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BioZ.com® Operator`s Manual

1. 89 Hemodynamic Trend Report 90 Print Screen Report sees 89 Reviewing Patient Records 34 35 85 S Serial Input 5 uo a 15 Serial Output essere 15 Signal Acquisition Error eese 93 Signal Strength Status sess 13 Skin Preparation eiae aieiaa 37 SOftKeyS Cisneros si Ere REHARI UU erui uit 8 SOFTWARE LICENSE AGREEMENT 103 Standard Features sse 5 Stop Monitoring sees enne 10 Stroke Index SD 0 cescesssscsssssesreesseceencesseesseeseaeenes 107 Stroke Volume SV sess 107 System Defaults essere 70 NES n er aA 62 Systemic Vascular Resistance SVR 107 Systemic Vascular Resistance Index SVRT 107 Systolic Time Ratio STR oocoococnicnconococrcnononornonornoros 107 118 T Muri pe 1 Theoretical Concepts eese 1 Thoracic Fluid Content TFC 108 Thoracic Fluid Index TFLI sss 108 Troubleshooting esee enne nnne nnne 93 U Update Patient Information eee 84 User Interface Symbol Key eene 8 V Velocity Index VI 108 Ww WARNINGS AND PRECAUTIONS 3 See General Warnings cccccsesseesssessceece
2. 106 Low Battery nrocos anaana rena ra grotte 94 M Mains AC Senn da 12 VE 99 Manual Deflate eese 12 Mean Arterial Presure MAP ooconocincnoonaranconconnoranonos 107 Me eene tdi E aaa 8 Monitor Screen Configuring eere niit eet RETE 79 Monitoring Screen viirietis ria eteesi iois 52 N Next CM adan 9 NIBP Port 5 incita is 14 Nominal Specifications ccccccsccecseessesecssseesssensenes 97 Normal Ranges esee eene ennt 66 O Optional Features sernpre nant e aia 6 P Patient Data Entry Fields esee 41 Patient Diagnostic Screen esee 54 PatientID iine e ei eta etre inert 41 Patient Monitoring esee 25 37 Patient Monitoring Screens eese 51 Patient Name aiii ida 42 Patient Preparation cesses ettet 37 Patient Therapeutic Screen eese 55 Patient Trend Screen essent 57 Power Source Status eese 12 Precautlons tae stre ec iie ere regi een 3 Pre Ejection Period PEP sss 107 Previous Screen ose i eret r iS 9 O 11 Printing Information eese 89 Pulmonary Artery Occluded Pressure PAOP 107 Q Quick Start Instructions eee 17 117 CardioDynamics International Corporation R Reports Hemodynamic Status Report 90 Hemodynamic Summary Report
3. 6 C Cardiac Index CD ooonoconocononononornnonncinnonnnnononinconconosons 105 Cardiac Output CO essere 105 Central Venous Pressure CVP sess 105 Charge ea oeste ecaes ereis ee nnt 12 Cleat caia rociero hehe ede 10 Configure Screens sirsenis iieo 27 78 Configure Status Report ssec 77 Contractility esas as 105 ContraindicatiONS oooconoconancnononanonnconacnnnaonororrnorcaconnananonos 4 D A A TE 106 Delta Z Impedance Waveform ssss 105 Diagnostic Screen Configuring toa eee eae 80 OLIN O dieci de gie rnt i eese 105 E ECG Vectots 5 eei aoa oi drei rene 52 Enter omen e ee NE de ner ode dues 10 EVE cani ow tie fecerit es 9 Exiting a Monitoring Session ccccssessreeseseneees 35 F Facility Name essere 75 G Ge hder iiia cots deer eee theo 43 General System Overview esses 7 GLOSSARY eor erae AE a aiite 105 H Hard ke Yi ii iii 8 Alarm ON OFF sssaaa neinei ii aaa 11 Clear ise E O Ee 10 EG O 10 ELVEN A nee GR Eae Rey 9 Previous SCcre b card 9 BioZ com Operator s Manual Heart R te HR auae tenter terret uet E Led oun aba 106 Helena tiara vid 44 I ICG Sensor Application eese 37 ICG Sensors decet erbe ente eere et D RU 37 Indications enden co ia 4 Internal Battery Power 6 L LED Indicators iie neon ttr fe eret eere 12 Left Ventricular Ejection Time LVET
4. 6 Press the More softkey The following screen will be displayed Data Cell 1 Data Cell 2 Data Cell 3 Data Cell 4 Data Cell 5 cheese Cell Te Configure DEMO MODE Feii 4 CELL 5 Figure 17 Monitoring Screen Configuration 2 7 Press the Data Cell 4 softkey The following screen will be displayed Thorac 2 Velocity Index S Acceleration Index D 5 4 Left Cardiac Work 5 Left Cardiac Work Index 6 Pre Ejection Period 7 Left Uentricular Ejection Time 8 Systolic Time Ratio 9 Respiration Rate Not fivailable 10 OFF ic Fluid Content Use J T to select parameter Press ACCEPT or ENTER to set Cell D X DEMO MODE ei A 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 L 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 Configuration Screen Figure 17 BioZ com 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 Choose Cell To Configure DEMO MODE DATA DATA DATA MEN EXIT CELL 1 CELL 2 CELL 3 Figure 19 Monito
5. BioZ com Operator s Manual Part 1095601 Revision E November 2001 Cardio Dynamics INTERNATIONAL CORPORATION 6175 Nancy Ridge Drive San Diego California 92121 USA 800 778 4825 858 535 0202 Fax 858 535 0055 European Authorized Representative Donawa Italia Srl Via Fonte di Fauno 22 00153 Rome Italy 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 Cardio Dynamics BioZ com and BioZtect are trademarked names protected by law TABLE OF CONTENTS TABLE OF CONTENTS 1 INTRODUCTION isc rios ainia dia caia 1 LI Theoretical Concord aa 1 2 WARNINGS AND PRECAUTIONS ccccsssessassiscsssososousessscssoesonbassecssdiesdsonseesisessisvebesvesvoesseesenstecsie 3 2 1 General WarniBgs oleo tees qan itc ern opi be serve ets Mi a 3 2 2 We TECAUTIONS dE O diamine EEEN E ni 3 23 TINA AL OWNS ERE RTT UU ee A E a Doe Si aware a ae E 4 BAe C nitraindicatofis o5 ate TI 4 3 SYSTEM FEATURES eee erc 5 Sol Standard Featulesco ok per ete RP is doom dE dde 5 3 22 Optional FESTES adiciona 6 4 GETTING STARTED costosos CP 7 Zr General System O velasco ideas 7 42 User Interface Symbol Key a NIESE 8 AAE OQ CACTUS p 8 427
6. No other periodic maintenance or inspection is required BioZ com Operator s Manual 99 Z Care Standard Warranty 12 Z Care Standard Warranty CardioDynamics International Corporation CDIC warrants that the BioZ or BioZ com 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 on each System for a period of sixty 60 months from the original CDIC invoice date This Warranty shall include all options and accessories purchased with the System except the external patient cable s and if applicable the external inflatable blood pressure cuff s and hose s which shail be covered under warranty for ninety 90 days from the original CDIC invoice date 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 sixty 60 month Warranty Period and no later than thirty 30 days after the expiration of the warranty period
7. System Set Up Menu Screen 2 2 Press the Event Labels softkey The Events List screen will be displayed Events List Press Exit when done 3 t i T Figure 67 Events List Screen 3 Press the Enter Label softkey Type in the desired label using the keyboard or the Text Entry screen on the BioZ com Each Event label is restricted to 50 characters 72 BioZ com Operator s Manual DETAILED DESCRIPTION 4 Press lt Enter gt from the external keyboard or the Enter hardkey on the BioZ com 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 com 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 Set Up Menu 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 Passvord Use keypad to enter passuord Figure 68 Password Entry Screen 2 Key in the factory default password 1111
8. 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 com then SVR 90 8 x 80 5 5 2 1193 dyne sec cm The percent error in the calculated SVR is Percent error 100 x SVReatc SVRirue SVR true 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 com Operator s Manual BIOZ COM 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 52 6 3 kg m If the actual PAOP is 15 mmHg a 5mmHg underestimation on the part of the BioZ com then LCW 0 0144 x 90 15 x 5 5 2 5 94 kg m The percent error in the calculated LCW is Percent Error 100 x 6 3 5 94 5 94 6 796 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 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 DatetMM DD YYYY gt 06 11 2000 Times 13 34 Patient IDs 223344556 Patient Name Demo Patient Gender Female Height 5 ft 6 in Heights 119 lbs BSA
9. INTERNATIONAL CORPORATION Y BERT B BER T Hemodynamic Monitoring System 800 778 4825 858 535 0202 www cardiodynanics con Software Versions 2 28 CDIC 2001 All Rights Reser ved AAA START REVIEW SYSTEM SYSTEM MONITOR BP ONLY RECORDS MENUS DEMO Figure 28 BioZ com Welcome Screen The BioZ com 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 com Operator s Manual 35 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 com 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 sealed package Sensors are single use disposable items Check the package expiration date before use Note The algorithm used to determine the stroke
10. Record function Patient waveforms are not saved with each data set BioZ com Operator s Manual 87 CardioDynamics International Corporation The BioZ com will display the 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 com Operator s Manual DETAILED DESCRIPTION 8 3 Printing Information The BioZ com 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 com 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 com 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 Car
11. 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 abnormally 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 z MAP PAOP CO 0 0144 LEFT CARDIAC WORK INDEX LCWT kg m m A value of LEFT CARDIAC WORK LCW indexed by the BODY SURFACE AREA BSA LCWI is a product of the ventric
12. This Warranty does NOT apply to dual sensors transducers fuses ink cartridges or other consumable or disposable items 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 CDIC will repair or replace any components of the System that cause the System to not function in accordance with the written materials provided with the System at time of sale CDIC will provide free shipping and freight charges for original and loaner unit exchanges UPS Ground or equivalent CDIC will provide subsequent operational software upgrade disks and installation instructions at no charge to the customer Warranty Coverage is void if 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 The System and or Software has not been properly operated or maintained in accordance with CDIC s then
13. 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 com and initiate a rnonitoring session as usual 3 When ready to print press the Print hardkey The following screen will be displayed ECG Uector 2 Impedance 30 Beat fiverage DEMO MODE PRINT STATUS TREND SUMMARY EXIT SCREEN REPORT REPORT REPORT Figure 27 Print Option Screen Demo Mode Re Configured 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 com Operator s Manual BIOZ COM 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 com 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 Monitoring Session 1 Press the Stop Monitoring hardkey The following screen will be displayed CardioDynamics
14. 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 com Operator s Manual DETAILED DESCRIPTION e Cardiac Index CI 2 5 4 71 min m e Stroke Index SI 35 65 ml m e Systemic Vascular Resistance 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 90 170 100 sec e Left Cardiac Work LCW 5 4 10kgm 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 keupad to enter password Figure 61 Password Entry Screen 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 gen
15. and wait at least 30 seconds to allow the screen to update Repeat for all four ECG vectors if necessary The User should 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 com 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 com is equipped with an optional battery the following screen will be displayed when the battery is less than 20 percent of full capacity WARNING BATTERY LOW PLUG BioZ com INTO WALL OUTLET OR RISK LOSING ALL DATA 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 display
16. parameters for the Trend Screen to display To set the default Trend Screen parameters perform the following steps 1 At the BioZ com Screen Configuration Menu press the Trend softkey The following screen will be displayed CURRENT TREND SELECTION TREND 1 TREND 2 TREND 3 TREND 4 Choose Trend To Configure TRENO_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 4 and or T 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 com 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 Impedanc
17. 1 60 fige 24 BP Manual Entry CUP Default 6 PAOP Default 10 Start Monitoring amp HEH FILE Press or ENTER to accept Press Start Monitor to begin DEMO MODE Start 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 com provides five 5 basic screens for presenting the various hemodynamic parameters Monitoring Screen e Diagnostic Screen e Therapeutic Screen BioZ com Operator s Manual 25 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 CL SVR SVRI LCW and LCWI may not be an accurate indication of the patient s actual values MONITORING SCREEN 13 19 DEMO MODE URN PACE CURRENT CHANGE SAVE TAKE NEH DETECT OFF PT RECORD ECG_VECTOR WAVEFORM
18. 1 Startup 1 Connect the Printer to the Printer Port located 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 com and plug into either a 110VAC or 220V AC power source Turn the Power Switch to the On position The following screen will be displayed after the boot up sequence is complete CardioDynamics INTERNATIONAL CORPORRTION BERT 6 Y BEA T Hemodynamic Monitoring System 800 778 4825 858 535 0202 wuw cardiodynamics com Softuare Version 2 28 CDIC 2001 All Rights Reserved AAA A ee ee START TAKE REVIEW SYSTEM SYSTEM MONITOR BP ONLY RECORDS MENUS DEMO Figure 2 BioZ com Welcome Screen BioZ com Operator s Manual 19 CardioDynamics International Corporation 4 Press the System Demo softkey The following screen is displayed DatecHt DD v vvv 0871172000 Time 13 28 Patient Name Gender Required Height Required Height Required Required Manual Entry 6 PAOP Default 10 Start Monitoring NEM FILE Press or ENTER to accept Use kegpad keuboard to input ID DEMO MODE Stored 4 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 w
19. 104 BioZ com Operator s Manual Appendix A GLOSSARY OF TERMS 14 Appendix A GLOSSARY OF TERMS ACCELERATION INDEX ACD 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 heart 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 dy Z 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 TFT BODY SURFACE AREA BSA m BSA is estimated by the DuBois and DuBois formula to be BSA W 9 5 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 ed CARDIAC INDEX CI I 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 min m CI CO BSA CARDIAC OUTPUT
20. 30 Beat Average WAVEFORM SCREEN 13 37 DEMO MODE MORE FREEZE CHANGE SAVE TAKE NEW 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 com 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 com 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 com 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 com turned off connect the printer cable from the printer port on the rear panel of the BioZ com to a printer that uses Hewlett Packard PCL3 or a more recent communication language protocol Note The Printer should be connected and turned on prior to turning on the BioZ com Caution
21. 5 6 MAP DBP KP SBP DBP For example If a BP 150 65 is entered manually into the BioZ com the calculated MAP would be BioZ com Operator s Manual 47 CardioDynamics International Corporation 150 65 65 1 31 therefore KP 0 25 and MAP 65 0 25 150 65 86 25 In the example above the simple equation of MAP DBP SBP DBP 3 the MAP would equal 93 33 instead of 86 25 Press the Manual Entry softkey The following screen will be displayed Systolic Diastolic Values EE abe Calculated Mean Arterial Pressure Use kegpad kegboard to input BP Press ENTER to accept MAP value must be betueen 30 220 mmHg SYSTOLIC DIASTOLIC es 2 ie weal BACK Figure 40 Manual Blood Pressure Entry Screen 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 ENTRY Figure 41 Blood Pressure Out of Range Screen 7 2 4 10 Central Venous Pressure The BioZ com allows the User to enter the patient s actual central venous press
22. 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 INDEX 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 com Operator s Manual 105 CardioDynamics International Corporation d Z dt Ohms sec The second derivative of the deltaZ waveform with respect to time d Z d 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 The number of beats performed by the heart in one minute HEMODYNAMIC MODULATORS
23. CT TT Optional internal 30 minute capacity Nickel Metal Hydride battery Optional noninvasive Automatic with emergency deflate key integrated blood pressure External Input Fuse 2 0 Amp Slo Blow 250 V o 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 com Operator s Manual 97 MAINTENANCE 11 MAINTENANCE The BioZ com 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 4525 or BZ 4575 patient simulator to verify the correct parameter specifications See Model BZ 4525 or BZ 4575 Operational Instructions It is not possible for any internal testing to be performed on the BioZ com The BioZ com does not have onboard diagnostic software 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 com 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
24. MAROC YS da ron n tiva tas asa sir term dn OLD te Ln area uade veneto 8 423 LED Indicators PC 12 4 2 4 External Connections ca c itn ii a tatit dt caeca edt a 14 5 QUICK START INSTRUCTIONS cccccscscciscicccccsescuseciecsssecnsecssecveceorsonsisnvesesnssesscnseecntonseassncaeizaes 17 BIOZ COM TUTORIAL cceceesssssssssssccssssssesnnssssecceeccenscensnunssssccncencesecssssenunnansscseseecesessessssseuuntet 19 Oder IA Dn A A AA ASES 19 6 2 Patent Data Entby a AS ds 20 6 3 Patient Monitoring Demo Mod ii po pne Veo DE VEA Ran 25 04 Mur ia 34 6 5 Reviewing Patient Records ita CO FRU c epa Flea uade iced iro at dose 35 6 0 Exiting Monitoring SessioDnu dide ice dei lidia 35 7 LIVE PATIENT MONITORING erit es SE Gpa inim desnebt eua esie in a Pire Een Ea acia pedo Una cincel 37 T L Patient PREDIO eX erc 37 PLL COSAS DEC EE 37 SEE Sigur icu indi A A ia t siei 37 T1 3 ICG Sensor Applications ss eot hh iate rt aa SUE RD alten VO EARS aS 37 1 2 Patient Monitoring ia il Aa banca 40 7 2 1 Blood Pressure without Starting ICG Monitoring Session eee 40 7 2 2 ACG Monitoring SESSION ien eo rre sir tinto peres bea lainen Ya kPa eh BS ilata Tat eitia HAMM iade 41 EI SOUR EY S arnica a E a sail hag A taunt tebbeged datos E a duns 41 T2 Patient Data Encino 41 125 Patient Monitoring SCreens cada irit eg ree ECRIRE PE a dede LETTER Va FOREN Dd dtes 51 8 DETAILED DES
25. Technical Service for more information 2 2 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 e Septic shock e Aortic valve regurgitation BioZ com 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 com 2 3 2 4 During open chest surgery the BioZ com 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 com Signal interference caused by other equipment may occur if cables and or power cords of the BioZ com and other equipment cross over each other The BioZ com should not be used concurrently on patients with Minute Ventilation pacemakers when the MV sensor function is activated Indications The BioZ com is designed for use with an adult in
26. applicable written operating and maintenance manuals 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 accident abuse or misapplication BioZ com Operator s Manual 101 CardioDynamics International Corporation Note There are no user serviceable components in the BioZ or BioZ com 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 CDIC and its authorized Distributors shall not be liable for any special incidental indirect or consequential damages arising out of the use of or inability to use the System Under no circumstances shall CDIC s and its Distributors liability under this Limited Warranty exceed the purchase price of the Syst
27. 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 com measures this change in impedance by injecting a high frequency 60 kHz Minimum low amplitude 4 0 mA rms Maxi
28. 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 various menus where numerical input is required from the User Keyboard equivalent 0 9 keys BioZ com Operator s Manual 9 CardioDynamics International Corporation 4 2 2 6 Clear d 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 Enter key 4 2 2 8 Stop Monitoring Pressing the Stop Monitoring hardkey will stop the monitoring session and take the User to the BioZ com 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 10 BioZ com Operator s Manual GETTING STARTED 4 2 2 9 Print Cl The Print hardkey is active at various times throughout the patient monitoring session including all patient clinical data monitoring screens and the Review Rec
29. 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 Backe softkey to return to the previous screen Y p The BioZ com 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 indicator 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 com Operator s Manual 65 CardioDynamics International Corporation 6 Press the Time Delay softkey the following screen will be displayed AFTER AN ALARM RESET KEYPRESS ENTER THE DELAY TIME BEFORE ALARMS RING AGAIN 01 30 Use keypad keyboard to enter time Press ENTER to accept MINUTES SECONDS z BACK 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 Set Up Menu screen 8 1 1 2 Normal Ranges The BioZ com Diagnosti
30. 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 com to determine the patient s hemodynamic parameters 7 1 2 Skin Preparation 7 1 2 1 Wet Gel Sensors BZ 200 201 1 Shave the hair over the sensor sites if necessary 2 Thoroughly clean the skin areas with alcohol or electrode prep pad Make sure that the skin is thoroughly dry before attaching sensors 7 1 2 2 BioZtect Sensors BZ 4550 01 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 7 1 3 1 Wet Gel Sensors BZ 200 201 1 Check the expiration date on the sealed pouch prior to opening Open the sealed pouch and remove the sensors Verify that the gel is still moist 2 Attach the reusable patient cable lead wires to the ICG sensors before removing the protective backing from the sensors The black and white snap leads should be snapped onto one dual ICG BioZ com Operator s Manual 37 3 4 5 CardioDynamics International Corporation sensor and the red and green snap leads should be snapped onto another dual ICG sensor This should be repeated for both the left and right sets of patient cable lead wires Remove the ICG sensor backing and apply eac
31. 42 Text Entry AA A M 42 Patient Data Entry Screen AAA nie pap n poo veo c s neh neon eroe ue eds Pe ao PR Rao o cU UU 43 Patient Data Entry Screen sssiscdissscessscsccsessetsscvtinncesssessssoscaneeasovepanceouavsocsssietonsusaticasesniasuius 44 Patient Data Entry Screen e eeeeeeeere EE E A 45 Patient Data Entry Screen ccccssscssssssccccssscccvscenscvsesssesossccessscessscenssstecostecscsseccssseesstsseesasesssoss 45 Patient Data Entry Screen 425 iiie in epeooes chere e eap entera Gee ce eas tho Pa Cree Da naa Ca VERS Eee a eE S RM a and nap dne 46 Manual Blood Pressure Entry Screen 4 eee eee eee eere e eere etes ases asse anas eee aa se eaaa 48 Blood Pressure Out of Range Screen 4 ener eee eee eee eene e een sesta a osse anos teen sse eaa 48 Patient Data Entry Screen stilo 49 Patient Data Entry Screen sisscescsssccvsscssiscsssccodssnecessoiecsdeseservetaseduccontessocaseoseshucssenddevosessensen 49 Patient Data Entry Screen AAA 50 Data Out of Range Screen ssesssecscsacccccssecsoacosseoossoosssocssoocsosesocecesoessosesoscessecesoccessesosee 50 Monitoring Screen Live Mode 4 Leere eene eee eee eese tene ense ease aee teens eoe es tau 52 111 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 Fig
32. BP 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 appropriate 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 com 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 com Operator s Manual BIOZ COM TUTORIAL The Menu hardkey provides the User with access to the necessary screens for making custom changes to the BioZ com To configure the Monitoring Screen 2 Press the Menu hardkey The following screen will be displayed BioZ com System Menus DEMO MODE SYSTEH CONFIG UPDATE RETURN TO SET UP SCREENS PT INFO MONITOR Figure 13 BioZ com User Menu Screen The screen configuration menu on the BioZ com 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 Passuord Use keupad to enter passuord DEMO MODE Figure 14 Password Ent
33. CRIPTION sssisccicedisessootsecsecasonsesisvovoveteedsscseedosonencscoavednsogesoostasnsnacateusecoorssessasies 61 8 1 Welcome SO tt Tinas 61 BILL A Set upon sce as ea cases ceed cua ptite A T ep Pe irr dur ue PR RONU A Miren ue peu 62 8 1 2 Configure IT it ia 78 8 1 3 Update Patient Information 5 inicial toria 84 BioZ com Operator s Manual i CardioDynamics International Corporation 8 2 Patient Records Management iia 85 8 2 1 Adding a New Patent ooo a chona 85 8 2 2 Add New Data to Previous Patient Record ooooconoonnnoccnonnnonaconcnnanccnnncnononcnncnnnancnnacrnanano 85 8 2 3 Review or Delete Patient Records assetto et anda Fa etse ue ou buds eno a big 85 8 3 Printing Information cer eee A te Nase exa dA Cor uS Du a ERE SRM 89 8 3 1 PrintScreen Report CR 89 8 3 2 Hemodynamic Summary Report unio aii ied e rr v rd ida 89 8 3 3 Hemodynamic Trend Report mais osea iodo eres trig Ese Ia tedio 90 8 3 4 Hemodynamic Status Report eoe arar ee HE Nep ener 90 9 TROUBLESHOOTING sinccissccusstndossssonseatboducteenpsdendonststunsdvovectssessenspasehonsebaphssesssdteisconscasessonseeesee 93 9 1 Signal Acquisition EME prse v eras b Ege tot Due dues co FUR e uet sigs 93 92 Loy BAY M 94 9 3 Printing A A O 94 10 NOMINAL SPECIFICATIONS cios MH nr 97 11 MAINTENANCE OST n 99 EEI Cleaning Aer TT EE 99 14 2 Patent Cabe od ovn as 99 12 Z CARE STANDARD WARRANT Y cccsscssssoss
34. CTIONS QUICK START INSTRUCTIONS NOTE Before using the BioZ com for monitoring a patient read all the information in this manual l 2 3 10 11 12 13 Cleanse the sensor sites and apply the sensors Connect Patient cable to the BioZ com and to the patient sensors If automatic blood pressure detection is desired connect the blood pressure cuff to the BioZ com if the model is equipped with this feature and to the patient Connect the printer cable between the printer and the BioZ com 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 110VAC or 220VAC power source Press the Start Monitor softkey Enter the patient information press Enter or the 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 com 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 com 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 t
35. 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 softkey The following screen will be displayed 112233445 DOE JOHN 03 06 2000 15 45 DATE TIME HR sI co CI 03 06 00 15 37 60 52 6 3 3 1 15 38 60 52 6 3 3 1 15 39 60 52 6 3 3 1 03 06 00 15 43 60 6 3 3 1 2206700 Use J T to select record to review Press ENTER to vieu screen displays MORE EXIT MESE UNI A AA 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 T 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 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
36. Diagnostic softkey The following screen will be displayed 80 BioZ com Operator s Manual DETAILED DESCRIPTION NORMAL HIGH Bar Graph Cell 1 BAR 1 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 1 Cardiac Output 2 Cardiac Index 3 Stroke Index 4 Stroke Volume S Systemic Vasc Res B 2 6 Systemic Vasc Res Index 7 Heart Rate 8 Blood Pressure 3 OFF Use T to select parameter Press ACCEPT or ENTER to set Bar B X ACCEPT MORE EXIT E RS Figure 80 Hemodynamic Parameter Set Up Menu 1 e Use the More softkey along with the 4 and or T 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 com Operator s Manual 81 CardroDynamics 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
37. E ir 11 SAVE TAKE NEM WAVEFORM BP Figure 23 Diagnostic 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 DEMO NODE BP Figure 24 Therapeutic Screen Demo Mode For an explanation of the Therapeutic Screen see section 7 2 5 3 32 BioZ com Operator s Manual BIOZ COM TUTORIAL 15 Press the Next Screen hardkey The following screen will be displayed 13 26 TREND_SCREEN DEMO MODE CHANGE SO MINUTE ONE HOUR EXPAND FULL DATA TRENDS SCALE SCALE DATA SCALE Figure 25 Trend Screen Demo Mode 13 41 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 Next Screen hardkey The following screen will be displayed Impedance
38. If Manual Entry is the method of blood pressure the User must enter a new blood pressure value before beginning the 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 com Operator s Manual 85 CardioDynamics International Corporation 112233445 00E JOHN 0370672000 112233445 DOE JOHN 03 06 2000 123456788 Demo Patient 03 06 2000 TEST 02 22 2000 02 22 2000 Demo Patient 02 22 2000 Demo Patient 02 22 2000 Demo Patient 02 22 2000 Demo Patient 02 13 2000 Demo Patient 0171672000 Use d T to select patient session Press ENTER for more options SORT EXIT pec tiga pee 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 com 1 Press the 1 and or T 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 86 112233445 DOE JOHN 03 06 2000 15 45 Select review function VIEW DELETE PATIENT BACK RECORD FILE DATA Figure 86 Patient Record Review Screen 2 BioZ com Operator s Manual
39. L 8 Data Collection 03 22 00 From 12 09 13 50 Report Generated 03 22 00 at 13 51 Signature BioZ com Operator s Manual 113 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 6ft4in ID 125785612 Sex Male Weight 235 Ib BSA 2 37 m 10 Beat Average Page 1 of 1 L mk mum m MEME SBP Systolic Blood Pressure 187 EDT HT ie d ee 4 Runs co canas Output ao ami ee A Stroke Index i SVRI Systemic Vascular Res Index 2325 MU SVR Systemic Vascular Resistance 985 Act aceende 108 j Lc pesetas 5 DES 9 icw fren Cardiac wok 00 RS pap Peja Period 19 Clinical Notez 0 0 0 02 2000000000000 Data Collection 03 22 00 at 12 44 Report Generated 03 22 00 at 12 45 Signature CardicDynamics BioZ com Operator s Manual 115 INDEX 19 INDEX A Acceleration Index ACT esses 105 Afterload it dee Yee eee ey 105 Age siste p DRE ERU See LX LER EE OAO 45 Alarm QN OEBE 2c od 11 Alarm Resta 11 BUON eise nte Senda 63 B Base Impedance Zo eese 105 Batteries 12 BioZ Col Citi 46 Body Surface Area BSA sss 105 Built in Noninvasive Blood Pressure Monitor
40. LEFT VENTRICULAR EJECTION TIME LVET STR PEP LVET BioZ com 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 Electrical Bioimpedance for thoracic measurements producing a measurement of global blood flow CO CI SV SD 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 Z THORACIC FLUID INDEX TFT Ohm See BASE IMPEDANCE VASOACTIVITY Vasoactivity is a change in vessel diameter controlling vascular resistance of the vessel s blood flow rate VELOCITY INDEX VD 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
41. Mode 0 6 14 2 106 1378 2014 150 230 See section 7 2 5 1 Patient Monitoring Screen for an explanation of the Take New BP softkey 54 BioZ com Operator s Manual LIVE PATIENT MONITORING 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 normovasoactivity 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 MAP 100 mm Hg The dynamic condition is represented by the circulation beat i e Stroke Index SI Normodynamic represented by the vertical lines 35 lt SI 65 ml m Left Stroke Work Index LSWD 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 myocar
42. OE JOHN Male 6 ft Gin 185 lbs BSA 2 06 Required Manual Entry 6 10 Start Monitoring lt NEW FILE gt Use keypad keyboard to input Age Press 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 J key the highlight bar will be advanced to the Blood Pressure field BioZ com Operator s Manual 45 CardioDynamics International Corporation 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 com may be compromised on persons whose MAP is less than 30 mmHg or greater than 220 mmHg The BioZ com allows the User to select one of two methods for obtaining the patient s blood pressure e BioZ com NIBP cuff optional feature not available on all models e Manual Entry DatecMM DD YYYY gt 0671272000 Time 06 32 Patient ID 112233555 Patient Names DOE JOHN Gender Male Height 6 ft Oin Height 185 lbs BSA 2 06 ge 40 Maral Entry PAOP Def ault gt s 10 Start Monitoring lt NEW FILE gt Press f or ENTER to accept Select BP Method BioZ com amp t re peer Figure 39 Patient Data Entry Screen 7 24 8 BioZ com Cuff optional feature not available on all models The BioZ com NIBP module uti
43. 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 User Menu Screen press the System Set up key The following screen will be displayed BioZ com System Set Up Menus ALARMS NORMAL SYSTEM BACK RANGES DEFAULTS a Figure 57 BioZ com Set Up Menu Screen 8 1 1 1 Alarms The BioZ com 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
44. The Display Update determines the frequency at which the hemodynamic values are refreshed updated on the screen The Display Update may be configured between l and 99 beats For example if the Display Update is set to 10 beats the screen will be refreshed every 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 YYYY 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 1 and 99 minutes 3 To accept the factory default setting for a particular field and move to another field press the 4 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 4 softkey or Enter hardkey to accept the entry and advance to the next field Note If a default value is
45. 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 measure the filling pressure of the left heart Zo See BASE IMPEDANCE 108 BioZ com 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 1 mi VR dun sep Inpedance 10 Beat Average Clinical Note Data Collection Report Generated 03 22 00 at 15 33 Signature CardioDynamics BioZ com Operator s Manual 109 Appendix C HEMODYNAMIC SUMMARY REPORT 16 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 SVR ACI TFC Event 1 15 21 08 147 87 105 70 80 992 106 31 o o 15 22 25 147 87 105 70 80 986 105 31 ____ 15 23 16 147 87 105 70 80 989 104 31 _
46. Z com 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 D 2 3 4 5 6 7 8 The Menu hardkey allows the User access to the system default settings while monitoring a patient 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 com blood pressure cuff is inflated The Print key allows the User to print any of the reports provided by the BioZ com The Alarm On Off hardkey allows the User to enable disable the alarm function of the BioZ com The Reset Alarm hardkey allows the User to silence an audible alarm signal and reset the alarm BioZ com Operator s Manual 51 CardioDynamics Internationa
47. ___ 15 24 07 147 87 105 70 80 985 amp 104 31 _ 0 15 25 25 147 87 105 70 81 982 103 34 15 26 16 147 87 105 70 80 991 amp 14 31 _ 4wQ 15 27 07 147 87 1059 70 80 990 104 313 5 5 15 28 24 147 870105 70 80 995 amp 103 31 L 15 29 15 147 87 105 70 amp 1 983 amp 104 31 amp 15 3006 147 87 005 70 80 989 amp 104 31 5 amp 15 31 22 147 87 005 70 79 1004 104 31 15 32 13 147 87 005 70 80 989 104 31 23D 5 15 33 05 147 87 105 70 80 992 is 3t o 15 34 22 147 87 105 70 80 986 amp 108 31 15 35 13 147 870905 70 80 985 105 31 0 O A A E a A Average aa 105 oo a Normal wia 59 112 mum 90 170 pum Ranges Vate 1100 see Clinical Note Data Collection 03 22 00 Report Generated 03 22 00 at 15 36 Signature CardioDynamics BioZ com Operator s Manual 111 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 6ft4 in ID 125785612 Sex Male Weight 235 Ib BSA 237 m Page 1 of 1 Trend Parameter Parameter Time Values WN
48. a resting position The BioZ com and its components are not designed 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 com is a FDA Class II device The blood pressure cuff provided with the BioZ com 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 com Operator s Manual 3 3 1 GETTING STARTED SYSTEM FEATURES Standard Features The BioZ com interfaces with Printers utilizing the Hewlett Packard PCL3 and more recent communication protocol External Keyboard IBM compatible PC s with specialized software installed The BioZ com measures the following parameters Thoracic Fluid Content TFC the inverse of the thoracic base impedance Indices of Contractility reported as Acceleration Index ACT and Velocity Index VI Pre Ejection Period PEP Left Ventricular Ejection Time LVET Heart Rate HR Blood Pressure if optional module purchased The BioZ com calculates the following parameters Cardiac Output CO Stroke Volume SV Systemic Vascular Resistance SVR also reported as Afterload Left Cardiac Work LCW Systolic Time Ratio STR Several of the above parameters are ind
49. 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 affect the operation of the BioZ com 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 li Figure 1 Text Entry Screen The 1 T gt softkeys are used to navigate through the alphabet in order to select the desired letter On the External Keyboard keys F1 through F5 correspond to the five softkeys from left to right 1 e the F1 keyboard key is equivalent to the left most softkey on the BioZ com 4 22 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 8 BioZ com Operator s Manual GETTING STARTED Keyboard equivalent Simultaneously pressing the Ctrl and M keys 4 2 2 2 Next Screen The Next Scre
50. are has multi language capability The User may choose any of the following languages e English e French e Spanish 76 BioZ com Operator s Manual DETAILED DESCRIPTION e Italian e German e Danish e Dutch To select the desired language perform the following steps At the BioZ com Set Up Menu press the Select Language softkey The following screen will be displayed MERA FRENCH SPANISH ITALIAN GERMAN DANISH DUTCH SELECT EXIT pao EE PU Figure 74 Language Selection Screen 1 Press the J 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 Menu 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 com 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 com Set Up Menu press the Config Status softkey The following screen will be displayed BioZ com Operator s Manual TI CardioDynamics International Corporation 1 Heart Rate 2 Systolic Blood Pressure 3 Diastolic Blood Pressure Mean Arterial Pressure Cardiac Index Cardiac Output Stroke Index Stroke Volume Systemic Vascular Res Index 10 Sys
51. ate Frequency from between one and 60 beats to meet their specific needs see section 8 1 1 3 Prior to monitoring a patient it is recommended that the User become familiar with the BioZ com through the use of the tutorial presented in SECTION 6 BIOZ COMO 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 com 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 com After completion of the Demo Mode Tutorial the User should feel competent to begin a live monitoring session on a patient BioZ com Operator s Manual 7 CardioDynamics International Corporation 4 2 User Interface Symbol Key The BioZ com 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 com not all the softkeys and hardkeys will be active at
52. c 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 parameters 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 CT and stroke index ST The BioZ com 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 CT and Stroke Index SD respectively For example if the patient s BSA was 2 0 mj and the lower limit for CI was 2 5 min m7 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 com are derived from the mean CI HR and MAP 2 SD as published by Milnor William R M D Hemodynamics 1982 Baltimore Williams amp
53. ceptable 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 com Operator 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 monitor e Patient Cable i 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 48 SK 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 com 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 com Operator s Manual 15 5 QUICK START INSTRU
54. cleared and the L 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 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 com Operator s Manual 7 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 com Set Up Menu Figure 57 8 1 1 4 Defining Event Labels The BioZ com 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 MS LABELS PASSWORD 4 Figure 66 BioZ com
55. d Weight Required fige Required BP Manual Entry CUP Default gt 6 PROP Default 10 Start Monitoring NEM FILE Press 4 f or ENTER to accept Select patient gender DEMO MODE A A De 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 Date lt MM D0 YYYY gt 06 11 2000 Time 13 34 Patient ID 223344556 Patient Name Demo Patient Female Required BSA Required Manual Entry 6 PAOP Default 10 Start Monitoring lt NEW FILE Use keypad keyboard to input Height Press 4 or ENTER to accept Height must be between 4 0 and 76 DEMO MODE Figure 5 Patient Data Entry Screen The accuracy of some of the data provided by the BioZ com may be compromised on persons under 120cm 4 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 cm softkey and enter the height in centimeters Press the Enter or the J key BioZ com Operator s Manual 21 CardioDynamics International Corporation Note If an entry greater than eleven 11 is entered into the in field the BioZ com 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
56. 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 Screen hardkey from the patient Trend Screen Figure 51 or the Previous Screen hardkey from the patient Monitoring Screen Figure 46 Ul A co 6 3 SUR 1033 BP x d TFC 33 CI a9 ECG Vector 4 Impedance 30 Beat Average WAVEFORM SCREEN 15 43 HR 60 MORE FREEZE CHANGE SAVE TAKE NEN WAVES 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 e 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 BioZ com Operator s Manual 59 CardioDynamics International Corporation The Change ECG Vector softkey toggles through the four available ECG vectors detected by the BioZ com see section 7 2 5 1 The Take New BP softkey triggers the BioZ com cuff blood pressure monito
57. der specific Please consult your operators manual for details Select lt MALE gt lt FEMALE gt to enter normal ranges BUT A A ta Figure 62 Normal Range Gender Screen 3 Press the appropriate gender softkey The appropriate gender specific screen will be displayed Male Normal Range Status Default Louer Upper USE CI RANGES 3 e Use T to select parameter Press ENTER to customize ranges O E CR ERES ES Figure 63 Normal Range Menu Screen 1 68 BioZ com Operator s Manual DETAILED DESCRIPTION 4 To select the desired parameter press the L T softkeys or the appropriate numerical hardkeys To select additional parameters press the More 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 Lover Upper USE CI RANGES Select and modify Louer or Upper Range Use keypad keyboard to enter neu value LOWER UPPER EXIT RANGE 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 th
58. dial 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 LSWI 70 8 g x m m Vasoactivity is determined on a beat by beat basis Stroke Systemic Vascular Resistance Index SSRD 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 diagonal lines indicates Vasodilation Hurst JW ed The Heart 5 ed New York McGraw Hill 1982 93 BioZ com Operator s Manual 55 CardioDynamics International Corporation 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 c
59. dioDynamics 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 Facility 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 com 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 com 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 Fig
60. e waveforms 82 BioZ com Operator s Manual DETAILED DESCRIPTION To set the two initial default waveforms 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 ECG Uector 4 WAVEFORM 1 Impedance 30 Beat fiverage WAVEFORM 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 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 com 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 J and or T 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 com Operator s Manual 83 CardioDynamics International Corp
61. e User has the ability to choose which hemodynamic parameters will be displayed and which cells will display them Follow the general steps outlined below to configure the Monitoring Screen e Press the appropriate softkey to select the desired data cell to configure e Use the L and or T 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 2 When finished configuring the Monitoring Screen press the Exit softkey to return to the BioZ com 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
62. e of the data provided by the BioZ com may be compromised on persons under 120cm 48in or over 230cm 90in in height see section 2 2 Precautions DatecMM DD V1YYY gt 06 12 2000 Time 06 32 Patient ID 112233555 Patient Name DOE JOHN Gender Male Height _ftt__in Weight Required Age Required BP Manual Entry CUP Default 6 PAOP Default gt 10 Start Monitoring lt NEW FILE gt Use keypadykeyboard to input Height Press Y T or ENTER to accept Height must be between 4 0 and 76 EXE ACA 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 l 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 com 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 com 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 pa
63. ed plug the BioZ com into the proper AC power source as soon as possible 9 3 Printing Errors Printer not detected This could be due to either the printer not being connected powered on prior to turning on the BioZ com no ink in the cartridge a bad printer cable or a fault within the BioZ com 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 com Operator s Manual TROUBLESHOOTING e Turn off the BioZ com and the printer Make sure the printer cable is attached to both the BioZ com LPT port and to the printer e Turn on the printer e Tur on the BioZ com e Attempt to print the report If the rror 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 com Operator s Manual 95 NOMINAL SPECIFICATIONS 10 NOMINAL SPECIFICATIONS The BioZ com 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 DN 20 mas an oc im CTN Pasen cate undam Sd
64. em and or Software paid by the End User BioZ com Operator s Manual SOFTWARE LICENSE AGREEMENT 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 conditions 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 I 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 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 otherwi
65. emodynamic 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 specified 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 com 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 T softkeys to select the record and press the Enter hardkey to print the Hemodynamic Status Report Note Hemod
66. en hardkey is active only while a patient clinical data monitoring screen is displayed Pressing the Next Screen hardkey 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 Ctrl 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 com is storing the record Keyboard
67. en 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 return to the BioZ com Set Up Menu Screen BioZ com Operator s Manual 69 CardioDynamics International Corporation 8 1 1 3 System Defaults In order for the BioZ com 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 com 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 CUP 2 PAOP 10 3 Weight Units lbs 4 Height Units ttrin 5 Data veraging 30 beats 6 fiutomatic Data Save 1 minute 7 Display Update 10 beats 8 Date and Format MyD Y gt 03 06 2000 9 Time 10 41 10 Decimal Character 11 Auto BP Update 5 minutes Exit System Default Menu Press T or ENTER to accept Use keypadykeyboard to enter neu value p cet Figure 65 System Default Menu Screen The above screen displays the default settings for the values and or formatunits of the patient data fields 2 System Default Ent
68. enu Scree i sicsnscsicicsesstcsesrdaseciaivasesesdsenseconssveonsnsscatestedsossacsazenstssecoovees 63 Alarm Status Screen NEP H 64 Alarm Limit Set Point Screen O A LESE Ms Alarm Reset Time Delay Screen hole sevoventsekesnanunse PA O Password Entry Screen a cavedavecasvevevienepsacccvedeesss 67 Normal Range Gender Screen coocoosommossnosiossosiccociccconnoscconoccoonococcononcconcconcncenorcnconss 68 Normal Range Menu Screen 1 ooccoccccroconoconncconesnaconocconecenocccoconosonocccnocconocinsoccronecsonconones 68 Normal Range Menu Screen 2 xsv Geb eu puRS dese S I SEINE TUNE 69 System Default Menu Screen ia UR rbien s essees 70 BioZ com System Set Up Menu Screen pA oacdedesesesscodencssvescstessevedcuessosseces esseste 72 Events List SCree i Mec c 72 Password Entry SCree AA A A A 73 New Password Entry Screen cacccasssscsocsssessdecssacsassssecscoissdecses s veassectssnsdsdnesroacdcgecectesese 74 New Password Re Confirmation Entry Screen sansdesbeusdaccastwases A 14 New Password Verification Screen omooccosssrcsss 75 System Set Up A 75 Facility Name Entry Screen sccccccsccsscsssesssssssseeseessest asacoseossonveasococoasssnd essecsscossectossensscenasaene 76 Language Selection Screen csscciscsscssccasicseseiccsessvessosuecacheevassonsvasqedsvaieioe sania acusacboosseiecodsecouee
69. er 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 com Cuff refer to section 7 2 4 7 DatecHH DD v 06711 2000 Time 13 34 Patient ID 223344556 Patient Name Demo Patient Gender Female Height 5 ft 6 in Weight 119 lbs BSA 1 60 fige 24 BP Manual Entry CUP Default 5 PAOP Default 10 Start Monitoring lt NEW FILE gt Use keypady keyboard to input CUP Press 4 T or ENTER to accept If no CUP is entered default is used DEMO MODE Figure 10 Patient Data Entry Screen The BioZ com 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 com 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 LCWD Depending on the value for the Mean Arterial Pressure MAP for every one mmHg error in the CVP and or PAOP a one to one and half percent error in SVR and or LCW will be introduced
70. essure e Press the Enter hardkey to accept the entry and return to the screen of entry BioZ com Operator s Manual 53 CardioDynamics International Corporation Note If the calculated MAP is out of range the User will receive the following message THE ENTERED VALUE IS OUT OF THE RECOMMENDED RANGE DATA ACCURACY MAY BE COMPROMISED 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 screen 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 com 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 po LOW NORMAL HIGH CO 1 min 6 3 SUR dun sec ACLT100 sec O TEC kohm 10 30 50 20 DIAGNOSTIC SCREEN 15 21 HR 60 WAVEFORM BP Figure 49 Diagnostic Screen Live
71. exed with reference to body surface area BS A to give indexed parameters The BioZ com calculates the following indexed parameters Cardiac Index CI Stroke Index ST Systemic Vascular Resistance Index SVRI Left Cardiac Work Index LCWT BioZ com Operator s Manual 5 3 2 CardioDynamics International Corporation Optional Features The BioZ com is available with the following optional features Internal Battery Power In the event that AC power becomes unavailable the BioZ com 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 com 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 com Operator s Manual GETTING STARTED 4 GETTING STARTED 4 1 General System Overview The BioZ com 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
72. ey The Patient Data Entry screen will be displayed DatecMM DD YYYY gt 06 12 2000 Time 06 28 Patient ID Patient Mame Sender Required Height Required Weight Required BSA Age Required BP Manual Entry CUP Default 6 PAOP Default 10 Start Monitoring lt NEW FILE gt Press or ENTER to accept Use keypadykeyboard to input ID Stored ER 8 ERUIT 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 J 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 com 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 com 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 softkey or the Enter hardkey to advance to the Patient Name field BioZ com Operator s Manual 41 Cardi
73. f 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 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 BioZ com Operator s Manual 57 CardioDynamics International Corporation 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 EXPANDABLE TREND SCREEN HR 60 EXPAND EH EXPAND BACK TO SEG 1 SEG 4 LIVE DATA Fi
74. 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 com Operator s Manual 63 CardioDynamics International Corporation A visual alarm is indicated by a flashing parameter symbol on the screen When an alarm condition arises the BioZ com 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 LEE OFF AUDIO OFF 1 All 2 HR 3 TFC OFF 4 CI OFF 5 Systolic Beep N A OFF to select parameter Hse to select parameter VISUAL AUDI EXIT ON OFF ONSOFF OPTIONS je eee 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 t
75. gular 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 transmitting sensor being positioned directly inferior and along the mid axillary line 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 Violet left and right lead wire connectors to the respective rectangular shaped detecting sensors on the neck BioZ com Operator s Manual LIVE PATIENT MONITORING 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 com to measure and process the bioimpedance signal Note Both the neck and thorax ICG
76. gure 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 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 15 39 TREND SCREEN CO SUR ACI TFC 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 58 BioZ com Operator s Manual LIVE PATIENT MONITORING 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 com as well as five
77. h sensor adhesive side down to the proper sites indicated on the diagram Figure 29 Position the right and left as indicated on the patient cable dual ICG sensor patches with the white and black leads on the corresponding side of the neck Use the root of the neck as a reference for vertically locating the white ICG sensor with the black sensor being placed directly superior and inline with the ear lobe Position the right and left as indicated on the patient cable dual ICG sensor patches with the red and green leads on the corresponding side of the thorax along the mid axillary line Use the xiphoid process as a reference for placing the red ICG sensor with the green sensor being placed directly inferior to the red sensor Caution Locating the ICG Sensors incorrectly will adversely affect the ability of the BioZ com to measure and process the bioimpedance signal 7 1 3 2 BioZtect Sensors BZ 4550 1 2 3 4 38 Check the expiration date on the sealed pouch prior to opening Open the sealed pouch and remove the four dual sensor patches Prep the skin as listed above 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 rectan
78. he Stop Monitoring hardkey to end the session BioZ com Operator s Manual 17 BIOZ COM TUTORIAL 6 BIOZ COM TUTORIAL The tutorial presented in this section should provide the User with a good working knowledge of the BioZ com 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 com 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 com 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 com By completing the tutorial the User is afforded an ideal opportunity to configure the BioZ com 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
79. ietary 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 nonexclusive 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 BioZ com Operator s Manual 103 CardioDynamics International Corporation 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 W
80. in 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 DatecMM DD Y YY 06 11 2000 Time 13 34 Patient ID 223344556 Patient Name Demo Patient Gender Female Height Required Manual Entry 6 PAOP lt Default 10 Start Monitoring lt NEW FILE gt Use keypady keyboard to input Weight Press 4 or ENTER to accept Range must be betueen 67 341 lbs DEMO MODE Figure 6 Patient Data Entry Screen 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 J 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 DatecHHzDD YYvYv v 06 11 2000 Time 13 34 Patient ID 223344556 Patient Name Demo Patient Gender Female Height 5 ft 6 in 119 lbs BSA 1 60 Required BP Manual Entry CUP Default 6 PAOP Default 10 Star
81. ing 1 Press the Facility Name softkey the following screen will be displayed BioZ com Operator s Manual 75 CardioDynamics International Corporation Enter Facility Name and Address Facility Name Address 1 Address 2 City States ZIP CODE POSTAL CODE Country Press Exit when done ENTER EXIT ps rag que Figure 73 Facility Name Entry Screen Use the 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 com Set Up Menu 8 1 1 7 Waveform Recording Options During a patient monitoring session or Demo Mode operation the BioZ com 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 com operational softw
82. ing Screen V sees ot epp corea Deis BioZ com Operator s Manual Error Reference source not found NOTE Before using the BioZ com 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 com is an innovative noninvasive impedance cardiography ICG device that provides hemodynamic parameters based on the measurement of thoracic electrical bioimpedance Specifically the BioZ com 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 com 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 interchangeably when
83. ion 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 com may update the data The Save Waveform softkey saves the previous 26 seconds of patient waveforms BioZ com Operator s Manual LIVE PATIENT MONITORING The Take New BP softkey performs one of two functions depending on the mode of blood pressure determination 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 com 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 us 80 Calculated Mean firterial Pressure 92 Use keypad keyboard to input BP Press ENTER to accept MAP value must be between 30 220 mmHg SYSTOLIC DIASTOLIC be c EL 3 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 pr
84. ithin 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 Licensee GOVERNING LAW This software license agreement shall be governed by and interpreted in accordance with the laws of the State of California 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
85. l Corporation 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 Impedance 30 Beat Average MONITORING SCREEN 15 17 HR 60 URN PACE CURRENT CHANGE DETECT OFF PT RECORD ECG UECTOR WAVEFORM BP 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 com provides the User with the ability to customize the number of active data cells as well as the parameters displayed by those cells see section 8 1 2 52 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 The Current Pt Record softkey allows the User to access the patient data record for the patient currently being monitored The Change ECG Vector softkey toggles through four available ECG vectors detected by the BioZ com 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 IP configurat
86. l Entry 6 Start Monitoring lt NEW FILE gt Use keypad keyboard to input PROP Press ff or ENTER to accept If no PAOP is entered default is used Figure 43 Patient Data Entry Screen e Use either the numerical hardkeys on the BioZ com face or the external keyboard to enter the current value or press the Enter or the Ll key to accept the default value The User will be prompted to Start Monitoring BioZ com Operator s Manual 49 CardioDynamics International Corporation DatetMM DD YYYY gt 06 12 2000 Times 06 32 Patient ID 112233555 Patient Mame DOE JOHN Gender Male Height 6 ft D in Weights 185 lbs BSA 2 06 fige 40 BP Manual Entry CUP Default 6 PROP CDetfault 10 Start Monitoring lt NEW FILE Press or ENTER to accept Press Start Monitor to begin Start ume uec cpm 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 UALUES ARE QUT OF THE RECOMMENDED RANGE DATA ACCURACY MAY BE COMPROMISED PLEASE CHECK THE FOLLOMING ENTRIES Rou 7 Height Rou 8 Height Row 10 Blood Pressure ENTRY Figure 45 Data Out of Range Screen 50 BioZ com Operator s Manual LIVE PATIENT MONITORING 7 2 5 Patient Monitoring Screens When monitoring a patient the Bio
87. lizes 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 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 NIBP 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 46 BioZ com Operator s Manual LIVE PATIENT MONITORING e Connect the coiled inflation tube to the NIBP Port on the front panel of the BioZ com e Press the BioZ com Cuff softkey if that is the desired method of blood pressure determination Once the mo
88. 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 afterload 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
89. mum 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 BioZ com Operator s Manual 1 CardioDynamics International Corporation activity of 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 com 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 2 BioZ com Operator s Manual WARNINGS AND PRECAUTIONS 2 WARNINGS AND PRECAUTIONS 2 1 General Warnings e Asa Class IIa Type BF device under the Medical Device Directive the BioZ com is not specifically intended to monitor variations in cardiac performance that could result in immediate danger to the patient e Caution Federal law restricts this device to use by or on the order of a physician e Explosive Hazard Do not use in the presence of flammable anesthetics or gases e Sensors are to be placed externally on the skin only and are not for direct cardiac ap
90. n Menu Screen eee eee eee Le eee eese seea seen ases s seen assa seas s seas seas 30 User Menu SCEGCI scri seeotIor egt Repeat 31 Patient Monitoring Screen Demo Mode Re Configured dsdteo pisss oaia e Diagnostic Screen Demo Mode ee eee eee Lee Leere eee ee eee eene senos tease ense esas eeaasea 32 Therapeutic Screen Demo Modle 4 ee eere cete esee eese eee se sees e ee eas escri cccranecones 32 Trend Screen Demo Mode 4 c crece e eee ee eese eee eas ses es esee esee e esse sese ss essence 33 Waveform Screen Demo Mode 4 eee e ee eere eene sese ee eae en nose eee e te een nosse eee eee eenao 33 Print Option Screen Demo Mode Re Configured EEEIEE A EER O BioZ com Welcome Screen sssssssccssssecessssssssssssssossnssncencsnesnececsecseccecsecsscussnsceceneseenceecenes 35 Impedance Cardiography Sensor Placement Diagram esseeseccccseeccecceecoeccecececcoecoecceece 39 Independent Blood Pressure Screen ss sooesesocssocooeosessoscscccesocceecoeccecsoecoecoeccoccseccoccceecoeee 40 Blood Pressure Measurement Results Screen 44 eee e eere ente eee eee seen seen netnuue 40 Patient Data Entry Screen O M Dani etu 41 Patient Data Entry Screen c mommanoscenacincnccernencanicsnanconeneci ncicconnacronecerncecosccconicarisocesass
91. nitoring Screen When a monitoring session begins the first screen displayed by the BioZ com is the patient Monitoring Screen The Monitoring Screen consists of a combination of up to five 5 data display 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 com 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 com 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 1 Press the Monitor softkey The following screen will be displayed BioZ com Operator s Manual 79 CardioDynamics International Corporation Data Cell 1 Data Cell 2 Data Cell 4 Data Cell 5 Choose Cell To Configure CELL 2 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 Th
92. nitoring session begins the BioZ com 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 e Use only the blood pressure cuff provided with the device e Use the proper size cuff for the patient s arm e Ensure that the cuff is evenly and snugly wrapped around the patient s arm e Ensure that the bladder within the cuff is not folded e Ensure that all connections are tight so as to prevent leakage e 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 e The patient s arm should remain relaxed and still while the blood pressure cuff is inflating and deflating The BioZ com 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 com will calculate a MAP using the following algorithm If SBP DBPYDBP lt 0 5 Then KP 0 333 If SBP DBPYDBP gt 1 0 Then KP 0 25 KP 0 333 SBP DBPYDBP 0
93. nscensceseereeecees 3 curi 101 Waveform Recording Options 76 Waveform Screen CONPIQUIING ciaci n 82 bolo m PE 44 Welcome Screen cccscscsssssscssscecessnssversentecrsesvees 61 BioZ com Operator s Manual A CardioDyn r mics Manufacturer CardioDynamics International Corporation Address 6175 Nancy Ridge Drive San Diego California 92121 USA Product Designation Hemodynamic Monitor Product Name BioZ com Model Numbers BZ 4110 BZ 4100 x BZ 4000 BZ 4010 Authorized Representative Donawa Italia Srl Via Fonte Di Fauno 22 Rome 00153 Italy We herewith declare that the above products meet the provisions of EC Directive 93 42 EEC which apply to them as stated in Annex and Annex II of this directive Certification under Annex II Certificate Number HD 9811719 01 Issued by TUV Rheinland Product Safety GmbH Place date Signature Name Title CE 0197 1037701 Rev B
94. o 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 and alarm reset Time Delay 3 To adjust the volume of the Audio Alarm press the Volume softkey accordingly 64 BioZ com 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 m s em 2 TFC 30 7kohm 50 kohm 3 C1 1 0 l minzm2 6 0 1 minsm2 Press ENTER to customize ranges Use to select parameter LIMIT LIMIT lt DECIM LA e Figure 59 Alarm Limit Set Point Screen Use the J 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
95. oDynamics International Corporation e Note If the Patient ID matches one that was previously entered into the BioZ com 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 2 Patient Name The Patient Name field is also an optional field DatecHrDD vY Y vv 06 12 2000 Times 06 32 Patient ID 112233555 Patient Nano Gender Required Height Required Weight Required Required Manual Entry CUP Default 6 PAOP Default 10 Start Monitoring lt NEW FILE Press f or ENTER to accept Press Enter Mame SOFTKEY to see alphabet screen pepe co ess Name 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 A Bo PE F Press Y Li after choosing each letter Press lt ENTER gt when done Accept f e Figure 34 Text Entry Screen e If an external keyboard is attached simply type in the desired alphanumeric entry Press the Enter key on the keyboard when finished 42 BioZ com Operator s Manual LIVE PATIENT MONITORING e If an external keyboard is not attached press the appropriate arrow softkey
96. oard equivalent Simultaneously pressing the lt Ctrl gt and R keys BioZ com Operator s Manual 11 CardioDynamics International Corporation 4 2 2 12 Manual Deflate if equipped with BioZ com Blood Pressure module CN 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 com 4 2 3 1 Power Source Status e Mains AC di There is a green LED labeled Mains AC that is illuminated when the BioZ com is turned on and the power source is from either 110V AC or 220VAC e Battery If the BioZ com 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 Charge gt During charging of the battery if equipped with the optional battery power source an LED which may be labeled Charge is illuminated 12 BioZ com Operator s Manual GETTING STARTED 4 2 3 2 Signal Strength Status There are LED bar g
97. ontractility 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 56 BioZ com Operator s Manual LIVE PATIENT MONITORING 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 com see section 8 1 2 3 for selecting 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 34 15 24 15 39 TREND_SCREEN HR 60 CHANGE 30 MINUTE ONE HOUR EXPAND FULL DATA 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 o
98. or the current password After the fourth number has been entered the following screen will be displayed BioZ com Operator s Manual 73 CardioDynamics International Corporation Enter neu Password Use keypad to enter password Figure 69 New Password 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 passuord Figure 70 New Password Re Confirmation Entry Screen 4 Confirm the new password by re entering the new four digit password 1f entered correctly the following screen will be displayed 74 BioZ com Operator s Manual DETAILED DESCRIPTION Password has been changed Use keypad to enter passuord p dps De Figure 71 New Password Verification Screen 5 Press the Exit softkey to return to the BioZ com Set Up Menu Figure 57 6 Press the More softkey the following screen will be displayed BioZ conm System Set Up Menus AAA E AAA FACILITY SET WAVES SELECT CONFIG NAME TO RECORO LANGUAGE STATUS ES Figure 72 System Set Up Menu 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 com can store the name and address of the User facility To enter the Facility information perform the follow
99. oration 8 1 3 Update Patient Information The BioZ com provides the User with a convenient method for updating information 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 User Menu press the Update Patient Information softkey the following screen will be displayed DatecHM DD vv 06 12 2000 Time 07 12 Patient ID 112233445 Patient Name DOE JOHN Gender Male Height 6 ft Din Weight 185 lbs BSA 2 06 Age 40 BP Manual Entry CUP Default 6 PAOP Default 10 Return To Monitoring Press T or ENTER to accept Press Return To Monitor to continue t Return To Monitor Figure 83 Patient Data Entry Confirmation Screen e Use the J and or T 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
100. ords screens After pressing the Print hardkey a menu appears giving printing options see section 8 3 After printing a green LED is on when the BioZ com 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 AX Pressing the Alarm ON OFF hardkey will enable and disable the BioZ com 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 11Reset 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 Keyb
101. ould be displayed The only difference 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 com 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 com Operator s Manual BIOZ COM TUTORIAL 2 Press the Enter hardkey or the 4 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 DatecHH DD YYY Y 0671172000 Time 13 34 Patient ID 223344556 Patient Name Demo Patient Required Height Require
102. plication e The conductive gel of the sensors should not contact any other conductive materials during patient monitoring e 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 com device to the institution s equipotential system e 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 com at all times The patient cables specified and included with the BioZ com 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 e Disposal of this product and or any of its accessories shall be in accordance with any and all local regulations e 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 e 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
103. raphs 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 be 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 com 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 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 com 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 ac
104. ries 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 respectively Weight Units Pounds ibs 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 com 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
105. ring 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 Screen To Configure DEMO MODE MONITOR DIAGNOSTIC WAVEFORM TREND Figure 20 Screen Configuration Menu Screen 30 BioZ com Operator s Manual BIOZ COM TUTORIAL 11 Press the Exit softkey again The following screen will be displayed BioZ com System Menus DEMO MODE EXE Figure 21 User Menu Screen The BioZ com 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 Impedance 30 Beat Average MONITORING SCREEN 13 31 DEMO MODE URN PACE CURRENT CHRNGE SAVE TAKE NEN 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 com Operator s Manual 31 CardioDynamics International Corporation 13 Press the Next Screen hardkey The following screen will be displayed NORMAL HIGH 10 0 30 0 50 0 70 0 DIAGNOSTIC SCREEN 10 21 DEMO MOD
106. ring device or the User is prompted to manually enter the blood pressure The Save Waveform softkey saves waveforms for exporting to another PC Press the Next Screen hardkey to return to the Monitoring Screen 60 BioZ com Operator s Manual DETAILED DESCRIPTION 8 DETAILED DESCRIPTION 8 1 Welcome Screen The Welcome Screen is the first screen displayed when the BioZ com 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 com 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 INTERNATIONAL CORPORATION Y BERT B BEA T Hemodynamic Monitoring System 800 778 4825 858 535 0202 www cardiodynanics com Softuare Version 2 28 CDIC 2001 All Rights Reserved START TAKE REVIEW SYSTEM SYSTEM MONITOR BP ONLY RECORDS MENUS DEMO Figure 55 Welcome Screen The BioZ com 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 com User Menus The BioZ com User Menus can be accessed from the Welcome Screen prior to beginning a patient monitoring session or from the va
107. rious patient monitoring screens during a patient monitoring session Thus the User need not exit from a patient monitoring session in order to customize the settings configuration of the BioZ com BioZ com Operator s Manual 61 CardioDynamics International Corporation To access the BioZ com User Menus from the Welcome Screen press either the System Menus softkey or the Menu hardkey From any of the patient Monitoring Screens press the Menu hardkey The User Menu Screen will be displayed BioZ com System Menus SYSTEM CONFIG UPDATE EXIT EE E Figure 56 BioZ com User Menu 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 com 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 com Set Up menu provides the User with the ability to modify a variety of the BioZ com 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 com
108. ry Screen BioZ com Operator s Manual 21 CardioDynamics International Corporation 4 Key in the correct password 1111 if the default password hasn t been altered If the password was entered 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 DIAGNOSTIC WAVEFORM TREND EXIT Figure 15 Screen Configuration Menu The BioZ com 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 B P mmHg T F C kohni Data Cell 4 2 ACI 100 sec Data Cell 1 Data Cell 2 Data Cell 5 Choose Cell To Configure DEMO MODE RN dw Hus mE nm CELL 1 CELL 2 CELL 3 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 com Operator s Manual BIOZ COM TUTORIAL
109. s 77 Custom Status Report Selection Screen 1 delia AN T TO Custom Status Report Selection Screen 2 ee eee eere tette eee ee seen sa eaas eene 78 BioZ com Screen Configuration Menu Screen eere eere e eere eee ene seen sae enosstaus 79 Patient Monitoring Screen Cell Configuration Menu 1 eere eene entes 80 Patient Diagnostic Screen Cell Configuration Menu 1 e eee eene eene 81 Hemodynamic Parameter Set Up Menu 1 PI d l Trend Screen Cell Configuration Menu Screen ccccccsccscscssossecssssesccsencsoscesossees 82 Waveform Screen Cell Configuration Menu Screen 83 Patient Data Entry Confirmation Screen ce eee eee e eere eere esee esset ee essen osea aus 84 Patient Data Entry Exit Screen aeree iinsoseeeott an ssa ot bene erro ee eP eee e bein nora PASO dare ede reU do ses 85 Patient Record Review Screen 1 A O REESE TU Patient Record Review Screen 2 Le eeee ee cede eee eese eee esee etes esee eese sees sooo esee 86 Patient Record Review Screen 3 1 eee ecce repe ee e eese esee ee ens esses esee eese sesso eee ee 87 Patient Record Review Monitor Screen 4 e eee cree ee eee ee eese ee ese esas see eesaose 87 Poor ECG Impedance Waveform Error Screen 93 Low battery Warn
110. s to highlight the desired character press the Accept Letter softkey to enter the selected character into the Patient Name field The and 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 hardkey 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 com requires the gender of the patient to accurately determine their hemodynamic status DatecHM DD YYv Y 06 12 2000 Time 06 32 Patient IO 112233555 Patient Name DOE JOHN Required Height Requir ed Meight Requir ed BSA fige Required BP Manual Entry CUP Default 6 PAOP Default 10 Start Monitoring lt NEW FILE Press T or ENTER to accept Select patient gender O O O A Figure 35 Patient Data Entry Screen e Press the appropriate Male or Female softkey The highlight bar will be advanced to the Height field BioZ com Operator s Manual 43 CardioDynamics International Corporation 7 2 44 Height The Height field is required for accurate processing of the patient s hemodynamic status The accuracy of som
111. screens not only display the various parameters and or waveforms but also offer instructions to the User for accomplishing the many functions provided by the BioZ com 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 com 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 com 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 Upd
112. se 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 LOOSE 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 propr
113. 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 Cardiography Sensor Placement Diagram BioZ com Operator s Manual 39 CardioDynamics International Corporation 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 OBP CMAP MES WAITING FOR DATA BP Figure 30 Independent Blood Pressure Screen Once the measurement has been calculated the following screen will be displayed BioZ com Blood Pressure SBP DBP lt MAP E 14 26 Measurement Taken fit 14 26 SS IA IIT EE BP Figure 3 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 40 BioZ com Operator s Manual LIVE PATIENT MONITORING 7 2 2 ICG Monitoring Session At the Welcome Screen Figure 28 press the Start Monitor softk
114. ssssesessessssssssssscsvscecevsssssccecsecseseesees 19 Patient Data Entry Screen 20 Patient Data Entry Screen MR 21 Patient Data Entry Screen e D 21 Patient Data Entry Screen ini 22 Patient Data Entry Screen e H 22 Patient Data Entry Screen aces POE O eese essais d caps ius OR oui Ud Ds Manual Blood Pressure Entry Screen 23 Patient Data Entry Screen acc dde 24 Patient Data Entry Screen icccsccc ccoicsussssescesoosssssensvatscescnasesessoncssedcesvedsseaseepiosecoosecesesionsvouse 25 Monitoring Screen Demo Mode eee eee ee eene eee eee ee eene e eee e snos teen esee tare tena 26 BioZ com User Menu Screen mocos 27 Password Entry Screen PET H 27 Screen Configuration Menwu e eee cede cree ee eese senses eese esses toe toss ee see ss Peste sese eese Pese U Ue 28 Monitoring Screen Configuration 1 A ee eee eee ee eere eee eese eee tb ae tet tae eene tne eeue 28 Monitoring Screen Configuration 2 eee ee e eee e eee ssepe eese eene ena etas s ease enses euue 29 Hemodynamic Parameter Menu 1 ee creen e eere ee eene rese neta anas sean ss aan ase aa ases ena 29 Monitoring Screen Cell Configuration Screen eee ee ee ee eee cesses aene 30 Screen Configuratio
115. sssssssssseeenses EET EN acord 101 13 SOFTWARE LICENSE AGREEMENT cccscsssssssssscsscssccscssosensesseessssceaccnssscssssessessessecees 103 14 APPENDIX A GLOSSARY OF TERMS 1 sccssorsccsccsnversccsccsecsscsseseaseccsensssesseacsnssessesnes 105 15 APPENDIX B PRINT SCREEN REPORT 0 ssscsscssscssscsssscssssscseccsecssessscccecssscssecnsecsoeses 109 16 APPENDIX C HEMODYNAMIC SUMMARY REPORT e eere eene reete toes ta snos 111 17 APPENDIX D HEMODYNAMIC TREND REPORT eere ceste eese etn tna tasto sin enatnn 113 18 APPENDIX E HEMODYNAMIC STATUS REPORT eere eee eret e enata tasso sn senata 115 19 INDEX ws sccsiescscsestedeasses O asen adas An m sie 117 ii BioZ com Operator s Manual Figure 1 Figure 2 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 BioZ com Operator s Manual TABLE OF FIGURES TABLE OF FIGURES is 8 BioZ com Welcome SCreen ccccscoscessessessescessesssssessessss
116. t Monitoring NELI FILE Use keypadvkeyboard to input fige Press 4 or ENTER to accept DEMO MODE Figure 7 Patient Data Entry Screen 22 BioZ com Operator s Manual BIOZ COM TUTORIAL 6 Press the appropriate numerical keys in order to enter the patient s age in years Press the Enter or the d key the cursor will automatically advance to the Blood Pressure field The following screen will be displayed Date tMM DD YYYY 06 11 2000 Time 13 34 Patient ID 223344556 Patient Name Demo Patient Gender Female Height 6 ft 6 in Weight 119 lbs BSA 1 60 Age 24 ER Hanual Entry CUP Default 6 PAOP Default 10 Start Monitoring lt NEW FILE gt Press T or ENTER to accept Select BP Method DEMO MODE la t Eg mes 9 Figure 8 Patient Data Entry Screen The BioZ com allows the User to select one of two methods for obtaining the patient s blood pressure the BioZ com Cuff or Manual Entry 7 Press the Manual Entry key The following screen will be displayed Systolic Diastolic Values Aes UNE Calculated Mean Arterial Pressure Use keypad keyboard to input BP Press ENTER to accept MAP value must be betueen 30 220 mmHg DEMO MODE SYSTOLIC DIASTOLIC dA BACK Figure 9 Manual Blood Pressure Entry Screen BioZ com Operator s Manual 23 CardioDynamics International Corporation 8 Press the appropriate numerical keys in ord
117. temic Vascular Resistance Use T to select parameter Press ON OFF to include or exclude from report i oz Figure 75 Custom Status Report Selection Screen 1 2 Press the and or T softkeys to highlight the desired parameters and press the ON OFF softkey to select the desired parameters to display on the Custom Status Report 3 Press the More softkey the following screen will be displayed Acceleration Index Velocity Index Thoracic Fluid Content Left Cardiac Work Index Left Cardiac Work Systolic Time Ratio Pre Ejection Period Left Ventricular Ejection Time Use amp T to select parameter Press ON OFF to include or exclude from report Figure 76 Custom Status Report Selection Screen 2 4 Press the and or T 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 com 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 com 8 1 2 1 Mo
118. the field will revert to the default setting e After changes have been made press the Return to Monitor softkey the following screen will be displayed 84 BioZ com Operator s Manual DETAILED DESCRIPTION SELECT lt Previous Menu gt OR lt Nelcome Screen PREVIOUSLY ENTERED INFO WILL BE ERASED WITH lt Welcome Screen SELECTION as ee LENIN PREVIOUS WELCOME ie MENU SCREEN Figure 84 Patient Data Entry Exit Screen e Press the Previous Menu softkey to return to the BioZ com User Menu Screen 8 2 Patient Records Management The BioZ com 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 8 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
119. tient s hemodynamic status The accuracy of some of the data provided by the BioZ com may be compromised on persons under 30 kg 67 lbs or over 155 kg 341 lbs in weight see section 2 2 Precautions 44 BioZ com Operator s Manual LIVE PATIENT MONITORING DatecMHy DD YY YY Time Patient ID Patient Names Gender Height PAOP Default 06 12 2000 06 32 112233555 DOE JOHN Male 6 tt Oin lhe Required Manual Entry 6 10 Start Monitoring lt NEW FILE gt Use keypad keyboard to input Weight Press f 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 Date lt MM OD YYYY gt Time Patient ID Patient Name Gender Height Weight BP CUP Default PAOP lt Default 06 12 2000 06 32 112233555 D
120. ular 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 LSWT 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 pressure 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 com Operator s Manual M 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 CD 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
121. ure CVP If this value is not known the BioZ com has a default setting of 6 mmHg see section 8 1 1 3 to change the default setting 48 BioZ com Operator s Manual LIVE PATIENT MONITORING DatecMM DD VY YY Time Patient ID Patient Mame Gender Height Weight fige i Cet sults PAOP Default 10 Start Monitoring lt NEW FILE gt t Use keypad keyboard to input CUP Press f or ENTER to accept If no CUP is entered default is used 06 12 2000 06 32 112233555 DOE JOHN Male 6 t Oin 185 lbs BSA 2 06 40 Manual Entry 5 Figure 42 Patient Data Entry Screen e Use either the numerical hardkeys on the BioZ com face or the external keyboard to enter the current value or press the Enter or the J 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 com allows the User to enter the patient s actual PAOP If this value is not known the BioZ com has a default setting of 10mmHg see section 8 1 1 3 to change the default setting DatecMM DD VY YY Time Patient ID Patient Name Gender Height Weight fige BP CUP Default PROP Default 06 12 2000 06 32 112233555 DOE JOHN Male 6 ft Oin 185 lbs BSA 2 06 40 Manua
122. ure 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 selects the Custom Start End softkey the User will be directed to use the 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 Patient demographics 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 8 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 J 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 H
123. ure 63 Figure 64 Figure 65 Figure 66 Figure 67 Figure 68 Figure 69 Figure 70 Figure 71 Figure 72 Figure 73 Figure 74 Figure 75 Figure 76 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 CardioDynamics International Corporation Manual Blood Pressure Entry Screen Live Mode c eese eee eee eres ta ann 53 Data Out of Range Screen sisccssisisceissscsivsscccascassensiccacdrssesssevssscssiaessoostacatsatevtvenctesdaeseipeatsvve 54 Diagnostic Screen Live Mode 54 Therapeutic Screen Live Mode 4 eere rete ee ee eese eene eee to sees te e tee re tease ee eaae ee eaa 56 Trend Screen Live Mode s iccrscccsncdeccssccasincsencsctenssSeesseivercssascsaetasscecacdeosenatesbesdsssbesvansceaace 57 Expandable Trend Screen Live Mode eee eee e eec eee ee eee eese sees et eess esas een 58 Trend Screen Set Up Screen Live Mode eee eee eee ee eene eee ee eee osea eee ea ee so sena 58 Waveform Screen Live Mode e eeene I EN ANDER 59 Welcome OTC siria dai A seas vauseaausbansceueesbounsees 61 BioZ com User Menu Screen ccccsscsssscsssscssessessessesesssssssessesessessecessesessesecsnsessessesessssessoes 62 BioZ com Set Up M
124. ynamic Status Reports printed in Review Records Mode will not have waveforms BioZ com Operator s Manual 91 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 cardiodynamics 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 X 9 1 Signal Acquisition Error In the event that the BioZ com 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 NO SIGNAL ACQUISITION 1 CHANGE ECG VECTOR 2 CHECK SENSORS CABLE 3 CALL CDIC TECH SERVICE 800 778 4825 858 535 0202 NO_DATA RECORDED DUE TO POOR SIGNAL ACQUISITION 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 HB MM e Change the ECG vector ensure that the systolic beep is activated and listen for detection

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BioZ.com® Operator`s Manual