User's Manual

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LipiPro
TM
Test Strip Information
*NOTE: Please read individual Package of LipidPro
TM
test strip for complete detail information.
LIMITATIONS OF SYSTEM (for Glucose test):
The LipidPro
TM
Glucose Test Strips provide accurate results when the following constraints
are observed:
• Inaccurate results may occur in severely hypotensive individuals or patients in shock.
Inaccurate low results low results may occur for individuals experiencing a hyperglycemic
hyperosmolar state, with or without ketosis. Critically ill patients should not be tested with
blood glucose meters.
• Use only the LipidPro
TM
glucose test strips with the LipidPro
TM
meter.
• Use fresh capillary whole blood only.
• Do not use neonate samples.
• The test strips are for siingle use only. Do not reuse.
• Dehydration may lower test results.
• Glucose test strips used above altitudes of 10,000 feet will have an effect on test results.
Physicians - Please note the following interferences that may affect test results:
• Extremes in hematocrit may affect test results. Hematocrit levels less than 30 % may cause
falsely high reading. Hematocrit levels greater than 55 % may cause falsely low readings.
• Interferences: Acetaminophen, Uric and, Ascorbic acid (Vitamin C), and other reducing
substances when occurring in normal blood or normal therapeutic concentrations do not
significantly affect results. However, abnormally high concentrations may cause
inaccurately high results.
• Lipemic samples; Cholesterol up to 500 mg/dL or triglyceride up to 3000 mg/dl do not
significantly affect the results. Values beyond these levels should be interpreted with
caution.
• Blood samples that contain a high concentration of dissolved oxygen may lower the test
result.
• EDTA containing tube is recommended as an anticoagulant tube.
Performance Characteristics:
The performance of the glucose test strips has been evaluated in laboratory and in clinical
tests.
Measurement Range: The measurement range of the LipidPro
TM
Glucose Testing is 20 to
600 mg/dL.
Accuracy:
The accuracy results obtained with the LipidPro
TM
lipid profile and glucose measuring system
were compared to glucose results obtained with the Hitachi Glucose Auto meter 747, a
laboratory instrument. Glucose levels were measured on 160 patients at three different
clinical centers.
System accuracy results for glucose concentration <75 mg/dL
System accuracy results for glucose concentration ≥ 75 mg/dL
Alternate site :
Alternate site glucose test results obtained from alternative sites were comparend to the
glucose results obtained with the Hitachi Glucose Auto meter 747(reperence method), a
laboratory instrument. Glucose levels were measured at three different clinical centers.
Test results of DORSAL HAND were compared to the reference method.
System accuracy results for glucose concentration<75mg/dL
Within ± 5mg/dL
24/27 (93%)
Within ± 10mg/dL
27/27 (100%)
Within ± 15mg/dL
27/27 (100%)
Within ± 5mg/dL
4/5 (80%)
Within ± 10mg/dL
5/5 (100%)
Within ± 15mg/dL
5/5 (100%)
Within ± 5mg/dL
84/133 (63%)
Within ± 10mg/dL
119/133 (89%)
Within ± 15mg/dL
129/133 (97%)
Within ± 20mg/dL
133/133 (100%)
System accuracy results for glucose concentration ≥ 75 mg/dL
Within ± 5mg/dL
84/133 (63%)
Within ± 10mg/dL
119/133 (89%)
Within ± 15mg/dL
129/133 (97%)
Within ± 20mg/dL
133/133 (100%)
Test results of VENTRAL HAND were compared to the reference method.
System accuracy results for glucose concentration<75mg/dL
Within ± 5mg/dL
4/5 (60%)
Within ± 10mg/dL
5/5 (100%)
Within ± 15mg/dL
5/5 (100%)
System accuracy results for glucose concentration ≥ 75 mg/dL
Within ± 5mg/dL
111/145 (77%)
Within ± 10mg/dL
143/145 (99%)
Within ± 15mg/dL
145/145 (100%)
Within ± 20mg/dL
145/145 (100%)