Terumo Advanced Perfusion System 1 Operators Manual

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B 91096

POWER CORD DAMAGE & EPGS CLARIFICATIONS, ADDITIONAL INFORMATION PN UPDATES

A 90374 NEW PART NUMBER

DESCRIPTIONCHG. NO.SYM.

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION

Ann Arbor, Michigan

TITLE

TEXT, ADVANCED PERFUSION SYSTEM 1 OPERATORS MANUAL

PART NUMBER

SHEET

1 1

______ OF ______

883325

DRAWING NUMBER

REV.

B883325

Page 2

Advanced Perfusion System 1

Operators Manual

Page 3

Page 4

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: (800) 441-3220 Fax: (734) 741-6449

Outside the United States, please contact your local Terumo company, your authorized distributor or the Technical Support Department at Terumo Cardiovascular Systems Corporation.

Telephone: (734) 663-4145 Fax: (734) 741-6449

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 +32 16 381204 at international rates E-mail: meservice@terumo-europe. com Fax: +3216381420

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Page 5

Table of Contents

About Advanced Perfusion System 1

Introduction ................................................................................................. 1-2

Using this manual Indications and Warnings

Indications Contraindications User Qualiﬁcations System Warnings System Equipment Precautions Copyright Classiﬁcation Patents

Training Overview

System Overview

System Philosophy ..................................................................................... 2-1

Institutional Controls

System Base

Features

Central Control Monitor

Features Display Areas

Roller Pumps

Features

Centrifugal Control Unit

Features

Modules

Electronic Gas Blender

.................................................................................................... 2-11

Features Air Bubble Detect Module Level Detect Module Pressure Module Temperature Module Flowmeter Module Occluder Module Interface Modules

....................................................................................... 1-3

........................................................................... 1-4

........................................................................................... 1-4

................................................................................ 1-4

.............................................................................. 1-4

............................................................................... 1-4

.......................................................... 1-5

............................................................................................. 1-6

....................................................................................... 1-6

................................................................................................ 1-6

....................................................................................... 1-7

........................................................................... 2-2

.............................................................................................. 2-3

.............................................................................. 2-4

.............................................................................................. 2-4

...................................................................................... 2-4

.............................................................................................. 2-8

.............................................................................. 2-9

.............................................................................................. 2-9

............................................................................................ 2-11

................................................................. 2-12

......................................................................... 2-12

.............................................................................. 2-13

........................................................................ 2-14

............................................................................ 2-15

............................................................................... 2-16

............................................................................. 2-17

............................................................................. 2-18

Page 6

Table of Contents

System Base

Base Components ...................................................................................... 3-2

Mains Power Cord Circuit Breakers Auxiliary Outlet Mains Power On and Off System Power Battery System System Network Casters and Wheel Lock System Poles, Shelf, and Brackets Module Bracket System Pump Platform

................................................................................................. 3-19

Lamp Hand Cranks Cable Management Module Covers Cable Cover

............................................................................... 3-2

.................................................................................. 3-2

.................................................................................... 3-3

..................................................................... 3-3

.................................................................................... 3-4

................................................................................... 3-4

............................................................................... 3-11

...................................................... 3-12

................................................................ 3-12

................................................................... 3-17

.................................................................................. 3-17

..................................................................................... 3-19

.......................................................................... 3-20

.................................................................................. 3-21

...................................................................................... 3-21

Central Control Monitor

Features ..................................................................................................... 4-1

Connect CCM Start-Up Messages

PC Card Compartment Functional Areas Displays and Controls

Device Icons and Displays

Buttons

Security Perfusion Screen

Perfusion Screen

Primary Pump

Pump Controls and Displays

Slide Bars

Displays

Perfusion Screen Tabs Perfusion Screen Tabs

Setup Tab

Safety Tab

CPG Tab

Aux Tab

System Tab

Post Case Tab

Pump Tab

Servo Subtab

Pulse Subtab

................................................................................................ 4-7

............................................................................................. 4-30

..................................................................................... 4-2

............................................................................. 4-3

...................................................................... 4-4

......................................................................................... 4-5

................................................................................. 4-6

.................................................................. 4-6

............................................................................................... 4-9

...................................................................................... 4-10

.............................................................................. 4-12

................................................................................... 4-12

............................................................ 4-13

......................................................................................... 4-14

............................................................................................ 4-16

...................................................................... 4-17

.............................................................................. 4-18

.......................................................................................... 4-18

......................................................................................... 4-25

........................................................................................... 4-25

....................................................................................... 4-31

................................................................................... 4-35

.......................................................................................... 4-35

.................................................................................... 4-35

.................................................................................... 4-36

Page 7

Table of Contents

Master and Follower Status Subtab .................................................. 4-37

Central Control Monitor Messages Conﬁguration

Conﬁguration..................................................................................... 4-47

System Settings

Perfusion Screens Conﬁgure Pumps

Add Primary Pump

Conﬁgure Perfusion Screen

Conﬁgure Other Pumps Conﬁgure Other Devices

Add Air Detectors

Add a Level Detector

Add an Occluder

Add Pressure Sensors (Transducers)

Add Flow Sensors

Add Temperature Sensors

Add CDI™ Devices

Add a CDI™ 100/101

Add a CDI™ 500

Add Timers Edit Safety Connections

Connection Matrix Assign Devices to Modules

Assign Air Detectors, Level Detectors, Occluder, Flow Sensors, CDI....... 4-93

Assign Pressure and Temperature Sensors

Assign Roller Pumps, Centrifugal Control Units

Save a Perfusion Screen

Edit a Perfusion Screen

View Summary, Rename, Set Password and Delete

Return to Main Screen

............................................................................................ 4-47

................................................................................ 4-48

............................................................................. 4-53

...................................................................................... 4-56

............................................................................ 4-56

.......................................................................... 4-65

.............................................................................. 4-66

........................................................................ 4-68

............................................................................... 4-69

............................................................................. 4-73

........................................................................... 4-76

........................................................................ 4-76

............................................................................... 4-78

........................................................................................ 4-81

........................................................................... 4-83

............................................................................. 4-90

...................................................................... 4-92

.................................................................... 4-100

........................................................... 4-38

............................................................. 4-58

.................................................................... 4-58

............................................... 4-71

................................................................ 4-75

...................................... 4-94

............................... 4-96

.................................................................. 4-97

.................................................................... 4-98

........................ 4-99

Roller Pumps

Features ..................................................................................................... 5-1

Installation and Connection

Pump Cable

Base Mounting

Sliding Back Cover Panel Kit

Pole Mounting

Rotating the Raceway

System Connection

Installing Tubing

Setting Occlusion

During Perfusion

Manual Operation of Pump

Controls and Displays

Check the Start-up Test

Pump Menu....................................................................................... 5-17

Continuous Mode

........................................................................................ 5-3

.................................................................................... 5-3

..................................................................................... 5-5

.................................................................................. 5-7

........................................................................ 5-3

.............................................................. 5-4

......................................................................... 5-5

............................................................................. 5-6

............................................................................. 5-10

............................................................................... 5-13

............................................................... 5-13

....................................................................... 5-14

.................................................................... 5-16

.............................................................................. 5-20

Page 8

Table of Contents

Pulse Mode ....................................................................................... 5-21

Servo Mode

Master/Follower Mode

Roller Pump Messages

Centrifugal Control Unit

Features ..................................................................................................... 6-1

Installation and Connection

Control Unit Cable

Pole Mounting

Drive Motor

Flexible Mounting Arm

Centrifugal Motor Mount Arm

System Connection

Manual Drive Unit

Set Up and Prime

Controls and Displays

Check the Start-up Test

Continuous Mode

™

Coast

Pulse Mode

Servo Mode

Using Standby Equipment

Centrifugal Control Unit Messages

...................................................................................... 5-23

...................................................................... 5-25

..................................................................... 5-27

........................................................................ 6-2

............................................................................... 6-2

..................................................................................... 6-2

......................................................................................... 6-3

........................................................................ 6-3

............................................................. 6-3

............................................................................. 6-4

............................................................................... 6-4

............................................................................... 6-5

......................................................................... 6-6

...................................................................... 6-7

................................................................................ 6-8

Response .............................................................................. 6-9

....................................................................................... 6-11

...................................................................................... 6-13

................................................................ 6-15

................................................... 6-15

Modules

Features ..................................................................................................... 7-1

Air Bubble Detection (ABD)

Connect ABD Module Connect ABD Sensor Enabling and Disabling Air Detection Alarms Test Before Use Air Bubble Detection Messages In the Event of an Air Alarm In the Event of an ABD Module Malfunction

Level Monitoring

Connect Level Sensor System Attach Sensors to Reservoir Enabling and Disabling Level Detection System Selecting the Level Detection Mode Test Before Use Level Monitoring Messages

Pressure Monitoring

Label and Connect Pressure System Setting Pressure Limits Calibrating the Pressure Transducer Pre-Case Check

.................................................................................. 7-5

......................................................................................... 7-8

................................................................................ 7-12

................................................................................. 7-15

........................................................................ 7-2

......................................................................... 7-2

.......................................................................... 7-3

..................................... 7-4

.......................................................... 7-5

................................................................ 7-6

...................................... 7-7

............................................................ 7-8

............................................................... 7-9

............................... 7-10

................................................. 7-10

.............................................................. 7-13

............................................... 7-15

................................................................... 7-16

................................................. 7-17

................................................................................ 7-19

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Table of Contents

Test Before Use ................................................................................ 7-19

Pressure Monitoring Messages

Temperature Monitoring

Label Probe Connect Probe and Module Setting Alarm Limits Test Before Use

Temperature Monitoring Messages................................................... 7-23

Flow Monitoring

Flow Monitoring Connect Flowmeter Module Attach Flow Sensor Test Before Use Flow Monitoring Messages

Occluder Module

Connect Occluder Head Connect Occluder Module

Occluder Module

Insert Tubing Calibration Test Before Use Control and Display Occluder Module Messages In the Event of an Occluder Module malfunction

Interface Module for CDI™ 100/101 and CDI™ 500

CDI™ 100 and CDI™ 101 CDI™ 500 CDI™ Messages

Interface Module RS-232

Data Transfer Interface Module

...................................................................................... 7-21

........................................................................................ 7-24

...................................................................................... 7-28

...................................................................................... 7-30

......................................................................................... 7-31

......................................................................................... 7-35

............................................................................ 7-21

......................................................................... 7-22

................................................................................ 7-23

................................................................................ 7-25

........................................................................... 7-25

................................................................................ 7-27

................................................................... 7-28

..................................................................................... 7-30

................................................................................ 7-31

........................................................................... 7-31

............................................................................... 7-37

.......................................................................... 7-37

........................................................ 7-19

.............................................................. 7-21

............................................................. 7-25

............................................................... 7-27

................................................................ 7-29

............................................................. 7-32

.............................. 7-32

................................ 7-33

............................................................... 7-33

......................................................... 7-37

Electronic Gas Blender

Features ..................................................................................................... 8-1

Installation and Connection

Setup ........................................................................................................ 8-3

Choosing the Blending Gas ................................................................ 8-4

Setting the FiO2 Alarm Calibrating the Oxygen Analyzer and Gas Flow Sensor

Control and Monitor Flow

Operating the Electronic Gas Blender from the CCM Local Control of the Electronic Gas Blender Electronic Gas Blender Messages

........................................................................ 8-2

....................................................................... 8-4

..................... 8-5

........................................................................... 8-8

......................... 8-9

..................................... 8-10

.................................................... 8-12

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Table of Contents

Run a Case

Check the System 1 ................................................................................... 9-1

Power On

Set Up ........................................................................................................ 9-1

Perfuse the Patient

Emergency Procedures

Perfusion Situations .................................................................................. 10-1

Equipment Situations

Technical Support

Using this Section ..................................................................................... 11-1

Communication Protocol EMC Tables Nominal Mains Power Consumption

.................................................................................................... 9-1

..................................................................................... 9-3

................................................................................ 10-5

.......................................................................... 11-2

............................................................................................ 11-12

....................................................... 11-15

Additional Information

Summary of Warnings and Precautions ................................................... 12-1

System Warnings System Equipment Precautions Warnings Equipment Precautions

Equipment Care

Clean and Check the System After Each Use

Test the Alarms, and Alerts Every Three Months ........................... 12-11

Electronic Gas Blender Maintenance.............................................. 12-13

The “Service O2 Sensor” Message Oxygen Sensor Maintenance Water Trap Maintenance Removal and Cleaning of Tube Clamps Removal and Cleaning of the Instrument Tray Replacing Air Filters and Lamp Bulbs

Service System Components Accessory Kit Recommended Spare Parts Symbol Key Glossary

.......................................................................................... 12-3

........................................................................................ 12-8

........................................................................................... 12-17

......................................................................................... 12-21

............................................................................................. 12-23

................................................................................................. 12-29

.............................................................................. 12-1

........................................................ 12-1

..................................................................... 12-6

.................................. 12-8

................................................. 12-13

......................................................... 12-13

................................................................. 12-13

.......................................... 12-13

................................ 12-13

............................................. 12-15

.............................................................................. 12-19

................................................................... 12-22

Index .................................................................................................... Index-1

Limited Warranty

Page 11

Page 12

About Advanced Perfusion System 1

Centrifugal Control Unit Local Display and Control and Centrifugal Motor

Occluder

Lamp

Small Roller Pump

Large Roller Pump

Roller Pump Local Display and Control

Central Control Monitor

Electronic Gas Blender Local Controls

Wheel Lock

Hand Cranks

Power Status Indicator LED

AC (Mains) Power Switch

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

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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

8 in use at any given time, 6 can be controlled from Central Control Monitor (CCM)

2 sensors per Module

}

1 in use at any given time

}

can be used with TLink Management System

Data

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.

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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.

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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.

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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.

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Page 17

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.

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

UL 60601-1

5P30

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.

* Virex® Tb is a registered trademark of JohnsonDiversy™.

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About Advanced Perfusion System 1

Training Overview

System Base

q System power (external and battery) q Power Cord q Power Indicator q Powering Down q Battery life q Casters, wheel locks q Poles q Modules

qLEDs q Channels

q Sensors q Dedicated connections q Pump connections q Dedicated connections for CCM q Dedicated connections for a lamp q Isolated AC outlet for ancillary

equipment

q Air Filters q Covers q Cable Management q Cable Cover

q Install Cover q Remove Cover

 q Occluder Subtab  q Timer Subtab  q Time/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 q Service Area q Shut down

Central Control Monitor

q Connection to System Base q Start up test q Main screen q Conﬁguring a perfusion screen

q Adding pumps q Adding devices q Safety connections q Assigning devices

q Saving a perfusion screen q Institutional Controls q Password Protection q PC Cards q Running a case q Message area q Alarm q Alert q Status q Error q Mute All button q Slide Bar Controls q Primary Pump q Gas System/Occluder q Other Pumps q Perfusion Screen Tabs q Setup Tab  q Patient Subtab  q Gas Subtab  q Pump Subtab

Roller Pumps

q Maximum number q Connected – 8 q Conﬁgured on perfusion screen – 6 q Large and Small q Raceway size q Large 6 inch (15 cm) q Small 4 inch (10 cm) q Flow ranges q Tubing sizes q Mounting and positioning (raceway orientation)

q Accessing power q Air Filters q Self diagnostics q Control

q Local q CCM q Local Control q Graphic Display

q Pump Name/Module ID q Direction icon q Speed control knob q Pump speed q Flow rate display q Alarm, alert, status, and error

messages q Speed indicator/Bar graph

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About Advanced Perfusion System 1

q Three buttons q Start/Stop q Select

q Direction q Flow Constant q Tube Size q Exit

q Manual q Central Control

q Pump Icon q Slide Bar q Pump Tab

q Summary Subtab q Servo Subtab  q Pressure  q Flow q Pulse Subtab q Master/Follower Subtab q Tube clamp mechanism q Setting occlusions q Hand cranking q Pump replacement q Verify direction of rotation q Operating modes

q Start q Stop q Continuous q Pulse q Master/follower q Servo q Roller Pump Events q Pump Stopped  q Pump Started q Pump Paused q Roller Pump Responses to Alerts/ Alarms/Other Pumps q Stop q Pause q Reduce speed q Message only q No response

q Safety Cover open, pause response q Alarm Messages q Alert Messages qStatus Messages q Error messages

Centrifugal Pump (Optional)

q Maximum number - 2 q Mounting and Positioning q Accessing Power q Self Diagnostics q Control

q Local q CCM

q Local Control q Graphic Display

q Pump Name q Centrifugal Icon q Speed control knob q Pump speed q Flow rate display q Alarm, alert, status, and error

messages

q Speed indicator/Bar graph q Three buttons q Start/Stop q Select q Manual q Central Control

q Pump Icon q Slide Bar q Pump Tab

q Summary Subtab q Servo Subtab  q Pressure  q Flow q Pulse Subtab q Min RPMs q Setting minimum ﬂow alarm q Hand cranking q Pump replacement q Operating Modes

qStart qStop qContinuous qPulse qServo q Centrifugal Pump Events q Pump Stopped

 q Pump Started  q Minimum Flow  q Pump goes to Coast speed q Centrifugal Pump Responses to

Alerts/Alarms/Other Pumps q Stop q Coast™ Response q Message only q No response

q Alarm Messages qStatus Messages q Alert Messages q Error Messages

Air Bubble Detect Modules and Sensors

q Maximum number – 4 q Proper positioning q Control with CCM q On, Off, Reset q Connection to Devices

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About Advanced Perfusion System 1

q Roller pumps q Centrifugal pumps q Reset button

q Testing the ABD q Alarm Messages q Status Messages q Error Messages

Level Detect Modules and Sensors

q Maximum number – 1 q Use with Hardshell reservoirs only q Dimensions q Pad, sensor attachment q Alarm/Alert Mode q Control with CCM q On, Off q Connection to Devices

q Roller pumps q Centrifugal pumps

q Testing the Level Detection System q Alarm Messages q Alert Messages q Status Messages q Error Messages

Pressure Modules and Transducers (Optional)

q Maximum number – 8 transducers qPlacement of transducers q Calibration of transducers q Pressure Display q Setting limits

q Positive q Negative q Connection to Devices q Roller pumps q Centrifugal pumps

q Testing the Pressure System q Servo control q Alarm Messages q Alert Messages q Status Messages q Error Messages

Temperature Modules and Probes (Optional)

q Maximum number – 8 probes q Probes used q Setting alarms q Testing the Temperature probes

q Alarm Messages q Status Messages q Error Conditions

Flowmeter Modules and Sensors (Optional)

q Maximum number – 4 q Connection to Devices

q Roller pumps q Centrifugal pumps q Connection to centrifugal pump for local display and min ﬂow alarm capability

qPlacement of Flowmeter Module qPlacement of Flow Sensors q Testing the Flow Sensor qServo Control q Alarm Messages q Status Messages q Error Conditions

Occluder Module and Head (Optional)

q Maximum number – 1 q Proper insertion of tubing q Setting up and controlling q Tubing sizes q Calibration q Percent Open q Occluder Responses to primary pump

q No Response q Full Open q Full Close q Go To Flow 0% (up to 100%)

q Testing the Occluder q Status Messages q Error Conditions

Connecting to CDI (Optional)

q Maximum number of CDI 500 monitors – 1 q Maximum number of CDI 100 monitors – 1 q Maximum number of CDI 101 monitors – 1 q Selecting and displaying data values

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About Advanced Perfusion System 1

Connecting to TLink™ DMS (Optional)

q Maximum number – 1 q Collecting data

Electronic Gas Blender Module (Optional)

q Connections q Blending gases

q 95/5 q Air q Control q Manual q CCM

q Flow Rate Range q Oxygen Analyzer q Calibrating the Oxygen Analyzer q FiO2 alarm q External Flowmeter q Water Trap Care q Alarm Messages q Alert Messages q Status Messages q Error Messages

Primary and Backup Pumps

q Assigning Primary Pump q Dedicated Slide Bar q Flow Display Choices q Pulse Mode q Assigning Backup Pump q Primary Pump functionality can be reassigned  q Different pump type q Centrifugal Coast™ responses

Cardioplegia Delivery

q Assigning cardioplegia pump q Volume tracking q Timers q Time since last delivery q Adjusting total volume delivered q Servo Control q Varying CPG ratios q Delivering a ﬁxed dose

q By Volume q By Time

Timers

q Maximum number – 4 q Two timers preassigned

q Pump q Clamp

q Auxiliary timers q Timer Modes

Emergency Procedures

q Emergency situations (wet run) q Air detected q Low level q High pressure q Unexpected return to CPB q Loss of (Hospital) gas supply q Loss of power

q System circuit breaker q Hospital supply

q Intermittent AC and DC power supply q Power failure – safety system functions

q Local pump controls q Local gas ﬂow controls q Air deprimes centrifugal pump q Equipment situations

q Arterial pump failure q Replacing Pumps  q Verify direction of rotation q ABD, level failure q Operating the system without the CCM q Operating the system in case of network failure  q Centrifugal pump decouples q Servo Loss

Equipment Care

q Cleaning and lubrication q Preventive maintenance q Batteries q Power off

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System Overview

System Philosophy

The System 1 uses a software-based design and a user interface to provide an adaptable perfusion system.

Each system device and sensor module contains software that allows it to transmit and receive messages via a Controller Area Network (CAN). This design allows users to:

• Connect modules to any connection point on the system base

• Enable communications links between sensors and devices

• Select how they want pumps and an occluder to respond to alert and alarm conditions

An additional advantage of this design is the ability to use advanced functions without requiring specialized hardware. All pumps can be conﬁgured to deliver advanced functions such as:

Roller and Centrifugal Pumps

• Pulse mode

• Servo regulation to pressure or ﬂow

Roller Pumps only

• Master/Follower operation

• Cardioplegia volume tracking

• Automatic cardioplegia dose delivery

The System 1 uses an intuitive patient graphic interface to organize the system information. This centralized monitoring helps the user to view current perfusion parameters without having to look at multiple displays.

The System 1 Central Control Monitor (CCM) also serves as the central area for controlling pumps, an occluder, and the gas ﬂow system. Pumps and the gas ﬂow system also have local controls and displays that can be used interchangeably with the central monitor controls. This allows the user to:

• Remotely mount pumps and sensors

• Reduce tube lengths

• Reduce the prime volume of the extracorporeal circuit

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System Overview

Institutional Controls

WARNING: 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.

To reduce the likelihood of such errors, user institutions should establish policies or procedures for developing, qualifying, controlling, maintaining and securing perfusion screen conﬁgurations. The following list includes suggested actions to be covered by such procedures. This is not intended as an all-inclusive list of actions, but is merely a guide to illustrate examples of what an institution should consider when using System 1. Additional or different actions may be necessary depending on particular use and/or institutional policies and procedures.

Suggested policies and/or procedures to be established:

• Authorization of appropriately qualiﬁed individuals to create, revise and approve Perfusion Screens.

• Use of passwords to prevent unauthorized changes to Perfusion Screens.

• Testing methods to assure all system responses are completely understood and

meet expectations.

• Establishment of protocols or methods for responding to situations that may occur during use.

• Establishment of a standard system direction for roller pump forward ﬂow.

• Establishment of a policy to re-set the roller pump default direction to the

institution’s chosen standard system direction. This particularly applies to replacement, loaner or returned pumps.

• Training of users.

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System Overview

System Base

Features

The system base houses the internal network architecture, electronics, power supply components, batteries, communications and power connections and circuit breakers.

The base has a pair of casters on each side. Each pair of casters has a 3 position locking lever to control the movement of the casters.

Roller pumps are mounted along a central rail on the top of the base or on the poles with mounting brackets. There are 2 sizes of pump mounting extensions to allow different combinations of large and small pumps to be mounted along the central mounting area. Cable clips are built in to the mounting area to aid in cable management. The centrifugal control unit is mounted on the system with a pole mounting bracket.

Modules are connected to the receptacles on the sides of the base. A locking rail protects the modules from accidental disconnection.

Protective cover panels are attached to the top and sides of the base after components are installed to protect cables and components from liquid spills.

Long mounting poles are installed on the back corners of the base and short mounting poles are installed on the front corners of the base. A crossbar can be mounted between the 2 longest poles.

A pole-mountable lamp is available in 2 sizes, long or short.

A hand crank bracket, which holds 2 hand cranks, can be mounted on a pole in a convenient location.

There is an auxiliary outlet on the back of the system base for powering additional equipment.

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System Overview

Central Control Monitor

Features

Power Cable Connection

PC Cards

PC Card Door Latch

The Central Control Monitor (CCM) is the primary control and monitoring center for the Advanced Perfusion System 1. The CCM comprises an embedded computer with an integrated graphical display and a touch screen.

Display Area

A power cable connects the Central Control Monitor to the system.

The Central Control Monitor holds 2 PC Cards: a system conﬁguration card and a service data card. The system conﬁguration card may be used to transfer perfusion screen conﬁgurations between systems. The service card collects and stores data for use by authorized service representatives. Service cards should be handled only by qualiﬁed service technicians.

Display Areas

Main Screen

The Main Screen is the ﬁrst screen that is displayed after the system completes initialization and a self test. If any device fails the start up test, a failure message will be displayed at the top of the screen.

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System Overview

Perfusion Screen

Open

View Summary >

Return to Main

Name

Password:

Choose a Perfusion Screen

CABG Roller

CABG Centrif

Yes

Min AVR

Circ-ARREST

Yes

Pediatric

CABG ROLLER

Perfusion Screen Summary

Graphic Orientation:

Primary Pump Left - Patient Head Left

Blood Reservoir Type:

Open

Air Detectors:

ART Air

Level Detectors:

Level

Occluders:

Occluder

Pressure Sensors:

ART Pres CPG Pres

Temperature Sensors:

ART Temp VEN Temp Bladder CPG1 Temp

CDI 500:

CDI 500

Large Roller Pumps:

Arterial

Safety Connections:

Device Event Response

Level Low Level Alarm Stop Level Low Level Alert Message 0nly ART Air Air Detected Alarm Stop ART Pres High Presure Alarm Stop ART Pres High Presure Alert Message 0nly

CPG

Safety Connections:

Device Event Response

Arterial Pump Stopped Stop Arterial Pump Paused Stop CPG Press High Pressure Alarm Stop CPG Press High Pressure Alert Message Only

Small Roller Pumps:

Vent Sucker 1 Sucker 2

Timers:

Pump Clamp TMR1

The system software version can be viewed on the lower right side of the Main Screen. Four buttons, Perfusion, Conﬁguration, Service, and Shut down allow access to the functional areas or provide a controlled shut down of the system computer before turning the AC (Mains) power off to the entire system.

Perfusion

A Perfusion Screen is a graphical representation of the perfusion circuit on the CCM touch screen that is used to control and monitor perfusion parameters during a case. The Perfusion area allows the user to select a Perfusion Screen for running a case. The initial screen lists all the Perfusion Screen names and their password protection status.

A Conﬁguration Summary can be viewed for each Perfusion Screen or the desired screen can be selected and opened.

Perfusion Screens are created or modiﬁed in the conﬁguration area. If desired, access to a Perfusion Screen can be limited by assigning a password.

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System Overview

Setup Safety CPG Aux System

Post Case

Power Source/Battery Status Icon

Select Primary Pump Displa

CDI

Venous

Shared Slide Bar Area

Occluder

FiO2 (if installed)

Gas Flow (if installed)

Fine Adjustment Arrow

Device Icon

Reservoir

Oxygenator

Gas Icon

Primary Pump Slide Bar

The illustration below is an example of a Perfusion Screen -the different elements and areas of the Perfusion Screen are labeled. For detailed information about the function of the Perfusion Screen, refer to the Perfusion Screen section of the Central Control Monitor chapter.

Arterial

0.000

L/min

10.78

Occluder

100

SO2

HCT

Mute All

Message Area

Gas

% O2

80.0

Time of Day

16:07:51

PO2

mmHg

PCO2

mmHg

K+

mmol/L

Pump

000:00

Reset

Clamp

000:00

Reset

Timer

CPG1

0.000

L/min

2.00

Pump Tab

Pulse (Primary Only)

Servo

Scroll Control

L/min

L/min/m

mL/kg/min

CDI

CPG2

0.000

0.00

L/min Total

Post Case

Arterial

1:1

Shared Pump

Slide Bar

Arterial

0.000 0.000

Setup

L/min

STOP

Safety

Tabs

Vent

L/min

STOP

CPG

Sucker1

L/min

START

Aux System

CPG1

0.000

L/mi n

STOP

Activates Shared Slide Bar

Tabs and Subtabs

Setup

Patient Gas Pumps Occluders Timers Time/Date

Safety

Air Level Pressures Temps Flow

CPG

Delivery Auto Dose Setup

Aux

Timers Messages

System

Settings Powe r Reassign Module Module Info

Post Case

End Case

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Page 28

System Overview

System Settings

Language:

English

Date Format:

dd/mm/yyyy

Roller Pump Direction:

Configuration

Change Settings >

Edit Config Password >

PC Card Utilities >

New

Edit

View Summary >

Rename >

Set Password >

Delete

Return to Main

Name

Ready:

Last Edit:

Password:

Perfusion Screens

Yes

15/05/2002

Yes

15/05/2002

CABG Roller

CABG Centrif

Min AVR

Circ-ARREST

Yes

Pediatric

15/05/2002

Password

Conﬁguration

The Conﬁguration area can be password protected and allows authorized users to view and change system settings and Perfusion Screens.

The System Settings area is used to select the display language, the date format, set the default system direction for roller pumps, edit the conﬁguration password, and access the PC Card Utilities.

The PC Card Utilities are used to move or copy Perfusion Screen ﬁles between the CCM and a PC Card, view a Perfusion Screen Summary, and rename or delete a Perfusion Screen.

The Perfusion Screens area is used to create, edit, rename, or delete perfusion screens. A Perfusion Screen Summary can be viewed and a password can be assigned to the screen in order to limit access to authorized users.

When creating a new Perfusion Screen, the user is led through a step by step process:

• Selecting primary pump and patient orientation

• Selecting additional pumps including on screen names and colors

• Selecting additional modules including names and, if available, colors

• Establishing safety connections

• Setting alert and alarm limits

• Selecting pump responses to external events

• Selecting occluder responses to primary pump events

• Assigning screen representation to physical modules and devices

• Naming the Perfusion Screen and identifying the screen as ready for use

For more details on the operation of the Conﬁguration area, refer to the

Conﬁguration section of the CCM chapter.

Service

Access to the Service area is password protected and limited to authorized personnel. This area is used to view the system log, export the system log to an external computer via the service data card, view module error event data and calibrate the touch screen. It is also used to manage security access control and view the system software version control area.

Shut down

Provides a controlled shut down of the system computer and must be performed before AC (Mains) power to the entire system is turned off. Failure to follow the controlled shut down procedure may result in improper start-up at the next power-on.

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Page 29

System Overview

ARTERIAL 1/2

L/min

4.50

Roller Pumps

Features

Roller pumps are available in 2 sizes. Large roller pumps have a 6 inch (15 cm) raceway and small roller pumps have a 4 inch (10 cm) raceway. Large roller pumps can be used for arterial, cardioplegia, vent and suction applications. Small roller pumps can be used for pediatric arterial, cardioplegia, vent and suction applications.

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. Various arrangements of large and small pumps can be mounted on the system base using the mounting extensions provided.

Roller pumps are connected to the system with a cable. There are 6 pump receptacles on the system, 3 on each side. Roller pumps can also be connected to any of the module receptacles. Up to 8 pumps can be connected to the system, but only 6 can be controlled through the Central Control Monitor at any given time.

The roller pump raceway can be rotated in 15° increments and locked into position to allow for options to reduce tubing length. A universal tube clamp mechanism accommodates a variety of tubing sizes, including dual tubing sets, without the need for different size inserts.

The occlusion mechanism allows the position of the rollers to be adjusted at any time, including while the pump is rotating. An audible click can be heard whenever the occlusion is being adjusted.

Roller pumps can be controlled from the Central Control Monitor or from controls on the pump itself. Tubing size, direction of rotation, speed, ﬂow rate or RPMs, and safety, status and error messages are displayed on the pump as well as on the Central Control Monitor. An amber colored bar graph represents pump speed.

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System Overview

There are 5 operating modes for a roller pump:

• Continuous: the pump operates at a constant speed set by the user.

• Pulse: available on the primary pump only; the pump speed alternates between a peak speed and a baseline speed. Base, Rate and Width can be adjusted through the Central Control Monitor.

• Master/Follower: set up during conﬁguration; involves two roller pumps in Continuous Mode. The Follower pump demand ﬂow rate or speed is a percentage of the master pump ﬂow rate or speed. The percentage can be adjusted through the Central Control Monitor or from the pump speed control knob on the follower pump. The pump designated as the primary or arterial pump cannot be designated as a master/follower pump.

• Servo Control: pump speed is regulated to maintain a speciﬁc pressure or ﬂow rate. The pressure and ﬂow rate setpoints can be adjusted through the Central Control Monitor or from the pump speed control knob on the pump.

• Automatic Delivery: the pump delivers a set ﬂuid volume or delivers ﬂuid for a set amount of time and then stops.

Roller pumps can be connected to safety and monitoring systems and other pumps during conﬁguration, followed by choosing pump responses. Roller pump response choices are No Response, Stop, Pause, Reduce Speed and Message Only. The choices allowed for a pump response vary depending on the type of alert or alarm and the type of device connected to the pump.

When a connected device is in alert or alarm mode, a message will display on the pump display.

Centrifugal Control Unit

Features

The centrifugal control unit provides an interface between the system and a centrifugal drive motor. A disposable centrifugal pump magnetically couples to the drive motor. The drive motor is mounted on a pole and connects to the centrifugal control unit with a cable. The centrifugal control unit mounts on a pole and connects to the system with a cable. The control unit can be connected to a pump receptacle or to any of the module receptacles.

Up to 2 centrifugal control units can be connected to the system at a time. The centrifugal pump can be controlled from the Central Control Monitor or from controls on the centrifugal control unit.

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Page 31

System Overview

ARTERIAL

2010 RPM

L/min

4.50

Motor speed, ﬂow rate, as well as safety, status, and error messages are displayed on the centrifugal control unit control panel as well as on the Central Control Monitor. Pump speed is displayed in RPMs on the pump as well as represented as an amber colored bar graph.

There are 3 operating modes for a centrifugal pump:

• Continuous: pump operates at a constant speed set by the user.

• Pulse: available on the primary pump only; the pump speed alternates between a peak speed and a baseline speed. The baseline speed can be adjusted through the Central Control Monitor.

The centrifugal system can be connected to safety and monitoring systems and other pumps during conﬁguration, followed by choosing centrifugal control unit responses. Centrifugal control unit response choices are No Response, Stop, Coast and Message Only. The choices allowed for a pump response vary depending on the type of alert or alarm and the type of device connected to the pump.

When a connected device is in alert or alarm mode, a message will display on the centrifugal control unit display.

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System Overview

Modules

Features

Sensor Connection

LED

System Connection

The following modules connect to the system: Air Bubble Detect, Level Detect, Occluder, Temperature, Pressure, Flowmeter, Interface Module for CDI 100/101, Interface Module for CDI 500, and Interface Module RS-232.

Modules provide an interface between an appropriate type of sensor or device and the system.

Each module has appropriate connections for the type of sensor needed.

Each module has a tricolor LED (light emitting diode) to indicate module status. Status modes are: Constant Green – Online Mode Blinking Yellow – Alert Condition Blinking Green – Assignment Mode Constant Red – Broken Mode Constant Yellow – Ofﬂine Mode Blinking Red – Alarm Condition

Up to 18 modules can be connected to the system; 9 on each side.

Modules are connected directly to the receptacles on either side of the system, with the exception of the ﬂowmeter module, which is mounted on a bracket and connected to the system by a cable from the module.

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Page 33

System Overview

Air Bubble Detect Module

The air bubble detect module (ABD) is used with an air sensor to detect air bubbles in the perfusion circuit. Use only Terumo® SarnsTM Ultrasonic Air Sensors with the system.

Up to 4 air bubble detect modules may be connected to the system at the same time.

The air sensor connects to the module with the air sensor cable. The air sensor can be mounted directly on the tubing or on a bracket.

Select the sensor which is appropriate for the tubing size and ﬂow rate to be used.

Tubing size can be 3/8 in (9,5 mm) I.D. (Inner Diameter) x 3/32 in (2,4 mm) wall thickness, 1/4 in (6,4 mm) I.D. x 3/32 in (2,4 mm) wall thickness or 1/4 in (6,4 mm) I.D. x 1/16 in (1,6 mm) wall thickness.

The air sensor detects air bubbles within clear, ﬂexible medical grade polyvinyl chloride (PVC) tubing in clear priming solutions or blood with a hematocrit from 15% to 40%.

The air sensor detects air bubbles of 0.3 cc or larger at ﬂow rates up to 3 L/min for 1/4 in (6,4 mm) I.D. tubing and gas bubbles of 0.5 cc or larger at ﬂow rates up to 6 L/min for 3/8 in (9,5 mm) I.D. tubing.

The air bubble detect module only operates in the alarm mode. Pump responses to an air alarm are selected during conﬁguration.

In the event of an alarm, an audible dual tone alarm sounds, a message appears on the Central Control Monitor, the appropriate air detect icon on the Central Control Monitor ﬂashes red, and the status LED on the appropriate air bubble detect module ﬂashes red. If a safety connection was made to a pump, a message will also appear on the message area on the pump control panel, and the pump will react with the response chosen.

Level Detect Module

Always use a level detect module with level sensors to monitor blood levels in hardshell reservoirs. Use only Terumo® SarnsTM Ultrasonic Level Transducers with the system.

One level detect module may be connected to the system.

Level sensors are attached to the color coded connectors on the module and then to a hardshell reservoir. A yellow alert sensor attaches to the yellow connector and a red alarm sensor attaches to the red connector. Level sensors are attached to the hardshell reservoir with level sensor pads.

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Page 34

System Overview

mmHg

The hardshell reservoir must be made of polycarbonate material with wall thicknesses of 0.07 inches (1,8 mm) – 0.15 inches (3,8 mm). Level sensors should be placed so that internal structures of the reservoir are more than 1 cm away from the transducer face. The level sensors function normally with clear priming solutions and blood of any hematocrit.

An operating mode for the module of Alert Only or Alert and Alarm is selected during conﬁguration. The operating mode can also be changed during a case.

In the event of an alarm, an audible dual tone alarm sounds, a message appears on the Central Control Monitor, the level detect icon on the Central Control Monitor ﬂashes red and the status LED on the level module ﬂashes red.

In the event of an alert, an audible single tone alert sounds, a message appears on the Central Control Monitor, the level detect icon on the Central Control Monitor ﬂashes yellow and the status LED on the level module ﬂashes yellow.

In the event of an alert or alarm, if a safety connection was made to a pump, a message will also appear in the message area on the pump control panel, and the pump will react with the response chosen.

Pressure Module

The pressure module provides the interface between pressure transducers and the system. Each pressure module has 2 channels. Two pressure transducers can connect to each pressure module.

Up to 4 pressure modules can be connected to the system at a time.

Terumo offers pressure transducers known to be compatible for use with the pressure module.

Pressure transducers must be calibrated before use.

Pressure alarm limits, alert limits, safety connections and pump responses are set up during conﬁguration. Pressure information can be viewed and changed through the Safety tab on the case screen.

The System 1 is capable of displaying pressure values between –250 mmHg and +900 mmHg. Information is displayed on the Central Control Monitor in the perfusion screen, in a square icon labeled mmHg.

“CAL” will be displayed if the pressure transducer requires calibration, “– – –” is displayed at pressures less than –250 mmHg or if no pressure transducer is connected, “999” is displayed at pressures greater than +900 mmHg. The display is blank in the event of a module malfunction.

CAUTION: The accuracy of the pressure information is dependent on the speciﬁcation of the pressure transducer. Always ensure the pressure transducers used are appropriately speciﬁed for the application. Refer to instructions for use provided with the pressure transducer for the transducer’s speciﬁcations.

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Page 35

System Overview

If a pressure module has been conﬁgured to operate with a pump in servo mode, pressure information will also be displayed on the pump control panel display during servo operation.

In the event of a pressure alarm, a dual tone audible alarm sounds, a message is displayed on the Central Control Monitor, the appropriate icon turns red and ﬂashes, and the status LED on the appropriate pressure module ﬂashes red.

In the event of a pressure alert, a single tone audible alert sounds, a message is displayed on the Central Control Monitor, the appropriate icon turns yellow and ﬂashes, and the status LED on the appropriate pressure module ﬂashes yellow.

In the event of overrange/underrange readings or pressure system malfunction, physiological alerts or alarms are cleared automatically. If a safety connection from a pressure event had paused or stopped a pump, that pump can then resume or be restarted (if no other pause or stop responses are in effect). If the pressure reading returns into range between -250 mmHg and +900 mmHg inclusive, the physiological alerts or alarms will reoccur as appropriate.

Temperature Module

The temperature module provides the interface between temperature sensors and the system. In order to maintain electrical isolation in accordance with applicable standards, insulated temperature probes must be used.

YSI Series 400 compatible probes, with the exception of Model 416, must be used in order to monitor temperature properly with System 1.

Each temperature module has 2 channels. Two temperature sensors can connect to each temperature module.

Up to 4 temperature modules can be connected to the system at a time.

Temperature information is displayed on the Central Control Monitor in the perfusion screen, in a rectangular icon labeled °C. The display will show – – – if no sensor is attached.

A high temperature alarm can be set for each temperature sensor.

In the event of a temperature alarm, a dual tone audible alarm sounds, a message is displayed on the Central Control Monitor, the appropriate icon ﬂashes red, and the status LED on the temperature module ﬂashes red.

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System Overview

L/min

Flowmeter Module

The ﬂowmeter module provides the interface between an ultrasonic ﬂow sensor and the system. Up to 2 ﬂowmeter modules can be mounted on each ﬂowmeter mounting bracket. Up to 4 ﬂowmeter modules can be connected to the system at a time.

It is recommended that a ﬂowmeter module always be used when a centrifugal pump is used.

Flow information is displayed in a rectangular icon, in L/min, on the Perfusion Screen. Placement of the icon is chosen during conﬁguration. If the ﬂowmeter has been placed on a centrifugal pump, ﬂow data will also be displayed on the centrifugal control unit display and the minimum ﬂow alarm will be functional.

For centrifugal pumping, a minimum ﬂow alarm can be set to warn of reduced ﬂow. In the event of a minimum ﬂow alarm, a dual tone audible alarm sounds, a message is displayed on the Central Control Monitor and on the control panel of the centrifugal control unit.

The ﬂowmeter module generates an alarm when backﬂow is detected. In the event of a backﬂow alarm, a dual tone audible alarm sounds, a message is displayed on the Central Control Monitor, the appropriate icon turns red and ﬂashes (unless the icon was placed on a centrifugal pump), and the status LED on the appropriate ﬂow meter module ﬂashes red. If a safety connection was made to a pump, a message will also appear on the pump control panel and the pump will react with the response chosen.

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System Overview

Occluder Head

Occluder Module

The occluder module is used with the occluder head to provide a computer-controlled tube clamping mechanism to regulate the ﬂow in the venous line. The occluder head is attached to the module with the occluder head power cable.

Occluder Module

Only 1 occluder may be connected to the system.

Tubing is positioned in the occluder head and is compressed by a plunger. Tubing can range in size from 1/4 in (6,4 mm) I.D. x 1/16 in (1,6 mm) wall thickness to 1/2 in (12,7 mm) I.D. x 3/32 in (2,4 mm) wall thickness with a recommended nominal durometer range of 65-70 Shore A.

The occluder is controlled through the occluder slide bar on the Central Control Monitor. Use the Open and Close buttons on the slide bar or choose a percentage open by using the scroll control. There are no local controls on the occluder head.

The occluder must be calibrated prior to use. The occluder icon on the Central Control Monitor will display “CAL” to indicate that the occluder needs calibration.

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System Overview

Interface Modules

Interface Module for CDITM 100/101

The Interface Module for CDITM 100/101 provides an interface between the system and a CDITM 100 or 101 Extracorporeal Hematocrit/Oxygen Saturation Monitor*. The module is connected to the CDITM 100 or CDI™ 101 monitor with a serial cable.

Data from the CDITM 100 or CDI™ 101 monitor can be conﬁgured to be displayed on the Central Control Monitor. Parameters that can be displayed are oxygen saturation, hematocrit and hemoglobin.

Interface Module for CDITM 500

The Interface Module for CDITM 500 provides an interface between the system and a CDITM 500 Blood Parameter Monitoring System. The module is connected to the CDITM 500 monitor with a serial cable.

Data from the CDITM 500 monitor can be conﬁgured to be displayed on the Central Control Monitor. Parameters that can be displayed are arterial PO2, arterial PCO2, arterial pH, arterial temperature, arterial oxygen saturation, bicarbonate, base excess, venous PO2, venous PCO2, venous pH, venous temperature, venous oxygen saturation, potassium concentration, oxygen consumption, hemoglobin, and hematocrit.

The CDITM 500 monitor receives ﬂow data from System 1. The ﬂow data is displayed on the front of the CDITM 500 monitor and is used to calculate and display the O2 consumption.

Interface Module RS-232

Data Transfer

The Interface Module RS-232 provides an interface between the system and the TLink™ Data Management System. The module is connected with a serial cable to the serial port on the computer on which the perfusion software has been installed.

During a case, perfusion data and events from System 1 are sent through the Interface Module to be captured by the perfusion software.

* The Terumo CDI™ 101 Hematocrit/Oxygen Saturation Monitoring System is not cleared for marketing in the United States by the US Food and Drug Administration (FDA).

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System Overview

Electronic Gas Blender

The electronic gas blender is a module that is internally installed in the system base. The gas blender provides control and monitoring of the gas output to an oxygenator. An integrated oxygen analyzer measures the oxygen content of the gas blend.

Electronic Gas Blender Controls

Front Panel Back Panel

The oxygen analyzer requires, at a minimum, daily calibration and can be calibrated from the Central Control Monitor.

An air or 95% oxygen/5% carbon dioxide (95/5) inlet, an oxygen inlet, a gas outlet, and an exhaust port are on the back of the system base. Use only medical grade gases supplied at an inlet pressure of 50 psi ± 20 psi with the difference between the two inlet gas pressures being no more than 18 psi.

Water trap

The gas blender can be controlled from the Central Control Monitor by using the Gas and FiO ﬂow information is displayed on icons labeled Gas, %O2 and FiCO2, if appropriate, on the Perfusion Screen. An external, mechanical ﬂowmeter, provided in the accessory kit, should be connected to the gas outlet and be positioned between the vaporizer and the oxygenator to monitor the gas ﬂow in the event Central Control Monitor capability is lost.

An alarm limit for Low FiO2 can be chosen during case setup.

High and low pressure alarms are generated by the system if the inlet pressure of a source gas exceeds 70 psi or falls below 30 psi. In the event of a pressure alarm, a dual tone audible alarm sounds and an alarm message is displayed on the Central Control Monitor.

slide bars or locally by using the control knobs on the front of the base. Gas

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System Base

Vertical Poles and Crossbar

Cable Cover

Module Cover

Wheel Lock

Hand Cranks

On/Off Switch

Power Status Indicator LED

Audio Output

The system base is a moveable platform designed for the ﬂexible mounting of system components on poles and on a central rail. The base houses the network infrastructure that provides power and communications to all system components. Each component connects to the system network via receptacles on the base. There are 6 pump connections, 2 receptacles for the Central Control Monitor (CCM), 18 receptacles for modules, and 2 receptacles for a lamp. The base also provides 1 AC outlet to supply power to auxiliary equipment.

AC (Mains)Power Switch

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System Base

Base Components

Mains Power Circuit Breakers

Auxiliary Outlet Circuit Breaker

Ground Equalization Stud

Auxiliary Outlet

Mains Power Cord

The AC (Mains) power cord connects the system to the wall electrical supply. When the system is operating from the AC (Mains) power supply, the AC (Mains) power status indicator LED located on the front panel is illuminated and steady.

Attach the system AC (Mains) power cord to an appropriate wall electrical supply as indicated on the name plate label.

WARNING: Check the AC (Mains) power cord and plug for damage prior to use.

Do not use the system if damage to the power cord or plug is found. Damage may include worn or twisted cord insulation and loose, bent, or missing plug pins. Additionally, damage may result from tightly wrapping the power cord around any HLM ﬁxture or pole.

CAUTION: Do not use extension cords to connect the system to AC (Mains) power or to connect modules or accessories to the system. Use of extension cords may compromise performance.

In some countries, regulations require potential compensation; in this case, connect the cable from the potential compensation network to the ground equalization stud.

Circuit Breakers

There are 3 resettable circuit breakers on the system base.

Two resettable circuit breakers located near the AC (Mains) power cord protect the system from excessive power consumption. The breakers are protected from liquid by a clear plastic cover.

The system will switch from AC (Mains) to Battery Power in the event that one or both circuit breakers protecting the system trips. To reset the circuit breakers, depress the push button(s) until it clicks into place. Verify that the system returns to AC (Mains) power.

CAUTION: In the event that the 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.

One resettable circuit breaker protects the auxiliary outlet from excessive AC (Mains) power draw.

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System Base

Please wait for the system to shut down. 10

Yes

Do you really want to shut down the system?

If the auxiliary outlet circuit breaker is tripped, devices plugged into this outlet will not power ON. To reset the circuit breaker, depress the button until it clicks into place.

Auxiliary Outlet

The auxiliary outlet is an AC outlet protected with a 1.5 amp resettable circuit breaker for the 100-120V system or a 0.7 amp resettable circuit breaker for the 220-240V system.

Do not use this outlet to power devices or equipment which require voltage or current above the speciﬁed limit.

CAUTION: 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 will remain unpowered until AC (Mains) power is restored.

Mains Power On and Off

The AC (Mains) power switch turns power to the system On or Off and enables or disables the automatic battery backup.

When the system is operating from AC (Mains) power, the power status indicator LED on the front panel is illuminated and steady.

To Turn the System On:

1. Press the top of the AC (Mains) power switch. The system start-up tone sounds and indicates the audio system is working prop-

erly. If you do not hear the start-up tone, call for service.

To Turn the System Off: Note: Failure to follow the controlled shut down procedure may result in improper

start-up at the next power-on.

1. Touch the Shut down button on the main screen. A screen prompts the user to shut down the system.

User returns to main screen

2. Select Yes to shut down.

The shut down process takes approximately 10 seconds. A message will display

when it is safe to power down the system.

AC (Mains) Power Switch (Switch Guard not shown)

It is safe to power down the system.

3. Turn the AC (Mains) power off by pressing the bottom of the AC (Mains) power switch.

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System Power

The power system is located within the base and includes two internal DC power supplies, integrated batteries, and an internal power manager. The power supplies transform AC (Mains) power into the DC levels required by the system components. The integrated batteries provide backup power in the event of AC (Mains) power loss during use or when power needed exceeds power available.

The internal power manager monitors the power needed to run the system and compares the power needed (load) with the power available (AC (Mains) power

capacity). If the power needed exceeds the power available, the system will switch to battery power. The auxiliary outlet will remain powered as long as AC (Mains) power

is still available. To decrease the load, noncritical modules or pumps may be turned off by the user. When the system power need falls below the available power limit for

at least 10 seconds, the system will automatically switch back to using AC (Mains) power.

If the system switches to battery power, the battery alert tone will sound and the power status indicator LED will ﬂash. If a Perfusion Screen is open, a message will be displayed on the CCM and posted in the Aux tab, the Power Source/Battery Status icon will ﬂash and display a color indicating approximate battery time available and the approximate battery run time in minutes will be displayed above the Power Source/Battery Status icon.

If the system switches to battery power, the battery alert tone will sound and the power status indicator LED will ﬂash. If the Main Screen is open, the Power Source/ Battery Status icon will ﬂash and display a color indicating the approximate battery time available and the approximate battery run time in minutes will be displayed above the Power Source/Battery Status icon.

Note: If the system is started by battery power, the auxiliary outlet will not be available. When AC (Mains) power is connected, the auxiliary outlet is immediately powered and, after a short delay, the system will automatically switch to AC (Mains)

power.

Battery System

Integrated batteries provide uninterruptible battery backup power in the event AC (Mains) power is lost or when power needed exceeds power available.

During power loss, fully charged batteries will power a fully loaded System 1 for at least 60 minutes. A fully loaded System 1 is deﬁned as:

A combination of 6 blood pumps, from the list below:

2 roller pumps, speed set to 120 RPM while using 1/2 in (12,7 mm) I.D. x 3/32 in (2,4 mm) wall tubing and/or speed set to 190 RPM while using 3/8 in (9,5 mm) I.D. x 3/32 in (2,4 mm) wall tubing, properly occluded and ﬂuid temperature of 25°C;

2 roller pumps, speed set to 100 RPM while using 1/4 in (6,4 mm) I.D. x 3/32 in (2,4 mm) wall tubing, properly occluded and ﬂuid temperature of 25°C;

1 roller pump, speed set to 50 RPM while using 1/4 in (6,4 mm) I.D. x 3/32 in (2,4 mm) wall tubing, properly occluded and ﬂuid temperature of 25°C;

1 roller pump, speed set to 30 RPM while using 8:1 dual tubing set, properly occluded and ﬂuid temperature of 5°C;

1 centrifugal pump, ﬂow set to 5.0 L/min, a backpressure of 400 mmHg and ﬂuid temperature of 25°C;

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18 monitoring modules; any combination of ﬂow, temperature, pressure, level, occluder, air bubble detect, and serial interface modules; all modules assigned and activated;

1 Electronic Gas Blender module, connected and activated;

1 lamp; connected and activated;

1 Central Control Monitor; connected and activated.

WARNING: If a partially charged battery system is used, there may be less than 60 minutes of battery power available for a fully loaded system.

WARNING: Turn the system power off at the AC (Mains) power switch on the system before inspection, cleaning, preparation for use, or storage in order to

turn off both the battery power and the AC (Mains) power.

WARNING: Charge the batteries monthly. Storage of a System 1 without charging the batteries monthly may damage the batteries and lead to overstated battery life. This damage, caused by a gradual discharge of the batteries, may cause loss of battery backup without warning.

Battery charge level should be checked before each case.

The batteries must be fully recharged after storage, prior to use on a case. During storage there is a gradual discharge of the batteries which may reduce the available battery backup time. A power status indicator LED on the front panel of the base indicates the status of the battery charge. When starting a system that has been in storage, allow at least 1 minute to elapse after the CCM displays the Main Screen, before checking the power status indicator LED.

On the Main Screen, the Power Source/Battery Status icon will display a color indicating the approximate battery time available. In addition, charge level information can be found within a Perfusion Screen. The Power Source/Battery Status icon will display a color indicating the approximate battery time available. More information is available in the Power subtab when a Perfusion Screen is open.

The batteries will charge, as needed, while the system is operating from AC (Mains) power.

To recharge the batteries, the system must be plugged into the AC (Mains) power supply with the AC (Mains) power switch turned on. It takes up to 13 hours to fully recharge the

batteries.

As the batteries recharge, the color of the power status indicator LED and Power Source/ Battery Status icon will change to indicate the condition of the batteries:

• Steady green indicates a battery system with one hour or more run time for a fully loaded system;

• Steady red indicates a battery system with less than one hour run time for a fully loaded system.

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When the system is operating from battery power, an audible battery alert tone sounds and repeats every 3 minutes. The battery alert tone is a unique, single tone pattern used only to indicate that the system is operating on battery power. The battery alert tone cannot be muted. In addition, the Power Source/Battery Status icon ﬂashes and the power status indicator LED on the front panel ﬂashes. If a Perfusion Screen is opened, a message is displayed in the message area of the CCM and in the Messages subtab in the Aux tab.

There are three different indicators that provide information regarding battery status: the Power Status Indicator LED, the Central Control Monitor Power Source/Battery Status Icon, and the Power subtab within the System tab.

Power Status Indicator LED – Provides a status as the batteries charge or the battery capacity if the battery system is actively providing backup power. When starting a system that has been in storage, allow at least 1 minute to elapse after the CCM displays the Main Screen, before checking the power status indicator LED.

Power Status Indicator LED

The Power Status LED provides information about battery life as follows:

When operating from AC (Mains) power:

• Steady green indicates a battery system with greater than one hour run time with a fully loaded system.

• Steady red indicates a battery system with less than one hour run time with a fully loaded system.

When operating from the battery system:

• Flashing green indicates 30 minutes or more battery life at present discharge rate

• Flashing yellow indicates 15 minutes or more, but less than 30 minutes battery life at present discharge rate

• Flashing red indicates less than 15 minutes battery life at present discharge rate.

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System Base

53 min

Central Control Monitor Power Source/Battery Status Icon (only displayed on the Main and Perfusion Screens) – Provides information about battery life as follows:

AC (Mains) Power

When operating from AC (Mains) Power:

• Steady green indicates a battery system with greater than one hour run time with a fully loaded system

• Steady red indicates a battery system with less than one hour run time with a fully loaded system

On Battery Indicator

When operating from the battery system:

• The approximate battery life in minutes is displayed above the Power Source/Battery Status icon

• The color of the Power Source/Battery Status icon will change as the estimated remaining capacity in minutes decreases:

• Flashing green indicates 30 minutes or more battery life at present discharge rate

• Flashing yellow indicates 15 minutes or more, but less than 30 minutes battery life at present discharge rate

• Flashing red indicates less than 15 minutes battery life at present discharge rate.

Indicator

The time displayed above the Power Source/Battery Status icon, the color of the icon, and the available capacity in minutes in the Power subtab within the System tab should only be used as approximations of the amount of time remaining.

Power subtab within the System tab (only displayed on the Perfusion Screen) Contains a summary of the power information for the system. See the Central Control Monitor section, Power Subtab for further details.

System

Settings

Power

Reassign

Module

Module Info

Power Source: AC Power

AC Power Capacity Used: 11.8 %

Estimated Battery Time Remaining (min): 82

Battery Charge Level:

16:07:51

The Battery Charge Level found in the Power subtab within the System tab provides a bar graph indicating the approximate charge status of the battery.

• Power Source - AC power or battery.

• AC Power Capacity Used - Indicator of power consumption when using AC power.

• Estimated Battery Time Remaining - Provides an estimated remaining battery backup time, regardless of current Power Source.

Note: This will be the same time estimate as shown over the Power Source/Battery Status icon when on battery backup.

• Battery Charge Level - Provides a bar graph indicating the charge status of the battery.

In summary, if the system is operating from batteries, the Power Status Indicator LED will ﬂash. If the system is operating from batteries and if a Perfusion Screen is opened, a message is displayed in the message area of the CCM and in the Messages

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System Base

subtab within the Aux tab, and an estimated battery time available appears above the Power Source/Battery Status icon.

WARNING: Failure to properly charge and maintain the System 1 Base Batteries can cause the unexpected loss of battery backup function.

WARNING: The Battery Charge Level bar graph and power status indicators depend on the proper charging and maintenance of the battery system. Failure to properly charge and maintain the System 1 battery system can cause battery failures.

CAUTION: Replace the batteries every 2 years, OR whenever the batteries cannot be fully recharged within 13 hours, OR whenever fully charged batteries will not power a fully loaded system for 60 minutes.

CAUTION: Do not store batteries in a discharged state as this will damage them.

Decreasing the power consumption of the system while operating on battery power can enable the batteries to power the system for more than 1 hour. Turning off noncritical devices will decrease the power needs of the system.

If the system shuts down due to depletion of battery power, make sure to plug the system into available wall power and that the system power switch is ON.

Battery System Testing

The batteries are tested at different times during use of the system.

Automatic Testing of Switching to Battery System

Each time the system is powered on, a switching test of the battery system is performed. If the system detects an issue with battery system circuitry at start-up, the following message will be displayed: “Battery Cannot be Charged - Full Backup May Not be Available”.

If this message is posted, contact Terumo Customer Service. Do not attempt to operate the system until it has been serviced.

In addition, battery circuit components are monitored constantly during operation. If a problem is detected, the following message will be displayed: “Battery Cannot be Charged - Full Backup May Not be Available”.

If this message is posted, contact Terumo Customer Service. Do not attempt to operate the system until it has been serviced.

Manual Testing of Switching to Battery System

To test the battery switching function, unplug the system when it is turned on. If the system does not immediately switch to battery power, contact Terumo Customer Service. Do not attempt to operate the system until it has been serviced.

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WARNING: The following behavior while operating on Battery power indicates discharged or damaged batteries:

• Battery Time Remaining decreases faster than elapsed time on battery

• Power Source/Battery Status Icon changes color faster than elapsed time on battery

• Red Power Source/Battery Status Icon after the system is returned to AC (Mains) Power.

Battery Capacity Updates (Battery Test)

Whenever the system is operating on battery power, it will update its estimate of battery capacity.

Watch for battery capacity updates whenever the system is operating on battery power.

If the Battery Test indicates a damaged or discharged battery AND the system may not be fully charged, recharge the batteries and then repeat Battery Capacity Test. To fully recharge the batteries, the system must be plugged into the AC power supply with the AC (Mains) Power switch turned On. It takes up to 13 hours to fully recharge the batteries. If the Battery Test indicates a damaged or discharged batteries AND the System should be fully charged, call Terumo Customer Service. Do not use the system until the battery system has been serviced.

WARNING: If the Battery Capacity Updates indicate less than 60 minutes battery power AND the battery system should be fully charged, call Terumo Customer Service. Do not use the system until the battery system has been serviced.

Battery Test Reminder

Every 60 days, if the system has not been run on battery for at least 5 minutes, the system will post a reminder at the Main Screen to perform a Battery Test. The most accurate estimate is achieved after 5 minutes operation without AC (Mains) Power. The Battery Test may be skipped or canceled at any time, but the reminder will return whenever the Main Screen is entered until the Battery Test is completed.

The Battery Test reminder appears in a message box as follows:

Select “No” to return to the Main Screen Selecting “Yes” will display the following message box:

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To return to the Main Screen, select “Cancel Battery Test” Unplugging the system will display the following message box:

The system will count down to zero from ﬁve minutes to complete the Battery Test. To cancel the test, select “Cancel Battery Test” (or plug the system back in). If the Battery Test is canceled without plugging the system back in to AC (Mains) Power, the following message box will be displayed:

Plugging in the system will remove the message box, canceling the Battery Test. Selecting “OK” will remove the message box canceling the Battery Test.

One of the following message boxes will display upon completion of the Battery Test:

The above message box will be displayed if the battery system has one hour or more capacity for a fully loaded system

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The above message box will be displayed if the battery system has less than one hour capacity for a fully loaded system

If the Battery Test indicates the batteries have less than one hour capacity AND the system may not be fully charged, recharge the battery and then repeat the Battery Test. To fully recharge the battery, the system must be plugged into the AC (Mains) Power with the AC (Mains) Power Switch turned on. It takes up to 13 hours to fully recharge the batteries, if battery charge is very low.

WARNING: If the Battery Capacity Updates indicate less than 60 minutes battery power AND the system should be fully charged, call Terumo Customer Service. Do not use the system until the battery system has been serviced.

System Network

The network design allows the different types of system modules and pumps to be connected to any dedicated receptacle on the base. It also allows multiple types of modules to be connected to the system. The user can deﬁne how these modules interact with the system and each other and can set alert and alarm responses and monitoring limits via the Central Control Monitor.

Lamp Receptacle

CCM Receptacle

Pump Receptacles

Module Receptacles

There are 9 module receptacles, 3 pump receptacles, a Central Control Monitor receptacle and a lamp receptacle on each side. If necessary, a pump can be plugged into a module receptacle.

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Standoffs are provided in the accessories kit. Two standoffs should be installed on a module receptacle to securely fasten a pump cable or ﬂowmeter cable to the module receptacle. Modules cannot be inserted into a module receptacle when standoffs are installed.

Casters and Wheel Lock System

The base is mounted on four casters. Each side of the base has a pair of casters and a locking lever that can be set in three positions to either lock the wheels of the casters to prevent unintended movement of the base, allow free movement of the casters and wheels, or lock the casters to allow the base to roll while maintaining a ﬁxed position of the wheels.

Position 1 Position 2 Position 3

Apply upward or downward pressure on the locking lever to change the position.

Position 1

The casters are locked in place and will not move. When the system is in use, the wheel lock should be set in the locked position.

Position 2

The casters are unlocked and move in all directions.

Position 3

The casters align parallel to the base and allow side-to-side movement only.

Poles, Shelf, and Brackets

There are two 1.30 in. (3,3 cm) diameter, stainless steel vertical telescoping poles attached to the base platform for mounting devices to the system.

Extend the inner section of the telescoping pole by adjusting the handle screw on the collar of the pole. Do not extend beyond a maximum of 18 in. (45,7 cm) from the retracted position.

Special ﬁttings connect a horizontal cross bar to the two vertical poles.

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There are two additional shorter vertical poles, one on either side of the front of the base.

Short Vertical Poles

The optional System 1 Shelf mounts between the 2 vertical telescoping poles. The shelf provides storage space for items up to a maximum of 50 pounds (22,6 kg).

Make sure that the shelf is positioned such that it does not interfere with access to the pumps or other devices. Ensure that all pumps can be hand-cranked without interference from the shelf.

Do not mount, or otherwise attach, any devices or accessories to the shelf. The shelf is for storage of lightweight items only.

Do not allow stored items to extend beyond the edge of the shelf.

To mount the shelf to the base:

Loosen the handle screws on the collars of both of the poles. Remove the inner section of the telescoping pole. Remove both of the collars. If the desired position of the shelf is below the horizontal crossbar, loosen the handle screws on both of the crossbar ﬁttings. Remove the crossbar and ﬁtting by sliding up off the poles. Use a 3/16 in. ball driver (provided with Accessory Kit) to loosen the end caps of the shelf. Position the shelf between the poles by lowering it from the top of the poles to the desired height. Make sure the shelf is level. Tighten the shelf end caps using the 3/16 in. ball driver. Reinstall crossbar (if removed) and tighten handle screws. Reinstall the collars taking care that the handle screws extend through the holes at the top of the vertical poles. Reinsert the inner section of the telescoping pole using the collar handle screws to adjust the desired height. Make sure all ﬁttings are tight and secure.

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The instrument tray in front of the pump platform provides storage space for items up to a maximum of 10 pounds (4,5 kg).

There are dedicated brackets for many of the components used with the Terumo® Advanced Perfusion System 1. Refer to speciﬁc chapters for instructions on how to attach pole mount brackets for: roller pumps, centrifugal control units, ﬂowmeter modules, occluder head, and the Central Control Monitor (CCM).

Loading Zones

To prevent tipping, only transport the system in the lengthwise direction. Do not transport the system up or down an incline greater than 10 degrees. Do not hang more than 10 lbs. (4,5 kg) total from the hooks on each telescoping pole. A minimum of two roller pumps must be placed on the system base pump platform. Distribute the weight of additional system components and accessories according to the following ﬁgures and instructions.

The System 1 Base includes four poles for mounting equipment and a pole-mounted shelf for holding loose items. When mounting equipment, it is important not to overload the system or to concentrate the weight where it could cause the system to tip. The mounting area is divided into six zones, with limits on the amount of that weight can be mounted in each zone. The table below shows the limits for each zone. The drawings below show the location of each zone. Some of the zones overlap (e.g., zones A and E). If you mount equipment in the overlap area, its weight counts against the limits for both zones (i.e., it is double counted). To help you calculate the loads, the table after the drawings shows the weight of various pieces of equipment. Some points to keep in mind:

• For stability, place at least two roller pumps on the base

• For calculating load, the center of the weight of the equipment determines which zone it is in, regardless of which pole the equipment is mounted on

• Area D is for the CCM only

• The load in Area C includes both equipment mounted in the area and the weight of anything placed on the shelf. The weight of the shelf is not included.

• The weight of ﬂuids contained in the equipment (e.g., a reservoir) must be included in the load calculations

Zone Weight

A 90 lbs. 40,8 kg

B 90 lbs. 40,8 kg

C 50 lbs. 22,7 kg

D CCM and Mounting Arm

E 90 lbs. 40,8 kg

F 90 lbs. 40,8 kg

Note: The dimensions noted in the following graphics refer to inches and (meters).

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29.5 in.

29.5 In.

(0,75 m)

(0.75 m)

67.5 in.

67.5 In.

(1,71 m)

(1.71 m)

29.5 In.

29.5 in.

(0,75 m)

(0.75 m)

33.5 in.

33.5 In.

(0,85 m)

(0.85 m)

2 PUMPS MINIMUM

9.5 in.

9.5 In.

(0,24 m)

(0.24 m)

(0,24 m)

(0.24 m)

Front View of System Showing Loading Zones

29.5 In.

29.5 in.

(0.75 m)

(0,75 m)

9.5 in.

9.5 In.

29.5 In.

29.5 in.

(0.75 m)

(0,75 m)

Side View of System Showing Loading Zone

3-15

34.9 in.

34.9 In.

(0,89 m)

(0.89 m)

Page 55

System Base

9.5 in.

9.5 In.

(0,24 m)

(0.24 m)

9.5 in.

9.5 In.

(0,24 m)

(0.24 m)

29.5 In.

29.5 in.

(0.75 m)

(0,75 m)

Transport Direction

A B

Top View of System Showing Loading Zones

Weights of various system components are given in the table below.

Component Weight

Central Control Monitor and mounting arm 26 lbs. (11,8 kg)

Roller Pump, 4 in. 23.5 lbs. (10,7 kg)

Roller Pump, 6 in. 28.5 lbs. (12,9 kg)

Centrifugal Control Unit 2.4 lbs. (1,1 kg)

Centrifugal Drive Motor 3.2 lbs. (1,5 kg)

Manual Drive Unit 5.1 lbs. (2,3 kg)

Lamp, 33 inch (83,8 cm) 3.1 lbs. (1,4 kg)

Lamp, 15 inch (38,1 cm) 2.2 lbs. (1 kg)

Occluder head 4.2 lbs. (1,9 kg)

Air Sensor 0.48 lbs. (0,22 kg)

Flowmeter Module 1 lb. (0,5 kg)

Roller Pump Pole Mount 3.6 lbs. (1,6 kg)

Dual Pumps Pole Mount 5.7 lbs. (2,6 kg)

Descending Pump Bracket 5.5 lbs. (2,5 kg)

Centrifugal Unit Pole Mount 1.4 lbs. (0,6 kg)

Shelf 7 lbs. (3,2 kg)

Flexible Mounting Arm 3.5 lbs. (1,6 kg)

Flowmeter Mounting Bracket 0.6 lbs. (0,27 kg)

Hand Crank Bracket and two Hand Cranks 1.7 lbs. (0,8 kg)

29.5 in.

29.5 In.

(0,75 m)

(0.75 m)

3-16

Page 56

System Base

Module Bracket System

Each module receptacle is surrounded by a rectangular shaped bracket that is mounted on the side of the base. This bracket, along with a crossbar, holds the modules in place.

To Insert or Remove Module:

1. Pull crossbar down.

2. Insert or remove module

from receptacle.

3. Release crossbar

Bracket

Crossbar

Pump Platform

The pump platform is designed to provide adaptable mounting combinations of roller pumps onto the system base. The platform consists of a rail, adjustable endcaps, and extensions that are used in conjunction with the endcaps.

The chart below represents the placement of roller pumps on the platform. L indicates a large roller pump, S indicates a small roller pump. Other roller pump combinations require the use of a pole mount bracket.

Based on the chart, determine the size extension that is required for the pump combination to be used. Extensions are located in the accessories kit.

No Extension Small Extension Large Extension

L S S S S S L S S L L

S S L L S S S S L S L

L S L L S S L L S L S

S L S S S L S L L S S

S L L S L S S L S L L

L L S S S S S L L S L

L L L S L L S

S S S

3-17

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System Base

To Install or Remove Extensions:

1. Remove cable cover.

2. Remove pumps.

3. Remove module cover.

4. Loosen set screws on each side of the base. Some modules may need to be

removed to access the set screws.

5. Slide endcaps out.

Set Screws

6. Insert or remove the extension.

• If removing extensions, remove securing screws and remove extension.

• If adding extension, insert extension and install securing screws.

Securing Screws

7. Push the end caps in until they stop.

8. Tighten set screws. Set screws must be securely tightened to ensure pump

stability during operation.

9. Install pumps according to the instructions in Roller Pump chapter.

10. Install module covers and cable cover according to the instructions at the end of

this chapter.

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Page 58

System Base

Lamp

The system lamp is an optional item. The lamp mounts to any of the system poles. It connects to the system base for power and uses a 20 watt, 24 volt halogen bulb. The lamp has a ﬂexible shaft for easy positioning.

CAUTION: The lamp may get hot when powered on for extended durations. Do not allow the lamp housing to touch the patient, user, perfusion circuit or other equipment

To Mount a Lamp to the System Base:

1. Mount lamp bracket to pole.

2. Plug lamp into base receptacle.

3. Turn lamp On.

4. Position as needed.

The front portion of the lamp bracket and the front portion of the hand crank bracket can be coupled into one system to reduce the number of brackets attached to the poles.

On Switch

To base connector

Hand Cranks

Hand cranks should be positioned for easy access during emergency conditions.

To Mount the Hand Cranks to a Pole:

1. Mount hand crank bracket to pole.

2. Place hand cranks in the bracket slots.

3-19

Page 59

System Base

WARNING: Hand cranks must be properly setup to allow hand cranking in the same direction as that selected for forward ﬂow for the roller pump.

WARNING: All roller pumps used in a hospital must be set to run in the same default direction for forward ﬂow to prevent unintended retrograde pumping. RETROGRADE PUMPING MAY CAUSE SEVERE PATIENT INJURY OR DEATH.

To Change Hand Crank Direction:

1. Remove screw and cap from the hand crank arm.

2. Remove shaft from the hand crank arm by sliding the shaft out of the bearing.

3. Insert the shaft into the bearing on the opposite side of the hand crank arm.

4. Reinstall the cap and screw and tighten screw.

5. Loosen the setscrew and remove the handle screw and remove the handle.

6. Insert handle into opposite side of hand crank and tighten setscrew and handle

screw.

Handle Screw

Cap and Screw

Handle

Hand Crank Arm

Shaft

Set Screw

Test Before Use

Test hand crank to ensure it rotates the pump rollers in the direction of forward ﬂow. If the pump is difﬁcult to turn, unplug the pump cable either at the system connection or at the pump. Reconnect the cable after test. Verify that the hand crank turns freely without moving the pump rollers when it is rotated in the opposite direction of forward ﬂow.

Ensure that the hand crank can be used properly without interference from pole mounted pumps.

Cable Management

The base provides a cable management system that uses a series of cable clips attached to the pump platform and cable management tray.

There are 3 clips on each side of the base and 5 clips on the back of the system.

To Arrange Cables:

1. Push the cable into individual clips and route cable toward the cable access area

of the module cover.

3-20

Page 60

System Base

2. For pump cables, route cable through the clips and attach to the pump.

3. For modules, the cable exits at the access area. Route to the appropriate

location.

4. Install module and cable covers.

Access Area

Module Covers

The module covers are located on each side of the base and provide protection from liquid spills. Users may view modules through the cover if required.

To Remove Module Cover:

1. Grasp the module cover handle.

2. Pull toward the front of the base.

To Replace Module Cover:

1. Align the cover on the slide rail.

2. Push into place.

Handle

Cable Cover

The cable cover is mounted on the back of the system base and provides protection from spills.

To Install Cover:

1. Slide front part of cover under roller pumps on the base.

2. Align the latches with the holes in the pole retaining brackets and insert the

latches through the holes.

3. Push the latch lever down to close each latch and secure the cable cover to the

base.

3-21

Page 61

System Base



To Remove Cover:

1. Pull up the latch lever to open each latch.

2. Lift the cover off the base and out from under the roller pumps.

Front

Latch

Cable Cover (for the Terumo® Advanced Perfusion System 1, 801763 and 801764, with serial numbers less than 1000)

To Install Cover:

1. Slide front part of cover under roller pumps on the base.

2. Place cover over rear cable management tray.

3. Apply pressure to the outer edges of the front of the tray until tabs snap into

place over the cable management tray.

4. Apply pressure to the rear of the tray to lock the cable cover into the snaps.

To Remove Cover:

1. Grasp the outer edges of the side of the cover ﬁrmly and lift.

Front

Tabs

Snaps



3-22

Page 62

Central Control Monitor

Features

The Central Control Monitor (CCM) combines an embedded computer, a touch screen, and a graphical user interface (GUI) to provide a centralized display of system information and on-screen control of all system devices. The CCM is used to create perfusion screens including selecting the number and types of devices and sensors, selecting device names and colors, assigning Perfusion Screen representations to physical modules, connecting devices to safety systems, and selecting alert and alarm limits and device responses. During use, the CCM monitors the system for alert, alarm, error, or status messages and displays the highest priority message in a dedicated message area. The CCM also allows the user to initiate automatic control functionality such as Pulse mode ﬂow, servo regulation to pressure and ﬂow, and automatic cardioplegia time or volume delivery.

A cover protects the CCM when the system is not in use. The cover must be removed and properly stored before the system is powered on.

PC Card Slot

Touch Screen

CAUTION: The computer touch screen is designed to be a single point control system. Use only one ﬁnger when operating the screen. Ensure that there is no additional contact with the touch screen during operation as unintended input may result.

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Central Control Monitor

Connect CCM

CAUTION: Use care when handling the Central Control Monitor as the controls, displays, or circuitry may be damaged if the display is dropped, struck, or immersed in liquid.

CAUTION: Pump control panels and Central Control Monitor are intended for hand and gloved hand operation only. Do not use any instruments on the pump control panels or Central Control Monitor as this may damage the device.

Attach the CCM bracket to a system pole that will provide easy viewing and access to the CCM while running a perfusion case.

Make sure AC (Mains) power is OFF before connecting or disconnecting the CCM.

Attach the CCM power cable to one of the receptacles located on the left or right side of the base, being careful not to damage the connector pins.

CCM Bracket

CCM Power Cable

Before use, check that the CCM is within reach and positioned for maximum visibility. The display should be positioned within a viewing angle of ± 45° horizontal and ± 30° vertical; exceeding these viewing angles will decrease the contrast of various colors.

When power to System 1 is turned on, the CCM, the entire system, and attached modules perform self tests.

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Central Control Monitor

Start-Up Messages

If the Power On Self Test fails, the results are displayed continuously at the top of the Main Screen as long as the Main Screen is displayed or the condition exists. The failure message is displayed in the following format:

<Module Type Name>: X “Fail”, where X is the number of modules of this type that failed their Power-On Self-Test.

A maximum of 8 failure messages can be displayed simultaneously. Possible messages are as follows:

“System Power” “Temperature Sensors” “System Computer” “Gas System” “System Network” “CDI 100” “Air Detectors” “CDI 500” “Level Detectors” “Large Roller Pumps” “Occluders” “Small Roller Pumps” “Pressure Sensors” “Centrifugal Pumps” “Flow Sensors” “Data Transfer”

The roller pump default direction is set to the system direction during start-up. For more information on setting system direction, see Conﬁguration, System Settings in this chapter.

In the event of a System Power, System Computer, System Network, or Gas System start-up failure, cycle power by turning the Mains Power off and then back on. If the message is still displayed, contact Terumo Customer Service.

For a roller pump, centrifugal pump, or ﬂow module start-up failure, disconnect and then reconnect the cable from the back of the pump or module. If the message appears again, follow the module reassign procedure in this chapter, System tab, Reassign Module subtab, and contact Terumo Customer Service.

For all other start-up failure messages, disconnect and then reconnect the module to the module receptacle. If the message appears again, follow the module reassign procedure in this chapter, System tab, Reassign Module subtab, and contact Terumo Customer Service.

In the event of a CCM start-up failure, the CCM may lose communication capability with the system. The message “No System Computer” will be displayed on the control panels of the roller pumps and centrifugal control unit and the message “System Computer Needs Service” may appear on the CCM.

4-3

Page 65

Central Control Monitor

PC Card Compartment

The CCM holds two PC cards: a system conﬁguration card and a service data card.

The system conﬁguration card is used to backup Perfusion Screens and can also be used to transfer Perfusion Screens between systems and upgrade the CCM and module software.

The service data card collects and stores data for use by authorized service representatives.

The system conﬁguration card and service data card are not interchangeable and must be used in the appropriate slot.

To Install a PC Card:

1. Slide the door latch down to open the compartment door.

2. Insert the PC card into the appropriate slot. The release button above the card protrudes when the card is fully seated in the slot.

3. Close the compartment door.

To Remove a PC Card:

Ensure the CCM is not accessing the card before removal.

1. Slide the door latch down to open the compartment door.

2. Depress the release button.

3. Remove the card.

4. Close the compartment door.

Release Button

Service Data Card Slot (Right)

System Configuration Card Slot (Left)

Front

Door Latch

4-4

Page 66

Central Control Monitor

Functional Areas

The CCM has 3 functional areas: Perfusion, Conﬁguration, and Service.

The main screen allows access to these functional areas and provides access to initiate a controlled system shut down.

The Perfusion area allows the user to select a Perfusion Screen and run a case. In preparation to run a case, patient information can be entered, calibrations can be performed, and safety system limits can be checked, modiﬁed if needed, and activated. During use, the CCM can be used to control and monitor all system modules and devices. The CCM monitors the system for any alert, alarm, error, or status messages and displays the highest priority message in a dedicated message area. The user can also initiate advanced functionality such as primary pump Pulse mode, ﬂow and pressure servo regulation, cardioplegia volume tracking, and automatic cardioplegia time or volume delivery.

The Conﬁguration area of the CCM is used to deﬁne Perfusion Screens including number and names of modules and devices, assignment of screen icons to physical devices, safety system connections, and selection of alert and alarm limits. The displays are organized around a patient graphic representation for identiﬁcation of system data.

The Service area is password protected and allows an authorized user to:

• View system log

• Export system logs, module logs, and Perfusion Screens to an external computer via the service data card

• View module error event data

• Manage security access controls

• View system software version control area

• Upgrade CCM and/or module software

• Calibrate the touch screen.

The Shut down button provides a controlled system shut down and must be used before turning power off to the system base. Failure to follow the controlled shut down procedure may result in improper start-up at the next power-on.

4-5

Functional Areas

Page 67

Page 68

Central Control Monitor

mmHg

L/min

0.00

SAT %

HCT %

g/dL

PCO2

K+

mmHg

PO2

mmHg

mmol/L

Gas % O2

FiCO2

0.00

Displays and Controls

The Graphical User Interface has features and functions common to both of the Perfusion and Conﬁguration functional areas. The action of the button or icon on the CCM is initiated when the user lifts the ﬁnger from the touch screen.

Ensure that the touch screen cursor arrow is within the perimeter of the button when using the touch screen. If the cursor arrow is outside the perimeter of the button, the control or icon will not be activated.

Device Icons and Displays

Icon/Display Device Action when Pressed

Air Detector Opens Air subtab in perfusion screen or selects the device in configuration.

Level Detector Opens Level subtab in perfusion screen or selects the device in configuration.

Pressure Sensor Opens Pressures subtab in perfusion screen or selects the device in configuration.

Temperature Sensor Opens Temp subtab in perfusion screen or selects the device in configuration.

Flowmeter Opens Flow subtab in perfusion screen or selects the device in configuration.

Occluder Occluder slide bar appears if hidden, disappears if displayed in perfusion screen, or selects the device in configuration.

CDI 100/101 display No action - display only.

CDI 500 display No action - display only.

Electronic Gas When %O2 button pressed, FiO2 slide bar appears Blender if hidden, disappears if displayed.

When Gas button pressed, Gas slide bar appears if hidden, disappears if displayed.

FiCO2 display, no action, displays only if using 95/5. Broken Module Opens Reassign Module subtab. (Refer to

Emergency Procedures chapter, Network Malfunction for further information.)

Opens Reassign Module subtab. (Refer to Emergency Procedures chapter, Network Malfunction for further information.)

Noncommunicating or missing module

4-6

Page 69

Central Control Monitor

Zero

Average

300

Alert:

Or Enter New Name:

Enter New Name >

To Add Device:

Cancel

Current defined: 0

Maximum allowed:1

Air Detector

Level Detector

Select Device Type:

Occluder

Pressure Sensor

Flow Sensor

Select From List:

Temperature Sensor

CDI 100

CDI 500

Next >

Select Device Name:

Level

VENLevel

CPGLevel

LEVEL1

LEVEL2

Level Detection:

Alert/Alarm

Safety

ART Pres

Average

Air

Pressures

Zero

mmHg

Display:

300 360

Alert:

Alarm:

Level

Limits (mmHg)

16:07:51

Buttons

There are several types of buttons used throughout the Graphical User Interface screens to select and display information or to accomplish speciﬁc tasks. The Safety tab and To Add Device Screens shown below illustrate examples for a Task button, Toggle button, Display button, arrows, Mute button, and Scroll arrows.

Mute Button

Arrows

Toggle ButtonTask Button

Display Button

Scroll Arrows

Button/Display Description Action when Pressed

Task Button Action displayed on the button will be taken.

Toggle Button Each time the button is pressed, the next value from a selection list is displayed. The label that is displayed is the enabled selection.

Display Button The button background turns white and value can be adjusted using control arrows that appear on the right side of the subtab. The button should be pressed again to confirm the new value. The control arrows disappear and other buttons may be activated when the new value is confirmed.

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Page 70

Central Control Monitor

Edit Perfusion Screen Password

Ok Cancel

!1@2#3$4%5^6&7*8(9)0_-+

WERTYUIOP

Caps EnterASDF GH JKL

ZXCVBNMShift

<,>

Back Del

Button/Display Description Action when Pressed

Arrows Appear when a display button is pressed to adjust the displayed value and disappear when the new value is stored. Touching the small arrows adjusts the selected parameter in small increments; touching the large arrows adjusts the selected parameter in large increments.

Mute Button This button appears on all safety subtabs and is activated by an alert or alarm. Pressing this button while active silences the audible alert or alarm tone for that specific alert or alarm.

Scroll Arrows Enabled when all the items in a list cannot be viewed within the display area. Touching the arrows will allow additional list items to be viewed.

Close Button Use this button to close subtab screen.

Keyboard

The keyboard is used to create and edit passwords and assign names. Please note the “shift + number” characters are not active.

Passwords are used to limit access to Perfusion Screens and the Conﬁguration area. A password may contain up to 12 characters, consisting of both upper and lower case letters, numbers, and the space key.

Perfusion Screen names are used to identify speciﬁc screens and may contain up to 12 characters, consisting of both upper and lower case letters, numbers, and the space key. Perfusion Screen names must be unique.

Device names are used to identify speciﬁc devices and may contain up to 8 characters, consisting of letters both upper and lower case, numbers, and the space key. Device names must be unique within each Perfusion Screen.

Use Ok or Enter

Use Back and Del to edit input

4-8

Page 71

Central Control Monitor

Security

Password protection can be used to limit access to the Perfusion Screens and the Conﬁguration area only to authorized users. If no passwords are created, any user will be able to select any Perfusion Screen or create and modify Perfusion Screen conﬁgurations using the Conﬁguration area.

If the password security feature of the System 1 is used, Terumo Cardiovascular Systems Corporation recommends including the following elements in any current security policies and procedures:

•Deﬁnition of user levels:

- Who will have access to Perfusion Screens.

- Who will have access to Conﬁguration area.

•Deﬁnition of password characteristics:

- Length (e.g., passwords shall contain a combination of at least 6 but no more than

8 alphanumeric characters).

- Characters (e.g., at least one character shall be a number).

- Unique (e.g., each Perfusion Screen shall have a unique password, all of which

shall be different from the Conﬁguration password).

•Description of whether passwords will be changed on a regular basis.

•Identiﬁcation of the title or name of the person responsible for the creation and/or

modiﬁcation of passwords.

•Description of how passwords will be communicated to deﬁned users.

•Description of any documentation that will be maintained to demonstrate that the

security procedures are being followed.

•In multilingual settings, only use characters that are common to all keyboards.

4-9

Page 72

Central Control Monitor

Open

View Summary >

Return to Main

Name

Password:

Choose a Perfusion Screen

CABG Roller

CABG Centrif

Yes

Min AVR

Circ-ARREST

Yes

Pediatric

Perfusion Screen

The Perfusion functional area is used to select and run a perfusion case. Touch the Perfusion button to go to Choose a Perfusion Screen.

The screen lists all Perfusion Screens by name and indicates whether the screen is password protected. All screens that are password protected require the password to be entered before the screen will display graphically on the CCM.

The user has three options from this screen:

1. View a summary of a Perfusion Screen.

2. Return to the Main Screen.

3. Open a Perfusion Screen.

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Page 73

CABG ROLLER

Perfusion Screen Summary

Graphic Orientation:

Primary Pump Left - Patient Head Left

Blood Reservoir Type:

Open

Air Detectors:

ART Air

Level Detectors:

Level

Occluders:

Occluder

Pressure Sensors:

ART Pres CPG Pres

Temperature Sensors:

ART Temp VEN Temp Bladder CPG1 Temp

CDI 500:

CDI 500

Large Roller Pumps:

Arterial

Safety Connections:

esnopseRtnevEeciveD

Level Low Level AlarmStop Level Low Level AlertMessage 0nly ART Air Air Detected AlarmStop ART Pres High Presure AlarmStop ART Pres High Presure AlertMessage 0nly

CPG

Safety Connections:

esnopseRtnevEeciveD

Arterial Pump Stopped Stop Arterial Pump Paused Stop CPG Press High Pressure AlarmStop CPG Press High Pressure AlertMessage Only

Small Roller Pumps:

Vent Sucker 1 Sucker 2

Timers:

Pump Clamp TMR1

Screen Name

Central Control Monitor

View Summary

The summary screen displays information about the deﬁned conﬁguration for that Perfusion Screen. The name of the Perfusion Screen, graphic orientation, type of venous reservoir, devices included in the Perfusion Screen, and the assigned names of the devices are displayed. Also included is information about the pumps, such as type, name, and any safety connections between the pumps and the other conﬁgured devices.

To view a Perfusion Screen Summary:

1. Touch the Perfusion Screen name. The selected screen will be highlighted.

2. Touch the View Summary button to view a summary of the screen.

3. Select the Close button to return to the previous screen.

To Return to Main:

Touch the Return to Main button to return to the Main Screen.

4-11

Page 74

Central Control Monitor

Setup

Safety

CPG

Aux System

Post Case

PCO2

K+

mmHg

PO2

mmHg

mmol/L

16:07:51

Arterial

0.000

L/min

10.78

Clamp

Reset

000:00

Pump

Reset

000:00

SO2

HCT

Arterial

L/min

START

Vent

L/min

START

Sucker1

L/min

START

Sucker2

L/min

START

CPG

L/min

START

mmHg

VO2

mL/min

Gas

% O2

To Open a Perfusion Screen:

1. Touch the Perfusion Screen name. The selected screen will be highlighted.

2. Touch the Open button.

3. Enter password if the screen is password protected. The CCM will open and display the Perfusion Screen. When a Perfusion Screen is opened, the status of all devices that are a part of the Perfusion Screen will change from ofﬂine to online. Online pumps display the pump name and the LED of online modules is constant green.

Perfusion Screen

Although a Perfusion Screen can be customized to accommodate many different perfusion setups, all Perfusion Screens share some common characteristics including the patient and perfusion circuit graphics, message area, system time, power source/ battery status icon, primary pump, pump and clamp timers, pump control area, tabs, control slide bars, and device icons.

Primary Pump

A Perfusion Screen must have a primary pump, usually the arterial pump, designated in the Conﬁguration area. The controls and displays for this pump are always displayed on the right or left side of the Perfusion Screen.

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Central Control Monitor

Arterial

L/min

START

CPG

L/min

STOP

0.000

Pump Controls and Displays

Pump control boxes displayed on the lower third of the CCM can be used to start and stop pumps and to monitor current pump speed or ﬂow values. Each pump has a corresponding slide bar located either on the right or left side of the Perfusion Screen which can be used to adjust the pump speed on the CCM. Pumps can also be

controlled from their front panel controls.

Pump Control Box

All pump control boxes consist of three elements: a Start/Stop button, a speed/ﬂow display button, and a pump icon button. The only exception is a master/follower pump control box (see Roller Pumps chapter for details of a master/follower pump control box). The pump type, name, color, display units, and position are all deﬁned in the CCM Conﬁguration area.

Centrifugal Pump Icon

Pump Name

Speed/Flow Display

Roller Pump Icon

Start/Stop Buttons

Start Button or Stop Button

The Start button activates and starts the pump at a speed of 0 RPM or a ﬂow of

0.000 L/min. The Stop button stops the pump if it is running and also deactivates it. If the pump is stopped and deactivated using the Stop button, it must be reactivated using the Start button for the pump to be used again.

To start a pump:

1. Touch the Start button.

• The button color changes to red and the label changes to Stop.

• The pump speed/ﬂow display button appears.

• The pump slide bar appears on one side of the CCM (the primary pump slide bar

is always displayed).

To stop a pump:

1. Touch the Stop button.

• The button color changes to blue and the label changes to Start.

• If the pump is not the primary pump, the speed/ﬂow button and the pump slide

bar disappear.

Pump Speed/Flow Display

The current value of the pump speed or ﬂow rate is displayed in the units selected during Conﬁguration.

Touching the button on a primary pump will scroll through three possible display selections: L/min, L/min/m2, or mL/kg/min.

Note: If a centrifugal pump is not conﬁgured to display ﬂow through the use of a ﬂowmeter, the button will display dashes.

For all other pumps, the pump speed/ﬂow display button appears when the pump is started and disappears when the pump is stopped. Touching the speed/ﬂow display button will open the slide bar for that pump and close any open slide bar in the shared location.

4-13

Page 76

Central Control Monitor

Setup

Safety

CPG

Aux System

Post Case

Arterial

0.000

L/min

10.78

Occluder

100

CPG

0.000

L/min

3.92

16:07:51

Arterial

L/min

Vent

L/min

START

Sucker1

L/min

START

Sucker2

L/min

START

CPG

L/min

PCO2

K+

mmHg

PO2

mmHg

mmol/L

Clamp

Reset

000:00

Pump

Reset

000:00

SO2

HCT

mmHg

VO2

mL/min

Gas

% O2

STOP

0.000

STOP

Pump Icon

The symbol on the pump icon button indicates whether a pump is a roller or centrifugal pump. When the pump is running, the icon will spin in relation to the pump speed. The roller pump icon also reﬂects the direction of rotation. Touching the pump icon button opens the Pump tab. See the Perfusion Screen Tabs, Pumps subtab section for more details.

Device Name

Set Point Display

Display Units

Adjustment Arrow

Maximum Value

Scroll Control Minimum Value

Slide Bars

Slide bars are vertical bars located on either side of the Perfusion

Arterial

RPM

Screen that are used to control roller and centrifugal pump speeds, occluder position, total gas ﬂow rate, and the FiO2 setting. All slide bars include a device name, set point display, display

3600

units, adjustment arrows, maximum and minimum value labels, and a scroll control. The central strip and scroll control are color coded to match the device color. When operating a slide bar from a shared location, ensure that the slide bar displayed is for the device you intend to operate.

To adjust an active slide bar:

1. Touch and hold the slide bar scroll control.

2. Slide the scroll control to the desired slide bar position. The set point display should display the new setting.

3. Use the adjustment arrows to make ﬁne adjustments.

Each pump has a corresponding slide bar which is used to adjust its speed on the CCM. While in a Perfusion Screen, the primary pump slide bar is always displayed and is conﬁgured to appear on the right or left side of the Perfusion Screen. All other pumps share a slide bar location on the side opposite the primary pump slide bar.

Primary Pump Slide Bar

While in a Perfusion Screen, the primary pump slide bar is always displayed on the same side as the primary pump. All other pump slide bars appear one at a time in a single location on the side opposite the primary pump slide bar when the pump speed/ ﬂow display button is pressed.

Primary Pump Slide Bar

4-14

Page 77

Occluder

100

4:1

1:1

2:1

8:1

16:1

Cryst

4:1

FiO2

0.21

% O2

1.00

0.21

Gas

0.00

L/min

21.2

Arterial

3600

RPM

Central Control Monitor

Roller Pump Slide Bar

A roller pump slide bar includes the roller pump name, current speed or ﬂow rate, a ﬂow direction icon, a minimum value of 0 and a maximum value determined by the pump size and selected tube size. The adjustment arrows can be used to adjust the pump speed by 1 RPM. The corresponding change in ﬂow rate will depend on the pump size and selected tube size.

Centrifugal Pump Slide Bar

A centrifugal pump slide bar will include the centrifugal pump name, motor speed in RPM, minimum value of 0 and maximum of 3600 RPM. The adjustment arrows can be used to adjust the motor speed by 10 RPM.

The bold black horizontal line on the slide bar indicates 1500 RPM. At the onset of a Coast response, the centrifugal slide bar is disabled and grayed out for 2 seconds. This occurs even if the Coast response does not include a speed change.

Note: Using the centrifugal pump slide bar to reduce the pump speed to 0 RPM will stop and deactivate the pump. Restarting the pump will required touching start. This is different than the roller pump behavior which does not stop and deactivate at 0 RPM.

Electronic Gas Blender Slide Bars

Two slide bars are associated with the electronic gas blender: gas ﬂow and FiO2. The slide bars share one location with the occluder slide bar. They appear one at a time, adjacent to the primary pump slide bar when either the gas ﬂow or the FiO2 icons is pressed.

The gas ﬂow slide bar displays the name Gas and the set point ﬂow rate in L/min. The minimum value is 0 and the maximum is 10 L/min. The adjustment arrows can be used to adjust the ﬂow rate by 0.1 L/ min.

The FiO2 slide bar displays the name FiO2, the FiO2 setpoint and the %O2 value from the oxygen analyzer, and the current FiO2 setting. When the blending gas is air, the minimum value is 0.21 and the maximum value is 1.00. When the blending gas is 95-5, the minimum value is 0.95 and the maximum is 1.00.

Occluder Slide Bar

The occluder slide bar appears adjacent to the primary pump slide bar and shares its location with the gas ﬂow and FiO2 slide bars. The occluder slide bar will appear when the occluder icon is pressed.

The occluder requires an initial calibration. If the calibration has not been performed, “CAL” will be displayed at the top of the slide bar and on the button at the bottom of the slide bar. To calibrate the occluder, touch the CAL button.

The calibrated occluder slide bar includes the occluder name, occluder symbol, current value in % open, a full close button, and a full open button. The minimum value is 0 and the maximum value is 100% open. The adjustment arrows can be used to change the % open by 1%.

Centrifugal Pump Slide Bar

Bold line indicates 1500 RPM

Electronic Gas Blender Slide Bars

Full Open

Follower Slide Bar

The follower slide bar includes the pump name, the current % of master ﬂow, and adjustment arrows. The minimum value is 0% and maximum value is 1:1 or 100%.

4-15

Occluder Slide Bar

Full Close

Follower Slide Bar

Page 78

Central Control Monitor

Displays

The information displayed in the top portion of the Perfusion Screen appears in all Perfusion Screens. This includes the Mute All button, Message area, Time Display, and the Power Source/Battery Status icon.

Mute All

All active alert and alarm tones are silenced when the Mute All button is touched with the exception of the battery alert tone.

Note: The unique, repeating, audible battery alert tone which indicates that the system is operating from battery power, cannot be muted.

Message Area and Priorities

The message area in the top part of the Perfusion Screen displays the highest priority alarm, alert, status, or error message. If two conditions of equal priority exist at the same time, the condition that was detected ﬁrst will be displayed on the screen. All messages will post in the Messages subtab within the Aux tab.

In general, the order in which messages are displayed in the Perfusion Screen message area is determined ﬁrst by the type of message, then by the order in which the Central Control Monitor receives the message. Messages are prioritized in order of importance as:

• Alarms – Flash red

• Alerts – Flash yellow

• Error messages – Flash white

• Status messages – White

If two conditions of equal priority exist at the same time, the message for the condition that occurred ﬁrst will be displayed in the message area until it clears. If the second condition still exists after the ﬁrst has been cleared, then that message will be displayed.

For example, if a pressure alert condition is detected and no alarm or other alert conditions exist, the pressure icon ﬂashes yellow, an audible alert tone sounds, the Pressures subtab within the Safety tab opens, and the message “<Pressure Name>: CHECK PRESSURE” is displayed in the message area. If a level alert condition now occurs, the level icon will ﬂash yellow, the alert tone will sound, but the level alert message is not displayed in the message area until the pressure alert condition clears.

Status messages post only once. If the message area has a higher priority message, the status message will post only in the Messages subtab within the Aux tab.

At any time during the case, the user can view all messages by pressing the Aux tab and opening the Messages subtab. This subtab displays all system messages along with the time the message was generated. See the CCM Aux Tab section for further details.

System Time

The time of day is displayed on the upper right side of the Perfusion Screen. See the Setup Tab, Time/Date subtab section in this chapter for details on modifying the time of day.

Power Source/Battery Status Icon

The Power Source/Battery Status icon on the upper right of the Perfusion Screen provides the user with:

• Power Source – AC or On Battery

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Page 79

Central Control Monitor

Setup

Safety

CPG

Aux System

Post Case

Clamp

Reset

000:00

Pump

Reset

000:00

53 min

• Estimated battery time remaining in minutes displayed above the Power Source/Battery Status icon when on battery. An AC (Mains) Power Indicator is shown over the Battery Status icon when on AC (Mains) Power.

• Estimated battery time remaining as indicated by icon color:

• When on AC (Mains) Power:

• Steady green indicates a battery system with greater than one hour run time with a fully loaded system

• Steady red indicates a battery system with less than one hour run time with a fully loaded system.

AC (Mains) Power

WARNING: If the Battery Capacity is indicated at less than 60 minutes battery power, do not start a case. If the system should be fully charged, but the Battery Capacity indicates less than 60 minutes, call Terumo Customer Service. Do not use the system until it has been serviced.

• When on Battery Power:

• Flashing green indicates 30 minutes or more battery life at present discharge rate

• Flashing yellow indicates 15 minutes or more, but less than 30 minutes battery life at present discharge rate

• Flashing red indicates less than 15 minutes battery life at present discharge rate

On Battery Indicator

Indicator

Pump and Clamp Timers

A pump and clamp timer are always available on the Perfusion Screen. A Perfusion Screen can be conﬁgured to include up to 2 additional timers, for a maximum of 4 timers. The additional timers can be conﬁgured to count up from zero or to count down from a chosen value. Count up timers have a range from 00:00 to 990:59; count down timers have a range from 990:59 to 00:00. The pump and clamp timer can only be used in count up mode.

Time Display Area

To operate a timer:

1. Start the timer by touching the Time Display area. The timer starts counting in minutes and seconds. The start time appears below the Time Display area.

2. To stop the timer, touch the Time Display area again. The stop time appears to the right of the start time. The Reset button is activated.

3. To restart the timer, touch the Time Display area again. The timer continues counting from the current value. The stop time disappears.

4. To reset a count up timer to 0 or a count down timer to its initial value, touch the Reset button. The start and stop times disappear.

Perfusion Screen Tabs

The area of the Perfusion Screen below the pump control boxes displays the 6 Perfusion Screen tabs: Setup, Safety, CPG, Aux, System, and Post Case. An additional tab, the Pump tab, is accessed by touching the pump icon. Pressing any one of these opens a screen. Each screen may contain a number of subtabs, which open additional screens that allow access to more information and functions for individual sensors and devices.

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Central Control Monitor

Setup

Gas

16:07:51

Occluders

Time/Date

Timers

Pumps

Patient

Setup

Gas

16:07:51

Height

Occluders

Patient

Time/Date

Timers

Pumps

Dubois

Body

Surface Area

Weight

Blood Volume:

Perfusion Screen Tabs

Setup Tab

The Setup tab contains six subtabs, which allow the user to enter patient data, control various functions of the gas system, pumps, occluders, and timers, as well as setting the system time and date.

Subtabs

Patient Subtab

Patient height and weight are entered during the case setup and the patient’s body surface area and blood volumes are calculated automatically. The patient data is retained for the current case only and is reset each time a Perfusion Screen is opened.

Arrows

Choices are: Dubois Boyd Pediatric

To Adjust the Height:

1. Touch the Height button. The Height button changes to white.

2. Use the arrows to enter patient height in cm. The large and small arrows initially adjust the value to 30 cm. Subsequent adjustments are 20 cm for the large arrows and 1 cm for the small arrows. The maximum height is 250 cm.

3. Touch the Height button again to store the new value.

To Adjust the Weight:

1. Touch the Weight button. The Height button changes to white.

2. Use the arrows to enter patient weight in kg. The large arrows adjust the value by 2 kg up to 20 kg, then adjust the value by 20 kg increments. The small arrows

value. The maximum weight is 300 kg.

adjust the value by 0.1 kg or 1 kg and correspond to the large arrow increment

3. Touch the Weight button again to store the new value.

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Central Control Monitor

Body Surface Area (BSA)

The BSA is calculated automatically when the height and weight data are entered.

Touch the Body Surface Area button to toggle through the selection for the formula used to calculated the BSA. BSA can be calculated using the Dubois, Boyd, or Pediatric formulas.

The Dubois formula is BSA = (Height)

.725

The Boyd formula is BSA = 3.207 (Height)

x (Weight)

0.3

x (Weight x 1000)

.425

x 0.007184.

(0.7285 – 0.0188 Log (Weight x 1000))

10000

The Pediatric formula is BSA = (Wt

.5378

x Ht

.3964

) x 0.024265.

Blood Volume

The Blood Volume is automatically calculated using the patient weight information and is displayed in milliliters. If the patient weight is greater than or equal to 20 kg, the formula used is 70 mL x Wt (kg). If patient weight is greater than or equal to 10 kg and less than 20 kg, the formula is 75 mL x Wt (kg). If the patient weight is less than 10 kg, the formula is 80 mL x Wt (kg).

Gas Subtab

From the Gas subtab, the user selects the type of gas to blend with O2, sets the low FiO2 alarm and calibrates the oxygen analyzer. See the Electronic Gas Blender chapter for detailed information about connecting and operating the gas blender.

Choices are:

Air

95/5

Setup

Patient

Gas

Pumps

Occluders

Timers

Time/Date

02 Blend:

Low FiO2 Alarm:

Air

O2 Analyzer:

Calibration Status:

Not Calibrated

16:07:51

Calibrate

To Select O2 Blend:

Touch the O2 Blend button to toggle between Air and 95/5. The O2 blend selected (95/5 or Air) will be displayed within the button.

To Set Low FiO2 Alarm:

1. Touch the Low FiO2 Alarm button. The button changes to white.

2. Use the arrows to change the alarm limit. The large arrows adjust the FiO2 limit by increments of 0.5 and small arrows adjust the limit by increments of 0.1.

3. Touch the Low FiO2 Alarm button again to store the new value.

Note: The low FiO2 Alarm is retained for the current case only and is reset each time a Perfusion Screen is loaded.

With air selected as the O2 blend, the Low FiO2 Alarm defaults to “---” and has a range of 0.21 - 0.99. With 95-5 selected as the O2 blend, the Low FiO2 Alarm defaults to “---” and has a range of 0.95 – 0.99. Asterisks are displayed and the alarm is disabled if the alarm limit is set lower than the default value.

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Page 82

Setup

Gas

Display Units:

Occluders

Patient

Time/Date

Timers

Pumps

Pump Response:

Events

Pump:

Arterial

Type: Large Roller Pump

Tube Size:

Custom

S4:1

S8:1

ART Pres Pres Alert Reduce Speed : 300 mmHg

ART Pres Pres Alarm Stop : 360 mmHg

ART Flow Back Flow

Stop

ART Pres Pres Alarm

Stop

16:07:51

FC144

Flow Constant

L/min

Tube Size Box

1/8 in. 3/16 in. 1/4 in. 5/16 in. 3/8 in. 7/16 in. 1/2 in.

6mm 8mm 10mm 12mm

Central Control Monitor

To Calibrate O2 Analyzer:

Touch the Calibrate button.

• Calibration takes approximately 2 minutes.

• “Calibrating O2 analyzer” is displayed during calibration.

When the calibration is complete, the message “O2 Analyzer Calibration Complete” will display in the Messages subtab within the Aux tab and in the message area of the CCM if there are no higher priority messages.

Pumps Subtab

The Pumps subtab allows the user to change the roller pump display units, tube size, and pump response to a safety event. The Pumps subtab also allows the user to change centrifugal pump display units, pump response to a safety event, and set the minimum ﬂow alarm. See the Roller Pumps or Centrifugal Control Unit chapter for detailed information about connecting and operating pumps.

For Roller Pumps

Touch the Pump button until the correct name is displayed on the button. The roller pump must be in Stop mode to change the display units and the tube size.

Pump Button

S1:1 S2:1 S4:1 S8:1 Custom

Display Units Button

• L/min

• RPM

• L/min/m

• mL/kg/min

Only 3 events can be viewed at one time. Use scroll arrows to view other conﬁgured events and pump response.

}

Primary Pump Only

To Change Display Units:

Touch the Display Units button to toggle through the selections. Stop when the desired selection is displayed. Changes are only retained for the current case.

To Change Tube Size:

1. Use the scroll arrows to view the list of available sizes.

2. Touch the correct tube size from the list. The tube size selection is highlighted

The system will retain this selection until a new selection is made from this

Device Name and Event

Response

Response Selection Button

and the tube size will display above the selection box and on the roller pump local display.

To enter a custom tube size:

1. Select Custom from the list.

2. Touch the Flow Constant button.

3. Use arrows to adjust value.

4. Touch button again to retain the value.

screen or from the pump local display.

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Page 83

Central Control Monitor

Only 3 events can be viewed at

one time. Use scroll arrows to

view other configured events

and pump response.

and Event

To Change Pump Response:

The bottom portion of the screen displays the conﬁgured safety connections and gives the user the ability to edit them for the current case only.

1. Select the event/pump response to be changed. The Response button at the bottom of the screen displays the current pump response.

2. Touch the Response button to toggle through the list of available response choices. The response that is displayed on the button is the response of the pump for the speciﬁed event.

Changes made to pump response from the Perfusion Screen are only retained for the current case. The response will revert to the response set in Conﬁguration when the case is exited.

For Centrifugal Pumps

Touch the Pump button until the correct name is displayed on the button. Changes can be made while the pump is operating.

Setup

Patient

Gas

Pumps

Occluders

Timers

Time/Date

Pump:

Display Units:

Events

Level Level Alarm Stop

Level Level Alert Message Only

ART Air Air Alarm

Level Level Alarm

Device Name

L/min

Arterial

Min Flow Alarm

(L/min):

Pump Response:

Stop

Response

Type:

Centrifugal Pump

1.0

Stop

Response Button

16:07:51

Change Display Units:

Touch the Display Units button to toggle through the choices. Stop when the desired selection is displayed. Changes are retained for the current case only.

Pump Button

Display Units Button

Primary Pump only with a configured

flowmeter

• RPM

• L/min

• L/min/m

{

• mL/kg/min

Set Min Flow Alarm:

The Min Flow Alarm button is only available when a ﬂowmeter has been placed on the centrifugal pump icon. The range for the Min ﬂow alarm is 0.0 to 8.0 L/min.

1. Touch the Min Flow Alarm button.

2. Use the arrows to adjust the minimum ﬂow value. The large arrows adjust the value by 1 L/min and the small arrows adjust the value by 0.1 L/min.

3. Touch the Min Flow Alarm button again to store the new value.

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Central Control Monitor

Setup

Gas

Occluders

Patient

Time/Date

Timers

Pumps

Arterial Pump Stop

Events

Occluder:

Occluder

Full Close

3/8 in.

Arterial Pump Start Full Open

Arterial Pump Stop Full Close

Arterial Pump Pause

Full Close

Occluder Response:

16:07:51

To Change Pump Response:

The bottom portion of the screen displays the conﬁgured safety connections and gives the user the ability to change them for the current case.

1. Select the event/pump response to be changed. The Response button at the bottom of the screen displays the current pump response.

2. Touch the Response button to toggle through the list of available response choices. The response that is displayed on the button is the response of the pump for the speciﬁed event.

Changes made to pump responses from the Perfusion Screen are only retained for the current case. The response will revert to the response set in Conﬁguration when the case is exited.

Occluders Subtab

From this subtab, the user can change an occluder response to an external event generated by the primary pump. The name of the occluder will be displayed on the Occluder button.

Occluder responses to the following centrifugal pump events must be the same: pump stop, pump Coast, and minimum ﬂow. The system will automatically assign the response chosen for stop, Coast, or minimum ﬂow to the other two events.

To Change Occluder Response:

1. Select the event/response to be changed. The Response button at the bottom of the screen displays the current occluder response.

2. Touch the Response button to toggle through the list of available response choices. Occluder response choices include No Response, Full Open, Full Close, or Go to % Flow. The response that is displayed on the button is the response of the occluder for the speciﬁed event. If Go to % Flow is a response that is selected, touch the 0% button. Use the arrows to adjust the value. Large arrows adjust the value by 10% and small arrows adjust the value by 1%.

Changes made to a safety response from the Perfusion Screen are only retained for the current case. The response will revert to the response set in Conﬁguration when the case is exited.

Response Button

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Page 85

Central Control Monitor

Setup

Gas

Timer:

Occluders

Patient

Time/Date

Timers

Pumps

Type:

Clamp

16:07:51

Count Up

Setup

Gas

Timer:

Occluders

Patient

Time/Date

Timers

Pumps

Type:

TMR1

010:00

Start Value:

16:07:51

Count Down

Timers Subtab

From this subtab, the user can check the mode of a timer. The Pump and Clamp timers are controlled from the Perfusion Screen. Other timers are controlled from the Timers subtab within the Aux tab.

For Count Up Mode:

The timer is ready for use.

For Count Down Mode:

Timer Button

Type Button

Start Value Button

1. Touch the Start Value button.

2. Use the arrows to set the start value. The large arrows adjust the value by 1 minute, the small arrows adjust the value by 1 second. The maximum value that can be entered is 990:59.

3. Touch the Start Value button to store the value.

4-23

+ 1 min

+ 1 sec

– 1 sec

– 1 min

Page 86

Central Control Monitor

Setup

Gas

16:07:51

Time:

Occluders

Patient

Time/Date

Timers

Pumps

Day

Year

09:58

01 29 2002

Month

Date:

Time/Date Subtab

The time is displayed in the upper right corner of the Perfusion Screen. The date appears in various locations throughout the Perfusion, Conﬁguration, and Service functional areas. Both the time and date are set from the Time/Date subtab. Please note that all pumps and timers must be stopped in order to change the time and/or date.

To Change the Time:

1. Touch the Time button. The button will turn white.

2. Use the large arrows to adjust the hour and the small arrows to adjust the minutes.

3. Touch the button again to store the new value.

To Change the Date:

1. Touch the Month button. The button will turn white.

2. Use the arrows to adjust the value. The large arrows adjust the value by 3 and the small arrows adjust the value by 1.

3. Touch the button again to store the new value.

4. Touch the Day button. The button will turn white.

5. Use the arrows to adjust the value. The large arrows adjust the value by 5 and the small arrows adjust the value by 1.

6. Touch the button again to store the new value.

7. Touch the Year button. The button will turn white.

8. Use the arrows to adjust the value. The large arrows adjust the value by 5 and the small arrows adjust the value by 1.

9. Touch the button again to store the new value.

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Page 87

Central Control Monitor

Safety

ART Air

Reset

Air

Pressures

Off

16:07:51

Level

CPG

Auto Dose

Setup

Delivery

Time Since Last Delivery:

000:00

Current Delivery:

0mL

Deliver:

Recirculate:

Total Delivery:

16:07:51

Safety Tab

There are 5 subtabs within the Safety tab: Air, Level, Pressure, Temperature, and Flow. If a device type was not conﬁgured for the Perfusion Screen, the name on the subtab for that type of module cannot be selected. Use the Previous or Next buttons to scroll through the subtabs.

Access an area by touching the subtab or by touching the device icon on the Perfusion Screen.

If more than one sensor for a device type is assigned to a Perfusion Screen, toggle through the sensor names by touching the button.

A Mute button appears in all the Safety subtabs. The Mute button becomes available when the selected safety device has an active alarm or alert and will silence the audible tone when pressed. If there is no active alarm or alert, the Mute button is unavailable.

Touch the Mute Button to silence an active alert or alarm

For detailed information about operating safety systems from the CCM, see the module chapters:

• Air Bubble Detection

• Level Monitoring

• Pressure Monitoring

• Temperature Monitoring

• Flow Monitoring

CPG Tab

If a pump was identiﬁed as the cardioplegia pump during perfusion screen conﬁguration, this tab can be used to track cardioplegia volume delivery and can be set up to deliver up to three separate cardioplegia doses based on delivery volume or delivery time.

Delivery Subtab

The Delivery subtab calculates the current and total accumulated volume delivered by the cardioplegia pump, based on the pump speed and tube size. A timer displays the time since last delivery between cardioplegia doses. The Deliver and Recirculate mode buttons enable and disable the cardioplegia volume tracking.

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Page 88

Central Control Monitor

CPG

Aux System

Post Case

001:18

CPG

Auto Dose

Setup

Delivery

Time Since Last Delivery:

000:00

Current Delivery:

0 mL

Deliver:

Recirculate:

Total Delivery:

16:07:51

CPG

Auto Dose

Setup

Delivery

Time Since Last Delivery:

001:18

Current Delivery:

1000

1000 mL

Deliver:

Recirculate:

Total Delivery:

16:07:51

CPG

Auto Dose

Setup

Delivery

Time Since Last Delivery:

001:18

Current Delivery:

1000

1000 mL

Deliver:

Recirculate:

Total Delivery:

16:07:51

Deliver Mode To start tracking cardioplegia delivery:

1. Select Deliver mode by pressing the Deliver button.

2. Start the cardioplegia pump. The cardioplegia pump must be in L/min mode for total ﬂow rate to be displayed on the CCM and pump local display.

• The system tracks and displays the volume for Current Delivery and Total Delivery.

• The Total Delivery value is grayed out indicating that it cannot be modiﬁed.

To stop cardioplegia delivery:

1. Touch the cardioplegia pump Stop button.

• Volume tracking stops.

• Time Since Last Delivery is set to 0 and the timer starts counting the time since last delivery.

• If the subtab is closed while the timer is active, the time since last delivery is displayed on the CPG tab on the CCM.

• The Total Delivery value is displayed in black indicating that it can be modiﬁed.

To modify the Total Delivery volume:

1. Touch the Total Delivery button. The button background turns white.

2. Use the arrows to adjust the total volume. The small arrows change the volume by 10 mL, the large arrows change the volume by 100 mL.

3. Touch the Total Delivery button again to store the new Total Delivery value.

• The adjustment arrows disappear and the Total Delivery button background turns gray.

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Page 89

Central Control Monitor

CPG

Auto Dose

Setup

Delivery

Time Since Last Delivery:

2:10

Current Delivery:

401

1401 mL

Deliver:

Recirculate:

Total Delivery:

16:07:51

Resume cardioplegia delivery:

1. Restart the cardioplegia pump.

• The Time Since Last Delivery timer stops.

• The Current Delivery value is set to 0 and the system tracks the volume for

Current Delivery and the accumulated volume for Total Delivery.

• The Total Delivery value is grayed out indicating that it cannot be modiﬁed.

Recirculate Mode

In Recirculate mode, cardioplegia volume tracking is disabled to allow the cardioplegia pump to run without tracking the volume. This may occur when the volume is being recirculated, but not delivered to the patient.

To use Recirculate Mode:

1. Select Recirculate mode by pressing the Recirculate button.

2. Start the cardioplegia pump.

• Volume is not tracked.

• Time Since Last Delivery timer continues counting.

• Total Delivery value is displayed in black indicating that it can be modiﬁed.

To Switch from Recirculate to Deliver Mode:

1. Select the Deliver mode by pressing the Deliver button.

• If the cardioplegia pump is running:

Time Since Last Delivery timer stops.

The Current Delivery value is set to 0 and the system tracks the volume for

Current Delivery and the accumulated volume for Total Delivery.

The Total Delivery value is grayed out indicating that it cannot be modiﬁed.

• If the cardioplegia pump is in Stop mode:

The Current Delivery value is set to 0.

To Switch from Deliver to Recirculate Mode:

1. Select Recirculate mode by pressing the Recirculate button.

• If the cardioplegia pump is running:

Volume tracking stops.

Time Since Last Delivery is set to 0 and the timer starts counting the time since

last delivery.

If the subtab is closed while the timer is active, the time since last delivery is

displayed on the CPG tab button on the CCM.

The Total Delivery value is displayed in black indicating that it can be modiﬁed.

• If the cardioplegia pump is in Stop mode:

No changes occur.

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Page 90

Central Control Monitor

CPG

Auto Dose

Setup

Delivery

Automatic Dose Delivery:

1000

Induction Dose:

Hide

Maintenance Dose:

Other Dose:

16:07:51

View

CPG

Auto Dose

Setup

Delivery

Time Since Last Delivery:

11:48

Current Delivery:

Deliver:

Recirculate:

Total Delivery:

Auto Dose Select:

137

Auto Manual

16:07:51

1614

Reset

Maintenance

Automatic Dose Delivery

The Automatic Dose Delivery feature is used to select one of three cardioplegia doses that automatically stop the pump once the dose has been delivered. This feature is set up and enabled using the Auto Dose Setup subtab.

Refer to the Roller Pumps chapter, Roller Pump Messages section for details on messages which will display in the display area on the front panel of the cardioplegia pump.

Auto Dose Setup Subtab

View and Hide Buttons

Enable the Auto Dose Delivery feature:

1. Touch the View button (default is Hide).

• View button background turns white. The Hide button background turns gray.

• Auto Dose Screen appears on the lower half of the Delivery subtab.

Disable the Auto Dose delivery feature:

1. Touch the Hide button (default is Hide).

• Hide button background turns white. The View button background turns gray.

• Lower half of the Delivery subtab is blank.

Dose Setup

For each selection, Induction Dose, Maintenance Dose, and Other Dose:

1. Touch the Dose toggle button to display the desired units – mL or time (minutes and seconds).

2. Touch the Dose Value button.

• The Dose Value button turns white. Adjustment arrows appear.

3. Use the arrows to modify the Dose Value. For mL, the small arrows change the volume by 10 mL and the large arrows by 100 mL. For time, the small arrows change the time by 1 sec and the large arrows change the value by 1 min.

4. Touch the Dose Value button again to conﬁrm the value.

• The adjustment arrows disappear. The Dose Value button background turns gray.

• If the View button has been pressed, the value corresponding to the Auto Dose selection appears on the Delivery subtab.

When Automatic Dose Delivery is enabled, the lower half of the Delivery subtab displays a toggle button for selecting the auto dose, a Reset button to reset the dose value after the automatic dose has been delivered, and two mode buttons - Auto and Manual - used to initiate and stop auto dose delivery. The dose value cannot be changed while the dose is being delivered.

Dose Value Button

Dose Toggle Button

• mL

• Time

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Central Control Monitor

CPG

Auto Dose

Setup

Delivery

Time Since Last Delivery:

11:48

Current Delivery:

Deliver:

Recirculate:

Total Delivery:

Auto Dose Select:

137

Auto Manual

16:07:51

1614

Reset

Maintenance

CPG

Auto Dose

Setup

Delivery

Time Since Last Delivery:

001:48

Current Delivery:

200

Deliver:

Recirculate:

Total Delivery:

Auto Dose Select:

Manual

16:07:51

1751

Maintenance

Reset

Auto

To select Auto Dose:

Make sure the cardioplegia pump is stopped or that the Manual button is selected. Otherwise, the Auto Dose Select button text will be gray indicating that the Auto Dose selection cannot be changed.

1. Touch the Auto Dose Select button to display the desired Auto Dose. Options are Induction Dose, Maintenance Dose, and Other Dose.

• The value displayed to the right of the Auto Dose Select button is its current value set up in the Auto Dose Setup subtab.

To initiate Auto Dose delivery:

1. Make sure the delivery mode is Deliver.

2. Touch Auto button (default is Manual). Start the cardioplegia pump.

• The auto dose value starts counting down.

• The Auto Dose Select and Reset button text turn gray indicating that the auto dose type cannot be changed and the auto dose value cannot be reset.

• Volume tracking operates as described in the Deliver mode and Recirculate mode sections.

• The volume delivered or time remaining is displayed on the cardioplegia pump control panel display.

To Interrupt Auto Dose Delivery:

• Stop the cardioplegia pump or change delivery mode from Auto to Manual.

• Auto Dose value stops decreasing and the current value is displayed.

• If the cardioplegia pump is running and Manual mode was selected, Current and Total Delivery continue to increase.

To Resume Auto Dose Delivery:

• Restart the cardioplegia pump or change delivery mode from Manual to Auto.

• Auto Dose continues to decrease.

• The Current Delivery resets to zero and counts up. Total Delivery continues to increase.

Auto Dose Delivery Completion:

• Auto Dose decreases to zero.

• Pump stops automatically when the auto dose delivery is ﬁnished.

• The Auto button turns gray and the Manual button background turns white indicating that the auto dose delivery is no longer active.

• A message indicating that the dose is ﬁnished is displayed on the cardioplegia pump control panel display.

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Central Control Monitor

TMR1

Reset

000:08

10:16

TMR1

Reset

000:21

10:16 10:17

Aux

Messages

TMR1

Reset

000:00

Timers

16:07:51

To Reset Auto Dose Selection:

Make sure the cardioplegia pump is stopped or that the Manual button is selected. Otherwise, the button text will be gray indicating that the Auto Dose value cannot be reset.

1. Touch the Reset button.

• The value set in the Auto Dose Setup subtab for the selected Auto Dose appears to the left of the Reset button.

• An additional dose can now be delivered and automatically stop the pump.

Aux Tab

The Aux tab has two subtabs: Timers and Messages.

Timers Subtab

Timers, other than Pump and Clamp, are controlled through the Timers subtab. To change the start value of a count down timer, use the Timers subtab within the Setup tab.

To start the timer:

1. Touch the black box.

• The start time appears on the left side of the button.

To stop the timer:

1. Touch the black box again.

• The stop time appears on the right side of the timer display.

To resume the timer:

1. Touch the black box again.

• The timer continues counting.

• The resume time appears on the left side of the button.

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Central Control Monitor

Aux

Timers

Messages

08:45 Air Detected: Arterial STOPPED

08:45 Gas System Warming Up

08:45 Gas Flow: Off

08:28 NO CDI 500 Data

08:28 Calibrate OCCLUDER

16:07:51

System

Power

Settings

Audio Volume:

High

Perfusion Screen Name: CABG Roller

Reassign

Module

Module Info

16:07:51

To reset the timer:

1. Stop the Timer.

2. Touch the Reset button.

• The timer resets to 0.

Messages Subtab

The Messages subtab allows the user to access a list of the system messages that have occurred during a case, along with the time that they occurred. The messages are sorted by order of occurrence, with the most recent messages listed ﬁrst. All system messages including alarm, alert, error, and status messages appear in this list. The list is accessible for the duration of the case and is capable of logging up to 3000 messages.

Use the scroll bar to view messages that are beyond the viewing area.

System Tab

The System tab has four subtabs: Settings, Power, Reassign Module, and Module Info.

Settings Subtab

This subtab allows the user to view the current Perfusion Screen name and adjust the volume of the audio tone.

Perfusion Screen Name

To Adjust Volume:

Touch the Audio Volume button to toggle through the choices: High, Medium, Low. Default is High and is reset to High when a Perfusion Screen is opened.

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Central Control Monitor

System

Settings

Module Name:

ART Air

Reassign

Module

Module Info

Module Type:

Air Sensor

Power

Select Replacement

Reassign

Module

Reassign

Module

Offline Air Sensor

16:07:51

Power Subtab

This subtab indicates the power sources currently in use, the % of AC power in use, an estimate of remaining battery time, and a graphical display of battery charge level.

System

Settings

Power

Reassign

Module

Module Info

Power Source: AC Power

AC Power Capacity Used: 11.8 %

Estimated Battery Time Remaining (min): 82

Battery Charge Level:

16:07:51

The Power Source is displayed as AC Power1, Battery, or SYSTEM POWER SHUTDOWN if the batteries are depleted and the system is about to shutdown completely. The AC Power Capacity Used is displayed in % if on AC and dashed out if on battery. This is an indicator of the power consumption. If the system power need approaches the limit of available power, the message, “Power System at 80% Capacity” is displayed on the CCM to alert the user.

The Battery Charge Level is displayed as a bar graph to indicate charge status of the battery.

Reassign Module Subtab

If a pump or module is broken, missing, or not communicating, use the Reassign Module function to replace the device. A reassigned device takes on the role of the broken device including icon control from the Perfusion Screen, all alert and alarm limits, and all safety connections.

Note: When a module/pump has been reassigned, it replaces the original module only for the duration of the case. If this reassigned module is a permanent replacement for the original module, it should be assigned to the system from the Conﬁguration area. If it is not assigned to the screen through the Conﬁguration area, the device icon will display a “?” each time the Perfusion Screen is opened and the module will need to be reassigned before it can be used.

AC power refers to AC (Mains) power.

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Central Control Monitor

Yes

Pressure Sensor: Reassign CPG Pres to Offline Pressure Sensor?

System

Settings

Module Name:

CPG Pres

Reassign

Module

Module Info

Module Type:

Pressure

Sensor

Power

Select Replacement

16:07:51

Reassign

Module

Offline Pressure Sensor

ART Pres / Pres 1

To Reassign a Module:

1. Select the module type by touching the Module Type button to toggle through the choices until the appropriate device is displayed.

2. Select the module name by touching the Module Name button to toggle through the choices.

3. Select the replacement module from the list of devices. Ofﬂine devices are on the top of the list followed by online devices which are identiﬁed by device name.

• When reassigning temperature and pressure modules, both channels will be assigned to the replacement module.

• When reassigning the primary pump, if a backup pump was designated during conﬁguration, it will automatically be highlighted.

• The primary pump appears on the bottom of the list when reassigning pumps of that same type.

Note: If an online device is selected as the replacement, conﬁrm that it is appropriate for reassignment.

• If a primary centrifugal pump is reassigned to a backup roller pump and if ﬂow has been placed on the centrifugal pump, ﬂow module data will no longer be displayed, and the backﬂow alarm and minimum ﬂow alarm are no longer available. In addition, the centrifugal Coast response becomes a roller pump Stop response for alarm events and a roller pump Message Only response for alert events.

4. Verify that the correct module LED, pump module Identiﬁcation (ID), or pump name is ﬂashing. When the correct module is ﬂashing, touch the Reassign Module button. This button is enabled when a selection has been made from the list.

The system prompts the user to conﬁrm the reassign process. Pump default direction will change to match the system direction except when the pump is running. If the pump is running during the reassign process, the pump direction will only change to match the system direction upon entering a Perfusion Screen or when the system is restarted.

5. Select Yes to complete the reassignment.

• Do not use the local control panel during reassignment.

• After reassigning modules, ensure that the LED on the reassigned module is constant green or that the reassigned pump displays the new name.

• If reassigning a Master or Follower pump, re-establish the communications link between the pumps. Use the Master or Follower Status subtab within the Pump tab to reconnect the pumps. See Central Control Monitor chapter, Pump tab, Master and Follower Status subtab section.

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Central Control Monitor

System

Settings

Module Name:

ART Air

Module ID: 00012 Self Test Result: PASS

Reassign

Module

Module Info

Module Type:

Air

Sensor

Power

Software Revision: 1.00 Operation Status: PASS

V5 Voltage (mV): 5084 PASS V5 Current (mA): 110 PASS Vmot Voltage (mV): 22915 PASS Vmot Current (mA):80PASS Temperature ( C): 37.2 PASS

16:07:51

System

Settings

Module Name:

Arterial

Module ID: 00019 Self Test Result: PASS

Reassign

Module

Module Info

Module Type:

Large Roller Pump

Power

Software Revision: 1.03 Operation Status: PASS

V5 Voltage (mV): 5020 PASS V5 Current (mA): 293 PASS Vmot Voltage (mV): 23871 PASS Vmot Current (mA): 176 PASS Temperature ( C): 30.0 PASS Total Volume (mL): 6710

16:07:51

Note: When reassigning pumps, verify all operating parameters after

reassignment, including tube size or ﬂow constant, direction, and display units.

Select No to return to the previous screen.

Module Info Subtab

Information about each module that is online can be displayed using the Module Info subtab. This information can assist in determining whether operating parameters for the module or pump are within operating range.

For each online module the following information will be displayed:

Module ID: Software Revision: Self Test Result: Pass/Fail Operation Status: Pass/Fail V5 Voltage (mV): and Pass/Fail Status V5 Current (mA): and Pass/Fail Status Vmot Voltage (mV): if applicable and Pass/Fail Status Vmot Current (mA): if applicable and Pass/Fail Status Temperature (degrees C): and Pass/Fail Status Total Volume (mL): total volume delivered for selected roller pump

A failure of the self test or operational status indicates the module or pump is not functioning properly and should be replaced. Values not applicable to a speciﬁc device will post an N/A in the Pass/Fail column.

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Central Control Monitor

Yes

End this case now? All pumps will stop. Gas flow will be turned off.

STOP

0.250

L/min

Pump icon

CPG

16:07:51

Summary

Servo

RPM:0 RPM

Direction: Forward

Flow:0.000 L/min

Tube Size:4:1

CPG Pres Pres Alarm Stop: 360 mmHg

Arterial Pump Stop

Stop

CPG Pres Pres Alert

Message Only: 300 mmHg

Event Pump Response:

CPG

16:07:51

Summary

0 mmHg

Servo Control:

Servo

Select Servo Source:

Setpoint:

CPG Pres

Auto

Manual

Post Case Tab

This tab allows the user to end the case.

To end the case:

Touch the Yes button.

Touch the No button to continue the current case.

Pump Tab

The Pump tab is accessed through the pump icon and is used to view a summary of pump parameters or initiate Servo mode and Pulse mode if applicable. For a primary pump, the

master or follower pump has three subtabs: Summary, Servo, and Master Status or Follower Status. For all other pumps, the Pump tab has two subtabs: Summary and Servo.

Touch the pump icon to access the Pump tab.

• The pump control box will highlight with a blue perimeter.

Only displayed if a gas blender is installed

CPG

Summary Subtab

The Summary subtab displays the pump name, the current RPM, direction of ﬂow, ﬂow in L/min, and the tube size for roller pumps or the minimum ﬂow alarm value for centrifugal pumps. The conﬁgured safety connections are also displayed.

CPG indicates the name of the pump

Servo Subtab

In Servo mode, the pump speed is automatically regulated to maintain a speciﬁc user selected pressure or ﬂow. During Conﬁguration, a pressure or ﬂow module is designated as a servo data source. If the servo control source designation is not enabled, a pump cannot be placed in Servo mode. See Edit Safety Connections section in this chapter for details on setting the servo source.

The Auto button enables Servo mode. The Manual button in the Servo subtab or on the pump local control panel disables Servo mode. See the Roller Pumps and Centrifugal Control Unit chapters for details of servo operation.

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Central Control Monitor

Arterial

16:07:51

Summary

Rate:

Pulse Control:

Pulse

100%

Servo

50%

Base:

Width:

Auto

Manual

60 BPM

85%

50%

Pulse Subtab

The Pulse subtab can be used to adjust pulse parameters and initiate Pulse mode for

a roller pump or centrifugal pump designated as the primary pump.

Roller Pump Pulse Parameters

The Rate, Width, and Base are set up using the Pulse subtab.

To Set the Rate:

1. Touch the Rate button.

2. Use the large arrows to change the Rate in increments of 10 beats per minute.

3. Use the small arrows to change the Rate in increments of 1 beat per minute.

4. Touch the Rate button again to store the new value.

To Set the Base:

1. Touch the Base button.

2. Use the large arrows to change the Base in increments of 10%.

3. Use the small arrows to change the Base in increments of 5%.

4. Touch the Base button again to store the new value. The recommended minimum Base is 30%.

To Set the Width:

1. Touch the Width button.

2. Use the large arrows to change the Width in increments of 10%.

3. Use the small arrows to change the Width in increments of 5%.

4. Touch the Width button again to store the new value. The recommended minimum Width is 30%.

See the Roller Pumps chapter for details of Pulse mode operation.

The use of the term “Pulse mode” refers to the variable pressure and ﬂow waveforms that result from the cyclic operation of the primary pump. Replication of a physiologic pulse from a natural heart is not obtained with a pump speed controller. No claim of clinical beneﬁt from the use of the Pulse mode has been reviewed by global Regulatory Agencies.

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Central Control Monitor

Arterial

Summary

Rate:

Pulse Control:

Pulse

100%

Servo

50%

Base:

Width:

Auto

Manual

85%

16:07:51

60 BPM

50%

Blood

Summary

Master Status

16:07:51

Servo

Master Pump: Blood

Follower Pump: Cryst

Master-to-Follower Ratio: 4:1

Connect Status: PASS

Cryst

Summary

Follower Status

16:07:51

Servo

Master Pump: Blood

Follower Pump: Cryst

Master-to-Follower Ratio:

Connect Status: FAIL

Stop and Reconnect

Centrifugal Pulse Parameters

Rate and Width are ﬁxed and only Base must be set up.

1. Touch the Primary Pump icon to access the Primary Pump tab.

2. Select the Pulse subtab.

To Set the Base

1. Touch the Base button.

2. Use the large arrows to change the Base in increments of 10%.

3. Use the small arrows to change the Base in increments of 5%.

4. Touch the Base button again to store the new value. The recommended minimum Base is 50%.

See the Centrifugal Control Unit chapter for details of Pulse mode operation.

Master and Follower Status Subtab

The Master and Follower Status subtab is a summary of the master and follower pump names, the speed or ﬂow ratio setting when the tab was opened, and the connect status of the pumps.

If the master and follower pumps lose their connection to each other, these pumps will stop automatically. The connection between these pumps must be reestablished

To reestablish pump connection:

1. Ensure both pumps are stopped.

2. Touch the Stop and Reconnect button.

• If reconnect is successful, the screen will display “Connect Status: PASS”. The display on each roller pump will indicate “M” or “F”.

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Central Control Monitor

Central Control Monitor Messages

The following table includes all the messages that can appear on the CCM display and corresponding operator responses.

Priority Condition CCM Display Message Operator Response

Alarm Battery is depleted SYSTEM POWER Use manual backup equipment to and system is shutting SHUTDOWN finish case. Fully recharge battery down. before using the system again.

Pump goes to 0 flow as < Pump Name >: STOPPED Correct condition. a result of a Reduce Start pump if stopped. Speed response to an alert or alarm.

Pump goes to 0 flow as < Pump Name >: STOPPED Correct the conditions that caused a result of receiving a the Reduce Speed/Pause responses. Pause and a Reduce Restart the pump. Speed response.

Air detected. < ABD Name > : Correct air condition, reset air sensor, AIR DETECTED restart pump if stopped.

Air detected. AIR DETECTED: Correct air condition, reset air sensor, < Pump Name > restart pump if stopped. < Pump Response >

Air sensor on, and < ABD Name > : Reconnect air sensor, reset air disconnected. AIR DETECTED sensor, restart pump if stopped.

Pressure has risen < Pressure Name > : Correct over pressure condition. above alarm limit. OVER PRESSURE Start pump if stopped.

Pressure has risen OVER PRESSURE: Correct over pressure condition. above alarm limit. < Pump Name > Start pump if stopped. < Pump Response >

Reservoir level below < Level Detector Name > : Fill reservoir to above alarm level. alarm level. LOW LEVEL Alarm clears automatically. Restart pump if stopped.

Reservoir level below LOW LEVEL: Fill reservoir to above alarm level. alarm level. < Pump Name > Alarm clears automatically. < Pump Response > Restart pump if stopped.

Backflow has been < Flow Sensor Name > : Correct backflow condition. detected. BACKFLOW Alarm clears automatically. Restart pump if stopped.

Backflow has been BACKFLOW: Correct backflow condition. detected. < Pump Name > Alarm clears automatically. < Pump Response > Restart pump if stopped.

Flow for flow sensor < Pump Name > : Correct low flow condition. placed on a centrifugal MINIMUM FLOW Alarm clears automatically. pump has gone below minimum limit.

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