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BioZ operators manual

1. ALARMS NORMAL SYSTEM BACK MORE RANGES DEFAULTS q Figure 57 BioZ com System Set Up Menus Screen 8 1 1 1 Alarms The BioZ provides both an audible and visual alarm for the following parameters e Heart Rate HR e Thoracic Fluid Content TFC e Cardiac Index CI The alarm system is active during all monitoring sessions including Demo Mode sessions The User can deactivate the alarm circuit by pressing the Alarm on off hardkey An LED next to the hard key will turn green when the alarm system is enabled monitoring has begun The LED will automatically turn amber red on some units if a User stops patient monitoring live or Demo Mode presses the Alarm On Off hard key or enters a message screen where the alarm system is not active The LED will automatically return to green along with the actual alarm system when patient monitoring has resumed or after exiting the message screen and going back to the patient monitoring screen The Reset Alarm hardkey is active only on patient monitoring screens when an alarm has been set off In the event that an alarm occurs pressing the Reset Alarm key will silence the audible alarm for the amount of time established by the Time Delay if the audio alarm for the alarming parameter is enabled The visual alarm indicator will not be reset otherwise the User might forget which parameter triggered the alarm system BioZ Operator s Manual 63 CardioDynamics Internati
2. SVR 742 1378 dyn sec cm e Systemic Vascular Resistance Index SVRI 1337 2483 dyn sec cm m e Heart Rate HR 58 86 beats min e Mean Arterial Pressure MAP 84 100 mmHg e Thoracic Fluid Content TFC males 30 50 kohm females 21 37 kohm e Velocity Index VI 33 65 1000 sec e Acceleration Index ACI males 70 150 100 sec females 90 170 1007 sec e Left Cardiac Work LCW 5 4 10 kg m e Left Cardiac Work Index LCWI 3 0 5 5 kg m m e Systolic Time Ratio STR 0 3 0 5 1 Press the Normal Ranges softkey the following screen will be displayed Enter Password Use keypad to enter password Figure 61 Password Entry Screen BioZ Operator s Manual 67 CardioDynamics International Corporation 2 Enter the four 4 digit password see section 8 1 1 5 for instructions on how to set a personal password or use the default password 1111 If the password is correct the following screen will be displayed otherwise the User will be prompted to re enter the correct password Normal ranges of hemodynamic parameters are gender specific Please consult your operators manual for details Select lt MALE FENALE to enter normal ranges MALE FEMALE Figure 62 Normal Range Gender Screen 3 Press the appropriate gender softkey The appropriate gender specific screen will be displayed Male Normal Range Status De
3. This Warranty does NOT apply to fuses or ink cartridges that are used in conjunction with the System Warranty Coverage Customer Technical Support is available Monday through Friday 6 a m to 5 p m Pacific Time at 800 778 4825 or 858 535 0202 option 3 CDIC will provide a loaner unit equivalent or similar to purchased unit within two 2 business days U S Customers only after it has been determined that the purchased unit needs repair This determination needs to be made before 3 00 p m Pacific Time in order for the two 2 day loaner provision and is dependent upon delivery services available to End User s location BioZ Operator s Manual 101 CardioDynamics International Corporation e CDIC will repair or replace any components of the System that cause the System to not function in accordance with the Operators Service manual and or instructions for use provided with the System at time of sale e CDIC will provide free shipping and freight charges for original and loaner unit exchanges UPS Ground or equivalent e CDIC will provide subsequent operational software upgrade disks and installation instructions at no charge to the customer Warranty Coverage is void if e The System and or Software has been maintained repaired modified or altered by any person other than an authorized CDIC representative or without prior approval from and authorized CDIC representative e The System and or Software has not bee
4. key the highlight bar will be advanced to the Blood Pressure field A4 BioZ Operator s Manual LIVE PATIENT MONITORING 7 2 4 7 Blood Pressure The Blood Pressure field is required for accurate processing of the patient s hemodynamic status The accuracy of some of the data provided by the BioZ may be compromised on persons whose MAP is less than 30 mmHg or greater than 220 mmHg The BioZ allows the User to select one of two methods for obtaining the patient s blood pressure e BioZ com Cuff optional feature not available on all models e Manual Entry Datethh O0e rra 06 12 2000 Times Od 32 Patient ID 112233555 Patient Name DOE JOHN Gender Male Height 6 ft Din Height 185 lbs BSA 2 06 Age 40 BP Manual Entry CUP Default 6 PAOP Default 10 Start Monitoring lt NEW FILE Press A f or ENTER to accept Select BP Method t Bi oz com Manual Exit Cutt Entr Figure 39 Patient Data Entry Screen 7 2 4 8 BioZ com Cuff optional feature not available on all models The BioZ NIBP module utilizes the Oscillometric method in determining blood pressure values The oscillometric method measures the pressure pulse within the cuff in incremental steps This pressure pulse has a maximum value of approximately 1 mmHg that occurs at the MAP A sophisticated algorithm is then applied to plot the Oscillometric Envelope of pulse pressure measurements vs cuff pressure measurements
5. Operator s Manual 113 CardioDynamics International Corporation 114 BioZ Operator s Manual 18 Appendix E HEMODYNAMIC STATUS REPORT Appendix E HEMODYNAMIC STATUS REPORT CDIC MEDICAL CENTER 1234 MAIN STREET SUITE 234 SAN DIEGO CA 92121 Hemodynamic Status Report Name JOHN DOE Age 76 Height 6 ft 4 in ID 125785612 Sex Male Weight 235 lb BSA 2 37 m 10 Beat Average Page 1 of 1 SBP Systolic Blood Pressure 147 CO Cardiac Output 80 St StrokeIndex e Systemic Vascular Res Index ii Left Ventricular Ejection Time Data Collection 03 22 00 at 12 44 Report Generated 03 22 00 at 12 45 Signature CardioDynamics ECG Vector 4 Clinical Note BioZ Operator s Manual 115 CardioDynamics International Corporation 116 BioZ Operator s Manual INDEX 19 INDEX A Acceleration Index ACI oooonnnoconocnnoconinonnconnnonnonannnos 105 Afterload syna aida cos Ma Mons echoes aves Ei 105 Adina 44 Alarm ON OFF cid 11 Alarm Restan a 11 Alarms edi 63 B Base Impedance Zo ceseceeseeceerceeseeceeeeeeneecsteeeeneees 105 Battery ice ietiis ir his Se OR ee 12 BioZ com A eer tikes tk scat hs 45 Body Surface Area BSA cccesceesseeseeeeeseeeseeeeeeeees 105 Built in Noninvasive Blood Pressure Monitor 6 C Cardiac Index Chonainn e E ERS 105 Cardiac Output CO coococococccoconoconononononononnnnnnonn
6. Return to Monitor softkey the following screen will be displayed 84 BioZ Operator s Manual DETAILED DESCRIPTION SELECT Previous Menu OR Helcome fcreen gt PREVIOUSLY ENTERED INFO HILL BE ERAZED WHITH Helcome creen SELECTION PREVIOUS WELCOME MENU SCREEN Figure 84 Patient Data Entry Exit Screen e Press the Previous Menu softkey to return to the BioZ com System Menus Screen 8 2 Patient Records Management The BioZ allows the User to add a new patient add new data to a previous patient s record and review or delete the stored patient records 8 2 1 Adding a New Patient From the Welcome Screen Figure 55 press the Start Monitor softkey Enter the patient s information into the Patient Data Entry screen When complete press the Start Monitor softkey 3 2 2 Add New Data to Previous Patient Record From the Welcome Screen press the Start Monitor softkey From the Patient Data Entry screen press the Stored Pt Info softkey When the desired patient is found press either the New File softkey or the Add to File softkey Either choice will bring up the Patient Data Entry Screen with the patient s data filled in Make changes by pressing the Make Changes softkey or press the Start Monitor softkey to start monitoring Note If Manual Entry is the method of blood pressure the User must enter a new blood pressure value before beginning t
7. The cuff pressure at which the peak pressure pulse occurs is the MAP The diastolic and systolic values are the cuff pressures that intersect at pre determined percentages not fixed percentages but percentages based on the measured MAP and pressure pulse amplitude of the peak pulse pressure The shape of an actual patient Oscillometric Envelope varies from measurement to measurement and from individual to individual Therefore it is quite possible to have different systolic and diastolic pressures for the same measured MAP as well as different MAPs for the same systolic and diastolic pressures To use the BioZ com Cuff e Wrap the Cuff around the patient s upper arm observe the precautions listed below Ensure that the cuff is positioned so that the arrow aligns with the patient s artery e Connect the coiled inflation tube to the NIBP Port on the front panel of the BioZ BioZ Operator s Manual 45 CardioDynamics International Corporation Press the BioZ com Cuff softkey if that is the desired method of blood pressure determination Once the monitoring session begins the BioZ will automatically operate the blood pressure cuff to obtain the measurement Note In order to obtain an accurate blood pressure measurement and to ensure the safety of the patient it is essential that the following precautions be observed Use only the blood pressure cuff provided with the device Use the proper size cuff for the patient
8. s arm Ensure that the cuff is evenly and snugly wrapped around the patient s arm Ensure that the bladder within the cuff is not folded Ensure that all connections are tight so as to prevent leakage While making blood pressure measurements be sure to avoid any compression or restriction of the pressure tube leading to the cuff The operator is advised to observe directly that inflation of the cuff does not result in prolonged impairment to the patient s circulation The patient s arm should remain relaxed and still while the blood pressure cuff is inflating and deflating The BioZ will update the patient s blood pressure every five 5 minutes The five minute interval may be customized to meet the User s requirements See section 8 1 1 3 for a detailed description 7 2 4 9 Manual Entry When Manual Entry is the source for entering the SBP and DBP the BioZ will calculate a MAP using the following algorithm If SBP DBP DBP lt 0 5 Then KP 0 333 If SBP DBP DBP gt 1 0 Then KP 0 25 KP 0 333 SBP DBP DBP 0 5 6 MAP DBP KP SBP DBP For example If a BP 150 65 is entered manually into the BioZ the calculated MAP would be 150 65 65 1 31 therefore KP 0 25 and MAP 65 0 25 150 65 86 25 BioZ Operator s Manual LIVE PATIENT MONITORING In the example above the simple equation of MAP DBP SBP DBP 3 the MAP would equal 93 33 instead of 86
9. 0 mA rms Maximum alternating electrical current through the thorax between a pair of sensors placed on the neck and another pair placed on the mid axillary line at the xiphoid process level Use of a high frequency current eliminates the possibility of interference with bioelectrical activity of BioZ Operator s Manual e is CardioDynamics International Corporation the heart and brain Additionally as the skin to sensor impedance is very low at high frequency there are no thermal effects to tissue thus no sensation to the patient By detecting and measuring the change in thoracic impedance as a function of time the BioZ is able to noninvasively calculate stroke volume cardiac output and many other hemodynamic parameters In comparison thermodilution invasively measures the change in temperature over a change in time in order to calculate stroke volume and cardiac output Dz BioZ Operator s Manual 2 1 2 2 WARNINGS AND PRECAUTIONS WARNINGS AND PRECAUTIONS General Warnings As a Class Ila Type BF device under the Medical Device Directive the BioZ is not specifically intended to monitor variations in cardiac performance that could result in immediate danger to the patient Caution Federal law restricts this device to use by or on the order of a physician Explosive Hazard Do not use in the presence of flammable anesthetics or gases Sensors are to be placed externally on the skin only and are not for direct cardia
10. 1 SUR dun sec Choose Bar To Configure BAR 2 BAR 3 BAR 4 EXIT Figure 79 Patient Diagnostic Screen Cell Configuration Menu 1 Note Figure 79 may not reflect the configuration of the Bar Graphs for your device e Press the appropriate softkey for the desired bar graph to configure the following screen will be displayed Cardiac Output Cardiac Index Stroke Index Stroke Volume Systemic Vasc Res B 2 Systemic Vasc Res Index Heart Rate Blood Pressure OFF 1 2 3 4 5 6 3 9 Use Y f to select parameter Press ACCEPT or ENTER to set Bar B X ACCEPT MORE EXIT gt Figure 80 Hemodynamic Parameter Set Up Menu 1 e Use the More softkey along with the J and or softkeys to select the parameter to assign to the bar graph e Press either the Accept softkey or the Enter hardkey to effect the change e Repeat the above three steps to set the other bar graphs e Press the Exit softkey to return to the BioZ com Screen Configuration Menu BioZ Operator s Manual 81 CardioDynamics International Corporation 8 1 2 3 Trend Screen The Trend Screen will display trending plots for two of the hemodynamic parameters at a given time as well as the current value for the parameter The User can define two combinations of two parameters for the Trend Screen to display To set the default Trend Screen parameters perform the followi
11. 2 Patient Name The Patient Name field is also an optional field DatetMh O0e77749 06 12 2000 Times O62 32 Patient ID 112233555 Patient Mame Gender Required Height Required Weight Required BSA Age Required BP Manual Entry CUP Default 6 PAOP Def aulta 10 Start Monitoring NEH FILE Press A f or ENTER to accept Press Enter Name SOFTEEY to see alphabet screen Figure 33 Patient Data Entry Screen The Patient Name field accepts up to 25 characters e Press the Enter Name softkey to enter text into the Patient Name field The Text Entry screen will be displayed Text Entry Screen Text Entry E MB CIDIEIF IG H I J K L MINIOIPIQIR YZ love Pe Press Accept Letter gt after choosing each letter Press lt ENTER gt when done Accept Letter Figure 34 Text Entry Screen e If an external keyboard is attached simply type in the desired alphanumeric entry Press the lt Enter gt key on the keyboard when finished BioZ Operator s Manual 4 CardioDynamics International Corporation e If an external keyboard is not attached press the appropriate arrow softkeys to highlight the desired character press the Accept Letter softkey to enter the selected character into the Patient Name field The and gt entries are for moving the cursor within the text string e Press the Clear hardkey if an incorrect entry was made e Press the Enter har
12. 25 Press the Manual Entry softkey The following screen will be displayed Systolic Diastolic Values a a Calculated Mean Arterial Pressure Use keypadvkeyboard to input BP Press ENTER to accept MAP value must be between 30 220 mmHg Figure 40 Manual Blood Pressure Entry Screen SYSTOLIC Press the appropriate numerical keys in order to enter the correct Systolic and Diastolic pressures Press the Enter hardkey If an incorrect entry is made press the Clear hardkey and re enter the correct value If the calculated MAP is NOT within the allowed range the Data Out of Range message screen Figure 41 will be displayed otherwise the highlight bar will be advanced to the CVP field THE ENTERED VALUE IS OUT OF THE RECOMMENDED RANGE DATA ACCURACY MAY BE COMPROMISED CHANGE PROCEED ENTRY Figure 41 Blood Pressure Out of Range Screen 7 2 4 10 Central Venous Pressure The BioZ allows the User to enter the patient s actual central venous pressure CVP If this value is not known the BioZ has a default setting of 6 mmHg see section 8 1 1 3 to change the default setting BioZ Operator s Manual 47 CardioDynamics International Corporation DatecHH DD rra De 12 2000 Time 06 32 Patient ID 112233555 Patient Name DOE JOHN Gender Male Height 6 ft Din Height 165 lbs BSA 2 06 Age 40 BP Manual Entry CUP Default 6 PAOP De
13. BioZ calculates the following indexed parameters e Cardiac Index CI e Stroke Index SD e Systemic Vascular Resistance Index SVRI e Left Cardiac Work Index LCWI BioZ Operator s Manual 25 3 2 CardioDynamics International Corporation Optional Features The BioZ is available with the following optional features Internal Battery Power In the event that AC power becomes unavailable the BioZ will continue to operate for up to 30 minutes An LED signal status light indicates the strength of the battery and a Charging LED indicates when the battery is being charged Built in Noninvasive Blood Pressure Monitor The BioZ utilizes a noninvasive pressure cuff placed on the upper arm for obtaining the mean systolic and diastolic arterial blood pressure values The noninvasive blood pressure monitor may also be used independently without starting an ICG monitoring session Serial Data Output The Patient Hemodynamic Parameter data may be accessed via the serial input port and can be viewed in TAB delimited format BioZ Operator s Manual GETTING STARTED 4 GETTING STARTED 4 1 General System Overview The BioZ provides a user friendly environment by which the User can easily enter patient information Hemodynamic parameters are displayed by screens that are easily configured to User specified preferences Display screens not only display the various parameters and or waveforms but also offer instructions to the Us
14. Patient Data Entry Screen road Ir Renardo tease rear o ee Patient Data Entry Screen iccsiscssccsicssscssoesnsssavsascosgeesvengivenesvadsoaveveaseveesicenesvgaecdceneioeenousavess 29 Manual Blood Pressure Entry Screen esssessseessecssocesocesoocssoeessecesocesooesoocesscessccssocesoosessees 29 Patient Data Entry Screen Monitoring Screen Demo Mode eessooesooesssesssccssocesooesooessocesoecssocesoossossssoesssesesosesosessse 20 BioZ com System Menus Screen eessesessosessocesscessccssocesocesoocesoccssocesoossooessosessoesssesssocssocsssse 27 Password Entry Screen sssssssecsseossececosccooceoseesooossocccosecooesoooesooossocscosseosesosoesssosessosssssesss 27 BioZ com Screen Configuration Menu Screen ss00e Monitoring Screen Configuration 1 essseesseessecssocesocesoocessccssocesocssooscsosesscsssocesoccesocsssse DO Monitoring Screen Configuration 2 esssessseessecssocesocesooccsocessocesocesooessosesseessocesoccesosessse 29 Hemodynamic Parameter Menu 1 esessssscoesssccesssossssooesesooecesooocesssoossssoossssooesessssessssse ZO Monitoring Screen Cell Configuration Screen eesseoesooesoocsssecssocesooesoosssoessscessocssossssse SU BioZ com Screen Configuration Menu Screen ses0e BioZ com System Menus Screen ccccsssscsssssosssssccssssecssssccssssccsssssssscscessssssssssssesssssssseees JL Patient Monitoring Screen Demo Mode Re Configured ommomss OL Diagnostic Scr
15. TROUBLESHOOTING 9 TROUBLESHOOTING If you have any problems that you are unable to solve contact CDIC s Technical Service Department at 800 778 4825 option 3 or outside of the USA at 858 535 0202 option 3 or by e mail at tech support cdic com Emergency After Hours Technical Support is available 7 days a week between the hours of 6 a m and 9 p m Pacific Time by cell phone at 866 880 6674 An optional Service Manual is available for purchase for non warranty repairs 9 1 Signal Acquisition Error In the event that the BioZ is unable to process an ECG and or Impedance delta Z waveform for more than a 1 minute period the following error message will be displayed UNABLE TO COLLECT DATA DUE TO POOR HO SIGNAL ACOUISITIOM 1 CHANGE ECG VECTOR 2 CHECK SENSORS CABLE 32 CALL EDIC TECH SERVICE 8009 778 4825 8559 535 0202 HO DATA RECORDED CUE TO POOR SIGNAL ACQUISITION PRESS TO CONTINUE Figure 89 Poor ECG Impedance Waveform Error Screen The Press to Continue softkey will return the User to the screen of entry The screen of entry will remain in a frozen state with the following message displayed until the condition has been remedied LAST GOOD DATA SET RECORDED AT HH MM e Change the ECG vector ensure that the systolic beep is activated and listen for detection and wait at least 30 seconds to allow the screen to update Repeat for all four ECG vectors 1f necessary The User shou
16. Weight fields perform the following e Select the desired field e Press the appropriate softkey for the desired unit of entry display Note the highlight bar is automatically advanced after selecting the desired unit of entry 6 To change the format for the date and or decimal character fields perform the following e Select the desired field e Use the appropriate softkeys at the bottom of the screen to select the desired format and or decimal character BioZ Operator s Manual Fie CardioDynamics International Corporation 7 After the desired system default settings have been entered select Exit System Default Menu and press either the Enter hardkey or the Exit softkey The User will be returned to the BioZ Set Up Menu Figure 57 8 1 1 4 Defining Event Labels The BioZ allows the User to define desired Events in the course of a patient s monitoring session In order to define the list of desired event labels perform the following 1 From the System Set Up screen Figure 57 press the More softkey The following screen will be displayed BioZ com System Set Up Menus EVENT CHANGE BACK MORE Figure 66 BioZ com System Set Up Menus Screen 2 2 Press the Event Labels softkey The Events List screen will be displayed Events List Press Exit when done ENTER EXIT t TA A Figure 67 Events List Screen 3 Press the Enter Label softkey Type in the d
17. a patient 1t is recommended that the User become familiar with the BioZ through the use of the tutorial presented in SECTION 6 BIOZ TUTORIAL of this Manual The Demo Mode is a comprehensive feature that provides the User with a pre programmed patient case study While in the Demo Mode the User has access to all Live Mode features of the BioZ including but not limited to screen configurations selection of parameters to be displayed and printing capabilities of data and or reports The Demo Mode provides the User with an excellent educational method for the operation and many features configurations of the BioZ After completion of the Demo Mode Tutorial the User should feel competent to begin a live monitoring session on a patient BioZ Operator s Manual ST CardioDynamics International Corporation 4 2 User Interface Symbol Key The BioZ consists of a 320 x 240 dot amber electroluminescent EL display screen with five software defined operating keys located below the screen These five keys will be referred to as softkeys throughout this document In addition to the software defined keys there are hardware defined keys referred to as hardkeys throughout this document Depending on the operational status of the BioZ not all the softkeys and hardkeys will be active at any given time Any softkey or hardkey that is not active for a given screen and pressed by the User will evoke an audible signal but will not affec
18. a trend line for the first 15 minutes and will only update every 15 minutes thereafter e The 30 Minute Scale softkey changes the scale to 30 minutes and displays the most recent 30 minutes of data for the selected parameter s e The One Hour Scale softkey changes the scale to 1 hour and displays the most recent 1 hour of data for the selected parameter s e The Full Data Scale softkey will reset the scale to a value up to 12 hours depending on the length of the monitoring session 56 BioZ Operator s Manual LIVE PATIENT MONITORING e The Expand Data softkey displays the trend data in an auto scaled format and provides the User with the ability to zoom in for a more detailed view of a particular time frame co 63 15 31 SUR 1033 10 5 lege I I 2 5 I ow sd oo I I I I I I 4 5 cz i I i 2 5 i i i 424 I I 1 15 17 15 20 15 23 15 26 15 23 EXPANDABLE TREND SCREEN HR 60 Figure 52 Expandable Trend Screen Live Mode The Expand Seg softkeys available to the User on the above screen allow the trending data to be divided and expanded into segments for easier viewing Note The minimum viewable segment length is 3 minutes e Press the Back to Live Data softkey to return to the updated Trend Screen the scale will be the same as when entering Full Data Scale function e The Change Trends softkey allows the User to view
19. or PAOP a one to one and half percent error in SVR and or LCW will be introduced For CVP SVR SVR dyne sec cm MAP CVP x 80 CO If MAP 90 mmHg CVP 6 mmHg and CO 5 5 L min then SVR 90 6 x 80 5 5 1221 dyne sec cm If the actual CVP was 8 mmHg a 2 mmHg underestimation on the part of the BioZ then SVR 90 8 x 80 5 5 1193 dyne sec cm The percent error in the calculated SVR is Percent error 100 x SVReate SWRue SWRtrue 100 x 1221 1193 1193 2 34 Therefore in this example a 2 mmHg underestimation of CVP would result in a 2 34 overestimation of SVR 24 BioZ Operator s Manual BIOZ TUTORIAL For PAOP LCW LCW kg m 0 0144 x MAP PAOP x CO If MAP 90 mmHg PAOP 10 mmHg and CO 5 5 L min then LCW 0 0144 x 90 10 x 5 5 6 3 kgm If the actual PAOP is 15 mmHg a 5mmHg underestimation on the part of the BioZ then LCW 0 0144 x 90 15 x 5 5 5 94 kg m The percent error in the calculated LCW is Percent Error 100 x 6 3 5 94 5 94 6 7 Therefore in this example a 5 mmHg underestimation of PAOP will result in a 6 7 overestimation of the LCW Press the Enter or the J key twice in order to accept the default values The cursor will automatically advance to the Start Monitoring field The following screen will be displayed Date MM DD YY 06 11 2000 Time 13 34 Patient ID 223344556 Patient Name Demo Patient Gender Fema
20. other waveforms besides the default setting e Press the Change Trends softkey to select other waveforms for viewing The Trend Screen Set up screen will be displayed co 6 3 15 39 SUR 1033 10 5 1696 dt DRE dad ana 1378 e Ss 2 5 424 15 17 15 24 15 32 15 39 15 47 TREND SCREEN HR 80 ECOSUR ACI TFE LEFT RIGHT EXIT TREND TREND Figure 53 Trend Screen Set Up Screen Live Mode e The two softkeys on the furthest left of the screen show the two default trending parameter settings see section 8 1 2 BioZ Operator s Manual 57 CardioDynamics International Corporation e Pressing the Left Trend and Right Trend softkeys allows the User to select the parameter that they wish to display during that monitoring session only Once the monitoring session has ceased the default left right trends will be displayed on subsequent monitoring sessions 7 2 5 5 Waveform Screen The Waveform Screen is similar to the Monitoring Screen There are two graphics display cells for displaying up to two of the five waveforms provided by the BioZ as well as five data display cells The data display cells are the same as provided on the Monitoring Screen the difference being that the User has no control over the data display cells from the Waveform Screen The advantage of this screen is that the User can cycle between all five waveforms at the press of a key The Waveform screen is accessed by pressing the Next
21. s Manual 13 CardioDynamics International Corporation 4 green LEDs between 36 and 40 of the last 40 beats were acceptable e Battery 1 red LED or amber depending on your model less than 20 percent of full capacity 1 green LED between 20 and 39 percent of full capacity 2 green LEDs between 40 and 59 percent of full capacity 3 green LEDs between 60 and 79 percent of full capacity 4 green LEDs 80 percent or greater of full capacity 4 2 4 External Connections 4 2 4 1 Front Panel e NIBP Port If equipped with the optional BioZ com blood pressure module e Patient Cable 0 This symbol indicates that the device has type BF defibrillation protection 4 2 4 2 Rear Panel e Warning Symbol With respect to electric shock fire and mechanical hazards only in accordance with UL 2601 1 lt 48 SK gt e Printer Port Uni directional communication with Hewlett Packard PCL3 and more recent print language protocol printers e Serial Output Not used at this time 14 BioZ Operator s Manual GETTING STARTED e Serial Input Used when communicating with an external device such as a PC e Keyboard Allows a standard PC keyboard to be connected to facilitate data entry BioZ Operator s Manual 15 CardioDynamics International Corporation 16 BioZ Operator s Manual 5 QUICK START INSTRUCTIONS QUICK START INSTRUCTIONS NOTE Before using the BioZ for monitoring a patient r
22. softkey The following screen will be displayed 112233445 DOE JOHN 03 06 2000 15 45 DATE TIME HR su sI co CI 03706700 15 37 g0 106 52 6 3 3 1 03706700 15 38 60 106 52 6 3 3 1 03 06 00 15 39 60 106 52 6 3 3 1 03 06 00 15 43 60 106 52 6 3 3 1 03706700 Figure 87 Patient Record Review Screen 3 The above screen will display the numerical data for the parameters shown on the patient s last recorded monitoring screen The first 1 to 5 hemodynamic parameters displayed will be those selected for that specific patient monitoring screen The remaining parameters will be displayed on the following screens To view the remaining hemodynamic parameters the User may press the More gt softkey If there are more than 8 recordings in a patient data file the User may press the 1 softkey or the Previous Screen hardkey to scroll up to the rest of the patient record data sets To access a record of an individual data set 2 Press the Enter hardkey after selecting the desired data set The following screen will be displayed MONITORING SCREEN PREVIOUS NEXT EXIT DATA SET OATA SET Figure 88 Patient Record Review Monitor Screen 4 Note Review Mode will be displayed in the lower right corner of the screen while in the Review Record function Patient waveforms are not saved with each data set BioZ Operator s Manual 87 CardioDynamics International Corporation The BioZ will display th
23. various menus where numerical input is required from the User Keyboard equivalent 0 9 keys BioZ Operator s Manual 9 CardioDynamics International Corporation 4 2 2 6 Clear L The Clear hardkey is used in various menus in conjunction with the 0 9 digit hardkeys When a field is displayed that requires either an alphabetical or numerical entry from the digit soft hardkeys pressing the Clear hardkey will let the User erase an entry and start over Keyboard equivalent Simultaneously pressing the lt Ctrl gt and C keys 4 2 2 7 Enter The Enter hardkey is used in various menus to accept a keyed in or selected value Keyboard equivalent Press the lt Enter gt key 4 2 2 8 Stop Monitoring E Pressing the Stop Monitoring hardkey will stop the monitoring session and take the User to the BioZ Welcome screen Figure 2 The LED next to this hardkey is illuminated when no monitoring is taking place The LED will be off while monitoring either an actual patient or when operating in demo mode Keyboard equivalent Press the lt Esc gt key 4 2 2 9 Print g The Print hardkey is active at various times throughout the patient monitoring session including all patient clinical data monitoring screens and the Review Records screens After pressing the Print 10 BioZ Operator s Manual GETTING STARTED hardkey a menu appears giving printing options see section 8 3 After pr
24. 76 Custom Status Report Selection Screen 2 ccccconcoonoccoonoccnonoccnonnccnnnaccnnnncconoccconacocanacacanas 7O Figure 77 Figure 78 Figure 79 Figure 80 Figure 81 Figure 82 Figure 83 Figure 84 Figure 85 Figure 86 Figure 87 Figure 88 Figure 89 Figure 90 1V BioZ com Screen Configuration Menu Screen cccsssccssssscsssscssssscsssssccssssssssssssssssees 79 Patient Monitoring Screen Cell Configuration Menu 1 cssssccssssssssssssssrsssssssees DU Patient Diagnostic Screen Cell Configuration Menu 1 sccsssccssssscssssesssssscssseeees OL Hemodynamic Parameter Set Up Menu 1 cccsccssssscssssscssssccssssccssssscssssccsssscsssseees SL Trend Screen Cell Configuration Menu Screen cssscccsssssssssscssssscsssssssssssssessssses OD Waveform Screen Cell Configuration Menu Screen OF Patient Data Entry Confirmation Screen oocom OF Patient Data Entry AAA OD Patient Record Review Screen 1 cccccccccscscssssssssssccsosccssssssssecsccccescsssssssssessccsccssssssces OO Patient Record Review Screen 2 ccccccccccccscssscssscssccsocccssssssssesscccccccssssscsssessccsesssssssces OO Patient Record Review Screen 3 ssssceeeee A Y Patient Record Review Monitor Screen 4 A YE Poor ECG Impedance Waveform Error Screen ssccssssscssssccssssscssssssssssssssssssssessees DO Low battery Warning Screen sssscccsssccssssscssssccsssscsssscsss
25. 995 103 31 _____ 15 29 15 147 8705 70 81 983 toa 31 fo o 15 30 06 147 870105 70 80 989 104 31 15 31 22 147 870105 70 79 1004 104 31 TT 15 32 13 147 8705 70 80 9890 104 31 ___ 15 33 05 147 8705 70 80 992 Jia 31 __ 15 34 22 147 87 105 70 80 986 103 31 T 15 35 13 147 87 105 70 8o 985 ios 31 o DAME EA MA Dd TIA E O HA A PRA AO A IO SN A UE AAA ATEO FEA MA A EA SS AO ES EMO ESA RIERA SQUARE MESES EDS NO DATA DIE CTO N DARA SERE ECOS MESS ASUS SIE REE A A EEES BESAS A AO AS ED TR A AA Average 147 87 105 70 80 989 oa 318 be de gt kk Clinical Note Data Collection 03 22 00 Report Generated 03 22 00 at 15 36 Signature CardioDynamics BioZ Operator s Manual 111 CardioDynamics International Corporation 112 BioZ Operator s Manual 17 Appendix D HEMODYNAMIC TREND REPORT Appendix D HEMODYNAMIC TREND REPORT CDIC MEDICAL CENTER 1234 MAIN STREET SUITE 234 SAN DIEGO CA 92121 Hemodynamic Trend Report Name JOHN DOE Age 76 Height 6 ft 4 in ID 125785612 Sex Male Weight 235 lb BSA 2 37 m Page 1 of 1 Trend Parameter Parameter Time Values WNL Time SERIO PERES EN E CESA O AA PA SR SERA OA O EA IEA A A RAE Data Collection 03 22 00 From 12 09 13 50 Report Generated 03 22 00 at 13 51 Signature CardioDynamics BioZ
26. AGREEMENT sessessesessossesossossescosoesessossesossossesocsossessossesossossesessse 102 14 APPENDIX A GLOSSARY OF TERMS sessessesessossesossossesossossoscsossesossesossossesoesossessossssossossse 105 15 APPENDIX B PRINT SCREEN REPORT eeseesesseseesossesoosossessossesossossesossesossossessossesossossse 109 16 APPENDIX C HEMODYNAMIC SUMMARY REPORT uu ec cttccececesccccecceescnscsencees 111 17 APPENDIX D HEMODYNAMIC TREND REPORT eseessesoossessoesoossoesosscssooesosssssooesosss 113 18 APPENDIX E HEMODYNAMIC STATUS REPORT seeseesoesooeseessessossosssesooesossosssesooesoeso 115 19 INDEX tii A E EEA E EE 117 ii BioZ Operator s Manual Figure 1 TABLE OF FIGURES TABLE OF FIGURES Text Entry AA ear edines cena ee a Figur 2 Welcome Ser n ii ic LD Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 Figure 18 Figure 19 Figure 20 Figure 21 Figure 22 Figure 23 Figure 24 Figure 25 Figure 26 Figure 27 Figure 28 Figure 29 Figure 30 Figure 31 Figure 32 Figure 33 Figure 34 Figure 35 Figure 36 Figure 37 Figure 38 Figure 39 Figure 40 Figure 41 Figure 42 Figure 43 Figure 44 Figure 45 Figure 46 Patient Data Entry AAA Patient Data Entry SOT iii nd RARO caera teesis ZL Patient Data Entry Screen Patient Data Entry ST iZ
27. BioZ Operator s Manual Part 1095601 CardioDynamics TAPAE ICG COMPANY 6175 Nancy Ridge Drive San Diego California 92121 USA 800 778 4825 858 535 0202 Fax 858 535 0055 European Representative medis A division of CardioDynamics Medizinische Messtechnik GmbH Werner von Siemens Str 8 98693 Ilmenau Germany CardioDynamics International Corporation This document contains confidential information that belongs to CardioDynamics International Corporation No part of this document may be transmitted reproduced used or disclosed outside of the receiving organization without the written consent of CardioDynamics International Corporation CardioDynamics BioZ com BioZ BioZ sim BioZtect and Z Care are trademarked names protected by law TABLE OF CONTENTS TABLE OF CONTENTS E INTRODUCTION a ds saesson eot oree aa enaa tasea Eoso Enere onat Sasis oa ceansabeacshaueoeaeenars 1 1 1 Theoretical Concepts usina dado tros 1 2 WARNINGS ANDPRECAUTTO NS Ad aii 3 ZU General Warnin s rd A ies 3 2 2 A autel gested ohayearaaas e duce aaae aA gel Seat ate gdaede a E E E A 3 ds A E E E A lal A O E EE E E E Re 4 24 GO OMUPALNONC ALLOWS 5 aasi eonia a E Mua ot io tai 4 3 SYSTEM FEATURES cisscascsicasecasscncessioccocdicocweascaticathoseoresausscasaksconseegsoccseaseosessgabiesadagoontanaseacssunsons 5 Doll Standard PEA TIFOSSI AAA A AA 5 39 2 Optional PEU tt 6 4 GETTING SEA RT ED isisi iesise isese
28. DEX CO See CARDIAC OUTPUT CONTRACTILITY The rate of shortening of the myocardial muscle fibers in time Contractility is a systolic phenomenon CVP See CENTRAL VENOUS PRESSURE DIASTOLIC BLOOD PRESSURE DBP mmHg The minimum arterial pressure at the end of diastole DELTA Z IMPEDANCE WAVEFORM deltaZ The change in the thoracic base impedance due to the cardiac cycle dZ dt Ohms sec The first derivative of the deltaZ waveform with respect to time dZ dtmax corresponds to the peak blood velocity in the aorta during systole BioZ Operator s Manual 105 CardioDynamics International Corporation d2Z d Ohms sec The second derivative of the deltaZ waveform with respect to time AZ ld max corresponds to the peak blood acceleration in the aorta during systole ELECTRICAL BIOIMPEDANCE EB A noninvasive technique for converting the measurement of electrical conductivity of a body segment into the blood flow through the segment and the content of fluids within the segment HEART RATE HR beats min J The number of beats performed by the heart in one minute p HEMODYNAMIC MODULATORS The parameters that affect modulate blood flow and blood pressure HR See HEART RATE HYPERDYNAMIC STATE The supernormal or abnormally high value for a specific condition HYPERTENSION A state where the mean arterial pressure exceeds 100 mmHg supine resting adults HYPODYNAMIC STATE The infranormal or abnormal
29. E LOGOS A The Licensed Program its package and the User documentation contain certain copyright and proprietary notices Licensee agrees that these notices shall not be removed or altered No rights of any kind under any trade name s trademark s or service mark s owned by Licensor are granted under this agreement nor is Licensee authorized to use any trade name s trademark s or service mark s owned by Licensor B Licensee agrees to reproduce the following notice on any copies of the Licensed Program This computer program includes proprietary trade secrets owned by CardioDynamics International Corporation Possession and use of this program must conform strictly to the User s License Agreement Receipt or possession does not convey any rights to divulge reproduce or allow others to use this program without the specific authorization of CardioDynamics International Corporation Copyright 1997 1998 1999 2000 all rights reserved CardioDynamics International Corporation TITLE Licensee acknowledges and agrees that title to all copyright trade secrets or any other intellectual and or proprietary rights in the Licensed Program are the property of Licensor Licensee agrees that during and after termination of this agreement Licensee shall not raise or cause to be raised any questions or objections concerning any of the rights held by Licensor in the Licensed Program Licensee further acknowledges and agrees that except for the nonexc
30. JOHN Gender Male Height 6 ft Din Weight Age Required BP Manual Entry CUP Default gt 6 PAOP Default gt 10 Start Monitoring lt NEW FILE gt Use keypad keyboard to input Weight Press 4 or ENTER to accept Range must be between 67 341 lbs Figure 37 Patient Data Entry Screen e Press the appropriate numerical keys in order to enter the patient s correct weight in lbs or press the kg softkey to enter the correct weight in kg Press the Enter or the key the highlight bar will be advanced to the Age field e Note If the value entered is out of the required range as displayed on the screen the Data Out of Range screen Figure 45 will be displayed prior to beginning the monitoring session e Note The Body Surface Area BSA will be calculated and displayed after the weight has been entered 7 2 4 6 Age The Age field is required for accurate processing of the patient s hemodynamic status DatecMM OD Y YY 06 12 2000 Time 06 32 Patient ID 112233555 Patient Name DOE JOHN Gender Male Height 6 ft Oin Weight 185 lbs BSA 2 06 Required BP Manual Entry CUP Default 6 PAOP Default 10 Start Monitoring lt NEW FILE gt Use keypadvkeyboard to input Age Press Y f or ENTER to accept Figure 38 Patient Data Entry Screen e Press the appropriate numerical keys in order to enter the patient s correct age Press the Enter or the Y
31. Monitoring NEW FILE Use keypad keyboard to input Age Press A f or ENTER to accept Weight 119 lbs BSA 1 Required BP Manual Entry CUP CDefaulto 6 PADR Defaults 10 DEMO MODE Figure 7 Patient Data Entry Screen 2 BioZ Operator s Manual BIOZ TUTORIAL 6 Press the appropriate numerical keys in order to enter the patient s age in years Press the Enter or the J key the cursor will automatically advance to the Blood Pressure field The following screen will be displayed DatecMM DOD ii O6 11 2000 Time 13 34 Patient ID 2233544556 Patient Mame Demo Patient Gender Female Height 5 ft 6 in Hei ght 119 lbs BSA 1 60 Age 24 Manual Entry CUP Defaults 6 PAQP Default 10 Start Monitoring lt NEW FILE Press or ENTER to accept Select BP Method DENO MODE Bicz com Manual Exit Cutt Entr Figure 8 Patient Data Entry Screen The BioZ allows the User to select one of two methods for obtaining the patient s blood pressure the BioZ Cuff or Manual Entry 7 Press the Manual Entry key The following screen will be displayed Systolic Diastolic Values a Calculated Mean Arterial Pressure Use keypadvkeyboard to input BP Press ENTER to accept MAP value must be between 30 220 mmHg DEMO MODE SYSTOLIC DIASTOLIC a ii BACK Figure 9 Manual Blood Pressure Entry Screen BioZ Operator s Manual 93 Cardi
32. P Defaulto 10 Start Monitoring NEW FILE Use keypad keyboard ta input Height Press or ENTER to accept Height must be between 470 and e Figure 36 Patient Data Entry Screen e Press the appropriate numerical hardkeys in order to enter the ft and in data in the respective fields or press the em softkey to enter the height in centimeters Press the Enter or the 4 key The highlight bar will be advanced to the Weight field e Note If an entry greater than eleven 11 is entered into the in field press Clear and re enter the correct value otherwise the BioZ will convert the entry to it s equivalent height in feet and inches For example if 5 feet 13 inches is entered into the ft and in fields respectively the BioZ will convert the entry to 6 feet 1 inch Also if the value entered is out of the required range as displayed on the screen an error screen will be displayed prior to beginning the monitoring session Figure 45 7 2 4 5 Weight The Weight field is required for accurate processing of the patient s hemodynamic status The accuracy of some of the data provided by the BioZ may be compromised on persons under 30 kg 67 Ibs or over 155 kg 341 lbs in weight see section 2 2 Precautions BioZ Operator s Manual 43 CardioDynamics International Corporation DatecMM DD YYYY gt 0612 2000 Time 06 32 Patient ID 112233555 Patient Name DOE
33. PROFITS LOST DATA OR ANY OTHER SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES RELATING TO USE OF THE PRODUCTS HOWEVER CAUSED WHETHER FOR BREACH OF WARRANTY CONTRACT TORT INCLUDING NEGLIGENCE STRICT LIABILITY OR OTHERWISE IN NO EVENT SHALL CDIC S LIABILITY IN CONNECTION WITH THE PRODUCTS EXCEED THE PRICE PAID THEREFOR BY THE BUYER Warranty is made on original product purchase only and is not transferable CDIC products are designed tested and warranted as complete systems consisting of integrated hardware and consumables As a result CDIC cannot guarantee or warrant the accuracy or results of tests done with CDIC hardware products when third party consumables such as sensors are used to perform tests with such products Any attempt to modify any CDIC product from its original condition as delivered to Buyer or any use or integration with or into a CDIC product of parts or components not approved by CDIC will void the warranty for that product CDIC s and or its Distributors liability and obligation and the End User s sole remedy shall be at CDIC s option to either repair or replace software and or System or any part thereof It is the responsibility of the End User to notify CDIC or CDIC s Distributor if CDIC requests the End User to notify its Distributor by telephone or in writing of any problem experienced by the End User within the Warranty Period and no later than thirty 30 days after the expiration of the warranty period
34. RING DatetMh O0 77 v4 06 12 2000 Time Od 32 Patient ID 112233555 Patient Name DOE JOHN Gender Male Height 6 tt Qin Height 165 lbs ESA 2 06 Age 40 BP Manual Entry CUP Defaulto 6 PAOP Defaultor 10 Start Monitoring lt NEW FILE Press t or ENTER to accept Press Start Monitor to begin Start Monitor Figure 44 Patient Data Entry Screen e Press the Start Monitor softkey to begin the monitoring session Note If any of the below fields are out of the recommended range the following screen will be displayed SOME OF THE ENTERED VALUES ARE OUT OF THE RECOMMENDED RANGE DATA ACCURACY MAY BE COMPROMISED PLEASE CHECK THE FOLLOWING ENTRIES Row ri Height Row 81 Height Row 10 Blood Pressure CHANGE PROCEED ENTRY Figure 45 Data Out of Range Screen BioZ Operator s Manual 49 CardioDynamics International Corporation 7 2 5 Patient Monitoring Screens When monitoring a patient the BioZ provides five 5 basic screens for presenting the various hemodynamic parameters Monitoring Screen Diagnostic Screen Therapeutic Screen Trend Screen Waveform Screen There are eight common features to the patient monitoring screens that are controlled by the following eight hardkeys section 4 2 2 1 2 3 4 5 6 7 8 50 The Menu hardkey allows the User access to the system default settings while monitoring a patien
35. Screen hardkey from the patient Trend Screen Figure 51 or the Previous Screen hardkey from the patient Monitoring Screen Figure 46 co SUR BP 115 75 TFC ACI 1099 ECG Vector Impedance 30 Beat Average WAVEFORM SCREEN 15 43 HR 60 MORE FREEZE CHANGE SAVE TAKE NEH HAVES SCREEN _ ECG VECTOR WAVEFORM BP Figure 54 Waveform Screen Live Mode Note The Change ECG Vector softkey is only displayed if the ECG waveform is displayed The More Waves function allows the User to cycle through the following waveforms Impedance Waveform delta Z ECG Waveform dZ dt Waveform Pacer Impulse Waveform Spike Enhancement Waveform The Un Freeze Screen softkey allows the User to unfreeze freeze the screen display to better view the waveforms 58 BioZ Operator s Manual LIVE PATIENT MONITORING e The Change ECG Vector softkey toggles through the four available ECG vectors detected by the BioZ see section 7 2 5 1 e The Take New BP softkey triggers the BioZ com cuff blood pressure monitoring device or the User is prompted to manually enter the blood pressure e The Save Waveform softkey saves waveforms for exporting to another PC Press the Next Screen hardkey to return to the Monitoring Screen BioZ Operator s Manual 59 CardioDynamics International Corporation 60 BioZ Operator s Manual DETAILED DESCRIPTION 8 DETAILED DESCRIP
36. Screen To Configure DEMO MODE MONITOR DIAGNOSTIC WAVEFORM TREND EXIT Figure 20 BioZ com Screen Configuration Menu Screen 30 BioZ Operator s Manual BIOZ TUTORIAL 11 Press the Exit softkey again The following screen will be displayed BioZ com System Menus DEMO MODE SYSTEM CONFIG UPDATE RETURN TO SET UP SCREENS PT INFO MONITOR Figure 21 BioZ com System Menus Screen The BioZ allows the User to define the default settings for many variables and or parameters such as Alarms Normal Ranges Event Labels and set Waveforms to Record See section 8 1 1 for a detailed description 12 Press the Return to Monitor softkey The following screen will be displayed CO iS YR dyn p mmHg AA re ea ECG Vector 2 Impedance 30 Beat Average MONITORING SCREEN 13 31 DEMO MODE URN PACE CURRENT CHANGE SAVE TAKE NEL DETECT OFF IPT RECORD ECG VECTOR WAVEFORM BP Figure 22 Patient Monitoring Screen Demo Mode Re Configured To observe the five 5 different screens for displaying patient data during a monitoring session the User can press either the Next Screen or Previous Screen hardkeys BioZ Operator s Manual 31 CardioDynamics International Corporation 13 Press the Next Screen hardkey The following screen will be displayed CO lzmin 89 50 70 0 DIAGNOSTIC SCREEN 10 21 DEMO MODE SAVE TAKE NEW WAVEFORM BP Figure 23 Diagnost
37. TION 8 1 Welcome Screen The Welcome Screen is the first screen displayed when the BioZ is powered on and when the Stop Monitoring key is pressed during a patient monitoring session The Welcome Screen represents the starting point for the User when operating the BioZ From the Welcome Screen the User is able to begin a monitoring session review patient records simulate a monitoring session and or access the various User menu functions CardioDynamics THE ICG COMPANY Ie S MONITOR 800 778 4825 858 535 0202 WWW Cardiodunanics con Software Wersion 3 3 1 Serial Output Version COIC 2002 All Rights Reserved START TAKE REUIEH SYSTEM SYSTEM MONITOR BP ONLY RECORDS MENUS DEMO Figure 55 Welcome Screen The BioZ is equipped with many features that provide the User with the ability to customize the settings and configurations of the various patient monitoring screens All system functions and settings are accessed through the BioZ System Menus The BioZ System Menus can be accessed by the User from the Welcome Screen prior to beginning a patient monitoring session or from the various patient monitoring screens during a patient monitoring session by pressing the MENU hardkey Thus the User need not exit from a patient monitoring session in order to customize the settings configuration of the BioZ BioZ Operator s Manual 61 CardioDynamics International Corporation To access the BioZ System Menus from the Welc
38. Up Menu press the Select Language softkey The following screen will be displayed ENGLISH FRENCH SPANISH ITALIAN GERMAN DANISH DUTCH SELECT EXIT LANGUAGE Figure 74 Language Selection Screen 1 Press the Y and or T softkeys to select the desired language 2 Press the Select Language softkey to lock in the desired language and return to the BioZ com System Set Up Menus Screen 8 1 1 9 Configure Status Report Note The ability to configure a Custom Status Report is not available on all models and software versions The BioZ has the ability to configure the Hemodynamic Status Report so that only the desired parameters are displayed To configure the Hemodynamic Status Report perform the following steps 1 At the BioZ System Set Up Menu press the Config Status softkey The following screen will be displayed BioZ Operator s Manual ang by ee CardioDynamics International Corporation i Heart Rate 2 Systolic Blood Pressure OM 3 Diastolic Blood Pressure OM 4 Mean Arterial Pressure OM 5 Cardiac Index ON 58 Cardiac Output ON 7 Stroke Index ON 2 Stroke Volume ON 9 Systemic Vascular Res Index ON 10 Systemic Vascular Resistance ON Use to select parameter Press ON OFF to include or exclude from report ON OFF Figure 75 Custom Status Report Selection Screen 1 2 Press the Y and or softkeys to highlight the desire
39. Waveform Screen Live Mode cccsccssscsssssssssscsscsscccsssssssssessccccsssssssssssececcssssssssssees DO Welcome A A AS OL BioZ com System Menus Screen cocos O2 BioZ com System Set Up Menus Screen cccsccssssccssssccssssscsssccsssssscssscssssssssssesssssessees OO Alarm Status SCTreen ccsccssssccssssccsssccsssscees Alarm Limit Set Point A A OD Alarm Reset Time Delay Screen oooocms OO PASS WOEG Entry SEGEN soest sieer toie sses T Normal Range Gender Screen OS Normal Range Menu Screen 1 ocommoomooooo Normal Range Menu Screen 2 cvisdcicorccsevescssdeccegcesseseds ocoseossevceccdsovesebeadsdscdeaveedertadecsevenses OF System Default Menu ScreeN oosmsssss 70 BioZ com System Set Up Menus Screen 2 sccsssscsssscssssccssssccssssscsssssscssssssssssssssssces 1 Events List Screen coomooo Password Entry Screen New Password Entry Screen sssssccssssscsssssessscsssssccssssssssscssscnscssscssssccssnssssssssssssssssossscses 14 New Password Re Confirmation Entry Screen ccomoocsmcsscsssss 4 New Password Verification Screen 9 BioZ com System Set Up Menus Screen Facility Name Entry Screen Language Selection Screen csscccssscssssscssssscsssscsssssssssscssssscsssssssssscssssssssssssssssssssessseces 7 Figure 75 Custom Status Report Selection Screen 1 cssccssssccssssscssssccsssccssssscssssssssssssssssssssees 7O Figure
40. al 99 CardioDynamics International Corporation 100 BioZ Operator s Manual SOFTWARE LICENSE AGREEMENT 12 Z Care Standard Warranty CardioDynamics International Corporation CDIC warrants that the BioZ System System and the System Software Software shall be free from errors defects in materials workmanship and programming that cause the System not to function in accordance with the accompanying written specifications provided with the System at the time of installation CDIC will provide this Warranty for a period of twelve 12 months from the original CDIC date of shipment This Warranty shall include all options and accessories purchased with the System except the external patient cable s the printer and if applicable the external inflatable blood pressure cuff s and hose s which shall be covered for ninety 90 days from the original CDIC invoice date If during the warranty period Buyer uses the Products as directed in the Operators Manual but the Products fail to conform to their specifications CDIC will repair or replace the Products at CDIC s sole election CDIC MAKES NO OTHER REPRESENTATIONS OR WARRANTY WHETHER EXPRESS OR IMPLIED AS TO MERCHANT ABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ARISING FROM COURSE OF DEALING OR USAGE OF TRADE CDIC SHALL NOT BE LIABLE TO BUYER OR ANY OTHER INDIVIDUAL OR ENTITY FOR ACTS OF GOD PROPERTY DAMAGE LOSS OF USE INTERRUPTION OF BUSINESS LOST
41. aphy Sensor Placement Diagram 38 BioZ Operator s Manual LIVE PATIENT MONITORING 7 2 Patient Monitoring 7 2 1 Blood Pressure without Starting ICG Monitoring Session Note This feature is only available with software version 2 28 and greater To obtain an independent blood pressure measurement without starting a monitoring session at the Welcome Screen Figure 28 press the Take BP Only softkey The following screen will be displayed Bioz com Blood Pressure SBP DBP MAP Figure 30 Independent Blood Pressure Screen Once the measurement has been calculated the following screen will be displayed Bioz com Blood Pressure SBP DBP CHAP Measurement Taken At 14126 TAKE NEW EF Figure 31 Blood Pressure Measurement Results Screen Press the Exit softkey to return to the Welcome Screen Press the Take New BP to repeat the blood pressure measurement BioZ Operator s Manual 39 CardioDynamics International Corporation 7 2 2 ICG Monitoring Session At the Welcome Screen Figure 28 press the Start Monitor softkey The Patient Data Entry screen will be displayed DatecMM DD YYY Y gt 06 12 2000 Time 06 28 Patient Name Gender Required Height Required Weight Required BSA Age Required BP Manual Entry CUP Default 6 PAOP Default gt 10 Start Monitoring lt NEW FILE gt Press J or ENTER to accept Use keypadvkeyboard t
42. as 40 1 2 5 Patient Monitoring SCreens unitaria a R ca cpausced ws loreh da ceras ondaa 50 8 DETAILED DESCRIPTION siisisssceetscicsscucessvoubecasesiacosdeovsnssieconteesoressenscdeedecuensdecastcoedghaveonnesdsonses 61 8 1 Welcome Screen A ti 61 pS NERD 62 SLD Contigua Or ass 78 8 1 3 Update Patient Information orinal E iia mendatveans 84 8 2 Patient Records Manara ios rt iia oia 85 BioZ Operator s Manual sits CardioDynamics International Corporation 8 2 1 Addins a New Palta oir a tios 85 8 2 2 Add New Data to Previous Patient Record ii di rta 85 8 2 3 Review or Delete Patient RECO ii A 85 8 5 Printing Information AA A OS 89 8 3 1 Print Screen Report ini dsd 89 8 3 2 Hemodynamic Summary REPU Ga sR ae 89 8 33 Hemodynamic Trend Re DO BA eda eset Be i ee ea BA Res 90 8 3 4 Hemodynamic Status Report inside codecs nsasaassdesdaceoane 90 9 TROUBLESHOOTING cosccascsscnescesuseivessocovessanaeousspoesehccsnsesncobeGeesss eneuaspecescesngesusessQoleh cute covessavenese 93 9 1 Signal Acquisition Error cccsccessscsssescecsavacssesceevave dra 93 OD Low Bala ia 94 JS Printing Errors We scandals O ET 94 10 NOMINA L SPECIFICA TIONS sici n ii iii 97 11 MAINTENANCE sort ice 99 IEI Cleaning re eane eae gin rae a a a aeea eaae Nay beadeied shed aaaea aiao E SIS 99 EL Patient Cable marisi A e ee 99 12 Z CARE STANDARD WARRANTY ccssssssssssssscsscsscsnsssssascancsscsnccascsucsncensenscancsscenceasesseenees 101 13 SOFTWARE LICENSE
43. c application The conductive gel of the sensors should not contact any other conductive materials during patient monitoring For safe and proper operation this device is to be connected to a grounded receptacle The Equipotential Bonding Receptacle per DIN 42801 is provided for users who wish to connect the BioZ device to the institution s equipotential system To maintain compliance with Electromagnetic Compatibility EMC standards if your device has an external Ferrite Core it must remain attached to the patient cable and keyboard cable when connected to the BioZ at all times The patient cables specified and included with the BioZ are designed specifically for protection against the effects of cardiac defibrillators and radio surgery equipment Do not use any other type of patient cable with this device Disposal of this product and or any of its accessories shall be in accordance with any and all local regulations The printer and serial output and input ports on the back of the BioZ com should only be connected to peripheral devices that meet the requirements of Safety Standard IEC 950 Consult the manufacturer or the user s manual of the peripheral device to verify that it complies with IEC 950 Caution When monitoring patients with indwelling catheters the printer must be used with a Hospital Medical grade power supply Should you have questions or require clarification please contact CardioDynamics Technical Service fo
44. censee GOVERNING LAW This software license agreement shall be governed by and interpreted in accordance with the laws of the State of California BioZ Operator s Manual 103 CardioDynamics International Corporation COMPLIANCE WITH GOVERNMENTAL REGULATION Licensee agrees to comply with all rules and regulations of any governmental or administrative authority which may from time to time restrict or impose conditions concerning its use of the Licensed Program Licensee specifically acknowledges that the Licensed Program and the User documentation supplied to Licensee in accordance with the terms of this Software License Agreement are subject to the United States Export Controls pursuant to the Administration Act of L979 as amended 50 U S C App 2401 ET SEQ and the Export Administration Regulations 15 C F R Parts 368 399 Licensee hereby agrees not to export or re export any Licensed Program or any direct product thereof directly or indirectly to or for use in any country other than the United States without the prior written authorization of Licensor and the United States Government 104 BioZ Operator s Manual Appendix A GLOSSARY OF TERMS 14 Appendix A GLOSSARY OF TERMS ACCELERATION INDEX ACI 100 sec An index of the peak acceleration of aortic blood flow The peak acceleration takes place approximately 15 30 msec after the opening of the aortic valve ACI is a measure of the true inotropic state of the hear
45. cility Information e An image of a patient monitoring screen e To print a report that contains an image of the screen that the User is currently viewing press the Print hardkey followed by the Print Screen softkey The Print Screen Report will be printed and the softkeys will return to those of the screen of entry Note If the printer is not connected or unrecognizable to the BioZ an error message will be displayed 8 3 2 Hemodynamic Summary Report The Hemodynamic Summary Report Appendix C HEMODYNAMIC SUMMARY REPORT generates a report that lists each recorded data set of the patient currently being monitored or of previously monitored patients The Hemodynamic Summary Report consists of the following e Facility information e Patient demographics e Values for the five hemodynamic parameters displayed on the patient Monitoring Screen e Event Labels BioZ Operator s Manual 89 CardioDynamics International Corporation To print the Hemodynamic Summary Report perform the following e Either press the Print hardkey while currently monitoring a patient or select a previously recorded patient record see section 8 2 and then press the Print hardkey The Print Command softkeys will be displayed Figure 27 e Press the Summary Report softkey Select the duration of the report from the available options Last 8 hours Last 12 hours or Last 24 hours or select Custom Start End If the User se
46. cnonnnonnnoconcninnccnno 107 Me o dead 8 Monitor Screen Configuring RT 79 Monitoring Sereen ariii sissien a 51 N Ne i Sereen son a a ise 9 NIBP Port ras 14 Nominal SpecificatiONS ocoonononononncnnnnnnnconcnncononinonacnno 97 Normal RangeS oooononnnnoninnninnncnnncnnncnncnan crac cnn cano cn naco nos 66 O Optional Features ceccceseesseesseeeceeeeeeseeeeeeeeeeseeeeensees 6 P Patient Data Entry FieldS oooonocccnoncnnccnccnnonnnnecinncnon 40 Patient Diagnostic Screen osonencs 53 Patent ID A A ERR ANST 40 Patient Monitoring cooccococcnnnononononannnonncnncnnnononccnncnss 25 37 Patient Monitoring Screens 50 PQUHENEN GME AE 41 Patient Preparate 37 Patient Therapeutic Screen 54 Patient Trend Screen ooonoooccninococonononccnnnnncnnnn nn noonnncnnnnno 56 Power Source Status coooooccnonocononononcnononnnononncononnnncnonnnns 12 PLECAUtIONS E ieiictiss 3 Pre Ejection Period PEP c ccsesseeseeereeeseeseeeees 107 PLEVIOUS S CLECM iria 9 TE 10 Printing Information oooocoonccnnnnoncnnnnncononononcnncnnnonannnonnono 89 Pulmonary Artery Occluded Pressure PAOP 107 Q Quick Start InsStructiONS ooocoooccoonnnooncconnnononcconononnnonno 17 R Reports 117 CardioDynamics International Corporation Hemodynamic Status Report cesceseeeeseeeeeeee 90 Hemodynamic Summary Report eeeeeteeeee 89 Hemodynamic Trend Report cesceeeeeeteeeeeeee 90 Print S
47. creen press either the Next Screen or Previous Screen hardkeys 7 2 5 2 Patient Diagnostic Screen The Patient Diagnostic Screen will display up to four of the hemodynamic parameters provided by the BioZ in a horizontal bar graph display The Diagnostic screen is divided into three sections in order to denote the low normal and high ranges for the displayed parameters Note See section 8 1 1 2 to select the parameters and normal ranges of operation The Diagnostic Screen is accessed by pressing the Next Screen hardkey from the patient Monitoring Screen Figure 46 or the Previous Screen hardkey from the patient Therapeutic Screen Figure 50 DIAGNOSTIC SCREEN SAVE TAKE_NEW WAVEFORM BP Figure 49 Diagnostic Screen Live Mode See section 7 2 5 1 Patient Monitoring Screen for an explanation of the Take New BP softkey BioZ Operator s Manual 532 CardioDynamics International Corporation 7 2 5 3 Patient Therapeutic Screen The hemodynamic status of a patient is displayed graphically Figure 50 on an integrated screen with Stroke Index SI on the horizontal axis and Mean Arterial Pressure MAP on the vertical axis The shaded region represents the therapeutic target and is determined by the pre defined normal ranges of SI and MAP The underlying hemodynamic conditions reflected in the boundaries of the shaded region are defined as normotension normodynamic normo strokework and normova
48. creen Report cccecceesceesceeseeeeceeeeeseeseeeeenees 89 Reviewing Patient Records cceeceeseereees 34 35 85 S Serial Input uta a a a aa 15 Serial Output aiii o 15 Signal Acquisition ElTOT ooooonccncnocnoncnnnononononnnnncnncnncnnos 93 Signal Strength Status o oooncnccnocnnonococononnnnncnncnncnncnncnncnnos 13 Skin Preparation isc ii 37 ELON KI AA AEE ari 8 SOFTWARE LICENSE AGREEMENT 006 103 Standard Features ocoocccnnoncncnonoconoconnncnnnnnonononononnnnnnncnnnnns 5 Stop MOMitoring isrann i i e 10 Stroke Index SD sc csscceevecteedegeesie i a candaigniss 107 Stroke Volume SV ccccccsssssecsessecesseeceesseeeeeseaeees 107 System Defaults o nire rre a EEEE rnnconos 70 System epi E E E E 62 Systemic Vascular Resistance SVR c cesceseeereees 107 Systemic Vascular Resistance Index SVRI 107 Systolic Time Ratio STR cccescceseeeseeseeseeeeeeneeees 107 118 T TED 1 Theoretical Concepts ccoooocononocononoconononnonncancnnono nono cononconns 1 Thoracic Fluid Content TFC ooooonccccoconinoncconnninnnconoss 108 Thoracic Fluid Index TED oooooonnncccnonnninnnconnnoconnnnos 108 TroubleshootiN8 ccooonconocnnonononononanncnnonncnncnncnononocanonn no 93 U Update Patient InformatiON ooooncnicnnniononononncnononannanono 84 User Interface Symbol Key 8 V Velocity Index VI erna a e 108 W WARNINGS AND PRECAUTIONS eee 3 See General Warn
49. d sold or intended for use except as described in this document For hygienic purposes single use patient sensors are specified when using this device The BioZ is a FDA Class II device The blood pressure cuff provided with the BioZ is non conductive thus assuring no risk of burning the patient during radio surgical procedures such as electrocautery The patient cable circuitry affords a high degree of patient isolation from potential ground faults Contraindications None known BioZ Operator s Manual GETTING STARTED 3 SYSTEM FEATURES 3 1 Standard Features The BioZ interfaces with e Printers utilizing the Hewlett Packard PCL3 and more recent communication protocol e External Keyboard e IBM compatible PC s with specialized software installed The BioZ measures the following parameters e Thoracic Fluid Content TFC the inverse of the thoracic base impedance e Indices of Contractility reported as Acceleration Index ACI and Velocity Index VI e Pre Ejection Period PEP e Left Ventricular Ejection Time LVET e Heart Rate HR e Blood Pressure if optional module purchased The BioZ calculates the following parameters e Cardiac Output CO e Stroke Volume SV e Systemic Vascular Resistance SVR also reported as Afterload e Left Cardiac Work LCW e Systolic Time Ratio STR Several of the above parameters are indexed with reference to body surface area BSA to give indexed parameters The
50. d alarm reset Time Delay 3 To adjust the volume of the Audio Alarm press the Volume softkey accordingly 64 BioZ Operator s Manual DETAILED DESCRIPTION 4 To set the high and low set points for generating an alarm condition press the Limits softkey The following screen will be displayed ALARM LIMITS STATUS LOWER UPPER 2 TFC 30 kohm 50 kohm 1 0 lyvminsm2 6 0 Lyminem2 Press ENTER to customize ranges to select parameter LOWER UPPER BACK LIMIT LIMIT DECIMAL Figure 59 Alarm Limit Set Point Screen Use the softkey to select the desired parameter To enter the desired high or low alarm limit press either the Lower Limit or Upper Limit softkeys in order to place the cursor in the desired field Press the numerical hardkeys and decimal point softkey to enter the desired value If a value is entered incorrectly press the Clear hardkey to erase the value and re enter the correct value Press the Enter hardkey to move to the next parameter Note If the lower limit is greater than the upper limit the cursor will not advance to the next parameter and will be placed in the lower limit box 5 Press the Back softkey to return to the previous screen The BioZ allows the User to select the duration for the audible alarm to remain silent after the Reset Alarm function has been activated Note Only the audible alarm is cleared the visual alarm i
51. d package Sensors are single use disposable items Check the package expiration date before use Note The algorithm used to determine the stroke volume by Impedance Cardiography is dependent on the ICG Sensor conductive gel electrode type spatial relationship and site placement Use of non CardioDynamics approved ICG sensors will affect the ability of the BioZ to determine the patient s hemodynamic parameters 7 1 2 Skin Preparation 1 Shave the hair over the sensor sites if necessary 2 Dry prep the sensor sites by mildly abrading the skin with the perforation on the sensor backing 7 1 3 ICG Sensor Application 1 Check the expiration date on the sealed pouch prior to opening Open the sealed pouch and remove the four dual sensor patches 2 Prep the skin as listed above 3 Remove the four dual sensor patches from the backing material and apply each sensor adhesive side down to the proper sites as indicated on the diagram Figure 29 and the package label The wide rectangular shaped end should be positioned closest to the heart For the neck use the root of the neck as a reference for vertically locating the rectangular shaped detecting sensor with the corresponding circular shaped transmitting sensor being positioned directly superior and inline with the ear lobe For the thorax use the xiphoid process as a reference for vertically locating the rectangular shaped detecting sensor with the corresponding circular shaped tra
52. d parameters and press the ON OFF softkey to select the desired parameters to display on the Custom Status Report 3 Press the More gt softkey the following screen will be displayed Figure 76 Custom Status Report Selection Screen 2 l Acceleration Index 2 Velocity Index OM 3 Thoracic Fluid Content OM 4 Left Cardiac Work Index ON 5 Left Cardiac Hork OM 6 Systolic Time Ratio OM z Pre Ejection Period OM 2 Left Ventricular Ejection Time ON Use to select parameter Press ON OFF to include or exclude from rep 4 Press the 4 and or 1 softkeys to highlight the desired parameters and press the ON OFF softkey to select the desired parameters to display on the Custom Status Report 5 When finished selecting the desired parameters press the Exit softkey to return to the BioZ com System Set Up Menus screen Figure 72 8 1 2 Configure Screens There are five basic patient monitoring screens e Monitoring Screen e Diagnostic Screen 78 BioZ Operator s Manual DETAILED DESCRIPTION e Therapeutic Screen e Trend Screen e Waveform Screen All but the Therapeutic screen may be configured to display the various hemodynamic parameters provided by the BioZ 8 1 2 1 Monitoring Screen When a monitoring session begins the first screen displayed by the BioZ is the patient Monitoring Screen The Monitoring Screen consists of a combination of up to five 5 data dis
53. dkey after the field is complete The highlight bar will advance to the Gender field Note If the Patient ID and Name fields are left blank the User will only be able to identify the file by the date and time of the session While both of these fields are optional it is beneficial to place an entry in at least one of the fields 7 2 4 3 Gender The BioZ requires the gender of the patient to accurately determine their hemodynamic status Date MM DD YY 06 12 2000 Time 06 32 Patient ID 112233555 Patient Name DOE JOHN Required Height Required Weight Required BSA Age Required BP Manual Entry CUP Default 6 PAOP Default 10 Start Monitoring lt NEW FILE gt Press f or ENTER to accept Select patient gender Figure 35 Patient Data Entry Screen e Press the appropriate Male or Female softkey The highlight bar will be advanced to the Height field 2A BioZ Operator s Manual LIVE PATIENT MONITORING 7 2 4 4 Height The Height field is required for accurate processing of the patient s hemodynamic status The accuracy of some of the data provided by the BioZ may be compromised on persons under 120cm 48in or over 230cm 90in in height see section 2 2 Precautions DatecMH DD rra 0612 2000 Time Od 32 Patient ID 112233555 Patient Name DOE JOHN Gender Hale Height Height Required ES z Age Required BP Manual Entry CUP Default 6 PAO
54. e green When the signal is weak undetectable or does not meet certain acceptance criteria a single red or amber depending on the model LED will be energized at the left end of the bar e ECG Automatic gain adjust is applied to the ECG signal for optimum detection and processing The BioZ records the number of gain changes that were applied in the previous 25 seconds In general the fewer gain changes the higher the signal quality and the more green LEDs displayed 1 red LED or amber depending on your model Four or more gain changes in the previous 25 seconds or no R wave detected within the last three seconds 1 green LED Three gain changes in the previous 25 seconds 2 green LEDs Two gain changes in the previous 25 seconds 3 green LEDs One gain change in the previous 25 seconds 4 green LEDs Zero gain changes in the previous 25 seconds e Impedance The BioZ applies specific rejection criteria to every heartbeat to determine the validity of the impedance signal The Impedance signal status lights are dependent on the ratio of acceptable beats to total beats during the previous forty 40 beat interval 1 red LED or amber depending on your model less than 6 of the last 40 beats were acceptable 1 green LED between 6 and 15 of the last 40 beats were acceptable 2 green LEDs between 16 and 25 of the last 40 beats were acceptable 3 green LEDs between 26 and 35 of the last 40 beats were acceptable BioZ Operator
55. e patient Monitoring Screen in the appropriate screen configuration set by the User during that particular patient monitoring session 3 Press the Next Screen or Previous Screen hardkeys to scroll through the patient monitoring screens 4 Press the Next Data Set or Previous Data Set softkeys to access other recorded data sets for the selected patient 5 Press the Exit softkey three 3 times to return to the patient Monitoring Screen 88 BioZ Operator s Manual DETAILED DESCRIPTION 8 3 Printing Information The BioZ provides the User with the ability to print pre formatted reports Printing functions are available to the User while both conducting a live or demo patient monitoring session and from the Record Review function The BioZ is compatible with Printers utilizing the Hewlett Packard PCL3 and more recent communication protocol Ensure that a printer connection has been established through the printer port located on the rear panel of the BioZ prior to pressing the Print hardkey Caution When monitoring patients with indwelling catheters the printer must be used with a Hospital Medical grade power supply Should you have questions or require clarification please contact CardioDynamics Technical Service for more information 8 3 1 Print Screen Report The Print Screen Report Appendix B PRINT SCREEN REPORT consists of the following e Patient Demographics e Fa
56. ead all the information in this manual 1 2 3 10 11 12 13 Cleanse the sensor sites and apply the sensors Connect Patient cable to the BioZ and to the patient sensors If automatic blood pressure detection is desired connect the blood pressure cuff to the BioZ if the model is equipped with this feature and to the patient Connect the printer cable between the printer and the BioZ Connect the power cord to the printer and turn on the printer Turn the Power switch on the back panel to On Ensure that the power cord is connected to either a 11OVAC or 220VAC power source Press the Start Monitor softkey Enter the patient information press Enter or the 4 directional arrow softkey after each entry Select the method of Blood Pressure determination i e BioZ com Cuff or Manual Entry Press the Start Monitor softkey after all entries are complete The BioZ displays the Monitoring screen If necessary press the Change ECG Vector softkey to obtain optimal ECG signal After 30 acceptable heartbeats depending on the Data Averaging frequency the BioZ displays the first data set Press either the Next Screen or Previous Screen hardkeys to scroll through the various patient clinical data monitoring screens When finished monitoring press the Stop Monitoring hardkey to end the session BioZ Operator s Manual 17 CardioDynamics Internatio
57. ed moment in time and can be configured to display the user s desired parameters The Complete and Custom status reports include the following e Facility information e Patient demographics 90 BioZ Operator s Manual DETAILED DESCRIPTION e Bar graphs of the 18 Hemodynamic Parameters as per User Configuration and their normal ranges e The two waveforms displayed by the Waveform Screen Live Mode only To print the Hemodynamic Status Report perform the following steps e Press the Print hardkey while currently monitoring a patient or select a previously recorded patient record see section 8 2 and then press the Print hardkey e Press the Status Report softkey Select either the Complete or the Custom softkey If the User is monitoring in Live Mode the Hemodynamic Status Report will print Note Custom status reports must be configured prior to pressing the Print hardkey See section 8 1 1 9 for details The ability to configure a Custom Status Report is not available on all models and software versions e To print the report in Review Records mode use the 1 and or softkeys to select the record and press the Enter hardkey to print the Hemodynamic Status Report Note Hemodynamic Status Reports printed in Review Records Mode will not have waveforms BioZ Operator s Manual 91 CardioDynamics International Corporation 92 BioZ Operator s Manual
58. ed on the rear panel and turn the printer on 2 Connect the keyboard to the Keyboard connector located on the rear panel Note It is necessary to perform the above steps prior to performing step 3 3 Connect the power cord to the rear panel of the BioZ and plug into either a 110VAC or 220VAC power source Turn the Power Switch to the On position The following screen will be displayed after the boot up sequence is complete CardioDynamics THE IC G COMPANY Ic S MONITOR 800 778 4825 858 535 0202 WWW Cardiodunanics con Software Wersion 3 3 1 Serial Output Version COIC 2002 All Rights Reserved START TAKE REWIELM SYSTEM SYSTEM MONITOR BP ONLY RECORDS MENUS DEMO Figure 2 Welcome Screen BioZ Operator s Manual 19 CardioDynamics International Corporation 4 Press the System Demo softkey The following screen is displayed DatecMH DD YY YYA 06711 2000 Times 15 25 Patient ID Patient Names Gender Required Height Required Height Required BSF Age Required BP Manual Entry CUP CDefaulti 6 PAQP Defaults 10 Start Monitoring NEH FILE Press 4 or ENTER to accept Use Eeypad Eeybosrd to input ID DEMO MODE Stored Exit Pr Into Figure 3 Patient Data Entry Screen Note When monitoring a patient for the first time the User would press Start Monitor not System Demo and the above screen would be displayed The only differe
59. een Demo Mode cssccsssccssssccssssccsssscesssssssssessescssssssssssscsssessessessessessesss J2 Therapeutic Screen Demo Mode cssssccssssccsssscsssssscssscssssscssssscssssssssssssseesssssesssses IZ Trend Screen Demo Mode ccccssescsoseees Waveform Screen Demo Mod e ccccccccssssssscssccscsccssssssssscscccccccssscssssscscccccsssssssesses DO Print Option Screen Demo Mode Re Configured omocommsss S Welcome SECC OD Impedance Cardiography Sensor Placement Diagram sccssssccssssscsssssssssssssssees IO Independent Blood Pressure Screen ccsssccssssscssssccssssccssssscsssscsssssscssssscssssscssssssssssces OD Blood Pressure Measurement Results Screen JD Patient Data Entry Screen anciana dies arica Patient Data Entry Sereno iS Na FL Text Entry Sres conse snucsvandnacsnasdovansoednaseveceseateasdviaestesemavncawaieecesnes A L Patient Data Entry Screen Patient Data Entry Screen ssessseessececsececoceccoccosoesooossocccosecooesosoesosossocecossesoesoscesssesssseesse FD Patient Data Entry AAA F Patient Data Entry Screen ssesssecesocessocesooessoessoccssocesocesoosssoessocessocesoossoosessessseessocssossssse 44 Patient Data Entry Screen esssesssesssocessocesooee O ae Manual Blood Pressure Entry Screen aia Blood Pressure Out of Range Scre N ocmomomcsso 4 Patient Data Entry Screen sscssssasivecesesstsnsesvesssecensovesassvcecssesnasesuvesse
60. er for accomplishing the many functions provided by the BioZ A Welcome screen is the first screen displayed after system start up Figure 2 From the Welcome Screen the User may e Begin a patient monitoring session e Take an independent Blood Pressure measurement optional feature not available on all models e Run the Demonstration Program e Access menus for various system configuration settings e Review patient records When monitoring a patient the BioZ provides five 5 basic screens for presenting the various hemodynamic parameters in a graphical trending and or data format These screens are referred to as the Monitoring Screen Diagnostic Screen Therapeutic Screen Trend Screen and Waveform Screen Each of these five screens is able to have its parameters and or display configurations customized by the User To ensure accuracy and stability in the display of the parameters provided by the BioZ the data is averaged over a 30 heartbeat interval The data is then updated i e recalculated and displayed every 10 heartbeats Therefore the displayed values are based on data from the 10 most recent beats plus the last 20 beats of the previous data update Note The 30 beat Data Averaging frequency and 10 beat Display Update frequency are the default settings The User may set the Data Averaging and Display Update Frequency from between one and 60 beats to meet their specific needs see section 8 1 1 3 Prior to monitoring
61. ered correctly the following screen will be displayed otherwise you will be prompted to re enter the correct password Bioz com Screen Configuration Menu Choose Screen To Configure DEMO MODE MONITOR OLAGNOSTIC WAVEFORM TREND EXIT Figure 15 BioZ com Screen Configuration Menu Screen The BioZ allows the User to customize the screen configuration s to their requirements For this tutorial only the Monitoring Screen will be customized The User should refer to section 8 1 2 to customize the configuration of the other patient monitoring screens 5 Press the Monitor softkey The following screen will be displayed Choose Cell To Configure DATA DATA MORE CELL 2 CELL 3 gt Figure 16 Monitoring Screen Configuration 1 The User has the ability to choose the hemodynamic parameters that are displayed and the data graphic cell in which they will be displayed In this tutorial Data Cells 4 and 5 will be deactivated When both of these cells are deactivated both Graphic Cells will elongate and fill the vacated screen area 28 BioZ Operator s Manual BIOZ TUTORIAL 6 Press the More softkey The following screen will be displayed CO Lemin SVR dyn sec BP Data Cell 3 Data Cell 1 Data Cell 2 TFC Data Cell 4 Choose Cell To Configure z ACI 100 sec Data Cell 5 DEMO MODE Figure 17 Monitoring Screen 7 Pre
62. ery 10 acceptable beats that the device detects e Date and Format The Date and Format can be selected as either MM DD YYYY or DD MM Y Y YY The User must enter in two digit values for the month and the day and four digit values for the year e Time The Time must be entered in 24 hour format e Decimal Character The Decimal Character can be configured as a period or a comma e Auto BP Update The Auto BP Update determines the frequency at which the device will automatically take a new blood pressure measurement This may be configured between and 99 minutes 3 To accept the factory default setting for a particular field and move to another field press the J softkey or the Enter hardkey to highlight the desired field 4 To change the default setting of a field that contains a numerical value i e the CVP PAOP Data Averaging Automatic Data Save Display Update and Time perform the following e Select the desired field e Press the Clear hardkey e Press the appropriate numerical hardkeys to enter the desired value e Press either the J softkey or Enter hardkey to accept the entry and advance to the next field Note If a default value is cleared and the J softkey or Enter hardkeys are pressed prior to entering a value in the field the default value will be restored and the highlight bar advanced to the next field 5 To change the unit of entry display for the Height and or
63. esired label using the keyboard or the Text Entry screen on the BioZ Each Event label is restricted to 50 characters 72 BioZ Operator s Manual DETAILED DESCRIPTION 4 Press lt Enter gt from the external keyboard or the Enter hardkey on the BioZ front panel to accept the label 5 From the Events List press the Exit softkey when finished adding event labels 8 1 1 5 Change Password The BioZ requires a four 4 digit numerical password in order to customize the System default settings configurations and or screen configurations The default password is 1111 The User is advised to set his or her own personal password Note If you forget your password contact the Technical Service Department at 800 778 4825 Option 3 USA or 858 535 0202 outside USA Option 3 Press the Menu hardkey to access the BioZ com System Set Up Menus Screen press the More gt softkey and perform the following 1 To set the password press the Change Password key The following screen will be displayed Enter Password Use keypad to enter password Figure 68 Password Entry Screen 2 Key in the factory default password 1111 or the current password After the fourth number has been entered the following screen will be displayed BioZ Operator s Manual 73 CardioDynamics International Corporation Enter new password Use keypad to enter password Figure 69 New Pas
64. eturn to the BioZ com System Set Up Menus Screen BioZ Operator s Manual 69 CardioDynamics International Corporation 8 1 1 3 System Defaults In order for the BioZ to begin a patient monitoring session certain information regarding the patient is required This information is entered at the Patient Data Entry Screen The BioZ provides the User with the ability to define the default values and or format units of the necessary data entry fields 1 To change the default settings for the Patient Data Entry Screen press the System Defaults softkey Figure 57 The following screen will be displayed System Defaults 1 6 2 PAOP 10 3 Weight Units lbs 4 Height Units ftvin 5 Data Averaging 30 beats 6 Automatic Data Save 1 minute 7 Display Update 10 beats 8 Date and Format M D v 03 06 2000 9 Time 10 41 10 Decimal Character a 11 Auto BP Update 5 minutes Exit System Default Menu Press Y f or ENTER to accept Use keypad vkeyboard to enter new value Figure 65 System Default Menu Screen The above screen displays the default settings for the values and or format units of the patient data fields 2 System Default Entries 70 CVP Central Venous Pressure is used in calculating the Systemic Vascular Resistance and its index SVR and SVRI respectively PAOP Pulmonary Artery Occlusion Pressure is used in calculating the Left Cardiac Work and its index LCW and LCWI respective
65. ey cycles the User through the five screens in the following order Monitoring Screen Diagnostic Screen Therapeutic Screen Trend Screen and Waveform Screen The order then repeats The Next Screen hardkey can also be used for scrolling through lists of patient records and lists of data records within a patient file Keyboard equivalent Simultaneously pressing the lt Ctrl gt and N keys 4 2 2 3 Previous Screen The Previous Screen hardkey is active only when one of the five 5 patient monitoring screens are being displayed Pressing the Previous Screen hardkey cycles the User through the five patient clinical data monitoring screens in the opposite order of the Next Screen hardkey The Previous Screen hardkey can also be used for scrolling through lists of patient records and lists of data records within a patient file Keyboard equivalent Simultaneously pressing the lt Ctrl gt and P keys 4 2 2 4 Event The Event hardkey is active while monitoring in both live and demo modes Pressing the Event hardkey performs the function of attaching a User defined text string to the patient record for use in patient summary and trend reports see Section 8 3 There is a green LED indicator next to the Event hardkey that is energized while the BioZ is storing the record Keyboard equivalent Simultaneously pressing the lt Ctrl gt and E keys 4 2 2 5 Digits 0 9 The 0 9 digit hardkeys are used in
66. fault 10 Start Monitoring NEH FILE Use keypad ekeyboard to input CUP Press t or ENTER to accept Tf no CUP is entered default is used Figure 42 Patient Data Entry Screen e Use either the numerical hardkeys on the BioZ face or the external keyboard to enter the current value or press the Enter or the Y key to accept the default value The highlight bar will be advanced to the PAOP field Note If an incorrect entry is made press the Clear hardkey and re enter the correct value 7 2 4 11 Pulmonary Artery Occluded Wedge Pressure The BioZ allows the User to enter the patient s actual PAOP If this value is not known the BioZ has a default setting of 10mmHg see section 8 1 1 3 to change the default setting DatecMH DD YYY D6 12 2000 Time Od 32 Patient ID 112233555 Patient Name DOE JOHN Gender Male Height 6 ft Qin Height 165 lbs BSA 2 06 Age 40 BP Manual Entry CUP Def aulta 6 EME Start Monitoring lt NEW FILE Use keypad keyboard to input PAOP Press A f oor ENTER to accept It no PAOP is entered default is used Figure 43 Patient Data Entry Screen e Use either the numerical hardkeys on the BioZ face or the external keyboard to enter the current value or press the Enter or the J key to accept the default value The User will be prompted to Start Monitoring 48 BioZ Operator s Manual LIVE PATIENT MONITO
67. fault Lower Upper USE CI RANGES ea al e zme f e or as E a E ae Use 4 to select parameter Press ENTER to customize ranges Figure 63 Normal Range Menu Screen 1 68 BioZ Operator s Manual DETAILED DESCRIPTION 4 To select the desired parameter press the T softkeys or the appropriate numerical hardkeys To select additional parameters press the More gt softkey After the desired parameter has been highlighted press the Enter hardkey The Softkey selection at the bottom of the screen will be replaced with the following Male Normal Range Status Default Lower Upper USE CI RANGES 3 USE SI RANGES 1378 6 SURI 1337 2483 5 3 MAP a w 3 TFC s Select and modify Lower or Upper Range 5 SUR 742 Use keypadzkeyboard to enter new value RANGE DECIMAL Figure 64 Normal Range Menu Screen 2 5 Press the Upper Range and or Lower Range softkeys to place the cursor in the respective cell Use the numerical hardkeys and the Decimal softkey to enter the desired value Press the Enter hardkey If the Lower Range value is less than the Upper Range value then the Softkey selection at the bottom of the screen will be returned to that of Figure 63 If this condition is not met then the cursor will return to the Lower Range cell and the correct value should be re entered 6 Press the Exit softkey twice to r
68. gonal lines indicates Vasodilation Hurst JW ed The Heart 5 ed New York McGraw Hill 1982 93 54 BioZ Operator s Manual LIVE PATIENT MONITORING The Therapeutic screen is accessed by pressing the Next Screen hardkey from the patient Diagnostic Screen Figure 49 or the Previous Screen hardkey from the patient Trend Screen Figure 51 THERAPEUTIC SCREEN Figure 50 Therapeutic Screen Live Mode The patient s status in relation to SI and MAP is displayed as a circle This circle moves as the patient s hemodynamic status changes The underlying hemodynamic conditions that affect the SI and MAP the location of the circle i e the patient s status are pre load contractility and after load vasoactivity There are multiple possible combinations of these conditions depending on the patient s underlying variables There are nine classifications of hemodynamic status Table 1 Hemodynamic Status Classifications Tension Status Dynamic Status Hypertensive Hyperdynamic Normodynamic Hypodynamic Normotensive Hyperdynamic Normodynamic Hypodynamic Hypotensive Hyperdynamic Normodynamic Hypodynamic BioZ Operator s Manual 55 CardioDynamics International Corporation 7 2 5 4 Patient Trend Screen The patient Trend Screen provides the User with the ability to view trending plots for up to two of the hemodynamic parameters provided by the BioZ see section 8 1 2 3 for se
69. he monitoring session 8 2 3 Review or Delete Patient Records To review a patient record press the Review Records softkey from the Welcome Screen BioZ Operator s Manual 85 CardioDynamics International Corporation 11 45 JOHN Q DO 112233445 DOE JOHN 0370672000 15 13 123456788 Demo Patient 0370672000 13 40 TEST 02 22 2000 14 54 02 22 2000 12 58 Demo Patient O2 22 2000 12 47 Demo Patient O2 22 2000 10 57 Demo Patient O2 22 2000 10 49 a Demo Patient 02 13 2000 18 59 iii Demo Patient 01 18 2000 23 02 Use AA to select patient session Figure 85 Patient Record Review Screen 1 Note The above screen is for informational purposes only and does not represent the actual Patient files stored in the BioZ 1 Press the Y and or 1 softkeys accordingly to highlight the desired patient record and press the Enter hardkey If there are more than 10 patient files the User may press the Next Screen or Previous Screen hardkeys to scroll down or up to the rest of the patient files The following screen will be displayed 112233445 DOE JOHN Os 06 2000 15 45 Select review function WIEH DELETE PATIENT BACK RECORD FILE DATA Figure 86 Patient Record Review Screen 2 86 BioZ Operator s Manual DETAILED DESCRIPTION From the above screen the User has the ability to view the patient record delete the file and or view patient data Press the View Record
70. ic Screen Demo Mode The Diagnostic screen will display up to four 4 of the available parameters at a time The User may customize the Diagnostic Screen to display the parameters of their choice see section 8 1 2 For an explanation of the Diagnostic Screen see section 7 2 5 2 14 Press the Next Screen hardkey The following screen will be displayed THERAPEUTIC SCREEN 13 33 DEMO MODE Figure 24 Therapeutic Screen Demo Mode For an explanation of the Therapeutic Screen see section 7 2 5 3 32 BioZ Operator s Manual BIOZ TUTORIAL 15 Press the Next Screen hardkey The following screen will be displayed co 2 9 13 34 SUR 1792 O 1696 MPa Mitte de de tt t 1378 hel eA ole SU heh Nica dia E O a 3 tl a 2 5 424 13 19 13 28 13 34 13 41 13 43 TREND SCREEN DEMO MODE CHANGE 20 MINUTE ONE HOUR EXPAND FULL DATA TRENDS SCALE SCALE DATA SCALE Figure 25 Trend Screen Demo Mode The X axis is auto scaled to display collected data The minimum initial length is 30 minutes The maximum display interval is 12 hours unless the User is in the Expanded Mode The User has the ability to look at expanded segments of the monitoring session by choosing the appropriate softkeys The User may also customize the parameters displayed on the Trend Screen by selecting the Change Trends softkey For an explanation of the Trend Screen see section 7 2 5 4 16 Press the Nex
71. ickel Metal Hydride battery Optional noninvasive Automatic with emergency deflate key integrated blood pressure External Input Fuse 2 0 Amp Slo Blow 250 V PO Environmental Storage Temperature and Humidity Specifications Range 0 C to 50 C 0 to 95 RH Automatic over pressure protection Operating Temperature and Humidity Range 10 C to 40 C 10 to 95 RH BioZ Operator s Manual 97 CardioDynamics International Corporation 98 BioZ Operator s Manual MAINTENANCE 11 MAINTENANCE Refer to the BioZ Service Manual BZ 4542 for detailed maintenance instructions The BioZ is a self calibrating device and as such no internal adjustment of electrical components is required To check the internal calibration the User may attach the BioZ sim BZ 4575 patient simulator to verify the correct parameter specifications It is not possible for any internal testing to be performed on the BioZ 11 1 Cleaning It is recommended that the device and patient cable be periodically disinfected This may be accomplished by wiping with a soft cloth dampened with a standard hospital disinfectant Note Take appropriate precautions to ensure that no liquid or aerosol enters the internal portion of the BioZ 11 2 Patient Cable The Patient Cable should be checked to ensure continuity of each connector every six 6 months or when there is doubt about the validity of the hemodynamic values BioZ Operator s Manu
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73. inting a green LED is on when the BioZ is communicating with a printer the User returns to the screen of entry A message is displayed informing the User of a connection problem if the printer does not respond Keyboard equivalent Simultaneously pressing the lt Ctrl gt and L keys 4 2 2 10 Alarm ON OFF LEX Pressing the Alarm ON OFF hardkey will enable and disable the BioZ alarm system An LED next to the hardkey will indicate green when the alarm system is enabled The LED will automatically indicate red or amber depending on the model if the User disables the system stops patient monitoring or enters a message screen where the alarm system is not active The alarm system will be enabled and the LED indicate green when monitoring is resumed Keyboard equivalent Simultaneously pressing the lt Ctrl gt and B keys 4 2 2 11 Reset Alarm The Reset Alarm hardkey is active only on patient monitoring screens when an alarm condition has been met Pressing the Reset Alarm hardkey will silence the audible alarm for the amount of time established by the Time Delay default if the alarm s audible feature is enabled see section 8 1 1 1 The Reset Alarm function will not deactivate the visual alarm indicator otherwise the User might forget which parameter triggered the alarm system Keyboard equivalent Simultaneously pressing the lt Ctrl gt and R keys BioZ Operator s Manual a bi ee CardioDynamics In
74. isana aoso esias Essais 7 dal General System VEL VIEW cscs A Add 7 4 2 User Interface Symbol Key viii drid 8 AIN O A a noni 8 42 2 Hardkey e O UI a Ne a it A 8 4 2 3 LED Indicators uiiinginasacnnca da nes ESEE ae 12 42A External COMES A tios 14 QUICKSTART INSTRUCTIONS sisiccassoussenssesscesivsseasneunconiovcsssadesssoseauncchonsdedssexsonasnoadensenarseiiaes 17 6 BIOZ TUTORIAL secs od suk exes cxeucnnnasaboues tence tedsconsasnsabeaaannconcuosreneetesssensnbnsenus tonne shacsssenebeosstonesenseoeee 19 Gal SAP o ld d daca anaes E a a 19 6 2 P t ent Data Bmir yas 28 ccstte tats pent a CaM areiendeccsasa esate 20 63 Patient Monitorime Demo Mode it ita 23 A I N 34 6 5 Reviewing Patient Record its 35 6 6 Exiting a Monitoring Session is oscc ces ceceissecsnatacayddecssdecansveajsccessndea adela extacdaaeasuataats lesccauastesdaavaesd 35 T LIVE PATIENT MONITORING j ccscavecesicucesusnssstasueteesaconcusessoyenehsaseguatedds sosbacencetksopnevebssstsebecs 37 Tel Patient Preparation secor io ee a R E AE EAE Ea EE EEES 37 TEL CNS CIS COIS sch ena a ae EA Sra E ad at A aP AANS 37 T2 Skin PACA ON 2a A i en ge ne E A AA 37 TZ Patient MOnitoring serios easeeaea tossed apenas paa 39 7 2 1 Blood Pressure without Starting ICG Monitoring Session ccocccoocnnonnnooncnoncnanncnnn ccoo ncnonennnos 39 P22 ICG Monitoring Session vice ote eee Beatie Ai ln iat ee aa 40 Wize ds PRS OTIC Sire cane ccs O 40 7 24 Patient Data Entry Pili i
75. l Bioimpedance for thoracic measurements producing a measurement of global blood flow CO CI SV SI Thoracic Fluid Content TFC base impedance and the parameters of left ventricular performance VI and ACI Velocity Index Acceleration Index THORACIC FLUID CONTENT TFC kOhm The total conductivity of the thorax representing parallel conductivity contributions of three compartments intravascular intra alveolar and interstitial The normal ranges are 30 50 for males and 21 37 for females Excessive TFC value indicates an excess in thoracic fluids however it does not specify if the fluids are in the intravascular intra alveolar or interstitial compartment s TFC 1000 Zo THORACIC FLUID INDEX TFI Ohm See BASE IMPEDANCE VASOACTIVITY Vasoactivity is a change in vessel diameter controlling vascular resistance of the vessel s blood flow rate VELOCITY INDEX VI 1000 sec Is a measurement of normalized peak aortic flow VI is a preload volume dependent measure of contractility The normal range for supine resting adults is 33 65 x 1000 sec VI 1000 dZ dt Zo VI See VELOCITY INDEX WEDGE PRESSURE A term that is often used simultaneously although incorrectly for Pulmonary Artery Occluded Pressure PAOP This term dates back to times before the introduction of the occlusive balloon At that time the catheter was actually wedged into a small pulmonary artery in order to measu
76. ld follow the instructions displayed on the screen and ensure that e The sensors are in the correct positions e There is good contact between the patient s skin and the sensors e The patient cable is attached to the sensors in the proper location s e The patient cable is connected to the BioZ BioZ Operator s Manual 93 CardioDynamics International Corporation If the above steps don t eliminate the error replace the sensors and resume monitoring the patient Should the error condition persist contact CDIC s Technical Service department at 800 778 4825 USA or 858 535 0202 Option 3 9 2 Low Battery If your BioZ is equipped with an optional battery the following screen will be displayed when the battery is less than 20 percent of full capacity HARNING BATTERY LOH PLUG BioZ com INTO HALL OUTLET OR RISK LOSING ALL DATA PRESS TO CONTINUE Figure 90 Low battery Warning Screen Note The Battery will re charge automatically each time AC power is applied to the device whether or not the power switch is turned on There are no special instructions that must be adhered to in order to safely operate and or charge the battery The Press to Continue softkey returns the User to the screen of entry This warning screen will be displayed every 60 seconds or until AC power is restored If the above error screen is displayed plug the BioZ into the proper AC power source as soon as possible 9 3 P
77. le Height 5S ft 6 in Weight 119 lbs BSA 1 60 Age 24 BP Manual Entry CUP Defaulto 6 PAOP Default gt 10 DEMO MODE Start Monitor Figure 11 Patient Data Entry Screen Press the Start Monitor softkey to begin monitoring 6 3 Patient Monitoring Demo Mode When monitoring a patient the BioZ provides five 5 basic screens for presenting the various hemodynamic parameters e Monitoring Screen e Diagnostic Screen e Therapeutic Screen BioZ Operator s Manual 252 CardioDynamics International Corporation e Trend Screen e Waveform Screen Each of these five screens is able to have its parameters and or display configurations customized by the User The tutorial will demonstrate how to accomplish these changes 1 Press the Start Monitor softkey to begin the monitoring session The following screen will be displayed Note If either the height weight or age were out of the recommended range or omitted an error message will be displayed prompting the User to enter or re enter the correct values or Proceed with the monitoring session with the out of range values If the User chooses to proceed the calculated SV SI CO CI SVR SVRI LCW and LCWI may not be an accurate indication of the patient s actual values Figure 12 Monitoring Screen Demo Mode Note Your screen configuration may vary depending on previous configuration settings The actual values will not appear until the a
78. lecting the trending parameters The Trend Screen provides the User with a graphical representation of the various hemodynamic parameters over time thereby allowing the User to quickly evaluate the effectiveness of any treatment and or therapy given to the patient The Trend Screen is accessed by either pressing the Next Screen hardkey from the patient Therapeutic Screen Figure 50 or the Previous Screen hardkey from the patient Waveform Screen Figure 54 co 6 3 15 27 SUR 1033 10 5 1636 SOE Ahh Md do He de ade A a a St 1378 e sa 2 5 424 15 17 15 24 15 32 15 39 15 47 TREND SCREEN HR g0 CHANGE 30 MINUTE ONE HOUR EXPAND FULL DATA TRENDS SCALE SCALE DATA SCALE Figure 51 Trend Screen Live Mode During a monitoring session the Trend Screen is auto scaled along the x axis to provide a display of up to 12 hours of the most recent recorded patient data collected within the current monitoring session the initial scale is set at 30 minutes Softkeys at the bottom of the screen provide the User with the ability to select isolate and expand desired timeframes of the monitoring session for a more detailed view Note The Trend Screen plots and updates based on the data that has been saved in the Patient s file The Trend Screen does NOT plot each screen update For example if the Auto Data Save Interval is set at 15 minutes and the Display Update is set at 10 beats the Trend screen will not plot
79. lects the Custom Start End softkey the User will be directed to use the J and or T softkeys to select the Start of Report and then the End of Report The User then presses the Enter hardkey and the Hemodynamic Summary Report will be printed 8 3 3 Hemodynamic Trend Report The Hemodynamic Trend Report Appendix D HEMODYNAMIC TREND REPORT graphically displays trending data for the five parameters displayed on the patient Monitoring Screen and includes the following information e Facility information e Patient demographics e Event labels e Percent of recorded data sets within the normal range To print the Hemodynamic Trend Report perform the following steps e Either press the Print hardkey while currently monitoring a patient or select a previously recorded patient record see section 8 2 and then press the Print hardkey e Press the Trend Report softkey Select the duration of the report from the available options Last hours Last 12 hours or Last 24 hours or select Custom Start End If the User selects the Custom Start End softkey the User will be directed to use the Y and or T softkeys to select the Start of Report and then the End of Report The User then presses the Enter hardkey to print the Hemodynamic Trend Report 8 3 4 Hemodynamic Status Report The Hemodynamic Status Report Appendix E HEMODYNAMIC STATUS REPORT consists of the patient s 18 hemodynamic parameters for a specifi
80. load It is calculated by substituting SI for CI in the SVRI equation MAP CVP SD x 80 The normal range for SSRI based on the ideal hemodynamic state where SI 50 ml m MAP 92 mmHG CVP 6 mmHg is 110 165 STROKE VOLUME SV ml The volume of blood delivered by the heart into the vasculature in one beat SV See STROKE VOLUME SVR See SYSTEMIC VASCULAR RESISTANCE SVRI See SYSTEMIC VASCULAR RESISTANCE INDEX SYSTEMIC VASCULAR RESISTANCE SVR dyne sec cm The vascular resistance of the systemic vasculature as seen by the left ventricle afterload Normal range for a supine resting adult is 770 1500 dyne sec cm SVR 80 MAP CVP CO SYSTEMIC VASCULAR RESISTANCE INDEX SVRD dyne sec cm m SVRI represents the primary component of afterload The normal range of SVRI for a supine resting adult is 1337 to 2483 dyne sec cm m SVRI 80 MAP CVP CI SYSTOLIC BLOOD PRESSURE SBP mmHg The highest level of arterial blood pressure reached with each heart beat SYSTOLIC TIME RATIO STR Calculated by the systolic time intervals STI of PRE EJECTION PERIOD PEP and LEFT VENTRICULAR EJECTION TIME LVET STR PEP LVET BioZ Operator s Manual 107 CardioDynamics International Corporation TEB See THORACIC ELECTRICAL BIOIMPEDANCE TFC See THORACIC FLUID CONTENT TFI See THORACIC FLUID INDEX THORACIC ELECTRICAL BIOIMPEDANCE TEB The special utilization of Electrica
81. lusive license granted hereunder Licensee shall acquire no right title or interest in the Licensed Program Acceptance by Licensee of any Licensed Program or User documentation from Licensor shall by deemed conclusive evidence of Licensee s agreement that the license for those Licensed Programs and User documentation is governed by this agreement TERMS AND TERMINATION A This software license agreement and the license hereby granted to Licensee shall remain in full force and effect for a period of fifteen 15 years unless terminated earlier in accordance with this clause B Licensor may terminate this software license agreement effective immediately or as of the date specified by giving written notice of termination upon 1 any breach by Licensee of this software license agreement if Licensor has given Licensee written notice of such breach and request that Licensee promptly cure such breach and Licensee has failed to cure such breach within thirty 30 days after receipt of Licensor s written notice of breach C Within ten 10 business days after the effective date of termination of this software license agreement Licensee shall return to Licensor all Licensed Program and User documentation without asserting any right of detention it being understood that Licensee hereby expressly waives any such right D Upon termination of this software licensee agreement for any reason whatsoever Licensor shall have no further obligation to Li
82. ly Weight Units Pounds lbs or Kilograms kgs The User may configure their device to accept weight values in either the standard or metric systems Height Units Feet and Inches ft and in or Centimeters cm The User may configure their device to accept weight values in either the standard or metric systems Data Averaging The data averaging determines the number of acceptable beats that are used to calculate the patient s hemodynamic values displayed on the screen This value may be set between 1 and 60 beats Automatic Data Save The Automatic Data Save determines the frequency at which the hemodynamic values displayed on the screen are saved to the patient s file This value may be set to a value between 1 second and 999 minutes or can be set to the display update frequency For example if the Automatic Data Save is set to 5 minutes a data set will be saved to the patient s file every 5 minutes If it is set to the display update frequency a new data set will be BioZ Operator s Manual DETAILED DESCRIPTION saved to the patient s file every time the display updates every 1 to 99 beats depending on Display Update configuration e Display Update The Display Update determines the frequency at which the hemodynamic values are refreshed updated on the screen The Display Update may be configured between 1 and 99 beats For example if the Display Update is set to 10 beats the screen will be refreshed ev
83. ly low value for a specific condition HYPOTENSION A state where the mean arterial pressure is lower than 84 mmHg supine resting adults INOTROPY Myocardial contractility or the force of contraction Normoinotropy is an adequate normal inotropic state hypoinotropy is an inadequate infranormal inotropic state corrected therapeutically through the use of positive inotropic therapy support hyperinotropy is an excessive supranormal level of inotropic state corrected therapeutically through the use of negative inotropic therapy LCW See LEFT CARDIAC WORK LCWI See LEFT CARDIAC WORK INDEX LEFT CARDIAC WORK LCW kg m The measure of work which the left ventricle must expend to pump blood it is a product of the ventricular pressure contribution MAP PAOP CO and a constant unit conversion factor LCW is proportional to the myocardial oxygen consumption The normal range for supine resting adults is 5 4 10 0 kg m LCW MAP PAOP CO 0 0144 LEFT CARDIAC WORK INDEX LCW kg m m A value of LEFT CARDIAC WORK LCW indexed by the BODY SURFACE AREA BSA LCWI is a product of the ventricular pressure contribution MAP PAOP CI and a constant The normal range for supine resting adults 3 0 5 5 kg m m LCWI MAP PAOP CI 0 0144 LEFT STROKE WORK INDEX LSWI g m m The measure of work which the left ventricle must expend to pump blood per heart beat it is a product of the ventricular pres
84. mination 1 Pressing the Take New BP softkey will trigger the optional BioZ com blood pressure measuring cuff to inflate deflate so as to obtain the blood pressure if the BioZ is equipped with this option 2 If the source of blood pressure readings is by manual entry pressing the Take New BP softkey will display the following pop up menu Systolic Diastolic Values 115 80 Calculated Mean rterial Pressure 32_ Use keypadvkeyboard to input BP Press ENTER to accept MAP value must be between 30 220 mmHg SYSTOLIC DIASTOLIC AA A BACK Figure 47 Manual Blood Pressure Entry Screen Live Mode e Press the Systolic Diastolic softkeys to place the cursor in the desired field e Press the Clear hardkey to clear the current entry e Use the numerical hardkeys to enter the correct blood pressure e Press the Enter hardkey to accept the entry and return to the screen of entry 52 BioZ Operator s Manual LIVE PATIENT MONITORING Note If the calculated MAP is out of range the User will receive the following message THE ENTERED VALUE 13 OUT OF THE RECOMMENDED RANGE DATA ACCURACY MAY BE COMPROMISED CHANGE PROCEED ENTRY Figure 48 Data Out of Range Screen e Select either the Change Entry softkey to re enter the correct value or the Proceed softkey to return to the Monitoring Screen To advance to another patient monitoring s
85. munication language protocol Note The Printer should be connected and turned on prior to turning on the BioZ Caution When monitoring patients with indwelling catheters the printer must be used with a Hospital Medical grade power supply Should you have questions or require clarification please contact CardioDynamics Technical Service for more information 2 Turn on the BioZ and initiate a monitoring session as usual 3 When ready to print press the Print hardkey The following screen will be displayed ECG Vector 2 Impedance 30 Beat Average SSA DEMO MODE STATUS TREND SUMMARY EXIT REPORT REPORT REPORT Figure 27 Print Option Screen Demo Mode Re Configured PRINT SCREEN Note When the Print hardkey is pressed the current screen display will not change only the soft keys at the bottom of the screen will change 34 BioZ Operator s Manual BIOZ TUTORIAL The User may print any of the available pre formatted reports See section 8 2 for a detailed description on the types of reports available 4 Press the appropriate softkey to print the desired report The green Print LED will remain illuminated until the report has been transmitted to the printer 6 5 Reviewing Patient Records The BioZ provides the User with access to patient records at all times From the Welcome Screen the User may review patient records by pressing the Review Records softkey 6 6 Exiting a Monit
86. n If the value entered is out of the required range i e less than 4 ft 0 in or greater than 7 ft 6 in the User will be prompted to either accept or proceed prior to beginning the session Note If Proceed is selected the monitoring session can still proceed but data accuracy may be compromised If the value for the patient s height is within range the cursor will automatically advance to the Weight field The following screen will be displayed DatecMAHADDA YYYY Time Patient 10 Patient Mame Gender Height Height Age BP CUP CDefault PAOP Default 06 11 2000 13 34 223344556 Demo Patient Female 5 ft Gin Required Manual Entry 10 Start Monitoring lt NEW FILE Use keypad keybostd to input Weight Press t or ENTER to accept Figure 6 Patient Data Entry Screen Range must be between 67 341 lbs DEMO MODE 5 Press the appropriate numerical keys in order to enter the patient s correct weight in units of lbs or press the kg softkey and enter the correct weight in units of kg Press the Enter or the 4 key the cursor will automatically advance to the Age field The following screen will be displayed Note The Body Surface Area BSA will be calculated and displayed after the weight has been entered Dater AM OA 77 V2 06211 2000 Time 13 34 Patient ID 223344556 Patient Mame Demo Patient Gender Female Height 5 ft amp in Start
87. n properly operated or maintained in accordance with CDIC s then applicable written operating and maintenance manuals e The configuration of the System and or Software has been altered by but not limited to the addition of any other computer software to the System The failure of the System and or Software has resulted from acts of God accident abuse misapplication or negligence Note There are no user serviceable components in the BioZ All units must be returned to CDIC for repair or replacement during the warranty period CDIC does not warrant either expressed or implied the correctness or validity of any output information or data provided by the System including but not limited to any information relating to any medical diagnosis treatment or to the health and safety needs of patients CDIC does not warrant that any output of the System will meet the standards or requirements of the End User s medical practice End User expressly acknowledges that End User is solely responsible for verifying that any results produced by the System are free from error and suitable for the applications for which they are to be used 13 SOFTWARE LICENSE AGREEMENT By this agreement CardioDynamics International Corporation a California Corporation Hereinafter referred to as Licensor in this agreement agrees to grant and the end User hereafter referred to as Licensee in this agreement agrees to accept the following terms and co
88. nal Corporation 18 BioZ Operator s Manual BIOZ TUTORIAL 6 BIOZ TUTORIAL The tutorial presented in this section should provide the User with a good working knowledge of the BioZ It is recommended that the tutorial be completed in the order presented For a detailed description on an individual topic feature the User should refer to the respective section of this manual The Demo Mode allows a User to become familiar with the BioZ without actually having a patient connected to the device A pre programmed waveform is stored in the device in order to represent an actual patient All normal BioZ features are accessible while operating in the demo mode Any configuration changes made while operating in the demo mode will apply to all future actual patient monitoring sessions The tutorial will demonstrate how to change various default settings configurations available on the BioZ By completing the tutorial the User is afforded an ideal opportunity to configure the BioZ to their specific requirements The only differences between live mode and demo mode from a User s perspective are the following Each screen will have Demo Mode flashing in the lower right corner Note If a patient is connected to the instrument while in Demo Mode the hemodynamic parameters and waveforms on the screen and recorded to the patient s file are not those of the actual patient 6 1 Startup 1 Connect the Printer to the Printer Port locat
89. nce is that Demo Mode would not be flashing in the lower right corner 6 2 Patient Data Entry The Patient Data Entry screen allows the User to enter all the patient information required by the BioZ to detect process and display various parameters relating to the patient s cardiac function Except for the Patient ID and Name all the fields displayed on the screen require User specific entries in order to begin a monitoring session 1 In the Patient ID field enter the patient s ID number by pressing the appropriate numerical hardkey s or typing from the keyboard Up to nine 9 digits may be entered Alphabetical characters can not be entered in this field If an incorrect number is entered press the Clear hardkey or the lt Backspace gt key if using a keyboard to re enter the number 20 BioZ Operator s Manual BIOZ TUTORIAL 2 Press the Enter hardkey or the d softkey to advance to the Gender entry field The following screen will be displayed Note When in the demo mode the Patient Name field will have Demo Patient locked in and therefore it will be skipped over after an ID number has been entered However when conducting a live monitoring session on an actual patient the highlight bar will advance to the Patient Name field DatecMH DO YYY 06 11 2000 Time 13 34 Patient ID 225344556 Patient Name Demo Patient Gender Required Height Required Height Required BSA Age Requi
90. ndicator will remain active while the alarm condition exists This feature is necessary so that the parameter that generated the alarm will be identifiable to the User BioZ Operator s Manual 65 CardioDynamics International Corporation 6 Press the Time Delay softkey the following screen will be displayed AFTER AN ALARM RESET KEYPREZZ ENTER THE DELAY TIME BEFORE ALARMS RING AGAIN 01 30 Use keypad keyboard to enter time Press ENTER to accept MINUTES SECONDS BACK EXIT Figure 60 Alarm Reset Time Delay Screen Press the Minutes and Seconds softkeys to place the cursor in the respective field Press the numerical hardkeys to enter in the desired value Press the Enter hardkey to lock in the value and place the cursor in the opposite field If an incorrect value is entered press the Clear hardkey to erase the selected field and re enter the correct value The User can press the Exit softkey to return to the BioZ com System Set Up Menus screen 8 1 1 2 Normal Ranges The BioZ Diagnostic Screen can display up to four of the calculated hemodynamic parameters at one time listed below in a horizontal bar graph format with vertical lines defining the Low Normal and High Ranges for the respective parameters Though these ranges are defined at the factory the User has the ability to specify the upper and lower limits of the Normal Range for each of the following pa
91. nditions described in this agreement including User documentation NON EXCLUSIVE LICENSE LICENSOR HEREBY GRANTS TO LICENSEE A LIMITED PERSONAL NONTRANSFERABLE AND NON EXCLUSIVE LICENSE TO USE THE LICENSED PROGRAM IN OBJECT CODE FORMAT ONLY LICENSEE EXPRESSLY UNDERSTANDS AND AGREES THAT IT WILL NOT 1 LICENSE OR SUBLICENSE TO ANY THIRD PARTY OR OTHERWISE DISTRIBUTE RELEASE SELL RENT OR PUBLISH THE LICENSED PROGRAM OR THE USER DOCUMENTATION II MODIFY ADAPT TRANSLATE REVERSE ENGINEER DECOMPILE OR DISASSEMBLE THE LICENSED PROGRAM LICENSEE EXPRESSLY UNDERSTANDS AND AGREES THAT IT HAS NOT BEEN GRANTED HEREUNDER ANY LICENSE OR RIGHT TO USE OR RECEIVE ANY SOURCE CODE 102 BioZ Operator s Manual SOFTWARE LICENSE AGREEMENT CONFIDENTIAL DISCLOSURE Licensee agrees that the Licensed Program includes trade secrets and proprietary know how belonging to Licensor and is being made available to Licensee in confidence and solely on the basis of a confidential relationship to Licensor Licensee agrees to hold the Licensed Program in trust and agrees not to use print copy provide or otherwise make available in whole or in part any portion of the Licensed Program or modifications thereof or any material related to the Licensed Program except as expressed in this agreement Licensee agrees that it will not reconstruct in whole or in part the code or algorithms contained in the Licensed Programs COPYRIGHTS TRADEMARKS LEGENDS AND LOOS
92. ng steps 1 At the BioZ com Screen Configuration Menu press the Trend softkey The following screen will be displayed CURRENT TREND SELECTION TREND 1 CO TREND 2 SUR TREND 3 ACI TREND 4 TFC Choose Trend To Configure TREND_1 TREND_2 TREND_3 TREND_4 EXIT Figure 81 Trend Screen Cell Configuration Menu Screen The two default settings for the Trend Screen consist of either Trends 1 and 2 or Trends 3 and 4 e Press the appropriate softkey for the desired trend e Use the More softkey along with the Y and or 1 softkeys to select the parameter to assign to the selected trending plot e Press either the Accept softkey or the Enter hardkey to effect the change e Repeat the above three steps to set the other trending plots e Press the Exit softkey to return to the BioZ com Screen Configuration Menu 8 1 2 4 Waveform Screen The Waveform Screen is similar to the Monitoring Screen There are two 2 graphics cells for displaying up to two 2 of the five 5 waveforms provided by the BioZ as well as five 5 data display cells The data display cells are the same as those displayed on the Monitoring Screen The advantage of this screen is that the User can cycle between all five 5 waveforms while the monitoring screen only lets the User view the two default ECG and Impedance waveforms 82 BioZ Operator s Manual DETAILED DESCRIPTION To set the two initial default wa
93. nnnnonnnono 105 Central Venous Pressure CVP cccecsseeeessreeeeeee 105 Charge iii 12 A TEREE AER ea asap ahaa tees 10 Configure Screens oocooncccncconcononnnonononnnnononononnonnnnnonss 27 78 Configure Status Repoftt oononicnnninnnnnnnnnnnncnnnannnancnnncnnos 77 Contractility Gia cadena 105 Contraindications seniorii a i o e 4 D dA A A PE 106 Delta Z Impedance Wavef0rM oooocccicnnocnionncncccnnonnos 105 Diagnostic Screen Conf suring estados hen edna denne 80 AA e A 105 E ECG Vectis aiii a Aa ak 51 Et ds 10 BVente 2 icc oe eer hi hele er edi iaa 9 Exiting a Monitoring Session ccononoccocnnnnononanonncnncnncnnnno 35 F Facility NGM au tido tr iste ss 75 G CONDE OEE eed Roe aa aa ca ck save Ls E EEE 42 General System OvervieW oocccncnnnccnconcnnnononononcnnninnonccnnos 7 GLOSSARY csscseesceds ie tescgvereeste delia detritos 105 H Hatdkeys iscsi eine ine ies 8 Alarm ON OFF i scccssctecsescepnecseciseescesneeovecdveneoteteeess 11 Clear i 10 AS 10 Edi dd nea 9 Previo s Screen eeina i ie a 9 BioZ Operator s Manual Heart Rate HR a 106 Height enere irmos a E E 43 I ICG SeS Ois ii 37 o A aainwoubeoies 4 Internal Battery PoWeT ooooonoccnocononconnnonnnancnancnnncnncconocnnos 6 L LED Indicators ovocitos 12 Left Ventricular Ejection Time LVED dono 106 Low Batteryc2 4 soba ee ahh Re 94 M Mais A Cocina tilda 12 ME AAA 99 Manual Deflte srmn i i e 12 Mean Arterial Presure MAP ooooconocc
94. nsmitting sensor being positioned directly inferior and along the mid axillary line BioZ Operator s Manual 37 CardioDynamics International Corporation 4 Connect the right and left with respect to the patient s right and left lead wires as indicated on the patient cable yoke and individual lead wire connectors to their respective dual sensor sites as follows e Depress the tab at the end of the connector place the connector over the sensor stud and release the tab The lead wires must be attached as follows e Blue left and right lead wire connectors to the respective circular shaped transmitting sensors on the neck e Purple left and right lead wire connectors to the respective rectangular shaped detecting sensors on the neck e Green left and right lead wire connectors to the respective rectangular shaped detecting sensors on the thorax e Orange left and right lead wire connectors to the respective circular shaped transmitting sensors on the thorax Caution Locating the ICG Sensors incorrectly will adversely affect the ability of the BioZ to measure and process the bioimpedance signal Note Both the neck and thorax ICG sensors must be positioned so that they are 180 degrees opposite each other Should the patient have an invasive line chest tube etc at the recommended locations the ICG sensors may be rotated slightly as long as they remain 180 degrees opposite of each other Figure 29 Impedance Cardiogr
95. nterchangeably when discussing impedance cardiography Thoracic electrical bioimpedance TEB thoracic electrical impedance and electrical bioimpedance In this manual the term impedance cardiography or ICG will be used ICG is a technology that quantifies the mechanical activity of the heart blood flow as opposed to its electrical activity ECG The fundamental theoretical basis of ICG involves direct measurement of base impedance velocity index acceleration index pre ejection period ventricular ejection time and heart rate These measurements are then used to calculate additional hemodynamic parameters The application of ICG to determine hemodynamic parameters is based on the following principles Biological tissues such as muscle bone fat and blood all have different electrical properties Of these tissues blood is the most electrically conductive Since arterial blood flow is pulsatile and arterial vessel walls are compliant pulsatile changes in blood volume occur in the thoracic arterial system predominantly in the aorta as a result of ventricular function This change in blood volume results in a change in the electrical conductivity and thus the impedance of the thorax to electrical current Changes in the electrical impedance of the thorax are primarily due to changes in the velocity and volume of the blood in the aorta The BioZ measures this change in impedance by injecting a high frequency 60 kHz Minimum low amplitude 4
96. o configure the Monitoring Screen e Press the appropriate softkey to select the desired data cell to configure e Use the Y and or fT softkeys to select the desired hemodynamic parameter to display in the cell or select off to deactivate the cell e Press the Accept softkey or the Enter hardkey to set the cell configuration e Repeat the above steps for each individual cell Note When data display cells D 4 and D 5 are both deactivated both of the Graphic Cells will elongate so as to fill the vacated screen area See section 6 3 for a sample Monitoring Screen configuration change 1 When finished configuring the Monitoring Screen press the Exit softkey to return to the BioZ Screen Configuration Menu 8 1 2 2 Diagnostic Screen The Diagnostic screen displays up to four of the hemodynamic parameters in a horizontal bar graph format Low normal and high ranges are defined along each bar so as to aid the User in quickly identifying the hemodynamic condition of the patient As with the patient Monitoring Screen the User may configure the Diagnostic screen to display the hemodynamic parameters of their choice Follow the general steps outlined below to configure the Diagnostic Screen At the BioZ com Screen Configuration Menu press the Diagnostic softkey The following screen will be displayed 80 BioZ Operator s Manual DETAILED DESCRIPTION NORMAL HIGH Bar Graph Cell
97. o input ID Stored Exit Pt Info Figure 32 Patient Data Entry Screen The Patient Data Entry Screen enables entry of all required patient information Note If an incorrect entry is made press the Clear hardkey and re enter the correct value 7 2 3 Softkeys e JL Softkey move highlight bar between fields e Stored Pt Info softkey allows the User to search for a previous monitoring session of the desired patient 7 2 4 Patient Data Entry Fields 7 2 4 1 Patient ID The Patient ID field is an optional field i e information in this field is not required for the BioZ to provide accurate hemodynamic parameters The Patient ID field accepts only numerical entries of up to nine digits e Data may be entered from either the numerical digit hardkeys on the BioZ front panel or an external keyboard If an incorrect value is entered press the Clear hardkey to erase the entry and then re enter the correct value e Press either the J softkey or the Enter hardkey to advance to the Patient Name field AQ BioZ Operator s Manual LIVE PATIENT MONITORING e Note If the Patient ID matches one that was previously entered into the BioZ the remaining data fields will automatically fill in with that patient s previously entered data The User is then given the opportunity to make changes to the previously entered data prior to beginning the current monitoring session 7 2 4
98. oDynamics International Corporation 8 Press the appropriate numerical keys in order to enter the correct systolic and diastolic pressures Press Enter If the calculated MAP is NOT within the allowed range the Data Out of Range message screen Figure 41 will be displayed otherwise the cursor will automatically advance to the CVP field The following screen will be displayed Note For information on obtaining blood pressure via the BioZ Cuff refer to section 7 2 4 7 DatecMH DD 77473 06 11 2000 Time 13 34 Patient ID 223344556 Patient Name Demo Patient Gender Female Height 5 ft 6 in Height 119 lbs BSA 1 60 Age 24 BP Manual Entry CUP Defaulto PADP Oefaulti 10 Start Monitoring MEH FILE Use keypad keyboard to input CUP Press A f oor ENTER to accept Tf no CUP is entered default is used DEMO MODE Figure 10 Patient Data Entry Screen The BioZ allows the User to enter the patient s actual CVP and or PAOP Refer to section 8 1 1 3 for a detailed description If these values are not known the BioZ default setting for CVP and PAOP is 6 and 10 mmHg respectively Note CVP is used in the calculation of Systemic Vascular Resistance SVR and the Systemic Vascular Resistance Index SVRI PAOP is used in the calculation of Left Cardiac Work LCW and Left Cardiac Work Index LCWI Depending on the value for the Mean Arterial Pressure MAP for every one mmHg error in the CVP and
99. ome Screen press either the System Menus softkey or the Menu hardkey From any of the patient Monitoring Screens press the Menu hardkey The BioZ com System Menus Screen will be displayed BioZ com System Menus SYSTEM CONFIG UPDATE EXIT SET UP SCREENS PT INFO Figure 56 BioZ com System Menus Screen Note The right most softkey will be Return to Monitor if accessed during a patient monitoring session or Exit if coming from the Welcome Screen The BioZ organizes the User Menus into three 3 main areas e System Set up e Configure Screens e Update Patient Information 8 1 1 System Set up The BioZ System Set Up menu provides the User with the ability to modify a variety of the BioZ s default settings By pressing the System Set up key the User has access to the following settings functions e Set up various parameter alarm conditions e Define the normal range s for the hemodynamic parameters as displayed on the Diagnostic Screen e Set system defaults for patient data entry screen e Set User password e Define which waveforms to record e Define event labels 62 BioZ Operator s Manual DETAILED DESCRIPTION e Enter facility name e Select the language of operation e Configure the custom hemodynamic status report From the BioZ com System Menus Screen press the System Set up key The following screen will be displayed BioZ com System Set Up Menus
100. onal Corporation A visual alarm is indicated by a flashing parameter symbol on the screen When an alarm condition arises the BioZ automatically displays the first patient monitoring screen in the viewing sequence that displays the alarming parameter The order of display is as follows Monitor then the Diagnostic Screen The alarms associated with the above parameters may be activated de activated at the User s discretion The User also has the option to adjust the high and low set points for generating the alarm condition s and the time delay associated with the Reset Alarm function 1 To adjust the alarm conditions for HR TFC and CI press the Alarms softkey Figure 57 the following screen will be displayed ALARM STATUS VISUAL AUDIO 1 All OFF OFF z HR OFF OFF 3 TFC OFF OFF CI OFF OFF 5 Systolic Beep HeA OFF to select parameter VISUAL AUDIO MORE EXIT ON OFF ON OFF OPTIONS Figure 58 Alarm Status Screen The User may activate de activate all or any combination of alarms for the parameters listed on the screen Use the J softkey to select the desired parameter then press either the Visual on off or Audio on off softkeys to achieve the desired alarm configuration Note It is not possible to activate an audio alarm without also activating the associated visual alarm for that given parameter 2 Press the More Options softkey in order to adjust the Volume Limits an
101. oring Session 1 Press the Stop Monitoring hardkey The following screen will be displayed CardioDynamics THE ICG COMPANY Ie S MONITOR 800 778 4825 858 535 0202 WWW Cardiodunanics con Software Wersion 3 3 1 Serial Output Version COIC 2002 All Rights Reserved START TAKE REUIEH SYSTEM SYSTEM MONITOR BP ONLY RECORDS MENUS DEMO Figure 28 Welcome Screen The BioZ is now ready for a live monitoring session See SECTION 5 QUICK START INSTRUCTIONS and SECTIONS 7 and 8 LIVE PATIENT MONITORING and DETAILED DESCRIPTION BioZ Operator s Manual 35 CardioDynamics International Corporation 36 BioZ Operator s Manual LIVE PATIENT MONITORING 7 LIVE PATIENT MONITORING A patient monitoring session is initiated from the Welcome Screen Figure 28 The Start Monitor function is used to begin a live monitoring session The following sections will explain the steps necessary to monitor a patient 7 1 Patient Preparation The first step in beginning a monitoring session is to attach the patient ICG sensors 7 1 1 ICG Sensors To obtain accurate results with the BioZ high quality ICG sensors with low skin to electrode impedance proper spacing between transmitting and receiving sensors and good adhesive properties are required The ICG sensors distributed by CardioDynamics meet these requirements Only use sensors that have been recently removed from the seale
102. play cells and two 2 graphics display cells Each data display cell will provide the value for one of the hemodynamic parameters provided by the BioZ The User has the option to configure these cells to their specific requirements The graphic display cells are used to display the ECG and Impedance waveforms or whatever the User has configured for the Waveform Screen The screen configuration menu on the BioZ is password protected Key in the password that was set in section 8 1 1 5 or enter in the default password 1111 When the password is entered correctly the BioZ com Screen Configuration Menu will be displayed Bioz com Screen Configuration Menu Choose Screen To Configure MONITOR DIAGNOSTIC WAVEFORM TREND EXIT Figure 77 BioZ com Screen Configuration Menu Screen Press the Monitor softkey The following screen will be displayed BioZ Operator s Manual 79 CardioDynamics International Corporation CO SVR BP Data Cell 1 Data Cell 2 Data Cell 3 TFC zE ahm Data Cell 4 zZ ACI 100 sec Data Cell 5 Choose Cell To Configure DATA CELL 3 Figure 78 Patient Monitoring Screen Cell Configuration Menu 1 Note Figure 78 may not reflect the configuration of the Data Graphic Display Cells for your device The User has the ability to choose which hemodynamic parameters will be displayed and which cells will display them Follow the general steps outlined below t
103. ppropriate number of heartbeats have been processed and accepted The Monitoring Screen consists of a maximum of five 5 data display cells and two 2 graphic display cells The BioZ provides the User with the ability to set the number of active graphic and data cells as well as the parameters displayed by those cells 26 BioZ Operator s Manual BIOZ TUTORIAL The Menu hardkey provides the User with access to the necessary screens for making custom changes to the BioZ To configure the Monitoring Screen 2 Press the Menu hardkey The following screen will be displayed BioZ com System Menus DENO MODE SYSTEM CONFIG UPDATE RETURN TO SET UP SCREENS PT INFO MONITOR Figure 13 BioZ com System Menus Screen The screen configuration menu on the BioZ is password protected A four 4 digit numerical password is required in order to make changes to the system default settings and or screen configurations The factory set default password is 1111 If desired the User may set their personal password at this time see section 8 1 1 5 3 Press the Configure Screens softkey The following screen will be displayed Enter Password Use keypad to enter password DEMO MODE Figure 14 Password Entry Screen BioZ Operator s Manual 27 CardioDynamics International Corporation 4 Key in the correct password 1111 if the default password hasn t been altered If the password was ent
104. r more information Precautions Impedance Cardiography ICG is a theoretical model of blood flow movement and is subject to inaccuracies in cases where the model does not fit a particular patient s clinical circumstances Conditions that may limit the accuracy of the data are listed below Septic shock Aortic valve regurgitation BioZ Operator s Manual 3 CardioDynamics International Corporation Severe hypertension MAP gt 130 mmHg Patient heights measuring below 48 120 cm or above 90 230 cm Patient weights measuring less than 67 lbs 30 kg or greater than 341 lbs 155 kg Patient Movement Aortic Balloon Pump Observe the following considerations when using the BioZ 2 3 2 4 During open chest surgery the BioZ may produce inaccurate values because of the change in the normal pattern of blood flow and or the electrical current flow through the chest cavity In addition during post operative recovery monitoring patient shivering and motion may produce excessive artifacts that may affect the accuracy of the BioZ Signal interference caused by other equipment may occur if cables and or power cords of the BioZ and other equipment cross over each other The BioZ should not be used concurrently on patients with Minute Ventilation pacemakers when the MV sensor function is activated Indications The BioZ is designed for use with an adult in a resting position The BioZ and its components are not designe
105. rameters In order to access this feature however a password is required see section 8 1 1 5 for instructions on how to set a personal password or use the default password 1111 For adults the normal range of cardiac output CO is between 4 5 8 5 l min depending on age overall body size and composition In the normal resting state the larger the body the greater the cardiac output Therefore the more clinically useful parameter for defining normal cardiac function is the cardiac index CI and stroke index SI The BioZ defines the limits for the normal range of CO and Stroke Volume SV as the product of the patient s Body Surface Area BSA and the limits for Cardiac Index CI and Stroke Index SI respectively For example if the patient s BSA was 2 0 m and the lower limit for CI was 2 5 1 min m then the lower limit for CO would be 2 0 x 2 5 5 0 l min Note The normal ranges defined in the BioZ are derived from the mean CI HR and MAP 2 SD as published by Milnor William R M D Hemodynamics 1982 Baltimore Williams amp Wilkins Therefore values lying within the normal range are not necessarily indicative of the optimal hemodynamic state for a given patient Patients must be assessed based on their individual physiologic state 66 BioZ Operator s Manual DETAILED DESCRIPTION e Cardiac Index CI 2 5 4 7 1 min m e Stroke Index SI 35 65 ml m e Systemic Vascular Resistance
106. re the filling pressure of the left heart Zo See BASE IMPEDANCE 108 BioZ Operator s Manual Appendix B PRINT SCREEN REPORT 15 Appendix B PRINT SCREEN REPORT CDIC MEDICAL CENTER 1234 MAIN STREET SUITE 234 SAN DIEGO CA 92121 Print Screen Report Name JOHN DOE Age 76 Height 6 ft 4 in ID 125785612 Sex Male Weight 235 lb BSA 2 37 m Page 1 of 1 CO 8 0 CG Vector e ee l PRINT STATUS TREND SUMMARY EXIT SCREEN REPORT REPORT REPORT Clinical Note Data Collection Report Generated 03 22 00 at 15 33 Signature CardioDynamics BioZ com MM BioZ Operator s Manual 109 CardioDynamics International Corporation 110 BioZ Operator s Manual 16 Appendix C HEMODYNAMIC SUMMARY REPORT Appendix C HEMODYNAMIC SUMMARY REPORT CDIC MEDICAL CENTER 1234 MAIN STREET SUITE 234 SAN DIEGO CA 92121 Hemodynamic Summary Report Name JOHN DOE Age 76 Height 6 ft 4 in ID 125785612 Sex Male Weight 235 ib BSA 2 37 m Total Monitoring Time 00 14 Page 1 of 1 Time BP MAP HR CO us Event 15 21 08 147 87 105 70 80 Bee e ae 15 22 25 147 87 105 70 80 ee Pte kak See te 15 23 16 147 87 105 70 8 0 a SES 15 24 07 147 8705 70 80 985 __ 104 31 982 J108 ETA NR 15 26 16 147 8705 70 80 o Jio 31 po 15 27 07 147 8705 70 80 990 104 31 ______ 15 28 24 147 87 105 70 80
107. red BP Manual Entry CUP Defaulta 6 PADR Defaultor 10 Start Monitoring lt NEW FILE Press A f or ENTER to accept Select patient gender DENO MODE Figure 4 Patient Data Entry Screen 3 Press the Male or the Female softkey The cursor will automatically advance to the Height field The following screen will be displayed DatecMM DD rro 0611 2000 Time 13 34 Patient ID 223344556 Patient Name Demo Patient Gender Female Height Height Required BSA Age Required BP Manual Entry CUP Default 5 PAOP Defaulto 10 Start Monitoring NEH FILE Use keypad keyboard to input Height Press f or ENTER to accept Height must be between 4 0 and 7 s DEMO MODE Figure 5 Patient Data Entry Screen The accuracy of some of the data provided by the BioZ may be compromised on persons under 120cm 0 or over 230cm 7 6 in height see section 2 2 Precautions 4 Press the appropriate numerical hardkeys in order to enter the ft and in data in the respective field or press the em softkey and enter the height in centimeters Press the Enter or the J key BioZ Operator s Manual 91 ix CardioDynamics International Corporation Note If an entry greater than eleven 11 is entered into the in field the BioZ will convert the entered value to it s equivalent feet and inch value For example 0 ft 71 in may be entered in lieu of 5 ft 11 i
108. rinting Errors Printer not detected This could be due to either the printer not being connected powered on prior to turning on the BioZ no ink in the cartridge a bad printer cable or a fault within the BioZ To determine the failure mode perform the following steps e Check the printer ink cartridge e Check the printer for any paper jams 94 BioZ Operator s Manual TROUBLESHOOTING e Turn off the BioZ and the printer Make sure the printer cable is attached to both the BioZ LPT port and to the printer e Turn on the printer e Turn on the BioZ e Attempt to print the report If the error message is still in effect repeat the above steps while using a different printer cable Contact CardioDynamics Technical Support department if the above steps fail to resolve the problem BioZ Operator s Manual 95 CardioDynamics International Corporation 96 BioZ Operator s Manual NOMINAL SPECIFICATIONS 10 NOMINAL SPECIFICATIONS The BioZ has input protection against defibrillators and electro surgical devices Physical Specifications Technical Information Portable Intel based 14 0 in x 12 1 in x 7 0 in Electrical isolation to CPU with built in flat 35 6 cm x 30 8 cm x 17 8 cm UL 2601 IEC601 screen EL monitor 12 1 Ibs 5 5 kg specifications and integrated membrane keyboard High Impact Plastic roman een Mensa Caer CAT PETT AA Povrce orem oS Optional internal 30 minute capacity N
109. senssuccesesvenssvansvensensontsses AO Patient Data Entry Screen ccccccecccsiscccsnesesconesseeactoavasecesossevedeuvedacvss vena ceeadevesucseencstvansossnssence FO Patient Data Entry Screen oomomoms Data Out of Range Screen cccscccsssceseseees Monitoring Screen Live Mod e cssscccsssccsssscssssscssssscesssscssssscsssssssssssssssssssssssssssesssseecs DL Pecccccccccccccccccs BioZ Operator s Manual iil Figure 47 Figure 48 Figure 49 Figure 50 Figure 51 Figure 52 Figure 53 Figure 54 Figure 55 Figure 56 Figure 57 Figure 58 Figure 59 Figure 60 Figure 61 Figure 62 Figure 63 Figure 64 Figure 65 Figure 66 Figure 67 Figure 68 Figure 69 Figure 70 Figure 71 Figure 72 Figure 73 Figure 74 CardioDynamics International Corporation Manual Blood Pressure Entry Screen Live Mode cssccssssssssssccssssscsssscsssssssesssees D2 Data Out of Range Screen cccscccsssccssssccssscesssccesssceseces Diagnostic Screen Live Mode csscccscscssssscssssssessssssssssssssssessssssssssssasssssasecesasesssssses DO Therapeutic Screen Live Mode comosssssssss DD Trend Screen Live Mode sacscsisccsssesssccccecdccssssesecdecsesccosestcusdevees cdosacasecccosesecesascsvecesosceceeess DO Expandable Trend Screen Live Mode c sssccssssccssssscssssccsssscsssssssssssssssssssssssssssssees D Trend Screen Set Up Screen Live Mode
110. soactivity conditions Note The shape of the shaded region varies depending on the normal ranges default values defined by the User The hemodynamic status variations of tension and dynamics are defined as Normotension represented by the horizontal lines 84 lt MAP lt 100 mm Hg The dynamic condition is represented by the circulation beat i e Stroke Index SD Normodynamic represented by the vertical lines 35 lt SI lt 65 ml m Left Stroke Work Index LSWI hyperbola curves on the Therapeutic Screen are proportional to the mean myocardial oxygen consumption per beat Myocardial energy production takes place during mechanical systole and corresponds to the forces utilized to shorten myocardial fibers i e the contractile force of the myocardial fibers LSWI is dependent on both pre load and contractility Normo strokework related to a combination of both pre load and contractility for the predefined normotensive state 47 2 g x m m lt LSWI lt 70 8 g x m m Vasoactivity is determined on a beat by beat basis Stroke Systemic Vascular Resistance Index SSRI SSRI MAP CVP 80 SI Normovasoactivity is defined as the ideal SSRI as determined by the ideal SI 50 mL m and MAP 93 mmHg Normovasoactivity is represented by the diagonal lines on the screen The diagonal lines are defined as ideal SSRI 20 The area to the left of the diagonal lines indicates Vasoconstriction The area to the right of the dia
111. ss the Data Cell 4 softkey The following screen will be displayed 1 2 3 4 5 6 7 S 3 10 Thoracic Fluid Content Velocity Index Acceleration Index D 5 Left Cardiac Work Left Cardiac Work Index Pre Ejection Period Left Ventricular Ejection Time Systolic Time Ratio Respiration Rate Not Available OFF Use f to select parameter Press ACCEPT or ENTER to set Cell D X DEMO MODE ACCEPT MORE EXIT gt Figure 18 Hemodynamic Parameter Menu 1 The Parameter that is currently displayed in Data Cell 4 will be highlighted and D 4 will be displayed to the right of the parameter To deactivate D 4 8 Press the softkey to select off Press either the Accept softkey or the Enter hardkey Press the Exit softkey the user will be returned to the Monitoring Screen Figure 17 BioZ Operator s Manual 29 CardioDynamics International Corporation 9 Repeat steps 5 through 7 for Data Cell D 5 The following screen will be displayed Data Cell 1 Data Cell 2 Data Cell 3 Data Cell Data Cell 5 Choose Cell To Configure DEMO MODE DATA DATA MORE EXIT ti cel F Pt Figure 19 Monitoring Screen Cell Configuration Screen The Graphic Cells expand to fill the screen 10 Press the Exit softkey The following screen will be displayed Bioz com Screen Configuration Menu Choose
112. sscssssscsssccsssssssssssscssssscsossscsss D eccccccccccccce Pecccccccccccccccccs Ccccccccccccccs Cocccccccccccccccccs BioZ Operator s Manual INTRODUCTION NOTE Before using the BioZ carefully and completely read the instructions in this manual If you do not understand the instructions or need additional information contact CardioDynamics International Corporation CDIC at the address listed on page one of this manual 1 INTRODUCTION The BioZ is an innovative noninvasive impedance cardiography ICG device that provides hemodynamic parameters based on the measurement of thoracic electrical bioimpedance Specifically the BioZ allows for assessment of a patient s hemodynamic status and ventricular function by determining twelve 12 hemodynamic parameters as well as four 4 indexed parameters In addition the BioZ allows the operator to e Observe trends in the patient s status e Measure Blood Pressure Independently with Optional integrated Blood Pressure monitor e View store and review the collected data and or waveforms e Print reports of the hemodynamic parameters with the date and time annotated accordingly e Copy Download files to a PC e Utilize security precautions Password protection for system configuration 1 1 Theoretical Concepts Note The initial use of thoracic electrical bioimpedance was supported by impedance cardiography and plethysmography assessments Today many terms are used i
113. sure contribution MAP PAOP SI and a constant The normal range for LSWI based on the ideal hemodynamic state where SI 50 ml m MAP 92 mmHg PAOP 10 mmHg is 47 2 70 8 g m m LEFT VENTRICULAR EJECTION TIME LVET msec The time between the opening and closing of the aortic valve LSWI See LEFT STROKE WORK INDEX 106 BioZ Operator s Manual Appendix A GLOSSARY OF TERMS MEAN ARTERIAL PRESSURE MAP mmHg A measure of the average arterial perfusion pressure which determines blood flow to the tissues NORMODYNAMIC STATE When the CARDIAC INDEX CI is within its respective normal range normodynamic adequate global blood flow level for a specific condition NORMOTENSION A state where mean arterial pressure MAP is within a normal range The normal MAP range for supine resting adults is 84 100 mmHg PAOP See PULMONARY ARTERY OCCLUDED PRESSURE PEP See PRE EJECTION PERIOD PRE EJECTION PERIOD PEP msec The period of isovolumetric ventricular contraction PULMONARY ARTERY OCCLUDED PRESSURE PAOP mmHg The filling pressure of the left heart Normal mean value is 10 mmHg SI See STROKE INDEX SSRI See STROKE SYSTEMIC VASCULAR RESISTANCE INDEX Same as SSVRI SSVRI See STROKE SYSTEMIC VASCULAR RESISTANCE INDEX STROKE INDEX SI ml m STROKE VOLUME indexed by BODY SURFACE AREA SI SV BSA STROKE SYSTEMIC VASCULAR RESISTANCE INDEX SSVRI or SSRI dyne cm m A measure of after
114. sword Entry Screen 3 Key in the desired four 4 digit numerical password After the fourth digit has been entered the following screen will be displayed Reconfirm new password Use keypad to enter password Figure 70 New Password Re Confirmation Entry Screen 4 Confirm the new password by re entering the new four digit password If entered correctly the following screen will be displayed 74 BioZ Operator s Manual DETAILED DESCRIPTION Password has been changed Use keypad to enter password Figure 71 New Password Verification Screen 5 Press the Exit softkey to return to the BioZ com System Set Up Menus Screen Figure 57 6 Press the More softkey the following screen will be displayed BioZ con Susten Set Up Menus FACILITY SET WAVES SELECT CONFIG BACK zE Figure 72 BioZ com System Set Up Menus Screen Note The Config Status feature is not available on all models or software versions 8 1 1 6 Facility Name For the purpose of printing reports the BioZ can store the name and address of the User facility To enter the Facility information perform the following 1 Press the Facility Name softkey the following screen will be displayed BioZ Operator s Manual 75 CardioDynamics International Corporation Enter Facility Name and Address Facility Name Address 1 Address 2 City State ZIP CODE POSTAL CODE Coun
115. t The Previous Screen hardkey cycles the User through the five patient monitoring screens in reverse direction The Next Screen hardkey cycles the User through the five patient monitoring screens in the forward direction Pressing the Event hardkey allows the User to select a pre defined text label which will be stored at the selected time point in the patient s record This text label will be visible on printed reports The Stop Monitoring hardkey will end the monitoring session and return the User to the Welcome screen Note The Stop Monitoring hardkey is inactive if the BioZ blood pressure cuff is inflated The Print key allows the User to print any of the reports provided by the BioZ The Alarm On Off hardkey allows the User to enable disable the alarm function of the BioZ The Reset Alarm hardkey allows the User to silence an audible alarm signal and reset the alarm BioZ Operator s Manual LIVE PATIENT MONITORING 7 2 5 1 Monitoring Screen Note The setting configuration of the Data and Graphic Display cells for the Monitoring Screen depicted in Figure 46 may be different for your device Figure 46 Monitoring Screen Live Mode The Monitoring Screen consists of a maximum of five 5 data display cells and two 2 graphic display cells The BioZ provides the User with the ability to customize the number of active data cells as well as the parameters displa
116. t Screen hardkey The following screen will be displayed P co 2 9 SUR 1792 B eo ECG Vector 2 Impedance 30 Beat Average WAVEFORM SCREEN 13 37 DEMO MODE MORE FREEZE CHANGE SAVE TAKE_NEW WAVES SCREEN ECG VECTOR WAVEFORM BP Figure 26 Waveform Screen Demo Mode The Waveform Screen displays up to two 2 of the five 5 different waveforms produced or detected by the BioZ at a time e Impedance Waveform Delta Z e ECG Waveform any of four vectors see section 7 2 5 1 e dZ dt Waveform first derivative of Delta Z BioZ Operator s Manual 33 CardioDynamics International Corporation e Pacer Impulse Waveform impulse for each pacemaker trigger e Spike Enhancement Waveform ECG and Pacemaker impulse The default waveforms for the Waveform Screen are the ECG and Delta Z waveforms The More Waves softkey provides the User with the ability to view the alternate waveforms See sections 7 2 5 5 and 8 1 2 4 17 Press the Next Screen hardkey The Monitoring Screen will be displayed Figure 12 6 4 Printing The BioZ provides the User with a variety of pre formatted reports The print command is active during all live monitoring sessions from the various patient monitoring screens as well as from the Review Record screens To Print 1 With the BioZ turned off connect the printer cable from the printer port on the rear panel of the BioZ to a printer that uses Hewlett Packard PCL3 or a more recent com
117. t and is fairly independent of AFTERLOAD The normal ranges for supine resting adults are 70 150 x 100 sec for males and 90 170 x 100 sec for females ACI 100 d Z dt Zo ACI See ACCELERATION INDEX AFTERLOAD Represents the forces that the ventricle must overcome to deliver blood into the systemic vasculature during contraction The primary component of afterload is vasoactivity represented by Systemic Vascular Resistance SVR The secondary component of AFTERLOAD is blood viscosity AFTERLOAD is a systolic phenomenon BASE IMPEDANCE Zo Ohm The mean electrical impedance of the thoracic cavity Also known as THORACIC FLUID INDEX TFI BODY SURFACE AREA BSA m BSA is estimated by the DuBois and DuBois formula to be BSA W x H x 0 007184 where H is the patient s height in cm and W is their weight in kg BSA See BODY SURFACE AREA CARDIAC INDEX CI 1 min m The value of CARDIAC OUTPUT CO indexed by the BODY SURFACE AREA BSA The normal range for supine resting adults is 2 5 4 7 1 min m mean value 3 6 1 min m CI CO BSA CARDIAC OUTPUT CO l min The total volume of blood pumped by the heart in one minute The normal range for adults is 4 5 8 5 liters per minute CO SV HR CENTRAL VENOUS PRESSURE CVP mmHg The pressure at the output of the systemic vasculature filling pressure of the right heart Normal mean value is 6 mmHg CI See CARDIAC IN
118. t the operation of the BioZ in any way 4 2 1 Softkeys Softkeys are screen specific i e they perform different functions depending on the current screen display For example text entries may be performed with the softkeys When it is necessary to enter text into a field e g the Patient Name field Facility Information the following screen is displayed Text Entry Screen Text Entry fl Accept Letter Figure 1 Text Entry Screen The Y T lt gt softkeys are used to navigate through the alphabet in order to select the desired letter On the External Keyboard keys lt F1 gt through lt F5 gt correspond to the five softkeys from left to right 1 e the lt F1 gt keyboard key is equivalent to the left most softkey on the BioZ 4 2 2 Hardkeys 4 2 2 1 Menu The Menu hardkey is active from the Welcome Screen Figure 2 and from the patient clinical monitoring screens Pressing the Menu hardkey will take the User to a screen with five softkey choices acting as a menu These softkeys will give the User access to menus that will provide control over system defaults features and screen display configurations Keyboard equivalent Simultaneously pressing the lt Ctrl gt and M keys 8 BioZ Operator s Manual GETTING STARTED 4 2 2 2 Next Screen The Next Screen hardkey is active only while a patient clinical data monitoring screen is displayed Pressing the Next Screen hardk
119. ternational Corporation 4 2 2 12 Manual Deflate if equipped with BioZ Blood Pressure module WY The Manual Deflate hardkey is used to manually trigger the BioZ com Cuff to deflate This key gives the User control over the cuff in case of system malfunction or patient discomfort During an error free blood pressure measurement cycle the cuff will deflate automatically Keyboard equivalent Simultaneously pressing the lt Ctrl gt and D keys 4 2 3 LED Indicators In addition to the LED indicators associated with the hardkeys listed above there are other LED Indicators associated with the operating status of the BioZ 4 2 3 1 Power Source Status e Mains AC NY There is a green LED labeled Mains AC that is illuminated when the BioZ is turned on and the power source is from either 110VAC or 220VAC e Battery If the BioZ is equipped with the optional battery power source there is a green LED which may be labeled Battery that is illuminated while power is being supplied by the battery e Charge gt During charging of the battery 1f equipped with the optional battery power source an LED which may be labeled Charge is illuminated 12 BioZ Operator s Manual GETTING STARTED 4 2 3 2 Signal Strength Status There are LED bar graphs that indicate the strength of the ECG and Impedance waveform signals and the Battery strength When the signal is strong the entire LED bar graph will b
120. tion regarding a patient This feature is available to allow the User to view the patient s information and make only necessary changes without having to re enter the patient s entire profile For example if the patient s weight needed to be amended or the method for monitoring blood pressure was changed the Update Patient Information function would provide access to effect these changes without having to stop monitoring and re enter the entire patient information into the system At the BioZ com System Menus press the Update Patient Information softkey the following screen will be displayed DatecMM DO YY 06 12 2000 Time OFiiz Patient ID 112233445 Patient Name DOE JOHN Gender Male Height 6 ft Din Height 185 lbs BSA 2 06 Age 40 BP Manual Entry CUP Defaults 6 PADR Default 10 Return To Monitoring Press ff or ENTER to accept Press Return To Monitor to continue Return To Monitor Figure 83 Patient Data Entry Confirmation Screen e Use the Y and or 1 softkeys to highlight the desired field s e Press the Clear hardkey to erase the current information e Enter the amended value and or text e Press the Enter hardkey to effect the change to the selected field and advance to the next field Note If the Enter hardkey is pressed while the field is cleared the field will revert to the default setting e After changes have been made press the
121. try Press Exit when done 4 ENTER EXIT TEXT Figure 73 Facility Name Entry Screen Use the 4 and or T softkeys to select desired field 2 Press the Enter Text softkey to access the Text Entry Screen and follow the steps displayed on the screen Note You must press the Enter Text softkey to enter numerical data also 3 Press the Enter softkey to select the next field listed on the Facility Name Entry Screen 4 After all entries have been completed press the Exit softkey to return to the BioZ Set Up Menu 8 1 1 7 Waveform Recording Options e During a patient monitoring session or Demo Mode operation the BioZ will automatically store patient data at a predetermined interval see section 8 1 1 2 In addition the User can press the Save Waveform softkey to save the previous 26 seconds of waveform to the patient s record Note The Save Waveform function is a diagnostic troubleshooting tool Saved waveforms may only be viewed by CardioDynamics Technical Support Engineers The User does not have access to this data 8 1 1 8 Select Language The BioZ operational software has multi language capability The User may choose any of the following languages e English e French e Spanish e Italian 76 BioZ Operator s Manual DETAILED DESCRIPTION e German e Danish e Dutch To select the desired language perform the following steps At the BioZ com System Set
122. veforms to display in the Waveform Screen perform the following At the BioZ com Screen Configuration Menu press the Waveform softkey The following screen will be displayed co SUR BP TFC ACI ECG Lector HAVEFORM 1 Impedance 30 Beat Average HAVEFORM 2 Choose Waveform to configure Figure 82 Waveform Screen Cell Configuration Menu Screen e Press the appropriate softkey to configure the desired waveform cell The following waveforms are available to choose from e Impedance Waveform Delta Z e ECG Waveform any of four vectors e dZ dt Waveform first derivative of Delta Z e Pacer Impulse Waveform For patients with pacemakers the BioZ can detect when the pacemaker triggers and then display that trigger as a series of corresponding impulses e Spike Enhancement Waveform The spike enhancement waveform is an ECG waveform that also displays a spike for each pacemaker trigger signal e Use the and or 1 softkeys to select the parameter to assign to the selected Waveform cell e Press either the Accept softkey or the Enter hardkey to effect the change e Repeat the above steps to set the remaining waveform cell e Press the Exit softkey to return to the BioZ com Screen Configuration Menu BioZ Operator s Manual 83 CardioDynamics International Corporation 8 1 3 Update Patient Information The BioZ provides the User with a convenient method for updating informa
123. yed by those cells see section 8 1 2 e The Turn Pace Detect Off On softkey allows the user to deactivate activate the pacemaker detector circuit By default the Pacemaker Detect Circuit is activated each time you begin a monitoring session There is no need for the User to change this setting e The Current Pt Record softkey allows the User to access the patient data record for the patient currently being monitored e The Change ECG Vector softkey toggles through four available ECG vectors detected by the BioZ 1 a transthoracic configuration across the superior thorax sensors 2 modified Lead II 3 modified Lead III 4 a cross torso configuration from the left inferior neck sensor to the right superior thorax sensor The default ECG presentation is the Modified Lead I configuration vector 2 The QRS signal should have sufficient magnitude To select the best R wave recognition setting the User may press the Change ECG Vector softkey to rotate through the four ECG presentations The User should wait at least 30 seconds after each time the Change ECG Vector softkey is pressed so that the BioZ may update the data e The Save Waveform softkey saves the previous 26 seconds of patient waveforms BioZ Operator s Manual 51 CardioDynamics International Corporation e The Take New BP softkey performs one of two functions depending on the mode of blood pressure deter

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