ApexBio GlucoSure Plus, User Manual

Page 1: ...od Glucose Meter 6 Touch In Plus Blood Glucose Test Strip 8 Contrex Plus Glucose Control Solution optional 9 2 Before Testing Changing Unit of Measurement 10 Monitor Checker Test 11 Quality Control Te...

Page 2: ...iabetes Findings 25 What This Means for You 25 5 Using Meter Memory 27 6 Caring for the Meter Cleaning the Meter 28 Storage and Precautions 28 7 Changing the Battery 30 8 Message Interpretations What...

Page 3: ...10 Specifications 37 11 Supplies 39 12 Symbols Used in this Manual 40 13 Product Warranty 41 3 USER S GUIDE Table of Contents...

Page 4: ...measuring the level of glucose sugar in capillary blood from the finger at specific points in time The results are plasma referenced which means that the results obtained from the GlucoSure Plus Bloo...

Page 5: ...rence from the above 5 USER S GUIDE Chapter 1 About Your GlucoSure Plus Blood Glucose Monitoring System GlucoSure Plus Blood Glucose Meter 1 Touch In Plus Blood Glucose Test Strips 10 Adjustable Lanci...

Page 6: ...or symbols Push Button Recalls test results in the memory Refer to chapter 5 p 30 Using Meter Memory for details Press and hold to turn off meter Test Strip Holder Insertion site for test strips and m...

Page 7: ...tery CR2032 Refer to Chapter 7 p 33 Changing the Battery Code Card Port Insertion site for the code card Located at the top back of the meter Code Card The code card programs the meter for a specific...

Page 8: ...ucose Meter is designed specifically to detect glucose in whole blood with the Touch In Plus Blood Glucose Test Strip only The Touch In Plus Blood Glucose Test Strips come in a moisture proof light pr...

Page 9: ...13 to check for system accuracy practice test procedure and when using a new lot of Touch In Plus Blood Glucose Test Strips 9 USER S GUIDE Chapter 1 able of Contents Suitable for self testing Storage...

Page 10: ...sults in either mg dL or mmol L The factory setting is mg dL Consult your healthcare professional before changing the unit of measurement Material you will need Your GlucoSure Plus Blood Glucose Meter...

Page 11: ...nitor Checker Test will help ensure that the electronics in your GlucoSure Plus Blood Glucose Meter is working properly This test should be done on a brand new meter or when the performance of the met...

Page 12: ...en You first get your meter before performing a blood glucose test You first begin to use a new bottle of Touch In Plus Blood Glucose Test Strips You suspect your GlucoSure Plus Blood Glucose meter an...

Page 13: ...ening DO NOT FREEZE Store the control solutions at room temperature If the result of the control solution test is outside of the expected range printed on the test strip package DO NOT use the system...

Page 14: ...efer to Chapter 2 p 12 Monitor Checker Test Step 2 After the display screen of the meter showing the screen will then display the current code number being used Verify that code number on screen is th...

Page 15: ...lace 6 Record the date opened on the test strip bottle label when you first open it Discard the bottle and any remaining test strips after 3 months Step 3 Insert a brand new Touch In Plus Blood Glucos...

Page 16: ...nge printed on the test strip package The test result falling within the range means the meter and the test strip are working together properly Remove the test strip Step 7 To perform test of Level 2...

Page 17: ...ach box of Touch In Plus Blood Glucose Test Strips Materials your will need A code card for the Touch In Plus Blood Glucose Strips A Touch In Plus Blood GlucoseTest Strip Your GlucoSure Plus Blood Glu...

Page 18: ...a beep sound Close the test strip bottle immediately after you take out a strip Step 5 A 3 digit code number will display on the meter screen Verify the code number on the screen with that on the code...

Page 19: ...is replaced or a new package of test strip is opened for use 19 USER S GUIDE Chapter 3 Glucose Testing The code number displayed on the meter should match the code number on the gray code card and on...

Page 20: ...strip bottle and box 2 Use each test strip immediately after removing it from the bottle 3 After removing a test strip from the bottle replace the bottle cap immediately and close it tightly 4 Do not...

Page 21: ...Plus Blood Glucose Meter is used the current code will appear on the display screen when turned on Verify that the code displayed on screen matches the code number printed on the test strip package b...

Page 22: ...of test result Step 2 Wash hands with soap and warm water and dry thoroughly Step 3 Obtain a drop of blood using your lancing device Consult your healthcare professional for the proper technique of us...

Page 23: ...test result in the glucose log book The test result is also automatically stored into the Meter s memory refer to Chapter 5 p 30 Using Meter Memory The meter will automatically turn off after the Tes...

Page 24: ...Blood Glucose Readings Abnormal blood glucose level above 250 mg dL above 13 9mmol L or below 50 mg dL below 2 8 mmol L may indicate a potential serious medical condition If your blood glucose reading...

Page 25: ...ou could reduce the risk of complications involving the eyes kidneys and nervous system by approximately 60 What This Means for You Frequent blood glucose testing is the best means you have for keepin...

Page 26: ...larke W L et al Diabetes Care 1987 Vol 10 No 5 p 628 662 3 Surwit R S and Feinglos M N Diabetes Forecast April 1988 p 49 51 4 Wickham N W R et al Practical Diabetes 1986 Vol 3 No 2 p 100 5 Cohen F E e...

Page 27: ...ach time a new result is added When the test results are recalled from memory the most recent result is always displayed first To recall the results from memory Step 1 Press the push button to turn on...

Page 28: ...or hold it under running water 2 DO NOT use glass cleaners or household cleaners on the meter 3 DO NOT try to clean the test strip holder Storage and Precautions Handle the meter with care severe shoc...

Page 29: ...kitchen Never immerse or hold the meter under running water Always replace the top bottle cap immediately after removing a test strip and make sure it is closed tightly DO NOT take the GlucoSure Plus...

Page 30: ...save battery power the GlucoSure Plus Blood Glucose Meter will turn itself off after 3 minutes of non use All results stored in memory will be saved even if the meter shuts off automatically To replac...

Page 31: ...questions after reviewing these messages call our authorized dealer Message Meaning What To Do code then The meter has not been Code your Meter with a Touch In the meter shuts coded with a code card P...

Page 32: ...and Not enongh blood sample First check if the yellow reaction zone flashing is applied to the yellow is filled with blood sample if it is not displaying after reaction zone discard the test strip fro...

Page 33: ...ional 1 A used test strip is Remove and discard the used test inserted strip then perform the Monitor 2 The meter does not Checker Test on p 12 If the function properly problem persists contact our au...

Page 34: ...coSure Plus Blood Glucose Monitoring System is referenced to the YSI 2300 Glucose Analyzer and the evaluation studies were performed according to ISO DIS 15197 guidelines A total of 127 fresh capillar...

Page 35: ...ariation is defined as precise A study was conducted with the GlucoSure Plus Blood Glucose Monitoring System using five heparinized blood specimens with concentrations ranging from 43 mg dL to 378 mg...

Page 36: ...g dL 43 84 120 198 378 S D mg dL 2 5 2 5 3 8 4 7 11 0 C V 5 8 3 0 3 2 2 4 2 9 For more information on the Touch In Plus Blood Glucose Test Strips please refer to the packaging insert found in each box...

Page 37: ...sult Dimension 100L x 58W x 21H mm Weight 64g Power Supply 1 x 3V Lithium coin cell battery CR2032 Operating Temperature 18 C to 38 C 64 F to 100 F Relative Humidity Less than 85 Storage Condition 4 C...

Page 38: ...Applied Product Standards ISO DIS 15197 IEC 61010 1 IEC 60601 1 EN 60601 1 EN 61010 1 EN 60601 1 2 EN 61326 38 USER S GUIDE Chapter 10 Specifications...

Page 39: ...103 Touch In Plus Blood Glucose Test Strips 100 s S5635066 Touch In Plus Blood Glucose Test Strips 50 s S5635067 Touch In Plus Blood Glucose Test Strips 2 x 25 s 65235010001 Lancing Device 80050000003...

Page 40: ...of month LOT Batch code Temperature limitations Consult instructions for use In vitro diagnostic device Caution warning consult accompanying documents Product code number Keep away from sunlight direc...

Page 41: ...t shall Apex Biotechnology Corp be liable for any collateral or consequential damages or loss Instruments subjected to misuse abuse neglect unauthorized repair or modification will be excluded from th...