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P62

EN ISO 10993-1:2009 -Biological evaluation of medical devices - Evaluation and testing within

a risk management process

EN ISO 10993-5:2009 -Biological evaluation of medical devices - Tests for in vitro cytotoxicity

ISO 10993-10:2010-Biological evaluation of medical devices. Tests for irritation and skin

sensitization

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Содержание LU700 Series

Страница 1: ...ASUS Ultrasound Imaging System LU700 Series LU700C LU700L USER MAUNAL REV A LK_UI LU700 01 E ...

Страница 2: ...ttery Specification 13 System Dimension 13 Probe 13 RF energy spec 15 Chapter 2 Product Usage 16 Intended Use 16 LU700C 16 LU700L 16 LU710C 16 LU710M 16 LU710PA 16 LU710E 16 Contraindications and Warnings 17 Contraindications 17 Warnings 18 Hardware 18 Purchases and Upgrades 18 Warranty 18 Disposal 19 Security 19 Information security 19 Network Security 19 Confidentiality 19 Integrity constrains 2...

Страница 3: ... 30 Applying ALARA 30 Using System Controls to Implement ALARA 30 Additional Considerations 31 Output Display 31 Mechanical Index MI Display 32 Thermal Index TI Displays 32 Controls Affecting the Indices 33 Acoustics 34 Acoustic Output and Measurement 34 Chapter 4 Device Maintenance 36 Turning the Device ON and OFF 36 Transducer Care 36 Cleaning Disinfecting 36 Maintenance 37 Chapter 5 Regarding D...

Страница 4: ...Met 58 Product Serial Number 58 System Specifications 59 Storage Limits 59 Standards 60 Acoustic 60 Biocompatibility 60 Chemical 60 Labeling 60 Battery 60 Wireless 60 Waterproof 60 Safety Conformance 61 Acoustic Output Tables 63 ID Label 69 Guidance and Manufacture s Declaration 69 Electromagnetic Emissions 69 Electromagnetic immunity 72 Trouble Shooting 75 Federal Communications Commission FCC St...

Страница 5: ... tasks you can perform Cleaning Disinfecting Explains how to clean and disinfect your System Safety Outlines important safety standards principles and policies to follow when using the product References Offers information such as product standards regulatory requirements terms and conditions glossary of terms and acoustic output data Target Audience This document is written for trained medical pr...

Страница 6: ...er revisions are not always possible ASUS assumes no liability for errors or omissions and information in this document may be subject to change without notice ASUS reserves the right to make changes to any products herein without further notice to improve reliability function or design ASUS reserves the right to make improvements or changes in the products or programs described in this document a...

Страница 7: ...on A Initial release 2018 07 18 User Manual Revision B Add TI MI related information Add company contact info 2018 08 16 User Manual Revision C Update the battery supplier Add LU710C LU710M LU710PA LU710E probe contents Update App introduction 2020 12 27 ...

Страница 8: ...s communication non ionizing radiation This way up Indicates this correct upright position of the transport package Manufacturer Indicates the medical device manufacturer as defined in EU Directives 90 385 EEC 93 42 EEC and 98 79 EC Batch Code Indicates the manufacturer s batch code so that the batch or lot can be identified Serial number It means manufacture s serial number and the medical device...

Страница 9: ...te Electrical and Electronic Equipment WEEE Directive When accompanied by or components of the device may contain lead or mercury respectively which must be recycled or disposed of in accordance with local state or federal laws The backlight lamps in an LCD system monitor contain mercury To identify electrical and electronic equipment that meets the Restriction of Hazardous Substances RoHS Directi...

Страница 10: ...uce an explosion Medical equipment should be installed and operated according to electromagnetic compatibility EMC guidelines Responsibility for image quality and diagnosis is with users This product has demonstrated EMC compliance under conditions that included the use of compliant peripheral devices The use of compliant peripheral devices is important to reduce the possibility of interference to...

Страница 11: ...ith ease Do NOT use non recommended gels lubricants These may damage the probe and void the warranty Ultrasound Gels should NOT contain any of the following ingredients which have the potential to damage the probe Olive oil Methyl or ethyl parabens para hydroxybenzoic acid Dimethyl silicone Iodine Lotions Lanolin Aloe Vera Mineral oils Methanol ethanol isopropanol alcohol or any other alcohol base...

Страница 12: ... transducers employing Wi Fi based technology to communicate with conventional tablet smartphone devices via Wi Fi directly This allows users to export ultrasound images and display them across a range of portable personal devices IV The imaging system houses a built in battery multichannel beamformer prescan converter and Wi Fi components The LU700 Series Ultrasound System included Tx Rx Analog I...

Страница 13: ...20mm 36mm 10 5mm Safety UN38 3 EN IEC 62133 System Dimension Item Length mm Width mm Height mm Weight g LU700L System 178 74 40 357 LU700C System 187 74 40 388 LU710M System 190 74 40 340 LU710C System 187 74 40 388 LU710PA System 194 74 40 350 LU710E System 370 74 40 412 Probe LU700L Array type Linear Number of elements 128 Depth cm 6 0 Frequency bandwidth MHz 5 0 10 0 Center Frequency 7 5MHz B m...

Страница 14: ...e Color Doppler Power Doppler LU710M Array type Micro convex Number of elements 128 Depth cm 12 0 Frequency bandwidth MHz 4 0 8 5 Center Frequency 6 2MHz Field of view 100 B mode M mode CF mode Color Doppler Power Doppler LU710PA Array type Phased array Number of elements 64 Depth cm 18 0 Frequency bandwidth MHz 1 7 3 7 Center Frequency 2 7MHz Field of view 90 B mode M mode CF mode Color Doppler P...

Страница 15: ...e CF mode Color Doppler Power Doppler RF energy spec Tx frequency 2412Mhz 2462Mhz TX modulation DSSS CCK OFDM Tx Power 18dbm 1DSSS 14 5dbm 54OFDM Rx frequency 2412Mhz 2462Mhz Rx Sensitivity 95 7dbm 1DSSS 74 0dbm 54OFDM ...

Страница 16: ...mbined mode B M B CD B PWD LU700C General abdominal imaging musculoskeletal conventional musculoskeletal superficial peripheral vessel and OB Gyn LU700L General abdominal imaging small organ breast thyroid musculoskeletal conventional musculoskeletal superficial and peripheral vessel LU710C Fetal abdominal pediatric small organ thyroid prostate scrotum breast musculoskeletal conventional urology g...

Страница 17: ...ed experts Users will be trained medical professionals e g doctors nurses technicians with previous training in ultrasound Images produced by this system are transmitted wirelessly to the user s smart device tablet or smart phone Untrained unqualified users purchasing and using this system may unable to measure up quality images Contraindications and Warnings Contraindications 1 Do NOT use the ASU...

Страница 18: ...s possibility of measurement errors or damage to the product 7 When the device LU700 is charged with a mobile charging power supply do NOT use it to work for diagnostic 8 Do not allow the transducer to contact the patient if the temperature of the transducer is higher than 43 C 109 F 9 Do not operate this system in the presence of flammable gases or anesthetics Explosion can result 10 Do not use i...

Страница 19: ... using WPA Wi Fi Protected Access User will be trained medical professionals e g doctors nurses technicians with previous training in ultrasound Images produced by the probe are transmitted wirelessly to the user s smart device tablet or smart phone As following actions could present new risks to patients operators and third parties It is your organization s responsibility to identify analyze eval...

Страница 20: ... any data is incomplete or invalid it is discarded TCP channels used over Wi Fi ensures that data is delivered correctly For transmitting image data a TCP channel is used Technical Features There are some of the technical aspects of the system as following list Wi Fi 802 11b g wireless connect Receive frequency and or band and bandwidth of receiving section Transmit frequency and or band modulatio...

Страница 21: ...g LU710C 350g LU710PA 412g LU710E with battery System Requirements Product Package Components 1 Software The Ultrasound App named as LELTEK for Android ASUSUltrasound for iOS Android OS 7 0 or above iOS 11 0 or above 2 Transducers LU700C Transducer C5 2 Convex probe or LU700L Transducer L10 5 Linear probe or LU710M Transducer M8 4 Micro Convex probe or LU710PA Transducer P4 2 Phased Array probe or...

Страница 22: ...due to small detachable parts and the transducer cable is a strangulation hazard Under no circumstances attempt to remove modify override or frustrate any safety device on the system Interfering with safety devices could lead to serious personal injury or death Do not misuse the system use the system only for its intended purposes Do not use the system with any product that not designated by ASUSa...

Страница 23: ... DO NOT drop the probe or subject it to any type of physical shock or impact Impaired performance or damage such as housing cracks or chips could result Do NOT modify this device without the authorization of Leltek Do NOT use the probe with high frequency surgical equipment Such use may damage the device Do Not use the product in proximity to a strong electromagnetic field electromagnetic wave or ...

Страница 24: ... For maximum safety observe these warnings and cautions Do not operate this system in the presence of flammable gases or anesthetics Explosion can result The system is not compliant in AP APG environments as defined by IEC 60601 1 To avoid risk of electrical shock hazards always inspect the transducer before use Check the face housing and cable before use Do not use if the face is cracked chipped ...

Страница 25: ...nt located nearby can cause emissions In cases where EMI is causing disturbance it may be necessary to relocate your system Battery Safety Lithium ion batteries are also used in medical diagnostic equipment as portable diagnostic equipment so cautions indicated information to a user should pay more attention Please be sure to take to comply with the specifications and the following precautions to ...

Страница 26: ...should mark their charts If latex sensitivity is suspected consider using devices made with alternative materials such as plastic For example a health professional could wear a non latex glove over the latex glove if the patient is sensitive If both the health professional and the patient are sensitive a latex middle glove could be used Latex gloves labeled Hypoallergenic may not always prevent ad...

Страница 27: ...rature increase associated with ultrasound occurs within the first minute of exposure 2 but temperature continues to rise as exposure time is prolonged Minimizing the exposure time is probably the single most important factor for ensuring patient safety from thermal injury 3 Other important parameters to be considered are The relative protein content of each tissue since absorption coefficients of...

Страница 28: ... there is no evidence that any of these physical phenomena has a significant biological effect on patients ALARA Principles The guiding principle for the use of diagnostic ultrasound is defined by the ALARA which means that we keep total ultrasound exposure as low as reasonably achievable while optimizing diagnostic information The decision as to what is reasonable has been left to the judgment an...

Страница 29: ... 2 dimensional 2D acquisitions which are then constructed by the computer into 3D 4D representations Hence whatever the settings are for B mode 2D imaging will be what determines the output Time will be the most important variable because on the one hand a 2D sweep will be fast and time limited but prolonged exposure may result from attempting to obtain the best set of images Second transducer cap...

Страница 30: ...ce temperatures Prudent use of the system occurs when patient exposure is limited to the lowest index reading for the shortest amount of time necessary to achieve acceptable diagnostic results A high index reading does not necessarily indicate the occurrence of a bioeffect however it must be taken seriously It is the operator responsibility to make every effort to reduce the possible effects of a ...

Страница 31: ...cting the transducer and the application which are based on patient anatomy adjustments to output power should be made to ensure that the lowest possible setting is used to acquire an image If an adequate image can be obtained with the increase in gain then a decrease in output should be made Only after making these adjustments should you increase output to the next level Having acquired the 2D di...

Страница 32: ... tissue path so that the actual potential for local zone heating is less than the thermal index displays Scanned modes versus un scanned modes of operation affect the thermal index For scanned modes heating tends to be near the surface for un scanned modes the potential for heating tends to be deeper in the focal zone Always limit ultrasound exposure time Do not rush the exam Ensure that the indic...

Страница 33: ...ou can choose to display TIS TIC or TIB Controls Affecting the Indices B mode Controls Transducer Frequency Color Controls Color Sector Width Narrower color sector width will increase color frame rate and the TI will increase The system may automatically decrease pulse voltage to stay below the system maximum A decrease in pulse voltage will decrease the MI Color Sector Depth Deeper color sector d...

Страница 34: ...dical Ultrasound Safety brochure 2014 A copy of this document is provided with each system Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers FDA September 2008 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment AIUM NEMA 2004 WFUMB Symposium on Safety of Ultrasound in Medicine ...

Страница 35: ... report Bioeffects and Safety of Diagnostic Ultrasound dated January 28 1993 provides more current information The acoustic output for this system has been measured and calculated in accordance with the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 AIUM NEMA 2004 the Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic...

Страница 36: ...s the low battery warning Before turning on transducer LU700 series please disconnect the transducer and all peripheral device Before turning off transducer LU700 series please end the current exam Transducer Care Transducers must be cleaned before each use and it suggested the parts that may be cleaned with isopropyl alcohol are the transducer housing and lens acoustic window Inspect all parts of...

Страница 37: ... emergency where the scanner is used to examine multiple patients in a short period of time the lack of proper cleaning and disinfecting between patients may spread infections to other patients and users Recommendations for cleaning the ultrasound probe as following step Turn off your devices before cleaning it To be ensured that all the coupling gel and other visible substances from the probe is ...

Страница 38: ...ity to conduct and interpret the results of an ultrasound examination depends on a thorough understanding of these ultrasound interactions LU700 Series Device Operation Overview of the Interface Please make sure to have full battery power on your smart device by charging it regularly Please download the ASUSLU700 App as A ASUS MediConnect from Android App store Link https play google com store app...

Страница 39: ...uipment s status lights please refer to following table Color Display Meaning White Solid Wi Fi connection Purple Solid Power On Blue Solid Battery Charging Purple Blue Flash Low battery The light goes off when the battery is full ...

Страница 40: ...P40 Equipment description ...

Страница 41: ... Charging Port 6 Probe case Device Operation Power On 1 Press the power button for 3 seconds 2 The power LED is purple 3 When the power LED is changed from purple to white Wi Fi is connected ready Power Down When press power button for 3 seconds the system will be turned off Idle Mode If the scanner does NOT move for approx 25 seconds the ASUSApp screen will be freeze and the LED is still white ...

Страница 42: ...be List e Patient info button f QRcode scan button g Refresh Button h Connect button i Connect percentage j Cancel Connection button Home Page iOS a Review Button b Exit Button c Current ultrasound probe d Wi Fi setting button e Patient info button f QRcode scan button g Connect button h Connect percentage i Cancel Connection button ...

Страница 43: ...e Page Patient Info DICOM Worklist a Back Button b Initial the server button c Edit the server setting d Set search criteria button e Patient info downloaded from the server Home Page Patient Info DICOM Worklist a Select and input search criteria b Barcode scan button c Cancel button d Download button Home Page Patient Info DICOM Worklist DICOM Server Setup a Existing server list b Cancel button c...

Страница 44: ...rver Setup a Server info edit b Check box for showing the input box of station name c Test the server response button d Cancel button e Save the server setting button f Delete server button Home Page Patient Info Saved Exam a Patient Info Record b Back Button Home Page Patient Info Review a Saved Image and Video b View selected saved Image and Video c Full Screen d Current Setting e Batch manageme...

Страница 45: ...port Button Including DICOM Optional d Tool Bar Home Page Patient Info DICOM Server Setup a Back Button b Return to Home Page button c Initial the server button d Edit the server setting Home Page Patient Info Export Report a Back Button b Patient info c Selected images d Measure info e Note f Signature and date g Export Button ...

Страница 46: ...d Measurement Save Restore and PlayBack Freeze Live a Live The combination of mode buttons in scanning state Optional b Freeze Parameter Tuning Parameter Tuning Select the scanned position of a body a Parameter name and value b SeekBar for tuning c Cancel button d Position of a body e Add customized preset b ...

Страница 47: ...degree mark Parameter Tuning Image Display and Gesture Scan a Menu Button b Patient Info c Image d Ultrasound Probe Status e End exam button f Current Settings g TGC button h Needle Guide i Full Screen Button j Make video button k Save image button l Preset Button m Parameters n Mode Button o Freeze Button Parameter Tuning Image Display and Gesture Mode ...

Страница 48: ...P48 B mode a Image b Depth Ruler c Gray Scale d Mirror Mark M mode Linear Convex a Area with B mode b M Line c Time Base Graticule b a c b b ...

Страница 49: ...ptional Linear Convex a Image b Color Scale c ROI Region of Interest PD Power Doppler mode Optional Except that only one color is used to indicate blood flow intensity the other is the same as CF mode Linear Convex ...

Страница 50: ... CF mode b LOI Line of Interest c Gap beam flow angle PW Pulsed wave mode Optional Linear Convex a Area with suspended CF mode b LOI Line of Interest c Gap beam flow angle difference d Time Base Graticule baseline blood velocity value and the range between blood velocity values c b ...

Страница 51: ... could be reviewing previously saved test data 2 EXIT The user touches the function button to exit from App LELTEK 3 The transducers that will be re auto detected to be connected via Wi Fi Android Only 4 Found probes The transducers that will be auto detected to be connected via Wi Fi then the user can select the transducer that is corresponding Android Only 5 Wi Fi setting button The user can man...

Страница 52: ... the worklist from the server or the latest records If the user would like to download the data he should set the worklist server first If there is an existing server the user can edit delete or connect it SCAN LIVE Step 3 Start scanning immediately in LIVE The ultrasound images appear and you can begin scanning Step 4 Select a parameter button on the left side to tune the parameter value in the B...

Страница 53: ...osition and adjust gate size gate angle and image gain base on CF mode 5 Touch PW Enter Optional the system would be selected for PW Pulsed wave Doppler mode it is moving objects change the characteristic of sound waves By sending short and quick pulses of sound it becomes possible to accurately measure the velocity of blood in a precise location and in real time 6 Touch PD Optional the system wou...

Страница 54: ...ntrast with a more black and white image 17 Gray Map When the user touches this button it is adjusting gray maps on ultrasonic image has a similar effect on an ultrasound image as changing the dynamic range but they are different While Dynamic Range adjusts the overall number of shades of gray a gray map determines how dark or light you prefer to show each level of white gray black based upon the ...

Страница 55: ...he transducer is off It can be changed by the sonographer by varying the depth to which the signal is sent 34 PW Gain Remove or strengthen parts of the pulse wave image that fall within a specified brightness range 35 PW Freq The carrier frequency of the ultrasound wave transmitted and received by the transducer in PW mode 36 Select the scanned part of human body The user can directly tap the scan...

Страница 56: ...an select item Review Edit Patient Info Current Exam and About 2 Review After entering Review in current diagnosis the user can choose to display an ultrasonic image or video in Cine Graphic to review When tapping user can choose Batch Management or Export report Tap Batch Management the user can multiple select delete export stored images Available Format jpg png bmp and dcm dcm is Optional or vi...

Страница 57: ...be calculated and the value will be displayed in Saved Exam Then updating the previous diagnosis list makes the status of this diagnosis no longer in progress Create a new exam automatically after back to Home Page Additional features 1 DICOM Optional When capturing images it can be saved as a medical image format dcm This format will add more complete image related information and can be uploaded...

Страница 58: ...pment Transducers Type BF applied parts IPX1 Ordinary Equipment Continuous Operation Non AP APG Electromechanical Safety Standards Met The transducers and software comply with the requirements of IEC 60601 1 Medical Electrical Equipment General Requirements for Safety including all applicable collateral and particular standards as well as all applicable deviations System users are responsible for ...

Страница 59: ... s responsibility to select a Leltek compatible device that meets the needs of the user s clinical environment For information about the user s device s environmental specifications consult the documentation that accompanies users device Probes must be operated stored or transported with the parameter outline as following Item Operational Storage Transport Pressure 700 hPa 525 mmHg to 1060 hPa 795...

Страница 60: ...on and Restriction of Chemicals REACH establishing a European Chemicals Agency LU700 Ultrasound Imaging System meets the minimum requirements for compliance with the European Union s Restriction of Hazardous Substances RoHS Directive 2011 65 EU and its amendments Labeling ISO 15223 1 2016 Medical devices Symbols to be used with medical device labels labelling and information to be supplied General...

Страница 61: ...gement process AIUM NEMA UD 2 2004 2009 NEMA Standards Publication UD 2 2004 R2009 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 Radiology AIUM NEMA UD 3 2004 2009 NEMA Standards Publication UD 3 2004 R2009 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Product Specification Design Review Ver...

Страница 62: ...devices Evaluation and testing within a risk management process EN ISO 10993 5 2009 Biological evaluation of medical devices Tests for in vitro cytotoxicity ISO 10993 10 2010 Biological evaluation of medical devices Tests for irritation and skin sensitization ...

Страница 63: ...101 10 N A P1x1 mW 38 82 38 82 ZS cm N A Zb cm N A ZMI cm 0 50 ZPII α cm 0 50 fawf MHz 3 27 3 27 3 27 N A Other Information prr Hz 5063 8 srr Hz 7 47 npps 1 00 Ipa α at ZPII α W cm2 15 97 Ispta α at ZPII α or ZSII α mW cm2 5 80 Ispta at ZPII or ZSII mW cm2 21 68 Pr at ZPII MPa 0 81 Operating Control Conditions Display focus cm 3 00 3 00 3 00 N A 3 00 N A Display depth cm 9 50 9 50 9 50 N A 9 50 N ...

Страница 64: ...F 2 26 B 19 85 CF 2 26 ZS cm N A N A Zb cm ZMI cm 0 50 ZPII α cm 0 50 fawf MHz B 5 90 B 5 90 C 4 91 B 5 90 C 4 91 N A Other Information prr Hz 8787 00 srr Hz 7 21 npps 1 Ipa α at ZPII α W cm2 64 83 Ispta α at ZPII α or ZSII α mW cm2 21 3 Ispta at ZPII or ZSII mW cm2 49 8 Pr at ZPII MPa 1 67 Operating Control Conditions Display focus cm 4 0 4 0 4 0 N A 4 0 N A Display depth cm 6 3 6 3 6 3 N A 6 3 N...

Страница 65: ...mW N A N A ZS cm 2 75 Zb cm 4 42 ZMI cm 4 43 ZPII α cm 4 43 fawf MHz 2 76 2 76 2 76 N A Other Information prr Hz 2000 00 srr Hz N A npps 1 Ipa α at ZPII α W cm2 182 1 Ispta α at ZPII α or ZSII α mW cm2 634 3 Ispta at ZPII or ZSII mW cm2 1474 00 Pr at ZPII MPa 2 76 Operating Control Conditions Display focus cm 3 0 N A 3 0 N A 3 0 N A Display depth cm 9 5 N A 9 5 N A 9 5 N A Working frequency MHz 2 ...

Страница 66: ...x1 mW 19 85 19 85 ZS cm N A N A Zb cm ZMI cm 1 22 ZPII α cm 1 22 fawf MHz 5 90 5 90 5 90 N A Other Information prr Hz 8787 00 srr Hz 7 21 npps 1 00 Ipa α at ZPII α W cm2 64 83 Ispta α at ZPII α or ZSII α mW cm2 11 10 Ispta at ZPII or ZSII mW cm2 18 20 Pr at ZPII MPa 1 67 Operating Control Conditions Display focus cm 4 00 4 00 4 00 N A 4 00 N A Display depth cm 6 30 6 30 6 30 N A 6 30 N A Working f...

Страница 67: ...F 2 26 B 19 85 CF 2 26 ZS cm N A N A Zb cm ZMI cm 0 50 ZPII α cm 0 50 fawf MHz B 5 90 B 5 90 C 4 91 B 5 90 C 4 91 N A Other Information prr Hz 8787 00 srr Hz 7 21 npps 1 Ipa α at ZPII α W cm2 64 83 Ispta α at ZPII α or ZSII α mW cm2 21 3 Ispta at ZPII or ZSII mW cm2 49 8 Pr at ZPII MPa 1 67 Operating Control Conditions Display focus cm 4 0 4 0 4 0 N A 4 0 N A Display depth cm 6 3 6 3 6 3 N A 6 3 N...

Страница 68: ...N A N A ZS cm N A Zb cm 1 5 ZMI cm 2 34 ZPII α cm 2 34 fawf MHz 4 95 4 95 4 95 N A Other Information prr Hz 3570 00 srr Hz N A npps 1 Ipa α at ZPII α W cm2 125 5 Ispta α at ZPII α or ZSII α mW cm2 441 6 Ispta at ZPII or ZSII mW cm2 983 6 Pr at ZPII MPa 2 23 Operating Control Conditions Display focus cm 4 0 4 0 N A N A 4 0 N A Display depth cm 6 3 6 3 N A N A 6 3 N A Working frequency MHz 5 0 5 0 N...

Страница 69: ...cent to or stacked with other equipment Using the wrong cable and accessories may adversely affect the EMC performance Electromagnetic Emissions The LU700 Series are intended for use in electromagnetic environments as specified below The customer or the user of the LU700 Series should ensure that it is used in such an environment ...

Страница 70: ...onment RF emissions CISPR 11 Group 1 The LU700 Series uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The LU700 Series is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network...

Страница 71: ...IEC 61000 4 5 0 5kV 1kV line s to line s 0 5kV 1kV 2kV line s to earth 0 5kV 1kV line s to line s Not applicable Mains power quality should be that of a typical professional healthcare environment Voltage Dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Voltage dips 0 UT 0 5 cycle 0 UT 1 cycle 70 UT 25 30 cycles Voltage interruptions 0 UT 250 300 cycle Vol...

Страница 72: ...s 0 15 MHz 80 MHz 6 Vrms in ISM bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz e 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz Portable and mobile RF communications equipment should be used no closer to any part of the LU700 Series including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d ...

Страница 73: ...output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 7 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equatio...

Страница 74: ...45 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation b 18 Hz 2 0 3 28 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0 3 28 28 5240 5 100 5 800 WLAN 802 11 a n Pulse modulation b 217 Hz 0 2 0...

Страница 75: ...led App has been enabled but could not be display an image Please check there is no background in the screen or other apps had been enabled first It should do repower on the device transducer and reconnect the device transducer via Wi Fi then re enable App App has been into image page but it would be immediately swapped to Wi Fi connected selection page Please disconnect Wi Fi first and delete the...

Страница 76: ...which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienc...

Страница 77: ...r s address ASUSTeK Computer Inc 6F 3 No 293 Sec 1 Beixin Rd Xindian Dist New Taipei City 23147 Taiwan R O C www asus com 0598 MedNet GmbH Borkstrasse 10 48163 Muenster Germany Phone 49 25132266 61 Fax 49 251 32266 22 ...

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