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1

1

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 

Ann Arbor, Michigan

B

883325

TEXT, ADVANCED PERFUSION SYSTEM 1 OPERATORS MANUAL

PART NUMBER

883325

TEXT:
8 1/2" X 11"
177 PAGES (354 ACTUAL)
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A      90374    

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B      91096   

POWER CORD DAMAGE & EPGS CLARIFICATIONS, ADDITIONAL INFORMATION PN UPDATES

Summary of Contents for 801763

Page 1: ...art Dull INK 4 COLOR PROCESS 8 1 2 X 11 28 White Translucent Vellum slip sheet to be inserted before first page of manual TABS PAPER 110 WHITE INDEX REINFORCED HOLES AND TABS 2 SETS 1 6 CUT TABS INK B...

Page 2: ...Advanced Perfusion System 1 Operators Manual...

Page 3: ...ii...

Page 4: ...ontact Terumo Cardiovascular Systems Corporation Service your local Terumo company or your authorized distributor for technical assistance and to arrange for service If the device is to be returned in...

Page 5: ...verview 1 7 System Overview System Philosophy 2 1 Institutional Controls 2 2 System Base 2 3 Features 2 3 Central Control Monitor 2 4 Features 2 4 Display Areas 2 4 Roller Pumps 2 8 Features 2 8 Centr...

Page 6: ...Module Covers 3 21 Cable Cover 3 21 Central Control Monitor Features 4 1 Connect CCM 4 2 Start Up Messages 4 3 PC Card Compartment 4 4 Functional Areas 4 5 Displays and Controls 4 6 Device Icons and...

Page 7: ...Safety Connections 4 83 Connection Matrix 4 90 Assign Devices to Modules 4 92 Assign Air Detectors Level Detectors Occluder Flow Sensors CDI 4 93 Assign Pressure and Temperature Sensors 4 94 Assign Ro...

Page 8: ...6 15 Centrifugal Control Unit Messages 6 15 Modules Features 7 1 Air Bubble Detection ABD 7 2 Connect ABD Module 7 2 Connect ABD Sensor 7 3 Enabling and Disabling Air Detection Alarms 7 4 Test Before...

Page 9: ...Tubing 7 30 Calibration 7 31 Test Before Use 7 31 Control and Display 7 31 Occluder Module Messages 7 32 In the Event of an Occluder Module malfunction 7 32 Interface Module for CDI 100 101 and CDI 5...

Page 10: ...Precautions 12 1 Warnings 12 3 Equipment Precautions 12 6 Equipment Care 12 8 Clean and Check the System After Each Use 12 8 Test the Alarms and Alerts Every Three Months 12 11 Electronic Gas Blender...

Page 11: ......

Page 12: ...etect Low Blood Level and Select Pump Responses Monitor Pressures and Select Pump Responses Monitor Temperatures Monitor Flow and Select Pump Responses Monitor Cardioplegia Fluid Delivery Times and Vo...

Page 13: ...system base or they can be pole mounted to reduce the lengths of tubing in the perfusion circuit Roller pumps can be mounted on the system base or on a pole with an appropriate mounting bracket The d...

Page 14: ...re for potential emergencies by studying the Emergency Procedures section Maintain the system as directed in the Equipment Care section Refer to the Additional Information section to find information...

Page 15: ...the manufacturer s instructions and good medical practice This device is qualified only for durations appropriate to cardiopulmonary bypass procedures It has not been qualified through in vitro in viv...

Page 16: ...accessories to the system Use of extension cords may compromise performance In the event that an AC Mains circuit breaker trips immediately after a reset DO NOT attempt to reset again The system will...

Page 17: ...ked use is necessary observe the system closely to verify normal operation in the configuration in which it will be used Read the additional Warnings and Precautions located in the appropriate section...

Page 18: ...mary Pump q Gas System Occluder q Other Pumps q Perfusion Screen Tabs q Setup Tab q Patient Subtab q Gas Subtab q Pump Subtab Training Overview q Occluder Subtab q Timer Subtab q Time Date Subtab q Sa...

Page 19: ...q Mounting and Positioning q Accessing Power q Self Diagnostics q Control q Local q CCM q Local Control q Graphic Display q Pump Name q Centrifugal Icon q Speed control knob q Pump speed q Flow rate d...

Page 20: ...CDI 100 monitors 1 q Maximum number of CDI 101 monitors 1 q Selecting and displaying data values q Roller pumps q Centrifugal pumps q Reset button q Testing the ABD q Alarm Messages q Status Messages...

Page 21: ...delivery q Adjusting total volume delivered q Servo Control q Varying CPG ratios q Delivering a fixed dose q By Volume q By Time Timers q Maximum number 4 q Two timers preassigned q Pump q Clamp q Au...

Page 22: ...figured to deliver advanced functions such as Roller and Centrifugal Pumps Pulse mode Servo regulation to pressure or flow Roller Pumps only Master Follower operation Cardioplegia volume tracking Auto...

Page 23: ...ures This is not intended as an all inclusive list of actions but is merely a guide to illustrate examples of what an institution should consider when using System 1 Additional or different actions ma...

Page 24: ...to aid in cable management The centrifugal control unit is mounted on the system with a pole mounting bracket Modules are connected to the receptacles on the sides of the base A locking rail protects...

Page 25: ...n card and a service data card The system configuration card may be used to transfer perfusion screen configurations between systems The service card collects and stores data for use by authorized ser...

Page 26: ...configuration area If desired access to a Perfusion Screen can be limited by assigning a password Perfusion Screen Open View Summary Return to Main Name Password Choose a Perfusion Screen CABG Roller...

Page 27: ...p Safety CPG Aux System Post Case PCO2 K pH mmHg PO2 mmHg mmol L 16 07 51 Clamp Reset Reset 000 00 Pump Reset Reset 000 00 Arterial L min Vent L min Sucker1 L min Arterial 0 000 L min 10 78 0 100 0 CP...

Page 28: ...nts Selecting occluder responses to primary pump events Assigning screen representation to physical modules and devices Naming the Perfusion Screen and identifying the screen as ready for use For more...

Page 29: ...m 3 on each side Roller pumps can also be connected to any of the module receptacles Up to 8 pumps can be connected to the system but only 6 can be controlled through the Central Control Monitor at an...

Page 30: ...luid volume or delivers fluid for a set amount of time and then stops Roller pumps can be connected to safety and monitoring systems and other pumps during configuration followed by choosing pump resp...

Page 31: ...through the Central Control Monitor Servo Control pump speed is regulated to maintain a specific pressure or flow rate The pressure and flow rate setpoints can be adjusted through the Central Control...

Page 32: ...sensor needed Each module has a tricolor LED light emitting diode to indicate module status Status modes are Constant Green Online Mode Blinking Yellow Alert Condition Blinking Green Assignment Mode C...

Page 33: ...ing and gas bubbles of 0 5 cc or larger at flow rates up to 6 L min for 3 8 in 9 5 mm I D tubing The air bubble detect module only operates in the alarm mode Pump responses to an air alarm are selecte...

Page 34: ...ressure Module The pressure module provides the interface between pressure transducers and the system Each pressure module has 2 channels Two pressure transducers can connect to each pressure module U...

Page 35: ...paused or stopped a pump that pump can then resume or be restarted if no other pause or stop responses are in effect If the pressure reading returns into range between 250 mmHg and 900 mmHg inclusive...

Page 36: ...unit display and the minimum flow alarm will be functional For centrifugal pumping a minimum flow alarm can be set to warn of reduced flow In the event of a minimum flow alarm a dual tone audible alar...

Page 37: ...size from 1 4 in 6 4 mm I D x 1 16 in 1 6 mm wall thickness to 1 2 in 12 7 mm I D x 3 32 in 2 4 mm wall thickness with a recommended nominal durometer range of 65 70 Shore A The occluder is controlled...

Page 38: ...ers that can be displayed are arterial PO2 arterial PCO2 arterial pH arterial temperature arterial oxygen saturation bicarbonate base excess venous PO2 venous PCO2 venous pH venous temperature venous...

Page 39: ...gas blender can be controlled from the Central Control Monitor by using the Gas and FiO2 slide bars or locally by using the control knobs on the front of the base Gas flow information is displayed on...

Page 40: ...onents 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 recepta...

Page 41: ...n some countries regulations require potential compensation in this case connect the cable from the potential compensation network to the ground equalization stud Circuit Breakers There are 3 resettab...

Page 42: ...es the automatic battery backup When the system is operating from AC Mains power the power status indicator LED on the front panel is illuminated and steady To Turn the System On 1 Press the top of th...

Page 43: ...ttery alert tone will sound and the power status indicator LED will flash If the Main Screen is open the Power Source Battery Status icon will flash and display a color indicating the approximate batt...

Page 44: ...ime available More information is available in the Power subtab when a Perfusion Screen is open The batteries will charge as needed while the system is operating from AC Mains power To recharge the ba...

Page 45: ...er Status Indicator LED Provides a status as the batteries charge or the bat tery capacity if the battery system is actively providing backup power When starting a system that has been in storage allo...

Page 46: ...used as approximations of the amount of time remaining Power subtab within the System tab only displayed on the Perfusion Screen Contains a summary of the power information for the system See the Cent...

Page 47: ...n battery circuit components are monitored constantly during operation If a problem is detected the following message will be displayed Battery Cannot be Charged Full Backup May Not be Available If th...

Page 48: ...t least 5 minutes the system will post a reminder at the Main Screen to perform a Battery Test The most accurate estimate is achieved after 5 minutes operation without AC Mains Power The Battery Test...

Page 49: ...ck 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...

Page 50: ...em modules and pumps to be connected to any dedicated receptacle on the base It also allows multiple types of modules to be connected to the system The user can define how these modules interact with...

Page 51: ...roll while maintaining a fixed position of the wheels Apply upward or downward pressure on the locking lever to change the position Position 1 The casters are locked in place and will not move When th...

Page 52: ...ars of both of the poles Remove the inner section of the telescoping pole Remove both of the collars If the desired position of the shelf is below the horizontal crossbar loosen the handle screws on b...

Page 53: ...concentrate the weight where it could cause the system to tip The mounting area is divided into six zones with limits on the amount of that weight can be mounted in each zone The table below shows the...

Page 54: ...s 29 5 In 0 75 m 29 5 In 0 75 m 9 5 In 0 24 m 9 5 In 0 24 m 33 5 In 0 85 m 67 5 In 1 71 m 2 PUMPS MINIMUM D A C B 29 5 in 0 75 m 29 5 in 0 75 m 67 5 in 1 71 m 33 5 in 0 85 m 9 5 in 0 24 m 9 5 in 0 24...

Page 55: ...Occluder head 4 2 lbs 1 9 kg Air Sensor 0 48 lbs 0 22 kg Flowmeter Module 1 lb 0 5 kg Roller Pump Pole Mount 3 6 lbs 1 6 kg Dual Pumps Pole Mount 5 7 lbs 2 6 kg Descending Pump Bracket 5 5 lbs 2 5 kg...

Page 56: ...ts of a rail adjustable endcaps and extensions that are used in conjunction with the endcaps The chart below represents the placement of roller pumps on the platform L indicates a large roller pump S...

Page 57: ...extension If removing extensions remove securing screws and remove extension If adding extension insert extension and install securing screws 7 Push the end caps in until they stop 8 Tighten set scre...

Page 58: ...ed The front portion of the lamp bracket and the front portion of the hand crank bracket can be coupled into one system to reduce the number of brackets attached to the poles Hand Cranks Hand cranks s...

Page 59: ...ing the pump rollers when it is rotated in the opposite direction of forward flow Ensure that the hand crank can be used properly without interference from pole mounted pumps Cable Management The base...

Page 60: ...Remove Module Cover 1 Grasp the module cover handle 2 Pull toward the front of the base To Replace Module Cover 1 Align the cover on the slide rail 2 Push into place Cable Cover The cable cover is mou...

Page 61: ...1764 with serial numbers less than 1000 To Install Cover 1 Slide front part of cover under roller pumps on the base 2 Place cover over rear cable management tray 3 Apply pressure to the outer edges of...

Page 62: ...onses During use the CCM monitors the system for alert alarm error or status messages and displays the highest priority message in a dedicated message area The CCM also allows the user to initiate aut...

Page 63: ...or maximum visibility The display should be positioned within a viewing angle of 45 horizontal and 30 vertical exceeding these viewing angles will decrease the contrast of various colors When power to...

Page 64: ...this chapter In the event of a System Power System Computer System Network or Gas System start up failure cycle power by turning the Mains Power off and then back on If the message is still displayed...

Page 65: ...and stores data for use by authorized service representatives The system configuration card and service data card are not interchangeable and must be used in the appropriate slot To Install a PC Card...

Page 66: ...ion cardioplegia volume tracking and automatic cardioplegia time or volume delivery The Configuration area of the CCM is used to define Perfusion Screens including number and names of modules and devi...

Page 67: ......

Page 68: ...e device in configuration Temperature Sensor Opens Temp subtab in perfusion screen or selects the device in configuration Flowmeter Opens Flow subtab in perfusion screen or selects the device in confi...

Page 69: ...New Name Enter New Name To Add Device Cancel Current defined 0 Maximum allowed 1 Air Detector Level Detector Select Device Type Occluder Pressure Sensor Flow Sensor Select From List Temperature Senso...

Page 70: ...creen Keyboard The keyboard is used to create and edit passwords and assign names Please note the shift number characters are not active Passwords are used to limit access to Perfusion Screens and the...

Page 71: ...ccess to Configuration area Definition of password characteristics Length e g passwords shall contain a combination of at least 6 but no more than 8 alphanumeric characters Characters e g at least one...

Page 72: ...a perfusion case Touch the Perfusion button to go to Choose a Perfusion Screen The screen lists all Perfusion Screens by name and indicates whether the screen is password protected All screens that a...

Page 73: ...ress High Pressure Alarm Stop CPG Press High Pressure Alert Message Only Small Roller Pumps Vent Sucker 1 Sucker 2 Timers Pump Clamp TMR1 Close Screen Name View Summary The summary screen displays inf...

Page 74: ...ght or left side of the Perfusion Screen Setup Safety CPG Aux System Post Case PCO2 K pH mmHg PO2 mmHg mmol L 16 07 51 Arterial 0 000 L min 10 78 0 Clamp Reset Reset 000 00 Pump Reset Reset 000 00 SO2...

Page 75: ...tivated using the Start button for the pump to be used again To start a pump 1 Touch the Start button The button color changes to red and the label changes to Stop The pump speed flow display button a...

Page 76: ...de bar position The set point display should display the new setting 3 Use the adjustment arrows to make fine adjustments Each pump has a corresponding slide bar which is used to adjust its speed on t...

Page 77: ...e bar displays the name Gas and the set point flow rate in L min The minimum value is 0 and the maximum is 10 L min The adjustment arrows can be used to adjust the flow rate by 0 1 L min The FiO2 slid...

Page 78: ...e message for the condition that occurred first will be displayed in the message area until it clears If the second condition still exists after the first has been cleared then that message will be di...

Page 79: ...ed 3 To restart the timer touch the Time Display area again The timer continues counting from the current value The stop time disappears 4 To reset a count up timer to 0 or a count down timer to its i...

Page 80: ...small arrows initially adjust the value to 30 cm Subsequent adjustments are 20 cm for the large arrows and 1 cm for the small arrows The maximum height is 250 cm 3 Touch the Height button again to st...

Page 81: ...ts the low FiO2 alarm and calibrates the oxygen analyzer See the Electronic Gas Blender chapter for detailed information about connecting and operating the gas blender To Select O2 Blend Touch the O2...

Page 82: ...is displayed Changes are only retained for the current case To Change Tube Size 1 Use the scroll arrows to view the list of available sizes 2 Touch the correct tube size from the list The tube size s...

Page 83: ...s button to toggle through the choices Stop when the desired selection is displayed Changes are retained for the current case only Set Min Flow Alarm The Min Flow Alarm button is only available when a...

Page 84: ...pump Coast and minimum flow The system will automatically assign the response chosen for stop Coast or minimum flow to the other two events To Change Occluder Response 1 Select the event response to b...

Page 85: ...lue button 2 Use the arrows to set the start value The large arrows adjust the value by 1 minute the small arrows adjust the value by 1 second The maximum value that can be entered is 990 59 3 Touch t...

Page 86: ...e To Change the Date 1 Touch the Month button The button will turn white 2 Use the arrows to adjust the value The large arrows adjust the value by 3 and the small arrows adjust the value by 1 3 Touch...

Page 87: ...tion about operating safety systems from the CCM see the module chapters Air Bubble Detection Level Monitoring Pressure Monitoring Temperature Monitoring Flow Monitoring CPG Tab If a pump was identifi...

Page 88: ...e CCM The Total Delivery value is displayed in black indicating that it can be modified To modify the Total Delivery volume 1 Touch the Total Delivery button The button background turns white 2 Use th...

Page 89: ...the Deliver mode by pressing the Deliver button If the cardioplegia pump is running n Time Since Last Delivery timer stops n The Current Delivery value is set to 0 and the system tracks the volume fo...

Page 90: ...button The Dose Value button turns white Adjustment arrows appear 3 Use the arrows to modify the Dose Value For mL the small arrows change the volume by 10 mL and the large arrows by 100 mL For time t...

Page 91: ...top the cardioplegia pump or change delivery mode from Auto to Manual Auto Dose value stops decreasing and the current value is displayed If the cardioplegia pump is running and Manual mode was select...

Page 92: ...tab has two subtabs Timers and Messages Timers Subtab Timers other than Pump and Clamp are controlled through the Timers subtab To change the start value of a count down timer use the Timers subtab wi...

Page 93: ...sages Use the scroll bar to view messages that are beyond the viewing area System Tab The System tab has four subtabs Settings Power Reassign Module and Module Info Settings Subtab This subtab allows...

Page 94: ...dule function to replace the device A reassigned device takes on the role of the broken device including icon control from the Perfusion Screen all alert and alarm limits and all safety connections No...

Page 95: ...events and a roller pump Message Only response for alert events 4 Verify that the correct module LED pump module Identification ID or pump name is flashing When the correct module is flashing touch th...

Page 96: ...us Temperature degrees C and Pass Fail Status Total Volume mL total volume delivered for selected roller pump A failure of the self test or operational status indicates the module or pump is not funct...

Page 97: ...yed Servo Subtab In Servo mode the pump speed is automatically regulated to maintain a specific user selected pressure or flow During Configuration a pressure or flow module is designated as a servo d...

Page 98: ...rements of 5 4 Touch the Base button again to store the new value The recommended minimum Base is 30 To Set the Width 1 Touch the Width button 2 Use the large arrows to change the Width in increments...

Page 99: ...hen the tab was opened and the connect status of the pumps If the master and follower pumps lose their connection to each other these pumps will stop automatically The connection between these pumps m...

Page 100: ...f stopped Pump Response Air sensor on and ABD Name Reconnect air sensor reset air disconnected AIR DETECTED sensor restart pump if stopped Pressure has risen Pressure Name Correct over pressure condit...

Page 101: ...tch source if 18 psi below the O2 necessary pressure 95 5 source pressure HIGH 95 5 SUPPLY Check 95 5 supply pressure and 70 psi PRESSURE switch source if necessary Over temperature Temperature Name C...

Page 102: ...ERCURRENT message reappears discontinue use overcurrent condition of the pump until it has been serviced by Terumo Cardiovascular Systems Reassign pump use standby equipment or use hand crank Primary...

Page 103: ...contact Terumo Customer Service Reassign pump use standby equipment or manual drive unit Pump speed is out of Pump Name Check the operation and placement of servo range limit MONITOR FLOW the servo so...

Page 104: ...age does not malfunction clear replace and reassign module Alarm level sensor or Level Detector Name Check alert alarm or level sensor alert level sensor self CHECK PROBE connections If message does n...

Page 105: ...l Cardiovascular Systems Reassign malfunction pump use standby equipment or use manual drive unit Centrifugal pump has Centrifugal Pump Name Try to restart the pump If the detected overspeed Overspeed...

Page 106: ...become disconnected Check Probe message clears automatically Temperature out of Temp Channel Name Correct out of range condition range Check Probe Message clears automatically Status AC Mains power t...

Page 107: ...age clears automatically to the venous reservoir Level system is off Level Detector Name Reconnect level sensor level sensor becomes Disconnected Message clears automatically disconnected from module...

Page 108: ...bration Cannot Calibrate O2 Check status code failed Analyzer XX may only Retry calibration If calibration does appear in Aux tab not pass use backup until unit can be 12 User pressed cancel serviced...

Page 109: ......

Page 110: ...guration button on the main screen to access the Configuration functional area Use the keyboard to enter password if necessary Configuration The Configuration area has two sections System Settings and...

Page 111: ...een and save the changes 4 Touch Cancel to exit and keep the previous settings Note Pumps connected to the base will have their direction changed to match the new system direction just selected unless...

Page 112: ...Card List windows will be displayed Do not remove card when the Accessing PC Card or Building PC Card List windows are displayed Accessing PC Card Do Not Remove PC Card Name Ready Last Edit Close PC...

Page 113: ...ch the appropriate Move button Name Ready Last Edit Close PC Card Utilities Card Edit Card Name System Computer Name Ready Last Edit Name Ready Last Edit Sample Move Move Copy Copy View Summary Rename...

Page 114: ...select a device type choose Assign devices in the top portion of the Assign Configuration Device to Physical Module window the Assigned Device field will be blank the device type appears under the Ass...

Page 115: ...ard to enter the new name 4 Touch OK or Enter to save the new name Delete To delete a Perfusion Screen 1 Touch the Perfusion Screen name 2 Touch the Delete button A confirmation window will be display...

Page 116: ...must be designated as the backup pump A Perfusion Screen can also contain Up to 4 Air Detectors One Level Detector One Occluder Up to 8 Pressure Sensors through the use of 4 modules Up to 4 Flowmeter...

Page 117: ...or cancel the creation of a new screen This is the first of a series of screens the user must complete in order to configure a Perfusion Screen 2 Use the Next and Previous buttons to go back and fort...

Page 118: ...t and Pump Left 1 Touch the patient and pump icon that corresponds to the preferred orientation or make no selection and accept the default 2 Touch Next to continue or touch Cancel to cancel the creat...

Page 119: ......

Page 120: ...on both the CCM and the roller pump display The default selection is L min If a centrifugal pump is selected as the pump type the display units default to RPM A centrifugal pump can be configured to d...

Page 121: ...name from the list 1 Use the up and down arrows to scroll through the list 2 Choose the desired name under Select Pump Name The default selection is Arterial To assign a name that is not on the list...

Page 122: ...kup pump A total of six pumps can be displayed and controlled on a Perfusion Screen A list of pumps that have been added appears below the menu The primary pump name should appear in the list Use the...

Page 123: ...display units default to RPM A centrifugal pump can be configured to display flow rates in L min if a flowmeter is added to the configuration and placed on the centrifugal pump icon See Add Flow Sens...

Page 124: ...No Backup Pump No 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...

Page 125: ...Pump Small Roller Pump Large Master Roller Pump Small Master Roller Pump Centrifugal Pump If a primary centrifugal pump is reassigned to a backup roller pump and if flow has been placed on the centrig...

Page 126: ...elect Pump Color Available Assigned No Selection Enter New Name Or Enter New Name Next Previous To Specify Follower Pump Cancel Arterial Large Follower Roller Pump Small Follower Roller Pump Select Fo...

Page 127: ...ose the Undo Place button to remove the pump from its place on the screen Choose Do Not Place and the pump will not be placed on the screen Up to 6 pumps can be placed on the screen A seventh pump can...

Page 128: ...een made to the pump The safety connections must be set up for the newly designated cardioplegia pump and removed from the previously designated cardioplegia pump Use the Place button to change the lo...

Page 129: ......

Page 130: ...en Configure Other Devices Menu CABG ROLLER Vent L min START Sucker1 L min START Sucker2 L min START CPG L min START Edit Place Remove Place Remove Edit When placing devices consider the appropriate l...

Page 131: ...of that type and the maximum number of devices of that type are displayed in the box below the list Touch Cancel to cancel the addition of a device Add Air Detectors Up to 4 Air Detectors can appear...

Page 132: ...t one safety connection is required between an Air Bubble Detect module and the primary pump It is highly recommended that an Air Bubble Detection system be used on the arterial line with a safety con...

Page 133: ...m mode Alert Only allows the user to set up one level sensor on a reservoir Alert sensors cannot be used to stop pumps Alert Alarm allows the user to set up two level sensors on a reservoir Alarm sens...

Page 134: ...Do you want to setup a safety connection for Level Event Response Yes No Primary Pump requires Level Detector Alert and Alarm Connections Place the Level Detector The available location for the level...

Page 135: ...choices 1 Touch the desired color The default color selection is blue 2 Touch Next to continue Place the Occluder The available location for the occluder appears as a white square Touch the white squ...

Page 136: ...the alarm limit and 300 mmHg for the alert limit The acceptable range for pressure alarms and alerts is between 250 mmHg and 900 mmHg If the alert limit chosen is in the positive range then the alarm...

Page 137: ...ure sensor in the location that most closely matches the actual location of the pressure sensor in the circuit by touching the appropriate white square Choose Do Not Place to allow placing the sensor...

Page 138: ...m 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 conn...

Page 139: ...on Choose Yes to set a safety connection Note If a centrifugal pump is placed in a position other than in the number 1 or number 6 position on the CCM the Speed Flow Display area will be hidden from v...

Page 140: ...value is 42 5 C The available range for temperature limit is between 1 0 C and 42 5 C To change the alarm limit touch the Alarm Limit button and use the arrows to set the new limit Touch the Alarm Lim...

Page 141: ...0 CDI 101 or a CDI 500 monitor can be added to a Perfusion Screen If a CDI device is added information from the CDI monitor will be displayed on the CCM Add a CDI 100 101 Choose CDI 100 101 from the S...

Page 142: ...ers are displayed on the screen in a stack display box The position of data values in the stack can be changed by selecting the parameter and using the arrows to choose the desired position Touch the...

Page 143: ...Display Data Display Up to 4 venous and 4 arterial parameters from the CDI 500 monitor can be displayed on the Perfusion Screen at any one time Additional Venous parameters are C HCT and HGB Additiona...

Page 144: ...e will be transferred to the Possible Data Values box To Add a Value 1 Select the value to be added to the display 2 Touch the Add button to add the value to the display C PO2 PCO2 SO2 Venous Configur...

Page 145: ...n conflicts with the CDI display a window appears and indicates that the device must be moved The device will be highlighted with a blue perimeter OK The above highlighted device s conflict with CDI d...

Page 146: ...button again to select the new value Choose Next to continue Pump and Clamp timers are always included in a Perfusion Screen and are located in fixed positions on the graphic display No other timers...

Page 147: ...L min START CPG L min START Occluder PCO2 K pH mmHg PO2 mmHg mmol L Clamp Reset Reset 000 00 Pump Reset Reset 000 00 SO2 HCT mmHg C mmHg C C C VO2 mL min CPG Vent Sucker1 Sucker2 Arterial Add Edit Co...

Page 148: ...gal control units are outlined in the Connection Matrix found at the end of this section Note that some pump responses are also events Prior to setting up safety connections study the Connection Matri...

Page 149: ...ating the event to a connected roller pump centrifugal control unit or occluder User actions may also generate some events such as decreasing the speed of a centrifugal pump to less than or equal to 1...

Page 150: ...itional information if needed A Stop response causes the pump speed to go to zero and the pump to enter stop mode The pump must be restarted manually after the event is cleared or the safety system is...

Page 151: ...selected by the user The occluder will remain in this position until the event is cleared unless the event is a pump start or pump stop If the event is a pump start or pump stop the occluder can still...

Page 152: ...low sensors placed on centrifugal pumps that are in the middle of the display will be covered by the screen above The flow icon may need to be temporarily moved to another location on the graphic disp...

Page 153: ...ction will be made See the Connection Matrix at the end of this section for a list of events and responses Edit Safety Connections Edit Remove or Cancel safety connections by selecting the device in t...

Page 154: ...ed pressure or flow source 2 Touch the Servo Control Source button until the button displays Yes 3 Select pump responses to pressure or flow events if desired 4 Touch the OK button when all servo cont...

Page 155: ...ly Primary Roller Pump No Response No Response No Response Started Full Open Stop Stop Full Close Reduce Speed Coast Go to Flow 0 100 Message Only Message Only Note If the cardioplegia pump is configu...

Page 156: ...ary Centrifugal No Response No Response No Response Started Full Open Stop Stop Full Close Reduce Speed Coast Go to Flow 0 100 Message Only Message Only Primary Centrifugal No Response No Response No...

Page 157: ......

Page 158: ...gned Devices button to make the question marks disappear Assign Devices by selecting the device type from the list and then touch the Assign Devices button Arterial L min START CABG Close Devices Assi...

Page 159: ...name of the device and then touching the Unassign button The device name moves from the Assigned list to the Unassigned list and disappears from the Assigned Device box In order to assign a device tha...

Page 160: ...a configuration device to the selected channel touch the device in the unassigned list then touch the Assign button Repeat the process for the other channel The device name will move from the Unassign...

Page 161: ...To assign another Pressure Sensor device Touch the Go to Next Module button and repeat from step 1 Assign Assign Unassign Cancel OK Assign Configuration Device to Physical Module Pressure Sensors 1 O...

Page 162: ...ear in the Assigned list may be unassigned by touching the name of the pump and then touching the Unassign button The pump name will move from the Assigned list to the Unassigned list and disappear fr...

Page 163: ...e same as it was before changes were made Touch Cancel to keep the screen open All configured devices must be assigned and required safety connections must be made in order for a Perfusion Screen to b...

Page 164: ...he color of the pump If the pump type must be changed remove the existing pump and add a new pump of the correct type to the configuration Edit is also used to change the name of the device the color...

Page 165: ...tton 3 To exit the summary screen touch the Close button CABG ROLLER Perfusion Screen Summary Graphic Orientation Primary Pump Left Patient Head Left Blood Reservoir Type Open Air Detectors ART Air Le...

Page 166: ...n 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 Return to Main...

Page 167: ......

Page 168: ...ardioplegia vent and suction pumping Because of the 4 inch diameter raceway the small roller pump is appropriate for low flow and dual sized tubing applications See the Select Tubing section in this c...

Page 169: ...use of the Pulse mode has been reviewed by global Regulatory Agencies When operating a device that shares a slide bar location make sure that the slide bar displayed is for the device you intend to op...

Page 170: ...k indicates that the connector is fully seated in the receptacle Pull gently on the cable to verify a secure connection Base Mounting Ensure the mounting lever is in the up position Grasp roller pump...

Page 171: ...he empty pump space 3 Loosen the set screws on the endcap Some modules may need to be removed to access the set screws 4 Slide the endcap out 5 Slide the 2 rail slides onto the mounting rail 6 Positio...

Page 172: ...e from poles or other devices Ensure pole mounted pumps do not interfere with hand cranking other pumps Ensure that the Descending Pump Bracket does not impede movement around the base Descending Pump...

Page 173: ...ons Do not use excessive force to seat the connector and make sure not to bend the connector pins Tighten screws to secure the connection Standoffs are included in the accessories kit Two standoffs mu...

Page 174: ...th a maximum outer diameter of 9 16 in 14 3 mm and wall thickness range of 1 16 3 32 in 1 6 2 4 mm A nominal durometer range of 65 70 Shore A is recommended Verify that the tubing meets any additional...

Page 175: ...fit into the slides of the universal tube clamp Large Clamp Minimum Maximum Upper 0 089 in 2 3 mm I D x 1 16 in 1 6 mm wall 1 4 in 6 4 mm I D x 1 16 in 1 6 mm wall Lower 1 4 in 6 4 mm I D x 1 16 in 1...

Page 176: ...he tubing in the failed lower tube clamp slide mechanism Remove the tubing 3 Replace and reassign the roller pump See Emergency Procedures chapter Equipment Situations Pump Failure section for instruc...

Page 177: ...way from the raceway as under occlusion may result Set the occlusion before each use with the actual tubing to be used Proper occlusion will vary with each tubing section due to variations in the wall...

Page 178: ...arious levels of myocardial dysfunction CAUTION Do not adjust the rollers of the occlusion mechanism past the limits of its travel which when reached is indicated by increased resistance on the occlus...

Page 179: ...the pump When tubing is set up and fully occluded several hours prior to the start of a case the tubing may take a set causing Pump Jam errors to occur during initial start up Tubing set is defined as...

Page 180: ...NG Hand cranks must be properly set up to allow hand cranking in the same direction as that chosen for forward flow for the roller pumps WARNING When hand cranking due to loss of AC Mains and battery...

Page 181: ...tton for the pump to be used again Select Button Pressing the Select button will result in the following responses depending on the pump state No response if pump is running or paused with no alerts o...

Page 182: ...splay This area displays various information depending on the pump mode Servo Source setpoint in Servo mode Total flow in Master Mode Master Follower percentage or ratio in Follower mode Pump Directio...

Page 183: ...ast tube size or flow constant entered READY CHECK DIRECTION is displayed when the pump cannot verify that its default forward direction matches the system direction No message is displayed if the pum...

Page 184: ...p to a Perfusion Screen and then opening that screen from the Perfusion functional area Verify that the pump default direction arrow now matches the system direction Pump Menu The pump menu can be use...

Page 185: ...button when SELECT DIRECTION is highlighted 2 Turn the pump speed control knob until the message SELECT REVERSE appears highlighted in reverse video in the message area 3 Press Select button again SE...

Page 186: ...Select button to save a new tube size 4 When the selection is made the main pump menu is displayed The system will retain this selection until a new selection is made from the CCM or from the pump co...

Page 187: ...lighted 2 KNOB CHANGE FC is displayed in the message area 3 Use the knob to adjust the flow constant to the desired value 4 Press the Select button to save the new flow constant 5 When selection is ma...

Page 188: ...peed is determined by the Base setting The high speed is displayed on the slide bar and the average speed is displayed in the pump control box and the pump local display The amount of time the pulse c...

Page 189: ...ntrol slide bar The average speed flow rate is calculated from the Peak Base and Width The Pulse mode parameters can be adjusted during use Note When monitoring the arterial pulse peak from the patien...

Page 190: ...ches 61 cm downstream of the pump operating in Servo mode The location of the servo source sensor in the perfusion circuit can affect servo performance Proper placement of the sensor is ultimately up...

Page 191: ...in Servo mode To change setpoint To change the servo setpoint turn the pump speed control knob or adjust the pump control slide bar Increase decrease the pump speed When the knob or slide bar adjustme...

Page 192: ...peed two small roller pumps should be employed for master follower mode Master Follower Pump Control Box Master and follower controls and data are displayed in one control box The single Start Stop bu...

Page 193: ...omatically controlled The secondary display shows the current master follower pump percentage or ratio The bar graph indicates the percentage of master pump flow or speed Communications Link Both the...

Page 194: ...ge condition has been detected Internal Status the status of a pump Normal video Message condition has changed The following table includes the messages that can appear on the roller pump display and...

Page 195: ...scular Systems Master stops due to STOPPED NO FOLLOWER Check the follower pump cable loss of data from connections Stop and start the Follower pump master pump If message appears again reassign the fo...

Page 196: ...until it is serviced by Terumo Cardiovascular Systems Service Loss of communication CHECK LINKED PUMP Check for proper operation of the from connected roller or linked pump If message does not centrif...

Page 197: ...ceway stops pump pump If the message reappears discontinue use of the pump until it has been serviced by Terumo Cardiovascular Systems Reassign pump use standby equipment or use hand crank Pump board...

Page 198: ...is base is reduced by 5 every 2 ramping down to target seconds Message clears when value the target Base setting is reached Manual button is MANUAL MONITOR FLOW Message should clear when speed pressed...

Page 199: ...auto dose been reset to zero delivery restarts Volume auto dose CANCELLED Message clears when auto dose delivery has been current volume mL delivery is resumed volume is cancelled reset to zero Time a...

Page 200: ...A centrifugal pump can be designated as a backup pump only for a primary centrifugal pump Each of these has unique functionality as described in the table below Function CCM Features Unique Functiona...

Page 201: ...l pumps are Stop Coast Message Only or No Response The control unit front panel will display a message indicating the event from a connected device Installation and Connection Control Unit Cable Conne...

Page 202: ...sting the tension control knob Do not loosen the knob beyond the stop Position the arm as desired and tighten the tension control knob Screw the drive motor onto the threaded stud Make sure the drive...

Page 203: ...be installed on a module receptacle to securely fasten a pump cable or flowmeter cable to the module receptacle Only a pump power cable or flowmeter power cable can be inserted into a receptacle which...

Page 204: ...recirculation as necessary 5 If a roller pump is used instead of the manual drive unit as standby equipment use tubing specified for roller pumps Insert the centrifugal pump inlet or outlet tubing in...

Page 205: ...Start Stop button once will stop and deactivate 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...

Page 206: ...ich speed cannot be adjusted This occurs even if the Coast response does not include a speed change Pump Name This area displays the pump name During the start up self test the pump s Module ID is dis...

Page 207: ...M the centrifugal Stop button will reappear when the Arterial RPM 1510 Arterial RPM STOP 1490 WARNING With a centrifugal pump maintain a minimum pump speed or clamp the pump outlet line and patient s...

Page 208: ...pump speed is 1560 RPM or above a Coast response causes the pump speed to reduce to 1500 RPM The Coast speed of 1500 RPM may be high enough to allow some forward flow or in rare instances may not be s...

Page 209: ...Bar Graph on the Centrifugal Control Unit blinks User control is returned after the lockout period Coast Event A Coast event is an event generated by a centrifugal control unit that can initiate a res...

Page 210: ...Base The high speed is controlled by the pump speed control knob or the pump control slide bar on the CCM and the low speed is determined by the Base setting The high speed is displayed on the slide...

Page 211: ...tting until the desired setting is reached Always adjust the centrifugal pump speed when changing to Pulse mode as the average flow rate will decrease and the speed may be too low resulting in retrogr...

Page 212: ...ical professional The setpoint must be in the correct operating range before Servo mode can be initiated The centrifugal pump must be above 1550 RPM to initiate Servo mode While operating in Servo mod...

Page 213: ...nt turn the centrifugal control unit pump speed control knob or adjust the pump control slide bar to increase decrease the pump speed When the knob or slide bar adjustment stops the pump locks onto th...

Page 214: ...centrifugal pump still in the circuit Note If the standby roller pump has been designated as a backup pump use the Reassign Module subtab within the System tab to assign primary pump functionality and...

Page 215: ...start the pump if stopped Alert Connected pump has Response PUMP STOP Restart connected pump restart stopped pump if stopped Connected pump has Response PUMP START Restart pump if stopped started Conn...

Page 216: ...ted roller or connected pump If message does not centrifugal pump clear be aware that the pump may not respond to messages or operations requiring information from the connected pump Loss of connected...

Page 217: ...until it has been serviced by Terumo Cardiovascular Systems Reassign or use standby equipment to maintain perfusion Motor draws too much STOPPED PUMP JAM Clamp the lines Try to restart the current pu...

Page 218: ...O 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 Pulse mode has been RAMP BASELINE XX Monitor the speed change activated...

Page 219: ...6 20...

Page 220: ...ffline Mode Blinking Yellow Alert Condition Constant Red Broken Mode Blinking Red Alarm condition Before opening a Perfusion Screen the module LED will cycle green yellow red then will remain constant...

Page 221: ......

Page 222: ...n must be verified before each use WARNING If an air or level detection system is turned OFF or is configured not to stop a pump then constant monitoring is required to reduce the risk of air embolism...

Page 223: ...be placed into the air sensor 2 Open the sensor by pushing up on the bottom of the latch and slide latch off the door bracket 3 Insert tubing 4 Close and latch the sensor door to secure the sensor aro...

Page 224: ...o be reset by touching the Select button on the pump control panel after the air has been cleared The ABD is the only safety device that requires a reset by the user to confirm that the issue has been...

Page 225: ...d the air module LED flashes red Dual tone alarm sounds Insert tubing containing clear liquid or blood into Air message clears from pump display sensor touch reset on the CCM or press Select on and CC...

Page 226: ...no setup issues were found consider backup air detection equipment Contact Terumo Customer Service During Cardiopulmonary Bypass If necessary stop the arterial and or cardioplegia pump CAUTION Failur...

Page 227: ...ircuit Any malfunction of a safety system requires consideration for converting to a circuit with a venous reservoir Contact Terumo Customer Service at the end of the case The following symptoms may o...

Page 228: ...system is turned OFF or is configured not to stop a pump then constant monitoring is required to reduce the risk of air embolism in the line WARNING Conduct a wet run and test that the level detectio...

Page 229: ...ically and align the center of the sensor pad at the level to be detected Press firmly on the tabs to secure the mounting pad to the reservoir 5 Allow the adhesive to set five minutes to get maximum a...

Page 230: ...uring configuration when the case is exited Enabling and Disabling Level Detection System Use the alert alarm warnings to warn of changing level conditions that may allow the blood or prime solution l...

Page 231: ...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 M...

Page 232: ...configured Single tone alert sounds Lower the blood or prime solution Level icon flashes red level module LED flashes level in the reservoir below the level red message on CCM and local display of of...

Page 233: ...s Pump Respose automatically Level system is on alarm Level detector name Mount the alarm or alert level level sensor or alert level NOT ATTACHED sensor to venous reservoir Alert sensor not mounted to...

Page 234: ...ervoir Level system is off Level detector name Reconnect level sensor Message level sensor becomes Disconnected clears automatically disconnected from module Level selection is changed Level Detector...

Page 235: ......

Page 236: ...mmHg and 900 mmHg inclusive the physiological alerts or alarms will reoccur as appropriate The pressure system has only been tested with pressure transducers provided by Terumo Cardiovascular Systems...

Page 237: ...device name button 3 To change the alert or alarm limit touch the Alert or Alarm button The background of the button will turn white 4 Use the increase decrease arrows to adjust the limit 5 Touch the...

Page 238: ...cer to atmospheric pressure 2 Select the Pressure subtab within the Safety tab or touch the pressure icon 3 Ensure the correct device name is displayed 4 Touch the Zero button to calibrate pressure sy...

Page 239: ...essure and open to the circuit it does not need to be turned on to enable pressure monitoring System Response to Alert Conditions Pressure Pressure Connected Audible Icon Module Message Device s Tone...

Page 240: ...CCM The pressure icon flashes red The LED on the module flashes red and a dual tone alarm sounds Pressure Monitoring Messages Priority Condition CCM Message Operator Response Alarm Pressure has risen...

Page 241: ...ansducer If message does not clear replace and recalibrate transducer Error Pressure transducer Pressure name Calibrate Failed Retry pressure transducer calibration failed calibration If message does...

Page 242: ...ntain electrical isolation in accordance with applicable standards insulated temperature probes must be used YSI Series 400 compatible probes with the exception of Model 416 must be used in order to m...

Page 243: ...evice name is displayed on the Safety Screen 3 To change the alarm value touch the Alarm button The background of the button will turn white 4 Use the arrows to adjust the limit 5 Touch the Alarm butt...

Page 244: ...Temperature Monitoring Messages Priority Condition CCM Message Operator Response Alarm Temperature has risen Temperature name Correct over temperature condition above alarm limit OVER TEMPERATURE Alar...

Page 245: ......

Page 246: ...in 0 001 L min between 0 091 to 0 999 L min and between 0 091 to 0 999 L min Between 0 090 and 0 090 L min inclusive the display shows 0 000 L min flowmeter placed outside centrifugal pump icon on CCM...

Page 247: ...dot on the power cable with the red dot on the flowmeter module Insert the connector into the receptacle An audible click indicates that the connector is fully seated in the receptacle Pull gently on...

Page 248: ...stem verify the flowrate display by varying the speed and seeing that the display changes accordingly System Response to Alarm Condition The flow system will alarm in a backflow condition Flow Flow Co...

Page 249: ...iority Condition CCM Message Operator Response Alarm Backflow has been Flow sensor name BACKFLOW Correct backflow condition Alarm detected clears automatically Restart pump if stopped Backflow has bee...

Page 250: ...an be configured to respond to primary pump events using the Configuration Screen on the Central Control Monitor Occluder responses are user selectable Valid responses for the occluder are Full Close...

Page 251: ...ball end of the mounting rod into the occluder head socket 3 Insert the rod into the mounting bracket and tighten the mounting screws as needed Connect Occluder Module 1 Attach the occluder cable to...

Page 252: ...ton to retract the plunger sufficiently to insert tubing 3 Unlatch and open the occluder cover 4 Insert tube into the tubing channel of the cover 5 Close the cover keeping the tubing properly aligned...

Page 253: ...d Display Note To reposition the tubing without recalibrating touch the Open button twice to free the tubing Reposition tubing without opening the occluder cover and adjust occluder to appropriate tub...

Page 254: ...the Event of an Occluder Module malfunction Symptoms How to respond The system responds with indications to the user that the occluder is non functional A connect occluder message appears on the CCM i...

Page 255: ......

Page 256: ...nd CDI 101 monitor are inline monitors that measure and output hematocrit hemoglobin and oxygen saturation values The Interface Module for CDI 100 101 Module collects blood parameter data and displays...

Page 257: ...mory Select Return to return to the main menu and make no change to the output interval 6 To connect a CDI 101 monitor install the gender changer on the serial communications port of the monitor Conne...

Page 258: ...prior to taking any action during the case This module is used with CDI 500 software versions 1 4 through 1 6 while operating in standard mode and versions 1 65 and above while operating in either st...

Page 259: ...enous four arterial and one other data values can be displayed on the CCM These values are selected during case configuration Refer to Central Control Monitor chapter Configuring Other Devices section...

Page 260: ...a Management System and the system The data collected and exported by the data transfer module includes physiological data and device events to record the progress and events during a procedure TLink...

Page 261: ...em 4 Route the cable to minimize exposure to spills Refer to the TLink Data Management System manual for instructions for using the software Data Transfer Data transfer takes place after a Perfusion S...

Page 262: ...cure other device icons that are on the Perfusion Screen Some device icons may need to be moved The electronic gas blender can be controlled from the Central Control Monitor CCM or from the FiO2 and f...

Page 263: ...rade air line from the air source to the air inlet An optional 95 5 supply hose allows this mixture to replace the medical grade air The hose with the 6 inch 15 2 cm adaptor section must be properly c...

Page 264: ...nt CCM capability is lost 7 To determine gas flow with the backup flowmeter view the float from eye level and use the center of the float to determine the rate Refer to the figure below 8 Securely mou...

Page 265: ...ble the alarm set the limit below 0 21 when using air as the blending gas or below 0 95 when using 95 5 as the blending gas The button will read when the alarm has been disabled by the user FiO2 alarm...

Page 266: ...ox will also appear the first time the user makes an adjustment to the FiO2 or gas flow setpoints in either of the following conditions Before warmup is complete After warmup is complete but before in...

Page 267: ...he values set prior to calibration Note Do not obstruct the gas flow outlet during calibration as this may affect the accuracy of the calibration Note Do not attempt to change the gas flow rate or the...

Page 268: ...sful 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 A dialog...

Page 269: ...value that provides further detail about the specific failure Refer to the Electronic Gas Blender Messages section of this manual for further details If calibration is not successful during setup take...

Page 270: ...t off the gas flow or when ending a case the gas flow knob may not return to its full off position and a small amount of gas may still be flowing Manually turn the gas flow knob clockwise until it sto...

Page 271: ...stops at both ends of its travel Turn the gas flow knob clockwise until it reaches the hard stop to shut off gas flow Turn the gas flow knob counter clockwise until it reaches the hard stop to achieve...

Page 272: ...increments from 0 95 to 1 00 Turn the FiO2 knob clockwise to increase the percentage of oxygen in the blended gas and counterclockwise to decrease Knob Adjust Only Mode If the system detects certain...

Page 273: ...cessary Air source pressure LOW AIR SUPPLY Check air hose connections Check 30 psi or more than PRESSURE air supply and switch source if 18 psi below the O2 necessary pressure Air source pressure HIGH...

Page 274: ...O2 Analyzer Calibration Complete Message displays for 10 seconds finished Warm up in progress Gas System Warming Up Message clears when warm up is complete O2 sensor exposure Service O2 Sensor Backup...

Page 275: ......

Page 276: ...available Circuit Breakers Verify that the three circuit breakers on the back of the system base are properly set AC Mains Power Cord Verify that the AC Mains power cord is securely connected to the...

Page 277: ...time is displayed above the Power Source Battery Status icon and the entire system is functional Reconnect the system to the AC Mains power supply Modules Verify that the module LEDs change to green...

Page 278: ...priming procedure and leave the sensors on Level Detection Verify the selection of alert and alarm and the level detection label in the Level subtab within the Safety tab or by touching the level ico...

Page 279: ...es can be viewed at any time during the case by pressing the Aux tab and opening the Messages subtab The subtab displays the messages and the time the message was generated Battery Monitor battery sup...

Page 280: ...chapters Central Control Monitor Roller Pumps Centrifugal Control Unit Modules Electronic Gas Blender Resolve the emergency as directed Clamp lines when necessary to prevent air from entering the pati...

Page 281: ...s displayed during cardiopulmonary bypass Verify the circuit pressure is not actually elevated or dropped to out of range levels Check transducer connections If troubleshooting is delayed consider han...

Page 282: ...they must be used with a pressure regulator The electronic gas blender requires that the source gases be within a specified range of 50 psi 20 psi and that there be no more than 18 psi difference bet...

Page 283: ...arterial and venous lines Discontinue vacuum assisted venous drainage if applicable If toggling the AC Mains power switch is NOT successful in restarting the system Initiate or continue manual hand cr...

Page 284: ...ety connections to the backup pump or another pump of the same type After reassignment verify all operating parameters including tube size or flow constant direction and display units on the pump disp...

Page 285: ...ing backup equipment either a manual drive unit or roller pump according to hospital protocol For additional information regarding Centrifugal Control Unit issues see Centrifugal Control Unit chapter...

Page 286: ...tors before attempting to start stop the pump or adjust speed Pressing the Start Stop button could result in the unintentional stopping of a running pump Module Failure If a module fails and or loses...

Page 287: ...ns 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 failur...

Page 288: ...through use of local controls A failure to understand how to use the manual controls in the case of a CCM failure may lead to patient harm WARNING Do not turn the system power off if the CCM fails as...

Page 289: ...lished safety connections alarm messages will be displayed on the pump display Upon hearing an alarm the user should check the pump display message area see below for the alarm type To reset an active...

Page 290: ...ype of alert has occurred for example an over pressure alert condition will cause the pressure module to have a flashing yellow LED For information on power refer to the LED located on the front panel...

Page 291: ...on bypass cycle power to reset the system If on bypass do not reset the system since all settings safety devices and safety connections will be lost Finish the case with local controls on the roller p...

Page 292: ...panel Master pump speed control knob can be used to change total flow rate Follower pump speed control knob can be used to change the ratio or percentage Centrifugal Control Unit Mode Alarm Status Di...

Page 293: ...larm sounds condition clears if connected to a pump Message on pump display of connected pump s Pressure Monitoring Condition Status Display Control Monitoring Monitoring LED on module displays status...

Page 294: ...om occluder head to primary pump and control flow manually with a safety connections tubing clamp Interface Module for CDI 100 101 or CDI 500 Condition Status Display Control Monitoring Monitoring LED...

Page 295: ......

Page 296: ...e 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 Cardio...

Page 297: ...dule provides one way communication from the System 1 to an external data collection system The interface on the module is a DTE female DB 9 connector Connect to an external data collection system usi...

Page 298: ...the fields in the RECORD CONTENT field The caret must be escaped if used in any device type data label or data value in the data stream The escape delimiter is the backslash character To include the e...

Page 299: ...s Mixer GASMIXER CDI 100 CDI 100 CDI 500 CDI 500 English Pumps ABD Level Timer Occluder Pressure Flow Temperature ART ART Air Level Pump Occluder ART Pres ART Flow ART Temp Arterial VEN Air VENLevel C...

Page 300: ...T4 TIM4 TRYK2 Nasophar Suger2 STANDtim TRYK3 Tympanic Ven s ISK tim TRYK4 Myo temp VEN TEMP1 TEMP2 TEMP3 TEMP4 Dutch Pumps ABD Level Timer Occluder Pressure Flow Temperature ART ARTlucht Niveau Pomp K...

Page 301: ...IR4 Chrono4 PRESS2 NasoPhar Aspir2 Chr CEC PRESS3 Tymp Veineuse ChroISCH PRESS4 Temp Myo VEIN TEMP1 TEMP2 TEMP3 TEMP4 German Pumps ABD Level Timer Occluder Pressure Flow Temperature ART ART Luft Nivea...

Page 302: ...4 Cronom4 PRESS2 Nasofar Aspirat2 Cron ARR PRESS3 Timpan Ven Cron Isc PRESS4 TempMIOC VEN TEMP1 TEMP2 TEMP3 TEMP4 Spanish Pumps ABD Level Timer Occluder Pressure Flow Temperature ART Burb ART Nivel B...

Page 303: ...Periodic Yes A_O2 Arterial PO2 10 500 1 67 mmHg kPa Periodic Yes A_TM Arterial Temperature 10 45 C Periodic Yes A_SO Arterial Oxygen 60 100 Periodic Yes Saturation A_HC Arterial Bicarbonate 0 50 mEq...

Page 304: ...OGPO O2 gas pressure over range Safety Event OGPU O2 gas pressure under range Safety Event OGPI O2 gas pressure in range Safety Event LFAM Low FiO2 alarm Safety Event LFMC Low FiO2 alarm cleared Safe...

Page 305: ...Periodic Yes PDIR Direction CW or CCW Event POCU Overcurrent Safety Event POCC Overcurrent cleared Safety Event POSP Overspeed Safety Event POSC Overspeed cleared Safety Event PPAU Pump paused only f...

Page 306: ...blood volume 0 to 21000 mL Periodic No PHGT Patient height 30 to 250 cm Periodic No PWGT Patient weight 1 0 to 300 0 kg Periodic No Cardioplegia device name is Part of Mnemonic Description Value Unit...

Page 307: ...tion during power mains interruptions it is recommended that the Terumo Advanced Perfusion System 1 be powered from an uninterruptible power supply or a battery Mains power frequency magnetic fields s...

Page 308: ...he higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The...

Page 309: ...idelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Table 205 Recommended separation distances between port...

Page 310: ...eed set to 250 RPM while using 1 2 inch 12 7mm I D x 3 32 inch 2 4mm wall tubing properly occluded and fluid temperature of 25 C All available module connections used with any combination of Flow Temp...

Page 311: ......

Page 312: ...Perfusion Screens Failure to establish such controls may result in operator error that could result in patient injury or death System Equipment Precautions Grounding reliability can only be achieved w...

Page 313: ...y be destructive to the device Do not disinfect with Virex Tb Do not spill anesthetics on the system or components as chemicals such as Forane isofluorane may be destructive Follow the cleaning proced...

Page 314: ...he performance of the level and air detection systems must be verified before each use If an air or level detection system is turned OFF or is configured not to stop a pump then constant monitoring is...

Page 315: ...ranking in the same direction as that chosen for forward flow for the roller pumps When hand cranking because of the loss of AC Mains and battery power the safety systems will not operate Monitor clos...

Page 316: ...ure reduced pumping capacity excessive blood trauma degradation or corrosion of blood contact materials with possibility of particles passing through the blood circuit to the patient leaks and increas...

Page 317: ...nd pins Check the connectors for damage before use Do not use a module if damaged or bent connector pins are found Do not use extension cords to connect the modules to the system Use of extension cord...

Page 318: ...e and triethanolamin Causes eye irritation Immediately flush eyes with large amounts of water Get immediate medical attention Gas System The oxygen and air supplies must both be connected or disconnec...

Page 319: ...ur Components Check the water trap Check the water trap located on the air or 95 5 inlet of the gas blender and drain if necessary Clean air level and Clean with mild soap and water solution Do not us...

Page 320: ...rumo Customer Service and do not use a damaged or malfunctioning device Monthly Clean Base Check Air Filters and Check Gas Flow Clean under pumps and Remove all of the pumps and clean the mounting are...

Page 321: ...ns power and confirm the system properly goes onto backup battery power Run the Battery Test by running system on battery for at least 5 minutes CAUTION If the Battery Test results in an indication of...

Page 322: ...switches to Stop mode and Pump Name Pump Jam appears on the Central Control Monitor message display and STOP PUMP JAM appears on the pump control panel Temperature Alarm Check that the audible alarm...

Page 323: ...t 60 minutes The batteries must be replaced every two years If the batteries are not replaced the system will post a reminder each time the Main Screen is entered The following message box will be pos...

Page 324: ...erumo Cardiovascular Systems service provider Recondition the Gas System The Electronic Gas Blender must be reconditioned every 24 months The Electronic Gas Blender must be returned to an authorized T...

Page 325: ...in front of the occlusion indicator arrow slides under the occlusion indicator ring 6 Rotate the occlusion knob until the metal dowel pin at the end of the tube clamp slides into the slot of the adjus...

Page 326: ...are tight and secure Replacing Air Filters and Lamp Bulbs Air Filters Base The fan filter located on the back panel of the base should be replaced every 6 months or more often if necessary Use a flat...

Page 327: ...e panel Lamp Bulb When replacing the 24 VDC lamp bulb hold the bulb with a cloth or tissue during installation to prevent skin oils from shortening the life of the bulb Long Term Storage Long term sto...

Page 328: ...Terumo Cardiovascular Systems Product Warranty and may increase the risk of a product failure Contact Terumo Cardiovascular Systems Corporation Service your local Terumo company or your authorized di...

Page 329: ...Additional Information 12 18 10 11 6 7 9 1 4 8 14 5 2 3 12 13 18 17 16 19 15 20...

Page 330: ...Pole 3 feet 0 9 m in length 131115 Mounting Pole 2 feet 0 6 m in length 16553301 Short Pole 801407 8 Crossbar 16426 9 Pole Collar 150826 10 Crossbar Fitting 145980 11 Solution Rack 146819 Shelf not s...

Page 331: ...clude adapters for hospital gas outlets Gas Supply Hose Adapter sets US NCG Hose Adapter Set 144207 DISS Hand Tight Hose Adapter Set 144215 Ohio Diamond Hose Adapter Set 144223 Gas Supply Hose Kit Out...

Page 332: ...369 Standoff 4 40 x 0 25 Hex 8 804459 Cinchstrap 10 147125 Wire Marker Tape with number 0 1 807897 Wire Marker Tape with number 1 1 807879 Wire Marker Tape with number 2 1 807884 Wire Marker Tape with...

Page 333: ...ck Pump Safety cover small 1 803720 Pump Safety cover large 1 803719 Halogen Bulb 24 V 20 W 1 132265 Intake Air Filter Base 1 802094 Intake Air Filter Pump 1 802280 Intake Air Filter CCM 1 804517 Wate...

Page 334: ...r s batch code so that the batch or lot can be identified ISO 15223 1 5 1 5 Prescription only Caution Federal U S A law restricts this device to sale distribution and use by or on the order of a physi...

Page 335: ...from moisture ISO 15223 1 5 3 4 This way up This way up ISO 7000 0623 Date of manufacture Indicates the date when the medical device was manu factured ISO 15223 1 5 1 3 Temperature limitation Indicate...

Page 336: ...elect Terumo Cardiovascular Systems Manual Manual Terumo Cardiovascular Systems Servo Mode Servo Mode Terumo Cardiovascular Systems Pulse Mode Pulse Mode Terumo Cardiovascular Systems M Master Pump Ma...

Page 337: ...scular Systems Occluder Module Occluder Module Terumo Cardiovascular Systems STOP STOP Terumo Cardiovascular Systems START START Terumo Cardiovascular Systems Direction of rotation counterclockwise Di...

Page 338: ...audible alert or alarm Mute silence an audible alert or alarm Terumo Cardiovascular Systems Mute all silence multiple audible alerts or alarms Mute all silence multiple audible alerts or alarms Terum...

Page 339: ...cular Systems Occlusion Knob Cover Describing direction to turn the occlusion knob to reduce or increase occlusion of tub ing within the pump raceway Terumo Cardiovascular Systems Symbol Title Descrip...

Page 340: ...sounds and repeats at one minute intervals to warn the user that an alert event has occurred Pumps can be set up to respond to certain alert events Assigning Devices Takes place in the Configuration...

Page 341: ...onitor values to the system for display on the CCM Central Control Monitor The Central Control Monitor CCM combines an embedded computer a touch screen and a Graphical User Interface GUI to provide a...

Page 342: ...pump speed is1560 RPM or above the centrifugal pump will slow down to a speed of 1500 RPM Regardless of the pump speed a safety event with a configured Coast response triggers a brief lockout of spee...

Page 343: ...p to respond to events in the Configuration area External Event An alert or alarm generated by an external device or sensor For example for the primary pump an air alarm would be defined as an externa...

Page 344: ...a variety of tubing sizes including dual tube sets The pump raceway can be positioned and locked in 15 degree increments for positioning of the tubing The occlusion mechanism allows the user to adjust...

Page 345: ...the total flow rate Message Area A message box that is located on the top portion of the Perfusion Screen This message area displays the highest priority alarm alert status or error message Message O...

Page 346: ...itor that is used 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 modi...

Page 347: ...efault forward direction and event response list Pump Tab The section of the Perfusion Screen used to view the pump summary initiate Pulse mode for the primary pump initiate Servo mode and view master...

Page 348: ...the pump speed to maintain a constant pressure or flow rate Servo Setpoint The target pressure or flow value to be maintained by a roller or centrifugal pump operating in Servo mode Servo Source A pre...

Page 349: ...be connected to any module receptacle on the base It also allows multiple types of modules to be connected to the system System Power The power system located within the base transforms AC Mains power...

Page 350: ...connection matrix 4 90 displays 4 16 4 17 Edit Safety Connections 4 83 electronic gas blender 8 9 features 2 4 4 1 functional areas 4 5 malfunctions 10 7 messages 4 38 PC card compartment 4 4 install...

Page 351: ...features 8 1 gas system precautions summary 12 7 gas system warning 12 5 installation and connection 8 2 local operation 8 10 maintenance 12 12 messages 8 12 operating from CCM 8 9 overview 2 18 setti...

Page 352: ...situations 10 1 Pressure Module 7 18 Temperature Module 7 23 Min Flow Alarm 4 21 Modules Air Bubble Detect Module ABD 7 2 bracket system 3 17 features 2 11 7 1 Flowmeter Module 7 24 Interface CDI 100...

Page 353: ...5 13 master follower 2 9 5 25 menu 5 17 messages 5 27 mounting 5 3 occlusion warnings 5 10 operating hand crank 5 13 Pulse mode 2 9 5 21 pumping warnings 12 4 Responses no response 4 85 pause response...

Page 354: ...g temperature sensors in CCM 4 75 connecting probe and module 7 21 labeling probe 7 21 messages 7 23 overview 2 14 setting alarm limits 7 22 system response to alarms 7 22 temperature monitoring 7 21...

Page 355: ...for personal injury by a third party Customers If a warranty condition develops contact Terumo Cardiovascular Systems Corporation Service or your authorized distributor This warranty gives you specif...

Page 356: ...System Overview System Base Central Control Monitor Roller Pumps Centrifugal Control Unit About System 1...

Page 357: ...Run a Case Emergency Procedures Technical Support Additional Information Electronic Gas Blender Modules...

Page 358: ...Configure Pumps Configure Other Devices Edit Safety Connections Assign Devices to Modules Configuration Perfusion Screen Displays and Controls...

Page 359: ...mmHg L min...

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