Instructions for Accu-Chek Instant Test Strips No. 50
Description
Accu-Chek Instant test strips, together with Accu-Chek Instant and Accu-Chek Instant S meters, are intended for the quantitative determination of glucose in fresh capillary whole blood obtained from the finger, palm, forearm and upper arm, as an aid in monitoring the effectiveness of glucose control.
Accu-Chek Instant test strips, together with Accu-Chek Instant and Accu-Chek Instant C blood glucose meters, are intended for in vitro diagnostics for self-monitoring by patients with diabetes.
Accu-Chek Instant test strips, together with Accu-Chek Instant and Accu-Chek Instant C meters, are intended for in vitro diagnostics by physicians in clinical settings. Venous, arterial and neonatal blood may only be used by physicians.
This system is not intended for the diagnosis of diabetes mellitus or for the analysis of neonatal cord blood samples.
Equipment
A package containing test strips and leaflets.
All packaging components can be disposed of with household waste. Dispose of used test strips according to local regulations. If you have any questions, contact Roche.
Storage conditions
Store test strips between 4 and 30°C. Do not freeze test strips. Use test strips between 4 and 45°C.
Use test strips in humidity between 10% and 90%. Do not store test strips in areas with high heat or humidity, such as bathrooms or kitchens.
Store unused test strips in the original test strip container with the cap closed.
Close the test strip container tightly immediately after removing the test strip to protect the test strips from moisture.
Use the test strip immediately after removing it from the test strip container.
Throw away test strips if they have expired. Test strips may give incorrect results after the expiration date. The expiration date is printed on the test strip package and on the label of the test strip container. Test strips can be used until the printed expiration date if stored and used correctly. This applies to test strips from a new, unopened test strip container and to test strips from an already opened test strip container.
Application features
A normal fasting glucose level in adults without diabetes is less than 5.6 mmol/L (100 mg/dL).
A normal glucose level in adults without diabetes 2 hours after a meal, such as when simulated by a 75-g oral glucose tolerance test (OGTT), is less than 7.8 mmol/L (140 mg/dL). The criterion for diagnosing diabetes in adults is a fasting blood glucose level of 7.0 mmol/L (126 mg/dL) or higher, confirmed by two measurements. Adults with a fasting blood glucose level of 5.6 to 6.9 mmol/L (100 to 125 mg/dL) are defined as having impaired fasting glucose (prediabetes). There are also other criteria for diagnosing diabetes. To find out if you have diabetes, talk to your doctor.
For people with diabetes: Talk to your doctor about the blood glucose range that is right for you. You should treat low or high blood glucose levels as recommended by your doctor.
Unusual blood glucose results
If the meter displays LO, your blood glucose level may be below 0.6 mmol/L (10 mg/dL). If the meter displays HI, your blood glucose level may be above 33.3 mmol/L (600 mg/dL). For detailed information on error messages, see the user manual.
If your blood glucose test result does not match how you feel, do the following:
Repeat the blood glucose test with a new test strip.
Perform a control determination as described in the user manual.
For information on other causes, see the user manual.
If your symptoms still don't match your blood glucose results, contact your doctor.
Never ignore symptoms or make significant changes to your diabetes management program without consulting your doctor.
Limitation
Samples with lipemia (triglycerides) >20.3 mmol/L (>1800 mg/dL) may result in elevated blood glucose results.
Do not use this system during xylose absorption testing.
Do not use this system if you are receiving intravenous ascorbic acid.
In case of impaired peripheral circulation, capillary blood sampling from approved sampling sites is not recommended, as the results may not correspond to physiological blood glucose levels. This may occur in the following conditions: Severe dehydration due to diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome without ketoacidosis, hypotension, shock, decompensated heart failure grade 4 on
NYHA or occlusive peripheral arterial disease.
Hematocrit should be between 10 and 65%. If you don't know your hematocrit, ask your doctor.
This system was tested at altitudes up to 3094 meters above sea level.
Recommendations for use
The Accu-Chek Instant system complies with ISO 15197:2013 (In vitro diagnostic test systems - requirements for blood glucose monitoring systems intended for self-monitoring of blood glucose levels in the management of diabetes mellitus).
Calibration and tracking:
The system (glucose meter and test strips) was calibrated using venous blood containing different concentrations of glucose as a calibration medium. Control values were obtained using the hexokinase method, which was calibrated using the ID-GCMS method. The ID-GCMS method, as a method of the highest metrological quality (order), corresponds to the NIST basic standard. Using this traceability chain, the determination result obtained using these test strips for control solutions can also be traced back to the NIST standard (traceable).
Lower limit of detection (lowest value displayed):
0.6 mmol/L (10 mg/dL) for test strip
System detection range:
0.6–33.3 mmol/L (10–600 mg/dL)
Sample volume:
0.6 μl
Determination time:
<4 seconds
Producer
Roche Diabetes Kea GmbH, Andhofer Strasse 116 68305, Mannheim, Germany
Roche Diabetes Care GmbH Sandhofer Strasse 116 68305 Mannheim, Germany
ACCU-CHEK, ACCU-CHEK INSTANT and ACCU-CHEK are trademarks of Roche.
Authorized representative in Ukraine
Roche Ukraine LLC, Ukraine 03150, Kyiv, Velyka Vasylkivska St. 139, 5th floor.
Official importer
LLC “Dialog Diagnostics”, Ukraine, 04205, Kyiv, Obolonskyi Avenue 32.
