Sirolimus eluting coronary stent system (80 pages)
Summary of Contents for Terumo CDI 550
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MADE CLARIFICATIONS TO CHAPTER 9 91979 UPDATED CLEANING AND CHAPTER 9 Refer to ECO SYM. CHG. NO. DESCRIPTION REVISIONS TERUMO CARDIOVASCULAR SYSTEMS CORPORATION Ann Arbor, Michigan TITLE CDI SYSTEM 550 OPERATORS MANUAL, TEXT 895230 PART NUMBER SHEET REV. DRAWING NUMBER...
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Table of contents Chapter 4 Choosing System Settings Selecting options on the setup screens ............... 4-1 Setting printer options ..................4-2 System Notifications .................... 4-3 Physiological Alarms.................... 4-4 Manufacturer-Defined Default Alarm Limits ............4-4 Setting alarms ...................... 4-5 Choosing graphic displays ................... 4-7 Choosing general settings ...................
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Table of contents Chapter 8 Concluding a Case Printing or sending a report ................. 8-1 Returning the monitor to “standby” mode ............8-2 Return the monitor to its pre-operation state ............8-2 Disposal of waste products .................. 8-3 Chapter 9 Troubleshooting Error messages and conditions ................
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Table of contents Appendix B System Specifications Electrical ......................B-6 Environment ....................B-9 EMC Tables ....................B-10 Safe Working Loads ................... B-15 Additional Warnings and Precautions ............B-15 Unpacking and inspection .................. B-16 Calculations ....................... B-16 Appendix C Communication with other Devices Communication with other devices ..............
What is the CDI System 550? The Terumo Cardiovascular Systems (Terumo CVS) CDI Blood Parameter Monitoring System 550 (CDI System 550) is a blood monitoring system to be used on a single patient during cardiopulmonary bypass procedures. It continuously monitors the blood in the extracorporeal circuit and provides ongoing information about the blood parameters.
Before you set up or operate the CDI System 550, it is vital that you read and under- stand all the material in this manual. To arrange additional training, please contact your local Terumo Cardiovascular Systems representative or call 1-800-521-2818 and ask about CDI System 550 training.
If, upon reading this manual, you find that you need clarification or additional informa- tion, you can direct questions to your local Terumo Cardiovascular Systems represen- tative, or to: Terumo Cardiovascular Systems 6200 Jackson Road, Ann Arbor, MI 48103 USA...
(LEDs) and a photodetector. The LEDs direct light pulses at the blood through an optical window in the Terumo CDI H/S Cuvette, which is inserted into the extracorporeal circuit. The intensity of the resulting reflections are analyzed (on the basis of the characteristic spectra of the oxy- and deoxy- forms of hemoglobin) to determine the oxygen saturation, hematocrit, and hemoglobin.
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1.5 LPM The Terumo CDI Shunt Sensor requires a minimum of 35 ml/min. Restoration of blood flow above the minimum through the CDI Shunt Sensor or the Terumo CDI H/S Cuvette will restore performance of the system. • Do not make simultaneous contact with the patient and certain parts of non-medical electrical equipment.
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• Do not attempt in vivo recalibration expecting to re-align values affected by interference due to intravascular dyes or pharmacological agents; the interference may be prolonged resulting in continuing inaccuracies. • Exposure of the shunt sensor to prime solutions and/or blood with pH less than 7.0 or greater than 7.8 pH units can interfere in the accurate measurement of potassium.
Terumo CDI blood parameter monitoring systems are intended to monitor blood gas values including pH, PCO ² , PO ² , K + , Oxygen Satu- ration (SO ²...
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Arterial parameter values (highlighted in pink). pH values are displayed in pH units, while PO , and PCO , can be displayed in either mmHg or kPa. Calcu- lated base excess and bicarbonate are displayed in mEq/L. Venous parameter values (highlighted in blue). pH values are displayed in pH units, while PO ²...
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The next figure shows the side panel of the monitor. (16) (18) (17) (16) (14) (15) 5000109 (14) Arterial and/or venous blood parameter module (BPM) cable-heads. Modules for monitoring pH, PCO , PO , potassium and temperature. Caution Do not stare directly into the light generated by the BPM LED. (15) H/S (Hematocrit/Saturation) Probe.
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Application of voltages greater than 5 Volts will damage the monitor. (20) Pump interface port. Allows the input of blood flow data from a Terumo Sys- tem 1/CDI Interface Module (Terumo), Sarns 8000 Communications Module (Terumo), Sarns Centrifugal Pump (Terumo), BioConsole®...
(25) Power cord connector. The receptacle for the power cord (when connected to an AC power supply). (26) Power cord. The CDI System 550 hospital grade AC power cord. (27) Fuse holder. Contains two fuses. (28) Cable guide. Excess cable can be wrapped here for convenient storage when not in use or during transport of the monitor.
, and PO values. The set of gas bottles shall provide enough gas for ap- proximately 80 individual sensor calibration procedures. Gas A (Terumo CDI Model CDI506): Gas B (Terumo CDI Model CDI507): : 7.5 +/- 0.1% : 2.8 +/- 0.1% : 27.5 +/- 0.1%...
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A transparent optical interface material found on the back side of the CDI Model CDI510H Shunt Sensors provides a means of consistent optical connection between the sensor and the fiberoptic cable connector. Optical Interface This material reduces the risk of measure- ment errors caused by moisture trapped between the microsensors and the cable- heads.
• 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.
• Secure all connections on the shunt bypass line with stay straps. Terumo CDI Hematocrit/Saturation Cuvette The CDI Hematocrit/Saturation (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 sup- plied sterile and individually packaged, for incorporation into the circuit at the time of use, or can be supplied non-sterile to tubing pack manufacturers for pre-connection.
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Note: When the CDI H/S Cuvette is inserted into the circuit, the optical window should be pointing down. This minimizes interference from intermittent air bubbles in the line. 5170116 Optical Window Magnets Aseptic technique must be used when adding the CDI H/S Cuvette to the circuit. End caps are provided on the sterile assemblies at each end of the cuvette to protect the blood pathway from contamination prior to insertion into the circuit.
• The CDI H/S Cuvette tubing connections should be secured with tie bands. Terumo CDI Monitor Pole Clamp The CDI Monitor Pole Clamp attaches to standard heart-lung machine poles, and consists of an arm and a tray with an alignment cone. The monitor attaches to the tray for easy mounting and dismounting.
Terumo CDI Cable-head Bracket The CDI Model CDI519 Cable-Head Bracket attaches to standard heart lung machine poles, and can accommodate one or two cable-head assemblies. The cable-head assembly slides into the bracket for easy mounting and dismounting. The bracket can be positioned vertically or horizontally, and at varying lengths from the pole.
This chapter gives a brief overview of the steps involved in setting up and using the Terumo Cardiovascular Systems CDI Blood Parameter Monitoring System 550. You can use this chapter to get a preview of the system’s operation, or refer to it when you need a reminder of one or more steps in the process.
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Open the sensor package and remove the sensor. Make sure the Loosen large blue luer buffer solution completely covers the microsensors. Small white luer cap Remove the cable-head from the monitor. Attach the sensor assembly to the cable-head. Note: Do NOT squeeze the plastic “wings”...
Installation See Chapter 6 for installation warnings and more details on installation. If the Terumo CDI H/S Cuvette is in a single sterile package, remove it and insert it into the extracorporeal circuit using aseptic technique. Prime the circuit. Install the CDI Shunt Sensor into the circuit us- ing aseptic technique: ...
Operation See Chapter 7 for cautions and warnings and more details about operating functions. Set the monitor to “Operate” mode. Warning Measured values prior to initial calibration may not be accurate. Do not use values prior to initial in vivo calibration for patient management. When the case has begun and the values have stabilized, complete a calibra- tion of all measurable blood parameters including;...
Conclusion of case See Chapter 8 for cautions and warnings and more details on concluding a case. Tear off printout. If necessary, press the “feed” button in the operate mode to clear printout from printer cover. Option: Print a post-case report (from the printer options setup screen). Set the monitor to “standby”...
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This chapter explains how to set up the Terumo Cardiovascular Systems CDI Blood Parameter Monitoring System 550 Monitor, printer, and Terumo CDI Model 540 Calibrator, and describes the process of powering up the monitor. Setting up the monitor To set up the monitor, follow these steps: Attach the monitor pole clamp securely to a heart-lung machine pole.
Note: When the monitor is not in use, always leave the cable-heads docked in their designated ports on the monitor side panel (their ports are color-coded for easy identification). Connecting the modules in this way provides protection for the optical surfaces.
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Errors that are recoverable will offer an option to continue — usually by press- ing the √ (OK) key. Any consequences of continuing despite the error are noted in the error message. The message may recommend contacting Terumo Tech- nical Service to resolve the error at a later time.
After the completion of the system diagnostics and the module self-tests, the printer prints a heading like the following: Terumo CVS CDI ® ® Blood Parameter Monitoring System Date: 09/25/2018 Time: 13:00:49 Serial Number: 1001 Patient ID: Monitor diagnostics: PASS...
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13:26 9-25-18 These colored tabs indicate which modules are included in the highlighted configuration. (A gray tab indicates an excluded module. A=arterial, V=venous, H/S=hematocrit/ saturation) A yellow highlight indicates the current selection. calibration Use the + and - keys or the keys to System mode select key move the highlight up and down.
Note: The printer cover must be securely closed for normal operation and for cleaning. Note: Thermal printer paper Terumo CDI Model 7310 is sensitive to heat, light, chemical, and mechanical damage. The paper remains sensitive even after an image has been printed on it. Used paper should be stored in the dark at an ambient tem- perature below 25°C (77°F) and 65% relative humidity.
To prepare the Terumo CDI Model 540 Calibrator to perform a tonometered calibration of the sensors, you need the CDI Model 540 Calibrator, one Terumo CDI Gas A bottle (Model CDI506), and one Terumo CDI™ Gas B bottle (Model CDI507).
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• Contact with combustible material may cause fire. Note: Terumo 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, the gas bottles should be removed but the openings should be covered to avoid introducing debris into the calibrator.
Preparing the Cable-head Bracket Place the cable-head bracket on the pole nearest to the shunt/purge line used for shunt sensing. Adjust the rod arm as desired so that the cable-head, when attached to the bracket plate, will be in a convenient position to route the shunt line tubing through the shunt sensor.
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You choose these settings on a series of numeric setup tabs that appear on the Terumo CDI System 550 Monitor. Here’s a list of the setup tabs and a brief description of what you do with each one (the details are in the sections that follow): Printer options screen.
When you’ve selected and confirmed all your choices on a screen, you can move on to the next screen by pressing the key. Note: You can return to the monitor configuration screen from any of the setup screens by pressing the configure key (near the upper-right corner of the screen). 13:26 9-25-18 Configure key...
Print case Executes the printing of the post-case summary report. License Executes the display of the software license agreement be- tween you and Terumo CVS. Use the keys to view the entire license agreement. System Notifications System notifications consist of physiological alarms and technical alarms (status and error messages) and information messages.
Physiological Alarms The Physiological Alarm System consists of audible and visual alarms to inform the user when monitored physiological parameter values are out of range. The specific parameters monitored are dependent on the modules that are part of the System. The alarms are activated if any of the monitored parameters are outside of the se- lected alarm limit ranges.
Setting Alarms This icon indicates that an audible alarm is set. When the audible alarm is muted, this icon is crossed out with 13:26 9-25-18 a solid line as a reminder of alarm state. setup 3 4 5 6 configure alarms Alarm volume Set the audible alarm...
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When muting is prohibited, the audible alarm can still be temporarily dismissed by pressing the X button in Operate Mode. If the password protection feature is desired, contact Terumo Technical Service and instructions (Ref 878829) will be provided upon request. Instructions for the password are provided separately per the regulation.
Choosing graphic displays During blood parameter measurement in the “operate” mode, the CDI System 550 can display the patient’s blood gas parameter values in a graphical format. The graph will show blood parameter values over two selectable time periods, so you can see changes in a patient’s blood parameters at a glance.
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Repeat steps 1-5 for all the groups you want to set. Depending on your chosen module configuration, you can select parameters avail- able from the following group: Arterial pH Arterial PCO Arterial PO Arterial Temp Arterial Arterial BE Arterial SO ḊO Venous pH Venous PCO...
Choosing general settings The fourth screen in setup mode — the general screen — allows you to choose general settings (as shown in the next figure). 13:26 9-25-18 To move the yellow high- light up or down, use the keys. 2018 To set the highlighted option, first press the...
13:26 keys. 9-25-18 To set the selected (highlighted) option, first press the edit key, then press +, –, keys to Terumo® System 1/CDI Module defaults change the value. D02 Display Enabled calibration Press √ to confirm your choice for the selected option.
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Pump (Terumo), BioConsole® 550/560 (Medtronic), S5/C5 (LivaNova/Sorin/Stöckert), HL 20/Rotaflow Console (Maquet/Jostra), NEO System (Terumo).” The default is “Not Used” Note: If you select the (LivaNova/Sorin/Stöckert), S5/C5, the arte- rial pump position number (1-6) is required. Enter this number in the adjacent numerical field by using the key to highlight, then using the keys to adjust.
Note: The oxygen saturation, hematocrit, and hemoglobin offset should be used only if a consistent difference appears between hospital laboratory results and the CDI System 550. When values are entered for these offsets, they are stored in system memory. The offset is in effect until an in vivo calibration is performed. The offset is reinstated at the next power cycle.
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The following table lists the possible settings for the parameters on the serial port configuration screen. Output Type Possible settings are “ASCII Output” , “Terumo® Systems,” or “Packet Mode” . Data Bits Possible settings are “8 data/1 stop” or “7 data/2 stop.”...
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Setting up and starting calibration For the calibration procedure, you need the following: the Terumo Cardiovascular Systems (Terumo) CDI System 550 Monitor, the Terumo CDI Model 540 Calibrator with the Gas A and Gas B bottles installed, and the sensor(s) you’re calibrating (arte- rial and/or venous sensors).
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calibration value consists of a three digit number and a letter. Verify that the K calibration value, from the sensor’s foil pouch label, K code matches what is shown on the screen. If the calibration value on the foil pouch does not match the value on the screen, adjust the screen value by using a +, −, , or key.
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Connect the calibrator cable to the monitor. Connect the calibrator cable to the monitor by aligning the red dots on each of the connectors and pushing the calibrator cable connector onto the monitor connector. 5000504a Verify that the gas bottle level indicators appear on the screen and that sufficient gas exists for the calibration.
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Caution • Do not use sensor assemblies that are not filled adequately with buffer solution. Sensor assemblies not filled with adequate buffer solution may not calibrate properly. • Do not wipe moisture or particulates from the surface of the sensor assembly that connects to the cable-head.
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Using sterile technique, fully loosen the large, blue top venting luer cap on the sensor(s). The cap will stay attached to the top of the sensor, allowing venting of the buffer solution without compromising the sterility. The filter/sparger assembly will prevent the buffer solution from leaking out of the sensor.
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Note: The barometric pressure as measured by the CDI System 550 is not a user- adjustable parameter. You can compare this value with a measured barometric pressure in the room if you suspect there is a problem. 13:26 9-25-18 calibrate stop These indicate how much gas is left in...
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Note: A full 2-point tonometered gas calibration procedure is highly recommended to get the best measurement performance. Use of default values should be limited to unusual circumstances which preclude the ability to do the normal calibration proce- dure. In any case, it is highly recommended that you enter the K calibration value from the sensor pouch to ensure optimal K measurement performance.
Concluding calibration After the calibration is finished, follow these steps to conclude the process: Verify that the sensors have been successfully calibrated by checking to make sure that no error messages or failures appeared on the monitor or were printed by the printer. Disconnect the calibrator cable from the monitor.
Note: The original calibration buffer solution must be retained. Press the “verify” key. The following screen appears: 13:26 9-25-18 stop verify print Note: Terumo CVS CDI calibration fluid must be retained. 3. Connect calibrator cable to monitor. calibration Pressing √ begins calibration verification.
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13:26 9-25-18 This shows how much time is left in the verification process. Note: At any time during calibration verification, you can press the stop key (in the upper-right corner of the monitor’s front panel) to halt the calibration verification process. You can then resume calibration verification by pressing the √...
Preparing to install sensors You need the following items: the Terumo Cardiovascular Systems (Terumo) CDI Shunt Sensor(s) you’re installing, Terumo CDI H/S Cuvette, and access to the bypass circuit. For additional information, refer to disposable instructions for use. Note: CDI Shunt Sensor can be used for either arterial or venous application.
Line and CDI H/S Cuvette remain sterile as long as the package is unopened and undamaged. Installing a CDI Shunt Sensor The heparin-coated, sterile Terumo 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.
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Note: If you’re placing the CDI Shunt Sensor in a sampling line, place it on the inlet side of the sample port to avoid intermittent interruption of blood parameter data dur- ing medication administration. Note: The end of the CDI Shunt Sensor that has the large blue luer cap is a male luer connector.
Warning • Prime solutions containing acetate ions such as Isolyte-S, Normosol-R, or Plasmalyte-A can cause damage to the PCO sensor. If the pH channel reads less than 7.00 after the sensor is placed in the circuit, you should either recirculate the prime solution using a CO -free sweep gas or add sufficient buffer to raise the pH of the prime above 7.00.
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Using sterile technique, remove the blue cap from the female luer end of the Shunt Bypass Line and the small top luer cap (white) from the top of the CDI Shunt Sensor. Attach the CDI Shunt Sensor to the female luer end of the Bypass Shunt Line.
Attaching the CDI H/S Probe for Hematocrit/ Saturation measurement Follow these steps to attach the CDI H/S probe to the CDI H/S Cuvette for hematocrit, hemoglobin, and oxygen saturation measurement. Remove the CDI H/S Probe from the probe holder by pressing down on the release lever on top of the probe.
Visual alarms indicat- ing specific alarm conditions can be perceived at a distance of 1 meter from the front of the CDI 550 Monitor. No other intended position of the user with respect to the alarm signals is defined.
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9-25-18 ° pH-stat D0 2 System calibration mode select Note: When you turn the monitor off and on again and return to “operate” mode, the previous case data is lost and cannot be printed. If you intend to print the case summary after power down, you must do so before entering the “operate”...
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Completing Calibration of the CDI System 550 measurements At the beginning of a case, you must complete calibration of all measurable blood param- eters by comparing them to a laboratory measurement done on a blood sample. The values are dimmed on the screen until an initial in vivo recalibration is done. Note: The terms “recalibrating the monitor”...
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Caution • Ensure that the stored and recalled temperature mode are the same as the laboratory sample to ensure proper calibration. Calibrating to different temperature modes will compromise the system accuracy limits, as described in Appendix B. When the lab value is received, press the “recall” key. The recalibration window opens (as shown in the next figure).
Choosing display modes During a case, you can press the operate mode toggle key to switch among three display modes — numeric, graphic, and tabular. Continuous blood parameter values are shown in each display mode. The soft keys — @/37°C, store, set , and feed — work the same way in the graphic and tabular display modes as they do in numeric display mode.
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In graphic display mode (shown in the next figure), the current blood parameter values are shown (in a reduced size) on the left side of the screen. This symbol indicates that the blood The current blood The values from the selected parameters were displayed at the parameter values.
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In tabular display mode (shown in the next figure), the current blood parameter values are shown (in a reduced size) on the left side of the screen. The newest data will be time stamped and added to the bottom (at 1 minute intervals). The values from the The current blood selected time.
Setting the patient temperature mode You can display arterial and venous blood gas values either at actual temperature (measured) /pH-stat or corrected to 37°C /alpha-stat. Use the “@/37°C” soft key (in the upper-right corner of the screen) to change the patient temperature mode. When the monitor is in numeric display mode, either “actual”...
Note: The user can enter flow data manually only if “manual” is specified for the “ Source” option on the “calculations” setup screen (in setup mode). Note: If oxygen consumption and oxygen delivery are desired when using 2 CDI BPMs (only), the user must supply a hematocrit value.
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Warning • If the lab-measured value is outside the operating range for a parameter, the user may not be able to adjust the CDI System 550 measured value to the lab-measured value. Accuracy has not been established for displayed values outside the operating range; therefore, displayed values outside the operating range should not be used for patient management.
If power to the monitor is interrupted, the backup battery can power the moni- tor continuously for up to 25 minutes (if it’s fully charged). Note: The Terumo CDI Model 540 Calibrator and the Terumo CDI System 550 Moni- tor printer will not work while the monitor is on battery power.
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3/4 charge 1/2 charge 1/4 charge Low battery (symbol flashes) Service Battery Icon The battery can be serviced only by trained, certified Terumo service technicians. Contact your Terumo representative or Customer Administration if the battery needs to be replaced. Caution •...
This chapter explains the procedures to be followed at the conclusion of a patient case. Printing or sending a report Immediately after an extracorporeal case, the user can print a case summary that con- tains the data recorded during the case. The user can also send the case summary data to a computer via the serial port.
Return the BPM cable-head(s) to their designated docking ports on the monitor. Detach the Terumo CDI H/S Probe from the Terumo CDI H/S Cuvette, and return the Probe to its monitor docking mechanism. Wipe down the CDI System 550 Monitor and cables with an appropriate cleaning agent.
Disposal of waste products Disposal of the CDI Shunt Sensors and CDI H/S Cuvette should be done along with the bypass tubing circuit. No disconnection or further handling of the CDI dispos- ables is necessary. Use your standard hospital protocol for disposal of the bypass tubing circuit.
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This chapter can help the user solve problems that might occur with the Terumo Cardiovascular Systems CDI System 550. If you see an error message or have a problem with the system, consult this chapter for assistance. If you can’t solve a problem you’re having with the system, or if you can’t determine the cause of a problem, you can call the Terumo troubleshooting hotline during normal business hours.
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System will con- attached (or attaching) to the BPM cable-head can tinue with remaining cause the silver thermistor cap to break. The failed module(s). BPM will need to be repaired by Terumo Technical Contact Terumo Service. Technical Service. Barometric pressure...
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Pressing “retry” repeats the test. If the problem persists, contact your Terumo Technical Service representative to arrange for repair. Note: The printer records the final result of this test.
A specific identifying code will appear in the blank — save this number for later Printer will be reporting to your Terumo Technical Service repre- disabled. sentative. This failure will disable further use of the printer although you may continue to use the system.
If re-installing the roller does not remove this error message, contact your Terumo Technical Service representative to arrange for printer repair. Calibration...
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An identifying error code appears in the blank. Contact Technical Record this error code for later reporting to Terumo Service. Technical Service. At this time, you have the option to re-initiate the calibration procedure. If the error code persists, re-attempt calibration with a new cali- brator if available.
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Verify the number of modules being used. If the error per- sists, contact your Terumo Technical Service repre- sentative to arrange for repair. Note: If the monitor configuration chosen has only...
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In this case, you will need to contact your Terumo Technical Service repre- sentative to arrange for repair. You have the option of continuing use of the system without the calibration process or trying another calibrator (if available).
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If the foil pouch has a leak in it, please keep the foil pouch and sensor and contact Terumo Customer Administration for instructions. Sensor intensity error The specific microsensors failing the calibration on:_________ intensity range check appear in the blank.
(from CDI), that the cable is connected to the right data ports, and that all connections are tight. If the error message persists, contact your Terumo Technical Service representative to arrange for repair. If you cannot get your pump interface working, your options are set to the “...
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An identifying error code appears in the blank. Record this Contact Terumo error code for later reporting to Terumo Technical Ser- Technical Service. vice. You will not be able to continue use of the system.
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Message/Problem Meaning and Corrective Action Inaccurate values Verify that a successful sensor calibration has been done. For added assurance, verify the calibration us- when compared to a ing the system’s calibration verification function. laboratory. Note: Verification can only be done after calibration but before operation.
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Note: The printer cover is designed to reduce the risk associated with fluids getting into the monitor. If fluids are suspected to have splashed into this area, unplug the device from the power source and contact Terumo for further support. troubleshooting...
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Has the battery been used (fully discharged, then charged) repeatedly over years of service? The bat- tery may exceed its normal life after about 200 com- plete cycles. In this case, call your Terumo Technical Service Representative to arrange for battery replace- ment.
Laboratory comparison troubleshooting table The following table details information you can use to determine why your CDI System 550 values appear to be inaccurate with respect to laboratory values: Issue Meaning and/or Corrective Action Make sure the circuit Wait approximately five minutes after making a change to blood flow rate, gas flow rate, FiO , temperature, has stabilized before...
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Issue Meaning and/or Corrective Action Make sure the lab The temperature mode of the CDI System 550 recalled temperature matches values must match that used by the laboratory. If the the CDI System 550 laboratory values are reported at 37°C, you have to either temperature.
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Check the freeze indicator on the sensor box to see if the sensors have been exposed to freezing temperatures. If the freeze indicator is positive, contact Terumo Customer Administration or your local Terumo Sales representative. Are your PO values ...
Aside from the fuses for the AC power line, there are no recommended maintenance or repair procedures to be done by hospital technical personnel. Please contact your Terumo Technical Service representative for any technical service needs. Fuse replacement The CDI System 550 fuses should be replaced only by people who are competent in electrical and mechanic repair, such as hospital Biomedical technicians.
Error Code Definitions Error code (Non- Description Cause Recommendation recoverable) None At start up (boot), MCU (microcontroller) Contact Terumo CVS Buzzer remains on Error Technical Service. None At start up (boot), SRAM Error Contact Terumo CVS Buzzer on, or keep on- Technical Service.
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Error code Description Cause Recommendation (Recoverable) F033 Display CDI error Arterial PC card error. Allow user to ignore error message. If ignored, message at start up. arterial BPM is disabled. Venous BPM, if installed, and H/Sat Probe will still be available for use. F034 Display CDI error Venous PC card error.
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Error code Description Cause Recommendation (Recoverable) F071 Display CDI error Venous PC card Rev Allow user to ignore error message. If ignored, message at start up. code error, or card is venous BPM is disabled. not plugged in. Arterial BPM and H/Sat Probe will still be available for use.
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Error code Description Cause Recommendation (Recoverable) F233 Displayed in EEPROM Arterial BPM Probe Allow user to ignore error message. If ignored, dump. EEPROM failure arterial BPM is disabled. All other functions are available. F234 Displayed in EEPROM Venous BPM Probe Allow user to ignore error message.
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Error code Description Cause Recommendation (Recoverable) CF01 Detected at Calibrator I2C failure. Exit calibration and contact Terumo calibration start up. CVS Technical Service. CF02 Detected at Calibrator ADC failure. Exit calibration and contact Terumo calibration start up. CVS Technical Service.
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The Terumo Cardiovascular Systems CDI Blood parameter Monitoring System 550 needs minimal routine maintenance including battery charging and surface clean- ing. This chapter gives the instructions you need for these two tasks as well as recommended routine maintenance. Note: If you suspect that the system isn’t functioning properly, see Chapter 9, “Troubleshooting,”...
This backup battery can power the monitor continuously for up to 25 minutes with the thermal printer disabled. Note: The Terumo CDI Model 540 Calibrator and the Terumo CDI System 550 Moni- tor printer will not operate while the CDI System 550 is on battery power.
When the service battery icon appears on the screen at startup, contact your local Terumo Cardiovascular Group representative or call 1-800-521-2818 for service. Monitor and Calibrator Disposal The CDI System 550 monitor contains batteries. The monitor, calibrator, and batteries shall be disposed of in accordance with hospital policy regarding waste of electrical and electronic equipment.
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(Sterile, Heparin-treated, case of 20 each) Terumo CDI H/S Cuvette, 1/4" 6914 (Sterile, case of 20 each) 3/8" 6913 1/2" 6912 Terumo CDI H/S Cuvette with 6” (15.2 cm) 1/4" 6934 extension tube, (Sterile, case of 10 each) 3/8" 6933 1/2" 6932 ACCESSORIES...
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Catalog Number PUMP INTERFACE ACCESSORIES Note: CDI System 550 was designed to utilize existing CDI modules and interface cables. CDI Module for Terumo Advanced Perfusion System 1 803479 CDI interface cable for Terumo Advanced Perfusion System 1 804981 CDI Comm module for Terumo Sarns 8000...
System Notification Specifications Determination of Priorities for Physiological Alarms and Rationale for Manufacturer Defined Default Limits. The CDI System 550 provides the user with alarm functionality for the parameters the system is capable of measuring in accordance with the IEC 60601-1-8:2006, Medi- cal electrical equipment –...
System display ranges 6.50 to 8.50 pH units 10 to 200 mmHg (1.3 to 26.7 kPa) 10 to 700 mmHg (1.3 to 93.3 kPa) 1.0 to 9.9 mmol/L 12 to 45% 4.0 to 15.0 g/dl 35 to 100% 10 to 400 ml/min 1 to 999 ml/min/m (Indexed) -25 to 25 mEq/L...
System accuracy limits The CDI System 550 has been subjected to rigorous bench tests to simulate the clinical use of the device and assessed its accuracy and precision over the system operating ranges of the 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 analyses provided by the CDI System 550.
Environmental and electrical specifications Dimensions Monitor: BPM and H/S Probe mounted on monitor H x W x D: 28 cm x 38 cm x 17 cm BPM and H/S Probe not mounted on monitor H x W x D: 28 cm x 32 cm x 17 cm 550AVHCT configuration Mass: 7.9 kg...
AC line power (120 VAC) to be applied to the monitor circuitry, testing on file at Terumo demonstrates that current flow through the patient would be well below the 10 microamp maximum specified in IEC 60601-1 and UL 60601-1.
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Classifications: This equipment is Type CF and Class 1. Classified by Underwriters Laboratories with respect to electric shock, fire and mechanical hazards only in accor- dance with UL 60601-1 <5P30> In accordance with UL 60601-1: This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2014.
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In accordance with IEC 60601-1: Accessory equip- ment connected to the analog and digital interfaces must be certified according to the respective IEC stan- dards (i.e. IEC 950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1.
Environment Operating Monitor and Calibrator 15°C to 30°C Temperature: (59°F to 86°F) Storage/Transport Conditions: Temperature: Monitor/Calibrator: -15°C to 40°C (5°F to 104°F) Shunt Sensors: 0°C to 35°C (32°F to 95°F) Calibration Gas A & B Not to exceed 50°C (122°F) Humidity: Operating range: 15% to 90% (non-condensing)
EMC Tables Table 1 The CDI System 550 is intended for use in the electromagnetic environment specified below. The customer or the user of the CDI System 550 shall assure that it is used in such an environment. The CDI System 550 uses RF energy RF emissions IEC CISPR 11:2009 +A1:2010...
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Table 2 The CDI System 550 is intended for use in the electromagnetic environment specified below. The customer or the user of the CDI System 550 shall assure that it is used in such an environment. The CDI System 550 is ±...
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Mains power quality should be that of a typical commercial or hospital environment. If the user of the CDI System 550 requires continued operation during power mains interruptions, it is recommended that the CDI System 550 be powered from an uninterruptible power supply or a battery.
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Table 3 SYSTEMS that are not LIFE SUPPORTING The CDI System 550 is intended for use in the electromagnetic environment specified below. The customer or the user of the CDI System 550 shall assure that it is used in such an environment. Portable and mobile RF communication equipment should be used no closer to any part of the CDI...
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Note 1: At 80 MHz and 800 MHz, the 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 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
Safe Working Loads Monitor Pole Clamp, Long, Calibrator Mount, for CDI517 32.5 lbs use with the CDI System 550 Monitor Pole Clamp, Short, for use with the CDI System CDI518 23.0 lbs 550 Monitor Cable-head Bracket for use with the CDI CDI519 7.0 lbs System 550 Monitor...
The calibration gas bottles are packaged separately. Be sure to keep all cartons and fillers. If any items are missing, or if there is visible damage to any of the contents, notify the Customer Administration Department at Terumo Cardiovascular Systems promptly (800-521-2818). They will provide instructions and make arrangements to resolve the problem.
CDI System 550 to this device. A second serial interface port, called the pump interface, allows the CDI System 550 to receive flow ( ) data from selected pumps. These are the Terumo® Advanced Perfusion System 1, Terumo Sarns™ 8000, Terumo Sarns™ Centrifugal, Medtronic®...
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Chapter 4, “Choosing system settings,” gives instructions for setting these pa- rameters: Output Type “ASCII Output,” “Terumo® Systems,” or “Packet Mode” Data Bits “8 data/1 stop” or “7 data/2 stop” Parity “none,” “even,” or “odd”...
Data output port pin assignments The CDI System 550 serial data output port is a female DB-9 connector. The data output port is set up as a DCE (Data Comm.) device at the factory, however, hard- ware handshaking is not supported. The CDI System 550 Monitor has two levels of protection to isolate the patient from shocks caused by AC line faults occurring in devices attached to the serial interface.
Terumo® Systems This selection offers compatibility with one of Terumo® System’s Legacy product: Sarns 9000 Perfusion System. This selection will send data specially formatted to be received by the Sarns 9000 Perfusion System. Selected values can then be displayed on the Sarns 9000 display and packaged with data sent to a data acquisition system.
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The first four parameters configure the RS-232 interface, while the last parameter indicates the interval that data will be sent out through the serial port. Intervals are measured in minutes, so an interval of 1.0 is once a minute, and an interval of 0.1 is once each six seconds.
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Field Parameter Format Description Size Blank if normal, "*" if marked data, Header "S" if stored data, "o" if recal data Military time is used as hh:mm:ss - Time xx:xx:xx i.e., 15:00:00 is 3:00PM Arterial pH x.xx measured in pH units xxx if monitor measuring in mmHg, Arterial CO xxx/xx.x...
Sample Output: Note: Example 1 includes no Venous Module, Arterial pH out of operating range, no pump flow and measurements in mmHg. @ Temp Data ARTERIAL VENOUS Time Temp HCO3 BE cSO2 Temp 08:56:38 8.13 23.4 100% 078% 08:56:44 8.13 23.4 100% 078%...
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Serial Packet Interface Structure. The format of a packet will be: <STX>ABBLLLLCSD...DZZ<ETX> where: <STX> Start of packet character, which will be character 0x02 (binary, not ASCII ‘2’). Single Character defining the device ID. See Device ID section for details. 8-bit ASCII hex-encoded sequence value. LLLL 16-bit ASCII hex-encoded length value.
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Command List. The following is a table of major Command values. These are identical to the CDI Pump Interface Protocol commands: Value Name Direction Description Information sent out in response to a re- From CDI quest or a timed action, such as calibration ‘...
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Sent when the pump ID character is not valid for incom- ‘1’ Invalid Device ID ing packets to the CDI Monitor. For the System 1/ Terumo NEO Pump Interface, the Device ID must be ‘ A ’ . ‘2’ Sent when the CRC calculation doesn’t match the CRC Invalid CRC Value value sent in the packet.
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Error (‘E’): Value Name Description ‘0’ System Error An error packet will always send a ’0’ in the SubCommand field. The 4-digit ASCII error code displayed on the screen will be included in the data field (e.g., "F038"). Get (‘G’): Value Name Description...
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CRC Information. The 8-bit CRC is generated using the following algorithm: const uchar CPIP_crc_table[]= 0x00, 0xcd, 0xd9, 0x14, 0xfl, 0x3c, 0x28, 0xe5, 0xal, 0x6c, 0x78, 0xb5, 0x50, 0x9d, 0x89, 0x44 unsigned char CPIP_crc(uchar *start_adr, int count) int i; uchar crc,idx; uchar *byte_ptr;...
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AA − Analyte descriptor − hex-encoded ASCII value indicating which analyte the value is for. Use the following table for definitions: Analyte Analyte Code Arterial pH Arterial CO Arterial O Arterial Temp Arterial SO Arterial Arterial Base Excess Potassium (K Consumption ( O Venous pH Venous CO...
Each type of pumping system will require a separate interface cable specially configured for that device and the CDI System 550. Please see the following section on pump interfacing tips or contact your Terumo Technical Service Representative for assistance. If a pump is selected in the “setup” mode, the CDI System 550 Monitor will begin look- ing for pump flow data from the pump interface port upon entering the “operate”...
Any pump interface cable used is specific to each pump and should be ordered from Terumo Customer Administration. The interface cable will always connect to the pump interface port (only) on the monitor. When an interface cable is not connected to the pump interface port, use the protective cap to cover the port.
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RX (IN) and pin 3 is TX (OUT). Hardware handshaking is not supported. Terumo NEO No special instruction available. The customized interface cable is accessory of Terumo NEO System. Follow the System instruction of Terumo NEO System to make the connection between the CDI 550 and Terumo NEO System.
CDI Pump Interface Protocol The CDI Pump Interface is a 2-way communications protocol designed for future pumping systems, including the Terumo® Advanced Perfusion System 1. It provides a flexible format to allow the CDI System 550 to get flow data as desired from the pump and for the pumping system to request data as desired from the monitor.
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CDI Pump Interface Packet Structure. The format of the packet will be: <STX>ABBLLLLCSD...DZZ<ETX> where: <STX> Start of packet character, which will be character 0x02 (binary, not ASCII ‘2’). Single Character defining the device ID. See Device ID section for details. 8-bit ASCII hex-encoded sequence value.
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Command List. The following is a table of major Command values: Value Name Direction Description ‘ A ’ Attention From CDI Information sent out in response to a request or a timed System 550 action, such as calibration data, or sending out a line of analyte data during Operate mode.
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SubCommand List. Each major Command type has a list of numeric SubCommand values used to pro- duce a specific action. Below are the SubCommands listed for each Command. Attention (‘A’): Value Name Description ‘0’ Unsolicited Analyte Packet sent by CDI System 550 at the speci- Data Packet fied output interval.
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Invalid Device ID Sent when the pump ID character is not valid for incoming ‘1’ packets to the CDI Monitor. For the System 1/Terumo NEO Pump Interface, the Device ID must be ‘ A ’ . Invalid CRC Sent when the CRC calculation doesn’t match the CRC ‘2’...
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Error (‘E’): Value Name Description ‘0’ System Error An error packet will always send a ‘0’ in the SubCom- mand field. The 4-digit ASCII error code will be included in the data field (e.g., “F038”) Get (‘G’): Value Name Description ‘0’...
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Set (‘S’): Value Name Description ‘0’ Arterial This sends the CDI System 550 an ASCII floating-point Flow value between ‘0.0’ and ‘10.0’ in 1/min (inclusive) indicating the arterial flow on the pumping system. The flow value shall be located in the Data portion of the packet. Arterial flow can be updated as often as once every six seconds.
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‘7’ Arterial Sent by the CDI System 550 to a pumping system, this sets Flow the interval, in seconds, that the CDI System 550 wants Auto Inter- Arterial flow. The pumping system shall respond with an Acknowledge packet telling the CDI System 550 the nego- tiated value for Arterial Flow.
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The start_adr indicates the starting address of the packet (should be pointing to the 0x02 STX value). The count indicates how many bytes, and includes the count of all parts of the packet up to but not including the CRC field. The function returns the CRC value, which shall be converted to a two-character hex-encoded ASCII value for inclusion in the packet.
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B − Unit descriptor − hex-encoded ASCII value indicating the units for this analyte. Use the table below for definitions: Unit Unit Code No Unit ‘0’ Degrees C ‘1’ mmHg ‘2’ ‘3’ Percent ‘4’ Milliequivalents/Liter ‘5’ Grams/Deciliter ‘6’ Millimoles/Liter ‘7’ Milliliters/Minute ‘8’...
Symbols Glossary The following symbols may appear in the labeling, marking, or display of the Terumo Cardiovas- cular Systems (Terumo) CDI System 550 Blood Parameter Monitoring System. These symbols are in accordance with the internationally harmonized standards. Symbol Title Description...
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Type T Type T. UL248-14 The International System of Hertz Hertz. Units (SI). The International System of Ampere Ampere. Units (SI). The International System of Volt Volt. Units (SI). Indicates the manufacturer’s serial Serial number number so that a specific medical ISO 15223-1-5.1.7 device can be identified.
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Terumo Cardiovascular 1 Bottle per case 1 Bottle per case. Systems. Terumo Cardiovascular Number of contents in carton Identifies the number of contents. Systems. Terumo Cardiovascular Gas A Gas A. Systems. Terumo Cardiovascular Gas B Gas B. Systems. Twist to remove/tighten gas Terumo Cardiovascular Twist to remove/tighten gas bottles.
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To indicate mass. To identify a function Mass; Weight ISO 7000-1321A related to mass. Do not turn upside Terumo Cardiovascular Indicates not to turn the UAS upside down. down Systems. Terumo Cardiovascular Service battery icon Service battery icon.
Because the operation of Terumo CVS’s monitors, disposables, and accessories depends on factors which are out of Terumo CVS’s control (such as the care of the products and the particular circumstances of the surgery), Terumo CVS does not warrant that its monitors, disposables, and accessories will be 100% effective in all circumstances.
Terumo CVS may give authorization at its discre- tion. Terumo CVS will not authorize the return of goods which are not in new and resal- able condition, which have fewer that 90 days remaining prior to the expiration date, or which do not appear on Terumo CVS’s most recently published price list.
550. Upon any such termination, you will immediately cease utilizing the SOFTWARE and return the SOFTWARE to Terumo CVS. These termination provisions shall be in addition to any other remedies available to Terumo CVS at law or equity. software license...
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CDI System 550, function in accordance with the instructions furnished with the SOFTWARE. Should the SOFTWARE fail to properly function, Terumo CVS’s sole obligation will be to utilize reasonable commercial efforts to resolve the problem, or at the option of Terumo CVS, to replace the SOFTWARE.
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Agreement will be binding unless in writing and signed by a duly authorized representative of Terumo CVS. NOTICES. Notices required to be sent to Terumo CVS under the terms of this Agreement should be sent to: Customer Service, Terumo CVS, 6200 Jackson Rd., Ann Arbor, MI 48103, USA.
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Glossary Note: These definitions are specific to the Terumo Cardiovascular Systems CDI Blood Parameter Monitoring System 550. 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.
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Optical Interface Material A transparent material found on the back side of the Terumo CVS CDI Model CDI510H Shunt Sensor. This material provides a means of consistent optical connection between the sensor and the fiberoptic cable connector. The transpar- ent optical interface material reduces the risk of measurement errors caused by moisture or air trapped between the microsensors and the fiber optics.
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Oxygen consumption ( O A measurement of the amount of oxygen transferred to the tissues, expressed in ml O /minute. The unit for measuring the degree of acidity or alkalinity of a substance, directly related to the concentration of hydrogen ions in the substance. pH Stat Maintenance of a constant pH at 7.40 and PCO at 40 mmHg, over varying...
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System map The area underneath the parameter display window that displays the labels for the different modes (setup, calibrate, standby, and operate) and the label for the operate mode display choice (numeric, tabular, or graphic). System mode select key The key that activates the system map. This key is near the lower-left corner of the monitor’s front panel.
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