Descrizione Clinica
IRIS Evolution
Description
Blood glucose monitoring system.
The IRIS Evolution system is designed to measure quantitatively the concentration of glucose in the whole capillary blood. IRIS blood glucose test Evo is based on the measurement of the electrical current caused by the reaction of glucose with reagents on the electrode of the reactive strip. The blood sample is sucked into the tip of the reactive strip by capillary action. Glucose in the sample reacts with the enzyme and mediator. Electrons are generated and produce a current that is directly proportional to the glucose concentration in the sample. After the reaction process, the concentration of glucose in the sample is displayed. The tool is calibrated to display plasma concentration results.
The IRIS Evolution system is intended for external use (in vitro diagnostic use) by people with diabetes and medical professionals, so as to effectively monitor diabetes. The system should not be used for diagnosis on diabetes.
Mode of use
Date and time settings
Set the format now for 12 or 24 hours. Press (O) for adjustment, then hold it down to save the choice and start setting the date.
The year will now flash. Press (O) for adjustment, then press (O) and hold it until the meter emits an acoustic signal for adjustment.
Afterwards it will pass to the next digit. Repeat the previous action until the setting of the year is complete.
The month will blink. Press (O) to adjust the month, hold it until the meter emits an acoustic signal for adjustment.
The date will flash. Press (O) to adjust the date, hold until the meter emits an acoustic signal. Afterwards it will pass to the next digit. Repeat the previous action until the setting of the year is complete.
The hour will flash. Press (O) to adjust the current time, hold until an acoustic signal is issued for the adjustment. Afterwards it will pass to the following digit for the setting. Repeat the previous action until the time setting is completed.
The minute will flash. Press (O) to adjust the minute and hold for adjustment. You'll feel a long beep.
Set audio functionality
After setting the time, the sound signal icon will flash. Press (O) to select "On" or "OFF". Hold down to set.
Now the meter setting is complete. A symbol of a reactive strip is displayed to report that the tool is ready to test.
Meter association with smartphone
The association prepares the IRIS Evolution meter and a smartphone to communicate with each other. Devices must be within 5 meters of each other for synchronization. Download the IRIS application Well before connecting the meter and the Smart Phone.
WARNING
Do not associate another person’s meter with your smartphone.
To pair the Smart Phone with the meter, start from the meter and adhere to the following procedure:
1. turn on the meter, the symbol appears to indicate that Bluetooth is on;
2. to activate Bluetooth on your smartphone, tap the "Settings" icon on the home screen;
3. select "General";
4. select "Bluetooth" and set Bluetooth to "ON";
5. will start the search of the meter within the available arrangements;
6. search for a device called IRIS Evolution. This will be your own meter;
7. touch the voice that represents the IRIS Evolution meter;
8. enter the code using the keyboard;
9. the code is formed by the last 5 digits of the serial number on the back of the meter;
10. Touch "Associa";
11. wait for the status of the smartphone to be "Connected".
Before starting the blood sugar test, you must initially sync the tool with the application. The first time you sync, your smartphone sets the time to the meter. However, the date and time will not be displayed on the meter display until the first test.
The smartphone controls and updates the date and time in the meter whenever it syncs. Check the date and time on your smartphone often to make sure they are correct. For instructions on setting the date and time on your smartphone, see the user manual of your phone.
After matching the tool with the smartphone and initially synchronized with the application, you are ready to start testing. Sync often to wirelessly send test results to the app.
- Open the app on your smartphone.
- Turn on the meter and make sure the Bluetooth symbol is displayed.
- The Synchronization symbol flashes on the meter display.
- "Data sync" will be displayed on your smartphone to inform you that the tool is sending results to the app.
- After synchronization, the application will display a list of new blood glucose results sent by the meter.
Using the meter without the app
The tool can be used without using the application. You can still test blood sugar and review the results on the meter screen.
Take a test
Preparation of reactive strips
1. Wash and dry your hands before testing.
2. Remove a reactive strip from the bottle. Carefully close the lid of the bottle immediately after removing the reactive strip.
3. Insert the reactive strip into the tool towards arrows. The meter lights up after an acoustic signal.
4. A symbol appears with a reactive strip with a flashing blood drop to indicate that the instrument is ready for testing.
Note: Check the expiration date on the reactive strip bottle. IRIS reactive strips Evo has a duration of 6 months after opening the bottle. Write the opening date on the bottle label when opening it for the first time. Make sure the strips are not damaged. Before the test, clean the test site with a tampon of alcohol or soapy water. Wash your hands thoroughly in hot water to increase blood flow if necessary. Then thoroughly dry your hands and the withdrawal site. Make sure there is no cream or lotion on the withdrawal site.
Preparation of the punched device
To obtain a blood sample of the tip of the fingers, adjust the penetration depth to reduce pain. You do not need the clear terminal (AST alternatives) to get a blood sample from your fingertips.
1. Unscrew the cover of the device punctuated by the body of it. Insert a sterile hand into the punched device and push it until the hand stops completely in the device.
2. Hold the hand firmly in the pointed device and rotate the safety tab of the hand, then extract the safety tab from the hand.
Store the safety tab for the subsequent disposal of the hand used.
3. Carefully screw the lid on the punched device. Avoid contact with the exposed needle. Make sure the cover is completely screwed onto the device.
4. Adjust the penetration depth by turning the cover of the punched device. There are a total of 5 penetration depth settings. To reduce pain, use the lower setting that produces an adequate drop of blood.
Regulation:
- 0 and 1 for delicate skins;
- 2 and 3 for normal skins;
- 4 and 5 For callous or thick skins.
Note: Increased pressure of the device on the finger also increases the drilling depth.
Get a drop of blood and run the test
1. Pull back the terminal to load the device punched. The device will issue a click; the release button changes color and becomes orange to indicate that the device pricked now is loaded and ready to get a drop of blood.
2. Press the boxing device as from image. Push the release button to punch the fingertip. You should feel a click when the punched device is activated.
3. Gently massage your finger from the base to the tip to obtain the desired blood volume. Avoid touching the drop of blood. To reduce pain it is recommended to puncture on the finger side. Test immediately after obtaining a necessary amount of blood.
4. Contact immediately the tip of the reactive strip with the drop of blood. The blood will be sucked into the reactive strip through the tip.
Make sure the reactive streak channel has been fully filled.
Keep the tip of the test strip in contact with the blood drop until the meter emits an acoustic signal.
Note: If the blood sample does not fill the reactive strip channel, do not add a second drop. Discard the reactive strip used and test again using a new reactive strip.
5. The meter will start a countdown of 5 seconds. An acoustic signal will alert the test term and the result will be displayed on the meter display.
Disposal of used reactive strips
You can manually extract the reactive strip used after the test. The meter will automatically turn off after an acoustic signal.
Expected results and ideal values for diabetes
Blood glucose values vary according to food intake, drug dosages, health, stress or exercise. It is ideal to control blood glucose levels and compare them to normal results (for non-diabetic patients).
WARNING
- If blood glucose reading is less than 50 mg/dL (2.8 mmol/L) or if you view LO (less than 10 mg/dL (0.6 mmol/L) on the meter display, contact your doctor as soon as possible. - If the test result is higher than 250 mg/dL (13.9 mmol/L) or if you view HI (up to 600 mg/dL (33.3 mmol/L)) on the meter display, please contact your doctor as soon as possible. - Do not modify pharmacological therapy based on the result of the test performed with IRIS Evolution before consulting your doctor. Discussable or inconsistent results: If the result of blood glucose does not match how it feels:
- check the expiry date of the reactive strips used. Make sure that the reactive strip bottle has not been opened for more than 6 months;
- confirm that the temperature in which you are performing tests is between 5 and 45 °C (41-113 °F);
- make sure the reactive strip bottle has been closed properly;
- make sure that the reactive strips have been kept in a cool and dry place;
- make sure the reactive strip has been used immediately after removing it from the bottle;
- make sure you have correctly followed the test procedure;
- run a test using a control solution.
After checking all the conditions listed above, repeat the test with a new reactive strip. If the problem is not solved or you do not feel sure of the result, contact the local dealer.
Remove sterile hand used
Unscrew the punched device cover. Place the safety tab of the hand on a flat and hard surface; carefully insert the needle of the hand into the safety tab.
Press the release button to make sure your device is unloaded. Slide the expulsion button forward to expel the used hand. Reposition the lid of the device pointed on the latter.
Always remove the hands used to prevent injury or contamination.
WARNING
- Do not use the hand if the safety tab is missing or loose when you extract the hand from the package.
- Do not use the hand if the needle is bent.
- Use caution when the needle is exposed.
- Never share lancets or lancing device with other people to prevent possible infections.
- To reduce the risk of infection, always use a new sterile lancet.Do not reuse lancets.
- Avoid contaminating the lancing device or lancets with lotions, oils or dust.
Precautions
- The meter is preset to display blood glucose concentration in millimoles per liter (mmol/L) or milligrams per deciliter (mg/dL) depending on the standard unit of measurement for your country.This unit of measurement cannot be adjusted.
- Do not insert water or other liquids within the meter.
- Keep the test strip slot clean.
- Keep the meter dry and avoid exposure to extreme temperatures or humidity. Don't leave him in the car.
- Don't drop the instrument or wet it. If the tool falls or wet, check the tool by performing a quality control test.
- Do not disassemble the instrument.If the instrument is disassembled, the warranty will be voided.
- Keep the meter and all associated parts out of the reach of children.
- Always keep test strips in the original vial.Close the vial immediately after removing the test strip.
- Do not use the instrument in the presence or if water is being used.
- Wash and dry your hands before and after testing.
- Test strips and lancets are for single use only.
- Don't drop blood directly on the flat surface of the reactive strip.
- Check the expiration dates on the test strip vial and control solution packaging.Do not use expired test strips and control solutions.
- Use only IRIS reactive strips I was with the IRIS Evolution system.
- Use only IRIS control solutions I was with the IRIS Evolution system.
- For self-analysis, consult your doctor or diabetologist before making any changes to the routine of using medication, diet or activity.
- If the system is used unspecifiedly by the manufacturer, the protection provided by the system can be compromised.
Format
Device + 10 reactive strips + 10 pointed hands.
Cod. 555022
Blood glucose monitoring system.
The IRIS Evolution system is designed to measure quantitatively the concentration of glucose in the whole capillary blood. IRIS blood glucose test Evo is based on the measurement of the electrical current caused by the reaction of glucose with reagents on the electrode of the reactive strip. The blood sample is sucked into the tip of the reactive strip by capillary action. Glucose in the sample reacts with the enzyme and mediator. Electrons are generated and produce a current that is directly proportional to the glucose concentration in the sample. After the reaction process, the concentration of glucose in the sample is displayed. The tool is calibrated to display plasma concentration results.
The IRIS Evolution system is intended for external use (in vitro diagnostic use) by people with diabetes and medical professionals, so as to effectively monitor diabetes. The system should not be used for diagnosis on diabetes.
Mode of use
Date and time settings
Set the format now for 12 or 24 hours. Press (O) for adjustment, then hold it down to save the choice and start setting the date.
The year will now flash. Press (O) for adjustment, then press (O) and hold it until the meter emits an acoustic signal for adjustment.
Afterwards it will pass to the next digit. Repeat the previous action until the setting of the year is complete.
The month will blink. Press (O) to adjust the month, hold it until the meter emits an acoustic signal for adjustment.
The date will flash. Press (O) to adjust the date, hold until the meter emits an acoustic signal. Afterwards it will pass to the next digit. Repeat the previous action until the setting of the year is complete.
The hour will flash. Press (O) to adjust the current time, hold until an acoustic signal is issued for the adjustment. Afterwards it will pass to the following digit for the setting. Repeat the previous action until the time setting is completed.
The minute will flash. Press (O) to adjust the minute and hold for adjustment. You'll feel a long beep.
Set audio functionality
After setting the time, the sound signal icon will flash. Press (O) to select "On" or "OFF". Hold down to set.
Now the meter setting is complete. A symbol of a reactive strip is displayed to report that the tool is ready to test.
Meter association with smartphone
The association prepares the IRIS Evolution meter and a smartphone to communicate with each other. Devices must be within 5 meters of each other for synchronization. Download the IRIS application Well before connecting the meter and the Smart Phone.
WARNING
Do not associate another person’s meter with your smartphone.
To pair the Smart Phone with the meter, start from the meter and adhere to the following procedure:
1. turn on the meter, the symbol appears to indicate that Bluetooth is on;
2. to activate Bluetooth on your smartphone, tap the "Settings" icon on the home screen;
3. select "General";
4. select "Bluetooth" and set Bluetooth to "ON";
5. will start the search of the meter within the available arrangements;
6. search for a device called IRIS Evolution. This will be your own meter;
7. touch the voice that represents the IRIS Evolution meter;
8. enter the code using the keyboard;
9. the code is formed by the last 5 digits of the serial number on the back of the meter;
10. Touch "Associa";
11. wait for the status of the smartphone to be "Connected".
Before starting the blood sugar test, you must initially sync the tool with the application. The first time you sync, your smartphone sets the time to the meter. However, the date and time will not be displayed on the meter display until the first test.
The smartphone controls and updates the date and time in the meter whenever it syncs. Check the date and time on your smartphone often to make sure they are correct. For instructions on setting the date and time on your smartphone, see the user manual of your phone.
After matching the tool with the smartphone and initially synchronized with the application, you are ready to start testing. Sync often to wirelessly send test results to the app.
- Open the app on your smartphone.
- Turn on the meter and make sure the Bluetooth symbol is displayed.
- The Synchronization symbol flashes on the meter display.
- "Data sync" will be displayed on your smartphone to inform you that the tool is sending results to the app.
- After synchronization, the application will display a list of new blood glucose results sent by the meter.
Using the meter without the app
The tool can be used without using the application. You can still test blood sugar and review the results on the meter screen.
Take a test
Preparation of reactive strips
1. Wash and dry your hands before testing.
2. Remove a reactive strip from the bottle. Carefully close the lid of the bottle immediately after removing the reactive strip.
3. Insert the reactive strip into the tool towards arrows. The meter lights up after an acoustic signal.
4. A symbol appears with a reactive strip with a flashing blood drop to indicate that the instrument is ready for testing.
Note: Check the expiration date on the reactive strip bottle. IRIS reactive strips Evo has a duration of 6 months after opening the bottle. Write the opening date on the bottle label when opening it for the first time. Make sure the strips are not damaged. Before the test, clean the test site with a tampon of alcohol or soapy water. Wash your hands thoroughly in hot water to increase blood flow if necessary. Then thoroughly dry your hands and the withdrawal site. Make sure there is no cream or lotion on the withdrawal site.
Preparation of the punched device
To obtain a blood sample of the tip of the fingers, adjust the penetration depth to reduce pain. You do not need the clear terminal (AST alternatives) to get a blood sample from your fingertips.
1. Unscrew the cover of the device punctuated by the body of it. Insert a sterile hand into the punched device and push it until the hand stops completely in the device.
2. Hold the hand firmly in the pointed device and rotate the safety tab of the hand, then extract the safety tab from the hand.
Store the safety tab for the subsequent disposal of the hand used.
3. Carefully screw the lid on the punched device. Avoid contact with the exposed needle. Make sure the cover is completely screwed onto the device.
4. Adjust the penetration depth by turning the cover of the punched device. There are a total of 5 penetration depth settings. To reduce pain, use the lower setting that produces an adequate drop of blood.
Regulation:
- 0 and 1 for delicate skins;
- 2 and 3 for normal skins;
- 4 and 5 For callous or thick skins.
Note: Increased pressure of the device on the finger also increases the drilling depth.
Get a drop of blood and run the test
1. Pull back the terminal to load the device punched. The device will issue a click; the release button changes color and becomes orange to indicate that the device pricked now is loaded and ready to get a drop of blood.
2. Press the boxing device as from image. Push the release button to punch the fingertip. You should feel a click when the punched device is activated.
3. Gently massage your finger from the base to the tip to obtain the desired blood volume. Avoid touching the drop of blood. To reduce pain it is recommended to puncture on the finger side. Test immediately after obtaining a necessary amount of blood.
4. Contact immediately the tip of the reactive strip with the drop of blood. The blood will be sucked into the reactive strip through the tip.
Make sure the reactive streak channel has been fully filled.
Keep the tip of the test strip in contact with the blood drop until the meter emits an acoustic signal.
Note: If the blood sample does not fill the reactive strip channel, do not add a second drop. Discard the reactive strip used and test again using a new reactive strip.
5. The meter will start a countdown of 5 seconds. An acoustic signal will alert the test term and the result will be displayed on the meter display.
Disposal of used reactive strips
You can manually extract the reactive strip used after the test. The meter will automatically turn off after an acoustic signal.
Expected results and ideal values for diabetes
Blood glucose values vary according to food intake, drug dosages, health, stress or exercise. It is ideal to control blood glucose levels and compare them to normal results (for non-diabetic patients).
WARNING
- If blood glucose reading is less than 50 mg/dL (2.8 mmol/L) or if you view LO (less than 10 mg/dL (0.6 mmol/L) on the meter display, contact your doctor as soon as possible. - If the test result is higher than 250 mg/dL (13.9 mmol/L) or if you view HI (up to 600 mg/dL (33.3 mmol/L)) on the meter display, please contact your doctor as soon as possible. - Do not modify pharmacological therapy based on the result of the test performed with IRIS Evolution before consulting your doctor. Discussable or inconsistent results: If the result of blood glucose does not match how it feels:
- check the expiry date of the reactive strips used. Make sure that the reactive strip bottle has not been opened for more than 6 months;
- confirm that the temperature in which you are performing tests is between 5 and 45 °C (41-113 °F);
- make sure the reactive strip bottle has been closed properly;
- make sure that the reactive strips have been kept in a cool and dry place;
- make sure the reactive strip has been used immediately after removing it from the bottle;
- make sure you have correctly followed the test procedure;
- run a test using a control solution.
After checking all the conditions listed above, repeat the test with a new reactive strip. If the problem is not solved or you do not feel sure of the result, contact the local dealer.
Remove sterile hand used
Unscrew the punched device cover. Place the safety tab of the hand on a flat and hard surface; carefully insert the needle of the hand into the safety tab.
Press the release button to make sure your device is unloaded. Slide the expulsion button forward to expel the used hand. Reposition the lid of the device pointed on the latter.
Always remove the hands used to prevent injury or contamination.
WARNING
- Do not use the hand if the safety tab is missing or loose when you extract the hand from the package.
- Do not use the hand if the needle is bent.
- Use caution when the needle is exposed.
- Never share lancets or lancing device with other people to prevent possible infections.
- To reduce the risk of infection, always use a new sterile lancet.Do not reuse lancets.
- Avoid contaminating the lancing device or lancets with lotions, oils or dust.
Precautions
- The meter is preset to display blood glucose concentration in millimoles per liter (mmol/L) or milligrams per deciliter (mg/dL) depending on the standard unit of measurement for your country.This unit of measurement cannot be adjusted.
- Do not insert water or other liquids within the meter.
- Keep the test strip slot clean.
- Keep the meter dry and avoid exposure to extreme temperatures or humidity. Don't leave him in the car.
- Don't drop the instrument or wet it. If the tool falls or wet, check the tool by performing a quality control test.
- Do not disassemble the instrument.If the instrument is disassembled, the warranty will be voided.
- Keep the meter and all associated parts out of the reach of children.
- Always keep test strips in the original vial.Close the vial immediately after removing the test strip.
- Do not use the instrument in the presence or if water is being used.
- Wash and dry your hands before and after testing.
- Test strips and lancets are for single use only.
- Don't drop blood directly on the flat surface of the reactive strip.
- Check the expiration dates on the test strip vial and control solution packaging.Do not use expired test strips and control solutions.
- Use only IRIS reactive strips I was with the IRIS Evolution system.
- Use only IRIS control solutions I was with the IRIS Evolution system.
- For self-analysis, consult your doctor or diabetologist before making any changes to the routine of using medication, diet or activity.
- If the system is used unspecifiedly by the manufacturer, the protection provided by the system can be compromised.
Format
Device + 10 reactive strips + 10 pointed hands.
Cod. 555022