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Cheetah Medical Starling SV User Manual

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Starling™ SV
User Guide
R-IFU-05 /Revision 3

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Summary of Contents for Cheetah Medical Starling SV

  • Page 1 Starling™ SV User Guide R-IFU-05 /Revision 3...
  • Page 2 600 SE Maritime Ave Suite 220 Vancouver, WA 98661 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...

  • Page 3: Table Of Contents

    4.2 Weight Units ..............73 Warnings................23 4.3 Electric Grid ..............73 Precautions ................24 4.4 Audible Alarm..............73 1.11 Cleaning and Disinfecting the Starling SV Device ..25 4.5 Date Format..............73 1.12 Special Patient Populations ........25 4.6 Time Format ..............73 1.13 Indications for Use............26 4.7 Test Type................74 1.14 Limitations of Use............27...
  • Page 4 6.11 TFCd0................83 6.12 BP..................83 6.13 MAP................83 6.14 TPR................84 6.15 TPRI ................84 6.16 CP..................84 6.17 CPI................84 6.18 Z0..................84 6.19 DO2I ................84 6.20 SpO2................84 6.21 Hgb ................84 6.22 SBP ................84 6.23 DBP ................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...

  • Page 5: Conventions Used In This Manual

    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. Consult operating instructions Manufacturer Temperature range Relative humidity range...
  • Page 6 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.

  • Page 7: 1.0 Introduction

    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 Starling SV System, in order to ensure optimal performance and trouble free service life. This manual...

  • Page 8: General Description

    Alternatively, pressing the 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.

  • Page 9: Rear And Cables

    Touch Screen: In addition to the three buttons and knob, the STARLING SV 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.
  • Page 10 Figure 1.2 Back panel of the Starling SV Figure 1.3 Front and side of the Starling SV...
  • Page 11 Starling SV to the Starling SV EMR PC application. In order to perform these actions it is necessary to install the Starling SV 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.

  • Page 12: Specifications

    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 60601-1 standard. Note The Starling SV is not defibrillator proof.

  • Page 13: Nibp

    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.
  • Page 14 For patients that have had a mastectomy, cuff should be applied to opposite arm. 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. Do not modify this equipment without authorization from Cheetah-Medical.
  • Page 15 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 monitoring equipment (i.e., pulse oximeter probe), the pressurization within the cuff can cause...
  • Page 16 CAUTION Neonates measurements must always use a 3 meters patient hose in order to avoide overpressure errors caused by a lack of air volume within the overall pneumatic system. CAUTION A compressed or kinked connection hose may cause continuous cuff pressure resulting in blood flow interference and potentially harmful injury to the patient.
  • Page 17 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 (Neonate, Pediatric). Cuff sizes available for use with the Starling SV: Range Bladder...
  • Page 18 NIBP Module Performance Method of Measurement Oscillometric. Diastolic values correspond to Phase 5 Korotkoff sounds. Systolic: ADULT 40-260 mmHg Blood Pressure Range: PEDIATRIC 40-230 mmHg NEONATE 40-130 mmHg MAP: ADULT 26-220 mmHg PEDIATRIC 26-183 mmHg NEONATE 26-110 mmHg Diastolic: ADULT 20-200 mmHg PEDIATRIC 20-160 mmHg...
  • Page 19 The module meets all relevant parts of the following Safety Standards:  IEC60601-1:1997 2nd Edition  IEC60601-1:2005 3rd Edition  IEC/EN60601-2-30:1999/2000  IEC 80601-2-30:2009  AAMI SP10:2002(R)2008  ISO 81060-2:2009  EN1060-1:1996+A2:2009  EN1060-3:1997+A2: Error Code List & Definitions CAUTION Wen an NIBP error occurs, measurement values will still be reported.
  • Page 20 • Check that the cuff is in the correct position. • 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.
  • Page 21 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.
  • Page 22 EEPROM calibration data failure Corrective Action: If possible, perform calibration. Service may be required. Call a Cheetah 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.

  • Page 23: Bedside Care

    Finally, use the skin-prep “sand paper” provided in the sensor set 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.

  • Page 24: Battery Mode

    Battery Mode The Starling SV monitor can function without external power connection. In this mode of operation, when fully charged, the batteries can provide up to 6 hours 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 4 hours.

  • Page 25: Precautions

    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 Starling SV. CAUTION To avoid damage to the instrument or sensors, be careful of liquid spillage while cleaning.

  • Page 26: Cleaning And Disinfecting The Starling Sv Device

    The Starling SV system is classified as non-waterproof. To avoid CAUTION damage to the STARLING SV monitor and its accessories (including the STARLING SV patient cable, the NIBP hose and cuff), avoid entrance of liquids during use and cleaning. CAUTION Be sure to turn the power off and disconnect the AC power cord from the power source before performing cleaning procedures.

  • Page 27: Indications For Use

    Starling SV 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.

  • Page 28: Limitations Of Use

     Changes in SV, CO and other hemodynamic parameters which are derived by Bioreactance® as a result of posture The Starling SV with NIBP and SpO2 functionalities is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care.

  • Page 29: Spo2

    Note It is possible to completely mitigate or significantly alleviate the problem by placing the Starling SV sensor 2.5 inches (approximately 6 cm) or more away from the external pacemaker percutaneous lead. Unipolar internal pacemakers are rarely used nowadays. SpO2 1.15...
  • Page 30 OxiCliq I: ± 2.5 digits *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.
  • Page 31 The Starling SV with the SpO2 functionality is supplied with the NONIN 8000AA SPO2 sensor. In addition, the Starling SV with NIBP and SpO2 functionality is compatible with any of the following NONIN SpO2 sensors that have the following accuracy specifications:...
  • Page 32 Cheetah Medical. CAUTION All SpO2 sensors used to connect the patient to the Starling SV 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.
  • Page 33 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...

  • Page 34: 2.0 Screens Overview

    Chapter 2.0 Screens Overview Note All STARLING SV screens are touch-sensitive. All on screen actions can also be performed by touching the on screen buttons. Start Up Screen The first activation of the device opens the “Start Up” screen, which is the gateway to the program.

  • Page 35: Menu Screen

    The purpose of the Menu Screen is to allow the user easy navigation through the system's main workflows and functionalities. In addition to the touch screen, the Starling SV's knob moves the cursor among the menu items. Pressing the knob opens the appropriate screen.

  • Page 36: New Patient Screen

    The purpose of the New Patient Wizard Screen is to add a new patient to the unit. Figure 2.3 Starling SV New patient screen The wizard screen opens with the ID field. In order to navigate between the numbers and letters of the keyboard scroll by using the knob and in order to select a specific letter or number, press the knob while the required digit is highlighted.

  • Page 37: Existing Patient

    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 knob or touch the desired selection, then press it in order to lock your selection.

  • Page 38: Run Screen

    Menu button on the STARLING SV. 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 Menu button again.
  • Page 39 To view the quality of the data generated during the test the raw data and the STARLING SV and STARLING SV average morphology are displayed in real-time. In addition, the user can customize the parameter boxes to be displayed by simply touching the parameter and selecting the desired parameter from the menu.
  • Page 40 Simply press the Menu button on the Starling SV to access the screen's pop-up menu or just select the Menu with the touch screen. In addition, the user can start the PLR and the Bolus Protocols directly from the Challenge stage.
  • Page 41 45 degrees. As the Challenge step ends, the Starling SV will produce a Starling SV PLR 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.
  • Page 42 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.
  • Page 43 Starling SV's Main Menu screen, then press 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.

  • Page 44: Trend Display Screen

    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.

  • Page 45: Tabular Display Screen

    Figure 2.9 STARLING SV 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 knob or swipe a finger over the trends to browse and see previous results. When viewing the results of a saved test, the pop-up menu contains several viewing options such as: Y Axis Auto Scaling, Time Scale, Switch Display and Patient Info.
  • Page 46 Figure 2.10 Starling SV Tabular display screen...

  • Page 47: Protocol Dashboard Display Screen

    Protocol Dashboard Display screen Starling SV Figure 2.11 Protocol Tabular display screen The Protocol Display contains the delta results between the baseline stage and challenge stage resulting from the protocol outcome in tabular format and also graphical format with the approximated starling curve graphic. It also displays the date, time and protocol type.

  • Page 48: Settings Screen

    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 STARLING SV is measuring. Note that the trends in the Dashboard are controlled independently from the trends in the Trend Display, i.e. changing the...
  • Page 49 Live Demo option will prompt a window where a desired Starling SV Recording file can be opened. When selected, the Run screen’s window will be prompted having all of its features.
  • Page 50 The About option will prompt a window with technical information that can facilitate the quality of service and support when needed. The Device Mode option allows the user to choose between the following operating modes: Monitoring Mode, Host Mode, Checkup 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.

  • Page 51: Set Option

    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. Starling SV Figure 2.14 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.

  • Page 52: General Options

    General Options 2.12 Starling SV Figure 2.15 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.

  • Page 53: Test Options

    Test Options 2.13 Starling SV Figure 2.16 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.

  • Page 54: Nibp Options

    NIBP Options 2.14 Starling SV Figure 2.17 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.

  • Page 55: Spo2 Options

    SpO2 Options 2.15 Starling SV Figure 2.18 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.

  • Page 56: Art Options

    Art Options 2.16 Starling SV Figure 2.18 Settings screen's SpO2 options In the Art Options' screen the user can choose to change the settings for the Art functionality.

  • Page 57: Connectivity

    Connectivity 2.17 Starling SV Figure 2.19 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.

  • Page 58: Network Configuration

    Network Configuration 2.18 Starling SV Figure 2.20 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.

  • Page 59: Date And Time

    Date and Time 2.19 Starling SV Figure 2.21 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...

  • Page 60: Device Mode

    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 device is used for monitoring.

  • Page 61: Service Mode Screen

    Cheetah Medical technicians and engineers. Thus, it is password protected. QC Mode - Once the Simulator is connected 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.

  • Page 62: Live Demo And Demo Screens

    'Service Mode' will be displayed on both ends of the Menu Bar on all of the Starling SV'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.

  • Page 63: 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. Starling SV Figure 2.26 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.

  • Page 64: Wi-Fi Options

    The user must make sure the Wi-Fi dongle is properly connected to the STARLING SV’s USB port by verifying that the Wi-Fi Icon in the bottom of the screen will indicate the connection status and signal strength.

  • Page 65: B Basic Functions

    Chapter Chapter Basic Functions 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 2. Insert the patient's personal details to the on-screen wizard: Use buttons and knob or the touch screen to navigate and select.
  • Page 66 The Starling SV Sensors' shelf life is indicated on the sensors' pack and depends on the batch. Both batch and shelf life information will always appear on the outer side of the sensors bag.
  • Page 67 9. 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 STARLING SV. Then select the Back button on the Starling SV in order to return to the Menu screen.

  • Page 68: Viewing Test Results

    Select the required test from the list according to the date and time it was taken. The Time Scale option, which appears on the Starling SV'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).
  • Page 69 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.

  • Page 70: Entering Events

    The events are displayed in the Trend Display screen and in the Numerical Display screen. In addition, the STARLING SV automatically adds events when the protocols are activated.
  • Page 71 Figure 3.3 Events displayed in the Trend Display screen 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 events that were entered during the time frame of the row.

  • Page 72: Calibrating The Touch Screen

    Figure 3.4 Events displayed in the Numerical Display screen Calibrating the Touch 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.

  • Page 73: 4.0 Settings & Advanced Functions

    Chapter 4.0 Settings & 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 and Art Options, SpO2 Options, Connectivity, Network Configuration, Wi-Fi options and Date &...

  • Page 74: Height Units

    Electric Grid The STARLING SV 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 are located in the USA and 50 Hz if located elsewhere.

  • Page 75: Test Type

     Test Options: From the Main Menu screen select the Settings option. Select Menu to enter the screen's pop-up menu. Select the Set option then select Test Options. Once entering the Test Settings screen all setting options for this section are displayed. The measurements listed below can be modified: Figure 4.2 Settings screen –...

  • Page 76: Tfcd

    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.

  • Page 77: Nibp Operation Mode

    Automatic +Manual measurements, which means that the operator can perform a measurement at any given time and the STARLING SV 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.
  • Page 78 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.

  • Page 79: Date And Time Setup

    Connectivity Wizard 4.15 STARLING SV 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...

  • Page 80: Networking Wizard

    Figure 4.7 Connectivity Wizard  Networking Networking Wizard 4.16 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.

  • Page 81: Hgb Posting Period

    Figure 4.8 Networking Wizard After defining the connectivity, the STARLING SV can be connected to the hospital 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. Select the Menu button to enter the screen's pop-up menu.

  • Page 82: Art Operation 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.

  • Page 83: 6.0 Measurements Short Description

    6.0 Measurements Short Description In this chapter you can find a short description of the primary measurements that are calculated and displayed by the Starling SV device. 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.

  • Page 84: Svi

    Stroke volume index relates the stroke volume (SV) to body surface area (BSA), thus relating heart performance to the size of the individual ( . The unit of SV/BSA) measurement is cc per minute per square meter (cc/min/m^2). Stroke volume variation is the calculated variation around the stroke volumes which occur at a window of time (for example during 30 seconds).

  • Page 85: Tpr

    6.14 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 TPRI 6.15 Total Peripheral Resistance Index is the indexed version of the TPR.

  • Page 86: Dbp

    6.23 SBP stands for Diastolic Blood Pressure.

  • Page 87: 7.0 Troubleshooting

    Starling SV cable. Check the connection of the Starling SV cable to its socket in the rear panel on the back side of the Starling SV device. Sometimes earlier sensor replacement is necessary, especially if the sensors are wet or if the underlying skin is hairy.
  • Page 88 Starling SV cable. Check the connection of the Starling SV cable to its socket in the rear panel on the back side of the Starling SV device. Sometimes earlier sensor replacement is warranted, especially if the sensors are wet or if the underlying skin is hairy.
  • Page 89 Cheetah Medical support representative. Cause: The NIBP module is disconnected from the device or it stopped functioning. Solution: Please contact a Cheetah medical representative Message: Phase Calibration Error. Unable 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.
  • Page 90 Errors during Protocols: Figure 7.3 STARLING SV Protocol Error – an example Several errors may occur while running the 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: ...

  • Page 91: Warning Messages

    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.
  • Page 92 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. Problem: Burned out pixels on the LCD screen...
  • Page 93 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. Problem: Buzzer failure during monitoring Cause: Buzzer turned off or buzzer malfunction...

  • Page 94: 8.0 Service And Maintenance

    The user or any technical personnel who are not formally authorized by Cheetah Medical should not open the Starling SV box under any circumstances. Opening the Starling SV box could damage the unit and will void the warranty provided by Cheetah Medical...

  • Page 95: Fuse Replacement

    Replace the blown fuse with a new one. 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 Cheetah Medical distributor in your area.

  • Page 96: Electromagnetic Compatibility - Manufacturer Declaration

    Guidance and manufacturer's declaration – electromagnetic emissions – STARLING SV The STARLING SV is intended for use in the electromagnetic environment specified below; The customer or the user of the STARLING SV should assure that it is used in such an environment. Emissions test...
  • Page 97 Guidance and manufacturer's declaration – electromagnetic immunity – STARLING SV The STARLING SV is intended for use in the electromagnetic environment specified below; The customer or the user of the STARLING SV should assure that it is used in such an environment. IEC 60601-1-2...
  • Page 98 0,5 cycle UT) for 0,5 cycle domestic purposes, commercial or hospital, clinical environment. voltage variations If the user of the STARLING SV requires on power supply 40 %UT 40 %UT continued operation during power mains interruptions; it is recommended that...
  • Page 99 Guidance and manufacturer's declaration – electromagnetic immunity – STARLING SV The STARLING SV is intended for use in the electromagnetic environment specified below; The customer or the user of the STARLING SV should assure that it is used in such an environment. IEC 60601-1-2...
  • Page 100 RF transmitters, an electromagnetic site 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.
  • Page 101 Table 6 Recommended separation distances between portable and mobile RF communications equipment and the STARLING SV Separation distance according to frequency of transmitter (in meters) Rated maximum Meters [m] output power of transmitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz Watts [W] d = 1.17 √P...
  • Page 102 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.

  • Page 103: 9.2 Equipment And Accessories Inventory

    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 system) as well as the effective date of the warranty.

  • Page 104: Shipping Parts

    Completed Complaint Form. This form may be obtained from Cheetah Medical or its distributor representative. Date of installation or purchase. 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.
  • Page 105 Chapter 10 Regulatory Representative United States Agent Information: Cheetah Medical Inc. 600 SE Maritime Ave Suite 220 Vancouver, WA 98661 Toll free: (+1) 866-751-9097 Telephone : (+1) 360-828-8685 Fax: (+1) 360-718-8154 cheetah@cheetah-medical.com Authorized Representative Information: MedNet GmbH Borkstrasse 10 48163 Münster, Germany...

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