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

MyLab

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

9 - 10

European and international standards

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IEC 60601-1:2012 (Ed 3.1)

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IEC 60601-1-2:2014 (Ed. 4)

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IEC 60601-1-6:2010 + A1:2013 (Ed. 3.1)



IEC 60601-2-37:2007 (Ed. 2) + A1:2015



IEC 61157:2007 (Ed. 2.1) + A1

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NEMA UD-2 / UD-3

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EN ISO 10993-1: 2009

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EN ISO 14971: 2012

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RoHS Compliance

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IEC 60601-1-9



Radio Equipment Directive RED 2014/53/UE

Содержание MyLabX75VET

Страница 1: ...Rev 03 June 2021 MyLabX75VET GETTING STARTED 350080800 ...

Страница 2: ......

Страница 3: ...014 30 EU and is CE marked MyLabX75VET complies with the Radio Equipment Directive 2014 53 EU and is CE marked MyLabX75VET is a device in Class 2 according to RED Directive For US Customers US Federal Law restricts this device to sale distribution and use by or on the order of a physician All information included in this manual is relative to the following Esaote ultrasound equipments MyLabX75VET ...

Страница 4: ... and may be different from what you see on the screen or device This manual has been written taking care to ensure the accuracy of all of the information included however Esaote assumes no liability for errors or omissions No translations of this documentation are allowed without the consent of Esaote S p A The information contained in this documentation is subject to change without prior notice T...

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

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

Страница 7: ...ement for the Software Included in the Apparatus1 8 Proprietary Rights 1 8 License Rights and Limitations 1 8 Third Part Software 1 9 Product Traceability 1 9 Vigilance System 1 11 2 Additional Information on Safety 2 1 Environmental Safety 2 1 Information about Reusing Recycling 2 1 Special waste 2 1 Exam Waste 2 1 Electrical Safety 2 1 Electromagnetic Compatibility 2 3 Electro Surgical Devices E...

Страница 8: ...logy Transvaginal 2 14 Gynecology Shear Wave 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 Users in the United States of America 2 18 Users in Australia 2 18 Wireless antenna position 2 20 3 MyLab Overview 3 1 About MyLab 3 1 Intended Purpose 3 1 Clin...

Страница 9: ...housing 4 7 Auxiliary Monitor 4 8 Gel warmer 4 9 Thermasonic gel warmer 4 9 Lifeguard UGW 01 gel warmer 4 10 External CD DVD and HDD drives 4 12 Moving and Transporting MyLab 4 12 5 Using MyLab 5 1 Connecting MyLab to the mains 5 1 Turning MyLab On and Off 5 1 MyLab Controls 5 2 Control Panel Section 5 2 TGC Sliding 5 4 Trackball 5 5 Encoders 5 5 Touchscreen Section 5 6 Menu Button 5 6 Touchscreen...

Страница 10: ...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 SHUTDOWN TYPE 6 13 Field AVAILABLE QWERTIES 6 14 CINE MODE Folder 6 14 APPLICATION PRESET Folder 6 14 Field ACTION ON FREEZE 6 16 FOOTSWITCH Folder 6 17 PROBE BUTTONS Folder 6 17 RAW DATA Folder 6 17 KEY...

Страница 11: ...ies 7 8 Reviewing Images 7 8 Ending the Exam 7 8 Monitor adjustments 7 9 8 Maintenance 8 1 Veterinary Applications 8 2 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 Cleaning the Touchscreen 8 5 Cleaning the LCD Screen 8 6 Cleaning the LCD case 8 6 9 Technical Specifications 9 1 MyLab Char...

Страница 12: ...T T I N G S T A R T E D xii Fuses 9 7 Batteries 9 8 Power Cables 9 8 Opti light 9 9 Operating Requirements 9 9 Storage requirements 9 9 Heat output 9 9 Probe Storage Requirements 9 9 European and international standards 9 10 ...

Страница 13: ...with MyLab and information on foreseeable medical emergency situations Safety and Standards provides information about the patient s and operator s safety Getting Started this manual describes how to install MyLab and provides the main instructions for using it Probes and Consumables provides detailed instructions for using and reprocessing MyLab probes and their accessories System Data provides d...

Страница 14: ...ons and accessories Some functions probes or applications described may be unavailable on your product s configuration NOTE Technology and features are device configuration dependent Specifications subject to change without notice Information might refer to productsormodalitiesnotyetapprovedinallcountries Productimagesare for illustrative purposes only For further details please contact your Esaot...

Страница 15: ...cifications accuracy and limitations and should be able to manipulate the ultrasound scanner correctly in order to ensure that patient diagnosis and management are not compromised For this reason anyone operating the ultrasound scanner should read and understand the ultrasound scanner operating manual Ultrasound scanner transducers cables monitor and image recorders should be regularly inspected a...

Страница 16: ... information please consult Guidelines For Professional Ultrasound Practice Society and College of Radiographers and British Medical Ultrasound Society December 2015 https www sor org 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 equipment The British Med...

Страница 17: ...sly stated by Esaote as well as incorrect use or operation may relieve Esaote or its agents from all or some responsibility for resultant noncompliance damage or injury MyLab Manual Conventions In this manual device controls are indicated using the following graphical conventions Control panel buttons are indicated by GREY CAPI TAL LET TERS Touchscreen keys are indicated by BOLD BLUE CAPITAL LETTE...

Страница 18: ... notifies the user of a condition in which the system must not be used The reason for this is that the risk involved clearly outweighs the benefits of using the system in such conditions Manufacturer s Responsibility Esaote is responsible for the safety reliability and functioning of this product only if the user follows all the instructions contained in the device manuals for the use and the main...

Страница 19: ...n the most suitable solution for its safe disposal Maintainability Time Esaote ensures maintainability of MyLab ultrasound scanners for seven 7 years from the purchase date End of Life Disposal MyLab ultrasound scanners fall within the application field of the 2002 96 EC Directive on waste electrical and electronic equipment WEEE amended by directive 2003 108 EC The main device label includes ther...

Страница 20: ...e propriety of Esaote S p A or its Software Suppliers The user will acquire no title or right on the SOFTWARE except for the usage license granted herein For any software updates and or upgrades installed on the Equipment after installation the terms herein shall apply in full License Rights and Limitations With this license Esaote S p A grants the end user the right to use the SOFTWARE on the sup...

Страница 21: ...oftware uses parts of the 7 Zip program The 7 Zip is licensed under the GNU LGPL license the source code can be found in www 7 zip org Product Traceability To guarantee the product traceability according to requirements of the standard EN ISO 13485 2016 and the European Directive on Medical Devices 93 42 EEC 1993 and subsequent amendments original owners in the event of equipment transfer to third...

Страница 22: ...RACEABILITY FORM To ESAOTE S p A Quality Assurance Department Via Enrico Melen 77 16152 Genova Italy or associate company or authorized distributor Esaote system device name REF Serial Number SN Name and address of original owner Name and address of new owner Date Signature ...

Страница 23: ...ell as any inadequacy in the labeling or the instructions for use which might lead to potential or real hazards for a patient or for an operator we kindly request to immediately inform Esaote central plants or one of our subsidiaries or one of our official distributors immediately through the following form or through a communication reporting the same data contained in this form All data relating...

Страница 24: ...ce 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 the potential real hazard Description of accident or potential accident Comments or suggestions Contact Person Department Address Phone Fax Date Signature ...

Страница 25: ...st 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 screens must be treated as special waste according to the applicable local regulations Dispose of the equipment as special waste according to the applicable local regulations For further information...

Страница 26: ...MyLab 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 replace the system fuses with different types from those specified by the MyLab Getting Started manual WARNING Electrical shock hazard Do not remove the system or the monitor cover Refer servicing and in...

Страница 27: ...iceable 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 authorized by Esaote may result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation CAUTION Portable RF communication equipmen...

Страница 28: ...ich CISPR 11 class B is normally required this equipment might not offer adequate protection to radio frequency communicationservices Theusermightneedtotakemitigationmeasures such as relocating or re orienting the equipment Guidance and manufacturer s declaration Electromagnetic emissions MyLab is suitable for use in the specified electromagnetic environment The purchaser or user of MyLab should a...

Страница 29: ...ological effect and which may alter the diagnosis Free from the display of inaccurate numerical values associated with the diagnosis to be performed Free from the display of inaccurate safety related indications Free from the production of unintended or excessive ultrasound output Free from the production of unintended or excessive transducer assembly surface temperature Free from the production o...

Страница 30: ...differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips IEC 61000 4 11 0 UT 0 5 cycles at 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 0 UT 0 5 cycles at 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 Mains power quality should be that of a typi...

Страница 31: ...om fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which MyLab is u...

Страница 32: ...te numerical values associated with the diagnosis to be performed the disturbance shall not produce an error displaying inaccurate safety related indications the disturbance shall not produce unintended or excessive ultrasound output the disturbance shall not produce unintended or excessive transducer assembly surface temperature MyLab according to the definition of the IEC 60601 1 2 ed 4 standard...

Страница 33: ... literature1 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 to maintain a balanced position while scanning not to grip the probe with excessive force to take work breaks to allow muscles to relax to introduce routine exercises such as gentle passive stretching Working with Vi...

Страница 34: ...rt in ultrasound diagnostic imaging Esaote has identified the following additional potential residual risks that are hereafter grouped for main applications Cardiac Stress Echocardiography Absolute and relative contraindications as indicated by American Society of Echocardiography must be applied to avoid serious complications The incidence rate of serious complications e g serious arrhythmias myo...

Страница 35: ...njunction 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 devices do not integrate or control the way how these medicinal products are administered to the patients Usually they are administered via an intravenous injection performed directly by a medica...

Страница 36: ...nction 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 devices do not integrate or control the way how these medicinal products are administered to the patients Usually they are administered via an intravenous injection performed directly by a medical d...

Страница 37: ...avoided 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 needle will be introduced e g for abscess drainage or PTCD must be sterilized After every examination residual US gel should be carefully removed with a disposable towel and the transducer cord wiped wi...

Страница 38: ...stimates 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 kept as less as possible to reduce the thermal stress to the targeted tissue Fetal Acoustic output from diagnostic ultrasound devices is sufficient to cause temperature elevations in fetal tissue In ge...

Страница 39: ...mester 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 fetuses and the lack of literature reporting an ascertaining risk in this field Biocompatibility and Infection Control Probes and electrodes intended to be used on intact skin have very limited proba...

Страница 40: ...e 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 Latex Containing Medical Devices For additional information in the U S A refer to FDA Medical Alert MDA91 1 Device Modifications Esaote is not responsible for any unauthorized modification of equipmen...

Страница 41: ...tance 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 Use in specific environments the use of wireless devices in hospitals is restricted to the limits set forth by each hospital the use of wireless devices in hazardous locations is limited by the constraints posed ...

Страница 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 FCC rules The FCC logo label placed on the device certifies that the device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harm...

Страница 43: ...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 19 GETTING STARTED ...

Страница 44: ...on 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 on the MyLab where indicated by the red circle in the figure below Fig 2 1 Wireless antenna position on MyLabX75 Family and MyLab XPro75 ...

Страница 45: ...right 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 MyLab Intended Purpose MyLabX75VET is intended to perform images of the internal structure of the animal s body that when interpreted by a medical expert trained in the use of ultrasound equipments can provide diagnostically useful...

Страница 46: ... probes can be connected to MyLabX75VET AC2541 including biopsy capabilities E 3 12 including biopsy capabilities IH 6 18 including biopsy capabilities IL 4 13 including biopsy capabilities IOT342 including biopsy capabilities L 3 11 including biopsy capabilities L 4 15 including biopsy capabilities mC 3 11 including biopsy capabilities P 1 5 P 2 9 P2 5 13 S2MCW SB2C41 including biopsy capabilitie...

Страница 47: ...C41 SL3116 Cardio bovine mC 3 11 P 1 5 P 2 9 P2 5 13 S2MCW SL3116 Cardio canine L 3 11 mC 3 11 P 1 5 P 2 9 P2 5 13 S2MCW SL3116 Cardio equine mC 3 11 P 1 5 P 2 9 P2 5 13 S2MCW SL3116 Cardio feline L 3 11 mC 3 11 P 1 5 P 2 9 P2 5 13 S2MCW SL3116 Cardio other L 3 11 mC 3 11 P 1 5 P 2 9 P2 5 13 S2MCW SL3116 Repro bovine AC2541 IOT342 mC 3 11 P 1 5 SL3116 Repro canine AC2541 E 3 12 IOT342 L 3 11 L 4 1...

Страница 48: ...plications are approved in all Countries Please refer to your Esaote local representative for further information Contraindications MyLabX75VET is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye WARNING Do not use MyLab for ophthalmic or transorbital applications The ultrasound beam must not be directed to the eyes ...

Страница 49: ...t designed to be both highly mobile and adjustable for a range of users and operating conditions The cart top is equipped to house peripherals It has a rear mains switch to power up the console the screen and the peripheral devices The device provides handles and independent brakes for front and rear wheels for movement and transportation Removable components can be locked in place so the cart can...

Страница 50: ...calibrated according to the Greyscale Standard Display Function GSDF defined in Part 14 of the DICOM medical standard Number Component 1 Monitor 2 On Off button 3 Loudspeakers on both sides 4 Control Panel Assembly 5 Orientation lever 6 Cable hangers 7 Printer slot 8 Connections panels 9 Wheel brake pedal on each wheel 10 Probe connectors 11 Probe connector locks 12 Pull out QWERTY keyboard 13 Lif...

Страница 51: ...and the Main Switch is on the lighting of the ON OFF button changes to indicate its status The different indicators are described in the table below Table 3 3 On Off button light Pressing the ON OFF button turns MyLab on or off activating or closing the examination session Optional Batteries When MyLab is equipped with optional batteries the same button can be configured in order to place the devi...

Страница 52: ...the panel The control module also allows to select transducers enter patient data review and annotate images perform measurements and calculations and change setups The Control Panel Assembly includes the handle the probe and ECG cables holders Two loudspeakers 3 are placed on both side of the touchscreen Fig 3 2 Control Panel Assembly Table 3 4 Control Panel Assembly description Number Control Pa...

Страница 53: ...erclockwise closed position for optimal handling Push the lever to rotate the control panel into the new position release it when the control panel is correctly positioned CAUTION When rotating the keyboard pay attention not to damage the peripherals placed on the console If the peripheral falls down injury may be caused The lifting lever 13 located on the right allows to adjust the position of th...

Страница 54: ...tive Press FREEZE before disconnecting the probe CAUTION Check to correctly align the probe connector before inserting it Close the connector securing device only after having completely inserted the connector When a transducer is not in use store it in one of the probe holders 15 on the sides of Control Panel Assembly Always loop transducer cables over the cable hangers 6 to prevent cables from b...

Страница 55: ... ports that can be used to connect a USB printer a USB footswitch or a USB digital archive medium LAN port Display port for video output Wheel Brakes MyLab is equipped with four rotational wheels and independent brakes on each of them When the pedal is fully pressed down the brake is engaged to avoid rotation of wheels keeping the device stationary during use To release the brake move the pedal to...

Страница 56: ...s 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 charging level of the battery reaches the minimum threshold needed for working the icon is contoured by a blinking frame and the residual time is displayed beside Either connect MyLab to the mains powe...

Страница 57: ...hed 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 battery is fully charged the Main power cable icon is displayed again First Use A new battery pack might be partially discharged before using it for the first time perform one full charging procedur...

Страница 58: ...case 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 indicates a failed access to the battery pack in this case information on batteries may not be correct MyLab displays the following message If this situation occurs shut down MyLab by keeping ON OFF pr...

Страница 59: ...yLab 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 problem persist contact the Esaote Service department Error 6 This error indicates that a fan is not working MyLab displays the following message If this situation occurs press OK and then shut down M...

Страница 60: ...n 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 shut down MyLab Contact the Esaote Service department Error 8 wrong impulse voltage Please contact the Service department ...

Страница 61: ...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 17 GETTING STARTED ...

Страница 62: ...utside 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 a Network To use connectivity features the device must be connected to a network The LAN plug is placed at the bottom of the rear side it supports Gigabit 10Base T and 100Base T Ethernet LAN An Esa...

Страница 63: ... switched off complete shut down not stand by or other conditions 2 Connect the peripheral device to the MyLab 3 Switch the peripheral device on making sure that the device is not in stand by condition 4 Switch the MyLab on by pressing the Power ON button NOTE Always observe the instructions given in the manual of the peripheral auxiliary device NOTE Contact Esaote personnel for recommended USB pr...

Страница 64: ...ments for medical electrical systems Attention is drawn to the fact that local laws take priority over the above mentioned requirements If in doubt consult your local representative or the technical service department WARNING Mobile configurations provide insulated plugs and connectors to manage optional hard copy devices VTR printers Follow the instructions below to install such a device Incorrec...

Страница 65: ...e or a storage room Possible configurations MyLab auxiliary device complying to IEC 60601 in area A No additional safety requirements MyLab auxiliary device not complying to IEC 60601 complying to IEC XXX1 in area A Auxiliary device must be powered through a safety insulation transformer complying to IEC 60601 1 IEC XXX stands for standards such as IEC 60601 for medical devices IEC 60950 for infor...

Страница 66: ...net cable No additional safety requirements MyLab auxiliary device not complying to IEC 60601 in area B or area C connected by cable USB HDMI Auxiliary device must be powered through a safety insulation transformer complying to IEC 60601 NOTE AuxiliaryDevicesmustbeapprovedbyEsaote AuxiliaryDevicesmustalso comply with EN 60601 1 2 safety standard and subsequent amendments or the electromagnetic com...

Страница 67: ...hing 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 other devices is responsible that the connections are safe WARNING Thesystemmustbepoweredsotosatisfytheelectricalsafetyrequirements Esaote recommends running a current leakage patient and environment te...

Страница 68: ...cted to USB printers via a USB Port The printer can be housed on the console top MyLab is equipped with belts to secure the peripheral device NOTE When selecting the peripheral consider its dimension so that it can be safely installed on the console The console top measures 29 x 20 cm CAUTION The peripheral weight does not have to exceed ten 10 kg The console could be damaged if the peripheral wei...

Страница 69: ...or USB 2 0 and 1A for USB 3 0 Peripherals exceeding this limit can be connected only if powered by theirexternal power supply through amedical insulation transformer WARNING Epson WF 110W printer the printer must be connected to the MyLab insulation transformer do not use the printer auxiliary battery the cover of the auxiliary battery shall never be removed if the battery cover is open do not use...

Страница 70: ...ion button to select the desired temperature and LEDs that provide working information and alarms if any Fig 4 4 Thermasonic gel warmer Heat indicator lamp The Heat Indicator Lamp in the lower front will blink while the unit is approaching the set temperature Once that temperature has been reached the lamp will remain illuminated Should the unit restart the heating process the Heat Indicator Lamp ...

Страница 71: ...l Warmer may be cleaned by using a soft damp cloth and a mild detergent or hospital grade disinfectant such as ProteX ULTRA Wipes Do not allow the electronic controls to get wet Do not use an abrasive cleaner or isopropyl alcohol to clean the Gel Warmer Do not submerge or immerse the Gel Warmer in water Lifeguard UGW 01 gel warmer Lifeguard UGW 01 gel warmer supplied by Esaote presents an operatio...

Страница 72: ...hted means the gel warmer is on and the temperature is set to 37 C Right LED is lighted means the gel warmer is on and the temperature is set to 40 C Both LEDs are flashing at 2Hz indicates the alarm if the gel warmer is over temperature higher than 42 5 C Both LEDs are flashing at 0 5Hz indicates the alarm if the gel warmer faces the following conditions temperature sensor error input power suppl...

Страница 73: ...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 through a medical insulation transformer Moving and Transporting MyLab MyLab is designed to be easily moved by the operator however you have to observe the following warnings and cautions WARNING The handles on the control panel cannot be used to ...

Страница 74: ...d move it to a comfortable height for moving 5 Turn the mains switch off and unplug the power cord wrapping it on the rear hook or on the handle to ensure it 6 Disconnect all external cables including network and external devices 7 Secure all cables probes and accessories so that they do not interfere with the wheels When transporting MyLab with the probes attached make sure the cables are not dra...

Страница 75: ... to avoid screen swing during transportation If present protect the monitor orientable arm so that no lateral movements are possible for example with film Use the brakes to lock the device when loaded on the vehicle Fasten securely the device inside the vehicle Quick Displacement When MyLab is equipped with batteries it can be quickly moved from one working position to another without partially sw...

Страница 76: ...that it can t be squashed by a misplaced foot or by heavy objects The earth terminal can be connected to an external protective earthing system as additional protection This connection is not necessary in most cases and is only recommended for situations involving multiple equipment in a high risk patient environment to provide assurance that all equipment is at the same potential and operates wit...

Страница 77: ...from the mains disconnect the cable from the power outlet CAUTION DonotturnMyLab offwhileworking forexamplesaving data orduringthe initialization phase the hard disk could be damaged by this operation CAUTION MyLab is a PC based device data loss or driver damage may occur if the device is turned off while working for example saving data or during the initialization phase Refer to the appropriate c...

Страница 78: ...Activates deactivates Color Doppler CFM The knob around this button amplifies both CFM and Power Color gains To increase gain turn the knob clockwise to reduce it turn the knob counter clockwise In B Mode a cursor delimits the Region of Interest ROI where color analysis is performed and displayed M Activates the M Mode and if necessary its selection cursor B Line B This button re activates a B Mod...

Страница 79: ... or disable it to select the M Mode or Doppler line During the exam when a trace is active the same button freezes the trace acquisition and temporarily reactivates the reference B Mode image ACQUI RE Activates advanced features further details on how to use them are described in the Advanced Operations manual FREEZE Stops the current analysis or scan and puts MyLab in Freeze mode To re activate r...

Страница 80: ...on the right side of the screen or to access to the archiving media and peripheral menus The buttons placed on the left and right side of the trackball can be set as mouse keys as confirmation and context menu buttons Regardless of the trackball configuration the confirmation and context menu buttons are respectively indicated as ENTER and UNDO in this manual Press POI NTER to change the trackball...

Страница 81: ...r keys that can be tapped while by NORMAL BLUE CAPITAL LETTERS for software text strings Tap the displayed key to activate deactivate the corresponding control Many modes provide two or more pages of controls Swipe left right to move to the next previous page A page indicator shows you the page in which you are The touchscreen layout changes depending on the different working modality as Exam pane...

Страница 82: ...uchscreen Each knob acts on the control key just above it Rotate the knob to change the control value Sometimes two controls are available for a knob Only one of the controls can be active at a time Pressing the corresponding knob or tapping the label toggles the active control Disabled Key Active Key Active Key with Sub menu Selected Key Gray text on dark gray background White text on light gray ...

Страница 83: ...tains functions whose value can be changed by rotating the knob beneath On top right a dedicated key activates the emulation of the Qwerty alphanumeric keyboard Tap the keyboard icon to display the keyboard Tap again to hide the keyboard Tap the cogwheel icon to access a menu for easy configuration of display settings to adapt the contrast and brightness of your display to the lighting conditions ...

Страница 84: ...d Section The alphanumeric keyboard is based on the QWERTY standard The alphanumeric keys are used to enter text data in the enabled windows The Caps Lock key sets the keyboard to upper case characters The Shift key is used to type in lower case or upper case characters according to how the keyboard is set the Fn key is used to type numeric functions for example AO Refer to the Advanced Operations...

Страница 85: ...Heading Area This area is used to display the following information center and patient data accession number and date Patient data are displayed only if entered at the beginning of the exam Data can be entered or modified at any time during the exam by pressing PATIENT ID Footer Area This area is used to display the following information Wi Fi icon when enabled archival media icons advanced featur...

Страница 86: ...val consult the relevant section on the Advanced Operations manual Advanced Features When advanced features such as XView or MView are activated the corresponding icons are displayed on the center of the footer area Peripheral Devices MyLab is able to simultaneously manage two peripheral devices b w or RGB printers The icons of the peripheral devices are shown at right of the footer area The icon ...

Страница 87: ...le 5 4 Image Area description Freeze Status Whenever an image is frozen a memory bar is displayed at bottom right concerning the scrolling memories The images acquired immediately before are frozen and archived in these memories The trackball can be used to examine the 2D M Mode Doppler and color information image by image Number Description 1 Frequency Bar active application probe and preset 2 Sy...

Страница 88: ... C or n n XView Algorithm or CrystaLine Imaging MView algorithm PRC n n n n Dynamic range Dynamic compression Density Gray map PRS n Persistence SV nn nnn mm Sample volume size and depth nn Doppler angle correction nn CFM PW steering angle when the beamline is present 0 when beamline has no steering positive value when steered to the right negative value when steered to the left Parameter Displaye...

Страница 89: ...rackball as gray text Thumbnails Area Clips and images both saved during the exam and previously archived are displayed on the right side of the screen as thumbnails The thumbnails are displayed in chronological order from left to right The tabs displayed at the top of the thumbnails columns allow to scroll among the images saved during current exam and images retrieved from other exams PRS n Pers...

Страница 90: ... You can do the following Create preset designed specifically for the exams you perform Change device settings to reflect your needs Add options to enhance your imaging abilities Create custom procedures for specific patients transducers and presets The M ENU button is used to access the device menu MyLab displays all the available options Fig 6 1 MyLab Menu ...

Страница 91: ...be in each application This means that the preset selected at the beginning of the exam or during the exam pressing PROBE establishes the initial settings of the exam controls like gray map depth together with the initial available measures measurement configuration the initial available library both for annotations and for bodymarks Annotation and Bodymark configurations and the customized touchs...

Страница 92: ... used in two structures differing in Network and DICOM connectivity two specific System Configuration profiles can be created each time the user will load the configuration required by the structure MyLab allows the user to save several system configurations If for example MyLab is used in two structures differing in Network and DICOM connectivity two specific System Configuration profiles can be ...

Страница 93: ...ng options Table 6 1 Configuration Menu Options Once in editing mode you can change the name of the selected item NAME field enter a description NOTES field confirm and save the settings SAVE or exit the menu without saving the settings CANCEL At any time you can go back to the main menu BACK TO MENU or exit from the menu and go back to Real Time CLOSE Option Description EDIT To modify the setting...

Страница 94: ...he real time image in all modes and create the customized preset Creating a new preset from MENU To create a new preset or modify an existing one press M ENU then select REAL TIME PRESET and then follow the generic configuration procedure taking in account that on the left of the screen is displayed the list of all clinical settings grouped by probes Within each probe clinical settings are grouped...

Страница 95: ...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 customized touchscreen Whenever the customized button is pressed MyLab will automatically launch the keys sequence Each configuration is linked only to one customized touchscreen NOTE Keys sequences th...

Страница 96: ...sage Prepare MyLab to be ready for the recording so that only the keys to be used can be pressed and then press ETOUCH to start Press the desired keys in sequence and press again ETOUCH to end the recording During the sequence recording the message turns color The eTouch configuration menu displays the customized button Place the cursor on the button and press ENTER to change its name using the al...

Страница 97: ...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 described here refer to relevant chapters in the Advanced Operations manual Profile Manager Profile Manager allows to create a profile for each user with a personalized system configuration To configure t...

Страница 98: ...er ID press M ENU then select CENTER ID and then follow the generic configuration procedure During editing you can configure many fields described below Center ID Field The name entered in this field will be displayed in the heading area of the screen Report Information Field This option allows to add to the report header the following information the hospital name the department name the contact ...

Страница 99: ...thout 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 you can set date and time manually or automatically Set Date Using the trackball scroll the month and select the day on the calendar to set date manually Date Format Various formats can be set the available options are...

Страница 100: ...y 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 option is used to set the desired units for height and weight You can choose between cm kg and ft lb The Celsius or Fahrenheit scale can be selected for probes equipped with temperature sensor BIOPSY Folder This o...

Страница 101: ...EN RESOLUTION Sets the screen resolution when secondary monitor is connected AVAILABLE QWERTIES Sets which alphanumeric keyboards are available in the touchscreen and which is the default one When more alphanumeric keyboards have been set the touchscreen displays an alphanumeric keyboard with dedicated tabs allowing to select the desired keyboard BEEP VOLUME Sets the volume of the beep FOCUS CONTR...

Страница 102: ...splayed on monitor TOUCHSCREEN Sets the brightness of the touchscreen CONTROL PANEL Sets the brightness of the control panel Fields Action STANDBY When the OFF button is pressed MyLab goes in hibernation state saving all configurations allowing a following quick boot up In these conditions MyLab can be unplugged from the main When OPTIMIZE MEMORY USAGE is checked all memory is erased to make repea...

Страница 103: ...us and restore MyLab Field AVAILABLE QWERTIES When more alphanumeric keyboards have been set the touchscreen displays an alphanumeric keyboard with dedicated tabs allowing to select the desired keyboard Fig 6 4 Qwerty keyboard CINE MODE Folder When set the AUTOMATIC PLAY and TRACE AUTOMATIC PLAY options respectively allow to review the stored images and the trace in cine mode when FREEZE is presse...

Страница 104: ...ROI box is overlaid to the B Mode image as a reference IMAGE SIZE Sets the default dimension for reference image in split format for the selected application ACTION ON FREEZE Sets the action after FREEZE pressure AUTO BUTTON SETUP Sets the action after AUTO pressure AUTOADJUST to automatically adjust the B Mode image ECFM to automatically optimize CFM image or BOTH of them EASYTRACE ENABLED When c...

Страница 105: ...LER 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 CFM scale Fields Action Fields Action NO ACTION When FREEZE is pressed MyLab goes in freeze without any other action associated GENERIC MEASUREMENTS When FREEZE is pressed MyLab goes in freeze with th...

Страница 106: ...ach of the four configurable buttons 1 2 3 and 4 From the curtain menu select the function you desire then press SAVE NOTE When the buttons 1 2 3 4 are associated to save image or save clip they will be named further in this manual as I M AGE or CLI P respectively SECURITY Folder Antivirus Microsoft Windows Defender anti virus protects your MyLab from external threats DEFINITION VERSION lets you k...

Страница 107: ...is necessary to decrypt the disk in the remote case the machine on which it is located is broken Without recovery 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 every boot MyLab reminds you to enable both features with a message on the screen Encrypti...

Страница 108: ...nse Activation To activate a new license type the license number in the KEYS field and press VERIFY to confirm If the number is correct the status changes to PERMANENT NOTE All license fields are not case sensitive with the exception of the CrystaLine license that is case sensitive Demo License If a demo license has been activated DEMO box checked EXPIRATION DATE shows the expiration date of each ...

Страница 109: ...settings Clinical Configuration Folder The clinical settings that can be exported are customized real time settings REALTIME PRESETS customized calculation packages MEASURE customized glossary libraries ANNOTATIONS customized body mark libraries BODYMARKS customized ETOUCH when available other customized profiles System Settings Folder The system configuration settings that can be exported are cus...

Страница 110: ...ll be exported IMPORT Folder This option allows the user to load customized clinical and system configuration settings MyLab allows the user to load specific clinical and system configurations Procedure Connect the USB medium containing the customized configurations to MyLab Select the configuration you want to import Press IMPORT to start the loading procedure MyLab shows the list of all saved co...

Страница 111: ...by Esaote Service personnel only Encryption can be applied to the internal hard disk and to one or more external USB memory devices At the end of encryption a recovery key will be given to you The recovery key is stored on USB pen drive or on file or by printing it You have the responsibility to store the key in a safe place for future use NOTE To make effective use of encryption it is strongly ad...

Страница 112: ...the 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 provided by the Esaote service This remote case is communicated by MyLab through a warning message at starting up Electronics manuals on Esaote website MyLab operation manuals are accessible also on Esaote...

Страница 113: ...ick 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 on your PC to consult them You can download for free the program Adobe Acrobat Reader from the Adobe web site ...

Страница 114: ...ructionsandpotential 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 published clinical guidelines and by the best clinical practices NOTE The operator must be familiar with the mechanical and thermal indexes display as well as know the ALARA As Low As Reasonably Achiev...

Страница 115: ... 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 and to select the probe the application and the preset CAUTION Do not turn MyLab off during the initialization phase the hard disk could be damaged by this operation Fig 7 1 Patient ID screen ...

Страница 116: ...G 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 Selecting probe 3 Selecting Application 4 Selecting Preset ...

Страница 117: ...e CURRENT retrieves the patient data of the last exam REOPEN EXAM allows to open an exam already closed to add images and or measurements NOTE The key is enabled only for exam closed in the same day of reopening It is not allowed to reopen exams taken the days before the current one RETR PAT INFO or RETR PAT INFO retrieves from the archive the patient data of a previously performed examination Onc...

Страница 118: ...g 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 Screen contains the patient data at the date and time of when the image has been taken Do not refer to these data but always check the current patient data Selecting Probe On the left side of the touchscr...

Страница 119: ...ng PROBE Selecting Preset The Preset or Clinical Setting can be selected only when both the probe and the application have been set Tap the name of the desired preset to select it The blue rounded preset indicates the active one At any time during the exam a different preset can be selected tapping PROBE At Preset selection the exam starts MyLab enables the selected probe to operate in the applica...

Страница 120: ...low the operator to scroll among the specific mode menu If the displayed menu has several levels swipe left right to scroll through all functions AO The control panel buttons and the commands displayed on the touchscreen make it possible to optimize presentation quality Different menus correspond to each format the Advanced Operations manual provides a detailed description of all active controls i...

Страница 121: ...viewing of the saved images and sequences and the trackball automatically changes to pointer mode allowing you to scroll through the thumbnails and select the item to be reviewed Alternatively press POI NTER select the thumbnail MyLab automatically switches to Exam Review The selected image or sequence is shown on the screen AO The functionalities available in Exam Review are the same of the Archi...

Страница 122: ... at a later time from Archive Review Refer to the specific section of the Advanced Operations manual for further information If the PAUSE EXAM option is checked in Saving Options Menu pressing END EXAM also PAUSE will be prompted NOTE At switch off MyLab will inform if there are any paused exams Monitor adjustments Tapping the gear icon in the advanced level of the touchscreen you can access a men...

Страница 123: ... 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 and screen every week user checking device housings for any damage every month user checking control panel and keyboard for defects every month user checking equipment for loose or missing hardware eve...

Страница 124: ... Refer to Probes and Consumables manual for periodic inspections for probes and cleaning instructions Veterinary Applications WARNING Due to the specificity of the veterinary working place Esaote recommends that the ultrasound devices used in veterinary applications should be thoroughly cleaned at least once every 6 months Please contact your Esaote distributor or dealer for further help in this m...

Страница 125: ...aning operation should be performed accordingly to the equipment environment requirements interms of temperature pressure and humidity Check the instructions supplied by the manufacturer of the cleaning agents for possible stricter limitation Do not use hot cleaning agents for cleaning the equipment CAUTION Apply the cleaning agents only for the time necessary to remove the dirt without exceeding ...

Страница 126: ...rd switch your MyLab off unplug it and use commercial wet wipes only CAUTION Do not use any kind of spray foam gel cleaner on the QWERTY keyboard either directly or on moistened soft cloths which could lead to a drop inside This can cause damage to the QWERTY keyboard which could lead to system malfunctioning NOTE The QWERTY keyboard can be protected with a latex free plastic cover The life of the...

Страница 127: ...clean the touchscreen switch 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 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 t...

Страница 128: ...onto a clean soft cloth and then wipe the surface Never spray or pour any liquid directly onto the screen or case WARNING Overspray or liquid may cause electrical shock Cleaning the LCD case Use a soft dry cloth to wipe the surface of the case If necessary apply a small amount of ammonia free and not abrasive detergent onto a clean soft cloth and then wipe the surface CAUTION Do not use any type o...

Страница 129: ...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 enable specific functions of MyLab they are linked to MyLab serial number and are therefore unique They should be carefully stored The device is delivered by Esaote with the licenses already installed Add...

Страница 130: ...ardiac Cardio Canine Cardio Feline Cardio Equine Cardio Bovine Cardio Other Presets Calculations Feature Description 3D 4D 3D and 4D Volumetric acquisition 3D 4D Advanced TPI TMI and TSI modalities VRA analysis XLight Advanced illumination rendering technique AutoAdjust It enables the automatic adjustment of imaging parameters Auto EF It automatically detects and tracks the left ventricle LV endoc...

Страница 131: ...rom different view angles MyLab Tablet Mobile application which allows to remotely review MyLab images on tablet or mobile MyLibrary Dedicated libraries for Rheumatology MSK Regional anesthesia Physioterapy and Advanced vascular Live Preview features allow to scan in real time while using anatomical references and scanning guidance Needle Enhancement Imaging It increases the needle visibility Prot...

Страница 132: ...nectivity I O connectors LAN RJ45 2 USB 2 0 on keyboard control panel 2 USB 3 0 on lateral panel Wi Fi 802 11 A B G N VPan Panoramic Imaging merges multiple B Mode images in one complete panoramic image XStrain XStrain allows to quantify endocardial velocities of contraction and relaxation and local deformation of the heart Strain Strain Rate analysis XStrain 4D XStrain 4D creates a volumetric mod...

Страница 133: ...h IHE integration profiles2 Image Files Formats BMP uncompressed PNG lossless JPEG lossy AVI Codec Microsoft MPEG 4 V2 and MS Video 1 Native formats Software Operating system Windows 10 Multi lingual Biometry Basic and advanced calculation application dependent Annotations bodymarks 1 Auxiliary monitors connected to this input have not to be used for diagnostic purposes 2 Refer to www esaote com f...

Страница 134: ...mm height of trackball In working position 605 W x 1315 1577 H x 730 D mm at top of the monitor Weight 85 kg basic configuration without peripheral units IP Grade According to the degree of protection against harmful ingress of water MyLab is IPX0 this means MyLab models are not watertight The probes are IPX7 this means Esaote probes are protected against the effects on temporary immersion in liqu...

Страница 135: ...ive range Power consumption 260 VA MyLab only excluding peripherals Fuses Table 9 3 Fuses used on MyLabX75 AC Mains Fuse F1 F2 Technical data Standards Marks For 100 120V mains supply 10A 250V T Time lag H High breaking capacity 1500A 5x20mm UL 248 1 CSA C22 2 No 248 14 IEC 60127 UR E10480 CSA 29862 VDE 40013521 For 200 240V mains supply 5A 250V T Time lag H High breaking capacity 1500A 5x20mm UL ...

Страница 136: ...onnector MyLab side Plug Type Mains side Cord Type Length Italy EN60320 C13 I 3G CEI 23 50 H05VVF3G Section 1 mm2 3 conductors 10A 250V 4 5 m Europe France Germany Spain EN60320 C13 Type VII G CEE 7 VII H05VVF3G Section 1 mm2 3 conductors 10A 250V 4 5 m USA North America C13M EN60320 C13 HG Hospital grade NEMA 5 15 SJT3x14AWG 3 conductors 15A 125V 4 5 m UK EN60320 C13 BS13 13 BS 1363 A H05VVF3G Se...

Страница 137: ... activated by a finger touch on the bottom right corner of the monitor frame The illumination level can be adjusted sliding the finger on the corner to increase decrease the level Operating Requirements Temperature 15 35 C Humidity 20 85 not condensing without batteries 20 80 not condensing with batteries Pressure 700 1060 hPa Storage requirements Temperature 20 60 C Humidity 10 85 not condensing ...

Страница 138: ...n and international standards IEC 60601 1 2012 Ed 3 1 IEC 60601 1 2 2014 Ed 4 IEC 60601 1 6 2010 A1 2013 Ed 3 1 IEC 60601 2 37 2007 Ed 2 A1 2015 IEC 61157 2007 Ed 2 1 A1 NEMA UD 2 UD 3 EN ISO 10993 1 2009 EN ISO 14971 2012 RoHS Compliance IEC 60601 1 9 Radio Equipment Directive RED 2014 53 UE ...

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