i-SENS AutoChek t Owner's Booklet
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i-SENS AutoChek t Owner's Booklet

i-SENS AutoChek t Owner's Booklet

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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

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  • Page 1 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...

  • Page 2: Blood Glucose Monitoring System

    Owner’s Booklet Blood Glucose Monitoring System Data Transmission...
  • Page 3 (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 t’s remote database by using cellular data transmission. AutoChek t securely uploads and manages...

  • Page 4: Table Of Contents

    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...
  • Page 5 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...

  • Page 6: Important Information : Read This First

    • 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 you’ll find in the AutoChek t User Manual, product packaging, and product inserts. in vitro...

  • Page 7: Important Information

    · 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.

  • Page 8: Specifications

    Electrochemical Power 3.7V Lithium – Polymer Battery (Rechargeable Type) Memory 250 test result Size 45L x 96.9W x 18H (mm) Weight 66.1g • Operating ranges Temperature 10~40°C(50 ~ 104 °F) Relativity humidity 10 ~ 90% Hematocrit 20 ~ 60% www.i-sens.com...

  • Page 9: Autochek T Blood Glucose Monitoring System

    ⑥Logbook • 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.

  • Page 10: Autochek T Blood Glucose Test Strip

    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...
  • Page 11 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...

  • Page 12: Autochek T Blood Glucose Meter

    Autochek t Blood Glucose Meter Display Shows results and messages ▲▼ Buttons Select or changes information S Button Turns the meter on/off and confirms menu selections Test Strip Port Insert test strip here www.i-sens.com...

  • Page 13: Autochek T Blood Glucose Meter

    Communication port Charging the Battery Used 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...

  • Page 14: Autochek T Blood Glucose Meter Display

    Autochek t Blood Glucose Meter Display Sound icon Appears when test Appears only when result stored in the the sound is set to memory are displayed alarm check Appears when the Appears when test time alarm has been result have not been...

  • Page 15: Adjusting The Date, Time And Unit

    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...
  • Page 16 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...
  • Page 17 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...
  • Page 18 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...

  • Page 19: Setting The Sound On/Off

    • 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...

  • Page 20: Setting The Cellular Function On/Off

    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...
  • Page 21 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...
  • Page 22 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...

  • Page 23: Setting The 'Test Result Reset

    ‘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...

  • Page 24: Checking The System

    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.

  • Page 25: Control Solution Testing

    Be careful not to break the strip while pushing it in. 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.
  • Page 26 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.

  • Page 27: Comparing The Control Solution Test Results

    • 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...

  • Page 28: Using The Lancing Device

    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. •...

  • Page 29: Preparing The Lancing Device For Blood Sample Retrieval

    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...
  • Page 30 The skin depth to retrieve samples will vary for various people at different sample sites. The lance’s 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...

  • Page 31: Preparing The Meter And Test Strip

    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...

  • Page 32: Applying Blood Sample

    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 icon appearing on the screen. If the turns off, remove the strip and reinsert into the meter. www.i-sens.com...
  • Page 33 5 to 1. The result will be automatically stored in the meter’s 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...

  • Page 34: Result Data Transmission I

    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...

  • Page 35: Result Data Transmission Ii

    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...
  • Page 36 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...

  • Page 37: Automatic Time Adjusting

    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...

  • Page 38: Discarding Used Lancets

    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...

  • Page 39: Alternative Site Testing

    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.
  • Page 40 If the test results do not reflect one’s opinion, please consult a doctor. • Do not rely on the AST results for changing one’s 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...
  • Page 41 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...

  • Page 42: Hi And Lo Message

    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...

  • Page 43: Target Blood Glucose Ranges

    Your target ranges Time of day from your healthcare expert Before breakfast Before lunch or dinner 1 hour after meals 2 hour after meals Between 2 a.m. and 4 a.m. Source : Diagnosis of Diabetes, NIH Publication No. 05-4642, January 2005 www.i-sens.com...

  • Page 44: Meter Memory

    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.
  • Page 45 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 meter’s 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...

  • Page 46: Setting The Post-Meal Alarm (Pp2 Alarm)

    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.
  • Page 47 ▲ 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...

  • Page 48: Setting The Time Alarms (Alarm 1~3)

    ‘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...
  • Page 49 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). Step 6 Press the S button for 3 seconds to finish and turn the meter off. www.i-sens.com...

  • Page 50: Charging Your Autochek T Blood Glucose Meter

    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 BGM’s charging port which is located on the side of the BGM.
  • Page 51 Once charging is completed, the ‘End’ will be appeared at bottom left of the screen. Caution : If the meter won’t 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...

  • Page 52: Caring For Your System

    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...

  • Page 53: Understanding Error And Other Message

    Move to an area where the temperature is The temperature within the operating range during the test was (10 ~ 40 °C/ 50 ~ 104 above or below the °F) and repeat the test operating range. after 30 minutes. www.i-sens.com...
  • Page 54 Do not use the meter. There is a problem Contact your with the meter. authorized i-SENS sales representative. Note: if the error messages persist, contact your authorized i-SENS sales representative www.i-sens.com...
  • Page 55 If there is any defect on the SIM card Check to see if there is Radio Signal error: Cellular coverage in your Can’t detect GSM Signal Area. Please move to the Or Signal strength is not Area where you get better enough Cellular coverage. www.i-sens.com...
  • Page 56 Message Send error: If the meter fails to send Your data transmission is the test result data, Not successful Please contact your authorized i-SENS sale representative System Error: Please contact your GSM MODEM Hardware Authorized i-SENS sales Error occurred representative www.i-sens.com...
  • Page 57 If testing indoors, move closer to a window for better Not successful 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...

  • Page 58: Performance Characterstic

    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.
  • Page 59 Precision: The precision of AutoChek t Test strip was estimated with venous blood sample in the laboratory. Within Run Precision Blood average 38.1 mg/dL (2.1 mmol/L) SD = 1.9 mg/dL (0.11 mmol/L) Blood average 86.1 mg/dL (4.8 mmol/L) SD = 3.2 mg/dL (0.2 mmol/L) Blood average 124.5 mg/dL (6.9 mmol/L)

  • Page 60: Warranty Information

    Warranty Information Manufacturer’s 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.
  • Page 61 * FCC ID : OELGM505YAA RF Exposure Statement (2.1091) FCC RF Radiation Exposure Statement: This equipment complies with FCC RF Radiation exposure limits set forth for an uncontrolled environment. This device and its antenna must not be co-located or operating in conjunction with any other antenna or transmitter. This equipment should be installed and operated with a minimum distance of 10mm between the radiator and your body.

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