Bruno Gd40 Delta Blood Glucose Test Strips 25 Pieces Bruno Farmaceutici

BLOOD GLUCOSE MEASUREMENT STRIPS BRUNO GD40 DELTA 25 PIECES BRUNO FARMACEUTICALS

BRUNO FARMACEUTICALS GLUCOSE

GD40
DELTA

Blood glucose test strip/
hemocritic / hemoglobin
- Small blood sample
(1.1 µL)
- No coding required

Warnings
> For in vitro diagnostic use (external use only).
> For single use only.
> Medical personnel and other operators who test multiple patients using this system must handle all components that come into contact with human blood, including disinfected objects, in a manner that prevents the transmission of infectious diseases.
> Read this leaflet and the Blood Glucose Monitoring System Owner's Manual before using this test strip. Use only Bruno GD40 DELTA test strips with the Bruno GD40 DELTA Blood Glucose Monitoring System to ensure accurate results and maintain manufacturer's warranty coverage.
> If the test is performed on patients with particularly low blood pressure or in shock, the results may not be accurate.
> Do not use the Bruno GD40 Test Strip Blood Glucose Monitoring System on critically ill patients. Capillary blood sampling from the appropriate sites is not recommended if the blood glucose monitoring result is hyperglycemia (above 600 mg/dL (33.3 mmol/L)), as peripheral circulation is impaired and the physiological glucose level may not be true. The results may be affected by the following circumstances: severe dehydration due to diabetic ketoacidosis, hyperglycemic stress, non-keto hyperosmolar coma, shock, NYHA Class IV decompensated heart failure, or peripheral arterial occlusive disease.
> Keep test strips and lancets out of reach of children. If swallowed, seek medical attention immediately.

Intended use
The Bruno GD40 DELTA, used in conjunction with the Bruno GD40 DELTA Blood Glucose Monitoring System test strips, allows the patient at home and medical personnel to measure blood glucose levels. Freshly drawn fingerstick blood samples must be used. The system cannot be used for the diagnosis or screening of diabetes mellitus.
Medical personnel may test venous and capillary blood samples; for self-examination, test only capillary whole blood samples. Use only heparin for whole blood anticoagulation.

Limitations
> Hematocrit: The hematocrit level is limited between 0% and 70%. If you do not know your hematocrit level, contact your doctor.
> Neonatal Use: This test strip can be used for testing newborns.
> This test strip is used to test freshly drawn samples of venous, capillary, arterial and neonatal blood.
> Metabolites: Normal blood concentrations of dopamine, L-dopa, methyldopa, uric acid, ascorbic acid, and acetaminophen do not significantly affect blood glucose test results.
> Lipemic effects: Blood triglyceride concentrations up to 3000 mg/dL (33.9 mmol/L) do not significantly affect results; higher levels may affect results.
> Altitude Effects: Altitudes up to 3275 m (10,742 ft) do not affect test results.

Storage and handling
IMPORTANT: Do not use test strips if they have expired.
> Store test strips in a cool, dry place at temperatures between 4°C and 30°C (39.2°F and 86.0°F) and relative humidity less than 85%.
> Keep test strips away from direct sunlight. Do not store strips in a high humidity environment.
> Do not touch the test strips with wet hands.
> Do not bend, cut, or alter the test strip.

Blood sugar test
WASH AND DRY YOUR HANDS BEFORE PERFORMING THE TEST.
The used lancet and test strip constitute a potential biological hazard.
Dispose of them properly in accordance with local regulations.
For more information, see your Owner's Manual.

Interpretation of results
The detected blood glucose values ​​provide plasma equivalent results and are displayed in mg/dL.
Reference values

Time of day	Normal plasma glucose range in people without diabetes
On an empty stomach and before meals	< 100 mg/dL (5.6 mmol/L)
2 hours after a meal	< 140 mg/dL (7.8 mmol/L)

Source: American Diabetes Association (2012). Clinical Practice Recommendations. Diabetes Care, 35 (Supplement 1): S1-100.
To determine your personal reference range, consult your doctor.
Uncertain or contradictory results
If the test results are abnormal or inconsistent with your perceived physical condition:
> Make sure the confirmation window on the test strip is completely filled with blood.
> Check the expiration date of the test strips.
> Check the performance of your meter and test strip using control solutions.
Note: Please note that unusually high or low blood sugar levels may be a sign of a serious medical condition. If most of your results are unusually high or low, contact your healthcare provider.

Quality control tests
Control solutions contain a known amount of glucose that will react with the test strips. You can check the performance of your device, test strip, and technique by comparing the control solution results to the range printed on the test strip package. Regular checking ensures that your test results are accurate. See your Owner's Manual for complete instructions.
IMPORTANT: The reference range of control solutions may change with each new test strip. Be sure to check the range on the package of the strip you are currently using.

Chemical components
> Glucose dehydrogenase (E. coli) 8%
> Enzyme protector 8%
> Electron shuttle system 55%
> Non-reactive ingredients 29%

Further information for medical personnel
When testing patient blood samples, always wear gloves and follow your facility's biohazard control procedures and policies. Use only freshly drawn whole blood samples. Medical personnel may use test strips to test venous and capillary whole blood samples.
Sample size: 1.1 µg
Reaction time: 5 seconds
System measurement range: 10 mg/dL to 600 mg/dL
Hematocrit range: 0% to 70%
Precision
The following table shows how often Bruno GD40 DELTA achieves this goal. The table is based on a study conducted on 100 patients (the test was repeated six times on each patient) to verify the performance level of Bruno GD40 compared to the reference results.

For results with glucose < 100 mg/dL (5.5 mmol/L), percentage (number) of results obtained with Bruno GD40 DELTA that did not deviate by more than ± 15 mg/dL (0.83 mmol/L) from the reference method.	100% (192/192)
For results with glucose ≥ 100 mg/dL (5.5 mmol/L), percentage (number) of results obtained with Bruno GD40 DELTA that did not deviate more than ± 15% from the reference method.	98.0% (400/408)

Precision
The coefficient of variation (%) is less than 5% for both intermediate precision and repeatability.

Format
Pack of 25 pieces.