Summary of Contents for Active Care Medical TD-4121
- Page 1 ActiveCare TD-4121 Blood Glucose Multi-Functional Monitoring System Owner’s Manual...
- Page 3 Regular monitoring of your blood glucose levels can help you and your doctor gain better control of your diabetes. You can use the ActiveCare TD-4121 to easily monitor your blood glucose levels by yourself anywhere and anytime.
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Page 4: Important Safety Precautions
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. - Page 5 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.
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Page 6: Table Of Contents
TABLE OF CONTENTS IMPORTANT SAFETY PRECAUTIONS ............4 BEFORE YOU BEGIN ..................7 Important Information ................7 Intended Use ................... 8 Test Principle ..................8 Contents of System ................9 Meter Overview ..................10 Display Screen ..................11 Test Strip ....................12 SETTING THE METER .................. -
Page 7: Before You Begin
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. -
Page 8: Intended Use
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. -
Page 9: Contents Of System
Contents of System Your new ActiveCare system kit includes: Meter 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. -
Page 10: Meter Overview
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. -
Page 11: Display Screen
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: Battery Alarm Icon... -
Page 12: Test Strip
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. -
Page 13: Setting The Meter
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. - Page 14 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.
- Page 15 Measuring Units Tap on to set the measuring unit. There are two measuring units to choose from: mg/dL and mmol/L. 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.
- Page 16 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.
- Page 17 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 as set/cancel the reminder alarm. 3. Tap on to set the time by tapping on .
- Page 18 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.
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Page 19: Calling
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. - Page 20 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.
- Page 21 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. ...
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Page 22: Touchscreen Calibration
Touchscreen Calibration Perform touchscreen calibration when you find the meter fails to respond properly. 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. -
Page 23: Before Testing
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: ... - Page 24 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.
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Page 25: Testing With Blood Sample
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. ... - Page 26 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.
- Page 27 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.
- Page 28 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: ...
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Page 29: Performing A Blood Glucose Test
Performing a Blood Glucose Test Please have the meter, test strips, lancets and lancing device ready before you start performing blood glucose tests. 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 to initiate the blood glucose measurement procedure... - Page 30 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.
- Page 31 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. Tap on or press home button to exit and back to the main page.
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Page 32: Reviewing Memory Record
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”... -
Page 33: Maintenance
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. -
Page 34: Caring For Your Meter
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. - Page 35 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.
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Page 36: Important Control Solution Information
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. -
Page 37: System Troubleshooting
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. - Page 38 MESSAGE WHAT IT MEANS WHAT TO DO Blood glucose tests Can not Measure when are prohibited when Please plug out USB before Charging the battery is performing a blood glucose test. recharging. Appears when the Battery low Recharge the battery immediately. battery is too low.
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Page 39: Troubleshooting
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 Insert the test strip with contact bars end incompletely. first and facing up. -
Page 40: Detailed Information
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: 88.6 g (With the battery) Power Source: one Li- Polymer rechargeable battery... - Page 41 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.
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Page 42: Symbol Information
SYMBOL INFORMATION SYMBOL REFERENT SYMBOL REFERENT Caution, consult In vitro diagnostic accompanying medical device documents Consult instructions for Humidity Limitation Collection for Temperature limitation electrical and electronic equipment Use by CE mark Batch code Manufacturer Authorized representative in the Serial number European Community... - Page 43 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.
- Page 44 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.
- Page 45 TaiDoc Technology Corporation B1-7F, No.127, Wugong 2nd Rd., Wugu Dist., 24888 New Taipei City, Taiwan www.taidoc.com For self-testing MedNet GmbH Borkstraβe 10, 48163 Mϋnster, Germany...