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
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
level
Conducted RF
IEC/EN 61000-4-6
3 V
rms
150 kHz to 80 MHz
outside ISM bands
10 V
rms
Radiated RF
IEC/EN 61000-4-3
150 kHz to 80 MHz in
ISM bands
10 V/m
80 MHz to 2.5 GHz
1
Compliance level Electromagnetic environment — guidance
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 V
rms
1
1 V
rms
d = 3.5√ P
d = 12√ P
10 V/m 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).
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:
2
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.
Operator and Reference Manual English 19
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.
Rated maximum
output power of
transmitter W
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)
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:
Separation distance according to frequency of transmitter
Rated maximum output power m
150 kHz to 80 MHz
Outside ISM bands
d = 3.5√ P
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output
■
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.
150 kHz to 80 MHz In
ISM bands
d = 12
√ P
80 MHz to 800 MHz
d = 1.2√ P
800 MHz to 2.5 GHz
d = 2.3√ P
20 Operator and Reference Manual English
Setup
1500
3000
4500
0
1
2
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).
2.
Tighten the knob.
3. Connect the User Interface cable to the back side of the User Interface and the receptacle
Figure 12. Secure User Interface to Base Unit
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.
Operator and Reference Manual English 21
Chapter 3
3
3
2
1
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).
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 Operator and Reference Manual English
Setup
3
4
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).
Operator and Reference Manual English 23
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).
24 Operator and Reference Manual English
1
Figure 17. Attach Flow Transducer Cable to Base Unit
2
1
4
3
Setup
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.
Figure 18. Attach Flow Transducer to Pole
Push and hold the button on the transducer mount.
1.
2. Insert the exposed pin into the recess at the bottom of the transducer and release the button.
Operator and Reference Manual English 25
Chapter 3
2
1
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.
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.
26 Operator and Reference Manual English
Figure 19. AC Power Cord Connection
Setup
1500
3000
4500
0
3000
0
1500
4500
2
1
3
1. Black detent release button and RPM
level indicator.
Mechanical stop at 2000 RPM.
2.
3. Clicked OFF position.
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.
Operator and Reference Manual English 27
Chapter 3
1500
3000
4500
0
1 2
3
4
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.
2. Opening Screen with Setup Screen button.
3. Setup Screen.
Figure 22. User Interface Screen Sequence for System Setup
Opening Screen.
28 Operator and Reference Manual English
4. Main Screen.
2
The Setup Screen is divided into five areas:
■
Alarm/Alert sound selection
■
Digital Output settings
■
Serial Port settings
■
Language selection
■
Software version
Selecting the Language
The Bio-Console allows the user to choose from a list of available languages.
Setup
Figure 23. Language Selection
Enter the Setup Screen.
1.
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.
Operator and Reference Manual English 29
Chapter 3
1
3
2
2
1
1.
2. Press the Test buttons to hear the selected sounds.
3. Press the volume up/down arrows and Test buttons to determine adequate volume.
Figure 24. Alarm and Alert Sound Selection
While in the Setup Screen, press the Alarm/Alert Sound Selection buttons for the desired
alarm and alert sound.
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.
30 Operator and Reference Manual English
Figure 25. Entering Data Output Refresh Rate and Format
Setup
2
1
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.
Figure 26. Setting the Serial Port Parameters
While in the Setup Screen, press the up/down arrows on the Baud Rate Selection button to
1.
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
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).
to
Operator and Reference Manual English 31
Chapter 3
Refer to page 86 in Chapter 7 for instructions to ensure the batteries are fully charged.
32 Operator and Reference Manual English
Case Preparation
2 3
1
Case Preparation 4
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.
Figure 27. System Status Indicator
When the green light is illuminated, all systems are functioning normally and (as
1.
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 English 33
Chapter 4
1500
3000
4500
0
3000
0
1500
4500
2
1
3
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.
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 (
locking pin engages.
34 Operator and Reference Manual English
1. Black detent release button and RPM level
indicator.
Mechanical stop at 2000 RPM.
2.
3. Clicked OFF position.
Figure 28. RPM Knob Turned to the Zero Position
Figure 29). Make sure the
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 and the bottom port corresponds to
on the User Interface.
Case Preparation
Operator and Reference Manual English 35
Chapter 4
P2
P1
P2
P1
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).
Figure 31. Atmospheric Pressure Opened to Transducer
36 Operator and Reference Manual English
Case Preparation
3
2. Press the Settings Screen button to open the Settings Screen.
3.
Press the zero buttons for one or both (
4.
After successful zeroing, the Main Screen will display a pressure value of 000 mm Hg and
and ) pressure monitors (Figure 32).
will stop flashing.
Note: Pressure values must be within ± 20 mm Hg of 0 in order to be zeroed.
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 (
Note: If
) and upper ( ) limits for and pressure monitors (Figure 33).
an alert occurs when in the Settings Screen, the system automatically Exits to the Main
Screen.
Operator and Reference Manual English 37
Chapter 4
1
Figure 33. Setting Pressure Alert Limits
If a low or high pressure alert is active a yellow down or up arrow icon will flash next to the pressure
monitor value on the Main Screen (Figure 34). For additional information, refer to page 33
in Chapter 4.
38 Operator and Reference Manual English
Case Preparation
Figure 34. High Pressure Alert
Note: If
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.
the patient is on bypass and the pressure display is not functioning, the pressure can be
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.
Operator and Reference Manual English 39
Chapter 4
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:
Place a tubing clamp distal to the transducer so fluid is not flowing through the transducer
1.
(Figure 36).
2. Press the Settings Screen button to open the Settings Screen.
40 Operator and Reference Manual English
Case Preparation
Figure 36. Stop Fluid Movement Through the Flow Transducer
3.
Press the Flow Transducer zero button (Figure 37).
4. After successful zeroing, the Main Screen will display a rate of 0.00 L/min and will stop
flashing.
5. Note: The flow rate must be within ± 0.1 L/min of 0 in order to be zeroed. Refer
to page 101 in Appendix A.
Operator and Reference Manual English 41
Chapter 4
3
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 Operator and Reference Manual English
Case Preparation
2
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.
) to accept settings and return to the Main Screen.
3.
Press the Screen Exit button (
Figure 38. Setting Flow Bar Graph Display Scale
Setting Low and High Flow Alerts
The Bio-Console allows the user to set lower and upper flow alert settings. The settings are
displayed
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 (
on the Main Screen as two triangular markers on the Flow Bar Graph (Figure 10). Alerts
) and upper ( ) flow monitor limits (Figure 39).
Operator and Reference Manual English 43
Chapter 4
2
Figure 39. Setting Flow Alert Limits
If a low or high flow alert is active, a yellow down or up arrow icon will flash next to the flow monitor
value (Figure 40). For additional information, refer to page 33.
44 Operator and Reference Manual English
Case Preparation
Figure 40. Low Flow Alert
Establishing the Target Flow Rate
Target
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:
3. Enter patient height and weight.
Flow is the nominal rate of flow needed to achieve a desired Cardiac Index for a specific
■
DuBois (m2) = 0.007184 x height (cm)
■
Boyd (m2) = 0.0003207 x height (cm)
■
Infant (m2) = 0.024265 x height (cm)
0.725
x weight (kg)
0.3
x weight (gm)
0.3964
x weight (kg)
0.425
[0.7285 - (0.0188 x Log (gm)]
0.5378
Operator and Reference Manual English 45
Chapter 4
1
3
2
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.
Figure 41. Calculating Target Flow
46 Operator and Reference Manual English
Case Preparation
3
1
2
4
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).
Figure 42. Timer Settings on the Settings Screen
Operator and Reference Manual English 47
Chapter 4
1
Figure 43. Adjust Light Intensity of Screen
48 Operator and Reference Manual English
On-Pump Operation
On-Pump Operation 5
Before beginning this section:
■
Complete the procedures described in
■
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.
Chapter 3 and Chapter 4.
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).
Operator and Reference Manual English 49
Chapter 5
1500
3000
4500
0
3000
0
1500
4500
2
1
3
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
1. Black detent release button and RPM level
indicator.
Mechanical stop at 2000 RPM.
2.
3. Clicked OFF position.
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.
50 Operator and Reference Manual English
1
3
2
Figure 45. Measured Flow Displays
On-Pump Operation
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 English 51
Chapter 5
3
2
1
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
52 Operator and Reference Manual English
Figure 46. Controlling Timers from the Main Screen
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
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.
On-Pump Operation
page 46
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 English 53
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).
Battery Alarm
The audible and visual battery alarms activate when approximately 5 minutes of battery charge
remains
batteries to 90% capacity takes approximately 18 hours and a full charge requires approximately
24 hours.
under normal operating conditions and cannot be adjusted (Figure 48). Recharging the
Figure 47. AC Power Status Button
54 Operator and Reference Manual English
Figure 48. Low Battery Alarm Activated
On-Pump Operation
Stopping Flow: Taking A Patient Off Cardiopulmonary Bypass
ending bypass or greatly reducing flow, occlude the arterial line before dropping below the
When
minimum flow rate (<100 mL/min).
When stopping the flow, the centrifugal pump outlet tubing and the patient venous tubing must
be occluded to prevent exsanguination of the patient. Partially occluding the outlet tubing for long
periods of time may cause blood damage.
When an arterial line is occluded, the centrifugal pump may continue revolving without excess
pressure build-up in the circuit.
Warning: Never occlude the inlet to the centrifugal pump because negative pressures will be
created within that portion of the circuit.
To stop flow:
1. Occlude the centrifugal pump outlet tubing.
2. Reduce the RPM to approximately 2000 (to the knob detent position).
3. Press the black detent release button on the knob and turn the RPM knob counterclockwise
below zero until it clicks OFF.
Warning: If flow to the patient stops, occlude the outlet tubing from the centrifugal pump to
prevent retrograde flow. Keep the outlet tubing occluded until flow is ready to be reestablished.
Failure to occlude the outlet tubing will cause retrograde flow and may exsanguinate the patient.
Operator and Reference Manual English 55
Chapter 5
Removing the Bio-Pump Centrifugal Blood Pump
Remove and discard the pump after each procedure. Discard the pump according to local and
hospital procedures.
1.
Push the pump motor locking pin to release the centrifugal pump.
2. Slide the centrifugal pump out of the pump motor receptacle.
Place the red cover on the pump motor receptacle. This helps prevent damage to the
3.
magnetic coupler and prevents the collection of metal objects.
4. Return the Bio-Console to standby mode and leave it connected to an AC power source. This
will ensure the battery remains charged.
Data Output
Note: For United States and Canada users: connect only to a UL/c-UL Listed ITE computer or
equivalent.
Note: For customers outside the United States and Canada: connect only to an ITE computer
evaluated to IEC 60950-1 or equivalent.
The RPM, flow, alarm conditions, and pressure measurements may be sent to a computer or
other data output devices through a digital connector. Bio-Console data are sent to a data output
device when the Bio-Console is turned ON and the device is connected to the User Interface.
Attaching a Digital Output Connector
Bio-Console data may be sent to a computer through the 9-pin, RS 232 connector on the back
of the User Interface (Figure 50).
Note: Transmission of data begins as soon as the Bio-Console is turned ON and the cable is
attached to both a data output device and the User Interface.
56 Operator and Reference Manual English
Figure 49. Removing the Centrifugal Pump
On-Pump Operation
1
2
3
If the cable does not work or if a different connector is needed, contact a qualified Medtronic
service technician.
1. Connector for the User Interface cable which
allows for remote location of the User
Interface.
2. Connector
for the data output device (typically
a computer).
3. RS 232 cable from User Interface connector to
remote data output device.
Figure 50. Connecting Data Acquisition Device to the RS 232 Interface
Refer to Appendix D for additional information on changing data output format.
Operator and Reference Manual English 57
Chapter 5
58 Operator and Reference Manual English
Safety Systems
2
1
3
Safety Systems 6
The optional safety systems used with the Bio-Console 560 function in two ways: to detect potential
hazards
level sensing system and the bubble detection system. Safety systems used to respond to potential
hazards include the AutoClamp system and Bio-Pump coast/stop. These safety systems are discussed
in detail in the following sections.
Note: Use of the optional safety systems requires installation of a safety board in the Base Unit.
Associated with the safety board are three additional connectors for plugging in the three safety systems
(Figure 51):
1. Level Sensing system
2. Bubble Detection system
3. AutoClamp system
Caution: The performance of the safety systems must be verified before each use.
and to respond to those conditions. Safety systems used to detect potential hazards include the
Figure 51. Safety Connectors on Back of Base Unit
Level Sensing System
Overview
The
level sensing system is used to detect blood and fluid levels in a reservoir. It incorporates a
pair of color-coded sensors that are attached to the outside of the reservoir using double-sided
adhesive tape. One sensor is designated as the upper level sensor (yellow); the other sensor is
designated as the lower level sensor (red). Each level sensor is configured independently. If the
fluid in the reservoir level drops below the position of a level sensor, it will trigger a system alert
or alarm and optionally may be configured to slow or stop the pump.
Note: The level sensing system is designed to be used with a Medtronic hardshell reservoir.
The level sensing system consists of the following components:
Operator and Reference Manual English 59
Chapter 6
■
■
Connecting the Level Sensors
The level sensors detect the presence of fluid within the diameter of the “target” symbol on the
level sensor. When fluid is detected, the red light on the level sensor is lit.
To connect the level sensors:
1.
Level sensor, Model LS100
Level sensor tape, Model LST
Attach the level sensor cable to the back panel of the Base Unit (Figure 52).
Figure 52. Attach Level Sensor Cable to Base Unit
2.
Attach the level sensor tape to the outside surface of the reservoir:
a. Remove one side of the protective strip on the adhesive tape.
b. Adhere tape to reservoir surface at the desired level.
c. Remove the outer protective strip on the adhesive tape.
3. Apply the upper and lower level sensors firmly to the adhesive tape with the cross-line target
at the desired level (Figure 53).
60 Operator and Reference Manual English
Safety Systems
Figure 53. Apply Level Sensors to Reservoir
Warning: Do not place level sensors below the minimum operating level recommended by the
reservoir manufacturer.
Configuring the Level Sensors
When the level sensors are connected to the Bio-Console, two level sensor buttons will appear
the lower portion of the Main Screen. These buttons indicate the level sensor status and allow
on
the user to configure the desired response to low fluid levels.
Operator and Reference Manual English 61
Chapter 6
Figure 54. Unconfigured Level Sensor Buttons
Note: When the level sensors are not plugged into the Base Unit, no level sensor buttons will
appear.
Pressing either of the level sensor buttons will cause the level sensor configuration window to
appear (Figure 55
). This window is divided into two sections:
62 Operator and Reference Manual English
Safety Systems
1 2
Figure 55. Level Sensor Configuration Window
1. Level Sensor Enable/Disable
— These buttons select whether the level sensor is enabled
or not. If set to ON, the level sensing system will respond as configured (see below) if a low
fluid level is detected. If set to OFF, the level sensing system will not monitor the reservoir.
Note: The level sensor enable/disable buttons will always default to OFF after the BioConsole is switched to standby.
2. Level Sensor Configuration — These buttons select how the level sensing system will
respond if a low fluid level is detected. The configuration setting is indicated with text under
the level sensor button. The configuration choices are as follows:
a. Alert Only (upper level sensor)/Alarm Only (lower level sensor) — If a low fluid level is
detected, a system alert or alarm will be generated and the button will change
appearance and color (yellow for alerts, red for alarms) (Figure 56).
Operator and Reference Manual English 63
Chapter 6
Figure 56. Upper Level Sensor Alert
b. Coast —
If a low fluid level is detected, the pump will temporarily decelerate to the coast
set speed until the sensor detects fluid. In addition, an alert or alarm will be generated.
For more information on Coast, refer to page 71.
Note: Coast will not engage if the pump speed is already less than the coast set speed.
c. Stop — If a low fluid level is detected, the pump will stop and, in addition, generate an
alarm. To restart the pump, the user must turn the RPM knob counterclockwise, past the
detent, to 0 RPM for a minimum of one second.
Warning: If for any reason the centrifugal pump has stopped, the arterial line must be
clamped either manually or by use of the AutoClamp system.
Note: When the RPM knob is turned counterclockwise to 0 after a stop event (manual
control), the safety system that is overridden is the sensor that is not in its normal
operating condition when the RPM knob is at 0. The applicable safety system icon color
will indicate its operating condition (Table 1).
For example, if the reservoir does not fill up to an “OK” status level for the upper level
sensor, then the upper level sensor alert function will be ignored; and its icon will show
gray (disabled) after the RPM knob is turned clockwise from 0.
However, a lower level sensor event or a bubble detector event will trigger an alarm if
those sensors are in their normal operating condition.
Note: Optionally, the clamp may be configured to close when the pump stops. Refer
to page 75.
64 Operator and Reference Manual English
Safety Systems
Note: The level sensing system will retain its configuration settings after the Bio-Console is
switched to standby.
Once a selection is made in a level sensor window, the selected item will blink and the window
will close. To close the window without making a selection, either press the level sensor button
again, press another safety system button, or wait 5 seconds and the window will close.
Level Sensor Status
The graphics on the level sensor buttons change to represent the current level sensor status.
Refer to Table 1 for a complete description of level sensor status indicators.
Table 1. Level Sensor Status Indicators
Icon
Status
Upper Level Sensor, status OK.
Upper Level Sensor, status alert.
Upper Level Sensor, status disabled.
Upper Level Sensor, status error.
Lower Level Sensor, status OK.
Lower Level Sensor, status alarm.
Lower Level Sensor, status disabled.
Lower Level Sensor, status error.
Verifying the Level Sensing System
To verify that the level sensors are functioning properly:
Ensure the level sensors are enabled.
1.
2. Manipulate the fluid levels in the reservoir in order to activate the upper and lower level
sensors.
3. Verify the system responds appropriately for each sensor.
Removing Level Sensors from Reservoir
To remove the level sensors from the reservoir, pull on the finger grip portion of the level sensor
(Figure 57).
Caution: To avoid damage to the level sensor, do not pull on the cable when removing the level
sensor from the reservoir.
Operator and Reference Manual English 65
Chapter 6
Figure 57. Removing Level Sensors from Reservoir
Bubble Detection System
Overview
The bubble detection system is used to detect macro air bubbles in the circuit tubing. If air is
detected in the circuit tubing, it will trigger a system alarm and optionally may be configured to
slow or stop the pump.
The bubble detection system consists of the following components:
■
Bubble detector cable for adult patients, Model BD38
■
Bubble detector cable for pediatric patients, Model BD14
The bubble detector must be selected for tubing size compatibility with either adult patients or
pediatric patients.
Connecting the Bubble Detector
Attach the bubble detector cable to the back panel of the Base Unit (Figure 58).
1.
66 Operator and Reference Manual English
Safety Systems
Figure 58. Attach Bubble Detector Cable to Base Unit
2.
Press the bubble detector onto the circuit tubing at an appropriate location (Figure 59).
Figure 59. Press Bubble Detector onto Circuit Tubing
Caution: Tubing must be firmly seated in the bubble detector for it to detect bubbles properly.
Warning: Proper positioning of the bubble detector is the responsibility of the user. Bubble
detectors
must be positioned to allow sufficient time for the user to respond to detected bubbles.
Configuring the Bubble Detector
When the bubble detector is connected to the Bio-Console, a bubble detector button will appear
on the lower portion of the Main Screen (Figure 60). This button indicates the bubble detector
status and allows the user to configure the desired response to the presence of bubbles in the
circuit tubing.
Operator and Reference Manual English 67
Chapter 6
Figure 60. Unconfigured Bubble Detector Button
Note: When the bubble detector is not plugged into the Base Unit, no bubble detector button will
appear.
Pressing the bubble detector button will cause the bubble detector configuration window to
appear (Figure 61). This window is divided into two sections:
68 Operator and Reference Manual English
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1
2
Figure 61. Bubble Detector Configuration Window
1. Bubble Detector Enable/Disable — These buttons select whether the bubble detector is
enabled or not. If set to ON, the bubble detection system will respond as configured
(Figure 62) if a bubble is detected. If set to OFF, the bubble detection system will not monitor
the circuit tubing.
Note: The bubble detector enable/disable buttons will always default to OFF after the BioConsole is switched to standby.
2. Bubble Detector Configuration — These buttons select how the bubble detection system
will respond if a bubble is detected. The configuration setting is indicated with text under the
bubble detector button. The configuration choices are as follows:
a. Alarm Only — If a bubble is detected, a system alarm will be generated and the button
will change appearance and color (red).
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Chapter 6
b. Coast — If a bubble is detected, the pump will temporarily decelerate to the coast set
until manually reset by the user. In addition, an alarm will be generated. For more
speed
information on Coast, refer to page 71.
Note: Coast will not engage if the pump speed is already less than the coast set speed.
c. Stop — If a bubble is detected, the pump will stop and, in addition, generate an alarm.
To restart the pump, the user must turn the RPM knob counterclockwise, past the detent,
to 0 RPM for a minimum of one second.
Warning: If for any reason the centrifugal pump has stopped, the arterial line must be
clamped either manually or by use of the AutoClamp system.
Note: Optionally, the clamp may be configured to close when the pump stops. Refer
to page 75.
Warning: Do not open the clamp after automatic closure until all air from the circuit has
been evacuated.
Note: The bubble detection system will retain its configuration settings after the Bio-Console is
switched to standby.
Once a selection is made in the bubble detector window, the selected item will blink and the
window will close. To close the window without making a selection, either press the bubble
detector button again, press another safety system button, or wait 5 seconds and the window will
close.
70 Operator and Reference Manual English
Figure 62. Bubble Detector Alarm
Safety Systems
Bubble Detector Status
The graphics on the bubble detector button change to represent the current bubble detector
status. Refer to
Table 2 for a complete description of bubble detection status indicators.
Table 2. Bubble Detector Status Indicators
Icon Status
Bubble Detector, status OK.
Bubble Detector, status alarm.
Bubble Detector, status disabled.
Bubble Detector, status error.
Clearing a Bubble Detector Alarm
After a bubble is detected, the bubble detector alarm must be cleared by pressing the bubble
detector button (Figure 65
).
Note: If the AutoClamp is closed, the Open Clamp button will not appear until the bubble detector
alarm is cleared.
Verifying the Bubble Detection System
To verify that the bubble detector is functioning properly:
1. Ensure the bubble detector is enabled.
2. Remove the tubing from the bubble detector.
3. Verify the system responds with a bubble detector alarm.
4. Reinsert the tubing into the bubble detector.
5. Ensure the tubing is fully primed with no air bubbles.
6. Clear the bubble detector alarm by pressing the bubble detector button.
7. Verify that the alarm is cleared.
Bio-Pump Coast/Stop
Coast
Coast is an automatic response that causes the Bio-Pump speed to be reduced to a user-selected
RPM of either 1500, 1750, or 2000 RPM.
Note: The default setting for Coast with every new system is 2000 RPM.
Warning: Before changing the Coast setting, be aware that varying conditions of patient
resistance (eg, the patient’s Mean Arterial Pressure, or MAP) and hydrostatic pressure gradient
between the patient and the venous reservoir affects the direction of fluid flow.
Warning: User-selected Coast settings of 1500 RPM or 1750 RPM may not generate sufficient
Bio-Pump pressure to prevent arterial backflow.
Operator and Reference Manual English 71
Chapter 6
Note: The system backflow alarm will activate when the flow goes below -100 mL/min.
To select a Coast speed:
1.
2. Press the UP or DOWN arrows until the desired Coast RPM is selected.
Enter the Settings Screen (Figure 63).
3. Press
to return to the Main Screen.
Figure 63. Setting Screen Coast Speed (RPM)
system can be configured to have the Bio-Pump enter the Coast mode in response to either
The
a level sensing or bubble detection event. While the Bio-Pump is in the Coast mode, the following
changes will occur on the screen (Figure 64):
1. The button for the safety system that initiated Coast will change appearance and display in
either yellow or red, depending on severity.
2. A (yellow) system alert will be generated and the event causing the pump to coast will display
in the System Status Message Box. Refer to Chapter 4.
Note: The coast message may be preempted if a higher priority alert or alarm is active.
3. A yellow box will enclose the user-selected RPM value and “Coast” will be displayed.
4. The RPM bar graph will split into two horizontal bars. The upper bar is black and displays
the speed setting of the RPM knob. The lower bar is yellow and displays the actual speed of
the pump.
5. The yellow coast speed indicator will mark the speed set on the Settings Screen for the coast
mode.
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2
4
3
5
1
The pump will remain at the user-selected Coast speed until the event is cleared or the safety
system is disabled. The pump speed will then automatically ramp up its speed to the previous
level.
Warning: If
the Bio-Pump enters the Coast mode in response to arterial air detection, the pump
will remain at the user-selected Coast speed. It will not automatically ramp up after the air is no
longer detected by the bubble detector, or even after the bubble detector is turned OFF.
Figure 64. Coast Mode Activated
Note: Coast will disengage if the pump speed is manually reduced below the coast set speed.
If
Coast is engaged due to low fluid level detection from a level sensor, and the fluid level returns
above the detector the following occurs:
■
Alert tone stops
■
Display “Reservoir Low” clears from the system status message bar on the screen
■
Bio-Pump RPMs ramp up to the speed that the RPM knob is set at
To manually disengage Coast, turn the RPM knob counterclockwise until the speed of the RPM
knob (displayed by the black bar) is equal or less than the actual pump speed (displayed by the
yellow bar).
Operator and Reference Manual English 73
Chapter 6
2
1
Stop
Stop
be configured to stop in response to either a low fluid level or bubble detection event. While the
pump is stopped, the following changes will occur on the screen (Figure 65):
1. The button for the safety system that stopped the pump will change appearance and display
2. A (red) system alarm will be generated and the event causing the pump to stop will display
is an automated response, which reduces the pump speed to 0 RPM. The Bio-Console may
in red.
in the System Status Message Box. Refer to Chapter 4.
Note: The stop message may be preempted if a higher priority alarm is active.
Note: When the RPM knob is turned counterclockwise to 0 after a stop event, the bubble
detector or level sensor will be disabled if it is not in the normal operating condition.
However, it may be necessary to enable each safety system again.
If air is detected, the pump will stop and, in addition, generate an alarm. In order to restart the
pump, the user must turn the RPM knob counterclockwise, past the detent, to 0 RPM for a
minimum of one second.
74 Operator and Reference Manual English
Figure 65. Pump Stop from Bubble Detected
AutoClamp System
2
1
Overview
The AutoClamp system is used to prevent retrograde flow. It may be configured to close in
response
it must be opened by the user via a button press on the Main Screen.
The AutoClamp system consists of the following components:
■
■
■
■
■
■
■
Note: The AutoClamp can be manually opened at any time (page 82).
Connecting the AutoClamp
1. Secure the interface module pole mount to a pole (Figure 66).
to a pump stoppage or a flow rate of less than –100 mL/min. If the AutoClamp is closed,
AutoClamp interface module, Model ACM100
AutoClamp interface module pole mount, Model ACMPM
Remote tube clamp, Model RTC100
Remote tube clamp mount adapter, Model RTCMA
Remote tube clamp pole mount TX50, Model RTC200
AutoClamp interface cable, Model ACM200
AutoClamp air supply line, Model ACM300
Safety Systems
Attach the interface module to the pole mount (Figure 66).
2.
Figure 66. Secure Interface Module to Pole
Operator and Reference Manual English 75
Chapter 6
4
3. Attach the interface cable to the back panel of the Base Unit (Figure 67).
4.
Figure 67. Attach AutoClamp Interface Cable to Back of Base Unit
Attach the other end of the interface cable to the left side of the interface module
(Figure 68).
Figure 68. Attach Console-Module Cable to Interface Module
5.
Attach the compressed air T-adaptor to the air inlet gas fitting of the oxygen-air blender
(Figure 69).
76 Operator and Reference Manual English
Safety Systems
6
5
7
Figure 69. T-adaptor/Blender Connections
Attach the gas supply line to the T-adaptor (Figure 69).
6.
7. Attach the other end of the gas supply line to the air inlet connector on the interface module
(Figure 70).
Figure 70. Attach Gas Supply Line to Interface Module
Caution: Loss of air pressure or air pressure below 379 kPa (55 psi) will cause the
AutoClamp to close.
Caution: Air
pressure greater than 689 kPa (100 psi) may damage the internal components
of the interface module.
8. Slide the remote tube clamp onto the mount adapter and tighten the setscrew on the adapter
(Figure 71).
Operator and Reference Manual English 77
Chapter 6
9
10
8
10
12
11
9. Secure the remote tube clamp pole mount to a pole (Figure 71).
10. Attach the remote tube clamp with mount adapter to the pole mount by pushing and holding
11. Connect the remote tube clamp air supply line to the interface module (Figure 72).
Figure 71. Remote Tube Clamp Attachment to Pole
the button on the pin and sliding it through the aligned holes (Figure 71).
Figure 72. Attach Air Supply Line and Communication Cable to Interface Module
Connect the remote tube clamp communication cable to the interface module (Figure 72).
12.
Case Setup
After priming the circuit, install a primed segment of the arterial circuit tubing into the remote tube
clamp (Figure 73):
1. Loosen the knob to open the security latch.
2. Insert the tubing.
78 Operator and Reference Manual English
Safety Systems
1
2 3
3. Close the security latch and tighten the knob.
Figure 73. Install Circuit Tubing into Remote Tube Clamp
Warning: Never place fingers inside remote tube clamp. Serious injury may occur if fingers are
caught in the remote tube clamp when it closes.
Configuring the AutoClamp
When the AutoClamp is connected to the Bio-Console, an AutoClamp button will appear on the
lower portion of the Main Screen (
Figure 74). This button indicates the AutoClamp status and
allows the user to configure the desired response to pump stoppage or a flow rate less than
–100 mL/min.
Note: When
Figure 74. Unconfigured AutoClamp Button
the AutoClamp is not plugged into the Base Unit, no AutoClamp button will appear.
Operator and Reference Manual English 79
Chapter 6
1
2
Pressing the AutoClamp button will cause the AutoClamp configuration window to appear
(Figure 75). This window is divided into two sections:
1. AutoClamp Enable/Disable — These buttons select whether the AutoClamp is enabled or
not. If set to ON, the AutoClamp system will clamp the circuit tubing in response to pump
stoppage or low flow rate (Figure 76). If set to OFF, the AutoClamp system will not clamp the
circuit tubing (Figure 76).
Note: The AutoClamp enable/disable buttons will always default to OFF after the BioConsole is switched to standby.
Note: Regardless of the enable/disable setting, the AutoClamp will only be activated after a
flow of >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).
80 Operator and Reference Manual English
Figure 75. AutoClamp Configuration Window
Safety Systems
Figure 76. Pump Stop from Backflow
c. Both — If the pump stops or the measured flow rate is less than –100 mL/min, 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.
Operator and Reference Manual English 81
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 (
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.
Icon Status
Figure 73):
Table 3. AutoClamp Status Indicators
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.
82 Operator and Reference Manual English
Figure 77. Backflow Alarm
Safety Systems
Operator and Reference Manual English 83
Chapter 6
84 Operator and Reference Manual English
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.
Operator and Reference Manual English 85
Chapter 7
1
2
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
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 Operator and Reference Manual English
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
Maintenance
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
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.
page 88.
Operator and Reference Manual English 87
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.
88 Operator and Reference Manual English
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