- IN4 Technology Corp.
Contents
1. ACTION TO TAKE If some parts of the display are not working Contact us or your local distributor for help Blood glucose result may be higher than 600 mg dL 33 3 mmol L If the reading is HI and you do not experience any hi blood glucose symptoms review proper testing procedure refers to page 13 and perform a quality check refers to page 7 and 8 Repeat test if the result persists contact your medical professional for help Blood glucose result may be lower than 20 mg dL 1 1 mmol L If the reading is LO and you do not experience any low blood glucose symptoms review proper testing procedure refers to page 13 and perform a quality check refers to page 7 and 8 Repeat test if the result persists contact your medical professional for help Temperature is above or below the operating range of test strips The result you have obtained may not be accurate Move to an area with temperature within the test strip s operating range temperature between 10 C to 40 C 50 F 104 F Do not artificially heat or cool the meter Battery is low Change battery soon DISPLAY DESCRIPTION Battery is dead ACTION TO TAKE Change battery now Test strip may be damaged Perform the test with a new test strip only Test strip is used or test was not performed correctly Perform the test with a new test strip only and follow the chapter of perform blood glucose test2. No responses when strip is inserted 1 Battery dead 2 Wrong strip inserted 3 Meter defective 1 Replace battery 2 Insert the test strip correctly 3 Contact us for help No responses after sample is applied 1 Sample not sufficient 2 Meter defective 1 Repeat test with sufficient sample 2 Perform Meter Quality Check NOTE If there is any error message displayed but not listed here or your meter shut down for no reason you can reset the meter by following two ways 1 Replace the battery 2 Use a lancet to prink the reset hole with a reset mark beside the battery component REFERENCE 1 Tietz N W textbook of Clinical Chemistry P 2190 1994 2 American Diabetes Association Position Statement Diabetes Care Vol 19 Suppl 1 p S4 1996 PERFORMANCE EVALUATIONS PRECISION Tests were carried by trained technicians in the laboratory setting The venous whole blood from one subject was adjusted to 3 different levels Strips out of a single lot were tested The results are shown in the following table Level No of tests Mean mg dL Mean mmol L WithinRun C V Low 20 43 2 4 3 4 Normal 20 109 6 0 3 6 High 20 324 18 0 2 4 ACCURACY Tests were performed at hospital by healthcare professionals and diabetic patients Fresh capillary finger whole blood samples were tested with the GlucoAlpha Enhance System plasma samples from the subjects were tested with YSI Model 2300 Glucose Analyzer
3. as reference The results are shown in the following table Slope 1 003 y intercept 1 07 mg dL 0 06 mmol L Correlation Coefficient R 0 991 Number of tests 150 Range tested 84 489 mg dL 4 7 27 2 mmol L SYMBOLS CONVEY Information Essential For Proper Use For in vitro diagnostic use LOT Lot number Use by Expiry date Temperature limitation Store at Do not reuse Please consult instructions for use Caution consult accompanying document EP OS Manufacturer EcJREP EC representative CE This product fulfils the requirements of Directive 0537 98 79 EC in vitro diagnostic medical device TAKING CARE OF YOUR METER REPLACING THE BATTERY The GlucoAlpha Enhance Blood Glucose Meter comes with a battery pre installed when new purchasing Battery life will vary depending on usage so always keep a spare on hand The battery should last about 12 months when testing 3 times a day When the battery symbol FIG appears on the meter display battery is getting low You will still be able to test with low battery but you should replace it as soon as possible When battery symbol appears flashing on the display the meter will no longer give results and you must replace the battery immediately TO REPLACE THE BATTERY 1 Make sure the meter is turned off 2 Let the front of the meter rest in the palm of your hand 3 Slide battery compartment door op
4. blood drop has saturated the test confirmation window When 3 Check that the code number in the meter matches the code on the vial of test strips you are using FIG 3 Exp Date iscard Date 853 Use within 904 Lot No Control Soluti lution Range jee spiton Renee 4 When the blood symbol flashes you are ready to perform the blood glucose test FIG 4 ol By applying blood sample to the aperture of the test strip you can press M button to set the test as BEFORE MEAL TEST AC or AFTER MEAL TEST PC test be done in 2 hours after meal or a CONTROL SOLUTION TEST qC If not setting the default of the meter is AC FIG 5 PE mg dL H 1 s blood is applied to the strip the meter will be started automatically FIG 7 8 Test result will show up in 15 seconds FIG 8 Before removing strip from the meter check if the AC PC qC setting is correct if not please press M button to correct the setting 9 Remove the strip from meter FIG 9 and discard the used strip and lancet safely in a puncture resistant container 10 Testing range of the meter is 20 600mg dL 1 1 33 3 mmol L If HI is displayed your blood glucose result may be higher than 33 3 mmol L or 600 mg dL If LO is displayed your blood glucose result may be lower than 1 1 mmol L or 20 mg dL FIG 10 Refers to page19 for details MEMORY RECALL The GlucoAlpha Enhance Blood Glucose M
5. memory mode and display next result after deleting DATA DOWNLOAD You may download test results to your computer To transfer test results to a computer you need to download GlucoAlpha Software from our web site or from the CD provided by us Use the interface cable provided with CD to download your test results to computer UNUSUAL TEST RESULT NORMAL BLOOD GLUCOSE RANGE The normal blood glucose range is 70 to 105 mg dL 3 8 to 5 8 mmol L 1 for a fasting non diabetic adult but less than 140 mg dL 7 7 mmol L 2 two hours after meals Consult your healthcare professional to find out your target blood glucose value If your blood glucose result seems unusually high or low or inconsistent with your previous results check the following 1 Does the code number on the strip vial match the code number on the meter 2 Was the blood sample applied immediately to the glucose strip after removing it from the vial Was the size of the blood sample sufficient Was the test strip vial cap tightly sealed Was the test strip used before the expiration date Dn oO KR W Were the test strips stored away from extreme temperatures in very cold or hot weather or from areas of high humidity Then run a quality control check with your GlucoAlpha Control Solutions and a new test strip The information of how to do the control test please refer to your control solution package insert for more information If the control
6. 3 Press S button to enter the code mode and the code value flashes FIG 3 0g I 4 Press S or M button to obtain the code number indicated on the new test strip vial FIG 4 Exp Date Discard Date 853 use within 90988 Lot No C ontrol Solution Range j 5 Upon obtaining the right code waiting new setting flash 4 times to validate the change After screen shows the proper code and a blinking blood symbol shows up FIG 5 your meter is ready to perform blood test AC mg dL aP a a N 853 NOTE when the meter is OFF you can also press and S button for 3 seconds to code the meter directly The coding procedures are the same as above step 4 and 5 PERFORM BLOOD TEST 1 Wash your hands in warm soapy water Rinse and dry com pletely Warm your fingers to increase blood flow FIG 1 2 Remove new test strip from vial Be sure to tightly replace vial cap after removing test strips Insert test strip immediately into strip slot as illustrated The meter turns on automatically FIG 2 6 Use the loaded lancing device to obtain a drop on the side of your finger FIG 6 Hold the device firmly against the side of your finger Press the release button Gently massage your finger to obtain the required blood volume To perform the test you need only 1 5uL of blood sample resting on your finger 7 Apply the blood to the aperture of strip and make sure that the
7. INFORMATION 1 GlucoAlpha Enhance System measures the amount of glucose in capillary whole blood Blood can be applied both to the right or left side of the test strip s apertures and is automatically drawn to the test confirmation window where the reaction takes place 2 GlucoAlpha Blood Glucose Strips are intended for in vitro diagnostic use with capillary whole blood or GlucoAlpha Control Solution Results will not be accurate if used with plasma or serum samples 3 Do not use glucose strips beyond the expiration date indicated on the strip vial label 4 The discard date for glucose strips is 90 days after first opening the vial Record the discard date on the vial when you open a new Vial of glucose strips vI GlucoAlpha Blood Glucose Strip can be damaged by heat and light Keep them sealed in the original vial 10 C 40 C 6 OF Ag 0 P store the vial in a cool dry place below to 40 C 104 F and above to 10 C 50 F Do not refrigerate 7 Do not use damaged glucose strips or glucose strips changed in any way Use glucose strip immediately after removing it from the vial replace the vial cap and close it tightly 8 Do not transfer glucose strips to a new vial Always carry glucose strips in their original vial 9 Do not place in direct heat or sunlight 10 Do not carry loose glucose strips in your carrying case 11 Blood glucose test strips are for single use only 12 Do not use fluoride o
8. Use caution when removing the used lancet from the device and when disposing the used lancet E The lancets are in conformity with MDD 93 42 EEC Refer to product labels for contact information of manufacturer and CE marking SET LANCING DEVICE 1 Remove the depth adjustment cap Insert a lancet into the lancet holder and push down until it is fully seated FIG 1 2 Twist off the protective cap until it separates from the lancet FIG 2 fa Ky Is 3 Replace the depth adjustment cap and set the puncture depth to the desired number FIG 3 NOTE The Larger The Number Setting The Deeper The Puncture 4 Pull back the cocking control until it makes a click and then release FIG 4 If it does not click the device may have been cocked when the lancet was inserted CODING YOUR METER Before you use your meter for the first time and every time you open a new box of test strips you need to set the meter to match the strips This is called coding 1 Insert the test strip into the strip slot FIG 1 to turn on the meter Then the last code number will appear on the screen _ CNY 2 Compare the code number shown on the meter display against the code number on the test strip vial FIG 2 If the two numbers match you may begin blood testing Otherwise continue to the next step Code mg dL CODE Exe Date 103 ap Gone O 18 18 38 em tl Solution Range lt T
9. User Guide About GlucoAlpha ENHANCE INTENDED USE The GlucoAlpha Enhance Blood Glucose Monitoring System The GlucoAlpha Enhance System is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes for self testing or by healthcare professionals for monitoring glucose in the home or in healthcare facilities The device is indicated for professional use and over the counter sale ABOUT THE SYSTEM The GlucoAlpha Enhance System uses the latest technology in blood glucose monitoring to provide you with easy and comfortable testing The system requires only a 1 5uL of blood sample to complete the testing in only 15 seconds The GlucoAlpha Enhance System consists of 1 GlucoAlpha Enhance Blood Glucose Meter 2 GlucoAlpha Blood Glucose Test Strips 3 GlucoAlpha Check Strip 4 GlucoAlpha Control Solution These products are intended to be used together to get accurate blood glucose test results Do not use other test strips or control solutions with your meter By IN4 Technology IMPORTANT INFORMATION GlucoAlpha Enhance System is intended for in vitro diagnostic use with capillary whole blood The system should not be used for diagnosis of diabetes or for testing newborn infant neonatal testing N CAUTION E The user should not take any decision of medical relevance without first consulting his or her medical practitioner E Call y
10. en 4 Remove the old battery and insert the new 3 volt Lithium battery CR2032 into the battery compartment being sure to align the plus and minus signs correctly 5 Slide battery compartment door closed Check to see that your meter is working If it fails to turn on the battery may have been inserted incorrectly Remove the battery and reinsert it NOTE EVERY TIME WHEN YOU REPLACE THE BATTERY THE METER WILL TURN ON AUTOMATICALLY AND ENTER TO THE TIME DATE SETTING PLEASE SET CORRECT TIME AND DATE BEFORE TESTING CLEANING Clean the outside of the meter with a soft cloth slightly dampened with water Do not get moisture into the strip slot and data port STORAGE AND HANDLING Keep your meter free of dust Protect it from extreme temperature and humidity CUSTOMER SERVICE Distributed by IN4 Technology Corporation www in4 technology com HMD BioMedical Inc No 257 Sec 1 Chunghwa Rd Hsinchu 300 Taiwan EC REP Zengqing Jian C G Maire Baum Str 3 D 76137 Karlsruhe Germany 0537 3K 02 223031 Sept 2007
11. eter automatically stores 153 test results letting you review them in order from the most recent to the oldest If you have set the AC PC and time date feature the AC PC and time date of the results are also displayed If the memory is full and a new result is added the meter deletes the oldest result The meter also calculates and displays your previous 7 14 and 30 day before meal AC and after meal PC test averages if you preset correct time and date TO RECALL RESULTS STORED IN MEMORY 1 Turn meter on by press M button 3 seconds to turn on the meter The first result displayed on the screen is your latest test result 2 By pressing M button you will see your test record from the most recent to the oldest 3 By pressing S button you will obtain your 7 days before meal AC setting You can press S button again to obtain your 7 days after meal PC setting 4 Following press S button to review your 14 days and 30 days before meal and after meal averages NOTE ANYTIME IN MEMORY MODE YOU CAN PRESS S BUTTON TO EXIT AND TURN OFF THE METER TO DELETE MEMORY 1 While in the memory mode select the test result you wish to delete and display it on the screen 2 Press M button until you hear a beep sound The blink dEL symbol will appear on the meter 3 Press M button again until the OK symbol appears which confirms that the selected test result has been deleted successfully 4 The meter will return to
12. ime and date should be set prior to testing if you plan to review your 7 14 30 days test average in before meal AC and after meal PC reading or if you want to download the results into computer or to review your memory to check when a test was done TO SET THE TIME AND DATE 1 Make sure the meter is turned off 2 Let the front of the meter rest in the palm of your hand 3 Slide battery compartment door open and you will find a RESET hole above the battery 4 Prink the RESET hole to enter time and date setting 5 At the beep sound the year will flash for example for the year 2006 number 06 will appear 6 Press S or M BUTTON to obtain the desired year 7 Wait the new setting flash 4 times to confirm and move to next setting 8 Repeat to set the month day hour and minute 9 After minute is set the meter displays OK and turn off automatically PREPARE FOR BLOOD SAMPLING Your lancing device and lancets are used for obtaining capillary blood samples from the fingertip ADJUSTABLE LANCING DEVICE 1 Depth Adjustment Cap 2 Depth Selector 3 Lancet Holder 4 Cocking Control 5 Release Button Important E The lancing device is in conformity with MDD 93 42 EEC Refer to package insert for contact information of manufacturer and CE marking _ _ LANCET e a N Protective cap A Important E Lancets are for single use only E Keep lancing device and lancets clean E
13. our doctor immediately if you experience symptoms that are not consistent with your blood glucose test results E Severe dehydration or excessive water loss may cause false low results Call your doctor right away if you believe you are suffering from dehydration E A sample with large amount of reducing substances such as ascorbic acid and uric acid may cause result slightly higher than the actual glucose level E A red blood cell count hematocrit that is either very high over 55 or very low under 30 can cause false result E High altitudes above than 2 750 meter 8 800 feet may affect the test results E Temperatures outside the range of 10 C to 40 C 50 F to 104 F may affect the test results GlucoAlpha ENHANCE BLOOD GLUCOSE METER Study this diagram and become familiar with all parts of your GlucoAlpha Enhance Blood Glucose Meter ny Ou 8 d8 DAYAVG 88 88 eM ENHANCE 1 DISPLAY The large easy to read display shows blood glucose results messages glucose results stored in memory time and date 2 S BUTTON Press S button to enter code setting and when you need to decrease values in setting mode 3 M BUTTON Press M button to enter memory recall mode and to increase values in setting mode 4 STRIP SLOT Holds a GlucoAlpha Blood Glucose Test Strip and Check Strip in place when you perform blood glucose test or perform check test 5 BATTERY COMPARTMENT Holds ONE 3v Lithium batter
14. r iodoacetic acid as a preservative for blood specimens GlucoAlpha CHECK STRIP The GlucoAlpha Check Strip can be used in 2 ways 1 To check that the meter is operating properly Use when performing quality control check on your meter 2 To change the measuring unit of your meter HOW TO CHECK METER BY CHECK STRIP Step 1 Insert the check strip into strip slot with label side up as above Step 2 You should obtain an acceptable OK reading within 3 seconds which mean your meter is working properly Step 3 Remove the check strip to exit Meter will automatically off NOTE IF YOU DO NOT GET OK READING BUT APPEAR OTHER ERROR MEEAGE REMOVE CHECK STRIP TO TURN OFF THE METER FIRST THEN REPEAT THE TEST IF THE SECOND RESULT PERSISTS PLEASE CONSULT YOUR LOCAL DISTRIBUTOR FOR HELP How To Change Measuring Unit The meter has two measuring units to choose from mg dL and mmol L The default unit is mg dL if you do not change Consult your doctor for the proper unit in your country Step 1 Insert check strip into strip slot with label side up Step 2 After OK displayed press S button for 3 seconds until flashing mg dL shows up Step 3 Press S button to switch from mg dL to mmol L Wait the new setting flash 4 times to validate the new setting Meter will display OK before OFF and the unit is been changed successfully Step 4 Remove the check strip from the meter SETTING TIME AND DATE T
15. test result is within the acceptable range review testing procedure and repeat your blood glucose test with a new test strip If your blood glucose value is still inconsistent with your previous results glucose trend or how you feel contact your doctor for help immediately SYSTEM SPECIFICATIONS Assay Method Electrochemical biosensor Test Sample Capillary Whole Blood Test Result Plasma Serum glucose Sample Size Less than 1 5 uL Measuring Range 20 600 mg dL or 1 1 33 3 mmol L Measuring Time Less than 15 seconds Memory Capacity 153 test results with time and date CON DO KRW N gt a Average Display 7 14 30 days AC and PC test average Result Setting AC PC and qC setting 10 Power Supply One 3 volt Lithium Battery CR2032 O 11 Battery Life Approximately 1000 tests 12 Operating Temp Range 10 C to 40 C 50 F 104 F 13 Hematocrit Limit 30 to 55 14 Operating Relative Humidity 20 80 RH 15 Automatic shut off In 10 minutes DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE When any of the following messages appears there is a problem with your GlucoAlpha Enhance Blood Glucose Meter or the way in which you are performing a test These messages will help you to identify certain problems If error messages appear that are not listed on the following pages please contact us for help DISPLAY DESCRIPTION Display All Code Mies at pura f am an aD 18 08 DAYAVG 8888 M
16. y CR2032 The battery is not yet installed into meter when new purchasing By using the meter please install the battery first Refer to Section TAKING CARE OF YOUR METER of the manual for more information IN4 Technology Corporation www in4 technology com GlucoAlpha ENHANCE LCD WINDOW O O Code M gg myd EC I AILIN de ale RAA L PM d O 1 TEST RESULT 2 BATTERY SYMBOL Appears when battery is weak 3 THERMOMETER SYMBOL Appears when ambient temperature is above or below the acceptable range needed for testing 4 BLOOD SYMBOL Appears when the test strip is inserted and meter is ready for blood testing 5 STRIP SYMBOL 6 M188 Memory capacity is 153 entries The display shows M188 to ensure that all digits are working properly 7 mg dL mmol L The meter has two units of measurement to choose from 8 DAY AVG Appears when the meter is in Memory Mode The meter automatically calculates your 7 14 30 days before meal AC and after meal PC test averages if you preset correct time and date 9 DATE Month date 10 TIME The meter is programmed for a 12 hours period format GlucoAlpha BLOOD GLUCOSE TEST STRIP O o 1 Aperture apply the blood from either side of strip 2 Test Confirmation Window make sure the part is filled up with blood to ensure the correct result 3 Gray Electrode End insert this end of test strip into meter A IMPORTANT TEST STRIP
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