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  5. User Manual

2in1 step User Manual

Summary of step

  • Page 1

    Blood glucose monitoring system for self testing 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. S...

  • Page 2: Features

    2in1. Step system is very easy to carry around and able to be used 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 2in1. Step meter does it automatically. The system should be u...

  • Page 3

    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 error messages troubleshooting performan...

  • Page 4: 2In1.Step System Includes:

    4 content of 2in1. Step 2in1.Step system includes: 1. 2in1. Step meter 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 6. 2in1. Step blood glucose test strips 10 pcs 7. Lancets 10 pcs the address and related...

  • Page 5: Symbols:

    5 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 test...

  • Page 6: Intended Use

    6 before starting intended use 2in1. Step system is intended for self-testing to monitor glucose concentrations in fresh whole blood. 2in1. Step system is for use outside body (in vitro diagnostic use) in fingertips, forearm, upper arm, hand, thigh and calf testing. Test principle the 2in1. Step sys...

  • Page 7: Display Screen

    7 names and functions of the parts display screen this is where you read your test results, steps and other informations. M-button the ‘m’ button is used to recall the stored results and adjust the parameters in set-up mode. You can turn the meter off by pressing and holding the ‘m’ button for 3 sec...

  • Page 8: Strap Hole

    8 names and functions 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: Clear Ast Cap

    9 names and functions of the parts clear ast cap * available separately lancet ejector sliding 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, erro...

  • Page 10: Cautions For

    10 cautions the 2in1. Step system is intended for use outside the body (in vitro diagnostic use) only. The 2in1. Step system is used only for measuring fresh capillary whole blood. The 2in1. Step meter should only be used with 2in1. Step test strip and 2in1. Step control solution. Do not use the 2in...

  • Page 11: Cautions For

    11 cautions keep the meter out of reach of children. If a child swallows battery, battery cover, immediately consult with a doctor. Do not swing the meter by holding the neckstrap. You may injure yourself or other people. Do not throw the battery into fire. Do not disassemble or modify the meter. Do...

  • Page 12: Cautions For

    12 cautions store the test strip in a cool, dry place 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. Do not drop the blood ...

  • Page 13: Place The Meter In Your Bag

    13 *available only with 2in1. Step about the step meter* the 2in1. Step system is your walking partner, along with built-in 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 o...

  • Page 14

    14 about the step meter 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° or horizontally to the ground. When the meter is placed in the bag that moves irregularly because it hits your ...

  • Page 15: Step 1

    15 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. Obtaining ...

  • Page 16: Step 3

    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. Step 6 hold the tip firmly in one hand then pull out the sli...

  • Page 17: Step 7

    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 ...

  • Page 18

    18 about alternate site testing the 2in1. Step lets you obtain a blood sample from your upper arm, 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 2in...

  • Page 19

    19 obtaining a blood sample from alternate sites is different than getting a sample from fingertips. After inserting a new sterile lancet into the bottom of lancet carrier, put the clear ast cap to the lancing device. Place the lancing device on the skin at the chosen site, press and hold the lancin...

  • Page 20: Step 1

    20 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 on. Step 2 time will be displayed for a moment. Then code number and strip s...

  • Page 21: Step 4

    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. Step 5 the meter will now show counting progress of 5 seconds. Step 6 the test result is complete when you hear beeps. Y...

  • Page 22: Step 7

    22 testing your blood glucose caution: important: the meter turns off automatically after one minute of no use. When this happens, test results are still saved in memory. Caution: used test strips and lancets may be considered biohazardous waste in your area. Be sure to follow your local regulations...

  • Page 23: Unexpected Results

    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 w...

  • Page 24: Step 1

    24 2in1. Step control solution contains a known amount of glucose 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. Control solut...

  • Page 25: Step 3

    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. Step 4 shake the control solution vi...

  • Page 26: Step 6

    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 to the control solution range printed on the test strip vial. If the results you get are not within t...

  • Page 27: Step 1

    27 reviewing results step 1 (to enter step meter mode)* with the meter off, press and release the ‘m’ button on the meter. The number of your steps will be displayed. If you attach the meter properly, the meter will start to count the number of your step. Step 2 (to enter review mode) in the step me...

  • Page 28: Step 3*

    28 reviewing results important: 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 wi...

  • Page 29: Step 5 (To Review Average)

    29 reviewing results important: your average result does not contain control test result. 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 fo...

  • Page 30: Step 1

    30 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. Step 3 the year will appear first, with the year flashing. Press the ‘m’ butto...

  • Page 31: Step 5

    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’ button to move to the hour setting. Step 7 w...

  • Page 32: Step 9

    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: Step 1

    33 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. Step 3 slide the battery cover back into pl...

  • Page 34

    34 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. Sys...

  • Page 35

    35 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. Review the instructions and re-test with a new test strip. I...

  • Page 36: Probable Cause

    36 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 incorrectly or there is no battery in the meter. Check that the battery is installed correctly with the positive (+) sign f...

  • Page 37: Clinical Accuracy

    37 performance characteristics clinical accuracy the accuracy of the 2in1. Step system was assessed by comparing blood glucose results obtained by patients with those obtained using a ysi 2300 glucose analyzer. System accuracy result for glucose concentra ons system accuracy result for glucose conce...

  • Page 38

    38 2in1. Step system mean glucose standard deviation (mg/dl) coefficient of variation (%) 41 mg/dl (2,3 mmol/l) 1.2 3.0 102 mg/dl (5,7 mmol/l) 2.8 2.7 147 mg/dl (8,2 mmol/l) 2.9 2.0 237 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/...

  • Page 39: Storing Your System

    39 system care and maintenance your 2in1. Step system does not need any special maintenance. 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. Keep all items away fro...

  • Page 40: Cleaning Your Meter

    40 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 te...

  • Page 41

    41 specifi cations model test method calibration method sample sample size test time memory result range maximum step hematocrit operating temperature operating relative humidity altitude power source size weight pg-201 ( 2in1. Step blood glucose monitoring system) electrochemical sensor plasma whol...

  • Page 42: Warranty

    42 specifi cations electrical and safety standards the meter has been tested for immunity to electrostatic discharge as specified in iec 61000-4-2. The meter has been tested for immunity to radio frequency interference at the frequency range and test levels specified in iec 61000-4-3. The meter has ...

  • Page 43: Glucose

    Glucose 2 in 1. Step.

  • Page 44

    Printed 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.