Sinocare TRUE METRIX AIR Manual Download | Manualshive

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网络安全：

1.数据接口
真睿TRUE METRIX AIR血糖仪与数据传输模块之间采用串口
通讯，8位数据位、1位停止位、无校验，无流控制，波特率固定
9600bps;数据为16进制形式传输。
内置蓝牙（4.2）是基于Bluetooth Low Energy标准设计的透
传模块，与其它蓝牙设备建立连接后，可以实现双向数据传输。
数据传输条件：血糖仪和蓝牙设备蓝牙功能打开。

2.用户访问控制
用户只有获取特定的通讯协议才能准确的解析数据，血糖仪与
外界进行数据交换必须遵循通讯协议的要求。

3.运行环境
软件环境详见操作指南。

采血笔：1支，经医疗器械备案的合格产品，具体使用及更换
方法见采血笔说明书。
电池：1颗3V纽扣电池#CR2032（不可充电），其安装、更换
及注意事项内容详见本说明书“4.1安装电池”内容。
拓展坞（选配）

十五、配件清单

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Summary of Contents for TRUE METRIX AIR

Page 1: ...1 1 1 2 1 3 1 4 2 1 2 2 4 1 4 2 4 3 4 4 6 1 6 2 1 3 3 3 3 3 3 3 3 6 10 10 10 12 14 15 15 15 16...

Page 2: ...2 17 1 17 2 17 3 17 4 17 18 18 19 19 19 24 25 26 27 27 28 29 30 31...

Page 3: ...3 1 1 2 1 TRUE METRIX TRUE METRIX AIR TRUE METRIX GO 2 2 1 2 TRUE METRIX TRUE METRIX AIR 1 3 TRUE METRIX 1 4...

Page 4: ...4 2 2 1 TRUE METRIX TRUE METRIX AIR TRUE METRIX TRUE METRIX AIR 1 2 3 1 2 3 4 5 6 1 2 3 4 5 6...

Page 5: ...5 PC 2 2 2...

Page 6: ...6 7 8 9 10 11 12 13 1 2 3 TRUE METRIX AIR 4 5 6 1 2 4 13 12 11 10 9 8 7 5 3 6...

Page 7: ...7...

Page 8: ...8 7 14 30 60 TRUE METRIX AIR 90 TRUE METRIX AIR TRUE METRIX AIR TRUE METRIX AIR...

Page 9: ...9 33 3mmol L 1 1mmol L...

Page 10: ...10 4 1 1 3V CR2032 1 2 3 4 4 4 2 TRUE METRIX AIR...

Page 11: ...11 1 1 2 3 4 2 TRUE METRIX AIR TRUE METRIX TRUE METRIX AIR 2...

Page 12: ...12 13 3 mmol L 4 10 1 2 3 4 1 3 3 2 1 4 3...

Page 13: ...13 4 2 10 3 4 1 5 6 7 8 9 10 11 12...

Page 14: ...14 4 4 1 2 TRUE METRIX 7 14 30 TRUE METRIX AIR 7 14 30 60 90 2 3 3 2 TRUE METRIX 500 501 TRUE METRIX AIR 1000 1001 1 2 3 30...

Page 15: ...15 6 1 1 2 13 3 mmol L 1 2 E 2 10 2 2 3 2 2 4 2 5 10...

Page 16: ...16 6 2 6 2 1 3 2 6 2 2 TRUE METRIX 1 3 4 2 10 3...

Page 17: ...17 3 4 5 6 7 8 9 10 TRUE METRIX AIR...

Page 18: ...18 5 1 2 75 3 75 4 5 75...

Page 19: ...19 1 2 3 4 5 6 7 8...

Page 20: ...20 1 2 2 2...

Page 21: ...21 3 5 C 4 0 C 1 0...

Page 22: ...22...

Page 23: ...23 33 3mmol L Hi 1 1mmol L Lo...

Page 24: ...mmolL 15mg dL 15 GB T19634 2005 ISO 15197 2013 In vitro diagnostic test systems Requirements for blood glucose monitoring systems for self testing in managing diabetes mellitus 95 1 2 1 1mmol L 5 55mm...

Page 25: ...33 3 mmol L 0 5 L 4 7 1 3V CR2032 TRUE METRIX 8 mA TRUE METRIX AIR 10mA 10 7 7 1000 1 TRUE METRIX V02 TRUE METRIX AIR V02 TRUE METRIX 500 TRUE METRIX AIR 1000 87mm 55mm 18mm 10 80 RH 5 40 10 93 RH 20...

Page 26: ...26 1 TRUE METRIX AIR 8 1 9600bps 16 4 2 Bluetooth Low Energy 2 3 1 1 3V CR2032 4 1...

Page 27: ...27 EMC GB T 18268 1 2010 GB T18268 26 2010 EMC 1 2 3 4 CMIIT ID SN...

Page 28: ...28 17 1 GB4824 GB 4824 GB 17625 1 GB 17625 2 1 B...

Page 29: ...17 2 ESD GB T 17626 2 2kV 4 kV 8 kV 2 kV 4 kV 2kV 4 kV 8 kV 2 kV 4 kV 30 GB T17626 8 3A m 50Hz 3A m 50Hz GB T17626 11 5 250 GB T17626 11 0 1 40 5 70 25 GB T17626 4 1kV 5 50ns 50kHz GB T17626 5 2kV 1k...

Page 30: ...30 17 3 GB T17626 6 GB T17626 3 3V 150kHz 80MHz 3V m 80MHz 2 0GHz 3V m 80MHz 2 0GHz 80MHz 800MHz 800MHz 2 0GHz W d m a b P d 1 2 P P d 2 3 1 80MHz 800MHz 2 a b 150kHz 80MHz 3V m...

Page 31: ...31 17 4 W m 0 01 0 1 1 10 100 80MH 800MHz 150kHz 80MHz d 1 2 0 12 0 38 1 2 3 8 12 800MHz 2 0GHz d 2 3 0 23 0 73 2 3 7 3 23 d m P W 1 80MHz 800MHz 2 d 1 2 0 12 0 38 1 2 3 8 12 P P P...

Page 32: ...32 2 2017 2 4 4 7 0mmol L 79 mg dL 126 mg dL 3 9 6 1 mmol L 70 mg dL 110 mg dL 2014 GDM 5 3mmol L 95mg dL...

Page 33: ...33 GB T 26572 GB T 26572 10 Pb Hg Cd Cr VI PBB PBDE...

Page 34: ...34 GB T 26572 GB T 26572 10 Pb Hg Cd Cr VI PBB PBDE...

Page 35: ...35 400 887 0036 1...

Page 36: ...36...

Page 37: ...37 2...

Page 38: ...38...

Page 39: ...iagram of Meter and Accessories 2 1 Main structure composition 2 2 Diagram of Meter and Accessories 3 Display 4 Operation 4 1 Changing Battery 4 2 Meter set up 4 3 Blood Glucose Testing 4 4 Meter Memo...

Page 40: ...ymbols 17 EMC Statement 17 1 Guidance and manufacturer s declaration electromagnetic emission 17 2 Guidance and manufacturer s declaration electromagnetic immunity 17 3 Guidance and manufacturer s dec...

Page 41: ...2 Structure and Diagram of Meter and Accessories Meter Meter is composed by PCB board buttons LCD display and case 1 2 Model TRUE METRIX TRUE METRIX AIR 1 3 Applicable test strip TRUE METRIX blood glu...

Page 42: ...cking station optional USB cable optional Note Docking station optional only apply to TRUE METRIX TRUE METRIX AIR USB cable optional only apply to TRUE METRIX GO 2 2 Diagram of Meter and Accessories 2...

Page 43: ...eter Label Docking Station Contacts It is used for data transmission with PC after connecting Docking station Docking station is an optional accessory If you need to buy Docking station please contact...

Page 44: ...er can only use with matched strip Do not use with other product 2 2 2 Lancing device Please refer to lancing device instruction of use for more information button spring cover adjustable comfort tip...

Page 45: ...Symbol 10 Temperature Symbol 11 Test Reminder Symbol 12 Ketone Test Alert Symbol 13 Units Symbol 1 Result is from Memory 2 Time Date 3 Bluetooth Symbol only for TRUE METRIX AIR and Event Tag Symbols...

Page 46: ...r apply sample During testing Blood glucose test result example Control solution test result example Event tag Test reminder on Test reminder off Ketone alert on ALT testing Setting year Setting date...

Page 47: ...test result Onlyfor TRUEMETRIXAIR 90 day average test result Onlyfor TRUEMETRIXAIR Bluetooth function on Onlyfor TRUEMETRIXAIR Bluetooth function off Onlyfor TRUEMETRIXAIR Blood glucose test result in...

Page 48: ...ong test strip Used test strip or apply the sample error Meter error Test strip error Test strip removed during test Communication error Low battery Broken Display Out of range Highresults 33 3mmol L...

Page 49: ...se according to local regulations 3 Insert new battery positive side facing up Close Battery Door 4 Press Button to turn meter on If meter does not turn on check that battery was installed properly In...

Page 50: ...year Note Meter beeps every time a setting is confirmed Set Bluetooth Smart only for TRUE METRIX AIR Uploading results using the Bluetooth Smart feature allows meter to send results by connecting Blu...

Page 51: ...Test Alert is a reminder to check ketones per the treatment plan Press or Button to turn Alert on or off Press Button to set Meter goes to set Test Reminder Note When a Ketone Test Alert Symbol appea...

Page 52: ...utes Press Button to set Meter goes to the next Test Reminder 4 Turn Reminders on and repeat steps 1 3 to set the time for next 3 Reminders if needed Note If Test Reminders are set the Test Reminder S...

Page 53: ...Press Button to remove ALT Symbol 6 Wait until Drop Symbol appears in Display Do not apply samples before insert strip into meter 7 Lance fingertip or forearm Obtain a blood sample allow drop to form...

Page 54: ...and lancet should be treated as medical waste Note If test strip has been out of the vial too long before testing an error message appears Remove and discard old test strip Use new test strip for test...

Page 55: ...est result is stored the earliest blood glucose test result is automatically covered 1 Press and release Button after meter displays Averages value 2 The screen shows the latest blood glucose test val...

Page 56: ...lt query interface and it will automatically turn off after about 2 minutes 4 When setting the blood glucose meter if there is no operation it will automatically turn off after about 2 minutes 5 Autom...

Page 57: ...not the recommended blood glucose level and is only used for reference to the quality control solution test results Do not take the quality control solution 6 2 1 When to perform control test before u...

Page 58: ...open the blood glucose quality control bottle please mark the date on the bottle label 3 Gently swirl or invert control solution bottle to mix DO NOT SHAKE Remove one test strip from vial Close test...

Page 59: ...service 10 After result is shown Hold glucose meter with test strip pointing down Press Strip Release Button to discard test strip And according to medical waste disposal Meter turns off Recap control...

Page 60: ...off the Bluetooth function will also be turned off No device connection allowed 1 Store meter in carrying case to protect from liquids dust and dirt Do not keep meter in an area where it may be crushe...

Page 61: ...battery 4 Do not clean the meter during a test 5 Never put Meter in liquids or allow any liquids to enter the Test Port 9 Warranty 1 Use of meter in a manner not specified in this Owner s Booklet is n...

Page 62: ...a medical setting health care workers should follow the appropriate infection control procedures for your health equipment such as wearing gloves or other personal protection 7 Children or special use...

Page 63: ...t test strip fully into meter Repeat with new test strip Replace battery Reinstall the battery let battery positive side face up Contact for assistance Reason Sample drop too small Sample applied afte...

Page 64: ...rature error Too cold Too hot Move meter and test strips to area between5 C 40 C wait10 minutes for system to reach room temperature before testing Sample not detected or using wrong test strip Retest...

Page 65: ...ror Retest with new test strip If error persists contact for assistance Test strip removed during test Retest with new test strip Make sure result is displayed before removing test strip Display Reaso...

Page 66: ...f range High results 33 3 mmol L Retest with new test strip If result is still Hi High contact doctor or healthcare professional immediately Display Reason Action Out of range Low results 1 1 mmol L R...

Page 67: ...systems General technical requirements for blood glu cose monitoring systems for self testing and International standard EN ISO 15197 2015 In vitro diagnostic test systems Requirements for blood gluc...

Page 68: ...years based on every day perform 7 tests The use period of this product is based on every day perform 7 tests During the use users should maintain and maintain the product according to the requiremen...

Page 69: ...way data transmission can be realized Data transmission conditions the blood glucose meter and Bluetooth device are enabled 2 User access control Only by obtaining specific communication protocols can...

Page 70: ...tion 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 Docking station Optional 15 Accessory li...

Page 71: ...r mobile radio emission device may effect performance of this meter 3 Do not use this meter near substantial radiation source such as non shielded RF sources otherwise may effect performance of this m...

Page 72: ...nt 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 fl...

Page 73: ...romagnetic 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...

Page 74: ...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...

Page 75: ...recommended below according to maximum output power of the communication equipment For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres ca...

Page 76: ...L 126 mg dL 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...

Page 77: ...ectrical 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...

Page 78: ...s 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...

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