Sartocheck 4 manual完整性测试仪说明书中文版

Integritest4自动完整性测试仪操作规程XXXXXXX 有限责任公司达标管理文件一、目的：建立Integrtest4XIT4S0001自动完整性测试仪的标准操作维修保养规程，延长仪器的使用寿命。

二、适用范围：Integritest 4XIT4S0001自动完整性测试仪操作规程标准操作维修保养规程。

三、责任者：质量管理部。

四、内容：1：概述：Millipore Integritest 4是一种适用于多种不同规格过滤器进行在位泡点，扩散流，压力保持及HydrocorrSM测试的自动完整性测试仪。

它可以对亲水性滤膜和疏水性滤膜进行测试，并且测试的范围不局限于Millipore 的过滤膜产品。

Integritest 4是针对连续的生产流程来设计的。

它只在过滤器的上游进行完整性测试从而保证了下游的无菌性。

测试仪可以追溯和管理测试数据及结果。

测试仪使用Microsoft ?Windows XP ?嵌入式操作系统，该操作系统已经在测试仪上经过验证。

任何不按照Millipore 指定的方法去使用，Integritest 4测试仪都有可能导致设备损坏及人员伤害。

2：使用条件：Integritest 4只能在室内使用。

它可以放置在标准实验台上并可在制药厂的潮湿区域和洁净室（100级）中进行操作。

使用条件数值/范围操作温度1-40oC 在海拔-80至2000米1-35o C 在海拔2000至4000米储存温度 -20至+80oC相对湿度 5至95%，无结露现象污染等级 2 入口保护IP222.1电气规格： 2.2压缩空气条件：参数数值/范围一般要求在环境温度下(±5oC)的洁净的(每立方米小于40个粒子), 干燥(≤-20o C 露点), 无油的压缩空气或氮气最大进气压力≤120psi(8,300mbar) 最小进气压力根据测试压力要求。

进气压力要比测试压力高15psi （1，040mbar ）为了尽量避免压缩空气中的水带来的污染而导致设备损坏，推荐使用设备附带的干燥过滤器。

4-IN-1 SOIL CONDITION METERUSER’S MANUALDSMM600Please read this manual carefully and thoroughly before using this product.TABLE OF CONTENTSIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2Key Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3What’s in the Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 –4Setup Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4Install Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 –5Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6Operating & Maintenance Tips . . . . . . . . . . . . . . . . . . . . .6 –7Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7Return for Repair Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8INTRODUCTIONThank you four purchasing General Tools & Instruments' (General's) DSMM600 4-in-1 Digital Soil Condition Meter. Please read this manual carefully and thoroughly before using the instrument.The DSMM600 is ideal for measuring the temperature, pH and moisture content of soil and the intensity of sunlight shining on it. The meter cannot accurately gauge the intensity of grow lights because most light bulbs lack the full spectral range of sunlight.KEY FEATURES• Measures soil pH and temperature• Also gauges soil moisture content within 5 levels and sunlight intensitywithin 9 levels• Large backlit triple readout LCD• °F/°C switch• Auto Power Off• Low battery indication• CE approved2WHAT’S IN THE PACKAGEThe DSMM600 comes in a blister pack with this user’s manual inside the fold-over card.PRODUCT OVERVIEWFigure 1 shows the names and locations of the meter’s controls, indicators and physical structures. Figure 2 shows all possible indications on the LCD.Familiarize yourself with the labels, positions, and functions of all buttons and switches and the meaning of all display indications before moving on to the Setup Instructions and Operating Instructions.A. pH/Temp switch (on back)B. ON buttonC. Moisture/pH/temperature sensorD. Sunlight sensorE. Backlit triple readout LCDF. C/F OFF buttonG. Battery compartment (on back)H. Sensor-tipped probeI. Sensor cap3A D E F H IB GC Fig. 1. The DSMM600’s controls,display and physical structuresA. Sunlight intensity readoutB. Indicates main readoutis showing pHC. Main readoutD. Moisture level readoutE. Indicates main readout isshowing temperature F. Low battery iconSETUP INSTRUCTIONSINSTALL BATTERYTo open the battery compartment, turn the meter over and lift the tab at the bottom of the battery compartment cover (Fig. 1, Callout G). Remove the cover and set it aside. Then plug a “9V” Alkaline battery into the wired socket inside the compartment. The terminals of the battery and the socket mate in only one way, with the smaller male terminal plugging into the larger female terminal.Close the battery compartment by replacing its cover and snapping it shut.OPERATING INSTRUCTIONSTo power on the meter , press the ON button (Fig. 1, Callout B). The meter will immediately display the sunlight intensity, moisture level and temperature of the ambient environment on the three readouts (Fig. 2, Callouts A, D and C).Note that the green LCD backlight comes on automatically when the meter powers on. It will remain on for 90 seconds. To reactivate the backlight after it goes out, briefly press (but do not hold) the C/F OFF button twice. The first press will change the temperature unit from °F to °C and turn the backlight back on. The second press will switch back to °F.Also note that the meter will automatically power off after any 5-1/2 minute period during which no front-panel buttons are pressed. This Automatic Power Off (APO) function extends battery life.4Fig. 2. All possibledisplay indicationsTo power off the meter, press and hold the C/F OFF button for at least3 seconds.To measure the conditions of soil in a pot or garden plot, first remove the protective sensor cap (Fig. 1, Callout I). Then insert the probe slowly and vertically into the soil:• For plants in pots less than 1 ft. in diameter, insert the probe halfwaybetween the plant stem and the edge of the pot. Be careful not todamage delicate roots by inserting the probe close to a plant’s stem.• For plants in larger pots, insert the probe one-third of the distancebetween the stem and the edge of the pot.• If the pot is deep, push the probe deeper—where plant roots are denser. The upper and lower readouts of the DSMM600 are dedicated to sunlight and moisture levels. The meter does not indicate the precise value of either level; instead, it displays the “ballpark” range containing the current reading. The Specifications section of this manual correlates the names of displayed ranges (HGH-, NOR, WET+, for example) with the sunlight or moisture level value measured. (NOR is shorthand for normal, HGH-and NOR-mean slightly less than high and normal, NOR+is slightly higher than normal, and WET+and DRY+should be interpreted as extremely wet and dry.)To maximize the accuracy of sunlight readings, point the light sensor at the top front of the meter (Fig. 1, Callout D) toward the sun.The middle (main) readout shows soil pH or soil temperature, depending on the position of the switch at the top of the back of the meter body (Fig. 1, Callout A). To display soil pH instead of soil temperature on the main readout, slide the switch to the left (the pH position). Note that doing so causes the lower, moisture level readout to disappear.To resume showing soil temperature on the main readout, slide the pH/Temp switch to the right. If the soil temperature is lower than 16°F (-9°C), Lo will appear on the main readout. If the soil temperature is higher than 122°F (50°C), HH will appear on the main readout.5SPECIFICATIONSpH Measurement Range: 3.5 to 9.0pH Accuracy and Resolution:±0.5 pH unitsTemperature Measurement Range:16° to 122°F (-9° to 50°C) Temperature Accuracy/Resolution:±1.8°F (1°C)/1° (F or C)Moisture Level Ranges:<5% (DRY+), 5 to 10% (DRY), 10 to 20%(NOR), 20 to 30% (WET), >30% (WET+) Light Level Ranges:<500 Lux (LOW-),500 to 5000 Lux(LOW), 5000 to 10,000 Lux (LOW+),10,000 to 25,000 Lux (NOR-), 25,000 to60,000 Lux (NOR), 60,000 to 80,000 Lux(NOR+), 80,000 to 100,000 Lux (HGH-),100,000 to 120,000 Lux (HGH),>120,000 Lux (HGH+)LCD Size: 1.8 in. (46mm) diagonal; main readouthas 0.48 in. (12mm) high digitsAuto Power Off Trigger:5-1/2 minutes of front-panel inactivity Backlight Duration:90 secondsOperating Temperature:41° to 104°F (5° to 40°C)@ 5 to 95%RH, non-condensing Storage Temperature:-4° to 140°F (-20° to 60°C)@ <85%RH (without battery) Dimensions of Meter Body: 4.8 x 2.5 x 1.4 in. (122 x 63 x 36mm) Dimensions of Probe(Length x Diameter):7.9 x 0.24 in. (200 x 6mm)Weight (without battery): 2.9 oz. (81g)Power Source:(1) “9V” Alkaline battery (not included)OPERATING & MAINTENANCE TIPSWhen the Low Battery icon appears in the center of the display (Fig. 2, Callout F), it’s time to change the “9V” battery that powers the meter (although measurements will remain valid for several hours after the icon first appears). To change the battery, follow the instructions on p. 4.Take the average of multiple measurements to improve accuracy.6Do not leave the probe inserted in soil longer than necessary to make a measurement.Do not drop the meter, bend the probe, or use the probe to break up clumps of soil.Wipe the probe clean with a soft, damp cloth and dry it before and after each measurement.Slide the sensor cap (Fig. 1, Callout I) over the end of the probe after each measurement session.Do not disassemble the meter body or the probe; doing so voids the product’s limited warranty.Remove the battery if you do not expect to use the meter for an extended period of time (months or years).WARRANTY INFORMATIONGeneral Tools & Instruments’ (General’s) DSMM600 4-in-1 Soil Condition Meter is warranted to the original purchaser to be free from defects in material and workmanship for a period of one year. Subject to certain restrictions, General will repair or replace this instrument if, after examination, the company determines it to be defective in material or workmanship. The warranty period begins on the date of purchase. You are encouraged to register your product online. General will extend your warranty an additional 60 days if you register at /ProductRegistry.This limited warranty does not apply to damages that General determines to be from an attempted repair by non-authorized personnel or misuse, alterations, normal wear and tear, or accidental damage. The defective unit must be returned to General Tools & Instruments or to a General-authorized service center, freight prepaid and insured.Acceptance of the exclusive repair and replacement remedies described herein is a condition of the contract for purchase of this product. In no event shall General be liable for any incidental, special, consequential or punitive damages, or for any cost, attorneys’ fees, expenses, or losses alleged to be a consequence of any damage due to failure of, or defect in any product including, but not limited to, any claims for loss of profits.Register now at /ProductRegistry to receive a 60-day extension to your warranty.7RETURN FOR REPAIR POLICYEvery effort has been made to provide you with a reliable product of superior quality. However, in the event your instrument requires repair, please contact our Customer Service to obtain an RGA (Return Goods Authorization) number before forwarding the unit via prepaid freight to the attention of our Service Center at this address:General Tools & Instruments80 White Street New York, NY 10013 212-431-6100 Remember to include a copy of your proof of purchase, your return address, and your phone number and/or e-mail address.8GENERAL TOOLS & INSTRUMENTS80 White StreetNew York, NY 10013-3567PHONE (212) 431-6100FAX (212) 431-6499TOLL FREE (800) 697-8665e-mail:**********************DSMM600 User’s ManualSpecifications subject to change without notice©2013 GENERAL TOOLS & INSTRUMENTSNOTICE - WE ARE NOT RESPONSIBLE FOR TYPOGRAPHICAL ERRORS.MAN# DSMM600 12/03/13。

测试仪使用说明书文章来源：/esite/detail10081083.htm安全信息理解并按操作规程使用仪表.如果仪表未按IDEAL公司说明使用,仪表保护性能将受到影响. 警告未防止可能出现的电击,人身伤害或死亡,请遵循以下说明操作:不要使用明显出现损坏,金属暴露,电极破裂的仪表,尤其注意连接器周围的绝缘性.由于测试电极间存在高电压,所以正常使用过程中也存在电击危险.仪表运行不正常时,不要使用,因为此时仪表保护功能可能失效.发生电气风暴或潮湿季节时不要使用不要在带电线缆中使用在不装电池或后盖打开时,不要使用出现电池低电压符号后,需马上更换电池,避免度数错误取下电池前,需先将测试线拔下使用合格连接器,正确选择功能与量程不要私自拆改流速测算仪,仪表内没有需调整部件遵守本地安全法规,并使用适当的个人防护措施.注意随时注意"安全第一"电压超过30VAC或60VDC就有电击危险使用适当的个人防护措施,如:安全眼镜,面罩,绝缘手套,绝缘靴,绝缘垫.进行电气测量时不用使自己的身体接地与他人协同工作使用电极时,尽可能使手指与电极尖端保持最远距离.设备描述测量交/直流电压按开机仪表显示V AC()选择V AC(),按1次将测试线插入相应接口测试线接入被测电路,仪表即显示电压值.电阻与导通性按开机按2次选择3. 将测试线插入相应接口测试线接入不带电线路,按键使用测试线显示电阻值2秒清零.重复3～5步,测量电阻.绝缘电阻按开机按选择1000V/250V或500V将测试线插入相应接口将被测电路与电源和所有负载断开将测试线连接到被测线路设置测试时间缺省时间为30秒按1秒后,用选择时间:1分钟～10分钟,按确认.连通性测试:按和.屏幕显示LOCK并有声音提示.按停止测试.7.按启动绝缘测试,屏幕显示MΩ值.保持测试线与测试点接触,泻放测试电压.警告:显示符号时,表示设备正在被测线路充电或放电,有电击危险.更换电池和保险丝警告:为防止电击,在打开电池舱盖前需将测试线取下.警告:为防止着火,必须使用用规定电压,电流和熔断速度的保险丝.维护用潮软布擦拭,不用使用溶剂量程与精度交流转换:61-795为平均值测量,有效值校准精度,测试条件23℃±5℃,相对湿度小于75%温度系数:0℃～18℃,28℃～50℃内0.1倍影响项目质保条款在正常使用及维护情况下,每款美国理想工业公司(IDEAL INDUSTRIES,以下简称:理想公司)的产品都保证从材料和工艺上没有缺陷.所有仪器主机的保修期是两年,始于交货之日.产品零部件,选件,产品修理和服务则有90天的质量担保.这个担保只适于原始买主,或理想公司授权的分销商和零售商的最终用户,不适于其它理想公司认为是由于事故或非正常操作或搬运条件而造成的被误用,替换,疏忽或损坏的产品.对于新的或未使用的产品, 理想公司授权分销商或零售商只向最终用户提供上述保修,但不能以理想公司的名义提供更多或不同的保修.如果买主在一个国家购买产品而送到另一个国家修理,理想公司保留向买主索取修理/替换零部件的进囗费用的权力.对有缺陷但在保修期内送达理想公司维修中心的产品,理想公司的保修责任限于以购买价退款,或免费修理,或替换,由理想公司选择其中一种方式.欲获得保修服务,请与最近的理想公司维修中心联系,或将产品送到理想公司维修中心,请写明产品的问题,并付邮资及保险费(目的地交货). 理想公司对运输中造成的损坏概不负责.保修后,产品归还给买主,运输费预付(目的地交货).如果理想公司确定产品的损坏是由于误用,替换,事故或非正常条件下操作或搬运而造成的,理想公司将估计修理费用,并征得买主的同意才开始修理.修理之后,预付运输费,产品还给买主.买主会收到一张帐单,包括修理费和返回时的运输费(寄发地交货).本担保书是买主仅有的和全部的补偿.它取代其它所有担保,不管是说明的还是隐含的,包括但不限于任何隐含的为某个特定目的而具有的产品可销性或合理性的担保.理想公司不负责任何或特殊的,或非直接的,或事故性的,或引发的损坏或损失,包括数据的损失,不管是由于违背担保条款造成的,或基于合同,侵权行为,信任还是其它任何理由.因为有些国家或地区不允许隐含担保的期限的限制,或者事故性,或间接损失的排除或限制,所以本担保书中的限制或免责条款可能不适于每一位买主.如果本担保书中的任何条款由当地具有司法权的法庭判定无效或无法执行,这个判决将不影响任何其它条款.输入端子——连接测试线量程精度过载保护直流电压0.1-600.0V±(0.5%+1)600V AC有效值交流电压0.1-600.0V±(0.8%+4)600V AC有效值电阻0.1-199.9Ω±(2.0%+3)600V AC有效值1分钟连通性0.01-19.99Ω±(2.0%+3)600V AC有效值绝缘电阻250V0.001-0.100MΩ±10600V AC有效值0.101-3.999 MΩ±(2.0%+5)4.00-39.99 MΩ40.0-399.9 MΩ±(5.0%+5)400-1000 MΩ500V0.001-0.250MΩ±150.251-3.999 MΩ±(2.0%+5)4.00-39.99 MΩ40.0-399.9 MΩ400-2000 MΩ±(5.0%+5)1000V0.001-0.250MΩ±150.251-3.999 MΩ±(2.0%+5)4.00-39.99 MΩ40.0-399.9 MΩ400-1000 MΩ±(3.0%+5)1000-4000 MΩ±(5.0%+10)连通性测试电流,R200mA,开路电压4-24VDC,符合EN61557-2/VDE 0413 Part4.自动量程.开路电压< 1.3×Vo,正常电压精度0%+10%,短路电流<3.0mA,正常测试电流1mA@1kΩ×V(1mA@500KΩ)一般技术指标显示:9999计数/4"液晶屏幕刷新率:2.0次/秒过量程显示:OL极性识别:自动自动关机:停止按键15分钟后电池低电压指示:显示海拔高度:2000m数据保持:显示电源:6节5号电池电池使用时间:50小时/1000次测试(1000V/480KΩ)保险丝:1A/600V(#F-105)使用温度:0-40℃存储温度:-10～60℃环境湿度:<80%尺寸:240mm×100mm×45mm重量:450克附件:测试线(TL-795),6节5号电池,说明书安全标准:UL/IEC/EN 61010-131-031,EN61557,EN61326-1+1A,(EMC) CATIII-1000V/CAT IV-600V显示屏幕AUTO——自动量程LOCK——测试被锁定,TEST按钮施放后解除ZERO——测试线电阻清零——停止按键15分钟后自动关机.接触自动关机,按LOCK键——电池电压低,需更换电池模拟指针——仿真指针表显示——绝缘测试正在进行中——测量项目功能V AC——交流电压0.1~600.0VVDC——直流电压0.1~600.0V——电阻与声音提示导通0.1~199.9——低阻值测试0.01~19.99250V/500V/1000V/MΩ——绝缘测试电压/量程:0.001-4000MΩ4.按钮——电源开关——取消自动关机设置测试时间——30秒背光开关,测试线电阻清零——启动测试——按逆时针顺序选择功能——按顺时针顺序选择功能。

在系统中或在程序上所进行的任何更改都会有记录。测 试结果可以进行电子签名。系统设置、测试程序、用户 数据和测试结果等都可以很容易地输出到计算机网络或 外部闪存驱动器。
接口连接
在仪器的背面有许多可以连接不同系统设备的连接口。 USB端口可以连接外部的打印机、鼠标、键盘、条形码 阅读器或闪存驱动器。串行端口可用于连接其他 Palltronic仪器或PLC。一个以太网端口和一个无线网络 适配器可连接计算机网络。在仪器侧面还有一些其他端 口，可用于连接外部压力传感器和外置排气阀。
根据GAMP（优良的自动化生产规范）指南而开发，完全 符合21 CFR 11要求，Palltronic Flowstar IV测试仪有完整 的验证文件包，包括安装指南和操作验证 （IQ/OQ）等。
体积流量测量
Palltronic Flowstar IV完整性测试仪对气压和流量测量 具有高度灵敏性。高灵敏度的压力传感器有很多来源， 但检测范围从0.01到1000mL/min的高度精确的气体流 量传感器却并不容易获得。然而即便如此，制药生产行 业还是需要该检测范围内的传感器，以保障成功的完整 性测试。
Palltronic Flowstar IV完整性测试仪采用的是颇尔公司开 发的、专门用于完整性检测的专利技术——体积流量测 量技术。现行的流量计由一个阀组件模块（包括三个高 精度压力传感器），一个压力调节器，三个精确定义的 腔体和专有的计算控制程序组成。
其中一个压力传感器用于持续测量过滤系统中的气体压 力，另外两个传感器常用于校验内部腔体的压力。由于 气体通过润湿的过滤器时会扩散（如前进流测试），因 此完整性测试仪需要不断地将气体补充到过滤系统中。 气体量可以通过特制的腔体精确测量，测量值就可表征 气体在过滤器中的扩散速度。