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2in1 step User Manual

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Blood glucose

monitoring system

for self testing use
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
USER GUIDE
.
".
ENG
SELF-TESTING IVD

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  • Page 1: Blood Glucose

    Blood glucose monitoring system for self testing use 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.
  • Page 2 2in1. STEP for measuring the glucose level in whole blood and steps* anytime. It is also very simple, easy and foolproof. You don’t have to worry about coding your meter because the meter does it 2in1.

  • Page 3: Table Of Contents

    Table of Contents Content of 2in1. STEP Before Starting Name and Function of the Parts Cautions About the STEP meter* Obtaining Blood Drop About Alternate Site Testing Testing Your Blood Glucose Control Solution Testing Reviewing Results Setting the Meter Replacing the Battery...

  • Page 4: Content Of 2In1. Step

    CONTENT of 2in1. STEP 2in1. STEP system includes: meter 2in1. STEP 1 pcs 2. Carrying Case 1 pcs 3. Lancing Device 1 pcs 4. Lithium Battery (CR2032) 1 pcs 5. Neck Strap (Available only with 2in1. STEP 1 pcs Blood glucose test strips 2in1.

  • Page 5: Before Starting

    Before Starting Symbols: Caution, see instructions for use Single use only Expiration 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: Intended Use

    Before Starting Intended Use system is intended for self-testing to monitor glucose 2in1. STEP concentrations in fresh whole blood. system is for use 2in1. STEP outside body (in vitro diagnostic use) in fingertips, forearm, upper arm, hand, thigh and calf testing.

  • Page 7: Name And Function Of The Parts

    ‘M’ button for 3 seconds. Test Strip Port Front View Insert the end of a test strip 2in1. STEP 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.
  • Page 8 Names and Functions of the Parts Strap Hole It is for hand-strap or neck-strap. Side View 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. Back View...
  • Page 9 Names and Functions of the Parts 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 Display units of measure. Clear AST cap * available separately Lancet ejector...

  • Page 10: Cautions

    Cautions Cautions for System is intended for 2in1. STEP System use outside the body (in vitro diagnostic use) only. System is used only for 2in1. STEP measuring fresh capillary whole blood. meter should only be 2in1. STEP used with Test Strip and 2in1.
  • Page 11 Do not throw the battery into fire. Do not disassemble or 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.
  • Page 12 Cautions Cautions for Store the test strip in a cool, dry place Test Strip between 2° and 32°C (36° and 90°F). Keep away from direct sunlight and heat. After removing test strip from the vial, immediately close the vial cap tightly. You may get an inaccurate if vial cap opened long period of time.

  • Page 13: About The Step Meter

    System is your walking partner, along with built-in 2in1. STEP STEP meter and can help you control your diabetes by counting your steps and testing your blood glucose level. We recommend that you place the meter in the upper front pocket of your jacket, in a bag you hold tightly, or wear the meter with neck strap around your neck.
  • Page 14 About the STEP meter The meter may not be able to count the steps correctly in the following cases. When the memory is being displayed, the blood glucose is being tested or the meter is being set. When the front of the meter is placed in the angle of less than 60°...

  • Page 15: Obtaining Blood Drop

    Obtaining Blood Drop STEP 1 Wash your hands carefully with warm water to 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.
  • Page 16 Obtaining Blood Drop STEP 3 While holding the lancet carrier, insert a new sterile 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.
  • Page 17 Obtaining Blood Drop STEP 7 Set the proper depth of penetration by rotating the cap of lancing device. 1-2 for soft or thin skin, 3 for average skin, 4-5 for thick or calloused skin. STEP 8 Place the lancing device in place. Hold the lancing device firmly against the side of the finger, with the cap resting on the finger.

  • Page 18: About Alternate Site Testing

    About Alternate Site Testing lets you obtain a blood sample from your upper arm, 2in1. STEP forearm, hand, thigh or calf. Obtaining 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.
  • Page 19 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 insulin pump bolus or within two hours after a meal. If you are testing for hypoglycemia (low blood glucose) or if you suffer from hypoglycemia unawareness.

  • Page 20: Testing Your Blood Glucose

    Testing Your Blood Glucose STEP 1 Hold the test strip with the silver end facing up. Insert the silver end into the test strip port on the meter. Insert a new test strip into the meter until it stops. The meter will turn STEP 2 Time will be displayed for a moment.
  • Page 21 Testing Your Blood Glucose STEP 4 Bring tip of the test strip to lightly touch the drop of blood. Hold until the Meter beeps. Blood is automatically pulled into the test strip. Important: The volume of blood sample must be at least 0.5 microliter (real size ”.“).
  • Page 22 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 with your steps* from last blood glucose test.
  • Page 23 Testing Your Blood Glucose Unexpected results If your test result is below 50mg/dL (2.8mmol/L), above 250mg/dL (13.9mmol/L), or you see “LOW” or “HIGH” on the mterer display, call your physician or healthcare professional immediately. If you continue to get unexpected results, check your system with control solution.

  • Page 24: Control Solution Testing

    Control Solution Testing control solution contains a known amount of glucose 2in1. STEP and is used to check that the meter and the test strips are working properly. Control solution is available separately. Control solution is not included and is not contained in the starter kit of meter or strips package.
  • Page 25 Control Solution Testing STEP 3 Make sure the code number showed on the screen is the same as the code number printed on the test strip vial. If the code number on the screen is different from the code number printed on the strip vial, try to insert new strip.
  • Page 26 Control Solution Testing STEP 6 The test result is complete when you hear beeps. Your control solution test result is shown on the display screen. STEP 7 Compare the result displayed on the meter Control Test Range to the control solution range printed on the 0.6-33.3 mmol/dL...

  • Page 27: Reviewing Results

    STEP meter mode. 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.
  • Page 28 If there is no result, the meter will display “- - -”. The meter will display time, date and the result alternatively after no pressing ‘M’ button for 3 seconds. STEP 3* Press and release the ‘M’ button. The counts of steps between previous and next glucose results will be displayed.
  • Page 29 Reviewing Results STEP 5 (To review average) To review your 7-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.

  • Page 30: Setting The Meter

    Setting the Meter STEP 1 When the meter is off, remove the battery cover. STEP 2 Then press the ‘SET’ button located in the battery compartment. The meter is now in the setting mode. You can start setting up the meter.
  • Page 31 Setting the Meter STEP 5 With the month flashing, press the ‘M’ button until the correct month appears. Press the ‘SET’ button to move to the day setting. STEP 6 With the day flashing, press the ‘M’ button until the correct day appears. Press the ‘SET’...
  • Page 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: Replacing The Battery

    Replacing the Battery STEP 1 Prepare the 3V lithium battery (CR2032) for replacement. Press firmly on the battery cover and slide in the direction of the arrow. STEP 2 Remove the old battery and place the new one in the tray with the “+” side facing up.

  • Page 34: Error Messages

    Error Messages Appears when environmental temperature is BELOW 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. Appears when environmental temperature is ABOVE system operation range. System operation range is 10~40°C (50~104°F).
  • Page 35 Error Messages This error message indicates the test strip may be inserted incorrectly or there is a problem. Repeat to remove and re-insert the test strip or repeat the test with a new test strip. This error message indicates the meter has a problem.

  • Page 36: Troubleshooting

    Troubleshooting Meter does not enter the test mode after inserting a test strip. Probable cause What to do The battery is dead. Replace the battery. The battery is installed Check that the battery is installed incorrectly or there is no correctly with the positive (+) sign battery in the meter.

  • Page 37: Performance Characteristics

    Characteristics Clinical accuracy The accuracy of the System was assessed by comparing 2in1. STEP blood glucose results obtained by patients with those obtained using a YSI 2300 Glucose Analyzer. System accuracy result for glucose concentra ons < 75 mg/dL (4.2 mmol/L) 2in1.
  • Page 38 Performance Characteristics Within run precision (100 venous blood tests per glucose level) 2in1. STEP System Standard deviation Coefficient of variation Mean glucose (mg/dL) 41 mg/dL (2,3 mmol/L) 102 mg/dL (5,7 mmol/L) 147 mg/dL (8,2 mmol/L) 237 mg/dL (13,2 mmol/L) 394 mg/dL (21,9 mmol/L) Total precision (100 control solution tests per glucose level) 2in1.

  • Page 39: System Care And Maintenance

    System Care and Maintenance Your System does not need any special maintenance. 2in1. STEP Storing your system Store your meter, strips and control solution in your carrying case after each use. Store each item in a cool, dry place below 32°C (90°F), but do not refrigerate.

  • Page 40: Cleaning Your Meter

    System Care and Maintenance Cleaning your meter To clean your meter, wipe the outside with a soft cloth dampened with water and mild detergent. Do not use alcohol or another solvent to clean your meter. Do not get any liquids, dirt, dust, blood, or control solution inside the meter through the test port.

  • Page 41: Specifications

    Specifi cations Model (2in1. STEP PG-201 Blood Glucose Monitoring System) Test Method Electrochemical sensor Calibration Method Plasma Sample Whole blood, capillary Sample Size 0.5 μL Test Time 5 seconds Memory 2in1. STEP 500 Blood glucose tests and steps Result Range...
  • Page 42 IEC 61326. Warranty VPD, Bled, d.o.o. warrants that your will be free of 2in1. STEP 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 STEP...
  • Page 44 VPD, Bled, d.o.o. Pot na Lisice 4, 4260 Bled Slovenia, EU tel.: +386 4 574 50 70 fax: +386 4 574 50 71 email: info@3in1.si web: www.3in1.si EDITION DATE AND LAST REVISION DATE: PRINTED IN 2IN1STEP_ED2013_5_REV02_E‐SL SLOVENIA...

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