Terumo Advanced Perfusion System 1 User manual

______ OF ______
TITLE
SHEET DRAWING NUMBER REV.
1 1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Ann Arbor, Michigan
B883325
TEXT, ADVANCED PERFUSION SYSTEM 1 OPERATORS MANUAL
PART NUMBER 883325
TEXT:
8 1/2" X 11"
177 PAGES (354 ACTUAL)
PRINT 2 SIDES
PAPER - 80# Euroart Dull
INK - 4 COLOR PROCESS
8 1/2" X 11" 28# White Translucent Vellum slip sheet to be inserted before first page
of manual.
TABS:
PAPER - 110# WHITE INDEX
REINFORCED HOLES AND TABS
2 SETS 1/6 CUT TABS
INK - BLACK REVERSE PRINTING
2 SETS 1/7 CUT TABS
INK - BLACK
3 HOLE DRILL LEFT MARGIN
COLLATE
NOTE: ARTWORK COPY MUST ACCOMPANY THIS PRINT.
A 90374 NEW PART NUMBER
DESCRIPTIONCHG. NO.SYM.
B 91096 POWER CORD DAMAGE & EPGS CLARIFICATIONS, ADDITIONAL INFORMATION PN UPDATES

Advanced Perfusion System 1
Operators Manual

ii

iii
Advanced Perfusion System 1
Operators Manual (synonymous with Instructions for Use)
REF 801763 100V - 120V, 15A (circuit breaker),
50/60 Hz (20A power source required)
REF 801764 220V - 240V, 7A (circuit breaker),
50/60 Hz (10A power source required)
Cautions
Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of
a physician.
Proper surgical procedures and techniques are the responsibility of the medical
professional.
It is the operator’s responsibility to use, check, and maintain this device according to the
labels of the product, accompanying instruction manuals, and any revisions of the labeling
or instructions that may be subsequently issued.
Service Policy
Only Terumo Cardiovascular Systems Corporation certified service technicians are
authorized to service or repair this device. Only Terumo Cardiovascular Systems
Corporation approved replacement parts may be used in this device. Terumo
Cardiovascular Systems Corporation approved parts are only available through Terumo
Cardiovascular Systems Corporation certified service technicians. Any service or repair
by an unauthorized service technician or use of unapproved parts will void your Terumo
Cardiovascular Systems Product Warranty and may increase the risk of a product failure.
Contact Terumo Cardiovascular Systems Corporation Service, your local Terumo
company or your authorized distributor for technical assistance and to arrange for service.
If the device is to be returned, instructions will be given for returning the device and a
Returned Goods (RG) number will be issued. For contaminated devices, request the
appropriate Product Return Safety Pack. Returned devices must be packaged with
adequate protection against shipping damage. Include a note describing the problem,
stating the RG number, and giving the name, address, and telephone number of a person
to contact for additional information.
In the United States, contact the Terumo Cardiovascular Systems Corporation Technical
Support Department:
Terumo Cardiovascular Systems Corporation
6200 Jackson Road, Ann Arbor, Michigan 48103 U.S.A.
Telephone: [phone] Fax: [phone]
Outside the United States, please contact your local Terumo company, your
authorized distributor or the Technical Support Department at Terumo
Cardiovascular Systems Corporation.
Telephone: [phone] Fax: [phone]
Europe: Technical Support - Medical Electronics - Call Free Number from:
AT 0800-293711 BE 0800-94410 DK 808-80701
FI 0800-115226 IE 1800-553224 CH 0800-563694
FR 0800-908793 IT 800-785891 GB 0800-9179659
DE 0800-1808183 NL 0800-0222810 NO 800-12270
GR 00800-3212721 ES 900-963251 SE 020-791373
Other countries call [phone] at international rates
E-mail: meservice@terumo-europe. com Fax: [phone]

iv
About Advanced Perfusion System 1
Introduction................................................................................................. 1-2
Using this manual....................................................................................... 1-3
Indications and Warnings ........................................................................... 1-4
Indications........................................................................................... 1-4
Contraindications ................................................................................ 1-4
User Qualifications.............................................................................. 1-4
System Warnings ............................................................................... 1-4
System Equipment Precautions.......................................................... 1-5
Copyright............................................................................................. 1-6
Classification....................................................................................... 1-6
Patents................................................................................................ 1-6
Training Overview ....................................................................................... 1-7
System Overview
System Philosophy ..................................................................................... 2-1
Institutional Controls ........................................................................... 2-2
System Base .............................................................................................. 2-3
Features.............................................................................................. 2-3
Central Control Monitor .............................................................................. 2-4
Features.............................................................................................. 2-4
Display Areas...................................................................................... 2-4
Roller Pumps.............................................................................................. 2-8
Features.............................................................................................. 2-8
Centrifugal Control Unit .............................................................................. 2-9
Features.............................................................................................. 2-9
Modules.................................................................................................... 2-11
Features............................................................................................ 2-11
Air Bubble Detect Module ................................................................. 2-12
Level Detect Module ......................................................................... 2-12
Pressure Module .............................................................................. 2-13
Temperature Module ........................................................................ 2-14
Flowmeter Module ............................................................................ 2-15
Occluder Module............................................................................... 2-16
Interface Modules ............................................................................. 2-17
Electronic Gas Blender............................................................................. 2-18
Table of Contents

v
Table of Contents
System Base
Base Components...................................................................................... 3-2
Mains Power Cord............................................................................... 3-2
Circuit Breakers .................................................................................. 3-2
Auxiliary Outlet.................................................................................... 3-3
Mains Power On and Off..................................................................... 3-3
System Power .................................................................................... 3-4
Battery System ................................................................................... 3-4
System Network ............................................................................... 3-11
Casters and Wheel Lock System...................................................... 3-12
Poles, Shelf, and Brackets ................................................................ 3-12
Module Bracket System ................................................................... 3-17
Pump Platform .................................................................................. 3-17
Lamp................................................................................................. 3-19
Hand Cranks..................................................................................... 3-19
Cable Management .......................................................................... 3-20
Module Covers.................................................................................. 3-21
Cable Cover ...................................................................................... 3-21
Central Control Monitor
Features ..................................................................................................... 4-1
Connect CCM ..................................................................................... 4-2
Start-Up Messages............................................................................. 4-3
PC Card Compartment ...................................................................... 4-4
Functional Areas......................................................................................... 4-5
Displays and Controls................................................................................. 4-6
Device Icons and Displays.................................................................. 4-6
Buttons................................................................................................ 4-7
Security............................................................................................... 4-9
Perfusion Screen ...................................................................................... 4-10
Perfusion Screen .............................................................................. 4-12
Primary Pump................................................................................... 4-12
Pump Controls and Displays ............................................................ 4-13
Slide Bars ......................................................................................... 4-14
Displays ............................................................................................ 4-16
Perfusion Screen Tabs ...................................................................... 4-17
Perfusion Screen Tabs.............................................................................. 4-18
Setup Tab.......................................................................................... 4-18
Safety Tab ......................................................................................... 4-25
CPG Tab ........................................................................................... 4-25
Aux Tab ............................................................................................. 4-30
System Tab ....................................................................................... 4-31
Post Case Tab................................................................................... 4-35
Pump Tab.......................................................................................... 4-35
Servo Subtab .................................................................................... 4-35
Pulse Subtab .................................................................................... 4-36

vi
Table of Contents
Master and Follower Status Subtab.................................................. 4-37
Central Control Monitor Messages........................................................... 4-38
Configuration ............................................................................................ 4-47
Configuration..................................................................................... 4-47
System Settings................................................................................ 4-48
Perfusion Screens............................................................................. 4-53
Configure Pumps...................................................................................... 4-56
Add Primary Pump............................................................................ 4-56
Configure Perfusion Screen ............................................................. 4-58
Configure Other Pumps .................................................................... 4-58
Configure Other Devices .......................................................................... 4-65
Add Air Detectors.............................................................................. 4-66
Add a Level Detector ........................................................................ 4-68
Add an Occluder ............................................................................... 4-69
Add Pressure Sensors (Transducers)............................................... 4-71
Add Flow Sensors............................................................................. 4-73
Add Temperature Sensors ................................................................ 4-75
Add CDI™ Devices ........................................................................... 4-76
Add a CDI™ 100/101........................................................................ 4-76
Add a CDI™ 500............................................................................... 4-78
Add Timers........................................................................................ 4-81
Edit Safety Connections ........................................................................... 4-83
Connection Matrix............................................................................. 4-90
Assign Devices to Modules ...................................................................... 4-92
Assign Air Detectors, Level Detectors, Occluder, Flow Sensors, CDI....... 4-93
Assign Pressure and Temperature Sensors...................................... 4-94
Assign Roller Pumps, Centrifugal Control Units ............................... 4-96
Save a Perfusion Screen .................................................................. 4-97
Edit a Perfusion Screen .................................................................... 4-98
View Summary, Rename, Set Password and Delete ........................ 4-99
Return to Main Screen.................................................................... 4-100
Roller Pumps
Features ..................................................................................................... 5-1
Installation and Connection ........................................................................ 5-3
Pump Cable ........................................................................................ 5-3
Base Mounting.................................................................................... 5-3
Sliding Back Cover Panel Kit .............................................................. 5-4
Pole Mounting ..................................................................................... 5-5
Rotating the Raceway......................................................................... 5-5
System Connection............................................................................. 5-6
Installing Tubing .................................................................................. 5-7
Setting Occlusion ............................................................................. 5-10
During Perfusion ............................................................................... 5-13
Manual Operation of Pump............................................................... 5-13
Controls and Displays ....................................................................... 5-14
Check the Start-up Test .................................................................... 5-16
Pump Menu....................................................................................... 5-17
Continuous Mode.............................................................................. 5-20

vii
Table of Contents
Pulse Mode....................................................................................... 5-21
Servo Mode ...................................................................................... 5-23
Master/Follower Mode ...................................................................... 5-25
Roller Pump Messages..................................................................... 5-27
Centrifugal Control Unit
Features ..................................................................................................... 6-1
Installation and Connection ........................................................................ 6-2
Control Unit Cable............................................................................... 6-2
Pole Mounting ..................................................................................... 6-2
Drive Motor ......................................................................................... 6-3
Flexible Mounting Arm ........................................................................ 6-3
Centrifugal Motor Mount Arm ............................................................. 6-3
System Connection............................................................................. 6-4
Manual Drive Unit ............................................................................... 6-4
Set Up and Prime ............................................................................... 6-5
Controls and Displays ......................................................................... 6-6
Check the Start-up Test ...................................................................... 6-7
Continuous Mode................................................................................ 6-8
Coast™Response .............................................................................. 6-9
Pulse Mode....................................................................................... 6-11
Servo Mode ...................................................................................... 6-13
Using Standby Equipment ................................................................ 6-15
Centrifugal Control Unit Messages ................................................... 6-15
Modules
Features ..................................................................................................... 7-1
Air Bubble Detection (ABD) ........................................................................ 7-2
Connect ABD Module ......................................................................... 7-2
Connect ABD Sensor.......................................................................... 7-3
Enabling and Disabling Air Detection Alarms ..................................... 7-4
Test Before Use .................................................................................. 7-5
Air Bubble Detection Messages.......................................................... 7-5
In the Event of an Air Alarm................................................................ 7-6
In the Event of an ABD Module Malfunction ...................................... 7-7
Level Monitoring ......................................................................................... 7-8
Connect Level Sensor System............................................................ 7-8
Attach Sensors to Reservoir ............................................................... 7-9
Enabling and Disabling Level Detection System............................... 7-10
Selecting the Level Detection Mode ................................................. 7-10
Test Before Use ................................................................................ 7-12
Level Monitoring Messages .............................................................. 7-13
Pressure Monitoring ................................................................................. 7-15
Label and Connect Pressure System ............................................... 7-15
Setting Pressure Limits ................................................................... 7-16
Calibrating the Pressure Transducer................................................. 7-17
Pre-Case Check................................................................................ 7-19

viii
Table of Contents
Test Before Use ................................................................................ 7-19
Pressure Monitoring Messages ........................................................ 7-19
Temperature Monitoring............................................................................ 7-21
Label Probe ...................................................................................... 7-21
Connect Probe and Module .............................................................. 7-21
Setting Alarm Limits ......................................................................... 7-22
Test Before Use ................................................................................ 7-23
Temperature Monitoring Messages................................................... 7-23
Flow Monitoring ........................................................................................ 7-24
Flow Monitoring ................................................................................ 7-25
Connect Flowmeter Module ............................................................. 7-25
Attach Flow Sensor........................................................................... 7-25
Test Before Use ................................................................................ 7-27
Flow Monitoring Messages ............................................................... 7-27
Occluder Module ...................................................................................... 7-28
Connect Occluder Head ................................................................... 7-28
Connect Occluder Module ................................................................ 7-29
Occluder Module ...................................................................................... 7-30
Insert Tubing ..................................................................................... 7-30
Calibration......................................................................................... 7-31
Test Before Use ................................................................................ 7-31
Control and Display........................................................................... 7-31
Occluder Module Messages ............................................................. 7-32
In the Event of an Occluder Module malfunction .............................. 7-32
Interface Module for CDI™ 100/101 and CDI™ 500 ................................ 7-33
CDI™ 100 and CDI™ 101 ............................................................... 7-33
CDI™ 500 ......................................................................................... 7-35
CDI™ Messages............................................................................... 7-37
Interface Module RS-232.......................................................................... 7-37
Data Transfer Interface Module......................................................... 7-37
Electronic Gas Blender
Features ..................................................................................................... 8-1
Installation and Connection ........................................................................ 8-2
Setup ........................................................................................................ 8-3
Choosing the Blending Gas................................................................ 8-4
Setting the FiO2 Alarm ....................................................................... 8-4
Calibrating the Oxygen Analyzer and Gas Flow Sensor..................... 8-5
Control and Monitor Flow ........................................................................... 8-8
Operating the Electronic Gas Blender from the CCM......................... 8-9
Local Control of the Electronic Gas Blender..................................... 8-10
Electronic Gas Blender Messages.................................................... 8-12

ix
Table of Contents
Run a Case
Check the System 1 ................................................................................... 9-1
Power On.................................................................................................... 9-1
Set Up ........................................................................................................ 9-1
Perfuse the Patient ..................................................................................... 9-3
Emergency Procedures
Perfusion Situations.................................................................................. 10-1
Equipment Situations................................................................................ 10-5
Technical Support
Using this Section..................................................................................... 11-1
Communication Protocol .......................................................................... 11-2
EMC Tables ............................................................................................ 11-12
Nominal Mains Power Consumption....................................................... 11-15
Additional Information
Summary of Warnings and Precautions ................................................... 12-1
System Warnings.............................................................................. 12-1
System Equipment Precautions........................................................ 12-1
Warnings .......................................................................................... 12-3
Equipment Precautions..................................................................... 12-6
Equipment Care........................................................................................ 12-8
Clean and Check the System After Each Use .................................. 12-8
Test the Alarms, and Alerts Every Three Months ........................... 12-11
Electronic Gas Blender Maintenance.............................................. 12-13
The “Service O2 Sensor” Message................................................. 12-13
Oxygen Sensor Maintenance ......................................................... 12-13
Water Trap Maintenance ................................................................. 12-13
Removal and Cleaning of Tube Clamps.......................................... 12-13
Removal and Cleaning of the Instrument Tray ................................ 12-13
Replacing Air Filters and Lamp Bulbs............................................. 12-15
Service ........................................................................................... 12-17
System Components .............................................................................. 12-19
Accessory Kit ......................................................................................... 12-21
Recommended Spare Parts ................................................................... 12-22
Symbol Key............................................................................................. 12-23
Glossary ................................................................................................. 12-29
Index .................................................................................................... Index-1
Limited Warranty

1-1
About Advanced Perfusion System 1
With this system, you may…
Use Central Control from the Central Control Monitor
Integrate Pump Responses with Safety and Monitoring Systems
Choose Direction of Flow
Choose Continuous or Pulse Mode
Choose Servo Control to Pressure or Flow
Choose Master/Follower Functionality
Choose Remote Mounting of Pumps to Reduce Tube Length
Blend Gases and Monitor Gas Flow
Detect Air Bubbles and Select Pump Responses
Detect Low Blood Level and Select Pump Responses
Monitor Pressures and Select Pump Responses
Monitor Temperatures
Monitor Flow and Select Pump Responses
Monitor Cardioplegia Fluid Delivery Times and Volumes
Occlude the Venous Line
Capture Data and Events for a Perfusion Record
Display Blood Chemistry Data from CDI Devices
Operate on Battery Backup
Small Roller Pump
Lamp
Centrifugal Control Unit
Local Display and Control
and Centrifugal Motor
Occluder
Wheel Lock
Hand Cranks
AC (Mains) Power Switch
Power Status Indicator LED
Electronic Gas Blender Local Controls
Large Roller Pump
Roller Pump Local
Display and Control
Central Control Monitor

1-2
About Advanced Perfusion System 1
Introduction
The Terumo®Advanced Perfusion System 1 allows users to choose system
components and mounting configurations to meet current clinical needs, while
providing adaptability to reconfigure the system as their needs change. The
Advanced Perfusion System 1 may also be referred to as the System 1 throughout
this Operators Manual.
The System Base uses a distributed network to provide power and communications
to all system components. This design allows users to select the number and types
of devices needed to control and monitor patient perfusion during cardiopulmonary
bypass. These devices include any combination of the following components up to
the system maximum of 24:
Device Maximum
Electronic Gas Blender 1
Large Roller Pump 8
Small Roller Pump 8
Centrifugal Pump 2
Occluder Module 1
Air Bubble Detect Module 4
Level Detect Module 1
Pressure Module 4
Temperature Module 4
Flowmeter Module 4
CDI 100/101 Module 1
CDI 500 Module 1
Data Transfer Module 1
Pumps can be mounted side by side on the system base or they can be pole
mounted to reduce the lengths of tubing in the perfusion circuit. Roller pumps can
be mounted on the system base or on a pole with an appropriate mounting bracket.
The distributed network design allows modules to be plugged into any of the System
Base module receptacles. This design allows users to connect modules to any
connection point on the system base.
A Central Control Monitor (CCM) allows users to configure up to 12 different
Perfusion Screens for different equipment and protocol setups. When setting up a
Perfusion Screen, the user can define not only the system components that will be
used, but also the pump responses to safety system alerts and alarms.
In addition to monitoring system and perfusion data during a procedure, the CCM
allows touch screen control of pump speeds, gas flow and FiO2 settings (if an
electronic gas blender is installed), and occluder position. Additional advanced
functions of System 1 include Pulse Mode, Servo Control to pressure or flow, Master/
Follower functionality, and Automatic Cardioplegia Delivery.
8 in use at any given time, 6 can
be controlled from Central Control
Monitor (CCM)
1 in use at any given time
can be used with TLinkTM Data
Management System
}
2 sensors per Module
}

1-3
About Advanced Perfusion System 1
Using this manual
This Operators Manual provides directions for operating the Terumo®Advanced
Perfusion System 1.
This manual is organized to be a training tool; simply begin with this section and
proceed through the manual.
• Understand this fully integrated, adaptable perfusion system and how various
features function together and independently.
• Study the Indications and Warnings section to ascertain the system’s uses and
functional boundaries.
• Learn to start, test and customize the system.
• Learn how the pumps function.
• Learn about the safety systems.
• Learn about using the gas flow system.
• Monitor and capture perfusion data.
• Prepare for potential emergencies by studying the Emergency Procedures.
section.
• Maintain the system as directed in the Equipment Care section.
• Refer to the Additional Information section to find information on components
available for the system.
• Refer to the Technical Support section for performance information.
Note: Only trained technicians should use the Technical Support information to
make installation adjustments and replace equipment.
• Locate specific aspects of the system by using the Index.
After you have read the manual, simulate a case for practice. Simulate the emergency
situations you may encounter during perfusion and practice responding to system
messages, alarms and alerts, especially those associated with the safety systems for
air and level detection.
Note: Store product updates and instructions for system components in the inside
pocket of the manual.

1-4
About Advanced Perfusion System 1
Indications and Warnings
Indications
The Terumo®Advanced Perfusion System 1 is indicated for use for up to 6 hours in
the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and
cardiopulmonary bypass procedures, when used by a qualified medical professional
who is experienced in the operation of this or similar equipment.
The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.
Contraindications
This device is not designed, sold or intended for use except as indicated.
The centrifugal pump is contraindicated for use as a cardiotomy suction device.
User Qualications
Proper perfusion procedures and techniques are the responsibility of the medical
professional.
User must read and understand all information in the Operators Manual for the
Terumo®perfusion system being used.
System Warnings
The System 1 is indicated for use for up to 6 hours duration. The safety and
effectiveness of System 1 for long-term use (longer than 6 hours duration) has not
been established.
Use the system and any attached equipment according to the manufacturer’s
instructions and good medical practice.
This device is qualified only for durations appropriate to cardiopulmonary bypass
procedures. It has not been qualified, through in vitro, in vivo, or clinical studies, for
long-term use in bridge to transplant or pending recovery of the natural heart.
Do not use an apparently malfunctioning device in an operation.
Do not modify the Advanced Perfusion System 1 or any attached equipment or
accessories. Only use spare parts provided by Terumo Cardiovascular Systems.
Modifying the system, using unapproved spare parts, or using the system in ways
not indicated by this manual could lead to injury, compromised performance, and/or
damage.
This device must not be allowed to run unattended. Patient safety requires that
operation be properly and continuously monitored by a qualified medical professional.
System 1 is a configurable system allowing users to create perfusion screens utilizing
different combinations of equipment with different responses to events. Because
of this high degree of configurability, it is important that user institutions establish
appropriate controls to assure that users are properly trained and qualified to run
Perfusion Screens. Failure to establish such controls may result in operator
error that could result in patient injury or death.

1-5
About Advanced Perfusion System 1
System Equipment Precautions
Grounding reliability can only be achieved when this equipment is connected to an
appropriate receptacle which has been inspected for proper grounding.
This device requires a dedicated 20 Amp AC (Mains) power source for the 100V –
120V model or a dedicated 10 Amp AC (Mains) power source for the 220V – 240V
model.
Complete any external equipment connections before turning the system on as
connecting equipment during use may cause system malfunction.
Do not use this device in the presence of explosive or flammable gases.
To avoid electrical shock hazard, do not remove panels; refer servicing to qualified
service personnel.
Do not operate the system without the module covers secured in place as spilled
liquids may damage the connections.
Connect only hospital equipment of appropriate voltage and current rating to the
auxiliary outlet.
The auxiliary outlet is not backed up by battery power. During loss of AC (Mains)
power any equipment connected to the auxiliary outlet will lose power and remain
unpowered until AC (Mains) power is restored.
Do not use extension cords to connect the system to AC (Mains) power nor to
connect modules or accessories to the system. Use of extension cords may
compromise performance.
In the event that an AC (Mains) circuit breaker trips immediately after a reset, DO
NOT attempt to reset again. The system will only operate from battery power until it
has been repaired. Call for service.
Use only the cables provided to connect pumps and flowmeter modules to the
system.
The use of accessory equipment not complying with the equivalent safety
requirements of this system may lead to a reduced level of safety of the resulting
system. Consideration relating to the choice shall include:
• use of the accessory in the patient vicinity;
• evidence that safety certification of the accessory has been performed in
accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized
international standards.
Equipment used to heat and cool the water used to regulate the temperature of the
blood supplied to a heat exchanger should be rated Type CF. If the equipment is not
Type CF and a malfunction occurs, the possibility exists that electrical current may
pass through the heat exchanger and into the patient perfusion circuit.
The system can be stored in a ventilated area with a temperature range of 0°C to
40°C (32°F to 104°F) and a relative humidity range of 10% to 95%, non-condensing.
The system can be operated at a temperature range of 10°C to 40°C (50°F to 104°F)
at 30% to 75% relative humidity, non-condensing.

1-6
About Advanced Perfusion System 1
Do not use chemical solvents such as ether, acetone, etc., in or on any part of the
system as such solvents may be destructive to the device. Do not disinfect with
Virex®Tb*. Do not spill anesthetics on the system or components as chemicals such
as Forane (isofluorane) may be destructive. Follow the cleaning procedure in the
Equipment Care section.
Following standard practices for electronic devices, monitor this equipment closely
when it is exposed to intense electrical noise or fluctuating line voltage. Strong
electromagnetic fields radiated from equipment elsewhere in the operating room
(particularly defibrillators and electrocautery devices) or fluctuations in AC line
voltage may compromise performance or damage the equipment.
This device needs special precautions regarding electro-magnetic compatibility
(EMC) and needs to be installed and put into service according to the EMC
information provided in the Technical Support section.
Portable and mobile radio frequency (RF) communications equipment can affect this
system.
Use only those components, transducers, or cables specified, as use of non-specified
items may result in increased emissions or decreased immunity of the system.
This system should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, observe the system closely to verify normal
operation in the configuration in which it will be used.
Read the additional Warnings and Precautions located in the appropriate sections
throughout the manual. A summary list of all the Warnings and Precautions in this
manual can be found in the Additional Information section. Use only recommended
components and meet all specifications to ensure the system will operate properly.
Copyright
Copyright © 2017 Terumo Cardiovascular Systems Corporation
This manual and the software described in this manual, are copyrighted. No part
of this manual or the described software may be copied, reproduced, translated or
reduced to any electronic medium or machine readable form without the prior written
consent of Terumo Cardiovascular Systems Corporation.
Classication
This device is classified according to UL 60601-1 as follows: Mobile, Continuous
Operation, Class 1 and Internally Powered, Type CF, Drip-Proof (with the exception of
the lamp). Not suitable for use in the presence of a flammable anesthetic.
With respect to electrical shock, fire and mechanical hazards only in
accordance with UL 60601-1, IEC 60601-1, and CAN/CSA C22.2
No. 601.1.
Patents
This device or components of this device are protected by U.S. Patents 5,752,931;
5,813,972; 6,164,920; 6,607,363; 6,609,900; 6,722,865; 6,736,617; 6,783,328;
6,971,143; 7,006,005; 7,148,786 and foreign equivalents. Other U.S. and foreign
patents pending.
UL 60601-1
5P30
* Virex®Tb is a registered trademark of JohnsonDiversy™.

1-7
About Advanced Perfusion System 1
System Base
qSystem power (external and battery)
qPower Cord
qPower Indicator
qPowering Down
qBattery life
qCasters, wheel locks
qPoles
qModules
qLEDs
qChannels
q Sensors
q Dedicated connections
qPump connections
qDedicated connections for CCM
qDedicated connections for a lamp
qIsolated AC outlet for ancillary
equipment
qAir Filters
qCovers
qCable Management
qCable Cover
qInstall Cover
qRemove Cover
Central Control Monitor
qConnection to System Base
qStart up test
qMain screen
qConfiguring a perfusion screen
qAdding pumps
qAdding devices
qSafety connections
qAssigning devices
qSaving a perfusion screen
qInstitutional Controls
qPassword Protection
qPC Cards
qRunning a case
qMessage area
q Alarm
q Alert
q Status
q Error
q Mute All button
qSlide Bar Controls
q Primary Pump
q Gas System/Occluder
q Other Pumps
qPerfusion Screen Tabs
q Setup Tab
 q Patient Subtab
 q Gas Subtab
 q Pump Subtab
Training Overview
 q Occluder Subtab
 q Timer Subtab
 qTime/Date Subtab
q Safety Tab
 q Mute Button
 q Air Subtab
 q Level Subtab
 q Pressure Subtab
 q Temperature Subtab
 q Flow Subtab
q CPG Tab
 q Delivery Subtab
 q Auto Dose Setup Subtab
q Auxiliary Tab
 q Timers Subtab
 q Messages Subtab
q System Tab
 q Settings Subtab
 q Power Subtab
 q Reassign Module Subtab
 q Module Info Subtab
q Post Case Tab
qService Area
qShut down
Roller Pumps
qMaximum number
qConnected – 8
qConfigured on perfusion screen – 6
qLarge and Small
qRaceway size
qLarge 6 inch (15 cm)
qSmall 4 inch (10 cm)
qFlow ranges
qTubing sizes
qMounting and positioning (raceway
orientation)
qAccessing power
qAir Filters
qSelf diagnostics
qControl
qLocal
qCCM
qLocal Control
qGraphic Display
qPump Name/Module ID
qDirection icon
qSpeed control knob
qPump speed
qFlow rate display
qAlarm, alert, status, and error
messages
qSpeed indicator/Bar graph

1-8
About Advanced Perfusion System 1
qThree buttons
qStart/Stop
qSelect
qDirection
qFlow Constant
qTube Size
qExit
qManual
qCentral Control
qPump Icon
qSlide Bar
qPump Tab
qSummary Subtab
qServo Subtab
 qPressure
 qFlow
qPulse Subtab
qMaster/Follower Subtab
qTube clamp mechanism
qSetting occlusions
qHand cranking
qPump replacement
qVerify direction of rotation
qOperating modes
qStart
qStop
qContinuous
qPulse
qMaster/follower
qServo
qRoller Pump Events
qPump Stopped
 q Pump Started
qPump Paused
qRoller Pump Responses to Alerts/
Alarms/Other Pumps
qStop
qPause
qReduce speed
qMessage only
qNo response
qSafety Cover open, pause response
qAlarm Messages
qAlert Messages
qStatus Messages
qError messages
Centrifugal Pump (Optional)
qMaximum number - 2
qMounting and Positioning
qAccessing Power
qSelf Diagnostics
qControl
qLocal
qCCM
qLocal Control
qGraphic Display
qPump Name
qCentrifugal Icon
qSpeed control knob
qPump speed
qFlow rate display
qAlarm, alert, status, and error
messages
qSpeed indicator/Bar graph
qThree buttons
qStart/Stop
qSelect
qManual
qCentral Control
qPump Icon
qSlide Bar
qPump Tab
qSummary Subtab
qServo Subtab
 qPressure
 qFlow
qPulse Subtab
qMin RPMs
qSetting minimum flow alarm
qHand cranking
qPump replacement
qOperating Modes
qStart
qStop
qContinuous
qPulse
qServo
qCentrifugal Pump Events
qPump Stopped
 q Pump Started
 q Minimum Flow
 q Pump goes to Coast speed
qCentrifugal Pump Responses to
Alerts/Alarms/Other Pumps
qStop
qCoast™ Response
qMessage only
qNo response
qAlarm Messages
qStatus Messages
qAlert Messages
qError Messages
Air Bubble Detect Modules and Sensors
qMaximum number – 4
qProper positioning
qControl with CCM
qOn, Off, Reset
qConnection to Devices

1-9
About Advanced Perfusion System 1
qAlarm Messages
qStatus Messages
qError Conditions
Flowmeter Modules and Sensors
(Optional)
qMaximum number – 4
qConnection to Devices
qRoller pumps
qCentrifugal pumps
qConnection to centrifugal pump for
local display and min flow alarm
capability
qPlacement of Flowmeter Module
qPlacement of Flow Sensors
qTesting the Flow Sensor
qServo Control
qAlarm Messages
qStatus Messages
qError Conditions
Occluder Module and Head
(Optional)
qMaximum number – 1
qProper insertion of tubing
qSetting up and controlling
qTubing sizes
qCalibration
qPercent Open
qOccluder Responses to primary pump
qNo Response
qFull Open
qFull Close
qGo To Flow 0% (up to 100%)
qTesting the Occluder
qStatus Messages
qError Conditions
Connecting to CDI
(Optional)
qMaximum number of CDI 500
monitors – 1
qMaximum number of CDI 100
monitors – 1
qMaximum number of CDI 101
monitors – 1
qSelecting and displaying data values
qRoller pumps
qCentrifugal pumps
qReset button
qTesting the ABD
qAlarm Messages
qStatus Messages
qError Messages
Level Detect Modules and
Sensors
qMaximum number – 1
qUse with Hardshell reservoirs only
qDimensions
qPad, sensor attachment
qAlarm/Alert Mode
qControl with CCM
qOn, Off
qConnection to Devices
qRoller pumps
qCentrifugal pumps
qTesting the Level Detection System
qAlarm Messages
qAlert Messages
qStatus Messages
qError Messages
Pressure Modules and Transducers
(Optional)
qMaximum number – 8 transducers
qPlacement of transducers
qCalibration of transducers
qPressure Display
qSetting limits
qPositive
qNegative
qConnection to Devices
qRoller pumps
qCentrifugal pumps
qTesting the Pressure System
qServo control
qAlarm Messages
qAlert Messages
qStatus Messages
qError Messages
Temperature Modules and Probes
(Optional)
qMaximum number – 8 probes
qProbes used
qSetting alarms
qTesting the Temperature probes