Contour Next Link 2.4, Руководство пользователя

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57
TECHNICAL
& CARE
Accuracy
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.
User Accuracy
A study evaluating glucose values from fingertip capillary blood samples obtained by
218 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 98.4% within ± 15% of
the medical laboratory glucose concentrations at or above 5.55 mmol/L.
Table 3 — System accuracy results for glucose concentrations between 2.0 mmol/L and
26.5 mmol/L
Within ±0.83 mmol/L or ±15% 600 of 600 (100%)
Precision
A repeatability study was conducted with the C
ONTOUR
N
EXT
LINK 2.4 blood glucose
monitoring system using 5 venous whole blood specimens with glucose levels from 2.2 to
18.5 mmol/L. Multiple replicates (n=300) were tested using multiple C
ONTOUR
N
EXT
LINK 2.4
blood glucose meters and 3 lots of C
ONTOUR
N
EXT
blood glucose test strips. The following
precision results were obtained.
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
LINK 2.4 meter using
C
ONTOUR
N
EXT
test strips
Control
Level
Mean,
mmol/L
Standard
Deviation
95% Confidence Interval of
Standard Deviation, mmol/L
Coefficient of
Variation (%)
Low 2.57 0.041 0.038 - 0.045 1.6
Normal 7.23 0.114 0.105 - 0.124 1.6
High
21.60 0.366 0.338 - 0.400 1.7
Table 4 — System repeatability results for C
ONTOUR
N
EXT
LINK 2.4 meter using
C
ONTOUR
N
EXT
test strips
Mean,
mmol/L
Pooled Standard
Deviation
95% Confidence Interval of
Standard Deviation, mmol/L
Coefficient of
Variation (%)
2.20 0.04 0.040 - 0.047 2.0
4.48 0.06 0.053 - 0.063 1.3
6.79 0.09 0.082 - 0.097 1.3
11.36 0.16 0.143 - 0.170 1.4
18.34 0.25 0.232 - 0.274 1.4
81552940_CntrNextLINK2_4_UG_EN_FpBp_v5.indd 57 8/18/16 11:21 AM
TECHNICAL
& CARE
56
®
Symptoms of High or Low Blood Sugar
Symptoms of High or Low Blood Sugar
You can better understand your test results by being aware of the symptoms of high or low
blood sugar. Some of the most common symptoms are:
Low blood sugar
(Hypoglycaemia):
High blood sugar
(Hyperglycaemia):
Ketones (Ketoacidosis):
• Shakiness
• Sweating
• Fast Heartbeat
• Blurred Vision
• Confusion
• Passing Out
• Irritability
• Seizure
• Extreme Hunger
• Dizziness
• Frequent Urination
• Excessive Thirst
• Blurred Vision
• Increased Fatigue
• Hunger
• Shortness of Breath
• Nausea or Vomiting
• Very Dry Mouth
Table 1 — System accuracy results for glucose concentration < 5.55 mmol/L
Within ± 0.28 mmol/L Within ± 0.56 mmol/L Within ± 0.83 mmol/L
160 of 186 (86.0%) 183 of 186 (98.4%) 186 of 186 (100%)
Technical Information
Accuracy
The C
ONTOUR ®
N
EXT
LINK 2.4 blood glucose monitoring system was tested in 100 capillary
blood samples using 600 C
ONTOUR ®
N
EXT
test strips. Two replicates were tested with each
of 3 lots of C
ONTOUR
N
EXT
test strips for a total of 600 readings. Results were compared to
the YSI
®
glucose analyzer, which is traceable to the CDC hexokinase method.
7
The tables
below compare the performance of the 2 methods.
WARNING
If you are experiencing any of these symptoms, test your blood sugar. If your
test result is under 2.8 mmol/L or above 13.9 mmol/L, contact your health care
professional immediately.
For additional information and a complete list of symptoms, contact your health
care professional.
Table 2 — System accuracy results for glucose concentration ≥ 5.55 mmol/L
Within ± 5% Within ± 10% Within ± 15%
307 of 414 (74.2%) 411 of 414 (99.3%) 414 of 414 (100%)
81552940_CntrNextLINK2_4_UG_EN_FpBp_v5.indd 56 8/18/16 11:21 AM
57
TECHNICAL
& CARE
Accuracy
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.
User Accuracy
A study evaluating glucose values from fingertip capillary blood samples obtained by
218 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 98.4% within ± 15% of
the medical laboratory glucose concentrations at or above 5.55 mmol/L.
Table 3 — System accuracy results for glucose concentrations between 2.0 mmol/L and
26.5 mmol/L
Within ±0.83 mmol/L or ±15% 600 of 600 (100%)
Precision
A repeatability study was conducted with the C
ONTOUR
N
EXT
LINK 2.4 blood glucose
monitoring system using 5 venous whole blood specimens with glucose levels from 2.2 to
18.5 mmol/L. Multiple replicates (n=300) were tested using multiple C
ONTOUR
N
EXT
LINK 2.4
blood glucose meters and 3 lots of C
ONTOUR
N
EXT
blood glucose test strips. The following
precision results were obtained.
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
LINK 2.4 meter using
C
ONTOUR
N
EXT
test strips
Control
Level
Mean,
mmol/L
Standard
Deviation
95% Confidence Interval of
Standard Deviation, mmol/L
Coefficient of
Variation (%)
Low 2.57 0.041 0.038 - 0.045 1.6
Normal 7.23 0.114 0.105 - 0.124 1.6
High
21.60 0.366 0.338 - 0.400 1.7
Table 4 — System repeatability results for C
ONTOUR
N
EXT
LINK 2.4 meter using
C
ONTOUR
N
EXT
test strips
Mean,
mmol/L
Pooled Standard
Deviation
95% Confidence Interval of
Standard Deviation, mmol/L
Coefficient of
Variation (%)
2.20 0.04 0.040 - 0.047 2.0
4.48 0.06 0.053 - 0.063 1.3
6.79 0.09 0.082 - 0.097 1.3
11.36 0.16 0.143 - 0.170 1.4
18.34 0.25 0.232 - 0.274 1.4
81552940_CntrNextLINK2_4_UG_EN_FpBp_v5.indd 57 8/18/16 11:21 AM
TECHNICAL
& CARE
56
®
Symptoms of High or Low Blood Sugar
Symptoms of High or Low Blood Sugar
You can better understand your test results by being aware of the symptoms of high or low
blood sugar. Some of the most common symptoms are:
Low blood sugar
(Hypoglycaemia):
High blood sugar
(Hyperglycaemia):
Ketones (Ketoacidosis):
• Shakiness
• Sweating
• Fast Heartbeat
• Blurred Vision
• Confusion
• Passing Out
• Irritability
• Seizure
• Extreme Hunger
• Dizziness
• Frequent Urination
• Excessive Thirst
• Blurred Vision
• Increased Fatigue
• Hunger
• Shortness of Breath
• Nausea or Vomiting
• Very Dry Mouth
Table 1 — System accuracy results for glucose concentration < 5.55 mmol/L
Within ± 0.28 mmol/L Within ± 0.56 mmol/L Within ± 0.83 mmol/L
160 of 186 (86.0%) 183 of 186 (98.4%) 186 of 186 (100%)
Technical Information
Accuracy
The C
ONTOUR ®
N
EXT
LINK 2.4 blood glucose monitoring system was tested in 100 capillary
blood samples using 600 C
ONTOUR ®
N
EXT
test strips. Two replicates were tested with each
of 3 lots of C
ONTOUR
N
EXT
test strips for a total of 600 readings. Results were compared to
the YSI
®
glucose analyzer, which is traceable to the CDC hexokinase method.
7
The tables
below compare the performance of the 2 methods.
WARNING
If you are experiencing any of these symptoms, test your blood sugar. If your
test result is under 2.8 mmol/L or above 13.9 mmol/L, contact your health care
professional immediately.
For additional information and a complete list of symptoms, contact your health
care professional.
Table 2 — System accuracy results for glucose concentration ≥ 5.55 mmol/L
Within ± 5% Within ± 10% Within ± 15%
307 of 414 (74.2%) 411 of 414 (99.3%) 414 of 414 (100%)
81552940_CntrNextLINK2_4_UG_EN_FpBp_v5.indd 56 8/18/16 11:21 AM 81552940_CntrNextLINK2_4_UG_EN_FpBp_v6_placed.pdf:60