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The performance of the Test Strips has been evaluated in clinical tests.
Accuracy:

The user performance for the Blood Glucose Monitoring System was evaluated

by using capillary blood samples from 405 patients with those obtained using a YSI Model

2300 STAT Plus Glucose Analyzer.

For glucose concentration < 75mg/dL

Site

Within ± 5 mg/dL

Within ± 10 mg/dL

Within ± 15 mg/dL

1/1 (100%)
7/7 (100%)
7/7 (100%)

15/15 (100%)

1/1 (100%)
7/7 (100%)
7/7 (100%)

15/15 (100%)

For glucose concentration ≥ 75mg/dL

Site 1
Site 2
Site 3

Total (3 Site)

0/1 (0%)

7/7 (100%)

5/7 (71.4%)

12/15 (80%)

Site

Site 1
Site 2
Site 3

Total (3 Site)

Within ± 5 %

103/142 (72.5%)
118/161 (73.3%)

71/87 (81.6%)

292/390 (74.9%)

Within ± 10 %

137/142 (96.5%)
156/161 (96.9%)

87/87 (100%)

380/390 (97.4%)

Within ± 15 %

142/142 (100%)
161/161 (100%)

87/87 (100%)

390/390 (100%)

Within ± 20 %

142/142 (100%)
161/161 (100%)

87/87 (100%)

390/390 (100%)

Performance Characteristics

Содержание metene AGM-513S

Страница 1: ......

Страница 2: ...n the strip vial label Insert a test strip The meter will automatically turn on The blood glucose result will be displayed on the meter in just 5 seconds Apply the blood drop to the side edge of the yellow window of the test strip Wait for the blood drop to completely fill the yellow window of the test strip and then the meter will begin the countdown Remove the battery cover and put the battery w...

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Страница 4: ...atients patients in shock dehydrated patients or hyper osmolar patients The Blood Glucose Monitoring System should not be for diagnosis of or screening for diabetes mellitus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose sugar in fresh capillary whole blood from fingertip Blood Glucose Monitoring System is intended to be used by a single person a...

Страница 5: ...red bio hazardous waste in your area Please contact your health provider for instructions on how to discard them The Blood Glucose Monitoring System are for single patient use only and for over the counter use Carefully read and follow the instructions in the User Manual and package inserts for the test strips and control solution and practice the testing procedures before using the Blood Glucose ...

Страница 6: ...ion If the meter does not work properly and you have followed the storage and handling instructions in this User Manual contact your healthcare provider Use the test strip immediately after removing it from the vial Use all the test strips within 4 months after the first opening Store test strips only in their original vial and do not transfer them to a new bottle or any other container Do not tou...

Страница 7: ...9 2010 http www fda gov medicaldevices safety alertsandnotices ucm224025 htm CDC Clinical Remider Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM html For single patient home use 1 Do not share the system with anyone 2 All parts of the kit are considered bio hazardous and can potentiall...

Страница 8: ...9 Troubleshooting Guide l 45 Specifications l 46 Performance Characteristics l 47 Additional Information Entering the EVENT RECORD MODE l 18 Understanding Your Test Results l 20 Recalling the Previous Test Results l 22 Caring for your Blood Glucose Monitoring System l 25 Checking Your System with Control Solution l 06 Blood Glucose Monitoring System l 01 Meter l 02 Meter LCD Display l 04 Test Stri...

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Страница 10: ...e than 3 seconds Delete all the stored test results in the AVERAGE MODE Delete each test results in the MEMORY MODE Test Port Insert the Test Strip for testing Then the meter turns on and BLOOD DROP ICON will blink Button Recall the stored test result in the MEMORY MODE Select an event in the EVENT RECORD MODE Change the date time and options in the SET MODE Meter 2 ...

Страница 11: ...Battery Cover Micro USB Port Transfer your test results from the meter to a computer Test Strip Eject Button 3 ...

Страница 12: ...sed at a recommended temperature range Er1 andTEMPERATURE ICON appear CURRENTTIME andTESTTIME in the MEMORY MODE CURRENT DATE andTEST DATE in the MEMORY MODE UNIT OF MESUREMENT EVENT ICON If you choose an event icon which correlates to test results it helps to manage glucose level more effectively ALARM You can set up to four different alarms Each alarm rings for 10 seconds HYPERGLYCEMIC HYPOGLYCE...

Страница 13: ...rip Confirm if enough blood entered the confirmation window Confirmation window Reaction chamber Insert this part into the meter s test port Gold electrodes Apply blood sample here blood is absorbed automatically Yellow Side edge Test Strip 5 ...

Страница 14: ...n a new vial of test strips When you think that the test results are not accurate When you drop the meter When you suspect your meter or test strips are not working properly When your blood glucose test results are not consistent Use only the Control Solution for the test Check the expiration date printed on the control solution vial Do not use when the expiration date is expired Discard the contr...

Страница 15: ...and insert it again If the BLOOD DROP ICON still does not appear contact the manufacturer Do not use the test strip beyond the expiration date Check the expiration date printed on the test strip vial Insert a test strip with the printed side facing up into the test port of the meter Gently push it all the way in until it goes no further The meter will turn on automatically and beep Then the BLOOD ...

Страница 16: ...tion window fills completely your meter will begin the countdown Prepare the control solution Remove the vial cap and place it on a flat surface with the top of the cap pointing up Squeeze the vial to discard the first drop Squeeze a drop into the small well on the top of the cap or onto another clean non absorbent surface Checking Your System with Control Solution Your meter will display countdow...

Страница 17: ...trol solution test result to the control solution range printed on the test strip vial The test result should fall within this range Each vial of test strips may have a different control solution range If the test result you get is not within this range the meter and test strips may not be working properly Repeat the control solution test Refer to the Test Strip Instruction for the use The image i...

Страница 18: ...stem may not be working properly If this is the case do not use the system to test your blood glucose levels Contact your healthcare provider and the manufacturer Out of range test results may be caused by one or more of the followings Expired or contaminated control solution Expired or damaged test strip Use of control solution or test strip past its discarding date Error in performing the test F...

Страница 19: ...Performing the Blood Glucose Test with Meter Test Strip Lancing Device Lancets 11 ...

Страница 20: ...e the cap Remove the cap Insert the lancet firmly into the holder until it comes to a full stop When the lancet is placed in the lancing device twist off the protective disk of the lancet Do not discard the protective disk of the lancet it will be used to dispose the lancet safely after its use Insert a Lancet into the Lancet Holder Turn the cap of lancing device clockwise until it fits Replace th...

Страница 21: ...nd then release it Charge the Lancing Device Do not use the test strip beyond the expiration date Check the expiration date printed on the test strip vial Insert a Test Strip Insert a test strip with the printed side facing up into the test port of the meter Push it all the way in until it goes no further The meter will turn on automatically and beep Lot No Exp Date Do not force the test strip int...

Страница 22: ...s Hepatitis B Virus HBV Transmission of this virus has been documented due to contaminated blood glucose meter Please refer to pages 25 30 for cleaning and disinfecting your Blood Glucose Monitoring System This lancing device is intended only for a single user and should not be shared Always wash your hands thoroughly with soap and water after handling the meter lancing device and test strips Befo...

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Страница 24: ...side edge of the test strip as directed Do not put blood on the top of the test strip If insufficient blood is inserted error message Er8 will be displayed As you can see in the left illustration you have to insert a sufficient amount blood in the blood checking area Even if the meter begins the countdown despite the fact that the confirmation window is not completely filled do not apply more bloo...

Страница 25: ...ment Once the meter completes the countdown from 5 to 1 your test result will appear on the meter display Without recording the event If you remove the test strip immediately only the test result will be automatically saved in the meter memory Only Test Results With recording the event To enter the EVENT RECORD MODE you may press button of the meter before removing the test strip from the meter Se...

Страница 26: ...ion of an EVENT ICON remove the used test strip The used test strip will be discharged automatically by pushing the Ejector Button on the left side of the meter After discharging the used test strip the test result with the EVENT ICON will be saved in the meter memory automatically Remove the Test Strip For effective diabetes management stored test results with your condition Pre Meal Post Meal wi...

Страница 27: ...N Select this icon when you have a test before meal PRE MEAL ICON Once you remove the test strip from the meter you cannot go back to the EVENT RECORD MODE Do not remove the test strip from the meter until selecting an EVENT ICON is completed Entering the EVENT RECORD MODE 19 ...

Страница 28: ... glucose level immediately with a new test strip If the same message appears check the system with the Control Solution If your meter and test strip are working correctly you must contact your healthcare professional immediately 20 Understanding Your Test Results Expected Values 1 The fasting adult blood glucose range for a person without diabetes Before meals 100 mg dL After meals 140 mg dL Refer...

Страница 29: ...g your healthcare professional If your test result is Low range limit set will appear on the meter display Your meter uses the low and high range limits set in your meter to tell you when a test result is within below or above the range limits If your result is High range limit set will appear on the meter display If you need to change the pre set limits please go the SET MODE page 34 Understandin...

Страница 30: ...ith date time and event It also provides you averages of your blood glucose test results over a period of time Options 7d 14d 30d 60d or 90d average You can review the test results stored in the memory by the following steps If there is no test result the meter will not display anything and button will not operate 22 Recalling the Previous Test Results ...

Страница 31: ...rage value is displayed Press and hold the power button for 5 seconds until CLr flashes and appears You can select the number of days for the average 7d 14d 30d 60d or 90d in the SET MODE 7d shown in the right side indicates that the value 96 is a calculated average for the past 7 days The meter is pre set with the average day of 7d Indicate the Average Value A Recalling the Previous Test Results ...

Страница 32: ...e meter display Every time you press and release button the meter will display the next result up to 500 test results Recall your Test Results To delete individual test result in the MEMORY MODE press and hold the power button for 5 seconds until dEL flashes and appears Press and release the power button once to exit from the MEMORY MODE Exit the MEMORY MODE 24 ...

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Страница 36: ...n providing testing assistance to the user the meter and lancing device should be decontaminated prior to use by the second person Always keep the meter free from dirt blood and liquid The meter should be periodically cleaned and disinfected 28 ...

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Страница 39: ...ppears on the meter display If you press and release the power button the meter advances next to the Month Setting Set the Year The Meter comes with date 1 1 date format dd mm time 12 00AM time format 12h alarm 0 average day 7d hypoglycemic limit hyperglycemic limit and unit of measurement mg dL beep On preset However if you need to change the setting of the meter or if you replace the battery you...

Страница 40: ...h If you press and release the power button the meter advances next to the Day Setting Set the Month The Day flashes Press and release button until you get the correct day If you press and release the power button the meter advances next to the Date Format Setting Set the Day The Date flashes Press and release button until you get the date format that you want If you press and release the power bu...

Страница 41: ...shes Press and release button until you get the correct hour If you press and release the power button the meter advances next to the Minutes Setting Set the Hour The 12h or 24h flashes Press and release button to adjust until you get the correct time format If you press and release the power button the meter advances next to the Average Period Setting Set the Time Format Setting Meter 33 ...

Страница 42: ...Limit Press button to select the hyper upper blood glucose level If you press and release power button the meter advances next to the Beep Setting Set Hyperglycemic Warning Limit Hypoglycemic warning limit cannot be higher than hyperglycemic warning limit Hyperglycemic warning limit cannot be lower than hypoglycemic warning limit Be sure to talk to your healthcare professional about the low and hi...

Страница 43: ...dvances next to the Alarm Setting If you set it Off you don t need to set the alarm and the meter exits the SET MODE Set the Alarm Time The Hour of the Alarm Time flashes Press and release button to set the alarm time the same as the Time Setting Save the Setting Information Press and release the power button and then the meter will turn off The setting information you entered will be saved Totall...

Страница 44: ...e times but the battery should be replaced to new one as soon as possible If bAt appears on the meter display the meter will not operate The battery must be immediately replaced Always turn off the meter before replacing the battery Replacing the battery with the meter power on may lead to malfunction of the meter Press the power button to turn off the meter Turn off the Meter Installing Battery 3...

Страница 45: ...attery Cover Remove the old battery and put the new one with sign facing up Replace the Battery Remove the battery door from the back of the meter by pushing the tab in the direction of the arrow and pulling up the door Remove the Battery Cover 37 Installing Battery ...

Страница 46: ...Date Range and click Yes Meter data will be transferred to your PC After the download is completed you can see the summary report and the meter turns off Until the download is completed do not disconnect the meter with PC and do not turn off the meter is designed to connect with PC using Micro USB cable and to transfer test results to PC Through diabetes management software LinkDr 2 0 you can revi...

Страница 47: ...lood glucose test result You should check that your meter matches the example exactly every time your meter turns on Do not use the meter if the display check screen does not exactly match the example Please contact your healthcare provider Insert a test strip into the test port of your meter Apply a blood sample to the test strip See page 12 17 for how to test your blood glucose level No action i...

Страница 48: ...the test using a new test strip and or check the system with the Control Solution If the test result is HI again even though your system is working correctly contact your healthcare professional immediately Your blood glucose result is lower than 20 mg dL Repeat the test using a new test strip and or check the system with the Control Solution If the test result is Lo again even though your system ...

Страница 49: ... hypoglycemic warning limit A blood glucose test result stored in the memory Battery is low but you can still perform a few more tests No action is required No action is required No action is required Turn off the meter and replace the battery as soon as possible Action What it means Message 41 Display Message Guide ...

Страница 50: ...days The meter is connected with PC using Micro USB cable No test result in memory Turn off the meter and replace the battery immediately No action is required Transfer meter data to PC page 39 No action is required The meter is used outside the proper range of temperature Leave the meter at a temperature between 50 104ഘ 10 40ഒ A 42 ...

Страница 51: ...ise during the test The meter has an internal electric circuit problem Retest with a new test strip Retest with a new test strip Do not remove the test strip until test result appears on the meter display Retest with a new test strip Contact your healthcare provider Action What it means Message 43 Display Message Guide ...

Страница 52: ...ection Not enough blood or control solution was drawn into the test strip for a test Blood is applied to wrong direction into the test strip Contact your healthcare provider Contact healthcare provider Retest with a new test strip Apply blood to right direction into a new test strip 44 ...

Страница 53: ...is no battery in the meter The meter may not be working properly The test strip is inserted upside down or incompletely Replace the battery Check if battery is correctly installed with the positive sign facing up See pages 36 37 Contact your healthcare provider Insert the test strip correctly with the printed side facing up Troubleshooting Guide 45 ...

Страница 54: ...GM 513S Electrochemicalmethod Freshcapillarywholeblood 0 5 20 600mg dL 5seconds Plasma equivalent One3 voltlithiumbattery coincelltypeCR2032 Approximately1 000tests mg dL Temperature 50 104ഘ 10 40ഒ RelativeHumidity 15 85 Altitude Upto10 000feet 3 048m Hematocrit 20 65 50X87 3X17 5 mm 2 0X3 4X0 69 inches Approximately47 2gor1 7oz withbattery 44 0X38 0 mm LCD 1 7X1 5 inches LCD 500testresults withda...

Страница 55: ...e Within 5 mg dL Within 10 mg dL Within 15 mg dL 1 1 100 7 7 100 7 7 100 15 15 100 1 1 100 7 7 100 7 7 100 15 15 100 For glucose concentration 75mg dL Site 1 Site 2 Site 3 Total 3 Site 0 1 0 7 7 100 5 7 71 4 12 15 80 Site Site 1 Site 2 Site 3 Total 3 Site Within 5 103 142 72 5 118 161 73 3 71 87 81 6 292 390 74 9 Within 10 137 142 96 5 156 161 96 9 87 87 100 380 390 97 4 Within 15 142 142 100 161 ...

Страница 56: ...L 6 3 3 9 3 7 3 4 3 7 37 2 mg dL 80 4 mg dL 118 mg dL 200 mg dL 353 mg dL 1 4 mg dL 1 8 mg dL 2 6 mg dL 3 5 mg dL 7 4 mg dL 3 7 2 2 2 2 1 7 2 1 Level STD CV Level STD CV Measurement repeatability using venous whole blood Intermediate measurement precision using control solution Measurement precision 48 ...

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