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TABLE OF CONTENTS

IMPORTANT SAFETY PRECAUTIONS

BEFORE YOU BEGIN

Important Information

Intended Use

Test Principle

Contents of System

Meter Overview

Screen Display

Test Strip

Setting the Meter

THE FOUR MEASURING MODES

CONTROL SOLUTION TESTING

Performing a Control Solution Test

TESTING WITH BLOOD SAMPLE

Overview of the Lancing Device

Setting up the lancing device

Preparing the puncture site

Alternative Site Testing

Performing a blood glucose test

METER MEMORY

Reviewing Test Results

Reviewing Blood Glucose Day Average Results

DOWNLOADING RESULTS ONTO A COMPUTER

Содержание Auto-Code Pro

Страница 1: ...ics P O Box 128 Williston Park NY 11596 USA 24 HOUR TOLL FREE TELEPHONE ASSISTANCE 1 877 DIABETK 1 877 342 2385 www SimpleDiagnostics com For in vitro diagnostic use only Read instructions before use For self testing Manual Owner s ...

Страница 2: ......

Страница 3: ...Dec 2009 Version 1 0 311 4267100 001 MANUAL OWNER S Blood Glucose Monitoring System ...

Страница 4: ...oroughly and carefully Regular monitoring of your blood glucose levels can help you and your doctor gain better control of your diabetes Due to its compact size and easy operation you can use the CLEVER CHOICE Auto Code Pro Blood Glucose Monitoring System to easily monitor your blood glucose levels by yourself anywhere any time If you have other questions regarding this product please contact the ...

Страница 5: ...rence only Always consult your doctor to have the results interpreted 7 Before using this device to test blood glucose read all instructions thoroughly and practice the test Carry out all the quality control checks as directed 8 Keep the device and testing equipment away from young children Small items such as the battery cover batteries test strips lan cets and vial caps are choking hazards 9 Use...

Страница 6: ... 14 THE FOUR MEASURING MODES 18 CONTROL SOLUTION TESTING 19 Performing a Control Solution Test 19 TESTING WITH BLOOD SAMPLE 22 Overview of the Lancing Device 22 Setting up the lancing device 23 Preparing the puncture site 24 Alternative Site Testing 26 Performing a blood glucose test 28 METER MEMORY 31 Reviewing Test Results 31 Reviewing Blood Glucose Day Average Results 32 DOWNLOADING RESULTS ONT...

Страница 7: ...ing for Your Test Strips 37 Important Control Solution Information 38 SYSTEM TROUBLESHOOTING 39 Result Readings 39 Error Messages 40 Troubleshooting 41 DETAILED INFORMATION 42 Reference values 42 Comparing Meter and Laboratory Results 43 SPECIFICATIONS 45 ...

Страница 8: ...advice of your healthcare professional Use only fresh whole blood samples to test your blood glucose Using other substances will lead to inaccurate results If you are experiencing symptoms that are inconsistent with your blood glucose test results and you have followed all the instruc tions given in this owner s manual contact your healthcare profes sional Inaccurate results may occur in severely ...

Страница 9: ... from the finger palm forearm upper arm calf and thigh It should not be used for the diagnosis of diabetes or testing on neonates Test Principle Your system measures the amount of sugar glucose in whole blood The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip Your meter measures the current calculates the blood g...

Страница 10: ...an be purchased separately Please make sure you have those items needed for a blood glucose test beforehand Daily Log Book Warranty Card Sterile Lancets One CR2032 Battery Meter Owner s Manual Storage case Quick Start User Guide If any items are missing from your kit or opened prior to use please contact local customer services or place of purchase for assistance NOTE Quick Start User Guide ...

Страница 11: ...memory and silence a reminder alarm TEST STRIP EJECTOR Eject the used strip by pushing up this button UP BUTTON DOWN BUT TON Select or change information S BUTTON Enter and confirm the meter settings TEST SLOT Insert test strip here to turn the meter on for testing DATA PORT Download test results with a cable connection ...

Страница 12: ...Display Measurement mode Blood drop symbol Test strip symbol Error message Test result Date Time Day average Low battery symbol Memory symbol Ketone warning Control solution mode Measurement unit Reminder alarms ...

Страница 13: ...e used with CLEVER CHOICE Auto Code Pro Test Strips Using other test strips with this meter can produce inaccurate results NOTE Contact Bars Insert this end of the test strip into the test slot Test Strip Handle Hold this part to insert the test strip into the slot Confirmation window Confirm if enough blood has been applied to the absor bent hole of the test strip Absorbent Hole Apply a drop of b...

Страница 14: ... your desired settings saved Entering the setting mode Start with the meter off no test strip inserted Press and firmly hold for 3 seconds until the meter turns on 1 Setting the date With the year flashing press or until the cor rect year appears Press With the month flashing press or until the cor rect month appears Press With the day flashing press or until the correct day appears Press ...

Страница 15: ... 24h Press 3 Setting the time With the hour flashing press or until the cor rect hour appears Press With the minute flashing press or until the cor rect minute appears Press 4 Deleting the Memory With dEL and a blinking symbol on the display press and select no to keep the results in memory ...

Страница 16: ... If you would like to delete ALL the results press or and select Yes then press to confirm OK and are displayed on the meter which indicates that all data stored is deleted Press or to select On then press to set the hour When the hour is flashing press or to add an hour Press to confirm and go to minutes press or to add one minute Press to confirm and go to the next alarm setting ...

Страница 17: ...omatically turn on You can press to silence the alarm and insert a test strip to begin testing If you do not press the meter will beep for 2 min utes then switch off If you do not want to test at this time press to switch off the meter Congratulations You have completed all settings These parameters can ONLY be changed in the setting mode If the meter is idle for 3 minutes during the setting mode ...

Страница 18: ...es Use when General displays as Gen any time of day without regard to time since last meal AC no food intake for at least 8 hours PC 2 hours after a meal QC testing with the control solution You can switch between each mode by 1 Start with the meter switched off Insert a test strip to turn on the meter the screen will display flashing blood drop and Gen ...

Страница 19: ... meter and test strips you begin using a new vial of test strips you suspect the meter or test strips are not working properly your blood glucose test results are not consistent with how you feel or if you think the results are not accurate practicing the testing process or you dropped or think you have damaged the meter Performing a Control Solution Test 1 Insert the test strip to turn on the met...

Страница 20: ...ueeze another drop and place it on the tip of the vial cap Hold the meter to move the absorbent hole of test strip to touch the drop Once the confirmation window fills completely the meter will begin counting down To avoid contaminating the control solution do not directly apply control solution onto a strip When doing the control solution test you have to mark it so that the test result will not ...

Страница 21: ...strip vial is for control solution use only It is not a recommended range for your blood glucose level See the Maintenance section for important information about your control solutions NOTE 4 Read and Compare the Result After counting down to 0 the test result of control solution will appear on the display Compare this result with the range printed on the test strip vial and it should fall within...

Страница 22: ...ction Never share a lancet or the lancing device Always use a new sterile lancet Lancets are for single use only Avoid getting hand lotion oils dirt or debris in or on the lan cets and the lancing device NOTE Overview of the Lancing Device If your lancing device differs from the one shown here please refer to the manufacturer s manual to ensure proper usage ...

Страница 23: ...til it is snug but not too tight The adjustable tip offers 5 levels of skin pen etration Twist the adjustable tip in either direc tion until the number lines up with the arrow 1 2 for soft or thin skin 3 for average skin 4 5 for thick or calloused skin Slide the cocking control back until it clicks If it does not click the device may have been cocked when the lancet was inserted The lancing device...

Страница 24: ...o blood extraction the difference was significantly reduced Please follow the suggestions below before obtaining a drop of blood Rub the puncture site for about 20 seconds before penetration Use a clear cap included in the kit while setting the lancing device Wash and dry your hands before starting Select the puncture site either at the fingertips or another body part please see section Alternativ...

Страница 25: ...btain blood from sites other than the finger replace the lancing device cap with the clear cap Turn the clear cap until it is snug but not too tight and then slide the cocking control back until it clicks Choose a different spot each time you test Repeated punc tures at the same spot may cause soreness and calluses Please consult your health care professional before you begin AST It is recommended...

Страница 26: ... with results equivalent to fingertip testing What is the advantage Fingertips feel pain more readily because they are full of nerve endings receptors At other body sites since nerve endings are not so condensed you will not feel as much pain as on the fingertips When to use AST Food medication illness stress and exercise can affect blood glu cose levels Capillary blood at fingertip reflects these...

Страница 27: ...ours since the last meal Two hours or more after taking insulin Two hours or more after exercise Do NOT use AST if You think your blood glucose is low You are unaware of hypoglycemia You are testing for hyperglycemia Your AST results do not match the way you feel Your routine glucose results are often fluctuating ...

Страница 28: ...sample Use the prior set lancing device to puncture your desired site After penetration discard the first drop of blood with a clean cotton swab Gently squeeze the punctured area to obtain another drop of blood Be careful NOT to smear the blood sample The volume of blood sample must be at least 0 5 microliter μL of volume actual size 4 Apply the Sample Hold the blood drop to touch the absorbent ho...

Страница 29: ... strip within 3 minutes the meter will automatically turn off You must remove and reinsert the test strip to start a new test The confirmation window should be filled with blood before the meter begins to count down NEVER try to add more blood to the test strip after your drop of blood has moved away Discard the used test strip and retest with a new one If you have trouble filling the confirmation...

Страница 30: ...rip and remove the lancet To eject the test strip point the strip at a dis posal container for sharp objects The meter will switch itself off automatically after the test strip is ejected Always use caution when removing the lancet Take the lancet out by hand carefully Place the disk on a hard surface and push the exposed tip into the protective disk ...

Страница 31: ...eading you see is the last blood glucose result along with date time and the measurement mode 2 Press to recall the test results stored in the meter each time you press 3 Exit the meter memory After the last test result press again and the meter will be turned off If the meter is left idle for more than 5 seconds after entering the memory mode the meter then will display the following message on t...

Страница 32: ...isplay keep pressing for 3 seconds until the blinking appears Release and then your 7 day average result measured in general mode will appear on the display 2 Press to review 14 21 28 60 and 90 day average results stored in each measurement modes in the order of Gen AC then PC For example ...

Страница 33: ...ry keep pressing for 5 seconds or leave it without any action for 3 minutes The meter will switch off automatically Control solution results are NOT included in the day average If using the meter for the first time displays when you recall the test results or review the average result It indicates that there is no test result in memory NOTE ...

Страница 34: ...System please visit Simple Diagnostics website at http www SimpleDiagnostics com 2 Connecting to a personal com puter Connect the cable to a USB port on your computer With the meter switched off connect the other end of the cable to the meter data port PC will appear on the meter display indicating that the meter is in communication mode 3 Data transmission To transmit data follow the instructions...

Страница 35: ...to do a test You must change the battery immediately Low Battery Signal The meter will display one of the messages below to alert you when the meter power is getting low Replacing the Battery To replace the battery make sure that the meter is turned off 1 Press the edge of the battery cover and lift it up to remove 2 Remove the old battery and replace with one 3V CR2032 lithium battery 3 Close the...

Страница 36: ...l children If swallowed promptly seek medical as sistance Batteries might leak chemicals if unused for a long time Re move the batteries if you are not going to use the device for an extended period i e 3 months or more Properly dispose of the batteries according to your local envi ronmental regulations NOTE BATTERY CR2032 BATTERY CR2032 BATTERY CR2032 ...

Страница 37: ...meter in its original storage case Avoid dropping and strong impact Avoid direct sunlight and high humidity Caring for Your Test Strips Storage condition 39 2 F 104 F 4 C 40 C below 85 relative humidity Do not freeze Store your test strips in their original vial only Do not transfer to other container Store test strip packages in a cool and dry place Keep away from direct sunlight and heat After r...

Страница 38: ...are at this specified temperature range before testing Shake the vial before use discard the first drop of control solution and wipe off the dispenser tip to ensure a pure sample and an ac curate result Store the control solution tightly closed at temperatures between 36 F and 86 F 2 C to 30 C Do NOT freeze Do not use test strips beyond the expiration date This may cause inaccurate results Do not ...

Страница 39: ...asurement limit which is less than 20 mg dL 1 1 mmol L This indicates hypoglycemia low blood glucose You should seek medical assistance immediately Appears when your result is equal to or higher than 240 mg dL 13 3 mmol L This indicates the possibility of ketone accumulation for type 1 diabetes Please seek medical assistance immediately Appears when your result is higher than the limit of mea sure...

Страница 40: ...w test strip If the meter still does not work please contact the customer service for as sistance Test strip has been removed during testing Appears when test strip is removed while counting down Repeat the test with a new test strip Room tem perature is out of range Thus un able to measure Appears when ambient tem perature is below system operation range System operation range is 10 F 40 F 50 C 1...

Страница 41: ...with a new test strip Sample applied after automatically shutoff 2 minutes after last user action Repeat the test with a new test strip Apply sample only when flashing appears on the display Defective meter Please contact customer services POSSIBLE CAUSE WHAT TO DO Error in performing the test Read instructions thoroughly and repeat the test again Control solution vial was poorly shaken Shake the ...

Страница 42: ...djust your treatment plan to gain better control of your diabetes Time of day Normal plasma glucose range for people without diabetes mg dL Fasting and before meal Less than 100 mg dL 5 6 mmol L 2 hours after meals Less than 140 mg dL 7 8 mmol L Source American Diabetes Association 2008 Clinical Practice Recommendations Diabe tes Care 31 Supplement 1 S1 108 Please work with your doctor to determin...

Страница 43: ...een meter and laboratory results follow the guidelines below Before going to the lab Perform a control solution test to make sure that the meter is work ing properly Fast for at least eight hours before doing comparison tests if pos sible Take your meter with you to the lab While staying at the lab Make sure that the samples for both tests test are taken and tested within 15 minutes of each other ...

Страница 44: ...spe cially if you have recently eaten exercised taken medication or experienced stress 2 In addition if you have eaten recently the blood glucose level from a finger prick can be up to 70 mg dL 3 9 mmol L higher than blood drawn from a vein venous sample used for a lab test 3 Therefore it is best to fast for eight hours before doing comparison tests Factors such as the amount of red blood cells in...

Страница 45: ...Auto turn off after 3 minutes without action Temperature Warning Operating Condition 10 C 40 C below 85 R H non condensing Storage Transportation Condition 20 C 60 C below 95 R H Measurement Units mg dL Measurement Range 20 600mg dL 1 1 33 3 mmol L This device has been tested to meet the electrical and safety requirements of IEC EN 61010 1 IEC EN 61010 2 101 EN 61326 1 IEC EN 61326 2 6 Distributed...

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