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Technical Information: Accuracy

The

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blood glucose monitoring system was

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test

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Table 1: System accuracy results for glucose concentration
< 5.55 mmol/L

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between YSI laboratory

reference method and

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meter

Within

± 0.28

mmol/L

Within

± 0.56

mmol/L

Within

± 0.83

mmol/L

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range

ʸʽʷÅ¼

ʸˀʹ

ƺʿʺƔʺ̈ƻ

ʸˀʷÅ¼

ʸˀʹ

ƺˀˀƔʷ̈ƻ

ʸˀʹÅ¼

ʸˀʹ

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Table 2: System accuracy results for glucose concentration

̟ʼƔʼʼÃÃÅÂƭ

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between YSI laboratory

reference method and

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meter

Within

± 5%

Within

± 10%

Within

± 15%

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range

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408

ƺʽʻƔʹ̈ƻ

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408

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408 of

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Содержание Contour Next

Страница 1: ...10 45 12 4 52 Uses only CONTOUR NEXT blood glucose test strips USER GUIDE Works with free CONTOUR DIABETES app www diabetes ascensia com registration...

Страница 2: ...confer a license to use under CONTOUR NEXT meters and CONTOUR NEXT No test strip supplier other than the supplier of this product is authorized The Bluetooth word mark and logos are registered tradem...

Страница 3: ...ertip testing Understand test results 3 LOGBOOK 4 SETTINGS Change the Time and Date Change Target Ranges Download the CONTOUR DIABETES app Put your meter in pairing mode 5 HELP Meter Care Replace mete...

Страница 4: ...lood glucose monitoring system is intended for self testing by persons with diabetes and health CONTOUR NEXT blood glucose monitoring system is intended for self testing The CONTOUR NEXT blood glucose...

Страница 5: ...r health care professional If your blood glucose reading is over the recommended limit set by your health care professional 1 2 If you get a similar result follow your health care Serious Illness Capi...

Страница 6: ...r testing or handling the using this system on multiple patients should follow the of blood borne transmissible diseases in health care settings as recommended for potentially infectious human should...

Страница 7: ...at altitudes higher Hematocrit CONTOUR NEXT test strip results are not Xylose Do not use during or soon after xylose absorption WARNING you suspect a battery has been swallowed or placed inside any p...

Страница 8: ...ns for use and care exactly as Examine the product for missing damaged or broken Contact Information Your CONTOUR NEXT CONTOUR NEXT test strips and CONTOUR NEXT control CONTOUR NEXT test strips in the...

Страница 9: ...ult is out of range contact Contact Information or test strip is outside this range you should not test until temperature of the new location before performing a blood Do not attempt to perform a bloo...

Страница 10: ...isplay screen to be sure the results are Contact Information The CONTOUR NEXT blood glucose monitoring system the LO screen contact your health care professional immediately the HI screen wash your ha...

Страница 11: ...n the meter On or Off Press OK to accept a selection Test Strip Port Light Grey Square End Insert end into test strip port Sample Tip Blood sample pulled in here Press to scroll up Press and hold to k...

Страница 12: ...isplays 8 8 8 and that the white light from the test strip port If there are missing characters or if the strip port light is a colour other than Contact Information NOTE Your meter comes with a pre s...

Страница 13: ...our Logbook Meter Settings Fasting Before Meal After Meal No Target Range or Target Range smartLIGHT same Bluetooth symbol means the Bluetooth wireless setting is On the meter can Total number of bloo...

Страница 14: ...and Settings 10 45 12 4 To highlight the Logbook or Settings press the To enter the Logbook press OK while the Logbook To enter Settings press OK while the Settings Your Meter Features sampling allow...

Страница 15: ...pen or damaged do not use those Contact Information Fingertip Testing testing CONTOUR NEXT CONTOUR NEXT 5 Help Control Solution Testing 6 Technical Information Customer Service Checklist CAUTION Your...

Страница 16: ...mmon symptoms are Low blood glucose Hypoglycaemia shakiness sweating fast heartbeat confusion passing out seizure irritability extreme hunger dizziness WARNING Potential Biohazard 5 Help Meter Care an...

Страница 17: ...ditional information and a complete list of symptoms WARNING If you are experiencing any of these symptoms test your blood glucose If your test result is under the critical level you have established...

Страница 18: ...the Lancing Device Refer to your lancing device insert for detailed instructions on preparing the lancing device and Insert the Test Strip WARNING Potential Biohazard WARNING Potential Biohazard CAUT...

Страница 19: ...f strips are stored in a bottle tightly close the bottle lid 1 CONTOUR NEXT 2 Insert the grey square end 10 45 12 4 The screen displays the blinking blood drop indicating it is ready to test a blood N...

Страница 20: ...2 Immediately touch the tip of the test strip to the drop of The blood is drawn into the 3 Hold the tip of the test strip in the blood drop until the meter NOTE If the Meal Marker the test strip unti...

Страница 21: ...he skin or place the blood on top lead to inaccurate results or Second Chance sampling Apply More Blood 00 60 1 If the meter beeps twice and the screen displays a blinking blood drop with a plus 2 sam...

Страница 22: ...asting no food or drink for 8 hours except water or non The meter compares your result against the Before Meal Target Range Before Meal Use when testing within 1 hour before The meter compares your re...

Страница 23: ...the Settings screen 2 Testing About Meal Markers Example 5 65 Do not press OK or remove the test strip yet You can select the blinking Meal Marker To turn Meal Markers 4 Settings Set Meal Marker Featu...

Страница 24: ...you do not make a Meal Marker Logbook without a Meal Marker Set a Test Reminder 1 Make sure the Reminder feature is On in Settings 4 Settings Set Reminder Feature 2 Mark a blood glucose reading as a...

Страница 25: ...he test strip port displays Before Meal After Meal or Overall Target Range Yellow means Above Target Green means In Target Red means Below Target If your blood glucose result is below target the smart...

Страница 26: ...ur medication based on test results If your blood glucose reading is under the critical level you have established with your health care professional If your blood glucose reading is over the recommen...

Страница 27: ...care LO or HI Results 10 45 12 4 l0 If the meter beeps twice and displays the LO screen your blood glucose Follow medical advice immediately 10 45 12 4 hi If the meter beeps once and displays the HI s...

Страница 28: ...ice lancets and test strips are for single patient use Do not share them with anyone including other family members Do not use on multiple patients All products that come in contact with human blood s...

Страница 29: ...EXT Contact Information WARNING Ask your health care professional if Alternative Site Testing AST is right for you Do not calibrate a continuous glucose monitoring device from an AST result Do not cal...

Страница 30: ...sults Logbook Review the Logbook NOTE To return to the Home Logbook press OK Logbook 1 Press and hold OK The Logbook 10 45 12 4 2 To select the blinking Logbook symbol press OK 3 the Logbook press the...

Страница 31: ...LO or HI Results 5 OK to go to the Home screen then select the Logbook View Averages 1 To enter the Logbook from the Home screen press OK while the Logbook 2 button from the Logbook 7 day Average Num...

Страница 32: ...anges smartLIGHT Bluetooth wireless NOTE Press OK to accept the current or changed setting before Access Settings 1 Press and hold OK until the The Home Logbook and Settings 10 45 12 4 2 To highlight...

Страница 33: ...u and return to the Home screen press the or button until the Settings 7 Press OK NOTE If you are in a setting such as Date and you need to exit press OK repeatedly until you get back to the Home Chan...

Страница 34: ...45 45 5 the or button then press OK 6 AM or PM as needed then press OK Change the Date 1 From the Home screen select the Settings symbol and press OK to enter Settings 2 Settings screen press the but...

Страница 35: ...th Day Year m d Day Month Year d m press the or button then press OK 12 4 00 00 4 the or button then press OK 12 4 00 4 5 the or button then press OK 12 4 00 12 6 the or button then press OK 32 TURN O...

Страница 36: ...ngs 2 Settings screen press the button repeatedly until the Sound symbol is blinking then press OK 0n or Off 3 To turn the Sound or 4 Press OK Your meter comes with the Sound Sound Sound is On Two bee...

Страница 37: ...press OK to enter Settings 2 Settings screen press the button repeatedly until the Meal Marker symbols are blinking then press OK On or Off Your meter comes with the Meal Marker 3 To turn Meal Markers...

Страница 38: ...fore Meal Meal Markers 4 Settings Set Meal Marker Feature 1 From the Home screen select the Settings symbol and press OK to enter Settings 2 Settings screen press the button repeatedly until the Remin...

Страница 39: ...s 2 Settings screen press the button repeatedly until the Target symbol is blinking then press OK 39 1 00 39 3 To change the blinking Low end of the Overall Target Range press the or 4 Press OK 39 1 0...

Страница 40: ...s OK to enter Settings 2 Settings screen press the button repeatedly until the Target symbol is blinking then press OK Before Meal After Meal Low Target 39 72 39 The Before Meal After Meal Low NOTE Th...

Страница 41: ...et Range press the or 8 Press OK Set smartLIGHT target range indicator Your meter comes with the smartLIGHT target range indicator Yellow means Above Target Green means In Target Red means Below Targe...

Страница 42: ...Bluetooth 4 Settings Pairing Mode 1 From the Home screen select the Settings symbol and press OK to enter Settings 2 Settings screen press the button repeatedly until the Bluetooth symbol is blinking...

Страница 43: ...meter Your CONTOUR NEXT meter is designed to work with the CONTOUR DIABETES app and your compatible smartphone or You can do the following with your CONTOUR DIABETES app The CONTOUR DIABETES app My Re...

Страница 44: ...s to Pair a Meter To put your meter in pairing mode 1 OK until the meter turns Home 2 button for blinking Bluetooth symbol as shown CAUTION The CONTOUR NEXT meter has not been tested for use with any...

Страница 45: ...CO de 89 12 34 4 Enter the pass code on the smart your meter with the CONTOUR DIABETES app the meter displays a blue light and the Bluetooth The meter returns to the Home Bluetooth NOTE You can updat...

Страница 46: ...ee tissue with soapy water or disinfect for 1 minute using a 2 3 Do not insert anything into the test strip port or attempt to CAUTION Do not allow cleaning solution to run into the meter through open...

Страница 47: ...can transfer test results from the CONTOUR NEXT meter to a computer where they can be summarized in a report with door is completely closed when USB Port CAUTION Do not attempt to perform a blood glu...

Страница 48: ...ode 1 2 3 Press and hold the down arrow button for three seconds to 4 Press OK 5 rFE The screen displays the Radio Frequency Engine software 6 dE 7 Press the down arrow until pressing it does not disp...

Страница 49: ...ormally displaying the Low Batteries symbol until you replace the a test the meter displays the Dead Batteries Replace the Batteries 1 2 tip of a pen into the small hole down lightly to depress the lo...

Страница 50: ...check the date and time after you replace the batteries 4 5 Press each battery into a 6 7 WARNING you suspect a battery has been swallowed or placed inside any part of the body seek medical attention...

Страница 51: ...han CONTOUR NEXT control solution can You should perform a control test when WARNING Shake the control solution well before testing WARNING Do not calibrate your continuous glucose monitoring device f...

Страница 52: ...AUTION Do not use expired material can cause inaccurate expiry dates on your test Refer to your control solution insert your CONTOUR NEXT meter with control solution only when the Contact Information...

Страница 53: ...bottle or foil 2 Insert the grey square end of the test strip into the test strip The meter turns on displaying a test strip with a solution write the date on the bottle 3 Unmixed control solution ma...

Страница 54: ...he meter beeps The meter counts down for 5 seconds before the meter included in your meter Logbook or in targets in the CONTOUR DIABETES 8 Compare your control test result with the range printed on th...

Страница 55: ...ion Displays The meter screen displays error codes E Press OK Contact Information Error Code What It Means What to Do Strip Errors E 1 Down E 4 Inserted test with a CONTOUR NEXT test Moisture E 8 Erro...

Страница 56: ...o Testing Errors Testing Error If the error persists contact Too Cold to Test control solution to a warmer Too Hot to Test Too Cold to Test Too Hot to Test System Errors Meter software or hardware mal...

Страница 57: ...ter CONTOUR NEXT test strips and CONTOUR NEXT control 2 A and serial number B 3 4 Parts Information To replace missing parts or reorder supplies contact Customer Contact Information CONTOUR NEXT CONTO...

Страница 58: ...glucose concentration 5 55 mmol L between YSI laboratory reference method and CONTOUR NEXT meter Within 0 28 mmol L Within 0 56 mmol L Within 0 83 mmol L range Table 2 System accuracy results for gluc...

Страница 59: ...lucose concentrations from 1 9 mmol L to 29 1 mmol L Within 0 83 mmol L or 15 User Accuracy results Technical Information Precision the CONTOUR NEXT blood glucose monitoring system using CONTOUR NEXT...

Страница 60: ...ndard Deviation mmol L 95 CI of SD mmol L Variation of CONTOUR NEXT test strips was tested once on each of Table 2 System intermediate precision results for CONTOUR NEXT meter using CONTOUR NEXT test...

Страница 61: ...emory Battery Type Battery Life Meter Storage Temperature Range Meter Operating Temperature Range Control Testing Temperature Range Meter Operating Humidity Range Test Strip Storage Conditions Dimensi...

Страница 62: ...th other nearby electronic equipment nor are emissions from nearby electronic equipment likely to interfere with the CONTOUR NEXT CONTOUR NEXT CONTOUR NEXT meter meets the requirements of frequency in...

Страница 63: ...system meter packaging and labeling and test strip and control solution Symbol What It Means Caution Read all warnings and precautions in instructions for use Do not reuse Discard Date Control Discar...

Страница 64: ...authority for medical waste Principles of the Procedure The CONTOUR NEXT blood glucose test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the...

Страница 65: ...es 1 Practical Diabetes 2 Annals of Internal Medicine 3 Mayo Clinic Proceedings 4 Diabetes Care 5 on more than one person poses risk for transmitting bloodborne 6 7 Tietz Fundamentals of Clinical Chem...

Страница 66: ...1 2 This warranty is limited to replacement due to defects in parts to replace any units that malfunction or are damaged due to abuse accidents alteration misuse neglect maintenance the use of test s...

Страница 67: ...he CONTOUR NEXT meter when used with any test strips other than CONTOUR NEXT test strips or when the CONTOUR NEXT 5 performance of the CONTOUR NEXT meter or test results when used with any control sol...

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