产品规格说明书模板

1、OK-A产品规格项目参数备注测量范围（检测极限）rangeEnzyme匍葡糖氧化酶GlucoseOxidase试片校准TestStripalibration样品类型SpecimenType微血管全血Capillarywholeblood测量时间ResponseTime客户固定要求6S,关2s开4s样品量SampleVolume0.7微升0.7PL血容比SensitivityinHCTRange20?60%多部位采血Alternate-SiteTestingYES(palm,forearm,upperarm,calf,andthigh)运行条件OperationConditions50?104T

2、(100C?40C)/10?85%R.H.Altitude=3,402m(11,158ft)abovethesealevel贮存条件StorageConditions-4140T(-20?50C)/三90%R.H.(stripexcluded)39?104T(440C)/三10?85%R.H.(stripincluded)货运条件DeliveryConditions-4140T(-2050C)/三90%R.H.(stripexcluded)39104T(1040C)/三1085%R.H.(stripincluded)电池寿命Lifeofbattery测量1000次Measurementswit

3、h1000times第三点侦测记忆笔数Memorynumber全部记忆删除DeleteMemory设置模式或者codecard删除是否删除单笔记忆单笔记忆是否显示对应code平均值计算Averagecalculation(specify)改7丽14匚15厂21人28匚30厂60匚190"days通讯USB(串口转USBPL2303通讯用波特率通讯软件ET厝音语音音量级别对应语言默认语言English1血糖单位默认单位mg/dL可用设置模式或codecard修改Codecard和SET模式修改单位后掉电保存否温度单位不可修改单位，插入温度卡，进入显示温度状态。背光插入试片是否显示-式片

4、启效期ExpirationforstripStorage:24monthsIn-Use:90days机型对应的试片OK-2自动识别试片功能机型所兼容的试片厂235厂123L34L345短接，艮制_imitations婴儿血不适用Notapplyforneonatalblood模拟液后效期ExpirationforcontrolsolutionStorage:18monthsIn-Use:90days批内精密度Within-runPrecisionS.D.=5,glucoseconcentration=75mg/dLCV%=5,glucoseconcentration>75mg/dL总计精密度Total-runPrecisionS.D.=5,glucoseconcentration=75mg/dLCV%=5,glucoseconcentration>75mg/dL准确性Accuracy>95%inAzoneofEGAvsYSI2300glucoseanalyzer:士15mg/dL,glucoseconcentration=75mg/dL±20%,glucoseconcentration>75mg/dL准确性2测里CV小于4%两值取大偏差小于0.8mmol/L显示哭