GD40 Delta

Blood glucose test strips

hematocritic / hemoglobin
- Small blood sample
(1.1 µL)
- No coding needed

Warnings
> For in vitro diagnostic use (for external use only).
> For single use only.
> Medical staff and other operators carrying 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 Bruno GD40 DELTA Reagent Strips with the Bruno GD40DELTA Blood Glucose Monitoring System to ensure accurate results and maintain manufacturer 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 blood glucose control system in critically ill patients. The detection of capillary blood from the appropriate sites is not recommended, if the result of the blood glucose monitoring is a hyperglycemia (above 600 mg / dL (33.3 mmol / L)), as the peripheral circulation is impaired and the physiological level glucose level may not be real. Results may be affected by the following circumstances: severe dehydration due to diabetic keto-acidosis, hyperglycemic stress, non-ketonic hyperosmolar coma, shock, NYHA Class IV decompensated heart failure, or peripheral arterial occlusive disease.
> Keep the test strips and lancets out of the reach of children. If swallowed, seek medical attention immediately.

Intended use
The Bruno GD40 DELTA, used together with the Bruno GD40 DELTA crawling blood glucose control system, allow the patient in the home and medical staff to measure blood glucose levels. Freshly drawn blood samples from a finger should be used. The system cannot be used for diagnosing and screening diabetes mellitus.
Medical personnel can test venous and capillary blood specimens; test only capillary whole blood specimens for self-examination.Use heparin only for whole blood anticoagulation.

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

Storage and handling
IMPORTANT: Do not use test strips if they have expired.
> Store the 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 below 85%.
> Keep the test strips out of direct sunlight. Do not store the 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 glucose test
WASH AND DRY HANDS BEFORE RUNNING THE TEST.
Used lancet and test strip pose a potential biological hazard.
Dispose of them properly in accordance with local regulations.
For more information, see the Owner's Manual.

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

Source: AmericanDiabetes Association (2012). Clinical Practice Recommendations. Diabetes Care, 35 (Supplement 1): S1-100.

Uncertain or contradictory results
If the test results are abnormal or inconsistent with the 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 the test strip for control solutions medium.
Note: Note that unusually high or low blood glucose levels can be a symptom of a serious medical condition. If most results are unusually high or low, contact your doctor.

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

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

Additional information for medical personnel
When testing patient blood samples, always wear gloves and follow your facility's biohazard control procedures and regulations. Use only freshly drawn whole blood samples. Clinicians can use the test strips to test whole venous and capillary 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 the frequency with which Bruno GD40 DELTA reaches 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 level of performance of Bruno GD40 compared to the reference results.

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

Format
Pack of 25 pieces.