i-SENS CARESENS DUAL, User Manual

Page 1: ...Symbols GDH FAD Visit the webpage below to see supported devices download app scan the QR code for easy access www i sens com smartlog Medical Technology Promedt Consulting GmbH Altenhofstrasse 80 663...

Page 2: ...r is designed to work with the SmartLog mobile app When using the CareSens Dual System we suggest you pair your CareSens Dual Meter with your smartphone and track your results The process of creating...

Page 3: ...er license All other trademarks and trade names are those of their respective owners WARNING Turn off the Bluetooth feature in areas where the use of wireless devices is restricted such as hospitals s...

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Page 5: ...he Hyperglycemia HI Indicator 28 Setting the Strip Expiration Date Indicator 29 Checking the System 30 Control Solution Testing 32 Comparing the Control Solution Test Results 34 Testing Using the Lanc...

Page 6: ...as an aid to monitor the effectiveness of diabetes management The system is for self testing or healthcare professional use and should not be used for the diagnosis of or screening for diabetes or for...

Page 7: ...w 15 for blood glucose and hematocrit level over 60 or below 20 for blood ketone may produce inaccurate results If your blood glucose test result is below 60 mg dL 3 3 mmol L or above 240 mg dL 13 3 m...

Page 8: ...uetooth Frequency range 2 4 2 4835 GHz technology Operating range distance maximum 10 metres unobstructed Operating channels 40 channels Security encryption 128 bit AES Advanced Encryption Standard Fo...

Page 9: ...8 seconds Sample type Fresh capillary whole blood Fresh venous whole blood healthcare professionals only Temperature 10 40 C Hematocrit 20 60 Storage and transport conditions Temperature Meter with ba...

Page 10: ...the following items CareSens PRO Blood Glucose Test Strips KetoSens Blood Ketone Test Strips Lancets Lancing Device Batteries Logbook Carrying Case Check all the components after opening the CareSens...

Page 11: ...m Step 1 Make sure the meter is turned off Push the cover in the direction of the arrow to open the battery compartment Step 2 Remove the used batteries one at a time Slip your index finger under the...

Page 12: ...strong shock Do not try to fix or alter the meter in any way Store all the meter components in the carrying case to prevent loss and help keep the meter clean Avoid getting any liquid or moisture in...

Page 13: ...s EDTA and Heparin are acceptable Iodoacetate or fluoride oxalate should not be used CareSens PRO Blood Glucose Test Strip The CareSens Dual Blood Glucose Monitoring System measures blood glucose quic...

Page 14: ...direct sunlight or heat and do not freeze Store test strips only in their original vial Close the vial tightly after taking out a test strip for testing and use the strip immediately Avoid getting an...

Page 15: ...It automatically absorbs the small blood sample applied to the narrow edge of the strip Contact bars Gently push the test strip with its contact bars facing up into the test strip port of meter Confi...

Page 16: ...90 relative humidity Do not freeze Keep test strips away from direct sunlight or heat and do not freeze Store test strips only in their original box Open the foil test strip packet to take out a test...

Page 17: ...d by the user CareSens Dual Blood Glucose Blood Ketone Meter Display Shows results and messages S Button Turns the meter on off confirms menu selections and changes information Data Port Used to trans...

Page 18: ...rs when the blood glucose measuring unit is set to mmol L mmol L mg dL unit for blood glucose or blood ketone alarm appears when the time alarm has been set Pre meal test flag used for tests done befo...

Page 19: ...w up Press the or button to select YES and press the S button to go to the next step Step 2 Bluetooth Pairing 1 If you do not want to connect your meter to your smartphone press the S button when the...

Page 20: ...your smartphone press the S button when PAIr blinks on the screen Note The symbol will appear on the screen when the Bluetooth feature is on When the symbol is not present on the screen the Bluetooth...

Page 21: ...ber on the SmartLog mobile app screen to correctly identify your meter Touch your meter s ID CareSens XXXX on the SmartLog mobile app screen 4 The meter will display six digit PIN number 5 Enter the P...

Page 22: ...ill display End on the screen Press the S button to go to Step 10 Sound Setting mode See page 25 If the meter displays FAIL and then OFF repeat steps 2 to 5 Note Some smartphones especially those that...

Page 23: ...selection and to go to the next step Step 5 Setting the Month A number indicating the month will blink on the screen Press the or button until the correct month appears Press the S button to confirm...

Page 24: ...our Press the or button until the correct hour appears After the hour is set press the S button to go to the next step Step 7 Setting the Time Format The meter can be set in the AM PM 12 hour or the 2...

Page 25: ...erted in the meter When the blood sample is absorbed into the test strip and the test starts When the test result is displayed When you press and hold the button to set the post meal PP2 alert When it...

Page 26: ...OFF Press the S button to confirm the setting If you do not want to set the indicator press the S button while the screen displays OFF Turning on the Strip Expiration Date Indicator Note If the pre se...

Page 27: ...hen On appears to enter the setting Press the or button until the desired hypoglycemia level between 10 90 mg dL 0 6 5 0 mmol L appears Press the S button to confirm the hypoglycemia level and to go t...

Page 28: ...Press the or button until the desired hyperglycemia level between 120 349 mg dL 6 7 19 4 mmol L appears Press and hold the S button to confirm the hyperglycemia level and turn the meter off Setting t...

Page 29: ...orner of the screen Press the or button until the correct year appears Press the S button to confirm the year and set the month Note The strip expiration date indicator functions only when CareSens PR...

Page 30: ...ou may conduct a control solution test following the procedure on pages 32 33 You may check your meter and KetoSens test strips using the KetoSens Control Solutions control L and or M The KetoSens Con...

Page 31: ...the control solution shake the bottle discard the first few drops and wipe the tip clean Close the control solution bottle tightly and store at a temperature between 8 30 C You may do a control soluti...

Page 32: ...re the confirmation window fills completely Step 2 Activating Control Solution Test Mode Press and hold the button for 3 seconds to activate the Control Solution Test Mode This will also flag the cont...

Page 33: ...verages 2 0 3 8 mmol L CareSens PRO Control Solution Range Control L XX XX mg dL X X X X mmol L Control H XX XX mg dL X X X X mmol L Note The meter may switch off if the control solution sample is not...

Page 34: ...en the control solutions are not used with their corresponding test strips When the control solution bottle was not shaken well When the meter test strip or the control solution were exposed to high o...

Page 35: ...test Using the Lancing Device You will need a lancing device in order to collect a blood sample You may use the lancing device that is included in the CareSens Dual System or any other medically appr...

Page 36: ...g device tip Step 3 Firmly insert a new lancet into the lancet holder Hold the lancet firmly Gently twist to pull off protective disk Save disk to recap lancet after use Replace lancing device tip Ste...

Page 37: ...ill vary for various people at different sample sites The lancing device s adjustable tip allows the best depth of skin penetration to get an adequate sample size Step 5 The lancing device has six pun...

Page 38: ...ul not to bend the test strip The symbol will appear on the screen When you insert KetoSens test strip the meter shows KETONE on the screen Preparing the Meter and Test Strip Check your ketone When yo...

Page 39: ...e to the narrow end of the test strip till the meter beeps If the confirmation window is not filled in time because of abnormal viscosity thickness and stickiness or insufficient volume the Er4 messag...

Page 40: ...er The meter may be damaged or may malfunction Follow the warning information provided below to prevent possible damage to the meter Do not apply the blood sample directly to the test strip port Do no...

Page 41: ...results from 8 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 second...

Page 42: ...ag If you do not want to add any flags on the test result remove the strip after the test result is displayed When you test your blood ketone there is no need to attach any flag Note To transmit gluco...

Page 43: ...ncet into the saved protective disk Push the lancet ejector forward with the thumb to dispose of the used lancet in a proper biohazard container Discarding Used Lancets Caution The lancet is for singl...

Page 44: ...r everyone and you should not use AST for your blood ketone test The following precautions should be observed during testing Alternate Sites for Testing Alternate Site Blood Sampling forearm and palm...

Page 45: ...o factors such as lifestyle and ingested food which affect glucose levels Note Acceptable Situations for AST When your blood glucose levels are stable Fasting period Before a meal Before going to bed...

Page 46: ...are professional Do not rely on the AST results for changing your treatment method The amount of glucose in alternate sites differs from person to person Note Results from alternate sites and fingerti...

Page 47: ...than 8 0 mmol L If HI is displayed again upon retesting please contact your healthcare professional immediately Lo Message Lo appears when a blood glucose test result is less than 10 mg dL 0 6 mmol L...

Page 48: ...loric intake for at least eight hours Reference American Diabetes Association Standards of Medical Care in Diabetes 2021 Diabetes Care January 2021 vol 44 Supplement 1 S15 S33 Transferring Test Result...

Page 49: ...emory is full the oldest test result will be deleted and the latest test result will be stored The meter only calculates and displays the averages of blood glucose test results by total test results p...

Page 50: ...view 1 7 14 30 60 and 90 day average values and the number of tests performed pre meals with the symbol for the last test period Step 4 Viewing Post meal Averages Press the button to view 1 7 14 30 60...

Page 51: ...m 51 Step 6 Use the button to scroll back through the averages seen previously Press the S button to turn off the meter Note The control solution test results saved with the symbol are not included in...

Page 52: ...2 Use the button to scroll through the test results starting from the most recent and ending with the oldest Press the button to return to the results seen previously After checking the stored test r...

Page 53: ...ally change to the memory recall mode At this time bell symbol indicating that the PP2 alert has been set will be displayed on the screen Setting the Alarm Function Four types of alarms can be set in...

Page 54: ...le OFF blinks on the screen Step 2 On pressing the button alarm 1 is set and On is displayed on the screen Press the button again to cancel alarm 1 OFF will blink on the screen Step 3 Press the button...

Page 55: ...he minute will start blinking Press the button to set the minute Step 5 Press the S button to finish and to go to alarm 2 mode Repeat steps 2 to 4 to set the remaining time alarms alarm 2 3 Step 6 Pre...

Page 56: ...ars before applying the blood or control solution 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 for...

Page 57: ...Sens test strip Repeat the test with a CareSens PRO or KetoSens test strip There is a problem with the meter Do not use the meter Contact your authorised i SENS sales representative There is a problem...

Page 58: ...if the confirmation window is filled completely Repeat the test after inserting a new test strip Repeat the test after inserting a new test strip Check the expiration or discard date of the test strip...

Page 59: ...l 2300 Glucose Analyzer a laboratory instrument The following results were obtained by diabetic patients at clinic centers Within 5 Within 10 Within 15 264 396 66 7 379 396 95 7 395 396 99 7 136 204 6...

Page 60: ...there could be variation of up to 4 2 Within 15 mg dL Within 0 83 mmol L and Within 15 598 600 99 7 System accuracy results for glucose concentrations between 46 2 mg dL 2 6 mmol L and 526 mg dL 29 2...

Page 61: ...sing the CareSens Dual Blood Ketone Monitoring Systems This study shows that there could be a variation of up to 4 4 Slope 1 012 Y intercept 0 0223 mmol L Correlation coefficient r 0 996 Number of sub...

Page 62: ...dL 1 32 mmol L 2 Ascorbic acid 3 mg dL 0 17 mmol L 3 D L arabinose 18 mg dL 1 20 mmol L 4 Bilirubin 20 mg dL 0 34 mmo L 5 Cholesterol 500 mg dL 12 93 mmol L 6 Creatinine 30 mg dL 2 65 mmol L 7 Dopami...

Page 63: ...rferent Concentration 19 L Dopa L 3 4 dihydroxyphenylalanine 5 mg dL 0 25 mmol L 20 Maltose 1000 mg dL 29 21 mmol L 21 Maltotriose 240 mg dL 4 76 mmol L 22 Maltotetraose 120 mg dL 1 80 mmo L 23 Mannos...

Page 64: ...toacetate 10 mg dL 0 98 mmol L 3 Acetone 60 mg dL 10 33 mmol L 4 Ascorbic acid 3 mg dL 0 17 mmol L 5 Bilirubin unconjugated 20 mg dL 0 34 mmol L 6 Captopril 10 mg dL 0 46 mmol L 7 Cholesterol 500 mg d...

Page 65: ...0 mg dL 33 87 mmol L 26 Uric acid 20 mg dL 1 19 mmol L 27 Xylose 25 mg dL 1 67 mmol L User Performance Evaluation Glucose A study evaluating glucose values from fingertip capillary blood samples obtai...

Page 66: ...handling tampering use or service of the meter Any claim must be made within the warranty period i SENS will at its discretion repair or replace a defective meter or meter part that is covered by this...