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Summary of Contents for OGM-281

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Page 2: ... instructions before use Use only On Call Extra Blood Glucose Test Strips with the On Call Extra Mobile Blood Glucose Meter For in vitro diagnostic use only Your blood glucose monitoring system is to be used only outside the body It is for monitoring the effectiveness of diabetes control It should not be used for the diagnosis of diabetes For self testing and professional use Test only whole blood...

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Page 4: ...od 18 Step 1 Getting a Drop of Blood 18 Step 2 Testing Blood Glucose 23 HI and LO Messages 26 Using the Meter Memory 27 Viewing Stored Records 27 Clearing the Memory 28 Manually Transferring Records by Bluetooth Wireless Technology 29 Maintenance 31 Replacing the Battery 31 Caring for Your On Call Extra Mobile Blood Glucose Monitoring System 32 Suggested Testing Times and Target Goals 33 Comparing...

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Page 6: ...toring System Depending on the On Call Extra Mobile 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 Carrying Case Test Strip Sterial Lancet Clear Cap Blood Glucose Meter Control Solution Lancing Device ...

Page 7: ... each blood draw 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 Control Solution 0 and Control Solution 2 are also available if you want to do a level 0 or level 2 test The three levels of control soluti...

Page 8: ...her menu selection functions Button Recalls next test results from the meter memory selects meter settings and performs other menu selection functions Strip Port Test strips are inserted into this area to perform a test OK Button Used to confirm the selection and enter the set up mode Battery Cover Remove the battery cover to install one CR 2032 coin cell battery Status Light The light blinks to i...

Page 9: ...ll also be displayed when control solution symbol appears Test Result Area Indicates a test result Measurement Unit Only one unit will be displayed on your meter It cannot be adjusted Before Meal Symbol Appears when before meal test results are displayed After Meal Symbol Appears when after meal test results are displayed Test Remind Symbol Appears to remind you to test your blood glucose MEM Show...

Page 10: ...er apart This will void the warranty Refer to the Caring for Your Meter section on page 32 for details on cleaning the meter Keep the meter and all associated parts out of the reach of children Note Follow proper precautions and all local regulations when disposing of the meter and used battery All Glucose Systems Preventive Warnings with Regard to EMC 1 This instrument is tested for immunity to e...

Page 11: ...he sample tip of the test strip Do not apply blood or control solution to the top of the test strip 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 The meter will then begin to count down If you applied blood but do not see the countdown start you may reapply a second drop of blood within 3 seconds If the ch...

Page 12: ...trips past the unopened expiration date printed on the label Using test strips past the unopened expiration date may produce incorrect test results Note The expiration date is printed in Year Month Date format Special Instructions for Test Strips 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 st...

Page 13: ... Solution The On Call Extra Glucose Control Solution contains a known concentration of glucose It is used to confirm that your On Call Extra Mobile Blood Glucose Meter and On Call Extra Blood Glucose test strips are working together properly It also confirms that you are performing the test correctly It is important to run a quality control test regularly to make sure you are getting correct resul...

Page 14: ...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 designed 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 15: ...the battery in your carrying case and install it according to the following steps 1 Turn over the meter and slide the battery cover off the top of the meter 2 Insert one CR 2032 3 0 V coin cell battery into the battery carrier Make sure it is aligned with the plus facing down 3 Slide the battery cover back on and make sure that it snaps shut ...

Page 16: ...he battery 3 Date Format m d or d m will appear at the top of the display to indicate either a month day year format or a day month year format Press the or button to switch between the two settings Then press the OK button to save your choice 4 Date The year will appear at the top of the display Press the or button to increase or decrease the year Once you have selected the correct year press the...

Page 17: ...below 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 There will be a short beep when it is turned on after sample detection and when the result is ready The meter will sound three short beeps to sound a warning when an error has occurred Please check the erro...

Page 18: ...minder set up Repeat the same set up procedure for Test Reminder 3 4 and 5 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 when it is first set It will beep again two minutes later and two minutes after that unless you insert a test strip This function will sti...

Page 19: ...press the OK button to exit the setup If you have a new device that needs to be paired with the glucose meter or you have a new meter that has never been paired with a mobile device select the yes option and press the OK button to enter pairing mode In pairing mode bt displays along with the word PAIr blinking at the top of the display The green Status Light on the side of the meter will also blin...

Page 20: ...end first and facing up It will turn on the meter and display all the display segments If the audio option is on the meter will beep signaling that 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 3 Following this display check the system will enter the test mode The display will show the date time and the strip ic...

Page 21: ...of the count down you may reapply a second drop within 3 seconds 6 Once a sufficient sample has been applied the meter display will count down from 3 to 1 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 moni...

Page 22: ...he quality control test with a new test strip If your results still fall outside of the control range shown on the test strip vial or on the foil pouch your meter may be defective Please contact your local distributor 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 I...

Page 23: ...Prior to testing wipe the test site with an alcohol swab or soapy water Use warm water to increase blood flow if necessary Dry your hands and the test site thoroughly Make sure there is no alcohol soap or lotion on the test site Fingertip Testing For fingertip sampling adjust the depth penetration to reduce the discomfort You do not need the clear cap for fingertip sampling 1 Unscrew the lancing d...

Page 24: ...y rotating the lancing device cover There are a total of 11 puncture depth settings To reduce discomfort use the lowest setting that still produces an adequate drop of blood Adjustment 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 se...

Page 25: ...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 for that reason you may find that obtaining blood from these sites is less painful than from the fingertip The procedure for forearm and palm sampling is different You need the clear cap to draw blood from th...

Page 26: ... forearm or palm Select a soft fleshy area of the forearm or palm that is clean and dry away from bone and free of visible veins and hair Note To bring fresh blood to the surface of the puncture site massage the puncture site vigorously for a few seconds until you feel it getting warm 3 Place the lancing device against the puncture site Press and hold the clear cap against the puncture site for a ...

Page 27: ...t 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 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 always use a new sterile lancet Do not reuse lancets Avoid...

Page 28: ...m 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 that a drop of blood can be added If the test strip has been inserted incorrectly the meter will not turn on The meter is ready for testing when the blinking blood drop and strip symbol appears At this time a blood drop ...

Page 29: ... test strip When the meal marker feature is turned on the test result will be displayed along with the suggested default meal marker based upon current time The before meal or after meal symbol is flashing until confirmed by pressing the OK button The meter allows the user to change the meal marker Press the or button to switch the marker from before meal after meal no marker or invalid result Aft...

Page 30: ...ssion has finished the words bt and SEnt appear at the top of the display If the transmission was interrupted and the data transfer failed the words not and SEnt appear at the top of the display Notes The default before meal time periods are 5 00 7 59 10 00 11 59 and 15 00 17 59 The default after meal time periods are 8 00 9 59 12 00 14 59 and 18 00 20 59 OR OR OR OR OR OR ...

Page 31: ...d LO messages indicate results outside of this range If HI appears on the display the measured concentration value is above 33 3 mmol L 600 mg dL The test should be retaken to ensure that no mistake was made in the procedure If you are certain the meter is functioning properly and no mistakes were made in the procedure and your blood glucose is still consistently measured as HI it indicates severe...

Page 32: ...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 the previous or next stored records Press the OK button to view the data averages The words DAY AVG will appear on the scr...

Page 33: ...s before meal or after meal in memory 7 Press the OK button to turn off the display Note Results from quality control tests will not be included in the averages When viewing results in memory these values are marked with a pound sign to show that they will not be included in the 7 14 30 60 and 90 day averages Clearing the Memory Take extreme caution when clearing the memory as this is not a revers...

Page 34: ...will stop blinking indicating a successful connection to the mobile device Note When meter is in bt mode sample application mode cannot be activated after a strip is inserted into the meter Do not insert test strips and attempt to test blood glucose while the meter is in bt mode 2 Once the data transfer is complete the meter will display SEnt and bt 3 After data transfer from meter to your device ...

Page 35: ...Bluetooth Notice The Bluetooth word mark and logos are registered trademarks owned by the Bluetooth SIG lnc and any use of such marks by ACON is under license Other trademarks and trade names are those of their respective owners ...

Page 36: ...til the battery is replaced Instructions 1 Turn the meter off before removing the battery 2 Turn the meter over to locate the battery cover Slide the battery cover off the top of the meter to get the battery 3 Press the symbol on the white plastic battery holder to loosen the old battery 4 Pull out and discard the old battery Insert one new CR 2032 3 0 V coin cell battery Make sure the plus side i...

Page 37: ...are to avoid getting liquids dirt blood or control solution into the meter through the strip port It is recommended that you store the meter in the carrying case after each use The On Call Extra Mobile 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 thorou...

Page 38: ...g uncomfortable over long periods of time Expected blood glucose levels for people without diabetes 2 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 doctor 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 3 AM Other Note 1 mmo...

Page 39: ...e a reasonable comparison follow these guidelines Before you go to the lab Bring your meter test strips and control solution with you 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 before testing Eight hours is preferable At the lab Wash your hands before obtaining a...

Page 40: ...frequency source or a high power electrical source is nearby place more distance between the meter and any of these sources then retest If the problem persists please contact your local distributor Test strip was removed during the test Repeat the test and ensure that the test strip remains in place Sample was applied to the test strip too soon Repeat the test and apply the sample after the blood ...

Page 41: ...e the battery and repeat the test Meter electronics failure If the problem persists please contact your local distributor Improper type of test strip used Please make sure you use the On Call Extra test strip with the On Call Extra Mobile Blood Glucose Meter If the problem persists please contact your local distributor Test strip damaged or calibration error Please test again using a new strip If ...

Page 42: ...0 glucose measurements 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 500 records with time and date Automatic shutoff 2 minutes after last action Meter Size 75 0 mm 40 0 mm 13 0 mm Display Size 50 0 mm 25 0 mm Weight 36 0 g with battery installed Operation Environmental Con...

Page 43: ...o 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 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 44: ... for n tests Do not reuse Use by Lot Number Manufacturer Authorized representative in the European Community Sterilized using irradiation CTRL Control Range REF Catalogue number MODEL Model Number SN Serial Number Do not dispose along with household waste Humidity limitation Atmospheric pressure limitation Direct currenta ...

Page 45: ...6 Maintenance 5 31 Meter vs Lab Results 34 Measure Unit of 5 16 Target Goals 33 Meter 3 Unit of Measure 16 37 Button 3 Status Light 3 14 Button 3 Suggested Testing Times 37 Audio feature 12 Symbols Index of 39 Cleaning 32 Test Strip 6 Display 4 Expiration 7 Error Messages 35 36 Precautions 8 HI and LO Messages 26 Testing Your Blood 18 Memory 27 Get a Drop of Blood 18 Meter Use and Precautions 5 Te...

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