GE GE200, User Manual

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Page 2: ... easy to use GE200 Blood Glucose Monitoring System provides accurate reliable test results to help you better manage your diabetes The GE200 Blood Glucose Monitoring System is designed for in vitro diagnostic use only for single patient use and self testing only Testing requires only a small amount of fresh capillary whole blood from either the fingertip palm or forearm The GE200 Blood Glucose Mon...

Page 3: ...ll environmental protection regulations when disposing of batteries The GE200 Blood Glucose Meter will be set as mmol L by default when sold in Canada If meter display shows mg dL during setting or test please contact Use of the wrong unit of measurement may cause incorrect treatment Auto Control Medical Distribution and Customer Service Center at 1 800 964 8434 The GE200 Blood Glucose Monitoring ...

Page 4: ... displayed if the sample size is too small In this case repeat the test with a new test strip Important Safety Notes The GE200 Blood Glucose Meter and Lancing Device are for single patient use Do not share them with anyone including other family members All parts of the kit are considered biohazardous and can potentially transmit infectious diseases even after following the cleaning and disinfecti...

Page 5: ...ting 26 Performing a Blood Glucose Test 27 Alternative Site Testing 32 View Window Appearance 34 Understanding Test Results and Messages 35 GE200 GE200 Quality Control About Quality Control Testing 37 Performing a Quality Control Test 40 Understanding Control Test Results 42 Test Memory Recalling Test Results 43 Recalling Average Test Results 44 Caring for Your Meter 46 Cleaning and Disinfecting P...

Page 6: ... Book Warranty Card Emergency Card 3 GE200 Blood Glucose Test Strip Package Insert 4 GE200 Control Solution Package Insert 5 GE200 Blood Glucose Meter with 2 CR2032 batteries installed 6 GE200 Blood Glucose Test strips 10 25 pcs 7 GE200 Control Solution 8 GE Lancing Device 9 Clear Cap 10 Disposable Sterile Lancets 10 pcs 11 Carrying Case not shown 12 Instruction for the lancing device not shown av...

Page 7: ... The GE200 Blood Glucose Meter The GE200 Blood Glucose Meter Left Button Main Button Display Window Test Strip Port Right Button Product name Battery Cover Meter Serial Number Backlight Battery Meter Battery ...

Page 8: ...ies are low or must be replaced Indicates when to apply the blood sample Test strip Blinks when strip is not compatible with your meter or if a strip is inserted incorrectly Current date under time mode or testing date under memory mode Warns when the operational temperature limit is exceeded during testing Indicates the time in 12H format Displays current time or testing time under memory mode un...

Page 9: ...st Strip vial immediately after removing a test strip Do not reuse GE200 Blood Glucose Test Strips Do not use expired GE200 Blood Glucose Test Strips When you open a new vial of GE200 Blood Glucose Test Strips record the date on the vial Discard the vial of test strips after 4 months from opening Store the GE200 Blood Glucose Test Strip between 39 86 F or 4 30 C and in a location 90 relative humid...

Page 10: ...Glucose Meter comes with two CR2032 3volt batteries installed Two new batteries will provide power to perform approximately 1000 tests under normal use Press the main button or insert a strip to activate your meter GE200 4 The GE200 Blood Glucose Meter 5 Press any button to exit the self test and enter Setting Mode will enter Self Testing Mode automatically when replacing the battery all symbols w...

Page 11: ...er the Setting Mode Press the main button to turn on the GE200 Blood Glucose Meter Hold down the main button for 7 seconds During this time the screen will go blank until you hear a beep After the beep the meter will turn on into the Setting Mode The display screen will show setting data 1 Year setting With the year format blinking Press the Main button to confirm Once the year is confirmed the Mo...

Page 12: ...urrent hour Press the Main button to confirm Once the hour is confirmed the Minute Setting will appear 6 Minute setting With the minutes blinking press the Left or Right button until you see the current minute Press the Main button to confirm Once the minute is confirmed the Volume Setting will appear NOTE will leave setting mode and power off automatically If you do no change any settings during ...

Page 13: ...seconds 3 Auto Power off The GE200 Blood Glucose Meter will power off automatically after 2 minutes if no buttons are pressed or no strip is inserted 1 Turn on the backlight Press and hold the Main button for 2 seconds 2 Manually turn off the backlight With the backlight on press and hold the Main button for another 2 seconds 3 Auto shutoff The GE200 Blood Glucose Meter backlight will turn off aut...

Page 14: ... window facing up 2 Put your forefinger on the side of the strip as shown 3 Insert the GE200 Blood Glucose Test Strip into test strip port until it clicks and firmly stops Removing the GE200 Blood Glucose Test Strip 1 Hold the GE200 Blood Glucose Test Strip as shown 2 Rotate the GE200 Blood Glucose Test Strip counterclockwise and pull up simultaneously 3 Take the GE200 Blood Glucose Test Strip out...

Page 15: ...pth adjustable cap in one hand and hold the base with the other hand Bend the cap down When a gap appears between the cap and base pull the cap and base in opposite directions 2 Pull off the depth adjustable cap 3 Insert a new disposable lancet firmly into lancet carrier 4 Twist off and set aside the protective cover of the disposable lancet 5 Replace the depth adjustable cap 6 Choose a depth of p...

Page 16: ... be accompanied by a beep if volume is turned on 12 A blood drop icon will appear on the display window and will be accompanied by a beep if volume is turned on Apply the blood sample within 2 minutes 13 Place the lancing device against your fingertip and press the release button 14 Touch and hold the blood drop to the edge of sample port until the view window is filled with blood If the view wind...

Page 17: ...l display and if you apply blood too soon If this occurs please repeat the test with a new test strip Record the opening date of a new test strip vial Discard the vial of test strips 4 months after opening Always keep the metal contacts of the test strip port clean If any dust or impurities are present please clean with a small soft brush The GE200 Blood Glucose Monitoring System and GE Lancing De...

Page 18: ...ertip If you use the normal lancing device for your palm or forearm the blood sample may not be sufficient for meter operation Periodically compare the test system to a laboratory test system that is known to be well maintained and monitored by a healthcare provider Alternative site testing palm or forearm blood sampling To perform alternative site testing install the clear cap for your GE Lancing...

Page 19: ...perature of the meter and the test strips to equilibrate Apply the blood sample only on the sample port of the test strip Blood glucose test results are shown on the GE200 Blood Glucose Meter as mmol L If your blood glucose result is unusually high or low or if you question your test results repeat the test with a new GE200 Blood Glucose Test Strip You can also run a Quality Control Test with the ...

Page 20: ...rip If you still get a result contact your healthcare professional GE200 Blood Glucose 1 1 and 33 3 mmol L What is a Quality Control Test To ensure proper monitoring function it is necessary to regularly perform a quality control test Use one of the GE200 Control Solutions when testing your GE200 Blood Glucose Monitoring System in the Control Solution Mode If the test result is within the Control ...

Page 21: ...results are not consistent with the way you feel To practice testing Required Items for Quality Control Tests To perform a quality control test prepare the items below GE200 Blood Glucose Meter GE200 Blood Glucose Test Strips GE200 Control Solution CAUTION Each time you open a new bottle of control solution write the expiration date on the label The GE200 Control Solution is good for 3 months afte...

Page 22: ...will hear a beep if the volume is turned on 10 Tightly replace the cap on the GE200 Control Solution bottle 11 The control solution result will appear Compare your Quality Control Test result to the Control Solution Range printed on the GE200 Blood Glucose Test Strip vial label CAUTION Your Control Solution Test results will not be included in the average calculations however they can still can be...

Page 23: ...lution results are still out of range do not use GE200 Blood Glucose Meter to test your blood glucose Please contact the toll free at Auto Control Medical Distribution and Customer Service Center 1 800 964 8434 The GE200 Blood Glucose Meter is able to automatically store a maximum of 1000 test results with time and date If your meter has stored 1000 results the newest test result will replace the ...

Page 24: ...urrent mode Press the Right button until the symbol changes to Keep pressing the Right button and while simultaneously pressing the Main button until appears The excluded test result is now included into the average calculation 5 Quick Searching To view test results in sequential order automatically enter the Memory Mode Press the Right or Left button for 2 seconds The Right button is for viewing ...

Page 25: ...ce should be decontaminated prior to use by the second person NOTE the cleaning procedure can only remove visible contaminates from surfaces Only the disinfecting procedure can eliminate non visible pathogens CaviWipes Disinfecting Towelettes has been tested and may be used to clean and disinfect the meter and lancing device Users may purchase the disinfecting wipes from the manufacturer Metrex di...

Page 26: ...wipes listed above to clean any possible dirt dust blood and other body fluids To disinfect the lancing device 2 Take another disinfecting wipe and wipe the Lancing device thoroughly Note All blood and body fluids should be cleaned from surface before performing disinfecting procedure 3 Allow the surface to remain wet for 2 minute 4 Allow to air dry NOTE Your GE200 Blood Glucose Meter has been tes...

Page 27: ...ips Please examine your LCD screen test strip port buttons and surface of your meter and lancing device after cleaning and disinfecting cycles Stop using the meter and or lancing device if any of the following occur Thin sliver streaks appear on the screen The screen becomes cracked soft dissolved brittle or swollen You are unable to turn on off your meter operate the right left button the lancing...

Page 28: ...ly after finishing the above steps If the meter still does not work please contact Auto Control Medical Distribution and Customer Service Center at 1 800 964 8434 Strip Error 1 When the test strip is inserted incorrectly the meter will beep 4 times while the flashes Do not apply a sample on the test strip Please re insert the unused test strip correctly 2 If after performing the required steps the...

Page 29: ...native site testing AST should only be performed during steady state times when glucose is not changing rapidly Alternative Site Testing should not be used to calibrate continuous glucose monitoring systems CGMS Alternative site testing should not be performed if testing for hypoglycemia Low blood glucose Results from alternative site testing should not be used in insulin dose calculation CAUTION ...

Page 30: ...x 46 mm x 17 5 mm 65 5g with batteries LCD 55 mm x 37 mm Measurement Technology Sample Minimum Sample Volume Measuring Range Test Time Memory Capacity Power Saving Operating Temperature Operating Relative Humidity Dehydrogenase Electrochemical Sensor Capillary whole blood 0 75 microliters 1 1 33 3 mmol L 5 seconds 43 111 F 6 44 C 10 90 1000 blood glucose test results with date and time Turns off a...

Page 31: ...nal purchaser of the GE 200 Blood Glucose Monitoring System Please complete and return the enclosed warranty card Different models have different specifications This warranty applies only to the GE200 Blood Glucose Monitoring System other models are not covered with this warranty card GE is a trademark of General Electric Company and is under license by Bionime Corporation NO 100 Sec 2 Daqing Stre...

Page 32: ...vice Directive 93 42 EEC EC Rep Bionime GmbH Klaus Ellensohn Tschuetschgasse 8 6833 Klaus Vlbg Austria Disposable Sterile Lancets Manufacturer SteriLance Medical SuZhou Inc No 68 LiTangHe RD XiangCheng SuZhou JiangSu 215133 P R China Product complies with Medical Device Directive 93 42 EEC CE0197 EC Rep EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands NO 100 Sec 2 Daqing Street South...

Page 33: ...ose nsulin Medication I Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Name Address Home Phone Doctor Pharmacy Insulin Pills In case of emergency contact Work Phone Doctor s Phone Pharmacy Phone Log book date From To ...

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Page 38: ...in Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Breakfast Lunch Dinner Bedtime Other Comments DATE M T W T F S S Blood Glucose nsulin Medication I Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication ...

Page 39: ...in Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Breakfast Lunch Dinner Bedtime Other Comments DATE M T W T F S S Blood Glucose nsulin Medication I Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication ...

Page 40: ...Bedtime Other Comments DATE M T W T F S S Blood Glucose nsulin Medication I Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Blood Glucose Insulin Medication Distributor name and address PLACE STAMP HERE ...

Page 41: ...he GE200 Blood Glucose Meter only if used as directed and provided that the failure to perform has not been caused in whole or in part by the use of test strips that are not GE200 Blood Glucose Test Strips manufactured by Bionime Use only GE200 Blood Glucose Test Strips in your GE200 Blood Glucose Meter 3 The sole obligation of Bionime under this warranty shall be to replace any defective GE200 Bl...