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S Y S T E M O V E R V I E W

MyLab

- G E T T I N G S T A R T E D

3 - 4

NOTE

System applications are dependent on your system configuration,

transducer and exam type. Not all applications are approved in all

Countries. Please refer to your Esaote local representative for further

information.

Small Organ

IH 6-18, IL 4-13, IOE323, IOT342, L 3-11, L 4-15, mC 3-11,

SC3123, SI2C41, SL1543, SL2325, SL3116

Thyroid

IH 6-18, IL 4-13, IOE323, L 3-11, L 4-15, mC 3-11, SC3123,

SL1543, SL2325, SL3116

Urology

AC2541, CA430E, SI2C41

Transrectal/Transvaginal: EC1123, SB3123, SE3133, TLC 3-13

Vascular

AC2541, CA430E, IH 6-18, IL 4-13, IOE323, IOT342, L 3-11,

L 4-15, mC 3-11, P 1-5, P2 5-13, S5MCW, SC3123, SHFCW,

SI2C41, SL1543, SL2325, SL3116, SP2442

1. Applications are listed here as they appear on user interface. Some clinical applica-

tions are managed by using proper probe and preset.

2. Both conventional and superficial (including nerve blocks)
3. Includes Neonatal and Neonatal Cephalic

Application

Probes

Содержание MyLabX6

Страница 1: ...Rev 08 February 2020 MyLabX6 MyLabX7 GETTING STARTED 350031500...

Страница 2: ...MyLab G E T T I N G S T A R T E D ii...

Страница 3: ...the Medical Device Directive MyLabX6 and MyLabX7 comply with the Radio Equipment Directive 2014 53 EU and are CE marked MyLabX6 and MyLabX7 are devices in Class 2 according to RED Directive For US Cus...

Страница 4: ...y and may be different from what you see on the screen or device This manual has been written taking care to ensure the accuracy of all of the information included however Esaote assumes no liability...

Страница 5: ...MyLab G E T T I N G S T A R T E D v GETTING STARTED EC Declaration of Conformity...

Страница 6: ...MyLab G E T T I N G S T A R T E D vi...

Страница 7: ...MyLab G E T T I N G S T A R T E D vii GETTING STARTED RED Declaration of Conformity...

Страница 8: ...MyLab G E T T I N G S T A R T E D viii...

Страница 9: ...MyLab G E T T I N G S T A R T E D ix GETTING STARTED...

Страница 10: ...MyLab G E T T I N G S T A R T E D x...

Страница 11: ...er s Responsibility 1 6 Product Life Cycle 1 6 Life Time 1 6 Maintainability Time 1 7 End of Life Disposal 1 7 Usage License Agreement for the Software Included in the Apparatus 1 7 Proprietary Rights...

Страница 12: ...atus 3 14 First Use 3 15 Battery Lifetime 3 15 Error Messages 3 16 Errors in Battery Management 3 16 Power Supply Error Messages 3 17 4 Preparing the System 4 1 Acclimation Time 4 1 Connecting the Sys...

Страница 13: ...omizing the System 6 1 Generic Configuration Procedure 6 4 Clinical Configurations 6 5 Real Time Preset 6 5 Creating a new preset from MENU 6 5 Creating a new preset from Real Time 6 6 eTouch Button 6...

Страница 14: ...7 3 Retrieving data from archive 7 3 Selecting Probe 7 4 Selecting Application 7 5 Selecting Preset 7 5 Performing the Exam 7 6 Acquiring images 7 6 Freeze and Scrolling Memories 7 6 Reviewing Images...

Страница 15: ...ING STARTED Image Files 9 5 Software 9 5 Biometry 9 5 Keyboard 9 5 Dimensions 9 5 Weight 9 6 IP Grade 9 6 Power supply 9 6 Batteries 9 6 Power Cables 9 7 Operating Requirements 9 8 Storage requirement...

Страница 16: ...I N D E X MyLab G E T T I N G S T A R T E D xvi...

Страница 17: ...e common to the other ultrasound systems belonging to the Esaote MyLab platform Safety and Standards SS The Safety and Standard manual contains information about the patient s and operator s safety Th...

Страница 18: ...ntenance releases depending on the Country and the respective clearances The instructions for use describe the most extensive configuration of your MyLabX6 or MyLabX7 system with the maximum number of...

Страница 19: ...dge of ultrasound system they should be aware of its specifications accuracy and limitations and should be able to manipulate the system correctly in order to ensure that patient diagnosis and managem...

Страница 20: ...g sites default files document versions ultrasound_guidance pdf AIUM guidelines for cleaning probes http www aium org officialStatements 57 Guidelines for the safe use of diagnostic ultrasound equipme...

Страница 21: ...ed by GREY CAPI TAL LET TERS Touchscreen keys are indicated by BOLD BLUE CAPITAL LETTERS Touchscreen software strings are indicated by NORMAL BLUE CAPITAL LETTERS Screen software buttons and options a...

Страница 22: ...electrical plant of the environment where the system is used complies with the current applicable rules and is perfectly efficient Product Life Cycle Life Time The safety and efficiency of MyLab ultr...

Страница 23: ...ll components used for the packaging are recyclable and or reusable except the closed coupled barriers CAUTION The system and its consumable parts must be disposed of at end of life according to the a...

Страница 24: ...OFTWARE but he may transfer on a permanent basis the rights granted herein on condition that he transfers all copies of the SOFTWARE and all written material and that the transferee accepts all the co...

Страница 25: ...following form duly compiled or written notification with the same data as specified in the form Equipment data are found on the relative identification label PRODUCT TRACEABILITY FORM To ESAOTE S p...

Страница 26: ...y inadequacy in the labeling or the instructions for use which might lead to potential or real hazards for a patient or for an operator we kindly request to immediately inform Esaote central plants or...

Страница 27: ...p A Quality Assurance Department Via Enrico Melen 77 16152 Genova Italy or associate company or authorized distributor ESAOTE system device name Code REF Serial Number SN Description of the potential...

Страница 28: ...I N T R O D U C T I O N MyLab G E T T I N G S T A R T E D 1 12...

Страница 29: ...w of all safety aspects of MyLab products Environmental Safety Special waste The system contains lithium ion batteries The fluorescent lamp included in the LCD screen contains mercury The batteries an...

Страница 30: ...ING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other equipment sh...

Страница 31: ...ce Free from noise on a waveform or artifacts or distortion in an image or error of a displayed numerical value which cannot be attributed to a physiological effect and which may alter the diagnosis F...

Страница 32: ...l or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital env...

Страница 33: ...ay occur in the vicinity of equipment marked with the following symbol a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios ama...

Страница 34: ...error displaying inaccurate numerical values associated with the diagnosis to be performed the disturbance shall not produce an error displaying inaccurate safety related indications the disturbance s...

Страница 35: ...transmitter as indicated by the symbol When the wireless is active MyLab might interfere with other equipment SS Refer to the Safety and Standards manual for further information on restrictions for th...

Страница 36: ...A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y MyLab G E T T I N G S T A R T E D 2 8...

Страница 37: ...bright scenario of the operative room to the dark scenario of the examination room passing through the medium light environment of the bed side examination setting About the system Intended Use MyLabX...

Страница 38: ...Vascular YES IOT342 Abdominal Musculo skeletal Pediatric Small Organ Vascular NO L 3 11 Abdominal Breast Musculo skeletal Obstetric and Fetal Pediatric Small Organ Thyroid Vascular YES L 4 15 Abdomina...

Страница 39: ...18 IL 4 13 IOE323 IOT342 L 3 11 L 4 15 mC 3 11 P 1 5 S2MCW SB2C41 SC3123 SI2C41 SL1543 Laparoscopic LP 4 13 Adult Cephalic P 1 5 S2MPW Breast IH 6 18 IL 4 13 IOE323 L 3 11 L 4 15 SI2C41 SL1543 SL2325...

Страница 40: ...SL3116 Thyroid IH 6 18 IL 4 13 IOE323 L 3 11 L 4 15 mC 3 11 SC3123 SL1543 SL2325 SL3116 Urology AC2541 CA430E SI2C41 Transrectal Transvaginal EC1123 SB3123 SE3133 TLC 3 13 Vascular AC2541 CA430E IH 6...

Страница 41: ...iologist and Internist System Administrator and Customer Service Engineer The operator must have read and understood the user manuals Contraindications MyLabX6 and MyLabX7 are not intended for ophthal...

Страница 42: ...he LCD and a console with the system electronics and connectors The console top is equipped to house peripherals It has a rear mains switch to power up the console the screen and the peripheral device...

Страница 43: ...ric keyboard is placed at the base of the control panel The keyboard is mounted on a sliding drawer just push it to extract the keyboard The control panel assembly can be rotated for optimal working o...

Страница 44: ...rts there are two 2 connectors one connector for the headphone and one connector for the microphone The microphone has not current use ECG Connector The ECG cable connector is placed on the right side...

Страница 45: ...onnection is not necessary in most cases and is only recommended for situations involving multiple equipment in a high risk patient environment to provide assurance that all equipment is at the same p...

Страница 46: ...e it move the securing device to its LOCK position Probes with small connector Connector securing devices are placed above the probe small connectors Make sure that the securing device is positioned o...

Страница 47: ...the screen into its working position The orientation lever located on the left allows lateral rotation of the assembly The lifting lever located on the right allows to lift or lower the control panel...

Страница 48: ...M O V E R V I E W MyLab G E T T I N G S T A R T E D 3 12 CAUTION When rotating the keyboard pay attention not to damage the peripherals placed on the console If the peripheral falls down injury may b...

Страница 49: ...S Y S T E M O V E R V I E W MyLab G E T T I N G S T A R T E D 3 13 GETTING STARTED...

Страница 50: ...main switch is on ON the battery is continuously charged even if MyLab is switched off On the other hand the battery discharges whenever the system is disconnected from the power mains When the chargi...

Страница 51: ...ed the residual operating time indicated in minutes replaces the main power icon surrounded by a flashing yellow frame When the battery is charging its icon replaces the Main power cable icon Once the...

Страница 52: ...rmation on batteries may not be correct The system displays the following message If this situation occurs shut down MyLab by keeping ON OFF pressed and contact Esaote Service Error 2 This error indic...

Страница 53: ...type of error Error 5 This error indicates an overheating problem of the power supply The system displays the following message If this situation occurs shut down the system and leave it off for a whi...

Страница 54: ...en shut down the system Contact the Esaote Service department Error 8 This error indicates that a fault of the impulse voltages occurs The system displays the following message If this situation occur...

Страница 55: ...the range given for its correct working 15 35 C it must acclimate before being switched on The following table indicates the necessary waiting times Table 4 1 Acclimation Time Connecting the System to...

Страница 56: ...tched off complete shut down not stand by or other conditions 2 Connect the peripheral device to the MyLab 3 Switch the peripheral device on making sure that the device is not in stand by condition 4...

Страница 57: ...ble that the system complies with the requirements for medical electrical systems Attention is drawn to the fact that local laws take priority over the above mentioned requirements If in doubt consult...

Страница 58: ...g to IEC 60601 MyLab auxiliary device not complying to IEC 60601 complying to IEC XXX1 in area B or area C connected by WiFi or Ethernet cable No additional safety requirements MyLab auxiliary device...

Страница 59: ...and the auxiliary device simultaneously Additionally the IEC60601 requires control measurement of leakage currents The system integrator any person connecting the medical device to other devices is re...

Страница 60: ...USB printers via a USB Port The printer can be housed on the console top MyLab is equipped with belts to secure the peripheral device NOTE When selecting the peripheral consider its dimension so that...

Страница 61: ...ab USB ports is 500mA for USB 2 0 and 1A for USB 3 0 Peripherals exceeding this limit can be connected only if powered by their external power supply through a medical insulation transformer Auxiliary...

Страница 62: ...be connected only if powered by theirexternal power supply through amedical insulation transformer Moving and Transporting the System MyLab is provided with wheels and handle to allow the user to easi...

Страница 63: ...e handles on the keyboard cannot be used to lift the system To steadily lock the system all the wheels must be locked Do not park the system on a slope Do not use the brakes to park the machine on a s...

Страница 64: ...the vehicle MyLab Quick Displacement When MyLab is equipped with batteries the system can be quickly moved from one working position to another without partially switching the system off Wait for the...

Страница 65: ...age indicating the residual time after which MyLab will automatically start the shut down procedure NOTE Fully charged batteries ensure more than half an hour of self powering Move the system to the w...

Страница 66: ...P R E P A R I N G T H E S Y S T E M MyLab G E T T I N G S T A R T E D 4 12...

Страница 67: ...it can t be squashed by a misplaced foot or by heavy objects The earth terminal can be connected to an external protective earthing system as additional protection This connection is not necessary in...

Страница 68: ...system has to be insulated from the mains disconnect the cable from the power outlet CAUTION Do not turn the system off while working for example saving data or during the initialization phase the ha...

Страница 69: ...elocity Mapping CW Activates the Continuous Wave Doppler CW At its pressure the positioning cursor is activated as well M EASURE Activates Advanced Measurements showing the list of available measureme...

Страница 70: ...ced Operations manual I M AGE During the exam it saves single images The stored images are displayed as thumbnails on the right of the screen CLI P During the exam it saves a sequence of images The st...

Страница 71: ...Press POI NTER to change the trackball operation from standard to mouse mode Touchscreen Section This section includes the ON OFF the M ENU and ETOUCH buttons a touchscreen and the TCG Sliders On Off...

Страница 72: ...sed to select probes enter patient data select applications and change setups it also displays exam controls related to the active modality Touchscreen controls are indicated in the operator manuals b...

Страница 73: ...nd settings 3 Knobs area it contains functions whose value can be changed by rotating the knob beneath 4 Exam management area it contains the keys for the exam management that are the keys allowing to...

Страница 74: ...mes two controls are available for a knob Only one of the controls can be active at a time Pressing the corresponding knob or tapping the label toggles the active control Multipurpose Panel Layout Thi...

Страница 75: ...in lower case or upper case characters according to how the keyboard is set the Fn key is used to type numeric functions for example AO Refer to the Advanced Operations manual for the use of the keybo...

Страница 76: ...d at any time during the exam by pressing PATIENT ID Footer Area This area is used to display the following information trackball functionality Wi Fi icon when enabled archival media icons advanced fe...

Страница 77: ...tions manual Advanced Features When advanced features such as XView or MView are activated the corresponding icons are displayed on the center of the footer area Battery When the battery pack is insta...

Страница 78: ...ble 5 5 Image Area description Freeze Status Whenever an image is frozen a memory bar is displayed at bottom right concerning the scrolling memories The images acquired immediately before are frozen a...

Страница 79: ...ion L Low H High G nn Imaging gain Min Max AG nn Auto Adjust D nn mm Depth X M C or n n XView Algorithm or CrystaLine Imaging MView algorithm PRC n n n n Dynamic range Dynamic compression Density Gray...

Страница 80: ...layed in chronological order from left to right The tabs displayed at the top of the thumbnails columns allow to scroll among the images saved during current exam and images retrieved from other exams...

Страница 81: ...ou can do the following Create preset designed specifically for the exams you perform Change system settings to reflect your needs Add options to enhance your imaging abilities Create custom procedure...

Страница 82: ...probe in each application This means that the preset selected at the beginning of the exam or during the exam pressing PROBE establishes the initial settings of the exam controls like gray map depth t...

Страница 83: ...le MyLab is used in two structures differing in Network and DICOM connectivity two specific System Configuration profiles can be created each time the user will load the configuration required by the...

Страница 84: ...owing options Table 6 1 Configuration Menu Options Once in editing mode you can change the name of the selected item NAME field enter a description NOTES field confirm and save the settings SAVE or ex...

Страница 85: ...mize the real time image in all modes and create the customized preset Creating a new preset from MENU To create a new preset or modify an existing one press M ENU then select REAL TIME PRESET and the...

Страница 86: ...th of the touchscreen and of the control panel Each recorded sequence Macro can be named and saved to be available as customized button in customized touchscreens ETOUCH switches between factory and c...

Страница 87: ...ng message Prepare MyLab to be ready for the recording so that only the keys to be used can be pressed and then press ETOUCH to start Press the desired keys in sequence and press again ETOUCH to end t...

Страница 88: ...pty tabs that is tab not containing customized button are not displayed in the customized touchscreen System Settings AO This chapter explains how to set many MyLab options For configurations not desc...

Страница 89: ...enter ID press M ENU then select CENTER ID and then follow the generic configuration procedure During editing you can configure many fields described below Center ID Field The name entered in this fie...

Страница 90: ...xits the menu without saving the new settings FACTORY retrieves all factory values and deletes all customized items DATE TIME Folder This option is used to set date and time displayed on the screen Se...

Страница 91: ...This option is used to set the desired units for height and weight You can choose between cm kg and ft lb The Celsius or Fahrenheit scale can be selected for probes equipped with temperature sensor BI...

Страница 92: ...creen button SHUTDOWN TYPE Sets the preferred shutdown type SCREEN RESOLUTION Sets the screen resolution when secondary monitor is connected AVAILABLE QWERTIES Sets which alphanumeric keyboards are av...

Страница 93: ...played on monitor TOUCHSCREEN Sets the brightness of the touchscreen CONTROL PANEL Sets the brightness of the control panel Fields Action STANDBY When the OFF button is pressed MyLab goes in hibernati...

Страница 94: ...us and restore the system Field AVAILABLE QWERTIES When more alphanumeric keyboards have been set the touchscreen displays an alphanumeric keyboard with dedicated tabs allowing to select the desired k...

Страница 95: ...zoom navigation window is displayed on the screen just as the zoom has been activated USE REFERENCE BOX ON DUAL COLOR DOPPLER When checked in dual visualization the ROI box is overlaid to the B Mode i...

Страница 96: ...er This option is used to set which function is associated to ACQUI RE button and to each of the four configurable buttons 1 2 3 and 4 From the curtain menu select the function you desire then press S...

Страница 97: ...licenses The INCLUDING field shown in the APPLICATIONS menu indicates which applications will be available once the license is activated License Activation To activate a new license type the license n...

Страница 98: ...on is organized in internal folders one folder for the clinical settings and one folder for the system configuration settings Clinical Configuration Folder The clinical settings that can be exported a...

Страница 99: ...ttings and all settings Select the desired options connect the USB medium to the system and press EXPORT to confirm NOTE Only custom configurations will be exported IMPORT Folder This option allows th...

Страница 100: ...allows to preserve health data storage confidentiality Encryption can be performed by Esaote Service personnel only Encryption can be applied to the internal hard disk and to one or more external USB...

Страница 101: ...rasound systems should perform ultrasound scanning on human subjects for medical diagnostic purposes NOTE The operator must be familiar with the mechanical and thermal indexes display as well as know...

Страница 102: ...A R T E D 7 2 Fig 7 1 Patient ID screen Fig 7 2 Probe Application Preset touchscreen Starting exam procedure The steps to be followed to start an exam are 1 Entering patient and application data 2 Sel...

Страница 103: ...archive CURRENT retrieves the patient data of the last exam REOPEN EXAM allows to open an exam already closed to add images and or measurements NOTE The key is enabled only for exam closed in the sam...

Страница 104: ...M and then proceed with the Starting Exam procedure Pressing I M AGE when the Patient ID Screen is displayed a screenshot of this window is saved WARNING The screenshot of the Patient ID Screen contai...

Страница 105: ...apping PROBE Selecting Preset The Preset or Clinical Setting can be selected only when both the probe and the application have been set Tap the name of the desired preset to select it The blue rounded...

Страница 106: ...ols in the different modes Acquiring images MyLab allows to capture and save a single image or a cineloop sequence pressing I M AGE or CLI P respectively These buttons respectively save still frames a...

Страница 107: ...f the Advanced Operations manual for further details Ending the Exam To end the exam press END EXAM The window displayed at the end of the exam is used to archive the exam This window shows the patien...

Страница 108: ...xam in progress The exams that have been performed and not archived into the local database can be locally saved at a later time from Archive Review Refer to the specific section of the Advanced Opera...

Страница 109: ...er use user checking the probes every week user cleaning control panel and system every week user cleaning touch screen every week user cleaning probe and gel holders every week user cleaning LCD case...

Страница 110: ...orm the safety inspection mentioned above Disconnect the system from the power outlet before checking it Contact Esaote personnel for any problem found during inspection PC Refer to Probes and Consuma...

Страница 111: ...before any cleaning operation NOTE The cleaning operation should be performed accordingly to the equipment environment requirements interms of temperature pressure and humidity Product Supplier Asept...

Страница 112: ...l amount of ammonia free and not abrasive detergent on a clean soft cloth and then wipe the surface WARNING Make sure that the detergent has completely evaporated before turning the equipment on CAUTI...

Страница 113: ...d gently wipe the touch panel surface afterwards dry the touch panel with a new dry cloth If strictly necessary to clean the touchscreen during an examination you can temporarily lock the keyboard and...

Страница 114: ...verspray or liquid may cause electrical shock Cleaning the LCD case Use a soft dry cloth to wipe the surface of the case If necessary apply a small amount of ammonia free and not abrasive detergent on...

Страница 115: ...re linked to the system serial number and are therefore unique They should be carefully stored The system is delivered by Esaote with the licenses already installed Additional features can be added bu...

Страница 116: ...e position of the heart is not perpendicular to the ultrasound beam CnTI Contrast Tuned Imaging used in combination with ultrasound contrast agents enhances the B Mode imaging Dicom including US Q R D...

Страница 117: ...Echo Stress Echo allows to acquire multiple views of the left ventricle LV under stress using customizable protocols TEI Tissue Enhanced Imaging improves the signal to noise ratio and enhances contra...

Страница 118: ...ragraph for basic configurations Display Built in color LCD WVGA resolution Full HD LED 18 5 monitor 21 5 optional 8 9 LCD touchscreen Probe connectors 3 electronic probes small 1 electronic probes bi...

Страница 119: ...system Windows 10 Multi lingual Biometry Basic and advanced calculation application dependent Annotations bodymarks Keyboard Height adjustable control panel Control panel Potentiometers for TGC Encode...

Страница 120: ...tive range 100 120 V 200 240 V Working frequency range 50 60 Hz 10 Power consumption 220 VA MyLab only Power consumption 600 VA MyLab peripherals Available power on peripherals up to 250 VA Fuses T 5A...

Страница 121: ...4AWG Section AWG 14 3 conductors 15A 125V 4 5 m China EN60320 C13 PCR 3 GB2099 GB1002 H05VVF3G Section 1 mm2 3 conductors 10A 250V 4 5 m Brazil EN60320 C13 BR 3 according to NBR14136 H05VVF3G Section...

Страница 122: ...perature 20 60 C Humidity 10 85 not condensing Pressure 700 1060 hPa Probe Storage Requirements Probe storage requirements are indicated in the probe case Denmark EN60320 C13 DK3 HGA SB 107 2D1 DK2 8a...

Страница 123: ...6 General requirements for basic safety and essential performance Collateral standard Usability IEC 60601 2 37 2007 Ed 2 1 A1 2015 EN 60601 2 37 2008 Medical electrical equipment Part 2 37 Particular...

Страница 124: ...for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment CAN CSA C22 2 NO 60601 2 37 Medical electrical equipment Part 2 37 Particular requirements f...

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