LinkSun G-425-3 Blood Glucose Monitoring System
User Manual
Introduction
Dear G-425-3 Blood Glucose Monitoring System Owner:
Thank you for choosing this system! This manual contains important information you must know about the system. Please read it thoroughly and carefully.
The system provides No Code function, which means that you don't need to calibrate your meter, making it easier for the user to monitor blood glucose at home.
Important Safety Instructions
- The meter and lancing device are for single patient use. Do not share them with anyone, including other family members! Do not use on multiple patients!
- All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.
- Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
Read This Before Using
DANGER - Misuse of this electrical device can cause electrocution, burns, fire, and other HAZARDS. Basic safety precautions should always be taken, including all those listed below.
Close supervision is necessary when equipment is used by, on, or near children, handicapped persons, or invalids.
The following basic safety notice should always be taken:
- Do not place the device in liquid, nor put it where it could fall into liquid.
- Use the device only for the intended use described in this manual.
- Do not use adjuncts which are not supplied by the producer.
- Do not make the device come into contact with surfaces which are too hot to touch.
- Do not use the device where aerosol sprays are being used.
- Do not use the device if it is not working properly, or if it has been damaged.
- Read all the manual, and practice the test, and then use the product to test your blood glucose. Do all quality control checks as directed and consult with a diabetes expert.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE.
Before You Begin
Installing the Battery
- Open the battery cover on the back of the meter.
- If replacing the batteries, please remove the used batteries.
- Insert 2 new (AAA) batteries with correct +/- direction.
- Close the battery cover.
Environment Protection
Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local Authority or retailer for recycling advice.
Introduction to the System
About Your System
Intended Use
The LinkSun G-425-3 Blood Glucose Monitoring System is comprised of the LinkSun G-425-3 Blood Glucose Meter and LinkSun Blood Glucose Test Strips. The system is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The LinkSun G-425-3 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The LinkSun G-425-3 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The LinkSun G-425-3 Blood Glucose Monitoring System is not for use in neonates.
User Manual
LinkSun®
Warnings
- The system is intended for use outside the body (in vitro diagnostic use). It is for single-patient use. It should be used only for testing glucose (sugar) and only with fresh capillary whole blood samples taken from the finger. The system is intended for use at home. It should not be used for the diagnosis of diabetes or for the testing of newborns.
- The System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
- This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician's offices, or long-term care facilities because it has not been determined to be safe and effective for use in these settings, including for routine assisted testing or as part of glycemic control procedures.
- Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.
- The meter and lancing device are for single patient use. Do not share them with anyone, including other family members! Do not use on multiple patients!
- All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.
Test Principle
The System uses electrochemical methodologies. The System quantitatively measures blood glucose levels using an Amperometric method. The method involves detecting the current produced from glucose oxidation. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen. The current level is converted into a readout displayed on the meter.
Contents of the Kit
- A Meter
- Owner's Manual
- Two AAA Alkaline Batteries (Optional)
- Test Strips
- Lancing Device
- Sterile Lancet
- Control Solution (Optional)
NOTE:
- The Lancing Device can be used for several times, however the sterile lancet should be changed after each use.
- There are three levels for the control solutions: level 1, level 2, and level 3 available. Please contact the place of purchase for more information.
If any items are missing from your kit or opened prior to use, please contact local customer services (Toll Free: 302-6089028) or place of purchase for assistance.
Meter Screen Display Message
The meter screen displays various messages and symbols to guide you through the testing process.
| Symbol/Message | Description |
|---|---|
1 Blood drop symbol Flashes when it is ready to apply the blood sample. |
Indicates the meter is ready for blood sample application. |
2 Test result area Displays glucose results. |
Shows the measured blood glucose level. |
3 Low battery symbol Appears when the battery power is low. |
Alerts the user to replace the batteries. |
4 Measurement unit Appears with the test result in mg/dL. |
Displays the unit of measurement for blood glucose. |
5 KETONE? Ketone warning. The symbol of "KETONE?" will appear when the test result is equal to or above 240 mg/dL. |
Warns of potentially high ketone levels. |
6 CTL Symbol Appears when doing a control test and indicates that the result won't be stored in the memory. |
Indicates a control solution test is being performed and results are not saved. |
Blood Glucose Meter
The Blood Glucose Meter has several key components:
- 1 Strip port: Where you insert the test strip. The meter will turn on automatically.
- 2 LCD Display: It guides you through the test using symbols and simple messages.
- 3 Strip ejector: Slide forward to eject the test strip after the test.
- 4 "M" Button: It is used to turn on the meter and enter the memory mode.
[Diagram Description: A diagram of the LinkSun G-425-3 Blood Glucose Meter showing the strip port, LCD display, strip ejector, and "M" button.]
Test Strip
Each strip can be used only once. The test strip consists of the following parts:
- 1-Absorbent hole: Apply a drop of blood here. The blood will be drawn in automatically.
- 2-Confirmation window: This is where you confirm if enough blood has been drawn into the absorbent hole of the strip.
- 3-Test strip handle: Hold this part to insert the test strip into the slot.
- 4-Contact bars: Insert this end of the test strip into the meter. Push it in firmly until it will go no further.
Attention! Test results might be wrong if the contact bar is not fully inserted into the test slot.
NOTE: The front side of the test strip should face up when inserting the test strip.
[Diagram Description: A diagram showing the LinkSun Blood Glucose Test Strip with labels pointing to the Absorbent hole, Confirmation window, Test strip handle, and Contact bars. The diagram also shows the front and reverse sides of the strip.]
Setting the Meter and Deleting the Memory
Memory Function
Short press the "M" button; the device will appear the most recent test result after a full display for 1 second. Short press the "M" button again to appear the next most recent test result. You can use this way to review all 500 memories.
Deleting the Memory
Press and hold the "M" button for 5 seconds. The device will appear "dEL". Release the "M" button, "dEL" will flash. Press the "M" button again within 5 seconds to delete all memories; otherwise, the device will turn off.
[Diagram Description: A visual representation of the "dEL" message appearing on the meter display.]
The Two Measuring Modes
The meter provides you with two modes for measuring: General and CTL. The CTL mode should be used when a control solution is being tested. See the table below.
| Mode | Use When |
|---|---|
| General (not display) | Any time of day without regard to time since last meal. |
| CTL | Testing with the control solution. |
Overview of the Lancing Device
The Lancing Device includes the following parts:
- A. Device Cap
- B. Handle
- C. Needle Cap
- D. Needle Holder
- E. Device Body
- F. Connecting Collar
- G. Adjustable tip
- H. Release Button
- I. Ejection Button
- J. Device control cap on
[Diagram Description: A diagram of the LinkSun Lancing Device with labels A through J pointing to each part.]
Setting Up the Lancing Device
- Screw the device cap off.
- Put the needle into the needle holder until the bottom.
- Screw the needle cap on.
- Adjust the proper level (usually level 3). The adjustable tip offers 5 levels of skin penetration. Twist the adjustable tip to the proper level: 1-2 level for soft or thin skin, 3 level for average skin, 4-5 level for thick or calloused skin.
- Cover the device cap.
- Aiming at the sterilized part for blood-taking, press the release button for blood-taking.
- Push the ejection button to discard the used lancet into an appropriate container.
- Put the needle cap in the recycling dustbin.
- Cover the device cap.
If your lancing device differs from the one shown here, please refer to the manufacturer's manual to ensure proper usage.
NOTE: To reduce the chance of infection:
- Never share a lancet or the lancing device.
- Always use a new, sterile lancet. Lancets are for single use only.
- Avoid getting hand lotion, oils, dirt, or debris when handling the lancets.
[Diagram Description: A series of illustrations showing the steps for setting up the lancing device: removing the cap, inserting the needle, adjusting the tip, and preparing for use.]
Preparing the Puncture Site
Stimulating blood perfusion by rubbing the puncture site prior to blood extraction has a significant influence on the glucose value obtained. Blood from a site that has not been rubbed exhibits a measurably different glucose concentration than blood from the finger. When the puncture site was rubbed prior to blood extraction, the difference was significantly reduced.
Please follow the suggestions below before obtaining a drop of blood:
- Rub the puncture site for about 20 seconds before penetration.
- Select the puncture site at the fingertips.
- Clean the puncture site using cotton moistened with 70% alcohol and let it air dry.
Fingertip Testing
Hold the lancing device firmly against the side of your finger. Press the release key. You will hear a click, indicating that the puncture is complete.
[Diagram Description: An illustration showing a finger being held by the lancing device, with the release button ready to be pressed.]
Testing with Blood Sample
CAUTION: To reduce the chances of infection:
- Choose a clean, dry work surface.
- Never share a lancing device and lancet with another person.
- Always use a new and sterile lancet. Lancets are for single use only.
- Always use a new test strip. Test strips are for single use only.
- Avoid getting lotion, oils, dirt, or debris in or on the lancet and lancing device.
Note: Before testing, please read the following steps thoroughly and carefully. Please relax and do the test step by step. Simplifying or changing the test procedure may produce inaccurate results.
[Diagram Description: A visual representation of a clean and dry work surface.]
Performing a Blood Glucose Test
- Step 1: Wash hands with soap and water and dry the skin before taking a blood sample. NOTE: If there are contaminants on the skin, which may affect results.
- Step 2: Remove a test strip from its vial. With clean, dry hands, you may touch the test strip anywhere on its surface. Do not bend, cut, or modify the test strips in any way. Remove the test strip from the vial and use it instantly.
- Step 3: Insert the test strip into the meter's test port, and the meter will turn on.
- Step 4: When the blood drop symbol flashes on the screen, you may select the appropriate measurement mode. For selecting the measurement mode of Control (CTL) or General, please refer to the "The Two Measuring Modes" section.
- Step 5: Apply your blood to the absorbent hole of the test strip. For collecting blood sample, please refer to the "Preparing the puncture site" section.
- Step 6: As soon as enough blood has filled the confirmation window of the test strip, you will hear a beep, letting you know the test has begun. A countdown of 5 seconds starts. Note: Make sure the confirmation window of the test strip is completely filled with your blood sample.
- Step 7: Your blood glucose level will appear on the display. Blood glucose results are automatically stored in the memory.
NOTE: Be sure to use LinkSun blood glucose test strips; other test strips may not produce an accurate result.
[Diagram Description: A sequence of illustrations depicting the blood glucose testing steps: 1. Hands being washed and dried. 2. A test strip being removed from its vial. 3. A test strip being inserted into the meter. 4. The meter displaying a flashing blood drop symbol. 5. Blood being applied to the test strip's absorbent hole. 6. The confirmation window of the test strip filling with blood. 7. The meter displaying the final blood glucose result.]
Reference Values
The following are general reference values for blood glucose levels. Consult your doctor for your specific target range.
| Test Time | Normal Blood Glucose Range (mg/dL) |
|---|---|
| Before meal (Fasting) | 90-130 mg/dL |
| 2 hours after meal | Less than 180 mg/dL |
| At bedtime | 100-140 mg/dL |
NOTE: These are general guidelines. Your doctor will provide you with specific target ranges based on your individual needs.
Quality Control
Control Solution Test
Use LinkSun Control Solution to check the meter and test strips' performance. It is recommended to perform a quality control test weekly or whenever you use a new batch of test strips, or if you suspect the meter is not working correctly.
When doing a control solution test:
- If your blood glucose test results are consistent with the control solution results, the meter and test strips are working properly.
- If your blood glucose test results are not consistent with the control solution results, do not use the meter or test strips. Contact LinkSun Customer Service.
- The control solution test results should be within the ranges specified on the test strip vial.
- The control solution test strips can work together as a system and work correctly.
Before Going to the Lab
- If possible, test your blood glucose level before going to the lab.
- Take the meter and the test strip with you to the lab.
- Talk to your lab technician.
Display Message
The meter displays various messages to indicate the status or potential problems. Below is a list of common messages and their meanings.
| Message | Meaning | Troubleshooting/Solutions |
|---|---|---|
| Lo | Blood glucose level is too low (below 20 mg/dL). | Repeat the test. If the result is still "Lo", consult your healthcare professional immediately. |
| Hi | Blood glucose level is too high (above 600 mg/dL). | Repeat the test. If the result is still "Hi", consult your healthcare professional immediately. |
| E-1 | Test strip is not inserted correctly. | Remove and re-insert the test strip. Ensure it is fully inserted. |
| E-2 | Sample applied is too small or applied after the strip was removed. | Ensure enough blood is applied to fill the confirmation window. Re-insert a new test strip and repeat the test. |
| E-3 | Test strip is damaged or expired. | Use a new, unexpired test strip. |
| E-4 | The test strip is dirty or contaminated. | Use a new test strip. Ensure hands are clean and dry. |
| E-5 | The meter is not working properly. | Contact LinkSun Customer Service. |
| E-6 | The ambient temperature is too low or too high. | Perform the test within the operating temperature range (10°C - 40°C / 50°F - 104°F). |
| E-7 | The ambient humidity is too high. | Perform the test within the operating humidity range (below 85% RH). |
| E-8 | The battery is low. | Replace the batteries. |
| E-9 | The test strip is expired. | Use a new, unexpired test strip. |
| E-10 | The test strip is not compatible or damaged. | Use only LinkSun G-425-3 test strips. |
| E-11 | The test strip is not inserted correctly. | Remove and re-insert the test strip. Ensure it is fully inserted. |
| E-12 | The sample applied was too small. | Ensure enough blood is applied to fill the confirmation window. |
| E-13 | The test strip is not inserted correctly. | Remove and re-insert the test strip. Ensure it is fully inserted. |
| E-14 | The test strip is not inserted correctly. | Remove and re-insert the test strip. Ensure it is fully inserted. |
| E-15 | The test strip is not inserted correctly. | Remove and re-insert the test strip. Ensure it is fully inserted. |
Problems
This section helps you identify and resolve common issues.
| Problem | Cause | Solution |
|---|---|---|
| Meter does not turn on. | Batteries are not installed or are dead. | Install new batteries or ensure batteries are correctly inserted. |
| No blood is drawn into the test strip. | Insufficient blood sample applied. | Apply a larger drop of blood to fill the confirmation window. Ensure the puncture site is properly stimulated. |
| Test result is not displayed. | Test strip not inserted correctly or sample applied too late. | Ensure the test strip is fully inserted and blood is applied promptly. |
| Meter displays "Lo" or "Hi". | Blood glucose level is too low or too high. | Repeat the test. If the problem persists, consult your healthcare professional. |
| Test results are inconsistent. | Incorrect test procedure, expired test strips, or environmental factors. | Follow the instructions carefully, use only LinkSun test strips, and ensure testing is done within the specified temperature and humidity ranges. Perform a quality control test. |
| Meter displays an error code (E-1 to E-15). | Various issues as described in the "Display Message" section. | Refer to the "Display Message" section for specific troubleshooting steps. |
Performance Characteristics
The following tables show the performance characteristics of the LinkSun G-425-3 Blood Glucose Monitoring System.
Between-specimen
| Test Result (mg/dL) | CV (%) | SD (mg/dL) |
|---|---|---|
| < 100 | < 5.0 | < 5.0 |
| ≥ 100 | < 5.0 | < 5.0 |
Between-day
| Test Result (mg/dL) | CV (%) | SD (mg/dL) |
|---|---|---|
| < 100 | < 5.0 | < 5.0 |
| ≥ 100 | < 5.0 | < 5.0 |
Between-meter
| Test Result (mg/dL) | CV (%) | SD (mg/dL) |
|---|---|---|
| < 100 | < 5.0 | < 5.0 |
| ≥ 100 | < 5.0 | < 5.0 |
Between-lot
| Test Result (mg/dL) | CV (%) | SD (mg/dL) |
|---|---|---|
| < 100 | < 5.0 | < 5.0 |
| ≥ 100 | < 5.0 | < 5.0 |
How to Perform a Quality Control Test
Follow these steps to perform a quality control test using LinkSun Control Solution:
- Ensure the meter is turned off.
- Insert a test strip into the meter. The meter will turn on automatically.
- Press the "M" button to select the CTL mode. The CTL symbol will appear on the display.
- Apply a drop of control solution to the absorbent hole of the test strip.
- The meter will beep, and a countdown will begin.
- The test result will be displayed. Compare this result with the range specified on the test strip vial or control solution bottle.
NOTE: If the control test result is outside the specified range, repeat the test. If the problem persists, contact LinkSun Customer Service.
Cleaning and Disinfection
To ensure the accuracy and longevity of your meter, it is important to clean and disinfect it regularly.
- Cleaning: Wipe the exterior of the meter with a soft, damp cloth. Do not use abrasive cleaners or solvents.
- Disinfection: The meter can be disinfected using a cloth moistened with 70% isopropyl alcohol. Wipe the exterior surfaces of the meter. Allow the meter to air dry completely before use.
Important: Do not immerse the meter in water or any other liquid. Do not spray cleaning or disinfecting solutions directly onto the meter.
For detailed cleaning and disinfection instructions, please refer to the manufacturer's website or contact customer support.
Storage and Care for Your System
Store your LinkSun G-425-3 Blood Glucose Monitoring System in a cool, dry place, away from direct sunlight and extreme temperatures. Keep the test strips in their original vial with the cap tightly closed.
Meter: Store the meter in its protective case when not in use.
Test Strips: Store test strips at room temperature (10°C - 40°C / 50°F - 104°F). Do not refrigerate. Protect from moisture and heat.
Lancing Device and Lancets: Store the lancing device and unused lancets in a clean, dry place.
Specifications
Below are the technical specifications for the LinkSun G-425-3 Blood Glucose Monitoring System.
| Specification | Details |
|---|---|
| Model | G-425-3 |
| Power Source | Two AAA alkaline batteries (1.5V, LR03) |
| Battery Life | Approximately 1000 tests (varies with usage) |
| Memory | 500 test results with date and time |
| Operating Temperature | 10°C - 40°C (50°F - 104°F) |
| Operating Humidity | Below 85% RH (non-condensing) |
| Measurement Range | 20 - 600 mg/dL (1.1 - 33.3 mmol/L) |
| Test Time | Approximately 5 seconds |
| Sample Size | 0.5 µL |
| Test Principle | Electrochemical Amperometric Method |
| Automatic Shut-off | 3 minutes after last operation |
| Dimensions (L x W x H) | Approx. 95 x 60 x 20 mm |
| Weight | Approx. 60g (without battery) |
Life Use Performance Study
Your G-425-3 Blood Glucose Monitoring System has undergone rigorous testing to ensure its accuracy and reliability. The system has been evaluated in clinical studies and meets the performance standards required for home blood glucose monitoring.
The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
Electrical and Safety Standards
This meter complies with relevant electrical and safety standards, including:
- EN 61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use.
- EN 61010-2-101: Particular requirements for electrical equipment for medical purposes.
- IEC 61010-2-031: Particular requirements for hand-held and hand-manipulated test equipment.
The meter is designed to be safe when used according to the instructions in this manual. It is important to follow all safety precautions to avoid potential hazards.
Manufacturer Information
Manufacturer:
LinkSun Medical Co., Ltd.
[Address details from the PDF would go here, but are not fully legible in OCR. Assuming a placeholder for now.]
Customer Service:
Toll Free: 302-6089028
Website: [Website URL if available, not in OCR]
[Diagram Description: The CE mark, a European conformity symbol, indicating that the product meets the health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).]
CE 0123
