EMA41001 rev.3 中文翻译

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EMAX 压缩器杆头压缩机产品说明书

EMAX 压缩器杆头压缩机产品说明书

EMAX Compressor Piston reciprocating Warranty StatementIMPORTANT!! You must register your compressor:To register your warranty and find theextended warranty options go to . Details and options for ourextended warranty will be provided online once you enter the required information.EMAX Compressor makes the following Warranty guarantee:•Standard Warranty: That each compressor unit is free from defects in material, workmanship, and parts for 1 year from the date of delivery. This Standard Warranty includes 1 year ofwarranty labor from an authorized technician. EMAX compressor is not responsible fordowntime during warranty service. If downtime is necessary, it is at the owner’s discretion,obligation, and expense, to have a redundant compressor. Parts shipped for warranty repairsshall only include ground freight charges for the first 90 days of the warranty period, thereafter owner is responsible for all freight charges of parts shipped for warranty. Any and all expresssh ipping charges of warranty parts would be at the owner’s expense. Standard technicalassistance is provided at no charge during and after the standard warranty period.•Honda Engine carry’s a 3 year Limited warranty under all warranty Tiers*Standard warranty has no obligation to maintain warranty status, warranty will expire one year from date of delivery. Please see available options below to extend your warranty.•Extended Warranty: EMAX compressor will extend your standard 1-year warranty to full 5 years when you opt to register for the extended warranty plan that includes using our SMART OIL™ and follow ing all routine maintenance set forth. Parts shipped for warranty repairs shall only include ground freight charges for the first 90 days of the warranty period, thereafterowner is responsible for all freight charges of parts shipped for warranty. Any and all expressshipping charges of warranty parts would be at the owner’s expense. Standard technicalassistance is provided at no charge during and after the standard warranty period.Required maintenance Schedule to maintain warranty status➢All units are shipped with break-in oil and must be changed no less than 70 hours to insure gasket seating.➢After the 70 hours of break-in you must change the oil➢Thereafter Oil Should be changed every 6 months or 1000 hours whichever occurs first.➢Always maintain proper oil level in unit. If the unit runs out of oil due to neglect the warranty will be void.➢Use only EMAX approved oils in your compressor, or your warranty is void.**Extended Limited Lifetime Pump Warranty With participation in our SMART OIL™ extended auto ship program EMAX compressor will extend your warranty plan to **Limited LifetimeWarranty on the pressure lubricated pump. All other non-wear and tear components to 10years. SMART OIL™ not only extends the life of your compressor pump, it also can reduceoperating noise levels and can create further energy savings. Warranty repair parts under theLimited Lifetime warranty will not include any shipping charges beyond the Standard Warranty, therefore owner is responsible for all freight charges for warranty parts. This plan includes our advanced technical air support. Smart Tech Support provides you with the highest level oftechnical support. Smart Tech support is an interactive support team available to you at yourfingertips by just downloading a free app. The app provides free remote meetings, interactivetouch display, real live personal to assist.Limited Lifetime Warranty is not prorated and has no hour limits.**Limited Lifetime Warranty, non-prorated, no hour limits. In the case the product has been discontinued atany point the Limited lifetime Pump warranty will last five years past the discontinued date. Warrantor hasdiscretion to substitute parts with current model for the five-year duration*In order to maintain Limited Lifetime Warranty status, the owner must adhere to and purchase from EMAX Compressor the required maintenance items as scheduled below utilizing our Smart Whisper Blue Auto Ship program:Required maintenance Schedule to maintain warranty status➢All units are shipped with break-in oil and must be changed no less than 70 hours to insure gasket seating.➢After the 70 hours of break-in you must change the oil➢Thereafter Oil Should be changed every 6 months or 1000 hours whichever occurs first using only our Smart Whisper Blue Oil➢Always maintain proper oil level in unit. If the unit runs out of oil due to neglect the warranty will be void.➢Use only Smart Whisper Blue Oil and filters purchased from Emax Compressor in yourcompressor, or your warranty will be voided.➢Must be an active member of EMAX Compressor auto ship program•Warranty Shall not apply and Emax Compressor shall not be responsible nor liable for: ➢Routine service such as oil changes, filter replacements, gasket tightening to correct oil seepage or drive belt tightening and valve cleaning and are not covered under warranty.➢Consequential damages such as but not limited to cost of loss of business, product damage, or down time➢Acts of nature, over abuse, malicious destruction, improper maintenance, undersized equipment➢In the case the product has been discontinued at any point the *Limited lifetime warranty will last five years past the discontinue date. EMAX Compressor has discretion to substitute partswith current model for the five-year duration.➢Deviation from operating instructions or specifications➢Labor charges for repairs or maintenance made by person(s) other than an authorized, approved service technician or any labor after the 1-year Standard Warranty expires.➢Normal wear and tear parts included but not limited to valves (intake/suction, check, blowdown, thermo, pop off, unloader), and ball valves. Belts, shaft seals, load/unloader solenoids, sensors(temperature or pressure), Electrical contractors and relays, and any parts with a routinemaintenance scheduleWarranty shall be voided under the following conditions: Exposing electrical components to rain or water, or installing the unit in a hostile environment such as acid vapors or any caustic or abrasive matter that may be ingested into the pump, or installing the unit in an enclosed area where lack of cooling ventilation is present, such as in boiler or equipment rooms where the ambient air exceeds 100F.Further exclusions include failure to fully and completely follow the guidelines set forth in the manual. Of specific note is environments where fine dust is common, such as granite, marble or concrete plants, the compressor MUST be installed in a separate area with its own dedicated ventilation. FAILURE TO PROVIDE THIS DUST FREE OPERATING AREA VOIDS THE WARRANTY.Parts used for warranty purposes must be supplied by EMAX Compressor. Warranty work should be performed by an EMAX Compressor approved Technician. If any maintenance (other than routine maintenance) is performed by a non-approved Technician, written pre-approval must be obtained from EMAX Compressor, to prevent voiding this warranty. Failure to fully comply with this warranty and fully comply with the manual instructions will void this warranty.Warranties are non-transferableThe oil purchase and maintenance program are effective as of Nov. 2019。

EMA3中文资料

EMA3中文资料

ansistorsTr Rev.A 1/2Emitter common(dual digital transistors)EMA3 / UMA3N / FMA3Az Features1) Two DTA143T s in a EMT or UMT or SMT package. 2) Mounting cost and area can be cut in half.z StructureEpitaxial planar type PNP silicon transistor (Built-in resistor type.)The following characteristics apply to both DTr 1 and DTr 2.z Equivalent circuitz External dimensions (Unit : mm)ansistorsTr Rev.A 2/2z Absolute maximum ratings (T a=25°C)ParameterV CBO V CEO V EBO I C P C Tj Tstg−50V V V mA ∗2mW ∗1˚C ˚C−50−5−100300 (TOTAL)150 (TOTAL)150−55 to +150Symbol Limits Unit EMA3, UMA3N FMA3ACollector-base voltage Collector-emitter voltage Emitter-base voltage Collector current Collector power dissipationJunction temperature Storage temperature∗1 120mW per element must not be exceeded.∗2 200mW per element must not be exceeded.z Electrical characteristics (T a=25°C)ParameterSymbol BV CBO BV CEO BV EBO I CBO h FE V CE (sat)R 1Min.−50−50−5−100−3.29−−−−250−4.7−−−−0.5600−0.36.11V I C =−50µA I C =−1mAI E =−50µA V CB =−50V V CE /I C =−5V/−1mA I C /I B =−5mA/−0.25mA−V V µA I EBO −−−0.5V EB =−4VµA −V k ΩTyp.Max.Unit Conditionsf T −250−V CE =−10V, I E =5mA, f =100MHzMHz ∗Collector-base breakdown voltage Collector-emitter breakdown voltage Emitter-base breakdown voltage Collector cutoff current DC current transfer ratio Collector-emitter saturation voltage Input resistanceEmitter cutoff currentTransition frequency ∗ Transition frequency of the devicez Electrical characteristic curvesD C C U R RE N T G A I N : hF ECOLLECTOR CURRENT : I C (A)Fig.1 DC current gain vs. collectorcurrent−−−−−−−−−−−C O L L E C T O R S A T U R A T I O N V O L T A G E : V C E (s a t ) (V )COLLECTOR CURRENT : I C (A)Fig.2 Collector-emitter saturation voltage vs. collector currentAppendixAbout Export Control Order in JapanProducts described herein are the objects of controlled goods in Annex 1 (Item 16) of Export T rade ControlOrder in Japan.In case of export from Japan, please confirm if it applies to "objective" criteria or an "informed" (by MITI clause)on the basis of "catch all controls for Non-Proliferation of Weapons of Mass Destruction.Appendix1-Rev1.1。

罗氏 E411中文报警信息

罗氏 E411中文报警信息

罗氏e-4111.综述仪器在运行过程中,若出现报警信息,屏幕上方状态栏的颜色会发生改变。

另外,报警代码,简要的描述以及报警类型都会显示出来。

产生报警信息之后,按ALARM键进入报警窗口,再按Message clear可以清除报警。

若ALARM键旁边的绿色指示灯亮,则是听不到报警声音的;若绿色指示灯不亮,则报警时会有声音伴随。

在报警窗口中,按Buzzer on/off可以打开或关闭报警声音。

按Utility—Message history—Print message history可以打印出报警信息。

以下列表给出了报警信息的详细说明,需要指出的是,报警类型分为以下几种:E.stop:仪器会立即停止所有操作。

待系统回到Standby后,必须要采取措施来清除此类报警。

Stop:仪器会在20秒钟之内停止操作。

同样,待系统回到Standby后,必须要采取措施来清除此类报警。

P.stop:仪器操作会部分停止。

不再做其它项目的测试,但当前的操作会继续完成。

A.stop:仪器已经不能继续工作,基本等同于上面的P.stop。

L.stop:仅在有自动进样装置时才会提示,等同于上面的P.stop。

S.stop:仪器停止继续吸引样品,但已经吸引过的样品测试会继续完成,通常该类报警是样品吸引完成的提示。

Warning:仪器操作会继续进行,它的作用是提示哪些情况需要注意。

本报警说明适用Elecsys 2010的软件版本号是V06-01和V06-03,若用户仪器的软件版本号不同,报警信息会有一些差异,敬请留意。

2.试剂盘4.搅拌针5.条形读码器6.样品盘7.S/R臂(左臂)8.S/R注射器9.机械抓手10.固体废物收集盒11.Sipper臂(右臂)12.Sipper注射器13.磁铁驱动14.移液台15.废液瓶16.蒸馏水瓶17.固体废物盒18.试剂仓盖19.GP控制器20.自动进样器GP控制21.GM控制器22.GP控制器暂停23.自动进样GP控制暂停24.GM控制暂停25.ADC26.Procell27.电源输出28.保险丝29.样品30.温度31.专用试剂32.稀释液33.预处理试剂34.BlankSet35.ProCell/CleanCell36.条形码37.孵育杯和吸头38.BlankCell39.软盘驱动40.通讯控制41.数据传输电脑42.Inventory43.吸入量检查44.凝块检查45.样品ID46.机械抓手调整47.电源48.CPU错误49.定标50.样品处理状况51.序列号52.试剂的合法性53.数据库54.维护。

Simplex 4100ES 产品手册

Simplex 4100ES 产品手册
至相邻 BAY 电源 / 通讯 端口 (P5) 至相邻 BAY 电源 / 通讯 端口 (P6)
2. 4100ES 型 火灾报警控制器
Slot 1 Slot 2 Slot 3 Slot 4 Slot 5 Slot 6 Slot 7 Slot 8
Block A
Block C
Block E
Block G
Block BБайду номын сангаас
2.3 主要技术特点 1)UL / FM / CCCf 认证 2)适用于不同大小系统 3)全新 640 x 480 分辨率超大彩色触摸显示屏 4)全新处理器,集成以太网上传下载功能和大容量闪存 5)模块化设计,与现存系统兼容,且便于升级 6)中英文双语切换 7)双程序存储器,下载程序时不影响正常监控,并可进行新旧程序切换 8)WalkTest 单人步行测试 9)10000 条超大历史记录 10)可选双 CPU 冗余功能,可在 CPU 发生故障时自动切换至第二个 CPU,确保系统正常工作 11)强大的网络功能,多种网络结构和网络连接方式可选 12)第三方协议接口包括 BACNet、Modbus 等 13)TrueInsight 远程监控 14)回路可使用屏蔽双绞线,也可使用非屏蔽双绞线 15)支持感烟探测器 7 级灵敏度可调
SPS 安装在主机箱单元,占用四个插槽位置(slot5, slot6, slot7 和 slot8)。如下图所示:
2. 4100ES 型 火灾报警控制器
4)扩展电源(XPS) XPS 为系统提供辅助电源,具有接地故障监视功能。 扩展电源自带 3 个声光报警设备 (NAC) 通道和一个 24 V 辅助电源输出。电源最大输出 电流达 9 A,每个 NAC 通道最大输出电流为 3 A,24 V 辅助电源输出电流为 2 A。 XPS 安装在扩展机箱单元,占用两个 Slot 位置(slot7 和 slot8)。如下图所示:

SERVOMEX4100操作说明书

SERVOMEX4100操作说明书

1.2:手册的范围本手册涵盖了软件设置和操作。

更多的复本可供订购,订购编号为04000/003C。

•获取技术支持及备件的联系方式请见本手册封底。

•随仪器提供一份安装手册,内容包括了技术指标、日常维护和备件信息,订购编号为04000/005C。

•维护手册是专为专业技术人员而编写的,购编号为04000/002C警告用户应当注意到Xentra仪器内部没有需要用户维护的部件。

仪器外壳保护用户免遭电击或其它危害。

所有维护工作应当由专业技术人员进行。

图A分析仪正视图1.样气过滤器(可选) 4.键盘2.流量计(可选) 5 .显示对比度调节3.显示6.样气调节针阀(可选) 图BXentra的显示1.标题7.报警图标2.模块位置(2字符) 8.预热图标3.测量值(6字符) 9.自动标定图标4.工程单位(3字符) 10.维护图标5.组份名称(6字符) 11.故障图标6.测量显示条目图C自动标定的典型时序(示例中,标气1为零点气,标气2为量程气) 1.自动标定开始,标气1通入分析仪2.标气1测量中3.标气2通入分析仪4.标气2测量中5.标气1再次通入分析仪6.再次测量标气17.样气体通入分析仪吹扫传感器(后吹扫)图D用户界面菜单结构图1概述11.1警告、注意和提示 11.2手册的范围 11.3用户界面介绍 42初始设置72.1开机和关机步骤72.2分析仪功能的一般操作72.3设定密码82.4设定时间和日期83主要设置93.1组份名称和单位的定义93.2报警10 3.3继电器的分配 11 3.4外部模拟量输入的设置 133.5模拟量输出 133.6定义和选择测量显示屏幕 15 3.7响应时间 16 3.8串行通讯输出163.9氮氧化物(NOx)浓度的计算17 4标定 184.1标定简介 18 4.2设定低点和高点标定的允许误差 19 4.3手动标定和检查19 4.4顺磁模块压力传感器的标定 22 4.5自动标定和自动检查的设置 24 5查看配置和历史文件 285.1显示当前的报警和故障 28 5.2显示报警设定 28 5.3设定显示输出 2 9 5.4显示分析仪历史记录30 5.5显示分析仪标识和诊断信息 32用户界面介绍用户界面由键盘和大屏幕LCD组成。

FMA-4100和FMA-4303电子表示器模块说明书

FMA-4100和FMA-4303电子表示器模块说明书

可编程气体质量 流量计和累加器适用于洁净气体D-9U 23种可供选择的工程单位 (包括用户定义的单位) U 可编程累加器 U 气体流量上限和下限报警 U 两组具有锁存功能的可编程SPDT 继电器 U 可选0 ~ 5 Vdc 或 4 ~ 20 mA 模拟输出 U 适用于多达32种气体 的内部转换系数 U 标配RS232数字通讯接口 U 自动传感器零点偏移调整 (通过数字通讯接口或本地 按钮) U 自诊断测试 U 显示屏可调节背光在FMA-4100/4300系列流量计中,流速可用23种不同的体积流量或质量流量工程单位(包括用户特定的单位)显示。

可以通过RS232或RS485(选配)对流量计编程。

FMA-4100/4300流量计支持多种不同功能,包括可编程流量累加器、流量上限和下限报警、自动零点调整、2种继电器输出、可通过跳线选择的0 ~ 5 Vdc 或4 ~ 20 mA 模拟输出、状态LED 诊断、存储多达10种不同气体标定、内部或用户特定的K 系数。

带显示屏的型号配有本机2行 x 16字符LCD 显示屏,显示屏具有可调节背光,可同时提供流量、累加流量以及诊断信息读数。

RS232或RS485(选配)数字接口可让您访问相关内部数据,包括流量、CPU 温度、自动调零、累加器和报警设置、气体表、转换系数与工程单位选择、动态响应补偿与线性化表调整。

模拟接口提供对应于流量读数的0 ~ 5 Vdc 或4 ~ 20 mA (可通过跳线选择)输出。

FMA-4100/4300流量计支持自动传感器零点偏移调整,可以通过检修按钮在本地启动该调整,或者可以通过数字通讯接口远程启动。

自动调零功能必须满足的条件是,在调整过程中流量计中完全没有流量。

可以通过数字指令启动、读取或者保存当前的自动调零值。

数字累加器指令包括:设置为零、在达到预设流量值时启动、为预设值指定动作、启动/停止累加以及读取。

还可以通过数字通讯接口对气体流量上限和下限报警编程。

Revtex 4.1 说明书

Revtex 4.1 说明书

REVT E X4.1Command and Options SummaryAmerican Physical Society∗One Research Road,Ridge,NY11961(Dated:August2010)This is the REVT E X4.1Command and Options Sum-mary.It details usage for many of the new commands and options that are available in REVT E X4.Please see the REVT E X4.1Author’s Guide for complete informa-tion on how to use REVT E X4.1.Class options for the \documentclass line are marked with square brackets. Environments are indicated by\begin{<env>}and al-ways require a matching\end{<env>}.TABLE I:REVT E X4.1Command SummaryREVT E X4/L A T E X2εMarkup Details and UsageFrequently Used Class Options[aps]American Physical Society styling.Default.[aip]American Institute of Physics styling.[prl],[pra],[prb],[prc],[prd],[pre],[prstab],[prstper],[rmp]Further customize[aps]styling for APS journals.[apl],[bmf],[cha],[jap],[jcp],[jmp],[rse],[pof],[pop],[rsi]Further customize[aip]styling for AIP journals.[twocolumn]Two-column formatting.[onecolumn]Single-column formatting.[preprint]Single-column formatting with increased interline spacing.[reprint]Closely approximate a given journal’s style.Can be either single ortwo-column formatting depending on the journal.[10pt],[11pt],[12pt]Set font size.[preprint]gives[12pt],[twocolumn]gives[10pt]bydefault.[groupedaddress]Group authors with same affiliations together.Default. [superscriptaddress]Associate authors with affiliations via superscript numbers.Appro-priate for collaborations or if several authors share some,but not all,affiliations.[draft]Mark overfull lines.[linenumbers]Number lines(requires lineno.sty).[longbibliography]Use alternative BibT E X stylefiles that show journal article titles in thebibliography.[amsfonts],[noamsfonts]Load(don’t load)amsfonts package.Adds AMS font support. [amssymb],[noamssymb]Load(don’t load)amssymb package.Adds additional AMS symbols. [amsmath],[noamsmath]Load(don’t load)amsmath package.Adds AMS-L A T E X features.Other Class Options[preprintnumbers],[nopreprintnumbers]Control display of preprint numbers given by\preprint com-mand.[preprintnumbers]is default for[preprint];otherwise[nopreprintnumbers]is default.[floatfix]Invoke emergency processing to avoid the L A T E X error‘‘Too many unprocessed floats’’or all subsequentfloats beingmoved to the end of the job.REVT E X4will display a messagerecommending this option if warranted.[bibnotes],[nobibnotes]Control location of author footnotes.Default varies with journal style. [footinbib],[nofootinbib]Control location of footnotes.Default varies with journal style. [altaffilletter],[altaffillsymbol]Use letters or symbols for\altaffiliation superscripts.[altaffillsymbol]is default.[unsortedaddress]Like[groupedaddress],but doesn’t combine authors together whoshare the same affiliations.∗revtex4@[runinaddress]Like[groupedaddress],but joins multiple affiliations together into asingle sequence separated by commas.[showpacs],[noshowpacs]Control display of PACS:line.[showkeys],[noshowkeyws]Control display of Keywords:line.[tightenlines]Single space manuscript(for use with[preprint]).[floats]Positionfloats near call outs.Default.[endfloats]Move allfloats to the end of the document.[endfloats*]Move allfloats to the end of the document and put each on a separatepage.[titlepage],[notitlepage]Control appearance of title page.[final]Don’t mark overfull lines.Default.[letterpaper],[a4paper],[a5paper]Select paper size.[letterpaper]is default.[oneside],[twoside]Control book syle layout.[oneside]is default.[fleqn]Flush displayed equations left.[eqsecnum]Number equations by section.[balancelastpage],[nobalancelastpage]Control[twocolumn]balancing on last page.[balancelastpage]isdefault.[raggedbottom],[flushbottom]Control[twocolumn]balancing.[flushbottom]is default. [raggedfooter],[noraggedfooter]Control positioning of footer.[noraggedfooter]is default. [byrevtex]Display“Typeset by REVT E X4”.[citeautoscript]Fix up spacing and punctuation when switching from non-superscriptstyle citations to superscript citation styles.\cite commands and as-sociated spacing and punctuation should be as for the non-superscriptstyle.[galley]Typeset in a single narrow column.[nomerge]Allows processing of legacy documents that use square brackets as partof the key in a cite command.Frontmatter Commands\title{<title>}The manuscript title.\author{One Author}Specify one author’s name.\surname{Lloyd Weber},\surname{Mao}Indicate which part of a name within\author should be used for alpha-betizing and indexing.\email[<optional text>]{author@}Specify an e-mail address for an author.Specify a URL for an author’s web site.\homepage[<optional text>]{/homepage/}Specify an alternate or temporary address for an author.\altaffiliation[optional text]{affiliation information}\thanks{text}Additional information about an author not covered by the more specificmacros above.\collaboration{<The Collaboration>}Specify a collaboration name for a group of authors.Should be placedafter the authors.\affiliation{text}Specify a single affiliation.Applies to all previous authors without aspecified affiliation.\noaffiliation For an author or collaboration without an affiliation.\date{<date>}Show the date on the manuscript.\date{\today}gives the current date. \begin{abstract}Start the manuscript’s abstract.Must appear before\maketitlecommand.\pacs{<pacs codes>}PACS codes for manuscript.Multiple PACS codes should be specifiedtogether in a single\pacs macro.\keywords{<keywords>}Suggested keywords for indexing.\preprint{<report number>}Specify an institutional report number to appear in the upper-righthandcorner of thefirst page.Multiple\preprint macros may be supplied,but space may limit how many can appear.\maketitle Typeset the title/author/abstract block.Sectioning Commands\section{<heading>},\subsection{<heading>},Start a new section or 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4100操作说明书

4100操作说明书

第一部分系统综述介绍S imlex 4100/4120是单个微机为基础,运用最新的安全技术的防火报警控制设备,该系统设备已通过美国U.L.认证,具有省电和自动巡监功能,并且可防止交流电源停电,并自动记录且显示该状态。

根据用户的选择,本设备可控制1270个点。

这个基本的系统包括一个主机板,现场接线端子,80个字符的LCD显示,电源和机箱。

根据不同要求,可配置各类卡或组件。

4100/4120系统单机最大可监控1270点。

4100主机和4120主机的区别在于是否有网卡,是否是网络的一台主机。

当主机不在网络中时为4100,当主机在网络中时称4120。

4100/4120主机的指采用了最新最快的微机处理器。

组态数据存在于可电擦除的FLACK EPROM中,使用现场修改组态数据更加简单。

主机板上更有备有电池的RAM 以保存重要的历史数据,哪怕完全将主机关闭。

4100/4120系统中采用的是开关电源,此电源提供24VDC 8安培的容量给负载设备和系统运行,提供4安培电流给蓄电池充电。

另外,此电源通过机内通开线路和主机板直接通讯,向主机板报告系统电压、当前电流和充电情况等30多个参数。

当系统存在不正常情况时,本机发出声音指示,并通过LCD显示出具体位置和电容。

4100/4120的面板上LCD显示器可显示出本系统的情况。

这个LCD显示器能显示出各种提示,通过菜单方式来指导用户按照程序操作以排除非正常状态。

本系统可完全现场编程组态,并且用户可按照建筑的实际情况和当地的规范要求进行变化。

系统操作描述4100/4120操作面板,后称面板,如下图所示:●绿色“PowerON”发光二极管(后称LED)指示交流电供电正常。

●其它LED不亮。

●LCD上字符显示如下,表示系统处于正常状态。

如果面板上的报警发光二极管二类报警发光二极管,监视发光二极管或故障发光二极管闪光,并且有声音报警就说明有不正常的情况出现,LCD显示可提供有关探测点的状况(报警, 二类报警监视和故障)。

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通过人用和兽用药物产品降低动物海绵状脑病传播风险的指南说明(EMA/410/01 rev.3)(2011/C 73/01)本文件提供通过人用和兽用药物产品降低动物海绵状脑病发生风险的指南此次第三版技术修订版的TSE(可传染性动物海绵状脑病) 指导说明已经考虑到了在传播性海绵状脑病领域的技术进步,以及全世界牛海绵状脑病传播的进展情况。

为根据BSE风险对国家和地区进行分类,修订的指南说明将参考世界动物卫生组织(OIE)制定的规则,以代替已有的GBR分类。

同时,对于根据BGR进行分类而没有根据世界动物卫生组织标准尚未分类的国家,在没有证据表明BSE风险有所改变的基础上仍然适用于BGR分类。

新的指南说明中引入了采购和加工用于生产人用或兽医用药品的明胶或牛血液衍生物制品的新标准,同时还有关于胨类标准的新内容。

新指南说明中更换了已出版的指南说明(EMEA/410/01 Rev. 2 published in the Official Journal of the European Union (C 24, 28.1.2004, p. 6)。

修订后指南说明应用日期定于2011年7月1日1、前言1.1背景介绍传染性可传染性动物海绵状脑病(TSEs)是一种慢性退行性神经疾病,以异常细胞糖蛋白(成为PrP或朊病毒蛋白)的异常同工积累为主要特征。

PrP(PrP TSE)的异常同工化和正常PrP(PrPc) 同工化的不同在于对蛋白酶以及热处理变形具有高度的抗性。

PrP TSE被认为是TSE产生传染性的传染媒介。

动物TSE疾病包括:-牛海绵状脑病(BSE)-绵羊和山羊的瘙痒病-鹿和麋鹿的慢性消耗性疾病(CWD)-养殖水貂的传染性貂脑病(TME)-猫和猫科动物的海绵状脑病(FSE,尤其是猫和圈养的大型猫科动物)以及-动物园中外来有蹄类动物海绵状脑病。

人类中,海绵状脑病包括不同形式的克雅氏病(CJD),库鲁病,Gerstmann-Sträussler-Scheinker综合症(GSS),致死性家族性失眠症(FFI)。

医源性传播性海绵状脑病已有报道,羊类瘙痒病是由跳跃病疫苗使用不当而不慎发生传染,经过甲醛处理的绵羊脑部和脾脏中,意外感染了羊骚病的感染组织。

同时在使用甲醛灭活传染性无乳症疫苗过程中在绵羊和山羊中发现了羊瘙痒病的感染。

此种疫苗是由感染了无乳支原体的绵羊脑和乳腺组织匀浆制备。

在已有的人CJD传播报道中,传播过程由于来源于非活体人生长激素和促性腺激素的胃肠外给药。

CJD病例的发生由于人脑膜或角膜移植术中使用了污染仪器设备。

因为来源种族,朊病毒菌株、剂量、暴露途径以及一些物种中PRNP基因的宿主基因的影响等自然界障碍,种间TSE传播受到限制。

在适当的条件下,种间障碍也可被突破。

BSE于1986在英国被首次发现,大量的牛群和个体受到影响。

很显然,疯牛病是一种食源性疾病,和受到TSE影响的动物来源的饲料(如肉粉和骨粉)相关,其他国家都经历了疯牛病案例,包括从英国进口的动物或在当地的动物。

有证据确信,克雅氏病(vCJD)的变种是疯牛病传染源引起的。

因此,对用于药品生产的生物材料,尤其是牛源材料,若有TSE感染风险,仍有必要对其进行谨慎控制。

在主动监控程序中,欧洲,北美和日本地区罕见为数不多的病例中确定了两种先前未被识别的非典型BSE(BSE-L,也称为BASE和BSE-H),其中L和H分别表示不同蛋白酶抗性程度的PrP TSE 亚型,分别具有较高的电泳位置和较低的电泳位置。

值得注意的是,迄今为止未发生BSE的国家中,如瑞典,或只发生了几个典型BSE病例的国家,如加拿大或美国,已经发现了非典型病例。

通过实验,非典型BSE的传播已经可以从表达人朊病毒的转基因小鼠和食蟹猴体间实现。

瘙痒病在全世界范围内均有发现,大多数欧洲国家已有报道,其中塞浦路斯的发病率最高。

虽然人类在发生瘙痒病的环境中暴露超过250年,但没有流行病学证据证明瘙痒并和人海绵状脑病具有直接联系(1)。

虽然如此,理论上仍然具有一定无法量化的风险,部分已经被BSE污染的蛋白补充物可能被当做羊饲料。

此外,仍然有必要假设,含有BSE传播介质的饲料用于小反刍动物,其中的BSE传播病原体仍有可能进行传播循环或扩大传播(2)。

部分研究人员兴趣在于将TSE传染病原体感染细胞开发检测方法用于基础科学研究,目前已获得部分成功报告。

虽然有例外,此类数据通常是从神经细胞中获得。

感染细胞所需要的条件并不能很好的研究清楚,同时操作过程困难,需要特定试剂和特定细胞组合。

对使用生物学/生物技术衍生物质而产生的细胞底物做出具体评论并不合适,然而在风险评估中应考虑到使用的细胞系含有TSE传播介质的可能性。

1.2 法规遵从性风险评估-由于动物源性材料的使用不可避免地用于生产一些药物产品,并且完全消除来源的风险是不可能的。

相较于完全消除风险,对通过药物场频传播动物源TSE的管理措施可以使风险最小化。

相应的,法规遵从性的依据应当基于风险评估,包括本指南说明(见下文)中的相关因素。

法律依据- 本指导说明由欧盟委员会出版-附件I,第1部分,模块3,第3.2节:内容:基本原则和要求,2001年11月6日欧洲议会和理事会2001/83 / EC号指令(9)点关于人用医药产品(3)法规,经修正,以及-附件I,标题I,第2部分,C节欧洲议会和理事会2001年11月6日关于兽药产品共同体法典的指令2001/82 / EC的原料的生产和控制(4),经修订。

这些指令要求市场营销授权人类和兽医产品的申请人必须证明药品是根据欧盟官方公报发布的本指南最新版本制造的。

在授予营销授权后,此项义务需一直持续。

根据定义,欧洲议会和理事会第999/2001号条例(EC)(5)规定的特定风险材料的原则不适用于医药产品。

然而,自2003年5月1日起适用的欧洲议会和理事会(EC)第1774/2002号条例(6),2003年5月1日开始实施。

规定了关于不供人类消费的动物副产品的健康规则。

作为一般规则,如在(EC)第1774/2002号条例中定义,除非有正当理由,在医药产品制造中用作起始材料的所有动物副产品应为第3类(即安全)材料或等同物。

使用源自其他高感染性物质的材料的理由必须遵循适当的利益/风险评估(见下文)。

本指导说明应与各种欧洲法律文书一起阅读,包括自1991年以来逐步实施的委员会决定。

适当时,参考相关法案法规。

由人类药用产品委员会(CHMP)和兽医用药物产品委员会(CVMP)提出的立场声明和解释性说明仍然适用于法规遵从性,除非本指南备注另有规定。

欧洲药典中包含标题为“具有动物海绵状脑病传播剂风险的产品”的个论。

此部分是指欧洲药典的一般章节,与本指导说明相同。

该个论构成了证明人类和兽医药品生产中使用的物质和材料符合TSE标准而颁发适用性证书作的程序基础。

指导说明的进一步解释- 随着对TSEs的科学理解,特别是对疾病发病机制研究不断发展,CHMP及其生物制剂研究组织与CVMP及其免疫学研究组织作的合作将来成为可能,以解释性说明的形式提供补充指导,进一步阐释本指导说明。

补充指南应由委员会和欧洲药监局网站上公布,并被纳入保健质量管理局(EDQM)的认证范围内。

2. 适用范围:TSE相关动物物种—牛,绵羊,山羊和天生易感染或通过口服途径易感染传染性海绵状脑病病原体的动物(除人(7)和非人类灵长类动物)定义为“TSE相关动物物种”(8)。

材料—本指导说明涉及来源于“TSE相关动物物种”的材料,这些材料用于生产:—原料药—辅料和添加剂—原料或起始材料以及生产中应用的试剂(例如:牛血清白蛋白,酶,工作细胞库培养基,或者是有新上市许可的用于药物生产的新开发细胞库的培养基)本指导说明也适用于由于直接和生产设备或和药物产品接触,因此具有潜在被污染可能的材料。

用于厂房和设备质量鉴定的材料,如用于验证无菌灌装工艺的培养基灌装实验用培养基应符合本指导原则所提供的来自无可检测的感染性组织的章节(IC组织类)。

该章节涉及了潜在可感染组织的交叉感染风险(参见第3.3节),和以微BSE风险或可控BSE风险的国家为来源的材料(分别为A类和B类- 见第3.2节)。

这些信息应在上市许可授权的档案中写明,并在例行检查中验证是否符合生产质量管理规范(GMP)。

常规制造阶段,收尾阶段或在初级包装阶段中与药物产品接触的其它材料如清洁剂,软化剂和润滑剂,如符合第六章中所述的通过严格的物理化学过程制备的动物脂衍生物,则必须符合本指导原则,种子批次,细胞库和常规发酵/生产(9)—为了符合法规,在2000年7月1日(人用药)或2000年10月1日(兽用药)之后提出上市许可申请的主种子批或主细胞库应包括在本指导原则内。

主种子或主细胞库—用于疫苗抗体—用于欧盟议会与理事会(10)提出的(EC)第726/2004号条例附件中所述生物制药物产品。

和—用于其他在生产中用到种子批或细胞库的药物产品即使上述产品已在2000年7月1日(人用药)或2000年10月1日(兽用药)后获得上市许可申请,并且已被批准用于生产授权药物产品,也应符合本指导原则。

2000年7月1日(人用药)或2000年10月1日(兽用药)之前生产但尚未被批准为授权药品成分的主细胞库和主种子应证明符合本指导原则的要求。

用于生产这些细胞库或种子的一些原料,起始材料或试剂,如果其完整的书面证明不再可用,申请人应提交本指导原则第4部分所述的风险评估。

在2000年7月1日(人用药)或2000年10月1日(兽用药)之前已建立的批准用于生产药物的工作种子或细胞库,若成员国或欧洲药品管理局进行风险评估并宣布合格,以上工作种子或细胞库也应视为合格。

但是,当来源于“与TSE相关的动物物种”的材料用于发酵/常规生产过程或建立工作种子和工作细胞库时,申请人必须证明他们满足本指导说明的要求。

3. 总论3.1 降低风险的科学原则当生产商可选择使用来自“非TSE相关动物物种”或非动物来源的材料时,应给出使用源自“TSE相关动物物种”而不是来自“非TSE相关物种”或非动物源物质的材料的理由。

如果必须使用“TSE相关动物物种”的材料,则应考虑采取所有必要措施以尽量减少TSE传播的风险。

体内TSE感染的快速适用诊断测试方法还未建立。

TSE感染诊断可通过组织病理学和/或蛋白质印迹或免疫测定检测PrPTSE来确定剖中出现的脑损伤特征。

目标物种或实验室动物接种疑似组织也用于确认是否感染。

然而,由于TSE潜伏期长,体内测试的结果仅在数月或数年后才可用。

用于非活体样本中检测PrPTSE的几种免疫化学测试已经开发,并且有些对PrPTSE极其敏感。

但是,它们对感染动物的检测取决于样品收集与暴露的时间长度,收集的组织类型和获得的感染剂量以及临床疾病发作的时间有关。

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