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10 Regulatory Representative

United States Agent 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

[email protected]

Authorized Representative Information:

MedNet GmbH

Borkstrasse 10

48163 Münster, Germany

Tel49 251 32266-61

Fax: +49 251 32266-22

Website www.medneteurope.com

Manufacturer:

Cheetah Medical Ltd.

38 Habarzel Str.; Tel Aviv;

Israel

Tel: (972)-3 644 0288

Fax: (972)-3 7254848

0482

This guide applies to both male and female users, though using masculine gender.

Chapter

Содержание Starling SV

Страница 1: ...R IFU 05 Revision 3 Starling SV User Guide ...

Страница 2: ...SA 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 2016 ...

Страница 3: ...ns 53 2 15 SpO2 Options 54 2 16 Art Options 55 2 17 Connectivity 56 2 18 Network Configuration 57 2 19 Date and Time 58 2 20 Device Mode 59 2 21 Service Mode Screen 60 2 22 Live Demo and Demo Screens 61 2 23 Shut down Screen 62 2 24 WI FI options 63 3 0B Basic Functions 64 3 1 Saving a New Patient 64 3 2 Performing a Session 64 3 3 Viewing Test Results 67 3 4 Entering Events 69 3 5 Calibrating the...

Страница 4: ...BP 85 7 0 Troubleshooting 86 7 1 Error Messages 86 7 2 Warning Messages 90 7 3 Other Problems 90 8 0 SERVICE AND MAINTENANCE 93 8 1 Cleaning 93 8 2 Fuse Replacement 94 8 3 Chargeable Batteries 94 8 4Electromagnetic Compatibility Manufacturer Declaration 95 9 2 Equipment and Accessories Inventory 102 Returning Parts under Warranty 102 Shipping Parts 103 ...

Страница 5: ...ortant information Consult operating instructions Manufacturer Temperature range Relative humidity range Atmospheric Pressure range Use by Do not reuse Latex Free European approval mark Authorized representative in the European Community Serial Number Type BF Applied Part Store in a cool and kept away from direct sunlight place Store in a dry place Do not open Do not dispose of contact for recycli...

Страница 6: ...lds 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 STARLING SV 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 STARLING SV s Back button Then either click the STARLING SV s OK b...

Страница 7: ...TFCd and Thoracic Fluid Content delta from baseline TFCd0 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 displa...

Страница 8: ...e 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 STARLING SV s knob in order to choose commands from the menu to change measurements display during a test In addition the knob can be used to browse and look up values within fields to move the cursor between fields to brows...

Страница 9: ...dedicated slider For faster browsing drag the Slider body It is also possible to sweep the finger over the trends to the direction required Browsing Through Events In the Numerical and Trends displays skip between events by touching the Events Browsing Tool on the screen Changing the trends scale In order to change the scale of the trends move two fingers apart or towards each other It is also pos...

Страница 10: ...9 Figure 1 2 Back panel of the Starling SV Figure 1 3 Front and side of the Starling SV ...

Страница 11: ...efer to figure 1 2 3 SpO2 connector Connect the SpO2 Sensor to the monitor using the SpO2 connector please refer to figure 1 2 In the rear of the monitor the following connector are preset 1 IBP connector For future functionality 2 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 th...

Страница 12: ... Weight units Dedicated Starling SV Electronic Medical Records interface XlS PDF 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 AmbientTemperatureandHumidity Operation condition 10 40 C 50 104 F 50 75 RH Atmospheric pressure 700hPa to 1060hPa Storage condition 0 ...

Страница 13: ...m Beats per minute which is the most common unit of measure for pulse rate Introduction The NIBP module of the STARLING SV 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 ...

Страница 14: ...140mmHg Warnings Precautions This device should not be used when oscillometric pulses may be altered by other devices or techniques such as External Counterpulsation ECP or Intra 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 flamma...

Страница 15: ...ill be altered when the cuff occludes the brachial 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 In...

Страница 16: ...llergic exanthema symptomatic eruption in the area of the cuff may result including the formation of urticaria allergic reaction including raised edematous 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 petechi...

Страница 17: ...misleading results Note The NIBP module is designed to work with SunTech cuffs and hoses The use of cuffs and hoses not supplied by Cheetah Medical or SunTech may compromise performance and accuracy Note The initial inflation pressure will be selected via the Initial Inflation option that is located on the NIBP Settings screen unless automatically specified by the NIBP patient population mode Neon...

Страница 18: ...uracy 3mmHg between 0 mmHg and 300 mmHg for operating conditions between 0 C and 50 C Recommended Frequency of Pressure Transducer Calibration The pressure transducer calibration should be verified on a yearly interval Operating Conditions 0 C to 50 C 15 to 95 non condensing humidity Storage Conditions 20 C to 65 C 15 to 90 non condensing humidity Altitude Measurement accuracy is not affected by a...

Страница 19: ...uch Check that the cuff is properly tightened Check that the cuff is in the correct position Check that the correct size cuff is being applied Check that there is no excessive clothing between the arm and the cuff Exceeded measurement time limit Corrective Action The patient may have been moving too much Check that the cuff is properly tightened Check that the cuff is in the correct position Check...

Страница 20: ...g applied Check that the cuff is not leaking air Check that the hose connections are not damaged or loose Safety Timeout Corrective Action Check the patient Check that the cuff is in the correct position The patient may have been moving too much Take another BP reading Power supply out of range or other hardware problem Corrective Action Service may be required Call a Cheetah Medical representativ...

Страница 21: ...ll 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 ...

Страница 22: ...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 Retry to obtain an NIBP reading 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 represe...

Страница 23: ...et to roughen the skin Place the STARLING SV Sensors on the patient s skin as seen bellow Figure 1 4 Figure 1 4 Starling SV 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 Starling SV sensors after the expiration date CAUTION In the unl...

Страница 24: ...acity When connected to the external power source the battery charge indicator will indicate that the battery is being charged and the amount of battery charge remaining in a graphic way If the battery level falls to 10 or lower a warning message will appear To protect the monitor and the monitor data the system will shut down automatically without user prompt if the charge level falls under 5 CAU...

Страница 25: ...e solvents or detergents for cleaning 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 User is prohibited from changing adding removing or disassembling any system parts Warranty shall not apply to any ...

Страница 26: ... and loss of hemodynamic parameters To clean or disinfect the monitor perform the following 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 To disinfect external monitor surfaces and reusable accessories such as the Starling SV patient cable clean with 70 medical grade alcohol using...

Страница 27: ...e and with a SpO2 function that non invasively measures and displays blood oxygen saturation SpO2 In addition by slaving off the Philip s patient monitor the STARLING SV can display continuous blood pressure measurements taken from the arterial line For slaving the Philip patient monitor contact a Cheetah Medical Service representative The device displays associated hemodynamic parameters based on...

Страница 28: ...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 Starling SV measures the ejection but does not subtract the backward regurgitation that takes place during diastole 2 Severe anatomic abnormalities of the th...

Страница 29: ...ght 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 PopulationsthatmayusetheSpO2function The Starling SV SpO2 module is intended for use with neonatal pediatric and adult patients during both no motion and m...

Страница 30: ... 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 When this is done SpO2 monitoring shall commence automatically NELL 1SpO2ModuleSpecifications The following are the SpO2 module specifications P...

Страница 31: ... Clip Sensors 8000AA 1 8000AA 3 8000AP 1 8000AP 3 Flex Sensors 8000J 1 8000J 3 8008J 8001J Soft Sensors 8000SS 8000SM 8000SL Disposable Group Flexi Form II 7000 Series Sensors 7000A 7000P 7000I 7000N 6000 Series Sensors 6000A 6000P 6000I 6000N 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...

Страница 32: ...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 ca...

Страница 33: ...pO2 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 SpO2 Low signal Please check sensor Adjustment Corrective Action Readjust the SpO2 sensor If problem persist replace the SpO2 sensor If prob...

Страница 34: ...reens are touch sensitive All on screen actions can also be performed by touching the on screen buttons 2 1 Start Up Screen The first activation of the device opens the Start Up screen which is the gateway to the program Figure 2 1 Starling SV Start Up screen ...

Страница 35: ...rder 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 To select an existing patient choose the required patient from the list to the right Use the Settings screen in order to set the system s time and date measure units...

Страница 36: ...D age weight and height 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...

Страница 37: ...at 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 2 4 Existing patient Figure 2 4 Starling SV Existing patient screen 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 k...

Страница 38: ...In addition by inserting a flash drive into the USB port and selecting the export button on the screen the monitor will automatically export all the patients test to the attached flash drive in Excel format 2 5 Run Screen The purpose of the Run screen is to run a new test save it and display its results during the test Figure 2 5 Starling SV Run screen The Run Screen is accessed by selecting the R...

Страница 39: ...g 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 initiate the measurement immediately after selection Following the manual reading the system will continue to periodically obtain an NIBP measurement according...

Страница 40: ...ence 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 Starling SV supported protocols The Protocol Wizard is designed to simplify administration and data management related to hemodynamic tests such as the Passive Leg Raise or Bolus injection Once chosen the tests perform automatically...

Страница 41: ... Baseline and Challenge During the baseline step the patient is to be 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 Starl...

Страница 42: ...termine when the bolus protocol ends as per the injection completion by selecting the stop bolus protocol option As the Challenge step ends the Starling SV will generate a Starling SV Bolus report The main outcome of this protocol is the Delta SVI which is calculated as the percent of change between the average baseline phase SVI and the maximum SVI during the challenge phase Manual Data Entry Ent...

Страница 43: ...s the knob as indicated on the screen s menu bar s help line see figure 2 2 In order to pause select the Pause option from the pop up menu 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 rep...

Страница 44: ...t Stop Art this option allows the user to start the Art functionality to measure automatically arterial blood pressure measurements In this working mode the Art functionality will continuously display Art results Note When the Art is enabled the NIBP functionality will be disabled automatically and vice versa 2 6 Trend Display Screen The purpose of the Trend Display screen is to display graphic re...

Страница 45: ...s The Time Scale option opens a sub menu that allows the user to choose different time scales this can also be done by moving the fingers apart towards each other while touching the trends The Patient Info option opens the Existing Patient screen 2 7 Tabular Display Screen The purpose of the Tabular Display screen is to display the numeric results of saved or ongoing measurements The Numeric Displ...

Страница 46: ...45 Figure 2 10 Starling SV Tabular display screen ...

Страница 47: ...n or scroll the knob while pressing it or swipe the finger vertically over the screen 2 9 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 parameters themselves ...

Страница 48: ... controlled independently from the trends in the Trend Display i e changing the Dashboard 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 With the protocol real time dashboard the user can view in real time the progress and results of the selected protoco...

Страница 49: ...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 ...

Страница 50: ...er 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 ...

Страница 51: ...k Configuration Wi Fi options and Date and Time Figure 2 14 Starling SV Settings screen When selecting the Settings option on the Main Menu screen the General Options screen which is the default screen for this section is presented 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 ...

Страница 52: ...igure 2 15 Starling SV 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 ...

Страница 53: ...13 Test Options Figure 2 16 Starling SV 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 ...

Страница 54: ...Starling SV 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 or disable the NIBP option ...

Страница 55: ... SpO2 Options Figure 2 18 Starling SV Settings screen s SpO2 options In the SpO2 Options screen the user can choose to change the settings for the SpO2 functionality Hgb Posting Period and SpO2 Operation Mode ...

Страница 56: ...55 2 16 Art Options Figure 2 18 Starling SV Settings screen s SpO2 options In the Art Options screen the user can choose to change the settings for the Art functionality ...

Страница 57: ...nectivity Figure 2 19 Starling SV Settings screen s Connectivity options In the Connectivity screen the user can choose to change the Starling SV connectivity method to an external system for continuous data flow ...

Страница 58: ...rk Configuration Figure 2 20 Starling SV Settings screen s Network Configuration options In the Network configuration screen the user can choose to change the configuration of the connection to the hospital network ...

Страница 59: ...Settings screen s Date and Time options 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 ...

Страница 60: ... and Service Mode Apart from Monitoring Mode the other three are intended for unique features outside routine use of the monitor 1 Monitoring Mode on startup and during patient testing the unit works in a standard mode where the information is presented on the Starling SV screen This is the Starling SV work mode WARNING The Starling SV s USB connector has a cap which is not to be removed when the ...

Страница 61: ...cted to a Starling SV monitor the Checkup Mode Wizard shall test the Starling SV monitor and shall verify that it works according to specs and within the factory calibration thresholds At the end of the test the Checkup Wizard shall report the user if the system is working according to specs and is calibrated or not WARNING If the Checkup fails please do not use the Starling SV monitor and contact...

Страница 62: ...oard 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 Figure 2 25 Starling SV Demo screen The Demo Screen is intended to show the various monitoring screens and to demonstrate how the information is presented during a test without the need to connect the monitor ...

Страница 63: ...hut Down screen is accessed by selecting the Shut Down option on the device s Main Menu screen Figure 2 26 Starling SV Shut Down screen To turn the device off select the on screen Yes option In order to cancel the Shut Down screen and return to the Main Menu screen choose the on screen the No option ...

Страница 64: ...e 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 signal strength so that 3 bars reflect good strength and no bars refelct no signal If the dongel is not connected the following sign will appear If Wi Fi is in enabled but not connected to a network the following icon will appear...

Страница 65: ...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 to be stored 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 The age weig...

Страница 66: ...ensors bag on clean prepped and preferably hairless skin Figure 3 1 Starling SV Sensors Instructions 5 Special Note The Starling SV double sensors are designed for single use only If the STARLING SV 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 Starling SV Sensors shelf life is indicated on t...

Страница 67: ... in and turning it clockwise Make sure that the NIBP is set to Enable on the NIBP Options settings screen When the Starling SV 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 Starling SV is set to Manual Automatic NIBP operation the Starling SV will inflate the cuff at a given time according to the sett...

Страница 68: ...s about these measurements 4 Slide your fingers horizontally on the screen to review the earlier or later results 5 Select the Patient Info option in order to finish and go back to the Existing Patient screen From the Existing Patient screen choose the menu then select the Exit option in order to return to the main menu Numericresults 1 Choose the Existing Patient option on the Menu screen and sel...

Страница 69: ...68 5 Select the Patient Info option in order to finish and go back to the Existing Patient screen From the Existing Patient screen select the Exit option in order to return to the main menu ...

Страница 70: ... 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 To add an event retrospectively 1 Browse to the required result 2 ChooseEvents Add Event The Add Event window opens 3 Enter the event...

Страница 71: ...isplay 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 events that were entered during the time frame of the row ...

Страница 72: ...Screen Perform this calibration procedure if the Touch Screen becomes less responsive 1 From the Side Menu choose Touch Screen Calibration Wait approximately 2 seconds until the Touch Screen Calibration tools opens Figure 3 3 Touch Calibration Screen Tool 2 Follow the onscreen instructions ...

Страница 73: ...on is divided into the following Settings options General Options Test Options NIBP and Art Options SpO2 Options Connectivity Network Configuration Wi Fi options and Date Time GeneralOptions From the Main Menu screen select the Settings option The General Options screen will then be presented The General Options screen allows modification of the measurements that are listed below Chapter 4 ...

Страница 74: ...t of the rest of the world To customize the filter to your geographic location select 60 Hz if you are 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 4 4...

Страница 75: ...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 to perform any measurement that includes very significant motion 4 8 Sample Interval Tests results which are calculated and displayed on the monitor represent information averaged through certain p...

Страница 76: ...lect NIBP Once entering the NIBP Settings screen all setting options for this section are displayed that allows modification of the measurements that are listed below Figure 4 3 Settings screen NIBP options 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 Di...

Страница 77: ...ar 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 STARLING SV 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 ...

Страница 78: ...signed to allow for 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 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...

Страница 79: ...me screen opens change the Date and Time correctly 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 Connectivity 4 15 Connectivity Wizard STARLING SV can ...

Страница 80: ...ectivity Wizard Networking 4 16 Networking Wizard STARLING SV 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 ...

Страница 81: ...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 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 Sp...

Страница 82: ... are listed below 4 19 Art Operation Mode This option allows the user to select which Art working mode shall be the default mode The user can decide between Manual mode and Automatic Mode When the Art default mode in Manual the Art is disabled and shall not prompt automatically Art measurements when monitoring a patient In this mode the user will be required to start the Art to enable it to Automa...

Страница 83: ... l min m 2 6 3 HR Heart Rate is the number of contractions heart beats of the heart in one minute The HR units are BPM Beats per Minute 6 4 VET Ventricular Ejection Time 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 6 5 dX dt Instantaneous thoracic BIOREACTANCE The input and output...

Страница 84: ...elow 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 r...

Страница 85: ... 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 M2 and is calculated by dividing CP by the BSA CPI CP BSA 6 18 Z0 Z0 is the electrical impeda...

Страница 86: ...85 6 23 DBP SBP stands for Diastolic Blood Pressure ...

Страница 87: ...V device and the patient s body This results in a low amplitude ECG signal Cause The Starling SV cable or one or more of the Starling SV Sensors are not connected properly to the Starling SV device or to the patient Solution Check that the Starling SV Sensors are well attached to the patient s body and are connected properly to the Starling SV cable Check the connection of the Starling SV cable to...

Страница 88: ...e wet or if the underlying skin is hairy If the problem persists stop the test and start a new one 3 Message 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 Starling...

Страница 89: ... to calibrate Please check cable and sensor connections and try again Cause The sensors are 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 conn...

Страница 90: ...col 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 lin...

Страница 91: ...ignal If there is a relatively high CI reported by the system verify that the Pacemaker lead distance from the Starling SV sensor is no less than 2 5 inches If not replace the Starling SV Sensors with new sensors and make sure the sensor is positioned more than 2 5 inches from the lead 2 Message Testing has not been completed on the MRI compatibility of either the sensor or the monitor Reason The ...

Страница 92: ... 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 Proble...

Страница 93: ...ction Please contact a Cheetah medical representative 6 Problem Buzzer failure during monitoring Cause Buzzer turned 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 ...

Страница 94: ...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 us...

Страница 95: ...ing only Figure 8 1 Starling SV mains socket and fuses drawer Use a finger nail to open the little drawer placed right below the power socket Figure 8 2 Starling SV fuses drawer and fuses Replace the blown fuse with a new one 8 3 Chargeable Batteries The Starling SV device contains internal chargeable batteries In case of malfunction please return the Starling SV to the factory or to an authorized...

Страница 96: ...EETAH MEDICAL Ltd as replacement parts may have the consequence of increasing the emissions or decreasing the immunity of the unit Electromagnetic Emissions STARLING SV is intended for use in the electromagnetic environment specified in the following tables 1 2 4 and 6 below The user and or installer of the unit must ensure that it is used in such an environment Table 1 Guidance and manufacturer s...

Страница 97: ...is used in such an environment Immunity test IEC 60601 1 2 Test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or Ceramic tile If floors are covered with synthetic material the relative humidity Should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV fo...

Страница 98: ... in UT for 25 cycles 5 UT 5 UT 95 dip in UT for 5 s Mains power quality should be that of a typical public low voltage power supply network that supplies buildings used for domestic purposes commercial or hospital clinical environment If the user of the STARLING SV requires continued operation during power mains interruptions it is recommended that STARLING SV be powered from a separate power supp...

Страница 99: ...ed RF IEC 61000 4 3 3 Vrms 150 k Hz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 Vrms 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the STARLING SV including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 17 P d 1 17 P 80 M Hz t o 800 MHz d 2 3 P 8...

Страница 100: ...ite survey should be considered If the measured field strength in the location in which the STARLING SV is used exceeds the applicable RF compliance level above the STARLING SV should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the STARLING SV b Over the frequency range 150 kHz to 80 MHz field st...

Страница 101: ...7 7 3 100 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 hi...

Страница 102: ...uipment and Accessory Inventory list below Forward orders to 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 ...

Страница 103: ... X 8 NIBP Cuff 1 X 9 Starling SV Carry Bag CMA Bag10 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 STARLING SV 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 ...

Страница 104: ...mber 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 ...

Страница 105: ...0 718 8154 cheetah cheetah medical com Authorized Representative Information MedNet GmbH Borkstrasse 10 48163 Münster Germany Telephone 49 251 32266 61 Fax 49 251 32266 22 Website www medneteurope com Manufacturer Cheetah Medical Ltd 38 Habarzel Str Tel Aviv Israel Tel 972 3 644 0288 Fax 972 3 7254848 0482 This guide applies to both male and female users though using masculine gender Chapter 10 ...

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