2in1 step, User Manual

Page 1: ...ting use SELF TESTING IVD ENG USER GUIDE Thank you for purchasing the 2in1 STEP Please read this User Guide carefully before using to ensure correct use Please keep this User s Guide for your future reference indicates Available only in 2in1 STEP ...

Page 2: ...ersons with use in the home and in clinical settings It should not be used for the diagnosis of diabetes or the testing of newborn Features 1 2 3 4 5 6 2in1 STEP has only one button to navigate all functions easily with simple operation It is small size stylish design and ease of use allows you to take it everywhere It can show all information variously It requires very small volume 0 5uL and disp...

Page 3: ...ternate Site Testing Testing Your Blood Glucose Control Solution Testing Reviewing Results Setting the Meter Replacing the Battery Error Messages Troubleshooting Performance Characteristics System Care and Maintenance Specifications 48 49 51 54 57 59 62 64 68 71 74 77 78 80 81 83 85 Available only in 2in1 STEP Table of Contents ...

Page 4: ...y with 2in1 STEP 1 pcs 6 2in1 STEP Blood glucose test strips 10 pcs 7 Lancets 10 pcs The address and related CE marks of lancets manufacturer and the address of lancing device manufacturer are mentioned on the outside box of starter kit packaging Lancets and lancing device are covered by Medical Device Directive MDD Documents in your system include USER GUIDE and QUICK GUIDE ...

Page 5: ...ation date Serial number Lot number In Vitro Diagnostic medical device Manufacturer Authorised representative Symbol for temperature limitation Consult instructions for use Biological risks Contains sufficient for n tests Direct current Separate disposal from other household waste ...

Page 6: ...eagents on the strip This current changes with the amount of glucose in the blood sample The glucose concentration in the sample is calculated based on the electrical current and displayed on the meter Setting the time and date Your 2in1 STEP meter comes preset time date year and measure unit Before using your meter for the first time or if you change the meter battery you should check and set the...

Page 7: ...e You can turn the meter off by pressing and holding the M button for 3 seconds Test Strip Port Insert the end of a 2in1 STEP test strip here The meter will turn on when you insert the test strip Silver Electrodes The end of the test strip is inserted into the test strip port of the meter with the silver end facing up Sample Tip The end of the test strip where the blood sample is drawn into Front ...

Page 8: ...s of the Parts Strap Hole It is for hand strap or neck strap Battery Cover Slide cover off to replace batteries SET Button Used to enter the setup mode for changing the date and time and unit of measure Side View Back View ...

Page 9: ...ing barrel Adjustable cap Lancet holder Release button Display Lancing Device Displays the mode of meter Warns when the battery is low or must be replaced Display test results steps measuring status error messages and other informations Results are displayed along with the units of measure ...

Page 10: ... the 2in1 STEP System for the diagnosis of diabetes testing on newborns and testing of arterial blood The 2in1 STEP System contains small parts that may be dangerous if swallowed Check the package before starting the measurement Be sure to read user guide and the test strip insert found in the test strip box carefully before testing Do not make any decision of medical relevance without first consu...

Page 11: ...modify the meter Do not subject the meter to severe shock drop or step on meter The meter is not waterproof Do not wash it or touch it with wet hands Do not wipe the meter with thinner or abrasive cleaners Avoid the meter being exposed to high temperature high humidity rain and or dust when using or storing the meter Do not test glucose instantly when the meter is moved to a place with a great dif...

Page 12: ...est strip against your finger This may affect inaccurate aspiration of blood Do not use a test strip that appears damaged or has been used Test strips are for single use only Store test strips in their original vial After you take a test strip out of the vial be sure to use it within three minutes Always use test strips within 3 months 90 days after first opening With clean dry hands you may touch...

Page 13: ...r the meter with neck strap around your neck Place the meter in your pocket Do not place the meter in the back pocket of your pants Place the meter in the pocket you hold tightly Place the meter in your bag Place the meter in your pocket or the partition of your bag Wear the meter with neck strap around your neck Use the supplied neck strap and place the meter near your chest Important The meter c...

Page 14: ...he meter is placed in the bag that moves irregularly because it hits your foot your belt or the top of your pants When the unit hangs from your belt the top of your pants or a bag When you walk at an inconsistent pace When you use the meter in the place where lots of up and down movements or vibrations take place When you walk extremely slowly The meter may not be able to count the steps correctly...

Page 15: ...o increase the circulation of the blood into the fingers Dry hands thoroughly until the finger to be pricked is completely dry STEP 2 Unscrew the cap of the lancing device by turning it counter clockwise while holding the base firmly Obtaining Blood Drop ...

Page 16: ...rile lancet into the bottom of lancet carrier STEP 4 Twist the cap of the lancet off STEP 5 Put the cap of the lancing device back on and turn it clockwise STEP 6 Hold the tip firmly in one hand then pull out the sliding barrel with the other hand This will cock the lancing device ...

Page 17: ...ng device firmly against the side of the finger with the cap resting on the finger The harder it is pressed the deeper the puncture Press the release button to take a sample Caution To reduce the chance of infection Make sure to wash the puncture site with soap and water before sampling Do not share a lancet or a lancing device with anyone Always use a new lancet lancets are for single use only Ke...

Page 18: ...ing a drop of blood from these alternate site testing may be less painful than a fingertip sample Following figure shows the areas where you can test with the 2in1 STEP System Avoid moles veins bones and tendons Consult to your healthcare professional before using alternate site testing Upper Arm Forearm Hand Fingertips Thigh Calf ...

Page 19: ...release button to take a sample Watch through the clear cap until a sufficient blood sample is taken If there is not enough blood gently massage the area until a sufficient sample has been collected About Alternate Site Testing Caution Do not test on alternate sites When you think your blood glucose level is changing rapidly such as within two hours of exercise a rapid acting insulin injection or ...

Page 20: ... on STEP 2 Time will be displayed for a moment Then Code number and strip symbol will be displayed A strip symbol with filling blood will appear letting you know the meter is ready to test STEP 3 Make sure the code number showed on the screen is the same as the code number printed in the test strip vial If the code number on the screen is different from the code number printed on the strip vial tr...

Page 21: ...eter beeps Blood is automatically pulled into the test strip STEP 5 The Meter will now show counting progress of 5 seconds STEP 6 The test result is complete when you hear beeps Your blood glucose test result is shown on the display screen Important The volume of blood sample must be at least 0 5 microliter real size ...

Page 22: ...your area Be sure to follow your local regulations for proper disposal If your test is above 600 mg dL 33 3 mmol L HIGH will appear on the display screen If your test result is lower than 10 mg dL 0 6 mmol L LOW will appear on the display screen STEP 7 To turn your Meter off simply remove the used test strip The Meter turns off automatically Your test result will automatically be stored in memory ...

Page 23: ...xpected results check your system with control solution See Control Solution Testing page 24 Range of expected results Blood glucose levels will vary depending on food intake medication dosages health stress or exercise Consult your healthcare professional for the target value that is appropriate for you Expected blood glucose levels for people without diabetes Fasting Less than 100 mg dL 5 6 mmol...

Page 24: ...ress VPD Bled Pot na Lisice 4 SI 4260 Bled Slovenia Customer Service Tel 386 457 45 070 Do a control solution test to practice the test process instead of using blood whenever you open a new vial of test strips if you suspect the meter or the test strips are not working properly if you have had repeated unexpected blood glucose results or if your meter is damaged Control Solution Testing STEP 1 Ho...

Page 25: ...p vial If the code number on the screen is different from the code number printed on the strip vial try to insert new strip STEP 4 Shake the control solution vial and remove the cap Gently touch a drop of control solution to the tip of the test strip Hold until the meter beeps STEP 5 The meter will now show counting progress of 5 seconds ...

Page 26: ...ontrol solution test STEP 8 To turn your meter off remove the used test strip Control Test Range 0 6 33 3 mmol dL not following the instructions on this USER GUIDE expired contaminated or watered down control solution expired or damaged test strip control solution test done outside 20 C to 25 C 68 F to 77 F or a problem with the meter Out of range results may be caused by If you continue to get co...

Page 27: ...of your step STEP 2 To enter review mode In the STEP meter mode Press and hold the M button The number of last glucose result will be displayed Release the M button The last glucose result will be displayed Important The meter s display will not change or display steps until after you have walked more than 5 steps The number of your step is reset to zero at every midnight or when pressing SET butt...

Page 28: ...TEP 3 Press and release the M button The counts of steps between previous and next glucose results will be displayed STEP 4 Press and hold the M button The number of next glucose result will be displayed Release the M button The next glucose result will be displayed Each time you press and release the M button the meter will display the next result up to the last 500 test results ...

Page 29: ... day average shake the meter slowly in the review mode The meter will display 7 day average and 7DAY alternatively Shaking the meter again allows you to scroll forward to 14 and 30 day averages with beep Continue to press the M button to view stored test results STEP 6 The Meter is off if you press and hold M button for 2 seconds ...

Page 30: ...w in the setting mode You can start setting up the meter STEP 3 The year will appear first with the year flashing Press the M button until the correct year appears Press the SET button to move to the date format setting STEP 4 With m d or d m flashing press the M button to select month day or day month format Press the SET button to move to the month setting ...

Page 31: ...tton until the correct day appears Press the SET button to move to the hour setting STEP 7 With the hour flashing press the M button until the correct hour appears The meter displays only the 24 hour time format Press the SET button to move to the minute setting STEP 8 With the minute flashing press the M button until the correct minute appears Press the SET button to move to the unit setting ...

Page 32: ...32 Setting the Meter STEP 9 With the unit flashing press the M button to select mg dL or mmol L Press the SET button to complete meter set up and turn off the meter ...

Page 33: ...place the new one in the tray with the side facing up STEP 3 Slide the battery cover back into place and close firmly Caution Dispose of battery according to your local environmental regulations Important If you do not replace the new battery within one minute of taking the old one out you have to reset the date and time Removing the battery does not affect the meter s memory or user settings ...

Page 34: ...st after the meter and test strip have reached the above temperature range Appears when environmental temperature is ABOVE system operation range System operation range is 10 40 C 50 104 F Repeat the test after the meter and test strip have reached the above temperature range Appear when inserting a used test strip Re test with a new test strip ...

Page 35: ...with a new test strip This error message indicates the meter has a problem Review the instructions and re test with a new test strip If this message appears again contact the local dealer Battery is low but you can still perform a few tests Replace the battery as soon as possible Battery is too low to perform a test Replace the battery immediately Error Messages ...

Page 36: ...nted side up and the silver end of the strip into the test strip port on the meter Defective meter or test strips Contact your local distributor Blood or foreign objects put into the test strip port Contact your local distributor Test does not start after applying the blood sample Probable cause What to do Blood sample is too small Repeat the test with a new test strip and a larger blood sample De...

Page 37: ...a ons 75 mg dL 4 2 mmol L System accuracy result for glucose concentra ons 75 mg dL 4 2 mmol L Regression sta s cs 2in1 STEP System within 5 mg dL 0 28 mmol L 87 26 30 within 10 mg dL 0 56 mmol L 100 30 30 within 15 mg dL 0 83 mmol L 100 30 30 2in1 STEP System within 5 63 107 170 within 10 95 162 170 within 15 99 169 170 within 20 100 170 170 2in1 STEP System Slope 0 9955 Intercept 1 9843 mg dL R2...

Page 38: ... mg dL 13 2 mmol L 4 3 1 8 394 mg dL 21 9 mmol L 9 9 2 5 2in1 STEP System Mean glucose Standard deviation mg dL Coefficient of variation 40 mg dL 2 2 mmol L 0 8 2 1 106 mg dL 5 9 mmol L 2 5 2 4 322 mg dL 17 9 mmol L 7 8 2 4 Performance Characteristics Within run precision 100 venous blood tests per glucose level Total precision 100 control solution tests per glucose level ...

Page 39: ...ginal vial Checking for expiration to strips and control solution Test strips and control solution have expiration dates printed on their vials When you first open a test strip or control solution vial you must record the opening date in the space provided on the label Use all test strips within 3 months after the first opening Caution Do not use the strips or control solution after the expiration...

Page 40: ...olvent to clean your meter Do not get any liquids dirt dust blood or control solution inside the meter through the test port Cleaning your lancing device and clear AST cap Clean and wipe the outside of the lancing device with a soft cloth dampened with mild soap and water Wash the adjustable cap and clear AST cap with mild soap Do not immerse the lancing device in any liquid ...

Page 41: ...e Size Weight PG 201 2in1 STEP Blood Glucose Monitoring System Electrochemical sensor Plasma Whole blood capillary 0 5 μL 5 seconds 2in1 STEP 500 Blood glucose tests and steps 10 600 mg dL 0 6 33 3 mmol L 99 999 steps available only in 2in1 STEP 20 60 10 40 C 10 90 Up to 3 048 meters 10 000 feets One CR2032 3 volt lithium battery replaceable 36 7mm x 61 7mm x 15 8mm 1 44 x 2 43 x 0 62 30g 1 06oz ...

Page 42: ... frequency interference at the frequency range and test levels specified in IEC 61000 4 3 The meter has been tested for electromagnetic emissions specified in IEC 61326 Warranty VPD Bled d o o warrants that your 2in1 STEP will be free of defects in materials and workmanship for 5 years valid from the date of purchase The warranty extends only to the original purchaser and is not transferable ...

Page 43: ...GLUCOSE 2in1 STEP ...

Page 44: ...ED IN SLOVENIA EDITION DATE AND LAST REVISION DATE 2IN1STEP_ED2013_5_REV02_E SL VPD Bled d o o Pot na Lisice 4 4260 Bled Slovenia EU tel fax email web 386 4 574 50 70 386 4 574 50 71 info 3in1 si www 3in1 si ...