i-SENS CareSens N Premier User Manual Download Page 8

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Specifications

Product specifications

Measurement range

20–600 mg/dL (1.1–33.3 mmol/L)

Sample size

Minimum 0.5 μL

Test time

5 seconds

Sample type

Fresh capillary whole blood

Calibration

Plasma-equivalent

Assay method

Electrochemical

Battery life

1,000 tests

Power

Two 3.0 V lithium batteries

(disposable, type CR2032)

Memory

1,000 test results

Size

103 x 54 x 17 mm

Weight

71.7 g (with batteries)

Bluetooth

technology

•

Frequency range: 2.4–2.4835 GHz

•

Operating range distance:

maximum 10 meters (unobstructed)

•

Operating channels: 40 channels

•

Security encryption: 128-bit AES

(Advanced Encryption Standard)

Summary of Contents for CareSens N Premier

Page 1: ...ed PGL4E1005 REV4 2021 11 i SENS Inc 43 Banpo daero 28 gil Seocho gu Seoul 06646 Korea www i sens com Medical Technology Promedt Consulting GmbH Altenhofstrasse 80 66386 St Ingbert Germany User Manual...

Page 2: ...The CareSens N Premier Meter is designed to work with the SmartLog mobile app When using the CareSens N Premier System we suggest you pair your CareSens N Premier Meter with your smartphone and track...

Page 3: ...r 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 so...

Page 4: ......

Page 5: ...e Control Solution Test Results 34 Testing Using the Lancing Device 35 Preparing the Lancing Device 36 Preparing the Meter and Test Strip 38 Applying Blood Sample 39 Discarding Used Lancets 43 Alterna...

Page 6: ...in vitro diagnostic use only CareSens N Premier Blood Glucose Monitoring System should not be used for the diagnosis of diabetes or for testing newborns Testing sites include the traditional fingerti...

Page 7: ...ow red blood cell count hematocrit level over 65 or below 15 may produce inaccurate results If your test result is below 60 mg dL 3 3 mmol L or above 240 mg dL 13 3 mmol L consult a healthcare profess...

Page 8: ...sma equivalent Assay method Electrochemical Battery life 1 000 tests Power Two 3 0 V lithium batteries disposable type CR2032 Memory 1 000 test results Size 103 x 54 x 17 mm Weight 71 7 g with batteri...

Page 9: ...rating ranges Temperature 5 50 C Relative humidity 10 90 Hematocrit 15 65 Storage transport conditions Temperature Meter with batteries 0 50 C Test strip 1 30 C Control solution 8 30 C Relative humidi...

Page 10: ...CareSens N Premier Blood Glucose Monitoring System may include the following items CareSens N Blood Glucose Test Strips Lancets Lancing Device Logbook Carrying Case Check all the components after open...

Page 11: ...is in use the batteries should be replaced as soon as possible The test results may not be saved if the batteries run out Step 1 Make sure the meter is turned off Push the cover in the direction of th...

Page 12: ...lace the cover on the battery compartment Push it down until you hear the tab click into place Note Removing the meter batteries will not affect your stored results However you may need to reset your...

Page 13: ...ort Do not drop the meter or submit it to strong shock Do not try to fix or alter the meter in any way Strong electromagnetic radiation may interfere with the proper operation of this device Keep the...

Page 14: ...away you should follow existing policies and procedures of your own country or region For information about correct disposal please contact your local council or authority If you need assistance cont...

Page 15: ...strip Insert Contact bars Gently push the test strip with its contact bars facing up into the test strip port of meter Confirmation window Check here to see whether sufficient blood sample has been ap...

Page 16: ...vial Close the vial tightly after taking out a test strip for testing and use the strip immediately Avoid getting any liquid or moisture in the test strip vial This can affect the test strips and caus...

Page 17: ...to discard the used strips Button Turns the meter on selects or changes information Test Strip Port Insert test strip here Data Port Used to transfer data from the meter to a computer with a cable No...

Page 18: ...set 3 Bluetooth symbol indicates that Blutooth is turned on 4 Mute symbol appears only when the sound is set to OFF 5 Control Solution flag appears when the control solution test results are saved or...

Page 19: ...ne after fasting for at least 8 hours Blood insertion symbol indicates meter is ready for the application of a drop of blood or control solution Month Day Hour Minute appears date and time Note It is...

Page 20: ...Press and hold the button for 3 seconds to enter SET mode After all the segments flash across the screen SET will show up Press the or button to select YES and press the button to go to the next step...

Page 21: ...mode 2 Press the or button The meter screen will display OFF On and PAIr in turn To pair your meter with your smartphone press the button when PAIr blinks on the screen Note The symbol will appear on...

Page 22: ...w the on screen instructions on SmartLogTM mobile app to begin searching your meter Some content or menus may differ depending on your smartphone s operating system or SmartLogTM version 3 Look for Ca...

Page 23: ...test results will be transferred to your smartphone 7 When the data transfer is finished the meter will display End on the screen Press the button to go to Step 10 Sound Setting mode See page 26 If th...

Page 24: ...ur 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 button to confirm...

Page 25: ...displayed in the 24 hour format After selecting the format press the button to go to the next step Step 8 Setting the Hour Press the or button until the correct hour appears After the hour is set pre...

Page 26: ...the test strip is inserted 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...

Page 27: ...n press the or button The screen will display On or OFF Press the button to confirm the setting If you do not want to set the indicator press the button while the screen displays OFF Note If the pre s...

Page 28: ...ll display On or OFF Press the button when On appears to enter the setting Press the or button until the desired hypoglycemia level between 20 and 90 mg dL 1 1 5 0 mmol L appears Then press the button...

Page 29: ...ip expiration date is printed on the test strip vial Step 2 Setting the Year A number indicating the year will blink in the left corner of the screen Press the or button until the correct year appears...

Page 30: ...vial of test strips you may conduct a control solution test following the procedure on pages 31 33 Note Use only the CareSens Control Solution available for purchase separately Check the expiration d...

Page 31: ...test results and you feel that the meter or test strips are not working properly If you drop or damage the meter Control Solution Testing Step 1 Insert a test strip into the meter s test strip port wi...

Page 32: ...ply 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 sample is not appli...

Page 33: ...ol Solution Range Control A XX XX mg dL X X X X mmol L Control B XX XX mg dL X X X X mmol L Caution The range printed on the test strip vial is for the CareSens Control Solution only It has nothing to...

Page 34: ...n was not discarded or the tip of the bottle was not wiped clean When the meter is not functioning properly Repeat the control solution test by referring to the Note on page 30 When the control soluti...

Page 35: ...Lancet The lancing device is for use by a single user only and should not be shared with anyone Use a soft cloth or tissue to wipe the lancing device If necessary a small amount of alcohol on a soft c...

Page 36: ...ith soap and warm water Rinse and dry thoroughly Step 2 Unscrew and remove the lancing device tip Step 3 Firmly insert a new lancet into the lancet holder Hold the lancet firmly Gently twist to pull o...

Page 37: ...deeper puncture Choose a depth by rotating the top portion of the adjustable tip until the desired number aligns with the arrow 1 2 3 4 5 6 7 Note 1 a shallow puncture for softer skin 7 a deeper punc...

Page 38: ...ustable tip allows the best depth of skin penetration to get an adequate sample size Preparing the Meter and Test Strip Step 7 Insert a test strip with the contact bars facing upwards into the meter s...

Page 39: ...orm A minimum volume of 0 5 microliter is needed to fill the confirmation window actual size of 0 5 L Step 9 After the symbol appears on the screen apply the blood sample to the narrow end of the test...

Page 40: ...ter into the meter 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...

Page 41: ...d the meter will automatically switch off after 3 seconds Discard used test strips safely in disposable containers If the Bluetooth feature is activated the meter will send the test result to the conn...

Page 42: ...the or button to select a pre meal flag a post meal flag a fasting flag or a control solution flag When you remove the test strip while the desired flag is blinking the test result is stored with the...

Page 43: ...tip Step 2 Stick the lancet into the saved protective disk Push the lancet ejector forward with the thumb to dispose of the used lancet in a proper biohazard container Caution The lancet is for singl...

Page 44: ...not be simple for everyone and the following precautions should be observed during testing Alternate Sites for Testing Alternate Site Blood Sampling forearm and palm Select a clean soft and fleshy sam...

Page 45: ...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 S...

Page 46: ...ot 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 fingertip samples may differ...

Page 47: ...is displayed again upon retesting please contact your healthcare professional immediately Lo Message Lo appears when a test result is less than 20 mg dL 1 1 mmol L and indicates severe hypoglycemia ve...

Page 48: ...m and 4 a m Expected Values Normal blood glucose levels for an adult without diabetes are below 100 mg dL 5 5 mmol L before meals and fasting and are less than 140 mg dL 7 8 mmol L two hours after me...

Page 49: ...omputer using SmartLog software and cable The meter screen displays Pc when it is connected to the computer using the data cable For more information contact your authorised i SENS sales representativ...

Page 50: ...asting test results from the last 1 7 14 30 and 90 days Viewing Averages Stored in Memory Step 1 Press the or button to turn the meter on The current date and time will be displayed at the bottom of t...

Page 51: ...ep 4 Viewing Post meal Averages Press the button to view 1 7 14 30 and 90 day average values and the number of tests performed post meals with the symbol for the last test period button button Post me...

Page 52: ...s com Step 6 Use the button to scroll back through the averages seen previously Press the button to turn off the meter Note The control solution test results saved with the symbol are not included in...

Page 53: ...ithin the current day The number of tests within the current day Step 2 Use the button to scroll through the test results starting from the most recent and ending with the oldest Press the button to r...

Page 54: ...ng the Post meal Alarm PP2 alarm Step 1 Turning the PP2 alarm On Without inserting a test strip press and hold the button for 3 seconds to set the post meal alarm PP2 bell symbol and On will be displa...

Page 55: ...mory recall mode without bell symbol displayed disappears Setting the Time Alarms alarm 1 3 Step 1 Without inserting a test strip press the and buttons simultaneously for 3 seconds to enter the time a...

Page 56: ...button to set the hour Step 4 On pressing the button the number indicating the minute will start blinking Press the button to set the minute Step 5 Press the button to finish and to go to alarm 2 sett...

Page 57: ...the symbol appears 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 oper...

Page 58: ...o not use the meter Contact your authorised i SENS sales representative There is a problem with Bluetooth communication Contact your authorised i SENS sales representative An electronic error occurred...

Page 59: ...ether the batteries are inserted with the side facing up Replace the batteries The test does not start even after applying the blood sample on the strip Check if the confirmation window is filled comp...

Page 60: ...odel 2300 Glucose Analyzer a laboratory instrument The following results were obtained by diabetic patients at clinic centers Slope 1 0041 Y intercept 1 93 mg dL 0 1 mmol L Correlation coefficient r 0...

Page 61: ...d Within 15 600 600 100 0 Precision The precision studies were performed in a laboratory using CareSens N Premier Blood Glucose Monitoring Systems Within Run Precision Blood average 42 mg dL 2 3 mmol...

Page 62: ...dL 6 7 mmol L CV 3 4 355 mg dL 19 7 mmol L CV 4 4 This study shows that there could be variation of up to 4 4 Influence Quantities Packed Cell Volume Hematocrit Packed cell volume evaluation was cond...

Page 63: ...nces shown below may cause inaccurate blood glucose results No Interferent Concentration 1 Acetaminophen paracetamol 20 mg dL 2 Ascorbic acid 3 mg dL 3 Bilirubin 20 mg dL 4 Ceftriazone 81 mg dL 5 Chol...

Page 64: ...mg dL 25 Triglycerides 3000 mg dL 26 Uric acid 20 mg dL 27 Xylose 25 mg dL User Performance Evaluation A study evaluating glucose values from fingertip capillary blood samples obtained by 100 lay per...

Page 65: ...er 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 t...

Page 66: ...66 www i sens com MEMO...

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