NICaS Operational Manual
Contents
1. 5 The package includes the following components See Figure 1 5 1 One NICaS CS device One laptop computer is required for system purchase from NI Medical is optional ICG Cable ECG Cable NICaS CS USB cable NICaS CS Sensor Kit pack of 20 ABE AAA applications may be sold separately det Figure 1 NICaS Components Note Please inspect the device to verify that no parts are missing and that no visible damage has occurred during shipment 10 6 5 According to IEC 601 1 1 if the computer or any other attached device is connected to an external power source the power supply should be listed to UL 60950 it must be kept at least 1 5m 60 inches away from the patient When the laptop connected to the NICaS is operated on a battery no distance limitations exist The lifespan of a fully charged battery is approximately one hour 6 1 CONNECTING TO A POWER OUTLET Connect the power cord to the NICaS CS back panel and to a laptop USB slot The AC power connects to a power supply that supplies DC power to the computer and simultaneously recharges its battery 6 2 CONNECTING THE LEAD WIRES TO THE CONNECTORS PANEL Connect the lead wire plugs as shown below in Figure 2 e Plug ECG connector into designated slot No 2 in Fig 2 e Plug Impedance Cardiography ICG connector into designated slot No 1 in Fig 2 e Connect power data cable to the laptop USB port No 3 in Fig 22. The NICaS device replaces the CD drive in any laptop computer transforming it into a medical instrument for non invasive measuring of various cardiac functions These measurements include the cardiac output and its derivatives as well as an assessment of the left ventricular cardiac contractility The NICaS is also unique in that it is the only method of Impedance Cardiography ICG which utilizes dual impedance electrodes placed on two limbs preferably one on the wrist and the other on the contra lateral ankle This type of electrical surveillance is called Regional ICG or RIC This technology is based on two independent principles The first is the fact that the electrical conductance of the blood is higher than that of the surrounding tissue structures Consequently with each arterial systolic expansion pulsation an increase in the electrical conductance or reduction in the electrical resistance of the body is measured This change in systolic resistance impedance is marked AR and the baseline body resistance is R measured in ohms The second principle which is called the Granov Goor Index GGI is based on the systolic time intervals STI which similarly to Left Ventricle Ejection Fraction LVEF can assess cardiac function i e as indicated by LVEF measurement the lower the GGI the graver the condition The NICaS is a tetrapolar apparatus which operates by an alternating current of 1 4 mA and 32 kHZ The analog
3. 72 years 28 May 06 17 02 20 30s Low J Normal 18 0 30 0 High X Figure 21 Measurement Report 40 11 2 PATIENT STATUS REPORT The Series Report is similar in form to a Measurement Report with certain additional data The tabular data displays the average of the series measurements results per parameter The scale displays the readings per series within the high low range for each parameter The continuous colored section on the scale indicates the values for the current series measurement In addition Patient Series report compares the current series measurements with those of the last series taken on the sequential date prior to the current one see Figure 22 M3 The earlier series is marked with a dot before the date column heading The dot indicating the values of earlier measurement it can be within the colored range lower or out of the colored range higher than the current value reading The graphic data displays the ECG and AR waveform The report displays 3 measurement trends chosen for that series Each dot on the trend display represents a single measurement Example HR SV CO The bottom of the page displays all the comments entered by the physician 41 NICaS Hemodynamic Status Report 53 Height 162 cm Birth Age 21 08 1944 68 years Weight 54 kg Date Time 16 10 2012 BSA 1 45 m2 Duration 2 min Supine 921 08 2012 16 10 2012 Low Normal High Heart rate 1 min 65 67
4. Systolic Arterial Pressure mmHg 112 104 Diastolic Arterial Pressure mmHg 54 53 Mean Arterial Pressure mmHg 73 70 Stroke Volume ml 43 59 Stroke Index ml m2 29 40 Cardiac Output L min 40 Cardiac Index L min m2 1 9 2 7 Cardiac Power Index w m2 Left Ventricle Systolic Function 7 Total Peripheral Resistance dn s cm5 TPR Index dn s cm3 Basal Impedance ohm Body Mass Index i kg m2 21 Total Body Water kg Total Body Water 440 Respiration rate 15 15 in ee ee ee ee NI L min Comments Day Care Repeat test on august 28 Signature c 2004 2013 New N I Medical 2011 LTD Program version 3 58 1 D6 Jan 14 14 13 15 Figure 18 Status Report 42 11 3 PATIENT HISTORY REPORTS The top of the page shows patient s permanent data A Hemodynamic Patient Report provides a tabular summary of a patient s previous measurements in ascending order of occurrence Additionally the values of three user selected parameters are plotted to display the trend with relation to its time sequence All the physician s comments are displayed at the bottom of the page 43 Nimecdical NICaS Hemodynamic History Report Name Height 192 cm ID Weight 93 kg Gend BSA 2 13 m2 HR 1 min 140 120 SS ee ee ee ee ee Birth Age 4 3 pd SN S c on Se 01 01 1958 56 Nimecdical SN Date Time SBP 19 01 14 14 04 151 19 0
5. an additional group of patients measured with the Volumetric algorithm see Figure 18 below 33 Correlation with Thermodilution of volumetric algorithm in 25 post operative patients NICAS CO lit min Thermodilution CO lit min Figure 16 Correlation of Volumetric Algorithm to TD in Post Operative Patients Range lines in the plot represent 0 8 L min for TD CO values lt 4 L min 20 for TD CO values gt 4 L min Print Screen is a function that enables converting the data the screen into a PDF format and then save or send it to a mail recipient Help Kd Click to access the electronic user guide Your NICaS version provides information regarding the version currently installed Exit To close the program click on the me at the top right of the main screen 34 Shut Down Pressing the laptop s Power button will begin the shutting down sequence Note If you wish to continue using your laptop simply exit the NICaS application by clicking on the X at the top right of the screen 35 10 5 The NICaS system offers users shift between the regular measurement Figure 7 Main screen screen to a comparative screen Figure 17 Comparative Screen The comparative screen is designed to enable users to perform a set of comparative measurements according to different parameters Stop Comments r3 BB ul gD E Parameter 1 Parame
6. be displayed in the trends charts at the bottom left of the main screen see Figure 11 Choose 3 of the 11 options for display per measurement by ticking the relevant checkbox Parameters Lists the parameters that selected to be displayed in the Parameters pane to the right of the main screen see Figure 11 Choose 10 of the 14 options for display per measurement by ticking the relevant checkbox Trends Speed Determines the rate at which measurement data will be displayed on the chart to create the trend graph Choose from 1 3 5 or 10 minute intervals Settings Techniques is available when measurement is paused or stopped It can be accessed only by authorized personal with validated password The advance setting enables the Algorithm Selection See Figure 12 30 Set Password Mew password Retype new password Cancel Figure 12 Advance Settings Authorization Algorithm selection The default setting is for volumetric measurement and should be the standard mode of measurement This option is for use by advance settings and should be changed only by an authorized technician see Figure 13 ALGORITHM f volumetric yvelocimetric Figure 13 Advance Settings Authorization There are two options for measuring the CO A The standard Volumetric method where the SV is calculated by Frinerman s AR algorithm B The alternative Velocimetric method where the SV is calc
7. 0 108 2147 per GGI TEW kg TBW CARDIAC FUNCTION AEA ANNAN NY ANNAN NTL ISR NN NISRA LENKEN SR IR NORRERDISSEASS NNER LLLLLEEERSELEEE 45 55 50 6 7B T5 80 H5 90 100 105 110 115 120 Heart rate 1imin Comments 486 70 5 308 Patient weaned from positive pressure ventilation Feel well 48 6 70 5 308 i Condusion Patient responding extrimiy well to aggresive aheroad reduction responding well to BB Action taken stop diriton bb cmmence Hydralazin high dose tapering Isoket New targets 70 HR 75 80 Figure 20 Hemodynamic Navigator 45 11 4 1 Cardiovascular Status Graph This graph displays Blood Pressure vs Cardiac Index and helps understand the vascular status To the left and right of the graph are the measurement scales for MAP SBP and DBP each with a graphic representation MAP black dot SBP red triangle DBP blue square The normal range is indicated by a green hexagon Measurement values within the hexagon boundaries are within norm Below the graph is a tabular display of the values for the two measurements parameters 11 4 2 Cardiac Function This graph display of Stroke Index SI vs Heart Rate HR Each series is represented by a blue dot on the graph The arrow indicated the sequence earlier measurement to later The Green graphic form i
8. 1 14 14 01 124 19 01 14 13 59 100 19 01 14 13 56 149 19 01 14 13 49 149 19 01 14 13 45 19 01 14 13 42 19 01 14 13 39 19 01 14 13 36 19 01 14 13 26 19 01 14 13 24 19 01 14 13 21 19 01 14 13 19 19 01 14 13 18 19 01 14 13 18 19 01 14 13 18 19 01 14 13 15 Comments Signature Figure 19 Patient History Report 44 TPRI 2384 2083 2039 3166 1972 2131 1923 1978 2235 2232 2128 2059 2509 2271 3 2315 10 7 2215 97 2562 TBW TBW 51 6 51 5 52 0 52 3 52 0 52 0 52 3 55 5 55 4 56 0 56 2 56 0 56 0 56 2 56 6 58 3 58 8 59 2 58 5 58 5 58 5 58 5 58 7 11 4 5 HEMODYNAMIC NAVIGATOR REPORT Provides Cardiovascular and Cardiac Function graphs for on line drug titration double mouse click on Patient name NICaS Hemodynamic Navigator Name Tibiban Michael 10 013584337 Gender Male 654 1 76 m2 Height 172 cm Weight 73kg Birth Age 01 01 1942 72 years CARDIOVASCULAR STATUS 220 130 TEIXUJLTTE AULA NULLA LLL SiR I pam aA V uns AL AL A Dp E IL JH A sums wet L Ya TN LZ a KL AVANT IN AKT TTT Ne 05 1 5 20 130 85 25 3 0 35 40 as Cardiac Inder Lire niriz SBP MAP HR 5 CI CPI 5 0 55 SM Date Time 009 18 06 13 15 33 134 55 81 74 44 33 060 122 1949 007 18 06 13 15 16 124 55 78 67 43 29 05
9. 1 ICG connector 3 USB connector 2 ECG connector Figure 2 NICas Device Connectors 14 7 PATIENT HOOKUP Five sensors connect to the patient two 2 are paired ICG sensors and three 3 are ECG sensors 7 1 CONNECTING THE ICG SENSORS ICD Cable is connected by a blue plug to the ICG slot of the NICaS The ICG Cable is split into two branches labeled 1 Red and 2 Blue each have 1 double connector and one single connector Connect the ICG sensors to the patient as follows see Figure 3 1 Red branch Single connector left wrist proximal Double connector left wrist distal 2 Blue branch Single connector right ankle proximal Double connector right ankle distal Figure 3 ICG Sensors locations and connection to ICG Cable 42 7 2 CONNECTING THE ECG SENSORS Place the ECG sensors onto the patient as described in Figure 4 e The White ECG lead wire is attached to the Right Arm e The Black ECG lead wire is attached to the Left Arm e The Red ECG lead wire ground is attached to the patient s lower abdomen or leg White ECG Clip Black ECG Clip RED ECG Clip ze Lead Figure 4 Connecting the ECG sensors NICaS CS is optimized for the wrist ankle WA connection which allows to estimate the SV based on both upper and lower peripheral flow In case that pulse can be palpated the signal is strong enough for the NICaS to correctly estimate the SV Note Do not place th
10. IN THE INTENDED PATIENT POPULATION SPECIFIED ABOVE AND THAT DO NOT FALL WITHIN ANY OF THE EXCLUSION CRITERIA SPECIFIED THEREIN 4 Limitation of Liability N I MEDICAL LTD IS NOT LIABLE TO CUSTOMER FOR INDIRECT SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM ANY BREACH OF WARRANTY OR BREACH OF THIS AGREEMENT OR UNDER ANY OTHER 56 LEGAL THEORY INCLUDING BUT NOT LIMITED LOST PROFITS DOWNTIME GOODWILL DAMAGE TO OR REPLACEMENT OF EQUIPMENT AND PROPERTY AND ANY COSTS OF RECOVERING REPROGRAMMING OR REPRODUCING ANY PROGRAM OR DATA STORED IN OR USED WITH AN EQUIPMENT EVEN IF N I MEDICAL LTD HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR LOSSES IN NO EVENT SHALL N I MEDICAL LTD BE LIABLE FOR THE CUSTOMER S COSTS OF PROCURING SUBSTITUTE PRODUCTS OR COMPONENTS IN NO EVENT SHALL N I MEDICAL LTD BE LIABLE FOR ANY THIRD PARTY PRODUCTS SUCH US COMPUTERS THAT ARE USED TOGETHER WITH THE EQUIPMENT EVEN IF THEY WERE PURCHASED N I MEDICAL LTD OR AUTHORIZED DISTRIBUTORS THE AMOUNT OF LIABILITY OF N I MEDICAL LTD FOR ANY CLAIM ARISING UNDER CUSTOMER S USE OR INABILITY TO USE THE EQUIPMENT WHETHER BASED ON BREACH OF CONTRACT BREACH OF WARRANTY NEGLIGENCE STRICT LIABILITY OR OTHERWISE WILL NOT EXCEED THE AMOUNT PAID BY CUSTOMER THESE LIMITATIONS APPLY TO ALL CAUSES OF ACTION IN THE AGGREGATE SOME OF THESE LIMITATIONS MAY NOT BE FULLY APPLICABLE IN CERTAIN JURISDICTIONS 57 58
11. MENT REPORT The report heading states the number of the selected measurement for the report see Figure 21 M13 Top of the page shows patient s permanent data and identifies the date and time of the measurement and the recording intervals 20 seconds This is followed by a tabular display of all the measurement parameters and their results The table states the name and abbreviation of each parameter the measurement unit and the actual reading The last column displays a scale with the low to high values for each parameter The measurement reading is indicated on the scale Green in norm Red out of norm The table is followed by 2 graphs representing a sample of ECG and AR waveform of the measurement 59 Nimecical A New Age n impedance Cardiography Accuracy amp Portabilify NICaS Hemodynamic Measurement Report M13 Height Weight BSA Gender male Body Mass Index Heart rate Stroke Volume Stroke Index Cardiac Output Cardiac Index Cardiac Power Index Granov Goor Index Systolic Arterial Pressure Diastolic Arterial Pressure Mean Arterial Pressure Total Peripheral Resistance Total Peripheral Resistance Index TPRI Basal Impedance R Total Body Water TBW Total Body Water TBW Respiration rate 180 cm 93 kg 2 06 m 2 kg m 2 1 min ml ml m 2 L min L min m 2 w m 2 mmHg mmHg mmHg dn s cm 5 1656 dn s cm 5 m 2 3413 344 47 9 51 5 27 Birth Age Date Time Duration 22 Aug 1933
12. Nimedical USER MANUAL FOR NEW NI MEDICAL 2011 LTD s MODEL NICaS CS With Software version 3 58 BIOIMPEDANCE CARDIAC MEASURING and ANALYZING SYSTEM Caution Federal Law restricts this device for sale distribution and use by or on the order of a physician 0473 Catalogue No NI5 0001 01 10 TABLE OF CONTENTS INTRODUCTION 4 SAFEGUARDS amp STANDARD CLASSIFICATION 6 2 1 CLASSIFICATION eet oia Pedes 6 2 2 SIGNS PU 6 2 3 CAUTION ee rete 6 2 4 WARNING 7 TECHNICAL SPECIFICATIONS ccccccssvsssessvsassesscnesevsestencevvenavseensaccsccvs 8 TAKING CARE OF YOUR SYSTEM 9 4 1 ROUTINE GARE Eh ER Roe dca es Eh 9 4 2 Mirage d AE 9 4 3 9 4 4 ORDERING INFORMATION 9 COMPONENTS e 10 UNIT SETUP Dn T DU de ss iV edis 11 PATIENT HOONKUD is iier RR reu ede Rp ef n e d e S rus 12 7 1 CONNECTING THE ICG SENSORS 12 7 2 CONNECTING THE ECG SEMSORS 13 GETTING STARTED 15 8 1 TYPICAL OPERATING SEQUENCE 15 8 2 FUNCTIONALITIES DURING MONITORING 17 8 3 TABLE OF PARAMETERS aie E eR E
13. Pressure Sensors Location Patient Position b Edit comments _ Opens a window for entering free text comments relevant to the patient the specific measurement or other data entered These comments will appear at the bottom of the series reports see Figure 11 To write a comment position cursor in the right box type in the comment and press the arrow to transfer the comment into the highlighted series at the left box The left box shows all the comments that were written for the selected patient and their dates All comments are displayed in the patient report with the date and time of entry 26 Patient 5 Figure 9 Add Comments View report _ Opens a window with the option to view the data through four types of reports Measurement Report Series Report History Report in ascending order and Hemodynamic Navigator d Export ta Excel _ Export data of specific patient or of all data base to Excel Review Use this option to review a selected measurement f Use this option to start additional measurement of an existing patient After patient has been selected clicking Continue will start a measurement Measurement Start m Starts the measurement Clicking this button changes it to Measurement Pause 27 Patient Reminder A window that opens when the program is reopened The window includes the name of the current patient and 4 options Patient Rem
14. R Us 18 8 4 GGI Granov Goor Index coa Rar 19 FUNCTIONAL DESCRIPTION 20 COMPARATIVE SCREEN Pao SPEM ERR 36 11 5 REPORTING SYSTEM 38 11 1 PATIENT SINGLE MEASUREMENT REPORT 39 PATIENT STATUS REPORT m pts ee 41 113 REPORTS 43 11 4 NICaS HEMODYNAMIC NAVIGATOR REPORT 45 115 REPORT OPTIONS 47 125 ALARM oiii seat Eb ate spreto a 48 13 INTENDED PATIENT POPULATION 50 14 TROUBLESHOOTING oh deese donde 51 15s llt t cese c 52 16 ORDERING INFORMATION 53 APPENDIX A KIMITED ONE YEAR WARRANTY 54 1 INTRODUCTION The NICaS Non Invasive Cardiac System is a bioimpedance system focusing on noninvasive assessment and monitoring of cardiovascular respiratory and fluid parameters The system provides real time data on various parameters of a patient s cardiac vascular functions The data from any given reading session is displayed on the screen according to the different parameters patient reports can be issued and saved trends in the patient s heart condition can be viewed and monitored and the system also provides historical data and comparative reports
15. atory rate of the present measurement Right pane displays 10 user pre selected parameters from a total of 14 The values of the parameters are preprogrammed to be updated at 10 20 or 30 seconds intervals during a measurement Bottom left pane below the wavelength displays the trends of three of the parameters selected from the vertical right side readings HR SV and CO during a measurement 20 Measurement 9 09 09 12 12 48 40 INE 128 Figure 7 Main Screen 9 2 THE DISPLAY Left pane screen waveform display refer to Figure 7 above l GREEN waveform represents the ECG Il RED waveform represents the bioimpedance AR IIl WHITE waveform represents the respiration The waveforms progress from left to right along a horizontal axis drawing the vertical values of the ECG ICG and respiratory measurements The Horizontal axis is marked by 1 second interval indicators 21 Right pane display The right pane displays 10 parameters that provide data on the current measurements These parameters display the real time values of the measurement for the selected parameters The normal measurement range for each parameter is displayed below the measured value The color display is to enhance distinction between the parameters in real time and does not qualify the measurement in any way For parameters glossary of abbreviations see the Table of Parameters in the section Getting Started Bottom left pane Tre
16. e Patient List window and by clicking this Review button in the Patient List the review of the selected measurement will appear To stop the measurement review press the Stop button Setting Options Use this window to select your default or pre measurement settings Click on Settings or the icon to open a window menu that displays all the system parameters and check boxes see Figure 11 ECG zoom Measurement duration sec w 2 gt 20 i 30 TRENDS INDICATORS Show trends 3 Show indicators 10 Heart Rate Heart Rate Stroke Yolume Stroke Volume Cardiac Output Cardiac Index Cardiac Output Cardiac Index Granov Goor Index Granoy Goor Index Cardiac Power Index Respiration Rate Stroke Index TPR TPR Index TBW relative 2 Cardiac Power Index Respiration Rate Stroke Index TPR TPR Index relative 2 R dR mm EST BS ISI 11444141 I I lt lt Trends speed every measurement im ALGORITHM C 3min C 5min C 10min C yvelocimetric wolumetric Patient Reminder Sound Cancel Figure 11 Setting Options 29 ECG zoom Choose one of three amplitude gain options for the ECG 1 2 or 4 Gain 2 is default Measurement duration Offers the option to choose rate of updating the data during the measurement 10 20 or 30 seconds intervals default is 20 seconds Trends Lists the parameters that can selected to
17. e connector on limb with the following abnormalities and choose a different limb e Peripheral Arterial Disease PAD e Significant Edema e Damaged skin Note Do not use any sensor paste as this will reduce the electrical conduction 13 Make sure area where sensors are to be placed on patient s arm and leg is clean free of perfumes colognes and lotions and the skin is not damaged Patient s limbs should not be cold and pulse should be palpated e Patient s limbs should be placed so that electrodes do not touch each other e There should be no metal in the vicinity of patient s limbs e Place a new set of disposable electrodes onto patient s skin before each measurement e To prevent the sensors from drying out do not open until immediately before use Caution Do not use sensors after specified shelf life has expired 44 8 GETTING STARTED 8 1 TYPICAL OPERATING SEQUENCE NICAS The following paragraphs describe a typical operating sequence with the NICaS CS monitor 8 1 1 Power Up 5 CS Ensure the laptop is on and running and that the NICaS CS is connected to its USB connector Double click the NICaS icon The start up process might take a few minutes to complete 8 1 2 Connecting Lead Wires to a Patient See explanation in section of Patient Hookup 8 1 3 Measurement Start Up To start the monitoring process select either New Patient or Existing Patient 8 1 3 1 To be
18. e system enters a default measurement o The numbers on the right indicate the accepted range for each of the data entered e Connecting the sensors choose 2 options left and right wrists RW LW and left and right ankles RA LA o Clicking on your choice of icons will change the not set to indicate the selected placement i e RW LA e Choose one of the three positions of the patient during the measurement supine sitting or standing Click save and measure e Click to save and exit e Click to cancel Patient measurements file display Click on a selected patient from the left pane list will display his her measurements file in the right pane The name of the patient appears at the top of the right pane Selecting the relevant patient s name displays the measurement data on a 3 level hierarchy Example Figure 9 left pane Patient 3 is selected Right pane shows the Patient 3 measurement library Click on Patient number to open all files P Patient name or number Patient 3 25 were taken 23 Sep 12 Each Series has several measurements M Listed Measurements stating by the measurement number M 817 and hour 10 34 34 The Patient Management window has additional 6 function buttons at the bottom of the window for accessing managing and retrieving patient data and issuing reports a Update senes _ enable changing the following parameters of existing series Systolic Blood Pressure Diastolic Blood
19. fic measurement Placing the cursor on the dot and right click on the mouse neutralizes it from the average calculation for that trend displayed numerically at the side The bottom right continues the numerical comparison between the current and average values for the other parameters When opening the Patient Management window from this screen the patient file also displays the date of each of the series 37 11 NICAS REPORTING SYSTEM There are 3 types of reports Patient Measurement report report of 1 measurement obtained by clicking on the required measurement e g M 12 in Figure 20 Patient Series report report of average of a few measurements obtained by clicking on the required series e g S 3 in Figure 20 Patient History report report of all historical series obtained clicking on the patient name e g Patient 1 in Figure 20 After required report has been selected press View Report View report generate a PDF report Hemodynamic Navigator provides Cardiovascular and Cardiac Function graphs for on line drug titration double mouse click on Patient name 15 10 39 58 H S H4 23 Aug 12 Figure 20 Selecting reports 58 All reports display the patient s identification as entered during registration Name ID number sex date of birth and height All other data and display varies according to the selected event and type of report 11 1 PATIENT SINGLE MEASURE
20. gin measurement of a new patient select one of the following 3 options a Press Patient button and select New b Press the first icon on the toolbar 55 After selecting one of these two options window with all the details relevant to the patient will open Fill in details and click The measurement will 45 begin c Press the Measurement Start button D The following window will open Patient Reminder Current patient is LL Enter Patient Find Existing Patient Figure 5 Patient Reminder Select Enter New Patient and the window with all the details required for the patient will open 8 1 3 2 To start the measurement of an existing patient select one of the following 2 options a Press Patient Button 55 and select Find b Press Measurement Start button m The Patient Reminder window opens see above i Ifthe name in the field following current patient is correct select Continue i If the name in the field following current patient 15 incorrect or blank select Find Existing Patient A Patient List window will open in which you can seek the relevant patient see a more detailed explanation in the Functional Description below 16 8 2 FUNCTIONALITIES DURING MONITORING 8 2 1 Alarms NICaS has a built in alarm system that alerts the user of a technical failure This alarm may sound while monitoring a pat
21. gt 10 0 equals an Ejection Fraction gt 55 Granov Goor Index Total Peripheral Resistance Total Body The amount of extracellular TBW 40 0 63 09 Water fluid in or kilograms A Respiration Number of breaths each 8 24 breaths rate minute minute 18 8 4 Granov Goor Index is a ratio that assesses Left Ventricular Systolic Function similarly to LVEF Higher GGI readings indicate a better Left Ventricular Systolic Function Below is the Correlation graph of GGI vs LVEF GGI lt 10 is associated with LVEF of lt 55 The graph represents Blinded comparison of EF and in 60 patients presenting at a cardiology clinic asymptomatic of ischemic heart disease selected to undergo echocardiography and selected in accordance with device exclusion criteria Data is not from an unselected population Granov Goor Index Figure 6 Granov Goor Index 19 FUNCTIONAL DESCRIPTION 9 1 Main Screen The main screen is used to navigate and operate the system and present the different views of the measurement data see Figure 7 below Toolbars and menus At the top of the screen there are 2 navigation toolbars They are functionally identical the top one is textual and the bottom one has icon representations The screen is divided into 3 main sections as follows Left pane display is divided horizontally into three sections The sections display waveforms representing real time ECG AR and Respir
22. hnical alarm sounds a unique technical alarm audio notification is heard and the status line in bottom of the screen displays the cause of the alarm Figure 23 demonstrates a technical alarm scenario 5 2004 Patient Measurement N 64 11 13 06 13 13 07 eam cec Cee 900 s Figure 22 Technical Alarm 48 Possible Technical Alarms are A B C Communication port problem there is no data received from the unit Root cause Communication cable is not properly connected e Hardware defect on the cable or port of NICaS or PC Bad electrodes No data from electrodes Root Cause e Electrodes are not attached properly e Hardware defect on electrodes Cannot calculate results Bad data from electrodes Root Cause e Electrodes are not attached properly e Electrodes are dry 49 13 INTENDED PATIENT POPULATION The NICaS CS is intended to monitor and display patients hemodynamic parameters including stroke volume stroke index heart rate cardiac index cardiac output total peripheral resistance and the Granov Goor Index in males and females with known or suspected cardiac disorders needing cardiac assessment Exclusion Criteria For proper use of the RIC technology the following exclusion criteria must be strictly adhered to Aortic valve insufficiency Significant aortic valve stenosis Severe mitral valve insufficiency The following aortic conditi
23. ient however it indicates a technical failure only In the event of a technical failure the system sounds an audio notification and the status line at the bottom of the screen will display the cause of the alarm Note See Alarms Section 11 for a more detailed explanation 8 2 2 Review Collected Data Review Mode enables the review of previously measured data This mode can be accessed by directly pressing the Review button on the main menu or by pressing e 17 8 3 TABLE OF PARAMETERS Parameter Abb Definition Normal Range HR Number of heart beats each 58 86 bpm beats minute per minute Number of heart beats each 60 130 milliliter minute S Stroke volume normalized 35 65 for body surface area milliliter beat m Amount of blood pumped by the left ventricle per minute Cardiac Output normalized 2 5 4 7 for body surface area liter min m Heart Rate Stroke Volume Stroke index Cardiac Output An indicator of myocardial contractility Cardiac Power 0 45 1 0 Index An indicator of Left Ventricular Function which is strongly related to Ejection Fraction The resistance to the flow of blood in the arterial system 770 1500 often referred to as dynes seccm Afterload Total The resistance to the flow of 1540 3000 Peripheral blood in the arterial system 5 TPRI dynes sec cm Resistance normalized for body surface Index area
24. inder Current patientis LL Enter New Patient Find Existing Patient Cancel Figure 10 Patient Reminder o Continue Choosing this option continues the measurement of the current patient o Enter New Patient Opens a window that includes all the data necessary for a new patient see above o Find Existing Patient Opens the Patient List window from which the relevant patient can be selected by marking his her name in the left screen o Cancel Closes this window Measurement Pause Stops the measurement To continue select Measurement Continue The measurement continues the sequence from where it was stopped without losing the data already accumulated for this series i e trends and last results of all parameters When Pause is activated 4 menus can be opened 1 Report for a single measurement 2 Settings options are available the number and or types of trends displayed on the screen can be changed 3 Comments and 4 Help Stop Stops the measurement When restarting the measurement continues the sequential numbering from the last measurement without retaining comparative data 28 Review e Opens a window with a 4 graphs display ECG dR dR dt and respiration and the calculated results of the patient s last measurement This option is available only when the patient is no longer connected to the NICaS system In addition any other measurement can be selected from th
25. ized distributor equipment has been combined with software hardware or other equipment not supplied by New NI Medical Ltd or its authorized distributor f if at any time the power supplied to any part of the equipments exceeds the rated tolerance design parameters or applicable local regulations g the equipment has been installed not in accordance with the written installation instructions provided by New NI Medical Ltd or by its authorized distributor h the equipment has been damaged by causes beyond the control of New NI Medical Ltd I the equipment has been modified without New NI Medical Ltd s written consent or j if any time the serial number plate is removed or defaced 55 Customer will reimburse New NI Medical Ltd for all expenses and costs involved in New NI Medical Ltd s efforts in the event the problem for which service sought is not covered by the above warranty 3 Limited Warranty EXCEPT FROM THE WARRANTY SPECIFIED ABOVE THE EQUIPMENT IS PROVIDED AS IS AND THERE ARE OTHER WARRANTIES EXPRESSED OR IMPLIED IN LAW OR IN FACT INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE TO CUSTOMER HEREUNDER CUSTOMER ACKNOWLEDGES THAT THE EQUIPMENT 5 NOT A DIAGNOSTIC OR THERAPEUTIC DEVICE AND MAY BE USED ONLY FOR THE PURPOSES APPROVED BY THE FDA SPECIFIED BELOW CUSTOMER ACKNOWLEDGES THAT EQUIPMENT MAY BE USED ONLY ON PERSONS WHICH ARE INCLUDED
26. lugs from the NICaS box WARNINGS DO NOT USE ANY ELECTRODE PASTE WHICH WILL REDUCE ELECTRICAL CONDUCTION DO NOT REMOVE COVERS OR PANELS REFER TO QUALIFIED SERVICE PERSONNEL NO MODIFICATION OF THIS EQUIPMENT IS ALLOWED 3 TECHNICAL SPECIFICATIONS NICaS Dimensions L 12 8 x W 13 1 x H 1 3 cm 5 0 x 5 2 x 0 5 inch Weight 150 gm 5 02 Power USB 5v 15 OmA DC Temperature 10C 50F to 32C to 90F for operation and sensor transport and storage G Method regional impedance 3 lead RA LA LL Lead mode 1 lead I V V single channel GND Waveform Gain Sweep speed Impedance range AR Range AR Signal Bandwidth Accuracy Sample Rate 200 Hz Injection Current 1 35 0 1mA RMS at 32 5 0 5kHz 4 TAKING CARE OF YOUR SYSTEM 4 1 ROUTINE CARE The following rules should be applied in everyday work to allow the NICaS CS extended durability e Keep the NICaS CS dry expose the NICaS CS to extreme temperatures Keep NICaS CS away from dust and any kind of dirt pay particular attention to the electrode connectors 4 2 MAINTENANCE repairs are to be performed only by New NI Medical 2011 Ltd service personnel or alternatively by authorized distributor personnel 4 3 CLEANING ECG and BIP cables and lead wires must be cleaned with soap and water before each application to a new patient 4 4 ORDERING INFORMATION See Section 16 5
27. ment The window displays the list of patients already registered in the system To enter a new patient or to search for an existing patient enter the patient s Last Name First Name or ID in one of the top 3 boxes If the patient exists click on the selected patient in the list of patients Patient First Name Last Name and ID will appear in the top 3 boxes 25 Enter LIpdate Clicking the button Enter Update patient data Ed on the upper right corner opens New Patient window were patient data need to be filled in In the event of an existing patient just update data that were changed from previous measurement see Figure 10 amp New Patient LAST NAME FIRST NAME ID NUMBER GENDER not set s e HEIGHT WEIGHT HEMATOCRIT SODIUM SYSTOLIC PR DIASTOLIC PR ELECTRODES RALA DATE OF BIRTH Month Day Year h 1933 M min max gt 66 661 15 75 100 160 20 300 0 200 POSITION not set mmm Figure 10 New Patient The following Patient data menu should be completed in full Type in full name and ID number Click on the icon to indicate sex M F Choose from scroll menu date of birth mm dd yy Enter the data for the Height Weight Hematocrit Sodium Systolic Blood Pressure Diastolic Blood Pressure O Note If no updated data on Hematocrit and Sodium for 24 Note If no updated on Hematocrit and Sodium for patient th
28. ndicates the norm Measurement values within the graphic boundaries are within norm Below the graph is a tabular display of the values for the two measurements parameters 46 11 5 REPORT OPTIONS 11 5 1 Quick Report Pointing the mouse to a measurement M or to a series S in the right hand pane will open a small window with the results of 5 parameters HR SV CO Cl TPR either for the specific measurement or the average for the series 11 5 2 Omitting a measurement s from a report Selecting a measurement or several measurements with the right mouse button excludes these measurements from Statistics and from calculated averages in reports see Figure 25 M 8 309486678 06 Sep 1937 50198043 19 May 1950 02069953 04 Apr 1928 7110734 21 Aug 1944 58047416 16 Mar 1963 4 23 Aug 12 23 Sep 12 23 Sep 12 27 Aug 13 19 Aug 12 Patient 4 S 1 21 Aug 12 S H2 16 Oct 12 S H3 16 Oct 12 M 6 12 05 04 7 12 05 24 H8 12 05 44 9 12 06 05 M 10 12 06 25 M 11 12 06 45 H4 12 Feb 13 H5 27 Aug 13 6 27 Aug 13 Update series Edit comments View report Export to Excel Send data Review Figure 21 Patient Management Windows 47 12 ALARMS As mentioned in the previous section system can set off one of alarm while monitoring a patient Technical Alarm Technical alarms are activated as a result of a technical or software failure When a tec
29. nds display This area is divided into 3 graphs The trends are chosen from a list of 14 parameters in the Options window see Figure 12 below whereas HR SV and CO are the default trends displayed Each point on the screen represents the measured and computed result of a single measurement The sequence of points displays the TREND for that parameter during the specific measurement at 10 20 or 30 seconds preset intervals The latest measurement point is located furthest to the right 9 3 Toolbar menus The main screen offers 2 options for navigating through NICaS system the top is a text menu and the bottom is a graphic tool bar see Figure 8 CS Patient Measurement start Stop CM Comments Review Recalculate Settings Print Screen Corporate Data Help Figure 8 Main screen navigating menu 22 Patient s Patient Management window Before entering a new patient you may want to check if he she is already registered in the system use this option to add a new patient find an existing one or to edit data of an existing patient See Figure 9 Last Patient First 3 Patient 3 308486578 06 Sep 1937 23 ug12 HS 1 23 Sep 12 50198043 19 1950 23 Sep 12 HS 2 235 1 02069953 04 1928 23 Sep 12 HS H3 235 12 1 5 4 23 Sep 12 16 102414 7110734 21 Aug 1344 2f Aug 13 59042416 16 Mar 1963 13 4ug 12 mM HB 10 34 54 M 19 103542 5 235 12 HE 235 12 Figure 9 Patient Manage
30. ons a aneurysm b coarctation c obstruction bifurcation Peripheral vascular disease with feeble or absent peripheral pulses Restlessness and or chaotic breathing Congenital cardiac malformations Extra cardiac shunts During renal dialysis Adiposity 5096 or more than normal Height under 1 50 m and above 2 00 m Attention For optimal results the patient must be motionless except for normal breathing If the patient cannot be immobile sedation is recommended 50 14 TROUBLESHOOTING When problems arise a message will be displayed at the top of the screen referring the user to the following chart PROBLEM ACTION 9 1 MESSAGE Check Check if power connection and the RS232 plug Connectors are properly plugged in If problem persists contact manufacturer s local Service Department 9 2 MESSAGE Bad Check ECG and impedance electrodes for dirt or Electrodes broken parts Unplug sensors clean connectors with a clean cloth and 90 alcohol If unsuccessful replace with new set of electrodes In case of a general problem refer to the following chart for further details PROBLEM RESOLUTION 54 15 SERVICE Should service be required during or after the warranty period please contact New NI Medical representative as per list below please visit our website www ni medical com for an update distributor list to obtain a Return Authorization Number Please repackage the device carefull
31. resistance signals are received by the device where they are amplified and filtered These signals are then transmitted to a microprocessor where they are digitized and analyzed via mathematical algorithms ECG resistance and respiratory waveforms as well as numerical patterns are displayed on the screen The collected data can be easily printed or viewed through several easy to define reports 2 SAFEGUARDS amp STANDARD CLASSIFICATION 2 1 CLASSIFICATION 2 1 1 Equipment Classification according to IEC 601 1 e CLASS EQUIPMENT according to the of protection against electrical shock e EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE with air or with oxygen or with nitrous oxide e CONTINUOUS OPERATION according to the mode of operation 2 1 2 Equipment Classification According to EU Medical Device Directive DEGREE OF PROTECTION against electric shock is type BF 2 2 SIGNS Class double isolated device N cenena warning sign BF type body protected floating symbol 2 3 CAUTION NOT FOR INTRACARDIAC USE The instrument does not utilize a protective earth ground The instrument is not protected 2 4 INPUT PROTECTION The device is not protected against defibrillation Therefore before the patient undergoes defibrillation all five electrodes 3 ECG and 2 dual impedance must be disconnected from the patient This can be achieved by pulling the two main cable p
32. rvice New NI Medical Ltd s sole obligation and customer s sole remedy for any failure of an equipment to perform as warranted above is the correction or replacement at New NI Medical Ltd s option of the non conforming equipment provided however that New NI Medical Ltd has been notified by customer or New NI Medical Ltd s authorized distributor of the non conformity prior to expiration of the warranty period set forth above replacement of equipment shall be made by New NI Medical Ltd only against receipt of the defective equipment unless otherwise agreed between the parties 2 Warranty Exceptions The warranty set forth herein will not apply and customer will reimburse New NI Medical Ltd or its authorized distributor as applicable for any costs and expenses incurred in connection with goods or services provided in the event a the equipment has been used other than in accordance with this User Manual its documentation or other written operating instructions or has been subject to negligence or accident by anyone 54 other than New NI Medical Ltd its authorized distributor b use of the equipment in excess of the maximum period determined by New NI Medical Ltd or its authorized distributor products or parts identification labels are removed altered from the equipment d the equipment has been modified repaired serviced maintained or altered by anyone other than New NI Medical Ltd or its author
33. ter 2 current Paramet Paramet CO 47 6 0 current average current average current current current current current current average average average average average average 02 21 14 4 ENG 21 02 2014 Figure 17 Comparative Screen Click on to shift from the regular to the comparative screen The top screen display is of the ECG green and AR red waveforms Note Enter the comparative parameters of your choice for each measurement series in Parameters 1 Parameter 2 These parameters can 36 be customized through the Setting Options menu Click to open the Comparative Measurement Options and edit Parameters 1 and 2 according to your comparative parameters Before starting a new measurement the system will open a dialog box reminding the user to change the comparative parameters for that measurement The right pane displays the data for each series in descending sequential order the current or last measurement appears at the bottom The numerical data in the right pane columns displays and updates the values per series with reference to the comparative parameters 1 and 2 The left pane displays 4 trends representing the series graphically and numerically each dot is a measurement in a series The numeric data displays current vs average values When the measurement is stopped a click on any of the dots changes the top ECG AR waveforms to that of the speci
34. ulated by the first derivative of AR 31 The velocimetric option should used only when the patient s admitting diagnosis is acute heart failure Enclosed is a graph showing correlations with range lines of the results from acute heart failure and another graph for all other patients The data from which these two graphs were constructed were published in Cotter s paper Physio Measures 2006 27 817 27 Correlation with Thermodilution of Volumetric vs Velocimetric Algorithm in post operative patients Velocimetric Volumetric 2 Thermodilution lit min Figure 14 Correlation with TD in P Operative Patients Range lines in the plot represent 0 8 L min for TD CO values lt 4 L min 20 for TD CO values gt 4 L min 32 Correlation with Thermodilution of Volumetric vs Velocimetric Algorithm in Acute Heart failure patients Velocimetric lt o Z O Volumetric Thermodilution lit min Figure 15 Correlation with TD in Acute Heart Failure Patients Range lines in the plot represent 0 8 L min for TD CO values lt 4 L min 20 for TD CO values gt 4 L min As one can see in the acute heart failure group the lower the cardiac output below 4 0 lit min the higher the accuracy of the velocimetric results and the higher the cardiac output the better the volumetric results Results of
35. y in its Original box or in a sturdy carton to prevent damage describing the nature of the problem and your return address Include a note We also suggest that you insure the package Send the medical device to Main Office New NI Medical 2011 Ltd 3 En Hay St Kfar Mallal 4592000 Israel Tel 972 9 7407031 Fax 972 9 7401030 Email sales nimedical co il Www ni medical com USA New NI Medical 2011 USA 500 Market St Suite205 Chapel Hill NC 27516 USA Tel 1 800 979 2904 Fax 1 888 724 2926 E mail sales ni medical com WWW ni medical com 52 EU Official representative New NI Medical 2011 UK TEL 44 0 758 049 8397 E mail sales nimedical co uk www ni medical com NI Medical will provide service and support for product for at least seven years from the day of manufacture 16 ORDERING INFORMATION If for any reason you wish to order one of the following items please write to us or to your supplier and remember to enter part number and description as specified below PartNo Description NI2 0009 04 NICaS CS Sensor Kit ICG only box of 100 applications 53 APPENDIX A LIMITED ONE YEAR WARRANTY 1 Warranty N I Medical Ltd warrants that for a period of twelve 12 months from installation of equipment at a customers premises such equipment excluding consumable component will materially conform to its published specifications under normal use and se
Download Pdf Manuals
Related Search