ActiveCare TD-4121 Blood Glucose Multi-Functional Monitoring System Owner’s Manual 1
Dear Owner of ActiveCare TD-4121 Blood Glucose Monitoring System Owner: Thank you for purchasing the ActiveCare TD-4121 Blood Glucose Monitoring System. This manual provides important information to help you use the system properly. Before using this product, please read the following instructions thoroughly and attentively. Regular monitoring of your blood glucose levels can help you and your doctor gain better control of your diabetes.
IMPORTANT SAFETY PRECAUTIONS READ BEFORE USE 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. Do NOT use this device to be close to your head since GPRS will be activated under two conditions to prevent any body damages.
10. Proper maintenance and periodically control solution test are essential to the durability of your device. If you are concerned about its accuracy, please contact TaiDoc or place of purchase for help. Action upon Delivery: Unpacking; checking delivery for completeness; checking for damage during transport.
TABLE OF CONTENTS IMPORTANT SAFETY PRECAUTIONS .......................................................... 4 BEFORE YOU BEGIN ..................................................................................... 7 Important Information ............................................................................. 7 Intended Use ........................................................................................... 8 Test Principle ...........................................................................
BEFORE YOU BEGIN Important Information Severe dehydration and excessive water loss may cause readings which are lower than actual values. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately. If your blood glucose results are lower or higher than usual, and you do not have any symptoms of illness, first repeat the test.
Intended Use This system is intended for use outside the body (in vitro diagnostic use) by people with diabetes. It is designed for home use and by health care professionals in clinical settings as an aid to monitoring the effectiveness of diabetes control. It is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples (from the finger, palm, forearm and upper arm) and from venous whole blood.
Contents of System Your new ActiveCare system kit includes: 1. Meter 2. 3. 4. 5. 6. 7. Owner’s Manual Quick Start User Guide Test Strips Protective wallet 1 x 3.7V Li- Polymer rechargeable battery Lancet NOTE: If any items are missing from your kit or opened prior to use, please contact local customer services or place of purchase for assistance.
Meter Overview 1. Test Strip Slot with Strip Indication Light Insert test strip here for testing. 2. Power Button Press to turn on/off the meter. 3. Recharge Indicator 4. USB Port (only for charge) For battery recharge 5. Home Button To enter the meter function, and click for confirmation or exit. 6. Display Window and Touchscreen The touchscreen allow users to interact with what is displayed directly by the finger. 7. Test Strip Ejector Eject the used test strip by pushing up this button. 8. Microphone 9.
Display Screen The display window and touchscreen allows you to interact with what is displayed. The meter features 4 main functions: measuring, calling, memory and setting, which are shown on the main page. Other icons on the Main Page are introduced as below: 1. 2. 3. 4. 5. 6. 7. 8. 9. Battery Alarm Icon Time Flight Icon GPRS Signal Date Measuring Memory Setting 10. Calling Indicator Meaning / You can do this The welcome screen that appears when you turn on the meter.
Setting: Set up date, time, reminder alarm, measuring units, displayed languages and so on. You may also turn on/off airplane mode from here. Calling: Call out to the service center or answer phone calls. This function activates for only 10 minutes after each measurement, allowing the service center to contact with users directly. Test Strip Absorbent Hole Apply a drop of blood here. The blood will be automatically absorbed.
NOTE: The ActiveCare TD-4121 should only be used with ActiveCare Blood Glucose Test Strips. Using other test strips with this system can produce inaccurate results. SETTING THE METER Before using your meter for the first time, you should check and update these settings. The touchscreen allows users to communicate with the meter by simply tapping on the screen with fingers. Meter Setting 1. Start with the system off. Press the power button for 1 second to activate the meter.
2. Tap on , and there are 6 sections: airplane mode, measuring units, volume, time/date, reminder alarms and language on display. Airplane Mode The airplane mode will terminate the meter’s cellular telephony and transmitting functions. 1. Tap on to enter the airplane mode setting page. 2. Tap on the preferred mode (airplane or general) for preference. Select the airplane mode when necessary, or “general mode” to activate the meter’s telecommunication function. 3. Tap on to save and exit.
Measuring Units 1. Tap on to set the measuring unit. There are two measuring units to choose from: mg/dL and mmol/L. 2. Tape on the desired one and to save and exit. Volume 1. Tape to set up the volume. 2. Tape on the “+” or “-” to adjust the volume. 3. Tap on to save and exit.
Time and Date There are two ways to set date and time: automatic or manually. IN AUTOMATIC MODE: to set time and date. Choose the “12” or “24” bar to set 1. Tap on your preferred time system. 2. Tap on automatic mode. In this mode, time and date are synchronized once the meter’s GPRS (General Packet Radio Service) is in service. Please contact your mobile communication providers for further information on GPRS. 3. Tap on to save the setting and exit. IN MANUALLY MODE: 1. Tap on 2. Tap on 3.
Reminder Alarms 1. Tap on to set the alarm. You may set up any or all of the reminder alarms (1 - 4). 2. Tap on □ to put/remove 3. Tap as set/cancel the reminder alarm. on to set the time by tapping on or . In 12-hour time setting, you may choose from AM and PM along with time adjustment. 4. Tap on to save and exit. 5. Press the home button to leave the alarm setting page and back to the main page. Note: At the time of your alarm, the meter will beep.
Language 1. Tap to set the displayed language. The default language is English. 2. Tap on the preferred language bar. 3. Tap to save and exit. Congratulations! You have completed all settings! NOTE: These parameters can ONLY be changed in the setting mode.
Calling ActiveCare TD-4121 Blood Glucose Monitoring System is equipped with GPRS (General Packet Radio Service) that allows users to call out directly to the service center, receive calls and stream data to the server. Calling feature is activated under 3 conditions and functional for 10 minutes only. 1. After every blood glucose measurement: To transmit the test result to the server. The service center will phone in if the uploaded result is atypical. 2.
MESSAGE WHAT IT MEANS Appears when a call is connected. Tap on to end the call. Appears a call comes in. Tap on to take or to reject the call. Appears when you are answering the phone. Tap on “-” or “+” to adjust the volume. Tap on to hang up the phone. Appears when the meter is searching for available GPRS signal for data transmission. Data is loading.
MESSAGE WHAT IT MEANS Loading is completed. Note: Press the emergency button when necessary. The emergency button at the back of the meter is designed for users to contact the service center in time of emergency, for instance, critical healthy condition, for immediate assistance. The phone number of the service center is programmed prior to your receipt of the meter. If not, please contact the customer service for assistance.
Touchscreen Calibration Perform touchscreen calibration when you find the meter fails to respond properly. 1. 2. 3. 4. 5. Start with the meter off. Press the power button for 1 second to start the meter. Wait for the main page to appear. At the main page, press the power button for 1 second to put the meter into the halt state. At the halt state, press the home button. Then, keep on pressing the home button with another finger pressing the power button for 1 second.
BEFORE TESTING Control Solution Testing ActiveCare Control Solution contains a known amount of glucose that reacts with test strips and is used to ensure your meter and test strips are working together correctly. WHEN TO CONDUCT A CONTROL SOLUTION TEST: You first receive the meter. Routinely check the meter and test strips at least once a week. You begin using a new vial of test strips. You suspect the meter or test strips are not working properly.
3. Apply control solution Shake the control solution vial thoroughly before use. Squeeze out a 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 absorbent hole of the test strip to touch the drop. Once the confirmation window fills completely, the meter will begin counting down. To avoid contaminating the control solution, do not directly apply control solution onto a strip. 4.
TESTING WITH BLOOD SAMPLE WARNING: To Reduce the Chance of Infection The meter and lancing device are for single use. 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 in or on the lancets and the lancing device. Wash and dry your hands thoroughly after handling the meter, lancing device, and test strips to prevent infection.
Rub the puncture site for about 20 seconds before penetration. Clean the puncture site using cotton moistened with 70% alcohol and let it air dry. Fingertip testing Press the lancing device’s tip firmly against the lower side of your fingertip. Press the release button to prick your finger, then a click indicates that the puncture is complete. Blood from sites other than the fingertip Replace the lancing device cap with the clear cap for AST. Pull the cocking control back until it clicks.
Alternative Site Testing Important: There are limitations with AST (Alternative Site Testing). The alternative site testing of the system can only be used in during steady-state blood glucose conditions. Please consult your health care professional before you perform AST. Measurements from alternative site testing should never be used to calibrate a continuous glucose monitoring systems (CGMs) or entered into insulin dose calculators for insulin dosing recommendations.
We strongly recommend that you perform AST ONLY at the following times: In a pre-meal or fasting state (more than 2 hours since the last meal). Two hours or more after taking insulin. Two hours or more after exercise. Do NOT use AST if: You think your blood glucose is low. You are unaware of hypoglycemia. You are testing for hyperglycemia. Your AST results do not match the way you feel. Your routine glucose results often fluctuate.
Performing a Blood Glucose Test Please have the meter, test strips, lancets and lancing device ready before you start performing blood glucose tests. 1. Starting with the meter off. Press the power button to activate the meter. Or you may directly insert the test strip into the strip slot to start measuring. When the main page appears, tap on measurement procedure 2. to initiate the blood glucose Perform the blood glucose test as directed on the display. Insert a test strip. 3.
4. Apply blood onto the strip Hold the blood drop to touch the absorbent hole of the test strip and blood will be drawn in automatically. Make sure to provide the minimum required sample volume to fill the confirmation window completely with blood before your finger leaves the absorbent hole or meter will give inaccurate glucose results. 5. Wait a few seconds for the measurement to process.
6. Data Transmission The measuring data will be uploaded to the server after every measurement, providing that the meter’s GPRS is in service. If GPRS is not in service or connection fails, the measurement data will be stored in the memory and waited to be uploaded at 6 o’clock every morning. 7. Tap on or press home button to exit and back to the main page. 8. Eject the used test strip and remove the lancet 9. Eject the test strip by sliding up the eject button on the side.
WARNING: The used lancet and test strip may be biohazards. Please discard them carefully according to your healthcare provider’s instructions. Wash and dry your hands thoroughly after handling the meter, lancing device, and test strips to avoid contamination. For more information, please refer to the “Cleaning and Disinfection” section. Reviewing Memory Record The meter stores the most recent blood glucose test results, up to 450 sets, along with respective dates and times in the memory feature.
NOTE: If using the meter for the first time, You will find “”Empty” showing on the display, indicating that there is no test result in the memory. MAINTENANCE Battery Your meter comes with one 3.7V Li-Polymer rechargeable battery. Please recharge the meter if the battery icon on the upper right flickers. That means the battery is low. The meter will shut down immediately once the battery is dead.
Caring for Your Meter To avoid the meter and test strips attracting dirt, dust or other contaminants, please wash and dry your hands thoroughly before and after the measurement. Cleaning 1. To clean the meter exterior, wipe it with a cloth moistened with tap water or a mild cleaning agent, then dry the device with a soft dry cloth. Do NOT rinse with water. 2. Do NOT use organic solvents to clean the meter. Meter Storage Storage conditions: -20℃ to 60℃ (-4℉ to 140℉), below 95% relative humidity.
Do not use test strips beyond the expiration date. This may cause inaccurate results. Do not bend, cut, or alter a test strip in any way. Keep the strip vial away from children since the cap and the test strip may be a choking hazard. If swallowed, promptly see a doctor for help. For further information, please refer to the test strip package insert.
Important Control Solution Information Use only ActiveCare 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 solution vial and discard the remaining solution after 3 months. It is recommended that the control solution test be done at room temperature 20°C to 25°C (68°F to 77°F).
SYSTEM TROUBLESHOOTING If you follow the recommended action but the problem persists, or error messages other than the ones below appear, please call your local customer service. Do not attempt to try to repair the meter yourself and never try to disassemble the meter under any circumstances. Result Readings MESSAGE WHAT IT MEANS LOW < 20 mg/dL (1.1 mmol/L) HIGH > 600 mg/dL (33.
MESSAGE WHAT IT MEANS Blood glucose tests Can not Measure when are prohibited when Charging the battery is recharging. Appears when the Battery low battery is too low. SIM card Error Airplane Mode No Strip detect TEMP. too low TEMP. too high Carry Error No phone number Data Full Fail to detect SIM card. WHAT TO DO Please plug out USB before performing a blood glucose test. Recharge the battery immediately. Please check the SIM card or re-insert it.
Troubleshooting 1. If the meter does not display a message after inserting a test strip: POSSIBLE CAUSE WHAT TO DO Battery exhausted. Recharge the battery. 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.
DETAILED INFORMATION The meter provides you with plasma equivalent results. Normal plasma glucose range for people Time of day without diabetes (mg/dL) Fasting and before meal < 100 mg/dL (5.6 mmol/L) 2 hours after meals < 140 mg/dL (7.8 mmol/L) Source: American Diabetes Association (2014). Clinical Practice Recommendations. Diabetes Care, 37 (Supplement 1): S16. SPECIFICATIONS Model No.: TD-4121 Dimension: 99 mm(L) x 59 mm(W) x 15.6 mm(H) Weight: 88.
This device has been tested to meet the electrical and safety requirements of: IEC/EN 61010-1, IEC/EN 61010-2-101, EN 61326-1, IEC/EN 61326-2-6. This device complies with the R&TTE Directive (1999/5/EC) issued by the Commission of the European Community. A minimum separation distance of 0.5 cm must be maintained between the user’s body and the device, including the antenna during body-worn operation to comply with the RF exposure requirements in Europe.
SYMBOL INFORMATION SYMBOL REFERENT SYMBOL REFERENT In vitro diagnostic medical device Caution, consult accompanying documents Consult instructions for use Humidity Limitation Temperature limitation Collection for electrical and electronic equipment Use by CE mark Batch code Manufacturer Serial number Authorized representative in the European Community 42
Federal Communication Commission Interference Statement This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursua nt to Part 15 of the FCC Rules.
The exposure standard for wireless device employs a unit of measurement known as the Specific Absorption Rate, or SAR. The SAR limit set by the FCC is 1.6W/kg. *Tests for SAR are conducted using standard operating positions accepted by the FCC with the device transmitting at its highest certified power level in all tested frequency bands.
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