1、User Training使用者培训FS 502 Step 5软件版本A 2.007/2011,Legal information法律信息,Legal information,3,UTS FibroScan 502.3 - Revision date 15/07/2012 - FibroScan 502 is a class IIa medical device according to Directive EC/93/42 and is manufactured by Echosens. Assessment of its conformity with the essential requ
2、irements of the Directive EC/93/42 is established by the LNE-G-MED (France). FibroScan is indicated for the non invasive measurement of liver stiffness (E) and controlled attenuation parameter (CAP) in human beings.It is expressly recommended to closely read the instruction of the users guide and la
3、beling of the device. FibroScan examination must be performed only by operator certified by the manufacturer or its accredited local representative. FibroScan must not be used in the following situation: other organs but liver, patients with active implantable medical devices (such as pacemaker, def
4、ibrillators, pump, etc.), wound at the measurement point, pregnant women. Presence of ascites can prevent from obtaining valid measurements. The values obtained with FibroScan must be interpreted by a physician experienced in dealing with liver disease, taking into account the complete medical recor
5、d of the patients.In France, liver stiffness measurement by FibroScan is included on the list of acts and services covered by the national Social Security medical insurance under the code HLQM002 and the following conditions. UTS FibroScan 502.3 - Revision date 15/07/2012 根据EC/93/42法规，FibroScan 502是
6、IIa类医疗器械，由Echosens公司生产。LNE-G-MED (法国)评估确认了其符合EC/93/42法规。Fibroscan是用来对人类进行肝脏硬度的无创测量【和控制衰减参数】（CAP）。强烈推荐详细阅读该设备的使用说明书和标贴。Fibroscan检查必须由制造商或其授权的当地代表颁发证书的操作者进行操作。Fibroscan在以下情况不能使用：肝脏以外的器官、移植有其他活性的医疗器械的患者（例如起搏器、除颤器、泵及其他）、测量点有伤口、孕妇。腹水会影响测量的准确性。Fibroscan的测量值必须由对肝脏疾病有经验的医师来解读，并参考该患者完整的医疗记录。在法国，Fibroscan所进行的
7、肝脏硬度测量项目被列入国家社会安全医疗保险所涵盖的医疗服务中（ code HLQM002 ） 并要求符合以下条件。,Legal information法律信息,Indications: (i) assessment of chronic untreated hepatitis C adult patients with no comorbidities except obvious diagnosis of cirrhosis or (ii) assessment of chronic untreated hepatitis C adult patients with HIV coinfect
8、ion except obvious diagnosis of cirrhosis. 适应症：1.用于排除有明显肝硬化诊断之外无其他并发疾病的未治疗的慢性丙肝成年患者的评估；2.用于排除有明显肝硬化诊断之外的合并HIV的未治疗的慢性丙型肝炎成年患者的评估。Invoicing note: Within the limit of one examination per year except in case of risk factors of rapid evolution toward cirrhosis, if this new examination is expected to have
9、 an impact on the therapeutic management of the patient. In case of chronic hepatitis C: (i) as first line test as an alternative to blood tests (ii) as second line test (in case of non agreement between the first line test and the clinical context or in case of non interpretable first line test) as
10、 an alternative to liver biopsy. In case of HIV-HCV coinfection: as first line test to evaluate the presence of cirrhosis. 报销要求：如果新的检查是用来对患者进行治疗管理，并限制在每年行一次检查（并成正朝着肝硬化快速进展的除外）。对于慢性丙肝：1.作为替代血液实验的首选；2.作为替代肝活检的二线检测（在首选检测和临床病史不符合的情况下或在首选试验无法确诊的情况下）。对于HIV-HCV合并感染的患者，作为诊断肝硬化的首选方法。Environment: consultation
11、 specialized in the management of patients with HCV, in collaboration with a center specialized in the management of the HIV infection for the second indication. 环境：精通于HCV管理的咨询会诊，对于第二适应症与精通于HIV感染管理的医生合作,07/2011,4,Training Warning 培训警告,07/2011,5,Warning,The aim of this training is to teach you how to
12、 perform good quality and reliable measurements in an efficient way.本次培训的目的是教会大家如何使用正确的方法执行精确、有效测量。Only operators who complete this whole training will be certified to use the FibroScan.操作者必须经过完整的培训才有资格使用FibroScan .,The training consists of two parts: 培训由两部分组成：A slide presentation幻灯片演示A practice ses
13、sion: 练习,07/2011,6,Introduction简介Elastography principle弹性成像原理Stiffness measurement principle硬度测定原理CAP measurement principle CAP测定原理Presentation of the device 设备介绍Select and launch an examination选择并启动检查Patient examination患者测定Safety recommendations安全建议Probe disinfection and calibration探头消毒和校准,Introduc
14、tion简介,Introduction (1)介绍,8,Introduction,Chronic liver diseases lead to fibrosis and then to cirrhosis and its potential complications.慢性肝病会导致纤维化、肝硬化及其他潜在并发症的发生Steatosis is also becoming more common especially in Western countries肝脂肪变性越来越普遍，特别在西方国家Might also lead to fibrosis when progresses to Alcoh
15、olic or Non Alcoholic Steatohepatitis (ASH or NASH)当进展为酒精性或非酒精性脂肪性肝炎也可能会导致纤维化,Introduction (2)介绍,1 :Friedrich Rust et al., Gastroenterology 2008 2 Sasso et al. Journal of Viral Hepatitis 2011,9,Introduction,FibroScan measures two quantitative parameters in a non-invasive and painless way :Fibroscan用
16、无创和无痛的方法测量两个定量参数,FibroScan is based on Vibration Controlled Transient Elastography (VCTETM) at 50Hz.Fibroscan是基于振动控制瞬时弹性成像技术（频率为50Hz）,Elastography Principle弹性成像原理,What is stiffness ?什么是硬度 ?,07/2011,11,Elastography Principle,Quantifies the ability of a medium not to get out of shape when under mechan
17、ical stress硬度是介质承受机械压力时的抗变形程度的量化表示Stiffness or Elastic modulus or Youngs modulus are expressed in Pascal (Pa)硬度或弹性模量或杨氏模量用 Pascal(Pa)表示。,硬度,弹性模量,杨式模量,弹性,Why measure stiffness ?为什么测量硬度?,07/2011,12,Elastography Principle,Stiffness is a key parameter depending on the pathological state of soft tissues硬
18、度对于软组织的病理状态而言是一个关键参数For centuries, physicians have used liver palpation 几个世纪以来, 医生已经用肝脏触诊。,How do we measure stiffness ?怎样测量硬度 ?,07/2011,13,Elastography Principle,In soft tissues, stiffness is related to the velocity of elastic waves called shear waves.在软组织中, 硬度与弹性波（剪切波）传播速度相关.Shear waves are widely
19、 present in biological tissues剪切波广泛存在于生物组织中,The stiffer the tissue, the faster the shear waves组织硬度越高，剪切波传播速度越快,Generate a shear wave within the liver肝脏内生成一个剪切波,Measure its speed of propagation VS测量传播的速度 VS,Stiffness硬度E VS2,Stiffness Measurement Principle硬度测量原理,Velocity of the Shear Wave剪切波的速度,07/201
20、1,15,Stiffness Measurement Principle,Comparison of consecutive ultrasonic signals to map the local strain of the medium.对连续的超声信号进行比较，定位介质中发生的局部应变。The strain rate image (elastogram) is NOT an anatomical image, it is the representation of the shear wave propagation through liver tissue as function of
21、time.弹性图不是解剖图像，它作为时间的函数，表示剪切波在肝组织中的传播,Strain rate image应变率图像,Time (ms),皮下深度（毫米）,dt,Examples in Human Liver在人体肝脏中的实例,07/2011,16,Stiffness Measurement Principle,VS = 1.1 m/sE 3 kPa,VS = 1.7 m/sE 9 kPa,VS = 3.6 m/sE 40 kPa,E VS2,The more fibrosis in the liver, the higher stiffness will be 肝脏纤维化程度越高，肝脏硬
22、度值越大*,Vibration Controlled Transient Elastography (VCTE TM)振动控制瞬时弹性成像,17,By courtesy of Rheolution Inc.,50 Hz controlled frequency,Thanks to VCTE technology, shear wave speed and equivalent liver stiffness measurement with FibroScan are:感谢VCTE技术，Fibroscan中的剪切波速度和相应的肝脏硬度测量是：Repeatable and reproducibl
23、e可重复的和可再生的Independent of device and operator不受设备和操作者的影响Independent of organ movements (breathing, heartbeat,)不受器官运动的影响（呼吸、心跳。）,Influence of shear wave frequency (Hz) on stiffness measurement (kPa),Stiffness measurement principle,CAP MeasurementPrinciple CAP 测量原理,What is CAP 什么是CAP?,19,CAP principle,
24、CAP (Controlled Attenuation Parameter) allows quantification of the decrease of the amplitude of the ultrasonic signals in the liver.控制衰减参数被用来对肝脏中超声波信号振幅的衰减进行定量,Definition: CAP is based on the quantification of the ultrasonic attenuation in the liver tissue. 定义：CAP是基于肝脏组织中超声波衰减的定量This attenuation/de
25、crease depends on:这种衰减/下降决定于：Distance of propagation of the ultrasonic signals into the medium超声波信号在介质中传递的距离The deeper in the tissue the weaker the ultrasonic signal传递的越深信号越弱Properties of the medium such as viscosity媒介的性质例如粘性Fat content (steatosis) will affect the viscosity of the medium脂肪含量（脂肪变性）将影
26、响媒介的粘性,CAP main features主要特性,CAP principle,* Sasso et al. Journal of viral hepatitis 2011,Quantitative parameter expressed in dB/meter以dB/米表示的定量参数Reflects the decrease in amplitude of ultrasound in the liver反应超声波在肝脏中的振幅下降程度Computed from the ultrasounds acquired for stiffness measurement使用硬度测量时所发生的超声
27、波计算Displayed only if liver stiffness measurement is valid仅在肝脏测量有效时才显示Independent of the device and of the operator unlike conventional ultrasonography不像传统的超声波检查受设备和操作者的影响,21,CAP Measurement Principle,CAP value increases with steatosis in liver tissue.CAP值随肝脏组织脂肪变程度的增加而升高,Acquisition with FibroScan M
28、Probe用M探头测定,Ultrasonic signal超声波信号,Elastogram弹性图,Valid stiffness measurement有效硬度测量,NO,No result无结果,Invalid measurement,Explored volume探查体积,22,CAP Measurement Principle,CAP and stiffness measurements are done simultaneously.CAP与硬度测量同时进行,la sonde,-,Measurement Principle测量原理,23,Stiffness & CAP Measurem
29、ent Principle,Click on Play,Presentation of the Device设备介绍,FibroScan 502,07/2011,25,Presentation of the Device, 一体化计算机Integrated computer数据获取软件Acquisition software检查记录列表List of stored examinations, 电子设备Dedicated electronics超声发射接收探头Ultrasound emission/reception 低频振动发生器 Shear wave generation信号处理程序 Sig
30、nal processing,The Probe 探头,07/2011,26,Presentation of the Device,Blue diodes蓝色指示针,Button开关,Vibrator振动发生器,Ultrasonictransducer超声转换器,Starting up the system系统开机,07/2011,27,Presentation of the Device,Connect the system to the mains and 连上设备Put the power switch in the | position 将开关放在I档,Connect the prob
31、e to the system 插入探头,07/2011,28,Presentation of the Device,Automatically loaded at power on打开后自动载入,Configuration access设置窗口,Archives access档案窗口,Acquisition access数据获取窗口,The Software 软件,07/2011,29,Presentation of the Device,Archives 档案管理,Acquisition 数据获取,The software: 2 main windows2个主要界面,07/2011,30,
32、Presentation of the Device,Number of patient files matching the search符合标准的患者数量,Selected patient file选定患者信息,Patient files management tools患者档案管理,Selected patient and corresponding examinations summary挑选的病人和检测数据,Archives window 档案窗口,07/2011,31,Presentation of the Device,UltrasonicImages 超声影像,Elastogr
33、am弹性图,Number and List of valid measurements (kPa)有效测定次数与列表,CAP ResultsCAP值,StiffnessResults硬度值,Acquisition window数据获取窗口,Invalid measurements and success rate无效测定和成功率,Pressure Indicator压力指示器,07/2011,32,Presentation of the Device,One red line一条红线Pressure too lowfor measurement 测量压力过低,Green level绿线Pres
34、sure suitableto trigger measurement 测量压力适宜,Red level 红线Pressure too highfor measurement 测量压力过高,Caution 提示Pressure on S probe is very sensitive !s探头对压力非常敏感,Ultrasonic Imaging超声影像,07/2011,33,Presentation of the Device,Depth below the skin surface (mm),Time,TM mode TM模式Ultrasonic AmplitudeAs function o
35、f depth and time超声振幅和时间与深度的关系,A mode A模式Ultrasonic signal Amplitude as function of depth超声深度信号,CAP value CAP值Current measurement in dB/m 测量以dB/m表示,提示：测量值同时包含肝脏硬度值与CAP 值 探头类型有（S 1、S 2、中号、加大号）,Stiffness and CAP Results硬度和CAP结果,34,Presentation of the Device,Stiffness 硬度(kPa) or CAP (dB/m) Median of all
36、 valid measurements within the current examination包括当前测量在内所有有效测定结果的中位数,IQR (kPa or dB/m)四分位间距Inter quartile range of all valid measurements within the current examination所有有效测量值的四分位间距 Reflects the dispersion/homogeneity of stiffness or CAP measurements反应硬度和CAP测量的离散型和一致性IQR/med. (%) Indicates the IQR
37、/median ratio表示四分位间距/中位数Must remain as low as possible to ensure reliable results此值必须足够的低以保证结果可靠,34,Reminder: median and IQR提醒：中位数和四分位间距,35,Presentation of the Device,M1,M2,M3,M4,M5,M6,M7,M8,M9,M10,35,Sort the valid measurements in an ascending order (from M1 to M10)将有效测量值升序排列（从M1到M10） Median Q2 div
38、ides the ordered data set into two halves中位数Q2将排列好的数据划分为两部分,Median,Select and Launch an Examination选择和启动检查,Examination selection,Select and Launch an Examination,07/2011,37,探头选择,S1探头,不是,不推荐,M Probe M探头,39,Select and Launch an Examination,S Probe,XL Probe,Next,S Probe S探头,Select and Launch an Examina
39、tion,40,S probe,XL Probe,Next,XL Probe XL探头,Select and Launch an Examination,41,07/2011,42,Use of Ultrasonic Device超声设备的用途,Select and Launch an Examination,Measure skin-capsule depth (SCD) :Ultrasonic imaging is used to assess the SCD.超声影像用于测量SCDLocalize the liver :肝脏定位Ultrasonic imaging also allows
40、 you to choose a measurement point where liver parenchyma is deep enough with optimal SCD.超声影像帮助您选取一个最理想SCD值的位置作为测量点。,If 2.5 cm SCD 3.5 cm, choose the XL Probe如果2.5 cm SCD 3.5 cm，选择XL探头,Main software options主要软件选择,Select and Launch an Examination,43,Changing exam type改变检测类型Change of probe cannot be
41、done within the examination检测中不能更换探头End the current examination and plug the new probe under the tray结束目前的检测并在托盘下插入新探头Start another examination开始下一个检测,Erase measurements during examination检测中删除检测结果A group of measurements is deleted. Median, IQR and IQR/Median ratio are updated accordingly.删除一组检测数据之后
42、，中位数、四分位间距和中位数间距/中位数相应发生改变,Patient Examination procedure患者检查流程,Patient Positioning 患者体位,Patient Examination,22/07/2018,45,Measurement on the right lobe of the liver between the ribs. 测量肋间的肝脏右叶Patient in dorsal decubitus position with the right arm in maximal abduction. 患者仰卧位，右臂最大限度伸展If the patient i
43、s stressed, measurements can be performed whilst the patients hold their breath. 如果病人受压（压迫感），可以屏息测量,07/2011,45,Operator Positioning操作者位置,Patient Examination,Operator sitting on a stool or a chair with wheels on the right side of the patient facing both the patients chest and the screen of the device
44、. 操作者坐在患者右侧的凳子或椅子上，面向病人的胸部和仪器屏幕。Right forearm should rest on the bed along the patients chest. 右前臂应该沿着患者的胸腔放在床上。All the weight of the probe should be within the right hand. 所有探头的承重都应在右手上。The left hand helps keeping the probe correctly positioned. 左手帮助保持探头处在正确的位置。,07/2011,46,Probe Positioning (1)探头位置
45、（1）,Patient Examination,Place the probe between the ribs adjacent to the right lobe of the liver in the middle of the parenchyma away from the border of the liver. If you are too close to the border the liver, stiffness will be overestimated. 将探头放在肋骨间，近肝脏右叶，肝实质中间，远离肝脏边缘。 如果与肝脏的边界太近，硬度值将被高估。The locat
46、ion where a liver biopsy would be performed should suit. 适合肝活检的位置应该合适。Dullness at percussion 叩诊浊音处Sternum and mid auxiliary line 胸骨和中部辅助线,07/2011,47,Probe Positioning (2)探头位置 (2),Patient Examination,Use the A mode and M mode images to find a liver portion at least 6-cm deep free of large vascular st
47、ructures 使用 A 模式和 M 模式图像，找到没有大血管结构的至少6cm深度的肝脏部分,07/2011,48,Probe Positioning (3)探头位置(3),Patient Examination,Keep the probe perpendicular to the skin surface or the liver stiffness will be overestimated. 保持探头与皮肤表面垂直，否则肝脏硬度将会过高。Make sure you check the perpendicularity along both axes by looking at the
48、 probe. 通过观察，确保探头沿两轴垂直。,07/2011,49,Increase the pressure applied with the probe on the patients skin until the pressure indicator is in the green level.按压与患者皮肤接触的探头，直至压力指示器在绿色区域。,CAUTION : Keeping the perpendicularity of the probe may be difficult with children (S probe)注意：在使用S探头给儿童做检测时，保持探头的垂直有一定难度
49、！,Measurement测量,Patient Examination,When all the conditions mentioned above are met you can trigger a measurement. 当上面提到的所有条件得到满足时，可以进行测量。Press the button on the probe without changing the probe position. 按压探头上按钮，并避免探头移动。Acquisition lasts a tenth of second and calculation a few seconds. 数据获取持续1/10秒的时间，同时计算几秒钟。Then the result of this measurement is displayed. 显示测量结果。The strain rate image (elastogram) quality should be checked 应该检查应变率图像（弹性图）质量。,
