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I N T R O D U C T I O N

MyLab

  -   G E T T I N G   S T A R T E D

1 - 11

GETTI

NG STARTED

POST-MARKET SURVEILLANCE FORM

ACCIDENT REPORT 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:..............................................................................

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:..........................................................

Содержание MyLabOmega

Страница 1: ...Rev 04 July 2019 MyLabOmega GETTING STARTED 350035100...

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

Страница 3: ...g to the Medical Device Directive MyLabOmega complies with the Radio Equipment Directive 2014 53 EU and is CE marked MyLabOmega is a device in Class 2 according to RED Directive For US Customers US Fe...

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

Страница 10: ...e 3 11 Installation at Working Site 3 11 Probe Connections 3 12 Batteries 3 13 Battery Status 3 13 First Use 3 14 Battery Lifetime 3 14 Error Messages 3 15 Errors in Battery Management 3 15 Power Supp...

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

Страница 12: ...plication data 7 3 Filling the Patient ID screen 7 3 Retrieving data from archive 7 3 Selecting Probe 7 4 Selecting Application 7 5 Selecting Preset 7 5 Performing the Exam 7 6 Acquiring images 7 6 Fr...

Страница 13: ...iii GETTING STARTED Connectivity 9 4 Image Files 9 5 Software 9 5 Biometry 9 5 Keyboard 9 5 Dimensions 9 5 Weight 9 5 IP Grade 9 5 Power supply 9 5 Operating Requirements 9 6 Storage requirements 9 6...

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: ...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...

Страница 16: ...sequent maintenance releases depending on the Country and the respective clearances The instructions for use describes the most extensive configuration of your MyLabOmega system with the maximum numbe...

Страница 17: ...dge of ultrasound system they should be aware of its specifications accuracy and limitations and should be able to manipulate the system correctly in order to ensure that patient diagnosis and managem...

Страница 18: ...g sites default files document versions ultrasound_guidance pdf AIUM guidelines for cleaning probes http www aium org officialStatements 57 Guidelines for the safe use of diagnostic ultrasound equipme...

Страница 19: ...ed by GREY CAPI TAL LET TERS Touchscreen keys are indicated by BOLD BLUE CAPITAL LETTERS Touchscreen software strings are indicated by NORMAL BLUE CAPITAL LETTERS Screen software buttons and options a...

Страница 20: ...electrical plant of the environment where the system is used complies with the current applicable rules and is perfectly efficient Product Life Cycle Life Time The safety and efficiency of MyLab ultr...

Страница 21: ...ll components used for the packaging are recyclable and or reusable except the closed coupled barriers CAUTION The system and its consumable parts must be disposed of at end of life according to the a...

Страница 22: ...OFTWARE but he may transfer on a permanent basis the rights granted herein on condition that he transfers all copies of the SOFTWARE and all written material and that the transferee accepts all the co...

Страница 23: ...following form duly compiled or written notification with the same data as specified in the form Equipment data are found on the relative identification label PRODUCT TRACEABILITY FORM To ESAOTE S p...

Страница 24: ...y inadequacy in the labeling or the instructions for use which might lead to potential or real hazards for a patient or for an operator we kindly request to immediately inform Esaote central plants or...

Страница 25: ...p A Quality Assurance Department Via Enrico Melen 77 16152 Genova Italy or associate company or authorized distributor ESAOTE system device name Code REF Serial Number SN Description of the potential...

Страница 26: ...I N T R O D U C T I O N MyLab G E T T I N G S T A R T E D 1 12...

Страница 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: ...l Urological Cardiovascular Adult Cardiovascular Pediatric Transoesophageal cardiac Peripheral Vessel The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of ne...

Страница 36: ...3 S2MCW S2MPW S5MCW SB2C41 SB3123 SC3123 including biopsy capabilities SE3133 including biopsy capabilities SHFCW SI2C41 including biopsy capabilities SL1543 including biopsy capabilities SL2325 inclu...

Страница 37: ...9 P2 5 13 S2MCW SC3123 SL1543 SP2442 ST2612 ST2613 Gynecology AC2541 IH 6 18 L3 11 SB2C41 SB3123 SE3133 SI2C41 TLC 3 13 Musculo skeletal2 2 Both conventional and superficial including nerve blocks AC2...

Страница 38: ...alified and trained in using ultrasound systems Sonographers Cardiologist Maternal fetal Medicine Obstetrician Perinatologist Radiologist and Internist System Administrator and Customer Service Engine...

Страница 39: ...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 ri...

Страница 40: ...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 of the system These por...

Страница 41: ...r WARNING Use only the XP Power AC DC adapter type AHM180PS19 XE1057 provided by Esaote with the MyLab When installing MyLab check that the power cable is not tightly bent that it can t be squashed by...

Страница 42: ...sulated 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...

Страница 43: ...D 3 9 GETTING STARTED Fig 3 2 MyLab Fold away Trolley CAUTION Beforeusingthesystemcarefullycleanitandthefold awaytrolleyafterthey have been transported outdoor Mobile Configuration A height adjustable...

Страница 44: ...wheels to be easily moved The trolley is equipped with an internal compartment to house and connect the AC DC adapter and an optional mains filter It has a compartment for additional accessories The t...

Страница 45: ...ferfurtherinthischapter for information on probe connection Place the console on the top surface of the trolley allowing it to slide to the bottom so that the profiles of the base match the housings S...

Страница 46: ...n 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 Probe Connections Both imaging and Doppler probes can be connected t...

Страница 47: ...occur 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 othe...

Страница 48: ...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 5 Battery icons The residual charge...

Страница 49: ...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 50: ...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 51: ...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 52: ...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 18...

Страница 53: ...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 54: ...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 55: ...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 56: ...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 57: ...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 58: ...USB printers via a USB Port The printer can be housed on the console top MyLab is equipped with belts to secure the peripheral device NOTE When selecting the peripheral consider its dimension so that...

Страница 59: ...limits indicated for insulated sockets There is a risk of blowing the system fuses WARNING The maximum current supplied by the MyLab USB ports is 500mA for USB 2 0 and 1A for USB 3 0 Peripherals excee...

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 Use the brakes to lock the system Fasten securely the system inside the vehicle MyLab Quick Displacement When MyLab is equipped with batteries the system can be quickly moved from...

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: ...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 cas...

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

Страница 65: ...the trackball 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 furt...

Страница 66: ...or 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...

Страница 67: ...gardless 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 stan...

Страница 68: ...s Touchscreen 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...

Страница 69: ...d by 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...

Страница 70: ...rols 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 pa...

Страница 71: ...er 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 s...

Страница 72: ...S while 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 appropria...

Страница 73: ...be activated ACTI ON switches among cursors Wi Fi When Wi Fi is enabled its icon is shown beside the archival media icons The icon is shown crossed out whenever Wi Fi is not connected AO For more det...

Страница 74: ...ems involving the specific peripheral device Image Area The visualization of the image depends on various factors such as the active mode the selected application and the probe The following figure sh...

Страница 75: ...lor information image by image Machine Parameters Table 5 6 Imaging Parameters SV and are displayed only if the relevant cursor is active Parameter Displayed format Description F l Imaging or TEI Tiss...

Страница 76: ...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 wh...

Страница 77: ...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 78: ...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 79: ...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 80: ...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 81: ...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 82: ...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 83: ...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 84: ...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 85: ...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 86: ...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 87: ...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 88: ...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 89: ...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 90: ...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 91: ...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 92: ...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 93: ...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 94: ...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 95: ...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 96: ...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 97: ...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 98: ...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 99: ...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 100: ...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 101: ...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 102: ...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 103: ...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 104: ...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 105: ...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 106: ...orm the safety inspection mentioned above Disconnect the system from the power outlet before checking it Contact Esaote personnel for any problem found during inspection PC Refer to Probes and Consuma...

Страница 107: ...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 108: ...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 109: ...d gently wipe the touch panel surface afterwards dry the touch panel with a new dry cloth If strictly necessary to clean the touchscreen during an examination you can temporarily lock the keyboard and...

Страница 110: ...verspray or liquid may cause electrical shock Cleaning the LCD case Use a soft dry cloth to wipe the surface of the case If necessary apply a small amount of ammonia free and not abrasive detergent on...

Страница 111: ...re linked to the system serial number and are therefore unique They should be carefully stored The system is delivered by Esaote with the licenses already installed Additional features can be added bu...

Страница 112: ...n the position of the heart is not perpendicular to the ultrasound beam CnTI Contrast Tuned Imaging used in combination with ultrasound contrast agents enhances the B Mode imaging Dicom including US Q...

Страница 113: ...o Stress Echo allows to acquire multiple views of the left ventricle LV under stress using customizable protocols TEI Tissue Enhanced Imaging improves the signal to noise ratio and enhances contrast r...

Страница 114: ...agraph for basic configurations Display main monitor 15 6 LCD full HD 1920x1080 touchscreen 8 9 LCD 1024x600 Probe connectors 2 electronic probes Connectivity I O connectors LAN RJ45 4 USB ports on le...

Страница 115: ...nt Annotations bodymarks Keyboard 8 sliders for TCG Encoders for general gains and other functions Keys for modes peripherals management and controls Reconfigurable touchscreen LCD for alphanumeric QW...

Страница 116: ...V Working frequency 50 60 Hz Frequency limit range 47 63 Hz Current consumption 2 2 A Operating Requirements Temperature 15 35 C Humidity 5 95 not condensing without batteries 20 80 not condensing wi...

Страница 117: ...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 118: ...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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