Sinocare TRUE METRIX GO Manual Download

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5.2 质控液测试：

5.2.1 何时需要进行质控液测试

5.2.2 质控检查步骤

六、保存和保养

七、保修

八、使用注意事项

九、故障

十、血糖测试系统测量性能

十一、产品性能参数

十二、配件清单

十三、符号的解释

十四、电磁兼容性声明

14.1 指南和制造商的声明–电磁发射

14.2 指南和制造商的声明–电磁抗扰度

14.3 指南和制造商的声明–电磁抗扰度

14.4 便携式及移动式射频通信设备和设备
或系统之间的推荐隔离距离

Summary of Contents for TRUE METRIX GO

Page 1: ...适用范围 1 2 规格型号 1 3 配套试纸 1 4 检测方法和原理二仪器主要结构及其各配件组成结构和示意图 2 1 主要结构组成 2 2 血糖仪及各配件组成示意图 2 2 1 真睿TRUE METRIX GO示意图 2 2 2 采血笔示意图三显示说明四使用操作 4 1 安装电池 4 2 仪器设置 4 3 测试 4 4 结果查询五检查系统 5 1 自动自测 1 3 3 3 3 3 3 3 4 4 4 5 7 7 8 9 11 11 11 目录 ...

Page 2: ...2 2 质控检查步骤六保存和保养七保修八使用注意事项九故障十血糖测试系统测量性能十一产品性能参数十二配件清单十三符号的解释十四电磁兼容性声明 14 1 指南和制造商的声明电磁发射 14 2 指南和制造商的声明电磁抗扰度 14 3 指南和制造商的声明电磁抗扰度 14 4 便携式及移动式射频通信设备和设备或系统之间的推荐隔离距离 12 12 12 13 14 14 14 19 20 21 21 21 22 23 24 25 ...

Page 3: ...要结构组成二仪器主要结构及其各配件组成结构和示意图主机血糖仪由电路板按键液晶显示屏外壳组成配件采血笔经医疗器械备案的合格产品电池拓展坞选配数据线选配注拓展坞选配仅适用于真睿TRUE METRIX 真睿TRUE METRIX AIR 数据线选配仅适用于真睿TRUE METRIX GO 1 2 规格型号真睿TRUE METRIX GO 1 3 配套试纸 TRUE METRIX血糖试纸如需购买血糖试纸请联系三诺或其授权经销商取得 1 4 检测方法和原理血糖试纸的反应区固定有特殊化学物质血样中的葡萄糖与之接触后发生化学反应产生微电流血糖仪检测微电流并转换成血糖浓度结果显示出来血糖值显示为血浆血糖值 ...

Page 4: ...4 2 2血糖仪及各配件组成示意图屏幕试纸插口设置键电池盖标签 Micro USB接口用于连接数据线后与PC进行数据传输数据线为选配件瓶盖锁槽注意血糖仪只能与配套试纸中注明的血糖试纸配合使用请勿与其他公司产品或本公司其他型号产品混用 2 2 1 真睿TRUE METRIX GO示意图 2 2 2 采血笔示意图 ...

Page 5: ...5 全屏显示各符号说明三显示说明时间日期质控符号平均值符号 7天 14天 30天测试结果测试值为储存结果符号电池符号单位符号滴血符号血糖测试结果示例质控液测试结果示例等待加样测试中 ...

Page 6: ...6 设置年设置日期设置时间 7天平均值 14天平均值 30天平均值使用过的试纸仪器错误血糖查询结果示例无效的血细胞压积超过仪器测试温度范围未检测出样本或加样错误 ...

Page 7: ...错误仪器错误电池电量低屏幕损坏试纸错误测试中移除试纸或测试中连接迷你USB接口测试结果低于 1 1mmol L 测试结果高于 33 3mmol L 4 1 安装电池四使用操作电池不可充电数据线仅用于仪器连接电脑传输数据请不要使用该数据线连接任何充电设备进行充电如果处理不当电池存在爆炸风险请勿将电池投入火中请勿拆卸电池或重复充电请勿随意丢弃请遵循当地法规要求处理废旧电池 ...

Page 8: ...仪器背后的电池盖 3 取出电池盖中的电池 4 使新电池正面朝上装入新电池将电池盖装入仪器 5 按设置键开机如果仪器不能正常开机打开电池盖检查电池是否正负端装反装上电池盖并重复步骤5 如果仪器仍然不能正常开机请拨打客服电话 4 2 仪器设置安装仪器 1 将试纸瓶盖面向左边 2 使试纸插口面向自己将仪器底部安装在试纸瓶盖上 3 握住试纸瓶顺时针旋转1 4 如果安装正确试纸插口与试纸瓶盖应在一条垂直线上取下仪器 1 握住试纸瓶逆时针旋转1 4 2 从试纸瓶上取下仪器注没有安装在试纸瓶盖上仪器也能正常工作试纸插口试纸瓶盖 ...

Page 9: ... 数字闪烁9次然后跳至分钟设置 4 重复步骤2 4设置分钟月日年如果在设置过程中仪器关机请按照步骤1开始重新操作每次按下设置键仅增加1位数字一旦数字达到最大限值屏幕回到最小数字按下设置键调整数字当数字调整完成后松开设置键当发生以下动作时仪器自动开机试纸插入试纸口按下设置键当发生以下动作时仪器自动关机移除试纸按下设置键３秒钟２分钟之内没有任何动作根据采血笔说明书安装好采血笔及采血针 1 检查血糖试纸瓶上的失效日期和开瓶日期如已超过失效日期或开瓶日期后4个月以先到期的为准请放弃使用并使用新的血糖试纸进行测试 2 使用前将血糖仪与血糖试纸置于室温环境10分钟 3 使用温水和肥皂清洗采血部位并风干设置时间日期 4 3 测试 ...

Page 10: ...按摩 8 保持血糖试纸插入血糖仪的状态使血糖试纸加样端边缘接触血样血样被吸入试纸 9 当血糖仪发出短促的哔提示音且屏幕显示3条横线时将试纸从血样中移开 10 血糖仪显示测试结果记录测试结果 11 移除试纸和采血针丢弃至指定容器内仪器关机测试结果自动储存使用过的试纸和采血针请按照医用废弃物处理注如果试纸在空气中暴露时间过长仪器显示错误提示移除并丢弃该试纸使用新的试纸重新测试请勿在试纸加样区之外滴加血样在测试结果显示之前移除试纸仪器显示错误提示该测试结果不储存于仪器内使用新的试纸重新测试请勿在测试结果显示之前移除试纸静脉血请由专门的医护人员进行血样采集与实验室测试结果对比当该仪器与实验室测试结果对比时使用仪器测试必须在实验室测试30分钟之内完成 ...

Page 11: ... 存入最早储存的血糖测试结果会被自动覆盖 1 在仪器显示平均值界面状态下再次按下并松开设置键 2 屏幕显示最近的血糖测试值及储存结果符号血糖测试结果与储存结果符号时间日期一同显示 3 再次按下并松开设置键浏览测试结果注仪器仅储存1个质控液测试结果质控液测试结果与质控液符号一同显示日常质控作为血糖测试系统运行状态的检测手段有以下两种质控测试方法让您了解您的测试系统是否正常工作及使用者测试步骤是否正确定期进行系统检查可以确保仪器提供准确的检测结果 4 4 结果查询注自动自测不能代替质控液测试 1 插入试纸 2 仪器出现全屏显示检查全屏显示是否有缺漏部分 3 滴血符号闪烁仪器准备开始测试如果显示错误提示请勿使用仪器进行测试并查看故障章节 5 1 自动自测 ...

Page 12: ...来测试系统是否正常工作试纸瓶贴上的质控范围并非建议血糖值仅用于质控液测试结果参考请勿服用质控液仅使用TRUE METRIX质控液进行质控测试 1 检查血糖质控液瓶和血糖试纸瓶上的失效日期如质控液已超过失效日期或开瓶日期后3个月以先到的日期为准请放弃使用并使用新的血糖质控液进行测试如试纸已超过失效日期或开瓶日期后4个月以先到的日期为准请放弃使用并使用新的试纸进行测试 2 使用前将血糖仪血糖试纸与血糖质控液置于室温环境10 分钟如果是首次打开血糖质控液瓶请在瓶标签上注明开瓶日期 3 洗手并风干 4 轻轻倒转血糖质控液瓶几分钟请勿摇晃从瓶中取出血糖试纸立即盖好瓶盖取出试纸后应立即使用 5 2 质控液测试 5 2 1 何时需要进行质控液测试 5 2 2 质控检查步骤 ...

Page 13: ...示出结果将其与血糖试纸瓶标签上的质控范围进行对照如果质控液测试结果在质控范围内该仪器可用于测试血样如果质控液测试结果不在质控范围内使用新的试纸再次进行质控液测试如果质控液测试结果仍然不在质控范围内请勿使用该仪器及试纸进行测试请致电售后服务机构 11 结果显示后将血糖试纸从血糖仪移除并按照医用废弃物处理仪器自动关机重新盖紧血糖质控液瓶六保存和保养 1 血糖仪保存应避免灰尘液体防止剧烈振荡和碰撞 2 如仪器表面粘有异物需要马上进行清洁保持仪器关机且无试纸插入状态使用棉签或干净无毛布沾75 的酒精或中性清洁剂进行擦拭擦拭完成后让仪器自然风干 3 如长时间不使用仪器使用棉签或干净无毛布沾75 的酒精或中性清洁剂进行擦拭擦拭完成后让仪器自然风干卸下电池后再保存 4 请勿在测试中清洁仪器 5 切勿让污垢尘埃血渍或液体经插口或缝隙进入仪器...

Page 14: ... 否则会对仪器造成损害或造成不准确的测试结果 2 本产品仅用于体外检测指尖毛细血样本 3 请勿在木糖吸收实验后进行测试 4 本仪器的测试结果只能作为血糖监测用不能作为糖尿病诊断的依据参考治疗医生和糖尿病专家的意见不能仅根据检测的结果而违背他们的指导当您使用本仪器得出同症状不相符的测试结果后应立刻到医院检查 5 不适用于重症患者或新生儿 6 测试期间仪器可能会与血液接触因此使用过的仪器有携带感染物的风险当本仪器在医疗场所使用时医护人员请遵循你单位对卫生设备相应的感染控制步骤如戴手套或其他个人防护九故障 1 试纸插入后不能开启仪器原因试纸插入时正反颠倒或上下颠倒试纸未完全插入试纸故障移除试纸重新正确插入试纸移除试纸重新正确插入试纸使用新试纸进行测试解决方法 ...

Page 15: ...血样进行测试如果仍然显示错误提示请与客服联系屏幕显示原因解决方法 2 加入样本后仪器不能开始测试原因样本量不足插入试纸后2分钟后加样试纸故障换用新试纸吸入足够的样本量重新测试使用新试纸进行测试在插入试纸后2分钟内滴加血样仪器故障请与客服联系使用新试纸进行测试如果仍然无法开始测试请与客服联系解决方法原因电池电力不足电池安装不正确仪器故障更换新电池重新安装电池使电极端面朝上请与客服联系解决方法 ...

Page 16: ...16 超过仪器测试温度范围将仪器和试纸在 5 C 40 C环境下平衡10分钟直至达到测试温度范围使用新试纸按照说明书重新进行测试未检测出样本或加样错误使用过的试纸试纸暴露在空气中时间过长使用新试纸进行测试如果仍然显示错误提示请与客服联系屏幕显示原因解决方法仪器错误请与客服联系 ...

Page 17: ...17 试纸错误使用新试纸进行测试如果仍然显示错误提示请与客服联系拔掉USB线使用新试纸进行测试确认试纸移除前仪器显示测试结果如果仍然显示错误提示请与客服联系测试中移除试纸或测试中连接迷你USB接口仪器错误请与客服联系屏幕显示原因解决方法仪器错误请与客服联系 ...

Page 18: ...18 电池电量低更换新电池请勿使用该仪器进行测试请与客服联系屏幕损坏测试结果高于 33 3mmol L 使用新试纸进行测试如果测试结果仍然显示Hi 请马上联系您的健康顾问或医生屏幕显示原因解决方法测试结果低于 1 1mmol L 使用新试纸进行测试如果测试结果仍然显示Lo 请马上联系您的健康顾问或医生 ...

Page 19: ...重复性标准参考国家标准 GB T19634 2005 体外诊断检验系统自测用血糖监测系统通用技术条件和国际标准ISO 15197 2013 In vitro diagnostic test systems Requirements for blood glucose monitoring systems for self testing in managing diabetes mellitus 系统的准确度要求 95 的测试结果的偏差应符合表1的要求系统的测量重复性要求测试结果应符合表2的要求 1 1mmol L 5 55mmol L 20mg dL 100mg dL SD 0 34mmol L 6 mg dL 精密度测试范围 CV 6 5 55mmol L 33 3mmol L 100mg dL 600mg dL ...

Page 20: ...CR2032 不可充电最大额定电流 10mA 电池寿命约1000次测试或1年生产日期见标签使用期限 10年按每天监测7次血糖的使用频率确定本产品使用期限是按照每天监测7次血糖的使用频率确定的在使用过程中用户应当按照产品说明书的要求对产品进行维护保养在维护保养后经确认仍能保持基本安全性和有效性的产品可以正常使用软件发布版本 V01 记忆容量 500 个血糖测试值尺寸 40mm 36mm 22mm 测试环境湿度 10 80 RH 不结露温度 5 40 血细胞压积 20 70 储运条件 10 93 RH 不结露 20 55 海拔最高可至3108 米十一产品性能参数 ...

Page 21: ...说明书 4 1安装电池内容数据线选配十二配件清单本仪器符合EMC标准GB T 18268 1 2010及GB T 18268 26 2010 的发射和抗扰度要求注意 1 在干燥的环境中尤其是存在人造材料人造织物地毯等的干燥环境中使用本设备时可能会引起损坏性的静电放电导致产生错误的结论 2 便携式和移动式射频通信设备可能影响本仪器的性能十四电磁兼容性声明十三符号的解释体外诊断医疗器械序列编号避免雨淋易碎小心轻放参考使用说明避免日晒生产企业电子电气产品有害物质限制使用标志生物危害注意参考随附文件 SN ...

Page 22: ... 否则可能会干扰设备正常工作 4 用户有责任确保设备的电磁兼容环境使设备能正常工作建议在设备使用之前评估电磁环境 14 1 指南和制造商的声明电磁发射指南和制造商的声明电磁发射本仪器预期使用在下列规定的电磁环境下购买者或使用者应该保证它在这种电磁环境下使用发射试验符合性电磁环境指南辐射发射GB4824 本仪器仅为其内部功能而使用射频能量因此它的射频发射很低并且对附近的电子设备产生干扰的可能性很小满足1组B类设备限值 ...

Page 23: ...用者应该保证它在这种电磁环境下使用试验电平符合电平电磁环境指南静电放电 ESD GB T 17626 2 空气放电 2kV 4 kV 8 kV 接触放电 2 kV 4 kV 空气放电 2kV 4 kV 8 kV 地面应该是木质混凝土或瓷砖如果地面用合成材料覆盖相对湿度应该至少 30 接触放电 2 kV 4 kV 指南和制造商的声明电磁抗扰度额定工频磁场 GB T 17626 8 3A m 50Hz 3A m 50Hz 工频磁场应具有在商业或医院环境中典型场所的工频磁场水平特性 ...

Page 24: ...z 2 0GHz 式中根据发射机制造商提供的发射机最大额定输出功率单位为瓦特 W d 推荐的隔离距离以米 m 为单位固定式射频发射机的场强通过对电磁场所的勘测a来确定在每个频率范围b都应比符合电平低在标记下列符号的设备附近可能出现干扰 P d 1 2 P P d 2 3 注1 在 80MHz 和 800MHz频率点上采用较高频段的公式注 2 这些指南可能不适合所有的情况电磁传播受建筑物物体及人体的吸收和反射的影响 a 固定式发射机诸如无线蜂窝无绳电话和地面移动式无线电的基站业余无线电调幅和调频无线电广播以及电视广播等其场强在理论上都不能准确预知为评定固定式射频发射机的电磁环境应考虑电磁场所的勘测如果测得血糖仪所处场所的场强高于上述适用的射频符合电平则应观测血糖仪以验证其能正常运行如果观测到不正常性能则补充措施可能是必须的...

Page 25: ...00MHz 2 0GHz d 2 3 0 23 0 73 2 3 7 3 23 本仪器预期在射频辐射骚扰受控的电磁环境中使用依据通信设备最大额定输出功率购买者或用户可通过下面推荐的维持便携式及移动式射频通信设备发射机和本仪器之间最小距离来防止电磁干扰对于上表未列出的发射机最大额定输出功率推荐隔离距离d 以米 m 为单位可用相应发射机频率栏中的公式来确定这里P是由发射机制造商提供的发射机最大额定输出功率以瓦特 W 为单位注1 在80MHz和800MHz频率点上采用较高频范围的公式注2 这些指南可能不适合所有的情况电磁传播受建筑物物体及人体的吸收和反射的影响便携式及移动式射频通信设备和本仪器之间的推荐隔离距离 P P ...

Page 26: ...型糖尿病防治指南 2017年版中国2型糖尿病血糖控制目标空腹 4 4 7 0mmol L 79 mg dL 126 mg dL 状态目标范围空腹 3 9 6 1 mmol L 70 mg dL 110 mg dL 状态正常范围妊娠合并糖尿病诊治指南 2014 妊娠期糖尿病患者 GDM 妊娠期血糖控制目标餐前 5 3mmol L 95mg dL 状态范围全国临床检验操作规程第四版正常血糖范围 ...

Page 27: ...少在该部件的某一均质材料中的含量超出GB T 26572规定的限量要求上表中打部分由于技术原因目前无法实现代替随着技术上的进步将逐渐改进表示部分产品型号含该部件用户按照产品说明正常使用时本产品中含有的有害物质不会发生外泄或突变不会对环境造成严重污染或对其人身财产造成严重损害的期限为10年有害物质部件名称铅 Pb 及其化合物印刷电路板五金件电子元器件壳体印刷电路板五金件电子元器件壳体汞 Hg 及其化合物镉 Cd 及其化合物六价铬 Cr VI 化合物多溴联苯 PBB 多溴二苯醚 PBDE ...

Page 28: ...料中的含量超出GB T 26572规定的限量要求上表中打部分由于技术原因目前无法实现代替随着技术上的进步将逐渐改进表示部分产品型号含该部件用户按照产品说明正常使用时本产品中含有的有害物质不会发生外泄或突变不会对环境造成严重污染或对其人身财产造成严重损害的期限为10年有害物质部件名称铅 Pb 及其化合物电源线或电源适配器电池血糖试条采血笔包装及印刷件电源线或电源适配器电池血糖试条采血笔包装及印刷件汞 Hg 及其化合物镉 Cd 及其化合物六价铬 Cr VI 化合物多溴联苯 PBB 多溴二苯醚 PBDE ...

Page 29: ...nd Diagram of Meter and Accessories 2 1 Main structure composition 2 2 Diagram of Meter and Accessories 2 2 1 Meter 2 2 2 Lancing device 3 Display 4 Operation 4 1 Changing Battery 4 2 Meter set up 4 3 Blood Glucose Testing 4 4 Meter Memory 5 Quality Control Testing 5 1 Automatic Self Test 1 3 3 3 3 3 4 4 4 4 5 5 8 8 9 11 12 13 13 Contents ...

Page 30: ...est 5 2 2 How to Test Control Solution 6 Preservation and Maintenance 7 Warranty 8 Matters need attention 9 Troubleshooting 10 Performance 11 Specification 12 Accessory lis 13 Explanation of symbols 14 EMC Statement 14 14 15 16 17 17 18 23 24 25 25 25 ...

Page 31: ... is not for use in diagnosis or screening of diabetes mellitus 1 2 Model 真睿TRUE METRIX GO 1 3 Applicable test strip TRUE METRIX blood glucose test strip 1 4 Test Principle The Test Strip is a plastic strip containing chemicals and electrodes When inserted into meters glucose is measured using amperometric technology employing a glucose dehydrogenase FAD reaction When whole blood or control solutio...

Page 32: ...eter is composed by PCB board buttons LCD display and case Accessories Lancing device product which already get registration certificate or filing batteries docking station optional USB cable optional Note Docking station optional only apply to 真睿TRUE METRIX 真睿TRUE METRIX AIR USB cable optional only apply to 真睿TRUE METRIX GO 2 2 Diagram of Meter and Accessories 2 2 1 Meter ...

Page 33: ... Site Symbol A Average Symbol 7 14 or 30 day Test Result Memory Result Battery Symbol Units of measure Factory set to mmol L or mg dL cannot be changed by user Drop Symbol 2 2 2 Lancing device Full screen display Please refer to lancing device instruction of use for more information Lancing Device adjustable comfort tip button spring cover ...

Page 34: ...year Setting date Setting time 7 day average test result 14 day average test result 30 day average test result Blood glucose test result in memory sample 30 day average test result Blood glucose test result example Control solution test result example ...

Page 35: ... outside of vial too long Sample not detected or Sample Drop on Top of Test Strip Meter error Meter error Low or dead battery Broken Display WARNING Out of range High results 33 3 mmol L WARNING Out of range Low results 1 1 mmol L Test strip Error Test strip removed during test or Micro USB Cable connected while testing ...

Page 36: ...l and twisting the meter turn counterclockwise Lift meter from vial top 2 Turn meter over until the meter label is facing up Pull Battery Tray out until battery is exposed 3 Holding the Battery Tray over your hand press on edge of battery until battery drops out 4 Insert new battery into Battery Tray with side facing up Slide Battery Tray back into meter 5 Turn meter back over and press Set Button...

Page 37: ...flat on top of vial cap 3 Holding the vial twist the meter 1 4 turn clockwise The Test Port area on the meter should cover the vial lip if attached properly To remove 1 Holding the vial twist the meter 1 4 turn counter clockwise 2 Lift off meter off the vial top To Attach Remove Meter to Test Strip Vial The meter may also be used for testing without attach ing to the vial Test Port Vial Lip ...

Page 38: ...lashes 8 times before going to the minutes 4 Repeat steps 2 4 to set up minutes month day and year If meter turns off at any time during Set Up go back to Step 1 and begin again Pressing and releasing the Set Button only makes the numbers increase by one Once the number reaches its limit it resets to the lowest number Pressing and holding the Set Button scrolls the numbers Release Set Button when ...

Page 39: ...ediately Use test strip quickly after taking it out of the vial 5 Insert test strip firmly into Test Port Meter turns on 6 Wait until Drop Symbol appears in the Display Keep test strip in meter until testing is finished Do not add blood to test strip before inserting into meter 7 Set lancing device aside Lance fingertip To help blood drop form lower hand to waist level and gently massage from palm...

Page 40: ...s the test An error message appears Result is not stored in Memory Retest with a new test strip Do not remove before result is displayed Only professional can collect venous samples System and Laboratory Testing When comparing results between the product and a laboratory system meter blood tests should be performed within 30 minutes of a laboratory test View Averages 7 14 and 30 Day 1 With meter o...

Page 41: ...l through results Blood test results are shown with the Memory Symbol the time and date Note One Control Test result is stored in Memory The Control Test result will show the Control Symbol in the lower left corner of the Display To assure accurate and reliable results the System offers two kinds of quality control tests an Automatic Self Test and a Control Test These tests ensure that the system ...

Page 42: ... opened exposed to extreme heat cold or humidity whenever a check on the performance of the system is needed if meter damage is suspected meter was dropped crushed wet etc Note It is important to perform Control Tests with more than one level of TRUE METRIX Control Solution Three levels of control solution are available for Control Tests Use contact on the cover for more information on how to obta...

Page 43: ... swirl or invert control solution bottle to mix DO NOT SHAKE 5 Remove one test strip from vial Close test strip vial immediately Use test strip quickly after removal from vial 6 Insert test strip into Test Port Meter turns on Keep test strip in meter until testing is finished Do not add control solution to test strip before inserting into meter 7 Remove cap from control solution bottle Gently sque...

Page 44: ...d Contact for assistance see Booklet cover for contact informa tion 11 After result is shown remove test strip from meter and discard Meter turns off Recap control solution bottle tightly 1 Store meter in carrying case to protect from liquids dust and dirt Do not keep meter in an area where it may be crushed i e back pocket drawer bottom of bag etc 2 Clean immediately after getting any blood on th...

Page 45: ...he meter does not work properly Sinocare will replace it with a new meter or equivalent product free of charge Failure of the meter due to abuse or use not in accordance with the instructions for use is not covered by this Warranty Use wipe or swab with 75 alcohol to clean meter before send back to Sinocare 8 Matters need attention 1 Use of meter in a manner not specified in this Owner s Booklet i...

Page 46: ...e pathogens after use even after cleaning and disinfecting Reuse of devices labeled for single use may result in product contamination and patient infection If the meter is being operated by a second person who provides testing assistance the meter and lancing device should be cleaned prior to use by the second person 18 9 Troubleshooting 1 Use of meter in a manner not specified in this Owner s Bo...

Page 47: ...rt test strip fully into meter Remove test strip from meter Repeat with new test strip Remove test strip from meter Replace battery Use new test strip for testing Battery must be placed in meter with positive side must face up Contact for assistance Reason Sample drop too small Sample applied after two minute shut off Test Strip Error Meter Error Action Repeat test with new test strip and larger d...

Page 48: ...old Too hot Move meter and test strips to area between 5 C 40 C wait10 minutes for system to reach room temperature before testing Sample not detected or Sample Drop on Top of Test Strip Retest with new test strip and larger sample Make sure Sample Tip of test strip touched top of sample drop Display Reason Action Used test strip Test strip outside of vial too long Repeat with new test strip If er...

Page 49: ...h as fatigue excess urination thirst or blurry vision follow a doctor or healthcare professional s advice for high blood glucose Test strip removed during test or Micro USB Cable connected while testing Unplug Micro USB cable Retest with new test strip Make sure result is displayed before removing test strip If error persists contact for assistance Display Reason Action Meter error Contact for ass...

Page 50: ...tery Broken Display WARNING Retest with new test strip If result is still Hi High contact doctor or healthcare professional immediately Display Reason Action WARNING Out of range High results 33 3 mmol L Repeat with new test strip If error persists contact for assistance ...

Page 51: ...ring systems for self testing in managing diabetes mellitus Accuracy requirement 95 of test result bias shall meet table 1 requirement Repeatability requirement test result shall meet table 2 requirement Table 1 Accuracy Requirement 1 10mmol L 5 55mmol L 20mg dL 100mg dL 5 55mmol L 33 30mmol L 100mg dL 600mg dL Within 0 83mmol L 15mg dL Within 15 Accept Bias Test Range WARNING Out of range Low res...

Page 52: ...tests or 1 year Manufacture date Refer to meter label Shelf life 10 years based on every day perform 7 tests Software release version V01 Memory Size 500 glucose results Size 40mm 36mm 22mm Operating Range Relative Humidity 10 80 Non condensing Temperature 5 C 40 C Hematocrit 20 70 Storage condition 10 93 RH 20 55 Altitude Up to and including 3108 meters 11 Specification 24 Table 2 Repeatability R...

Page 53: ... 14 EMC Statement 12 Accessory list Lancing device 1 pcs product which already get registra tion certificate Operation method please refer to lancing device instruction of use Battery One 3V lithium battery CR2032 non recharge able Details please check 4 1 Changing Battery USB cable Optional 13 Explanation of symbols For in vitro Diagnostic Testing Only Serial Number Keep Dry Fragile handle with c...

Page 54: ...ended for sue in the electromagnetic environment specified below The customer or the user of the equipment should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions GB4824 RF emissions GB 4824 Harmonic emissions GB 17625 1 Voltage fluctuations flicker emissions GB 17625 2 The equipment uses RF energy only for its internal funct...

Page 55: ...uidance Guidance and manufacturer s declaration electromagnetic immunity The equipment is intended for sue in the electromagnetic environment specified below The customer or the user of the equipment should assure that it is used in such an environment Power frequency magnetic field GB T17626 8 3A m 50Hz 3A m 50Hz Power frequency magnetic fields should be at levels characteristic of a typical loca...

Page 56: ...s from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol d 1 2 d 2 3 Note 1 At 80MHz and 800MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by ...

Page 57: ... recommended below according to maximum output power of the communication equipement For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer Note ...

Page 58: ...L State Range Before meal 3 9 6 1 mmol L 70 mg dL 110 mg dL State Normal range Gestational diabetes mellitus prevention guideline 2014 Gestational diabetes mellitus GDM glucose control range Preprandial plasma glucose before meal 5 3mmol L 95mg dL State Range National clinical laboratory operating procedures Fourth Edition Normal glucose range ...

Page 59: ...lectrical product hazardous substance limited use regulation Means this hazardous substance in all component meet GB T 26572 requirement Means this hazardous substance in some component do not meet GB T 26572 requirement Electronic components include ceramic resistor National suggest contamination control attestation limit substance application exception do not require limit value for ceramic resi...

Page 60: ...is table is refers to SJ T 11364 Electrical product hazardous substance limited use regulation Means this hazardous substance in all component meet GB T 26572 requirement Means this hazardous substance in some component do not meet GB T 26572 requirement Electronic components include ceramic resistor National suggest contamination control attestation limit substance application exception do not re...

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