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MyLab

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Summary of Contents for MyLabSigma elite

Page 1: ...Rev 05 June 2021 MyLabSigma elite GETTING STARTED 350061100...

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

Page 3: ...o the Medical Device Directive MyLabSigma elite complies with the Radio Equipment Directive 2014 53 EU and is CE marked MyLabSigma elite is a device in Class 2 according to RED Directive For US Custom...

Page 4: ...y and may be different from what you see on the screen or device This manual has been written taking care to ensure the accuracy of all of the information included however Esaote assumes no liability...

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

Page 6: ...MyLab G E T T I N G S T A R T E D vi...

Page 7: ...d in the Apparatus 1 7 Proprietary Rights 1 7 License Rights and Limitations 1 8 Third Part Software 1 8 Product Traceability 1 8 Vigilance System 1 10 2 Additional Information on Safety 2 1 Environme...

Page 8: ...Elastography 2 14 Fetal 2 14 Items in Contact with Patient 2 15 Latex Sensitive Patient 2 16 Device Modifications 2 16 Explosive Hazard 2 16 Wireless safety 2 17 Users in the European Union 2 18 User...

Page 9: ...al housing 4 7 B W Thermal Medical USB Printer 4 7 Non medical USB Printer 4 7 Moving and Transporting the System 4 9 Portable Configuration 4 9 Mobile Configuration 4 9 MyLab Quick Displacement 4 10...

Page 10: ...r 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 UNITS Folder 6 11 BIOPSY Folder 6 11 CONTROL PANEL Folder 6 12 Field S...

Page 11: ...8 Ending the Exam 7 8 8 Maintenance 8 1 Cleaning Operations 8 3 Cleaning control panel and device 8 4 Cleaning the QWERTY keyboard 8 4 Cleaning the trackball 8 4 Cleaning Probe and Gel Holders 8 5 Cl...

Page 12: ...I N D E X MyLab G E T T I N G S T A R T E D xii Standards 9 6...

Page 13: ...h MyLab and information on foreseeable medical emergency situations x Safety and Standards provides information about the patient s and operator s safety x Getting Started this manual describes how to...

Page 14: ...f options and accessories Some functions probes or applications described may be unavailable on your product s configuration NOTE Technology and features are device configuration dependent Specificati...

Page 15: ...performance In case of device failure to operate correctly the operator should contact the nearest Esaote Service Office Special attention should be dedicated to intra cavitary probes e g vaginal rect...

Page 16: ...ations Committee Opinions Committee on Obstetric Practice Guidelines for Diagnostic Imaging During Pregnancy and Lactation MyLab use This product is intended to be installed used and operated only in...

Page 17: ...or with the trackball over the desired option and pressing ENTER to confirm Right click means positioning the cursor with the trackball over the desired option and pressing UNDO to confirm Double clic...

Page 18: ...x the electrical plant of the environment where the device is used complies with the current applicable rules and is perfectly efficient Product Life Cycle Life Time The safety and efficiency of MyLab...

Page 19: ...x all components used for the packaging are recyclable and or reusable except the closed coupled barriers CAUTION The device and its consumable parts must be disposed of at end of life according to th...

Page 20: ...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...

Page 21: ...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...

Page 22: ...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...

Page 23: ...Assurance Department Via Enrico Melen 77 16152 Genova Italy or associate company or authorized distributor and competent authorities ESAOTE system device name Code REF Serial Number SN Description of...

Page 24: ...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...

Page 25: ...t of the cart components plastics are also recyclable Special waste The device contains lithium ion batteries The fluorescent lamp included in the LCD screen contains mercury The batteries and the LCD...

Page 26: ...yLab models are not watertight and provide a class IP X 0 degree of protection to liquids do not expose the system to rain or moisture Avoid placing liquid containers on the system CAUTION Do not repl...

Page 27: ...able in Doppler modes In the presence of RF interference the physician must evaluate the image degradation and its diagnostic impact CAUTION Use of accessories probes and cables other than those autho...

Page 28: ...hich CISPR 11 class B is normally required this equipment might not offer adequate protection to radio frequency communicationservices Theusermightneedtotakemitigationmeasures such as relocating or re...

Page 29: ...cal effect and which may alter the diagnosis x Free from the display of inaccurate numerical values associated with the diagnosis to be performed x Free from the display of inaccurate safety related i...

Page 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...

Page 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...

Page 32: ...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 shall not produce uninte...

Page 33: ...rature1 as a result of repetitive scanning These musculoskeletal disorders are also referred to as Repetitive Strain Injury RSI To prevent the risk of RSI it has been recommended x to maintain a balan...

Page 34: ...art in ultrasound diagnostic imaging Esaote has identified the following additional potential residual risks that are hereafter grouped for main applications Cardiac Stress Echocardiography Absolute a...

Page 35: ...junction with such kind of medicinal products in order to assist them in achieving their own specific intended purpose Esaote does not support or encourage the off label use of contrast media Our Medi...

Page 36: ...ction with such kind of medicinal products in order to assist them in achieving their own specific intended purpose Esaote does not support or encourage the off label use of contrast media Our Medical...

Page 37: ...voided during the procedure despite the use of sterile disposable transducer covers Critical medical products which include ultrasound transducers that are used intraoperatively or through which a nee...

Page 38: ...timates while the SWE is generated by the ultra fast repetitive of short duration focused acoustic pulses So far no specific risk indicator has been developed thus the duration of the SWE should be ke...

Page 39: ...ester spectral Doppler examination of the fetus should be used with caution The application of SWE in human fetuses was not approved so far due to the potential risk concerns of SWE to the developing...

Page 40: ...exam Serious allergicreactions to latexhavebeen reported and the user should be ready to react accordingly for further information refer to the FDA Medical Alert March 29 1991 Allergic Reactions to L...

Page 41: ...ance of 20 cm 8 inches or more from the antennas of the equipment and the body of patient and operators If a shorter distance is needed to work temporarily switch the wireless device off x Use in spec...

Page 42: ...5150 5350 MHz Users in the United States of America MyLab contains radio modules fully compliant with CFR47 Part 15 Sub C under FCC Rules This equipment meets the requirements of CFR47 Part 18 under F...

Page 43: ...antenna position MyLab generates and radiates radio frequency energy A minimum body to antenna distance of 20 cm must be maintained when the device is installed and operated The antennas are located...

Page 44: ...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 20...

Page 45: ...al Abdominal Intraoperative Abdominal Laparoscopic Pediatric Small organ Neonatal Neonatal Cephalic Transrectal Transvaginal Musculoskeletal Conventional Musculoskeletal Superficial Urological Periphe...

Page 46: ...all Organ Thyroid Urology Vascular NO L 3 11 Abdominal Breast Musculo skeletal Pediatric Small Organ Thyroid Vascular YES L 4 15 Abdominal Breast Musculo skeletal Pediatric Small Organ Thyroid Vascula...

Page 47: ...are managed by using proper probe and preset Probes Abdominal AC2541 IH 6 18 L 3 11 L 4 15 SC3421 SL3323 Breast IH 6 18 L 3 11 L 4 15 SL2325 SL3116 SL3235 SL3323 Musculo skeletal2 2 Both conventional...

Page 48: ...ified and trained in using ultrasound scanner x Sonographers x Cardiologist x Maternal fetal Medicine Obstetrician Perinatologist x Radiologist and Internist x System Administrator and Customer Servic...

Page 49: ...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...

Page 50: ...e 3 4 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...

Page 51: ...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...

Page 52: ...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...

Page 53: ...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...

Page 54: ...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...

Page 55: ...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...

Page 56: ...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...

Page 57: ...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...

Page 58: ...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...

Page 59: ...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...

Page 60: ...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...

Page 61: ...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...

Page 62: ...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...

Page 63: ...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...

Page 64: ...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 for...

Page 65: ...ations provide insulated plugs and connectors to manage optional hard copy devices VTR printers Follow the instructions below to install such a device Incorrect connections may compromise the electric...

Page 66: ...r a storage room Possible configurations x MyLab auxiliary device complying to IEC 60601 in area A No additional safety requirements x MyLab auxiliary device not complying to IEC 60601 complying to IE...

Page 67: ...et cable No additional safety requirements x 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 insulat...

Page 68: ...uching the patient and the auxiliary device simultaneously Additionally the IEC60601 requires control measurement of leakage currents The system integrator any person connecting the medical device to...

Page 69: ...the printer 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...

Page 70: ...NG The maximum current supplied by the MyLab 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 WARNING...

Page 71: ...that the 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...

Page 72: ...s 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 from one...

Page 73: ...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...

Page 74: ...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...

Page 75: ...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...

Page 76: ...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...

Page 77: ...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...

Page 78: ...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...

Page 79: ...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...

Page 80: ...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...

Page 81: ...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...

Page 82: ...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...

Page 83: ...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...

Page 84: ...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...

Page 85: ...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...

Page 86: ...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...

Page 87: ...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...

Page 88: ...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...

Page 89: ...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...

Page 90: ...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...

Page 91: ...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...

Page 92: ...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...

Page 93: ...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...

Page 94: ...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...

Page 95: ...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...

Page 96: ...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...

Page 97: ...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...

Page 98: ...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...

Page 99: ...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...

Page 100: ...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...

Page 101: ...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...

Page 102: ...ER SCALE When checked it makes the palette scale inversion completely independent even when the automatic inversion controlled by the steering is enabled i e invert PW spectrum without inverting the C...

Page 103: ...QUI 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 o...

Page 104: ...very key Esaote Service personnel will not be able to recover any encrypted data from the disk Disk encryption security access are the strongest way to protect the personal data of your patients so at...

Page 105: ...cations 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...

Page 106: ...ized 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 x custom...

Page 107: ...ual settings 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 allo...

Page 108: ...ncryption 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 ext...

Page 109: ...he Esaote 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 provid...

Page 110: ...ck 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 installed o...

Page 111: ...uctionsandpotential hazards of using ultrasound before proceeding to use the device It is the user responsibility to operate according to currently approved recommendations provided by the relevant pu...

Page 112: ...up at end of the initialization phase or when starting every new exam MyLab displays the Patient ID screen and the touchscreen is configured to allow the operator to enter patient and application data...

Page 113: ...S T A R T E D 7 3 GETTING STARTED 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 Selectin...

Page 114: ...ve 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...

Page 115: ...END EXAM 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 Scree...

Page 116: ...g 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 pres...

Page 117: ...ve controls 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...

Page 118: ...vanced 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 patient s name...

Page 119: ...ng the exam 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 Advanc...

Page 120: ...P E R F O R M I N G A N E X A M MyLab G E T T I N G S T A R T E D 7 10...

Page 121: ...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...

Page 122: ...nspection mentioned above Disconnect MyLab from the power outlet before checking it Contact Esaote personnel for any problem found during inspection PC Refer to Probes and Consumables manual for perio...

Page 123: ...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...

Page 124: ...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...

Page 125: ...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...

Page 126: ...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...

Page 127: ...d to MyLab serial number and are therefore unique They should be carefully stored The device is delivered by Esaote with the licenses already installed Additional features can be added buying the rela...

Page 128: ...mages on different devices on the same network Fiber Guidance It enables on MyLab a dedicated guidance to be used with Echolaser X4 laser units produced by Elestab MView It is an ultrasound technique...

Page 129: ...r 15 6 LCD full HD 1920x1080 x 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 V...

Page 130: ...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 general gains and other...

Page 131: ...atteries 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 47 y...

Page 132: ...tandard Electromagnetic compatibility Requirements and tests IEC 60601 1 6 2010 A1 2013 Ed 3 1 EN 60601 1 6 2010 A1 2015 Medical electrical equipment Part 1 6 General requirements for basic safety and...

Page 133: ...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 Mechanical Acoustic Output Indices...

Page 134: ...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 8...

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