Descrizione Clinica
VTRUST TD-4279
Monitoring System
glycemia and beta-chetoni
Description
This system is designed to be used outside the body (in vitro diagnostic use) by diabetics at home and healthcare personnel in clinical environments such as help to monitor the effectiveness of diabetes control and beta ketones.
The system is intended to be used for quantitative measurement of glucose (sugar) in fresh whole blood samples taken from the finger.
Professionals can use the system to test capillary, venous, arterial blood samples; domestic use is limited to the whole capillary blood test.
Specifications
Mode of use
Before using the tool for the first time or when you change the battery, you need to check and update the settings.
Glycemia test
The tool offers 4 measuring modes, General, AC, PC and QC. You can switch from one mode to another: start with the switched tool. Insert a reactive strip to turn on the device. The screen will display the drop symbol that will flash on the display and "Gen". Press the button to switch from General to AC, PC and QC modes.
Test beta-chetoni
The tool only offers a “Gen” measurement mode. Start with the tool off. Insert a reactive strip to turn on the device. The screen will display the drop symbol that will flash on the display and "Gen".
Test with control solutions
Control solutions contain a known quantity of glucose or beta-chetons that reacts with reactive strips and are used to ensure that the tool and strips are working properly together.
Test with control solutions when:
- use the meter for the first time;
- at least once a week to regularly check the reactive strips and the instrument;
- you start using a new bottle of reactive strips;
- it is suspected that strips or meter do not function properly;
- the results of the blood sugar test are not consistent with the patient's feelings or the results are not accurate;
- to practice with the test;
- if the meter fell or damaged.
Strips, control solutions, stinging or sterile hands may not be included in the kit (please check the content on the product packaging). They can be purchased separately. Make sure in advance you have all the necessary elements to perform a blood glucose test or beta-chetoni.
It is recommended to test the control solution at room temperature (20-25 °C). Before testing make sure that control solutions, meter and reactive strips are in this specified temperature range.
Insert the reactive strip into the tool to turn it on. Wait for the device to display the simobole of the reactive strip and blood drop.
Press the button to mark the test as a test of the control solution. When "QC" is displayed, the tool will store the test result in memory under "QC". If you press the button again, "QC" will disappear and the test will no longer be a test of the control solution. When running the test with the control solution, you must mark in such a way that the test result is not confused with the results of the blood glucose tests stored. Otherwise, the results of blood glucose tests will be mixed with the test results performed with the control solution.
Shake the bottle of the control solution before use. Remove the first drop and apply the second drop on the tip of the bottle cap. Tap the drop with the absorbent hole of the reactive strip inserted in the meter. Once the strip confirmation window is fully filled, the device will start the countdown.
To avoid contaminating the control solution, do not apply it directly on a strip.
After counting until 0, the test result of the control solution is displayed on the display. Compare the result with the printed range on the strip bottle: the result should return to this interval. Otherwise, please read the instructions again and repeat the test with the control solution.
The range of the control solution printed on the reactive strip bottle only concerns the control solution. It does not refer to the level of glucose or beta ketones in the blood.
Test with blood
To reduce the risk of infection:
- never share a hand or sting;
- always use a new sterile hand. The hands are only for single use;
- avoid using lotions for the hands, oils, dirt or residues on the hands and on the sting.
Massaging the puncture site prior to blood sampling to stimulate blood influx has a significant influence on the blood glucose value obtained. The blood taken knows a site that has not been massaged has a concentration of glucose considerably different from that of the blood taken from the massaged finger.
Before starting, wash and dry your hands. Select the puncture site on the fingertip. Clean the sting site with cotton filled with 70% alcohol and let it dry in the air. Massage the puncture site for about 20 seconds before stinging.
Press the tip firmly against the lower side of the finger tip. Press the button to punch your finger; the click indicates that the typing was completed. Choose a different typing site each time you run the test. Repeated bites on the same site can cause pain and calluses. It is recommended to discard the first drop of blood.
Insert the reactive strip into the tool to turn it on. Wait for the device to display the symbol of the reactive strip and drop. Select the desired measurement mode by pressing "M".
Use the adjusted sting to type. Eliminate the first drop of blood using clean cotton. The minimum amount of blood the instrument needs is 0.5 microliters (mcL) for glucose and 1 mcL for beta-chetons. Gently press the puncture site to get another drop of blood. Do not press the sting site against the reactive strip. Be careful not to spread the blood sample.
Suction the drop of blood from the absorbent channel of the reactive strip. The confirmation window must be fully filled, if a sufficient quantity of sample has been applied. Do not remove the finger until an acoustic signal is issued.
If you do not apply a blood sample on the reactive strip within 3 minutes, the tool will turn off automatically. You need to remove and reinsert the reactive strip to start a new test.
The confirmation window must be filled with blood before the device starts the countdown. Never try to add more blood on the reactive strip after it has already applied. Eliminate the reactive strip used and run another test with a new strip. If you have problems filling the confirmation window, please contact your physician or Customer Service for assistance.
The result of the blood test will be displayed after the device has finished the countdown to zero. The results will be stored automatically.
Expel the strip by pressing the expulsion button on the side. The device will turn off automatically after expelled the strip.
The hands and strips used constitute a biological risk. Please dispose of it carefully according to local regulations.
Maintenance and cleaning
To replace the batteries, make sure the instrument is switched off. Press the edge of the cover and lift it to remove it. Remove old batteries and replace them with two new 1.5 V AAA alkalines. Close the battery cover. If the batteries are inserted correctly, a "beep" will be heard.
Battery replacement does not affect the results of the tests stored. As with all small batteries, these must be kept away from children. In case of ingestion, consult a doctor immediately. Batteries could leak chemicals if not used for a long time. Remove batteries if you do not intend to use the device for a long time (for example, 3 months or more). Dispose of batteries according to local regulations.
To clean the meter externally, use a moistened cloth with water or a neutral detergent, then dry the device with a soft and dry cloth. Do not rinse with water. Do not use organic solvents to clean the tool.
Warnings
Use the appliance only for the intended use described in the user manual.
Do not use accessories not specified by the manufacturer.
Do not use the appliance if it does not work properly or if it is damaged.
This device does not serve as a cure for symptoms or diseases. The measured data is only reference data. Always consult your physician for the interpretation of results.
Before using the device to perform the blood sugar test, carefully read all instructions and practice the test. Perform all quality controls as indicated.
Keep the device and material to run the blood sugar test away from the reach of children. Small objects such as battery cover, batteries, reactive strips, hands and bottle caps constitute a danger of suffocation.
Use this device in a dry environment; in particular the presence of synthetic materials (synthetic clothing, carpets, etc.) can cause harmful electrostatic discharges that can give rise to incorrect results.
Do not use the instrument near sources of strong electromagnetic radiation, as these may interfere with proper functioning.
Correct maintenance and periodic control with control solutions are essential for the longevity of the device. If you are not convinced of the accuracy of the measure, please contact Customer Service.
Avoid strong impacts or drop the instrument.
The meter used must be treated as a contaminated object that can lead to a risk of infection during measurement. The batteries of the device used must be removed and the instrument must be disposed of in accordance with current regulations.
Tap the reactive strip with clean and dry hands. Use the reactive strip immediately after extracting it from the bottle. Do not use reactive strips beyond the expiry date. This can cause unsatisfactory results.
Do not bend alter or cut a reactive strip in any way. Keep the strip bottle out of the reach of children as the cap and strips can constitute a risk of suffocation. In case of ingestion, consult a doctor immediately.
Conservation
Store the instrument at a temperature ranging from -20 °C to 60 °C, relative humidity below 95%. Avoid direct sunlight and high humidity.
Store strips in cool and dry place, away from direct sunlight and heat sources (temperature 2-30 °C). Don't freeze. Store reactive strips only in their original bottle. After picking a strip from the bottle, close the bottle cap immediately. Strips are valid until the expiry date of the package.
Store the hermetically closed control solution at temperatures between 2 °C and 30 °C. Don't freeze.
Post-opening validation (control solution): three months.
Format
Contains:
- meter;
- reactive strips;
- control solution.
Cod. 3800501
This system is designed to be used outside the body (in vitro diagnostic use) by diabetics at home and healthcare personnel in clinical environments such as help to monitor the effectiveness of diabetes control and beta ketones.
The system is intended to be used for quantitative measurement of glucose (sugar) in fresh whole blood samples taken from the finger.
Professionals can use the system to test capillary, venous, arterial blood samples; domestic use is limited to the whole capillary blood test.
Specifications
| Model | TD-4279 B |
| Size and weight | 96 (L) x 61 (W) x 26 (H) mm 67.2 g |
| Power supply | Two 1.5 V AAA alkaline batteries (sufficient for about 1,000 measurements) |
| Display | LCD |
| Memory | 1,000 results included date and time |
| External Output | Bluetooth |
| Strip insert detection | Automatic |
| Sample detection | Automatic |
| Countdown | Automatic |
| Automatic shutdown | After 2 minutes of non-use |
| Temperature warning | Automatic |
| Working conditions | From 10 °C to 40 °C (from 50 °F to 104 °F) relative humidity (non-condensing) below 85% |
| Storage meter/Transport conditions | From -20 °C to 60 °C (from -4 °F to 140 °F) relative humidity below 95% |
| Conservation strips/Transport conditions | From 2 °C to 30 °C (from 35,6 °F to 86 °F) relative humidity below 85% |
| Measuring units | mg/dL for glucose mmol/L for beta-tones |
| Measurement range | 20 to 600 mg/dL for glucose From 0.1 to 8,0 mmol/L for beta-chetons |
Mode of use
Before using the tool for the first time or when you change the battery, you need to check and update the settings.
Glycemia test
The tool offers 4 measuring modes, General, AC, PC and QC. You can switch from one mode to another: start with the switched tool. Insert a reactive strip to turn on the device. The screen will display the drop symbol that will flash on the display and "Gen". Press the button to switch from General to AC, PC and QC modes.
Test beta-chetoni
The tool only offers a “Gen” measurement mode. Start with the tool off. Insert a reactive strip to turn on the device. The screen will display the drop symbol that will flash on the display and "Gen".
Test with control solutions
Control solutions contain a known quantity of glucose or beta-chetons that reacts with reactive strips and are used to ensure that the tool and strips are working properly together.
Test with control solutions when:
- use the meter for the first time;
- at least once a week to regularly check the reactive strips and the instrument;
- you start using a new bottle of reactive strips;
- it is suspected that strips or meter do not function properly;
- the results of the blood sugar test are not consistent with the patient's feelings or the results are not accurate;
- to practice with the test;
- if the meter fell or damaged.
Strips, control solutions, stinging or sterile hands may not be included in the kit (please check the content on the product packaging). They can be purchased separately. Make sure in advance you have all the necessary elements to perform a blood glucose test or beta-chetoni.
It is recommended to test the control solution at room temperature (20-25 °C). Before testing make sure that control solutions, meter and reactive strips are in this specified temperature range.
Insert the reactive strip into the tool to turn it on. Wait for the device to display the simobole of the reactive strip and blood drop.
Press the button to mark the test as a test of the control solution. When "QC" is displayed, the tool will store the test result in memory under "QC". If you press the button again, "QC" will disappear and the test will no longer be a test of the control solution. When running the test with the control solution, you must mark in such a way that the test result is not confused with the results of the blood glucose tests stored. Otherwise, the results of blood glucose tests will be mixed with the test results performed with the control solution.
Shake the bottle of the control solution before use. Remove the first drop and apply the second drop on the tip of the bottle cap. Tap the drop with the absorbent hole of the reactive strip inserted in the meter. Once the strip confirmation window is fully filled, the device will start the countdown.
To avoid contaminating the control solution, do not apply it directly on a strip.
After counting until 0, the test result of the control solution is displayed on the display. Compare the result with the printed range on the strip bottle: the result should return to this interval. Otherwise, please read the instructions again and repeat the test with the control solution.
The range of the control solution printed on the reactive strip bottle only concerns the control solution. It does not refer to the level of glucose or beta ketones in the blood.
Test with blood
To reduce the risk of infection:
- never share a hand or sting;
- always use a new sterile hand. The hands are only for single use;
- avoid using lotions for the hands, oils, dirt or residues on the hands and on the sting.
Massaging the puncture site prior to blood sampling to stimulate blood influx has a significant influence on the blood glucose value obtained. The blood taken knows a site that has not been massaged has a concentration of glucose considerably different from that of the blood taken from the massaged finger.
Before starting, wash and dry your hands. Select the puncture site on the fingertip. Clean the sting site with cotton filled with 70% alcohol and let it dry in the air. Massage the puncture site for about 20 seconds before stinging.
Press the tip firmly against the lower side of the finger tip. Press the button to punch your finger; the click indicates that the typing was completed. Choose a different typing site each time you run the test. Repeated bites on the same site can cause pain and calluses. It is recommended to discard the first drop of blood.
Insert the reactive strip into the tool to turn it on. Wait for the device to display the symbol of the reactive strip and drop. Select the desired measurement mode by pressing "M".
Use the adjusted sting to type. Eliminate the first drop of blood using clean cotton. The minimum amount of blood the instrument needs is 0.5 microliters (mcL) for glucose and 1 mcL for beta-chetons. Gently press the puncture site to get another drop of blood. Do not press the sting site against the reactive strip. Be careful not to spread the blood sample.
Suction the drop of blood from the absorbent channel of the reactive strip. The confirmation window must be fully filled, if a sufficient quantity of sample has been applied. Do not remove the finger until an acoustic signal is issued.
If you do not apply a blood sample on the reactive strip within 3 minutes, the tool will turn off automatically. You need to remove and reinsert the reactive strip to start a new test.
The confirmation window must be filled with blood before the device starts the countdown. Never try to add more blood on the reactive strip after it has already applied. Eliminate the reactive strip used and run another test with a new strip. If you have problems filling the confirmation window, please contact your physician or Customer Service for assistance.
The result of the blood test will be displayed after the device has finished the countdown to zero. The results will be stored automatically.
Expel the strip by pressing the expulsion button on the side. The device will turn off automatically after expelled the strip.
The hands and strips used constitute a biological risk. Please dispose of it carefully according to local regulations.
Maintenance and cleaning
To replace the batteries, make sure the instrument is switched off. Press the edge of the cover and lift it to remove it. Remove old batteries and replace them with two new 1.5 V AAA alkalines. Close the battery cover. If the batteries are inserted correctly, a "beep" will be heard.
Battery replacement does not affect the results of the tests stored. As with all small batteries, these must be kept away from children. In case of ingestion, consult a doctor immediately. Batteries could leak chemicals if not used for a long time. Remove batteries if you do not intend to use the device for a long time (for example, 3 months or more). Dispose of batteries according to local regulations.
To clean the meter externally, use a moistened cloth with water or a neutral detergent, then dry the device with a soft and dry cloth. Do not rinse with water. Do not use organic solvents to clean the tool.
Warnings
Use the appliance only for the intended use described in the user manual.
Do not use accessories not specified by the manufacturer.
Do not use the appliance if it does not work properly or if it is damaged.
This device does not serve as a cure for symptoms or diseases. The measured data is only reference data. Always consult your physician for the interpretation of results.
Before using the device to perform the blood sugar test, carefully read all instructions and practice the test. Perform all quality controls as indicated.
Keep the device and material to run the blood sugar test away from the reach of children. Small objects such as battery cover, batteries, reactive strips, hands and bottle caps constitute a danger of suffocation.
Use this device in a dry environment; in particular the presence of synthetic materials (synthetic clothing, carpets, etc.) can cause harmful electrostatic discharges that can give rise to incorrect results.
Do not use the instrument near sources of strong electromagnetic radiation, as these may interfere with proper functioning.
Correct maintenance and periodic control with control solutions are essential for the longevity of the device. If you are not convinced of the accuracy of the measure, please contact Customer Service.
Avoid strong impacts or drop the instrument.
The meter used must be treated as a contaminated object that can lead to a risk of infection during measurement. The batteries of the device used must be removed and the instrument must be disposed of in accordance with current regulations.
Tap the reactive strip with clean and dry hands. Use the reactive strip immediately after extracting it from the bottle. Do not use reactive strips beyond the expiry date. This can cause unsatisfactory results.
Do not bend alter or cut a reactive strip in any way. Keep the strip bottle out of the reach of children as the cap and strips can constitute a risk of suffocation. In case of ingestion, consult a doctor immediately.
Conservation
Store the instrument at a temperature ranging from -20 °C to 60 °C, relative humidity below 95%. Avoid direct sunlight and high humidity.
Store strips in cool and dry place, away from direct sunlight and heat sources (temperature 2-30 °C). Don't freeze. Store reactive strips only in their original bottle. After picking a strip from the bottle, close the bottle cap immediately. Strips are valid until the expiry date of the package.
Store the hermetically closed control solution at temperatures between 2 °C and 30 °C. Don't freeze.
Post-opening validation (control solution): three months.
Format
Contains:
- meter;
- reactive strips;
- control solution.
Cod. 3800501