be generated and the button will change appearance and color (red). Note: The AutoClamp system will retain its configuration settings after the Bio-Console is switched to standby. Once a selection is made in the AutoClamp configuration window, the selected item will blink and the window will close. To close the window without making a selection, either press the AutoClamp button again, press another safety system button, or wait 5 seconds and the window will close. Opening the AutoClamp If the AutoClamp closes for any reason, an Open Clamp button appears. Once the user has determined 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 could cause retrograde flow. Note: In order to gradually reintroduce flow, it is recommended to use a hemostat in combination with opening the AutoClamp.

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Chapter 6 Manually Opening the AutoClamp If for any reason you need to override the AutoClamp system, the AutoClamp can be manually opened as follows (Figure 73): 1. Loosen the remote tube clamp knob to open the security latch. 2. Remove the tubing. AutoClamp Status The graphics on the AutoClamp button change to represent the current AutoClamp status. Refer to Table 3 for a complete description of AutoClamp status indicators. Table 3. AutoClamp Status Indicators Icon

Status AutoClamp, status OK. AutoClamp, status alarm. AutoClamp, status disabled. AutoClamp, status error.

Verifying the AutoClamp System To 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 Alarm If the RPM knob is set above zero, the Bio-Console backflow alarm will activate when flow goes below –100 mL/min. If a backflow alarm is active, a red down arrow will flash next to the flow monitor value (Figure 77). For additional information, refer to Chapter 4.

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Safety Systems

Figure 77. Backflow Alarm

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Chapter 6

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Maintenance

Maintenance

7

Cleaning the Flow Transducer To clean the flow transducer, refer to the instructions included with the Bio-Probe blood flow monitoring system.

Cleaning the Bio-Console and Accessories 1. 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 AC power source during servicing or cleaning. 3. Use a mild detergent to clean the Base Unit and accessories with a sponge or a soft cloth moistened with water. 4. Use a mild detergent to clean the User Interface with a sponge or a soft cloth moistened with water. Caution: Do not immerse the Base Unit or accessories, nor allow water to run into the interior of the Base Unit or accessories. Do not use alcohol or alcohol-based cleaning solutions. Do not spray fluid into electrical connectors or onto the User Interface screen.

Servicing the Pump Motor The 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 an annual preventative maintenance check with a Medtronic service technician. The inspection and maintenance may be done either on site or at the factory. A Preventative Maintenance Log form is 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 Module Note: Do not attempt to service the Bio-Console or AutoClamp interface module; doing so will void the warranty. Schedule an annual preventative maintenance check with a Medtronic service technician. The inspection and maintenance may be done either on site or at the factory. A Preventative Maintenance Log form is included in Appendix F. If the Bio-Console or AutoClamp interface module appear to be malfunctioning, refer to Appendix A or consult with a Medtronic service technician. Warning: Do not adjust, modify, repair, or touch the internal circuitry. These actions could cause operator injury or cause faulty operation of the Bio-Console or AutoClamp interface module.

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Chapter 7 Medtronic employs highly trained representatives and engineers located throughout the world to serve their customers. Upon request, training about Medtronic products is provided to qualified hospital personnel. In addition, Medtronic maintains a professional staff of consultants to provide technical consultation to product users. For supplemental information, contact your local Medtronic representative at the address or telephone number listed on the back cover.

Maintaining and Charging the Batteries The 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 full charge 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. AC Power Switch 2. Power Cord Port

1

2

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 the other 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 Status Battery charge status is indicated by the Battery Charge Status Indicator icon on the User Interface Screen, on the Base Unit Console Screen and an LED Indicator. If you wish to check battery charge status further, you may follow this procedure: 86

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Maintenance 1. Turn OFF the AC power switch on the back panel of the Base Unit. An alert will sound indicating the loss of AC power. (Press the AC Power Status button to silence the Alert for 10 minutes.) The Bio-Console will automatically switch to battery backup due to the loss of AC 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 are not fully charged. (Recharging the batteries to 90% capacity takes approximately 18 hours and a full charge requires approximately 24 hours.) Ensure the availability of another BioConsole 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 before showing actual battery status.

Battery Service and Disposal To 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 Handcrank To ensure that the handcrank is accurate and operational, inspect the handcrank visually and functionally every month. Visual Inspection 1. 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 Inspection 1. 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. Operator and Reference Manual

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Chapter 7 4. If the magnet does not couple or if the RPM display is not functioning, consult with a qualified Medtronic service technician.

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

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Emergency

Emergency

8

This section describes the necessary emergency actions if: ■

the pump motor stops functioning

■

AC power fails

■

battery backup fails

Blood Pump Failure If 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

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Chapter 8

Electrical Power Failure AC Power Failure If hospital AC power fails, the internal batteries in the Base Unit will immediately provide backup power to the system. Battery backup will last for one half hour to allow for appropriate surgical decision-making. Ensure that the AC power cord is plugged into the back panel of the Base Unit and into the wall outlet, and ensure that the AC power switch on the back panel is turned ON. This will allow the Bio-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 Failure In the unlikely event that hospital power and emergency generation power are lost and battery backup 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 will function for approximately 1/2 hour. These time durations are based on new, fully-charged batteries. Instructions for ensuring that the batteries have a full charge are described in page 86.

Bio-Console System Failure If there is a Bio-Console System failure (as opposed to an electrical power failure), the Bio-Pump must 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-Console 1. 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 and venous lines.

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

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Emergency The handcrank has an LED display calibrated for the centrifugal pump speed to indicate the RPM of 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 the mounting 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 still pumps fluid through the outlet, but the efficiency is reduced and the LED display does not illuminate. Table 4. Properties of Handcrank Model 150 Feature Operator Handle Turning Mount RPM Display Range Gear Ratio Display Weight

Model 150 Left or Right Side Heart Lung Machine Pole 1000 to 3250 RPM 1 handcrank RPM: 25 centrifugal pump RPM 88 handcrank RPM: 2200 centrifugal pump RPM Light Emitting Diode (LED) 3.2 kg (approximately 7 lb)

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Chapter 8 Components of the Model 150 Handcrank

1

2

3

Figure 81. Handcrank Components 1. Pump Receptacle. 2. RPM Display. 3. Handle.

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Emergency Attaching and Using the Model 150 Handcrank

7

4 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 have additional 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 still pumps 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 and venous lines and maintain an appropriate handle rotation speed, as viewed on the handcrank Operator and Reference Manual

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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 Pump If 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 part of the circuit.)

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Use of Base Unit Display

Use of Base Unit Display

9

Using the Base Unit Display Instead of the User Interface The Base Unit display area (Figure 83) presents basic information of extracorporeal flow rate and centrifugal 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. The up/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 Interface and will continue its functionality even if the touch screen fails.

Bio-Console® 560 1

2 6

4 3

5

Figure 83. Bio-Console Base Unit Display 1. 2. 3. 4. 5. 6.

Graphic/character display. “AC Power connected” LED (flashes when battery is charging). Alarm mute key. Enter key (applies selected values). Up/Down Menu Selection keys. Left/Right Value Selection keys. Note: Depress key for 5+ seconds to increase values faster.

Base Unit Display Startup Screen When the power switch on the front panel is turned ON, the Base Unit will perform a self test. Operator and Reference Manual

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Chapter 9 Base Unit Screen 1 — System Status During the case, Base Unit Screen 1 displays the current flow and RPM settings and is the default display.

L/min RPM Figure 84. Base Unit Screen 1 1. Flow Rate (L/min) 2. Centrifugal Pump Speed 3. Battery Charge Level 4. 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 Flow Zero Yes

L/min Flow Zero

No

Figure 85. Base Unit Screen 2 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.

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Use of Base Unit Display Base Unit Screen 3 — Set High Flow Rate Alarm

L/min High Flow Alarm

L/min Figure 86. Base Unit Screen 3 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 Low Flow Alarm

L/min Figure 87. Base Unit Screen 4 1. Screen identifier 2. 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.

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Chapter 9 Base Unit Screen 5 — Error Status

L/min Error 77

Figure 88. Base Unit Screen 5 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.

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Checklist and Troubleshooting

Checklist and Troubleshooting

A

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

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

1.

2.

3.

4.

Item Activity Be sure the Bio-Console ■ Turn the Power On/Standby switch to OFF. is turned OFF before attaching components to the back panel. Connect the components ■ Connect the User Interface cable to the User Interface and the Base to the back panel of the Unit. Base Unit. ■ Attach the pump motor cable to the back of the Bio-Console.

Check the internal batteries.

Check the functionality of the pump drive motor.

■

Lock the centrifugal blood pump into the external pump receptacle with the outlet positioned away from the top center.

■

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

■

Connect a 3-way stopcock and a fluid barrier to the male luer lock PRESSURE 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 interface on the back of the User Interface. 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 to a centrifugal pump, turn the RPM to the highest setting for 10 seconds.

■

Make sure the battery status indicator remains green.

■ ■

Turn ON the AC power switch on the back panel. Turn the RPM knob to MAX RPM and back to the clicked OFF position. While doing this, make sure the PUMP SPEED and RPM display and graph show appropriate values.

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Appendix A

5.

6.

7.

Item Activity Connect, prime, and zero ■ Attach the pressure tubing with a fluid barrier and a 3-way stopcock the pressure transducer. to the PRESSURE connector on the back of the console.

Assemble the Bio-Probe blood flow monitoring system.

Zero the flow transducer.

■

Prime the pressure tubing.

■

Turn the 3-way stopcock so that the pressure transducer is exposed to air.

■

Press the Pressure Zero button on the User Interface Settings Screen until 0 mm Hg is displayed. Attach the arterial tubing to one side of the insert and the centrifugal pump outlet tubing to the other side. Note: Make sure an adult insert (DP-38) is used with an adult transducer (TX-50); similarly, use a pediatric insert (DP-38P) with a pediatric transducer (TX-50P).

■

■

Align the insert (under the transducer cover) according to the fluid path direction shown on the transducer cover.

■

Prime the centrifugal pump, insert, and tubing as described in the instructions included with the Bio-Pump centrifugal pump. Clamp the tubing on the outlet of the centrifugal blood pump.

■ ■

8.

Check the flow range and flow alarm.

■

Press the Flow Zero button on the User Interface Settings Screen until 0.00 L/min is displayed. Press the appropriate Flow Range Display button on the User Interface Settings Screen.

■

Press the upper and lower Flow Alarm Limit buttons on the User Interface Settings Screen until the desired limits are displayed. THE CONSOLE IS READY FOR USE

AC Power and External Motor Troubleshooting 1.

Situation Checklist for Resolution No AC power to the Bio■ Verify AC power cord is plugged into an electrical outlet. Console. ■ Verify AC power cord is plugged into the back panel of the Base Unit. ■

2.

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

If pump motor function is not restored, use a Model 150 handcrank or transfer the centrifugal blood pump to a standby Bio-Console. The pump motor does not ■ Turn the knob to zero for a minimum of one (1) second, then turn the spin. knob to the desired RPM value. ■

Verify the pump motor cable is properly connected to the back panel of 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 standby console.

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Checklist and Troubleshooting

Bio-Pump Centrifugal Blood Pump Troubleshooting 1.

2.

Situation Checklist for Resolution The disposable pump ■ Verify flow transducer is installed with proper flow orientation and is rotates but flow is not indiplugged into the Bio-Console. cated. ■ Verify the centrifugal blood pump is primed.

The disposable pump vibrates when the RPM is increased.

■

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 transducer is not zeroed.)

If the flow display still does not function, use a standby flow transducer. ■ Verify the centrifugal blood pump is placed securely in the remote drive receptacle. ■

Verify there are no foreign objects on the centrifugal blood pump or drive magnets.

If the centrifugal blood pump still vibrates, replace it.

Flow Troubleshooting 1.

Situation Checklist for Resolution The flow value is flashing ■ Verify the flow transducer cable is properly connected to the Biodashes. Console.

2.

The flow value is flashing.

3.

If the flow display is still flashing dashes, use a standby transducer. ■ 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 or normal saline solution (not 5% Dextrose in Water [D5W] or sterile water)?

■

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

If the flow value is still flashing, use a standby transducer. The flow value flashed for This is normal operation. (The flow changed abruptly, eg, the RPM knob a moment. was turned very quickly or a clamp was placed or removed quickly.)

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Appendix A

4.

5.

6.

7.

Situation Checklist for Resolution ■ Verify the flow transducer is installed with proper flow orientation and The centrifugal pump is revolving but a flow value plugged into the Bio-Console. is not displayed. ■ Verify the centrifugal blood pump is primed.

The centrifugal pump is revolving but a negative flow value is displayed. The flow transducer will not zero.

The displayed flow differs from the expected values.

■

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 transducer is not zeroed.)

If the flow value is still not displayed, use the standby transducer or plot the RPM and difference in pressure between the inlet and outlet of the centrifugal blood pump on the charts in Appendix B. ■ Verify the fluid flow direction is aligned with the arrow on the transducer. ■ ■

Verify the RPM is adequate to achieve positive flow. 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. ■ Verify there are no flow circuit occlusions. Flow resistance affects the flow rate. ■

Verify the transducer is zeroed correctly.

RPM Troubleshooting 1. 2.

3. 4. 5.

102

Situation Checklist for Resolution The RPM display is flash- Minor User Interface malfunction, but the RPM value is valid. Call a Meding. tronic service technician. The RPM display is flash- ■ Verify the pump motor is connected. ing dashes. If the pump motor is connected, there is a system failure. Use a backup Bio-Console. Call a Medtronic service technician. The RPM display indiTurn the knob clockwise. cates zero. If the RPM is still displayed as zero, use a standby console. The RPM knob will not Normal operation for the RPM knob. To reduce the RPM below 2,000, turn below 2,000. press the black button on the RPM knob while turning the knob. When using the batteries, The battery charge is low. Prepare to use a standby Bio-Console or a RPM is insufficient. handcrank.

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Checklist and Troubleshooting

Battery Power Troubleshooting 1.

Situation Checklist for Resolution The internal batteries are ■ Verify the AC power switch is turned ON. not charged. ■ 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 technician.

Digital Output Troubleshooting Refer to Appendix D in this manual for complete instructions. 1.

Situation The computer does not receive data.

Checklist for Resolution ■ 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 the device.

Safety Systems Troubleshooting 1.

2.

3.

Situation Checklist for Resolution Cannot get green light ■ Verify no system errors are present. status on the System Sta■ Verify all safety systems are enabled and configured. tus Indicator when safety Note: All safety systems that are plugged in must be enabled and systems are connected. configured to achieve green light status except for the upper level sensor. The level sensor reports ■ Verify sensor is firmly fixed to reservoir. low fluid level when fluid ■ Verify target on sensor is at or below the fluid level. level is normal. ■ Verify red light on sensor is lit (red light is lit when fluid is present within sensor target). The level sensor reports adequate fluid level when fluid level is low.

If sensor is properly applied and fluid is present, replace sensor cable. ■ Verify sensor is positioned correctly. ■

Verify red light on sensor is not lit (red light is lit when fluid is present within 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 sensor cable.

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Appendix A

4.

5.

6.

7.

Situation Checklist for Resolution ■ Verify tubing is properly seated in bubble detector. The bubble detector reports bubbles when no ■ Verify tubing size is compatible with bubble detector. bubbles are present. ■ Reposition bubble detector to a known bubble-free section of tubing. The bubble detector fails to report bubbles when present.

AutoClamp will not open when Open Clamp button is pressed.

If bubbles are still falsely detected, disable or replace bubble detector. ■ 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. ■ 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 the tubing and replace clamp. AutoClamp will not close. ■ Verify AutoClamp is enabled and configured. ■

8.

AutoClamp malfunction error message appears.

■

Verify bubble detector and level sensors are configured to stop the pump and are enabled. Note: The AutoClamp will close for pump stop or backflow or both conditions, depending on the configuration. Verify air pressure is adequate.

■

Verify AutoClamp cables are securely attached to interface module.

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

Alert and Alarm Message Priority

104

Priority

Text-line 1

Text-line 2

Color

1 2

Communication to Base Unit Lost Bubble Detected

Call Service Press Bubble Detector Button To Acknowledge

Red Red

3 4 5 6 7 8 9 10 11 12 13 14

Motor Disconnected Reservoir Low (Lower Sensor) Reservoir Low (Upper Sensor) Reservoir Low (Lower Sensor) Reservoir Low (Upper Sensor) Biopump Stopped — Clamp Closed Biopump Stopped Backflow — Clamp Closed Clamp Closed Clamp Closed Backflow Reservoir Low (Lower Sensor)

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Bio-Pump Stopped — Clamp Closed Bio-Pump Stopped — Clamp Closed Bio-Pump Stopped Bio-Pump Stopped Turn Knob To 0 To Restart Turn Knob To 0 To Restart Press “Open Clamp” Button To Open Low Clamp Air Pressure Press “Open Clamp” Button To Open Bio-Pump Coasting

Red Red Red Red Red Red Red Red Red Red Red Red

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Checklist and Troubleshooting 15 16 17 18 19 20 21 22 23 24 25

Reservoir Low (Lower Sensor) Bio-Pump Coasting Low Battery Flow Transducer Disconnected Reservoir Low (Upper Sensor) Reservoir Low (Upper Sensor) High Flow Low Flow P1/2 High Pressure P1/2 Low Pressure AC Power Failure

26 27 28

Low Clamp Air Pressure Flow System Interference Detected Motor Controller Malfunction

29

Flow System Malfunction

30

Pressure Monitor 1/2 Malfunction

31

Pressure Monitor 1/2 Malfunction

32

Clamp Malfunction

33

Bubble Detector Malfunction

34

UL/LL Sensor Malfunction

35

Servo System Malfunction

36

Safety System Malfunction

37

UPS Malfunction

38

Motor Controller Malfunction

39

Flow System Malfunction

40

Pressure Monitor 1/2 Malfunction

41

Pressure Monitor 1/2 Malfunction

42

Clamp Malfunction

43

Bubble Detector Malfunction

44

UL/LL Sensor Malfunction

Red Red Red Red Bio-Pump Coasting Yellow Yellow Yellow Yellow Yellow Yellow Press AC Power Failure Button To Clear Yellow Alert Yellow Yellow Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Press Service (Wrench) Button to Yellow Acknowledge Lower Knob Speed To Disengage

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Appendix A

106

45

Servo System Malfunction

46

Safety System Malfunction

47

UPS Malfunction

48 49 50 51

Clamp Disabled Bubble Detector Disabled LL Sensor Disabled Medtronic Bio-Console 560

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Press Service (Wrench) Button to Acknowledge Press Service (Wrench) Button to Acknowledge Press Service (Wrench) Button to Acknowledge

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Hydraulics

Hydraulics

B

Viscosity and Flow Rate The following charts show the relationship between RPM, pressure, and flow. The flow rates reflect a fluid viscosity of 2.1 mPa·s. This viscosity is similar to the combination of blood and balanced 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 centrifugal blood pumps.

Determining the Flow The following charts are useful if a flow display malfunctions. To determine the flow, plot the RPM and 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 drop across the devices in the line. BPX80 30% Hct Bovine Blood RPM

Differential Pressure (mm Hg)

Flow (L/min)

Figure 89. Model BPX-80 Centrifugal Pump Flow Rate

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Appendix B BP-50 Flow Curve

4000 RPM Difference in Pressure (mm Hg) from the Inlet to the Outlet

3000 RPM

2000 RPM 1000 RPM 0

0.25

0.5

0.75

1

1.25

1.5

1.75

Figure 90. Model BP-50 Centrifugal Pump Flow Rate

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Battery Longevity

Battery Longevity

C

Variable Factors Many 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 Estimates Under operating conditions of 4 L/min and 400 mm Hg differential pressure, the batteries will function for approximately 1/2 hour. These time durations are based on new, fully-charged batteries. Instructions for ensuring that the batteries have a full charge are described in Chapter 7.

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Appendix C

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Digital Output

Digital Output

D

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

Selecting the Appropriate Transmission Mode The Bio-Console 560 RS 232 interface supports two basic modes to determine the interval between data transmissions, periodic transmission, and on-request transmission. Periodic Transmission During periodic transmission, data are automatically sent at a predefined interval as specified by the 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 as HyperTerminal which comes with most PCs) can be used to capture the data that can then be formatted and manipulated using standard PC tools. On-Request Transmission During 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 application can request data when required. This allows the custom application to enable/disable data output and determine the transfer rate.

Selecting the Appropriate Protocol The RS 232 protocol refers to the specific data transmitted periodically or in response to a DR command. The 550 protocol is a subset of the 560 protocol; therefore the 560 protocol is preferred for most applications. The 550 protocol is provided to support applications where a custom data output application has already 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, the following 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 to determine the appropriate protocol. This would allow both the 550 and 560 Bio-Consoles to be supported for data output without compromising the transmitted data.

Once the desired protocol has been determined, the protocol may be selected using the Setup Screen or through the DR command “format” parameter. Operator and Reference Manual

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Appendix D

RS 232 Commands This section defines the 560 RS 232 interface commands. Command Syntax An external data output device can request data from the 560 by sending a command string. A command 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 by the specific command or an error as defined under “Command Errors.” Note: Items enclosed in “{}” are optional. Items enclosed in “” are mandatory. Items enclosed in “(..)” may be repeated as required. Commands are defined utilizing the following syntax: {(…)} where:

ASCII characters used to define a command. Separator, used to separate data fields. The space character (0x20) is used as the separator. Data field, used to provide data required by the command. Used to check validity of data. It is the sum of ASCII values of all the characters in the command excluding the checksum. This total is represented by a 4 digit ASCII hexadecimal number with leading zeros as required. The checksum value must be in upper case characters. Carriage Return (0x0D), used to specify the end of the command string.



Command Errors The error response is sent from the Bio-Console to the PC/data output device in response to an invalid message received. The format of this response is:

ER: Error code

Indicates an error response. 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 Error

Example: Field



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Characters E 0 0

English

R 1 1

3

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Digital Output Example of data output as displayed in terminal emulator application (HyperTerminal): ER 01 0138 DR, Set Data Rate The DR command is sent from the terminal to the Bio-Console 560 to select the periodic rate in which the data output commands will be sent. After receiving this command, the User Interface will begin sending the data output (DA) command at the specified rate. If the rate parameter is set to zero or is not provided (default), then the data is sent immediately only once. {}{} Command Rate

Format

A 2-character constant value (“D” 0x44 “R” 0x52). The number of seconds between sending the data output commands. Range 0–32767 seconds. (default = 0) It is the desired output format. 0 — Use 550 format 1 — Use 560 format

Note: The format parameter defaults to the last specified format from the Setup Screen or DR command. 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 D 1 0

R 5 1

3

C

Example of command as displayed in terminal emulator application (HyperTerminal): DR 15 013C ET, Request Elapsed Time The elapsed time command provides the instrument’s operating time since turned ON (System Elapsed Time) and the total elapsed time since manufacturing (Total Elapsed Time). ET Command:

Example: Field

Characters E 0

T 0

B

9

As displayed in terminal emulator application (HyperTerminal): ET 00B9 ET Response:

Command is a 2-character constant value (“E” 0x45 “T” 0x54). Operator and Reference Manual

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Appendix D System Elapsed Time and Total Elapsed Time are 7-character values with leading zeros and no decimal point. The assumed precision is the hundredths. System Elapsed Time is the elapsed time since the console was turned ON. Total Elapsed time is the elapsed time the console has been used since manufacturing. Example: Elapsed time = 1.47 hours, Total elapsed time = 132.05 hours ET 0000147 0013205 0390 ID, Identification Command The ID command provides the ability for an external data output system to identify the type of Bio-Console connected. The command will respond in accordance with the type of protocol selected through the User Interface or DR command (550 or 560). ID Command:

Command is a 2-character constant value (“I” 0x49 “D” 0x44). Example Command: Field

Characters



I 0

D 0

A

D

As displayed in terminal emulator application (HyperTerminal): ID 00AD ID Response, 560 Protocol

Command Model Number Software Version

A 2-character constant value (“I” 0x49 “D” 0x44). A 3-character constant value identifying the 560. “560” A 10-character value representing the version of the User Interface software. Leading zeroes are used.

Example 560 Response Field



Characters I 5 0 0

D 6 1 3

0 . 4

0 7

0

0

.

0

1

1

As displayed in terminal emulator application (HyperTerminal): ID 560 01.000.011 0347 ID Response, 550 Protocol

Command Model Number

A 2-character constant value (“I” 0x49 “D” 0x44). A 5-character constant value identifying the emulated instrument. “540-D”

Example 550 Response

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Digital Output Field



Characters I

D

0 0

1 2

5 1 E

4

0

-

D

9

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

Data Output Format The data are sent from the Bio-Console 560 to the terminal/DAQ device at the specified interval or in response to the DR command. To be compatible with older Bio-Console systems, there are two formats of this command. The user can select which format is to be sent with the DR command 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 Format If the 550 compatible output format is selected, the fields will be output in the following sequence:







The following table shows the 550 compatible data output format in terms of parameters and some example ASCII characters. Field







Characters D + + 2 0 1 1 0 0 0

A 0 2 0

4 1 1

0 0 0

4

8

6

0

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

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Appendix D 560 Data Output Format If the 560 compatible output format is selected, the fields will be output in the following sequence:























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Digital Output













The following table shows the 560 data output format in terms of parameters and some example ASCII characters.

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Appendix D Parameter



















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Characters D 1 0 0 0 0 0 0 0 1 2 0 + + 0 + 0 0 0 + + 1 + 0 0 0 1 0

A 6

0

9

0

0

4

0

0

0 0

4 5

0 0

0 0

0

2

3

0

0 0

1 1

5 0

0 0

0

0

5

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Digital Output Parameter



















+ + 0 + 0 0 0 0 0 1 2 0 0 0 1 2 0 0 1 1 0 0 1 2 0 0 1

0 0

Characters 4 4

0 5

5 0

0

3

0

0

0

A

E

Data Output Parameter Format Parameter Description/ASCII Format Command 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” protocol will be appended at the end of the message — therefore, parsers may be written to check the message length, compute the checksum, and then only parse the portions of the message it understands (recently added fields at the end of the message may be ignored). 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 errors 1 — Soft error occurring, minor issue 2 — Hard error occurring, major issue UPS, Battery Battery charge capacity. This field indicates the relative charge of the batteries. Capacity 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 being fully charged.

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Appendix D Parameter Description/ASCII Format UPS, Low Bat- Low battery alarm. tery 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, AC AC power failure alarm. Power Failure The AC power failure alarm is a 1-character field representing the status of the AC mains Alarm supply. An ASCII 0 indicates the alarm is not active. An ASCII 1 indicates the alarm is active. UPS, System The system error is a 3-character field representing the current system error code. Error Code Error code 0 indicates that no errors are occurring. Contact an authorized field service representative for a list of all system errors. MC, Status Motor controller status. This field indicates the error status of the Motor controller within the 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 errors 1 — Soft error occurring, minor issue 2 — Hard error occurring, major issue MC, Low RPM Low RPM disable status bit. This field indicates the state of the low RPM disable control Disable bit from the motor controller. An ASCII 0 indicates motor is running. An ASCII 1 indicates the motor is stopped. MC, Motor Motor detect status bit. Detect 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 (ASCII 0x31 0x39 0x30 0x30). PM, Status 1 Pressure monitor status for channels 1 and 2. This field indicates the error status of the PM, Status 2 pressure 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 errors 1 — Soft error occurring, minor issue 2 — Hard error occurring, major issue

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Digital Output Parameter PM, Pressure 1 PM, Pressure 2 PM, Pressure 1, High Alert Limit PM, Pressure 1, Low Alert Limit PM, Pressure 2, High Alert Limit PM, Pressure 2, Low Alert Limit PM, Pressure 1, High Alert PM, Pressure 1, Low Alert PM, Pressure 2, High Alert PM, Pressure 2, Low Alert PM, Pressure 1 Zero PM, Pressure 2 Zero

Description/ASCII Format 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).

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

Pressure channel zeroed indicator. This field indicates the status of the pressure zero function. 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 the instrument. FS status is a 1-character field representing error status of the flow system. The FS status is defined as follows: 0 — Normal operation, no errors 1 — Soft error occurring, minor issue 2 — Hard error occurring, major issue FS, TX Detec- Flow transducer detection status bit. ted An ASCII 0 indicates the flow transducer has not been detected. An ASCII 1 indicates the flow transducer has been detected. FS, InterferFlow system interference detection status bit. ence Detected An ASCII 0 indicates that no RF interference has been detected. An ASCII 1 indicates that RF interference has been detected.

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Appendix D Parameter FS, Flow FS, High Alert Limit FS, Low Alert Limit

Description/ASCII Format Flow rate measurement and alarm limits The 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. No decimal 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 (ASCII 0x2B 0x30 0x30 0x33 0x35 0x34). Flow, High High/low flow alert. Alert The AC high/low flow alert is a 1-character field representing the status of the associated Flow, Low Alert flow 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 RPM Alarm status bits are each 1-character fields which represent the values of the associated Alarm alarms. 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 the instrument. 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 errors 1 — Soft error occurring, minor issue 2 — Hard error occurring, major issue 3 — Board not present/ready Motor state. This field indicates the motor state. SS, 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 setting 1 — Coasting 2 — Stopped Servo, Status Servo systems status. This field indicates the error status of the servo system within the instrument. 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 errors 1 — Soft error occurring, minor issue 2 — Hard error occurring, major issue

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Digital Output Parameter Clamp, Status Bubble Detector, Status Upper Level Sensor, Status Lower Level Sensor, Status Bubble Detector, Config Upper Level Sensor, Config Lower Level Sensor, Config Clamp, Config

Clamp, Air Pressure

Clamp, State

Bubble Detector, State

Upper Level Sensor, State Lower Level Sensor, State

Description/ASCII Format 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 errors 1 — Soft error occurring, minor issue 2 — Hard error occurring, major issue 3 — Device not present (disconnected) 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 only 1 — Coast 2 — Stop 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 stop 1 — Clamp on backflow 2 — Clamp on either pump stop or backflow 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 pressure 1 — Insufficient air pressure 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 open 1 — Clamp closed 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 detected 1 — Bubble detected 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 Detected 1 — Air detected

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Appendix D Parameter Clamp, Enable Bubble Detector, Enable Upper Level Sensor, Enable Lower Level Sensor, Enable Checksum

Description/ASCII Format 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 — Disabled 1 — Enabled

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

RS 232 Hardware Interface Pin Number 2 3 4 5 8

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RS 232 Interface Pin Assignments Signal Name Function/Direction RX Receive Data/Input TX Transmit Data/Output RTS Ready-To-Send/Output GND Ground CTS Clear-To-Send/Input

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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 the Medtronic Bio-Console, Model 560 Extracorporeal Blood Pumping Console, hereafter referred 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 delivery of the Bio-Console to the purchaser, Medtronic will at its option: (a) repair or replace any part or parts of the Bio-Console; (b) issue a credit to the purchaser equal to the Purchase Price, as defined in Subsection A(2), against the purchase of the replacement BioConsole; 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 the original, or current functionally comparable, or replacement Bio-Console. B. To qualify for the repair, replacement or credit set forth in Section A, the following conditions must 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 any way which, in the judgment of Medtronic, affects its stability and reliability. The BioConsole 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 CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE OR MALFUNCTION OF THE BIOCONSOLE, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT OR OTHERWISE. (2) This LIMITED WARRANTY is made only to the purchaser of the Bio-Console. EXCEPT AS SET FORTH IN THIS LIMITED WARRANTY, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM OR OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO THE CUSTOMER. (3) The exclusions and limitations set out above are not intended to, and should not be construed 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 United States. Areas outside the United States should contact a local Medtronic representative for exact terms of the LIMITED WARRANTY.

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Appendix E term of this LIMITED WARRANTY is held to be illegal, unenforceable or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid. This LIMITED WARRANTY gives the purchaser specific legal 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 or warranty with respect to the Bio-Console other than as set forth in this LIMITED WARRANTY.

Equipment Limited Warranty2 (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 the Medtronic Bio-Console, Model 560 Extracorporeal Blood Pumping Console, hereafter referred to as the “Bio-Console,” that 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 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 equal to the original Bio-Console purchase price (but not to exceed the value of the replacement Bio-Console), against the purchase of replacement Bio-Console; or (c) provide functionally comparable 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 and reliability. (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 failure of 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 construed so as to, contravene mandatory provisions of applicable law. If any part or term of this LIMITED 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 the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid.

2

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

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Warranties

Equipment Limited Warranty3 The following LIMITED WARRANTY Applies to United States Customers Only: A. This LIMITED WARRANTY provides the following assurance to the purchaser of the Medtronic 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 the Equipment to the purchaser, Medtronic will at its option: (a) repair or replace any part or parts 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 the original, or current functionally comparable, or replacement Equipment. B. To qualify for the repair, replacement or credit set forth in Section A, the following conditions must 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. The Equipment 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 CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE OR MALFUNCTION OF THE EQUIPMENT, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT OR OTHERWISE. (2) This LIMITED WARRANTY is made only to the purchaser of the Equipment. AS TO ALL OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM OR OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY TO THE PATIENT SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON. (3) The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of applicable law. If any part or term of this LIMITED WARRANTY is held to be illegal, unenforceable or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular

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

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Appendix E part or term held to be invalid. This LIMITED WARRANTY gives the purchaser specific legal 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 or warranty except this LIMITED WARRANTY.

Equipment Limited Warranty4 (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 the Medtronic Emergency Handcrank Model 150, hereafter referred to as the “Equipment,” that 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 the Equipment to the purchaser, Medtronic will at its option: (a) repair or replace any defective part or parts of the Equipment; (b) issue a credit equal to the original Equipment purchase price (but not to exceed the value of the replacement Equipment), against the purchase of replacement Equipment; 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 not responsible for any incidental or consequential damages based on any use, defect or failure of 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 construed so as to, contravene mandatory provisions of applicable law. If any part or term of this LIMITED 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 the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid.

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

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Preventative Maintenance Log

Preventative Maintenance Log

F

Bio-Console Extracorporeal Blood Pumping Console Model 560 Serial Number _____________________________________________________ Date Bio-Console received ___________________________________________ The Bio-Console should be checked annually. Date

Comments

Initials of Person Completing the Check

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Appendix F

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Index A AC Power 100 Caution 8 Failure 90 Status Alert 53 Troubleshooting 100 Warning 85 AC Power Cord 85, 90, 100 Connection 26 AC Power Status Button 12, 90 Pressing to Silence Audible Alert 53 AC Power Switch 8, 26, 86, 90, 100, 103 Activity Indicator 13 Description 53 Alarm/Alert Description 33 Mute Button 13 Selecting Sounds 29 Sound Selection Buttons 11 Speaker 9 Test Buttons 11, 30 Volume Control from the Main Screen 13, 53 Volume Control from the Setup Screen 11, 29 AutoClamp Air Pressure Minimum/Maximum 75 Backflow Configuration 79 Both (Stop and Backflow) Configuration 79 Case Setup 78 Configuration 79 Connecting Components 75 Opening from User Interface 81 Opening Manually 82 Service 85 Status Icons 82 Stop Configuration 79

AutoClamp System Components 75 Overview 75 Verifying Function 82 B Backflow Alarm 82 Backflow Prevention of 51 Base Unit 3 Cable Connector for User Interface 8 Caution 85 Cleaning 85 Dimensions 16 Display Screen 8 Front Panel 7 Mounting Post for User Interface 7, 21 Rear Panel 8 Using the Base Unit Display Instead of the User Interface 95 Base Unit Display Error Status 98 Screen List 95 Set High Flow Rate Alarm 97 Set Low Flow Rate Alarm 97 System Status 96 Zeroing Flow Rate 96 Batteries Battery Alarm 54 Battery Charging 26 Battery Service and Disposal 87 Battery Status Indicator 13, 86 Checking Charge Status 31, 86 Life Estimates 90, 109 Maintaining and Charging the Batteries 86 Troubleshooting 103 Variable Factors 109 Battery Backup 13, 90 Battery Backup Failure 90 i

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Baud Rate Range 31 Bio-Console 3 Cleaning 85 Components 3 General Description 7 Service 85 Standby Bio-Console 90 System Failure 90 Turning On 26 Bio-Probe 3 Bio-Pump 3 Failure 89 Priming the Circuit 40 Removal After Procedure 56 Troubleshooting 101 BSA Algorithm Equations 45 Selection 14 Bubble Detection System Bubble Size Detected 66 Components 66 Verifying Function 71 Bubble Detector Clearing an Alarm 71 Coast Configuration 67 Configuring 67 Connecting to Base Unit 66 Placement on Circuit Tubing 66 Status Icons 71 Stop Configuration 67 C Cardiac Index Entered Value 14 Measured Value 14 Centrifugal Pump Speed 95, 96 Coast Mode Disengaging 73 Screen Changes Resulting From 72

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Coast Speed Button 14 Coast Speed Setting Indicator 13 Components of the Bio-Console 3 Connecting the Bio-Console Components 21 Contraindications 4 D Data Exchange Handshake Buttons 11 Data Format Selection Buttons 11 Data Output Attaching a Digital Output Connector 56 Data Refresh Rate Selection Button 11 Data Transfer Cable 3 Digital Output 3, 99 Data Output Format 115, 116, 119 Overview 111 RS 232 Commands 112, 113, 114 RS 232 Hardware Interface 124 Selecting the Appropriate Protocol 111 Selecting the Appropriate Transmission Mode 111 Troubleshooting 103 E Electrical Power Failure 90 AC Power Failure 90 Battery Backup Failure 90 Electrocautery Interference with User Interface Displays 51 Electromagnetic Emissions and Immunity Declarations 17 F Factory Default Settings 17 Flow Alert Limits 14 Flow Bar Graph 13 Flow Connector 8 Flow Digital Display 13 Flow Determining the Flow 107 Monitoring from the Base Unit 52 Troubleshooting 101

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Flow Insert 3 Flow Limit Setting Indicators 13 Flow Limits Setting Flow Alert Limits 43 Flow Limits Set Buttons 14 Flow Monitor Zero Button 14 Flow Range 99 Flow Rate 96, 107 Adjusting 49 Dependencies 49 Flashing Dashes 50 Flashing Values 50 How Displayed 50 Minimum Allowed 50 Monitoring 50 Flow Transducer Adult Model 39 Attaching Insert 39 Connecting to the Base Unit 24 Correcting a Negative Flow Reading 42 Mounting to a Pole 25 Pediatric Model 39 Zeroing 40 Fuse Access 8 H Handcrank 3 Attaching and Using the Handcrank 93 Checking the Handcrank 87 Components 92 Emergency Use of 90 Properties 91 I Indications for Use 4 Interface Module Connecting to Base Unit 75 Mounting to Pole 75 L Language Selection Button 11 Language Selection 29

Level Sensing System Components 60 Verifying Function 65 Level Sensors Alarm Only Configuration 63 Alert Only Configuration 63 Attaching to Reservoir 60 Coast Configuration 63 Configuring 61 Connecting to Base Unit 60 Removing from Reservoir 65 Status Icons 65 Stop Configuration 63 M Main Screen Overview 12 Settings Screen Button 12 N Negative Flow 101 P Power Cord Connector 9 Power On/Standby Switch 7 Pressure Alert Limits 14 Setting Pressure Alert Limits 37 Pressure Limits Set Buttons 14 Pressure Monitor Displays 13 Pressure Monitoring Circuit 3-way Stopcock 35 Attaching to Base Unit 35 Fluid Barrier 35 Pressure Monitor Zero Buttons 14 Pressure Flashing Dashes 53 Flashing Values 53 Monitoring 53 Pressure Transducer Ports 8 Pressure Transducer Zeroing 36

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Pressure Values Range 53 Pump Motor Connector 8 Pump Motor 3, 100 Connecting to the Base Unit 23 Servicing the Pump Motor 85 Pump Stop Restarting the Pump 74 Screen Changes Resulting From 74 Q Quick Start Guide 99 R Remote Tube Clamp Connecting to Interface Module 75 Mounting to Pole 75 Retrograde Flow 89 Roller Pump 90 Emergency Use of 94 RPM Bar Graph 13 RPM Digital Display 13 RPM Knob 9 Components 34 Independent Function 95 Mechanical Stop 49 RPM Troubleshooting 102 S Safety Systems Board 9 Safety Systems 3 Coast/Stop 71 Overview 59 Troubleshooting 103 Screen Contrast Button 14 Screen Contrast Adjusting 47 Serial Port Baud Rate Selection Button 11 Serial Port Setting Parameters 31 Service Log Button 13 iv

Service Log Function of 53 Service Port Cover 8 Settings Screen Flow Monitor 14 Overview 14 Pressure Monitor 14 Screen Exit Button 14 Setup Screen Overview 11 Saving Selections 31 Screen Exit Button 11 Specifications 16 Stopping Flow Taking A Patient Off Bypass 55 System Indicator LED Lights 8 System Status Indicators 33 Green Light 33 Red Light 33 Yellow Light 33 System Status Indicator 13 System Status Message Box 13 T T-adaptor/Blender Connections 75 Target Flow Indicator 13 Target Flow Rate Calculation 14 Patient Height 14 Patient Weight 14 Target Flow Definition 45 Establishing Rate 45 Timer Displays 14 Timer Mode Selection Buttons 14 Timer Set Buttons 14 Timers Count Down Mode 46 Count Up Mode 46 Pause Button 52 Reset Button 52

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Setup 46 Start Button 52 Using 52 Time Unit Selection Buttons 14 Transducers Cleaning the Flow Transducer 85 U Unit Cooling Fans 8 Unit Label 8 User Interface 3, 9 Cable Connector 9 Connection to a Pole Mount 22 Connection to the Base Unit 21 Data Output Connector 9 Dimensions 16 Locking/Release Handle 9 Remote Mounting Bracket 21 Screen Sequence 10, 11, 13, 14 Setting Up 28 Touch Screen 9 V Versions Button 11 Viscosity 107 W Warnings and Precautions 4 Warranties 125

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Europe

Americas

Europe/Africa/Middle East Headquarters Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH - 1131 Tolochenaz Switzerland Internet: www.medtronic.co.uk Tel. 41-21-802-7000 Fax 41-21-802-7900 Authorized Representative in the European Community Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. 31-45-566-8000 Fax 31-45-566-8668

Latin America Medtronic Latin America 3750 NW 87th Avenue Suite 700 Miami, FL 33178 USA Tel. 305-500-9328 Fax 786-709-4244 Canada Medtronic of Canada Ltd. 99 Hereford Street Brampton, Ontario L6Y 0R3 Canada Tel. 905-460-3800 Fax 905-826-6620 Toll-free: 1-800-268-5346 United States Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA Internet: www.medtronic.com Tel. 763-514-4000 Fax 763-391-9100 Toll-free: 1-800-328-2518 (24-hour consultation service) Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 USA Tel. 763-391-9000 Fax 763-391-9100 Customer Service and Product Orders Toll-free: 1-800-854-3570 Visit Medtronic at www.perfusionsystems.com

Asia-Pacific Japan Medtronic Japan Comodio Shiodome 5F 2-14-1 Higashi-Shimbashi, Minato-ku Tokyo 105-0021 Japan Tel. 81-3-6430-2011 Fax 81-3-6430-7140 Australia Medtronic Australasia Pty. Ltd. 97 Waterloo Road North Ryde NSW 2113 Australia Tel. 61-2-9857-9000 Fax 61-2-9878-5100 Asia Medtronic International Ltd. Suite 1602 16/F, Manulife Plaza The Lee Gardens, 33 Hysan Avenue Causeway Bay Hong Kong Tel. 852-2891-4068 Fax 852-2591-0313

© 2008, 2011 Medtronic M937416A001 Rev. 1.0 *M937416A001*