產(chǎn)品規(guī)格說明書模板

1、OK-A產(chǎn)品規(guī)格項目參數(shù)備注測量范圍（檢測極限）rangeEnzyme匍葡糖氧化酶GlucoseOxidase試片校準(zhǔn)TestStripalibration樣品類型SpecimenType微血管全血Capillarywholeblood測量時間ResponseTime客戶固定要求6S,關(guān)2s開4s樣品量SampleVolume0.7微升0.7PL血容比SensitivityinHCTRange20?60%多部位采血Alternate-SiteTestingYES(palm,forearm,upperarm,calf,andthigh)運行條件OperationConditions50?104T

2、(100C?40C)/10?85%R.H.Altitude=3,402m(11,158ft)abovethesealevel貯存條件StorageConditions-4140T(-20?50C)/三90%R.H.(stripexcluded)39?104T(440C)/三10?85%R.H.(stripincluded)貨運條件DeliveryConditions-4140T(-2050C)/三90%R.H.(stripexcluded)39104T(1040C)/三1085%R.H.(stripincluded)電池壽命Lifeofbattery測量1000次Measurementswit

3、h1000times第三點偵測記憶筆數(shù)Memorynumber全部記憶刪除DeleteMemory設(shè)置模式或者codecard刪除是否刪除單筆記憶單筆記憶是否顯示對應(yīng)code平均值計算Averagecalculation(specify)改7麗14匚15廠21人28匚30廠60匚190"days通訊USB(串口轉(zhuǎn)USBPL2303通訊用波特率通訊軟件ET厝音語音音量級別對應(yīng)語言默認(rèn)語言English1血糖單位默認(rèn)單位mg/dL可用設(shè)置模式或codecard修改Codecard和SET模式修改單位后掉電保存否溫度單位不可修改單位，插入溫度卡，進入顯示溫度狀態(tài)。背光插入試片是否顯示-式片

4、啟效期ExpirationforstripStorage:24monthsIn-Use:90days機型對應(yīng)的試片OK-2自動識別試片功能機型所兼容的試片廠235廠123L34L345短接，艮制_imitations嬰兒血不適用Notapplyforneonatalblood模擬液后效期ExpirationforcontrolsolutionStorage:18monthsIn-Use:90days批內(nèi)精密度Within-runPrecisionS.D.=5,glucoseconcentration=75mg/dLCV%=5,glucoseconcentration>75mg/dL總計精密度Total-runPrecisionS.D.=5,glucoseconcentration=75mg/dLCV%=5,glucoseconcentration>75mg/dL準(zhǔn)確性Accuracy>95%inAzoneofEGAvsYSI2300glucoseanalyzer:士15mg/dL,glucoseconcentration=75mg/dL±20%,glucoseconcentration>75mg/dL準(zhǔn)確性2測里CV小于4%兩值取大偏差小于0.8mmol/L顯示哭