Home

Cheetah NICOM User Manual

Contents

1. or Check Right Sensor Cable or Connectivity These messages appear with an additional message Poor Signal Reason disconnection between the NICOM device and the patient s body This results in a suboptimal NICOM signal Cause Patient s cable or one or more of the NICOM Sensots are not connected properly to the NICOM device or to the patient Solution Check that the NICOM right or left according to the message sensors are well attached to the patient body and connected properly to the NICOM cable Check the connection of the NICOM cable to its socket in the rear panel on the back side of the NICOM device Sometimes earlier sensor replacement is warranted especially if the sensors are wet or if the underlying skin is hairy If the problem persists stop the test and start a new one 3 Message Problematic Results Movement or Sensor Problem Reason This message will only appear at the end of a Study period for 5 seconds when the device is unable to report reliable results at the end of a Study due to long periods of excessive movements or long periods of sensor disconnections Cause Patient s cable or one or more of the NICOM Sensors were not connected properly to the NICOM device or to the patient or and the device detected patient or cable movements that distorted excessively the signal Solution The user should discourage excessive cable or patient movements in Rest type tests or minimize as much as poss
2. A On product means consult accompanying documentation Bi On product means see instructions for use 1122 2 n Demo Doe Male AgeS3 92kg 165cm BSA1 99 R Patient Info Bar Run Bar Test Controls Pop Up Menu Protocols Manual Data Entry Switch Display ete 28 Menu Bar Patient Information Bar Appears on all Run screens This bar holds all of the patient s info as it was inserted into the system such as ID Name Gender Age Weight Height and BSA The Patient Information Bar also holds the Test Type Icon R for rest testing or S for stress testing Run Bar Appears on all Run screens This bar holds the Study Refresh Clock Alarm status icon Test status icons play pause or stop and the Message Display area Menu Bar Appears on all of the NICOM s screens This bar holds the Screen Name Operation Help line Date Time and Battery status Note In order to reach the sub menu first enter the screen s pop up menu by clicking the NICOM s Back button Then either click the NICOM s OK button or use its Right arrow key to enter the sub menu All icons described according to order of appearance from left to right Chapter 1 0 Introduction 11 Introduction The Cheetah NICOM Reliant System is a portable non invasive cardiac output CO monitoring device based on BIOREACTANCE technology It also measures Heart Rate HR Stroke Volume SV Stroke Volume Variation SVV Ventricular Ejection
3. In the US Cheetah Medical Inc 600 SE Maritime Ave Suite 220 Vancouver WA 98661 USA Toll free 1 866 751 9097 Telephone 1 360 828 8685 Fax 1 360 718 8154 In Europe and Asia Cheetah Medical UK Limited 1 Irmar House 59 Cookham Road Maidenhead Berkshire SL6 7EP United Kingdom Telephone 44 1628 636806 Fax 44 1628 788802 E mail cheetah cheetah medical com Web Site www cheetah medical com Note Equipment accessories and replacement parts are generally shipped from the company within 10 business days following receipt of order It may be recommended to stock strategic parts The following section outlines the recommended replacement parts inventory 101 Note It is strongly recommended that all NICOM parts be replaced with parts purchased from Cheetah Medical or an authorized distributor Use of other parts may damage the unit and could void the unit warranty 9 2 Equipment and Accessories Inventory The minimum recommended order of equipment and accessories is as follows Equipment inventory No Description Qty Product Code Supplied 1 Cheetah NICOM Cardiac Output 1 CMM RE1 X Monitor 2 USB cable A to B 1 8 cm 1 CMA USB10 X 3 NICOM Patient cable 2 CMA Cable10 X 4 NICOM Sensors CME50 CME100 CME200 5 Cheetah NICOM User Manual CD 1 X 6 NICOM EMR CD 1 X 7 Cheetah NICOM Quick Reference l X Guide 8 NIBP Cuff 1 X 9 Cheetah NICOM Carry Bag CMA Bag1
4. NIBP options 68 4 10 NIBP This option allows the user to enable or disable the NIBP monitoring option When the NIBP is set to Disable the NIBP and TPR boxes on the Run screen will be turned off and the word Disabled will appear next to the word NIBP in the NIBP box When the NIBP is set to Enable the NIBP and TPR boxes on the Run screen will be turned on and the word Enabled will appear next to the word NIBP in the NIBP box NIBP will be available for performing NIBP measurements only when it is set to Enabled When the NIBP is set to disabled the NIBP is not functional and will not respond to NIBP measurements requests ID 99999DEMO John Demo Doe Male Age 53 92 kg 165 cm BSA 1 99 05 45am 11 11 09 De Figure 4 4 Run screen NIBP disabled 4 11 NIBP Operation Mode This option allows the user to choose between manual NIBP measurements which means the operator can take a measurement at any given time according to his patient s needs and Automatic Manual measurements which means that the operator can perform a measurement at any given time and the NICOM will perform an automatic NIBP measurement at a specific period of time every 30mins for example according to the Time Interval settings that were set by the operator While using the NIBP Automatic Manual option if a manual measurement is taken 2 minutes prior to the beginning of an automatic one the automatic measurement will be delayed Should the t
5. RELIANT The RELIANT is intended for use in the electromagnetic environment specified below The customer ot the user of the RELIANT should assure that it is used in such an environment I ity test TEC G00 re eenpuance Electrom tic environment guidance mmunity tes Test level level ectromagnetic enviro gui Portable and mobile RF communications equipment should be used no closer to any part of the RELIANT including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 17VP TEC 61000 4 6 150 k Hz to 80 MHz d 117VP 80M Hz to 800 MHz 3V m d 23VP 800 MHz to 2 5 GHz 3V m Radiated RF 80 MHz to 2 5 TEC 61000 4 3 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation Distance in meters m Field strengths from fixed R F transmitters as determined by an electromagnetic site survey a 98 should be less than t he compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol o NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from str
6. 140 160 180 and 200 Setting the correct initial inflation pressure reduces the incidence of both over inflation and under inflation of the blood pressure cuff which also affects the rate at which the blood pressure measurement is taken while increasing patient comfort Note In any case of over inflation of the blood pressure cuff the NIBP measurement can be stopped immediately by using one of two methods see figure 4 5 below 1 While in the Run Screen press the NICOM s BACK button to view the pop up menu options then choose the End NIBP option which stops the NIBP operation and deflates the cuff immediately 2 The cuff connectors which are located on the back and in the middle of the air tube are designed to allow for be rapid disconnection by the user which results in immediate deflation of the cuff a disconnection of just one of the cuff connectors will result in immediate cuff deflation 70 Maie AgeS3 92kg 165cm BSA1S9 nR NIBP Time interval 7 2 Manual NIBP jenan Protocots Manual Data Entry Switch Display onesam 11 5100 a Figure 4 5 NIBP disconnection options Software option upper figure hardware option bottom figure Note In case that the NIBP cuff is not correctly adjusted to the patient or when there is an air leakage in the NIBP cuff connection the system will prompt a failure message Date and Time From the Main Menu screen select the Settings option using the
7. Browsing Through Trends and Table Display To browse through the trends and tables presented by the monitor touch the arrows of the dedicated slider For faster browsing drag the Slider body Browsing Through Events In the Numerical and Trends displays skip between events by touching the Events Browsing Tool on the screen 1 4 Rearand cables Observe the tear side of the monitor box Figure 1 2 Back panel of the NICOM In the rear of the device there are five cable sockets 1 NICOM Patient Cable connector the wide socket is intended for the NICOM Patient Cable The other end of the patient cable should be connected to the NICOM Sensors which are applied to the patient s body as described in the section Performing a Test section number 3 2 Note The NICOM Patient Cable is connected to the NICOM using a D type connector with screws Make sure to tighten the screws when connecting the cable to the device in order to prevent disconnection that would lead to loss of monitoring function WARNING It is advised to clean the NICOM Patient Cable between patients in order to prevent the transfer of infectious diseases see in Section 8 2 Service and Maintenance Cleaning Power socket standard electric power socket The device can also function on its internal chargeable batteries Connecting this cable to an electric source will supply the monitor from the main grid and charge the batteries USB port connect
8. O Management a Retrieve Data Open Delete amp Change Password Log Out Figure 5 2 NICOM EMR Change Password screen In this screen you will be asked to enter your current password to the first field You will then be asked to enter a new password of your choice to the following field then enter it again in order to verify it Select the OK button on the screen to accept changes or choose Cancel to discard password change 77 5 2 Retrieve Data B NICOM EMR Connect the USB Cable to the Reliant 9S illustrated Management G __ Retrieve Data Change Password Log Out Figure 5 3 NICOM EMR Retrieve data wizard In order to allow data to be transferred from your NICOM device to your PC select the Retrieve Data option at the bottom left side of the screen A data wizard will be prompted Follow the on screen instructions to connect the NICOM device to your PC and start retrieving data When instructed use a USB cable supplied to connect the two devices When data import from the NICOM to the PC is completed the NICOM EMR Management screen will be displayed see Figure 5 4 below where the new information will be prompted and ready to be accessed immediately 78 5 3 Management BD wicom ene Search for a Patient Patenio Pinnae Lan hime Entry Date From Entry Date To Update Date From Update Date To 02032009 owesz09 Clear Patient List U
9. This screen was developed for training purposes It simulates the procedure of running a test on a patient using the system only no disposables are needed for this action Press the OK button to start a study scroll between the various screens using the Up Down arrow keys in order to visualize a demonstration test 2 23 Shut down Screen The purpose of the Shut Down screen is to safely turn the device off The Shut Down screen is accessed by selecting the Shut Down option on the device s Main Menu screen Existing Patient gt New Patient Settings Are you sure you want to shut down Shut Down menu 05 45AM 11 11 09 Be Figure 2 26 NICOM Shut Down screen To turn the device off select the on screen Yes option by using the NICOM s arrow keys and press the NICOM s OK button In order to cancel the Shut Down screen and return to the Main Menu screen choose the on screen No option 55 2 24 WI FI options Wi Fi Status Enable O Disable Connection status Select a network from the list IP Address Subnet Mask with WRAMWPA2 PSK Default Gateway Cheetah_AP Secured with WPAMYPAZ PSK DNS Server vasona with WPA MAC Address Close 08 08 11 06 20 PM amp Figure 2 27 NICOM Wi Fi options screen The purpose of this screen is to allow the user to set the Wi Fi connectivity and operate it The user can enable disable it he can select a network to connect to by selecting it from the list and
10. Time VET Mean Arterial Pressure MAP Systolic Blood Pressure SBP Diastolic Blood Pressure DBP Blood Oxygenation SpO2 and Thoracic Fluid Content TFC In addition the system calculates clinical parameters such as Cardiac Index CI Stroke Volume Index SVJ Total Peripheral Resistance TPR Total Peripheral Resistance Index TPRI Cardiac Power CP Cardiac Power Index CPI Oxygen Delivery Index DO21D Thoracic Fluid Content delta TFCd and Thoracic Fluid Content delta from baseline FCd0 based on the above measured parameters or based on a manually entered parameters such as manually entered Hemoglobin Hgb manually entered blood oxygenation SpO2 or manually entered Mean Arterial Pressure MAP The NIBP functionality measures and displays systolic diastolic and mean arterial pressures The SpO2 functionality measures and displays SpO2 The Cheetah NICOM Operator s Manual contains instructions and information for the operation and maintenance of the Cheetah NICOM System A thorough understanding of the system controls and connections is vital for instrument operation It is therefore essential to read this manual carefully before attempting to use the Cheetah NICOM System in order to ensure optimal performance and trouble free service life This manual should be retained for future reference 12 General Description The Cheetah NICOM System dimensions are Height 22 cm Width 26 cm Depth 20 cm Total
11. Weight 4 5 Kg 1 3 Front and Buttons On the front there is an 8 LCD screen and eight buttons The green button is the Power button In order to turn the unit on press continuously for a few seconds until the Cheetah Logo is prompted in order to turn the unit off use the Shut Down command on the main menu section 2 22 Alternatively pressing the green power button continuously for several seconds will also turn the unit off however this shut down method is discouraged because some test information may not be saved Use the NICOM s Up A and Down VY buttons in order to choose commands from the menu to change measurements display during a test and to browse and look up values within fields The NICOM s OK button is used to set selection of commands from the menu values in fields and to start and pause tests Use the NICOM s Left lt and Right buttons to move the cursor between fields and to browse test segments when reviewing patient test results The NICOM s Back button serves to operate the pop up menu and to return the cursor to previous placement The NICOM s Print button is intended for future use and is currently not operational Figure 11 NICOM System Front Panel Touch Screen In addition to the hardware keypad the NICOM System is equipped with a touch screen Navigation in Menus Touch a menu option to immediately select it To open the Side Menu with the Touch Screen touch the Menu Name on the side of the screen
12. blood oxygenation 6 21 Hgb Hgb stands for the Hemoglobin concentration in the blood 85 Chapter 7 0 Troubleshooting This chapter is intended to enable the user to troubleshoot problems that may occur during the operation of the system Problems that are not covered in this manual should be referred to a Cheetah Medical service engineer 7 1 ErrorMessages The following error messages may be encountered in the course of normal system operation The following instructions are intended to assist the user in dealing with them 1 Message Possible Sensor Cable or Connectivity Error This message appears with an additional message Poor Signal Reason disconnection between the NICOM device and the patient s body This results in a low amplitude ECG signal Cause The NICOM cable or one or more of the NICOM Sensors ate not connected properly to the NICOM device or to the patient Solution Check that the NICOM Sensors are well attached to the patient s body and are connected properly to the NICOM cable Check the connection of the NICOM cable to its socket in the rear panel on the back side of the NICOM device Sometimes earlier sensor replacement is necessary especially if the sensors are wet ot if the underlying skin is hairy If the problem persists try to replace the sensors that seem less ideally attached and to stop the test and start a new one 2 Message 86 Check Left Sensor Cable or Connectivity
13. entered and proceed to monitor the patient or review more options 57 32 Performing a Test The following instructions summarize the basic actions that should be complied with in order to perform a measurement and save the results ik 2 5 Turn on the NICOM monitor by holding the power switch down for 3 seconds Prior to monitoring the patient make sure that the Settings are appropriate for the test including test type NIBP options SpO2 options sample interval and the like Choose an existing patient from the Existing Patient list on the main menu screen of insert a new patient through the New Patient screen section 2 3 and section 3 1 respectively Measurement cannot be performed without being associated with a specific patient Attach the NICOM Sensors to the patient in locations as shown below instructions ate also provided on the sensors bag on clean prepped and preferably hairless skin Peel Sensor a7 Place on Secure lead cables to patient using supplied adhesive tapes Figure 3 1 NICOM Sensors Instructions Special Note The NICOM double sensors are designed for single use only If the NICOM Sensors become detached or are removed from the patient s body for any reason they should be replaced with a new set before continuing with the test The NICOM Sensots shelf life is indicated on the sensors pack and depends on the batch Both batch and shelf life information will always appear on the
14. events that were entered during the time frame of the row there can be an event every 10 sec thus six events every minute ID 167207703 Seth Reginald Smith Male Age 53 92 kg 165 cm BSA 1 99 Date Time HR 1 14 08 09 17 59 03 AM 72 2 14 08 09 18 00 04 AM 7 3 14 08 09 18 01 05 AM oum Booo E3 05 45AM 11 11 09 Be Figure 3 4 Events displayed in the Numerical Display screen 63 35 Calibrating the Touch Screen Perform this calibration procedure if the Touch Screen becomes less responsive 1 From the Side Menu choose Touch Screen Calibration The Touch Screen Calibration tools opens Carefully press and briefly hold stylus on the center of the target Repeat as the target moves around the screen Press the Esc key to cancel nE Figure 3 3 Touch Calibration Screen Tool 2 Follow the onscreen instructions 64 Chapter 4 0 Settings amp Advanced Functions The purpose of the Settings screen is to allow the user to control some options related to the device s behavior The Settings screen s pop up menu Set option is divided into the following Settings options General Options Test Options NIBP Options SpO2 Options Connectivity Network Configuration Wi Fi options and Date amp Time General Options From the Main Menu screen select the Settings option using the NICOM s arrow keys Once this option is selected press the NICOM s OK button The General Options screen will then be presented The G
15. if required he can enter a network password in order to connect to The user must make sure the Wi Fi dongle is properly connected to the NICOM s USB port by verifying that the Wi Fi Icon in the bottom of the screen will indicate the connection status and signal strength A Wi Fi indicator appears in the menu and indicates the Wi Fi connection status The number of bars next to the stick indicates the K strength so that 3 bars reflect good strength and no bars refelct no signal in the following sigh will appear AN If Wi Fi is in enabled but not connected to a If the dongel is not connected network a cross will apear over the icon il When selecting a network from the list described in figure 2 27 the same indicator will appear with the same meaning only that when a network is secured it will be Q marked with a lock next to the Wi Fi stick lal the dongel status and the Wi Fi enabele disable status will not be reflected in the list 56 Chapter 3 0 Basic Functions 31 Saving a New Patient The following instructions go through the process of saving new patient details 1 Choose the New Patient option on the Main Menu screen and press the OK button on the NICOM 2 Insert the patient s personal details to the on screen wizard Use the arrow keys to choose the requested digit Press the NICOM s OK button for the digit to be inserted to the field Select the on screen Next button in order to be directed to the
16. of monitoring and observe a longer term trend The user has a choice of six different time scale options 5 min 20 min 30 min 1 hour 4 hours and 10 houts Test Controls Initiate Calibration This option enables the user to run a new patient calibration process on the system while a test is ongoing at any given time Start by choosing this option the user will begin running a new test Another way to do so is by clicking the OK button while on the main Run screen as long as a Test is not already running at the time Pause this option allows the user to halt a running test for an unlimited period of time without terminating it The test can be resumed at any time by pressing the NICOM s OK button or by choosing the Continue option on the Test Controls sub menu When pause is operated pause indicator will appear in the alerts bar Stop this option prompts a pop up screen asking the user to decide whether or not to quit a running test Silence Alarm this option allows the user to silence the alarm for two minutes during a test Protocols The Protocol Wizards guide the user in step by step fashion through NICOM supported protocols The Protocol Wizard is designed to simplify administration and data management related to hemodynamic tests such as the Passive Leg Raise an Orthostatic Bioreactance maneuver or Bolus injection Once chosen the tests perform automatically without interruption of monitoring and will on
17. run bar of the display screen Run Dashboard Trend and Numeric display 45 Date Format This option allows the user to set the date display format in the device to show either Day Month Year or Month Day Year 46 Time Format This option allows the user to set the time format in the device to 24 hrs or 12 hrs AM PM formats Note The Set Date and Time option is located in the Settings screen s pop up menu Press BACK then select the Set option In the small window that opens to the right of the pop up menu select the Date and Time option to access the Date and Time settings screen as explained in point 4 15 below 66 lt Test Options From the Main Menu screen select the Settings option using the NICOM s arrow keys Once this option is selected press the NICOM s OK button to enter the Settings screen Press an option to enter the screen s pop up menu Select the Set option then select Test Options and press the NICOM s OK button Once entering the Test Settings screen all setting options for this section are displayed The measurements listed below can be modified Test Type Sample Interval 30min Cancel Apply menu 05 45AM 11 11 09 Be Figure 4 2 Settings screen general options 47 Test Type The Test Type icon will appear on the top right side of the patient information bar of the display screens Run Dashboard Trend and Numeric display Change this field from Rest to Stress before attempting
18. screen and choose the Audible Alarm on 91 In case of buzzer malfunction Please contact a Cheetah medical representative 6 Problem Buzzer failure during monitoring Cause Buzzer tutned off or buzzer malfunction Solution In case the buzzer has been turned off Enter the General settings screen and choose the Audible Alarm on In case of buzzer malfunction Please contact a Cheetah medical representative 92 Chapter 8 0 SERVICE AND MAINTENANCE Note The user or any technical personnel who are not formally authorized by Cheetah Medical should not open the NICOM box under any circumstances Opening the NICOM box could damage the unit and will void the warranty provided by Cheetah Medical 8 1 General Care CAUTION Do not expose the instrument to direct sunlight for prolonged periods of time in order to avoid damage to the screen 8 2 Cleaning CAUTION The system is approved for IPX0 to avoid damage to the instrument patient cable or clips be careful of liquid spillage while cleaning Do not expose the instrument Patient Cable clips or sensors to sprays liquids or any other type of solvents This instrument requires routine cleaning which includes removal of any soil or dirt from the external surfaces A soft cloth dampened lightly with water may be used Be sure to turn the power off and disconnect the AC power cord from the instrument before performing cleaning procedures When cleaning the unit
19. the most common unit of measure for pulse rate Introduction The NIBP module of the NICOM device is an oscillometric blood pressure system The module is designed to take blood pressure measurements on demand After each blood pressure measurement the Module will discard the previous blood pressure results All Module operating parameters will reset to default values at power up All Module blood pressure values are discarded when the Module is reset Populations that may use the NIBP function For adult patients blood pressure measurements made with the Advantage OEM BP Module Series are equivalent to those obtained by trained observers using the cuff stethoscope auscultatory method within the limits prescribed by ANSI AAMI SP10 1992 amp 2002 mean error difference of 5 mmHg or less standard deviation of 8 mmHg or less Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff stethoscope auscultation method within the limits prescribed by the American National Standard Electronic or automated sphygmomanometets The NIBP Module performance with common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation has been verified by use of a patient simulator 10 Wamings amp Precautions This device should not be used when oscillometric pulses may be altered by other devices or techniques such as External Counterpulsation ECP or Intr
20. up menu contains several viewing options such as Y Axis Auto Scaling Time Scale Switch Display and Patient Info Select the Switch Display option or use the Up Down arrow keys on the device in order to navigate between the Numerical Display and Trend Display screens The Time Scale option opens a sub menu that allows the user to choose different time scales The Patient Info option opens the Existing Patient screen The CI and the CO are separated in two different trends to present a better resolution for each The index parameter trend is presented in broken line and the clinical parameter trend is presented in full solid line The SpO2 and DO2I trends are displayed as well 27 Tabular Display Screen The purpose of the Tabular Display screen is to display the numeric results of saved of ongoing measurements The Numeric Display contains the key clinical information in a tabular format In addition the last column of the Numerical contains the number of events per Study were applicable By clicking on the annotated row the system displays the Event list of the specified Study In order to view the Tabular display select the Switch Display option or use the Up Down arrow keys on the device 39 ID 167207703 Seth Reginald Smith Male Age 53 92 kg 165 cm BSA 1 99 Date Time HR NIBP MAP TPR TPRI SV SVI SVV SpOz DOzI TFC 1 14 08 09 17 59 03 AM 72 f 75 2 38 12 100 man 600 66 1 2 14 08 09 18 4 AM 72 130 80 98 1456 1456 75 2 3
21. 0 10 Cheetah Pole Mount Connector CMA PoleConn10 11 SpO2 Sensor Table 1 Cheetah Medical reserves the right to change the items provided free of charge with the NICOM monitor Returning Parts under Warranty When contacting the company make sure the serial number of the system in question is in hand as appears on the sticker at the back of the system as well as the effective date of the warranty All parts are included in a one year warranty for workmanship and material To replace parts during the warranty period send the part prepaid to Cheetah Medical at the address listed on page 76 or to an authorized distributor from which the equipment was purchased To qualify for credit warranty parts should be labeled with the following information 1 The Invoice number under which the unit part was purchased 102 2 Completed Complaint Form This form may be obtained from Cheetah Medical or its distributor representative 3 Date of installation or purchase 4 Warranty number Shipping Parts Note All parts should be returned in their original packages Parts to be returned to the factory should be carefully packed Each of the parts should be cushioned in antistatic packaging material to prevent damage from Electrostatic Discharge Note The shipper is responsible for any shipping damage and should insure the shipment as necessary 103 Chapter 10 Regulatory Representative United States Age
22. 5 9 8x20 3 98 0080 05 All Purp Small Adult Long 17 25 9 8x20 4 98 0080 06 All Purp Adult 23 33 13x27 5 20x40 Error Code List amp Definitions Artifact Erratic Oscillometric Signal Corrective Action e The patient may have been moving too much e Check that the cuff is in the correct positions e Check that the correct size cuff is being applied NOTE If an NIBP error occurs measurement values can still be reported In all cases and applications these values should be disregarded when concurrent with an NIBP error Exceeded retry count Corrective Action e The patient may have been moving too much e Check that the cuff is properly tightened e Check that the cuff is in the correct position e Check that the correct size cuff is being applied e Check that there is no excessive clothing between the arm and the cuff 13 Exceeded measurement time limit Corrective Action e The patient may have been moving too much e Check that the cuff is properly tightened e Check that the cuff is in the correct position e Check that the correct size cuff is being applied e Check that there is no excessive clothing between the arm and the cuff Pneumatic Blockage Corrective Action e Check that the hose has no sharp bends or is pinched e Check that the patient is not lying on the cuff e Check that the cuff is in the correct position Inflate Timeout Air Leak or Lo
23. 8 12 98 600 66 1 NT C E3 05 45AM 11 11 09 ie Figure 2 10 NICOM Tabular display screen 2 8 Protocol Tabular Display screen ID 167207703 Seth Reginald Smith Male Age 53 92 kg 165 cm BSA 1 99 Gon hostatic Protocol 130 80 130 80 130 80 130 80 afs 130 80 130 80 130 80 130 80 130 80 afa Result A 130 80 she 05 45AM 11 11 09 Be Figure 2 11 NICOM Protocol Tabular display screen The Protocol Display contains the same clinical parameters as the Numerical display but in addition the last row displays the delta between the baseline and challenge stages of the protocol It also displays the date time and protocol type 40 The protocols results are displayed 13 line items at a time in case the Study is set to 30 seconds or 7 line items at a time per protocol in case the Study is set to 1 min In order to view the protocol s Tabular display select the Switch Display option or use the Up Down arrow keys on the device The Bolus protocol results which can have up to 60 lines in case of 230 sec samples are displayed in three lines only average baseline maximum challenge and the delta in percentage 29 Hemodynamic Dashboard Screen The Hemodynamic Dashboard screen is the main monitoring screen It allows the clinician to maximize the information that is viewed without having to skip between screens The waveforms are not shown and the extra space is used to further highlight the measured par
24. COM sensors after the expiration date CAUTION In the unlikely event that the patient has an allergic reaction to the NICOM sensors detach the sensors immediately from the patient and avoid any further placement of NICOM sensors on this patient 18 Label The following label is attached to the Cheetah NICOM device 16 i Cheetah Medical Inc 600 SE Maritime Ave N l co M R e l lan t Suite 220 Vancouver WA 98661 USA 7 Tel 1 503 241 5405 Fax 1 503 345 6890 Serial No V32011071407 A ECJREP Cheetah Medical UK Limited Rating 100 240V 50 60 Hz 2A 1 Irmar House 59 Cookham Road Maidenhead oe Berkshire SL6 7EP United Kingdom Fuse Rating 2x T2AL250V Tel 44 1628 636806 Fax 44 1628 788802 A X tl Cheetah Medical Israel Ltd 38 Habarzel St Floor 1 Ramat Hachayal Tel Aviv 69710 Israel Tel 972 3 644 0288 Fax 972 3 725 4848 ey C 0482 Rev 006 L R www cheetah medical com 19 Battery Mode The NICOM monitor can function without external power connection In this mode of operation when fully charged the batteries can provide up to 90 minutes of power To fully charge the battery when it is depleted it is necessary to connect the device to the external power supply for approximately 6 hours When the monitor is disconnected from the external power supply the batteries automatically power the unit so that the user should not experience any interruption I in the test The battery c
25. Format Cancel Apply menu 05 45AM 11 11 09 Be Figure 2 13 NICOM Settings screen Select a field in the Settings screen and the options related to the field are automatically displayed After choosing the desired option select Apply in order to accept changes and stay in the Settings screen select the on screen OK button in order to accept changes and go back to the Main Menu screen select Cancel in order to discard changes and go back to the Main Menu screen Note On all settings screens select Apply in order to approve changes and remain in the Settings screen or select the on screen OK button to approve changes and go directly back to Main Menu All other actions will result in changes not being saved The Pop up menu on this screen offers the following options The Demo option will prompt a window with all of the Run screen s features Selection of Demo allows a Demo test to be performed on a simulated patient This option is intended for new users to better understand how to run a test on a patient 42 Live Demo option will prompt a window where a desired file can be opened When selected the Run screen s window will be prompted having all of its features Selecting the Live Demo allows a recorded test to be performed This option is intended for new users to better understand how to run a test on a patient and how to perform protocols The About option will prompt a window with technical information that can faci
26. ICOM Sensors with new sensors and make sure the sensor is positioned more than 2 5 inches from the lead 2 Message Battery Low Please Connect to Main Power Supply Reason The battery supply is low and is under 10 of its capacity Cause The device was not charged for a long period of time Solution Connect the device to Main power supply as soon as possible 7 3 Other Problems 1 Problem One or more channels do not display correctly Cause 1 Sensors are not properly connected 2 Patient movement during the measurement process Solution 90 Check the cable outlets for loose contacts at both ends 2 Problem The screen remains black after starting the system does not start Cause Battery discharged or damaged or the fuse is blown Solution Recharge the battery and re start the system If the problem persists refer to Section 8 dealing with fuse replacement or contact a Cheetah Medical service person 3 Problem Burned out pixels on the LCD screen Cause LCD malfunction Solution Please contact a Cheetah medical representative for service 4 Problem LCD failure during monitoring Cause DC power supply to the inverter or inverter failure Solution Please contact a Cheetah medical representative for service 5 Problem Buzzer failure upon power on Cause Buzzer turned off or buzzer malfunction Solution In case the buzzer has been turned off Enter the General settings
27. In addition to the touch screen the NICOM s Up Down buttons move the cursor among the menu items The NICOM s OK button opens the appropriate screen Existing Patient gt ID 766258914 Johan Andreas McCole New Patient Settings ID 456278919 Sten Reginald Smith Shut Down ID 036278945 Michael E Conrad menu 05 45AM 11 11 09 Be Figure 2 2 NICOM Main Menu screen In order to perform a measurement it is required to insert the patient s details this action can be performed in the New Patient screen for patients who have not been tested before For returning patients select the Existing Patient screen by placing the arrow on Existing Patient and pressing the NICOM s OK button To select an existing patient choose the required patient from the list to the right by using the arrow keys to highlight the patient s name and then press the NICOM s OK button Use the Settings screen in order to set the system s time and date measure units etc For more details about the settings screen please see 2 7 Choose the Shut Down screen in order to safely turn off the device 29 23 New Patient Screen The purpose of the New Patient Wizard Screen is to add a new patient to the unit Patient ID Text p BackSpace 14 Delete lt l 4 7 Cancel Finish 05 45AM 11 11 09 Be Figure 2 3 NICOM New patient screen The wizard screen opens with the ID field In order to navigate between the numbers and letters of the keyboard
28. JR Scam Cheetah Medical Cheetah NICOM Reliant User Guide CHEETAH NICOM SYSTEM User Guide In the US Cheetah Medical Inc 600 SE Maritime Ave Suite 220 Vancouver WA 98661 USA Toll free 1 866 751 9097 Telephone 1 360 828 8685 Fax 1 360 718 8154 In Europe and Asia Cheetah Medical UK Limited 1 Irmar House 59 Cookham Road Maidenhead Berkshire SL6 7EP United Kingdom Telephone 44 1628 636806 Fax 44 1628 788802 E mail cheetah cheetah medical com Web Site www cheetah medical com Cheetah Medical 2012 Table of Contents CHAPTER 1 Height Units eee ee PEB o 0 i 1 Qo KS ne er E POE EE E NIBP Ss T aa emma OD NBPOpA ONMOE seoor SD NIBP Tine irva ee NIBP initial Inon PSS enenensnennnnenennoninannnennnannanasnsnenannananaane I Date and Time Setup R PLNM A CHAPTER 5 NICOMEMP ecsssssssstsssstsssntnssntntsntsnsntstsnsnnsesnnnesete 75 SERVICE AND MAINTENANCE rvcsrstemneineted 98 PARTS INFORMATION errctntenetnntntenetenntnet 101 Oing OMN N es Equiprerntand Accessoes PVEMAY moomoo 2 Returning Parts ander Watts LQ SHIP oie LOB CHAPTER 10 REGULATORY REPRESENTATIVE sssestee 104 Conventions used in this manual WARNING Indicates conditions or practices that could lead to patient injury illness or death CAUTION Indicates conditions or practices that could damage the equipment or other property Note Provides additional important information
29. Main Menu screen the General Options screen which is the default screen for this section is presented In order to toggle through the different Set options press the Back button to activate the screen s pop up menu Select the Set option using the up and down keys then select the desired Set screen and press the NICOM s OK button In order to operate the fields of the selected Set screen highlight the desired option select OK on the NICOM to operate the field and then use the Left Right buttons to move between the options the flickering red highlight marks the chosen option Select the NICOM s OK button again in order to lock your selection Use the arrow keys in order to move to the next field In order to save the new settings select the on screen OK button Select Cancel in order to discard the changes and go back to Main Menu Select Apply in order to accept all changes and remain in the Settings screen 44 2 12 General Options Height Units Metric Weight Units Metric Electric Grid Audible Alarm Date Format Day Month Year Time Format Cancel Apply menu 05 45AM 11 11 09 Be Figure 2 15 NICOM Settings Screen s General Options In the General Options screen the user can choose to change the settings of the device s Height Units Weight Units Electric Grid Audible Alarm Date Format and Time Format 45 2 13 Test Options Test Type Sample Interval 30min Cancel Apply menu 05 45AM 11 11 09 B
30. NICOM measures the ejection but does not subtract the backward regurgitation that takes place during diastole 2 Severe anatomic abnormalities of the thoracic aorta Severe anatomic abnormalities of the thoracic aorta such as a large synthetic aortic graft large aortic aneurysm or large aortic dissection can impact the accuracy or performance of hemodynamic parameters The abnormality has to be large in order to have a meaningful impact on monitor accuracy 3 External pacemakers and internal pacemakers with unipolar electrodes Use caution in monitoring patients with external pacemakers and patients with relatively older models of internal pacemakers which utilize unipolar electrodes Some external pacemakers and unipolar internal pacemakers can add electrical artifact to the NICOM BIOREACTANCE signal Note It is possible to completely mitigate or significantly alleviate the problem by placing the NICOM sensor 2 5 inches approximately 6 cm or more away from the external pacemaker percutaneous lead Unipolar internal pacemakers are rarely used nowadays 1 15 SpO2 Introduction 21 Pulse oximetry is a non invasive method allowing the monitoring of the oxygen content of a patient s hemoglobin A sensor is placed on a thin part of the patient s body usually a fingertip or earlobe or in the case of an infant across a foot Light with red wavelengths and light with infrared wavelengths is sequentially passed from one side to a photo d
31. NICOM s OK button Now follow steps 2 4 5 Press the NICOM s Back button and select the Patient Info option in order to finish and go back to the Existing Patient screen From the Existing Patient screen select BACK again to enter the pop up menu then select the Exit option in order to return to the main menu 60 Numeric results Choose the Existing Patient option on the Menu screen select the required patient and press the NICOM s OK button Select the Display Results button by using the arrow keys and pressing the NICOM s OK button In case the patient has had several tests run at different times a window that displays all of the individual patient s different tests will pop up Select the desired test off of the list according to the date and time it was taken by using the arrow keys and pressing the NICOM s OK button You will be transferred to the Trend Display screen Press the Back button to view the pop up menu options for the Trend Display screen Choose the Switch Display option then select the Numeric option or use the UP and DOWN buttons without entering the pop up menu first until reaching the desired display screen Each page of the Numeric Results screen contains 18 lines of results To browse through the results use the NICOM s Left and Right arrow keys Each row contains the Data and Time when the measurements were acquired and the monitored measurements See chapter 4 for more details about these measuremen
32. NICOM s OK button When setup is done select the on screen Apply button in order to save the settings and stay in the settings screen press the OK button in order to save the settings and be directed back to the Main Menu screen or select Cancel to discard the changes and be directed back to the Main Menu screen s Connectivity 4 15 Connectivity Wizard NICOM can be connected to the hospital s IT system via the Ethernet Serial port or external Wi Fi port on the back of the unit by using the Connectivity Wizard The IT department and the EMR provider will be required to make the necessary customization to tead and present the NICOM information ID 167207703 Seth Reginald Smith Male Age 53 92 kg 165 cm BSA 1 99 Connectivity Type Network Serial Sotngs 05 45AM 11 11 09 7 90 Figure 4 7 Connectivity Wizard 72 lt Networking 4 16 Networking Wizard NICOM may be connected to the hospital network by using the Networking Wizard The Wizard should be used by a network administrator from the hospital s IT department IP address BackSpace Next Cancel menu 05 45AM 11 11 09 Be Figure 4 8 Networking Wizard After defining the connectivity the NICOM can be connected the to hospitals Wi Fi network by using the Wi Fi setting options as described in chapter 2 24 SpO2 From the Main Menu screen select the Settings option Once this option is selected press the NICOM s OK button to enter the Settings screen P
33. NICOM s arrow keys Once this option is selected press the NICOM s OK button to enter the Settings screen Press the BACK button to enter the screen s pop up menu Select the Set option then select Date amp Time Option and press the NICOM s OK button Once entering the Date amp Time Settings screen all setting options for this section are displayed that allow modification of the measurements that are listed below Set Date 11 11 09 Set Time Cancel Apply menu 05 45AM 11 11 09 Be Figure 4 6 Settings screen Date and Time screen 71 4 14 Date and Time Setup The Date and Time are displayed for every result in the Tabular Display screen and appear on the right lower side of every screen Clock setup is necessary the first time the device is turned on as well as after battery charge if the battery was completely discharged Press the Back button while in the Settings screen which will open the pop up menu Select Set and then the Date amp Time option by using the NICOM s arrow keys then press the NICOM s OK button Once the Date and Time screen opens press the NICOM s OK button to operate the Date setup field use the NICOM s Up Down atrow keys to set the correct date and press the NICOM s OK button When done setting the date use the arrow keys to move to the Time setting field Click the NICOM s OK button to operate the time setup field use the NICOM s Up Down atrow keys to set the correct time and then click the
34. V e Heart Rate HR e Ventricular Ejection Time VET e Total Peripheral Resistance TPR e Total Peripheral Resistance Index TPRI e Cardiac Power CP e Cardiac Power Index CPJ e Blood Oxygenation SPO2 e Oxygen Delivery Index DO2D e Electrical impedance of the chest cavity Z0 e Thoracic Fluid Content TFC e Thoracic Fluid Content change from preset time period FCd and e Thoracic Fluid Content from baseline TFCd0 e Changes in SV CO and other hemodynamic parameters which are derived by Bioreactance as a result of posture 20 The Cheetah Reliant with NIBP and SpO2 functionalities is intended for use within hospitals and other healthcare facilities e g outpatient clinics that provide patient care 1 14 Limitations of Use Clinical Situations Potentially Affecting NICOM Algorithm Accuracy or Performance Note Most of the clinical situations and patient conditions listed below may impact absolute values but should not affect device responsiveness and sensitivity specificity to assess directional hemodynamic changes The exception is in circumstances of severe external pacemaker interference Examples of conditions that can influence reported CO influence monitor accuracy or result in suboptimal signal quality 1 Severe aortic insufficiency The regurgitation fraction associated with severe cases of aortic insufficiency may result in overestimation of the net forward CO That is because
35. a Aortic Balloon Pump Counterpulsation DO NOT use the NIBP module for any purpose other than specified in this manual without written consent and approval from Cheetah Medical DO NOT use the device in the presence of flammable gaseous anesthesia agents DO NOT attach the cuff to a limb being used for IV infusions as the cuff inflation can block the infusion potentially causing harm to the patient CAUTION Substitution of a component different from that supplied may result in measurement error Repairs should be undertaken only by personnel trained or authorized by Cheetah Medical CAUTION Accuracy of any blood pressure measurement may be affected by the position of the subject his or her physical condition and use outside of the operating instructions detailed in this manual Interpretation of blood pressure measurements should be made only by a physician or trained medical staff CAUTION All air hoses and cuffs used to connect the patient to the module must be approved by Cheetah Medical Hoses of a certain material and or durometer may cause the module to perform in an improper fashion Also cuffs that are extremely small or large in volume may cause errors to occur depending on the BP mode selection Air hoses as well as cuffs are offered as accessories from Cheetah Medical CAUTION If the blood pressure cuff is on the same limb as a pulse oximeter probe the oxygen saturation results will be altered when the cuff occludes the brach
36. ameters themselves The Hemodynamic Dashboatd screen is accessed by using the arrow keys or by selecting the switch display option on the pop up menu and then choosing the Dashboard option on the sub menu ID 99999DEMO John Demo Doe Male Age 53 92 kg 165 cm BSA 1 99 05 45am 11 11 09 ie Figure 2 12 NICOM Hemodynamic Dashboard screen The results are shown for CI CO HR SV SVV SVI TPR TPRI NIBP CP CPI MAP TFCd0 TFC TFCd SpO2 DO2I along with the Dashboard Grid With the Dashboard Grid the clinician can view in the Dashboard screen the trends of two selected clinical parameters from a list that includes all the clinical parameters the NICOM is measuring Note that the trends in the Dashboard are controlled independently from the trends in the Trend Display i e changing the Dashboard 41 trend time scale or Y Axis does not influence the settings of the trends in the Trend Display and changing the time scale and Y axis in the Trend display does not influence the Dashboard trend 2 10 Settings Screen The Settings screen is accessed via the Main Menu screen The purpose of this screen is to allow the user to control various device features such as Date and Time settings NIBP settings SpO2 settings Connectivity settings Network Configuration Settings Wi Fi settings Test settings and General device settings Height Units Metric Weight Units Metric Electric Grid Audible Alarm Date Format Day Month Year Time
37. ate the measurement immediately after selection Following the manual reading the system will continue to periodically obtain an NIBP measurement according to the default time interval chosen in the Settings screen End NIBP this option allows the user to quit all NIBP measurements immediately which also deflates the cuff The change is relevant for that specific test only The NIBP measurements for the following test will be set according to the pre defined default as appears on the settings screen This option is available through all Run screens pop up menus Resume NIBP this option replaces the End NIBP option on the sub menu It only becomes available after the End NIBP option was selected and is meant to re enable NIBP measurements during a running test View Y Axis Auto Scaling this option activates an automatic focus on the dynamic area of interest vs the whole spectrum of potential results Thus this option provides more insight on trends Index Display by selecting this option the CO SV CP and TPR parameters will be replaced by their indexed parameters on the display Indexed parameters are corrected to the patient s BSA Once selected a small V sign will appear on the left hand side of the Index Display option on the pop up menu Time Scale this option enables the user to create wider or narrower timescale view for example in order to focus on a short period of interest or to visualize many hours 33
38. context and look for appropriate periods in using this parameter More insight is available in medical publications about SVV and preload responsiveness Literature on this topic as on hemodynamics and cardiac output monitoring may be referenced by the company upon request 69 TFC Thoracic Fluid Content is the simple the inverse of Zo see 6 13 below or 1 Zo Because it is the inverse of the impedance it reflects the electrical conductivity of the chest cavity which is also a corollary to the content of fluid in the thorax 6 10 TFCd The TFCd parameter indicates the dynamic change in TFC over time It calculates this by measuring the percentage change between the average of the last 10 TFC measurements and the average of 10 consecutive TFC readings measured at a specific time as set by the operator For example if the user chooses to view TFCd in increments of 1 hour the average of the last 10 studies is 60 and the average of 10 consecutive TFC readings occurring one hour before is 50 then the TFCd is 20 6 11 TFCd0 The TFCd0 parameter indicates the change in percentage terms from the average TFC acquired in the first five studies To illustrate if average TFC during the first 5 studies was 40 and the current TFC is 44 this represents a 10 elevation in the TFC relative to the TFC baseline average absolute value Thus the TFCd0 that will be displayed will be 70 6 12 NIBP Non Invasive Blood Pressure is the pressure exerted by t
39. e Figure 2 16 NICOM Settings screen s Test options In the Test Options screen the user can choose to change the settings for the device s Test Type Sample Interval and TFCd measuring time 46 2 14 NIBP Options ID 167207703 Seth Reginald Smith Male Age53 92kg 165cm BSA1 99 Hgb 12 0 g dL Disabled Time Interval Min Operation Mode Manual Initial Inflation mmHg 160 Cancel Apply menu 05 45AM 11 11 09 Be Figure 2 17 NICOM Settings screen s NIBP options In the NIBP Options screen the user can choose to change the settings for the NIBP module Operation Mode Time Interval Initial Inflation pressure or choose to enable ot disable the NIBP option 47 2 15 SpO2 Options ID 167207703 Seth Reginald Smith Male Age 53 92kg 165cm BSA 1 99 Hgb Posting Period SpO2 Operation Mode Manual Cancel Apply menu 05 45AM 11 11 09 Be Figure 2 18 NICOM Settings screen s SpO2 options In the SpO2 Options screen the user can choose to change the settings for the SpO2 functionality Heb Posting Period and SpO2 Operation Mode 48 2 16 Connectivity ID 167207703 Seth Reginald Smith Male Age 53 92kg 165cm BSA 1 99 Connectivity Type Network Cancel menu 05 45AM 11 11 09 ie Figure 2 19 NICOM Settings screen s Connectivity options In the Connectivity screen the user can choose to change the NICOM connectivity method to an external system for continuous data flow 49 2 17 Net
40. e Gender Male Age 26 Weight 76 ko Height 178 om BSA 196 onnsa snes nent Number of Tests 1 Test Date 0F0 2009 Test Start Tene 105462 Test Type Rest Sample interval tmin 1 10 cm Report gt gt by Pationt gt gt by Test Figure 5 6 NICOM EMR Patient record Numerical display screen The menu buttons in this section Report by Test will produce a report for an individual patient s specific test the data is presented minute by minute as presented on the NICOM device on real time The screen offers two report options to choose from Full Report the report includes Trends Table of results and Average beat morphologies that are representative for a certain time segment during the test Executive Report the report includes Trends and Table of results Both the Full Report and the Executive Report are automatically saved in My Documents After being saved the report will be opened on the screen 81 2 Report by Patient will produce a report for each and every one of the tests that were conducted on the current patient Again there are two report options the Pull Report and the Executive Report If the Report by Patient option is chosen the operator will be asked to choose the folder in which the report is to be saved out of a list of options folders 3 Export by Test The operator will be asked to choose the format to save the report in from two options Excel and XML Excel will automatically b
41. e NICOM s versions When retrieving 75 data from the NICOM it will automatically detect the NICOM s version and proceed with the data retrieval without user involvement Click on the EMR application s icon which is located on your desktop and allow the application to open NICOM EMR Version 1 5 5 Figure 5 1 Example of a NICOM EMR Splash screen A password will be required at start up in order to enter the application The initial password is 123456 Note The NICOM EMR password protects your patient information It is highly recommended that after first installation the password should be changed in order to prevent unauthorized personnel from accessing confidential clinical data 5 1 Change Password After entering the initial password the user is led to the Management screen It is recommended that the initial password be changed before entering new data in order to do so select the Change Password button that appears on the bottom left side of the screen A small pop up Change Password screen will appear a NICOM EMR Search for a Patient Patient ID FirstName LastName Entry Date From Entry Date To Update Date From Update Date To Search Clear Patie Enter Current Password Updat Enter New Password Tests Entry Date Verify New Password The new password must contain between 6 to 12 characters
42. e is the time of ejection of blood from the ventricle beginning with aortic valve opening and ending with aortic valve closure The unit of measurement is millisecond 65 dX dt Instantaneous thoracic BIOREACTANCE The input and output of blood through the thorax at each systole causes modifications of the electric properties of the thorax which can be measured by calculating the electrical bio reactance The electrical bio reactance of the thorax cyclically drops with each pulsatile volume of blood ejected from the heart 66 SV Stroke volume is the amount of blood cc pumped by the ventricle of the heart in one contraction 83 6 7 SVI Stroke volume index relates the stroke volume SV to body surface area BSA thus relating heart performance to the size of the individual SY BSA The unit of measurement is cc per minute per square meter cc min m 2 68 SVV Stroke volume variation is the calculated variation around the stroke volumes which occur at a window of time for example during 30 seconds SVV reflects the patient s preload responsiveness SVV is meaningful only in positive pressure mechanically ventilated patients during stable periods for example no movement or unstable respiration SVV is not accurate during cardiac arrhythmia During other periods SVV may reflect non respiratory influences on the stroke volume and be less predictive of actual preload responsiveness The user should take the SVV results in this
43. e pop up menu first until reaching the desired display screen The Time Scale option which appears on the NICOM s Run screens pop up menu determines the different clinical parameters results appearance as trend graphs on the Trend Display screens See chapter 4 for more details about these measurements If a disconnection incident or another type of signal quality disturbance took place during the measurement no results will be shown for the affected time intervals In other words there will be a gap in the trend graph skipping the areas of questionable or suboptimal signal 3 Press the Back button on the NICOM to view the pop up menu options Choose the Switch Display option then select Trend 2 in order to view more clinical parameters results trend graphs on the same page See chapter 4 for more details about these measurements 4 Press the NICOM s Left arrow to display the earlier results page or press the Right arrow for later results page Note in order to display another patient s results press the BACK button on the NICOM to enter the screen s pop up menu then choose the Patient Info option and click the NICOM s OK button in order to be redirected to the Existing Patient screen Press BACK to enter the pop up menu options of this screen Select the Change Patient option a window that states all of the existing patients details will pop up Select the desired patient off of the list by using the arrow keys and pressing the
44. e saved in My documents After being saved the report will be opened on the computer screen XML The operator will be asked to save as the automatic file name will be consistent with the patient s ID 4 Export by Patient This feature enables the user to export ALL the tests for an individual patient at once The operator will be asked to choose the file format with which to export the data Excel or XML Excel The operator will be asked to choose the folder to save the report in out of a list of folders XML The operator will be asked to save as the automatic file name will be consistent with the patient s ID 82 Chapter 6 0 Measurements Short Descnption In this chapter you can find a short description of the primary measurements that are calculated and displayed by the Cheetah NICOM device 6 1 CO Cardiac Output is the volume of blood being pumped by the heart in one minute It is equal to the heart rate multiplied by the average stroke volume The unit of measurement is liters per minute CO HR x SV 6 2 Cl Cardiac Index is a parameter that relates the cardiac output CO to body surface area BSA thus relating heart performance to the size of the individual The unit of measurement is liters per minute per square meter min m 2 63 HR Heart Rate is the number of contractions heart beats of the heart in one minute The HR units are BPM Beats per Minute 64 VET Ventricular Ejection Tim
45. e use of Cheetah Medical technicians and engineers Thus it is password protected Check up Mode Once the Simulator is connected to a NICOM monitor the Check up Mode Wizard shall test the NICOM monitor and shall verify that it works according to specs and within the factory calibration thresholds At the end of the test the Check up Wizard shall report the user if the system is working according to specs and is calibrated or not Warning If the Check up fails please do not use the NICOM monitor and contact a Cheetah Medical representative 52 WARNING The NICOM s USB connector has a cap which is not to be removed when the device is used for monitoring Should the operator work in PC Mode while the unit is connected to a patient regardless of the above warning the connection of the PC Main through a NICOM Isolation Transformer is required In the event that the user wishes to use the device in PC Mode while running a test or while otherwise connecting NICOM to a patient please contact Cheetah Medical in order to purchase a NICOM Isolation Transformer first 2 20 Host Mode Screen Host Mode menu 05 45AM 11 11 09 Be Figure 2 23 NICOM Host Mode screen The Host Mode screen has two purposes The primary purpose is to enable the NICOM EMR application which allows the user to download and manage testing information see more in Chapter 5 The other purpose of this screen is to manage the technical aspects and functionalities o
46. ected to the NICOM Moreover NICOM EMR should not be used while the unit is connected to a patient unless the PC is connected to a NICOM Isolation Transformer which is not routinely provided with the Cheetah NICOM The NICOM EMR application which stands for NICOM Electronic Medical Records allows the user to download to a PC store print or recall for future reference test information that was previously recorded on the NICOM system This application is a library function which enables users to save patient records compare sequential test results print test reports and so forth The NICOM EMR application is in read only format Data retrieved from the NICOM system cannot be altered Note all screens described in this section are shown on the PC System Requirements Windows XP Professional Windows XP Home Edition Windows Vista e NICOM EMR is best viewed on a screen resolution of 1024 x 768 pixels e In order to use the application install the NICOM EMR Software to your PC by loading the software installation CD and following the on screen setup wizatd s instructions e If installing from file or after loading the EMR installation CD the installation wizatd would need to be accessed via double clicking the SETUP EXE file Note In order to maintain existing NICOM EMR data do not uninstall previous EMR versions Note As of EMR 1 3 all EMR versions ate backward compatible with previous EMR versions therefore it supports all of th
47. eneral Options screen allows modification of the measurements that ate listed below Height Units Weight Units Electric Grid Audible Alarm Date Format Time Format Metric Metric Day Month Year Cancel Apply 05 45AM 11 11 09 Be Figure 4 L General Options screen with Settings pop up menu 65 41 Height Units This option allows user to set the device to work according to the Metric or USA system Moving from one system to another changes all measurable units from cm units to inch units and vice versa 42 Weight Units This option allows user to set the device to work according to the Metric or USA system Moving from one system to another changes all measurable units from kg units to lb and vice versa 43 Electric Gnd The NICOM filters away interferences caused by the electric grid The electric grid emits signals with frequency of 60 Hz in the US and 50 Hz in Europe and most of the rest of the world To customize the filter to your geographic location select 60 Hz if you ate located in the USA and 50 Hz if located elsewhere If you are not sure about the local grid system parameters please contact your IT personnel or electricity provider CAUTION Choosing an incorrect grid system might result in signal interference problems which can lead to suboptimal performance 44 Audible Alarm Change this field to Off to avoid low battery audible alerts The buzzer status icon will appear on the top left side of the
48. ent on the SpO2 sensor used SpO2 Sensors for the NELL 1 SpO2 Module The NELLCOR DS100 SPO2 sensor comes supplied with the NICOM with the SpO2 functionality In addition the Cheetah Reliant with NIBP and SpO2 functionality is also compatible with any of the following NELLCOR SpO2 sensors that have the following accuracy specifications Arms Sensor Adults Pediatrics Neonates Accuracy Accuracy REUSABLE D YS Infant to Adult 3 digits 4 digits D YS with D YSE Ear 3 5 digits N A Clip D YS with D YSPD 3 5 digits N A SpotClip DS 100A 3 digits N A OXI A N 3 digits 4 digits 22 OXI P I 3 digits N A DISPOSABLE OxiClig A 2 5 digits N A OxiCliq P 2 5 digits N A OxiCliq N adult 2 5 digits 3 5digits OxiCliq I 2 5 digits N A Arms All accuracies are expressed as X digits Pulse oximeter equipment measurements are statistically distributed about two thirds of pulse oximeter measurements can be expected to fall in this accuracy ARMS range Neonatal Accuracy When sensors are used on neonatal subjects as recommended the specified accuracy range is increased by 1 digit as compared to adult usage to account for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood For example OxiCliqN accuracy on neonates is 3 5 digits rather than 2 5 Cleaning and maintenance instruction for the SpO2 sensor are described in the specific SpO2 sensor user manual which
49. equired test from the list presented in a pop up window The Run option will open the Run screen to allow a new monitoring session to be performed on the patient The Update Details option opens the Patient Form screen to allow the update of any patient detail that requires modification or update The Close option navigates back to the main menu screen In order to use the screen s pop up menu choose the desired menu button and choose an option The Change Patient option opens a pop up window that shows the list of existing patients as shown in the Main Menu screen In order to change patient highlight the patient s ID then press the NICOM s OK button The selected patient s details will be loaded onto the Existing Patient screen In order to dismiss the pop up window without changing the patient press BACK on the NICOM Choose Exit in order to navigate back to the Main Menu screen In order to dismiss the pop up menu without choosing any option press the BACK button again 25 Run Screen The purpose of the Run screen is to run a new test save it and display its results during the test ID 167207703 Seth Reginald Smith Male Age 53 92kg 165cm BSA 1 99 Qumu dX dt 115 i NTE rol Lob egi ee ae VET 220 Zo 22 1 al N Ey yE S he Leth 4 ave A N 05 45AM 11 11 09 De Figure 25 NICOM Run screen The Run Screen is accessed by selecting the Run option in the New Patient or Existing Patient screens After accessing the Run Sc
50. ere are populations of specific interest in which this monitor has not been tested including e Patients with congenital heart disease associated with complex intra cardiac shunts e Patients with Continuous Flow LVADs The NICOM technology works by detecting pulsatile changes in aortic blood volume With a continuous flow LVAD by definition there are little if any pulsations unless the heart itself ejects Therefore use of the NICOM device in these patients could be useful in detecting the contribution of the native heart to the cardiac output but would not detect the contribution of the LVAD The results therefore should be interpreted with this in mind 19 1 13 Indications for Use The Cheetah Reliant with NIBP and SpO2 functionalities is a portable hemodynamic monitoring non invasive Cardiac Output monitoring device that monitors and displays a patient s Cardiac Output CO in Ltr Min with a Non Invasive Blood Pressure NIBP function that non invasively measures and displays blood pressure diastolic systolic and mean arterial pressure and heart rate and with a SpO2 function that non invasively measures and displays blood oxygen saturation SpO2 The device displays associated heamodynamic parameters based on measurements or calculations of measurements already incorporated into the Cheetah Reliant These parameters are e Cardiac Index CI e Stroke Volume SV e Stroke Volume Index SVJ e Stroke Volume Variation SV
51. ere with the RELIANT The recommended separation distances in this paragraph must therefore be complied with The RELIANT must not be used near or on top of another device If this cannot be avoided it is necessary before clinical use to check the equipment for correct operation under the conditions of use e The use of accessories other than those specified or sold by CHEETAH MEDICAL Ltd as replacement parts may have the consequence of increasing the emissions or decreasing the immunity of the unit Electromagnetic Emissions RELIANT is intended for use in the electromagnetic environment specified in the following tables 1 2 4 and 6 below e The user and or installer of the unit must ensure that it is used in such an environment Table 1 Guidance and manufacturer s declaration electromagnetic emissions RELIANT The RELIANT is intended for use in the electromagnetic environment specified below The customer or the user of the RELIANT should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions The RELIANT uses RF energy only for its internal function Group 1 Therefore its RF emissions are very low and are not likely to CISPR 11 cause any interference in nearby electronic equipment 95 RF emissions CISPR 11 Class A Harmonic emissions TEC 61000 3 2 Class A Voltage fluctuatio
52. etector on the other side Changing absorbance of each of the two wavelengths is measured allowing determination of the absorbances due to the pulsing arterial blood alone excluding venous blood skin bone muscle fat and in most cases fingernail polish Based upon the ratio of changing absorbance of the red and infrared light caused by the difference in color between oxygen bound bright red and oxygen unbound dark red or blue in severe cases blood hemoglobin a measure of oxygenation SpO2 the percent of hemoglobin molecules bound with oxygen molecules can be made The SpO2 functionality of the NICOM device can be operated by either the NELL 1 OEM SpO2 module manufactured by Covidien Ple or the XPOD SpO2 device manufactured by NONIN Inc Both the NELL 1 and XPOD are indicated for the continuous non invasive monitoring of functional oxygen saturation of arterial hemoglobin SpO2 The operation of the SpO2 functionality is controlled by the Reliant monitor as described in following sections The SpO2 module is incorporated inside the Reliant monitor when using the NELL 1 OEM SpO2 module The XPOD is an auxiliary SpO2 device which is connected to a dedicated XPOD connector on the Reliant monitor Populations that may use the SpO2 function The NICOM SpO2 module is intended for use with neonatal pediatric and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused depend
53. f the NICOM unit such as software updates extracting performance logs and the like and is intended for qualified NICOM technicians only 53 2 21 Service Mode Screen Male AgeS3 92kg 165cm BSA 1 99 R NIBP Lnabled Height Units eS 7 2 130 80 814 3 x eR 38 66 12 2014 BackSpace Svv TPC s s TPR nE DOAA E 214480 E al Figure 2 24 NICOM Password Entry left and Service Mode Screens right Note The Service Mode screen is password protected For service please contact the Cheetah Medical technical support team The Service Mode screen is intended to better support special requirements that ate relevant only for service purposes When entering the Service Mode the words Service Mode will be displayed on both ends of the Menu Bar on all of the NICOM s screens The Hemodynamic Dashboard screen will now display four technical parameters that are intended for Cheetah Medical technicians only alongside all other system monitoring parameters 2 22 Live Demo and Demo Screens ID 167207703 Seth Reginald Smith Male Age 53 92 kg 165 cm BSA 1 99 CH E dXidte axat VETe miec VET msec ZOc ohm ZO ohm Vep to vo Phase 05 45AM 11 11 09 Be Figure 2 25 NICOM Demo screen 54 The Demo Screen is intended to show the vatious monitoring screens and to demonstrate how the information is presented during a test without the need to connect the monitor to a patient and run a real test
54. following wizatd screen select the on scteen Cancel button in order to discard of the form and move back to the Main Menu screen select the on screen Back in order to move back one step at the wizard select the on screen Finish button in order to save the inserted data and move on to the Patient Information screen and to monitor the patient Note The Finish button will only be enabled when all mandatory fields have been filled in with the patient s information Note The new patient information will be kept in the system as long as it is not shut down In order for the patient to be added to the existing patients list and stored there even after system shut down a test must be run first with at least one recorded result Conversely if the system is shut down prior to obtaining at least one reading the patient information will be lost 3 On multiple choice fields such as Gender use arrow keys in order to move between the options The red highlighted option is recognized as the chosen option Press OK in order to set your selection 4 The age weight height and gender fields affect some of the calculations and results Therefore if it is not possible to enter true values the user should attempt to estimate them these are also mandatory fields on the system 5 Select the on screen Finish button in order to save the inserted data You will then be forwarded to the Patient Information screen where you can glance at the information
55. ge to the NICOM monitor and its accessories including the NICOM patient cable the NIBP hose and cuff avoid entrance of liquids during use and cleaning 18 CAUTION Be sure to turn the power off and disconnect the AC power cord from the power source before performing cleaning procedures CAUTION To avoid damage to the surface of the instrument e Avoid excessive pressure when cleaning the printed labeling on the monitor frame in the front and rear panel as well as the adhesive labels on the rear panel e Take care not to scratch the front display while cleaning CAUTION NICOM sensors are single use disposable products and should never be reused cleaned or exposed to liquids If necessary replace the sensors if they become wet or soiled To clean or disinfect the monitor perform the following e This instrument requires routine cleaning which includes removal of any soil or dirt from the external surfaces A soft cloth dampened lightly with water may be used e To disinfect external monitor surfaces and reusable accessories such as the NICOM patient cable clean with 75 medical grade alcohol using a dampened soft towel or wipe e Do not expose the instrument patient cable or sensors to sprays or any other type of solvents For NICOM accessories labeled as manufactured by third party suppliers follow the respective manufacturer s instructions for recommended care and maintenance 1 12 Special Patient Populations Th
56. harge indicator T reflects that the system currently operates in battery mode and is dependent on battery capacity When connected to the external power source the battery charge indicator will indicate that the battery is being charged E and the amount of battery charge remaining in a graphic way If the battery level falls to 10 or lower mm warning message will appear To protect the monitor and the monitor data the system will shutdown automatically without user prompt if the charge level falls under 5 CAUTION In order to prevent loss of data or study interruption working in battery mode is only recommended for short periods of time for example during transport and not for routine testing 1 10 Warnings and Precautions Wamings WARNING US Federal Law restricts the sale of this instrument to or on the order of a physician WARNING When the USB connection is not used the socket should be coveted with the USB cap at all times Precautions CAUTION Strictly follow the warning instructions in this manual 17 CAUTION The instrument is fragile to prevent damage please handle with care and avoid dropping it Be careful while unpacking For system repacking instructions please refer to page 75 on this guide CAUTION Ensure that the system is only used by a trained person familiar with all system operating procedures Hospital personnel should complete a training program prior to operating the Cheetah NICOM CAUTION To a
57. he blood against the walls of the blood vessels 6 13 MAP Mean Arterial Pressure is the mean blood pressure It depends on the flow of blood from the heart cardiac output and the resistance to flow in the small arteries and microscopic resistance vessels arterioles 84 6 14 TPR Total Peripheral Resistance is the resistance to flow that must be overcome in order to push blood through the circulatory system or the net resistance to blood flow in all the small arteries and microscopic arterioles TPR MAP CO 6 15 TPRI Total Peripheral Resistance Index is the indexed version of the TPR TPRI MAP CI 6 16 CP Cardiac Power represents the work product generated by the heart and is measured in units of Watts It is dertved from CO and MAP by the following formula CP CO MAP 451 see reference for this formula below Reference Mendoza DD Cooper HA Panza JA Cardiac power output predicts mortality across a broad spectrum of patients with acute cardiac disease American Heart Journal 2007 Volume 153 3 366 370 6 17 CPI Cardiac Power Index is the indexed version of the CP It is measured in units of Watts M and is calculated by dividing CP by the BSA CPI CP BSA 6 18 ZO ZO is the electrical impedance of the chest cavity 6 19 DO2I DO2I is the oxygen delivery index It is calculated according to the following formula DO2I 1 39 x Hgb x SpO2 100 x CI x 10 6 20 SpO2 SpO2 stands for the arterial
58. heetah Medical representative Error Measuring NIBP Critical NIBP module error Corrective Action Service may be required Call a Cheetah Medical representative Device Busy NIBP device is not responding as it is in the middle of an activity Corrective Action e Retry to obtain an NIBP reading e If this error persists restart the unit and try again to obtain an NIBP reading If you still encounter the error message after restarting the unit service may be required Call a Cheetah Medical representative 15 1 7 Bedside Care To ensure that the NICOM signals will be recorded to an adequate standard it is important to follow the following guidelines NICOM Sensor Placement 1 Shave body hair and wipe the patient s skin with alcohol 75 if necessary If alcohol is used to prep the skin it is advised to let the skin dry prior to placement of the NICOM sensors in order to preserve optimal gel performance Finally use the skin prep sand paper provided in the sensor set to roughen the skin Place the NICOM Sensors on the patient s skin as seen bellow Figure 1 4 Peel Sensor Place on Secure lead cables to patient using supplied adhesive tapes Figure 1 4 NICOM Prewired Sensor Placement Note When the sensors are misplaced or become detached the screen will display a warning that will notify the user that there is loss of signal or poor signal quality CAUTION Do not use NI
59. ial artery CAUTION To obtain accurate blood pressure readings the cuff must be the correct size and also be correctly fitted to the patient Incorrect size or incorrect fitting may result in incorrect readings CAUTION When a cuff is used on a patient for an extended length of time be sure to occasionally check the limb for proper circulation CAUTION Intra arm differences vary between people Do not assume that measurements from both arms are same CAUTION The module may not operate correctly if used or stored outside the relevant temperature or humidity ranges described in the Performance specifications Adverse Reactions Allergic exanthema symptomatic eruption in the area of the cuff may result including the formation of urticaria allergic reaction including raised edematous 11 patches of skin or mucous membranes and intense itching caused by the fabric material of the cuff Petechia a minute reddish or purplish spot containing blood that appears on the skin surface formation or Rumple Leede phenomenon multiple petechia on the forearm following the application of the cuff which may lead to Idiopathic thrombocytopenia spontaneous persistent decrease in the number of platelets associated with hemorrhagic conditions or phlebitis inflammation of a vein may be observed Cuff Selection amp Placement It is important to select the cuff size that is appropriate to the diameter of the patient s upper arm Use the Ra
60. ible cable movements when performing a test in Stress test mode The user should be alerted to sensor or cable disconnections and repair the problem if occurs as soon as possible 4 Message NIBP module is not recognized NIBP functionality will be disabled Please contact a Cheetah medical support representative sil by Cheetah Medical Figure 7 1 NIBP Eror at system startup Cause The NIBP module is disconnected from the device or it stopped functioning Solution Please contact a Cheetah medical representative 5 Message Phase Calibration Error Unable to calibrate Please check cable and sensor connections and try again Cause The sensors ate not applied appropriately or are detached from the patient body The sensors may need to be replaced Alternatively the patient cable is disconnected either from the device or from the sensors Solution Replace sensors if you suspect suboptimal sensor application Check that the sensors are well placed and connected to the patient cable Check that the patient cable is securely connected to the back of the monitor 88 6 Errors during Protocols ID 167207703 Seth Reginald Smith Male Age 53 92 kg 165 cm BSA 1 99 Oe an dX dt 115 VET me 220 Error Insufficient data for calculating baseline ZOam 22 1 Would you like to restart the PLR protocol Cancel Ga os asam 11 11 09 Be Figure 7 3 NICOM Protocol Error an example Several error
61. ime interval be set to 30 minutes the next automatic measurement will take place 32 minutes after the manual measurement has been taken 69 Note While actively measuring blood pressure the NIBP activity timer will appear on the NIBP box to state that the NIBP module is being used Special Note The NIBP MAP CP CPI TPR TPRI and DO2I are not as frequently refreshed as the rest of the NICOM s parameters Once a parameter has not been refreshed for a period of ten minutes its color will begin to fade out by a gradual color fade out process that takes another ten minutes to complete The parameter will regain its full display color only when a new measurement is taken 4 12 NIBP Time Interval This option allows the user to set the NIBP time interval for the Automatic Manual option so that an automatic NIBP measurement will take place at a pre set period of time according to his patient s needs The options to choose from for time presets are 1min 3min 5min 10min 15min 30min 60min and 90min Note The time interval icon appears on the NIBP box to state the time left before the next automatic measurement 4 13 NIBP Initial Inflation Pressure The initial inflation pressure system default is set to 160 mmHg This option allows the user to set the NIBP initial inflation pressure to a different threshold level from the system s default according to the patient s systolic blood pressure The options to choose from are in mmHg 120
62. ing a standard USB cable allows the user to download results of previous tests stored in the NICOM to the NICOM EMR PC application In order to perform these actions it is necessary to install the NICOM EMR PC software to a PC The software CD comes with every new monitor and can also be accessed by contacting a Cheetah Medical Service representative The USB port also enables various technical operations such as uploading of software upgrades NIBP cuff connector Connect the NIBP cuff to the monitor using the NIBP connector please refer to figure 1 2 SpO2 connector Connect the SpO2 Sensor to the monitor using the SpO2 connector please refer to figure 1 2 15 Specifications Skin Voltage Tolerance 300 mV Frequency Response 8Hz Time Constant 0 125 Sec CMRR 70db Filter 75KHz Safety Requirements According to IEC EN 60601 1 standard Class I Equipment BF type applied part Rated Voltage Current Power switch supply 100V to 240V Rated frequency 50 60 Hz Fuses 2 X T2AL250V A D converter at 12 bit 2 5 mV LSB Sample rate 500 per sec Features Hemodynamic display options Height Weight units Dedicated NICOM Electronic Medical Records interface XIS PDF amp XML file formats Password Protection Hemodynamic status report with visit to visit data Clinical Protocol Wizards Event Management Touch Screen control Serial and Ethernet connections Ambient Temperature and Humidity Operation co
63. is set to Manual Automatic NIBP operation the NICOM will inflate the cuff at a given time according to the settings that were selected for NIBP prior to beginning the test see chapter 4 and will display the pressure on the screen A manual measurement can be taken at any given time Note The arm is to be passively raised to the level of the heart this should not be done by the patient Moreover the patient should be as relaxed as possible throughout the NIBP measurement At the end of the measurement in order to completely end the test select the Stop option from the screen s pop up menu or by clicking the OK button on the NICOM Then select the Back button on the NICOM in order to return to the Menu scteen 59 33 Viewing Test Results Follow the instructions below to view results of prior tests Graphic results 1 Choose the Existing Patient option on the Main Menu screen by using the arrow keys and pressing the NICOM s OK button Select the required patient and press OK on the NICOM 2 Select the Display Results button by using the arrow keys and pressing the NICOM s OK button In case that the patient has had several tests run at different times a window that presents all of the individual patient s different tests will pop up Select the required test off of the list according to the date and time it was taken by using the arrow keys and pressing the NICOM s OK button or use the UP and DOWN buttons without entering th
64. is supplied with the sensor The SpO2 sensor is connected to the monitor via the dedicated SpO2 cable that connects to the dedicated connection on the back of the monitor See Figure 1 2 Place the sensor on a thin part of the patients body e g fingertip or earlobe or in the case of an infant across a foot To start SpO2 monitoring while running a test select Start SpO2 from the main menu if SpO2 automatic mode is not the default mode When this is done SpO2 monitoring shall commence automatically NELL 1 SpO2 Module Specifications The following are the SpO2 module specifications e Patient Range Neonate through adult e Operating Temperature 0 C to 60 C e Relative Humidity 15 to 95 non condensing e Altitude 1 000 feet below sea level to 10 000 feet above sea level e Operating Mechanical Shock Per IEC 600068 2 27 100G 6 ms half sine e Operating Sinusoidal Vibration Per IEC 600068 2 6 10 Hz to 500 Hz 1 G peak 10 sweeps axis e Operating Random Vibration Per IEC 600068 2 34 20 Hz to 500 Hz 0 02 g2 Hz e Storage Temperature 40 C to 70 C e Relative Humidity 15 to 95 non condensing e Storage Altitude 1 000 feet below sea level to 20 000 feet above sea level e Vibration Per NSTA Project 1A e Drop Per NSTA Project 1A 23 e Saturation 1 to 100 SpO2 SpO2 Sensors for the XPOD SpO2 Device The NICOM with the SpO2 functionality is supplied with the NONIN 8000AA SPO2 sensor In addition the Cheetah Relia
65. l units may adversely affect SpO2 readings CAUTION Do not immerse sensors SpO2 Enor Code List amp Definitions 26 SpO2 System is being Reset Corrective Action Wait until the SpO2 measurements are initiated If after 3 minutes the SpO2 measurements are not updated service may be required Contact Cheetah Medical Representative SpO2 Low signal Please check sensor Adjustment Corrective Action Readjust the SpO2 sensor If problem persist replace the SpO2 sensor If problem persist call Cheetah Medical representative SpO2 sensor malfunction Please replace SpO2 Sensor Corrective Action Stop the SpO2 module Replace the SpO2 sensor Start the SpO2 module SpO2 Module Error please contact Cheetah Medical Corrective Action Service is required Call a Cheetah Medical representative 27 Chapter Note All NICOM screens are now touch sensitive All on screen actions can be performed by touching the on screen buttons while the hardware buttons operation hasn t changed and still works as described below 2 1 The first activation of the device opens the Start Up screen which is the gateway to the program Cheetah NICOM Version 4 2 Starting up system please wait E 28 Figure 21NICOM Start up screen 22 Menu Screen The purpose of the Menu Screen is to allow the user easy navigation through the system s main workflows and functionalities
66. le monitoring 1 From the Side Menu choose Menu gt Events Add Event The Add Event window opens 2 Enter the event description Up to 30 characters and choose to add it The event is automatically time stamped according to when the Event window was opened The user can also choose not to enter an event description In that case the first event without an event description will be called Time Stamp 1 the second Time Stamp 2 etc Note that only one event can be added per cycle approximately every 10 seconds To add an event retrospectively 1 Browse to the desired result From the Side Menu choose Menu Events gt Add Event The Add Event window opens 3 Enter the event description Up to 30 characters 4 Enter the date and time Viewing events Events display in the Trend Display Screen In the Trend Display screen the events are displayed graphically as markers within the Trend When selecting an Event Marker the system displays the Events in the Event bar with the date and time of its entry 1D 467207703 Seth Reginald Smith Male Age 3 S2kg 165 em BSA 1 9 R 10 167207703 Seth Reginald Smith Male Age 53 Ske 165 cm BSA 199 R atau Qata Figure 3 3 Events displayed in the Trend Display screen 62 Events display in the Numerical Display Screen In the Numerical displays the system specifies the number of events in a row that contain events When selecting the row an event display window is prompted with the list of
67. litate the quality of service and support when needed The Calibration option allows a technical support person or otherwise authorized uset to calibrate the system whenever needed Note Should not be attempted by user The Device Mode option allows the user to choose between four operating modes Monitoring Mode PC Mode Host Mode and Service Mode The Set option allows the user to toggle through the following options General Test NIBP SpO2 Connectivity Network configuration Wi Fi options and Date and Time Each option opens a screen where different parameters can be changed From the Settings Screen select Apply to approve changes and remain in the Settings screen or select the on screen OK to approve changes and go directly back to Main Menu Select Cancel to disregard the changes and go directly back to the Main Menu The Exit option will navigate back to the Main Menu screen 43 2 11 Set Option The purpose of the Settings screen s Set option is to allow the user to change the device s settings The settings are divided into the following groups General options Test options NIBP options SpO2 options Connectivity Network Configuration Wi Fi options and Date and Time Height Units Metric Weight Units Metric Electric Grid Audible Alarm Date Format Day Month Year Time Format Cancel Apply menu 05 45AM 11 11 09 Be Figure 2 14 NICOM Settings screen When selecting the Settings option on the
68. ly request user involvement and confirmation where required The wizard will track the relevant clinical parameters and will also calculate additional clinical information to provide the user with the end point of the protocol A protocol can be initiated at any stage during a test except for the calibration phase Simply press the Back button on the NICOM to access the screen s pop up menu In addition the user can start the PLR and the Bolus Protocols directly from the Challenge stage If this is selected the system will automatically analyze the last 3 minutes of readings to establish whether or not there is a valid Baseline stage The system will not allow for a direct challenge stage if the last 3 minutes readings contain poor signals or excessive movements When selecting the Protocols option a sub menu opens with a choice of the following protocols Orthostatic Bioreactance PLR test and Bolus Once selected the protocol wizard will appear on screen and state the steps that are to be taken The Protocol results can later be viewed on the designated Protocol Tabular Display screen see section 2 8 for more details The NICOM s Protocol Wizards consists of 34 Orthostatic Bioreactance Screening ID 167207703 Seth Reginald Smith Male Age 53 92kg 165cm BSA 1 99 Q un Orthostatic Bioreactance NIBP setup 72 dX dt 115 VET 220 Apply the NIBP cuff Zo 22 1 Cancel Next N 05 45AM 11 11 09 Be Figure 2 6 NICOM O
69. maining until the results refresh and appear on the screen SpO2 Start Stop SpO2 this option allows the user to start the SpO2 module to measure automatically SpO2 measurements In this working mode the spO2 module will continuously display SpO2 results If Hemoglobin was entered the Do2I shall be calculated continuously as well at the same rate the CI is updated Note When the SpO2 in not in automatic mode or was disabled automatically by the system the SpO2 title on screen shall be displayed with an annotation man which means the SpO2 is enabled for manual entry Note When the SpO2 is on automatic mode the option to enter manually SpO2 readings is disabled The SpO2 title in this working mode will not be annotated with the annotation man 38 26 Trend Display Screen The purpose of the Trend Display screen is to display graphic results of all saved or ongoing measurements CO CI HR NIBP SBP DBP and MAP TPRI TPR SV SVI SVV TFCd0 SpO2 DO2I 10 167207703 Seth Reginald Smith Male Age 3 Stkg 168 em BSA 1 99 R Qeoau 1D 167207703 Seth Reginald Smith Male Age 53 S2kg 168 com BSA 199 R ata Figure 2 9 NICOM Trend display screens To reach this screen press the Display Results button in the Existing Patient screen Figure 2 4 The results are shown graphically in the time scale defined for the screen Use Right and Left buttons to browse and see previous results When viewing the results of a saved test the pop
70. mitter in meters output power of Meters m transmitter 150kHz to 830MHz 80MHz to 800MHz 800MHz to 2 5GHz Watts W d 1 17VP d 1 17 VP d 2 3 VP 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 73 1 1 17 1 17 2 3 10 3 7 3 7 73 100 11 7 11 7 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 100 Chapter 9 0 Parts Information This Section outlines information for ordering and shipment of replacement parts for the Cheetah NICOM 9 1 Ordering Information All equipment and accessories are available directly from Cheetah Medical or from an Authorized Distributor For a list of Cheetah Medical Distributors please visit our web site at www cheetah medical com When ordering parts specify the serial number of your unit and the part number of the item s you are ordering A schedule of part numbers may be found in the Equipment and Accessory Inventory list below Forward orders to
71. n this is done the SpO2 monitoring shall commence automatically 24 XPOD SpO2 Module Specifications The following are the SpO2 module specifications e Patient Range Neonate through adult e Oxygen Saturation Range SpO2 0 to 100 e Displayed Pulse Rate Range 18 to 321 beats per minute BPM e Measurement Wavelengths and Output Power e Red 660 nanometers 0 8 mW maximum average e Infrared using NONIN PureLight Sensor 910 nanometers 1 2 mW maximum average e SpO2 Accuracy Arms 70 100 1 Arms represents approximately 68 of measurements e Temperature Operating 0oC to 500C 320F 1220F o Specified operating temperature is for the module Operating temperature of Sensor is not to exceed 400C 1040F e Temperature Storage Transportation 200C to 500C 40F 1220F e Humidity Operating 10 to 90 non condensing e Humidity Storage Transportation 10 to 95 non condensing e Power Draw 60 mW typical operation e Voltage Input 2 to 6 VDC w 100 mV max ripple e I O Signals 0 to 5 0 VDC nominal e Patient Isolation Meets IEC 60601 1 Dielectric withstand e Leakage Current Not applicable e Fluid Spill Resistance None e Ruggedness Shock IEC 60068 2 27 e Ruggedness Vibration Sinusoidal IEC 60068 2 6 e Random IEC 60068 2 64 e Sensors Designed to use NONIN branded PureLight sensors only e Shielding An RF shield is included placed over the analog components Wamings amp Precautions DO NOT use the S
72. ndition 10 40 C 50 104 F 50 75 RH Atmospheric pressure 700hPa to 1060hPa Storage condition 0 50 C 32 122 F 50 75 RH Delivery condition 0 50 C 32 122 F 50 75 RH Technical Characteristics of Acquisition Module Isolated preamplifier in accordance with IEC 601 1 standard Note The Cheetah NICOM is not defibrillator proof 16 NIBP Terminology Oscillometry The oscillometric method of blood pressure measurement is a non invasive method that monitors the amplitude of cuff pressure changes during cuff deflation to determine arterial blood pressure The cuff pressure is first elevated above the patient systolic blood pressure level and the cuff begins to deflate at a certain rate The initial rise in amplitude of these pressure fluctuations during cuff deflation corresponds closely to the systolic blood pressure As the cuff is further deflated these pressure fluctuations increase in amplitude until a peak is reached which is usually referred to as the mean arterial pressure MAP As cuff deflation continues the diastolic pressure can be determined based upon the rapidly diminishing amplitude of the pressure fluctuations Thus systolic MAP and diastolic blood pressures can be accurately obtained by supervising the pressure fluctuations while controlling the cuff deflation rate mmHg Millimeters of Mercury which is the most common unit of measure for pressure in non invasive blood pressure bpm Beats per minute which is
73. nge Lines on the inside of the cuff to determine the correct size cuff to use Wrap the cuff around the arm making sure that the Artery Marker is aligned over the brachial artery as shown in Figure 1 3 If possible do not wrap the cuff over the patient s clothing The cuff should fit snug to the patient s arm for maximum oscillometric signal quality An appropriate sized cuff should be placed on the non dominate arm where the lower edge of the cuff is located 2cm above the antecubital fossa interior bend of the elbow Figure 13 NIBP Cuff Placement Ensure that the air hose from the monitor to the cuff is not compressed crimped or damaged The midpoint of the subject s upper arm should be supported at heart level for proper measurement accuracy When the cuff is below heart level measurement results may be higher and when the cuff is above heart level measurement results may be lower than comparative results obtained at heart level Please remember that using a cuff that is the wrong size may give false and misleading results 12 Note All cuffs and hoses sold with the NICOM system containing an NIBP module must be approved for use by Cheetah Medical Note The initial inflation pressure will be selected via the Initial Inflation option that is located on the NIBP Settings screen Cuff sizes available for use with the Cheetah NICOM Range Bladder Description Size cm cm 98 0080 04 All Purp Small Adult 17 2
74. ns flicker emissions TEC 61000 3 3 Complies The RELIANT is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Table 2 Guidance and manufacturer s declaration electromagnetic immunity RELIANT The RELIANT is intended for use in the electromagnetic environment specified below The customer ot the user of the RELIANT should assure that it is used in such an environment P TEC 60601 1 2 Compliance Electromagnetic environment Immunity test Test level level guidance Floors should be wood conctete or Electrostatic LI6kV contact LI6kV contact Ceramic tile If floors are covered with discharge ESD IEC 61000 4 2 LI8kV ar LI8kV ar synthetic material the relative humidity Should be at least 30 2 kV for powr 2 kV for power Mains power quality should be that of a Electrical fast cal public l ny R supply lines supply lines typical public low voltage power supply SENSE network that supplies buildings used for TEC 61000 44 m 1kV for l Cot Applicable domestic purposes commercial or input output lines hospital clinic environment Surge TEC 61000 4 5 01 kV differentid 11 kV Mains power quality should be that of a typical public low voltage power supply 96 mode differential mode network that supplie
75. nt Information Cheetah Medical Inc 600 SE Maritime Ave Suite 220 Vancouver WA 98661 USA Toll free 1 866 751 9097 Telephone 1 360 828 8685 Fax 1 360 718 8154 cheetah cheetah medical com Europe Agent Information Cheetah Medical Ltd 1 Irmar House 59 Cookham Road Maidenhead Berkshire SL6 7EP United Kingdom Telephone 44 1628 636806 or 44 7836 725331 Fax 44 1628 788802 cheetah cheetah medical com Manufacturer Cheetah Medical Ltd 38 Habarzel Str Tel Aviv Israel Tel 972 3 644 0288 Fax 972 3 7254848 This guide applies to both male and female users though using masculine gender 104
76. nt with NIBP and SpO2 functionality is compatible with any of the following NONIN SpO2 sensors that have the following accuracy specifications Adults Pediatrics Neonates No Motion REUSABLE Finger Clip 2 digits 3 digits Flex 3 digits 3 digits Soft Sensor 2 digits N A 8000R 3 digits N A 8000Q 4 digits N A DISPOSABLE 6000 Series 2 digits 3 digits 7000 Series 3 digits 4 digits Motion REUSABLE Finger Clip 2 digits 3 digits Plex 3 digits 4 digits Soft Sensor 3 digits 4 digits Low All Sensors 2 digits 3 digits Perfusion Notes Reusable Group Finger Clip Sensors S000 AA 1 8000AA 3 8000AP 1 8000 AP 3 Flex Sensors 8000 1 8000 3 8008 8001 Soft Sensors 8000SS 8000SM 8000SL Disposable Group Flexi Form IT 7000 Series Sensors 7000A 7000P 70001 7000N 6000 Series Sensors 6000A 6000P 60001 GOOON Instruction for cleaning and maintenance of the SpO2 sensor are described in the specific SpO2 sensor user manual which is supplied with the sensor The SpO2 sensor is connected to the monitor via the dedicated SpO2 cable that connects to the dedicated connection on the back of the monitor See Figure 1 2 Place the sensor on a thin part of the patient s body e g fingertip or earlobe or in the case of an infant across a foot To start SpO2 monitoring while running a test select Start SpO2 from the main menu if SpO2 automatic mode is not the default mode Whe
77. o access the pop up menu options There are four Device Mode options Monitoring Mode Host Mode PC Mode and Service Mode and Apart from Monitoring Mode the other three are intended for unique features outside routine use of the monitor 1 Monitoring Mode on start up and during patient testing the unit works in a standard mode where the information is presented on the NICOM screen This is the NICOM s work mode 2 Host Mode enables the NICOM EMR application for download and management of testing information 51 3 PC Mode transfers control of the unit to a PC via the NICOM PC software application PC Mode is not intended for commercial users Note It is necessary for the user to enter the Service Mode option and insert the required password in order for the PC Mode option to become enabled Note This functionality is currently reserved for highly select research applications In order to discuss access to NICOM PC Mode and to obtain the required NICOM PC software application please contact an authorized Cheetah Medical agent Use of this feature also requires connection of the PC to a special isolation transformer because most PCs are not safe for use when connected to a person and thus require isolation to prevent electric shock hazard 4 Service Mode this working mode enables technicians to retrieve data directly from the system s analog board without opening the unit This mode is intended exclusively for th
78. or when passing a patient cable between patients clean all Non disposable parts such as Patient cable and clips with 75 medical grade alcohol CAUTION To avoid damage to the surface of the instrument e Avoid excessive pressure when cleaning the printed symbols on the monitor frame in the front and real panel as well as the stickers on the rear panel e Scratches on the surface of the sensors will cause inaccurate recording 93 83 Fuse Replacement The device uses 2 fuses to protect it against accidental short circuits The fuses are rated at 2A SB WARNING Before replacing a fuse disconnect the power cord from the mains socket Use fuses of the same type and rating only Figure 8 amp 1NICOM mains socket and fuses drawer Use a finger nail to open the little drawer placed right below the power socket Figure 8 2 NICOM fuses drawer and fuses Replace the blown fuse with a new one 84 Chargeable Batteries The NICOM device contains internal chargeable batteries In case of malfunction please return the NICOM to the factory or to an authorized Cheetah Medical distributor in your area 94 85 Electromagnetic Compatibility Manufacturer Declaration Notes The RELIANT requires special precautions with regard to electromagnetic compatibility e It must be installed and prepared for use as described in this User Guide e Certain types of mobile telecommunication devices such as mobile telephones are likely to interf
79. ose Cuff Corrective Action e Check that the hose is connected to the system and the cuff e Check that the cuff is properly tightened e Check that the cuff is in the correct position e Check that the correct size cuff is being applied e Check that the cuff is not leaking air e Check that the hose connections are not damaged or loose Safety Timeout Corrective Action e Check the patient e Check that the cuff is in the correct position e The patient may have been moving too much e Take another BP reading Cuff Overpressure Corrective Action e Check that the correct size cuff is being applied e Check that the hose has no sharp bends or is pinched e Check that the cuff is in the correct position e Check that the patient is not lying on the cuff Power supply out of range or other hardware problem Corrective Action Service may be required Call a Cheetah Medical representative 14 Permission problem Corrective Action Service may be required Call a Cheetah Medical representative Transducer out of range Corrective Action If possible perform calibration Service may be required Call a Cheetah Medical representative ADC out of range Corrective Action Service may be required Call a Cheetah Medical representative EEPROM calibration data failure Corrective Action If possible perform calibration Service may be required Call a C
80. ould you like to start immediately from the Challenge stage Cancel 08 23 11 01 44 PM aap Figure 2 8 NICOM Bolus Protocol This option allows the user to determine the homonymic response to a Bolus injection It is persist of two main steps Baseline and Challenge During the baseline step the patient is to be still with minimal movement or clinical intervention while being monitored for three minutes The challenge step consists of monitoring the patient while bolus is being injected to him You can determine when the bolus protocol ends as per the injection completion by selection the stop bolus protocol option As the Challenge step ends the NICOM will produce a NICOM Bolus report Manual Data Entry Enter MAP this option allows the user to insert the patient s MAP value into the system as retrieved from another BP monitor such as arterial line or a manual BP test The inserted MAP reading will be presented on the screen no later than 10 seconds after the manual entry and will also serve to derive the MAP related parameters namely TPR TPRI CP and CPI Enter SpO2 and Hgb From the Side Menu the user can manually enter the Hgb and SPO2 through the dial box window Following the entry of these two parameters the system will update DO2I 37 Switch Display this option allows the user to toggle through the different run screens in order to view all changes in real time Use the Switch Display option to navigate between
81. outer side of the sensors bag Open the Run screen section 2 5 make sure that all the sensors are connected and if possible that the patient is moving as least as possible during the calibration phase 58 see immediately below Press the OK button on the NICOM to start the measurement First result shall appear after approximately 70 seconds Special Note During the first 130 seconds of operation the system performs an automatic calibration function and a corresponding message is posted on the screen At this time for optimal results the patient should lie or sit as quietly as possible preferably without speaking or making sudden movements Once the initial calibration is completed the message is taken off the screen signaling that standard monitoring can resume In the event of excessive patient movement or talking during this period the system will filter away interferences however this may prolong the initial calibration period beyond 130 seconds During the measurement the screen display can be changed and the measurement can be paused as explained in section 2 5 In order to take an NIBP measurement connect the air hose by pushing it in and turning it clockwise Make sure that the NIBP is set to Enable on the NIBP Options settings screen When the NICOM is set place the cuff around the patient s arm over bare skin above the elbow Lift the patient s arm to the level of the heart In case that the NICOM
82. pO2 module for any purpose other than specified in this manual without written consent and approval from Cheetah Medical CAUTION Substitution of a component different from that supplied may result in measurement error Repairs should be undertaken only by personnel trained or authorized by Cheetah Medical CAUTION All SpO2 sensors used to connect the patient to the NICOM SpO2 module must be approved by Cheetah Medical Unauthorized SpO2 sensors may cause the module to perform in an improper fashion Authorized SpO2 sensors are offered as accessories from Cheetah Medical 25 CAUTION Do not use NIBP or constricting instruments on the same appendage as the sensor CAUTION The SpO2 module may not operate correctly if used or stored outside the relevant temperature or humidity ranges described in the Performance specifications WARNING Intravascular dyes such as indocyanine green methylene blue etc and darkly pigmented skin can adversely affect SpO2 readings WARNING Significant amounts of dysfunctional hemoglobins such as catboxyhemoglobin methemoglobin etc may adversely affect oximetry performance WARNING Oximetry performance may be impaired when patient perfusion is low or signal attenuation is high WARNING Long cables such as the sensor or extension cable may cause patient strangulation if routed incorrectly WARNING Electromagnetic interference which includes devices such as defibrillators MRIs or electro surgica
83. paate Date FirstName middie Name LastName Gender Wests Entry Date owwa omm om Doe M Ow02009 f Caa F Retrieve Data Open Dolete GBs change Password E toa out Figure 5 4 NICOM EMR Management screen The Management screen is divided to two sections 1 Search for a patient Insert patient details 1 or more into the table to find a specific patient from the local patient data base Select Search to find the specific patient select Clear to discard any entered data Note To access all patients clear all the fields and choose Seatch 2 Patient List All the results that were retrieved from the search will be listed in the patient list table Select the required patient or test from the list by clicking on it once with the mouse and then clicking on the Open button below To delete a required row from the list select it first and then click the Delete button Note A unique patient ID is entered to the NICOM for each patient by the operator which prevents patient mix ups The NICOM EMR is a read only library application and so no data can be altered on it Furthermore the software attributes the data by the unique ID only during the data retrieval from the NICOM 79 5 4 Patient Record Oceanon nn ce Figure 5 5 NICOM EMR Patient Record trend display screens The screen is divided to three sections 1 Patient and Test information A constant table that dis
84. plays the selected patient s personal information ID Gender etc and test information such as Test Date Test type and patient biometric details that were obtained at the time of the test such as weight height age and more 2 Test list A list is available of all the tests that were saved for the specific patient s data base When selecting a test by clicking on the required test from the list the test information will be loaded on to the screen 3 Trend and Numerical Display Tabs Trend Display Shows the trend graphs of the selected test as specified in the NICOM Use the Up Down buttons on the screen in order to switch the display from CO CI HR NIBP SBP and DBP MAP TPRI and TPR to SV SVI SVV SpO2 DO2I and TFCd0 Use the scroller at the bottom of the screen in order to browse through the study Use Set X Axis To buttons at the bottom of the screen in order to view the display in the desired time scale every 5 min every 20 min Etc The Y Axis amplitude can be adjusted manually by clicking the up down arrows that are located to the right of each parameter s display The Y Axis amplitude can 80 be set automatically by clicking the check box at the bottom of the screen Click again to cancel auto Y axis settings Numerical Display This tab contains the Tabular Display of numerical information as presented on the NICOM Test List Patient and Test Info ote statin tye 1D 02951111 Name John Do
85. press the NICOM s Left Right and Up Down arrow keys and in order to select a specific letter or number press the OK button while the required digit is highlighted In fields that have multiple options to choose from such as Gender move the cursor to the selected field when the selected option is highlighted press the NICOM s OK button in order to lock the selection In order to move to the next field press Next and fill in the required data The ID age weight height and gender fields are mandatory All other fields that follow are optional When reaching the final mandatory field the on screen Finish button will be enabled indicating that from this point on the wizard can be completed at any stage and the remaining patient information is discretionary and not mandatory When entering the patient s age note that it is possible to enter months as well as years For instance refer to the following examples E For 1 months enter 0 1 E For 10 months enter 0 10 E For 20 6 years enter 20 6 30 Note The new patient information will be kept in the system as long as it is not shut down In order for the patient to be added to the existing patients list and stored there even after system shut down a test must be run first with at least one recorded result Conversely if the system is shut down prior to obtaining at least one reading the patient information will be lost from the existing patients list Note In o
86. rder to prevent confusion between patients a unique patient ID for each patient is entered by the operator If the exact same patient ID is entered into the system the user will be prompted to use a different ID number in order to prevent confusion in storage Note The new patient s information will be displayed on the top of all Run screens The posted information includes ID full name gender age weight height and BSA The measure units lb ft or kg cm will appear alongside the relevant parameters to prevent mix ups The measured units may be set or modified in the device Settings screen Note In order to prevent confusion between units and measurements if the system recognizes that the weight or the height entered by the user does not match the normal weight and height per a given age it will prompt a warning message 24 Existing patient ID Age First Name Weight Middle Name Height Last Name BSA Gender Display Update Results Details menu 05 45AM 11 11 09 Be Figure 24 NICOM Existing patient screen Close The purpose of the Existing patient screen is to upload the information of a patient that already exists in the monitor s data base In order to navigate between the screen s options use the arrow keys or touch the desired selection then press the NICOM s 31 OK button in order to lock your selection To present the results of a patient s previous tests select the Display Results option and then select the r
87. reen press the NICOM s OK button to run a test The Stop icon that appears on the top left hand side of the Run Bar will be replaced by the Play icon in order to pause the test press the NICOM s OK button again the play icon will now be replaced by the pause icon In order to browse between the different types of display screens select the Switch Display 32 option from the Run screen s pop up menu then use the UP and Down buttons to select the display screen of interest In order to access the Run pop up menu press the BACK button then use the arrow keys to navigate between the options To view the quality of the data generated during the test the raw data and dNICOM average morphology are displayed in real time In addition to the technical data dxdt VET and Z0 are also displayed The pop up menus accesses from the various Run screens Run Dashboard Trends and Numerical Display enable the following options NIBP NIBP Time Interval this option allows the user to change the time interval settings during an ongoing test Once selected a small V sign will appear to the left of this option The change is relevant for that specific test only The NIBP time interval for the following test will be set according to the pre defined default as appears on the Settings screen This option is available through all Run screens pop up menus Manual NIBP this option allows the user to start a manual NIBP measurement The NIBP will initi
88. ress the BACK button to enter the screen s pop up menu Select the Set option then select SpO2 Options and press the OK button Once entering the SpO2 Settings screen all setting options for this section are displayed that allows modification of the measurements that ate listed below 4 17 Hgb Posting Period This option allows the user to adjust the Hemoglobin posting period This posting period controls when the manual entered Hgb value is not updated and shall color the value in fading gray The options are 1hr 4hr 8hr 12hr 24hr 73 4 18 SpO2 Operation Mode This option allows the user to select which SpO2 working mode shall be the default mode The user can decide between Manual mode and Automatic Mode When the SpO2 default mode in Manual the SpO2 is disabled and shall not prompt automatically SpO2 measurements when monitoring a patient In this mode the user will be required to start the SpO2 to enable it to Automatic Mode but every new test the SpO2 shall return to Manual mode as it is set as the default working mode When the spO2 is in Automatic default mode it will automatically activate the SpO2 module and shall display the SpO2 measurements on screen when monitoring a patient If the user shall require using the manual SpO2 mode he she will be required to stop the SpO2 module when monitoring a patient 74 Chapter 5 0 NICOM EMR Electronic Medical Records WARNING NICOM EMR does not require the patient to be conn
89. rthostatic Bioreactance Protocol This option allows the user to determine the hemodynamic response to an orthostatic maneuver This protocol persists of two main steps Baseline and Challenge During the baseline stage the patient is monitored for three minutes while in a sitting position The Challenge step is based on monitoring the patient for three more minutes while lying in supine position As the Challenge step ends the NICOM will produce an Orthostatic Bioreactance protocol outcome report 35 Passive Leg Raise PLR Test ID 167207703 Seth Reginald Smith Age 53 92 kg 165 cm BSA 1 99 Oona dX dt 115 Question Would you like to start immediately from the challenge stage Cancel Yes Ga 05 45AM 11 11 09 Be Figure 2 7 NICOM PLR Protocol This option allows the user to determine the hemodynamic response to a passive leg raise maneuver This protocol persists of two main steps Baseline and Challenge During the baseline step the patient is to be lying in a semi recumbent position where the head and shoulders are elevated by 30 45 as when resting on a high pillow while being monitored for three minutes The Challenge step is based on monitoring the patient for three more minutes while lying in supine position with legs elevated to 45 degrees As the Challenge step ends the NICOM will produce a NICOM PLR report 36 Bolus injection Protocol Age 55 145 5 lb 71in BSA 1 83 R Pause Question W
90. s buildings used for domestic purposes commercial or L12kV common L12 kV common hospital clinic environment mode mode Voltage dips lt 5 UT lt 5 UT Mains power quality should be that of a short typical public low voltage power supply gt 95 dip in UT gt 95 dip in network that supplies buildings used for interruptions and for 0 5 cycle UT for 0 5 cycle domestic purposes commercial or hospital clinical environment voltage variations If the user of the RELIANT requires on power supply 40 UT 40 UT continued operation during power mains f f eae Seite i interruptions it is recommended that input lines 60 Yodip in UT 60 Yodip in UT RELIANT be powered from a separate for 5 cycles for 5 cycles power supply UPS etc lt 5 UT lt 5 UT TEC 61000 4 11 70 UT 70 UT 30 Yodip in UT 30 Yodip in UT for 25 cycles for 25 cycles lt 5 YUT lt 5 UT lt 5 UT lt 5 UT gt 95 dip in UT gt 95 dip in for 5s UT for 5s Power frequency 3 A m 3 A m Power frequency magnetic fields should 50 60 Hz magnetic field be at levels characteristic of a typical public low voltage power supply network that supplies buildings used for domestic purposes commercial or hospital clinic environment 97 TEC 61000 4 8 NOTE UT is the a c mains voltage prior to application of the test level Table 4 Guidance and manufacturer s declaration electromagnetic immunity
91. s may occur while running the Orthostatic Bioreactance PLR and Bolus You may need to restart the protocol or troubleshoot according to the on screen error text Protocol errors might persist of the following texts Protocol Failed Unable to perform the protocol due to low signal quality Please check sensors patient cable connection or patient movements and then press restart Result timeout error Unable to obtain NIBP reading NIBP Inflate timeout air leak or loose cuff Select Next to continue without NIBP results or correct the problem and select Restart Unable to obtain NIBP reading NIBP timeout Unstable base line results Select restart to start the baseline or next to continue to challenge phase 89 7 2 Waming Messages The following warning messages may be encountered in the course of normal system operation The following instructions are intended to assist the user in dealing with them 1 Diagnosis CO is extremely high and a pacemaker is active on the patient Cause The patient has a Pacemaker which can result in interruption in the NICOM signal Solution Usually Pacemaker activity will not affect the NICOM signal unless it is a Unipolar Pacemaker or External Pacemaker activities which can result in distorted NICOM signal If there is a relatively high CI reported by the system verify that the Pacemaker lead distance from the NICOM sensor is no less than 2 5 inches If not replace the N
92. the Run screen the Dashboard the Numerical Display the Trend Display and Protocol display screens see figure 2 6 below Note The Protocol Display screen will only be enabled in case a protocol was tun successfully during a test Exit this option navigates back to the Main Menu screen In order to begin monitoring a patient open the Run screen by entering the new patient information or by selecting an existing patient of the list that appears on the NICOM s Main Menu screen then press the NICOM s OK button as indicated on the screen s menu bar s help line see figure 2 5 In order to pause the test press OK again In order to completely stop the test choose the Stop option on the Run screen s pop up menu A window will then emerge state that a test is being run and ask the user to confirm whether or not to end it If a choice is made to stop the test the stop icon will replace the play icon on the run bar at the top left side of the screen Note All tests can be started and paused using the pop up menu options On the lower section of the screen 3 oscillograms run during a measurement two ECG time marker channels and one NICOM channel Eleven empty numeric display boxes appear on the top and side of the screen During measurement the system will display results of CO CI HR SV SVI SVV NIBP CP CPI MAP TPR TPRI dxdt VET and Z0 Note A refresh clock appears on the Run bar on all Run screens that counts the number of cycles re
93. to perform any measurement that includes very significant motion 48 Sample Interval Tests results which are calculated and displayed on the monitor represent information averaged through certain periods of time The corresponding time period can be changed using the field options The user may choose to recetve 30 seconds averages or 1 minute averages Use the NICOM s Right and Left buttons to choose the desired averaged period of time 67 49 TFCd The TFCd parameter is designed to capture the change in TFC by calculating the percentage of change between the current TFC measurement and the one that was measured at a specific prior time as set by the operator i e the TFCd Measuring time This option allows the user to choose between 15min 30min 1hr 4hrs and 10hrs NIBP Options From the Main Menu screen select the Settings option Once this option is selected press the NICOM s OK button to enter the Settings screen Press the BACK button to enter the screen s pop up menu Select the Set option then select NIBP Options and press the OK button Once entering the NIBP Settings screen all setting options for this section are displayed that allows modification of the measurements that are listed below ID 167207703 Seth Reginald Smith Male Age53 92kg 165cm BSA1 99 Hgb 12 0 gdl Disabled Time Interval Min Operation Mode Manual Initial Inflation mmHg Apply menu 05 45AM 11 11 09 Be Figure 4 3 Settings screen
94. ts Rows with red texts and no reported results represent time intervals of suboptimal signal quality or lead or sensor disconnect Press the Left arrow key on the NICOM to display earlier results or press the NICOM s Right arrow key for later results Note in order to display another patient s results press the BACK button on the NICOM to enter the screen s pop up menu then choose the Patient Info option and click the NICOM s OK button in order to be redirected to the Existing Patient screen Press BACK to enter the pop up menu options of this screen Select the Change Patient option a window that displays all of the existing patients details would pop up Select the desired patient off of the list by using the arrow keys and pressing the NICOM s OK button Now follow steps 2 4 Press the NICOM s Back button and select the Patient Info option in order to finish and go back to the Existing Patient screen From the Existing Patient screen select BACK again to enter the pop up menu then select the Exit option in order to return to the main menu 61 34 Entering Events This application allows the user to enter free text events either in real time during monitoring or when browsing through the results after the end of the test The events are displayed in the Trend Display screen and in the Numerical Display screen In addition the NICOM automatically adds events when the protocols are activated Adding events To add an event whi
95. uctures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the RELIANT is used exceeds the applicable RF compliance level above the RELIANT should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the RELIANT b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended Separation Distances The RELIANT is intended for use in an electromagnetic environment in which radiated radiofrequency disturbances are controlled The user and or installer of the unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile radiofrequency communications equipment emitters and the RELIANT according to the maximum output power of the equipment as recommended in the table below 99 Table 6 Recommended separation distances between portable and mobile RF communications equipment and the RELIANT Rated maximum Separation distance according to frequency of trans
96. void damage to the instrument or sensors be careful of liquid spillage while cleaning CAUTION Do not expose the instrument or sensors to sprays liquids or any other type of solvent CAUTION To avoid damage to the surface of the instrument or sensors e Avoid excessive pressure when cleaning the lettering e Do not use solvents or detergents for cleaning e Do not clean the sensors with an abrasive Note Scratches on the surface of the sensors will cause inaccurate data recording CAUTION To avoid damage to the LCD screen do not expose the instrument to direct sunlight for long periods of time CAUTION Uset is prohibited from changing adding removing or disassembling any system parts Warranty shall not apply to any defects failure or damage caused by improper use and or improper or inadequate maintenance and care CAUTION The unit is classified as Class IIb continuously operated ordinary equipment with applied part and with signal input output parts The device is not intended for use in the presence of flammable mixtures Note The contents of this manual are subject to change without prior notice for improvement of analysis precision Note Used sensors should not be placed with common household waste products Contact local authorities for the location of a chemical waste collection program nearest you 111 Cleaning and Disinfecting the NICOM Device CAUTION The NICOM system is classified as non waterproof To avoid dama
97. work Configuration Network Setup Wizard IP address BackSpace Next Cancel Settings 05 45AM 11 11 09 Figure 2 20 NICOM Settings screen s Network Configuration options In the Network configuration screen the user can choose to change the configuration connection to the hospital network 2 18 Date and Time Date and Time Set Date 11 11 09 Set Time Cancel Apply menu 05 45AM 11 11 09 Be Figure 2 21 NICOM Settings screen s Date and Time options 50 Use the Date and Time screen to set the time and date of the device s clock This clock controls the date and time that are saved for every record and displayed on the Trend Display and Tabular Display screens Press the NICOM s OK button to operate the field Use the arrow keys to set the desired date time Press the NICOM s OK button again and use the arrow keys in order to move to the next field In order to save the new settings and remain in the settings screen select the Apply button in order to save the new settings and go back to the Main Menu screen press the on screen OK button Select Cancel in order to discard the changes and go back to the Main Menu screen 2 19 Device Mode Metric Calibrate Touch Screen Host Mode Device Mode gt Checkup Mode Cancel Apply 05 45AM 11 11 09 Be Figure 2 22 NICOM Settings screen s Device mode options Note The Device Mode option is located in the Settings pop up menu Press the Back button t

Download Pdf Manuals

Related Search

Related Contents

RockHound Attachments - Minnesota Department of Transportation  Mouse CCL20 ELISA Kit User Manual Catalog  Description of the appliance  指導し  Sanibel Panoramic Electric Stove with Infrared Quartz      Belkin F5U307EAWHT    Operating the TV - Manuals, Specs & Warranty  

Copyright © All rights reserved. Failed to retrieve file