MEDDE V2.7.1(中文版翻译)
MedWin软件使用
目录MedWin 概述 (1)MedWin 集成开发环境的特点 (1)MedWin 对系统的要求 (2)快速入门适用范围 (2)内容安排 (2)一、安装MedWin (3)二、设置MedWin (6)三、MedWin 开发入门 (11)四、MedWin 调试实例 (18)五、MedWin 断点功能 (24)六、MedWin 菜单命令 (26)七、MedWin 右键弹出式菜单 (2)八、MedWin 的表达式 (4)MedWin 概述MedWin 是万利电子有限公司Insight® 系列仿真开发系统的高性能集成开发环境。
集编辑、编译/ 汇编、在线及模拟调试为一体，VC 风格的用户界面，内嵌自主版权的宏汇编器和连接器，并完全支持Franklin/Keil C 扩展OMF 格式文件，支持所有变量类型及表达式，配合Insight® 系列仿真器，是您开发80C51 系列单片机的理想开发工具。
图1:MedWin 集成开发环境窗口界面MedWin 集成开发环境的特点1. 完美的Windows 版集成开发环境MedWin2. 内嵌自主版权的宏汇编器A51 和连接器L51,并支持Keil/Franklin 编译、连接工具3. 具有分别独立控制项目文件的工程项目管理器4. 在工程项目管理下，实现多模块和混合语言编程调试5. VC 风格的窗口停驻、窗口切分和工作簿模式界面6. 在线编辑、编译/ 汇编、连接下载运行和错误关联定位7. 符合编程语言语法的彩色文本显示8. 完全的表达式分析，支持所有数据类型变量的观察9. 无须点击的感应式鼠标提示功能10. 外部功能部件编程向导11. 不限制打开数据区观察窗口的数目12. 调试状态下用户程序自动重装功能13. 提供真实的软件模拟仿真开发环境MedWin 对系统的要求为使MedWin 集成开发环境能够正常地运行，您必须提供以下软硬件环境：1. 586 以上的PC 及兼容机2. 100M 以上的剩余硬盘空间3. 分辨率为800x600 以上的显示器4. 具有SPP 功能的打印机接口5. 中文或英文Windows/95/98，Windows/Me，Windows 2000/NT,Windows XP6. 尽量减少DOS 自动批处理中关于系统路径及环境变量的设置，或删除DOS 下的批处理文件Autoexec.bat 文件快速入门适用范围1. MedWin 集成开发环境V2.3x2. 标准80C51 系列仿真器SE-52P,ME-52A,ME52P,AE-52E3. 标准扩展80C51 系列仿真器ME-52H/SE-52H,ME-32004. 专用80C51 系列仿真器ME-12055. PHILIPS 51LPC 系列仿真器SE-764内容安排本书从以下八部分，介绍MedWin 集成开发环境的快速入门方法：一、安装MedWin二、设置MedWin三、Med Win 开发入门四、MedWin 调试实例五、MedWin 断点功能六、MedWin 菜单命令七、MedWin 右键弹出式菜单八、MedWin 的表达式一、安装MedWin本章分三节介绍怎样获得MedWin 集成开发环境安装程序、MedWin 集成开发环境对系统的要求和安装MedWin 集成开发环境步骤。
MEDDEV 2[1].12-1 rev 6 附录 中英文
![MEDDEV 2[1].12-1 rev 6 附录 中英文](https://img.taocdn.com/s3/m/12691fc20c22590102029d6e.png)
附件3 制造商向国家主管当局提交报告格式表ANNEX 3 REPORT FORM FOR MANUFACTURER’S TO THE NATIONAL COMPETENTAUTHORITYManufacturer’s Incident Report制造商事故报告医疗器械警戒系统本人保证就本人所掌握的知识范围,上述信息是正确的。
I affirm that the information given above is correct to the best of my knowledge.签名Signature姓名Name：城市City:日期Date:Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the National Competent Authority that the content of this report is complete or accurate, that the medical device(S) caused or contributed to the alleged death or deterioration the state of the health of any person.本报告的提交本身并不代表制造商和／或其授权代表或国家主管当局对本报告的内容完整或准确的结论，也不代表所列医疗器械的任何错误和／或医疗器械引起或促成了宣称的任何人的死亡或其健康六况的严重损坏。
附录4 欧洲市场安全纠正措施ANNEX 4 EUROPEAN FIELD SAFETY CORRECTIVE ACTION REPORT FORM医疗器械警戒系统(MEDDEV 2.12/1 rev 5)本人保证就本人所掌握的知识范围,上述信息是正确的。
英文版GeomagicStudio9修改为中文界面的步骤
英文版Geomagic Studio 9内带中文界面，可以设置为中文界面。
将英文版Geomagic Studio 9修改为中文界面的步骤如下：
3 点击我的电脑→右键属性→高级选项→找到环境变量按钮。
如图l所示
图L
点击图中画红圈的地方，打开环境变量。
如图m所示
点击画红线部分的新建，新建变量名为lang 变量值为chs 接着按下确定。
6 打开Geomagic Studio 9已经安装好的pointstopolys文件夹
路径是Program Files\Geomagic\Geomagic Studio 9\wizards\lang\pointstopolys 找到文件夹里面的zh-cn.qm 文件
复制到\Program Files\Geomagic\Geomagic Studio 9\Lang 文件夹里
运行Geomagic Studio 9 程序，按住ctrl+X 跳出一个对话框
如下图
general选项里的langyage and fonts 看到右边语言选择的部分选择最后一个Chinese(prc)
按OK退出.
最后关掉程序,再打开程序.现在就是中文版的了.
全部安装完毕.。
wemod森林之子翻译
wemod森林之子翻译
“WeMod森林之子翻译”是一款免费的游戏翻译工具，目前可以用于翻译大量的PC游戏，包括《寂静岭4》、《使命召唤14》、《血源诅咒2》等。
它旨在帮助玩家更好地理解游戏，而不必过多地去理解游戏中的文本或对话内容。
WeMod森林之子翻译是一个开源工具，由一群致力于游戏翻译的人打造而成，它能够自动将游戏中的文本和对话翻译成更易懂的语言，以便玩家能够更好地理解游戏的内容。
它也可以帮助玩家节省宝贵的时间，从而更好地投入游戏中。
WeMod森林之子翻译工具非常容易使用，只需要点击一下就可以立即获得翻译后的结果。
此外，它还支持多种语言，包括中文、英文、法文、德文、意大利文、西班牙文、日文等等。
此外，它还可以用来翻译社交媒体上的文字，以便玩家能够更容易地交流和互动。
WeMod森林之子翻译软件还支持自定义翻译，让玩家更轻松地翻译游戏中的某些特定的文本或对话。
它还支持自动保存翻译结果，以便玩家可以随时查看和修改翻译后的内容。
总而言之，WeMod森林之子翻译是一款非常实用的游戏翻译工具，它可以帮助玩家更轻松地理解游戏内容，并且节省玩家宝贵的时间，让玩家可以更轻松地投入游戏。
MEDDEV 2.7.1_REV 3_医疗器械指南_中文版
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10 在评估临床评价资料过程中公告机构的角色…………
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10.1 设计档案的检查
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10.2 作为质量体系程序一部分的评价
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10.3 公告机构特定程序和专门知识 Nhomakorabea24
附件....................................................................................................................……
关于上市后行动，制造商被期望执行和保持监督程序，日常监测器械的临床性能 和安全，作为质量管理体系的一部分。上市后监督的范围和性质应适用于该器械 以及它的预期用途。使用由此程序(比如安全报告, 包括不良事件报告; 出版文献 的结果, 任何进一步的临床调查和正式的上市后监督研究等)生成的资料, 制造商 应通过临床评价定期评审器械的性能，安全和利害评估，并相应地更新临床证 据。这个持续的临床评价过程应允许制造商根据当地的报告要求，以及任何对器 械的利害评估有重要影响或需要对关于禁忌症，注意事项或说明书要做出更改的 任何信息，与符合性评估机构和监管当局进行交流。
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2.0 范围................................................................................................................................ 6
3.0 参考文献........................................................................................................................ 7
先看TheKlub17编辑基础知识+一个问题的案例
基礎知識 - Mod安裝篇:2. Mod安裝教學:(1) 遊戲包 (.txx 文件):Archives/2.114.00(2) 遊戲材質 (皮膚, 衣服, 房間等 png/txf 文件):Mod/ActiveMod(4) 自定玩具(tes文件及其icon圖):Community/ToyEdit(3) 自製電影 (Sequence-####文件夾sq文件及其icon圖):Community/Sequencer(4) 自定姿勢 (pes文件及其icon圖):Community/PoseEdit(5) 動作文件 (bvh 文件):Mod/PoseEdit(6) 遊戲角色 (Model#### 文件夾):Save/Models(7) 社群遊戲角色 (Customization#### 文件夾):Community/Customizer3. 遊戲包的優先序:∙許多遊戲包(txx)有相同的文件名的內容物. 遊戲包載入順序不同, 將會有截然不同的結果∙3DV是透過 txx文件命名, 依據的是文件名稱字母排序, 來決定遊戲包的優先序.∙也就是 a.txx 優先於 b.txx 優先於 c.txx, 當文件發生衝突時. 以 a.txx的內容為主.4. Mod衝突處理:(1) 遊戲包衝突:∙衝突描述: txx遊戲包的部分內容物相同∙解決方法: 更改衝突 txx的文件名稱, 調整載入優先權(2) 材質解析度衝突∙衝突描述: 通常是安裝 4xHD 高清材質, 才會發生∙解決方法:i. 安裝 4xHD 高清材質, 須搭配 R9 或 Sam5的高清材質集(也可安裝JZenma的整合版). 防止疊圖錯位 ii. 安裝 4xHD 高清材質, 須刪除 Mod/ActiveMod 的低清皮膚(3) ID衝突∙衝突描述: 遊戲腳本中, 同一個 Dress ID/Item ID 被重複定義, 導致部分腳本失效∙解決方法: 須使用 Mod 工具解開遊戲包修改腳本進階知識 - Mod工具篇:1. Mod 類型:(1) 3D替換模組 (3D replacer mods)∙直接替換掉遊戲原有的3D模型. 被替換的對象將無法使用.∙(更換模型, 可能會使部分遊戲貼圖發生錯誤)(2) 3D擴充模組 (3D addon mods)∙透過修改遊戲腳本. 額外新增3D模型. 不會替換遊戲原有的3D模型.(3) 腳本模組 (Script mods)∙透過修改遊戲腳本. 新增新的滑動條, 操作選項, 人物表情.(4) 材質模組 (Image mods)∙替換遊戲中的貼圖(5) 音效模組 (Sound Mods)∙新增語音與音效2. 遊戲包結構:∙Archives/2.114.001 目錄下, 有許多 txx 文件.∙txx文件其實是一種加密過的壓縮文件, 存放遊戲內的設定, 腳本, 模型, 腳本, 貼圖, 聲音, 及語言包.3. txx解壓縮後的常見文件:∙bs/bh: 遊戲的設定與腳本文件, 也可以是3D模型文件∙[bsb]/[bhb]: 加密後的 bs/bh∙po: 語言包, 存放遊戲中的字串. 需設定對應的字庫 (utf-8)∙jp2: 遊戲中的貼圖與圖示∙png: 遊戲中的貼圖與圖示. 同路徑下, 若是存在同檔名的jp2圖, 則以png為準.∙tri: 遊戲中3D模型, 骨架∙gzip: 部分[bsb]/[bhb]文件, 會加一層gzip壓縮, 可用winrar/7z 等壓縮工具解壓縮∙ogg: 遊戲內的語音與音效4. Mod環境設定:作業系統: Windows, LinuxWindows環境設定:∙如果想用 cmd 編譯, 需設定path環境變量 Binaries/tk17sh∙(使用 TK17 Command Shell.exe 就不用設定環境變量)Linux環境設定:∙需設定path環境變量 Binaries/tk17sh∙需安裝 wine 才能使用解包與打包工具5. Mod工具介紹:(1) 遊戲內建基本Mod工具TK17 Command Shell.exe (Binaries/TK17_Shell.exe)∙功能: 命令介面, 可直接使用 Binaries/tk17sh 的工具∙使用方法: 與 windows 中的 cmd 大致相同txx_tools.exe:∙功能: txx解包與打包工具∙使用方法:1. 開啟 TK17 Command Shell.exe (或windows cmd, Linux terminal)2. txx解包:txx_tools -x <txx文件>3. txx打包:txx_tools -k 1 -b <要打包成txx文件的目錄>blex.exe:∙功能: bs/bh <--> [bsb]/[bhb]解包與打包工具∙使用方法:1. 開啟 TK17 Command Shell.exe (或windows cmd, Linux terminal)解密:blex.exe -d DcDress.[bsb] -o DcDress.bs加密:blex.exe -e DcDress.bs -o DcDress.[bsb]2. 要載入bs 文件到 blender, 要裝 tkm 工具裝好後左邊的工具列會有導入選項]logdec.exe∙功能: 遊戲除錯紀錄. 查看mod載入是否正常∙使用方法:1. 開啟 TK17 Command Shell.exe (或windows cmd, Linux terminal)2. 輸入logdec.exe(2) Tri_utils 工具集(包在 MDK 中)安裝方法:1.解壓縮 Tri_utils.7z, 及裡面的zip文件.2.將AddAnimateMorph.exe, FileConvert.exe, tri2egm.exe 全丟到 Binaries/tk17sh/目錄下fileconvert∙功能: 轉換 tri, vrml, obj, 3ds 的文件轉換工具, 我們主要使用它來將tri文件轉換成obj文件.使一般的3D編輯軟件得以編輯遊戲內的模型∙使用方法: 轉換 3ds1. 開啟 TK17 Command Shell.exe (或windows cmd, Linux terminal)2. 轉換 fg_head.tri --> fg_head.3dsfileconvert tri-3ds fg_head3. 轉換 fg_head.3ds --> fg_head.trifileconvert 3ds-tri fg_head∙使用方法: 轉換 obj1. 開啟 TK17 Command Shell.exe (或windows cmd, Linux terminal)2. 轉換 fg_head.tri --> fg_head.objfileconvert tri-obj fg_head3. 轉換 fg_head.obj --> fg_head.trifileconvert obj-tri fg_head(3) Blender v2.64a(包在 MDK 中)∙功能: 一套免費的3D編輯軟體, 可搭配 Klub17 3D object io tools使用∙使用方法: 參考我自製的 40頁slide (包在 MDK 中)(4) Klub17 3D object io tools (tkm) (包在 MDK 中)∙安裝方法:1. 解壓縮 io_tkm17_v0.8.3.7z2. 將 io_tkm17 目錄複製到 Blender 安裝目錄的addons 目錄中X:\Program Files (x86)\Blender Foundation\Blender\2.64\scripts\addons\3. 開啟 Blender4. 使用者偏好設定 --> 附加元件5. 找尋 klub17 3D object io tools 打勾6. 存為預設值∙功能說明: 主要功能是將bs 3D模型文件, 匯入/匯出Blender ∙使用方法:1. 在Blender左方工具列中, 會看到 TKM17 Importer2. 可以點選[匯入] 將 bs 3D模型文件匯入 Blender3. 可以點選[匯出] 3D模型匯出成bs文件1. 打勾後, 儲存設定, 左方會出現tkm2. 載入模型前, 先存檔3. 設定 blex, txx_tools等工具4. 使用匯入, 將模型載入好好摸索吧, tkm 還有不少功能一些要遵守的規則:(整理中)參考資料:以下是國外的一些資料1. WIKI∙/doku.php∙/wiki/TheKlub17_Wiki2. JU 的移植教學1，3DV的自带拍照程序，所生成的照片，是不带游戏画面的渲染效果的。
新视野大学英语读写教程2-（第三版）-unit-2-课文原文及翻译
Text A课文 AThe humani ties: Out of date?人文学科：过时了吗？When the goinggets tough, the toughtakeac count ing. When the job market worsen s, manyst udent s calcul ate they can't majorin Englis h orhist ory. They have to studysometh ing that boosts their prospe cts of landin g a job.当形势变得困难时，强者会去选学会计。
当就业市场恶化时，许多学生估算着他们不能再主修英语或历史。
他们得学一些能改善他们就业前景的东西。
The data show that as studen ts have increa singl y should eredthe ever-rising c ost of tuitio n,they have defect ed from the studyof the humani tiesand toward applie d scienc e and "hard"skills that they bet will lead to employ ment. In oth erwords, a colleg e educat ion is more andmor e seen as a meansfor econom ic better mentrather than a meansfor humanbetter ment.This is a trendthat i s likely to persis t and even accele rate.数据显示，随着学生肩负的学费不断增加，他们已从学习人文学科转向他们相信有益于将来就业的应用科学和“硬”技能。
全新版大学英语（第二版）综合教程4学生用书课后习题答案（后附testyourself重要词翻译）
UNIT1Vocabu laryI.1.T l allian ce;2.T ies at the cost of;3.B e stroke;4.M s limp;5.T ees minus;6.T t region s;7.T e declaration s;8.A n siege;9. O d raw; 10.B t bide his time; 11.T yes have taken theirtoll;12.W y in the case of短文填空In bring1. allow; 2. reckon ed; 3. highly; 4. foreca sts; 5. rapidl y;6. instan t;7. delive ry;8. advantage;9. observ i ng; 10. powerful;II.1.翻译1)多收Mr. Dohert y and his family are curren tly engage d in gettin g the autumn harvest in onthe farm.2)我器We must not undere stima te the enemy. They are equipp ed with the most sophis ti cat edweapon s.3)菲望Havi ng been out of a job/Not having had a job for 3 months, Phil is gettin g increa singl ydesperate.4)作确Sam, as the project manage r, is decisi ve, effici ent, and accura te in his judgme nt.5)既位Since the chemic al plant was identi fiedas the source of polluti on, the villag e neighborhoo d commit tee decided to closei t down at the cost of 100 jobs.UNIT2Vocabu laryI.1. expansi on;2. automa ted;3. vapor;4. take contro l of;5. hazard s;6. satell i te;7. vibrat ed;8. magneti c;9. bunche d;10. in the air;11. got/was stucki n; 12. approxi mate l y;短文填空1. genera tes;2. relate d;3. revolu tioni zed;4. enable d;5. opport uniti es;6. overal l;7. manufa cturi ng;8. depend ent;9. intera ct; 10. fatali ties;II.1.翻译6)There was an unusual quietn ess in the air, except for the soundof artill ery in the distan ce.7)The expansi on of urbanareasi n some Africa n countri es has been causin g a signifi cant fallin living standa rds and an increa se in social proble ms.8)The resear ch showsthat atmosp heric carbon dioxid e levels are closel y correl atedwith global temperature s.9)The freque ncy of the bus servic e has been improved from 15 to 12 minute recentl y.10)The diverstoodon the edge of the diving board, poised to jump at the signal from the coach.UNIT3Vocabu laryI.1. rude;2. physic ally;3. struct ure;4. made a difference;5. blurte d (out);6. chuckl ing;7. measurable;8. prospe ctive;9. preparation s;10. sparkl ed; 11. took a crackat; 12. partne r;短文填空1. encouraging;2. inquiry;3. releva nt;4. sample s;5. refere n ces;6. advice;7. prepari ng;8. seriou sly;9. probab l y; 10. exhibi t;II.1.翻译11)Despit e the inadeq uatel ength of the airstri p in this emerge ncy landin g, the vetera n pi l otmanaged to stop the planeafter taxiin g for only o short while.12)Grille d by the report ers, the moviestar eventu allyblurte d (out) that she had underg one towplasti c surgeri es.13)We have the technol ogyand our partne r has the capita l. Workin g togeth er, we’ll have thefuture in our hands.14)If I had knownbefore handthat you wouldbringso many friend s home, I wouldhavemade better preparation s. Y ou see, I have barely enough food and drinks for a snack.15)People gave genero u slyupon learni ng that new school rooms with stronger struct ures wereto be builti n the earthq uake-strick en area.UNIT4词汇1 advant ageou s2 let alone3 witnessingvanish i ng4 landma rk 5entitl ed6 displa ce7 Establ ished8 patrio ti c streng then9 contra di cti ons 10 aspire s 11 divorced 12 pendul ums短文填空1.aided;2.effect s;3.distan ces;4.connected;5.invested;6.features;7.prevai ling;8.qualin gushi ng 9.volume10.distin guish i ng翻译因为……其他地方Due to his pessim i stic outloo k on Europe an econom y, John has movedhis assets from Europe to elsewh ere.我喜欢……职守I like hiring youngpeople. They are earnes t learne rs and commit ted to work.玛丽…..成长Unlike her girlfri ends who center theirl iveson theirchildren, Mary caresmore about her personal growth.有一天……回事Why is it that a consid erabl e number of collea guesare at odds with you?中国……合作The Chinese govern menthas introd uced a variet y of polici es to streng then cooperation with develo pingcountri es.UNIT5Vocabu laryI.1. In a way;2. in accord ancewi th;3. vacancy;4. in good conditi on;5. transp arent;6. rub;7. spicy;8. hitherto;9. with (a) bad grace;10. instin ct; 11. pawned;12. curren t;短文填空1. suspected;2. pleadi ng;3. confir med;4. stunne d;5. lucrati ve;6. jewell ery;7. wealth y;8. urge;9. spell;10. arrest ed;II.翻译1.16)I have an instin ct that Henrywill seek to join the expedi tion, because he is someth i ng of anadvent urer.17)He is capabl e of sticki ng to the task at hand, even if he is expose d to noises.18)The tradem ark was regist eredi n accord ance with与一致the laws hitherto到目前为止inforce.19)Oddlyenough, many people volunteered to help organi ze the meetin g, but only a few turnedup.20)The teache r’s affecti onat e words, along with his candid commen ts, change d the way Mikepercei ved 感知thesociet y and himsel f.UNIT6Vocabu laryI.1. applia nces;2. comparative;3. multip l y;4. distri butio n;5. prospe rity;6. decora te;7. famine;8. largequanti tiesof/a largequanti t y of9. stream line;10. fax; 11. pointe d the way to; 12. bewild ered;短文填空1. advantage;2. wisely;3. faithfully;4. waking;5. includ es;6. schedul e;7. sticki ng;8. priori ties;9. set; 10. respect;II.翻译1.21)They are explori ng the new fronti ers of medica l science in an attemp t to find remedi es forincura ble diseases/curesfor diseases that are beyond remedy治疗so far.22)Her unique teachi ng method s apart, Ms Wilson, my math teache r, never t riedto cram knowledge into my head.23) The regul a r weath e r forec a st by the Centr a l TV Stati o n keeps u s up with the chang e s ofweath e r where v er we go on a trip.24) The appal l ing 骇人的ex pl osi o n start e d a big fire and cause d the parti a l colla p se 坍塌 o f thebuild i ng.25) In the moder n world , there are more ways than ever to waste a wa y time, and all kinds ofdistr a ctio n s are eatin g into our preci o us time.阅读理解T he inter v iew is an impor t ant event in the job -hunti n g proce s s, becau s e the 20 or 30 minut e s you spend with the inter v iewe r may deter m ine wheth e r or not you get the parti c ular job you want .There f ore ,it is impor t ant to remem b er that your objec t ive durin g the inter v iew may diffe r from the objec t ive 目的of the poten t ial emplo y er . You want to make yours e lf stand out as a whole perso n who has perso n al stren g ths , is well quali f ied , and shoul d be consi d ered the right perso n for the job. It is encou r agin g to know that the inter v iew’s task is not to embar r ass you or to trip you up , but to hire the right perso n for the job.Remem b er , job hunti n g is very compe t itiv e . Anyth i ng you can do to enhan c e your inter v iew techn i ques 技术 will be to your advan t age . The follo w ing sugge s tion s may help you land the most impor t ant job. Your goal in this inter v iew is to make sure your good point s get acros s . The inter v iewe r won’t know them unles s you point them out, so try to do this in a factu a l 真实的an d since r e manne r . Do not make sligh t ing refer e nces 一点也不要提到 to forme r emplo y ers or profe s sors . If you have been fired from a job and the inter v iewe r asks about it, be frank in your answe r . Show the inter v iewe r that you are inter e sted in the compa n y by askin g relev a nt quest i ons . Ask about respo n sibi l itie s , worki n g condi t ions , promo t ion oppor t unit i es and fring e （附加）benef i ts of the job you are inter v iewi n g for. If at some point you decid e the inter v iew is not going well , do not let your disco u rage m ent show . You have nothi n g to lose by conti n uing a show of confi d ence , and you may have much to gain . It may be real , or it may be a test to see how you react to adver s e 不利的co nditi o ns. Some inter v iewe r s may bring up 提出sal ary early in the inter v iew . At this time , you may indic a te 表明 that you are more inter e sted in a job where you can prove yours e lf than a speci f ic 特定的 salar y . This polit e ly passe s the quest i on back to the inter v iewe r . If possi b le , you shoul d negot i ate 洽谈 for salar y after you have been offer e d a job and when you are when you are ready to compl e te the paper w ork. 1. To get the job you want , durin g the inter v iew you shoul d _________A. avoid the inter v iewe r ’s quest i ons that are desig n ed to trip you up.B. rememb er that you are the best qualif ied candid ate.C. make yourse lf standout as the rightperson for the job.m ineswhethe r or not you get the partic ularD. keep in mind that it deterjob you want.with your former employ er, you_______2. If you did not get alongA. should tell the interv iewer frankl y.B. should not speakill of him.C. should referto him in a factua l manner.D. should nevermentio n it.3. When you find the interv iew is not goingwell you should _______.A. keep up your confid ence.B. bringit to an end as soon as possib le.C. tell your interv iewer how you reactto advers e condit ions.D. tell yourse lf you have much to gain and nothin g to lose.s s your salary is _________.4.The best time to discuA. when you have been offere d the job.v iew.B. at the end of the interC. afteryou have comple ted the paperw ork.D. when the interv iewer brings this matter up.5. The most import ant thingto do during an interv iew is _________.A. to make your streng ths unders tood.i ng for.B. to show your intens e intere st in the job you are applyC. to be frankand sincer e.D. to be natura l and confid ent.答案：CBAAALike many othersmallboys, I was fascin atedby cars, especi allybec aus e my oldest brothe r was a bit of a car guy and subscr ibedto cool magazi nes like Car and Driver and MotorTrend. Everyso often, one of thosemagazi nes wouldrun an articl e on the“Car of the Future”. They featur ed unconv entio nal things like smallnuclea r reacto rs反应堆 as powersource s. Yet, frankl y, my car doesn’t do anythi ng that my brothe r’s Studeb akerdidn’t do. It goes, it stops, it burnsgas oli ne. I stillhave to steerit, and it stillruns into things if I don’t steerit carefu lly.But guesswhat? All of thesethings are likely to change in the not-so-distan t future. It may not burn gasoli ne, I may not have to steer it, and it may be a lot better at not runnin g into things.Airbag s aren’t the be-all and end-all in safety. In fact, consid eri ng the recent news aboutpeople occasi onall y beingkilled by theirairbag s in low-speedcollis ions（碰撞), they obviou sly stillneed some develo pment. But they aren’t go ingaway, and in fact, you can expect to see cars appear ing with add iti onal, side-impact airbag s, someth ing some Europe an car manufa cturers alread y offer.Better than system s to minimi ze（使减少到最低限度） injury in the eventof an accide nt ,howeve r, are system s that m inimi ze the likeli hoodof an accide nt happen ing. Future cars may be able to remove many of the majorcauses of accide nts, includ ing drun k-drivin g, and tailga ting. Cars couldbe equipp ed with sensor s that can detect alcoho l in a driver’s system and preven t the car from b eingstarte d, for exampl e. As earlyas next year, you’ll be able to buy cars with radar-equipp ed contro l system s. If the radardeterm in esyou’re closin g too quickl y with the car in front, it will ease u p on the thrott le .Will cars eventu allybe able to drivethemse lves? There’s no reason to thinkit won’t be techni cally possib le, and Merced es is workin g on a system that can brake, accele rateand steera vehicl e down a h ighwa y on its own. Nobody really expect s people to give up all control to theircars, but such system s couldbe used as failsa fe system s to keep cars on the road and bringthem safely to a stop even if the driver sudden ly became disabl ed.71.Why was the author fascin atedby cars becaus e _______.A. othersmallboys likedto own a car of theirown, too.B. he read unconv entio nal things aboutcars in his brothe r’s magazi nes.C. his oldest brothe r lovedto take him to places in his car.D. he subscr ibedto cool car magazi nes.72.By saying "my car doesn’t do anythi ng that my brothe r’s Studeb a kerdidn’t do", the authormeansthat_____.A. my car is far better than my brothe r’sB. my car is not as go od as my brothe r’sC. not much has change d in the perfor mance of cars so farD. much improv ement has been made in the design of cars recent ly73. Whichof the follow ing statem entsis true of airbag s?A. They are in need of furthe r improv ement.B. They are goingto disapp ear gradua lly.C. They kill people instea d of protec tingthem in low-speedcollis io ns.D. They are a standa rd featur e of Europe an cars.74.Accord ing to the author, what will future cars do if the sensor s det ect alcoho l in the driver's system?A. They will give a warnin g in advanc e.B. They will brakeautoma tical ly.C. They will ease up on the thrott le.D. They will not start.75.Whichof the follow ing statem entsis true accord ing to the last para gr aph?A. People will give up all contro l to theircarsB. Cars will be able to drivethemse lves.C. No cars will ever breakdown on the roads.D. Cars will all be equipp ed with failsa fe system.答案：BCADBU5 TO U8I studypoliti cal violen ce暴力for a living, yet I, too, am shaken and unsure how to react.As I sit here todayin my office, only a few milesfrom the still-burnin g Pentag on, images of the slaugh ter屠杀in my native New York domina te统治my though ts. It makesit hard to concen trate on work, and it makesthe everyd ay things seem so trivia l轻微的. Only now, twenty-four hoursafterthe traged y 悲剧began to unfold,展开 have I begunto realiz e how this has affect ed me on so many levels.As an Americ an, I feel threat ened危机的and confus ed, whereonly yester day I felt proudand invinc ible(不可战胜的). As a citize n of the global commun ity, I have been shocke d into the realit y of the reachof global terror ism. As a humanbeing, I am appall ed at the cruelt y and inhuma nityof theseacts of terror ism. As someon e who hopesto unders tandunspea kable acts, I am at a loss to unders tandthis one, perhap s becaus e it hits so closeto home.I know only thesethings: Someon e, for some reason, has decide d to strike打击at the United States. Despit e the many people killed, the intend ed target of this attack was Americ an power.The goal was to strike a paraly zingfear into the hearts and mindsof all citize ns of the U.S., and perhap s its allies协约国 as well. Thus, we -- all of us -- are the real target s of this attack. This explai ns why many of us, even thoseof us who were not near the attack s, or who knew no one affect ed by them, felt this traged y so deeply.Yet we must not succum b屈从 to fear, for if we do the terror istshave won. Surely our liveswill be differ ent now. We may be more aware, more inconv enien ced不方便,more insecu re不安全. But we must learnto deal with this traged y and to move on, to live our livesas fullyand as entire ly as before. I came to my office today,even though classe s here have been cancel led, to live my life as normal ly as possib le, for to do so in the face of yester day's terror ist attack s is itself an act of defian ce.D21. How did the author feel follow ing the terror ist attack?A) He felt proudand invinc iblebecaus e Americ ans did not succum b to fear.B) He felt reliev ed becaus e no one dear to him was injure d.C) He felt sorryfor thosekilled or injure d in the traged yD) He felt threat enedand confus ed becaus e he couldn't unders tandit.A22. The "unspea kable acts" (Para. 2) the author hopesto unders tandare ________.A) acts of politi cal violen ceB) acts of attack s for unknow n reason sC) acts of warD) acts of murderA23. We can inferfrom the passag e that the author ________.A) did not expect global terror ism couldhit Americ aB) had a deep unders tandi ng of terror ism even before the attackC) knew that Americ ans wouldnot succum b to terror ismD) believ ed that life wouldgo on as before despit e the attackC24. Accord ing to the author, the aim of the terror ist attack is _________.A) to kill as many Americ ans as possib leB) to make Americ ans awareof the terror ists' streng thC) to sow panicamongthe Americ ansD) to destro y the vitalinstit ution s of the Americ an Govern mentC25. The author's purpos e in goingto his office on the day follow ing the terror ist attack is ________.A) to give classe sB) to discus s the terror ist attack with his collea guesC) to show defian ce by living his life as normal ly as possib leD) to get the latest news of the terror ist attackGray clouds move as low as smokeover the treeto ps树梢at Lolo Pass. The ground is white. The day is June 10. It has been snowin g for the past four days in the Bitter rootMounta ins. WayneFairch ild is gettin g worrie d aboutour trek 徒步旅行over the Lolo Trail-- 95 milesfrom Lolo Montan a to Weippe in Idaho,across some of the roughe st countr y in the West. Lewisand Clarkwere nearly defeat ed 200 yearsago by snowst ormson the Lolo. TodayFairch ild is nervou sly checki ng the weathe r report s. He has agreed to take me across the toughe st, middle sectio n of the trail小路-- "but with this weathe r?"When Lewisclimbe d atop LemhiPass, 140 milessouthof Missou la, on Aug. 12, 1805, he was astoni shed惊讶的by what was in frontof him: "immens e关阔的ranges of high mounta ins stillto the West of us with theirtops partia lly covere d with snow." Nobody in what was then the US knew the RockyMounta ins existe d, with peakstwiceas high as anythi ng in the Appala chian s back East. Lewisand Clarkweren't merely off the map; they were travel ing outsid e the Americ an imagin ation.Todaytheirpathwa y小路 throug h thosemounta ins holdsmore attrac tionthan any otherground over whichthey travel ed, for its raw wilder nessis a testim ony 证明to the charac ter of two cultur es: the explor ers who braved its hardsh ips and the Native Americ ans who prizeand conser ve 保存the path as a sacred (神圣的) gift. It remain s todayin virtua lly实际上 the same condit ion as when Lewisand Clarkwalked it.The Lolo is passab le only from July to mid-Septem ber. Our luck is holdin g with the weathe r, althou gh the snow keepsgettin g deeper. As we climbto Indian Post Office, the highes t pointon the trailat 7,033 ft., the drifts are 15 ft. and up. We have covere d 13 milesin soft snow, and we barely have enough energy to make dinner. Aftera meal of chicke n and cousco us, I sit on a rock on top of the ridge.山脊 Thereis no lightvisibl e in any direct ion, not even anothe r campfi re. For four days we do not see anothe r humanbeing.We are isolat ed in a way that mixesfear with joy. In our imagin ation we have finall y caught up with Lewisand Clark.26. We learnfrom the passag e that before 1805 _A______.A) no Americ ans knew of the existe nce of the RockyMounta insB) therewere no people living in the wester n part of Americ aC) no one ever imagin ed goingwest to the Pacifi c OceanD) the Appala chian s were the wester n fronti er of the United States27. Judgin g from the contex t, the word "trek" (Para. 1) is closes t in meanin g to _____B__.A) a lonely walk in isolat ed countr yB) a long, hard journe y over roughterrai nC) a toughclimbup high mounta insD) a journe y over un-travel ed pathwa ys28. We learnfrom the passag e that the Lolo Pass _A________.A) remain s much as it was 200 yearsagoB) has change d a lot since1805C) now attrac ts largenumber s of touris tsD) is the meetin g pointof two cultur es29. Judgin g from the contex t, Lewisand Clarkwere most probab ly _B_______.A) two native Indian sB) explor ers of the early19th centur yC) mercha nts who did busine ss with the Indian sD) travel ers whosecurios ity took them over the Lolo Pass30. We can inferfrom the passag e that in crossi ng the Lolo Pass the author _A_______.A) was follow ing the trailof Lewisand ClarkB) was trying to set a worldrecordC) was attemp tingthe imposs ibleD) was gambli ng with weathe r and taking unnece ssary risks全新版大学英语综合教程第二版第四册第二课课文翻译第二课Smart Cars1 Even the automo bileindustry, whichh as remain ed largel y unchan g ed for the last seventy years, is aboutto feel the effect s of the comput er revolu tion.即便是过去70年间基本上没有多少变化的汽车工业，也将感受到计算机革命的影响。
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MEDDEV.2.7.12003年4月医疗器械指南临床数据评价：制造商和认证机构指南说明本指南为一系列与EC—医疗器械指令应用问题相关的指南中的一部分。
并不具有法律约束力。
该指南在经过与各个利益方（主管机构、欧盟委员会服务处、工业、其他有兴趣的团体）进行深入协商之后谨慎拟定而成，期间对中期草案进行了传阅，而且部分意见还为本文件所采纳。
因此，本文件反映出了来自医疗器械行业的利益团体代表所持的立场。
Commission européenne, B-1049 Bruxelles / Europese Commissie, B-1049 布鲁塞尔–比利时. 电话：（32-2）299.11.11. 传真：（32-2）296 70 13. 电子邮件：entr-medical-devices@cec.eu.int1. 引言与目的本文件之主要目的是为制造商提供审核和分析临床数据方面的指导意见，并且在当认证机构对制造商临床数据评价进行审核的时候，作为90/385/EEC（AIMD）[1]和93、42、EEC（MDD）[2]所规定的符合性评估程序的一部分提供给认证机构。
本文件还通过提供期望方面的指导意见给予制造商一定帮助。
2. 背景制造商必须按照指令中的规定，论证其预期目的和就其实现的安全性与性能所做出的声明。
根据一般规律，上述论证需要临床数据的支持（附录X，MDD 1.1）MDD附录X和AIMD附录7中所述的临床数据评价与以下规定之间存在密切关系：MDD 附录I：通用要求第1节和第3节；AIMD附录1：通用要求第1节和第2节。
还应注意附录I之I.6（MDD）和附录1之1.5（AIMD）。
3. 术语解释在本指南中：3.1 临床数据是指与器械临床安全和性能各方面有关的数据。
必须包括来自以下来源的数据：（i）与待评估器械市场经验有关的已发表和（或）未发表数据；或能够证明与上述待评估器械等价的类似器械；或（ii）相关器械的前瞻性临床研究；或（iii）临床研究结果，或针对能够证明与上述待评估器械等价的类似器械的科技文献报道的其他研究结果。
3.2 临床数据评价是对来自所有选定来源（文献、临床研究结果及其他）的数据进行评估、分析并判定其是否足以判定器械符合指令中与安全性和性能有关的基本要求，以及证明该器械与制造商预期目的相符的过程。
这一过程的结果是一份报告，该报告在权衡器械的预期利益时，就其风险和副作用的可接受性做出结论。
4. 供应商应提供的临床数据有源可植入医疗器械指令和医疗器械指令规定，按照一般规律，尤其对于可植入器械、有源可植入器械和III类器械，一台医疗器械的临床性能和安全性方面的证据应以供应商按照附录X（MDD）和附录7（AIMD）提供的临床数据的形式予以提供。
但是，至于是否需要临床数据，这一决定必须根据证明每台器械符合相关基本要求、针对待评估器械做出的声明以及风险管理评估所需要的数据类型来做出。
决定CE认证的所有符合性评估程序均阐述了制造商进行临床评价的问题。
附录II和附录III还涉及到认证机构。
临床评价基于对器械使用的风险和利益所进行的评估，手段有：（i）目前可获得的相关科技文献汇编以及含有对该文献汇编给予关键评价的书面报告（如合适）（以下简称“文献路线”）；或（ii）与待评估器械有关的所有临床研究（简称“临床研究路线”）；或（iii）上述（i）和（ii）条相结合。
如果临床评价是基于这种结合路线的话，那么它应包括一项总体评估。
条件允许的话，该评估应将市场经验考虑在内。
另外，制造商应将数据与具体器械关联起来，同时注意已发现的危险，这一点很重要（见4.2）。
制造商必须证明现有数据足以确定其符合指令，同时注意：（i）证明与数据关联的器械和正在接受符合性评估的器械等价，以及器械的评估结果的适用性（见第4.3.1（i）d节）；和（ii）数据在阐述指令符合性的相关方面的充分性。
4.1 制造商关于用以申请CE标志的临床数据的声明制造商应在技术文档中收入一份与用以申请CE标志的临床数据有关的简短声明。
该声明应明确澄清临床数据是取自已出版文献或临床研究结果，抑或是二者兼而有之。
如果数据与其他器械有关，声明应给出与其他器械之间的比较情况，并确定二者的等价性如何。
用以申请CE标志的完整临床数据应编入技术文档之中。
4.2 临床数据中阐述安全性和性能的方面的鉴定根据指令规定，制造商应进行风险分析。
风险分析很重要，它不仅可以帮助制造商发现使用器械时的已知或可合理预见的危险，还可决定如何才能最有效地估计各种危险有关的风险1。
利用风险分析的结果，制造商可部署如何规避各种风险，并对照预期利益决定风险的可接受性。
风险分析包括与具体器械有关的技术和临床方面。
它应对如下相关方面加以区分：（i）器械预期的医疗程序；比如：和传统（手术和非手术）肾结石摘除方法相比，体外碎石术的风险和益处。
（ii）所采用的技术解决方案；比如：各种体外碎石技术的风险与益处，如那些利用电磁发电机或介电系统使用电火花（电液压法）生成震波的技术。
（iii）与相关特定器械的设计和使用有关的方面；_______________________1制造商声称的或可能导致治疗效果降低的指定器械的性能损失/ 缺失均可视为是一种危险。
如：与震波耦合法相关的风险和益处，焦区的大小、结石定位和靶系统（X射线、超声波）以及触发方法这种区别应用来确定所需临床数据的类型和特异性。
如果现有数据不足以规避已发现的与上述一个或几个方面有关的临床危险，那么就需要进行临床研究了（见第4.4.1节）。
临床研究的目标应将重点放在现有数据不足以阐明的方面上。
制造商还应确定器械的预期利益，并将这些利益和有关广泛认可的“先进”公认利益关联起来。
4.3 文献路线对于已公开数据与待评估器械相关特性和器械预期的医疗程序相关和适用的程度应给予应有的重视。
应由具备相关领域资质、对“先进”知识有一定见地并且能够表现出客观性的人员进行文献评述。
4.3.1 要求制造商提交给认证机构的临床评价对相关科技文献进行评述时，应满足如下要求：（i）方法a）总则鉴定、选择、比较相关研究的标准应以书面形式制定，最好基于系统性文献评述的公认惯例。
b）目标文献评述的目标应予以明确确定。
应指定与文献评述目标相关类型的研究，同时考虑已约定俗成的器械知识。
c）数据的甄别数据应来源自获得公认的科技刊物。
另外，还应考虑未发表的数据，以避免发表偏倚。
文献评述应说明：数据来源和数据库或其他信息源检索的程度；已发表文献的选择/相关性原理；确信已选出所有有利或不利的相关参考资料的理由；排除特定参考资料的原则以及排除理由。
注：系统性文件评述的可能数据源有：医学和与医学有关的数据库相关标准委员会的技术论文其他语种的文献“灰色文献”（论文、内部报告、非同行评议期刊、互联网、行业文件）主要来源列出的参考资料其他未发表但为业内专家认可的来源（通过个人通信获得）已发表试验的原始数据（通过个人通信获得）d）数据的相关性文献评述应明确指出文献与待考察器械的具体特性和特征的相关性。
如果已发表的研究未直接提及待考察的器械，以下条款应予以适用。
制造商必须证明其产品的如下基本特性与已发表报告中所提及的器械等价。
等价是指：临床方面：----用于相同的临床条件或目的；----用于人体内相同的部位；----用于类似的人群（包括年龄、解剖和生理）；----根据特定预期用途的预计临床效果，具有类似的相关关键性能。
技术方面：----在类似的使用条件下使用；----具有类似的规格和性质，如抗拉强度、粘度、表面特性----设计相似；----采用类似的配置方法（如相关的话）；----操作原理相似生物方面：----与相同人体组织或体液接触的材料相同；如要实现等价，器械在临床、技术和生物参数方面具有相似性，同时请特别注意性能、操作原理以及材料；或者，如果发现存在差别，必须对安全性和性能方面的重要性进行评估和论证。
例如，我们可以考虑待考察器械和已发表研究中提及的器械不具有相同操作原理的情况，也就是说，新器械具有新的操作原理。
由于新的作用原理不一定会产生新的临床效果，要证明新器械的临床效果就需要利用从精心设计的临床研究中获取的数据了，因为两种器械不能视为是等价器械。
制造商必须能够证明数据足以阐明目标中规定的各方面的符合性。
e）临床数据的评估文献评述应从各种因素的角度明确指出某些参考资料的重要意义。
其中包括：作者在某种器械和（或）涉及到的医疗程序方面的背景和专业知识。
作者结论是否得到现有数据的证实。
文献是否反映出了最新的医疗实践和获得广泛承认的“先进”技术。
参考资料是否取自公认的科技刊物，同行评议杂志上是否对这些资料进行过报道。
已发表文献的是否是一项/多项遵从与设计有关的科学原则（譬如，具有可证明的适当的观察终点，容斥原理，提交的一定数量的患者，实施过一段时间，提供所有不良事件的证据和分析，死亡人数，排斥人数，停药人数与失访偏倚的对象，制定适当的分析统计计划）的研究的成果。
从理论上讲，证据应来自临床试验（适当时予以控制）、精心设计的队列/案例受控研究、记录齐全的案例历史或由相关经验丰富的专家进行的连续报告，而无论是与器械本身还是与等价器械相关。
如果未发表的数据被收入在评估之中，文献评述将需要权衡每份报告的重要性。
证据不得含有：孤立的案例报告；随机经验；缺乏足以进行科学评价的细节的报告（包括缺乏获得认可和确认的统计设计，如果与预期研究设计相关的话）；未经证实的观点。
（ii）文献的关键评价文献评述应包含对文献的关键评价。
该评价应：由具备相关领域资质、对“先进”知识有一定见地并且能够表现出客观性的人员执笔；包含医疗器械的简要描述、预期功能、预期用途描述及其应用等信息；包含对所有现有数据的分析，不论有利还是不利；确定文献与待评估器械的具体特性和特征的相关程度，同时还应考虑给出文献提及的器械与待评估器械这二者之间的相似性；证明风险分析中临床部分所阐述的器械使用的各个方面（包括性能）与制造商所声称的相符，以及该器械可实现其作为医疗器械的预期用途；分析已鉴别出的危险、相关风险以及针对患者、医护人员和研究中涉及到的第三方的适当的安全措施，比如可参考制造商的风险分析（见ISO14155-2）；包含与器械设计、材料和程序相关的风险分析，同时考虑不良事件、售后监督研究、改良和召回（如果已知的话）（见ISO14155-2）；包含有对不同论文的权衡以及分析所采用的统计方法的描述，同时考虑评估方法、研究的类型和持续时间以及本研究中所采用人群的异质性。
应特别注意相同作者就同一群患者重复发表成果的情形，以避免对经验过分关注；收录相同或类似器械的市场经验的分析，其中包括售后研究结果、售后监督以及短期和长期不良事件；包含评价中进行适当对照的刊物清单；如果临床数据与等价器械相关，请收录一份表明所有相关特性的等价性已获证明的声明；收录结论及其正当理由，其中包括根据制造商预期的通过使用本器械可能给健康带来的益处做出评估，同时从“先进性”方面指出使用时可能产生的伤害或疾病风险。