Bruno GD40 Delta Blood Glucose Measurement Strips 25 Pieces

Glucose/emtocritical / hemoglobin test strip
- Small blood sample
   (1,1 µL)
- No need for a blood test. of coding

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

Intended Use
The Bruno GD40 DELTA, used in conjunction with the Test Strips Glucose Monitoring System Bruno GD40 DELTA, allow the patient in the home and medical staff to measure blood sugar levels. Freshly drawn blood samples from a finger should be used. The system cannot be used for the diagnosis or screening of diabetes mellitus. perform tests on venous and capillary blood samples; For self-examination, test capillary whole blood samples only. Use only heparin for anticoagulation of whole blood.

Limitations
> Hematocrit: The hematocrit level is 50%. limited between 0% and 70%. If you do not know your hematocrit level, consult your doctor.
> Neonatal use: This test strip can be used in newborns. be used for tests on newborns.
> This test strip is used to test freshly drawn venous, capillary, arterial and neonatal blood samples.
> Metabolites: A normal blood concentration of dopamine, L-dopa, methyldopa, uric acid, ascorbic acid, and acetaminophen does not significantly affect blood glucose test results.
> Lipemic effects: a blood triglyceride concentration up to 3000 mg/dL (33.9 mmol/L) does not significantly affect the results; higher levels high temperatures may affect the 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 humidity. relative less than 85%.
> Keep test strips out of direct sunlight. Do not store the strips in a humid environment. high.
> Do not touch the test strips with wet hands.
> Do not bend, cut, or alter the test strip.

Testing your blood glucose
WASH AND DRY YOUR HANDS BEFORE PERFORMING THE TEST.
The used lancet and test strip are a potential biohazard.
Dispose of them properly in accordance with the health and safety regulations. local regulations.
Refer to your Owner's Manual for more information.

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

Time of day	Glucose range in normal plasma in people without diabetes
Fasting 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.
Consult your physician to determine your personal reference range.
Uncertain or contradictory results
If the test results are abnormal or inconsistent with your perceived physical condition:
> ; Make sure the test strip confirmation window is completely filled with blood.
> Check the expiration date of the test strips.
> Check the performance of your meter and test strip with control solutions.
Note: Note that unusually high or low blood sugar levels may be a sign of a serious medical condition. If most of the results are the same. check your doctor.

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

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

Additional information for medical professionals
When testing patient blood samples, always wear gloves and follow procedures and your facility's biohazard control policies. Use only freshly drawn whole blood samples. Medical staff can use the test strips to test capillary and venous 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%
Accuracy
The following table shows the the frequency with which Bruno GD40 DELTA achieves this goal is indicated. The table is based on a study conducted on 100 patients (the test was repeated six times on each patient) to verify the level of performance of Bruno GD40 compared to the reference results.

For glucose < 100 mg/dL (5.5 mmol/L), the percentage (number) of Bruno GD40 DELTA results 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 Bruno GD40 DELTA results that deviated within ± 15% from the reference method.	98.0% (400/408)

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

Format
Pack of 25 pieces.