Klippel-qc
SOP-QC吡啦西坦检验操作规程
吡拉西坦检验操作规程1. 目的建立吡拉西坦检验标准操作规程，使吡拉西坦检验操作规范化。
2. 范围适用于吡拉西坦的质量检验。
3. 术语或定义3.1 GMP：药品生产质量管理规范(Good Manufacturing Practice)的英文简称。
3.2 SMP：标准管理程序（Standard Management Procedure），用于指导工作的管理类文件。
3.3 SOP：标准操作程序（Standard Operating Procedure），用于指导如何完成一项工作的文件。
4. 职责质量控制部对本规程的实施负责。
5. 程序5.1 检验依据5.1.1 《中国药典》2020年版二部（576页）。
5.1.2 吡拉西坦质量标准（质量标准编号：5.1.3《中国药典》2020年版四部。
1.【性状】1.1本品为白色或类白色的结晶性粉末；无臭。
本品在水中易溶，在乙醇中略溶，在乙醚中几乎不溶。
熔点依熔点测定法操作规程进行测定。
本品的熔点应为151～154℃。
2.【鉴别】2.1鉴别⑴2.1.1试药高锰酸钾试液、氢氧化钠试液2.1.2操作方法取本品0.1g，置点滴板上，加水数滴溶解，加高锰酸钾试液与氢氧化钠试液各1滴，搅匀，放置，溶液应显紫色，渐变成蓝色，最后显绿色。
2.2鉴别⑵在含量测定项下记录的色谱图中，供试品溶液主峰的保留时间应与对照品溶液主峰的保留时间一致。
2.3鉴别⑶2.3.1仪器与用具双光束红外分光光度计、压片机、玛瑙研钵2.3.2操作方法取供试品约1mg，置入玛瑙研钵研细，再取溴化钾粉(约200mg)，在玛瑙研钵中充分研磨混匀，移置于直径13mm的压模中，使铺布均匀，加压至20MPa，约60秒取出。
目视检查应均匀，无明显颗粒。
将供试片置于仪器的样品光路中，进行光谱扫描。
供试品的红外光吸收图谱应与对照的图谱（光谱集185图）一致。
3.【检查】3.1溶液的澄清度与颜色取本品2.0g，加水10ml溶解后，溶液应澄清无色；如显浑浊，与1号浊度标准液比较不得更浓。
在线测试的目标
www.klippel.de扬声器制造业中驱动和悬吊系统非线性的快速测量, 1扬声器制造业中驱动和悬吊系统非线性的快速测量Fast Measurement of Motor andSuspension Nonlinearities in LoudspeakerManufacturing2009by Wolfgang Klippel KLIPPEL GmbH在线测试的目标Objectives in end -line -testing :1.基本目标:将有缺陷的单元从交货的产品中分离出来.Basic Goal:Separate defect units from delivered goodsÆ使用限制文件简单进行PASS/FAIL判定simplePASS/FAIL decision using limits2.最终目标:避免制造出不良的产品Ultimate Goal:Avoid manufacturing of defect unitsÆ使用诊断来获取有意义的特性反馈来控制生产过程use diagnostics to get meaningful characteristics used asfeedback in controlling the production processwww.klippel.de扬声器制造业中驱动和悬吊系统非线性的快速测量, 3KLIPPEL1020304050607080901001021032nd HarmonicH A 2 [%]frequency [Hz]ha2_av ha2_plus ha2_minus ha2_maxha2_minthd_limit二次諧波失真2nd -order Harmonic Distortionbatch A (30 Duts )25 units failed in THDlimitmicrophoneHeadphone driverMean valueStandard variation maximumminimum如何來減小不良率?How to reduce the rejection rate ?步驟Steps:1.物理原因是什麼？What is the physical cause ?2.如何能快速地檢測出物理原因？How can the cause quicklybe detected ?3.如何使用這些信息來進行過程控制？How to use thisinformation for process control ?www.klippel.de扬声器制造业中驱动和悬吊系统非线性的快速测量, 5目标: 减小不良率Target: Reduce Rate of Rejection 解决方案: 在线诊断Solution: On -line DiagnosticsFault Analysis不良单元Defective Unit系统本身Systematic偶然性Accidential物理产生Physical CauseGlue problem Bad spider Voice coil offset Loose particle维修单元Repair unit重新使用单元Recycle unit调节过程Adjust Process從諧波成分中獲取訊息Exploiting Information from ComponentsHarmonic Distortion2次諧波失真2nd -orderharmonic distortion3次諧波失真3rd-order harmonicdistortion非線性曲線不對稱Asymmetry of nonlinear curveshape非線性曲線對稱度Symmetry of nonlinear curveshape存在問題Open Questions:非線性的種類What kind of nonlinearity ?自身缺陷還是裝配問題?A defective part or an assembling problem ?如何修理問題How to fix the problem ?高次諧波失真higher-order harmonic distortion限制，雜音，線撞擊Limiting, rub&buzz Wire beatwww.klippel.de扬声器制造业中驱动和悬吊系统非线性的快速测量, 7基於非線性參數的診斷Diagnostics based on Nonlinear Parameters大信號識別Large Signal Identification (LSI)耦合係數曲線Force Factor Bl(x)-curve悬吊结构Suspension Geometry线圈偏移Coil Offset勁度係數曲線Stiffness Kms(x)-curveBut themeasurement time > 10 minutesKLIPPEL0,000,250,500,751,001,251,50-0,75-0,50-0,250,000,250,500,75B l [N /A ]<< Coil in X [mm] coil out >>best of Aworst of Aworst of BBest of B耦合系数曲线Force Factor Curve Bl(x)Batch BBatch A大信号识别技术测量的曲线Curve measured by using Large signal Identification (LSI)测量时间：10minMeasurement time: 10minwww.klippel.de扬声器制造业中驱动和悬吊系统非线性的快速测量, 9KLIPPEL0,000,050,100,150,200,250,30-0,75-0,50-0,250,000,250,500,75K m s [N /m m ]<< Coil in X [mm] coil out >>best of Aworst of Aworst of Bbest of B 劲度系数曲线Stiffness Curve Kms(x)Batch BBatch A大信号识别技术测量的曲线Curve measured by using Large signal Identification (LSI)测量时间：10minMeasurement time: 10min非線性曲線對在線測試有用嗎？Are nonlinear curves good for end -of -line testing ?Good point:•曲線提供所有相關的訊息Curves provide all relevant informationBad points:•全部識別需要更多的時間Full identification requires more time •複雜的狀態導致解釋困難Complexity makes interpretation difficult •曲線表徵多種多樣的物理原因Curves reveals multiple physical causes •不可以運用Cpk, Ppk Cpk and Ppk can not be applied Æ單值數據的規格參數顯示更適合於QCsingle-value characteristics are preferable for QCwww.klippel.de扬声器制造业中驱动和悬吊系统非线性的快速测量, 11耦合係數限制的偏移X BForce Factor Limited Displacement x B defined according IEC standard 62458根據IEC 62458 標準規定0,01,0 2,0 3,0 4,0 6,0 -5,0-2,50,02,55,0BlN/A<< Coil in X mm coil out >>Bl min =82 %Bl(x=0)Bl(x B )x BSteps:1.在大訊號模式下激勵換能器Operatetransducer in large signal domain2.在耦合係數下降到靜態位置Bl(x=0) 的82%的地方讀取偏移數值X BRead displacement X B where force factorBl(x ac ) decreases to 82 % of the value Bl(x=0) at rest positionCriterium:最大峰值偏移Xb 產生10% 的互調失真Maximal Peak Displacement x B generating 10 %intermodulation distortion順性係數限制的偏移x CCompliance Limited Displacement x C defined according IEC standard 62458根據IEC 62458標準規定Steps:1.在大訊號模式下激勵換能器Operate transducer in large signal domain2.在順性係數下降到靜態位置的75%的地方讀取偏移值XcRead displacement X C where compliance value C ms (x ac ) decreases to 75 % of the value C ms (x=0) at rest position0.2 0.4 0.6 0.8 1 -5,0 -2,50,02,55,0C ms (x)mm/Nxmm x Ccoil incoil out C MS (x=0)0.75C MS (x=0)Criterium:最大的峰值偏移產生10%的諧波失真Maximal Peak Displacement x C generating 10 %harmonic distortionwww.klippel.de扬声器制造业中驱动和悬吊系统非线性的快速测量, 13Xmax 和其他位移限制Xmax and other Displacement LimitsX max產生不超過10%的THD 或10%的IMDGenerating not more than 10 % THD or 10 % IMDminimumX cX limited by Cms(x)10 % THDX [mm]C lim = 75 %顺性系数ComplianceX BlX limited by Bl(x)10 % IMDX [mm]B lim = 82 %耦合系数Force FactorX DX limited by Doppler 10 % IMDDopplerX LX limited by Le(x)10 % IMDMagnitude of electric impedance Z(f)Z lim = 10 %自感Inductance校正音圈的靜態位置Adjusting C oil ‘s Rest P ositionInduction Bpole piecepole platemagnetvoice coildisplacementx=0Induction Bpole piecepole platemagnetvoice coildisplacementx=x bForce factor Bl vs. displacement XForce factor Bl vs. displacement X根據Bl 曲線來移動音圈的靜態位置Shifting the coil‘s rest position by the offset of the Bl curveoffsetwww.klippel.de扬声器制造业中驱动和悬吊系统非线性的快速测量, 150,01,0 2,0 3,0 4,0 6,0 -5,0 -2,5 0,0 2,55,0BlN/A<< Coil in X mm coil out >>x symx ac x acx 1x 2x offset音圈偏移X offsetVoice Coil Offset x offset defined according IEC standard 62458根据IEC 62458标准定义步骤Steps:1.在大信号模式下激励换能器Operate transducer in large signal domain2.在最大峰值位移xac 处读取对称点Xsym Read symmetry point X sym at maximal peak displacement x ac3.X offset =x sym if X ac >X Bl劲度不对称度A kStiffness Asymmetry A K defined according IEC standard 62458根据IEC62458标准定义步骤Steps:1.在大信号模式下激励换能器Operate transducer in large signaldomain2.在最大峰值偏移处读取劲度值Read stiffness values X ms (X peak ) and X ms (-X peak ) at maximal peak displacement3.根据公式计算劲度不对称度Calculate stiffness asymmetry according1 2 3 4 5 -5,0 -2,50,02,55,0K ms (x)N/mmxmm x peakK MS ( -x peak )coil in-x peakK MS ( x peak )coil out ()%,100)()()()(2)(peak MS peak MS peak MS peak MS peak K x K x K x K x K x A +−−−=www.klippel.de扬声器制造业中驱动和悬吊系统非线性的快速测量, 17驱动和悬吊系统检查Motor & Suspension Check (MSC)用于品质控制的特别的LSISpecial LSI dedicated to Quality Control (e.g. end -of -line testing )AVDigital processing unitPower amplifierSpeaker M OTOR-S USPENSION-C HECK结果Results:•音圈偏移Voice coil offset•悬吊不对称度Suspension asymmetry •测量过程中的峰值位移peak displacement•10%失真时的位移Displacement(Xmax) producing 10 % distortion•X=0处的T/S 参数T/S parameters atx=0•箱体参数Box parameters fb,Qb •x=0处的阻抗Impedance at x=00.2 –2 s 测量时间0.2-2s measurement time电压和电流Voltage & currentMSC 中使用的模型Models used in MSC))(())(()(2121b s b s a s a s s Z a −−−−=•超低音Subwoofer •低音Woofer •耳机Headphone•小型喇叭Microspeaker •麦克风Microphone •混合器Shaker带孔的箱体系统Vented -box system具有复杂的机构或声学负载的系统System withcomplex mechanical or acoustical load (panel , horn, transmission line )www.klippel.de扬声器制造业中驱动和悬吊系统非线性的快速测量, 19MSC 中使用的特殊的激励信号Special Stimulus used in MSCFundamental linesDistortionNoise floor•需要对换能器设备进行持续的激励Persistant excitation of the transducer is required !•少量的，综合不同的长度的多音信号是最佳的激励Sparse multi-tone complex of length T is the best stimulus•需要预激励来达到稳定状态Pre-excitation (fraction of T) is required for steady stateT= 170 ms ... 2.7 s测量所得电流的波形Waveform of the measured current测量所得电流的频谱Spectrum of the measured current失真是鉴别非线性的基础Distortion are the basis for the identification of the nonlinearitiesMSC 的高速测量High Measurement Speed of MSC典型的激励长度Typical stimulus length最小激励长度Minimal stimuluslength喇叭类型Speaker Type Subwoofer Woofer Midrange Tweeter Headphone Microspeaker Exciter (shaker)Closed-box System Vented-box System典型的共振频率Typical resonance frequency30 Hz 60 Hz 300 Hz 2000 Hz 100 Hz 500 Hz 100 Hz 60 Hz 50 Hz2.73 s 1.3 s 0.68 s 0.17 s 0.68 s 0.34 s 0.68 s 1.3 s 1.3 s1,3 s 0.68 s 0.34 s 0.17 s 0.34 s 0.17 s 0.34 s 0.68 s 0.68 swww.klippel.de扬声器制造业中驱动和悬吊系统非线性的快速测量, 21不需要额外的感应器No Additional Sensor RequiredVented-box SystemAnalyzer with electrical sensorsComputerPower amplifier•在连接端仅仅测量电压和电流Only voltage and current is monitored at the terminals•换能器安装好了也能够检测出驱动和悬边Motor and suspension canbe checked when the transducer is mounted in enclosure•可以通过长线材测量Measurementvia long cables possible•对环境噪声的免疫Full immunity against ambient noise测试密闭体Testing the Enclosure•传统的测量表征扬声器系统的总体表现Conventional measurements show totalbehavior of the loudspeaker system•MSC 将驱动单元的缺陷与密闭体的缺陷区别开来MSC separates defects in thedrive unit from defects of the enclosure (port , sealing , damping )•不必将驱动单元拿到密闭体外面来No need for taking the drive unit out of the enclosure•对租赁的客户来讲，是防止由于老化、疲累、气候的影响的检测扬声器系统品质的最佳选择Perfect for checking the quality of loudspeaker systems in rental companies due to ageing , fatigue , climate influenceswww.klippel.de扬声器制造业中驱动和悬吊系统非线性的快速测量, 23Xmax for10 % distortion in IMD or THD Parameters at x=0Thiele -Small Parameters 单一数值参数总览Overview on Single -Valued Parameters representing loudspeaker nonlinearities in MSCMSC 中表征扬声器非线性Electrical Parametersee L R ,Relative Parametersbb es ms ts s Q f Q Q Q f ,,,,,Mechanical Parametersmsms ms ms K C R M Bl ,,,,Nonlinear Parameters at x=x peakCompliance limited displacement x CForce factor limited displacement x BVoice Coil Offset x offsetStiffnessasymmetry A KX offset = 0.060 mm X offset = 0.072 mm X offset = 0.084 mmMSC 的灵敏度Sensitivity of MSC, Example showing Influence of Gravity on Voice Coil Position重力对音圈位置的影响的样例msms offset gC M X =∆Prediction usinggravity constant g=9.81 ms -2Moving mass Mms = 4.94 gram Compliance Cms (x=0)= 0.4 mm/N Compliance Cms (x=3mm)= 0.2 mm/NmX offset µ12−=∆mX offset µ12=∆≈10 ... 20 µmwww.klippel.de扬声器制造业中驱动和悬吊系统非线性的快速测量, 25MSC 的可重现性Reproducibility of the MSC在许多换能器上进行的R&R 测量结果Result of an R&R test performed on various transducersA Kms%-0,60-0,50-0,40-0,30-0,20-0,100,000,100,200,500,60X offsetMworstσ-σmmworstσ -σ bestMσ −σσ−σbatchvariationbatch variationreproducibility reproducibilityideal value ideal valuebestbestworstbestworstX offsetin mm耳机的音圈位移X offsetVoice coil offset X offset of the headphoneBl offset-0,60-0,50-0,40-0,30-0,20-0,100,000,100,200,300,400,500,60BATCH ABATCH Bo f f s e t [m m ]X offsetX offset bestworstbestworstσ-σσ-σIdeal valuein mmBl curve measured with R&DX offsetwww.klippel.de扬声器制造业中驱动和悬吊系统非线性的快速测量, 27劲度不对称度Stiffness Asymmetry A Kms-100.00-90.00-80.00-70.00-60.00-50.00-40.00-30.00-20.00-10.000.0010.0020.0030.0040.0050.0060.0070.0080.0090.00100.00BATCH ABATCH BA [%]A Kmsbestworstσ-σσ-σbestworstIdeal value在线诊断On -Line DiagnosticsKLIPPEL QC系统集成了先进的诊断技术，用于生产线终端测试，简化了测试结果的说明，指示出扬声器缺陷产生的根源。
KlippelQCsystem操作说明书
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5. 系统提示进行 MIC 较正，点击确认； 6. 点击较正，进行 MIC 较正(需要注意 MIC1 与 MIC2 不能随意交换使用)；
FOSTER ELECTRIC (PANYU) FACTORY
7. 出现以下界面，MIC 较正完成，退出完成所有较正。
FOSTER ELECTRIC (PANYU) FACTORY
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4．开始测试标准品，连续测试 5 次，确认 5 次无大的偏差后，点击一下“Activate Limit Calculation Mode”关闭激活，关闭设置窗口后就可以进行生产测试了。
点击这里关 闭窗口
点击这里关 闭激活
FOSTER ELECTRIC (PANYU) FACTORY
5．测试结果 PASS 与 FAIL 界面如下图所示。
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三、系统较正方法 当测试系统硬件有变动，包括功放更换、功放增益变化、系统移动、插头拔
出插入等时，需要对系统进行较正，较正方法如下：
1. 打开工程师模式，出现登录界面，选择校正——较正分析仪；
2. 输入用户名与密码； 3. 点击较正，系统会自动完成较正； 4. 出现以下项目全部显示绿色，分析仪较正完成，点击 Exit 退出；
FOSTER ELECTRIC (PANYU) FACTORY
较正时出现 这种情况
FOSTER ELECTRIC (PANYU) FACTORY
ENG1/HHJZ—20100117 10/25
MilliporeSigma Milli-Q CLX 7000系列连接水纯化系统用户说明书
®7000 SeriesRobust & Reliable Performancefor Maximum Lab ProductivityYour biomedical laboratory is a busy and demanding environment, with clinical analyzers capable of processing several thousand samples per day. As water is the most frequently used fluidic reagent onboard an analyzer, your choice of water purification system is key to smooth and uninterrupted daily lab operations.The water purification solution must reliably provide your clinical analyzer(s) with consistent water quality that meets CLRW standards of the CLSI®. With the high-throughput Milli-Q® CLX 7000 analyzer feed series, your clinical laboratory benefits from a high-performance and economical water purification solution that fulfills its many critical needs:3Simply log into the MyMilli-Q™ web interface todiscover MyMilli-Q™ Remote Care , our online service and monitoring capability designed to support you in maximizing uptime. This unique service gives you and our support teams access to your Milli-Q ® CLX 7000 system and its data, for quick and precise remote diagnostics as well as repairs. Learn more about thisnew service capability on pages 8 and 9 of this brochure. And because every lab situation is different, our Milli-Q ® Services offering can be customized around your needs:• Before installation, a certified Field Service Engineer will analyze your feed water quality to provide the optimal parameter configuration for your system. This maximizes the performance and reliability of your Milli-Q ® CLX 7000 instrument and associated clinical analyzers.• Choose the Milli-Q ® Service Plan that’s right for your lab—from a single annual Preventive Maintenance Visit with replacement of aging parts, to full system coverage. • Online Contract Management lets you moreefficiently track your water system’s service history and easily schedule maintenance visits.• A range of options lets you customize your service solution. Choices include qualification, calibration and verification services, scheduled consumables shipments, and sanitization.Best-in-class Milli-Q ®Services,now supported by MyMilli-Q™ Remote CareBecause the reliability of biomedical laboratories is critical to patients and doctors alike, we offer an unprecedented level of service with the Milli-Q ® CLX 7000 Series.Trust in Pure Experience & ExpertiseWe are a partner you can count on. As one of the top three R&D investors in the Life Science Toolsindustry, we have a long history of strong partnerships with both biomedical laboratories and major clinical analyzer manufacturers. This valuable experience has enabled us to develop our expertise concerning end-user applications, such as biology, biochemistry, microbiology and immunology, and to design top-quality water purification solutions dedicated to feeding clinical analyzers.The Milli-Q ® CLX 7000 Series is manufactured in an ISO ® 9001- and ISO ® 14001-registered site. Additionally, to ensure efficiency and safety ofoperation, systems are CE-, cULus-, and FCC-certified. Furthermore, to reduce environmental impact, the Milli-Q ® CLX 7000 Series follows European Restriction of Hazardous Substances (RoHS) and Waste Electricaland Electronic Equipment (WEEE) directives.Contact your local Merck office for information about the service offer available for your facility, or visit /milli-qservices4® technology purification stepsElix ® module: Our unique technology is based on anion-permeable and cation-permeable membranes and high-quality, ion-exchange resin.Water produced by the Elix ® module enters the reservoir with resistivity greater than 5 MΩ·cm @ 25 °C (typically up to 15 MΩ·cm @ 25 °C).*The Milli-Q ® CLX 7000 Series relies on complementary water purification techniques, including state-of-the-art Elix ® electrodeionization (EDI) technology, to ensure production of consistently high quality water meets CLRW standards – at low and predictable running costs.In the Milli-Q ® CLX 7000 Series, potable tap water is first treated with a Progard ® pack and purified by reverse osmosis (RO) to remove up to 99% of contaminants. The resulting RO permeate water then enters the Elix ®Bacteria and their by-products interfere with chemistry assays and enzyme immunoassays, typically leading to unstable analyzer calibrations, high absorbance of blanks, reference drifts, and errors on mean patient values.In the Milli-Q ® CLX 7000 Series, UV lamp sanitization occurs at three stages:• During water production , a 254 nm bactericidal UV lamp inactivates bacteria.• In the tank , a UV lamp (ASM, Automatic Sanitization Module) regularly irradiates stored water and the tank walls, preventing bacterial growth and the formation of biofilm.* When CO dissolved in feed water is less than 30 ppm.5Optimize water consumption with an environmentally responsible system containing E.R.A.® technologyMilli-RX™ system(1992)Elix system (2003) with RO recovery loop Today’s Mili-Q CLX 7000Series system with E.R.A. technology10000m 900080007000600050004000300020001000WASTE (m )CLRW (m )Over the last 25 years, we have dramatically reduced water purification system water consumption, enabling laboratories to save up toseveral thousand dollars per year on tap water expenses . The graph shows water consumption and the split between CLRW produced and reject water for three of our water purification systems over a seven-year period (production of 1000 L/day of CLRW-quality water, 312 days per year).The Milli-Q ® CLX 7000 Series incorporates our E.R.A.® (Evolutive Reject Adjustment) technology — providing users with even greater savings.With its innovative and efficient reverse osmosis (RO) recovery loop, the Milli-Q ® CLX 7000 Series optimizes water consumption by recycling part of the waterrejected to the drain, thus reducing water waste and also extending RO cartridge and Progard ® pack lifetimes.Furthermore, depending on the feed water qualityanalysis, the Milli-Q ® CLX 7000 Series will calculate the best water recovery and will automatically optimize water consumption by means of motorized valves.No matter what the feed water temperature, inlet pressure, or conductivity may be, E.R.A.®technology’s automated valves ensure that the Milli-Q ® CLX 7000 Series flow rate and water recovery remain constant.* Users no longer need to manually adjust valves to maintain production flow rate and protect RO cartridge lifetime.These latest RO technologies illustrate our dedication to developing environmentally responsible waterpurification solutions to reduce tap water and system consumables use. The solutions reduce maintenance time, as well as the risk of human error — letting users save money on system operation, and also enjoy peace of mind with higher reliability, and optimized water purification system/analyzer uptime.* Please refer to Feed Water Requirements in the Specifications Table.6User-friendly system interface with all relevant information at a glanceWith its large, innovative touchscreen, the system is designed for intuitive operation, with all information available at a glance in a dashboard format. Nine different languages are available for greater convenience. Navigating and interacting with your water purification system has never been easier!... where a wizard will guide you through the maintenance procedure with easy, step-by-step instructions. You don’t need to be an expert to perform regular maintenance on your system!Clear, visible status of all consumables Notification zone for alerts and alarmsLarge display shows water qualities and storage volumeSystem status zone7An easy-to-use,low-maintenance systemA mobile, customizable systemLow maintenance saves time and increases profitability• Robust and patented Elix ® technology ensuresconsistent pure water, as well as low and predictable running costs – regardless of your feed water quality.* No maintenance is required for the Elix ® module.• An ergonomic and patented pack-locking system lets you change packs easily and quickly.• RFID technology prevents insertion of an incorrect purification cartridge in Milli-Q ® CLX 7000 systems, and also ensures automatic traceability of pack use and replacement, saving time for the user.• Automatic self-maintenance functions significantly reduce tap water use and increase cartridge lifetime: –The Progard ® pretreatment pack incorporatesseveral purification media in just one consumable to protect the RO membrane from particles, free chlorine, and scaling. Maintenance is easier and quicker with only one pack to change! –The system’s flush mode and cleaning cycles keep the RO membrane in top operating condition.Never before has it been so easy—or so time-saving—to use and maintain your water purificationsystem.Optimal use of lab spaceThe Milli-Q ® CLX 7000 Series is compact, quiet, and mounted on wheels with brakes, so it can be placed wherever it’s convenient — and moved to another location as the lab configuration grows or evolves.Customizable systems to fit your specific requirementsA number of options and accessories are available for the Milli-Q ® CLX 7000 Series to fit your specific requirements and to improve water quality monitoring:• An online TOC (Total OrganicCarbon) monitor allows verification that the TOC level of system water is below 500 ppb as required for CLRW quality. This avoids the need for duplicate assays or repeated analyzer calibrations. • Degassing option provides asolution for feed water that is highly contaminated with gases, such as a CO 2 concentration above 30 ppm.• RO regeneration tool , for use whenfeed water quality is poor, provides additional RO membrane cleaning, and completes the action of the Progard ® Autoclean pack.• Sanitary sampling valve for safe and reliable water sampling for microbiological analysis.• Water sensor(s) and alarm output(s) also can be easily added to your Milli-Q ®CLX 7000 system.* P lease refer to Feed Water Requirements in the Specifications Table.An ergonomic and patented pack-locking system.245 13 67What can MyMilli-Q™ Remote Care help you to achieve?• Assure productivity 24/7. Access real-time system information, water quality data and much more from anywhere at any time for 24/7 confidence in your lab’s performance.• Save time. In the event you need support, your interaction with Milli-Q® Services is streamlinedas MyMilli-Q™ Remote Care provides our service organization a secure and direct view of your system information. Our service teams can remotely diagnose and potentially repair your system, avoiding the need to wait for a service visit.• Maximize uptime. Receive notification of alertsand alarms (by email or SMS) allowing you to promptly and remotely manage your system, either independently or with our remote assistance.• Easier data traceability & accreditation. Audit preparation and lab accreditation have never been so effortless as data are automatically saved and can be easily accessed, searched and retrieved. Choose to download a standard Quality Report, or to create your own tailored reports.Connect to Peace of Mind Milli-Q® Services presents MyMilli-Q™ Remote Care, an onlineservice that simplifies the management of your Milli-Q® CLX7000 water purification system.1 Quickly view all system details.2E asily share water quality and system information with your analyzer supplier’sservice hotline.† CAP , College of American Pathologists9A water purification system that facilitates accreditation.Water used to feed an analyzer is a critical reagent. Its quality must be documented forbiomedical laboratories seeking accreditation (or reaccreditation) to the ISO 15189:2012 standard supported by CAP † 15189SM accreditation.To facilitate compliance with worldwide regulatory organization guidelines, Milli-Q ® CLX 7000 systems allow for full monitoring capabilities as well as automatic e-record archiving both:• Directly in the system — data are retrievable by USB key or via your lab’s intranet connection.• In the cloud when MyMilli-Q™ Remote Care is activated.E-record archiving supports traceability of all water-related daily operations, measurements and events. It saves time and is less expensive to manage versus paper documentation, as it removes the need for daily checks of the water purification system, hand-recording of parameters in a lab book, and physically archiving years of paper data.Now, with the user-friendly MyMilli-Q™ web interface and MyMilli-Q™ Remote Care service capability, data management is even moresimplified. Your system and water data are readily accessible and rapidly searchable, graphable and reportable — from anywhere at any time.An interactive Event Traceability tool lets you view events by type and over the timeline you specify. View past events (alarms, alerts, consumable replacements, service visits, custom events) and plan for future systemmaintenance. Click on any event and its details are displayed in the blue banner above the timeline. In this example, aProgard ® cartridge was replacedby J.SMITH on Aug 19, 2019.Water quality parameters (resistivity, temperature, TOC) are graphed over the timeline of your choice and can be easily downloaded.The system automatically stores a fully traceable—and easily retrievable—record of service history. In addition to archiving data, MyMilli-Q™ online tool lets you streamline contract management. You’ll be able to schedule maintenance visits, manage consumable deliveries and renew your service contracts, all online.Milli-Q® CLX 7000 Series Water Purification Process1. Inlet Valve2. Progard® Pretreatment Pack3. Conductivity Cell4. RO Pump5. Pressure Sensor6. RO Cartridge7. Twin Motorized Valve –RO Recirculation 8. RO Recirculation Loop9. Temperature Sensor10. Flow Sensor11. 3-Way AutomaticRinsing Valve12. Elix® Module13. Resistivity Cell14. UV Lamp (254 nm)15. Vent Filter16. Sanitary Overflow Sensor17. Automatic SanitizationModule (ASM)18. Distribution Pump19. Emergency Back Up –Quick Connector20. Q-Gard® Polishing Pack21. Opticap® Filter (0.22 μm)22. Sampling Valve23. Automatic Loop Rinsing Valve24. Back Pressure Regulator25. Recirculation Loop Valve26. TOC Monitor (Option)27. Degassing Unit (Option)Milli-Q® CLX 7000 Series SpecificationsThe Clinical Laboratory Reagent Water (CLRW) Quality Standard, defined by the CLSI®Resistivity> 10 MΩ.cm @ 25 °C Total organic carbon (TOC)< 500 ppbBacteria< 10 CFU/mL Filtration0.22 μmMilli-Q® CLX 7000 Series PerformanceMilli-Q® CLX 7040Milli-Q® CLX 7080Milli-Q® CLX 7120Milli-Q® CLX 7150 Make-up flow rate to reservoir*40 L/h (10.6 gal/h)80 L/h (21.1 gal/h)120 L/h (31.7 gal/h)150 L/h (39.6 gal/h) Make-up resistivity> 5 MΩ.cm @ 25 °C (10-15 MΩ.cm @ 25 °C typically)Built-in reservoir volume (net volume)90 L90 L140 L140 LDistribution flow rate to analyzers 4 L/minDistribution pressure to analyzers Adjustable: 0.9 up to 2.1 bar†Water Quality Distributed to AnalyzersResistivity> 15 MΩ.cm @ 25 °C Total organic carbon (TOC)Typically < 30 ppb Bacteria Typically < 1 CFU/mL Dissolved silica< 0.05 mg/L* Nominal flow rates ± 10% between 10 and 35 °C. Additional deviation of -3% per °C from 10 °C to 5 °C.† With a distribution loop length of 20 m.Technical Appendix10*Subject to subscription. Please contact your local Merck office for information about the service offer available for your facility.Dimensions and WeightsDimensions (H x W x D)1255 x 543 x 797 mm(49.4 x 21.4 x 31.4 in)1255 x 543 x 797 mm(49.4 x 21.4 x 31.4 in)1255 x 543 x 947 mm(49.4 x 21.4 x 37.3 in)1255 x 543 x 947 mm(49.4 x 21.4 x 37.3 in)Net weight (shipping box)134 kg (295.4 lb)143 kg (315.3 lb)155 kg (341.7 lb)167 kg (368.2 lb) Operating weight222 kg (489.4 lb)234 kg (515.9 lb)303 kg (668 lb)318 kg (701.1 lb)Feed Water RequirementsPressure 2 – 6 barFlow rate> 10 L/min at 2 barTap water connection¾ in. Gaz MFeed water type PotableTemperature 5 – 35 °CConductivity10 – 2000 μS/cm at 25 °C pH 4 – 10Total hardness (as CaCO3)< 300 ppmCO2< 30 ppmSilica< 30 ppmMerck KGaAFrankfurter Strasse 25064293 Darmstadt, Germany /labwater。
Klippel操作指引
Klippel 操作指引Klippel 测试主要有三种测试模式：LPM 测试（主要测参数，阻抗）LSI 测试（主要测定位）SPL 测试（主要测试SPL 曲线及失真）。
以下就介绍这三种测试方法的详细操作指引。
一 LPM 测试1.测试之前先选好通道(一般情况 ，微型喇叭用SPEAKER 2,大喇叭用SPEAKER1)2.固定喇叭：将雷射激光对准喇叭中间反射面（可用涂改液涂在雷射光束照射喇叭位置，增强反射强度，白色贴纸也可），距离调至绿灯及黄灯皆连续亮，不闪动，将连接线正确接上喇叭正负端子。
3.参数设置1）建立档案，如图，选择第一行第一个图标，然后在弹出对话框选择New ，然后输入档案名（一般为机种名）。
2）选择模块，在新建的档案中选择红框中的图标，然后在弹出的对话框中选择第三行LPM Linear parameters ,然后在右边的框内选择所需要的模块，例如：低频大喇叭选择 倒数第三行的 LPM Woofer T/S(Sp1)。
高音微型喇叭选择LPM Tweeter T/S(Sp2)3)设置参数，选择红框中图标，然后在在弹出的对话框中按照红框内内容输入。
4）点选绿箭头图标，就可以完成一个小信号测试。
二 LSI 测试LSI 测试一般是在测试LPM 的基础上再进行测试，喇叭的放置以及激光的调距都跟LPM 一样。
1.建立测试模块（以普通喇叭为例）选择左边第一行中LSI Woofer drive 右边选输入振动面积 输入阻抗输入功率择（Default）.注意1：微型喇叭，请选择LSI Headphone ,高音喇叭请选择LSI Tweeter Driver。
注意2：KLIPPEL大信号测试最多支持500 ohm阻抗，超过500 ohm将无法测试大信号，如果正好是500 ohm ,请在大信号的参数设置里将阻抗改为499，才可以继续进行测试。
2.设置参数选择Protection，然后按红框内输入，点选Im/Export,,然后按照红框内容输入参数输入最大功率输入BL输入振动质量输入阻抗3.设置完点选绿色箭头按钮就可以进行测试了。
拜科奇产品手册
目录
.1 . . . . . .1 .1.1 .1. .1. .1. .1. . ..1 .. .1 . . . . . . . 10 11
拜科奇的产品特性 ......................................................................................................... 质量保证........................................................................................................................ 产品纯度........................................................................................................................ 耐受性和安全性的临床前证据 ....................................................................................... 临床前免疫原性模型...................................................................................................... 临床前疗效研究............................................................................................................. 拜科奇临床前研究小结 .................................................................................................. 临床研究........................................................................................................................ 对既往接受过治疗的患者（PTPs）的研究.................................................................... 0 药代动力学 .................................................................................................................... 0 疗效............................................................................................................................... 临床免疫原性 ................................................................................................................ 外科手术中的应用 ......................................................................................................... 安全性 ........................................................................................................................... 对既往未接受过治疗（PUPs）或仅接受过最低限度治疗（MTPs）的患者的研究 ....... 拜科奇用于治疗PUPs/MTPs的安全性及疗效 ................................................................ PUPs/MTPs中抑制物的产生率...................................................................................... 重组人凝血因子VIII抑制物的形成.................................................................................. 1 抑制物形成的潜在标志物 .............................................................................................. 1 抑制物形成的发生率...................................................................................................... 抑制物分子 ................................................................................................................... 抑制物的特异性............................................................................................................. 对PTPs的临床免疫原性研究 ......................................................................................... PUPs/MTPs中抑制物发生率的比较 ............................................................................. 抑制物产生的累积风险 .................................................................................................. 0 小结：拜科奇与凝血因子VIII抑制物 .............................................................................. 1 免疫耐受诱导 (ITI) ........................................................................................................ 长期预防........................................................................................................................ 产品亮点总结 ................................................................................................................ 0 参考文献........................................................................................................................
MilliporeSigma LC-Pak 产品说明书
Data SheetLC-Pak®LCPAK00A1IntroductionThe LC-Pak® polisher is areverse-phase C18 granularsilica-based cartridge. It has beenvalidated to produce 500 L of watersuitable for trace and ultra-traceorganic analysis, when fed withMilli-Q® ultrapure water.Ultrapure water treated by anLC-Pak® polisher is suitable foreluent, buffer or blank preparation,sample dilution and standardpreparation, as well as columnrinsing in applications such asUHPLC, LC-MS, LC-MS-MS.Instructions are available as aself-guided wizard, directly on theQ-POD® dispenser display of theMilli-Q® IQ 7000. You can accessthem from the Consumables menuor the Maintenance menu.For more information, refer tothe user manual or quick guide.The life science business of Merck operates asMilliporeSigma in the U.S. and Canada.2Note:The flow tip can be located either on your old LC-Pak ® or, if it is a new a installation, it is provided with the Application-Pak installation kit (EDSKIT001).1. Remove the new LC-Pak ® from the package.2. Remove and discard the caps at the inlet and outlet of the cartridge.3. Install the flow tip at the outlet.Step 21. Syringe adapter2. Clean glass Luer slip tip syringe (50 mL) *3. 50 mL of high grade methanol *Required material for LC-Pak ® conditioning:Step 1Conditioning• The LC-Pak ® polisher is manufactured, packed and shipped dry.• Prior to installation, it is necessary to condition its reverse-phase silica with high grade methanol (99.9+%).W ear eye safety glasses, laboratory gloves and other appropriate safety equipment when working with methanol.* Purchased separately.23• T wist the new LC-Pak ® into place.Flush the cartridge with ultrapure water for at least 10 minutes.• T he LC-Pak ® installation is now complete. You can dispense ultrapure water from the cartridge for your application.• R emove the expired Application POD-Pak if any.Step 4Step 5Step 6Step 7Installation• The LC-Pak ® cartridge has a Luer female inlet connection designed for direct connection to the outlet of Q-POD ® remote dispenser of Milli-Q ®IQ 7000 system.1. Press the dispenser wheel to start rinsing.2. After 10 minutes (at least 20 L) of rinsing, press the dispenser wheel again to complete the installation.Your LC-Pak ® certificate of quality is available onLit. No. DS5434ENEU Ver. 1.02017 - 0634701/2018OperationEvery day, discard the first liter of water produced by the water purification system to minimize environmental contamination from the water outlet.Multiple applicationsIf water dispensed requires bacteria levels below 0.1 CFU/mL and particles < 0.22 μm, you can adapt a Millipak ® filter after the LC-Pak ® cartridge using the connector provided in the installation and conditioning kit (EDSKIT001).Water purified through this cartridge may not be suitable for other applications.For your Milli-Q ® water to match several applications, you may connect up to 4 Q-POD ® remote dispensers to your Milli-Q ® production unit. Install your LC-Pak ® at the outlet of one Q-POD ® dispenser and select amongst our range of POD-Paks the suitable ones for your other applications (visit )MaintenanceValidation tests performed in our laboratories have demonstrated that, once conditioned, the LC-Pak ® cartridge can deliver ultrapure water suitable for UHPLC, LC-MS, LC-MS-MS applications for at least 500 liters when fed by ultrapure water from a Milli-Q ® IQ 7000 water purification system.Feed waterResistivity 18.2 MΩ.cm @ 25°C and TOC < 5 ppb Inlet connectionLuer female Water temperature5 – 30°C Cartridge lifetime 500 litersHousingPolypropylene ConnectorPolyethylene Purification mediaReverse-phase silica beads Sintered filterPolypropylene Reverse-phase silica compression disc PolypropyleneDescriptionCat. No.LC-Pak ® polisherLCPAK00A1Application-Pak Installation Kit EDSKIT001© 2018 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved. Merck, the vibrant M, LC-Pak, Milli-Q, Millipak and Q-POD are trademarks of Merck KGaA, Darmstadt, Germany and/or its affiliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources.Merck KGaA Frankfurter Strasse 250, 64293 Darmstadt, Germany。
BlazeTaqSYBRGreenqPCRMix2.0用户手册说明书
BlazeTaq™SYBR®Green qPCR Mix2.0For universal quantitative real-time PCRWith ROX Reference Dye Without ROX Reference Dye Cat.No.QP031(20μl×200reactions)Cat.No.QP041(20μl×200reactions) Cat.No.QP032(20μl×600reactions)Cat.No.QP042(20μl×600reactions) Cat.No.QP034(20μl×1000reactions)Cat.No.QP044(20μl×1000reactions) Performance optimized for All-In-One™qPCR Primers,All-In-One™miRNA qPCR Primers, miProfile™miRNA qPCR Arrays,ExProfile™Gene qPCR Arrays,All-In-One™First-Strand cDNA Synthesis Kit and All-In-One™miRNA First-Strand cDNA Synthesis KitUser ManualGeneCopoeia,Inc.9620Medical Center Drive,#101Rockville,MD20850USA301-762-0888866-360-9531***********************USER MANUALBlazeTaq™SYBR®Green qPCR Mix2.0I.DescriptionII.Related ProductsIII.Contents and StorageIV.PreparationV.ProcedureVI.ExampleVII.Trouble Shooting GuideVIII.Limited Use License and WarrantyI.DescriptionBlazeTaq™SYBR®Green qPCR Mix2.0is a SYBR®Green-based fluorescence quantitative PCR assay. This product is a ready-to-use5×premix solution that allows for rapid,specific quantitation of template DNA by simply adding your DNA template,primers,and sterile water.The product incorporates a new antibody-modified BlazeTaq™hot-start DNA polymerase that can block enzyme activity at room temperature and block nonspecific amplification more efficiently.With initial denaturation at95ºC for30s,polymerase can be fully activated,which can significantly reduce the qPCR reaction time.In addition,the optimized buffer system significantly improves the sensitivity and repeatability of the Real Time PCR reactions,and has the characteristics of high amplification efficiency,strong specificity and wide linear dynamic range.Also it can effectively inhibit the production of primer dimers and further enhance reliability of experimental results.II.Related ProductsGeneCopoeia offers comprehensive solutions for studying gene expression.A careful process of co-development ensures that they work well together and provide robust and reproducible results.Product DescriptionSureScript™First-Strand cDNASynthesis KitReverse transcribe mRNA into first–stand cDNAAll-in-One™qPCR Primers Validated,gene-specific primers ensure specificity and sensitivity (human,mouse and rat)ExProfile™Gene qPCR Arrays High-throughput or focused group profiling of gene expression All-in-One™miRNA First-StrandcDNA Synthesis KitReverse transcribe miRNA into first–stand cDNAAll-in-One™miRNA qRT-PCR Detection Kits SYBR®Green-based detection kit accurately quantifies miRNA expressionAll-in-One™miRNA qPCR Primers Validated human,mouse,rat miRNA primers for robust, reproducible and reliable quantitation of miRNA activitymiProfile™miRNA qPCR Arrays High-throughput or focused group profiling of miRNA expression RNAzol®RT RNA Isolation Reagent Easy isolation of mRNA,microRNA or total RNAIII.Contents and StorageContents and storage recommendations for the BlazeTaq™SYBR®Green qPCR Mix2.0are provided in the following table.For kits with the catalog number QP031,QP032and QP034Catalog Number Contents Quantity Storage temperature/conditionsQP031-015×BlazeTaq qPCR Mix 1×800µL3×800µL5×800µLStore at-20°C(Stable for at least12months)Alternatively,thesolution can also be stored at-80°C in aliquots.Avoid repeatedfreezing/thawing.QP001-02ROX Reference Dye(30μΜ)1×80µL3×80µL5×80µLStore in dark at-20°C(Stable for atleast12months)Alternatively,thesolution can also be stored at-80°Cin aliquots.Avoid repeatedfreezing/thawing.Contents and storage recommendations for the BlazeTaq™SYBR®Green qPCR mix2.0(without ROX) are provided in the following table.For kits with the catalog number QP041,QP042and QP044Catalog Number Contents Quantity Storage temperature/conditionsQP031-015×BlazeTaq qPCR Mix 1×800µL3×800µL5×800µLStore at-20°C(Stable for at least12months)Alternatively,thesolution can also be stored at-80°C in aliquots.Avoid repeatedfreezing/thawing.IV.PreparationWearing a lab coat,disposable gloves and protective goggles are recommended when handling chemicals.IMPORTANT NOTES:1.When using the BlazeTaq™SYBR®Green qPCR Mix2.0with miProfile miRNA qPCR Arrays andAll-in-One miRNA First-Strand cDNA Synthesis Kit for miRNA expression profiling,please follow the miProfile miRNA qPCR array user manual for the complete instruction.2.Store the kit at–20°C.Avoid storage or leaving reagents at4°C or room temperature.Avoid lightexposure at all times.3.Mix reagents thoroughly by gently inverting tubes several times while avoiding bubbles,and thenbriefly centrifuge before use.4.Prepare the reaction mix with PCR grade water.5.Follow standard procedures for PCR to avoid nucleic acid contamination and non-specific amplification.6.Read all procedures before setting up the PCR reaction.V.Procedure1.Thaw the5×BlazeTaq qPCR Mix and ROX Reference Dye(only supplied in Cat.Nos.QP051,QP052, and QP054)as needed.2.Prepare the PCR reaction mix on ice.See the example below.Reagent Volume Final concentration 5×BlazeTaq qPCR Mix a4μl1×PCR forward primer(2µM)b2µl0.2µM cPCR reverse primer(2µM)2µl0.2µMTemplate d2μlROX Reference Dye e(30μΜ)ifneeded0.4-0.1μl600nM-150nMWater(double distilled)■Not using ROX Reference Dye10μl■Using ROX Reference Dye9.6-9.9μlTotal20μle the5×BlazeTaq qPCR Mix as half of the total reaction volume and adjust other reagents accordingly.If the total reaction volume is changed,maintain each component in the proper proportion.b.Primers are important considerations to ensure success with real-time PCR.All-in-One™human,mouseand rat primer sets from GeneCopoeia have been validated to provide specific and sensitive amplification even with low copy number genes.For designing your own primers,you may wish to use Oligo primer analysis software(Molecular Biology Insights)or Primer Premier software(Premier Biosoft International).c.Primer concentration should be in the range of0.2to0.6µM.In general,a PCR reaction using0.2µMprimers produces good results.If the PCR efficiency is low,consider increasing primer concentration.However,keep in mind that non-specific PCR products may also increase with increased primer concentration.d.Generally,the amount of DNA template should be less than100ng.Because different templates containvarying copies of a target gene,it may be necessary to perform a gradient dilution to determine the optimal amount of DNA template to use.If reverse transcript cDNA is used as template,dilute before use.Do not add more than5%of the original cDNA solution volume to the total qPCR reaction solution.e.ROX Reference Dye is only supplied in BlazeTaq™SYBR®Green qPCR Mix2.0(Cat.Nos.QP031,QP032and QP034).It should be added only for qPCR instruments that require ROX for calibration.ROX Reference Dye provides an internal reference to which the reporter-dye signal can be normalized during data analysis.Normalization is necessary to correct for fluorescence fluctuations due to changes in concentration or volume.Adjust the ROX Reference Dye to optimal concentration according to different qPCR instruments.Instrument ROX per20µl PCR Reaction Final ConcentrationNone No ROXBioRad iCycler,MyiQ,iQ5,CFX-96,CFX-384,EppendorfMastercycler realplex,RocheLightCycler480,LightCycler2.0ABI PRISM0.4µl(0.2-0.4µl)600nM(300-600nM)7000/7300/7700/7900HT and7900HTFast,ABI Step One,ABIStep One PlusABI7500,7500Fast,ABI ViiA7,0.1µl(0.02-0.1µl)150nM(30-150nM) Stratagene Mx3000P,Mx3005P,Mx4000For other instruments that need calibration of ROX but have not been listed out in the table,please optimize the concentration of ROX according to the guideline of specific instrument.3.Mix the PCR reaction mix sufficiently and add to the PCR reaction tubes.4.Briefly centrifuge to make sure all the reagents are at the bottom of the reaction tubes.5.The following two-step method for programming the PCR reaction is recommended:Cycles Steps Temperature Time Detection1Initial denaturation95°C30sec NoDenaturation95°C10sec No 40Annealing and Extension60°C30sec Yes Notesi.When using SYBR Green dye to monitor the qPCR reaction,a melting curve analysis should beperformed immediately at the end of cycling.(the example was adapted from the ViiA™7real-time PCR detection system from Applied Biosystems):Step Temperature range Heating Rate Constant temperature/Duration Detection 172-95°C 2.05°C/sec95°C/15sec No295-60°C-1.71°C/sec60°C/60sec No360-95°C0.05°C/sec95°C/15sec YesThe conditions for your instrument may differ,consult the documentation of your qPCR instrument for instructions.ii.The DNA polymerase used in the5×BlazeTaq qPCR Mix is a special antibody modified hot-start enzyme.Incubation for30seconds at95°C will sufficiently activate the enzyme.iii.The optimal fragment length to use for amplification during real-time PCR is in the range of80-150bp.However,fragment lengths up to500bp are possible.iv.The main condition for the above reaction are referred to in the ViiA7qPCR instrument manual from ABI.If a qPCR instrument from another commercial source is used,please reference the instrument manual and adjust the extension time and melting curve conditions accordingly.VI.ExampleObjective:The amplification efficiency and detection sensitivity of the5×BlazeTaq qPCR Mix are assessed by standard curves made by gradient dilution of double stranded DNA standard.The target fragment is452bp.Equipment:ViiA™7System real-time PCR instrument(ABI)Procedure:1.The DNA standard was serially diluted to8concentrations ranging from107to1molecules/µl.2.PCR reaction mix was prepared(at RT).Reagent components Volume5×BlazeTaq qPCR Mix4µlPCR forward primer(2µM)2µlPCR reverse primer(2µM)2µlddH2O7µlTotal15µl3.Mix the above reagents sufficiently.Aliquot to PCR tubes after a brief centrifugation.4.Add5μl of the diluted DNA template to each PCR e5μl ddH2O as a negative control.5.Program the PCR reaction and corresponding reading conditions of the melting curve:Cycles Steps Temperature Time Detection1Initial denaturation95°C30sec No40Denaturation95°C10sec No Annealing and Extension60°C30sec YesMelting curve analysis:Step Temperature range Heating Rate Constant temperature/Duration Detection 172-95°C 2.05°C/sec95°C/15sec No295-60°C-1.71°C/sec60°C/60sec No360-95°C0.05°C/sec95°C/15sec Yes6.Analyze the amplification and corresponding melting curves after the qPCR experiment:Amplification curves of serially diluted DNA standard.Peak values of amplified products in melting curves.7.Construct a standard curve using the Ct values from each amplification curve:8.Conclusion :The peak values from the amplification and melting curves show that as low as 5molecules can be detected when using DNA as a template and that there is only a single amplified product,showing that very high sensitivity can be attained using the BlazeTaq™SYBR ®Green qPCR mix 2.0.At the same time,high amplification efficiency is also shown by the good linear relationship among each concentration of serially diluted DNA standard.Melting CurveVII.Trouble Shooting GuidePoor precision or failed qPCR reactions ∙Make sure the initial denature time was set as10min,sufficiently activating of the hot-start polymerase could avoid non-specific amplification and production of primer-dimers.∙The fluorescence detection temperature may not be appropriate.Adjust accordingly.∙The set up position for reaction samples in the real-time PCR instrument may not be right.Adjust accordingly.∙PCR cycle conditions,primer concentration and primer sequences may not be appropriate.Adjust the primer concentration and annealing temperature.If this does not work,redesign the primers.∙The template sample purity may not be adequate.Purify the template sample by phenol/chloroform extraction and ethanol precipitation.If the samples are reverse transcribed cDNA,set up the qPCR reaction with a diluted sample as other concentrated reagents in the RT reaction mixture may be interfering with the qPCR.∙Try to use3.0%agarose gel electrophoresis to check the qPCR products.Check the purity of the primers by electrophoresis or use PAGE-purified primers if the bands are diffused.One may also use phenol/chloroform extraction and ethanol precipitation methods to treat the primers before the experiment.Abnormal meltingcurvesSignal in the blank(No Template Control)sample∙There may be contamination of the positive samples in the qPCR reaction system if the T m of the melting curve of the blank control is the same as the positive control.Eliminate sample application error first.If the situation still persists,replace the PCR grade water and/or primers and/or use a new5×BlazeTaq™qPCR Mix.∙If the T m of the melting curve of the blank control is lower than the positive control,the qPCR reaction may have produced nonspecific amplification such as primer-dimers.Prepare the qPCR reaction mix on ice and increase the temperature of fluorescence detection.If this does not work,redesign the primers.Double peaks and multiple peaks in the melting curve of the positive control∙In the absence of other primers present in the reaction,double or multiple peaks in the melting curve of the positive control indicate that the qPCR reaction produced nonspecific amplification fragments.Prepare the qPCR reaction mix on ice;optimize the qPCR reaction conditions,for example,by increasing the annealing temperature, decreasing the primer concentration or increasing the fluorescence detection temperature(not more than the T m value of the expected product).If this does not work,redesign the forward primer.No peaks or abnormal peaks in the melting curve(or theamplification curves)of the positive control∙Adjust the ROX Dye to optimized concentration according to instrument.No signal(Ct)or late appearing signal ∙Not enough PCR cycles.For good sensitivity,one should generally set up more than35PCR cycles,but more than45cycles may result in too much background signal.∙The amount of template used may not be enough or the template may be e the highest concentration possible of diluted template samples to set up the qPCR.At the same time,avoid freezing and thawing the samples repeatedly.∙The amplification efficiency is low and the qPCR reaction conditions are not optimal.Redesign the primers and optimize the reaction conditions.VIII.Limited Use License and WarrantyLimited Use LicenseFollowing terms and conditions apply to use of all BlazeTaq™SYBR®Green qPCR mix2.0(the Product).If the terms and conditions are not acceptable,the Product in its entirety must be returned to GeneCopoeia within5calendar days.A limited End-User license is granted to the purchaser of the Product.The product shall be used by the purchaser for internal research purposes only.The Product is expressly not designed,intended,or warranted for use in humans or for therapeutic or diagnostic use.The Product must not be resold,repackaged or modified for resale,or used to manufacture commercial products without prior written consent from GeneCopoeia.This Product should be used in accordance with the NIH guidelines developed for recombinant DNA and genetic e of any part of the Productconstitutes acceptance of the above terms.Limited WarrantyGeneCopoeia warrants that the Product meets the specifications described in the accompanying Product Datasheet.If it is proven to the satisfaction of GeneCopoeia that the Product fails to meet these specifications,GeneCopoeia will replace the Product.In the event a replacement cannot be provided,GeneCopoeia will provide the purchaser with a refund.This limited warranty shall not extend to anyone other than the original purchaser of the Product.Notice of nonconforming products must be made to GeneCopoeia within30days of receipt of the Product.GeneCopoeia’s liability is expressly limited to replacement of Product or a refund limited to the actual purchase price.GeneCopoeia’s liability does not extend to any damages arising from use or improper use of the Product,or losses associated with the use of additional materials or reagents.This limited warranty is the sole and exclusive warranty.GeneCopoeia does not provide any other warranties of any kind,expressed or implied,including the merchantability or fitness of the Product for a particular purpose.GeneCopoeia is committed to providing our customers with high-quality products.If you should have any questions or concerns about any GeneCopoeia products,please contact us at301-762-0888.©2019,GeneCopoeia,Inc.GeneCopoeia,Inc.9620Medical Center Drive,#101Rockville,MD20850Tel:301-762-0888Fax:301-762-3888Email:***********************Web:GeneCopoeia Products are for Research Use Only Copyright©2019GeneCopoeia,Inc. Trademarks:GeneCopoeia™,SureScript™,BlazeTaq™,All-in-One™,ExProfile™,miProfile™(GeneCopoeia Inc.);RNAzol®(Molecular Research Center, Inc.);SYBR®(Molecular Probes);iQ™5(Bio-Rad);ROX®(Invitrogen);ViiA™(Applied Biosystems).QP031011019。
Keyence LK-Navigator 2 TN11 技术说明说明书
Keyence LK-Navigator 2TN11 Technical Note for the KLIPPEL R&D and QC SYSTEM (Document Revision 1.1)The Keyence LK-Navigator 2 software is dedicated to all Laser Sensors from the Keyence LK-G5000 Laser Series.The LK-Navigator 2 is not included with LK-G5000 Lasers Sets bought from Klippel. It has to beordered separately. Following note giving just a short introduction to the customer who ownit.From Klippel bought LK-G5000 Lasers Sets came with a small Klippel Keyence Tool to loadKlippel provide setups to the Laser Controller. This tool requires a serial connection. A specialserial adapter cable and USB to serial converter are included.1How to load a Klippel provided Setup file into the software1.1Start LK-Navigator 21.2Load from fileAfter program start:Or from menu during program operation:1.3Select Setup fileLoad from file2How to connect the LK-Navigator to the Laser Controller 2.1Connection Settings2.2Connection via RS-2322.3Connection via USB3How to load a Setup File to the Laser ControllerWait until:4How to use the Measurement Value Display 4.1Open the Measurement Value Display4.2Start the Measurement Value Display5 How to change settingKlippel provides approved and dedicated settings for loudspeaker measurements. It is strongly recommend to keep the Klippel settings. Klippel does not support own settings. For more information read the Keyence provide LK-Navigator 2 manual.6 ReferencesAll screenshots are taken from the German software version.Related English screenshots can be found in the included Keyence Manual.Find explanations for symbols at:http://www.klippel.de/know-how/literature.html Last updated: 27.3.2018。
深究扬声器频响曲线的测量
深究扬声器频响曲线的测量杨军;谢守华【摘要】扬声器及其系统的频响曲线无疑是设计及生产环节最重要的性能指标.但通过对市面上的一些主流电声测试系统的研究发现,其频响曲线的算法不尽相同,在特殊情况下频响曲线的结果会产生较大差异.问题的关键在于对“频响曲线”的定义.【期刊名称】《电声技术》【年(卷),期】2018(042)006【总页数】5页(P58-62)【关键词】频率响应曲线;谐波分量;声压【作者】杨军;谢守华【作者单位】国光电器股份有限公司,广东广州510800;国光电器股份有限公司,广东广州510800【正文语种】中文【中图分类】TN6431 引言扬声器的频率响应曲线(也就是我们常说的频响曲线)一直是设计及质量控制的最基本也是最重要的参数。
是否准确的测量这个参数对于设计和生产尤为关键。
2 基本原理目前扬声器的频响曲线主要是依据行业内通行的国际标准《IEC60268-5 Sound system equipment-Part 5:loudspeaker》［1］和与之等效的国标《GB/T 12060.5声系统设备:扬声器主要性能测试方法》［2］的相关章节来进行，如图1所示。
图1 IEC标准第21节国标GB/T 12060.5的相关内容如下，基本是 IEC标准的翻译稿。
如图2所示。
图2 国标第21节从标准的定义来看，自由场及半自由场条件下的扬声器频响曲线应该是在参考轴线(一般是扬声器的轴心线方向)并馈给被测扬声器特定正弦波或者带通噪声电压及频率下的声压级。
所以按照字面的意思来理解的话，这个频响应该是包含了该点的所有谐波的响应，也就是总的声压级，并未单指基波(Fundamental)。
从扬声器的理论角度来看，其频响曲线的定义并未明确指出是包含了全部谐波分量的总声压级，还是只有基波。
但是从设计或是工程的角度来说，基波是我们期望的结果，谐波分量并不是我们希望看到的(理论上来说谐波越少越好)，可以通过THD总谐波失真的测量来另外分析。
KLIPPEL 品质控制测试系统 说明书
QC 品质控制测试系统 - 线上终端测试C3版本：2.0特点效益• 在物理门限下非常快速地测量 • 高精度扫描技術• 简单门限计算，合格/不合格分类 • 自動檢測 Golden Unit – 标准参考件 • 自行開發的獨有Rub & Buzz 异音測試 (Meta Hearing 技术)• 自动重复生产线环境噪声检测 • T/S 參数 (Re, fs, Qts) • 阻抗, 频率响应 • 极性, 平均电平 • 闸性脈冲响应• 總諧波失真THD, 2nd – 5th 次失真，多音 • 驱动和悬边测试 • 線圈位置 - 毫米 • 悬边不平衡 – 百分比 % • 測試数據輸出工具 • 生產指数 (Cpk, Ppk) • 不同的操作级别（操作员、 品质控制工程师、程序员） • 高级編程版本 • 揚声器配对功具 • 自動檢測功放增益 • 測試報告产生器• 通过数字接口方便整合到生产装配线 • 中、英文操作手册特定的配置可能不包括上面列的所有特点提供100%的产品测试 确保产品的一致性比人耳听觉测试更加可靠 简易的直接的操作 生产线噪声免疫在生产进程中可以无缝整合 与Klippel R&D 分析仪系统兼容灵活可靠的解决方法满足不同 公司的需求高级编程语言提供不同编程要求应用扬声器 、耳机 、微声器 整個音頻系统 线上终端测试来料检查内容:总览 (2)硬件...............................................................................................................................................3 - 4 QC 軟件 (标準版本)....................................................................................................................5 - 7 操作模式.. (8)Rub & Buzz 异音....................................................................................错误！未定义书签。
Kruppel样因子15——多功能转录因子的功能研究
Kruppel样因子15——多功能转录因子的功能研究李丽;朱伟;魏盟【摘要】Kruppel样因子15(KLF15)是Kruppel样转录因子家族中的一员.Kruppel样转录因子家族特征性结构是含有3个Kruppel样锌指结构,与DNA 的CACCC元件和富含GC区连接,从而调控转录激活或抑制.KLF15在许多生物过程中起重要作用,包括细胞的增殖、分化、发展和凋亡.研究证实,KLF15参与调节三大物质代谢:糖代谢、脂肪酸代谢、氨基酸代谢.在循环系统方面,KLF15过表达能够抑制心肌肥厚,而KLF15的缺乏会引起心力衰竭、主动脉瘤的产生.此外,KLF15在肾病、肾纤维化、骨骼肌脂质利用、昼夜节律等诸多方面起重要作用.随着对KLF15功能的认识越来越深入,KLF15有望成为有效治疗致死性疾病的新靶点.【期刊名称】《医学综述》【年(卷),期】2014(020)016【总页数】3页(P2916-2918)【关键词】Kruppel样因子15;糖异生;心脏;肾病【作者】李丽;朱伟;魏盟【作者单位】上海交通大学附属第六人民医院心内科,上海200233;上海交通大学附属第六人民医院心内科,上海200233;上海交通大学附属第六人民医院心内科,上海200233【正文语种】中文【中图分类】R541.4;R587.1Kruppel样因子15(Kruppel-like factor-15，KLF15)由KLF15基因表达，具有3个高度保守的锌指结构[1]。
研究证实,3个锌指结构具有核定位信号，使KLF15转入细胞核并与DNA的CACCC元件和富含GC区连接定位，而锌指结构2和3是KLF15进行核定位的必备条件[2]。
KLF15在组织器官中广泛表达，尤以心脏、肾、肝、脂肪细胞、骨骼肌为甚，KLF15的表达受许多物质的调控：激活的糖皮质激素受体、糖皮质激素信号、禁食等上调 KLF15表达，喂食、肥胖、白细胞介素17等抑制其表达[3]。
摩尔克斯 Pico-Clasp 线路到板面连接器说明书
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LabChip GXII Touch电泳系统产品说明书
The LabChip® GXII Touch Capillary Electrophoresis System usesa single sipper microfluidic chip to rapidly characterize protein samples from 24-, 96- or 384-well plates. The microfluidics chip technology automatically stains, destains, electrophoretically separates and analyzes the protein samples. After the Labchip instrument optics detect the laser-induced fluorescent signal, easy to use system software automatically analyzes the data and provides the user with protein concentration, molecular weight sizing and percent purity using ladder and marker calibration standards. Digital data results are immediately available for review or reporting in virtual gel, electropherogram or table summary formats (Figure 1).Choose from multiple assays to characterize protein(s) of interest - from the Protein Express, Pico and Low Molecular • A utomated analysis provides significant cost savings relative to the materials and labor required to run manual gels for protein analysis• E asy to use digital format facilitates review, export, and archiving of data• E xtended workflow setup allows a single chip preparation to support multiple sample processing runs within an eight hour window• F lexible data display options - Results shown in your choiceof virtual gel, electropherogram graph or tabular formatsLabChip GXII Touch Protein Assay PortfolioFigure 1. Shown is the graphical user interface for the LabChip GXII Touch software.For a complete listing of our global offices, visit /ContactUsCopyright ©2014-2017, PerkinElmer, Inc. All rights reserved. PerkinElmer ® is a registered trademark of PerkinElmer, Inc. All other trademarks are the property of their respective owners.011768C_01 PKIPerkinElmer, Inc. 940 Winter StreetWaltham, MA 02451 USA P: (800) 762-4000 or (+1) 203-925-4602Specifications for LabChip Protein KitsOrdering Information。
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第一个 测试站
第四页 4
被测设备
两套电流和电压传感器可以 在生产线两个测试站之间交替测量， 利用测试时间间隔来连接下一个扬 声器，避免了使用两套仪器。
第二个 测试站
全面的测量
Comprehensive Testing
KLIPPEL QC 系统提供对换能器系统、电子线路系统如功放、混音器以及其他具有模拟/数字输入接口的多通道音 频设备等系统灵活的、高性能表现的、全面的测量。麦克风多路复用器、输入和输出可以由分析仪后面的 GPIO 接口来控制。
动作
校正静态 位置
音圈
第八页 8
不合格: 音圈位移
音圈
音圈位移 (mm) 硬度不对称性 (%) 最大峰值位移 (Xmax) 磁力因数位移 XBl 顺性位移 XC
在线诊断
On-Line Diagnostics
KLIPPEL QC 系统集成了先进的诊断技 术，用于生产线终端测试，简化了测试 结果的说明，指示出扬声器缺陷产生的 根源。不仅是提供维修的依据，而且还 可以发现参数变化的趋势，调节 制造 过程，及时减少产品不良率，确保产品 的高品质和一致性。
非常简易
as simple as possible
用启动工具组织测试与测试模板自动设置限制条件工具
灵活的数据导出功能以及后续处理
flexible data export and post-processing
报告产生、生成文本文件的提取工具扬声器的匹配选择工具
提供快速的过程自动化
ready for process automation
对 Rub & Buzz、松散微粒和其他激励失真进行时域分析检测与定位空气泄漏噪声
生产线环境下，非常耐用和强力测试
robust in a production environment
可靠的噪声检测自动重复测试以及合并有效数据来免除噪声干扰
最小化不良率
minimal rejection rate
在线诊断扬声器的缺陷驱动和悬吊系统检测(亳米的音圈位移 mm)
我的應用 品质控制系统
可靠的硬件用于在线测试
Solid Hardware for End-of-line Testing
100dB 信噪比 4 个 输入模块(2XLR 线输入+ 2BNC 输入)可选 通過先置放大器控制步进 1dB，保证了最大的信噪比 使用 ICP 供电模式的麦克风、加速计和其它 2个 扬声器连接端可保证同时测量高音和低音喇叭
28% 有效
62% 累閃
85% 累閃
100% 累閃
7 第七页
音圈偏移
最小化不良率
Minimal Rejection Rate
电子测 量
驱动及悬吊系统检查
Motor and Suspension Check
通风箱系统
功放
在小信号和大信号模式下测量 T/S 参数和非线性参数。扬声 器放在自由场中或者密封的扬声器箱中，不需要测试麦克风 或其他传感器，所有的测试信息将使用电子线路的输入电流 来测量，避免环境噪声的干扰，以下参数在1秒或更短的时 间内测量出来。
限制条件
常规的 Meta-Hearing 限制条件
Meta-Hearing 异音
微粒
KLIPPEL QC 系统检测来自于密封箱体的空气泄 漏、防尘盖上的杂乱物质、支架、孔的各种噪 声。快速的检测技术远优于人耳听力，用来区分 环境噪声和其他扬声器单元产生的异音，空气 泄漏追踪器在手动检查过程中是一个检测空气泄 漏点的非常好用的工具。
任何类型的换能器 (音圈移动，靜电，压电和平衡电枢) 安装在密闭的、敞开的扬声器箱体内的单元，喇叭 ......... 车身上的单元 音频电子产品(功放、DSP 数字处理器) 单一的或多通道的扬声器系统 具有数字与声学延迟的系统(MP3 播放器) 無源，有源含模拟、数字接口的系统(USB) 0.5Ω 至 20k Ω 阻抗: (車机，100V 專业功放) 1mW 到 1kW 功率的测试范围(通讯领域、专业应用) 1mA 到 60A 电流(麦克风、混音器) 5Hz 到 90kHz 的频率范围(重低音、高音单元)
对于 QC 工程师和操作员，提供不同级别的访问权限。操作员仅仅可以看到测试所需的控制元件，因此，降低 了测试复杂性，确保了很短的培 训时间。开始阶段，操作说明表将指导工程师和操作员如何操作。
直观的、可自定义的用户接口 预置最优的测试任务 QC 工具箱-普通的测量无需经过编写程序 多重任务可连接到一个测试序列
数据库 被测设备
概要文件
提取工具
美国资訊 交換标準 代碼文字 檔案
测量系统产生 ASCII 格式的概要文件 (pass, fail, 结论, 单值测试参数)，存储为易读的文件格式。快速导出 可以将所有测试结果保存为一个二进制文件。提取工具提供对所有测试数据的访问功能，并且可以灵活地 形成你所需求的文件格式。不同的输出格式可以用来产生测试过程控制、长时间的统计分析、诊断以及客 户的测试报告。
参量测量
Parameter Measurement
加重量的技术测量 T/S 参数 Re, fs, Bl, Mms, Qts, Qes, Qms Rms Vas, Kms 通风箱系统的共振频率fb 和功耗因数 Q1 最大峰值位移(Xmax)
多音失真来揭示失真与互调成分保证同时测量 高音和 音圈偏移(mm) 硬度不对称性(%)
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比人耳听力更灵敏
More Sensitive Than Human Hearing
异音
Rub and Buzz
在标准系统里采用独特的跟踪滤波器，获取时域 高次谐波的相位和幅度信息，以及音圈碰撞或摩 擦产生的冲击失真缺陷。
信号发生器
可选的 Meta-Hearing 技术提供额外的灵敏度，用 来检测扬声器异音。自适应模型测量扬声器的非 线性和综合良好单元也会产生的常规失真 这种 有效的测量信号常规失真补偿清晰地揭示了扬声 器缺陷，而这些缺陷是不可聽的，而且完全被常 规失真所掩蔽 。
伽伐尼式去耦电流传感器高达 60A 电压传感器高达 300V 温度和湿度传感器用来监测大气条件 通用的数字输入输出引脚 (GPIO)
温度湿度 传感器
开关(脚 踏、手动)
测试麦 克风
环境噪声 (1m 距离)
功放
系统提供多种配置选择。这里仅 仅是 PA2 生產分析仪、控制电 脑、脚踏开关、功放、测试麦克 风、环境噪声监测麦克风。外置 的功放可以灵活选择不同要求的 测试应用。
如果新的支架系统导致音圈静态位 发 生改变时，当第一个产品被 KLIPPEL QC 检测到时，音圈的位移量可以 马上 测量出来；这一信息可以用来校准音圈 的静态位置，以及用来补偿悬吊系统改 变的部分，有音圈位移问题 的扬声器单元就不会输送出来。
非常简易
As Simple as Possible
klippel® 品质ห้องสมุดไป่ตู้制系统
klippel® qc system
100%
在线终端测试
100% end-of-line testing
KLIPPEL QC 可以在线终端测试提供什麽:
What KLIPPEL QC Offers for End-of-line Testing:
KLIPPEL 仪器，扬声器设计开发领域世界公认的标准，开发了新一代专门用于品质控制的诊断工具。
使用 200 ms 的chirp 信号
声压级
异音
谐波失 真
T/S 参数
阻抗
2nd-5th 谐波
测量进行时，同时作出强大的信号分析，减少了后续处理的时间。多种测试任务交迭，处理上一个任务回应的 同时，下一个任务的激励已信号产生，并开始激励设备。在采用這种瞬态响应这种新的分析技术，被测设备已 达到稳定状态下测量
KLIPPEL instruments, the recognized standard in R&D loudspeaker analysis, developed a new generation of diagnostics tools dedicated to Quality Control.
基本原理
统计
移动 总谐波失真
绝对
异音
抖动
底值
限制曲线可以由测试结果中自动产生，包括使用标准的变化、应用抖动、移动平均曲线、插入底值或其他运算 法则来增加有用容差等。
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灵活的数据导出和后续处理
Flexible Data Export and Post-Processing
后续统计分析 (如試算表)
激励信号
测试结 果列表
测试任 务序列
线性测量 Linear Measurements
幅频、相频响应 脉冲响应的门控 在特定频率下相位测量的极性 两通道间的串音
特定频率范围内的灵敏度 多种测试信号(正弦扫频、步进正弦、双音、 多音、波形文档) 幅度扫描条件确保最佳的信噪比 速度扫描条件-在特定的频率点提供高精度
跟 R&D 系统非常相似 自动监测连接到硬件的被测设备 多种语言支持 中文操作手册，中文开始指导表
模板管理的 QC 开始工具简化了对扬声器单元的测试 设置和对测量结果的组织，扬声器的型号和序列号 可以经由条形码阅读器获取。
智能设置限制条件
Smart limit setting
基于随机样品和统计分析计算，KLIPPEL 提供强大的手动或自动设置测试限制文件的工具。这些数据可以用来 查找出所谓的“黄金参考单元”，测试参数接近平均测量值。如果测试环境温度或其他条件发生改变，测试限 制条件可根据这些黄金单元数据来作校准或调节。
通过硬件信号与软件的輸入/ 輸出监视作出整合通过本地或者网络来远程控制多线测量
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