| all | frequencies |
|
|
exhibits | applications |
|---|---|---|---|---|---|
| manuals | |||||
| app s | submitted / available | |||||||
|---|---|---|---|---|---|---|---|---|
| 1 2 |
|
User Manual | Users Manual | 2.38 MiB | ||||
| 1 2 |
|
User's Manual (revised) | Users Manual | 1.94 MiB | May 09 2012 / December 02 2013 | |||
| 1 2 | Cover Letter(s) | |||||||
| 1 2 | External Photos | |||||||
| 1 2 | Cover Letter(s) | |||||||
| 1 2 | ID Label/Location Info | |||||||
| 1 2 | RF Exposure Info | |||||||
| 1 2 | Test Setup Photos | |||||||
| 1 2 | Cover Letter(s) | |||||||
| 1 2 | Cover Letter(s) | |||||||
| 1 2 | Internal Photos | / December 02 2013 | ||||||
| 1 2 | Parts List/Tune Up Info | |||||||
| 1 2 | RF Exposure Info | |||||||
| 1 2 | Test Report | |||||||
| 1 2 | Parts List/Tune Up Info |
| 1 2 | User Manual | Users Manual | 2.38 MiB |
i-SENS, Inc. 465-6 Wolgye4-dong, Nowon-gu Seoul 139-845, Korea www.i-sens.com Medical Technology Promedt Consulting GmbH, Altenhofstrasse 80,D-66386 St. Ingbert, Germany 2012 i-SENS, Inc. All Rights Reserved. PGA1E3121 REVx 05/2012 0123 Owners Booklet Blood Glucose Monitoring System Data Transmission Welcome to the AutoChek t BGMS Blood Glucose Monitoring System Thank you for purchasing the AutoChek t Blood Glucose Monitoring System. The system provides you with safe, convenient, and painless blood glucose in vitro
(i.e., outside the body) diagnostic monitoring. You can obtain accurate results in just 5 seconds with a small (0.5 ) blood sample. The AutoChek t Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. The AutoChek t Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AutoChek t is capable of sending test results to AutoChek ts remote database by using cellular data transmission. AutoChek t securely uploads and manages blood glucose readings, eliminating the need to maintain personal logbooks. Table of Contents Information Important Information : Read This First! -------------------------------------- 6 Important Information----------------------------------------------------------- 7 Specifications ------------------------------------------------------------------- 8 AutoChek t Blood Glucose Monitoring System ------------------------------ 9 AutoChek t Blood Glucose Test Strip --------------------------------------- 10 AutoChek t Blood Glucose Meter -------------------------------------------- 12 AutoChek t Blood Glucose Meter -------------------------------------------- 13 AutoChek t Blood Glucose Meter Display ---------------------------------- 14 Preparation Adjusting the Date, Time and Unit ------------------------------------------- 15 Setting up Your System ------------------------------------------------------- 15 Setting the Sound On/Off ---------------------------------------------------- 19 Setting the Cellular function On/Off ----------------------------------------- 20 Setting the Test Result Reset ----------------------------------------------- 23 Checking the System --------------------------------------------------------- 24 Comparing the Control Solution Test Results ------------------------------ 27 Testing Using the Lancing Device ---------------------------------------------------- 28 Preparing the Lancing Device for Blood Sample Retrieval --------------- 29 Preparing the Meter and Test strip ------------------------------------------ 31 Applying Blood Sample ------------------------------------------------------ 32 Result Data Transmission I--------------------------------------------------- 34 Result Data Transmission II -------------------------------------------------- 35 Automatic time adjusting ----------------------------------------------------- 37 Discarding Used Lancets ----------------------------------------------------- 38 Alternative Site Testing ------------------------------------------------------- 39 HI and Lo Message ------------------------------------------------------------ 42 Target Blood Glucose Ranges ----------------------------------------------- 43 Additional function Meter Memory ----------------------------------------------------------------- 44 Setting the post-meal alarm (PP2 alarm) ------------------------------------ 46 Setting the Alarm Function --------------------------------------------------- 46 Setting the Time Alarms (alarm 1~3) ---------------------------------------- 48 Maintenance Charging Your AutoChek t Blood Glucose Meter -------------------------- 50 Caring for Your System ------------------------------------------------------- 52 Understanding Error and Other Message ----------------------------------- 52 General Troubleshooting ----------------------------------------------------- 52 Understanding Error and other Message ----------------------------------- 53 Performance Characterstic --------------------------------------------------- 58 Warranty Information --------------------------------------------------------- 60 Important Information : Read This First!
To receive safe and optimum system benefits, please read the entire manual contents before the system. Please note the following instructions:
Do not use the system for the diagnosis of diabetes or for testing newborns. Use only fresh capillary whole blood samples for testing. Alterative site and fingertip test result may differ significantly due to rapid change in the glucose level post meal, insulin injection, or exercise. The following chart explains the symbols youll find in the AutoChek t User Manual, product packaging, and product inserts. For in vitro diagnostic use This product fulfills the requirements for Directive 98/79/EC 0123 In vitro diagnostic medical devices Cautions for safety and optimum product use Consult instruction for use Manufacturer Authorized representative Temperature limitations Serial number Do not reuse Batch code Use by (unopened or opened test strip container) Do not discard this product with other household-type waste www.i-sens.com 6 Important Information The AutoChek t blood glucose monitoring system is intended for self-
testing outside the body (in vitro diagnostic use). The glucose in the blood sample mixes with special chemicals on the test strip where to produce a small electrical current. The AutoChek t meter detects this electrical current and measures the amount of glucose in the blood sample. The AutoChek t blood glucose meter is designed to minimize code related errors in monitoring by using the no-coding function. The AutoChek t blood glucose meter should be used only with the AutoChek t strip. Do not use the system for testing newborns or pregnant women because test results may be affected by the red blood cell count
(hematocrit). Very high (60% or more) or very low (20% or less) hematocrit can lead to incorrect test results. A glucose value of less than 3.9 mmol/L may indicate hypoglycemia and a value of more than 13.3 mmol/L may indicate hyperglycemia. If you need assistance, please contact your authorized i-SENS sales representative or visit www.i-sens.com for more information. www.i-sens.com 7 Specifications Product specifications Reported result range 20 ~ 600 mg/dL(1.1 ~ 33.3 mmol/L) Sample size Test time Sample type Calibration Assay method Power Memory Size Weight Minimum 0.5 5 seconds Fresh capillary whole blood Plasma-equivalent Electrochemical 3.7V Lithium Polymer Battery
(Rechargeable Type) 250 test result 45L x 96.9W x 18H (mm) 66.1g Operating ranges Temperature Relativity humidity Hematocrit 10~40C(50 ~ 104 F) 10 ~ 90%
20 ~ 60%
www.i-sens.com 8 Autochek t Blood Glucose Monitoring System Components Glucose Meter Lancing Device Lancets(10) Owners Booklet Quick Reference Guide Logbook Carrying Case Test Strip Certain components may not be included depending on the place of purchase Check all the components after opening the AutoChek t blood glucose monitoring system package. The exact contents are listed on the main box The cable for data transmission can be ordered separately. Please contact your authorized i-SENS sales representative. www.i-sens.com 9 Autochek t Blood Glucose Test Strip The AutoChek t blood glucose monitoring system measures blood glucose quickly and accurately. It automatically absorbs the small blood sample applied to the narrow edge of the test strip. www.i-sens.com 10 Warning!
The AutoChek t test strip should be used only with fresh capillary whole blood samples. Do not reuse test strips. Do not use test strips past the expiration date. Test strips in new, unopened containers and test strips in containers that have been opened can be used up until the expiration date printed on the test strip box and container label if the test strips are used and stored according to its storage and handling methods. Store test strips in a cool and dry place at a temperature of 1 ~ 30C (34 ~ 86F). Keep away test strips from direct sunlight or heat and do not refrigerate or freeze. Store test strips only in their original vial. Close the vial tightly after removing a test strip for testing and use the strip immediately. Handle test strips only with clean and dry hands. Do not bend, cut, or alter test strips in any way. For detailed storage and usage information, refer to the AutoChek t test strip package insert. Caution:
Keep the meter testing supplies away from young children. www.i-sens.com 11 Autochek t Blood Glucose Meter Buttons Select or changes information S Button Turns the meter on/off and confirms menu selections Test Strip Port Insert test strip here Display Shows and messages results www.i-sens.com 12 Autochek t Blood Glucose Meter SIM Card Slot Insert a Mobile SIM Card Communication port Charging the Battery or Used to transfer data from the meter to a computer a Mini USB Cable Note:
The mini USB cable for data transmission to PC can be ordered Separately, Please contact your authorized i-SENS sales representative. www.i-sens.com 13 Autochek t Blood Glucose Meter Display mem Appears when test result stored in the memory are displayed alarm Appears when the time alarm has been set mmol/L Unit for measuring blood glucose Battery icon Battery level indicator Post-meal test flag Appears during post-
Meal testing and When post-meal test Result are displayed Alarm icon Appears when the post
-meal alarm has been set Sound icon Appears only when the sound is set to OFF check Appears when test result have not been saved Test result Test results displaying panel Decimal point Appears when the blood glucose measuring unit is set to mmol/L mg/dL Unit for measuring blood glucose Blood insertion icon Unit for measuring blood glucose www.i-sens.com 14 Setting up Your System Press and hold the S button for 3 seconds to turnon the meter. After all settings are finished, press and hold the S button for 3 seconds to turn off the meter. Press or to reach the accurate value. Press and hold to scroll faster Adjusting the Date, Time and Unit Step 1 Entering the SET Mode Press and hold the S button for 3 seconds to turnon the meter. After all the segments flash across the screen, the SET character icon will be displayed on the screen. Press the S button again to enter the year setting mode. Step 2 Select the automatic time adjusting mode Enter the SET mode and press the S button until the AUT appears on the screen. By pressing the S button one more time, the meter will automatically adjust itself to the correct current time.
(refer the Automatic time adjusting) www.i-sens.com 15 Step 3 Setting the Year If user didnt select the automatic time adjusting mode at the Step 2, The number that appears on the screen after the meter is turned on indicates the year of manufacture. Press and release the or to adjust until the correct year appears. Press and hold the button to scroll through the numbers quickly. After setting the year, press the S button to confirm your selection and enter the month setting mode Step 4 Setting the Month A number indicating the month will be blinking on the left corner of the screen. Press the or until the correct month appears. Press the S button to confirm your selection and enter the date setting mode. www.i-sens.com 16 Step 5 Setting the Date Press the or until the screen displays The correct date. Press the S button to confirm the date and enter the time setting mode. Step 6 Setting the Time The meter can be set in AM/PM 12-hour or 24-hour clock format. Press the or to select a format. The AM / PM icon is not displayed in the 24-
hour format. After selecting the format press the S button to enter the hour setting mode. Step 7 Setting the Hour Press the or until the correct hour appears. After the hour is set, press the S button to enter the minute setting mode. www.i-sens.com 17 Step 8 Setting the Minute Press the or until the correct minute appears. After setting the minute, press the S button to enter the unit setting mode www.i-sens.com 18 Setting the Sound On/Off Step 9 On the sound option menu, pressing the or , the screen will display the On or OFF. Press the S button to confirm the selection. The meter will beep in the following instances, if the meters sound is set to On. When the test strip is inserted in the meter When the blood sample is absorbed into the test strip and the test starts When the test result is displayed When you push the S button or button to check the memory When you push the button to set the post-
meal (PP2) alarm When it is time for a preset blood glucose test If the sound is set to OFF, none of the sound functions will work Note:
Only when the sound is set to OFF, icon appears on the display www.i-sens.com 19 Setting the Cellular function On/Off Step 10 Enter the SET mode and press the S button until the CEL appears on the screen. On this screen, the cellular function of the meter can be activated or deactivated. Step 11 From the CEL screen, press the or button until the On character icon appears on the screen. Press the S button to turn on the cellular function of the meter. From the CEL screen, press the or button until OFF appears on the screen. Press the S button to turn off the cellular function of the meter. www.i-sens.com 20 Step 12 Once the cellular function of the meter is turned on, the meter can immediately transmit the test result data to the designated server by choosing Transfer Mode 1 (T1 mode). After turning on the cellular function is turned on, the T1 will be appeared, once the T1 appears, press the S button to choose Transfer Mode 1 Step 13 Once the cellular function of the meter is turned on, the meter can transmit the test result data to the designated SMS server once a day at a reserved time by choosing Transfer Mode 2 (T2mode). In order to choose Transfer Mode 2, press the or until T2 appears from the T1 screen. Once the T2 appears, press the S button and the OFF will blink. Press the button to turn on Transfer Mode 2. www.i-sens.com 21 Step 14 Once Transfer Mode 2 is turned on, press the or until the correct hour appears. After the hour is set, press the S button to enter the minute setting mode. Press the or until the correct minute appears. Once correct hour and minutes are set, press S button to confirm the schedule. www.i-sens.com 22 Setting the Test Result Reset
(Deleting all the saved test result) Step 15 In this mode all the test results stored in the meter can be deleted. Please note that if you select YES, all the stored test results will be deleted and cannot be restored. After the beeper mode is set, press the S button to enter the Test Result Reset mode. The dEL will blink on the screen. Press the or to alternate between YES or no. To delete all the stored test results press the S button when the screen displays YES. Then, all the test results stored in the meter will be deleted and the screen will be similar to the picture on the right. If you do not want to delete the results press the S button when the screen displays no. Then, the screen will return to step 2. Please, see page 12. Note:
At any stage, If the S button is pressed for 3 seconds, Time, Date another setting mode will finish and meter will be turned off. Press and hold the to scroll through number quickly www.i-sens.com 23 Checking the System You may check your meter and test strips using the AutoChek t Control Solution. The AutoChek t Control Solution contains a known amount of glucose and is used to check that the meter and the test strips are working properly. The test strip vials have AutoChek t Control Solution ranges printed on their labels. Compare the result displayed on the meter to the AutoChek t Control Solution range printed on the test strip vial. Before using a new meter or a new vial of test strips, you may conduct a control solution test following the procedure on page 18. Note:
Use only the AutoChek t Control Solution. Check the expiration dates printed on the vial. When you first open a control solution vial, record the discard date (date opened plus three months) in the space provided on the label. Make sure your meter, test strips, and control solution are at room temperature before testing. Control Solution tests must be done at room temperature (20 ~ 25C, 68 ~ 77F). Before using the control solution, shake the vial, discard the first few drops and wipe the tip clean. Close the control solution vial tightly and store at a temperature of 8 ~ 30C (46 ~ 86F). You may do a control solution test:
When using the meter for the first time. Whenever you open a new vial of test strips. If the meter or test strips do not function properly. If your symptoms are inconsistent with the blood glucose test results, and when you feel that the meter or test strips are not working properly If you drop or damage the meter. www.i-sens.com 24 Caution:
If all the results you get from testing continuously (at least three times)are within the range printed on the test strip, the meter and test strips are working properly and you may use them for your blood glucose test. Control Solution Testing Step 1 Insert a test strip into the meters test strip port, with the contact bars facing upwards. Gently push the test strip into the port until the meter beeps. Be careful not to break the strip while pushing it in. The icon will be displayed on the screen. Step 2 Shake the AutoChek t Control Solution vial before each test. Remove the cap and squeeze the vial to discard the first drop. Then wipe the tip with a clean tissue or cloth. After the symbol appears on the display, apply the solution to the narrow edge of the test strip until the meter beeps. Make sure the confirmation window fills completely. www.i-sens.com 25 Note:
The meter may be turned off, if the blood sample is not applied within 2 minutes of the icon appearing on the screen. If the meter is turned off, remove the strip, reinsert, and start from step 1. Step 3 A test result will appear after the meter counts down from 5 to 1. After your control solution result appears on the display, press the for 3 seconds until the check icon appears on the display. When the check icon is displayed, the result is not stored in the meters memory and is not included in the averages. Step 4 Compare the result displayed on the meter to the range printed on the test strip vial. The result should fall within the range on the test strip vial. Used strips should be discarded and disposed. Caution:
If the results you get are not within this range, the meter and test strip may not work properly. Then, stop using the meter and contact the nearest i-SENS representative. The range printed on the test strip vial is for the AutoChek t Control Solution only. It does not have any connection to your blood glucose level. www.i-sens.com 26 Comparing the Control Solution Test Results Repeat the control test if the test result falls outside the range printed on label of the test strip vial. Out of range results may occur due to the following factors:
When the control solution vial was not shaken well, When the control solution is past contaminated, its expiration date or is When the meter, the strip or the control solution were exposed to high or low temperatures, When the first few drops of the control solution were not discarded or the tip of the vial was not wiped clean, When the test strip is past its expiration date, When the meter is not functioning properly. Note:
The AutoChek t Control Solution can be purchased separately. Please contact your authorized i-SENS sales representative. www.i-sens.com 27 Using the Lancing Device You will need a lancing device in order to collect a blood sample. You may use the lancing device contained in the AutoChek t Blood Glucose Monitoring System or any other medically approved lancing device. The lancing device should be used by one individual and communal use is strongly discouraged Use a soft cloth or tissue to wipe the lancing device. If necessary, a small amount of alcohol on a soft cloth or tissue may be used. Caution:
To avoid infection when drawing a sample, use a lancet only one time, and:
Do not use a lancet that has been used by others. Always use a new sterile lancet. Keep the lancing device clean. Note:
Repeated puncturing at the same sample site may cause pain or skin calluses. Choose a different site each time you test. www.i-sens.com 28 Preparing the Lancing Device for Blood Sample Retrieval Step 1 Wash hands and fingertip sample site with soap and warm water. Rinse and dry thoroughly. Step 2 Unscrew the lancing device tip Step 3 Firmly insert the new lancet into the lancet holder. Hold lancet firmly. Gently twist to pull off the protective disk. Save the disk to recap the lancet after use. Replace the lancing device tip. www.i-sens.com 29 Step 4 Select a desired depth of one-to-five
(1-5) on the lances adjustable tip. Rotate the to align the desired number with the A beginning setting of three (3) is recommended. Step 5 To cock the lancing device, hold the tip in one hand. Pull the sliding barrel on with the other hand. The lancing device is cocked when you feel a click. Note:
The skin depth to retrieve samples will vary for various people at different sample sites. The lances adjustable tip allows the best depth of skin penetration for an adequate sample size. A beginning setting of three (3) is recommended. www.i-sens.com 30 Preparing the Meter and Test strip Step 6 Insert a test strip with the contact bars facing upwards into the meter port. Push the strip in gently until the meter beeps. Be careful not to bend the test strip. The symbol will appear on the screen. Flagging Post-meal Test Result The AutoCheck t meter allows you to flag a result of an post-meal test with the ( ) icon. The post-meal test flag ( ) can be attached just before applying the blood sample. Once you attach the post-meal flag ( ) to the test results, it cannot be deleted. Step 7 If you want to attach an post-meal flag ( ) to a test result, press and hold the for 3 seconds after inserting the test strip. The post-meal flag( ) and the symbol will appear on the screen The test result will also be displayed with the post
-meal flag( ). If you do not want to save the result the result as a Postmeal test, move on to the step 8 after the step 6. www.i-sens.com 31 Applying Blood Sample Step 8 Obtain a blood sample using the lancing device. Place the device against the pad of the finger. The best puncture sites are on the middle or ring fingers. Press the release button. Remove the device from the finger. Wait a few seconds for a blood drop to form. A minimum volume of 0.5 microliter is needed to fill the Confirmation window. (actual size of 0.5 : ) Step 9 After the symbol appears on the screen, Apply the blood sample to the narrow end of the test strip till the meter beeps. If the confirmation window filled before the meter Finishes down then discard the test strip new one. If confirmation window is not filled in because of Abnormal viscosity or insufficient volume, Er4 message will appear. Note:
The meter may switch off if the blood sample is not applied within 2 minutes of The icon appearing on the screen. If the turns off, remove the strip and reinsert into the meter. www.i-sens.com 32 Step 10 The test result will appear after the meter counts down from 5 to 1. The result will be automatically stored in the meters memory. If the test strip is removed after the test result is displayed, the meter will be automatically turned off after 3 seconds. Discard used test strips safely and dispose. www.i-sens.com 33 Result Data Transmission I Step 1 In the T1 mode, the measured data is sent to a server immediately after each measurement.
(Refer the Setting the Cellular function On/Off ) After measuring Blood glucose and discard an used test strip, the meter will starting the data transfer operation. Snd will be appeared on the screen. Step 2 Once the data transfer begins, the progress indication dash dot (blinking) will be appeared at the bottom of the screen. Step 3 When the meter successfully sent the test result, SUCC ESS will be appeared at the bottom of the screen. www.i-sens.com 34 Result Data Transmission II Step 1 Transfer mode 2 (T2 Mode)
(Refer the Setting the Cellular function On/Off ) User can set the schedule, then BGM sends all test results to the server once a day only at a reserved time. Step 2 At the reserved time, GSM meter wakes up automaticallyandgathering all measured data of the day The data will be sentto the server. Snd appears during the data transfer. Step 3 At the bottom of thescreen, it displays the progress indicator dots. www.i-sens.com 35 Step 4 When the meter successfully sent the test result, SUCC ESS will be appeared at the bottom of the screen. www.i-sens.com 36 Automatic time adjusting Step 1 In the sleep mode, press the button until display TIM Step 2 When TIM appears, release the button Step 3 When the Autochek t retrieve cellular network time, it will display the local time at the bottom of the screen. www.i-sens.com 37 Discarding Used Lancets Step 1 Unscrew the general lancing device tip. Step 2 Place the protective cover on the lancet. Push the lancet ejector forward with the thumb and simultaneously pull out the sliding barrel to dispose the used lancet into a proper biohazard container. Cautions:
The lancet is for single use only. Never share or reuse a lancet. Always dispose of lancets properly. www.i-sens.com 38 Alternative Site Testing What is AST(Alternative Site Testing)?
AutoChek t BGMS is caplable of testing your blood glucose from your palm, arms, tight, or calves, usually referred to as an alternative site test, or AST. Alternate site testing can be less painful than fingertip testing,. However, because of the physiological differences between your fingertip and palm, AST results may be significantly different. While AST may reduce the pain during testing, it may not be simple for everyone and the following precautions should be observed during testing. You should consult with your doctor before using alternate site testing. Things to know when using AST Please understand the following informationbefore testing outside of the fingertip
(palm, arms, thighs, or calves). The capillary blood of the fingertip shows the change in glucose more rapidly than AST. Therefore, the test results from the fingertip test and AST may differ. This might caused by lifestyle or ingested food have an effect on glucose levels. www.i-sens.com 39 Acceptable situation for AST two hours after a meal or exercise Fasting period Before a meal Before sleeping Situation requiring fingertip test When the glucose levels are rapidly increasing during the When sick or when glucose levels seem quite lower than test value When hypoglycemia is not well recognized When insulin has the biggest effect 2 hours after an insulin injection AST Precautions Do not ignore the symptoms of hyperglycemia or hypoglycemia. When the results of the test do not reflect ones opinion, retest using the fingertip test. If the test results do not reflect ones opinion, please consult a doctor. Do not rely on the AST results for changing ones treatment method The amount glucose in alternative sites differs from person to person Before using AST, please consult your regular physician www.i-sens.com 40 Note:
Results from alternative site and fingertip samples may appear differently as there is a time lag for the glucose levels to reach the same value. Use a fingertip for drawing if you suffer from hypoglycemia or have experienced hypoglycemic shock or symptoms. drawing if you suffer from hypoglycemia or have experienced hypoglycemic shock or symptoms. Note:
If the sample drop of blood runs or spreads due to contact with hair or with a line in you palm, do not use that sample. Try puncturing again in a smoother area. www.i-sens.com 41 HI and Lo Message HI Message The meter displays results between 20 ~ 600 mg/dL (1.1 ~ 33.3 mmol/L). The Hi icon will be appeared when the blood glucose level is more than 600 mg/dL (33.3 mmol/L) and indicates hyperglycemia. If the Hi icon is displayed again on re-testing, please contact your healthcare professional immediately. Lo Message The Lo icon appears when the result is less than 20 mg/dL (1.1 mmol/L) and indicates hypoglycemia If the Lo icon is displayed again on re-testing, please contact your healthcare professional immediately. Note:
Please contact your authorized i-SENS sales representative, if such messages are displayed even though you do not have hyperglycemia or hypoglycemia. www.i-sens.com 42 Your target ranges from your healthcare expert Reminders Time of day Before breakfast Before lunch or dinner 1 hour after meals 2 hour after meals Between 2 a.m. and 4 a.m. Target Blood Glucose Ranges Source : Diagnosis of Diabetes, NIH Publication No. 05-4642, January 2005 www.i-sens.com 43 Meter Memory The AutoChek t meter can save up to 500 glucose test results with time and date. If the memory is full, the oldest test result will be deleted and the latest test result will be stored. The AutoChek t meter calculates and displays the averages of total test results, pre-meal test (Pr) results, and post-meal test ( ) results from the last 1, 7, 14, 30 and 90 days. Viewing Test Result Stored in the Meters Memory Step 1 Press the or S button to turn the meter on. p The current date and time will be displayed at the bottom of the screen for 2 seconds, followed by the 1 day average value and the number of the test results saved within the last 14 days. Press the button to view the average value and the number of tests performed before a meal for the last 14 days. Press the button again to check the average value and the number of tests performed after a meal for the last 14 days. Step 2 www.i-sens.com 44 Step 3 Use the button to scroll through the test results, starting from the most recent and ending with the oldest. Press the button to return to the result seen previously. After checking the stored test results, press the S button to turn off the meter. Note:
Bypressing the button ,the latest test result saved in the meters memory will be displayed on the screen along with the date and time. Press and hold the button to scroll through the test results. www.i-sens.com 45 Setting the Alarm Function Four types of alarms can be set in the AutoChek t meter: one post- meal alarm
(PP2 alarm) and three time set alarms (alarm1 ~ 3). The PP2 alarm goes off 2 hours after setting the alarm. The alarms ring for 15 seconds and can be silenced by pressing ,, or the S button. Also the alarms can be turned of by inserting a test strip. Setting the post-meal alarm (PP2 alarm) Step 1 Setting the PP2 alarm On Without inserting a test strip, press and hold the button for 3 seconds to set the post-meal alarm. The PP2 character, the bell ( ) icon and then the On character will be displayed. The screen will then automatically be switched to the memory check mode. Thenthe bell ( ) icon, which indicating that the PP2 alarm has been set, will be displayed on the screen. www.i-sens.com 46 Step 2 Setting the PP2 alarm Off To turn off the PP2 alarm, press and hold the button for 3 seconds. The PP2 character, the bell ( ) icon, and then the OFF character will be appeared on the screen. Then the screen will be switched automatically to the memory check mode without the bell ( ) icon being displayed. www.i-sens.com 47 Setting the Time Alarms (alarm 1~3) Step 1 Without inserting a test strip, press the button and the S button simultaneously for 3 seconds to enter the time alarm mode. The alarm1 will be displayed while the OFF character blinks on the screen. Step 2 By pressing the button, the alarm1 is set and the On character will be displayed on the screen. Press the button again to cancel the alarm1. The OFF icon will be blinked on the screen. Step 3 Press the button to adjust the time of the alarm1. A number representing the time will be blinked on the screen. Press the button to set the time. Press the button to end. www.i-sens.com 48 Step 5 Step 4 By pressing the button, the number indicating the minute will start blinking. Press the button to set the accurate minute. Press the S button to finish and to enter the alarm 2 mode. Repeat steps 2 to 5 to set the remaining time alarms (alarm 2 ~ 3). Press the S button for 3 seconds to finish and turn the meter off. Step 6 www.i-sens.com 49 Charging Your AutoChek t Blood Glucose Meter Step 1 Plug the mini USB cable into AC adaptor Plug the other end of the mini USB cable into the BGMs charging port which is located on the side of the BGM. Once the mini USB cable is plugged, the BGM will start charging and the Chr will be displayed on the screen. www.i-sens.com 50 Step 2 Once charging is completed, the End will be appeared at bottom left of the screen. Caution :
If the meter wont charge, please do not attempt to take apart, repair, or modify the meter. Please contact your authorized i-SENS sales representative, www.i-sens.com 51 Caring for Your System Use a soft cloth or tissue to wipe the meter exterior. If necessary the soft cloth or tissue might be dipped in a small amount of alcohol. Do not use organic solvents such as benzene, or acetone, or household and industrial cleaners that may cause irreparable damage to the meter. Store all the meter components in the portable case to prevent loss. Caution Do not expose the meter to direct sunlight or heat for an Prevent the entry of dirt, dust, blood, or water at the meters extended period of time. test strip port. Do not drop the meter or submit it to strong shocks. Do not try to fix or alter the meter in any way. Keep the meter away from strong electromagnetic fields such as cell phones and microwave ovens. AutoChek t meter should be used only with AutoChek t strips. Keep the meter in a cool and airy place. www.i-sens.com 52 Understanding Error and other Message Message What It Means What To Do A used test strip was inserted. Repeat the test with a new test strip. The blood or control solution sample was applied before the icon appeared. The temperature during the test was above or below the operating range. Repeat the test with a new test strip and wait until the icon appears before applying the blood sample. Move to an area where the temperature is within the operating range
(10 ~ 40 C/ 50 ~ 104 F) and repeat the test after 30 minutes. www.i-sens.com 53 Message What It Means What To Do The blood sample has abnormally high viscosity or insufficient volume. Repeat the test after inserting a new test strip. A non-AutoChek t test strip was used. Test strip was not inserted properly. There is a problem with the meter. Repeat the test with a AutoChek t test strip. Insert a test strip with the contacting bars facing upwards and push in gently until the meter beeps. Do not use the meter. Contact your authorized i-SENS sales representative. Note:
if the error messages persist, contact your authorized i-SENS sales representative www.i-sens.com 54 Message What It Means What To Do When battery level is low Charge the battery. SIM Card error:
No SIM Card or invalid SIM Card insertion Check if the SIM card is Properly inserted in the Meter. If the SIM card is Properly inserted. Check If there is any defect on the SIM card Radio Signal error:
Cant detect GSM Signal Or Signal strength is not enough Check to see if there is Cellular coverage in your Area. Please move to the Area where you get better Cellular coverage. www.i-sens.com 55 Message What It Means What To Do Network registration error:
System cant register at Service network
(AT&T, T-mobile or other Service providers) Check if the SIM card Is properly inserted in The meter or contact The service provider To see if there is any Network issue Message Send error:
Your data transmission is Not successful Try to send the test Result data one more time. If the meter fails to send the test result data, Please contact your authorized i-SENS sale representative System Error:
GSM MODEM Hardware Error occurred Please contact your Authorized i-SENS sales representative www.i-sens.com 56 Problem The display is blank even after inserting a test strip. The test does not start even after applying the blood sample on the strip Trouble shooting Check whether the test strip is inserted with the contact bars facing up. Check if the strip has been inserted completely till the end. Check whether the batteries are inserted with the + side facing up. Charging the batteries. Check if the confirmation window is filled adequately. Repeat the test after inserting a new test strip. The test result doesnt match your expectation. Repeat the test after inserting a new test strip. Check the validity period of the test strip. Check the meter. The data transmission is Not successful Check the battery level Check the SIM card is properly inserted in the meter or if the SIM card is activated. If testing indoors, move closer to a window for better cellular reception Test outdoors and check see if there is cellular coverage in your area Note:
If the problem is not resolved, please contact your authorized i-SENS sales representative. www.i-sens.com 57 Performance Characteristic The performance of AutoChek t Blood Glucose Monitoring System Strips has been evaluated in laboratory and in clinical tests. Accuracy: The accuracy of the AutoChek t BGM System (ModelGM505YAA) was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer, a laboratory instrument The following results were obtained by 110 diabetic patients at clinic centers. Slope Y-intercept Correlation coefficient(r) Number of sample Range tested 0.961 3.5 mg/dL 0.995 110 30 ~ 485 mg/dL Accuracy results for glucose concentration<75 mg/dL (4.2 mmol/L) Within5mg/dL
(Within0.28mmol/dL) Within10mg/dL
(Within0.56mmol/dL) 16/17(94%) 13/17(76%) Accuracy results for glucose concentration75 mg/dL (4.2 mmol/L) Within15mg/dL
(Within0.83mmol/dL) 17/17(100%) Within5%
45/93(48%) Within 10%
88/93(96%) Within15%
93/93(100%) Within20%
93/93(100%) www.i-sens.com 58 Precision: The precision of AutoChek t Test strip was estimated with venous blood sample in the laboratory. Within Run Precision Blood average Blood average Blood average Blood average Blood average 38.1 mg/dL (2.1 mmol/L) 86.1 mg/dL (4.8 mmol/L) 124.5 mg/dL (6.9 mmol/L) 189.1 mg/dL (10.5 mmol/L) 334.5 mg/dL (18.6 mmol/L) SD = 1.9 mg/dL (0.11 mmol/L) SD = 3.2 mg/dL (0.2 mmol/L) CV = 4.1%
CV = 2.6%
CV = 2.8%
Total Precision Control average Control average Control average SD = 2.0 mg/dL (0.11 mmol/L) 43.1 mg/dL (2.4 mmol/L) CV = 3.3%
113.4 mg/dL (6.3 mmol/L) 381.2 mg/dL (21.2 mmol/L) CV = 4.2%
This study shows that there could be variation of up to 4.2%
www.i-sens.com 59 Warranty Information Manufacturers Warranty i-SENS, Inc. warrants that the AutoChek t Meter shall be free of defects in material and workmanship in normal use for a period of five (5) years. The meter must have been subjected to normal use. The warranty does not cover improper handling, tampering, use, or service of the meter. Any claim must be made within the warranty period. The i-SENS company will, at its discretion, repair or replace a defective meter or meter part that is covered by this warranty. As a matter of warranty policy, i-SENS will not reimburse the consumers purchase price. Obtaining Warranty Service To obtain warranty service, you must return the defective meter or meter part along with proof of purchase to your nearest i-SENS Authorized Warranty Station. www.i-sens.com 60
| 1 2 | User's Manual (revised) | Users Manual | 1.94 MiB | May 09 2012 / December 02 2013 |
i-SENS, Inc. 465-6 Wolgye4-dong, Nowon-gu Seoul 139-845, Korea www.i-sens.com Medical Technology Promedt Consulting GmbH, Altenhofstrasse 80,D-66386 St. Ingbert, Germany 2012 i-SENS, Inc. All Rights Reserved. PGA1E3121 REVx 05/2012 0123 Owners Booklet Blood Glucose Monitoring System Data Transmission Welcome to the AutoChek t BGMS Blood Glucose Monitoring System Thank you for purchasing the AutoChek t Blood Glucose Monitoring System. The system provides you with safe, convenient, and painless blood glucose in vitro
(i.e., outside the body) diagnostic monitoring. You can obtain accurate results in just 5 seconds with a small (0.5 ) blood sample. The AutoChek t Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. The AutoChek t Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AutoChek t is capable of sending test results to AutoChek ts remote database by using cellular data transmission. AutoChek t securely uploads and manages blood glucose readings, eliminating the need to maintain personal logbooks. Table of Contents Information Important Information : Read This First! -------------------------------------- 6 Important Information----------------------------------------------------------- 7 Specifications ------------------------------------------------------------------- 8 AutoChek t Blood Glucose Monitoring System ------------------------------ 9 AutoChek t Blood Glucose Test Strip --------------------------------------- 10 AutoChek t Blood Glucose Meter -------------------------------------------- 12 AutoChek t Blood Glucose Meter -------------------------------------------- 13 AutoChek t Blood Glucose Meter Display ---------------------------------- 14 Preparation Adjusting the Date, Time and Unit ------------------------------------------- 15 Setting up Your System ------------------------------------------------------- 15 Setting the Sound On/Off ---------------------------------------------------- 19 Setting the Cellular function On/Off ----------------------------------------- 20 Setting the Test Result Reset ----------------------------------------------- 23 Checking the System --------------------------------------------------------- 24 Comparing the Control Solution Test Results ------------------------------ 27 Testing Using the Lancing Device ---------------------------------------------------- 28 Preparing the Lancing Device for Blood Sample Retrieval --------------- 29 Preparing the Meter and Test strip ------------------------------------------ 31 Applying Blood Sample ------------------------------------------------------ 32 Result Data Transmission I--------------------------------------------------- 34 Result Data Transmission II -------------------------------------------------- 35 Automatic time adjusting ----------------------------------------------------- 37 Discarding Used Lancets ----------------------------------------------------- 38 Alternative Site Testing ------------------------------------------------------- 39 HI and Lo Message ------------------------------------------------------------ 42 Target Blood Glucose Ranges ----------------------------------------------- 43 Additional function Meter Memory ----------------------------------------------------------------- 44 Setting the post-meal alarm (PP2 alarm) ------------------------------------ 46 Setting the Alarm Function --------------------------------------------------- 46 Setting the Time Alarms (alarm 1~3) ---------------------------------------- 48 Maintenance Charging Your AutoChek t Blood Glucose Meter -------------------------- 50 Caring for Your System ------------------------------------------------------- 52 Understanding Error and Other Message ----------------------------------- 52 General Troubleshooting ----------------------------------------------------- 52 Understanding Error and other Message ----------------------------------- 53 Performance Characterstic --------------------------------------------------- 58 Warranty Information --------------------------------------------------------- 60 Important Information : Read This First!
To receive safe and optimum system benefits, please read the entire manual contents before the system. Please note the following instructions:
Do not use the system for the diagnosis of diabetes or for testing newborns. Use only fresh capillary whole blood samples for testing. Alterative site and fingertip test result may differ significantly due to rapid change in the glucose level post meal, insulin injection, or exercise. The following chart explains the symbols youll find in the AutoChek t User Manual, product packaging, and product inserts. For in vitro diagnostic use This product fulfills the requirements for Directive 98/79/EC 0123 In vitro diagnostic medical devices Cautions for safety and optimum product use Consult instruction for use Manufacturer Authorized representative Temperature limitations Serial number Do not reuse Batch code Use by (unopened or opened test strip container) Do not discard this product with other household-type waste www.i-sens.com 6 Important Information The AutoChek t blood glucose monitoring system is intended for self-
testing outside the body (in vitro diagnostic use). The glucose in the blood sample mixes with special chemicals on the test strip where to produce a small electrical current. The AutoChek t meter detects this electrical current and measures the amount of glucose in the blood sample. The AutoChek t blood glucose meter is designed to minimize code related errors in monitoring by using the no-coding function. The AutoChek t blood glucose meter should be used only with the AutoChek t strip. Do not use the system for testing newborns or pregnant women because test results may be affected by the red blood cell count
(hematocrit). Very high (60% or more) or very low (20% or less) hematocrit can lead to incorrect test results. A glucose value of less than 3.9 mmol/L may indicate hypoglycemia and a value of more than 13.3 mmol/L may indicate hyperglycemia. If you need assistance, please contact your authorized i-SENS sales representative or visit www.i-sens.com for more information. www.i-sens.com 7 Specifications Product specifications Reported result range 20 ~ 600 mg/dL(1.1 ~ 33.3 mmol/L) Sample size Test time Sample type Calibration Assay method Power Memory Size Weight Minimum 0.5 5 seconds Fresh capillary whole blood Plasma-equivalent Electrochemical 3.7V Lithium Polymer Battery
(Rechargeable Type) 250 test result 45L x 96.9W x 18H (mm) 66.1g Operating ranges Temperature Relativity humidity Hematocrit 10~40C(50 ~ 104 F) 10 ~ 90%
20 ~ 60%
www.i-sens.com 8 Autochek t Blood Glucose Monitoring System Components Glucose Meter Lancing Device Lancets(10) Owners Booklet Quick Reference Guide Logbook Carrying Case Test Strip Certain components may not be included depending on the place of purchase Check all the components after opening the AutoChek t blood glucose monitoring system package. The exact contents are listed on the main box The cable for data transmission can be ordered separately. Please contact your authorized i-SENS sales representative. www.i-sens.com 9 Autochek t Blood Glucose Test Strip The AutoChek t blood glucose monitoring system measures blood glucose quickly and accurately. It automatically absorbs the small blood sample applied to the narrow edge of the test strip. www.i-sens.com 10 Warning!
The AutoChek t test strip should be used only with fresh capillary whole blood samples. Do not reuse test strips. Do not use test strips past the expiration date. Test strips in new, unopened containers and test strips in containers that have been opened can be used up until the expiration date printed on the test strip box and container label if the test strips are used and stored according to its storage and handling methods. Store test strips in a cool and dry place at a temperature of 1 ~ 30C (34 ~ 86F). Keep away test strips from direct sunlight or heat and do not refrigerate or freeze. Store test strips only in their original vial. Close the vial tightly after removing a test strip for testing and use the strip immediately. Handle test strips only with clean and dry hands. Do not bend, cut, or alter test strips in any way. For detailed storage and usage information, refer to the AutoChek t test strip package insert. Caution:
Keep the meter testing supplies away from young children. www.i-sens.com 11 Autochek t Blood Glucose Meter Buttons Select or changes information S Button Turns the meter on/off and confirms menu selections Test Strip Port Insert test strip here Display Shows and messages results www.i-sens.com 12 Autochek t Blood Glucose Meter SIM Card Slot Insert a Mobile SIM Card Communication port Charging the Battery or Used to transfer data from the meter to a computer a Mini USB Cable Note:
The mini USB cable for data transmission to PC can be ordered Separately, Please contact your authorized i-SENS sales representative. www.i-sens.com 13 Autochek t Blood Glucose Meter Display mem Appears when test result stored in the memory are displayed alarm Appears when the time alarm has been set mmol/L Unit for measuring blood glucose Battery icon Battery level indicator Post-meal test flag Appears during post-
Meal testing and When post-meal test Result are displayed Alarm icon Appears when the post
-meal alarm has been set Sound icon Appears only when the sound is set to OFF check Appears when test result have not been saved Test result Test results displaying panel Decimal point Appears when the blood glucose measuring unit is set to mmol/L mg/dL Unit for measuring blood glucose Blood insertion icon Unit for measuring blood glucose www.i-sens.com 14 Setting up Your System Press and hold the S button for 3 seconds to turnon the meter. After all settings are finished, press and hold the S button for 3 seconds to turn off the meter. Press or to reach the accurate value. Press and hold to scroll faster Adjusting the Date, Time and Unit Step 1 Entering the SET Mode Press and hold the S button for 3 seconds to turnon the meter. After all the segments flash across the screen, the SET character icon will be displayed on the screen. Press the S button again to enter the year setting mode. Step 2 Select the automatic time adjusting mode Enter the SET mode and press the S button until the AUT appears on the screen. By pressing the S button one more time, the meter will automatically adjust itself to the correct current time.
(refer the Automatic time adjusting) www.i-sens.com 15 Step 3 Setting the Year If user didnt select the automatic time adjusting mode at the Step 2, The number that appears on the screen after the meter is turned on indicates the year of manufacture. Press and release the or to adjust until the correct year appears. Press and hold the button to scroll through the numbers quickly. After setting the year, press the S button to confirm your selection and enter the month setting mode Step 4 Setting the Month A number indicating the month will be blinking on the left corner of the screen. Press the or until the correct month appears. Press the S button to confirm your selection and enter the date setting mode. www.i-sens.com 16 Step 5 Setting the Date Press the or until the screen displays The correct date. Press the S button to confirm the date and enter the time setting mode. Step 6 Setting the Time The meter can be set in AM/PM 12-hour or 24-hour clock format. Press the or to select a format. The AM / PM icon is not displayed in the 24-
hour format. After selecting the format press the S button to enter the hour setting mode. Step 7 Setting the Hour Press the or until the correct hour appears. After the hour is set, press the S button to enter the minute setting mode. www.i-sens.com 17 Step 8 Setting the Minute Press the or until the correct minute appears. After setting the minute, press the S button to enter the unit setting mode www.i-sens.com 18 Setting the Sound On/Off Step 9 On the sound option menu, pressing the or , the screen will display the On or OFF. Press the S button to confirm the selection. The meter will beep in the following instances, if the meters sound is set to On. When the test strip is inserted in the meter When the blood sample is absorbed into the test strip and the test starts When the test result is displayed When you push the S button or button to check the memory When you push the button to set the post-
meal (PP2) alarm When it is time for a preset blood glucose test If the sound is set to OFF, none of the sound functions will work Note:
Only when the sound is set to OFF, icon appears on the display www.i-sens.com 19 Setting the Cellular function On/Off Step 10 Enter the SET mode and press the S button until the CEL appears on the screen. On this screen, the cellular function of the meter can be activated or deactivated. Step 11 From the CEL screen, press the or button until the On character icon appears on the screen. Press the S button to turn on the cellular function of the meter. From the CEL screen, press the or button until OFF appears on the screen. Press the S button to turn off the cellular function of the meter. www.i-sens.com 20 Step 12 Once the cellular function of the meter is turned on, the meter can immediately transmit the test result data to the designated server by choosing Transfer Mode 1 (T1 mode). After turning on the cellular function is turned on, the T1 will be appeared, once the T1 appears, press the S button to choose Transfer Mode 1 Step 13 Once the cellular function of the meter is turned on, the meter can transmit the test result data to the designated SMS server once a day at a reserved time by choosing Transfer Mode 2 (T2mode). In order to choose Transfer Mode 2, press the or until T2 appears from the T1 screen. Once the T2 appears, press the S button and the OFF will blink. Press the button to turn on Transfer Mode 2. www.i-sens.com 21 Step 14 Once Transfer Mode 2 is turned on, press the or until the correct hour appears. After the hour is set, press the S button to enter the minute setting mode. Press the or until the correct minute appears. Once correct hour and minutes are set, press S button to confirm the schedule. www.i-sens.com 22 Setting the Test Result Reset
(Deleting all the saved test result) Step 15 In this mode all the test results stored in the meter can be deleted. Please note that if you select YES, all the stored test results will be deleted and cannot be restored. After the beeper mode is set, press the S button to enter the Test Result Reset mode. The dEL will blink on the screen. Press the or to alternate between YES or no. To delete all the stored test results press the S button when the screen displays YES. Then, all the test results stored in the meter will be deleted and the screen will be similar to the picture on the right. If you do not want to delete the results press the S button when the screen displays no. Then, the screen will return to step 2. Please, see page 12. Note:
At any stage, If the S button is pressed for 3 seconds, Time, Date another setting mode will finish and meter will be turned off. Press and hold the to scroll through number quickly www.i-sens.com 23 Checking the System You may check your meter and test strips using the AutoChek t Control Solution. The AutoChek t Control Solution contains a known amount of glucose and is used to check that the meter and the test strips are working properly. The test strip vials have AutoChek t Control Solution ranges printed on their labels. Compare the result displayed on the meter to the AutoChek t Control Solution range printed on the test strip vial. Before using a new meter or a new vial of test strips, you may conduct a control solution test following the procedure on page 18. Note:
Use only the AutoChek t Control Solution. Check the expiration dates printed on the vial. When you first open a control solution vial, record the discard date (date opened plus three months) in the space provided on the label. Make sure your meter, test strips, and control solution are at room temperature before testing. Control Solution tests must be done at room temperature (20 ~ 25C, 68 ~ 77F). Before using the control solution, shake the vial, discard the first few drops and wipe the tip clean. Close the control solution vial tightly and store at a temperature of 8 ~ 30C (46 ~ 86F). You may do a control solution test:
When using the meter for the first time. Whenever you open a new vial of test strips. If the meter or test strips do not function properly. If your symptoms are inconsistent with the blood glucose test results, and when you feel that the meter or test strips are not working properly If you drop or damage the meter. www.i-sens.com 24 Caution:
If all the results you get from testing continuously (at least three times)are within the range printed on the test strip, the meter and test strips are working properly and you may use them for your blood glucose test. Control Solution Testing Step 1 Insert a test strip into the meters test strip port, with the contact bars facing upwards. Gently push the test strip into the port until the meter beeps. Be careful not to break the strip while pushing it in. The icon will be displayed on the screen. Step 2 Shake the AutoChek t Control Solution vial before each test. Remove the cap and squeeze the vial to discard the first drop. Then wipe the tip with a clean tissue or cloth. After the symbol appears on the display, apply the solution to the narrow edge of the test strip until the meter beeps. Make sure the confirmation window fills completely. www.i-sens.com 25 Note:
The meter may be turned off, if the blood sample is not applied within 2 minutes of the icon appearing on the screen. If the meter is turned off, remove the strip, reinsert, and start from step 1. Step 3 A test result will appear after the meter counts down from 5 to 1. After your control solution result appears on the display, press the for 3 seconds until the check icon appears on the display. When the check icon is displayed, the result is not stored in the meters memory and is not included in the averages. Step 4 Compare the result displayed on the meter to the range printed on the test strip vial. The result should fall within the range on the test strip vial. Used strips should be discarded and disposed. Caution:
If the results you get are not within this range, the meter and test strip may not work properly. Then, stop using the meter and contact the nearest i-SENS representative. The range printed on the test strip vial is for the AutoChek t Control Solution only. It does not have any connection to your blood glucose level. www.i-sens.com 26 Comparing the Control Solution Test Results Repeat the control test if the test result falls outside the range printed on label of the test strip vial. Out of range results may occur due to the following factors:
When the control solution vial was not shaken well, When the control solution is past contaminated, its expiration date or is When the meter, the strip or the control solution were exposed to high or low temperatures, When the first few drops of the control solution were not discarded or the tip of the vial was not wiped clean, When the test strip is past its expiration date, When the meter is not functioning properly. Note:
The AutoChek t Control Solution can be purchased separately. Please contact your authorized i-SENS sales representative. www.i-sens.com 27 Using the Lancing Device You will need a lancing device in order to collect a blood sample. You may use the lancing device contained in the AutoChek t Blood Glucose Monitoring System or any other medically approved lancing device. The lancing device should be used by one individual and communal use is strongly discouraged Use a soft cloth or tissue to wipe the lancing device. If necessary, a small amount of alcohol on a soft cloth or tissue may be used. Caution:
To avoid infection when drawing a sample, use a lancet only one time, and:
Do not use a lancet that has been used by others. Always use a new sterile lancet. Keep the lancing device clean. Note:
Repeated puncturing at the same sample site may cause pain or skin calluses. Choose a different site each time you test. www.i-sens.com 28 Preparing the Lancing Device for Blood Sample Retrieval Step 1 Wash hands and fingertip sample site with soap and warm water. Rinse and dry thoroughly. Step 2 Unscrew the lancing device tip Step 3 Firmly insert the new lancet into the lancet holder. Hold lancet firmly. Gently twist to pull off the protective disk. Save the disk to recap the lancet after use. Replace the lancing device tip. www.i-sens.com 29 Step 4 Select a desired depth of one-to-five
(1-5) on the lances adjustable tip. Rotate the to align the desired number with the A beginning setting of three (3) is recommended. Step 5 To cock the lancing device, hold the tip in one hand. Pull the sliding barrel on with the other hand. The lancing device is cocked when you feel a click. Note:
The skin depth to retrieve samples will vary for various people at different sample sites. The lances adjustable tip allows the best depth of skin penetration for an adequate sample size. A beginning setting of three (3) is recommended. www.i-sens.com 30 Preparing the Meter and Test strip Step 6 Insert a test strip with the contact bars facing upwards into the meter port. Push the strip in gently until the meter beeps. Be careful not to bend the test strip. The symbol will appear on the screen. Flagging Post-meal Test Result The AutoCheck t meter allows you to flag a result of an post-meal test with the ( ) icon. The post-meal test flag ( ) can be attached just before applying the blood sample. Once you attach the post-meal flag ( ) to the test results, it cannot be deleted. Step 7 If you want to attach an post-meal flag ( ) to a test result, press and hold the for 3 seconds after inserting the test strip. The post-meal flag( ) and the symbol will appear on the screen The test result will also be displayed with the post
-meal flag( ). If you do not want to save the result the result as a Postmeal test, move on to the step 8 after the step 6. www.i-sens.com 31 Applying Blood Sample Step 8 Obtain a blood sample using the lancing device. Place the device against the pad of the finger. The best puncture sites are on the middle or ring fingers. Press the release button. Remove the device from the finger. Wait a few seconds for a blood drop to form. A minimum volume of 0.5 microliter is needed to fill the Confirmation window. (actual size of 0.5 : ) Step 9 After the symbol appears on the screen, Apply the blood sample to the narrow end of the test strip till the meter beeps. If the confirmation window filled before the meter Finishes down then discard the test strip new one. If confirmation window is not filled in because of Abnormal viscosity or insufficient volume, Er4 message will appear. Note:
The meter may switch off if the blood sample is not applied within 2 minutes of The icon appearing on the screen. If the turns off, remove the strip and reinsert into the meter. www.i-sens.com 32 Step 10 The test result will appear after the meter counts down from 5 to 1. The result will be automatically stored in the meters memory. If the test strip is removed after the test result is displayed, the meter will be automatically turned off after 3 seconds. Discard used test strips safely and dispose. www.i-sens.com 33 Result Data Transmission I Step 1 In the T1 mode, the measured data is sent to a server immediately after each measurement.
(Refer the Setting the Cellular function On/Off ) After measuring Blood glucose and discard an used test strip, the meter will starting the data transfer operation. Snd will be appeared on the screen. Step 2 Once the data transfer begins, the progress indication dash dot (blinking) will be appeared at the bottom of the screen. Step 3 When the meter successfully sent the test result, SUCC ESS will be appeared at the bottom of the screen. www.i-sens.com 34 Result Data Transmission II Step 1 Transfer mode 2 (T2 Mode)
(Refer the Setting the Cellular function On/Off ) User can set the schedule, then BGM sends all test results to the server once a day only at a reserved time. Step 2 At the reserved time, GSM meter wakes up automaticallyandgathering all measured data of the day The data will be sentto the server. Snd appears during the data transfer. Step 3 At the bottom of thescreen, it displays the progress indicator dots. www.i-sens.com 35 Step 4 When the meter successfully sent the test result, SUCC ESS will be appeared at the bottom of the screen. www.i-sens.com 36 Automatic time adjusting Step 1 In the sleep mode, press the button until display TIM Step 2 When TIM appears, release the button Step 3 When the Autochek t retrieve cellular network time, it will display the local time at the bottom of the screen. www.i-sens.com 37 Discarding Used Lancets Step 1 Unscrew the general lancing device tip. Step 2 Place the protective cover on the lancet. Push the lancet ejector forward with the thumb and simultaneously pull out the sliding barrel to dispose the used lancet into a proper biohazard container. Cautions:
The lancet is for single use only. Never share or reuse a lancet. Always dispose of lancets properly. www.i-sens.com 38 Alternative Site Testing What is AST(Alternative Site Testing)?
AutoChek t BGMS is caplable of testing your blood glucose from your palm, arms, tight, or calves, usually referred to as an alternative site test, or AST. Alternate site testing can be less painful than fingertip testing,. However, because of the physiological differences between your fingertip and palm, AST results may be significantly different. While AST may reduce the pain during testing, it may not be simple for everyone and the following precautions should be observed during testing. You should consult with your doctor before using alternate site testing. Things to know when using AST Please understand the following informationbefore testing outside of the fingertip
(palm, arms, thighs, or calves). The capillary blood of the fingertip shows the change in glucose more rapidly than AST. Therefore, the test results from the fingertip test and AST may differ. This might caused by lifestyle or ingested food have an effect on glucose levels. www.i-sens.com 39 Acceptable situation for AST two hours after a meal or exercise Fasting period Before a meal Before sleeping Situation requiring fingertip test When the glucose levels are rapidly increasing during the When sick or when glucose levels seem quite lower than test value When hypoglycemia is not well recognized When insulin has the biggest effect 2 hours after an insulin injection AST Precautions Do not ignore the symptoms of hyperglycemia or hypoglycemia. When the results of the test do not reflect ones opinion, retest using the fingertip test. If the test results do not reflect ones opinion, please consult a doctor. Do not rely on the AST results for changing ones treatment method The amount glucose in alternative sites differs from person to person Before using AST, please consult your regular physician www.i-sens.com 40 Note:
Results from alternative site and fingertip samples may appear differently as there is a time lag for the glucose levels to reach the same value. Use a fingertip for drawing if you suffer from hypoglycemia or have experienced hypoglycemic shock or symptoms. drawing if you suffer from hypoglycemia or have experienced hypoglycemic shock or symptoms. Note:
If the sample drop of blood runs or spreads due to contact with hair or with a line in you palm, do not use that sample. Try puncturing again in a smoother area. www.i-sens.com 41 HI and Lo Message HI Message The meter displays results between 20 ~ 600 mg/dL (1.1 ~ 33.3 mmol/L). The Hi icon will be appeared when the blood glucose level is more than 600 mg/dL (33.3 mmol/L) and indicates hyperglycemia. If the Hi icon is displayed again on re-testing, please contact your healthcare professional immediately. Lo Message The Lo icon appears when the result is less than 20 mg/dL (1.1 mmol/L) and indicates hypoglycemia If the Lo icon is displayed again on re-testing, please contact your healthcare professional immediately. Note:
Please contact your authorized i-SENS sales representative, if such messages are displayed even though you do not have hyperglycemia or hypoglycemia. www.i-sens.com 42 Your target ranges from your healthcare expert Reminders Time of day Before breakfast Before lunch or dinner 1 hour after meals 2 hour after meals Between 2 a.m. and 4 a.m. Target Blood Glucose Ranges Source : Diagnosis of Diabetes, NIH Publication No. 05-4642, January 2005 www.i-sens.com 43 Meter Memory The AutoChek t meter can save up to 500 glucose test results with time and date. If the memory is full, the oldest test result will be deleted and the latest test result will be stored. The AutoChek t meter calculates and displays the averages of total test results, pre-meal test (Pr) results, and post-meal test ( ) results from the last 1, 7, 14, 30 and 90 days. Viewing Test Result Stored in the Meters Memory Step 1 Press the or S button to turn the meter on. p The current date and time will be displayed at the bottom of the screen for 2 seconds, followed by the 1 day average value and the number of the test results saved within the last 14 days. Press the button to view the average value and the number of tests performed before a meal for the last 14 days. Press the button again to check the average value and the number of tests performed after a meal for the last 14 days. Step 2 www.i-sens.com 44 Step 3 Use the button to scroll through the test results, starting from the most recent and ending with the oldest. Press the button to return to the result seen previously. After checking the stored test results, press the S button to turn off the meter. Note:
Bypressing the button ,the latest test result saved in the meters memory will be displayed on the screen along with the date and time. Press and hold the button to scroll through the test results. www.i-sens.com 45 Setting the Alarm Function Four types of alarms can be set in the AutoChek t meter: one post- meal alarm
(PP2 alarm) and three time set alarms (alarm1 ~ 3). The PP2 alarm goes off 2 hours after setting the alarm. The alarms ring for 15 seconds and can be silenced by pressing ,, or the S button. Also the alarms can be turned of by inserting a test strip. Setting the post-meal alarm (PP2 alarm) Step 1 Setting the PP2 alarm On Without inserting a test strip, press and hold the button for 3 seconds to set the post-meal alarm. The PP2 character, the bell ( ) icon and then the On character will be displayed. The screen will then automatically be switched to the memory check mode. Thenthe bell ( ) icon, which indicating that the PP2 alarm has been set, will be displayed on the screen. www.i-sens.com 46 Step 2 Setting the PP2 alarm Off To turn off the PP2 alarm, press and hold the button for 3 seconds. The PP2 character, the bell ( ) icon, and then the OFF character will be appeared on the screen. Then the screen will be switched automatically to the memory check mode without the bell ( ) icon being displayed. www.i-sens.com 47 Setting the Time Alarms (alarm 1~3) Step 1 Without inserting a test strip, press the button and the S button simultaneously for 3 seconds to enter the time alarm mode. The alarm1 will be displayed while the OFF character blinks on the screen. Step 2 By pressing the button, the alarm1 is set and the On character will be displayed on the screen. Press the button again to cancel the alarm1. The OFF icon will be blinked on the screen. Step 3 Press the button to adjust the time of the alarm1. A number representing the time will be blinked on the screen. Press the button to set the time. Press the button to end. www.i-sens.com 48 Step 5 Step 4 By pressing the button, the number indicating the minute will start blinking. Press the button to set the accurate minute. Press the S button to finish and to enter the alarm 2 mode. Repeat steps 2 to 5 to set the remaining time alarms (alarm 2 ~ 3). Press the S button for 3 seconds to finish and turn the meter off. Step 6 www.i-sens.com 49 Charging Your AutoChek t Blood Glucose Meter Step 1 Plug the mini USB cable into AC adaptor Plug the other end of the mini USB cable into the BGMs charging port which is located on the side of the BGM. Once the mini USB cable is plugged, the BGM will start charging and the Chr will be displayed on the screen. www.i-sens.com 50 Step 2 Once charging is completed, the End will be appeared at bottom left of the screen. Caution :
If the meter wont charge, please do not attempt to take apart, repair, or modify the meter. Please contact your authorized i-SENS sales representative, www.i-sens.com 51 Caring for Your System Use a soft cloth or tissue to wipe the meter exterior. If necessary the soft cloth or tissue might be dipped in a small amount of alcohol. Do not use organic solvents such as benzene, or acetone, or household and industrial cleaners that may cause irreparable damage to the meter. Store all the meter components in the portable case to prevent loss. Caution Do not expose the meter to direct sunlight or heat for an Prevent the entry of dirt, dust, blood, or water at the meters extended period of time. test strip port. Do not drop the meter or submit it to strong shocks. Do not try to fix or alter the meter in any way. Keep the meter away from strong electromagnetic fields such as cell phones and microwave ovens. AutoChek t meter should be used only with AutoChek t strips. Keep the meter in a cool and airy place. www.i-sens.com 52 Understanding Error and other Message Message What It Means What To Do A used test strip was inserted. Repeat the test with a new test strip. The blood or control solution sample was applied before the icon appeared. The temperature during the test was above or below the operating range. Repeat the test with a new test strip and wait until the icon appears before applying the blood sample. Move to an area where the temperature is within the operating range
(10 ~ 40 C/ 50 ~ 104 F) and repeat the test after 30 minutes. www.i-sens.com 53 Message What It Means What To Do The blood sample has abnormally high viscosity or insufficient volume. Repeat the test after inserting a new test strip. A non-AutoChek t test strip was used. Test strip was not inserted properly. There is a problem with the meter. Repeat the test with a AutoChek t test strip. Insert a test strip with the contacting bars facing upwards and push in gently until the meter beeps. Do not use the meter. Contact your authorized i-SENS sales representative. Note:
if the error messages persist, contact your authorized i-SENS sales representative www.i-sens.com 54 Message What It Means What To Do When battery level is low Charge the battery. SIM Card error:
No SIM Card or invalid SIM Card insertion Check if the SIM card is Properly inserted in the Meter. If the SIM card is Properly inserted. Check If there is any defect on the SIM card Radio Signal error:
Cant detect GSM Signal Or Signal strength is not enough Check to see if there is Cellular coverage in your Area. Please move to the Area where you get better Cellular coverage. www.i-sens.com 55 Message What It Means What To Do Network registration error:
System cant register at Service network
(AT&T, T-mobile or other Service providers) Check if the SIM card Is properly inserted in The meter or contact The service provider To see if there is any Network issue Message Send error:
Your data transmission is Not successful Try to send the test Result data one more time. If the meter fails to send the test result data, Please contact your authorized i-SENS sale representative System Error:
GSM MODEM Hardware Error occurred Please contact your Authorized i-SENS sales representative www.i-sens.com 56 Problem The display is blank even after inserting a test strip. The test does not start even after applying the blood sample on the strip Trouble shooting Check whether the test strip is inserted with the contact bars facing up. Check if the strip has been inserted completely till the end. Check whether the batteries are inserted with the + side facing up. Charging the batteries. Check if the confirmation window is filled adequately. Repeat the test after inserting a new test strip. The test result doesnt match your expectation. Repeat the test after inserting a new test strip. Check the validity period of the test strip. Check the meter. The data transmission is Not successful Check the battery level Check the SIM card is properly inserted in the meter or if the SIM card is activated. If testing indoors, move closer to a window for better cellular reception Test outdoors and check see if there is cellular coverage in your area Note:
If the problem is not resolved, please contact your authorized i-SENS sales representative. www.i-sens.com 57 Performance Characteristic The performance of AutoChek t Blood Glucose Monitoring System Strips has been evaluated in laboratory and in clinical tests. Accuracy: The accuracy of the AutoChek t BGM System (ModelGM505YAA) was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer, a laboratory instrument The following results were obtained by 110 diabetic patients at clinic centers. Slope Y-intercept Correlation coefficient(r) Number of sample Range tested 0.961 3.5 mg/dL 0.995 110 30 ~ 485 mg/dL Accuracy results for glucose concentration<75 mg/dL (4.2 mmol/L) Within5mg/dL
(Within0.28mmol/dL) Within10mg/dL
(Within0.56mmol/dL) 16/17(94%) 13/17(76%) Accuracy results for glucose concentration75 mg/dL (4.2 mmol/L) Within15mg/dL
(Within0.83mmol/dL) 17/17(100%) Within5%
45/93(48%) Within 10%
88/93(96%) Within15%
93/93(100%) Within20%
93/93(100%) www.i-sens.com 58 Precision: The precision of AutoChek t Test strip was estimated with venous blood sample in the laboratory. Within Run Precision Blood average Blood average Blood average Blood average Blood average 38.1 mg/dL (2.1 mmol/L) 86.1 mg/dL (4.8 mmol/L) 124.5 mg/dL (6.9 mmol/L) 189.1 mg/dL (10.5 mmol/L) 334.5 mg/dL (18.6 mmol/L) SD = 1.9 mg/dL (0.11 mmol/L) SD = 3.2 mg/dL (0.2 mmol/L) CV = 4.1%
CV = 2.6%
CV = 2.8%
Total Precision Control average Control average Control average SD = 2.0 mg/dL (0.11 mmol/L) 43.1 mg/dL (2.4 mmol/L) CV = 3.3%
113.4 mg/dL (6.3 mmol/L) 381.2 mg/dL (21.2 mmol/L) CV = 4.2%
This study shows that there could be variation of up to 4.2%
www.i-sens.com 59 Warranty Information Manufacturers Warranty i-SENS, Inc. warrants that the AutoChek t Meter shall be free of defects in material and workmanship in normal use for a period of five (5) years. The meter must have been subjected to normal use. The warranty does not cover improper handling, tampering, use, or service of the meter. Any claim must be made within the warranty period. The i-SENS company will, at its discretion, repair or replace a defective meter or meter part that is covered by this warranty. As a matter of warranty policy, i-SENS will not reimburse the consumers purchase price. Obtaining Warranty Service To obtain warranty service, you must return the defective meter or meter part along with proof of purchase to your nearest i-SENS Authorized Warranty Station. www.i-sens.com 60
| frequency | equipment class | purpose | ||
|---|---|---|---|---|
| 1 | 2013-01-14 | 1850.2 ~ 1909.8 | PCB - PCS Licensed Transmitter | Class II Permissive Change |
| 2 | 2012-08-24 | 1850.2 ~ 1909.8 | PCB - PCS Licensed Transmitter | Original Equipment |
| app s | Applicant Information | |||||
|---|---|---|---|---|---|---|
| 1 2 | Effective |
2013-01-14
|
||||
| 1 2 |
2012-08-24
|
|||||
| 1 2 | Applicant's complete, legal business name |
i-SENS, Inc.
|
||||
| 1 2 | FCC Registration Number (FRN) |
0021843529
|
||||
| 1 2 | Physical Address |
43, Banpo-daero 28-gil, Seocho-gu, Seoul
|
||||
| 1 2 |
SEOUL, N/A
|
|||||
| 1 2 |
South Korea
|
|||||
| app s | TCB Information | |||||
| 1 2 | TCB Application Email Address |
L******@ul.com
|
||||
| 1 2 |
c******@ccsemc.com
|
|||||
| 1 2 | TCB Scope |
B1: Commercial mobile radio services equipment in the following 47 CFR Parts 20, 22 (cellular), 24,25 (below 3 GHz) & 27
|
||||
| app s | FCC ID | |||||
| 1 2 | Grantee Code |
OEL
|
||||
| 1 2 | Equipment Product Code |
GM505YAA
|
||||
| app s | Person at the applicant's address to receive grant or for contact | |||||
| 1 2 | Name |
M**** L******
|
||||
| 1 2 | Telephone Number |
82-2-********
|
||||
| 1 2 | Fax Number |
82-2-********
|
||||
| 1 2 |
m******@i-sens.com
|
|||||
| app s | Technical Contact | |||||
| n/a | ||||||
| app s | Non Technical Contact | |||||
| n/a | ||||||
| app s | Confidentiality (long or short term) | |||||
| 1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
| 1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
| 1 2 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 07/13/2013 | ||||
| 1 2 | 02/12/2013 | |||||
| if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
| app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
| 1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
| 1 2 | Equipment Class | PCB - PCS Licensed Transmitter | ||||
| 1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | AUTO-CHEK T | ||||
| 1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
| 1 2 | Yes | |||||
| 1 2 | Modular Equipment Type | Does not apply | ||||
| 1 2 | Purpose / Application is for | Class II Permissive Change | ||||
| 1 2 | Original Equipment | |||||
| 1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
| 1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
| 1 2 | Grant Comments | Class II permissive change to replace Low Duty Factor evaluation with a SAR test report for rf exposure Output power is ERP for Part 22 and EIRP for Part 24. This device also contains functions that are not operational in U.S. Territories. This filing is only applicable for US operations. The highest reported SAR value under this filing is 0.82 W/Kg. | ||||
| 1 2 | Output power is ERP for Part 22 and EIRP for Part 24. End-users must be provided with specific information required to satisfy RF exposure compliance, including operating the meter such that the transmission duty cycle does not exceed more than one transmission every 2 hours. This device also contains functions that are not operational in U.S. Territories. This filing is only applicable for US operations. | |||||
| 1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
| 1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
| app s | Test Firm Name and Contact Information | |||||
| 1 2 | Firm Name |
SGS Korea Co., Ltd.
|
||||
| 1 2 | Name |
F****** L****
|
||||
| 1 2 | Telephone Number |
82(0)********
|
||||
| 1 2 | Fax Number |
82(0)********
|
||||
| 1 2 |
f******@sgs.com
|
|||||
| Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 1 | 1 | 22H | 824.2 | 848.8 | 1.48594 | 2.5 ppm | 246KGXD | ||||||||||||||||||||||||||||||||||
| 1 | 2 | 24E | 1850.2 | 1909.8 | 0.69024 | 2.5 ppm | 243KGXD | ||||||||||||||||||||||||||||||||||
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 2 | 1 | 22H | 824.2 | 848.8 | 1.48594 | 2.5 ppm | 246KGXD | ||||||||||||||||||||||||||||||||||
| 2 | 2 | 24E | 1850.2 | 1909.8 | 0.69024 | 2.5 ppm | 243KGXD | ||||||||||||||||||||||||||||||||||
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC