Terumo CDI OneView Operator's Manual

Monitoring system

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Operator's Manual

CDI OneView

Monitoring System

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Summary of Contents for Terumo CDI OneView

Page 1 Operator’s Manual CDI OneView Monitoring System...
Page 2 Table of Contents System Overview Indications for Use ��1-1 How the System Works ��1-4 System Components ��1-8 Battery Power ��1-25 Initial Assembly and Admin Setup System Hardware Assembly ��2-1 Administrator Setup ��2-12 System Settings ��2-14 Case Profile Configuration The Toolbar ��3-1 Case Profile Management ��3-4 Calibration and Circuit Setup Calibration ��4-1...
Page 3 Table of Contents Troubleshooting Error Messages and Conditions ��6-1 Laboratory Comparison Troubleshooting Table ��6-16 Routine Maintenance and Disposal Routine Cleaning ��7-1 Battery Maintenance ��7-2 Replacement Procedures ��7-3 System Disposal ��7-3 System Components Brackets�� A-1 Flow Components �� A-1 Disposables �� A-1 External Data Modules ��...
Page 4 Symbols Glossary Symbols Glossary ��D-1 Standards ��D-8 Warranty and Service Warranties �� E-1 Limitations of Remedies �� E-1 Service �� E-2 Returned Goods Policy ��E-2 Software License End User License Agreement: CDI OneView System Software ��F-1 Glossary and Acronyms Glossary ��G-1...
Page 5 The CDI OneView System is a modular and user-configurable design comprised of a central Core, a Display, a Calibrator unit, probes for different parameters measurements, cables to external module devices, mounting accessories and disposables.
Page 6 System Overview Intended Patient Population Intended Patient Population The CDI OneView System is used during cardiopulmonary bypass procedures with patient populations ranging from neonates to adults. Frequently Used Functions Frequently Used Functions Module components connection • Connecting probes and components •...
Page 7 Training Requirements Training Requirements Before setup or operation of the CDI OneView System, it is vital that the user read and understand all the material in this manual. To arrange training, please contact your local Terumo Cardiovascular representative or call (800) 521-2818 and ask about CDI OneView System training.
Page 8 Any user of the CDI OneView System must read and understand all the information in this manual — the CDI OneView System Operator’s Manual — as well as the instructions for use included with all associated disposables before using the system.
Page 9 The CDI OneView System should only be used when there is blood flow through the extracorporeal circuit. To perform accurately, reference the minimum and maximum blood flow rates (Q̇ ) as listed in the H/S Cuvette Instructions for Use.
Page 10 The values are greyed out and not bold on the CDI OneView System screen to indicate the values are not accurate until an initial in vivo recalibration has been performed.
Page 11 Note: The hemoglobin measurement technique used in this instrument measures total hemoglobin, and therefore includes other hemoglobin species such as carboxy-, met-, sulf-, and fetal hemoglobin. Terumo Cardiovascular CDI blood parameter monitoring systems are intended to monitor values including pH, pO...
Page 12 System Overview System Components CDI OneView Touchscreen Display CDI751 CDI OneView Calibrator CDI740 CDI OneView Processing Core CDI750...
Page 13 System Overview Brackets Brackets Core Bracket CDI780 Display Bracket CDI781 BPM Bracket CDI782 Calibrator Bracket CDI783...
Page 14 System Overview Additional Components Additional Components CDI OneView BPM Probe CDI753 CDI OneView H/S Probe CDI754 CDI OneView Flow Interface Module CDI760 CDI OneView HLM Interface Module CDI770 CDI OneView DMS Interface Module CDI771 CDI OneView RSO Interface Module CDI772...
Page 15 System Overview Display Display The Display is a configurable touchscreen that facilitates operation of the system, docks the BPM and H/S Probe(s), and provides a USB port to connect a USB drive. Front Back Touchscreen deactivation button: To disable the touchscreen for cleaning, press and hold the button for one second.
Page 16 System Overview Core Core The CDI Core provides power to all connected modules and module-to-module communication, such as between the Calibrator and the BPM. Any calculated parameter that requires input from more than one module is calculated in the Core and sent to the Display.
Page 17 System Overview BPM Probe BPM Probe Arterial and/or venous blood parameter modules (BPM) are for monitoring pH, pO and temperature. The BPM Probe receives power and commands from and transmits data and parameter values to the Core using a USB cable. The BPM cable is detachable from the Core, and the BPM probe may be replaced during a case in the event of a failure.
Page 18 Calibrator Calibrator The CDI Model 740 Calibrator uses gases for automatic calibration of the CDI OneView System and CDI Shunt Sensors. It can calibrate up to two sensors simultaneously. Note: When calibrating only one CDI Shunt Sensor, either Calibrator pocket can be used.
Page 19 System Overview Calibration Gases Calibration Gases The two-point tonometered calibration of the CDI Shunt Sensors requires the use of precision mixtures of carbon dioxide (CO ) and O gas to expose the sensors to well defined pH, pO and pCO values.
Page 20 System Overview CDI Model CDI510H Optical Interfac CDI Model CDI510H Optical Interface e A transparent optical interface material found on the back side of the CDI Model CDI510H Shunt Sensors provides a consistent optical connection between the sensor and the fiberoptic cable connector.
Page 21 System Overview Warning Elevated levels of blood substances including irregular cell morphologies, protein levels, plasma free hemoglobin and bilirubin may interfere with blood measurements. Independent external blood gas and blood chemistry analysis is required for accurate determination of all measured parameters needed to guide therapeutic decisions.
Page 22 System Overview The Shunt Bypass Line The Shunt Bypass Line The shunt bypass line is a tubing pack modification designed to connect to the CDI Shunt Sensor when an in-line application is desired. Two opposing Y-connectors allow a small fraction of the total blood flow to pass through the sensor while minimizing any additional flow resistance.
Page 23 System Overview CDI Hematocrit/Saturation Cuvette CDI Hematocrit/Saturation Cuvette The CDI H/S Cuvette is a flow-through device inserted directly into the extracorporeal circuit. The CDI H/S Cuvette is for a single use only. It is supplied sterile and individually packaged for incorporation into the circuit at the time of use, or it can be supplied non- sterile to tubing pack manufacturers for preconnection.
Page 24 System Overview Warning Maintain adequate levels of anticoagulation during extracorporeal circulation by monitoring activated clotting time (ACT) or another appropriate measurement. Do not attempt to re-sterilize the CDI H/S Cuvette. Improper sterilization can reduce system accuracy or cause the CDI H/S Cuvette to leak under pressure.
Page 25 (DMS) equipment connected to an external data module. Module for HLM Module for HLM The CDI OneView System can communicate with any of the following HLM devices for flow rate acquisition: Terumo Advanced Perfusion System 1 •...
Page 26 Flow Sensors Flow Sensors The CDI OneView Flow Sensor measures blood flow circulating in the perfusion circuit. Multiple sensor sizes are available for use with a wide variety of tubing types and sizes. The system allows connection and configuration of up to four flow sensors.
Page 27 System Overview CDI Display Bracket CDI Display Bracket The CDI Model CDI781 Display Bracket attaches to a standard heart-lung machine pole and can accommodate one Display. The Display attaches to the bracket for mounting and dismounting, and it can be adjusted in all four directions. CDI Core Bracket CDI Core Bracket The CDI Model CDI780 Core Bracket attaches...
Page 28 System Overview CDI Calibrator Bracket CDI Calibrator Bracket The CDI Model CDI783 Calibrator Bracket attaches to standard heart-lung machine poles and can accommodate one Calibrator. The Calibrator slides onto the bracket for mounting and dismounting. The bracket can be positioned vertically or horizontally on the pole.
Page 29 System Overview Battery Power The CDI OneView System comes with a 14.4 V rechargeable lithium-ion battery for backup power. The toolbar shows battery charge status and how many minutes are remaining. When the system is plugged into AC power, the plug indicator turns green and the battery status is shown as grey.
Page 30 CDI OneView System. System Hardware Assembly The CDI OneView Display, Core, Calibrator and BPM each have brackets that attach to a heart-lung machine. This section provides instructions on how to set up these brackets and assemble the system hardware.
Page 31 Initial Assembly and Admin Setup 6. Ensure the bracket is securely attached before proceeding. 7. Tilt the Core to align the notches on the mounting disk with the mounting plate, then press the Core until it is firmly in place. 8.
Page 32 Initial Assembly and Admin Setup Display Setup Display Setup Warning The Display Bracket pole clamp cannot be placed on a horizontal pole. It must only be placed on a vertical pole. To assemble the Display, follow the steps below: 1.
Page 33 Display firmly in one hand, then squeeze the quick disconnect lever (B) on the bottom side of the bracket. Warning Do not roll equipment over the cables of the CDI OneView System. Mishandling can cause damage and deterioration of system performance.
Page 34 Calibrator Setup Calibrator Setup The CDI OneView Calibrator requires one Gas 1 bottle and one Gas 2 bottle to perform a gas calibration of the sensors. 1. Close the pole clamp around an HLM pole, then tighten the knob clockwise.
Page 35 Initial Assembly and Admin Setup 4. Connect the right-angle end of the Calibrator cable to the back of the Calibrator by aligning the notch and red dots, then pushing until it clicks. 5. Connect the other end of the Calibrator cable to the Calibrator port on the back of the Core by aligning the red dots and pushing until it clicks.
Page 36 Contact with combustible material may cause fire. ƒ Note: Terumo Cardiovascular recommends that the gas bottles remain in the Calibrator at all times to avoid introducing debris into the calibrator. If the Calibrator is to be stored for a long period of time, remove the gas bottles but ensure the openings are kept covered.
Page 37 Initial Assembly and Admin Setup BPM Bracket Setup BPM Bracket Setup The CDI BPM Bracket should be placed on the HLM pole nearest the shunt/purge line used for shunt sensing. Pole 1. Close pole clamp Clamp around an HLM pole, then twist the knob clockwise.
Page 38 Initial Assembly and Admin Setup Module Connections Module Connections Prepare all the module connections to the Core. 1. Connect desired modules [BPM(s), H/S(s), External Device Module(s) and Flow Interface] to any module ports (1-6) on the back of the Core by aligning the red dots and pushing until they click.
Page 39 Initial Assembly and Admin Setup Module Storage Module Storage When the system is not in use, always leave the BPM(s) and H/S(s) in their designated holders on the back of the display. Storing the modules in this way protects their optical surfaces.
Page 40 These checks should be done completely and routinely prior to each use of the CDI OneView System. Caution After shutting down the system, ensure the Core and Display LEDs ƒ...
Page 41 ADMIN ONLY ADMIN ONLY Administrator Setup An admin account allows full setup of the CDI OneView System for use. Only accounts with administrative privileges can create new case profiles and configure default system settings. The rest of this chapter details how to create new admin accounts, as well as how to create and manage normal user accounts.
Page 42 ADMIN ONLY First Time Administrator Setup First Time Administrator Setup All new CDI OneView Systems require an admin account for first-time setup. To create a new admin login: 1. Type in a username and password. 2. Retype the same password for confirmation.
Page 43 Initial Assembly and Admin Setup ADMIN ONLY ADMIN ONLY System Settings System Settings allow the admin to configure the following: User Management • Security • Language • Sound • Tap the Admin button in the bottom left corner of the screen to access System Settings. System Settings Tabs System Settings Tabs After tapping the Admin button, the following tab selector appears on the upper left...
Page 44 Initial Assembly and Admin Setup ADMIN ONLY ADMIN ONLY User Management (Optional) User Management (Optional) The User Management Tab allows admins to create new users, edit passwords for existing users, and assign users a permission level of admin or normal user. To create a new user, tap New.
Page 45 Initial Assembly and Admin Setup ADMIN ONLY ADMIN ONLY Security Security The Security Tab configures settings pertaining to user authorization. Password Complexity can be set to High, Medium, or Low. • Login Requirements for user access can be toggled on or off. •...
Page 46 ADMIN ONLY ADMIN ONLY Language Language The Language Tab sets the default language of operation for the CDI OneView System. Sound Sound The Sound Tab allows the admin to enable or disable the global alarm mute. When enabled, alarms can be muted during an active case.
Page 47 Case Profile Configuration This chapter provides instructions on customizing case profiles for the CDI OneView System. This includes information on the following: The toolbar icons • Pop-up messages and the message center • The battery status and AC power indicators •...
Page 48 Case Profile Configuration Pop-Up Messages Pop-Up Messages Pop-up messages are short-duration dialog windows that confirm an action has been either successful or unsuccessful. These are colored in green or orange and show either checkmarks or error messages. They stay active on screen for two to five seconds. Successful action Unsuccessful action Message Center...
Page 49 Case Profile Configuration Volume Indicator Volume Indicator This icon indicates whether the alarm volume is enabled, paused or muted. For further information on configuring the alarm volume settings, see Chapter 5 “Volume Settings.” Paused Muted Time/Date Time/Date To change the date or time: 1.
Page 50 Case Profile Configuration ADMIN ONLY ADMIN ONLY Case Profile Management Case profiles can be created, deleted and configured by admin users. Case profiles provide preset configurations to suit users’ preferences, as well as to meet the differing requirements of various cases encountered by an institution. Case profile menu for admin users To create a new case profile, tap New, enter a case profile name and tap Save.
Page 51 Case Profile Configuration Modify a Case Profile Modify a Case Profile To modify a case profile, select the desired case profile, then tap Configure at the bottom of the screen. Case profile menu for normal users Note: A message will be displayed if the selected profile has been modified by an administrator since the last time it was used.
Page 52 Case Profile Configuration Sensor Connections Sensor Connections The Sensor Connections Tab shows the modules currently connected to the Core and allows the user to configure what modules will be visible during measurement. Use the scrollbar on the right to navigate through all connections. Module types are listed in the following order: Arterial and Venous BPMs •...
Page 53 Case Profile Configuration Display Layout Display Layout The Display Layout Tab shows the Display Layout Builder at the top of the screen, which provides a list of all available parameters previously configured in Sensor Connections. At the bottom it shows the Display Preview, which provides a preview of the current Measurement Screen configuration.
Page 54 Case Profile Configuration The Arterial, Venous and Other containers can be resized. To resize a container, follow the steps below: 1. To expand a container, first shrink another container. 2. Touch and hold the right side of the container to initiate resizing. 3.
Page 55 Case Profile Configuration Data Options Data Options The Data Options Tab gives various choices of how data is displayed and whether certain functionality is enabled. This screen has three different types of interactions: Button Selection. Tap for desired selection. • Toggles.
Page 56 Alerts/Alarms The Alerts/Alarms Tab sets thresholds for the physiological parameters measured or calculated by the CDI OneView System. The parameters available depends on the modules configured in Sensor Connections. Set high and low alerts as well as alarm thresholds to notify the user when parameters fall outside of clinically relevant limits.
Page 57 Case Profile Configuration Reset to System Defaults resets all alarm limits to the manufacturer- defined default limits. The manufacturer-defined default limits are derived from typical clinical values that can occur during cardiopulmonary bypass for which user intervention may be required. Reset to Profile Defaults resets all alert and alarm settings to the case profile defaults set by the admin.
Page 58 Case Profile Configuration Events (Optional) Events (Optional) The Events Tab allows configuration of events that can be marked during measurement. To create and delete event names and set the order in which they are listed: To create a new event, tap New, then type the new event name. •...
Page 59 Multi-Graphs (Optional) Multi-Graphs (Optional) The CDI OneView System can display the patient’s blood gas parameter values in graphical format. The purpose of Graph Layout Builder is to create optional, multi-parameter graphs. Up to four such multi-graphs can be configured to view simultaneously.
Page 60 Case Profile Configuration Save Default Permanent / Temporary Toggle Save Default Permanent / Temporary Toggle ADMIN ONLY ADMIN ONLY Permanent: Changes to the case profile will be made permanently. ADMIN ONLY ADMIN ONLY Temporary: Changes to the case profile will be saved for this case only, after which all changes will revert to case profile defaults.
Page 61 CDI OneView Touchscreen Display [CDI751] • CDI OneView Processing Core [CDI750] • CDI OneView Calibrator [CDI740] with Gas 1 and Gas 2 bottles installed • CDI OneView BPM Probe(s) [CDI753] • CDI Shunt Sensor(s) [CDI510H] to be calibrated (Arterial and/or Venous) •...
Page 62 Calibration and Circuit Setup Calibration Home Calibration Home First select a case profile, then tap Calibrate from the Home Screen. Note: Tap Skip at the top right of the calibration screen to skip calibration. Prepare the BPM Assembly Prepare the BPM Assembly 1.
Page 63 Calibration and Circuit Setup 3. The K Code is a three-digit number and letter listed on the label of the Shunt Sensor’s foil pouch. Tap the entry field on screen and input the K Code. Optional: For Shunt Sensor packaging that includes a 2D barcode, the K Code can be entered by scanning using the camera under the Display.
Page 64 Calibration and Circuit Setup Warning Using uncalibrated BPM assemblies may result in inaccurate values. A K Code is required to skip calibration. If calibration is skipped, the system will use the last K Code entered. Do not remove the sensor filter/sparger assembly from the CDI Shunt Sensors until ready to connect them to the circuit.
Page 65 Calibration and Circuit Setup Prepare to Calibrate Prepare to Calibrate 10. Place BPM assembly in either pocket of the Calibrator, pushing it down until it stops and locks into place. The BPM is connected properly if it can resist a gentle tug.
Page 66 Calibration and Circuit Setup 13. When all the previous steps have been completed, tap Note: If the Continue button is not enabled, double-check the following: A valid K Code has been entered. • The Calibrator cable is connected to the Core and to the Calibrator. •...
Page 67 Calibration and Circuit Setup Note: If the BPM assembly is not properly seated, the following window will appear. The Calibrator pockets will reflect the BPM assignments in the case profile. Note: When only one BPM needs to be calibrated again, the Start Calibration button can be tapped despite appearing inactive.
Page 68 Calibration and Circuit Setup Conclude Calibration Conclude Calibration After the calibration is successfully completed, the following window appears. Follow the steps below to conclude calibration: 1. Verify that the calibration was successful by ensuring no error messages have appeared on screen and that a green checkmark is displayed next to both sensors.
Page 69 Sensors that have been calibrated successfully are ready for placement into the extracorporeal circuit. Continue to the next page for further instructions. The CDI OneView System remembers the most recent calibration data, even when paused or switched off. The calibration data is replaced only when a new calibration is performed.
Page 70 Calibration and Circuit Setup Sensors and Cuvettes This section explains how to place the CDI Shunt Sensors and H/S Cuvette into the extracorporeal circuit and how to attach Flow Sensors. Prepare Disposables to Install Prepare Disposables to Install To install Shunt Sensors, the following is required: CDI Shunt Sensor(s) •...
Page 71 Calibration and Circuit Setup Install the Shunt Bypass Line and CDI H/S Cuvette Install the Shunt Bypass Line and CDI H/S Cuvette If the Shunt Bypass Line and CDI H/S Cuvette are supplied in a single sterile package, remove them from the package and aseptically insert them into the extracorporeal circuit.
Page 72 Calibration and Circuit Setup Install a CDI Shunt Sensor Install a CDI Shunt Sensor The heparin-coated, sterile CDI Shunt Sensors, Model CDI510H, are intended for placement into shunt lines, purge lines, sampling lines, Shunt Bypass Lines or any similar line that has constant blood flow. Warning ...
Page 73 Calibration and Circuit Setup Follow these steps to install the CDI Shunt Sensor into a shunt/purge line: 1. Ensure the positioning of the BPM and CDI Shunt Sensor is convenient for connection into the shunt/purge line. 2. Using sterile technique, remove the top Luer cap (white) from the CDI Shunt Sensor and attach one end of the “shunt/purge”...
Page 74 Calibration and Circuit Setup Install a CDI Shunt Sensor into the Shunt Bypass Line Install a CDI Shunt Sensor into the Shunt Bypass Line Warning Do not allow the CDI Shunt Sensor to dry out. Make sure the circuit has prime fluid in it before attaching the Shunt Sensor.
Page 75 Calibration and Circuit Setup Attach the CDI H/S Probe for Hematocrit/Saturation Measurement Attach the CDI H/S Probe for Hematocrit/Saturation Measurement Follow the steps below to attach the CDI H/S Probe to the CDI H/S Cuvette for HCT, Hgb and SO measurement.
Page 76 Calibration and Circuit Setup Attach Flow Sensor Attach Flow Sensor Follow the steps below to attach a Flow Sensor. 1. Open the Flow Sensor latch. 2. Seat the tubing in the sensor. Ensure the arrow on the sensor points in the direction of the circuit flow.
Page 77 This section provides instructions on how to observe and record patient data while in the Measurement Mode of the CDI OneView System. Initiate Measurement Mode While in Measurement Mode, the CDI OneView System continuously measures blood parameters. Measurement Mode will always start in Pause Mode, whether by tapping Measure on the Home Screen or following a successful calibration.
Page 78 Visual alarms indicating specific alarm conditions are perceptible at a distance of one meter from the front of the CDI OneView Display. No other intended position of the user with respect to the alarm signals is defined.
Page 79 Running a Case Single-Parameter Graphs Single-Parameter Graphs Any parameter displayed in Measurement Mode can be tapped to view a graph of that parameter. This graph includes all marked events. The current parameter’s value and alert/alarm limits are shown on the right. •...
Page 80 Running a Case Measurement Mode Taskbar The Measurement Mode Taskbar provides a variety of functions. The following section will look at each function of the taskbar in greater detail. 1. Home 2. Measurement/Pause Toggle 3. BSA 4. Flow Source for Calculation 5.
Page 81 Running a Case Tap the BSA button and use the number pad to enter the patient BSA. Flow Source for Calculation Flow Source for Calculation Tap the Flow button to choose the Flow Source for Calculation of oxygen consumption and oxygen delivery. The Flow Source options are to choose one of the four connected Flow Sensors, retrieve flow information from an external source or enter a manual flow using the number pad.
Page 82 Running a Case Temperature pH/ Temperature pH/α α -Stat Selection -Stat Selection Tap the pH-stat/37° α-stat button to display arterial and venous blood gas values either at pH-stat (actual temperature/measured) or corrected to 37°C alpha-stat. Toggle the pH-stat/37° α-stat to change the patient temperature mode. Note: The temperature measured by a CDI Shunt Sensor will be that of the shunt / purge line, which may differ slightly from the temperature in the rest of the circuit because of the exposure of the shunt line to room air temperatures.
Page 83 Running a Case Multi-Graphs (Optional) Multi-Graphs (Optional) Tap the Multi-Graph menu to view preconfigured, multi-parameter graphs. Up to four multi-graphs can be arranged to view simultaneously. Multi-graphs can be shown as either Stacked or Overlay graphs. See the images • below for examples.
Page 84 Running a Case Alerts/Alarms Alerts/Alarms To set alert and alarm thresholds: 1. Tap the Alerts/Alarms button. 2. Tap the cell to edit that value. 3. Enter value with the number pad or use arrows to increase/decrease the value. 4. Tap outside the number pad to accept the value. 5.
Page 85 Running a Case Volume Settings Volume Settings Tap the volume button to adjust the alarm volume setting. Tap the + or – icons or the slider to raise or lower the volume. The system will • generate an example sound to demonstrate the current volume level. Tap Pause to pause an alarm until another alarm is triggered.
Page 86 Note: In vivo recalibration should not be confused with gas calibration, which is a separate preliminary step also required for proper usage of the CDI OneView System. Steps to perform a gas calibration are detailed in Chapter 4, “Calibration.”...
Page 87 Running a Case Caution For the best comparison with your laboratory, press the store key ƒ only after the circuit has been stabilized for approximately five minutes (when there have been no changes in temperature, fraction of inspired oxygen in a gas mixture (FiO2), gas or blood flows, other parameters or addition of medications that would cause changes in displayed values).
Page 88 Running a Case 5. Enter a laboratory value into the adjusted cell by tapping the desired cell. The cell will auto-fill with the stored value. The value can be adjusted with the number pad. Tap outside the flyout to cancel, or delete the number on the number pad.
Page 89 Running a Case Screenshot Screenshot Tap the Screenshot button to capture and save a copy of the currently displayed screen. If a screenshot capture fails, a pop-up message will show Screenshot failed. • A checkmark highlighted in green appears if a screenshot capture is successful. •...
Page 90 Display, gently press it into the mount until it clicks into place. 5. Open Flow Sensor latch to remove tubing. 6. Wipe down the CDI OneView Display, Core and cables with an appropriate cleaning agent. See Chapter 7, “Routine Cleaning”...
Page 91 Running a Case Disposal of Waste Products Disposal of Waste Products Disposal of the CDI Shunt Sensors and CDI H/S Cuvette must be done along with the bypass tubing circuit. No disconnection or further handling of the CDI disposables is necessary.
Page 92 Running a Case Data Export The CDI OneView System can export both case data and log data to an external USB drive connected to the bottom of the Display. Case data includes all recorded data from a case, including events and screenshots.
Page 93 This chapter provides a list of error messages and suggested solutions for problems that might occur with the Terumo Cardiovascular CDI OneView™ System. If you see an error message or have a problem with the system, consult this chapter for assistance.
Page 94 Display cable is securely connected to both the Core and Display. If still not illuminated, try a replacement Display cable. If the issue persists, contact Terumo Cardiovascular Technical Support. Battery error A failure was detected in the battery during system startup.
Page 95 If the module was not intentionally disconnected from the Core, disconnect and reconnect the module, try a different port on the Core or try a replacement module. If the issue persists, contact Terumo Cardiovascular Technical Support. Core error A read/write failure was detected in the Core electronics.
Page 96 Ensure Display cable is properly connected to the Core and Display. Power off the system, wait for Core LED to turn steady white, and then power system back on. If the issue persists, contact Terumo Cardiovascular Technical Support. Data transfer failure Data could not be transferred to/from an external hard drive.
Page 97 Ensure the large blue venting cap(s) on the top of the Shunt Sensor(s) are loosened. If the proper setup was conﬁ rmed, this indicates the problem is with the Shunt Sensor(s). Replace the Shunt Sensor(s) and try again. If the problem persists, contact Terumo Cardiovascular Technical Support.
Page 98 G007 G010 It may be possible to reset the system by G001 disconnecting and reconnecting to the Core. G008 If the issue persists, contact Terumo Cardiovascular G011 Technical Support. Barometric pressure This indicates an ambient pressure measurement outside operational range outside the acceptable range.
Page 99 Calibrator. It may be possible to reset G415 the system by disconnecting and reconnecting it G416 to the Core. If the issue persists, contact Terumo G418 Cardiovascular Technical Support. Note: You will need to replace the Shunt Sensor(s) on the BPM(s) before restarting calibration.
Page 100 24 hours. Retry calibration for this BPM with a new Shunt Sensor. If the foil pouch is visibly compromised, please keep the foil pouch and contact Terumo Cardiovascular Technical Support. Calibration error There is a communication issue preventing the calculation timeout completion of the calibration process.
Page 101 BPM optical head. If the error persists, use a replacement BPM Probe and contact Terumo Cardiovascular Technical Support. (Arterial or Venous) The calibration data stored on the Probe has been BPM-[SN] error corrupted. B104 Use a replacement BPM Probe and contact Terumo Cardiovascular Technical Support.
Page 102 Ensure the BPM Probe is not placed directly next to a light source. To retry the BPM Probe, disconnect and reconnect to the Core. If the error persists, use a replacement BPM Probe and contact Terumo Cardiovascular Technical Support. H/S PROBE...
Page 103 Connect the H/S Probe to the Cuvette. Ensure the release lever of the H/S Probe is latched by pressing the Probe and Cuvette together. If the alarm continues, replace the Cuvette and contact Terumo Cardiovascular Technical Support. Note: Connecting the H/S Probe to the Cuvette will deactivate the alarm.
Page 104 F201 tubing. Confirm the Flow Sensor size matches the tubing (ID, OD) being used. If the alarm continues, replace the Flow Sensor and contact Terumo Cardiovascular Technical Support. Note: Proper coupling of the Flow Sensor to tubing will deactivate the alarm.
Page 105 It may be possible to reset the HLM Interface P006 Module by disconnecting and reconnecting it to P007 the Core. If the issue persists, use a replacement P008 HLM Interface Module and contact Terumo P010 Cardiovascular Technical Support. P011 P012 P013...
Page 106 It may be possible to reset the DMS Interface M006 Module by disconnecting and reconnecting it to M007 the Core. If the issue persists, use a replacement M008 DMS Interface Module and contact Terumo M010 Cardiovascular Technical Support. M011 M012 M013...
Page 107 Check connections between the Core and Interface M052 Module and between the Interface Module and Data M054 Management System. Try a replacement Interface Module. If the issue persists, contact Terumo Cardiovascular Technical Support. IN MEASUREMENT MODE IN MEASUREMENT MODE Message...
Page 108 Troubleshooting Laboratory Comparison Troubleshooting Table The following table details information you can use to determine why your CDI OneView System values appear to be inaccurate with respect to laboratory values: PARAMETER ACCURACY PARAMETER ACCURACY Problem Problem Corrective Action Corrective Action Wait approximately five minutes after making •...
Page 109 Problem Corrective Action Corrective Action Accuracy problems? The temperature mode of the CDI OneView System Does the lab recalled values must match what is used by the laboratory. temperature match If the laboratory values are reported at 37°C, ensure the the CDI OneView comparison values at 37°C or changed to 37°C values...
Page 110 If the freeze indicator is positive, contact Terumo Cardiovascular Customer Administration or your local Terumo Cardiovascular Sales representative. Check to make sure halothane is not being used •...
Page 111 Switch off the system power before inspection, cleaning or storage. Routine Cleaning To keep the CDI OneView System working properly, follow the guidelines listed below. In addition to these cleaning instructions, comply with your institution’s cleaning practices and applicable AmSECT guidance. For additional information about reprocessing the device or details of the validation performed, contact Terumo Cardiovascular Technical Support.
Page 112 25 minutes. The system will remain fully functional while connected to AC power. When the battery replacement message appears on the screen, contact your local Terumo Cardiovascular representative or call (800) 521-2818 for service.
Page 113 Replacement fuses must be the correct size and rating to protect against the risk of fire. The CDI OneView System fuses can be replaced. To test and/or change the fuses: 1. Remove the fuse holder from the back of the Core.
Page 114 CDI OneView BPM Probe CDI753 CDI OneView H/S Probe CDI754 CDI OneView Calibrator CDI740 CDI OneView Calibrator Cable CDI741 CDI OneView Calibration Gas 1 CDI746 CDI OneView Calibration Gas 2 CDI747 Brackets CDI OneView Core Bracket CDI780 CDI OneView Display Bracket...
Page 115 External Data Modules CDI OneView HLM Interface Module CDI770 CDI OneView DMS Interface Module CDI771 CDI OneView RSO Interface Module CDI772 Accessories CDI Module for Terumo Advanced Perfusion System 1 803479 CDI Interface Cable for Terumo Advanced Perfusion System 1 804981...
Page 116 – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. Based on these requirements and the known clinical use of the CDI OneView System, manufacturer-defined default limits provide alarm functionality at the medium-priority level.
Page 117 System Specifications System Operating Ranges System Operating Ranges are the ranges in which parameter measurement performance meets system accuracy limits when adhering to instructions for use. Parameter Parameter Operating Range Operating Range 6.80 to 7.65 10 to 80 mmHg 20 to 500 mmHg 3.0 to 8.0 mmol/L Shunt Temp 15°...
Page 118 System Specifications System Display Ranges System Display Ranges are the full ranges in which parameter values will be displayed by the system. Parameter Parameter Display Range Display Range Resolution (*) Resolution (*) 6.50 to 8.50 0.01 10 to 200 mmHg 1.3 to 26.7 kPa 10 to 700 mmHg 1.3 to 93.3 kPa...
Page 119 System Specifications System Accuracy The CDI OneView System has been subjected to rigorous bench tests to simulate clinical use of the device and assess its accuracy and precision over the system operating ranges of measured parameters. Blood samples taken from the test circuit were analyzed in conventional analyzers, and these results were compared on a sample-by-sample basis to values displayed by the CDI OneView System.
Page 120 System Specifications System Accuracy Limits Parameter Operating Range Post In Vivo Performance 6.80 to 7.65 ±0.070 pH units for ≥6.80 and <7.30 ±0.050 pH units for ≥7.30 and ≤7.50 ±0.070 pH units for >7.50 and ≤7.65 10 to 80 mmHg ±5.0 mmHg for ≥10 mmHg and ≤55 mmHg ±10% for >55 mmHg and ≤80 mmHg 20 to 500 mmHg...
Page 121 System Specifications Environmental Specifications Operating Conditions Temperature 10 °C to 40 °C (50 °F to 104 °F) Humidity 30% to 75% Storage Temperatures Hardware 10 °C to 40 °C (50 °F to 104 °F) Shunt Sensors 0 °C to 35 °C (32 °F to 95 °F) Calibration Gas 1 and 2 18 °C to 25 °C (64.4 °F to 77 °F) Transport Temperatures...
Page 122 Compliance: IEC 62133, PSE Note: To provide isolation from supply mains, remove power cord from the CDI OneView System appliance coupler. Do not position the CDI OneView System so that it is difficult to isolate the appliance coupler from the supply mains.
Page 123 Consult the manufacturer of the receiving device for help. • Electromagnetic Compatibility (EMC) Electromagnetic Compatibility (EMC) The CDI OneView System is suitable for use only in the electromagnetic environments specified in the following tables, in accordance with these standards: IEC 60601-1:2005+A1:2012+A2:2020 •...
Page 124 Electromagnetic Emissions Guidelines and Compliance Electromagnetic Emissions Guidelines and Compliance The CDI OneView System is intended for use in the electromagnetic environment specified in the following tables. The user of the system must ensure it is used in such an environment.
Page 125 0.5 cycles (at 0°, 0.5 cycles (at 0°, or hospital environment. If the 45°, 90°, 135°, 45°, 90°, 135°, user of the CDI OneView System 180°, 225°, 270° 180°, 225°, 270° requires continued operation and 315°) and 315°)
Page 126 150kHz to 80MHz communications equipment Outside ISM Outside ISM should be used no closer to bands bands any part of the CDI OneView System, including cables, than the recommended separation distance ISM bands ISM bands calculated from the equation between 150kHz...
Page 127 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CDI OneView System is used exceeds the applicable RF compliance level above, the CDI OneView System should be observed to verify normal operation.
Page 128 Recommended RF Separation Distance Recommended RF Separation Distance The CDI OneView System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user can prevent electromagnetic interference by maintaining a minimum distance of 30 cm (12 inches) between portable and mobile RF communications equipment and any part of the CDI OneView System.
Page 129 (such as a laboratory or point-of-care blood gas analyzer) before initiating treatment if performance is lost or degraded due to EM disturbances. There are no precautions specific to the CDI OneView System to be taken when a cardiac defibrillator is used on a patient. The typical recovery time from these events is less than 30 seconds.
Page 130 Use a connecting lead with a 6 mm socket conforming to DIN 42801-part 2 Potential Equalization Leads - Connecting Sockets. Security Security The CDI OneView System incorporates several features to ensure the security of the system. These features include inherent design elements as well as user settings and functions. General Recommendations...
Page 131 Ongoing Security Information Ongoing Security Information In the event that new information regarding the security of the CDI OneView becomes available, Terumo Cardiovascular will notify users of such information or required actions. Such information includes security patches, identification of vulnerabilities, or security lifecycle information.
Page 132 System Specifications Physical Specifications Component Part # Dimensions Weight Core CDI750 22.2 cm x 27.2 cm x 8.3 cm 3 kg Display + Backplate CDI751 30 cm x 20.5 cm x 9.5 cm 2.4 kg Calibrator CDI740 23 cm x 21 cm x 18 cm 3.3 kg Brackets CDI780...
Page 133 System Specifications Unpacking and Inspection The CDI OneView System has been packaged to prevent shipping damage. The cartons contain a Display (with a Display cable), Core (with a power cable) and Calibrator. The Display Bracket, Core Bracket, Calibrator Bracket, BPM Bracket, Calibration Gas Bottles, BPM Probes, H/S Probes, Calibrator Cable, External Data Modules, Flow Interface Module, and Flow Sensor are packaged separately.
Page 134 Communication with Other Devices The CDI OneView System has Modules that can connect to external devices to import or export patient parameter values over the course of an operation. When using a CDI OneView Module with the Terumo™ Advanced Perfusion System 1 along with a CDI module, blood parameter values can also be displayed on the Central Control Monitor.
Page 135 Communication with Other Devices Connecting an External Device to the Port This section explains how to connect an external serial device to the CDI OneView and how to set the communication parameters. 1. Use a 9-pin, D-type, RS-232 straight through cable to attach the CDI OneView Module to the external device.
Page 136 DCE (Data Communications Equipment) device at the factory. Hardware handshaking is not supported. The CDI OneView Core has two levels of protection to isolate the patient from shocks caused by AC line faults occurring in devices attached to the serial interface.
Page 137 Terumo Cardiovascular Technical Service Representative for assistance. If a pump and/or oximeter is selected in the Sensor Connections Tab, the CDI OneView System will begin looking for pump flow data and/or oximetry from the Module(s) upon entering Measurement Mode. If no data is received within a certain time period, the...
Page 138 The CDI uses the following serial port settings to communicate with System 1: 19200 baud, 8 bits, no parity, 1 stop bit. To set up the CDI OneView System, select the System 1 HLM in the Sensor Connections tab. Terumo™...
Page 139 Communication with Other Devices Oximeter Special Instructions Nonin The SenSmart must be configured for the Nonin 5 output SenSmart® X-100 data format. Refer to the SenSmart User manual or contact Nonin Technical Service for assistance. A female/female straight through cable is required to interface the SenSmart to the Module.
Page 140 Terumo™ Advanced Perfusion System 1. It provides a flexible format to allow the CDI OneView System to get flow data as desired from the pump and for the pumping system to request data as desired from the system.
Page 141 Symbols Glossary The following symbols may appear in the labeling, marking or display of the CDI OneView. These symbols are in accordance with the internationally harmonized standards. Symbol Title Description Source indicate that operating Operator’s Manual; instructions should be considered ISO 7000-1641 operating instructions when operating the device or control...
Page 142 ISO 15223-1-5.3.8 exposed. Battery recycling Battery recycling (European). WEEE 2012/19/EU (European) Battery recycling Battery recycling (USA). ISO 7000-1135 (USA) G AS Terumo Gas 1 Gas 1. Cardiovascular G AS Terumo Gas 2 Gas 2. Cardiovascular Number of contents in Terumo Identifies the number of contents.
Page 143 Symbols Glossary Symbol Title Description Source Non-ionizing radiation Non-ionizing radiation. IEC 60417-5140 Indicates the manufacturer’s catalogue Catalogue Number number so that the medical device can ISO 15223-1-5.1.6 be identified. Authorized Indicates the Authorized representative in the representative in the European ISO 15223-1-5.1.2 European Community Community.
Page 144 To indicate a ground terminal. IEC 60417: 2002 Terminal China Restriction of 10 10 Environment Friendly Use Period Hazardous Substances SJ/T 11364-2014 (EFUP) of ten years. (RoHS) Terumo Create new item. Cardiovascular Terumo Deselect Deselect item. Cardiovascular Terumo Select all Select all items.
Page 145 Symbols Glossary Symbol Title Description Source AC power – System is plugged in, and battery has Terumo Battery @ 20 minutes 20 minutes of backup power. Cardiovascular AC power – System is plugged in, and battery has Terumo Battery @ 15 minutes 15 minutes of backup power.
Page 146 Symbols Glossary Symbol Title Description Source Terumo Light mode Light mode. Cardiovascular Terumo Admin/System settings System settings. Cardiovascular Terumo Data export Access to case data and log export. Cardiovascular Terumo Calibrate Gas calibration. Cardiovascular Terumo Configure Case profile configuration. Cardiovascular...
Page 147 Symbols Glossary Symbol Title Description Source Terumo Alarm pause Alarm pause. Cardiovascular Terumo Alarm mute Alarm mute. Cardiovascular Terumo Alarm on Alarm on. Cardiovascular Terumo Store/Recall Store and recalibrate lab values. Cardiovascular Terumo Add event Add event. Cardiovascular Terumo Event flag Event flag on graph.
Page 148 Symbols Glossary Symbol Title Description Source Terumo Admin user Admin user access. Cardiovascular Terumo 1x1 tile size Parameter is 1x1 tile size. Cardiovascular Terumo 1x2 tile size Parameter is 1x2 tile size. Cardiovascular Terumo 2x2 tile size Parameter is 2x2 tile size.
Page 149 Terumo Cardiovascular also warrants that the Display, Core, Calibrator and probes will be fit for use in accordance with CDI OneView System indications for use. Terumo Cardiovascular does not warrant that they are fit for any other use.
Page 150 Gas bottles must be removed prior to returning a Calibrator. Improper shipment of gas bottles is an explosion hazard. Terumo Cardiovascular will not authorize the return of goods which are not in new and resalable condition, which have fewer than 90 days remaining prior to the expiration date, or which do not appear on Terumo Cardiovascular’s most recently published...
Page 151 Terumo Cardiovascular at law or equity. 6. LIMITED WARRANTY. Terumo Cardiovascular warrants only that the SOFTWARE will, for a period of one year following shipment of the CDI OneView, function in accordance with the instructions furnished with the SOFTWARE. Should the SOFTWARE fail to properly function, Terumo Cardiovascular’s sole obligation...
Page 152 Agreement will be binding unless in writing and signed by a duly authorized representative of Terumo Cardiovascular. 13. NOTICES. Notices required to be sent to Terumo Cardiovascular under the terms of this Agreement should be sent to: Customer Service, Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd., Ann Arbor, MI 48103, USA.
Page 153 Glossary and Acronyms Note: These definitions are specific to the Terumo Cardiovascular CDI OneView™ System. Alpha-stat Maintenance of a constant OH−/H+ ratio, accomplished by measuring blood gas values at 37°C and keeping a constant pH of 7.40 and pCO of 40 mmHg.
Page 154 Glossary and Acronyms In vivo recalibration Recalibrating the CDI OneView System during on-line operation so that its measured values correlate more closely with those from the institution’s blood parameter laboratory. LEDs Light Emitting Diodes. Mean A numerical average calculated as the sum of all values in the set divided by the number of values in the set.
Page 155 A silver cap located on the BPM that measures the temperature of the blood when connected to a sensor. Tonometered A measurement characteristic of the calibration gases used with the CDI OneView System. The gas concentrations used with the CDI OneView System meet guaranteed specifications to ensure every gas bottle provides consistent calibration.
Page 156 CDI OneView Monitoring System Calibrator CDI740 ® IPX2 Rx Only 10 10 2797 Date of Release TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 6200 Jackson Road, Ann Arbor, MI 48103, USA May 2024 EC REP TERUMO EUROPE N.V. Interleuvenlaan 40, 3001 Leuven, Belgium...

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Cdi oneview cdi751 Cdi oneview cdi740 Cdi oneview cdi750