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GEN blood glucose monitoring system

TECHNICAL INFORMATION

Symbol

Graphic/Title Explanatory Text

Standard

Reference

6-8

Batch Code

Indicates the manufacturer’s

batch code so that the medical

device can be identified.

ISO 15223-1,

Clause 5.1.5

IEC 61010-2-

101, Table 1,

Symbol 102

In Vitro

Diagnostic

Medical Device

Indicates a medical device that is

intended to be used as an in vitro

diagnostic medical device.

ISO 15223-1,

Clause 5.5.1

Manufacturer

Indicates the medical device

manufacturer.

ISO 15223-1,

Clause 5.1.1

Temperature

limit

Indicates the temperature limits

to which the medical device can

be safely exposed.

ISO 15223-1,

Clause 5.3.7

Control

Indicates a control material

that is intended to verify the

performance characteristics of

another medical device.

ISO 15223-1,

Clause 5.5.2

Consult

instructions

for use

Indicates the need for the user to

consult the instructions for use.

ISO 15223-1,

Clause 5.4.3

Symbol

Graphic/Title Explanatory Text

Standard

Reference

6-8

Caution: Read

all warnings and

precautions

in instructions

for use

Indicates the need for the user

to consult the instructions for

use for important cautionary

information such as warnings and

precautions that cannot, for a

variety of reasons, be presented

on the medical device itself.

ISO 15223-1,

Clause 5.4.4

IEC 61010-1,

Table 1,

Symbol 14

Do not re-use

Indicates a medical device that

is for single use or for use on

a single patient during a single

procedure.

ISO 15223-1,

Clause 5.4.2

Sterilized using

irradiation

Indicates a medical device

that has been sterilized using

irradiation.

ISO 15223-1,

Clause 5.2.4

Principles of the Procedure: The

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GEN blood

glucose test is based on measurement of electrical current caused

by the reaction of the glucose with the reagents on the electrode of

the test strip. The blood sample is drawn into the tip of the test strip

through capillary action. Glucose in the sample reacts with FAD

glucose dehydrogenase (FAD-GDH) and the mediator. Electrons are

generated, producing a current that is proportional to the glucose in

the sample. After the reaction time, the glucose concentration in the

sample is displayed. No calculation by the user is required.

Comparison Options: The

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GEN system is designed

for use with capillary whole blood. Comparison with a laboratory

method must be done simultaneously with aliquots of the same sample.

NOTE: Glucose concentrations drop rapidly due to glycolysis

(approximately 5%–7% per hour).

Содержание Next GEN 7383

Страница 1: ...45 4 12 22 93 USER GUIDE Uses only Contour Next blood glucose test strips Works with the Contour Diabetes app available for download from the App Store or on Google PlayTM Blood Glucose Monitoring Sys...

Страница 2: ...teries Contour Next GEN user guide Contour Next GEN quick reference guide Contour Next test strips Contour Next control solution Microlet Next lancing device Microlet lancets Carrying case Web registr...

Страница 3: ...Always dispose of used test strips and lancets as medical waste or as advised by your health care professional All products that come in contact with human blood should be handled as if capable of tr...

Страница 4: ...nded for use in healthcare or assisted use settings such as hospitals physician offices or long term care facilities because it has not been cleared by FDA for use in these settings including for rout...

Страница 5: ...ver have a decimal point Results in mmol L will always have a decimal point Example 93 or 52 Check your display screen to be sure the results are shown correctly mg dL If not contact Customer Service...

Страница 6: ...trademark SM service mark All other trademarks are properties of their respective owners and are used solely for informative purposes No relationship or endorsement should be inferred or implied Table...

Страница 7: ...n to scroll continuously through a list Press the OK button to accept a selection To exit from the Logbook or Averages and return to the Home screen press the OK button NOTE When a symbol is blinking...

Страница 8: ...esult is below 20 mg dL Your Logbook Meter Settings Fasting marker Symbol What the Symbol Means Before Meal marker After Meal marker No marker selected A Target Range or Target Range setting smartLIGH...

Страница 9: ...ht from the test strip port is visible If there are missing characters or if the strip port light is a color other than white contact Customer Service This may affect the way you see your results NOTE...

Страница 10: ...gainst the Before Meal Target Range Pre set Before Meal Target Range 70 mg dL 130 mg dL Symbol What the Symbol Means Comparison Target Range After Meal Use the After Meal marker when testing blood sug...

Страница 11: ...our hands with antibacterial soap and water and dry them well before and after testing or handling the meter lancing device or test strips If your meter is being operated by a second person who is pro...

Страница 12: ...ld not be used for assisted blood draws by health care providers or at health care provision sites and should never be shared with anyone else even a family member due to risk of infection Do not reus...

Страница 13: ...est strip and reinsert it to begin a test CAUTION Do not use expired materials Using expired material can cause inaccurate results Always check the expiration dates on your test materials Get the Bloo...

Страница 14: ...ps twice and the screen displays a blinking blood drop with a plus sign the test strip does not have enough blood 2 Apply more blood to the same test strip within 60 seconds NOTE If the screen display...

Страница 15: ...al Marker press the or button on the meter to scroll between markers 118 Example If you scroll up to Before Meal the Before Meal marker blinks 118 Example If you scroll down to After Meal the After Me...

Страница 16: ...sult with the units time date meal marker if selected and target range symbol Above Target In Target or Below Target Example Blood test result with Meal Marker selected and a Reminder set 10 45 4 12 2...

Страница 17: ...care professional s advice immediately Expected Test Result Values Blood sugar values will vary depending on food intake medication dosages health stress or activity Nondiabetic plasma glucose concent...

Страница 18: ...reuse lancets Used lancets are not sterile Use a new lancet each time you test Always wash your hands with antibacterial soap and water and dry them well before and after testing or handling the mete...

Страница 19: ...p from the bottle 2 Tightly close the bottle lid immediately after you remove the test strip 3 Hold the test strip with the grey square end facing up 4 Insert the grey square end of the test strip int...

Страница 20: ...a problem with the test strips the meter or your testing technique If your control test result is out of range do not use your Contour Next GEN meter for blood sugar testing until you resolve the issu...

Страница 21: ...Averages press the button 4 To return to your Logbook readings press the button on the 7 d Avg 7 day Average 5 To exit Averages and return to the Home screen at any time press the OK button Settings...

Страница 22: ...turns on The Home screen has 2 options Logbook and Settings 10 45 4 12 22 2 To highlight the Settings symbol press the button 3 When the Settings symbol is blinking press the OK button to enter Setti...

Страница 23: ...m d or d m is blinking 5 To select Month Day Year m d or Day Month Year d m press the or button then press the OK button 4 12 22 22 6 To change the year blinking press the or button then press the OK...

Страница 24: ...f for a below target blood sugar reading turn the smartLIGHT feature to Off The meter returns to the Home screen Set Meal Markers 1 Press and hold the OK button until the meter turns on The Home scree...

Страница 25: ...Press the OK button The meter returns to the Home screen Change Overall Target Range When the Meal Marker feature is Off your meter provides a pre set Overall Target Range A Target Range has a low li...

Страница 26: ...until the Target symbol is blinking then press the OK button The meter displays the Low Target screen WARNING Discuss your Target Range settings with your health care professional NOTE There is only...

Страница 27: ...l is blinking then press the OK button On or Off smartLIGHT Symbol 5 To turn the smartLIGHT feature On or Off press the or button to display the option you want 6 Press the OK button Set Bluetooth Wir...

Страница 28: ...est results as they compare with your targets When your Contour Next GEN meter is paired with the Contour Diabetes app You can set or change a Meal Marker in the meter Logbook from the app The app wil...

Страница 29: ...Meter Care Caring for your meter Store the meter in the carrying case provided whenever possible Wash and dry hands well before handling to keep the meter and test strips free of water oils and other...

Страница 30: ...is providing testing assistance to you the meter and lancing device should be disinfected prior to use by the second person Evaluate your device after performing cleaning and disinfection to ensure th...

Страница 31: ...lancing device for cleaning and disinfection Transfer Results to the Contour Diabetes app You can automatically transfer results from your Contour Next GEN meter wirelessly to your compatible smartpho...

Страница 32: ...TION Use only approved equipment e g USB cable from the manufacturer or certified body such as UL CSA TUV or CE Replace the Batteries 1 Before replacing your batteries turn off your meter 2 Turn the m...

Страница 33: ...Repeat the test with a new strip If the error persists contact Customer Service WARNING Keep batteries away from children Many types of batteries are poisonous If swallowed immediately contact your p...

Страница 34: ...range between the actual blood glucose level and the Contour Next GEN meter result Within 5 Within 10 Within 15 Within 20 Percent and number of samples within specified range 64 96 241 371 93 53 347 3...

Страница 35: ...rence will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the use...

Страница 36: ...GEN meter complies with the electromagnetic requirements specified in IEC 60601 1 2 Edition 4 0 Electromagnetic emissions are low and unlikely to interfere with other nearby electronic equipment nor...

Страница 37: ...rtant cautionary information such as warnings and precautions that cannot for a variety of reasons be presented on the medical device itself ISO 15223 1 Clause 5 4 4 IEC 61010 1 Table 1 Symbol 14 Do n...

Страница 38: ...abetes 1986 3 2 100 4 Atkin SH et al Fingerstick glucose determination in shock Annals of Internal Medicine 1991 114 12 1020 1024 5 American Diabetes Association 2 Classification and diagnosis of diab...

Страница 39: ...previously manufactured instruments 4 Ascensia Diabetes Care has no knowledge of the performance of the Contour Next GEN blood glucose meter when used with any test strips other than Contour Next test...

Страница 40: ...ure 20 38 Second Chance sampling viii 17 Settings 20 31 32 34 35 37 38 42 43 Bluetooth wireless functionality 43 Date 34 Meal Markers 37 Reminder Feature 20 38 smartLIGHT target range indicator 42 Sou...

Страница 41: ...supplier of this product is authorized to grant such a license Ascensia the Ascensia Diabetes Care logo Contour Microlet the No Coding logo Second Chance the Second Chance sampling logo Smartcolor and...

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