Prodigy VOICE - Performance Characteristics

PRODIGY Voice® Blood Glucose Meter PRODIGY Voice® Blood Glucose Meter
Owner’s Manual Owner’s Manual
taken and tested within 15 minutes of each
other.
• Wash your hands before obtaining a blood
sample.
• Never use your meter with blood that has
been collected in a gray top test tube.
• Use fresh capillary blood only.
You may still have a variation from the result
because blood glucose levels can change
signicantly over short periods, especially if you
have recently eaten, exercised, taken medication
or experienced stress.
1
In addition, if you have
eaten recently, the blood glucose level from a
nger stick can be up to 70 mg/dL (3.9 mmol/L)
higher than blood drawn from a vein (venous
sample) used for a lab test.
2
Therefore, it is best to fast for eight (8) hours
before doing comparison tests. Factors such as
the amount of red blood cells in the blood (a high
or low hematocrit) or the loss of bodily uids
(severe dehydration) may also cause a meter
result to be different from a laboratory result.
References:
1
Surwit, R.S., and Feinglos, M.N.:
70
Diabetes Forecast (1988), April, 49-51.
2
Sacks, D.B:“Carbohydrates.” Burtis,C.A, and
Ashwood,E.R.(ed.),Tietz Textbook of Clinical
Chemistry. Philadelphia:W.B. Saunders Company
(1994),959.
Performance Characteristics
• Accuracy: ±15 mg/dL when glucose <75 mg/dL
±20% when glucose >75 mg/dL
• Precision: This study shows the CV
(correlation variation) is less
than 5%.
• The device has been certied to meet the
following standards:
98/79/EC, IEC 60601-1, IEC 61010-1,
IEC 60601-1-2, IEC61326, and ISO 15197
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