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User's Guide
Thank you for purchasing the Gmate™
System.
Please read this User's Guide carefully
before using to ensure correct use.
Please keep this User's Guide for your
future reference.

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Summary of Contents for philosys gmate step

  • Page 1 User's Guide Thank you for purchasing the Gmate™ System. Please read this User's Guide carefully before using to ensure correct use. Please keep this User's Guide for your future reference.
  • Page 2 Gmate™ 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 Gmate™ meter does it automatically.
  • Page 3: Table Of Contents

    Table of Contents About Gmate™ System Before Starting Name and Function of the Parts Cautions About the Pedometer 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 Performance Characteristics...
  • Page 4: About Gmate System

    About Gmate System Gmate™ System includes:...
  • 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: Test Principle

    If you have received a Gmate™ meter with the glucose unit different from the method you use to measure your glucose levels, do not perform any tests, and contact your local Philosys distributor for assistance .
  • Page 7: Name And Function Of The Parts

    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 2 seconds.
  • 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 set- up mode for changing the date and time. 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 *Clear AST cap is an optional accessory.
  • Page 10: Cautions

    Cautions Cautions for The Gmate™ System is intended for use System outside the body(in vitro diagnostic use) only. The Gmate™ System is used only for measuring fresh capillary whole blood. The Gmate™ meter should only be used with Gmate™ Test Strip and Gmate™ Control Solution.
  • Page 11 Cautions Cautions for Keep the meter out of reach of young Meter children. If a young 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.
  • 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 the inaccurate result if vial cap opened long period of time.
  • Page 13: About The Pedometer

    About the Pedometer Gmate™ STEP System is your walking partner, along with built-in pedometer 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 Pedometer 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 The Gmate™ Meter 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 Gmate™...
  • 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 electrode end facing up. Insert the electrode 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.
  • 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" "). STEP 5 The Meter will now show counting progress during 5 seconds.
  • Page 22 Testing Your Blood Glucose Caution : 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.
  • 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 meter 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 Gmate™ 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. 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...
  • Page 25 Control Solution Testing STEP 3 Make sure the code number showed on the screen is 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 in the strip vial, try to insert new strip. STEP 4 Shake the control solution vial and remove the cap.
  • 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 to the control solution range printed on the test strip vial.
  • Page 27: Reviewing Results

    Reviewing Results STEP 1(To enter pedometer 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.
  • Page 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 step 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 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.
  • 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' button to move to the hour setting.
  • Page 32 Setting the Meter STEP 9 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. Caution : Dispose of battery according to your local environmental regulations.
  • 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 have 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 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 correctly with incorrectly or there is no battery the positive(+) sign facing upward.
  • Page 37: Performance Characteristics

    Performance Characteristics Clinical accuracy The Gmate™ System is calibrated to yield results equivalent to plasma glucose concentrations and is traceable to a NIST standard. The accuracy of the Gmate™mini System was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI 2300 Glucose Analyzer.
  • Page 38 Performance Characteristics Within run precision(100 venous blood tests per glucose level) Gmate STEP System Standard Coefficient of Mean glucose deviation variation(%) 41 mg/dL(2.3 mmol/L) 1.2mg/dL(0.07mmol/L) 102 mg/dL(5.7 mmol/L) 2.8mg/dL(0.16mmol/L) 147 mg/dL(8.2 mmol/L) 2.9mg/dL(0.16mmol/L) 237 mg/dL(13.2 mmol/L) 4.3mg/dL(0.24mmol/L) 394 mg/dL(21.9 mmol/L) 9.9mg/dL(0.55mmol/L) Total precision(100 control solution tests per glucose level) Gmate...
  • Page 39: Caring For System

    Caring for System Your Gmate™ 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 from direct sunlight and heat.
  • Page 40 Caring for System 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

    Specifications Model PG-201 (Gmate™ STEP Blood Glucose Monitoring System) Electrochemical sensor Test Method Plasma-equivalent Calibration Method Sample Whole blood, capillary Sample Size 0.5 μL Test Time 5 seconds Memory 500 Blood glucose tests and steps Result Range 10 ~ 600 mg/dL(0.6~33.3 mmol/L) Maximum Step 99,999 steps Hematocrit...
  • Page 42 IEC 61326. Warranty Philosys warrants that your Gmate™ meter 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...
  • Page 44 Obelis SA philosys Co., Ltd. Boulevard Général 827-3, Sangpyeong-ri, Wahis 53 1030 Okgu-eup, Gunsan-si, Brussels, Belgium Jeollabuk-do, Korea Tel +32 2 732-59-54 Tel +82-63-453-1421 Fax +32 2 732-60-03 Fax 82-63-453-1423 Email mail@obelis.net Email help@gmate.biz 0202R8 Rev. Date 2014-12 Printed in Korea...

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