User Manual - i-SENS
Contents
1. Case e Certain components may not be included depending on the place of purchase e Check all the components after opening the CareSens N Mini Blood Glucose Monitoring System package The exact contents are listed on the main box e Please contact your authorized i SENS sales representative if any component is missing or damaged The device can be sent back to the manufacturer for recycling or proper disposal after its useful life Alternatively the device should be disposed in accordance with national laws after its useful life 10 CareSens N Mini Blood Glucose Monitoring System Specifications e Model GM505VAA e Test Range 20 600 mg dL 1 1 33 3 mmol L e Sample Size Minimum 0 5 uL e Test Time 5 seconds e Test Sample Fresh capillary whole blood e Calibration Plasma equivalent e Assay Method Electrochemical e Operating Range Temperature 10 40 C 50 104 F Relative Humidity 10 90 Hematocrit 20 60 ns 11 Warranty Information Manufacturer s Warranty i SENS Inc warrants that the CareSens N Mini 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 tampering improper handling 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 by2. for at least eight 8 hours 07 Error Messages and Troubleshooting appeared Repeat the test with a new test strip and wait until the amp symbol appears before applying the blood sample The temperature during the test was above or below the operating range Move to an area where the temperature is within the operating range 10 40 C 50 104 F and repeat the test after the meter and test strips have reached a temperature within the operating range The blood sample has abnormally high viscosity or is insufficient Repeat the test after inserting a new test strip This error message may appear when the wrong blood glucose test strip is used instead of CareSens N blood glucose test strip Repeat the test with a CareSens N test strip fio Z A used test strip was inserted E Repeat the test with a new test strip Z The blood or control solution sample cre was applied before the amp symbol CT There is a problem with the meter Lr i Do not use the meter Contact your authorized i SENS sales representative 08 Replacing Battery If Lo message blinks when the meter is turned on or a test strip is inserted it means there is not enough power for tests So the battery needs to be changed Use only non rechargeable replaceable type CR2032 lithium battery with 3 V nominal voltage 220 mAh nominal capacity and a 0 2 mA no
3. or low red blood cell count hematocrit level over 60 or below 20 may produce inaccurate results e Severe dehydration excessive water loss may cause false low results If you believe you are suffering from severe dehydration consult your physician immediately e There is no effect from altitude up to 3 000 m 10 000 ft above sea level METER AND TEST STRIP PERFORMANCE CHECK The CareSens Control Solution contains a known amount of glucose that reacts with the CareSens N Test Strip in combination with the CareSens N Mini Meter to make sure they are working properly together and the correct testing procedure is being followed You may run a check with the control solution when you e Want to practice the test procedure using the control solution instead of blood e Use the meter for the first time e Open a new vial of test strips e Have symptoms that are inconsistent with your blood glucose test results e Believe your test results are not accurate e Suspect your meter and test strips are not properly performing If your control solution test results do not fall within the range printed on the test strip vial repeat the test Out of range results may be due to one or more of the following factors e Error in performing the test e Expired or contaminated control solution e Expired or damaged test strip e Failure to shake control solution bottle e Failure to discard first drop of control solution and w
4. this warranty As a matter of warranty policy i SENS will not reimburse the consumer s 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 authorised i SENS sales representative CareSens N Blood Glucose Test Strips Strip information IMPORTANT Please read this information and the CareSens N Mini User Manual before using CareSens N Test Strips INTENDED USE AND TEST PRINCIPLE The CareSens N Test Strips work with the CareSens N Mini Blood Glucose Meter to quantitatively measure glucose in capillary whole blood The CareSens N Mini Blood Glucose Monitoring Systems are for self testing outside the body in vitro diagnostic use The CareSens N Mini Blood Glucose Monitoring Systems should not be used for the diagnosis of diabetes or for testing newborns The glucose in a blood sample mixes with special test strip chemicals where a small electrical current is produced The CareSens N Mini Blood Glucose Meter detects the electrical current which reflects the amount of glucose in the blood sample STORAGE AND HANDLING e Store vial in a cool and dry place between 1 30 C 34 86 F Do not freeze e Keep the vials of test strips away from direct sunlight or heat e Store unused test strips in their original vials to 1 avoid damage or contamination e Close the vials tight immediately after taking out a test st
5. CareSens NJ Blood Glucose Monitoring System User Manual INDEX 01 Preparing Lancing Device for Blood Sampling 2 02 Using Lancing Device at Fingertip Sample Site 3 03 Testing Your Blood Glucose Level 4 04 Viewing Test Results in Meter Memory ____ 6 05 Checking the System 6 06 HI and Lo Messages 8 07 Error Messages and Troubleshooting 10 08 Replacing Battery 11 09 Please Note 12 10 CareSens N Mini Blood Glucose 11 Monitoring System Specifications ____ __ 13 Warranty Information 14 PGA1E3182 REV2 08 2012 01 Preparing Lancing Device for Blood Sampling Step1 Wash your hands and the sample site with soap and warm water Rinse and dry thoroughly Step2 Unscrew and remove the adjustable tip Step3 Insert a new disposable lancet firmly into the carrier Step4 Twist off and set aside the protective cover of the disposable lancet and replace the adjustable tip Step5 Choose a depth of penetration by rotating the top portion of the adjustable tip until the setting number matches the arrow Step6 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 69 Helpful Tip The skin depth varies for various people at different sample sites The lancing device adjustable tip allows the best depth of skin penetration for
6. Model GM505VAA Within 5 268 516 52 Within 10 461 516 89 Within 15 Within 20 511 516 99 516 516 100 PRECISION The precision studies were performed in a laboratory using CareSens N Mini BGM Systems Within Run Precision e Blood avg 35 mg dL 1 9 mmol L SD 1 9 mg dL 0 1 mmo L e Blood avg 83 mg dL 4 6 mmol L SD 2 3 mg dL 0 1 mmo L e Blood avg 128 mg dL 7 1 mmol L CV 3 5 e Blood avg 288 mg dL 16 0 mmol L CV 3 3 e Blood avg 347 mg dL 19 3 mmol L CV 2 7 Total Precision e Control avg 37 mg dL 2 1 mmol L SD 1 7 mg dL 0 1 mmol L 122 mg dL 6 8 mmol L CV 2 8 394 mg dL 21 9 mmol L CV 3 1 e Control avg e Control avg This Study shows that there could be variation of up to 3 5 Reference 1 American Diabetes Association Standards of Medical Care in Diabetes 2012 Diabetes Care January 2012 35 1 S11 S63 For in vitro diagnostic use Consult instruction for use Manufacturer Temperature limitations Use by unopened or opened test strip vials Batch code Authorized representative CE Mark reg IVDD 98 79 EC Serial number Do not discard this product with other household type waste 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 In
7. TT If your test result is above 600 mi mgt mg dL 33 3 mmol L HI appears on the display A test HI Message result above 600 mg dL 33 3 mmol L indicates hyperglycemia high blood glucose If your test result is below 20 mg dL M 1 1 mmol L Lo will appear on the display Lo Message This indicates hypoglycemia low blood glucose X If a Lo message blinks when the meter is turned on or a test strip is inserted it means the battery needs to be replaced It may also appear when the meter battery seems temporarily discharged due to exposure to cold or low temperature Take the meter to an area where the temperature is within the operating range 10 40 C 50 104 F and repeat the test after the meter and test strips have reached a temperature within the operating range If you get a HI or Lo message repeat the test If the HI or Lo message is displayed again on retesting please contact your healthcare professional immediately If HI or Lo message appear irrespective of your condition contact your authorized i SENS sales representative Normal Blood Glucose Results The range of a normal fasting blood glucose level for non diabetic adults is between 70 99 mg dL 3 9 5 5 mmol L Two 2 hours after a meal the range of a normal blood glucose level for non diabetic adults is between 100 139 mg dL 5 6 7 7 mmol L Fasting is defined as no caloric intake
8. an adequate sample size A beginning setting of three 3 is recommended 02 Using Lancing Device at Fingertip Sample Site Step1 Place the cocked lancing device against the pad of the finger The best puncture sites are on the middle or ring fingers Helpful Tip Choose a different site each time you test Repeated puncturing at the same sample site may cause pain or skin calluses Step2 Press the release button Remove the device from the finger Wait a few seconds for a blood drop to form oS e The lancing device should be used by one individual e 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 5 A 03 Testing Your Blood Glucose Level Step1 Insert a test strip with contact bars facing up into the test strip port Push the strip gently until the meter beeps Then the amp symbol will appear Step2 Use your lancing device to get blood sample A minimum volume of 0 5 microliter is needed to fill the confirmation window actual size of 0 5 UL e After the amp symbol appears on the screen apply the blood sample to the narrow end of the test strip until the meter beeps To avoid infection when drawing a sample use a lancet only one time and e Do not use a lancet that has been used by others e Always use a new sterile lancet e Keep the lancing device clean If the confirmation window is not fi
9. gbert Germany C Gow 2012 i SENS Inc All Rights Reserved
10. he order it was measured and you can view stored results by pushing the button When the button is pushed number 1 will appear on the screen for one second and then the result will be shown This is the most recent test result that is saved in the memory To go on to the second recent result press the button again Now number 2 will appear for one second and the next result will be displayed By repeating this process you can go through to result number 10 which is the oldest data saved in the memory To exit from the memory mode press and hold down the button for about two 2 seconds The meter will turn off 05 Checking the System You may check your meter and test strips using the CareSens Control Solution control A and or B Control Solution Testing Step1 Insert a test strip into the meter s test strip port with the contact bars facing upwards until the meter beeps Be careful not to bend the strip while pushing it in The symbol will be displayed on the screen a Step2 Shake the CareSens Control Solution bottle before each test Remove the cap and squeeze the bottle 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 NOTE The meter may switch off if the control solution drop is not ap
11. ipe bottle tip clean If results continue to fall outside the range printed on the test strip vial the CareSens N Test Strip and Meter may not be working properly If so do not use your system and contact your authorized i SENS sales representative CHEMICAL COMPOSITION e Glucose oxidase 2 7 units e Hexaaminerutheniumi Ill chloride 45 7 ug e Other ingredients 1 6 ug PERFORMANCE CHARACTERISTICS The performance of CareSens N Mini BGM System has been tested in laboratory and clinical studies The testing range of the CareSens N Mini BGM System is 20 600 mg dL 1 1 33 3 mmol L ACCURACY The accuracy of the CareSens N Mini BGM System Model GM505VAA 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 diabetic patients at clinic centers The results were a e Y intercept 1 0053 mg dL 0 0559 mmol L e Correlation coefficient r 0 9864 e Number of Sample e Range tested 33 455 mg dL 1 8333 25 278 mmol L Accuracy results for glucose concentration lt 75 mg dL 4 2 mmol L CareSens N Mini Model GM505VAA Within 5 mg dL Within 0 28 mmol L 71 84 85 Within 10 mg dL Within 0 56 mmol L 84 84 100 Within 15 mg dL Within 0 83 mmol L 84 84 100 Accuracy results for glucose concentration gt 75 mg dL 4 2 mmol L CareSens N Mini
12. lled in time because of abnormally high viscosity or insufficient volume Er4 message will appear n lt X gt A NOTE If the test strip does not take in the blood sample please contact your authorized i SENS sales representative Ea Da Cr mg dL Ll l E amoi Step3 The test result will appear after the meter counts down from 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 automatically switch off after 3 seconds Discard used test strips safely in biohazard containers NOTE The meter may switch off if the blood sample is not applied within 2 minutes of the amp symbol appearing on the screen If the meter turns off remove the strip and reinsert it and apply the blood sample after amp symbol appears on the screen NOTE Results from alternative site and fingertip samples may appear different 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 NOTE If the sample drop of blood runs or spreads due to contact with hair or with a line in your palm do not use that sample Try puncturing again in a smoother area A 04 Viewing Test Results in Meter Memory The meter memory can store up to ten 10 results at one time The results will be saved in t
13. minal standard discharge Step1 To replace the battery make sure that the meter is turned off Turn the meter over press down slightly and push the battery compartment cover in the direction of arrow shown to remove it Step2 Remove the old battery by gently pushing the edge of the battery Insert a new battery and make sure the positive side of the battery is facing up X The meter will not operate if the battery is placed upside down Step3 Place the cover over the battery compartment Push it down until you hear the tab click into place Af Caution There is a risk of explosion if the battery is replaced with an incorrect type Please dispose of the used battery according to your local regulations 09 Please Note The unit of measurement is fixed Caring for the Meter e Do not expose the meter to direct sunlight or heat for an extended period of time e Prevent the entry of dirt dust blood or water at the meter s test strip port e Do not drop the meter or submit it to strong shocks e Do not try to fix or alter the meter in any way e Keep the meter away from strong electromagnetic fields such as cell phones and microwave ovens e Keep the meter in a cool and well ventilated place CareSens N Mini BGM System Components e CareSens N Mini Blood Glucose Meter e CareSens N Blood Glucose Test Strips e Lancing Device e User Manual e Quick Reference Guide e Battery e Lancets e Carrying
14. plied within 2 minutes of the amp symbol appearing on the screen If the meter turns off remove the strip reinsert it Then start from step 1 Step3 A test result will appear after the meter counts down from 5 to 1 ot ot Lv m mg dL gt i aI Aamo aia Step4 Compare the result displayed on the meter to the range printed on the test strip vial The result should amp fall within that range Used strips should be discarded safely in biohazard containers Control Solution Range Control A 101 151 mg dL 5 6 8 4 mmo L Control B 184 276 mg dL 10 3 15 3 mmo L i Caution The range printed on the test strip vial is for the CareSens Control Solution only It does not have any connection to your blood glucose level CareSens Control Solution Storage and Handling For accurate results e Close the control solution bottle tightly and store at a temperature of 8 30 C 46 86 F e Do not refrigerate or freeze e 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 25 C 68 77 F The CareSens Control Solution can be purchased separately Please contact your authorized i SENS sales representative 06 HI and Lo Messages The CareSens N Mini Meter displays test results between 20 to 600 mg dL 1 1 33 3 mmol L and a HI or Lo message outside this range
15. rip in order to maintain airtightness Exposing test strips to humidity for a long period of time can produce incorrect test results even if the test strips are new e Handle test strips only with clean and dry hands e Use the test strip immediately after taking it out of the vial e Do not bend cut or alter the test strips in any way Do not force a test strip into the meter Gently push it into the meter s test strip port e Apply only fresh capillary whole blood for testing e Use all of the test strips within the expiration date printed on the test strip box and vial label e Dispose of test strips past the expiration date immediately because using test strips past their expiration date can produce incorrect test results e Test strips in new unopened vials and test strips in vials that have been opened can be used up until the expiration date printed on the test strip box and vial label if the test strips are used according to its storage and handling methods WARNINGS AND PRECAUTIONS e Keep test strips and test strip vial away from children The test strips and vial cap may be choking hazards Drying agents in the vial cap may be harmful if inhaled or swallowed or may cause skin or eye irritation e Test strips are for single use only Do not reuse e If the test strip does not absorb the blood sample properly please contact your authorized i SENS sales representative Please note that e An abnormally high
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