BIO-CONSOLE® 560
Extracorporeal Blood Pumping Console
Operator and Reference Manual
Caution:
of a physician.
Federal law (USA) restricts this device to sale by or on the order
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.
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
i
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
ii
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
iii
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
iv
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
v
vi
Table of Contents
About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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
1
vii
Activity Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Monitoring Pressure
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
AC Power Status Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Battery Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Stopping Flow: Taking A Patient Off Cardiopulmonary Bypass . . . . . . . . . . . . . . . . . . . . . . . 55
Removing the Bio-Pump Centrifugal Blood Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Data Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
6 Safety Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Level Sensing System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Bubble Detection System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Bio-Pump Coast/Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
AutoClamp System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
7 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Cleaning the Flow Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Cleaning the Bio-Console and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Servicing the Pump Motor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Servicing the Bio-Console and AutoClamp Interface Module . . . . . . . . . . . . . . . . . . . . . . . . . 85
Maintaining and Charging the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Checking Battery Charge Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Battery Service and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Checking the Handcrank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
End of Life Disposition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
8 Emergency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Blood Pump Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Electrical Power Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Bio-Console System Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Emergency Use of the Handcrank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Emergency Use of a Roller Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
9 Use of Base Unit Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Using the Base Unit Display Instead of the User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
viii
Appendix C Battery Longevity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Variable Factors
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Battery Life Estimates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Appendix D Digital Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Selecting the Appropriate Transmission Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Selecting the Appropriate Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
RS 232 Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Data Output Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
RS 232 Hardware Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Appendix E Warranties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Equipment Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Equipment Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Equipment Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Equipment Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Appendix F Preventative Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Index
ix
x
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
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
one-time setup and general procedures for the Bio-Console, such as attaching the User
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.
Operator and Reference Manual English 1
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.
2 Operator and Reference Manual English
Bio-Console 560 Overview
Bio-Console 560 Overview 1
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
■
Bio-Pump disposable centrifugal pump for either adult patients (Model BPX-80, CBBPX-80,
or BPX-80T) or pediatric patients (Model BP-50 or CBBP-50)
■
Bio-Probe blood flow monitoring transducer for either adult patients (Model TX-50) or
pediatric patients (Model TX-50P)
■
Disposable flow monitoring insert for either adult patients (Model DP-38) or pediatric patients
(Model DP-38P)
■
Handcrank, Model 150
■
A data transfer cable is available for digital output
■
Safety systems (optional). Refer to Chapter 6.
Bio-Console 560
1500
3000
0
4500
Bio-Pump BPX-80
540T Pump Motor
Bio-Probe TX-50 and DP-38
Model 150
Handcrank
Figure 1. Components of the Bio-Console Blood Pumping System
Operator and Reference Manual English 3
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 Operator and Reference Manual English
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.
Operator and Reference Manual English 5
Chapter 1
Tubing must be firmly seated in the bubble detector for it to detect bubbles properly.
Loss
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.
of air pressure or an air pressure below 379 kPa (55 psi) will cause the AutoClamp to close.
6 Operator and Reference Manual English
General Description and Specifications
1500
3000
4500
0
1
2
3
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.
1. The Power On/Standby Switch is
located
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.
in the center of the Base Unit front
Base Unit Display Screen
Base Unit display area presents basic information of extracorporeal flow rate and centrifugal
The
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.
Figure 2. Base Unit Front Panel
Operator and Reference Manual English 7
Chapter 2
Bio-Console® 560
2
1
4
3
5
6
2
1
4
11
3
10
8
9
5
6
7
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
8 Operator and Reference Manual English
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.
Figure 4. Base Unit Rear Panel
General Description and Specifications
3. Bio-Probe
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.
Flow Connector for the Bio-Probe blood monitoring system containing a flow
1.
A speaker for the alert/alarms.
Back SideFront Side
Figure 5. User Interface
Operator and Reference Manual English 9
Chapter 2
1 2
5
3 4
User Interface Screen Sequence
The User Interface display progresses through the screen sequence as shown in Figure 6.
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).
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.
10 Operator and Reference Manual English
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
the user presses the System Setup button, the Setup Screen (Figure 9) will appear. The Setup
If
Screen allows the user to select interface profiles.
Operator and Reference Manual English 11
Chapter 2
2
3
4
6
1
8
7
5
9
10
Figure 9. Setup Screen Information and User Functions
1. The Alarm/Alert
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:
12 Operator and Reference Manual English
■
alert and alarm status
■
blood flow and pump speed
Sound Selection Buttons allow the user to select between 3 distinctive
■
12
1
4
3
8
9
10
11
7
6
5
2
17
13
14 15
16
line pressure
■
user configurable timers
■
safety systems (if installed)
■
power status
General Description and Specifications
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.
Figure 10. Main Screen Elements
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 English 13
Chapter 2
Settings Screen
The Settings Screen (Figure 11) provides the capability to set the following parameters:
■
■
■
■
■
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.
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.
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
14 Operator and Reference Manual English
General Description and Specifications
3
1
4
11
13
12
9
6
7
5
2
8
10
14
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 English 15
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
External Pump Drive Motor
Brushless DC (non-arcing)
Internal Batteries
Type Two, series connected, 12 VDC lead-acid gel; rechargeable
Discharge Time Refer to Appendix C
Recharge Time 18 hours to 90% capacity; 24 hours to 100% capacity
Dimensions: Base Unit
Size 31.88 cm (12.55 in) high by 22.83 cm (8.99 in) wide by 43.02 cm (16.9 in)
Weight 17.19 kg (37.9 lb)
100-240 VAC, 50-60 Hz, 3.25 amps
long
Dimensions: User Interface
Overall Size 22.18 cm (8.7 in) wide by 34.5 cm (13.6 in) long
Screen Size 26.41 cm (10.4 in) diagonal
Weight 4.26 kg (9.4 lb)
System Limits
Flow –9.99 to +9.99 L/min ± (5% + 50 mL)
RPM 0 to 4500 revolutions per minute (RPM)
Pressure –300 to +999 mm Hg ± (5% + 5 mm Hg)
Operating Limits
Temperature +18 to +33°C (+64 to +92°F)
Humidity 10% - 95%, non-condensing
Storage Limits
Temperature –40 to +66°C (–40 to +150°F)
Humidity 10% - 95%, non-condensing
Pressure 700 hPa to 1063 hPa
Output Signal
Digital RS 232 Interface: flow, RPM, pressure, alarm status
Baud Rate 1200 to 19200
16 Operator and Reference Manual English
General Description and Specifications
Resolution
Pressure 1 mm Hg
Flow 10 mL
RPM 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 560 format
Cable 9-pin PC compatible cable
Transmission Interval 10 seconds
Baud Rate 9600
Language 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
RF Emissions, CISPR 11 Class A Class A equipment is equipment suitable for use in all
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker emis-
sions, IEC 61000-3-3
Class A
Complies
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
establishments
nected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
other than domestic and those directly con-
Operator and Reference Manual English 17
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 discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge IEC 61000-4-5 ±1 kV line(s) to line(s)
Voltage dips, short
interruptions and voltage variations on
power supply input
lines IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level.
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output
lines
±2 kV line(s) to earth
<5% UT (>95% dip in
UT) for 0.5 cycle
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip in
UT) for 5 sec
<5% UT (>95% dip in
UT) for 0.5 cycle
3 A/m 3 A/m Power frequency magnetic fields should be at
±6 kV contact
±8 kV air
±2 kV for power supply
lines
±1 kV for input/output
lines
±1 kV differential mode
±2 kV common mode
<5% UT (>95% dip in
UT) for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT (30% dip in UT)
for 25 cycles
<5% UT (>95% dip in
UT) for 5 sec
<5% UT (>95% dip in
UT) for 0.5 cycle
Floors should be wood, concrete or ceramic
tile.
If floors are covered with synthetic material,
the relative humidity should be at least 30%.
Mains power quality should be that of a typical
commercial or hospital environment.
levels characteristic of a typical location in a
typical commercial or hospital environment.
18 Operator and Reference Manual English