GIMACARE Multi-Functional Monitoring System Owner's Manual

Introduction

Dear GIMACARE System Owner:

Thank you for choosing the GIMACARE Multi-Functional Monitoring System. This manual provides important information to help you use the system properly. Before you begin, please read the following contents thoroughly and carefully. If you have other questions regarding this product, please contact the local customer service or place of purchase.

Intended Use

This system is intended for use outside the body (in vitro diagnostic use) to quantitatively measure the biochemical parameters: blood glucose, β-ketone, total cholesterol, triglycerides, uric acid, hemoglobin, and lactate in fresh capillary whole blood. It is for home use or for healthcare professional use. It should NOT be used for diagnosis or screening of diseases.

Professionals may also use the test strips for blood glucose and hemoglobin measurement in venous, arterial, neonatal whole blood, and for β-ketone and lactate measurement in venous whole blood. Home use is limited to performing all biochemical parameter testing with fresh capillary whole blood.

Test Principle

Your system measures the amount of blood glucose / β-ketone / total cholesterol / triglycerides / uric acid / hemoglobin / lactate (biochemical parameters) in whole blood. The test is based on the measurement of electrical current generated by the reaction of the biochemical parameters with the reagent of the strip. The meter measures the current, calculates the biochemical parameters in the blood, and displays the result on the screen. The strength of the current produced by the reaction depends on the amount of biochemical parameters in the blood sample.

Important Safety Precautions

Please read the following carefully before use:

1. Use this device ONLY for the intended use described in this manual.
2. Do NOT use accessories that are not specified by the manufacturer.
3. Do NOT use the device if it is not working properly or is damaged.
4. This device does NOT serve as a cure for any symptoms or diseases. The data measured is for reference only. Always consult your doctor to have the results interpreted.
5. Keep the device and testing equipment away from children. Small parts such as the battery cover, batteries, test strips, lancets, and vial caps are choking hazards.
6. The presence of synthetic materials (synthetic clothing, carpet, etc.) may cause damaging static discharges that lead to erroneous results.
7. Do NOT use this device in close proximity to sources of strong electromagnetic radiation, as these may interfere with the accurate operation.
8. Proper maintenance and control solution tests are essential to the longevity of your device. If you are concerned about your accuracy of measurement, please contact local customer service or place of purchase for assistance.
9. Severe dehydration and excessive water loss may cause readings that are inaccurate. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately.
10. We do not recommend using this product on severely hypotensive individuals or patients in shock. Please consult a healthcare professional before use.
11. Only use fresh whole blood sample. Using any body substances other than blood will lead to incorrect results.
12. If you are experiencing symptoms that are inconsistent with your test results and you have followed all the instructions in this owner's manual, contact your healthcare professional.
13. Before using this device to test blood glucose, β-ketone, total cholesterol, triglycerides, uric acid, hemoglobin or lactate, read all instructions thoroughly and practice the test. Carry out all the quality control checks as directed.
14. If your biochemical parameter results are lower or higher than usual, and you do not show any symptoms of illness, repeat the test first. If you develop any symptoms or continue to get results that are lower or higher than usual, consult your healthcare professional.
15. If any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

KEEP THESE INSTRUCTIONS AT A SAFE PLACE

Meter Overview

The meter has the following components:

• 1) Bluetooth Indication Light: Indicates Bluetooth status for data transmission.
• 2) Display Screen: Shows test results, settings, and error messages.
• 3) Left Scroll Button ([◀]): Used to enter Day Average and adjust values (decrement).
• 4) Main Button ([M]): Used to enter the meter memory.
• 5) Right Scroll Button ([▶]): Used to enter Bluetooth function, adjust values (increment), and silence a reminder alarm.
• 6) Test Strip Slot with Strip Indication Light: Insert test strips here to turn the meter on. The indicator lights up when results appear.
• 7) Test Strip Ejector: Ejects the used strip by pressing this button.
• 8) Battery Compartment: Houses the batteries.

Display Screen Details:

• 1 Code: Indicates the code for the test strip.
• 2 Blood Glucose Symbol: Indicates blood glucose testing.
• 3 Test Result: Displays the measured value.
• 4 Measuring Mode: Gen (any time of day), AC (before meal), PC (after meal).
• 5 QC Mode: Indicates a control solution test.
• 6 High / Low Indicator: Shows if the result is high or low.
• 7 Day Average: Displays average results over a period.
• 8 Memory Mode: Accesses stored test results.
• 9 Date / Time: Displays current date and time.
• 10 Alarm Symbol: Indicates reminder alarms.
• 11 Error Message / Ketone Warning: Displays errors or ketone warnings.
• 12 Bluetooth Symbol: Indicates Bluetooth status.
• 13 Measurement Unit: Displays the unit (e.g., mg/dL, mmol/L).
• 14 Triglycerides Symbol: Indicates triglycerides testing.
• 15 Hemoglobin Symbol: Indicates hemoglobin testing.
• 16 Uric Acid Symbol: Indicates uric acid testing.
• 17 β-Ketone Symbol: Indicates β-ketone testing.
• 18 Low Battery Symbol: ? Indicates low battery.
• 19 Lactate Symbol: Indicates lactate testing.
• 20 Test Strip Symbol: Indicates test strip status.
• 21 Total Cholesterol Symbol: Indicates total cholesterol testing.
• 22 Blood Drop Symbol: ? Indicates blood sample application.

Test Strip

The test strip has the following parts:

• 1 Absorbent Hole: Where the blood sample is applied.
• 2 Confirmation Window: Fills to confirm sufficient sample.
• 3 Test Strip Handle: For holding the strip.
• 4 Contact Bars: Inserted into the meter.

NOTE: The front side of the test strip should face up when inserting into the test strip slot. Test results might be inaccurate if the contact bar is not fully inserted into the test strip slot. The GIMACARE Multi-Functional Monitoring System should only be used with GIMACARE test strips. Using other test strips with this meter can produce inaccurate results.

Letter Indicator Guide

This guide illustrates various steps and symbols used during testing. Refer to it when necessary.

[Diagram Description: A series of images labeled (a) through (l) showing steps like inserting a test strip, applying blood, using a lancing device, and interpreting results with checkmarks (✔️) and crosses (❌).]

Setting The Meter

Setting your meter to the correct date and time ensures accurate test results. Update settings when changing the meter battery or after a long period of disuse.

Entering the Setting Mode:

Start with the meter off (no test strip inserted). Press and hold the [◀] and [▶] buttons simultaneously for 3 seconds.

1. Setting the date: The sequence is YEAR → MONTH → DAY. With the YEAR / MONTH / DAY flashing, press [◀] or [▶] to select the correct number. Press [M].
2. Setting the time format and time: Press [◀] or [▶] to select the desired time format (12h or 24h). Press [M]. With the HOUR / MINUTE flashing, press [◀] or [▶] to select the correct number. Press [M].
3. Setting the blood glucose measuring unit: With the measuring unit flashing, press [◀] or [▶] to switch between mg/dL and mmol/L. Press [M].
4. Setting the total cholesterol measuring unit: With the measuring unit flashing, press [◀] or [▶] to switch between mg/dL and mmol/L. Press [M].
5. Setting the uric acid measuring unit: With the measuring unit flashing, press [◀] or [▶] to switch between mg/dL and µmol/L. Press [M].
6. Setting the triglycerides measuring unit: With the measuring unit flashing, press [◀] or [▶] to switch between mg/dL and mmol/L. Press [M].
7. Setting the hemoglobin measuring unit: With the measuring unit flashing, press [◀] or [▶] to switch between g/dL and mmol/L. Press [M].
8. Setting the blood glucose's measuring mode target range: The sequence is Gen low → Gen high → AC low → AC high → PC low → PC high. With the target range settings flashing, press [◀] or [▶] until the desired target number appears. Press [M].

   Target Range Table (Blood Glucose)

   	Gen:	~CA	PC
   LOW	60 – 100 mg/dL 3.3 – 5.5 mmol/L	60 – 100 mg/dL 3.3 – 5.5 mmol/L	60 – 100 mg/dL 3.3 – 5.5 mmol/L
   HIGH	101 – 220 mg/dL 5.6 – 12.2 mmol/L	101 – 220 mg/dL 5.6 – 12.2 mmol/L	101 – 220 mg/dL 5.6 – 12.2 mmol/L

   NOTE: The meter comes with default target ranges. Consult your doctor to determine a range that works best for you and customize it. This function applies to blood glucose tests only. The target range is fixed within the values shown in the table.

9. Setting the buzzer: With the buzzer display, press [◀] or [▶] to switch between "On" and "OFF". Press [M].
10. Deleting the memory: With "dEL" and " " on display, select "no" to keep results, press [M]. To delete all records, select "yes" and press [M].
11. Setting the reminder alarm: Your meter has 4 reminder alarms. The meter displays "On" or "OFF" and "AL1". To skip, press [M]. To set, press [◀] or [▶] to select "On", then press [M]. With HOUR/MINUTE flashing, press [◀] or [▶] to select the correct time. Press [M] to go to the next alarm setting.

    NOTE: When the alarm beeps, press [◀] to switch it off. Otherwise, it will beep for 2 minutes then switch off.

12. Setting the Bluetooth function: With "BLE" on display, press [◀] or [▶] to select "On" or "OFF". Press [M].

    NOTE: This function enables Bluetooth data transmission. If "On" is selected, results will be transmitted automatically after the test.

Congratulations! You have completed all settings!

NOTE: These parameters can ONLY be changed in the setting mode. If the meter is idle for 1 minute during the setting mode, it will switch off automatically.

Calibration

Each time you start testing with a new package of β-ketone / total cholesterol / triglycerides / uric acid / hemoglobin / lactate test strips, you must calibrate the meter with the correct code. Ensure the code number displayed on the meter matches the code number on the test strip vial or individual foil packet before testing. Mismatched codes may lead to inaccurate results. Do not proceed with the test and contact customer service for assistance.

Always follow the calibration instructions in the test strip insert.

Quality Control Tests

When to Perform a Control Solution Test?

• If it is mandatory following local regulations in your country.
• If you suspect the meter or test strips are not working properly.
• If your test results are not consistent with how you feel, or if you think the results are not accurate.
• To practice the testing process.
• If you have dropped or think you may have damaged the meter.

Test strips (c), control solutions (d), lancing device (e), or sterile lancets (a) may not be included in the kit (please check the contents on your product box). They can be purchased separately. Please ensure you have these items needed for the test beforehand.

Performing a Control Solution Test

To perform a control solution test, you will need: (b), (c), and (d).

1. Insert the test strip to turn on the meter: Insert the test strip into the meter. Wait for the meter to display " ", a flashing " ", and "GLU" / "KET" / "CHOL" / "TG" / "UA" / "Hb" / "LAC".
2. Press [M] to mark this test as a control solution test (for Triglycerides and Hemoglobin test): With "QC" displayed, the meter will store your test result in memory under "QC". If you press [M] again, the "QC" will disappear, and this test will no longer be a control solution test.

WARNING: When doing the control solution test, you must mark it so that the test result will NOT mix with the blood test results stored in the memory. Failure to do so will mix up the blood test results with the control solution test results in memory.

3. Apply the control solution (g): Shake the control solution vial thoroughly before use. Squeeze out the first drop and wipe it off, then squeeze out another drop and place it on the tip of the vial cap. Hold the meter to move the test strip absorbent hole to the droplet. Once the confirmation window fills completely, the meter will begin counting down.
4. Read and compare the result: After counting down to 0, the control solution test result will appear on the display. Compare this result with the range printed on the test strip vial or foil packet; it should fall within the range. If not, please read the instructions again and repeat the control solution test. With "QC" displayed, the meter will store your test result in memory under "QC".

NOTE:

• The control solution range printed on the test strip vial or foil packet is for control solution use only. It is not a recommended range for your blood test levels.
• For blood glucose, β-ketone, total cholesterol, uric acid, and lactate control solution tests, your device will tag this measurement as a QC test automatically.
• To avoid contaminating the control solution, do NOT directly apply the control solution onto a strip.

Important Control Solution Information

• ONLY use TAIDOC's control solutions with your meter.
• Do not use the control solution beyond the expiration date or 3 months after first opening. Write the opening date on the control.
• It is recommended that the control solution test be done at room temperatures between 20°C to 25°C (68°F to 77°F). Please make sure your control solution, meter, and test strips are at the specified temperature range before testing.
• Shake the vial before use, discard the first drop of control solution, and wipe it off the tip to ensure a pure sample and an accurate result.
• Store the control solution with the cap tightly closed at temperatures between 2°C to 30°C (35.6°F to 86°F). Do NOT freeze.

Prepare For Blood Tests

Prepare the Lancing Device for Blood Tests

Please follow the instructions in the lancing device insert on how to prepare the lancing device and collect a blood sample.

WARNING: To reduce the chance of infection:

• Never share the lancet or lancing device.
• Always use a new, sterile lancet. Lancets are for single use only.
• Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the lancing device.
• The used lancet may potentially be biohazardous. Discard it according to your local regulations.
• Do not reuse lancets. Always use a new, sterile lancet for testing.

Prepare the Puncture Site

Stimulating blood perfusion by rubbing the puncture site before blood extraction has a significant influence on the test value. Blood from a site that has not been rubbed exhibits a measurably different substance concentration than blood from the finger. When the puncture site was rubbed prior to blood extraction, the difference was significantly reduced.

Follow the steps listed below before obtaining a blood sample:

• Wash and dry your hands before you begin.
• Select a puncture site.
• Rub the selected site for about 20 seconds before penetration.
• Clean the puncture site using cotton moistened with 70% alcohol and let it air dry.

Perform Blood Tests

To perform a blood test, you need: (b), (c), (e), and (f).

1. Turn on the meter by inserting a test strip: Wait for the meter to display " ", " ", and "GLU" / "KET" / "CHOL" / "TG" / "UA" / "Hb" / "LAC".
2. Select the appropriate measuring mode by pressing [M] (For Blood Glucose: Gen / AC / PC).
3. Fingertip testing (h): Hold the pre-set lancing device's tip firmly against the lower side of your fingertip. Press the release button to prick your finger. A click indicates that the puncture is complete.
4. Obtaining a blood sample (i): Gently squeeze the punctured site to obtain a drop of blood and use it as the sample for the test. Be careful NOT to smear the blood sample.

5. Apply the sample (j): Gently apply the drop of blood to the absorbent hole of the test strip at a tilted angle. Confirmation window should be completely filled if enough blood has been applied. Do NOT remove your finger until you hear a "beep" sound.

NOTE:

• Do NOT press the punctured site against the test strip or try to smear the blood.
• Always apply a blood sample after the test strip is inserted into the meter.
• If you do not apply a blood sample to the test strip within 3 minutes, the meter will automatically turn off. You must remove and reinsert the test strip to start a new test.
• The confirmation window should be filled with blood before the meter begins to count down. NEVER try to add more blood to the test strip. Discard the used test strip and retest with a new one.
• If you have trouble filling the confirmation window, please contact your healthcare professional or customer service for assistance.

1. Read Your Result: The result of your test will appear after the meter counts down to 0. The result will be stored in the memory automatically.
2. Eject the used test strip (k): Eject the test strip by pushing the eject button on the side. Use a sharps bin to dispose of used test strips. The meter will switch off automatically.

Always follow the instructions in the lancing device insert when removing the lancet.

WARNING:

• The used lancet and test strip are considered biohazardous. Please discard them carefully according to local regulations.
• Clean and disinfect the meter and lancing device after each test.

Blood Glucose Tests

The meter provides you with three measuring modes: Gen, AC, and PC. You can switch between each mode by:

• Insert a test strip to turn on the meter. The screen will display " ", a flashing " " and "GLU". Press [M] to select the appropriate measuring mode (Gen, AC, or PC).
• The measurement unit used for indicating the concentration of blood or plasma glucose can either have a weight dimension (mg/dL) or a molarity (mmol/L). The approximate calculation rule for conversion of mg/dL into mmol/L is:

Reference Values

Blood glucose monitoring plays an important role in diabetes control. A long-term study showed that maintaining blood glucose levels close to normal can reduce the risk of diabetes complications by up to 60%*1. The results provided by this system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes. The blood glucose readings deliver plasma equivalent results and are displayed either in milligrams of glucose per deciliter of blood (mg/dL) or in millimoles of glucose per liter of blood (mmol/L).

*1 American Diabetes Association. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes—2022 Jan; 45(Supplement 1): S17-S38. https://doi.org/10.2337/dc22-S002

*2 Fasting is defined as no caloric intake for at least 8 hours.

Result Readings

Always consult your doctor to determine a target range that works best for you.

β-Ketone Tests

The meter provides you with one measuring mode: General.

• Insert a test strip to turn on the meter. The screen will display " ", a flashing " " and "KET".

Reference Values

The β-Ketone readings deliver plasma equivalent results and are displayed in millimoles of β-Ketone per liter of blood (mmol/L).

The β-Ketone test measures Beta-Hydroxybutyrate (β-OHB), the most important of the three β-Ketone bodies in the blood. Normally, levels of β-OHB are expected to be less than 0.6 mmol/L¹.

β-OHB levels may increase if a person fasts, exercises vigorously, or has diabetes and becomes ill. If your β-Ketone result is "Lo", repeat the β-Ketone test with new test strips. If the same message appears again or the result does not reflect how you feel, contact your healthcare professional. Follow your healthcare professional's advice before you make any changes to your diabetes medication program. If your β-Ketone result is between 0.6 and 1.5 mmol/L, this indicates a development of a problem that may require medical assistance. Follow your healthcare professional's instructions. If your β-Ketone result is higher than 1.5 mmol/L, contact your healthcare professional promptly for advice and assistance. You may be at risk of developing diabetic ketoacidosis (DKA).

¹: Wiggam MI, O'Kane MJ, Harper R, et al. Treatment of diabetic ketoacidosis using normalization of blood 3-hydroxybutyrate concentration as the endpoint of emergency management. Diabetes Care. 1997; 20(9): 1347-52

Result Readings

Please consult your doctor to determine a target range that works best for you.

Total Cholesterol Tests

The meter provides you with one measuring mode: General.

• Insert a test strip to turn on the meter. The screen will display " ", a flashing " " and "CHOL".
• After obtaining the first drop of blood, wipe it off. Squeeze again to obtain another drop of whole blood as the sample for the test.
• The measurement unit used for indicating the concentration of blood or plasma cholesterol can either have a weight dimension (mg/dL) or a molarity (mmol/L). The approximate calculation rule for conversion of mg/dL into mmol/L is:

Reference Values

The total cholesterol readings deliver plasma equivalent results and are displayed in milligrams of total cholesterol per deciliter of blood (mg/dL) or in millimoles of total cholesterol per liter of blood (mmol/L).

A healthcare professional will discuss values that are specifically appropriate for each patient. At least two measurements of cholesterol in separate occasions should be made before a medical decision is made, since a single reading may not be representative of a patient's usual cholesterol concentration. An elevated cholesterol level is only one risk factor for heart disease. There are many others. A cholesterol less than 200 mg/dL is desirable.

Source: National Institutes of Health, National Heart, Lung, and Blood Institute. ATP III Guidelines At-A-Glance Quick Desk Reference. https://www.nhlbi.nih.gov/files/docs/guidelines/atglance.pdf. Published May, 2001.

Result Readings

Please consult your doctor to determine a target range that works best for you.

Triglycerides Tests

The meter provides you with one measuring mode: General.

• Insert a test strip to turn on the meter. The screen will display " ", a flashing " " and "TG".
• After obtaining the first drop of blood, wipe it off. Squeeze again to obtain another drop of whole blood as the sample for the test.
• The measurement unit used for indicating the concentration of blood or plasma triglycerides can either have a weight dimension (mg/dL) or a molarity (mmol/L). The approximate calculation rule for conversion of mg/dL into mmol/L is:

Reference Values

The triglycerides readings deliver plasma equivalent results and are displayed in milligrams of triglycerides per deciliter of blood (mg/dL) or in millimoles of triglycerides per liter of blood (mmol/L).

A healthcare professional will recommend an appropriate value that is specific for individual patient. At least two measurements in separate occasions should be performed before a medical decision is made, since a single reading may not represent a patient's usual triglycerides concentration. An elevated triglycerides level is only one of the risk factors for heart disease. There are many others. A triglycerides level less than 150 mg/dL (1.70 mmol/L) is desirable. Source: National Cholesterol Education Program. Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Final Report. National Institutes of Health. National Heart, Lung and Blood Institute. NIH Publication No. 02-5215, September 2002.

Result Readings

Please consult your doctor to determine a target range that works best for you.

Uric Acid Tests

The meter provides you with one measuring mode: General.

• Insert a test strip to turn on the meter. The screen will display " ", a flashing " " and "UA".
• After obtaining the first drop of blood, wipe it off. Squeeze again to obtain another drop of whole blood as the sample for the test.
• The measurement unit used for indicating the concentration of blood or plasma uric acid can either have a weight dimension (mg/dL) or a molarity (µmol/L). The approximate calculation rule for conversion of mg/dL in µmol/L is:

Reference Values

The uric acid readings deliver plasma equivalent results and are displayed in milligrams of uric acid per deciliter of blood (mg/dL) or micromoles of uric acid of blood (µmol/L).

Source: National Kidney Foundation. 2014.

Result Readings

Please consult your doctor to determine a target range that works best for you.

Hemoglobin Tests

The meter provides you with one measuring mode: General.

• Insert a test strip to turn on the meter. The screen will display " ", a flashing " " and "Hb".
• The measurement unit used for indicating the concentration of blood or plasma hemoglobin can either have a weight dimension (g/dL) or a molarity (mmol/L). The approximate calculation rule for conversion of g/dL into mmol/L is:

Reference Values

Source: Laboratory Reference Range Values

Result Readings

Always consult your doctor to determine a target range that works best for you.

Lactate Tests

The meter provides you with one measuring mode: General.

• Insert a test strip to turn on the meter. The screen will display " ", a flashing " " and "LAC".
• After obtaining the first drop of blood, wipe it off. Squeeze again to obtain another drop of whole blood as the sample for the test. It is important that you perform the test IMMEDIATELY after drawing the blood sample.

Reference Values

The meter provides you with plasma equivalent results and are displayed in millimoles of lactate per liter of blood (mmol/L). The desirable range is 0.3 to 2.4 mmol/L¹.

¹: Williamson MA, Snyder LM. Wallach's Interpretation of Diagnostic Tests: Pathways to Arriving at a Clinical Diagnosis. 10th ed. Philadelphia: Wolters Kluwer Health.2015.

Result Readings

Please consult your doctor to determine a target range that works best for you.

Review Test Results

The meter stores the most recent 1000 test results along with respective dates and times in its memory. To enter memory mode, start with the meter switched off.

1. Press and release [M], " " will appear on the display and the first reading you see is the latest test result with the date, time, and measuring mode.
2. Press [◀] or [▶] to scroll through all the test results stored in the meter. Press [▶] to view the old test result and press [◀] to see the new one. "toP" will be on display when you reach the latest test result. "End" will be on display when you reach the oldest result.

Reviewing Blood Glucose Average Results

1. Start with the meter switched off. Press and release [M] to enter memory mode for average results with " " and "DAY AVG" display on the screen. Your 7-day average result measured in general mode will appear on the display.
2. Press [◀] or [▶] to review 14-, 21-, 28-, 60-, and 90-day average results stored in each measuring mode in the order of Gen, AC, and PC.

NOTE:

• Any time you wish to exit the memory mode, keep pressing [M] for 3 seconds or leave it without any action for 1 minute. The meter will switch off automatically.
• Control solution results are NOT included in the day average.

Data Transfer via Bluetooth

Data Transfer to a Computer

You can use the Health Care Management System to view test results on a Windows 10 (or above) computer. To learn more about the Health Care Management System, please contact TAIDOC or place of purchase for assistance. Please note that you must complete the pairing between the meter and your computer before transferring data.

Pairing with your computer

1. Obtaining and installing the software: To download the Health Care Management System, please visit TAIDOC's website: www.taidoc.com.
2. Connecting to a computer: Turn on the Bluetooth function on the meter and your computer, then pair the meter with your computer.
3. Data transfer: To transfer data, follow the instructions provided with the software. Results will be transferred with date and time.

Data Transfer to a Mobile Device

You can transfer testing results from the meter to ProCheck app on your mobile device via Bluetooth. The ProCheck app is designed for self-monitoring and analysis of your health. Please download and install the ProCheck app first. For the requirement of OS version, please find on App Store or Google Play when you download the app.

Please note that you must complete the pairing between the meter and your mobile device before transferring data.

Pairing with your mobile device

1. Turn on the Bluetooth function on your mobile device.
2. Follow the Quick Start Guide (For Bluetooth Pairing) to pair the device. (E.g. Search to find the meter and then add it into the app).
3. After successfully pairing the app with the device, the Bluetooth function of the meter shall be on before transferring data to the ProCheck app.

Bluetooth Indicator on the Meter

NOTE:

• The meter will be unable to perform a test while it is in transfer mode.
• Please make sure your device supports Bluetooth Smart Technology, the Bluetooth setting on your device is turned on, and the meter is within the receiving range before transferring the data.
• The Bluetooth functionality is implemented in different ways by various mobile device manufacturers; compatibility issues between your mobile device and the meter may occur.

Maintenance

Meter Cleaning and Disinfecting

• Wipe the meter exterior with a soft damp cloth or mild cleaning agent, then dry the device with a soft dry cloth. Do NOT use organic solvents to clean the meter.
• Do NOT rinse or immerse in water or other liquids.
• Always disinfect the surfaces of the meter with cotton moistened with 70% alcohol after taking a test.
• Avoid getting any moisture into any openings (e.g., test strip port, battery compartment).

Meter Storage

• Always store or transport the meter in its original storage case.
• Avoid dropping the meter or heavy impact.
• Avoid direct sunlight or high humidity.

Meter Disposal

The used meter should be treated as a contaminated item that may carry a risk of infection during measurement. The batteries in the used meter should be removed and the meter should be disposed of in accordance with local regulations.

Caring for Your Test Strips

• Store the test strips in their original vial ONLY. Do NOT transfer them to a new vial or any other containers. (For strip vial only)

Battery

Your meter comes with two 1.5V AAA size alkaline batteries.

Low Battery Signal

The meter will display one of the messages below to alert you when the meter power is getting low.

1. When the " " symbol appears along with display messages: The meter is functioning properly and the result remains accurate, but it is time to change the batteries.
2. When the " " symbol appears with E-b: The power is too low to perform a test. Please change the batteries immediately.

Replacing the Battery

To replace the batteries (I), make sure the meter is turned off.

1. Press the edge of the battery cover and lift it up to remove.
2. Remove the old batteries and replace with two 1.5V AAA size alkaline batteries.
3. Close the battery cover. If the batteries are inserted correctly, you will hear a "beep" afterwards.

NOTE:

• Replacing the batteries does not affect the test results stored in the meter.
• All batteries should be kept away from children. If swallowed, seek medical assistance immediately.
• Batteries might leak chemicals if left unused for a long time. Remove the batteries if you are not going to use the device for an extended period of time (i.e., 3 months or more).
• Properly dispose of the batteries according to your local environmental regulations.

System Troubleshooting

If you follow the recommended action but the problem persists, please call your local customer service.

Error Messages

Troubleshooting

1. If the meter does not display a message after inserting a test strip:

   POSSIBLE CAUSE	WHAT TO DO
   Batteries exhausted.	Replace the batteries.
   Test strip inserted upside down or incompletely.	Insert the test strip with contact bars end first and facing up.
   Defective meter or test strips.	Please contact customer service.

2. If the test does not start after applying the sample:

   POSSIBLE CAUSE	WHAT TO DO
   Insufficient blood sample.	Repeat the test using a new test strip with larger volume of blood sample.
   Defective test strip.	Repeat the test with a new test strip.
   Sample applied after automatic switch-off (1 minute after last user action).	Repeat the test with a new test strip. Apply sample only when flashing " " appears on the display.
   Defective meter.	Please contact customer service.

3. If the control solution testing result is out of range:

   POSSIBLE CAUSE	WHAT TO DO
   Error in performing the test.	Read instructions thoroughly and repeat the test again.
   Control solution vial was poorly shaken.	Shake the control solution thoroughly and repeat the test again.
   Control solution that is too warm or too cold.	Control solution, meter, and test strips should be at room temperature 20°C to 25°C (68°F to 77°F) before testing.
   Defective test strip.	Repeat the test with a new test strip.
   Meter malfunction.	Please contact customer service.
   Improper working of meter and test strip.	Please contact customer service.

Symbol Information

Specifications

Model: GIMACARE

Dimension: 102.5 (L) x 59.6 (W) x 21.8 (H) mm

Weight: 64.4 g (without batteries)

Power Source: Two 1.5V AAA alkaline batteries

Display: LCD with backlight

Memory: 1000 measurement results

External Output: Bluetooth ?

Auto sample loading detection

Auto electrode insertion detection

Auto reaction time count-down

Auto switch-off after 1 minute without action

Temperature Warning

Operating Conditions:

• Blood Glucose: 8°C to 45°C (46.4°F to 113°F) and 10% to 90% R.H. (non-condensing).
• β-Ketone, Total Cholesterol, Triglycerides, Uric Acid and Lactate: 10°C to 40°C (50°F to 104°F) and 10% to 85% R.H. (non-condensing).
• Hemoglobin: 10°C to 40°C (50°F to 104°F) and 10% to 90% R.H. (non-condensing).

Meter Storage / Transportation Conditions:

• -20°C to 60°C (-4°F to 140°F) and 10% to 93% R.H. (non-condensing).

Strip Storage/Transportation Conditions:

• Blood Glucose, Hemoglobin: 2°C to 30°C (35.6°F to 86°F) and 10% to 90% R.H. (non-condensing).
• β-Ketone, Total Cholesterol, Triglycerides, Uric Acid and Lactate: 2°C to 30°C (35.6°F to 86°F) and 10% to 85% R.H. (non-condensing).

Measurement Units:

• Blood Glucose / Total Cholesterol / Triglycerides: mg/dL or mmol/L
• β-Ketone / Lactate: Fixed mmol/L
• Uric Acid: mg/dL or µmol/L
• Hemoglobin: g/dL or mmol/L

Measurement Range:

• Blood Glucose Test: 10 to 800 mg/dL (0.56 to 44.4 mmol/L)
• β-Ketone Test: 0.1 to 8.0 mmol/L
• Total Cholesterol Test: 100 to 400 mg/dL (2.5 to 10.3 mmol/L)
• Triglycerides Test: 70 to 600 mg/dL (0.79 to 6.77 mmol/L)
• Uric Acid Test: 3 to 20 mg/dL (178 to 1189 µmol/L)
• Hemoglobin: 6.8 to 24 g/dL (4.22 to 14.89 mmol/L)
• Lactate Test: 0.3 to 22 mmol/L

Expected service life: 5 years

Operating Altitude: Up to 2000m, for indoor use

Degree of Pollution: Pollution degree 2

This device has been tested to meet the electrical and safety requirements of: IEC/EN 61010-1, IEC/EN 61010-2-101, IEC/EN 61326-1, IEC/EN 61326-2-6, EN 300 328.

GIMA WARRANTY TERMS

The Gima 12-month standard B2B warranty