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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

AIUM/NEMA UD-3:2004 

(R2009)

Standard 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 for the basic safety and essential 

performance of ultrasonic medical diagnostic and 

monitoring equipment

Standard

Title

Содержание MyLabX5VET

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

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

Страница 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...

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: ...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...

Страница 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...

Страница 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...

Страница 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...

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: ...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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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 2000 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: ...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...

Страница 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...

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: ...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...

Страница 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...

Страница 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...

Страница 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...

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: ...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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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