Gima OGM-211 User Manual Download Page 47

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Index of Symbols

Consult instructions for use

IVD

In vitro

diagnostic medical device

Temperature limit

Contains sufficient for <n> tests

Use by

LOT

Lot Number

Manufacturer

Authorized representative in the European Community

Sterilized using irradiation

CTRL

Control Range

REF

Catalogue number

Serial Number

MODEL

Model Number

Do not dispose along with household waste

Do not reuse

Humidity limitation

Atmospheric pressure limitation

Direct current

Data transmission port

Summary of Contents for OGM-211

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Page 2: ...m and palm Only professionals may also test neonatal arterial and venous blood samples To ensure accurate results from your GIMA Blood Glucose Monitoring System please follow these guidelines Read instructions before use Use only GIMA Blood Glucose Test Strips with the GIMA Blood Glucose Meter For in vitro diagnostic use only Your blood glucose monitoring system is to be used only outside the body...

Page 3: ... 1 Getting a Drop of Blood 22 Step 2 Testing Blood Glucose 27 HI and LO Messages 30 Hypo and Hyper Messages 30 Ketone Message 31 Using the Meter Memory 32 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 R...

Page 4: ...oring 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 Lancing Device Sterile Lancet Carrying Case Blood Glucose Meter Clear Cap Control Solution Test Strips ...

Page 5: ...w and discarded after use 6 Control Solution Verifies the proper operation of the blood glucose monitoring system by checking the test strips and meter against a pre calibrated control solution Control Solution 1 is all you need most of the time If you want to do additional levels of test Control Solution 0 and Control Solution 2 are available The three levels of control solution CTRL 0 CTRL 1 and...

Page 6: ... 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 OK Button Button Data Port Battery Cover ...

Page 7: ...through the testing process Button Recalls previous test results from the meter memory and performs other menu selection functions Button Selects meter settings and performs other menu selection functions OK Button Used to manually turn the meter on or off check the display to confirm that all the display segments turn on and check the date time Data Port Sends information to a computer via an opt...

Page 8: ... low blood sugar target level that you have set Test Remind Symbol Reminding you to test blood glucose Blood Drop Strip Symbol Wait for the Blood Drop Strip Symbol to appear before applying the sample These two symbols appear at the same time to tell you when to apply the sample Test Result Area Indicates test result Pound Sign Appears with the control solution test result or when you mark an inva...

Page 9: ... test Refer to Performing a Quality Control Test on page 19 for instructions Do not take the meter apart Taking the meter apart will void the warranty Refer to the Maintenance section on page 36 for details on cleaning the meter Keep the meter and all associated parts out of reach of children Note Follow proper precautions and all local regulations when disposing of the meter and used batteries Al...

Page 10: ...t apply blood or control solution to the top of the test strip as this may result in an inaccurate reading Hold the blood drop to the sample tip of the test strip until the check window is completely full and until the meter begins to count down If you applied blood but do not see the starting of the count down you may reapply a second drop of blood within 3 seconds If the check window does not fi...

Page 11: ...ed expiration date may produce incorrect test results Note The expiration date is printed in Year Month Date format Special Instructions for Test Strip in the Vial Test strips must be stored in the original vial with the cap tightly closed This keeps them in good working condition Do not transfer test strips to a new vial or any other container Replace the cap on the test strip vial immediately af...

Page 12: ...ucose 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 You should run a quality control test Before you first use your meter to familiarize yourself with its operation Before using a new box of test...

Page 13: ...on the bottle label Control Solution Precautions For in vitro diagnostic use The control solution is for testing only outside the body Do not swallow or inject Shake well before using Control solution tests are specified to be accurate only when tested between 10 and 40 C 50 104 F The control ranges shown on the test strip vial or on the foil pouch are not recommended ranges for your blood glucose...

Page 14: ...d install them according to the following steps 1 Turn over the meter to locate the battery cover Slide the battery cover in the direction of the arrow to open it 2 Insert two new CR 2032 3 0 V coin cell batteries on top of the plastic tape Make sure it is aligned with the plus side facing up in the battery carrier 3 Close the battery cover and make sure that it snaps shut ...

Page 15: ...e battery 3 Date Format m d or d m will appear at the top of the display to indicate either a month date year format or a date month year format Press the or button to switch between the two settings Then press the OK button to save your choice and then start setting the year month and date 4 Date The year will appear at the top of the display Press the or button to increase or decrease the year O...

Page 16: ...ress the OK button to save your choice and move to set the meal marker feature 6 Meal Marker The meter comes with the meal marker feature disabled The meter allows the user to enable or disable the meal marker option The words On or OFF will be displayed on the large center segments of the display and the before meal symbol together with the after meal symbol will be displayed as shown below OR OR...

Page 17: ...he Ketone indicator feature disabled Press the or button to switch between turning the Ketone indicator On and Off Press the OK button to confirm your selection When the Ketone indicator is enabled if the test result is higher than 16 7 mmol L 300 mg dL the symbol of Ketone will appear on the display 9 Hyper Indicator The meter comes with the Hyper indicator feature disabled Press the or button to...

Page 18: ...he OK button to go to the Test Reminder set up Note The meter allows the hypoglycemia level to be as high as 5 6 mmol L 100 mg dL The hypoglycemia level should be below the hyperglycemia level Consult your diabetes healthcare professional before determining what your hypo blood glucose level is 11 Test Reminder Test reminders are a useful way to remind you when to test You can set 1 to 5 reminders...

Page 19: ...up mode and power off the meter If one or more test reminders have been set the reminder symbol will always appear on the LCD screen when the meter is turned on The display sample is shown below The meter beeps 5 times at the time you set again two minutes later and two minutes after that unless you insert a test strip or press any button This function will still work with Audio feature turned off...

Page 20: ...tton and decrease the number of minutes by pressing button The time increments are in intervals of 15 minutes The maximum number of minutes that the post prandial alarm allows user to setup are 480 minutes The minimum number of minutes that the post prandial alarm allows user to setup are 15 minutes Press OK to confirm and the alarm will beep twice with the clock icon flashing with screen display ...

Page 21: ...e and change the alarm time by pressing or buttons and re confirm by pressing OK button You can always exit out of the post prandial alarm interface by pressing and OK buttons The alarm will beep at the time set by you The meter screen will display test strip time and date to remind you to measure your post prandial blood glucose while the meter beeps The meter will beep for 20 seconds and alarm w...

Page 22: ... 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 If the audio option is on the meter will beep signaling the meter is turned on 2 Check the display to confirm that all the display segments turn on Next a dash will move across the display See illustrations below 3 The meter is ready for testing when the blinking ...

Page 23: ... applied the meter display will count down from 5 to 1 and then the result and a control solution symbol will be displayed on the screen The control solution test results should be within the control range CTRL 1 printed on the test strip vial or on the foil pouch This means that your blood glucose monitoring system is working properly and that you are performing the procedure correctly Test resul...

Page 24: ...control range shown on the test strip vial or on the foil pouch your meter may be defective Contact your local distributor for help Three levels of control solution are available labeled Control Solution 0 Control Solution 1 and Control Solution 2 Control Solution 1 is sufficient for most all self testing needs If you think your meter or strips may not be working correctly you may also want to per...

Page 25: ...od IMPORTANT Prior to testing wipe the test site with an alcohol swab or soapy water Use warm water to increase blood flow if necessary Then dry your hands and the test site thoroughly Make sure there is no alcohol soap cream or lotion on the test site Fingertip Testing For fingertip sampling adjust the depth penetration to reduce the discomfort 1 Unscrew the lancing device cover from the body of ...

Page 26: ...rotating the lancing device cover There are a total of 11 puncture depth settings To reduce the discomfort use the lowest setting that still produces an adequate drop of blood Adjustments 0 1 5 for delicate skin 2 3 5 for normal skin 4 5 for calloused or thick skin Note Greater pressure of the lancing device against the finger will also increase the puncture depth 5 Pull the cocking barrel back to...

Page 27: ...the base of the finger to the tip of the finger to obtain the required blood volume Avoid smearing the drop of blood For the greatest reduction in pain lance on the sides of the fingertips Rotation of sites is recommended Repeated punctures in the same spot can make your fingers sore and callused Forearm and Palm Testing The forearm and palm areas have less nerve endings than the fingertip You may...

Page 28: ...mia unawareness Please refer to Fingertip Testing to insert the lancet and load the lancing device 1 Screw the clear cap onto the lancing device 2 Choose a puncture site on the forearm or palm Select a soft and fleshy area of the forearm and palm that is clean and dry away from bone and free of visible veins and hair To bring fresh blood to the surface of the puncture site massage the puncture sit...

Page 29: ...ing device cover back on the lancing device Lancet Precautions Do not use the lancet if the safety tab is missing or loose when you take the lancet out of the bag Do not use the lancet if the needle is bent Use with caution whenever the lancet needle is exposed Never share lancets or the lancing device with other people In order to reduce the risk of infection from prior use of the instrument alwa...

Page 30: ... display to ensure no inappropriate segments or icons are permanently turned on 2 Following this display check the system will enter the test mode The display will show the date and time and the strip icon with the blood sample icon blinking to indicate that the test strip is inserted correctly and a drop of blood can be added If the test strip has been inserted incorrectly the meter will not turn...

Page 31: ... and to prevent them from being included in the 7 14 30 60 and 90 day averages press the and button together when a pound sign appear on the display then press OK button A pound sign means that the result will not be included when calculating the 7 14 30 60 and 90 day averages If a result is marked by accident press the and button together and then press the or to unmark the result After marking t...

Page 32: ...marked run the test again with a new test strip If an error message appears on the display refer to the Troubleshooting Guide on page 40 If a HI or LO error appears on the display refer to HI and LO messages below 5 After inspection record valid results in your logbook with the date and time and compare them to the target goals set by your diabetes healthcare professional Refer to Suggested Testin...

Page 33: ...akes were made in the procedure and your blood glucose is still consistently measured as HI it indicates severe hyperglycemia high blood glucose You should contact your healthcare professional immediately If LO appears on the display the measured concentration value is below 0 6 mmol L 10 mg dL The test should be retaken to ensure that no mistake was made in the procedure If you are certain the me...

Page 34: ...at 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 Consult your healthcare professional about testing for ketones Precautions and Limitations Please refer to the test strip insert OR OR OR ...

Page 35: ... display 2 If you are using the meter for the very first time the meter display will show three dashed lines the word MEM and the unit of measure This shows that no data have been stored in memory 3 The date and time will be displayed together with the results stored in memory A pound sign indicates records that will be omitted from the 7 14 30 60 and 90 day averages 4 Press the or button to view ...

Page 36: ...90 day averages 6 If there are fewer than 7 14 30 60 and 90 days in memory all the readings without the pound sign currently stored in memory will be averaged 7 If you are using the meter for the very first time no value will appear on the display This means that no records have been stored in memory If you have not marked any results as before meal or after meal no value will appear on the displa...

Page 37: ...to exit without deleting the recorded data press the OK button This will turn the meter off without deleting any data Transferring Records 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 1 Install...

Page 38: ... data transfer the meter will display to and PC This indicates the data is being transferred from the meter to the PC 5 Once the data transfer is complete the meter will display End and PC 6 After data transfer from meter to PC is completed press the OK button to turn off the meter If nothing else happens to meter 2 minutes after data transfer from meter to PC is completed the meter will automatic...

Page 39: ...ced Note Make sure to replace the used up batteries with two new ones Instructions 1 Turn the meter off before removing the batteries 2 Turn the meter over to locate the battery cover Slide the battery cover in the direction of the arrow to open it 3 Remove and discard the old batteries Insert two new CR 2032 3 0 V coin cell batteries in the battery carriers Make sure the plus side facing up 4 Clo...

Page 40: ... getting liquids dirt blood or control solution into the meter through the strip or data ports It is recommended that you store the meter in the carrying case after each use The GIMA Blood Glucose Meter is a precision electronic instrument Please handle it with care Lancing Device Use mild soap and warm water to clean with a soft cloth as required Carefully dry the device thoroughly Do not immerse...

Page 41: ...feeling uncomfortable over long periods of time Expected blood glucose levels for people without diabetes2 Time Range mg dL Range mmol L Fasting and Before Meals 70 100 3 9 5 6 2 Hours after Meals Less than 140 Less than 7 8 Talk to your healthcare professional to set your own daily target ranges Time of Day Your Target Range Waking up Fasting level Before meals 2 hours after meals Bedtime 2 AM to...

Page 42: ...le comparison follow these guidelines Before you go to the lab Bring your meter test strips and control solution with you to the lab Make sure your meter is clean Perform a quality control test to make sure the meter is working properly Comparisons will be more accurate if you do not eat for at least four hours preferably eight hours before testing At the lab Wash your hands before obtaining a blo...

Page 43: ...tor Internal calibration check error Turn off meter or remove test strip and then turn on meter again to retest If the problem persists please contact your local distributor Test strip was removed during the test Repeat the test and ensure test strip remains in place Sample was applied to the test strip too soon Repeat test and apply sample after blood drop test strip symbol appears Test strip is ...

Page 44: ...e contact your local distributor Communications failure There is an error in transferring data to the PC See the package insert included in the GIMA Diabetes Management Software for troubleshooting Strip testing error Sample Perturbation Repeat the test and apply enough sample to fill the test strip check window within 3 seconds When repeat testing do not touch the strip during meter count down Pl...

Page 45: ...ng data transfer Glucose Units of Measure The meter is preset to either millimoles per liter mmol L or milligrams per deciliter mg dL depending on the standard of your country Memory Up to 1000 records with time and date Automatic shutoff 2 minutes after last action Meter Size 90 mm 60 mm 16 mm Display Size 43 mm 40 mm Weight 71 6 g with batteries installed Operation Environmental Conditions Tempe...

Page 46: ...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 Date of purchase __________________________________________________ Note This warranty applies only to the meter in the original purchase and does not apply to the battery supplied with the meter ...

Page 47: ...s Use by LOT Lot Number Manufacturer Authorized representative in the European Community Sterilized using irradiation CTRL Control Range REF Catalogue number SN Serial Number MODEL Model Number Do not dispose along with household waste Do not reuse Humidity limitation Atmospheric pressure limitation Direct current Data transmission port ...

Page 48: ...etones 14 31 Blood Glucose 28 Lancing Device 1 22 37 Control Solution 9 20 Lancets 1 22 Meter vs Lab Results 39 Maintenance 6 36 Target Goals 38 Measure Unit of 5 20 Unit of Measure 20 38 Meter 3 Suggested Testing Times 38 Audio feature 14 Symbols Index of 44 Cleaning 37 Test Strip 7 Display 5 Expiration 8 Error Messages 40 41 Precautions 9 HI and LO Messages 30 Testing Your Blood 22 Button 3 Get ...

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