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Esaote MyLabX5VET, Getting Started, Page: 13 / 114

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Summary of Contents for MyLabX5VET

Page 1: ...Rev 03 July 2019 MyLabX5VET GETTING STARTED 350037100...

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

Page 3: ...of the 2014 30 EU and is CE marked MyLabX5VET complies with the Radio Equipment Directive 2014 53 EU and is CE marked MyLabX5VET is a device in Class 2 according to RED Directive For US Customers US F...

Page 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...

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

Page 6: ...MyLab G E T T I N G S T A R T E D vi RED Declaration of Conformity...

Page 7: ...MyLab G E T T I N G S T A R T E D vii GETTING STARTED...

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

Page 9: ...Manual Conventions 1 5 Manufacturer 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...

Page 10: ...bly Orientation 3 9 Batteries 3 11 Battery Status 3 11 First Use 3 12 Battery Lifetime 3 12 Error Messages 3 13 Errors in Battery Management 3 13 Power Supply Error Messages 3 14 4 Preparing the Syste...

Page 11: ...al 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 6 Configuring eTouch button 6 6 System Settings 6 8 Profile Mana...

Page 12: ...7 5 Selecting Preset 7 5 Performing the Exam 7 6 Acquiring images 7 6 Freeze and Scrolling Memories 7 6 Reviewing Images 7 7 Ending the Exam 7 7 8 System Maintenance 8 1 Veterinary Applications 8 2 Cl...

Page 13: ...T A R T E D xiii GETTING STARTED Keyboard 9 5 Dimensions 9 5 Weight 9 5 IP Grade 9 5 Power supply 9 5 Batteries 9 6 Power Cables 9 6 Operating Requirements 9 8 Storage requirements 9 8 Probe Storage...

Page 14: ...I N D E X MyLab G E T T I N G S T A R T E D xiv...

Page 15: ...on 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 The syst...

Page 16: ...sequent maintenance releases depending on the Country and the respective clearances The instructions for use describe the most extensive configuration of your MyLabX5VET system with the maximum number...

Page 17: ...te offers dedicated software intended for veterinary use providing specific probes and measurements WARNING The application of our imaging diagnostic devices to other species practices as well as for...

Page 18: ...error could result in mistaken diagnosis It should be considered that ultrasound system is not meant for long term data storage and that in case of serious system failure and consecutive repair the st...

Page 19: ...ly stated by Esaote as well as incorrect use or operation may relieve Esaote or its agents from all or some responsibility for resultant noncompliance damage or injury MyLab Manual Conventions In this...

Page 20: ...roduct only if the user follows all the instructions contained in the system manuals for the use and the maintenance of this system the manuals are kept integral and readable in all parts calibrations...

Page 21: ...tronic equipment WEEE amended by directive 2003 108 EC The main system label includes therefore the symbol shown below indicating in an unequivocal way that the system must be disposed of in a separat...

Page 22: ...s license Esaote S p A grants the end user the right to use the SOFTWARE on the supplied DEVICE The user may not under any circumstances make unauthorized copies and or reproductions of the SOFTWARE o...

Page 23: ...ity according to requirements of the standard EN ISO 13485 2000 and the European Directive on Medical Devices 93 42 EEC 1993 and subsequent amendments original owners in the event of equipment transfe...

Page 24: ...ACEABILITY FORM To ESAOTE S p A Quality Assurance Department Via Enrico Melen 77 16152 Genova Italy or associate company or authorized distributor Esaote system device name REF Serial Number SN Name a...

Page 25: ...ll as any 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 p...

Page 26: ...lity 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 real ha...

Page 27: ...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...

Page 28: ...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...

Page 29: ...Otherwise degradation of the performance of this equipment could result Essential performance Free from noise on a waveform or artifacts or distortion in an image or error of a displayed numerical va...

Page 30: ...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...

Page 31: ...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...

Page 32: ...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...

Page 33: ...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...

Page 34: ...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...

Page 35: ...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 MyLab...

Page 36: ...d probes can be connected to MyLabX5VET AC2541 including biopsy capabilities IH 6 18 IL 4 13 including biopsy capabilities L 3 11 including biopsy capabilities L 4 15 including biopsy capabilities mC...

Page 37: ...Cardio canine AC2541 L 3 11 mC 3 11 P2 3 11 S2MCW SC3123 SL3116 SP2730 ST2612 Cardio equine AC2541 mC 3 11 P2 3 11 S2MCW SC3123 SL3116 SP2730 Cardio feline AC2541 L 3 11 mC 3 11 P2 3 11 S2MCW SC3123...

Page 38: ...g Sales Area manager for further information MyLab is equipped with a free orientable LCD The orientable LCD holder can be easily adjusted to reach the optimal LCD position for the exam The system con...

Page 39: ...the probes gel and ECG cables holders The LCD is installed on top of the assembly The ON OFF switch is located beside the touchscreen on the left side USB Port Two 2 USB ports are located on the left...

Page 40: ...Microphone On the left side of the console just below the USB ports there are two 2 connectors one connector for the headphone and one connector for the microphone The microphone has not current use...

Page 41: ...and Doppler probes can be connected to three 3 connectors indicated by symbols EA1 EA2 and EA3 The EA1 EA3 connector can host any probe equipped with a small connector Connector securing devices are p...

Page 42: ...ntation 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 The LCD can be directly rotated and oriented...

Page 43: ...ccur following exposure to a leaking battery When the system is connected to the power mains and the main switch is on ON the battery is continuously charged even if MyLab is switched off On the other...

Page 44: ...battery LED When the battery can t be charged the LED starts blinking Battery Status Icons When the battery pack is installed MyLab displays the icons below Table 3 2 Battery icons The residual charge...

Page 45: ...n manual for further information and contact the Esaote Service department Errors in Battery Management The battery icon is shown crossed out whenever an error in the battery management occurs The num...

Page 46: ...contact Esaote Service Power Supply Error Messages Whenever an error in the management of the power supply occurs the system displays a numbered error message the number in the warning message indica...

Page 47: ...f the internal voltages occurs The system displays the following message If this situation occurs press OK and then shut down the system Contact the Esaote Service department Error 8 This error indica...

Page 48: ...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 14...

Page 49: ...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...

Page 50: ...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...

Page 51: ...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...

Page 52: ...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...

Page 53: ...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...

Page 54: ...n Connect the monitor cable to the connector of the rear panel Moving and Transporting the System MyLab is provided with wheels and handle to allow the user to easily move the device The following pre...

Page 55: ...tem 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 slope Avoid any unnecessary mechanical shock to the system while moving it Transporta...

Page 56: ...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 8 Fig 4 4 Transporting Configuration Use the brakes to lock the system Fasten securely the system inside the vehicle...

Page 57: ...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...

Page 58: ...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...

Page 59: ...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...

Page 60: ...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...

Page 61: ...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...

Page 62: ...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...

Page 63: ...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...

Page 64: ...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...

Page 65: ...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...

Page 66: ...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...

Page 67: ...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...

Page 68: ...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...

Page 69: ...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...

Page 70: ...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...

Page 71: ...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...

Page 72: ...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...

Page 73: ...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...

Page 74: ...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...

Page 75: ...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...

Page 76: ...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...

Page 77: ...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...

Page 78: ...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...

Page 79: ...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...

Page 80: ...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...

Page 81: ...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...

Page 82: ...e When more alphanumeric keyboards have been set the touchscreen displays an alphanumeric keyboard with dedicated tabs allowing to select the desired keyboard BEEP VOLUME Sets the volume of the beep F...

Page 83: ...an alphanumeric keyboard with dedicated tabs allowing to select the desired keyboard Fields Action STANDBY When the OFF button is pressed MyLab goes in hibernation state saving all configurations allo...

Page 84: ...elds and the corresponding actions Table 6 5 Application Preset Folder Fields Action ABSOLUTE ANGLE The angle correction factor of linear probes can be correlated either to the line cursor or to the l...

Page 85: ...o the Archive section of this manual for further information on this feature KEYBOARD BUTTONS Folder This option is used to set which function is associated to ACQUI RE button and to each of the four...

Page 86: ...demo license NOTE To activate a new license the operator needs the appropriate form listing the licenses associated to the system License codes are generated accordingtothesystemHardwareID shownonthel...

Page 87: ...and press VERIFY to confirm If the number is correct the status changes to PERMANENT NOTE All license fields are not case sensitive with the exception of the CrystaLine license that is case sensitive...

Page 88: ...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...

Page 89: ...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...

Page 90: ...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...

Page 91: ...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...

Page 92: ...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...

Page 93: ...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...

Page 94: ...xam 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 contains the patient data at the date and ti...

Page 95: ...h the probe and the application have been set Tap the name of the desired preset to select it The blue rounded preset indicates the active one At any time during the exam a different preset can be sel...

Page 96: ...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...

Page 97: ...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...

Page 98: ...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...

Page 99: ...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...

Page 100: ...during inspection PC Refer to Probes and Consumables manual for periodic inspections for probes and cleaning instructions Veterinary Applications WARNING Due to the specificity of the veterinary worki...

Page 101: ...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...

Page 102: ...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...

Page 103: ...oth lightly rubbing the display surface To remove stains lightly dampen the cloth with ethanol and water mixed in a 1 1 ratio and gently wipe the touch panel surface afterwards dry the touch panel wit...

Page 104: ...aner onto a clean soft cloth and then wipe the surface Never spray or pour any liquid directly onto the screen or case WARNING Overspray or liquid may cause electrical shock Cleaning the LCD case Use...

Page 105: ...lled The tables below list all the available licences regardless the model on which they could be installed Refer to the corresponding Sales Area manager for further information Licenses Licenses enab...

Page 106: ...o Other Presets Calculations Cardiac Cardio Canine Cardio Feline Cardio Equine Cardio Bovine Cardio Other Presets Calculations Licence Feature description 3D 4D 3D and 4D Volumetric acquisition 3D 4D...

Page 107: ...dance Needle Enhancement Imaging It increases the needle visibility Protocols Clinical protocolsb Stress Echo Stress Echo allows to acquire multiple views of the left ventricle LV under stress using c...

Page 108: ...io 8 9 LCD touchscreen Probe connectors 3 electronic probes Video Output HDMI type 1 Connectivity I O connectors LAN RJ45 2 USB 2 0 on keyboard control panel 2 USB 3 0 on console left side 1 USB for t...

Page 109: ...able control panel Control panel Potentiometers for TGC Encoders for general gains Keys for modes peripherals management and controls Reconfigurable touchscreen LCD Dimensions Closed 490 L x 1000 1120...

Page 110: ...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 5Ah 250 V 220V T 10Ah 250 V 110V 5x 20mm Batteries Batteries...

Page 111: ...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...

Page 112: ...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...

Page 113: ...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...

Page 114: ...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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