Bayer HealthCare Contour USB Guia do Utilizador descarregar pdf (Página 30)

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Technical,

Service & Care

Technical,

Service & Care

System Performance Information

Precision and Accuracy Summary:

Accuracy: The accuracy of the CONTOUR

USB blood

glucose monitoring system has been assessed in a

correlation study conducted by healthcare professionals. In

this study 100 fresh capillary blood specimens were tested

with the CONTOUR USB blood glucose monitoring

system by 100 untrained people with diabetes using three

test strip lots. The reference measurement was done on

the YSI™ Glucose analyzer. CONTOUR USB data compare

well with the results from the YSI method.

Regression Statistics (Plasma/Serum Reference):

plasma reference glucose range: 3.2 mmol/L to 22.8 mmol/L

Lot y =

Correlation

Coefﬁ cient (r)

1 0.97x + 0.25 mmol/L 0.975

2 1.04x – 0.23 mmol/L 0.971

3 1.01x + 0.15 mmol/L 0.979

Precision: A study was conducted with the CONTOUR

USB blood glucose monitoring system with ﬁ ve heparinized

whole blood specimens with glucose levels from 2.3 mmol/L

to 18.9 mmol/L. Multiple replicates (n=100) were tested

using multiple CONTOUR

USB blood glucose meters and

one lot of CONTOUR

blood glucose test strips. The

following precision results were obtained.

Plasma/Serum:

Mean SD

Coefﬁ cient

of variation

2.4 mmol/L 0.06 mmol/L 2.4%

4.7 mmol/L 0.08 mmol/L 1.7%

7.3 mmol/L 0.10 mmol/L 1.3%

11.3 mmol/L 0.19 mmol/L 1.7%

18.4 mmol/L 0.21 mmol/L 1.2%

Limitations:

• Preservatives: Blood may be collected by healthcare

professionals into test tubes containing heparin.

Do not use other anticoagulants or preservatives.

• Altitude: Up to 3048 meters (10,000 feet) does not

signiﬁ cantly affect results.

• Lipemic Specimen: Cholesterol concentrations

>12.9 mmol/L or triglyceride concentrations

>34.3 mmol/L may produce elevated readings.

• Peritoneal dialysis solutions: Icodextrin does not

interfere with CONTOUR

test strips.

• Xylose: Do not use during or soon after xylose

absorption testing. Xylose in the blood will cause

an interference.

• Contraindications: Capillary blood glucose testing

may not be clinically appropriate for persons with

reduced peripheral blood ﬂ ow. Shock, severe

hypotension, hyperosmolar hyperglycemia and severe

dehydration are examples of clinical conditions that

may adversely affect the measurement of glucose in

peripheral blood.

• Interference: Reducing substances occurring in the

blood naturally (uric acid, bilirubin) or from therapeutic

treatments (ascorbic acid, acetaminophen) will not

signiﬁ cantly affect results. The limiting concentrations

of these compounds are listed in your test strip insert.

System Requirements:

Windows

XP SP3, Vista SP2

Mac: OS

X v10.5.2 (Intel

64 bit processors only)

High-Power USB port

Java 1.6.0_07 or higher

For latest compatibility: www.bayerdiabetes.ca

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