Terumo Advanced Perfusion System 1 Operator's Manual

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TEXT, ADVANCED PERFUSION SYSTEM 1 OPERATORS MANUAL

883325

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Page 1 NEW PART NUMBER COLLATE SYM. CHG. NO. DESCRIPTION TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NOTE: ARTWORK COPY MUST ACCOMPANY THIS PRINT. Ann Arbor, Michigan TITLE TEXT, ADVANCED PERFUSION SYSTEM 1 OPERATORS MANUAL 883325 PART NUMBER SHEET REV. DRAWING NUMBER 883325 ______ OF ______...
Page 2 Advanced Perfusion System 1 Operators Manual...
Page 4 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.
Page 5: Table Of Contents
Table of Contents About Advanced Perfusion System 1 Introduction ....................1-2 Using this manual ..................1-3 Indications and Warnings ................1-4 Indications ................... 1-4 Contraindications ................1-4 User Qualifications ................1-4 System Warnings ................1-4 System Equipment Precautions ............1-5 Copyright .....................
Page 6 Table of Contents System Base Base Components ..................3-2 Mains Power Cord ................3-2 Circuit Breakers .................. 3-2 Auxiliary Outlet ..................3-3 Mains Power On and Off ..............3-3 System Power ..................3-4 Battery System ................... 3-4 System Network ................3-11 Casters and Wheel Lock System ............
Page 7 Table of Contents Master and Follower Status Subtab ..........4-37 Central Control Monitor Messages ............4-38 Configuration .................... 4-47 Configuration..................4-47 System Settings ................4-48 Perfusion Screens ................4-53 Configure Pumps ..................4-56 Add Primary Pump ................4-56 Configure Perfusion Screen ............. 4-58 Configure Other Pumps ..............
Page 8 Table of Contents Pulse Mode ..................5-21 Servo Mode ..................5-23 Master/Follower Mode ..............5-25 Roller Pump Messages ..............5-27 Centrifugal Control Unit Features ..................... 6-1 Installation and Connection ................ 6-2 Control Unit Cable ................6-2 Pole Mounting ..................6-2 Drive Motor ..................
Page 9 Table of Contents Test Before Use ................7-19 Pressure Monitoring Messages ............7-19 Temperature Monitoring ................7-21 Label Probe ..................7-21 Connect Probe and Module .............. 7-21 Setting Alarm Limits ................. 7-22 Test Before Use ................7-23 Temperature Monitoring Messages........... 7-23 Flow Monitoring ..................
Page 10 Table of Contents Run a Case Check the System 1 ................... 9-1 Power On ....................9-1 Set Up ......................9-1 Perfuse the Patient ..................9-3 Emergency Procedures Perfusion Situations .................. 10-1 Equipment Situations ................10-5 Technical Support Using this Section ..................11-1 Communication Protocol ................
Page 12 About Advanced Perfusion System 1 Centrifugal Control Unit Local Display and Control and Centrifugal Motor Lamp Small Roller Pump Large Roller Pump Roller Pump Local Display and Control Central Control Monitor Occluder Electronic Gas Blender Local Controls Wheel Lock Power Status Indicator LED...
Page 13: Introduction
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.
Page 14: Using This Manual
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.
Page 15: Indications And Warnings
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.
Page 16: System Equipment Precautions
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 –...
Page 17: Copyright
Copyright Copyright © 2017 Terumo Cardiovascular Systems Corporation This manual and the software described in this manual, are copyrighted. No part of this manual or the described software may be copied, reproduced, translated or reduced to any electronic medium or machine readable form without the prior written consent of Terumo Cardiovascular Systems Corporation.
Page 18: Training Overview
About Advanced Perfusion System 1 Training Overview System Base q Occluder Subtab q Timer Subtab q System power (external and battery) q Time/Date Subtab q Power Cord q Safety Tab q Power Indicator q Mute Button q Powering Down q Air Subtab...
Page 19 About Advanced Perfusion System 1 q Three buttons q Local Control q Start/Stop q Graphic Display q Select q Pump Name q Direction q Centrifugal Icon q Flow Constant q Speed control knob q Tube Size q Pump speed q Exit...
Page 20 About Advanced Perfusion System 1 q Roller pumps q Alarm Messages q Centrifugal pumps q Status Messages q Reset button q Error Conditions q Testing the ABD Flowmeter Modules and Sensors q Alarm Messages (Optional) q Status Messages q Error Messages q Maximum number –...
Page 21 About Advanced Perfusion System 1 Timers Connecting to TLink™ DMS (Optional) q Maximum number – 4 q Maximum number – 1 q Two timers preassigned q Collecting data q Pump q Clamp Electronic Gas Blender Module q Auxiliary timers (Optional)
Page 22: System Overview
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: •...
Page 23: Institutional Controls
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.
Page 24: System Base
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.
Page 25: Central Control Monitor
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. A power cable connects the Central Control Monitor to the system.
Page 26 System Overview 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.
Page 27 System Overview 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.
Page 28 System Overview Configuration The Configuration area can be password protected and allows authorized users to view and change system settings and Perfusion Screens. Configuration System Settings Language: Change Settings > English Date Format: dd/mm/yyyy Edit Config Password > Roller Pump Direction: PC Card Utilities >...
Page 29: Roller Pumps
System Overview 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.
Page 30: Features
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.
Page 31 System Overview 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.
Page 32: Modules
System Overview Modules Features Sensor Connection 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.
Page 33: Air Bubble Detect Module
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 Sarns Ultrasonic Air Sensors with the ® system. Up to 4 air bubble detect modules may be connected to the system at the same time.
Page 34: 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.
Page 35: Temperature Module
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.
Page 36: Flowmeter Module
System Overview 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.
Page 37: Occluder Module
System Overview 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 Head Occluder Module Only 1 occluder may be connected to the system.
Page 38: Interface Modules
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).
Page 39 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 Water trap Controls...
Page 40 System Base 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.
Page 41 System Base Base Components Mains Power Circuit Breakers Auxiliary Outlet Circuit Breaker Ground Equalization Stud Auxiliary Outlet Mains Power Cord 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.
Page 42 System Base 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.
Page 43 System Base 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.
Page 44 System Base 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.
Page 45 System Base 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 bat- tery alert tone cannot be muted.
Page 46 System Base Central Control Monitor Power Source/Battery Status Icon (only displayed on the Main and Perfusion Screens) – Provides information about battery life as follows: 53 min AC (Mains) Power Indicator When operating from AC (Mains) Power: • Steady green indicates a battery system with greater than one hour run time with a fully loaded system •...
Page 47 “Battery Cannot be Charged - Full Backup May Not be Available”. If this message is posted, contact Terumo Customer Service. Do not attempt to oper- ate 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...
Page 48 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.
Page 49 System Base 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.
Page 50 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.
Page 51 System Base 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.
Page 52 System Base 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.
Page 53 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).
Page 54 System Base 29.5 In. 29.5 In. 29.5 in. 29.5 in. (0,75 m) (0,75 m) (0.75 m) (0.75 m) 67.5 In. 67.5 in. (1,71 m) (1.71 m) 2 PUMPS MINIMUM 33.5 in. 33.5 In. (0,85 m) (0.85 m) 9.5 In. 9.5 In. 9.5 in.
Page 55 System Base 9.5 in. 9.5 In. (0.24 m) (0,24 m) 9.5 in. Transport Direction 9.5 In. (0,24 m) (0.24 m) Transport Direction 29.5 in. 29.5 In. (0,75 m) (0.75 m) 29.5 In. 29.5 in. (0.75 m) (0,75 m) Top View of System Showing Loading Zones Weights of various system components are given in the table below.
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.
Page 57 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.
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.
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.
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 Access Area Module Covers The module covers are located on each side of the base and provide protection from liquid spills.
Page 61 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.
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...
Page 63 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.
Page 64 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.
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.
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.
Page 68: Electronic Gas Blender
Central Control Monitor 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.
Page 69: Buttons
Central Control Monitor 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.
Page 70 Central Control Monitor 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.
Page 71: Security
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:...
Page 72: Perfusion Screen
Central Control Monitor 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.
Page 73 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.
Page 74: Primary Pump
Central Control Monitor 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.
Page 75: Pump Controls And Displays
Central Control Monitor 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.
Page 76: Slide Bars
Central Control Monitor 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.
Page 77 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.
Page 78: Displays
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.
Page 79 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.
Page 80: Perfusion Screen Tabs
Central Control Monitor 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. 16:07:51 Setup Patient...
Page 81 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.
Page 82 Central Control Monitor To Calibrate O Analyzer: Touch the Calibrate button. • Calibration takes approximately 2 minutes. • “Calibrating O analyzer” is displayed during calibration. When the calibration is complete, the message “O 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.
Page 83 Central Control Monitor 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.
Page 84 Central Control Monitor 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.
Page 85 Central Control Monitor 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. 16:07:51 Setup Patient...
Page 86 Central Control Monitor 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.
Page 87: Safety Tab
Central Control Monitor 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.
Page 88 Central Control Monitor 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. •...
Page 89 Central Control Monitor 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. •...
Page 90 Central Control Monitor 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.
Page 91 Central Control Monitor 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.
Page 92: Aux Tab
Central Control Monitor 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. •...
Page 93: System Tab
Central Control Monitor 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.
Page 94 Central Control Monitor 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. 16:07:51 System Settings Power Source: AC Power Power AC Power Capacity Used:...
Page 95 Central Control Monitor 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.
Page 96 Central Control Monitor 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.
Page 97: Post Case Tab
Central Control Monitor Post Case Tab This tab allows the user to end the case. End this case now? All pumps will stop. Only displayed if a gas blender Gas flow will be turned off. is installed To end the case: Touch the Yes button.
Page 98: Pulse Subtab
Central Control Monitor 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. 16:07:51 Arterial Summary...
Page 99: Master And Follower Status Subtab
Central Control Monitor 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. 16:07:51 Arterial Summary 100% Pulse Control: Rate: 60 BPM 60 BPM...
Page 100: Central Control Monitor Messages
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.
Page 101 SERVICE PUMP equipment or use hand crank. Discontinue use of the pump until it has been serviced by Terumo Cardiovascular Systems. Primary pump low level < Primary Pump Name > : Try to restart motor. If message motor faults cause the...
Page 102 < Primary Pump Name > : Stop and start the pump. If the detected underspeed UNDERSPEED message reappears, discontinue use condition. of the pump and contact Terumo Customer Service. Reassign pump, use standby equipment or use hand crank. Roller pump has <...
Page 103 Reconnect button. Start the Master pump. If Master pump cannot be reconnected, do not use the pump until it has been serviced by Terumo Cardiovascular Systems. Reassign pump or use standby equipment. Centrifugal pump has <Centrifugal Pump Name>: Clamp the lines.
Page 104 If the knobs cannot be turned, use standby gas blender. Do not use gas system until it has been serviced by Terumo Cardiovascular Systems Service. See the Messages subtab within the Aux tab for any additional error or status messages.
Page 105 Discontinue use of the pump until it has been serviced by Terumo Cardiovascular Systems Service. Centrifugal motor has <Centrifugal Pump Name>: Message should clear when the...
Page 106 Battery time Service. available may be less than 60 minutes. Battery cannot hold Battery Needs Service, Finish the case, then contact Terumo maximum charge Full Back Up May Not Be Customer Service. level. Battery time Available. available may be less than 60 minutes Cover is open.
Page 107 Central Control Monitor Priority Condition CCM Display Message Operator Response Status Centrifugal pump speed <Centrifugal Pump Name>: Verify forward flow. Check reduced to 1550 RPM Coasting connected devices. Increase pump speed when appropriate. Reconnecting Master Reconnecting Message will clear when connection and Follower <Master Pump Name>...
Page 108 Message clears when warm up is complete. sensor exposure Service O2 Sensor Backup analyzer should be used until limit reached. sensor is replaced by Terumo Cardiovascular Systems Service. Gas system warm up Calibrate O2 Analyzer Perform O Analyzer calibration. complete.
Page 110: Configuration
Central Control Monitor Configuration The Configuration functional area is used to design, configure, and edit a graphical representation of the devices and pumps used in a perfusion case. Up to 12 Perfusion Screens may be stored in the Central Control Monitor. Options, including language, date format, default roller pump direction, and security passwords, are set through Configuration.
Page 111: System Settings
Central Control Monitor System Settings System settings are language, date format, and roller pump direction. The user can change the settings, edit configuration passwords, or copy and back up Perfusion Screens using PC cards. To Change Settings: 1. Touch the Change Settings button to choose or change language, date format, or default roller pump direction.
Page 112 Central Control Monitor Configuration Password Assigning a configuration password restricts user access to the Configuration area. 1. Touch the Edit Config Password button to set a password. 2. Use the keyboard to enter a password. 3. Touch OK or Enter to save password. PC Card Utilities To save a copy of a Perfusion Screen to a PC card, touch the PC Card Utilities button.
Page 113 Central Control Monitor In the center are the utilities buttons. These buttons are used to move, copy, view summaries, rename, or delete the Perfusion Screens that appear on either list. The utilities buttons are activated by selecting a Perfusion Screen. There must be a System PC card installed in the Central Control Monitor for the move and copy utilities to activate.
Page 114 Central Control Monitor Transfer Perfusion Screen A PC card can be used to transfer Perfusion Screens from one System 1 to another. Insert a PC card into the System Card slot of the CCM. Use the Move or Copy function of the PC Card Utilities to copy the desired screen or screens onto the PC card.
Page 115 Central Control Monitor View Summary A summary is a text version of a Perfusion Screen. It contains information about the screen name, graphic orientation, reservoir type, assigned devices, assigned pumps, and enabled safety connections. To view the summary of a Perfusion Screen 1.
Page 116: Perfusion Screens
Central Control Monitor Perfusion Screens Perfusion Screens are graphical representations of the pumps and other devices that are to be used in a case. The pumps and other devices are controlled through the graphical representation displayed on the touch screen of the Central Control Monitor, known as central control.
Page 117 Central Control Monitor The process of creating a Perfusion Screen involves adding and placing pumps and devices, then creating and/or editing safety connections, and, finally, assigning the physical pumps and devices to their graphical icons. Note: If using TLink™ Data Management System software to collect data, device names must be selected from the list of predefined names in order for the data to be recognized by the software.
Page 118 Central Control Monitor Select Primary Pump Location and Patient Direction Select a location for the primary or arterial pump and a patient orientation. The default orientation is Patient Left and Pump Left. 1. Touch the patient and pump icon that corresponds to the preferred orientation or make no selection and accept the default.
Page 120: Configure Pumps
Central Control Monitor Configure Pumps Add Primary Pump After selecting patient and pump orientation, the next step in creating a Perfusion Screen is to add the primary pump. The primary pump is the arterial pump. Pump type, display units, reservoir type, pump name, and pump color are selected from this screen.
Page 121 Central Control Monitor Select Blood Reservoir Type Open designates a hardshell venous reservoir or open system. Closed designates a softshell venous reservoir, venous reservoir bag, or a closed system. The reservoir icon is a visual representation only and doesn’t have functionality on the touch screen.
Page 122: Configure Perfusion Screen
Central Control Monitor Configure Perfusion Screen This screen shows a graphical depiction of the patient and primary pump orientation, as well as the primary pump type and reservoir type selected. Pumps Added List Menu Configure Perfusion Screen > Configure Pumps CABG ROLLER CABG Menu...
Page 123 Central Control Monitor Select Pump Type 1. Select the pump type. The default selection is Large Roller Pump. The number of pumps currently defined and the maximum number of pumps allowed is displayed. Select pump type before making other selections on this screen. Select Display Units If the pump type selected is a roller pump, choose a display unit related to flow rate.
Page 124 Central Control Monitor Select Pump Name Each pump and device is assigned a unique name for identification. The assigned names are used in the alarm, alert, status, and error messages displayed by the system. To select a name from the list, touch the name. Use the up and down arrows to scroll through the list.
Page 125 Central Control Monitor Backup Pump Designate whether the pump being added is to be used as a backup pump. The functionality of the primary pump can be reassigned to the backup pump in the event of primary pump failure, including Pulse mode capability, expanded flow display choices, and the automatic assignment of safety connections that were made to the primary pump.
Page 126 Central Control Monitor Master Roller Pump If the pump type selected for the pump being added was a master roller pump, a follower roller pump must be selected. The master/follower operation always involves two roller pumps operating in tandem. The follower pump demand flow rate is defined as a percentage of the master pump flow rate.
Page 127 Central Control Monitor Place the Pump Select a place on the screen for the pump to appear. Touch the white rectangle that corresponds to the desired location of the pump. Change the placement position by touching any other blank rectangle. Choose the Undo Place button to remove the pump from its place on the screen.
Page 128 Central Control Monitor Configure Perfusion Screen > Configure Pumps CABG ROLLER CABG Menu Pump Configure Pumps 000:00 Configure Other Devices Edit Safety Connections Reset Reset Assign Devices to Modules Clamp Pumps: 000:00 Arterial Vent Reset Reset Sucker1 % O2 FiCO2 Sucker2 Edit >...
Page 130: Configure Other Devices
Central Control Monitor Configure Other Devices Configure and add other devices to the Perfusion Screen through the Configure Other Devices menu selection. Maximum allowed Air Detector Level Detector Occluder Pressure Sensor Flow Sensor Temperature Sensor CDI™ 100/101 or CDI™ 500 Timers Note: Two of the 4 timers are designated as Pump and Clamp timers.
Page 131: Add Air Detectors
Central Control Monitor Add a Device To add a device to the graphic display, touch the Add button. To Add Device: Select Device Type: Select Device Name: Select Device Name: Air Detector Level Detector Select From List: Occluder Pressure Sensor Flow Sensor Temperature Sensor CDI 100...
Page 132 Central Control Monitor Place the Air Sensor Available locations for the air sensor appear as white squares on the screen. Place the air sensor in the location that most closely matches the actual location of the air sensor in the circuit by touching the appropriate white square. Pump 000: 00 Reset...
Page 133: Add A Level Detector
Central Control Monitor Add a Level Detector To Add Device: Select Device Type: Select Device Name: Level Detection: Air Detector Level Detector Select From List: Alert/Alarm Occluder Level Pressure Sensor VENLevel Alert Only Flow Sensor Alert/Alarm CPGLevel Temperature Sensor LEVEL1 CDI 100 LEVEL2 CDI 500...
Page 134: Add An Occluder
Central Control Monitor Place the Level Detector The available location for the level detector appears as a white square. Touch the white square to place the level detector. Pump 000: 00 Reset Reset Clamp 000: 00 Reset Reset % O2 FiCO2 Vent Sucker1...
Page 135 Central Control Monitor Select a Color The color chosen for the occluder appears in the control slide bar for the occluder. There are two color choices. 1. Touch the desired color. The default color selection is blue. 2. Touch Next to continue. To Add Device: Select Device Type: Select Device Name:...
Page 136: Add Pressure Sensors (Transducers)
Central Control Monitor Set Safety Connections After the occluder is placed, the system automatically prompts the user to set a safety connection for the occluder. Choose Yes to set a safety connection for the occluder. Choose No to defer setting a safety connection.
Page 137 Central Control Monitor Alarm limits must always be higher than alert limits. The system maintains a 10 mmHg pressure difference between the alert and alarm limit to ensure that the alert is always less than the alarm. To change the alarm or alert limit, touch the Alarm Limit or Alert Limit button and use the arrows to set a new limit.
Page 138: Add Flow Sensors
Central Control Monitor Choose Undo Place to remove the pressure sensor from the Perfusion Screen. Choose Next to continue. Set Safety Connections After a pressure sensor is placed, the system automatically prompts the user to set a safety connection. Alert and alarm safety connections are required between a pressure sensor and the primary pump.
Page 139 Central Control Monitor Place the Flow Sensor Place the flow sensor by touching a white square. In order for flow information to be displayed on a centrifugal control unit, a flow sensor must be placed on the centrifugal pump speed/flow display area. Change the placement of the flow sensor by touching any other white square.
Page 140: Add Temperature Sensors
Central Control Monitor Add Temperature Sensors A maximum of 8 temperature sensors is allowed in a Perfusion Screen. 1. Select Add. 2. Select Temperature Sensor as device type. 3. Name the temperature sensor. Choose name from the list or choose Enter New Name and use the keyboard to enter a device name.
Page 141: Add Cdi™ Devices
Central Control Monitor Place the Temperature Sensor Place the temperature sensor by touching a white square. Change the placement of the temperature sensor by touching any other white square. Pump Placing a device icon in 000: 00 this location may interfere with a CDI display icon.
Page 142 Central Control Monitor Choose Next button to continue. Configure CDI™ 100/101 Data Display Three parameters from the CDI™ 100 or CDI™ 101 monitor are displayed on the screen: oxygen saturation (SAT), hematocrit (HCT), and hemoglobin (HB). Configure CDI 100 Data Display: Select Display: Venous Venous:...
Page 143 Central Control Monitor Add a CDI™ 500 Choose CDI™ 500 from the Select Device Type list. Select Device Name The name CDI™ 500 is automatically chosen as only one monitor of this type is allowed in a Perfusion Screen. This name is used in status and error messages displayed by the system.
Page 144 Central Control Monitor Modify Data Values Only 4 values can be displayed at once. If there are 4 values in the list, 1 must be removed before another can be added. To Remove Value: 1. Touch the value to be removed from the list on the right hand side. 2.
Page 145 Central Control Monitor Arrange Data Values Arrange the order in which the data values appear by using the arrows to position a particular data value in the display. Touch OK to accept the modified data display. CDI 500 Pump Pump mL/min 000: 00 000: 00...
Page 146: Add Timers
Central Control Monitor Add Timers A maximum of 4 timers is allowed in a Perfusion Screen including the Pump timer and Clamp timer. Up to 2 additional timers can be added to a Perfusion Screen configuration. 1. Select Add. 2. Select Timer as device type. 3.
Page 147 Central Control Monitor Typical Perfusion Screen A typical Perfusion Screen with pumps and devices in place may look something like this: Configure Perfusion Screen > Edit Safety Connections CABG ROLLER CABG Menu Pump Configure Pumps mL/min 000:00 Configure Other Devices Edit Safety Connections Reset Reset...
Page 148: Edit Safety Connections
Central Control Monitor Edit Safety Connections A safety connection is a communications link set up between two system components that allows a device to receive information from another device or module. Safety connections allow the user to set up pump responses to events generated by air sensors, level sensors, pressure sensors, flow sensors, roller pumps, and centrifugal pumps.
Page 149 Central Control Monitor WARNING: When configuring a screen with multiple safety connections, the user must consider the risks and benefits of the additional complexity introduced to the operation of the system. It is possible to configure the system to have events that trigger responses, with the response being events that trigger more responses.
Page 150 Central Control Monitor centrifugal pump speed less than 1560 RPM after the safety connection is enabled, the centrifugal pump must be temporarily stopped then restarted to disable the safety connection and then the cardioplegia pump can be started at any centrifugal pump speed.
Page 151 Central Control Monitor Occluder Responses An Occluder responds only to events from the primary pump. The same occluder response must be selected for these centrifugal pump events: pump stop, pump Coast, and minimum flow. The system automatically assigns the response chosen for stop, Coast, or minimum flow to the remaining two events. Occluder responses are Full Close, Full Open, Go to % Flow, and No Response.
Page 152 Central Control Monitor 2. Touch the Add/Edit Connections button to add or edit the safety connections to the device selected. Safety Connections Arterial Connected Device: Add Connection > Remove Connection Remove Connection Cancel • A screen appears which shows the safety connections for the selected device. A blank screen indicates that no safety connections are currently set.
Page 153 Central Control Monitor 5. Select the device by touching the device icon. The border color will change to blue. • Touch Undo to release the current device and select a different device. Touch Previous to view the preceding screen. • Touch Cancel to cancel the creation of the safety connection.
Page 154 Central Control Monitor Set Servo Mode Connections Roller pumps and centrifugal pumps can be configured to operate in Servo mode. In Servo mode, the pump speed is automatically regulated to maintain a selected pressure or flow setpoint. To operate in Servo mode, the desired pressure or flow must be designated as a servo control source.
Page 155: Connection Matrix
Central Control Monitor Note: If the cardioplegia pump is configured to stop when the primary roller pump stops or pauses, a message that this has occurred will appear on local display of the cardioplegia pump. This message will remain on the local display for a short period of time after the event occurs.
Page 156 Central Control Monitor Events Occluder Response Roller Pump Response Centrifugal Response Primary Roller Pump No Response No Response No Response Paused Full Open Stop Full Close Message Only Go to Flow 0%-100% Roller Pump Stopped Not Applicable No Response No Response Stop Stop Reduce Speed...
Page 158: Assign Devices To Modules
Central Control Monitor Assign Devices to Modules The pumps and devices configured in the Perfusion Screen must be assigned to the corresponding physical components on the system base. All components must be connected to the system base before they can be assigned. Select Assign Devices to Modules button and the configured pumps and devices appear in the Devices list.
Page 159 Central Control Monitor Assign Air Detectors, Level Detectors, Occluders, Flow Sensors, and CDI Select device type. Touch the Assign Devices button. Assign Configuration Device to Physical Module: Air Detectors 1. On the base, locate the module with the green flashing light. Go to Next Module Assigned Device: 2.
Page 160: Assign Pressure And Temperature Sensors
Central Control Monitor Assign Pressure and Temperature Sensors Select device type. Touch the Assign Devices button. Assign Configuration Device to Physical Module: Pressure Sensors 1. On the base, locate the module with the green flashing light. Select 'Channel 1' or 'Channel 2'. Channel 1 Go to Next Module Assigned:...
Page 161 Central Control Monitor The device name moves from the Assigned list to the Unassigned list and disappear from the Assigned box in the top of the screen. In order to assign a device that has been previously assigned to a different module, it must first be unassigned, and then reassigned.
Page 162: Assign Roller Pumps, Centrifugal Control Units
Central Control Monitor Assign Roller Pumps and Centrifugal Control Units Select device type. Touch the Assign Devices button. Assignment screen will appear. Assign Configuration Device to Physical Module: Large Roller Pumps 1. On the base, locate the pump display with the flashing label. Go to Next Module Assigned Device: 2.
Page 163: Save A Perfusion Screen
Central Control Monitor Save a Perfusion Screen To save an existing Perfusion Screen under a different name, touch the Save As button. Enter the new name of the Perfusion Screen using the keyboard. To save a Perfusion Screen under the current name, touch the Yes button. Unplaced devices will be lost.
Page 164: Edit A Perfusion Screen
Central Control Monitor Edit a Perfusion Screen To change an existing Perfusion Screen, select the Perfusion Screen from the list and touch the Edit button. Perfusion Screens Name Ready: Last Edit: Password: CABG Roller 15/10/2002 Password CABG Centrif 15/10/2002 Edit Edit Button Min AVR 15/10/2002...
Page 165: View Summary, Rename, Set Password And Delete
Central Control Monitor View Summary, Rename, Set Password, and Delete View Summary The summary screen displays information about the selected 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.
Page 166: Return To Main Screen
Central Control Monitor Delete To delete a Perfusion Screen from the CCM, touch the Perfusion Screen name and then touch the Delete button. A confirmation window will be displayed to allow the user to confirm or cancel the deletion. Choose Yes to delete the Perfusion Screen. Touch No to keep the Perfusion Screen in the CCM.
Page 168: Roller Pumps
The Advanced Perfusion System 1 offers two roller pump sizes - a large pump and a small pump. •...
Page 169 Roller Pumps In the Configuration area of the Central Control Monitor, a roller pump can be designated as primary, backup, cardioplegia, master, follower, or none. Each of these has unique functionality as described in the table below. Function CCM Features Unique Functionality Primary •...
Page 170: Installation And Connection
Roller Pumps Installation and Connection Pump Cable Connect the pump cable to the receptacle located on the back of the roller pump. Align the red dot on the pump cable connector with the red dot on the pump receptacle. Insert the connector into the receptacle; an audible click indicates that the connector is fully seated in the receptacle.
Page 171: Sliding Back Cover Panel Kit
Roller Pumps Sliding Back Cover Panel Kit If a full complement of pumps is not installed across the width of the base, the opening to the cable management area is exposed in each vacant pump space. To cover this opening, protect the area from dust and spills, and hide the wiring and cabling from view, use the appropriate sized cover from the Sliding Back Cover Panel Kit.
Page 172: Pole Mounting
Roller Pumps Pole Mounting Select the desired pole position and secure the mounting arm to the pole. Select the desired plate position and secure plate. Ensure the pump mounting lever is in the up position. Grasp roller pump firmly with two hands. Tilt pump forward and insert the mounting tab into the front of the mounting plate.
Page 173: System Connection
Roller Pumps System Connection Route and arrange the pump cable to minimize exposure to spills. With a clear view of the desired pump or module connection, carefully connect the pump cable to one of the system pump connections on either side of the system base or, if necessary, to any of the system module connections.
Page 174: Installing Tubing
Roller Pumps Installing Tubing WARNING: Tubing must not be reversed in the pump head as air embolism may occur. WARNING: Make sure tubing is properly aligned before closing tube clamp. WARNING: The pump must be in Stop mode during tubing installation as accidental starting of the pump could injure the operator and may damage the tubing or the pump.
Page 175 Roller Pumps 5. Insert the tubing and lift the lock release lever to release the dial. Make sure the tubing is secured in the grooves of the universal tube clamp mechanism. 6. Feed the tubing between the guide rollers while rotating the pump by hand or with the hand crank and position the tubing in the outlet side of the universal tube clamp mechanism.
Page 176 4. Follow the same instructions if the tube clamp failure is observed during unexpected return to bypass that requires the urgent replacement of the perfusion circuit. 5. If a broken tube clamp mechanism is detected, contact Terumo Customer Service.
Page 177: Setting Occlusion
Roller Pumps Setting Occlusion The roller pump occlusion mechanism is used to adjust the position of the rollers with respect to the pump raceway. The occlusion knob can be adjusted while the roller mechanism is rotating. Turning the occlusion knob in a clockwise direction draws the roller assembly away from the pump raceway;...
Page 178 Roller Pumps See the Resolving Pump Jam section for instructions regarding Pump Jam errors. If an unexpected pump stop occurs when the pump is used for arterial flow, a temporary interruption in arterial blood flow will occur. A number of variables influence patient risk including the duration of the pump stop, the patient’s status, and the patient’s temperature.
Page 179 1 inch (2,5 cm) per minute, contact Terumo Customer Service. Using a pump in this condition may compromise tube life and increase blood trauma.
Page 180: During Perfusion
If a Pump Jam error reappears after the above steps are taken, use a hand crank until able to reassign to an alternative pump or use standby equipment. Following the case, contact Terumo Customer Service. Manual Operation of Pump WARNING: When turning the roller assembly by hand, always turn the roller assembly in the direction of forward flow.
Page 181: Controls And Displays
Roller Pumps Controls and Displays 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. Tube Size or Flow Constant Default Forward Direction Primary Display...
Page 182 Roller Pumps Pump Speed Control Knob Use the pump speed control knob to set the pump speed. Turning the knob clockwise increases the speed, counterclockwise decreases the speed. Always use the Start/Stop button to stop the pump. Note: The roller pump does not deactivate at 0 RPM or a flow of 0.000 L/min.
Page 183: Check The Start-Up Test
If the message appears again and remains on the display, do not use the pump. Contact Terumo Customer Service. The pump display will be determined by the pump state. Offline indicates the pump is not assigned to the current Perfusion Screen or a Perfusion Screen has not been opened.
Page 184: Pump Menu
Roller Pumps Change Pump Default Direction: Use one of the methods below to change pump default direction. • Plug the pump into the system, power the system on and allow the start-up sequence to complete. Verify that the pump default direction arrow now matches the system direction.
Page 185 Roller Pumps Select: Direction The pump direction can be temporarily reversed from the default forward setting. The pump direction will revert to its default forward direction when the Stop button is pressed or when the pump is stopped in response to any alert or alarm messages or another pump event.
Page 186 Roller Pumps Select: Tube Size The correct flow constant must be entered in order for the flow rate to be properly calculated. For PVC medical grade tubing, a number of predefined flow constants for standard tubing sizes can be selected using the “SELECT: TUBE SIZE” menu (see the following tables for flow constants for large and small tube sizes).
Page 187: Continuous Mode
Roller Pumps Select: Flow Constant To determine the flow constant (FC) for a nonstandard PVC or silicone tubing size, set the flow rate display to show speed in RPM and stabilize flow through a water circuit with the pump speed above 30 RPM and the water near the intended delivery temperature.
Page 188: Pulse Mode
Roller Pumps Ending Continuous Mode Pressing the Stop button on the CCM or the Start/Stop button on the front panel will stop the pump. WARNING: Always check the pump for proper operational mode after a Pause or Reduce Speed response has been executed. A pump may go to Stop mode and need to be started manually if the pump has received multiple high priority messages.
Page 189 Roller Pumps 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%.
Page 190 Roller Pumps Servo Mode In Servo mode, the pump speed is automatically regulated to maintain a specific user selected pressure or flow setpoint. Pressure or flow servo sources are chosen using the Configuration area on the CCM. The servo source should be located at least 24 inches (61 cm) downstream of the pump operating in Servo mode.
Page 191 Roller Pumps To Initiate Servo Mode: 1. Touch the Pump icon to open the Pump tab. 2. Open the Servo subtab. 3. Select the source pressure or flow. 4. Touch the Auto button. The pump control panel shows the Servo mode symbol next to the current servo setpoint value.
Page 192: Master/Follower Mode
Roller Pumps Master/Follower Mode Pumps are designated as master and follower in the CCM Configuration area. Master/follower mode involves two pumps operating in tandem, where the follower pump demand flow rate or speed is a percentage of the master pump flow rate or speed.
Page 193 Roller Pumps Follower Operation The follower pump speed adjusts automatically to maintain the currently set percentage or, for select percentages, ratio according to the following formula: Desired Follower Speed = Master Flow Rate x Ratio (%) x 10 Master Flow Constant Use the follower pump speed control knob or pump control slide bar to adjust the percentage (%) of the master pump flow rate or speed, but not the percentage of the follower pump flow rate or speed in the total cardioplegia delivery.
Page 194: Roller Pump Messages
Roller Pumps Roller Pump Messages Roller pump messages are displayed in the message area on the pump display. There are five categories of pump messages. Response to Messages Table Message Type Display Reverse video, blinking, <Response>: <Message> External Alarm - A device or sensor that Possible displays: is connected to the roller pump has •...
Page 195 Master pump. master pump. If message appears again, reassign the master pump. Do not use the master pump until it has been serviced by Terumo Cardiovascular Systems. Master stops due to STOPPED: NO FOLLOWER Check the follower pump cable loss of data from connections.
Page 196 Be aware that the pump may not respond to events from connected devices. Do not use the system again until it is serviced by Terumo Cardiovascular Systems Service. Network communication NO COMMUNICATION Continue use of roller pump from failure.
Page 197 Pump board temp- SERVICE PUMP Discontinue use of the pump until erature > 80 ºC for it has been serviced by Terumo more than 2 seconds. Cardiovascular Systems. Reassign pump, use standby equipment, or use hand crank.
Page 198 Roller Pumps Priority Condition Pump Display Message Operator Response Status Follower pump has STOPPED: MASTER Message should clear when stopped in response to Master pump is restarted. master pump event. Follower pump has PAUSED: MASTER Message should clear when paused in response to master pump resumes.
Page 199 Roller Pumps Priority Condition Pump Display Message Operator Response Status Time auto dose has RESET TO: <new time value> Message clears when auto dose been reset to zero. delivery restarts. Volume auto dose CANCELLED: Message clears when auto dose delivery has been <current volume>...
Page 200: Centrifugal Control Unit
Centrifugal Control Unit Features The primary function of a centrifugal pump is to move fluids through a cardiopulmonary bypass circuit. Centrifugal pumps are used primarily for arterial pumping applications and as augmented venous return pumps. The System 1 centrifugal system consists of the control unit for control and display functions and a drive motor which couples magnetically to a disposable centrifugal pump head.
Page 201: Installation And Connection
Centrifugal Control Unit CCM. The system provides the capability to automatically regulate the centrifugal pump speed to maintain a desired pressure or flow set point. This is known as Servo mode. In this mode, the user selects a pressure or flow source and initiates servo operation on the Central Control Monitor.
Page 202: Drive Motor
Centrifugal Control Unit Drive Motor Select the desired pole position and secure the flexible mounting arm to the pole. Note: To reduce the potential for an air embolism, the drive motor is typically positioned so that the pump will be near and just below the outlet of the reservoir from which the blood is being pumped.
Page 203: System Connection
Modules cannot be inserted into a module receptacle when standoffs are installed. Manual Drive Unit Terumo Cardiovascular Systems Corporation recommends that either the manual drive unit or a roller pump be prepared for use as standby equipment. Ensure that the tubing length is sufficient.
Page 204: Set Up And Prime
Perfusion, published by ECRI, September 1988, 1(2):6-7. Consult the disposable centrifugal pump instructions for directions, warnings, etc., regarding the pump. Use only the Terumo Sarns™ Centrifugal Pump. Install the pump ® but do not start the drive motor until ready to prime the circuit.
Page 205: Controls And Displays
Centrifugal Control Unit Controls and Displays 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. Pump Name Centrifugal Icon Motor Speed...
Page 206: Check The Start-Up Test
If the message appears again and remains on the display, do not use the pump. Contact Terumo Customer Service. The control unit display will be determined by the pump state. Offline indicates the pump is not assigned to the current Perfusion Screen or a Perfusion Screen has not been opened.
Page 207: Continuous Mode
Centrifugal Control Unit WARNING: With a centrifugal pump, maintain a minimum pump speed or clamp the pump outlet line and patient’s venous line in order to prevent backflow and drainage of the patient’s blood. Minimum pump speed is the speed which overcomes line and patient resistance.
Page 208: Coast ™ Response
Centrifugal Control Unit pump speed is reduced to 1500 RPM. Pressing the Stop button will stop and deactivate the pump. Decreasing the speed to zero using the control slide bar will stop the pump. If the pump is stopped and deactivated using the Start/Stop button, it must be reactivated using the Start/Stop button for the pump to be used again.
Page 209 Centrifugal Control Unit CAUTION: A pump may drop to a speed below 1500 RPM if the pump was previously in pulsatile mode with an average speed lower than 1500 RPM when a Coast response occurs. Coast Lockout When a safety event with a configured Coast response occurs, a centrifugal pump will lock out manual adjustments to the pump speed for 2 seconds.
Page 210: Pulse Mode
Centrifugal Control Unit Pulse Mode 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 When using Pulse mode during a case, monitor the patient waveform on the...
Page 211 Centrifugal Control Unit To Set the Base: 1. Touch the Base button. Use the large arrows to change the Base in increments of 10%. 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%.
Page 212: Servo Mode
Centrifugal Control Unit To End Pulse Mode: Use one of the following options: Press the Manual button on the control panel and the pump will transition to • Continuous mode at the midpoint between the Peak and Base speeds. The message “MANUAL: MONITOR FLOW”...
Page 213 Centrifugal Control Unit 16:07:51 Arterial Select Servo Source: Summary Setpoint: Servo Control: Servo 4.5 L/min ART Flow Auto ART Pres Manual Pulse Circuit and clinical parameters, including setpoint value and pump flow rate, should be stabilized in Continuous mode and be within normal operating ranges before initiating Servo mode.
Page 214: Using Standby Equipment
Centrifugal Control Unit Using Standby Equipment If the centrifugal control unit fails or the pump will not couple to the drive motor, use the manual drive or a roller pump to provide arterial flow. Manual Drive Unit Temporarily clamp the patient venous line and the pump outlet line, remove the pump from the drive motor and mount it in the manual drive unit.
Page 215 Motor speed < demand UNDERSPEED Clamp the lines. Stop and start the speed for more than 2 pump. If the message reappears, seconds. contact Terumo Cardiovascular Service. Reassign pump, use standby equipment, or manual drive unit. Pump cannot maintain MANUAL: MONITOR FLOW Check that the servo source servo set point.
Page 216 Be aware that the pump may not respond to events from connected devices. Do not use the system again until it is serviced by Terumo Cardiovascular Systems Service. Network NO COMMUNICATION Continue use of centrifugal control unit communication failure.
Page 217 Pump board temperature SERVICE PUMP Discontinue use of the pump until it > 80 ºC for more than has been serviced by Terumo 2 seconds. Cardiovascular Systems. Reassign or use standby equipment. Low level motor fault STOPPED: MOTOR ERROR Clamp the lines.
Page 218 Centrifugal Control Unit Priority Condition CCU Display Message Operator Response Status Stop button is pressed TURN SPEED TO ZERO Message clears in 4 in Servo mode with seconds if no action is average RPM > 1550. taken. Press Stop button again to stop the pump.
Page 219 6-20...
Page 220: Modules
Terumo ® Advanced Perfusion System 1. There are 9 types of modules that connect to the system base and they are held in place with the module bracket system. Module types and the maximum number of modules that can be used in a Perfusion Screen are:...
Page 222: Air Bubble Detection (Abd)
Modules Air Bubble Detection (ABD) A Perfusion Screen can contain up to 4 air sensors. It is recommended that an ABD system be used on the arterial line for every case. There are three air sensor sizes. The 3/8 in. x 3/32 in. sensor (red) will detect air bubbles of 0.5 cc or larger at flow rates up to 6 L/min for 3/8 in.
Page 223: Connect Abd Sensor
Modules Air Bubble Detection (ABD) Connect Air Sensor The air sensor size and weight allow it to mount directly on the tubing. However, the sensor can be mounted on a bracket to provide stability and is recommended for 1/4 in. tubing. CAUTION: Do not drop air, level, or flow sensors as shock may damage the sensor.
Page 224 Modules Air Bubble Detection (ABD) Enabling, Resetting, or Disabling Air Bubble Detection Alarms Select the Air subtab within the Safety tab on the Perfusion Screen or touch the Air icon on the CCM. 1. Touch the air detection On button to enable the alarm capability for the air detection system and the icon on the CCM turns green.
Page 225: Test Before Use
Modules Air Bubble Detection (ABD) Test Before Use The performance of every air bubble detection system must be verified before each use. Action Results Make necessary safety connections. This is done in the Configuration Screen. Refer to CCM chapter Configuration section for details. Air bubble detection system is off;...
Page 226: In The Event Of An Air Alarm
Disable the air sensor by turning it OFF on the CCM in the Air subtab within the Safety tab. It will be necessary to use an alternate air monitoring method. • Use a backup Air Sensor and Cable, if possible. • Contact Terumo Customer Service after the case is completed.
Page 227: In The Event Of An Abd Module Malfunction
• Contact Terumo Customer Service at the end of the case. • The LED light on the module cycles between green, yellow, red, and Off.
Page 228: Level Monitoring
Modules Level Monitoring A Perfusion Screen can be configured to monitor one alert and one alarm level location through the use of one module. The system detects blood/prime solution level in polycarbonate venous hard shell reservoirs. WARNING: The level detection and air bubble detection systems must be properly set up and turned ON as UNDETECTED AIR in the line may cause gaseous emboli to be pumped into the patient, with attendant risk of DEATH OR SEVERE INJURY.
Page 229: Attach Sensors To Reservoir
Modules Level Monitoring 0.07 – 0.150 in (1,78 – 3,81 mm) Attach Sensors to Reservoir • Do not position sensors within 1 cm of internal reservoir structures. • Verify that the reservoir wall thickness is within > 1 cm 0.07 – 0.150 in (1,78 – 3,81 mm). Thin walls may cause false alarms while thick walls prevent alarms from activating.
Page 230: Enabling And Disabling Level Detection System
Modules Level Monitoring Selecting the Level Detection Mode Touch the Level Detection button to select the desired mode: Alert Only when using only the alert sensor or select Alert/Alarm when using both the alert and alarm sensors. Alert/Alarm Alert Only When switching to Alert/Alarm from Alert Only, the level alarm probe will take •...
Page 231 Modules Level Monitoring System Response to Alert Condition When no blood or prime solution is present at the alert level sensor, the system will respond as indicated in the following table. Level Level Connected Audible Icon Module Message Device(s) Tone Flashes yellow LED flashes Message with sensor name in...
Page 232: Test Before Use
Modules Level Monitoring Test Before Use The performance of the level detection system must be verified before each use. Action Results Make necessary safety connections. This is done in the Configuration Screen. Refer to CCM chapter Configuration section for details. Turn level detection on.
Page 233: Level Monitoring Messages
Modules Level Monitoring Level Monitoring Messages Priority Condition CCM Display Message Operator Response Alarm 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.
Page 234 Modules Level Monitoring Priority Condition CCM Display Message Operator Response Status Level system is off, < Level detector name > : Mount level sensor to reservoir. level sensor is not Not Attached Message clears automatically. mounted to the venous reservoir. Level system is off, <...
Page 236: Pressure Monitoring
The pressure system has only been tested with pressure transducers provided by Terumo Cardiovascular Systems. Pressure data can be used as a servo setpoint to regulate roller and centrifugal pump speeds. See the Roller Pumps and Centrifugal Control Unit chapters, Servo mode sections for instructions on using pressure data as a servo setpoint.
Page 237: Setting Pressure Limits
Modules Pressure Monitoring 4. Attach pressure transducer to perfusion circuit. Note: The pressure transducer, and if used, pressure dome, must be located at the correct elevation recommended by the manufacturer in order to obtain the correct pressure reading. Use a pressure line isolator if erratic displays occur during continuous flow because of the particular setup.
Page 238: Calibrating The Pressure Transducer
Modules Pressure Monitoring Setting Pressure Display 1. Touch the Display button until the desired selection is displayed. Average is an average pressure reading; Systolic is the high pressure reading; Diastolic is the low pressure reading. Calibrating the Pressure Transducer The pressure monitoring system requires each transducer to be calibrated to establish a zero reference.
Page 239 Modules Pressure Monitoring 6. Close the Safety Screen by touching the Close button. 7. Repeat steps 1-6 for each transducer assigned to the system. Once a pressure transducer is calibrated, closed to atmospheric pressure, and open to the circuit, it does not need to be turned on to enable pressure monitoring. System Response to Alert Conditions Pressure Pressure...
Page 240: Pre-Case Check
Modules Pressure Monitoring Pre-Case Check Once the alert and alarm limits have been set, a pre-case check should be performed to ensure the pressure monitoring system is operating as the user intends. Test Before Use Ensure every pressure monitoring system is functioning properly prior to use. Action Results Make necessary safety connections.
Page 241 Modules Pressure Monitoring Priority Condition CCM Message Operator Response Alert Loss of data for Check transducer connections. <Pressure name>: calibrated pressure NO PRESSURE DATA Disconnect/reconnect and transducer. recalibrate transducer. If message does not clear, replace and recalibrate transducer. Error Pressure transducer Retry pressure transducer <Pressure name>: Calibrate Failed calibration failed.
Page 242: Temperature Monitoring
Modules Temperature Monitoring A Perfusion Screen can be configured to monitor up to 8 Channel 1 temperature locations through the use of 4 modules with each module having 2 channels. The temperature monitoring Channel 2 system provides high temperature alarm monitoring for each temperature channel.
Page 243: Setting Alarm Limits
Modules Temperature Monitoring Setting Alarm Limits The default alarm limit is set when a Perfusion Screen is configured. To change the default value for the current case only: 16:07:51 Safety Previous ART Temp Limits ( C) + 0.1 Temps 38.0 C Alarm: –...
Page 244: Test Before Use
Modules Temperature Monitoring The alarm will clear when the condition has been corrected. 16:07:51 ART Temp : OVER TEMPERATURE Safety Previous ART Temp Limits ( C) Temps 43.0 C Alarm: Flow 42.5 Test Before Use The performance of the temperature probes must be verified before each use. Action Results Cool probe below room temperature.
Page 246: Flow Monitoring
Modules Flow Monitoring The Perfusion Screen can be configured to monitor up to 4 flow locations. A flow sensor can be used to monitor flow generated by a roller pump or centrifugal pump. Flow is measured in the range of –9.99 to +9.99 L/min. The flowmeter system is compatible with medical grade PVC tubing 3/8 in.
Page 247: Connect Flowmeter Module
Modules Flow Monitoring Connect Flowmeter Module 1. Mount the flowmeter module bracket to the desired pole location. 2. Mount flowmeter module to the bracket. Note that two flowmeter modules can be mounted on each bracket. 3. Install 2 standoffs on the desired base module receptacle to securely fasten a power cable to the module receptacle.
Page 248 Modules Flow Monitoring 4. Close the sensor latch. Ensure the latch closes securely. The flow system is operational when Perfusion Screen has initialized and the flow icon displays “0.00” L/min. 16:07:51 Safety Previous ART Flow Temps 0.00 L/min Flow 0.00 L/min Once a flow sensor is connected to the circuit, it does not need to be calibrated or turned on to enable flow monitoring.
Page 249: Test Before Use
Modules Flow Monitoring The alarm will clear when the backflow condition has been corrected. Note: When the flow icon has been placed on a centrifugal pump icon, the flow icon will not flash red during an alarm and touching the flow icon will not open the Safety tab.
Page 250: Occluder Module
Modules Occluder Module A Perfusion Screen can be configured to operate 1 occluder. The occluder system provides a computer-controlled tube clamping mechanism used to control flow in the venous line. The occluder display on the CCM displays % open from 0-100% in 1% increments. The occluder display shows the approximate % that the venous tube is open over the range from 0% or fully closed to 100% or fully opened in only 1/2 in.
Page 251: Connect Occluder Module
Modules Occluder Assembly Mount the occluder head on a pole according to these installation instructions. 1. Attach the occluder mounting bracket to the desired pole location. 2. Place the ball end of the mounting rod into the occluder head socket. 3.
Page 252: Occluder Module
Modules Occluder Module Insert Tubing 1. From the Perfusion Screen, touch the Occluder icon on the CCM. This will activate the occluder control slide bar. 2. On the occluder control slide bar, touch the Open OCCL1 button to retract the plunger sufficiently to insert tubing.
Page 253: Calibration
Modules Occluder Module Calibration 1. On the occluder control slide bar, touch the CAL button. When calibrated, the occluder icon displays 0% Q and the control slide bar changes to the operational control slide bar. 0 % Q 2. After calibration, ensure the tube is properly positioned in occluder head. Test Before Use OCCL1 1.
Page 254: In The Event Of An Occluder Module Malfunction
If a venous reservoir is not available, use extra diligence and be prepared to manually clamp the line immediately in response to a pump stop/coast event triggered by an air alarm. • Contact Terumo Customer Service at the end of the case. 7-32...
Page 256: Interface Module For Cdi™ 100/101 And Cdi™ 500
2. Insert module into base receptacle as close as possible to the location where the monitor is located. * 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).
Page 257 Modules Interface Module for CDI™ 100/101 and CDI™ 500 3. To connect a CDI™ 100 monitor, connect the serial cable to the serial communications connector of the monitor. On Switch CDI™ 100 CDI™ 101 4. Route cable to minimize exposure to spills. 5.
Page 258: Cdi™ 500
Modules Interface Module for CDI™ 100/101 and CDI™ 500 CDI™ 500 The CDI™ 500 Monitor is an inline blood parameter monitoring system that is used during cardiopulmonary bypass procedures. It monitors the blood in the extracorporeal circuit and provides information about the blood parameters. The Interface Module for CDI™...
Page 259 Modules Interface Module for CDI™ 100/101 and CDI™ 500 3. Connect the serial cable to the CDI™ 500 monitor at the pump interface port. The serial cable must be connected to the pump interface port on the monitor to input blood flow data from the System 1 primary pump. Pump Interface Port 4.
Page 260: Cdi™ Messages
100/101 Check CDI 100/101 settings and No CDI 100/101 Data disconnected or not cable connections. If message all data is being still appears, contact Terumo detected. Cardiovascular Systems Service. Interface Module for CDI™ 500 Priority Condition CCM Message Operator Response ™...
Page 261 Modules Interface Module RS-232 Connect Data Transfer Module 1. Attach the serial cable to the appropriate data transfer module. 2. Insert module into base receptacle as close as possible to the location where the data collection system will be used. 3.
Page 262: Electronic Gas Blender
It also provides monitoring of the carbon dioxide if 95% oxygen / 5% carbon dioxide (95/5) is used as the blending gas instead of air. The electronic gas blender is an optional component of the Terumo Advanced ®...
Page 263: Installation And Connection
Electronic Gas Blender Installation and Connection Gas inlet connections are located on the back panel of the system base. The air inlet connector incorporates an externally mounted water trap. Depress the valve on the bottom of the water trap to empty any water. Note: See Additional Information, System Components for selections of color-coded hoses and wall supply adapters.
Page 264: Setup
Gas Blender Vaporizer 6. Use of the backup external mechanical flowmeter (supplied in the Terumo APS1 Accessory Kit) is strongly recommended. Position the backup flowmeter just before the oxygenator to detect any possible gas leak between the gas outlet and the oxygenator, and as a backup to monitor gas flow in the event CCM capability is lost.
Page 265 Electronic Gas Blender Choosing the Blending Gas The user has the option to blend the oxygen with either medical grade air or 95/5. The default O Blend is Air. To change the O Blend: 1. Touch the Setup tab in the Perfusion Screen and then touch the Gas subtab. 2.
Page 266 Electronic Gas Blender Calibrating the Oxygen Analyzer and Gas Flow Sensor Calibration of the oxygen analyzer and flow sensor should be performed prior to each case. Note: In an emergency situation, the user may proceed to go on bypass without performing calibration.
Page 267 Electronic Gas Blender Calibration takes approximately 1 minute and 50 seconds. During the calibration process, gas flow is temporarily shut off. Following the gas flow shut off: • If the O2 blending gas is air, the FiO knob automatically adjusts to 21% and then to 100%.
Page 268 Electronic Gas Blender If Calibration is Not Successful: An unsuccessful calibration is indicated by the following items: • The label for Calibration Status in the Gas subtab within the Setup tab remains “Not Calibrated”. • CAL remains on the %O2 icon. •...
Page 269 • Contact Terumo Cardiovascular Systems Customer service for assistance. Note: During a case, if the oxygen sensor and gas blender readings do not agree, the %O2 icon will display CAL and a CCM message “Calibrate O2 Analyzer” will appear.
Page 270 Electronic Gas Blender Operating the Electronic Gas Blender from the CCM Controlling the Gas Flow Gas Flow Set point 1. Touch the Gas icon. FiO2 2. Use the gas slide bar to increase and decrease the 0.80 2.00 Set point gas flow rate within the range of 0 to 10 L/min.
Page 271 Electronic Gas Blender Local Control of the Electronic Gas Blender Controlling the Gas Flow The gas flow control knob has a graphic indicating the direction to turn the knob to increase or decrease gas flow. Turn the knob counterclockwise to increase the gas flow rate and clockwise to decrease the gas flow rate.
Page 272 Electronic Gas Blender Controlling the FiO The FiO knob has a reference mark and tic marks on the front panel approximately indicating 0.1 increments in FiO from 0.21 to 1.00 when using air as the blending gas. When using 95/5 (95% oxygen/5% carbon dioxide) as the blending gas, the tic marks approximately indicate 0.00625 increments from 0.95 to 1.00.
Page 273 If the knobs cannot be turned, use standby gas blender. Do not use gas system until it has been serviced by Terumo Customer Service. See the Messages subtab within the Aux tab for any additional error or status messages.
Page 274 If the knobs cannot be turned, use standby gas blender. Do not use gas system until it has been serviced by Terumo Customer Service. See the Messages subtab within the Aux tab for any additional error or status messages.
Page 276 Run a Case These are condensed directions on how to check, start-up, set up, and use the System 1. When necessary, refer to other sections of the manual for specific information. Check the System 1 Hand Cranks/Standby Pumps Verify that the hand cranks and any standby pumps are present, set to direction of forward flow, and are accessible.
Page 277 Run a Case Online Pumps Access the Pumps subtab within the Setup tab and verify pump labels, display units, and tube size. Verify safety connections and pump responses. Adjust tube sizes, display units, and pump responses if necessary. Verify pump labels, pump direction, and tube size on the pump local display.
Page 278: Perfuse The Patient
Run a Case Pressure Transducers Verify that all pressure icons read CAL. Check that each transducer is at the correct elevation. Calibrate the pressure sensors while the transducers are open to atmospheric pressure. Verify pressure labels and the alarm and alert limits via the Pressure subtab within the Safety tab or by touching the icon(s).
Page 279 Run a Case Monitor Monitor the patient and system controls and displays, adjusting the controls as necessary. Servo Control Initiate servo control when appropriate and when pump flow rates and servo setpoints have stabilized. CPG Delivery Utilize the Delivery subtab within the CPG tab to track cardioplegia delivery, employ cardioplegia timers, and to deliver auto doses, if desired.
Page 280: Emergency Procedures
Emergency Procedures The situations in this section will help you use this system proficiently should an actual emergency occur. Practice operating the system during a wet run, simulate the emergency condition, and follow the suggested operator responses. Perfusion Situations Conditions such as Air Detected, Low Blood Level, High Pressure, Backflow, and Minimum Flow Provided you have configured your System 1 to include air, level, pressure, flow and/ or centrifugal control units, and they have been enabled, the first indication of an...
Page 281 Emergency Procedures Air Detection Stops a Centrifugal Pump When an Air Bubble Detector stops the centrifugal pump, clamp both the arterial and venous lines. Remove any air from the arterial line before resetting the air detection and restarting the pump. Air Detection Causes a Centrifugal Pump to Coast When an Air Bubble Detector causes the centrifugal pump to go to Coast speed, clamp both the arterial and venous lines.
Page 282 Response to “Message Only”. This should prevent potentially erratic pressure readings from stopping/pausing the pump, if the pressure system malfunction manifests intermittently. • Contact Terumo Customer Service after the case is completed. Unexpected Return to Bypass • Power up the system.
Page 283 Emergency Procedures Loss of Power Without Automatic Switch To Battery Backup System WARNING: Confirm that the entire system has lost power before continuing with these instructions. Check the central control monitor (CCM), the local pump dis- plays, the LED indicators on the modules, and the power status indicator on the front of the system to confirm that power has been lost.
Page 284: Equipment Situations
Emergency Procedures Equipment Situations Pump Failure An audible alert or alarm and message or only a message will be generated to indicate a pump failure involving a roller pump overspeed condition, a roller pump jam, or centrifugal pump overcurrent condition. Check the message area on the CCM to identify whether there is an overspeed condition, roller pump jam, or centrifugal pump overcurrent condition.
Page 285 If the coupling cannot be accomplished or the desired flow cannot be achieved, use standby equipment. Contact Terumo Cardiovascular Systems and do not use the drive motor until it is serviced.
Page 286 Emergency Procedures Loss of Local Control (roller pump or centrifugal control unit) A failure of the local controls may result in the pump failing to respond to a user command from these local control points: Start/Stop button, pump speed control knob, Select button, or Manual button.
Page 287 Central Control Monitor Malfunctions Pumps and connected safety devices will function even if the Central Control Monitor fails. If there is a failure, contact Terumo Cardiovascular Systems Service before using the system again. A failure of the Central Control Monitor may be expressed as: a frozen touch screen, portions of the screen may appear blank, or there may be a message “System...
Page 288 Emergency Procedures If the system computer is lost, it will not be possible to follow the recommended shut down procedure. The system power should be turned off when the case is finished by depressing the bottom of the AC (Mains) power switch. Using Local Control upon a Central Control Monitor Failure If the Central Control Monitor Fails During Bypass Failures of the CCM include frozen touch screen, portions of the screen may appear...
Page 289 Emergency Procedures • The electronic gas blender manual controls for output gas flow and FiO located on the front of the system base under the front tray. An external gas flow meter should always be connected to the output for confirmation of the output gas flow.
Page 290 Emergency Procedures • If an occluder was in use, the occluder latch can be opened at any time to realease the tubing. Utilize tubing clamps to occlude the line for the remainder of the case. • Note: Occluder safety connection configurations active prior to loss of the CCM will still be active, but the occluder will not be controllable through the CCM.
Page 291 Be aware that pumps may not communicate with or respond to events from connected devices. There may be no alarm or alert audible tones or messages. No data transfer will occur if CCM is unavailable. Contact Terumo Cardiovascular Systems for service.
Page 292 Emergency Procedures Roller Pump Mode Status Display Control Start Remains as set Flow rate or speed on pump Complete control from knobs and Stop display buttons on pump control panel. Pause Continuous Servo Control Remains as set Setpoints and status displayed Control from pump speed control on pump display knob.
Page 293 Emergency Procedures Air Bubble Detect Module Condition Status Display Control On/Off Remains as set LED on module displays status Cannot enable if disabled. Air Detect Functional LED flashes red Reset Air Bubble Detect module via Alarm Dual tone alarm sounds if Select button on pump control panel connected to a pump.
Page 294 Emergency Procedures Flowmeter Module Condition Status Display Control Monitoring Monitoring LED on module displays status. None. capability is lost Flow displayed on the centrifugal unless flow was pump display if flowmeter was placed on placed on the Centrifugal Pump Centrifugal Pump icon.
Page 296: Technical Support
System 1. 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.
Page 297: Communication Protocol
Technical Support Communication Protocol Functional Description The data transfer module of the System 1 collects and sends formatted ASCII information through an RS-232 port. Two types of case information are output from the data transfer module: periodic and event data. Periodic data is sent every 30 seconds. Event data is sent when the event occurs.
Page 298 Technical Support Frame Definitions ASCII Start of text transmission control character, decimal value 2. Single ASCII numeric character 0 through 7, decimal values 48 through 55, representing the frame number, modulo 8. In this application, FN is always 0. RECORD CONTENT Variable length record content.
Page 299 Technical Support Units Field (9 bytes maximum) The units field is an ASCII string that represents the units of the data value. Device Names Device names are defined in the CCM Configuration area. The following tables show the standard, provided device names. Custom names are allowed but not recommended.
Page 300 Technical Support Danish Pumps Level Timer Occluder Pressure Flow Temperature ART luft Niveau Pumpe Klemme ART tryk ART flow ART temp Arteriel VEN luft VEN niv Klem tim VENklemm VEN tryk VEN flow VEN temp CPG luft CPG niv CPG tim ARTklemm CPG tryk CPG flow CPG1temp...
Page 301 Technical Support French Pumps Level Timer Occluder Pressure Flow Temperature AirART Niveau Pompe Clamp PressART DébitART TempART AirVEIN NivVEIN Clampage ClmpVEIN PresVEIN DébVEIN TempVEIN AirCPG NivCPG ChronCPG ClampART PressCPG DébitCPG TempCPG1 CPG1 AirCPG1 Niveau1 ChroCPG1 ClampCPG PresCPG1 DÉBIT1 TempCPG2 CPG2 AirCPG2 Niveau2 ChroCPG2...
Page 302 Technical Support Italian Pumps Level Timer Occluder Pressure Flow Temperature BolleART Livello Pompa Occl PressART FlussART TempART BolleVEN LivVEN Clamp OcclVEN PressVEN FlussVEN TempVEN BolleCPG LivCPG CronoCPG OcclART PressCPG FlussCPG TempCPG1 CPG1 BollCPG1 LIVELLO1 CronCPG1 OcclCPG PresCPG1 FLUSSO1 TempCPG2 CPG2 BollCPG2 LIVELLO2 CronCPG2 OCCL1...
Page 303 Technical Support Variable Names Each configured device in System 1 has a set of periodic data or events that it provides to the data transfer module. Each of the System 1 devices is listed in the following sections with the specific periodic data and event information that is transmitted from the data transfer module.
Page 304 Technical Support Flow Part of Mnemonic Description Value Units Type Snapshot? BFAM Back flow alarm Safety Event BFMC Back flow alarm cleared Safety Event FLOW Flow -10000 to 10000 mL/min Periodic Gas (device name is “GASMIXER”) Part of Mnemonic Description Value Units Type...
Page 305 Technical Support Pressure Part of Mnemonic Description Value Units Type Snapshot? OPAL Over pressure alert Safety Event OPLC Over pressure alert cleared Safety Event OPAM Over pressure alarm Safety Event OPMC Over pressure alarm cleared Safety Event PRES Average pressure -250 to 900 mmHg Periodic...
Page 306 Technical Support Temperature Part of Mnemonic Description Value Units Type Snapshot? OTAM Over temperature alarm Safety Event OTMC Over temperature alarm cleared Safety Event TEMP Temperature 0.0 to 50.0 Periodic Timer Part of Mnemonic Description Value Units Type Snapshot? TRST Timer Reset Event TSTA...
Page 307: Emc Tables
EQUIPMENT and SYSTEMS (see 6.8.3.201 a) 6)) Guidance and manufacturer’s declaration – electromagnetic immunity The Terumo Advanced Perfusion System 1 is intended for use in the electromagnetic environment specified ® below. The user of the Terumo Advanced Perfusion System 1 should assure that it is used in such an ®...
Page 308 SUPPORTING EQUIPMENT and SYSTEMS (see 6.8.3.201 b)) Guidance and manufacturer’s declaration – electromagnetic immunity The Terumo Advanced Perfusion System 1 is intended for use in the electromagnetic environment specified ® below. The user of the Terumo Advanced Perfusion System 1 should assure that it is used in such an ®...
Page 309 RF communications equipment and the Terumo Advanced Perfusion System 1 ® The Terumo Advanced Perfusion System 1 is intended for use in an electromagnetic environment in which ® radiated RF disturbances are controlled. The user of the Terumo ®...
Page 310: Nominal Mains Power Consumption
Technical Support Nominal AC (Mains) Power Consumption System Configuration* 100 VAC 115 VAC 120 VAC 220 VAC 240 VAC 4-Pump System 9.5A – 11.5A 8.5A – 10A 8A – 10A 4.5A – 5A 4A – 5A 5-Pump System 10.5A – 13A 9.5A –...
Page 312: Additional Information
Use the system and any attached equipment according to the manufacturer’s instructions and good medical practice. 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.
Page 313 Additional Information In the event that the 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.
Page 314: Warnings
Additional Information Warnings Central Control Monitor • If the Central Control Monitor fails, the system can be controlled through the local controls on the roller pumps, centrifugal control unit, and electronic gas blender, if installed. • In the event the Central Control Monitor fails, only those sensors that have a safety connection to at least 1 roller pump or centrifugal control unit will be able to display messages on a local control panel.
Page 315 Additional Information Roller Pumping • Use caution when roller pumping in the opposite direction of forward flow as air may be drawn into the blood line. WARNING: Always check the pump for proper operational mode after a Pause or Reduce Speed response has been executed. A pump may go to Stop mode and need to be started manually if the pump has received more than one high priority safety messages such as low level alarm and air alarm.
Page 316 Additional Information Centrifugal Pumping • With a centrifugal pump, maintain a minimum pump speed or clamp the pump outlet line and patient’s venous line in order to prevent backflow and drainage of the patient’s blood. Minimum pump speed is the speed which overcomes line and patient resistance.
Page 317: Equipment Precautions
Additional Information Battery Power • If a partially charged battery is used, there may be less than 60 minutes of battery power available for a fully loaded system. • 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.
Page 318 Additional Information Air Sensors • Do not drop air, level, or flow sensors as shock may damage the sensor. • Do not sterilize air, level, or flow sensors as sterilization may damage the sensor. Level Sensors • Do not drop air, level, or flow sensors as shock may damage the sensor. •...
Page 319: Equipment Care
Do not sterilize the air, level, or flow sensors as this will damage the sensor. Wipe the level sensor transducer lens to remove gel. If a sensor is damaged, contact Terumo Customer Service. Clean the CCM. Use a cloth dampened with glass cleaner to clean the Central Control Monitor display screen.
Page 320 Inspect all components. Inspect all components for worn, cracked, or frayed cables, loose connector parts, or malfunctioning parts. If a malfunctioning part is found, contact Terumo Customer Service and do not use a damaged or malfunctioning device. Monthly. . .
Page 321 5 minutes. CAUTION: If the Battery Test results in an indication of less than one hour battery life for a fully loaded system, call Terumo Cardiovascular Systems service. WARNING: Do not start a case with less than one hour battery life.
Page 322: Test The Alarms And Alerts Every Three Months
Additional Information Test the Alarms and Alerts Every Three Months The following checks and tests should be performed periodically. Every Three Months. . . Test Your Alarms and Alerts Pressure Limit Alerts and Set an alert and alarm. Apply a pressure (slightly above alert Alarms value) to the pressure transducer.
Page 323 When OK is selected, the system will return to the Main Screen. WARNING: Do not operate the System with Batteries that have exceeded their 2-year Service life. Less than specified battery life may result. Contact Terumo Customer Service for replacement batteries. 12-12...
Page 324: Electronic Gas Blender Maintenance
If the oxygen sensor exposure limit is reached, the message ‘Service O2 Sensor’ will be displayed in the message area of the CCM. A backup analyzer should be used until the oxygen sensor is replaced by an authorized Terumo Cardiovascular Systems service provider.
Page 325: Removal And Cleaning Of Tube Clamps
Additional Information Removal and Cleaning of Tube Clamps The tube clamp mechanism can be removed from the roller pump for cleaning. To clean the tube clamp assembly: 1. Use a flat head screwdriver (provided with Accessory Kit) to loosen the two screws that hold the tube clamp to the pump head.
Page 326: Replacing Air Filters And Lamp Bulbs
Additional Information Align the studs on the bottom of the tray with the holes in the tray mounting surface of the base and position the tray against the mounting surface. Install the thumbnuts onto the studs. Make sure the nuts are tight and secure. Replacing Air Filters and Lamp Bulbs Air Filters Base...
Page 327 Long Term Storage Long term storage is defined as greater than one month without charging the backup battery system by connecting the Advanced Perfusion System 1 to AC (Mains) power and turning the System 1 on. 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.
Page 328: Service
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.
Page 329 Additional Information 12-18...
Page 330: System Components
Additional Information System Components Description /Catalog No. Central Control Monitor 816300 System Configuration PC Card 803739 Service Data PC Card 803740 Monitor Mounting Arm 801441 Roller Pump, 6 inch 801041 Roller Pump, 6 inch, Gray 816571 Cover-Hinge Assembly, 6 inch 871928 Roller Pump, 4 inch 801040...
Page 331 Additional Information Description /Catalog No. 16 Modules (Continued) Level Detect Module Level Sensor Pads 195240 Temperature Module 802114 Pressure Module 802112 Occluder Module 803480 17 Occluder Head 806455 18 Flowmeter Module 802018 Flow Sensor 6382 Flowmeter Mounting Bracket 801550 Ultrasonic Sensor Gel 164278 19 Electronic Gas Blender Module 801188...
Page 332: Accessory Kit
Additional Information Accessory Kit Description Qty. /Catalog No. Colored Magnetic caps for pump occlusion knobs: 837760 Yellow 837763 Blue 837761 Green 837762 Purple 837765 837764 Light Blue 837767 Orange 837766 Cable Retainer, 1/2 inch 806441 Cable Retainer, 1 inch 806459 Halogen Bulb, 24 V 20 W 132265 Intake Air Filter, Base...
Page 333: Recommended Spare Parts
Additional Information Recommended Spare Parts It is recommended these replacement parts be kept in stock. Pump Safety cover, small 803720 Pump Safety cover, large 803719 Halogen Bulb, 24 V 20 W 132265 Intake Air Filter, Base 802094 Intake Air Filter, Pump 802280 Intake Air Filter, CCM 804517...
Page 334 Additional Information Symbols Glossary The following symbols may appear in the labeling, marking, or display of the Terumo Cardiovascular Systems (TCVS) Advanced Perfusion System 1. These symbols are in accordance with the internationally harmonized standards. Symbol Title Description Source Indicates the need for the Consult instructions for use.
Page 335 Indicates the range of humid- Humidity Limitation ity to which the medical ISO 15223-1-5.3.7 device can be safely exposed Identifies the number of Terumo Cardiovascular Number of contents in carton. contents Systems Indicates the Authorized rep- Authorized representative in the Euro- resentative in the European ISO 15223-1-5.1.2...
Page 336 Description Source Indicates the manufacturer’s catalogue number so that Catalogue Number ISO 15223-1-5.1.6 the medical device can be identified Terumo Cardiovascular ON, circuit closed. ON, circuit closed. Systems Terumo Cardiovascular OFF, circuit open. OFF, circuit open. Systems Indicates not to turn the...
Page 337 Additional Information Symbol Title Description Source Terumo Cardiovascular Temperature Module Temperature Module Systems Terumo Cardiovascular Flowmeter Module Flowmeter Module Systems Data transfer, RS-232 protocol, output Data transfer, RS-232 proto- Terumo Cardiovascular only col, output only Systems Terumo Cardiovascular Data transfer, CDI™ 500 Monitor, input Data transfer, CDI™...
Page 338 Additional Information Symbol Title Description Source Terumo Cardiovascular Centrifugal Pump Centrifugal Pump Systems Terumo Cardiovascular Open reservoir Open reservoir Systems Terumo Cardiovascular Close reservoir Close reservoir Systems Terumo Cardiovascular Oxygenator Oxygenator Systems Terumo Cardiovascular Battery Battery Systems Terumo Cardiovascular Occluder fully open, on occluder slide Occluder fully open, on bar.
Page 339 Additional Information Symbol Title Description Source Turn counterclockwise to increase gas Turn counterclockwise to Terumo Cardiovascular flow and clockwise to decrease gas increase gas flow and clock- Systems flow wise to decrease gas flow Terumo Cardiovascular Recyclable Recyclable Systems Terumo Cardiovascular...
Page 340: Glossary
Additional Information Glossary Air Bubble Detect Module The air bubble detect (ABD) module is the interface between an air sensor and the system. The ABD module monitors the air sensor and communicates any alarms to the system. Air Sensor The air sensor is a non-invasive, ultrasonic sensor which can detect air bubbles in the perfusion circuit.
Page 341 CCM can be used to configure the centrifugal control unit safety connections and pump responses to alert and alarm events. * 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).”...
Page 342 Additional Information Centrifugal Motor The centrifugal motor is the drive mechanism necessary to pump fluid through a disposable centrifugal pump which is magnetically coupled to the motor. The motor is detachable from the centrifugal control unit. Centrifugal Pump A disposable centrifugal pump head coupled to the centrifugal motor, which spins the impeller of the pump head in response to control signals from the centrifugal control unit.
Page 343 Additional Information CPG Tab The section of the Perfusion Screen used to track cardioplegia delivery and to set up and deliver automatic cardioplegia doses. Device A device is any component of the System 1 which can be actively controlled from the CCM including roller pumps, centrifugal pumps, occluders, the gas blender, and timers.
Page 344 Additional Information Graphical User Interface The touch screen area of the CCM that allows the user to interact with the system. It is divided into three functional areas – Configuration, Perfusion, and Service. Graphical User Interface Interface Module RS-232 The RS-232 module provides the interface between RS-232 protocol data acquisition software and the system.
Page 345 Additional Information Local Display A display area located on the device itself. Devices with local displays are roller pumps and centrifugal control units. Main Screen The first screen displayed when the system is started up. From this screen, the user can access the Perfusion, Configuration, and Service areas, and perform a controlled shut down of the system computer.
Page 346 Additional Information Occluder Module The occluder module serves as the interface between the occluder head and the system. The occluder system is controlled from the CCM and can be configured to respond to primary pump events. Offline Device A device that has not been configured as part of the current Perfusion Screen. Online Device A device that has been configured as part of the current Perfusion Screen.
Page 347 Additional Information Pressure Transducer The pressure transducer converts pressure into electrical signals detected by the pressure module. Primary Pump A designation that is assigned to one pump in a Perfusion Screen, usually the arterial pump. Pulse Mode 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.
Page 348 Perfusion Screens and is used by authorized service personnel. Service Screen Service is a functional area of the Central Control Monitor that is used by Terumo authorized service personnel to perform service functions. It is password protected. Examples of functions that can be performed are: viewing the logs; exportation of the system logs, module logs, and Perfusion Screens to an external computer via the service data card, and viewing module error event data.
Page 349 Additional Information Subtab A view contained within a tab. Summary A description of the components, connections, and responses for a Perfusion Screen that can be viewed in the Perfusion Screen selection area. System Base The system base is a moveable platform designed for the adaptable mounting of system components on poles and on a central rail.
Page 350: Index
Index features 2-4, 4-1 functional areas 4-5 Accessory Kit 12-21 malfunctions 10-7 Air Bubble Detect Module (ABD) messages 4-38 adding air detectors in CCM 4-66 PC card compartment 4-4 air bubble detection 7-2 installing and removing 4-4 connecting ABD sensor 7-3 precautions summary 12-6 connecting module 7-2 pump controls and displays 4-13...
Page 351 Index adding timers 4-81 setup 8-3 selecting device type 4-66 EMC Tables 11-12 Configure Perfusion Screen Emergency Procedures configuring pumps 4-56, 4-57 centrifugal pump decouples from drive Configure Pumps motor 10-6 adding primary pump 4-56 equipment situations 10-5 adding pump color 4-57, 4-60 perfusion situations 10-1 backup pump 4-61 Equipment Care...
Page 352 Index Interface CDI™ 100/101 4-76, 7-33 Indications and Warnings 1-4 CDI™ 500 4-78, 7-35 Institutional Controls 2-2 Data Transfer Module RS-232 7-37 Interface Modules Level Detect Module 7-8 CDI™ 100/101 7-34 module failure 10-6 CDI™ 500 7-35 Occluder Module 7-28 Data Transfer Module RS-232 7-37 precautions summary 12-6 overview 2-17...
Page 353 Index Power Responses auxiliary outlet 3-3 no response 4-85 battery 3-4 pause response 4-85 circuit breakers 3-2 reduce speed response 4-85 equipment precautions 12-1 stop response 4-84 nominal power consumption 11-15 rotating raceway 5-5 power cord 3-2 servo control 2-9 verify on 9-1 setting occlusion 5-10 Power Cord 9-1...
Page 354 Index poles, shelf, brackets 3-12 power cord 3-2 pump platform 3-17 extensions 3-17 system network 3-11 System Components 12-18 System Network 3-11 System Philosophy 2-1 System Tab Module Info Subtab 4-34 Power Subtab 4-32 Reassign Module Subtab 4-32 Settings Subtab 4-31 System Time 4-16 Tabs Aux Tab 4-30...
Page 355: Limited Warranty
Limited Warranty Terumo Cardiovascular Systems Corporation warrants that this product will be free from defects in workmanship or material for one year from the date of shipment. This warranty does not apply to filters, light bulbs, fuses, or other expendable items, or to those parts damaged by improper use, accident, improper maintenance or unauthorized repair.

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Terumo Advanced Perfusion System 1 Operator's Manual

About Advanced Perfusion System 1

System Overview

Roller Pumps

Centrifugal Control Unit

Modules

Electronic Gas Blender

Emergency Procedures

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