Gima OGM-211 User Manual
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Gima OGM-211 User Manual

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Summary of Contents for Gima OGM-211

  • Page 2 Self monitoring of blood glucose (SMBG) is an integral part of diabetes care, but the high cost of testing can make this impossible. At GIMA, our goal is to provide high quality glucose monitoring at a price that allows you to test as often as necessary.

  • Page 3: Table Of Contents

    Viewing Stored Records ................32 Clearing the Memory .................34 Transferring Records.................34 Maintenance .......................36 Replacing the Battery ................36 Caring for Your GIMA Blood Glucose Monitoring System ......37 Suggested Testing Times and Target Goals............38 Comparing Meter and Laboratory Results ............39 Troubleshooting Guide ..................40 Specifications ....................42 Warranty ......................43...

  • Page 4: Getting Started

    Getting Started Before testing, read the instructions carefully and learn about all the components of your GIMA Blood Glucose Monitoring System. Depending on the GIMA product you purchased, some of the components may need to be purchased separately. Please check the list of contents on the outer box for details on which components are included with your purchase.

  • Page 5: Component Descriptions

    Control Solution 0 and Control Solution 2 are available. The three levels of control solution, CTRL 0, CTRL 1 and CTRL 2 are available in the GIMA Glucose Control Solution package which is sold separately. 7. Carrying Case: Provides portability for blood glucose testing wherever you go.

  • Page 6: Gima Blood Glucose Meter

    GIMA Blood Glucose Meter The meter reads the test strips and displays the blood glucose concentration. Use these diagrams to become familiar with all the parts of your meter. Strip Port Strip Ejector Liquid Crystal Display (LCD) ▲ Button ▼ Button...
  • Page 7 Strip Port: Test strips are inserted into this area to perform a test. Strip Ejector: Slide the ejector forward to discard the used test strip. Note: Dispose of blood samples and materials carefully. Treat all blood samples as if they are infectious materials. Follow proper precautions and obey all local regulations when disposing of blood samples and materials.

  • Page 8: Meter Display

    Meter Display Battery Symbol Date Hour Minutes Blood Drop / Control Solution Strip Symbol Symbol Test Result Area Before Meal Symbol After Meal Symbol Pound Sign (#) Measurement Unit Memory Hyper Symbol Ketone Test Remind Symbol Hypo Symbol Battery Symbol: Warns when you should replace the battery. Control Solution Symbol: Indicates a control test result.
  • Page 9 your healthcare professional about testing for ketones. Note: This symbol does not mean that the system has detected ketones. It recommends that a ketone test should be taken. Meter Use and Precautions  Wait for the Blood Drop and Strip Symbol to appear together before applying the sample.

  • Page 10: Gima Blood Glucose Test Strips

    GIMA Blood Glucose Test Strips The GIMA Blood Glucose Test Strips are thin strips with a chemical reagent which work with the GIMA Blood Glucose Meter to measure the glucose concentration in whole blood. After the strip is inserted into the meter, blood is applied to the sample tip of the test strip.
  • Page 11 Storage and Handling Please review the following storage and handling instructions:  Store test strips in a cool, dry place at 2 - 35 °C (36 - 95 °F). Store them away from heat and direct sunlight.  Do not freeze or refrigerate. ...

  • Page 12: Gima Glucose Control Solution

    GIMA Glucose Control Solution The GIMA Glucose Control Solution contains a known concentration of glucose. It is used to confirm that your GIMA Blood Glucose Meter and test strips are working together properly and that you are performing the test correctly. It is important to run a quality control test regularly to make sure you are getting correct results.
  • Page 13 Storage and Handling Please review the following storage and handling instructions:  Store the control solution at 2 - 35 °C (36 - 95 °F).  Do not refrigerate or freeze.  If the control solution is cold, do not use until it has warmed to room temperature.

  • Page 14: Installing The Battery

    Installing the Battery Batteries may not be preinstalled in the meter. Two CR 2032 3.0 V coin cell batteries are required. Please find the batteries in your carrying case and install them according to the following steps: Turn over the meter to locate the battery cover. Slide the battery cover in the direction of the arrow to open it.

  • Page 15: Meter Setup Before Testing

    Meter Setup Before Testing Before using your meter for the first time, you will need to adjust the settings that are listed in detail below. 1. Meter Setup Mode: Press the ▲ button for 2 seconds to enter the meter setup mode.
  • Page 16 Year Month Date 5. Time: The hour will appear at the top of the display. Adjust the hour with the ▼ or ▲ button until the correct hour is displayed. Press the OK button to save your choice and set the minutes. Press the ▼ or ▲ button to change to the correct minute.
  • Page 17 Press the ▼ or ▲ button to switch between turning the meal marker “On” and “Off”. Press the OK button to confirm your selection. 7. Audio Feature: The meter comes with the meter audio feature enabled. The meter will give one short beep when it is turned on, after sample detection and when the result is ready.
  • Page 18 Note: The meter allows the hyperglycemia level to be as low as 6.7 mmol/L (120 mg/dL) or higher. The hyperglycemia level should be above the hypoglycemia level. Consult your diabetes healthcare professional before determining what your hyper blood glucose level is. 10.
  • Page 19 to confirm the first Test Reminder time and then go to the second Test Reminder set up.  When the Test Reminder is “Off” during the second Test Reminder set up, pressing the OK button will go to the set up of the third Test Reminder. When the Test Reminder is “On”, pressing the OK button will go to the set up of the time for the second Test Reminder.
  • Page 20 alarm has a distinct beep sound that is different from other meter sounds like meal markers and test reminders. You can start setting up an alarm by pressing ▼ and OK buttons together when the meter is off. After pressing▼ and OK buttons, the interface with default 120 min and a clock icon with on/off status will appear on the screen.
  • Page 21 The alarm will beep at the minute mark set by you. You can always go back and change the alarm time if needed after setting up the alarm. To do so, press ▼ and OK buttons together and the post prandial alarm interface will appear and display the time remaining.

  • Page 22: Performing A Quality Control Test

    Performing a Quality Control Test The quality control test confirms that the test strips and meter are working together properly, and that you are performing the test correctly. It is important to perform this test:  Before you first use your meter. ...
  • Page 23 4. Shake the control solution bottle well, then squeeze it gently and discard the first drop. If the tip clogs, tap the tip gently on a clean, hard surface. Then shake again and use. Squeeze out a second small drop on a clean nonabsorbent surface.
  • Page 24 If you cannot fix the problem, contact your local distributor for help. Please contact your local distributor for information on ordering the GIMA Glucose Control Solution kit, which contains Control Solution 0, Control Solution 1 and...

  • Page 25: Testing Your Blood

    Step 1 – Getting a Drop of Blood The GIMA Blood Glucose Monitoring System requires a very small drop of blood which may be obtained from the fingertip, palm (at base of the thumb) or forearm.
  • Page 26 2. Hold the lancet firmly in the lancing device and twist the safety tab of the lancet until it loosens. Then pull the safety tab off the lancet. Save the safety tab for lancet disposal. 3. Carefully screw the cover back onto the lancing device. Avoid contact with the exposed needle.
  • Page 27 6. Prior to testing, clean your hands with an alcohol wipe or wash your hands with soap. Use warm water to increase blood flow in your fingers if necessary. Then dry your hands thoroughly. Massage the hand from the wrist up to the fingertip a few times to encourage blood flow.
  • Page 28 samples that you should know. Important Information about forearm and palm glucose testing:  You should consult your healthcare professional before choosing to perform forearm or palm testing.  When blood levels are changing rapidly such as after a meal, insulin dose or exercise, blood from the fingertips may show these changes more rapidly than blood from other areas.
  • Page 29 Disposal of the Lancet 1. Unscrew the lancing device cover. Place the safety tab of the lancet on a hard surface. Then carefully insert the lancet needle into the safety tab. 2. Press the release button to make sure that the lancet is in the extended position.

  • Page 30: Step 2 - Testing Blood Glucose

    Step 2 – Testing Blood Glucose Note: Insertion of a new test strip at any time, except while in the data transfer mode (detailed on page 34) will cause the meter to automatically enter the test mode. 1. Insert a test strip into the strip port, contact bars end first and facing up, to turn on the meter and display all the display segments.
  • Page 31 blood within 3 seconds. DO NOT:  Apply sample to the front or back of the test strip.  Smear the blood drop onto the test strip.  Press your finger against the test strip. 4. The meter will count down from 5 to 1 and then display the measurement results.
  • Page 32  Press the ▼or▲ button again to display the pound sign (#), indicating an invalid result.  Press the ▼or▲ button again then none of the above markers will be displayed for the result. After deciding the selection, press the OK to confirm the selection as either “before meal marker”, “after meal marker”, “invalid result”...

  • Page 33: Hi" And "Lo" Messages

    Note: Dispose of blood samples and materials carefully. Treat all blood samples as if they are infectious materials. Follow proper precautions and obey all local regulations when disposing of blood samples and materials. “HI” and “LO” Messages The meter can accurately measure blood glucose concentrations between 0.6 to 33.3 mmol/L (10 to 600 mg/dL).

  • Page 34: Ketone" Message

    If “Hyper” appears on the display, the measured concentration value is above the “Hyper” (high blood sugar) target level that you have set. “Ketone” Message If “Ketone?” appears on the display, the measured concentration value is above 16.7 mmol/L (300 mg/dL). This simply suggests that a ketone test is recommended.

  • Page 35: Using The Meter Memory

    Using the Meter Memory The meter automatically stores up to 1000 test records. Each record includes the test result, time and date. If there are already 1000 records in memory, the oldest record will be erased to make room for a new one. The meter will also calculate the average values of records from the last 7, 14, 30, 60 and 90 days.
  • Page 36 5. While in data average mode:  If the meal marker feature is off, press the ▲ button to switch between the general 7, 14, 30, 60 and 90-day averages.  If the meal marker feature is on, press the ▲ button to switch between the general, pre-meal and post-meal 7, 14, 30, 60 and 90-day averages.

  • Page 37: Clearing The Memory

    The meter can transfer stored information to a Windows-based personal computer (PC) using an optional data transfer cable and software package. To make use of this feature, you need the GIMA Diabetes Management Software and a data transfer cable from GIMA.
  • Page 38  When meter is in “PC” mode, meter does not turn to waiting for sample application mode after strip is inserted into meter. 3. Run the GIMA Diabetes Management Software, and refer to the instructions from the software for how to transfer records.

  • Page 39: Maintenance

    Maintenance Proper maintenance is recommended for best results. Replacing the Battery Your GIMA Meter uses two 3.0 Volt CR 2032 lithium batteries. When the battery icon ( ) is blinking, it means the battery is running low. You should replace the battery as soon as possible. An “E-6” error message will appear if the battery is too low to perform any more blood glucose tests.

  • Page 40: Caring For Your Gima Blood Glucose Monitoring System

    Caring for Your GIMA Blood Glucose Monitoring System Blood Glucose Meter Your GIMA Blood Glucose Meter does not require special maintenance or cleaning. A cloth dampened with water and a mild detergent solution can be used to wipe the outside of the meter. Take care to avoid getting liquids, dirt, blood or control solution into the meter through the strip or data ports.

  • Page 41: Suggested Testing Times And Target Goals

    Suggested Testing Times and Target Goals Tracking your blood glucose concentration through frequent testing is an important part of proper diabetes care. Your healthcare professional will help you to decide the normal target range for your glucose levels. They will also help you to determine when and how often to test your blood glucose.

  • Page 42: Comparing Meter And Laboratory Results

    The meter results can be affected by factors and conditions that do not affect laboratory results in the same way. See GIMA Test Strip package insert for typical accuracy and precision data, and for important information on Limitations.

  • Page 43: Troubleshooting Guide

    Troubleshooting Guide The meter has built-in messages to alert you of problems. When error messages appear, note the error number, turn off the meter and then follow these instructions. Display Causes Solution Battery may be damaged or Replace battery. not be charged Meter fails to If meter has been exposed to or stored turn on...
  • Page 44 There is an error in transferring data to the PC. See the package insert included Communications failure in the GIMA Diabetes Management Software for troubleshooting. Repeat the test and apply enough sample to fill the test strip check window within 3 seconds.

  • Page 45: Specifications

    Specifications Feature Specification Meter Model Number OGM-211 Measurement Range 0.6 - 33.3 mmol/L (10 – 600 mg/dL) Plasma-equivalent, calibrated by using YSI (Model 2300 STAT PLUS) Glucose Analyzer reference Result Calibration instrument, which is traceable to NIST reference standard. Sample...

  • Page 46: Warranty

    Warranty Please complete the warranty card that came with this product and mail it to your local distributor to register your purchase. If the meter fails to work for any reason other than obvious abuse within the first five (5) years from purchase, we will replace it with a new meter free of charge. For your records, also write the purchase date of your product here.

  • Page 47: Index Of Symbols

    Index of Symbols Consult instructions for use In vitro diagnostic medical device Temperature limit Contains sufficient for <n> tests Use by Lot Number Manufacturer Authorized representative in the European Community Sterilized using irradiation Control Range CTRL Catalogue number Serial Number Model Number MODEL Do not dispose along with household waste...

  • Page 48: Index

    Index Averaging Results…………….. Set the Clock…………………. Battery, Replacing the ………… Specifications………………… Carrying Case…………………… Strip ejector…………………… 3,29 Clearing the Memory…………… 34 Procedure Data Port........Precautions and Limitations Date Format......8,10 Testing Your Blood…………… Guidelines......... I Quality Control Test………… Hematocrit......... Control Solution…………… Hyperglycemia......

Table of Contents