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Terumo CDI 550, Operator'S Manual

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software license

appendix g

G-1

Software License

End User License Agreement 
CDI System 550 Software 

Important/read carefully:

  This License Agreement (“Agreement”) is a legal agree-

ment between you and Terumo Cardiovascular Systems (“Terumo CVS”) for the 
computer software included with the CDI System 550, which includes computer soft-
ware and associated documentation (“SOFTWARE”).  By using the SOFTWARE, you 
agree to be bound by the terms of this Agreement.

The SOFTWARE is protected by copyright laws and treaties, as well as other intellec-
tual property laws.  The SOFTWARE is licensed, not sold, to you.

1 

GRANT OF LICENSE.  You are hereby granted a non-exclusive, non-transfer-
able, non-assignable license to install and use one copy of the SOFTWARE on 
the CDI System 550.  The SOFTWARE is intended specifically for use on the 
CDI System 550, and may not under any circumstances be utilized or operated 
on any other processor without the express written permission of Terumo CVS.

2 

LIMITATIONS.  You agree to  not decompile, decrypt, disassemble, reverse 
engineer, or otherwise reduce the SOFTWARE to a human-perceivable form, 
even if such activity is expressly permitted by applicable law in the absence of 
an agreement. You may not rent or lease the SOFTWARE.

3 

UPGRADES.  If you receive an upgrade or other revision to the SOFTWARE 
you agree to immediately install the upgrade on the CDI System 550.  The 
upgrade will be considered SOFTWARE for the purposes of this Agreement.

4 

COPYRIGHT.  All title and copyrights in and to the SOFTWARE (including but 
not limited to any source code, object code, images, and text incorporated into 
the SOFTWARE), the accompanying printed materials, and any copies of the 
SOFTWARE are owned by Terumo CVS.  As the SOFTWARE is copyrighted, 
you must treat the SOFTWARE as you do any other copyrighted material 
except that you may make one copy of the SOFTWARE for backup purposes.  
You may not copy the printed materials accompanying the SOFTWARE.

5 

TERMINATION.  You may terminate this Agreement at any time without no-
tice to Terumo CVS.  This Agreement will terminate immediately without no-
tice to you if you fail to strictly comply with the terms of this Agreement.  This 
Agreement will also terminate should there be an unremedied breach of your 
obligations under any Bundle Purchase Agreement, Equipment Loan 
Agreement, or other agreement with Terumo CVS pertaining to the CDI Sys-
tem 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.

Summary of Contents for CDI 550

Page 1: ...PART NUMBER NOTES 8 1 2 x 11 86 PAGES 172 ACTUAL PRINT 2 SIDES PAPER 80 SAPPI EUROART DULL TEXT OR EQUIVALENT INK 4 COLOR PROCESS 3 HOLE PUNCH COLLATE NOTE ARTWORK COPY MUST ACCOMPANY THIS PRINT D CD...

Page 2: ...12 Terumo CDI Shunt Sensor 1 12 The Shunt Bypass Line 1 14 Terumo CDI Hematocrit Saturation Cuvette 1 15 Terumo CDI Monitor Pole Clamp 1 17 Terumo CDI Cable head Bracket 1 18 Setup 2 1 Calibration 2...

Page 3: ...e mode 7 8 Entering the blood flow rate 7 8 Recalibrating during a procedure 7 9 Batteries contained within the CDI System 550 7 11 System Batteries 7 11 Operating on emergency battery power 7 11 Sele...

Page 4: ...ned Default Alarm Limits B 2 System operating ranges B 2 System display ranges B 3 Priming volumes B 3 System accuracy limits B 4 Environmental and electrical specifications B 5 Dimensions B 5 Error m...

Page 5: ...erface Protocol C 17 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 Communic...

Page 6: ...xcess BE Bicarbonate Oxygen saturation SO2 calculated when measured is not available Oxygen consumption O2 Oxygen delivery O2 The CDI System 550 can display the blood parameters either at actual tempe...

Page 7: ...1 800 521 2818 and ask about CDI System 550 training How to use this manual Before you set up or operate the CDI System 550 it s vital that you read and under stand all the material in this manual Onc...

Page 8: ...ogy to measure blood gases pH and potassium In addi tion it uses an optical reflectance technology to measure oxygen saturation hemato crit and hemoglobin Optical fluorescent measurement Two cable ass...

Page 9: ...Devices with heparin treated surfaces may cause an adverse reaction Use of the following substances can potentially cause inaccuracies in displayed values Indocyanine green Cardiogreen Methylene Blue...

Page 10: ...ocytic may affect the accuracy of hemoglobin and hematocrit measurements Independent external analysis is required for accurate determination of these measurements as needed to guide therapeutic decis...

Page 11: ...calibration may not be accurate Do not use values prior to initial in vivo calibration for patient management At the beginning of a case after the initiation of cardiopulmonary bypass and when condit...

Page 12: ...nstructions can cause the monitoring system to display inaccurate values The accuracy of the results is dependent upon the following Reading and understanding the instructions for use Proper set up fu...

Page 13: ...blood gas module is used calculated venous oxygen saturation is displayed Note Calculated SO values are distinguished by a calc label 6 Flow values The pump flow rate used for calculating oxygen cons...

Page 14: ...oxy gen saturation hematocrit and hemoglobin 16 Cable head ports Secures the cable heads to the monitor when the monitor is not in use protecting the cable head optics 17 H S probe holder Secures the...

Page 15: ...SD interference when the pump interface port is not in use 22 Calibrator cable port The receptacle for attaching the Terumo CDI Model 540 Calibrator 23 System power switch Turns the power to the monit...

Page 16: ...l potential between bodies of medical electrical devices and conductive parts of other objects Calibrator The CDI Model 540 Calibrator is designed for automatic calibration of the CDI Sys tem 550 Moni...

Page 17: ...use Do not spray the contents of the gas bottles on a naked flame or any incandescent material Caution Check the expiration date on the gas bottles before use Use of the calibration gas bottles after...

Page 18: ...e CDI Shunt Sensor remains sterile as long as the package is unopened and undamaged Each shunt sensor is individually packaged in a foil pouch and has a recommended shelf life indicated by the lot num...

Page 19: ...after the lot number expiration date printed on the package label Using a CDI Shunt Sensor after its lot number expiration date can result in inaccurate performance Do not use a CDI Shunt Sensor if t...

Page 20: ...ide of the circuit This protects against the introduction of air into the blood circulation Caution For single sterile shunt bypass line assemblies Do not use the shunt bypass line after the date prin...

Page 21: ...to leak under pressure Do not reuse CDI H S Cuvettes CDI H S Cuvettes are intended for a single use only The H S cuvettes are sterile non toxic non pyrogenic single use devices and for use in cardiop...

Page 22: ...ured 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...

Page 23: ...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...

Page 24: ...n the monitor The system diagnostics and module self tests will auto matically run 7 Set up the software by choosing options on the monitor configuration and monitor setup screens 8 Manually route cab...

Page 25: ...sen sor filter sparger assembly 10 Loosen the large blue top luer cap using aseptic technique Do not remove the small white luer cap 11 Place the cable head assembly into the calibrator pocket 12 If t...

Page 26: ...e 1 4 inch legs of the shunt bypass line Remove the blue cap from the female 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 Sen...

Page 27: ...ibration for patient management 2 When the case has begun and the values have stabilized complete a calibra tion of all measurable blood parameters including pH PCO2 PO2 SO2 K HCT and Hgb by performin...

Page 28: ...e monitor to standby mode or turn it off 3 Remove the sensor s from the cable head s 4 Return the cable head s to their docking mechanisms on the monitor 5 Detach the H S Probe from the CDI H S Cuvett...

Page 29: ...chapter 2 2 6 This page is intentionally left blank...

Page 30: ...lamp Place the monitor on the tray positioning it correctly on the alignment cone then pushing up while turning the locking screw on the bottom of the tray until it s tight Loosen the adjustment knob...

Page 31: ...the moni tor 1 Make sure that all the cable connectors are correctly in place on the monitor and that the monitor is off Secure the connections of the monitor s power cord the cable heads any se rial...

Page 32: ...time Errors that are not recoverable will not offer an option to continue A brief de scription of the error perhaps with a specific error code will be displayed This information should be provided to...

Page 33: ...use Note If any of the modules failed their SRS or color chip checks an error message REFERENCE SENSOR TEST FAILURE appears in the message bar The A V and or H S module indicators will flash indicatin...

Page 34: ...indicates the current selection Note If any module self tests fails clean the affected module with water and a soft cloth re seat the module onto the monitor and retry the self test If the module sti...

Page 35: ...positioned under the roller and place the roller on top of the paper Press the roller down evenly to snap it into place Note The printer may sense the paper and try to automatically advance the paper...

Page 36: ...tles Each gas bottle has a shelf life indicated by an expiration date printed on the bottle label 4 Remove the caps from the calibration gas bottles 5 Place the bottle of Gas A into the corresponding...

Page 37: ...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 Note The calibrator must be placed in an up...

Page 38: ...sted four ways 1 The location of the cable head bracket on the pole can be changed using the pole clamp tightening knob 2 The rod arm length can be changed using the arm adjustment knob 3 The bracket...

Page 39: ...chapter 3 3 10 This page is intentionally left blank...

Page 40: ...uration screen Set parameters for sending data to a computer or data acquisition system For most of the options once you ve made your selections you don t need to do it again unless there are changes...

Page 41: ...irst screen in setup mode the printer options screen allows you to specify your printing preferences When this screen appears the first option Printing On Off is highlighted in yellow calibration 13 2...

Page 42: ...ously Regardless of where the case summary is sent the printing On Off option must be set to On Note A case summary will only be sent when the print case soft key is pressed When you have made all you...

Page 43: ...ous 7 00 7 70 pH units PCO2 Venous 35 4 7 60 8 0 mmHg kPa PO2 Venous 30 4 0 65 8 7 mmHg kPa SO2 Venous 60 95 HCT Venous 24 38 Hgb Venous 8 0 12 6 g dl The Manufacturer defined default alarm limits hav...

Page 44: ...alarm thresholds to the Manufacturer de fined default limits Note The minimum and maximum values set will become the range of values on the y axis in the graphic display screen See chapter 7 for more...

Page 45: ...organization 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 Techni...

Page 46: ...use the selection and edit keys 1 Press the and keys to select a group 2 Press edit 3 Use the and keys to highlight a particular item within the selected group 4 Use the and or and keys to change the...

Page 47: ...our selections and confirmed them press the key to move on to the next screen The following figure shows an example of bar graphs that display blood parameter values during an operation The graphs mak...

Page 48: ...rmat Use the and or and keys to choose either the Month Day Year format or the Day Month Year format Time Use the and keys to highlight an item you want to change the hour or minute Press the and or a...

Page 49: ...its found in Appendix B Note Once changed the default calibration status will not take effect until the monitor is turned off and on again Verify Calibration Use the and or and keys to choose either E...

Page 50: ...mo The default is Not Used Note If you select the LivaNova Sorin St ckert 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...

Page 51: ...ur selections and confirmed them press the key to move on to the next screen Setting parameters for communicating with an external device On the sixth screen in setup mode the serial port configuratio...

Page 52: ...s option is set to 0 the CDI System 550 sends data on demand only Note The data bit parity and baud rate selections will depend on the specific receiv ing device Note The serial port settings are appl...

Page 53: ...chapter 4 4 14 This page is intentionally left blank...

Page 54: ...ibration on the shunt sensor before use may result in compromised system performance that does not meet the System Accuracy Limits found in Appendix B Warning Failure to complete calibration as descri...

Page 55: ...reen adjust the screen value by using a or key To change the letter code following the numeric value enter that value by using the key to highlight the entry field and use the and keys to enter the co...

Page 56: ...in 24 hours or inaccurate calibration may result Do not use the sensor if the foil pouch has been damaged Damage to the foil pouch can result in inaccurate calibration 5 Check that the sensor contains...

Page 57: ...o attach the shunt sensor to the cable head Align the shunt sensor with the cable head and then press firmly in the cen ter of the shunt sensor between the wings until the shunt sensor snaps into plac...

Page 58: ...engaged in that sensor cable head pocket 12 To calibrate a second sensor repeat steps 4 11 for that sensor Note If only one sensor is being calibrated the calibrator will automatically detect the port...

Page 59: ...s the cancel X key to exit and return to Standby If you switch to operate mode and begin measurement without having completed the two point calibration the CDI System 550 automatically uses the calibr...

Page 60: ...u must turn the monitor off and back on for a change in calibration status to take effect Note If you intend to turn off the monitor after calibration and then power it back up before operation you sh...

Page 61: ...ter sparger should remain attached to the sensor until you to connect it to the cir cuit Warning Do not empty calibration fluid from sensor assembly as microsensors must be kept wet If the shunt senso...

Page 62: ...nitor will require another calibration to enable verification If you want to verify the calibration follow these steps 1 Make sure the sensors are still on the cable heads and the cable heads are in t...

Page 63: ...n press the cancel X key to exit and return to Standby When the calibration verification is finished the results are reported 4 Press the print key to print the results table Note If there are any fai...

Page 64: ...hould replace the sensor and repeat the calibration Installing 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 pack age remove t...

Page 65: ...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 Warning The C...

Page 66: ...CDI Shunt Sensor and attach one end of the shunt purge line to the top of the CDI Shunt Sensor Make sure the large blue top venting luer is com pletely tightened Note The sensor remains attached to t...

Page 67: ...reater than 7 8 pH units can interfere in the accurate measurement of potassium Exposure of the shunt sensor to prime solutions and or blood with sodium measurement less than 120 or greater than 160 m...

Page 68: ...low can go either direction through the shunt sensor but the sensor will fit onto the Shunt Bypass Line only one way 4 Unclamp the Shunt Bypass Lines and start the pump to circulate prime solution thr...

Page 69: ...et in the CDI H S Cuvette ensures the correct connection between the CDI H S Probe and the CDI H S Cuvette Warning Avoid touching the optical surfaces of the CDI H S Cuvette and the CDI H S Probe Fing...

Page 70: ...tor No other intended position of the user with respect to the alarm signals is defined Warning Use of Halothane anesthetic will result in significant PO2 inaccuracy Prime solutions containing acetate...

Page 71: ...ues 2 store You press this to store the current blood parameter values for a lab comparison After you press store its function changes to recall until you press it again for a review of the stored val...

Page 72: ...Potassium calibration value from the pouch should still be entered Note For calibrating the potassium sensor and to ensure accuracy of the potassium value the pH of the blood must be between 7 0 and 7...

Page 73: ...romised system performance that does not meet system accuracy limits found in Appendix B To perform additional in vivo recalibrations see page 7 9 Monitoring a Patient Recalibrating During a Procedure...

Page 74: ...do in numeric display mode However the mark key is different it becomes the print key in the tabular display It prints all the blood parameter values displayed in the current tabular format The mark f...

Page 75: ...re displayed in the original temperature mode either actual or 37 C regardless of the current temperature mode Note If you change the PCO2 PO2 units mmHg or kPa during a case the historical graphic da...

Page 76: ...hile in the graphic or tabu lar display modes the background color of the affected parameter value will be solid yellow If a medium priority physiological alarm event occurs while in the graphic or ta...

Page 77: ...type in the same calculations setup screen If the Manual is specified as the source of flow data the user can enter the flow rate manually during a case To do this in operate mode follow these steps 1...

Page 78: ...d by this practice Follow these steps to recalibrate the monitor 1 When the blood parameter values have stabilized press the store key before drawing the sample s This saves the currently displayed va...

Page 79: ...e as the laboratory sample to ensure proper calibration Calibrating to different temperature modes will compromise the system accuracy limits as described in Appendix B 2 Draw a blood sample from each...

Page 80: ...m informs the user during system initialization by providing an error code The system will normally allow the user to continue with certain provisions such as loss of date and time by accepting the co...

Page 81: ...y exhibit lower battery life even after a full 8 hour charge In this case the battery will need to be replaced to regain full 25 minute capability It is recommended that the user plugs the monitor in...

Page 82: ...mary Caution The case data is lost if the user returns to the operate mode after the next power up Be sure to print the case report before that point To print or send a case report 1 Go to the setup m...

Page 83: ...ndby mode or turned off the user can return it to its pre operation state by following these steps 1 Detach the BPM cable head s from the bracket 2 Remove the CDI Shunt Sensor from the cable head by p...

Page 84: ...s and gas mixtures To dispose of the cylinders 1 Open the valve slowly and allow all residual pressure to escape For gases or mixtures containing less than 21 oxygen this should be done in a well vent...

Page 85: ...chapter 8 8 4 This page is intentionally left blank...

Page 86: ...done to correct each situation Monitor Start Up Message Problem Meaning and Corrective Action Monitor won t power on Make sure the monitor is securely plugged into an AC power outlet by checking to s...

Page 87: ...ot recoverable will have no option to continue Please contact your Terumo Technical Service representative to arrange for repair Note Failure code F00D indicates one or more keys stuck down during sta...

Page 88: ...contact your Terumo Technical Service representative to arrange for repair Note The printer records the final result of this test H S module color chip failure Press cancel to return to configuration...

Page 89: ...ng startup if printer hardware failure occurs A specific identifying code will appear in the blank save this number for later reporting to your Terumo Technical Service repre sentative This failure wi...

Page 90: ...nter repair Calibration Message Problem Meaning and Corrective Action Calibration or verifica tion procedure unavail able while on battery power Verify power source Make sure the monitor is plugged in...

Page 91: ...sentative to arrange for repair Calibration or verifica tion process stopped This message occurs when the stop soft key is pressed during calibration or verification Pressing the OK key will restart c...

Page 92: ...tle One or both of the gas bottles in the calibrator has insufficient gas to complete the calibration process Replace the empty gas bottle s No gas flow through sensor s A or B Verify proper placement...

Page 93: ...amaged or mishandled sensors contaminated calibration solution or poor placement of sensors onto gas nozzles Make sure a Gas A calibration gas bottle is in the Gas A orange port and a Gas B calibratio...

Page 94: ...lem persists you will need to replace the failing sensor s and repeat the calibration Keep the failed sensor s along with the printed failed calibration results and contact your Terumo Technical Servi...

Page 95: ...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 ge...

Page 96: ...o Technical Service You may continue using the system although measurements from this mod ule will be discontinued and will no longer be displayed Contact your Terumo Technical Service representative...

Page 97: ...be maintained with this practice Check the shunt line If it s too long the blood in the line may have started equilibrating to room air values Make sure the laboratory and the monitor are correct ing...

Page 98: ...ng on battery power Temperature measurement from BPM is significantly different from an other temperature probe in the blood Make sure the thermistor cap on the BPM is not stuck in the retracted posit...

Page 99: ...promised Call your Terumo Tech nical Service Representative to arrange for battery replacement Has the battery been used fully discharged then charged repeatedly over years of service The bat tery may...

Page 100: ...on that dynamic blood parameter changes and the system s time response are responsible for the comparison differ ence Performing an in vivo recalibration under these conditions is not recommended A bl...

Page 101: ...rime are you using Certain primes including Normosol R Plasmalyte A and Isolyte S contain acetic acid ions acetate that may ad versely affect the CDI System 550 CO2 sensor To avoid this contamination...

Page 102: ...towards 150 mmHg for PO2 The longer it takes for the lab sample to be analyzed the more pro nounced the room air contamination will be O2 calculation seems to be off Check screen 5 in the setup mode a...

Page 103: ...CDI System 550 fuses should be replaced only by people who are competent in electrical and mechanic repair such as hospital Biomedical technicians To test and or change the fuses 1 Remove the fuse hol...

Page 104: ...reezes SBC board failure Contact Terumo CVS Technical Service F009 Monitor freezes at start up or run time Module error or no module detected Contact Terumo CVS Technical Service F00A At start up boot...

Page 105: ...error message If ignored H Sat probe is disabled Venous BPM if installed and arterial BPM will still be available for use F038 Display CDI error message at start up AUX board failure or software upda...

Page 106: ...low user to ignore error message If ignored venous BPM is disabled All other functions are available F103 Display CDI error message at runtime HSAT 5V reference voltage out of range 5V 30mV Allow user...

Page 107: ...BPM Probe ADC failure Allow user to ignore error message If ignored arterial BPM is disabled All other functions are available F0A1 Display CDI error message at start up Arterial BPM Probe thermistor...

Page 108: ...vice CF07 Detected at calibration start up Mix line transducer failure or bottle A B valve failure Exit calibration and contact Terumo CVS Technical Service CF08 Detected at calibration start up Bad b...

Page 109: ...chapter 9 9 24 This page is intentionally left blank...

Page 110: ...the cleaning procedure described in the next section Routine cleaning To keep the CDI System 550 working properly make sure the optical pathways stay clean and free of surface cuts abrasions and conta...

Page 111: ...iquid Battery charging The CDI System 550 comes with a 12 volt rechargeable sealed lead acid battery for backup power and transport operation This backup battery can power the monitor continuously for...

Page 112: ...n will alert the user at startup when a battery is nearing the end of its expected service life The backup battery has an expected service life of 4 years from installation date The system batteries w...

Page 113: ...chapter 10 10 4 This page is intentionally left blank...

Page 114: ...ach CDI510H Terumo CDI H S Cuvette Sterile case of 20 each 1 4 6914 3 8 6913 1 2 6912 Terumo CDI H S Cuvette with 6 15 2 cm extension tube Sterile case of 10 each 1 4 6934 3 8 6933 1 2 6932 ACCESSORIE...

Page 115: ...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...

Page 116: ...out of range High and out of range Low blood parameter values based on the type of potential harm to the patient and the time to occurrence of harm if the user ignored the alarm The following criteria...

Page 117: ...Venous 24 38 Hgb Venous 8 0 12 6 g dl System operating ranges pH 6 80 to 7 80 pH units PCO2 10 to 80 mmHg 1 3 to 10 7 kPa PO2 20 to 500 mmHg 2 7 to 66 7 kPa K 3 0 to 8 0 mmol L HCT 15 to 45 SO2 60 to...

Page 118: ...HCT 12 to 45 Hgb 4 0 to 15 0 g dl SO2 35 to 100 O2 10 to 400 ml min O2 Indexed 1 to 999 ml min m2 BE 25 to 25 mEq L 0 to 50 mEq L O2 10 to 2000 ml min O2 Indexed 1 to 20000 ml min m2 Temperature 1 0 t...

Page 119: ...he results from the CDI System 550 minus conven tional analyzer results The following table shows the mean difference between the two measurement techniques and the standard deviation of the distribut...

Page 120: ...kg Pole Clamps H x W x D Mass H x W x D Mass H x W x D Mass CDI517 12 cm x 56 cm x 24 cm 2 4 kg CDI518 12 cm x 50 cm x 24 cm 2 3 kg CDI519 8 cm x 30 cm x 22 cm 1 0 kg Calibrator H x W x D Mass 32 cm x...

Page 121: ...the monitor serial port causing 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 mi...

Page 122: ...radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity However there is no guarantee that interferenc...

Page 123: ...stem and is therefore responsible that the system complies with the requirements of IEC 60601 1 If in doubt consult the technical service department or your local representative Restrict use of IEC 95...

Page 124: ...n Gas A B 15 C to 40 C 5 F to 104 F 0 C to 35 C 32 F to 95 F Not to exceed 50 C 122 F Humidity Operating range Storage Shipping 15 to 90 non condensing 5 to 95 non condensing Atmospheric Pressure 500...

Page 125: ...emissions IEC CISPR 11 2009 A1 2010 RF emissions IEC CISPR 11 2009 A1 2010 Note The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals CISPR 11 clas...

Page 126: ...d with a power cord with the following specifications Length 3m Ampacity 10A Termination IEC 60320 C13 for 8 kV contact 8 kV contact 15 kV air 15 kV air 1 kV The CDI System 550 is classified as level...

Page 127: ...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...

Page 128: ...including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter The CDI System 550 is intended for use in the electromagnetic envi...

Page 129: ...agnetic environment due to fixed RF transmit ters consider conducting an electromagnetic site survey If the measured field strength in the location in which the CDI System 550 is used exceeds the appl...

Page 130: ...as cell phones pagers walkie talkies and Bluetooth devices Portable RF communications equipment should be used no closer than 76 cm 30 inches from the H Sat probe head and no closer than 30 cm 12 inch...

Page 131: ...p 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...

Page 132: ...interference will not occur care must be taken in the selection of computer equipment or printers to be interfaced with the Terumo CDI System 550 Monitor and in the manner in which this interface is...

Page 133: ...erial port configuration screen 5 Set the CDI System 550 s serial communication parameters to match those of the external device Chapter 4 Choosing system settings gives instructions for setting these...

Page 134: ...interface has the same pin assignments as the RS 232 standard The next table defines the pin assignments for the serial data output port Pin Number RS 232 Name CDI System 550 Connection DCE 1 Data Car...

Page 135: ...d for more sophisticated devices that can be more interactive with the monitor such as how when and what it wants in receiving data The packet mode is described in detail below Terumo Systems This sel...

Page 136: ...icating temperature display value will be output initially and every time the user changes temperature modes This line will either be Temp Data or 37C Temp Data depending on the condition of the monit...

Page 137: ...ation xxx 4 parameter calculated if no HSAT module is operating 9 Potassium x x 4 measured in mEq L 10 VO2 Oxygen Consumption xxx 4 measured in ml min calculated in ml min or ml min m 11 Q Pump Flow x...

Page 138: ...CDI System 550 hardware supports RS 232 signals on the Serial Port and is used for communication with any device with an RS 232 interface for the purposes of capturing analyte data from the CDI System...

Page 139: ...i tions D D Variable length data field in ASCII format The data field will be used to pass parameters if necessary If no data is necessary this field will be omitted ZZ 8 bit ASCII hex encoded CRC Thi...

Page 140: ...om CDI Sys tem 550 Sent to the CDI System 550 to set certain parameters such as Arterial Flow or certain toggles The CDI System 550 also sends a Set type packet to try and set the frequency that Arter...

Page 141: ...ted G2HH MM SS No Acknowledge N Value Name Description 0 Invalid Packet Length Sent when the driver detects more or less characters than the length field indicated 1 Invalid Device ID Sent when the pu...

Page 142: ...ither 1 CDI System 550 is in Operate mode or 0 CDI System 550 is not in Operate mode Set S Value Name Description 1 Auto Output Interval Sends the CDI System 550 data on how often Analyte packets shou...

Page 143: ...ould include the count of all parts of the packet up to but not including the CRC field The function returns the CRC value which should be converted to a two character hex encoded ASCII value for incl...

Page 144: ...sium K 07 Consumption O2 08 Venous pH 09 Venous CO2 0A Venous O2 0B Venous Temp 0C Venous SO2 0D Venous 0E Venous Base Excess 0F Hematocrit 10 Hemoglobin 11 Arterial Flow 12 Body Surface Area 13 B Uni...

Page 145: ...set up automatically through the selection of the specific pump being connected to see Chapter 4 Choosing System Settings for options and instructions Selections are made in the setup mode screen 5 C...

Page 146: ...te Please consult the Operator s manual of the specific pumping system being used for instructions on how to properly setup the pump for sending data through its serial interface Pumping System Specia...

Page 147: ...ontact your Maquet Jostra Technical Service representative to setup the HL 20 soft ware before interfacing Make sure the correct interface cable is used LivaNova Sorin St ckert S5 C5 Interfacing with...

Page 148: ...a pumping system or other device The communication packet infrastructure will have start and stop characters in binary with the rest of the packet in ASCII Binary data transfers are not currently supp...

Page 149: ...will be used to pass parameters if necessary If no data is necessary this field will be omitted ZZ 8 bit ASCII hex encoded CRC This CRC is calculated using the entire packet up to but not including t...

Page 150: ...the CDI System 550 to both confirm that the request came through successfully and to provide any data associated with the request N No Acknowl edge From CDI System 550 Indicates a problem with packet...

Page 151: ...Analyte Packet sent by CDI System 550 when the Store key is pressed 3 Recal Data Packet Analyte Packet sent by CDI System 550 when the Re cal key is pressed 4 Solicited Date Packet Analyte Packet sen...

Page 152: ...lus the data requested G2HH MM SS No Acknowledge N Value Name Description 0 Invalid Packet Length Sent when the driver detects more or less characters than the Length field indicated 1 Invalid Device...

Page 153: ...uffer Request the Case Summary buffer be dumped in packet format This will cause the CDI System 550 to send Case Summary data Attention 5 each packet a separate line 4 EEPROM Dump Request the EEPROM d...

Page 154: ...e Indicates if Store Recal data shall be sent A 0 in the data portion indicates that it shall not a 1 indicates that is shall be sent The CDI System 550 will send an Acknowledge packet with the desire...

Page 155: ...r Arterial Flow For example if the CDI System 550 sends a S712 indicating that the Arterial Flow Auto Interval shall be 12 seconds the expected response from the pump would be a K0S712 where the S712...

Page 156: ...II and fields are tab delimited The first field indi cates the time in military format that the data was recorded on the CDI System 550 Data is recorded every 6 seconds in the CDI System 550 so it is...

Page 157: ...37 degree value 1 Actual temperature value Bit 1 0 Normal data 1 Low alarm status Bit 2 0 Normal data 1 High alarm status Bit 3 MSB 0 Normal data 1 Analyte unavailable This means that if the status va...

Page 158: ...or a variety of reasons be presented on the medical device itself ISO 15223 1 5 4 4 On for a part of Equipment On for a part of Equip ment IEC 60417 5264 Off for a part of Equipment Off for a part of...

Page 159: ...5 3 1 Keep dry Indicates a medical device that needs to be protected from moisture ISO 15223 1 5 3 4 This way up This way up ISO 7000 0623 Date of manufacture Indicates the date when the medi cal devi...

Page 160: ...to the serial data output port Terumo Cardiovascular Systems Audible alerts are active Audible alerts are active Terumo Cardiovascular Systems Audible alerts are temporarily silenced Audible alerts ar...

Page 161: ...been sterilized ISO 7000 2608 Do Not Use if Pack age is Damaged To indicate that the device must not be used if the package holding the device is damaged ISO 7000 2606 Fluid Path On medical devices t...

Page 162: ...ors disposables and accessories This warranty does not cover damage due to unauthorized service Because the operation of Terumo CVS s monitors disposables and accessories depends on factors which are...

Page 163: ...ministration Department Please be prepared to provide the product description the quantity of product to be returned the lot or serial num bers and the reason for the return Terumo CVS may give author...

Page 164: ...patent information F 1 Patent Information U S Patents 5 296 381 5 508 509 5 591 400...

Page 165: ...appendix f F 2 This page is intentionally left blank...

Page 166: ...t or lease the SOFTWARE 3 UPGRADES If you receive an upgrade or other revision to the SOFTWARE you agree to immediately install the upgrade on the CDI System 550 The upgrade will be considered SOFTWAR...

Page 167: ...OR INABILITY TO USE THE SOFTWARE EVEN IF TERUMO CVS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES TERUMO CVS S LIMIT OF LIABILITY FOR DIRECT DAMAGES HEREUNDER REGARDLESS OF LEGAL THEORY OR CAUSE...

Page 168: ...or portions thereof to be unenforceable that provi sion of the Agreement shall be enforced to the maximum extent permissible so as to affect the intent of the parties and the remainder of this Agreeme...

Page 169: ...appendix g G 4 This page is intentionally left blank...

Page 170: ...carbonate HCO3 The primary buffering system of the body It minimizes changes in pH when either acids or bases are added to the blood BPM Blood Parameter Module Arterial and or Venous cable modules tha...

Page 171: ...ic Not poisonous Non pyrogenic Not fever producing Operate mode toggle key The key you press during operate mode to switch among the three types of dis plays Numeric Tabular and Graphic This key is ne...

Page 172: ...tassium K The major cation of intercellular fluid Blood flow value in L min obtained manually or via the pump interface port Soft keys Software driven function keys located along the right side of the...

Page 173: ...rature of the blood when connected to a sensor Tonometered A measurement characteristic of the calibration gases used with the CDI System 550 The gas concentrations used with the CDI System 550 meet g...

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