GE GE006, Manual

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Page 2: ... GE006 Blood Glucose Monitoring System is designed for in vitro diagnostic use only for self testing by a single user outside the body Testing requires only a small amount of fresh capillary whole blood from either the fingertip palm or forearm The GE006 Blood Glucose Monitoring System is manufactured and supported by Bionime Corporation If you have any questions or concerns please contact your lo...

Page 3: ...re exposed to a substantial change in temperature please wait 30 minutes before measurement Follow all environmental protection regulations when disposing of batteries Avoid contact with dripping or splashing liquids The minimum blood sample size to test using the GE006 Blood Glucose Monitoring System is 0 75µL Blood sample size above 3 0µL might contaminate the test strip port and the meter Blood...

Page 4: ...ng View Window Appearance Understanding Test Results and Messages GE006 GE006 Quality Control About Quality Control Testing Performing a Quality Control Test Understanding Control Test Results NCC 警語 Test Memory Recalling Test Results Recalling Average Test Results Caring for Your Meter Cleaning and Disinfecting Procedures Error Messages and Troubleshooting Limitations Real Time Synchronize Specif...

Page 5: ...Strip Package Insert 4 Rightest Control Solution GC550 Package Insert 5 GE006 Blood Glucose Meter with 2 AAA batteries installed 6 GE006 Blood Glucose Test strips 10 25 pcs 7 8 Lancing Device 9 Clear Cap 10 Disposable Sterile Lancets 10 pcs 11 Carrying Case not shown 12 Instruction for the lancing device not shown Different packages have different bundled items Some of packages might not include i...

Page 6: ...11 10 The Blood Glucose Meter GE006 The Blood Glucose Meter GE006 Left Button Main Button Display Window Right Button Test Strip Port Meter Battery Product name Battery Cover Meter Serial Number ...

Page 7: ...H format The GE006 Blood Glucose Meter The GE006 Blood Glucose Meter Appears when an error occurs Appears after you insert test strip into meter Current date under time mode or testing date under memory mode Warns when the operational temperature limit is exceeded during testing Displays current time under time mode or testing time under memory mode Manufacturing use only Indicates a meal marker w...

Page 8: ...not reuse GE006 Blood Glucose Test Strips Do not use expired GE006 Blood Glucose Test Strips When you open a new vial of GE006 Blood Glucose Test Strips record the date on the vial Discard the vial of test strips after 3 months from opening Store the GE006 Blood Glucose Test Strip between 4 30 C or 39 86 F and in a location 90 relative humidity Do not expose to direct sunlight or heat If the GE006...

Page 9: ... battery cover back until it snaps into place Meter Activation and Battery Change CAUTION Please follow the local regulation to properly discard a used battery Risk of explosion if battery is replaced by an incorrect type You can enter the Setting Mode two ways 1 Replace the Battery 2 With Battery Inserted After removing the battery press the main button several times until there is no signal on s...

Page 10: ...the current day Press the Main button to confirm Setting Up Your Meter Setting the Date Time and Volume Setting Up Your Meter Setting the Date Time and Volume 4 Time format 12 24H selection With the time format blinking press the Left or Right button to switch between 12H and 24H Press the Main button to confirm 5 Hour setting With the hour blinking press the Left or Right button until you see the...

Page 11: ...ch Then press the Main button to confirm it and finish the settings 9 Ending setting After measurement of unit setting for confirmation you will hear a beep if volume is turned on All the settings are saved and completed and will return to time screen Setting Up Your Meter Setting the Date Time and Volume 1 How to turn on the GE006 Blood Glucose Meter Press the Main button or Insert a test strip 2...

Page 12: ...tch to the blinking symbol with a beep If Volume is turned on 1 2 NOTE 1 The blinking symbol should turn to steady immediately when the Bluetooth connection is established 2 Blinking back and forth symbol on the screen means the meter is transferring data 1 2 Handling the GE006 Blood Glucose Test Strip How to handle the GE006 Blood Glucose Test Strip Inserting the GE006 Blood Glucose Test Strip 1 ...

Page 13: ...f the test strip port Please follow your health care professional s direction and discard used strips properly 2 3 Getting Ready for Testing Before performing a blood glucose test prepare the items below GE006 Blood Glucose Meter GE006 Blood Glucose Test Strips Please check the expiration date on the test strip vial Do not use expired test strips Rightest GD500 Lancing device Sterile lancet Alcoho...

Page 14: ...r average skin for thick or calloused skin 1 2 3 4 5 Performing a Blood Glucose Test 7 Hold the base in one hand and pull on the plunger with the other hand The device will be cocked Release the plunger and it will automatically move back to its original position near the base 8 Wash your hands with warm soapy water and dry thoroughly 9 Take one GE006 Blood Glucose Test Strip from the vial Close t...

Page 15: ...d the test strip and repeat with a new GE006 Blood Glucose Test Strip 15 Countdown Mode will begin on the display window After 5 seconds your test result will appear 15 12 14c 14a 14b 13 Performing a Blood Glucose Test 16 Pull off the depth adjustable cap Without touching the used disposable lancet insert the lancet tip into the protective lancet cover 17 Hold the release button in one hand see pi...

Page 16: ...ughly with soap and water after handling the meter lancing device and test strips Please refer to the section Cleaning and Disinfecting Procedures on page 47 for cleaning and disinfecting instructions Performing a Blood Glucose Test Setting Markers According to actual life status you can set meal markers with test result You have to perform meal marker setting immediately after the meter displays ...

Page 17: ...earm Alternative Site Testing Alternative Site Testing CAUTION Test results may vary if blood samples are taken from different sites or under certain conditions where glucose levels are changing rapidly such as following a drink a meal an insulin dose or exercise In these cases only the fingertip should be used DO NOT test on the palm or forearm if you are testing for hypoglycemia Low blood glucos...

Page 18: ...ther e g after coming indoors from the outside Allow 45 minutes for the temperature of the meter and the test strips to equilibrate Understanding Test Results and Messages If your blood glucose result is unusually high or low or if you question your test results repeat the test with a new GE006 Blood Glucose Test Strip You can also run a Quality Control Test with the Control Solution GC550 to chec...

Page 19: ...ecessary to regularly perform a quality control test Use one of the Control Solution GC550 when testing your GE006 Blood Glucose Monitoring System in the Control Solution Mode If the test result is within the Control Solution Range printed on the strip vial label the GE006 Blood Glucose Monitoring System passes the Quality Control Test and your GE006 Blood Glucose Monitoring System is working prop...

Page 20: ... dropped damaged or exposed to liquids If you suspect that your test results are inaccurate or if your test results are not consistent with the way you feel Control Solution GC550 Rightest CAUTION Each time you open a new bottle of control solution write the expiration date on the label The is good for 3 months after opening the bottle or until the expiration date printed on the label whichever co...

Page 21: ...re your Quality Control Test result to the Control Solution Range printed on the GE006 Blood Glucose Test Strip vial label Rightest Control Solution GC550 CLOSE 9 CAUTION Your Control Solution Test results will not be included in the average calculations however they can still can be recalled and viewed The Control Solution Test result will be shown with the icon on the screen The Control Solution...

Page 22: ...Meter to test your blood glucose please contact Bionime Customer Service at 886 0800 241 688 Control Solution Range 88 120 mg dL 250 340 mg dL Level 2 Level 4 Recalling Test Results The Blood Glucose Meter is able to automatically store a maximum of 500 test results with time and date If your meter has stored 500 results the newest test result will replace the oldest one To recall your test memory...

Page 23: ...e Test Results 5 Quick Searching To view test results in sequential order automatically enter the Memory Mode Press the Right or Left button for 2 seconds The Right button is for viewing from the most current to the oldest test results The Left button is for viewing from the oldest to the most current test results Release the button to stop at any particular test result NOTE Test results must exis...

Page 24: ...d use of fingerstick lancing devices and point of care blood testing devices The cleaning procedure is to remove dust blood and body fluid from the surface and should be performed whenever the meter or lancing device is visibly dirty Performing the cleaning procedure once per week is recommended The disinfecting procedure is necessary to kill pathogens such as HIV HBV and HCV on the device This pr...

Page 25: ...sinfecting cycles The testing simulates 2 cleaning and disinfecting cycles per week over the typical life of the meter 5 years 1 Allow to remain wet for 1 minute Cleaning and Disinfecting Procedures To clean the lancing device 1 Throughly wipe the entire surface of the lancing device with disinfecting wipes listed above to clean any possible dirt dust blood and other body fluids To disinfect the l...

Page 26: ... left right button the lancing device release button or depth adjustable cap You are unable to enter meter settings function modes or recall your testing results If you have any questions or concerns please contact your GE006 Blood Glucose Monitoring System authorized representative or call the Customer Service at 886 0800 241 688 51 50 Error Messages and Troubleshooting Temperature Error 1 In ord...

Page 27: ...r displays Discard the test strip If the meter shows 1a 1b 2 1 2 53 52 Error Messages and Troubleshooting Er1 strip Er2 The meter has malfunctioned Do a Quality Control Test or reinstall the batteries to check if the meter works properly Er3 The signal transmission is disrupted Repeat the test using a new test strip Er4 The blood sample volume is insufficient Repeat the test using a new test strip...

Page 28: ...erum or plasma testing Inaccurate test results may be obtained at altitudes greater than 10 000 feet 3048 meters above sea level Severe dehydration and excessive water loss may cause inaccurately low results High concentrations of Uric acid 10 0 mg dL L Dopa 3 mg dL Dopamine 2 mg dL Ascorbic acid Vitamin C 5 mg dL may result in inaccurate test results Not for neonatal use For over the counter use ...

Page 29: ...f the GE006 Blood Glucose Meter as well as a step by step walk through of performing a new blood glucose test A blood drop icon will appear on the display window of Meter And the indication of applying blood will also appear on the screen of your mobile phone Countdown Mode will begin both on the display window of the meter and the screen of your mobile phone NOTE For more information of HeartSqua...

Page 30: ...dio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Incr...

Page 31: ...Sensor Capillary whole blood 0 75 microliters Operating Temperature Operating Relative Humidity Power Saving Turns off automatically 2 minutes after last user action To turn off manually press themain button for 3 seconds A 根據NCC低功 電波 射性電機管 辦法第十條規定 率 輻 理 第十二條 第十四條 經型式認證合格之低功率射頻電機 非經許可 公司 商號或使用者均不得擅 自變更頻率 加大功率或變更原設計之特性及功能 低功率射頻電機之使用不得影響飛航安全及干擾合法通信 經發現有干擾現象 時 應立即停用 並改善至無干擾時方得繼續使用 前項合法通信 指依電信 法規定作業之無...

Page 32: ...the original purchaser of the Blood Glucose Monitoring System Please complete and return the enclosed warranty card NOTE During blood glucose measurement the GE006 Blood Glucose Meter itself may come into contact with blood All parts of the GE006 Blood Glucose Monitoring System are considered biohazardous and can potentially transmit infectious diseases Please follow your health care professional ...

Page 33: ...vitro diagnostic use Temperature limitation Manufacturer LOT IVD Lot number Expiry date For single use only Method of sterilization using irradiation Description of used symbols EC Representive CE mark with No of notified body Consult the instruction for use Please review all of the instructions to make sure you are performing the steps correctly If you have any questions or concerns please contac...

Page 34: ...Product complies with Medical Device Directive 93 42 EEC Disposable Sterile Lancets Manufacturer SteriLance Medical SuZhou Inc No 68 LiTangHe RD XiangCheng SuZhou JiangSu 215133 P R China Product complies with Medical Device Directive 93 42 EEC CE0197 EC Rep EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands No 100 Sec 2 Daqing St South Dist Taichung City 40242 Taiwan EC Rep Bionime Gm...

Page 35: ...tion Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Breakfast Lunch Dinner Bedtime Other Comments DATE M T W T F S S Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Log Book ...

Page 36: ...tion Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Breakfast Lunch Dinner Bedtime Other Comments DATE M T W T F S S Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Log Book ...

Page 37: ...tion Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Breakfast Lunch Dinner Bedtime Other Comments DATE M T W T F S S Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Log Book ...

Page 38: ...tion Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Breakfast Lunch Dinner Bedtime Other Comments DATE M T W T F S S Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Log Book ...

Page 39: ...tion Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Breakfast Lunch Dinner Bedtime Other Comments DATE M T W T F S S Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Log Book ...

Page 40: ...tion Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Breakfast Lunch Dinner Bedtime Other Comments DATE M T W T F S S Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Log Book ...

Page 41: ...n Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Breakfast Lunch Dinner Bedtime Other Comments DATE M T W T F S S Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Log Book 81 ...

Page 42: ...f purchase 2 Bionime guarantees the performance of the GE006 Blood Glucose Meter only if used as directed and provided that the failure to perform has not been caused in whole or in part by the use of test strips that are not GE006 Blood Glucose Test Strips manufactured by Bionime Use only GE006 Blood Glucose Test Strips in your GE006 Blood Glucose Meter 3 The sole obligation of Bionime under this...

Page 43: ...ur purchase of the GE006 Blood Glucose Monitoring System Thank you for purchasing our product Please complete and mail this warranty card within 30 days of purchase of your GE006 Blood Glucose Monitoring System Name Male Female Date of Birth Address City Country Postal Code Phone Number Healthcare Professional Who Recommended City Country Store Pharmacy Name Where Purchased City Country Date of Pu...