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TECHNICAL,

  

SER

VICE & CARE

TECHNICAL,

  

SER

VICE & CARE

®

Technical Information

Mean, 

mmol/L

Pooled 

Standard 

Deviation

95% Confidence 

Interval of Standard 

Deviation, mmol/L

Coefficient of 

Variation, %

 2.6

0.04

0.04 – 0.05

1.7

 4.7

0.06

0.06 – 0.07

1.3

 7.7

0.12

0.11 – 0.13

1.5

 11.2

0.15

0.13 – 0.16

1.3

 18.1

0.28

0.26 – 0.30

1.5

Intermediate precision (which includes variability 

across multiple days) was evaluated using 3 control 

solutions. With each of 3 lots of C

ontour

 n

ext

 

test strips, each control was tested once on each 

of 10 instruments on 10 separate days for a total of 

300 readings.
Table 5 – System intermediate precision results 
for C

ontour

 n

ext

 EZ meter using C

ontour

 n

ext

 

test strips

Control 

Level

Mean, 

mmol/L

Standard 

Deviation, 

mmol/L

95% Confidence 

Interval of Standard 

Deviation, mmol/L

Coefficient 

of Variation, 

%

Low

 2.37

0.03

0.031 – 0.036

1.4

Normal  7.12

0.09

0.080 – 0.095

1.2

High

 20.89

0.36

0.331 – 0.392

1.7

Technical Information

Technical Information

Technical Information

Acceptance criteria in ISO 15197: 2013 are 

that 95% of all differences in glucose values 

(i.e., between reference method and meter) should 

be within ±0.83 mmol/L for glucose values less than 

5.55 mmol/L, and within ±15% for glucose values 

greater than or equal to 5.55 mmol/L.

Table 3 – System accuracy results for glucose 
concentrations between 1.0 mmol/L and 
25.6 mmol/L

Within ± 0.83 mmol/L or ±15%

600 of 600 (100%)

A repeatability study was conducted with the 

C

ontour

®

n

ext

 EZ blood glucose monitoring system 

using 5 venous whole blood specimens with glucose 

levels from 2.6 to 18.8 mmol/L. Multiple replicates 

(n=300) were tested using multiple C

ontour

 n

ext

 EZ 

blood glucose meters and 3 lots of C

ontour

®

n

ext

 

blood glucose test strips. The following precision 

results were obtained.

Table 4 – System repeatability results for 
C

ontour

®

n

ext

 eZ meter using C

ontour

®

n

ext

 

test strips

User Accuracy

Precision

A study evaluating glucose values from fingertip 

capillary blood samples obtained by 115 lay 

persons showed the following results: 100% within 

± 0.83 mmol/L of the medical laboratory values at 

glucose concentrations below 5.55 mmol/L and 

98.8% within ± 15% of the medical laboratory glucose 

concentrations at or above 5.55 mmol/L.

Содержание Contour next EZ

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Страница 2: ...oisonous If swallowed immediately contact your poison control center The Contour Next EZ blood glucose monitoring system is intended for single patient use only and should not be shared Intended Use T...

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Страница 6: ...label Information For Safety Information For Safety Have all the materials you will need ready before you begin testing This includes your Contour Next EZ meter the Contour Next test strips the lancin...

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Страница 12: ...keep all meter surfaces wet for 60 seconds Using a new germicidal wipe carefully wipe all outer surfaces of your meter until wet Do not allow cleaning solution to run into the meter through areas suc...

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Страница 24: ...to see this error please contact Customer Service See the back cover for contact information What You See What You Should Do What It Means E11 Abnormal result Remove the test strip and retest using a...

Страница 25: ...be damaged If result is still out of range contact Customer Service See the back cover for contact information What You See What You Should Do What It Means Error Codes and Symbols Error Codes and Sym...

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Страница 27: ...e humidity heat cold dust or dirt Your meter should be cleaned and disinfected once a week For cleaning and disinfection instructions see pages 16 19 Symptoms of High or Low Blood Glucose You can bett...

Страница 28: ...the Contour Next EZ meter The Contour Next EZ meter meets the requirements of IEC 61000 4 2 for immunity to electrostatic discharge Avoid use of electronic devices in very dry environments especially...

Страница 29: ...e Do not use during or soon after xylose absorption testing Xylose in the blood will cause an interference Technical Information Accuracy Difference range in values between YSI laboratory reference me...

Страница 30: ...n ISO 15197 2013 are that 95 of all differences in glucose values i e between reference method and meter should be within 0 83 mmol L for glucose values less than 5 55 mmol L and within 15 for glucose...

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Страница 32: ...warranty regarding the performance of the Contour Next EZ meter or test results when used with any software other than the Glucofacts Deluxe diabetes management software where supported from Ascensia...

Страница 33: ...olution Normal 84329992 Contour Next control solution Low 84330001 Contour Next control solution High Part numbers are subject to change without notice 1 Canadian Diabetes Association 2013 Clinical Pr...

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Страница 35: ...licenses see www patents ascensia com Ascensia the Ascensia Diabetes Care logo Clinilog Contour Glucofacts and the No Coding logo are trademarks and or registered trademarks of Ascensia Diabetes Care...

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