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T E C H N I C A L S P E C I F I C A T I O N S

MyLab

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

9 - 10

European and international standards

Table 9-4: Standards

Reference and title of the standard (and reference document)

EN 60601-1:2006

Medical electrical equipment - Part 1: General requirements for basic safety and essential

performance

EN 60601-1:2006/AC:2010

EN 60601-1:2006/A1:2013

IEC 60601-1:2005

IEC 60601-1:2005/A1:2012

EN 60601-1-2:2015

Medical electrical equipment - Part 1-2: General requirements for basic safety and

essential performance - Collateral Standard: Electromagnetic disturbances -

Requirements and tests

IEC 60601-1-2:2014

EN 60601-1-6:2010

Medical electrical equipment - Part 1-6: General requirements for basic safety and

essential performance – Collateral standard: Usability

EN 60601-1-6:2010/A1:2015

IEC 60601-1-6:2010

IEC 60601-1-6:2010/A1:2013

EN 60601-2-37:2008

Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and

essential performance of ultrasonic medical diagnostic and monitoring equipment

EN 60601-2-37:2008/A1:2015

IEC 60601-2-37:2007

IEC 60601-2-37:2007/A1:2015

IEC 61157:2007

Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic

equipment

IEC 61157:2007/A1:2013

EN 62304:2006

Medical device software - Software life cycle processes

EN 62304:2006/A1:2015

IEC 62304:2006

IEC 62304:2006/A1:2015

Summary of Contents for MyLab 9VET

Page 1: ...Rev 05 February 2020 MyLab 9VET GETTING STARTED 350041300 ...

Page 2: ......

Page 3: ... I of the 2014 30 EU and is CE marked MyLab 9VET complies with the Radio Equipment Directive 2014 53 EU and is CE marked MyLab 9VET is a device in Class 2 according to RED Directive For US Customers US Federal Law restricts this device to sale distribution and use by or on the order of a physician All information included in this manual is relative to the following Esaote ultrasound equipments MyL...

Page 4: ...ly 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 for errors or omissions No translations of this documentation are allowed without the consent of Esaote S p A The information contained in this documentation is subject to change without prior notice...

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 Apparatus 1 7 Proprietary Rights 1 8 License Rights and Limitations 1 8 Third Part Software 1 9 Product Traceability 1 9 Vigilance System 1 11 2 Additional Information on Safety 2 1 Environmental Sa...

Page 10: ... Connectors 3 10 Probe Connectors and Cable Management 3 10 Peripherals Housing 3 10 Connections panels 8 3 11 Wheel Brakes 3 11 4 Preparing the System 4 1 Acclimation Time 4 1 Connecting the System to a Network 4 1 Connecting Peripherals 4 2 Safety Concept 4 2 Medical environments 4 3 B W Thermal Medical USB Printer housing 4 6 USB Printer housing 4 6 Auxiliary Monitor 4 7 Gel warmer 4 7 External...

Page 11: ...e 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 6 Configuring eTouch button 6 6 System Settings 6 8 Profile Manager 6 8 Corrupted System Profile 6 9 Center ID 6 9 Center ID Field 6 9 Report Information Field 6 9 DICOM Field 6 9 General Settings 6 9 General Setup 6 10 DATE TIME Folder 6 10 MEASURE UN...

Page 12: ...Application 7 5 Selecting Preset 7 5 Smart Preset 7 6 Performing the Exam 7 6 Acquiring images 7 6 Freeze and Scrolling Memories 7 7 Reviewing Images 7 7 Ending the Exam 7 7 Monitor adjustments 7 8 8 System Maintenance 8 1 Veterinary Applications 8 2 Cleaning Operations 8 3 Cleaning control panel and system 8 4 Cleaning the trackball 8 4 Cleaning Probe and Gel Holders 8 5 Cleaning the Touchscreen ...

Page 13: ...mage Files 9 6 Software 9 6 Biometry 9 6 Keyboard 9 6 Dimensions 9 6 Weight 9 6 IP Grade 9 7 Power supply 9 7 Power Cables 9 8 Operating Requirements 9 9 Storage requirements 9 9 Probe Storage Requirements 9 9 European and international standards 9 10 Opti light 9 11 ...

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: ... 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 system s conformity standards are also indicated Getting Started GS This present manual describes how to install the system and provides the main instructions for using it Probes and Consumables PC The Prob...

Page 16: ...nt maintenance releases depending on the Country and the respective clearances The instructions for use describe the most extensive configuration of your MyLab 9VET system with the maximum number of options and accessories Some functions probes or applications described may be unavailable on your product s configuration NOTE Technology and features are system configuration dependent Specifications...

Page 17: ...ote 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 conventional species is done under veterinary specialist s exclusive responsibility knowledge and belief Disclaimer Ultrasound system should only be used by persons who are fully trained in its safe ...

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 stored data can be lost Thus a regular backup of data is recommended For more detailed information please consult Guidelines For Professional Ultrasound Practice Society and College of Radiographers an...

Page 19: ...sly 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 manual system controls are indicated using the following graphical conventions Control panel buttons are indicated by GREY CAPI TAL LET TERS Touchscreen keys are indicated by BOLD BLUE CAPITAL LETTE...

Page 20: ...product 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 modifications and repairing are performed only by Esaote qualified personnel the environment where the system is used complies with the current safety rules the electrical plant of the environment w...

Page 21: ...ctronic 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 separate collection from urban waste and that it was introduced in the market after August 13th 2005 When disposing of any system part the user shall consider the following points any recyclable part of the...

Page 22: ...is 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 or parts of it including the enclosed documentation On the basis of the above and if the SOFTWARE is not protected against copying only one copy of the SOFTWARE may be made for security purposes back ...

Page 23: ...lity according to requirements of the standard EN ISO 13485 2016 and the European Directive on Medical Devices 93 42 EEC 1993 and subsequent amendments original owners in the event of equipment transfer to third parties are requested to notify ESAOTE S p A associate company or authorized distributor of the said transfer by means of the following form duly compiled or written notification with the ...

Page 24: ...RACEABILITY 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 and address of original owner Name and address of new owner Date Signature ...

Page 25: ...ell 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 plants or one of our subsidiaries or one of our official distributors immediately through the following form or through a communication reporting the same data contained in this form All data relating...

Page 26: ...ality 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 hazard Description of accident or potential accident Comments or suggestions Contact Person Department Address Phone Fax Date Signature ...

Page 27: ...ew 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 and the LCD screens must be treated as special waste according to the applicable local regulations Dispose of the equipment as special waste according to the applicable local regulations For further in...

Page 28: ...NING 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 should be observed to verify that they are operating normally Guidance and manufacturer s declaration Electromagnetic emissions MyLab is suitable for use in the specified electromagnetic environment Th...

Page 29: ...nce 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 Free from the display of inaccurate numerical values associated with the diagnosis to be performed Free from the display of inaccurate safety related indications Free from the production of unintended...

Page 30: ...al 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 environment Voltage dips IEC 61000 4 11 0 UT 0 5 cycles at 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 0 UT 0 5 cycles at 0 45 90 135 180 225 270 and 315 0 UT 1...

Page 31: ...may 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 amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site su...

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 shall not produce unintended or excessive ultrasound output the disturbance shall not produce unintended or excessive transducer assembly surface temperature MyLab according to the definition of the I...

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 the use of wireless connections WARNING The system is equipped with a standard Wireless LAN RF receiver and transmitter module that uses the following frequencies The system may be interfered with by o...

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: ...ly 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 9VET is intended to perform images of the internal structure of the animal s body that when interpreted by a medical expert trained in the use of ultrasound equipment can provide useful diagnostic ...

Page 36: ...ear array and phase array and Doppler probes Clinical Applications and Supporting Probes A variety of ultrasound probes can be connected to MyLab 9VET C 1 8 including biopsy capabilities C 2 9 E 3 12 IH 6 18 L 3 11 including biopsy capabilities L 4 15 including biopsy capabilities L 8 24 mC 3 11 including biopsy capabilities P 1 5 P 2 9 P2 5 13 S2MCW SB2C41 SI2C41 including biopsy capabilities ST2...

Page 37: ...C 2 9 IH 6 18 L 3 11 L 4 15 mC 3 11 P 1 5 P2 5 13 SB2C41 SI2C41 Abdominal other C 1 8 C 2 9 IH 6 18 L 3 11 L 4 15 mC 3 11 P 1 5 P2 5 13 SB2C41 SI2C41 Cardio bovine mC 3 11 P 1 5 P 2 9 P2 5 13 S2MCW Cardio canine L 3 11 mC 3 11 P 1 5 P 2 9 P2 5 13 S2MCW ST2612 Cardio equine mC 3 11 P 1 5 P 2 9 P2 5 13 S2MCW Cardio feline L 3 11 mC 3 11 P 1 5 P 2 9 P2 5 13 S2MCW ST2612 Cardio other L 3 11 mC 3 11 P ...

Page 38: ...T E D 3 4 Contraindications The MyLab 9VET is not intended for opthalmic use or any use causing the acoustic beam to pass through the eye WARNING Do not use MyLab for opthalmic or transorbital applications The ultrasound beam must not be directed to the eyes ...

Page 39: ... cart designed to be both highly mobile and adjustable for a range of users and operating conditions The cart top is equipped to house peripherals It has a rear mains switch to power up the console the screen and the peripheral devices The system provides handles and independent brakes for front and rear wheels for movement and transportation Removable components can be locked in place so the cart...

Page 40: ...Physio connector black 7 ECG connector gray 8 Connections panels 9 Probe holders 10 Front wheel brake pedal 11 Probe connectors 12 Probe connector locks 13 Printer Drawer 14 Pull out QWERTY keyboard 15 Lifting lever 16 Gel holder 17 Probe holder 18 Touch screen 19 USB ports 20 DVD drive 21 Loudspeakers 22 Power cord hook 23 Virtual Navigation connection optional 24 Main switch 25 Rear wheel brake ...

Page 41: ...must be considered an Information Technology IT device it can be safely used inside the patient area only when it is powered through the cart insulation transformer On Off Button 2 The ON OFF button is located beside the touchscreen on the left side of the control panel assembly while the Main Switch 23 is located on the rear bottom of the system Beside the Main Switch is also located an earth ter...

Page 42: ...ontrol module also allows to select transducers enter patient data review and annotate images perform measurements and calculations and change setups The Control Panel Assembly includes the system handle the probe and ECG cables holders Two loudspeakers 21 are placed on both side of the touchscreen Fig 3 2 Control Panel Assembly Table 3 4 Control Panel Assembly description Number Control Panel Ass...

Page 43: ...pheral falls down injury may be caused The lifting lever 15 located on the right allows to adjust the position of the control panel vertically lifting or lowering it Push the lever and act on the handle to adjust the height of the control panel This lever allows a vertical displacement of 20 cm Pull out Qwerty Keyboard 14 Beneath the Control Panel there is a pull out alphanumeric keyboard The keyb...

Page 44: ...touch the probe connector pins or the system probes receptacle Never disconnect the probe while it is active Press FREEZE before disconnecting the probe CAUTION Check to correctly align the probe connector before inserting it Close the connector securing device only after having completely inserted the connector When a transducer is not in use store it in one of the probe holders 17 on the sides o...

Page 45: ...the corner of the console allows to access peripherals power connections and the fuse box The main switch the power cable socket and an earth terminal are placed on the rear bottom of the system Wheel Brakes MyLab is equipped with four rotational wheels Each couple of wheels has a brake pedal 10 and 24 between them When the pedal is fully pressed down the brake is engaged to avoid rotation of whee...

Page 46: ...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 12 ...

Page 47: ... 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 a Network To use connectivity features the system must be connected to a network The LAN plug is placed at the bottom of the rear side it supports Gigabit 10Base T and 100Base T Ethernet LAN An Esao...

Page 48: ...itched 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 Switch the MyLab on by pressing the Power ON button NOTE Always observe the instructions given in the manual of the peripheral auxiliary device NOTE Contact Esaote personnel for recommended USB print...

Page 49: ...ible 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 your local representative or the technical service department SS The Safety and Standards manual provides the safety requirements and standards to be observed for using peripherals devices with MyLa...

Page 50: ...ng 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 not complying to IEC 60601 in area B or area C connected by cable USB HDMI Auxiliary device must be powered through a safety insulation transformer complying to IEC 60601 NOTE AuxiliaryDevicesmustbea...

Page 51: ... 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 responsible that the connections are safe WARNING Thesystemmustbepoweredsotosatisfytheelectricalsafetyrequirements as specified in the Safety and Standards manual Esaote recommends running a current le...

Page 52: ...o 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 it can be safely installed on the console The console top measures 29 x 20 cm CAUTION The peripheral weight does not have to exceed ten 10 kg The console could be damaged if the peripheral weight ex...

Page 53: ...Lab 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 Monitor Any auxiliary monitor connected to the Display Port has not to be used for diagnostic purposes NOTE The resolution of the auxiliary monitor cannot be lower than the main display The system a...

Page 54: ... 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 easily move the device The following precautions must be observed Moving the system 1 Switch the system off 2 Engage the wheel brakes by pressing the pedals fully down 3 Push in the QWERTY keyboard compl...

Page 55: ...he 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 slope Avoid any unnecessary mechanical shock to the system while moving it Transportation When transporting the system in a vehicle remember to Disconnect and remove all probes and peripheral devices ...

Page 56: ... E T T I N G S T A R T E D 4 10 Fig 4 4 Transporting Configuration Protect the screen orientable arm so that no lateral movements are possible for example with film Use the brakes to lock the system Fasten securely the system inside the vehicle ...

Page 57: ...that 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 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 potential and operates wit...

Page 58: ...e 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 hard disk could be damaged by this operation CAUTION This is a PC based system data loss or driver damage may occur if the system is turned off while working for example saving data or during the initialization phase R...

Page 59: ...ping C Activates deactivates Color Doppler CFM The knob around this button amplifies both CFM and Power Color gains To increase gain turn the knob clockwise to reduce it turn the knob counter clockwise In B Mode a cursor delimits the Region of Interest ROI where color analysis is performed and displayed M Activates the M Mode and if necessary its selection cursor B Line B This button re activates ...

Page 60: ...or disable it to select the M Mode or Doppler line During the exam when a trace is active the same button freezes the trace acquisition and temporarily reactivates the reference B Mode image ACQUI RE Activates advanced features further details on how to use them are described in the Advanced Operations manual FREEZE Stops the current analysis or scan and puts the system in Freeze mode To re activa...

Page 61: ...ges displayed on the right side of the screen or to access to the archiving media and peripheral menus The buttons placed on the left and right side of the trackball can be set as mouse keys as confirmation and context menu buttons Regardless of the trackball configuration the confirmation and context menu buttons are respectively indicated as ENTER and UNDO in this manual Press POI NTER to change...

Page 62: ...TTERS for keys that can be tapped while by NORMAL BLUE CAPITAL LETTERS for software text strings Tap the displayed key to activate deactivate the corresponding control Many modes provide two or more pages of controls Swipe left right to move to the next previous page A page indicator shows you the page in which you are The touchscreen layout changes depending on the different working modality as E...

Page 63: ...e touchscreen Each knob acts on the control key just above it Rotate the knob to change the control value Sometimes 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 Disabled Key Active Key Active Key with Sub menu Selected Key Gray text on dark gray background White text on light g...

Page 64: ... contains functions whose value can be changed by rotating the knob beneath On top right a dedicated key activates the emulation of the Qwerty alphanumeric keyboard Tap the keyboard icon to display the keyboard Tap again to hide the keyboard Tap the cogwheel icon to access a menu for easy configuration of display settings to adapt the contrast and brightness of your display to the lighting conditi...

Page 65: ...re used to enter text data in the enabled windows The Caps Lock key sets the keyboard to upper case characters The Shift key is used to type 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 keyboard in annotation modality Information about the Screen Lay...

Page 66: ...nd date Patient data are displayed only if entered at the beginning of the exam Data can be entered or modified at any time during the exam by pressing PATIENT ID Footer Area This area is used to display the following information joystick functionality trackball functionality Wi Fi icon when enabled archival media icons advanced features icons peripherals icons Trackball The trackball function is ...

Page 67: ... crossed out whenever there are management problems involving the specific archival system AO For more details on data archival consult the relevant section on the Advanced Operations 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 Peripheral Devices The system is able to simultaneously mana...

Page 68: ... Table 5 4 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 and archived in these memories The trackball can be used to examine the 2D M Mode Doppler and color information image by image Number Description 1 Frequency Bar active application probe and preset ...

Page 69: ...tion 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 map PRS n Persistence SV nn nnn mm Sample volume size and depth nn Doppler angle correction Parameter Displayed format Description F nnn MHz Color frequency or TVM Tissue Velocity Mapping frequency ...

Page 70: ...ayed on the right side of the screen as thumbnails The thumbnails are displayed 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 Parameter Displayed format Description F nnn MHz Doppler frequency or TV Tissue Velocity frequency when enabled G nn Doppler ...

Page 71: ...You 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 procedures for specific patients transducers and presets The M ENU button is used to access the system menu The system displays all the available options Fig 6 1 System Menu ...

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 together with the initial available measures measurement configuration the initial available library both for annotations and for bodymarks Annotation and Bodymark configurations and the customized to...

Page 73: ...ple 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 structure MyLab allows the user to save several system configurations If for example MyLab is used in two structures differing in Network and DICOM connectivity two specific System Configuration prof...

Page 74: ...lowing 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 exit the menu without saving the settings CANCEL At any time you can go back to the main menu BACK TO MENU or exit from the menu and go back to Real Time CLOSE Option Description EDIT To modify the set...

Page 75: ...imize 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 then follow the generic configuration procedure taking in account that on the left of the screen is displayed the list of all clinical settings grouped by probes Within each probe clinical settings are ...

Page 76: ...oth 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 customized touchscreen Whenever the customized button is pressed MyLab will automatically launch the keys sequence Each system configuration is linked only to one customized touchscreen NOTE Keys sequ...

Page 77: ...ing 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 the recording During the sequence recording the message turns color The eTouch configuration menu displays the customized button Place the cursor on the button and press ENTER to change its name using...

Page 78: ...mpty 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 described here refer to relevant chapters in the Advanced Operations manual Profile Manager Profile Manager allows to create a system profile for each user with a personalized system configuration To con...

Page 79: ...Center 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 field will be displayed in the heading area of the screen Report Information Field This option allows to add to the report header the following information the hospital name the department name the cont...

Page 80: ...exits 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 Set Date Using the trackball scroll the month and select the day on the calendar Date Format Various formats can be set the available options are listed in the following table Table 6 2 Date Formats Fo...

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 BIOPSY Folder This option is used to set the type of needle guide line to be superimposed on the image during biopsy procedures For further information about biopsy and needle guides refer to the relat...

Page 82: ...screen 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 available in the touchscreen and which is the default one When more alphanumeric keyboards have been set the touchscreen displays an alphanumeric keyboard with dedicated tabs allowing to select the des...

Page 83: ...splayed 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 hibernation state saving all configurations allowing a following quick boot up In these conditions MyLab can be unplugged from the main When OPTIMIZE MEMORY USAGE is checked all memory is erased to make repea...

Page 84: ...rus 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 keyboard Fig 6 4 Qwerty keyboard CINE MODE Folder When set the AUTOMATIC PLAY and TRACE AUTOMATIC PLAY options respectively allow to review the stored images and the trace in cine mode when FREEZE is ...

Page 85: ... 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 image as a reference IMAGE SIZE Sets the default dimension for reference image in split format for the selected application ACTION ON FREEZE Sets the action after FREEZE pressure AUTO BUTTON SETUP Set...

Page 86: ...der 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 SAVE NOTE When the buttons 1 2 3 4 are associated to save image or save clip they will be named further in this manual as I M AGE or CLI P respectively Security For further information about security ...

Page 87: ... 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 number in the KEYS field 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 licens...

Page 88: ...ion 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 are customized real time settings REALTIME PRESETS customized calculation packages MEASURE customized glossary libraries ANNOTATIONS customized body mark libraries BODYMARKS customized ETOUCH when ava...

Page 89: ...ettings 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 the user to load customized clinical and system configuration settings MyLab allows the user to load specific clinical and system configurations Procedure Connect the USB medium containing the customiz...

Page 90: ...n 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 memory devices At the end of encryption a recovery key will be given to you The recovery key is stored on USB pen drive or on file or by printing it You have the responsibility to store the key in a...

Page 91: ...trasound 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 the ALARA As Low As Reasonably Achievable principle The patient must be exposed to ultrasound for as short time as possible and only for as long as it takes to achieve the diagnostic information Star...

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 Selecting probe 3 Selecting Application 4 Selecting Preset ...

Page 93: ...m 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 same day of reopening It is not allowed to reopen exams taken the days before the current one RETR PAT INFO or RETR PAT INFO retrieves from the archive the patient data of a previously performed examina...

Page 94: ...AM 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 contains the patient data at the date and time of when the image has been taken Do not refer to these data but always check the current patient data Selecting Probe On the left side of the touchscreen all ...

Page 95: ...tapping 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 preset indicates the active one At any time during the exam a different preset can be selected tapping PROBE At Preset selection the exam starts the system enables the selected probe to operate in t...

Page 96: ... allow the operator to scroll among the specific mode menu If the displayed menu has several levels swipe left right to scroll through all functions AO The control panel buttons and the commands displayed on the touchscreen make it possible to optimize presentation quality Different menus correspond to each format the Advanced Operations manual provides a detailed description of all active control...

Page 97: ...viewing of the saved images and sequences and the trackball automatically changes to pointer mode allowing you to scroll through the thumbnails and select the item to be reviewed Alternatively press POI NTER select the thumbnail the system automatically switches to Exam Review The selected image or sequence is shown on the screen AO The functionalities available in Exam Review are the same of the ...

Page 98: ...ved at a later time from Archive Review Refer to the specific section of the Advanced Operations manual for further information If the PAUSE EXAM option is checked in Saving Option Menu pressing END EXAM also PAUSE will be prompted NOTE At switch off the system will inform if there are any paused exams Monitor adjustments Tapping the gear icon in the advanced level of the touchscreen you can acces...

Page 99: ...ter 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 and screen every week user checking system housings for any damage every month user checking control panel and keyboard for defects every month user checking equipment for loose or missing hardware ...

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 working place Esaote recommends that the ultrasound devices used in veterinary applications should be thoroughly cleaned at least once every 6 months Please contact your Esaote distributor or dealer for f...

Page 101: ...t 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 Asepti Wipes II Ecolab Co www ecolab com Cavicide Caviwipes Metrizyme Metrex Research Corporation www metrex com company contact index cfm CidezymeXTRA Enzol Advanced Sterilization Products www aspjj com ...

Page 102: ...ll 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 CAUTION Do not use any type of ammonia or benzene based cleaners on the case Cleaning the trackball The trackball can be accessed for cleaning purpose only by rotating counterclockwise the upper locking d...

Page 103: ...loth 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 with a new dry cloth If strictly necessary to clean the touchscreen during an examination you can temporarily lock the keyboard and the touchscreen pressing FREEZE while keeping ETOUCH pressed When the ...

Page 104: ...eaner 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 a soft dry cloth to wipe the surface of the case If necessary apply a small amount of ammonia free and not abrasive detergent onto a clean soft cloth and then wipe the surface CAUTION Do not use any ...

Page 105: ...alled 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 enable specific functions of the system they are 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 in...

Page 106: ...epro Caprine Repro Other Presets Calculations Cardiac Cardio Canine Cardio Feline Cardio Equine Cardio Bovine Cardio Other Presets Calculations Feature Description 3D 4D 3D and 4D Volumetric acquisition 3D 4D Advanced TPI TMI and TSI modalities VRA analysis XLight Advanced illumination rendering technique Auto EF Automatically detects and tracks the left ventricle LV endocardial borders to calcula...

Page 107: ...icroV It automatically recognizes the lowest speeds with ultra sensitivity for small vessels and slow flow detection MView It is an ultrasound technique which applies beam line steering and acquires several coplanar scans of an organ from different view angles MyLab Tablet Mobile application which allows to remotely review MyLab images on tablet or mobile MyLibrary Dedicated libraries Live Preview...

Page 108: ...merges multiple B Mode images in one complete panoramic image Virtual Biopsy Virtual Biopsy combined with Intelligent Positioning increases confidence during ultrasound real time biopsy procedures thanks to virtual tracking of the needle XStrain XStrain allows to quantify endocardial velocities of contraction and relaxation and local deformation of the heart Strain Strain Rate analysis XStrain 4D ...

Page 109: ...spect ratio 12 1 LCD touchscreen Probe connectors 4 electronic probes 2 parking supports Video Output DVI main monitor DVI auxiliary monitor 1 Mini Display Port type1 Connectivity I O connectors LAN RJ45 2 USB 2 0 on keyboard control panel 4 USB 2 0 on rear panel 4 USB 3 0 on rear panel Wi Fi 802 11 A B G N Dedicated connectors ECG input Other Laser Ink jet printers Complies with IHE integration p...

Page 110: ... Height adjustable control panel Control panel Potentiometers for TGC Encoders for general gains Keys for modes peripherals management and controls Reconfigurable touchscreen LCD Pull out alphanumeric QWERTY keyboard Dimensions Closed approximately 570 L x 1100 H x 857 D mm In working position 570 L x 728 1260 H x 857 D mm height of trackball In working position 570 L x 940 1472 H x 600 D mm at to...

Page 111: ...rative range 100 120 V 200 240 V Voltage limit range 90 132 V 180 264 V Working frequency range 50 60 Hz 10 Available power on peripherals up to 400 VA NOTE The total power available on the three power outlets for peripheral devices is 400VA maximum Power consumption 400 VA MyLab only Power consumption 1000 VA MyLab peripherals Fuses T 3 15 A H 250V 220V T 6 3 A H 250V 110V 5x20 mm ...

Page 112: ...0320 C19 I 3 16 CEI 23 50 H05VVF3G Section 1 50 mm2 3 conductors 16A 250V 4 m Europe France Germany Spain EN60320 C19 Type VII CEE 7 VII H05VVF3G Section 1 50 mm2 3 conductors 16A 250V 4 m USA North America Latam EN60320 C19 HG Hospital grade NEMA 5 15 SJT3X14AWG Section 14AWG 3 conductors 15A 125V 4 m UK EN60320 C19 BS13 13 BS 1363 A H05VVF3G Section 1 50 mm2 3 conductors 13A 250V 4 5 m ...

Page 113: ...ETTING STARTED Operating Requirements Temperature 15 35 C Humidity 15 85 not condensing Pressure 700 1060 hPa Storage requirements Temperature 20 60 C Humidity 5 85 not condensing Pressure 700 1060 hPa Probe Storage Requirements Probe storage requirements are indicated in the probe case ...

Page 114: ...ements and tests IEC 60601 1 2 2014 EN 60601 1 6 2010 Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability EN 60601 1 6 2010 A1 2015 IEC 60601 1 6 2010 IEC 60601 1 6 2010 A1 2013 EN 60601 2 37 2008 Medical electrical equipment Part 2 37 Particular requirements for the basic safety and essential performance of ultrasonic...

Page 115: ...edical devices Part 1 Evaluation and testing within a risk management process EN ISO 10993 1 2009 AC 2010 ISO 10993 1 2009 EN ISO 14971 2012 Medical devices Application of risk management to medical devices ISO 14971 2019 EN ISO 15223 1 2016 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Part 1 General Requirements ISO 15223 1 2016 Corrected ...

Page 116: ...T E C H N I C A L S P E C I F I C A T I O N S MyLab G E T T I N G S T A R T E D 9 12 ...

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