TEST STRIPS FOR THE APPARATUS FOR BLOOD SUGAR 50 pieces

PURPOSE: The system controls the level of glucose in the blood Rightest is intended for use by persons suffering from diabetes mellitus. This system is used to quantify the level of glucose in whole blood capillary and helps to monitor the effectiveness of treatment of patients with diabetes at home and at medical institutions.
Test Strips GS100 intended solely for carrying out assays in vitro (outside the body). Rightest GM100 system examines overall capillary blood, but the results of measurements (meter readings) are equivalent to the results of the analysis of glucose in the blood plasma obtained in laboratory conditions.
Test strips GS 100 is designed for use with meter GM100. System control the level of glucose in the blood Rightest GM100 consists of meter GM100, test strips GS100, lancing device (appliance) and lancet.

PREPARATION lancing device:
1) Remove the tip of the device for determining the depth of the puncture.
2) Firmly put new disposable needle (lancet) in the nest.
3) Unscrew the protective cap of the needle (lancet) and set it aside. Do not throw away because you need at the completion of the measurement.
4) Replace the tip of the lancing device.
5) Select the required depth of the puncture, by turning the top of the device to the required window. The depth of the puncture is calculated in accordance with the type of skin: soft and thin skin to skin with an average thickness; for thick or calloused skin.
6) Hold the device in one hand and with the other pull the trigger - the mechanism will be charged. Release the trigger. It automatically returns to its original position. Leave it aside, you will need during the next stage.

ATTENTION: different systems to control the level of glucose in the blood may have different lancing device. Please carefully follow the owner's manual to be sure of the proper implementation of measurement.

SEQUENCE OF MEASURING:
7) Wash and dry your hands well.
8) Take a test strip from the vial and immediately close the door.
9) Place the test strip port in the arrow-pointer to be located on top. The test strip is inserted, if you hear a beep, and the test strip is not moving. The meter turns on automatically.
10) Once you see the display flashing sign drop, touch the lancing device to the side of the pad of your finger and press prick. Best places to prick are average and ring finger.
11) Squeeze a small amount of blood. For the measurement using the system Rightest GM100 recommend that you take a sample size from 1.4 to 2.5 l. Do not squeeze the very large amount of blood. Blood sample over 4.0 l may be too large for proper operation of the encoder port.
12) blood drop gently touch the entrance bled and hold until you hear a beep, and while the test window is not completely filled with blood. If the test window is not completely filled with blood and / or measurement does not start, remove the test strip and repeat the measurement with a new one.
13) Once the blood enters the test strip, the screen started working mode countdown time. The result is displayed after 8 seconds. For the measurement results in detail
You can read the user manual.
14) Unscrew the cap of the mobile device. Without touching the needle (lancet) pinned her to the protective cap.
15) Pressing the button prick with one hand with the other pull the trigger on the device - used needle (lancet) will be automatically removed.
16) Dispose of used needles (lancets) in special containers for sharps or biohazard substances.
17) After the test, turn the nozzle with a device for determining the depth to its original position.

More detailed information on using the meter and interpretation of the results of the measurements can be read in the User Guide.
The results of the measurements appear on the screen in mmol / l. Before applying the changes to the program for the treatment of diabetes, talk to your doctor.
Repeat the test with a new test strip if indicators of the level of glucose in the blood are abnormally high or low, or if you doubt the results. If the results remain unusually high or low, immediately contact a doctor. Measurement accuracy of the meter can be defined further in customer service by using the control solution.
GM100 meter shows the results of between 0.6 and 33.3 mmol / l. If the measurement result is lower than 0.6 mmol / L (10 mg / dL), the screen displays "Lo" (low). Repeat measurement once again with a new test strip. If again get the result "Lo", immediately contact a doctor.
If the test result is greater than the highest indicator is provided in the system (higher than 33.3 mmol / L), the screen displays a sign "Hi" (high). Repeat measurement once again with a new test strip. If again get the result "Hi", immediately contact a doctor.

POSSIBLE MEASURES: Diagnosis of diabetes *

Glucose levels (mmol / l)
Overall plasma capillary blood
Norma Fasting (8 hours without food and drinks) 4.0 to 6.1 3.3 to 5.5
After PTTG **
Under 7.8 Under 7.8
Diabetes mellitus Fasting (8 hours without food and drinks) Over 7.0 Over 6.1
2 hours after eating or PTTG Over Over 11.1 11.1 ***
Random glucose (raised blood sugar) Over 11.1 Over 11.1

* According to the "Criteria for violation of carbohydrate metabolism" (WHO, 1999).
** PTTG - oral test to detect violations glucose tolerance.
*** In recent years, the criterion of level of glycemia 2 hours after PTTG is reduced to a reading of 7.5 mmol / l.

PRECAUTIONS:
Each time before using the test strip check its expiry date stated on the packaging. Do not use tape expired;
Precision close vial immediately after you have removed it from the test strip;
Do not bend the test strip. Damage to the test strip may result in the occurrence of false results;
Do not use twice the same test strip;
Do not use twice a lancet. Observe the rules for the utilization of lances;
If you've moved from an environment where the temperature is outside the limits set by the technical capabilities of the meter in another environment with acceptable temperature, wait 30 minutes before making the measurement.
CAUTION:
Keep test strips and vial caps into the reach of children. If swallowed, they can lead to suffocation.

RESTRICTIONS:
The contents of a large amount of lipids (fats) in the blood can affect the value of the testimony. To take account of such effects, patients should know the basic data on the level of glucose in the blood, which are established under the supervision of their physician in clinical laboratory methods to start measurements at home. These basic indicators need to periodically be specified.
The data for the level of glucose in capillary blood, measured by the meter can be significantly lower than the "real" level of blood glucose in patients with hyperglycemic hyperosmolar state and regardless of the presence or absence of ketoacidosis. Patients who are in critical condition should not use the system Rightest GM100 or need to use it very carefully.
Upon receipt of data lower than 2.7 mmol / L or greater than 14 mmol / l is needed as quickly as possible to consult a doctor.
Healthcare providers should periodically compare the readings of the apparatus of patients with laboratory instruments. For this purpose it is necessary to take the same sample and the same time to measure the glucose level with the meter and laboratory equipment, and then to compare the results. As a comparison should be used oxidase- and hexokinase laboratory methods that have proven effective.
When operating the meter should use fluoride as a preservative for samples of venous blood.
Incorrectly inflated results can be obtained if on the fingers are traces of food or drinks containing sugar.
The difference in performance that exists at "determining glucose in whole blood and plasma / serum can be a reason for obtaining variable results.
STORAGE AND USE:
Keep the test strips in the original packing, at a temperature of 4 ° C to 30 ° C and a relative humidity below 90%. Do not freeze.
After removing the test strip from the vial, immediately replace the cap and screw it tightly. The vial Do not leave open. If the tape is left in air for a long time, it sucks in itself moisture, which may be the cause of an incorrect result of measurement.
Use the vial of test strips for three months from the opening of the vial.
The amplitude of the measurement:
The amplitude of the measurements of the system Rightest GM100 is from 0.6 mmol / l to 33.3 mmol / l.

QUALITY CONTROL: For information refer to the "Quality Control" in the User Guide.

ACCURACY:
The accuracy of the results using a glucometer GM100 is demonstrated by comparing the measurement results with him a blood sample (equivalent to the testimony of plasma glucose) with indications for plasma glucose level measured by laboratory instrument. 164 patients were studied. Each patient self-conducted analysis of blood (taken from the finger), using a glucometer GM100. After 5 minutes the test is evaluated with a laboratory instrument which determines the concentration of plasma gpyukoza. 99% of all measurements are in the meter range ± 20% of the laboratory reference method results in glucose concentration> 4.1 mmol / L and ± 15% at a concentration of <4.1 mmol / L.

Troubleshooting and service:
Refer service center on questions arising in connection with the operation of the system to control the level of glucose in the blood Rightest GM100.

PRINCIPLE OF THE DETERMINATION OF THE LEVEL OF BLOOD GLUCOSE:
Glucose oxidase and potassium ferricyanide, which is located in the test strip react with glucose present in the sample of blood. As a result of a chemical reaction occurs in the device electrical current whose strength is proportional to the glucose in the blood sample. In accordance with the magnitude of the current, the meter determines the concentration of glucose in the test coupon.

SPECIFICATIONS:
The amplitude of the measurement system to control the level of glucose in the blood Rightest GM100 is from 0.6 to 33.3 mmol / l.

ACCURACY:
Accuracy was assessed by comparing samples of overall venous blood (I) and control solution samples at concentration levels of glucose (II) 10-day period. Used a lot of test strips and 10 unit.

(I) Model comprehensive venous blood
Parameters P-01 P-02 P-03 P-04 P-05
(1) Total amount of analysis (n) | 100 100 100 100 100
(2) indication mmol / l 2.3 5.4 7.0 11.7 16.6
(3) Drift mmol / L 0.06 0.11 0.12 0.16 0.18
(4) CV (%) 2,8% 2,2% 1,7% 1,4% 1,1%

(II) Control solution:
Features Low Medium High
(1) Total analyzes (n) 100 100 100
(2) Indication, mmol / l 2,4 5,5 16,5
(3) Drift mmol / L 0.06 0.10 0.21
(4) CV (%) 2,6% 1,8% 1,3%

ACCURACY:
The accuracy of the results using a glucometer GM100 is demonstrated by comparing the measurement results with him a blood sample (equivalent to the testimony of plasma glucose) with indications for plasma glucose level measured by laboratory instrument. 164 patients were studied. Each patient self-conducted analysis of blood (taken from the finger), using a glucometer GM100. After 5 minutes the test is evaluated with a laboratory instrument which determines the concentration of plasma glucose.
Received the following ratio (As a reference was used laboratory instrument Olympus AU2700).
Test range - from 1.9 to 31.6 mmol / l;
Total quantity of tests - 164;
Deviation - 0.99;
Correlation coefficient - 0.993
Factors affecting the measurement results:
Measurement of glucose in blood, may be inaccurate at elevated content in the blood of:
uric acid> 0.54 mmol / L (> 9mg / dl);
L-dopa> 0.076 mmol / l (> 1,5mg / dL);
Methyl-dopa> 0.071 mmol / L (> 1,5mg / dl);
Cholesterol> 6.5 mmol / L (> 250 mg / dL).
Reagents:
Test strip GS100 incorporates the following reagents:
Glucose oxidase (Aspergillus niger) (GOD) - 8,5%;
Potassium ferrocyanide - 48.5%;
Inactive ingredients - 43%.