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MyLab

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Содержание MyLabOmegaVET

Страница 1: ...Rev 08 November 2020 MyLabOmegaVET GETTING STARTED 350038000...

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

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

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 RED Declaration of Conformity...

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

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

Страница 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...

Страница 10: ...e configuration 3 11 Accesorized mobile configuration 3 12 Connections of mobile configuration 3 13 Batteries 3 14 Battery Status 3 14 First Use 3 15 Battery Lifetime 3 15 Error Messages 3 16 Errors i...

Страница 11: ...1 Image Area 5 12 Machine Parameters 5 13 Thumbnails Area 5 14 6 Customizing MyLab 6 1 Generic Configuration Procedure 6 4 Clinical Configurations 6 5 Real Time Preset 6 5 Creating a new preset from M...

Страница 12: ...on Esaote website 6 22 7 Performing an Exam 7 1 Starting an Exam 7 1 Entering Patient and Application data 7 3 Filling the Patient ID screen 7 3 Retrieving data from archive 7 3 Selecting Probe 7 4 S...

Страница 13: ...istics 9 1 Licenses 9 1 Technical Characteristics 9 4 Display 9 4 Probe connectors 9 4 Connectivity 9 4 Image Files 9 5 Software 9 5 Biometry 9 5 Keyboard 9 5 Dimensions 9 5 Weight 9 6 IP Grade 9 6 Po...

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

Страница 15: ...common to the other ultrasound devices 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...

Страница 16: ...ent maintenance releases depending on the Country and the respective clearances The instructions for use describe the most extensive configuration of your MyLabOmegaVET device with the maximum number...

Страница 17: ...ware 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...

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

Страница 19: ...ated 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 manu...

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

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

Страница 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...

Страница 23: ...ity 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 transfe...

Страница 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...

Страница 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...

Страница 26: ...e Department Via Enrico Melen 77 16152 Genova Italy or associate company or authorized distributor or competent authorities ESAOTE system device name Code REF Serial Number SN Description of the poten...

Страница 27: ...w of all safety aspects of MyLab products Environmental Safety Special waste The device contains lithium ion batteries The fluorescent lamp included in the LCD screen contains mercury The batteries an...

Страница 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...

Страница 29: ...ree 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 x Fre...

Страница 30: ...r1 kV differential mode r2 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...

Страница 31: ...m 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...

Страница 32: ...or displaying inaccurate numerical values associated with the diagnosis to be performed x the disturbance shall not produce an error displaying inaccurate safety related indications x the disturbance...

Страница 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...

Страница 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...

Страница 35: ...logies of species and the related applications including x Cardiac for canine feline equine bovine and other species x Abdominal for canine feline equine bovine and other species x Reproductive for ca...

Страница 36: ...ncluding biopsy capabilities x L 4 15 including biopsy capabilities x LA435 including biopsy capabilities x mC 3 11 including biopsy capabilities x P 1 5 x P 2 9 x P2 5 13 x S2MCW x SB2C41 including b...

Страница 37: ...2C41 SL1543 SL2325 SL3116 Cardio bovine AC2541 mC 3 11 P 1 5 P 2 9 P2 5 13 S2MCW SC3123 SL3116 Cardio canine AC2541 L 3 11 mC 3 11 P 1 5 P 2 9 P2 5 13 S2MCW SC3123 SL3116 ST2612 Cardio equine AC2541 m...

Страница 38: ...c or transorbital applications The ultrasound beam must not be directed to the eyes Repro other AC2541 IOT342 L 3 11 L 4 15 LA435 mC 3 11 P 1 5 P 2 9 SC3123 SI2C41 SL1543 SL2325 SL3116 SV3513 TLC 3 13...

Страница 39: ...he peripherals and the security lock connector Fig 3 1 Portable Configuration The ON OFF button is located on the upper left part of the control panel the batteries status led is located on the lower...

Страница 40: ...e 3 3 Connectors on left side Connector Symbol Description EA1 EA2 Two probe connectors ECG cable connector Connector Symbol Description Four USB ports are located on the left side These ports can be...

Страница 41: ...1004301 When installing MyLab check that the power cable is not tightly bent that it can t be squashed by a misplaced foot or by heavy objects HDMI Type Output MyLab can be connected to an auxiliary m...

Страница 42: ...ated from the mains disconnect the cable from the power outlet Press the LCD s safety push buttons to open the screen and rotate it into its working position Connect the probes and all accessories Acc...

Страница 43: ...efore using MyLab carefully clean it and the fold away trolley after they have been transported outdoor Probe Connections Both imaging and Doppler probes can be connected to the two 2 connectors indic...

Страница 44: ...ecuring device up WARNING Do not touch the probe connector pins or the probes receptacle Never disconnect the probe while it is active Press the FREEZE key before disconnecting the probe CAUTION Make...

Страница 45: ...the housings and drop down WARNING Do not use the lateral stirrups to push the device The MyLab AC DC adapter can be placed on the dedicated tray of the trolley At working site At the examination site...

Страница 46: ...3 kg The dedicated tray could be damaged if the peripheral weight exceeds this limit CAUTION The weight in the compartment for additional accessories may not exceed 3 kg The compartment could be damag...

Страница 47: ...er supply P N 530000137 connected to the insulation transformer through the jumper P N 8820074000 both P Ns provided by Esaote Connections of mobile configuration Fig 3 5 Insulation transformer probe...

Страница 48: ...and the main switch is on ON the battery is continuously charged even if MyLab is switched off On the other hand the battery discharges whenever MyLab is disconnected from the power mains When the ch...

Страница 49: ...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 50: ...ase information on batteries may not be correct MyLab displays the following message If this situation occurs shut down MyLab by keeping ON OFF pressed and contact Esaote Service Error 2 This error in...

Страница 51: ...Lab displays the following message If this situation occurs shut down MyLab and leave it off for a while Verify that there is adequate ventilation to prevent the overheating of the device Should the p...

Страница 52: ...MyLab Contact the Esaote Service department Error 8 This error indicates that a fault of the impulse voltages occurs MyLab displays the following message If this situation occurs press OK and then sh...

Страница 53: ...ide 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 MyLab to...

Страница 54: ...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 printers and...

Страница 55: ...ntioned 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...

Страница 56: ...g to IEC 60601 x 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 x MyLab auxiliary dev...

Страница 57: ...nt 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...

Страница 58: ...ter 7 Lodge the printer into the dedicated tray on the trolley 8 Connect the USB printer cable to any MyLab USB ports 9 Plug the printer power cable into any mains socket 10 Switch the printer on and...

Страница 59: ...ipheral verify that the total power consumption does not exceed 350VA that is the maximum power available on insulated sockets WARNING The maximum current supplied by the MyLab USB ports is 500mA for...

Страница 60: ...safety push buttons are closed 3 Disconnect all external cables including network and external devices 4 Secure all cables probes and accessories so that they do not interfere with the wheels 5 Perip...

Страница 61: ...buttons are closed x Use the brakes to lock the system x Fasten securely the system inside the vehicle MyLab Quick Displacement When MyLab is equipped with batteries the system can be quickly moved f...

Страница 62: ...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 10...

Страница 63: ...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 necessar...

Страница 64: ...initialization phase Refer to the appropriate chapters of this manual for detailed information on when and how to safely power the device off MyLab Controls MyLab controls are located on the Control...

Страница 65: ...ackball operation from standard to mouse mode Refer to the Trackball paragraph further in this chapter ACTI ON Changes the function linked to the trackball Refer to the Trackball paragraph further in...

Страница 66: ...directly press the button of the required mode B This button re activates a B Mode image in real time when any other mode is active If pressed in M Mode Doppler or Freeze it restores a full screen bi...

Страница 67: ...less 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 the trackball operation from standard...

Страница 68: ...The touchscreen displays controls used to select probes enter patient data select applications and change setups it also displays exam controls related to the active modality Touchscreen controls are...

Страница 69: ...rotating the knob beneath 4 Exam management area it contains the keys for the exam management that are the keys allowing to change the probe or the preset to access the tools and other additional fun...

Страница 70: ...are available for a toggle Only one of the controls can be active at a time tap the label to change the active control Furthermore each toggle can be associated to the EKNOB key of the control panel...

Страница 71: ...ext 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 t...

Страница 72: ...ile strings and fields are indicated with NORMAL BLACK CAPITAL LETTERS Symbol on Screen When this symbol is displayed on the screen it indicates to carefully read the manual Refer to the appropriate s...

Страница 73: ...the relevant section on the Advanced Operations manual Archival Media Archival media are shown on the left The icon is shown crossed out whenever there are management problems involving the specific...

Страница 74: ...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 and a...

Страница 75: ...esolution or Penetration 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 com...

Страница 76: ...low to scroll among the images saved during current exam and images retrieved from other exams Parameter Displayed format Description F nnn MHz Color frequency or TVM Tissue Velocity Mapping frequency...

Страница 77: ...can do the following x Create preset designed specifically for the exams you perform x Change device settings to reflect your needs x Add options to enhance your imaging abilities x Create custom proc...

Страница 78: ...n 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...

Страница 79: ...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...

Страница 80: ...ing options Table 6 1 Configuration Menu Options x 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 81: ...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 fol...

Страница 82: ...h 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 cu...

Страница 83: ...g 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 x Press the desired keys in sequence and press again ETOUCH to end...

Страница 84: ...ty 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 descr...

Страница 85: ...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 b...

Страница 86: ...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 you can set date and time manu...

Страница 87: ...and country related information from SET TIME ZONE drop down menu When AUTOMATICALLY SET DAYLIGHT SAVING TIME is checked MyLab automatically sets the daylight saving time MEASURE UNITS Folder This opt...

Страница 88: ...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 a...

Страница 89: ...ightness 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 allowi...

Страница 90: ...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...

Страница 91: ...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 O...

Страница 92: ...RD BUTTONS Folder 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 desi...

Страница 93: ...onnel is not permitted to know the recovery key that is the file used to decrypt the disk Only you as user of MyLab are allowed to access recovery key data SHOW offers to you when logging into MyLab a...

Страница 94: ...ivation Tabs APPLICATIONS and OPTIONS allow to respectively activate the application licenses and the optional licenses The INCLUDING field shown in the APPLICATIONS menu indicates which applications...

Страница 95: ...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...

Страница 96: ...ings and all settings Select the desired options connect the USB medium to the MyLab and press EXPORT to confirm NOTE Only custom configurations will be exported IMPORT Folder This option allows the u...

Страница 97: ...n Mode Encryption 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...

Страница 98: ...e service personnel The UPDATE MANUALS button on top right is for the unlikely event you have to update manuals on your own If this particular case happens the package for the update is provided by th...

Страница 99: ...re 6 Click on the manual to open it or click on to download it NOTE You can download the entire set of manuals by clicking on DOWNLOAD ALL FILES ZIP Manuals are PDF files you may need a PDF reader ins...

Страница 100: ...C U S T O M I Z I N G M Y L A B MyLab G E T T I N G S T A R T E D 6 24...

Страница 101: ...g ultrasound scanners 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...

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: ...om 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 s...

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: ...d 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 roun...

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: ...use user checking the probes every week user cleaning control panel and device every week user cleaning touch screen every week user cleaning probe and gel holders every week user cleaning LCD case an...

Страница 110: ...spection 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...

Страница 111: ...aning 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 Ecol...

Страница 112: ...ts Otherwise apply a small 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 turni...

Страница 113: ...MyLab off unplug it and use a soft dry cloth 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 s...

Страница 114: ...nto 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...

Страница 115: ...led 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 enabl...

Страница 116: ...s 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 T...

Страница 117: ...y review MyLab images on tablet or mobile MyLibrary Dedicated libraries Live Preview features allow to scan in real time while using anatomical references and scanning guidance Needle Enhancement Imag...

Страница 118: ...touchscreen 8 9 LCD 1024x600 Probe connectors x 2 electronic probes Connectivity x I O connectors LAN RJ45 4 USB ports on left side Wi Fi 802 11 ac a b g n BT4 1 M 2 x Video Output HDMI1 XStrain 4D XS...

Страница 119: ...e formats Software x Operating system Windows 10 x Multi lingual Biometry x Basic and advanced calculation application dependent x Annotations bodymarks Keyboard x 8 sliders for TCG x Encoders for gen...

Страница 120: ...new batteries standby suspension for quick startup x Battery charger inside x Voltage operative range 100 y 240 V x Voltage limit range 90 y 264 V x Working frequency 50 60 Hz x Frequency limit range...

Страница 121: ...equipment Part 1 2 General requirements for safety Collateral Standard Electromagnetic compatibility Requirements and tests IEC 60601 1 6 2010 A1 2013 Ed 3 1 EN 60601 1 6 2010 A1 2015 Medical electri...

Страница 122: ...d Part 1 General Requirements AIUM NEMA UD 2 2004 R2009 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment AIUM NEMA UD 3 2004 R2009 Standard for Real Time Display of Thermal and...

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