i-SENS CareSens N Premier Manual Download Page 3

6

   www.i-sens.com

www.i-sens.com 

7

Important Information: Read This First!

For optimum safety and benefits, please read the entire manual 

contents before using the system. 

Intended use:

CareSens N Premier Blood Glucose Monitoring System is 

used for the quantitative measurement of the glucose level 

in capillary whole blood as an aid in monitoring diabetes 

management effectively at home or in clinical settings. 

CareSens N Premier Blood Glucose Monitoring System 

should be used only for self-testing outside the body (

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 fingertip testing along with alternate site testing 

on forearm and palm.

t (MVDPTFJOCMPPETBNQMFTSFBDUTXJUIUIFDIFNJDBMJOUIF

test strip to produce a small electrical current. The CareSens 

N Premier meter detects this electrical current and measures 

the amount of glucose in the blood sample.

t 5IF$BSF4FOT/1SFNJFSCMPPEHMVDPTFNFUFSJTEFTJHOFE

to minimise code related errors in monitoring by using the 

no-coding function.

t 5IF$BSF4FOT/1SFNJFSCMPPEHMVDPTFNFUFSTIPVMECF

used only with the CareSens N Test Strips.

t "OBCOPSNBMMZIJHIPSMPXSFECMPPEDFMMDPVOU IFNBUPDSJU

level over 65% or below 15%) may produce inaccurate 

results.

t *GZPVSUFTUSFTVMUJTCFMPXNHE- NNPM-PSBCPWF

240 mg/dL (13.3 mmol/L), consult a healthcare professional 

immediately.

t *OBDDVSBUFSFTVMUTNBZPDDVSJOTFWFSFMZIZQPUFOTJWF

individuals or patients in shock. Inaccurate low results 

may occur for individuals experiencing a hyperglycemic- 

hyperosmolar state, with or without ketosis. Critically ill 

patients should not be tested with blood glucose meters.

t *OBDDVSBUFSFTVMUTNBZPDDVSJOQBUJFOUTVOEFSHPJOHPYZHFO

therapy.

If you need assistance, please contact your authorised i-SENS  

sales representative or visit www.i-sens.com for more information.

For 

in vitro

 diagnostic use 

Authorised representative

This product fulfills the requirements for Directive 98/79/EC 

on 

in vitro

 diagnostic medical devices

Cautions for safety and optimum product use
Use by (unopened or opened test strip vial)
Do not discard this product with other household-type 

waste 
Do not reuse 

Batch code

Consult instructions for use 

Manufacturer

Temperature limitation 

Serial number

Meaning of Symbols Used: 

 

Summary of Contents for CareSens N Premier

Page 1: ...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...

Page 2: ...he Strip Expiration Date Indicator 25 Checking the System 26 Control Solution Testing 27 Comparing the Control Solution Test Results 30 Testing Using the Lancing Device 31 Preparing the Lancing Device...

Page 3: ...ors in monitoring by using the no coding function t 5IF BSF4FOT 1SFNJFS CMPPE HMVDPTF NFUFS TIPVME CF used only with the CareSens N Test Strips t O BCOPSNBMMZ IJHI PS MPX SFE CMPPE DFMM DPVOU IFNBUPDS...

Page 4: ...logy t Operating range distance maximum 10 meters unobstructed t Operating channels 40 channels t Security encryption 128 bit AES Advanced encryption standard Temperature 5 50 C 41 122 F Relative humi...

Page 5: ...o place Caring for Your System Use a soft cloth or tissue to wipe the meter exterior If necessary dip the soft cloth or tissue in a small amount of alcohol Do not use organic solvents such as benzene...

Page 6: ...U TUSJQ GPS UFTUJOH BOE use the strip immediately t BOEMF UFTU TUSJQT POMZ XJUI DMFBO BOE ESZ IBOET t P OPU CFOE DVU PS BMUFS UFTU TUSJQT JO BOZ XBZ t PS EFUBJMFE TUPSBHF BOE VTBHF JOGPSNBUJPO SFGFS U...

Page 7: ...al test flag used for tests done after eating Fasting test flag used for tests done after fasting for at least 8 hours Month Day Hour Minute 10 12 7 8 9 11 13 14 15 1 2 3 5 4 6 7 11 10 9 15 12 13 14 N...

Page 8: ...our smartphone The devices must be within 10 metres of each other to pair and synchronise Before pairing your meter and smartphone download and install the SmartLog mobile app on your smartphone Step...

Page 9: ...splays FAIL and then OFF repeat steps 2 to 5 4 The meter will show six digit PIN number 5 Enter the PIN number into the SmartLog mobile app and touch OK Make sure the PIN you enter on your smartphone...

Page 10: ...T OPU EJTQMBZFE JO UIF IPVS format After selecting the format press the S button to go to the next step Adjusting the Date and Time Step 4 Setting the Year Press the or button to adjust until the corr...

Page 11: ...fter the test If the expiration date is set to October of 2017 the meter will display EP at the start of November 2017 Step 10 On pressing the or button the screen will display On or OFF Press the S b...

Page 12: ...ng press and hold the S button for 3 seconds to turn off the meter Step 12 This mode allows you to turn the hypoglycemia indicator possible low blood sugar On or OFF and to select the desired level fo...

Page 13: ...drops and wipe the tip clean t MPTF UIF DPOUSPM TPMVUJPO CPUUMF UJHIUMZ BOE TUPSF BU B temperature between 8 30 C 46 86 F Press and hold Checking the System You may check your meter and test strips us...

Page 14: ...276 mg dL 10 2 15 3 mmol L Note The CareSens Control Solution can be purchased separately Please contact your authorised i SENS sales representative Step 3 Shake the bottle before each test Remove the...

Page 15: ...Results The test result of each control solution should be within the range printed on the label of the test strip vial Repeat the control solution test if the test result falls outside of the range O...

Page 16: ...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 Note 1 least penetration of lancet into...

Page 17: ...and stickiness or insufficient volume the Er4 message may appear Good Sample Insufficient Sample Step 8 Obtain a blood sample using the lancing device Place the device against the pad of the finger T...

Page 18: ...the meter must be turned On t The meter and a smartphone must be paired t The SmartLog mobile app must be launched The meter will transmit data in the following cases t When the strip is ejected afte...

Page 19: ...ree of visible veins and hair and away from bones Gently massage the sample site to help blood circulation to minimise result differences between fingertip and alternate site sampling Firmly press and...

Page 20: ...toms t G UIF TBNQMF ESPQ PG CMPPE SVOT PS TQSFBET EVF UP DPOUBDU with hair or with a line in your palm do not use that sample Try puncturing again in a smoother area Things to KnowWhen Using AST Pleas...

Page 21: ...screendisplays Pc whenitisconnectedtothecomputerusingthedata cable Formoreinformation contactyourauthorised i SENSsalesrepresentativeorvisitwww i sens com Note Test results can also be transferred wir...

Page 22: ...30 90days Fasting average 1 7 14 30 90days Meter Memory Step 1 Press the or S button to turn the meter on The current date and time will be displayed at the bottom of the screen followed by the 1 day...

Page 23: ...m the most recent and ending with the oldest Press the button to return to the result seen previously After checking the stored test results hold the S button to turn off the meter Thenumberoftests wi...

Page 24: ...e button for 3 seconds PP2 bell symbol and OFF will appear on the screen Then the screen will change automatically to the memory recall mode without bell symbol displayed Four types of alarms can be s...

Page 25: ...larm1 OFF will blink on the screen Step 3 Pres the button to adjust the time of alarm1 A number representing the hour will blink on the screen Press the button to set the hour Setting the Time Alarms...

Page 26: ...ithin the operating range 5 50 C and repeat the test after the meter and test strips have reached a temperature within the operating range This error message may appear when the wrong blood glucose te...

Page 27: ...please contact your authorised i SENS sales representative Performance Characteristics The performance of CareSens N Premier Blood Glucose Monitoring System has been evaluated in laboratory and in cl...

Page 28: ...t of glucose concentration Difference Averages NO Interferent 1 Acetaminophen 2 3 mg dL 0 1 mmo L 3 3 2 Ascorbic acid 7 3 mg dL 0 4 mmol L 0 9 3 Bilirubin unconjugated 0 1 mg dL 0 01 mmol L 1 4 4 Ceft...

Page 29: ...he medical laboratory values at glucose concentrations below 100 mg dL 5 55 mmol L and 98 9 within 15 of the medical laboratory values at glucose concentrations at or above 100 mg dL 5 55 mmol L Warra...

Page 30: ...60 www i sens com MEMO...

Reviews: