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Fora TD-3261G Owner's Manual

Blood glucose plus blood pressure monitoring system
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FORA TD-3261G
Blood Glucose Plus Blood Pressure Monitoring
System
Ownerʼs Manual

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Summary of Contents for Fora TD-3261G

  • Page 1 FORA TD-3261G Blood Glucose Plus Blood Pressure Monitoring System Ownerʼs Manual...
  • Page 3 English TD-3261G Dear System Owner: Thank you for purchasing the TD-3261G Blood Glucose plus Blood Pressure Monitoring System. This manual provides important information which helps you to operate this system smoothly. Before using this product, please read the following contents thoroughly and carefully.

  • Page 4: Important Safety Precautions

    IMPORTANT SAFTY INSTRUCTIONS READ BEFORE USE 1. Use this device ONLY for the intended use described in this manual. 2. Do NOT use accessories which are not specified by the manufacturer. 3. Do NOT use the device if it is not working properly or damaged.
  • Page 5 10. Use of this instrument in a dry environment, especially if synthetic materials are present (synthetic clothing, carpets etc.) may cause damaging static discharges that may cause erroneous results. 11. Do NOT use this instrument in close proximity to sources of strong electromagnetic radiation, as these may interfere with the correct operation.

  • Page 6: Table Of Contents

    TABLE OF CONTENTS IMPORTANT SAFETY PRECAUTIONS BEFORE YOU BEGIN Important Information Intended Use Test Principle Monitor Overview Screen Display Test Strip Features SETTING THE MONITOR TESTING YOUR BLOOD GLUCOSE The Four Measuring Modes QUALITY CONTROL TESTING Performing a Control Solution Test TESTING WITH BLOOD SAMPLE Preparing the Lancing Device for Blood Testing Preparing the Puncture Site...
  • Page 7 TESTING YOUR BLOOD PRESSURE Before Measurement Taking a Single Measurement Average Mode Measurement Auto Cycle Mode MONITOR MEMORY Reviewing Test Results Reviewing Day Average Results DATA TRANSMISSION VIA BLUETOOTH DATA TRANSMISSION VIA 4G MAINTENANCE Battery Using AC Adapter Caring for Your Monitor Caring for Your Test Strips Important Control Solution Information SYSTEM TROUBLESHOOTING...

  • Page 8: 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 symptoms of illness, first repeat the test.

  • Page 9: Intended Use

    Intended Use This system is a 2 in 1 system designed to measure blood glucose outside the human body (in vitro diagnostic use) and to measure blood pressure non-invasively. It is intended for use at home and in clinical settings as an aid to monitoring the effectiveness of diabetes control.

  • Page 10: Monitor Overview

    Monitor Overview Front Back Side Pressure Cuff...
  • Page 11 POWER INDICATOR TEST SLOT Insert test strip here to turn the Indicates the power status of the device. monitor on for testing. BATTERY DISPLAY SCREEN RF BUTTON COMPARTMENT Assists you with wireless data STRIP EJECTOR transmission. Eject the used strip by S BUTTON pushing up this button.

  • Page 12: Screen Display

    Screen Display Date Pulse Rate Systolic Pressure Symbol Day Average Measurement Mode Result Indicator Systolic Pressure Value Low Battery Symbol Diastolic Pressure Symbol Memory Symbol Diastolic Pressure Value Unit for Blood Pressure Volume Symbol Unit for Blood Glucose Face/Low/High Symbol Time Ketone Warning Test Strip Symbol...

  • Page 13: Test Strip

    Test results might be wrong if the contact bar is not fully inserted into the test slot. Front NOTE The TD-3261G monitor should only be used with TD-3261G Test Strips. Using other test strips with this meter can produce inaccurate results.

  • Page 14: Features

    Features Model Data Transmission Function Test results can be viewed through a wireless connection by using 4G. For TD-3261G Test results can be viewed through a wireless connection by using Bluetooth. For TD-3261B...

  • Page 15: Setting The Monitor

    SETTING THE MONITOR Before using your monitor for the first time or if you change the meter battery, check and update these settings. Make sure you complete the steps below and have your desired settings saved. ► Entering the setting mode Start with the monitor off (no test strip inserted).
  • Page 16 With the day flashing, press until the correct day appears. Press Step 2 Setting the time With the hour flashing, press until the correct hour appears. Press With the minute flashing, press until the correct minute appears. Press Step 3 Setting the time format Press to select the desired time...
  • Page 17 Step 4 Setting the measurement unit Press to select the desired blood glucose measurement unit- mg/dL or mmol/L. Press Step 5 Setting a language Press to select L1 / L2. The default language for the meter is L1, which is English; L2 is French. To confirm your selection, press Step 6 Setting the auto-send Press...
  • Page 18 Step 7 Deleting the memory While “dEL” and a flashing “ ” symbol appear on the display along with user numbers, if you do not wish to delete the saved results, press to skip this step. If you wish to delete ALL the results, press twice.

  • Page 19: Testing Your Blood Glucose

    TESTING YOUR BLOOD GLUCOSE The Four Measuring Modes The monitor provides you with four modes for measuring, General, AC, PC and QC. Use when Modes any time of day without regard to time since last meal (not displayed) no food intake for at least 8 hours 2 hours after a meal testing with the control solution You can switch between each mode by:...
  • Page 20 Step 2 Press to switch between General, AC, PC and QC mode.

  • Page 21: Quality Control Testing

    QUALITY CONTROL TESTING When should the control solution test be performed? • if it is mandatory following the local regulations in your country, • if you suspect the monitor or test strips are not working properly • if your blood glucose test results are not consistent with how you feel, or if you think the results are not accurate •...
  • Page 22 WARNING When doing the control solution test, you have to mark it so that the test result will NOT mix with the blood glucose TEST RESULTS be stored in the memory. Failure to do so will mix up the blood glucose test results with the control solution test results in memory.
  • Page 23 Step 4 Read and Compare the Result After counting down to 0, the test result of control solution will appear on the display. Compare this result with the range printed on the test strip vial and it should fall within this range. If not, please read the Normal instructions again and repeat the control 109~165...

  • Page 24: Testing With Blood Sample

    TESTING WITH BLOOD SAMPLE 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 in or on the lancets and the lancing device.
  • Page 25 • 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. • Use a clear cap (included in the kit) while setting up the lancing device.

  • Page 26: Alternative Site Testing

    Alternative Site Testing IMPORTANT: There are limitations with AST (Alternative Site Testing). Please consult your health care professional before you perform AST. What is AST? Alternative site testing (AST) means that people use parts of the body other than the fingertips to check their blood glucose levels.

  • Page 27: Performing A Blood Glucose Test

    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: •...
  • Page 28 Step 3 Obtaining a blood sample Use the pre-set lancing device to puncture your de- sired site. After penetration, discard the first drop of blood with a clean tissue or cotton. Gently squeeze the punctured area to obtain another drop of blood. Be careful NOT to smear the blood sample.
  • Page 29 NOTE • Do not press the punctured site against the test strip or try to smear the blood. • If you do not apply a blood sample to the test strip within 3 minutes, the monitor will automatically turn off. You must remove and reinsert the test strip to start a new test.

  • Page 30: Testing Your Blood Pressure

    TESTING YOUR BLOOD PRESSURE This monitor provides you two different ways to measure your blood pressure. Select from the options below: • Single measurement Perform an individual blood pressure measurement. • Average measurement Automatically perform three (3) consecutive blood pressure mea- surements and display the final average result.
  • Page 31 ► Fitting the Cuff Correctly Step 1 Connect the air plug of the tubing to the air jack of the monitor. Step 2 Pile Side Material Assemble the cuff as shown on the RED LINESHOULD BE AT THE INSID right. The smooth surface should be inside the cuff loop and the metal D-ring should not touch your skin.
  • Page 32 Step 5 Press the hook material firmly against RED LINESHOULD BE AT THE INSID the pile material. The top and bottom edges of the cuff should be tightened INDEX MUST evenly around your upper arm. ►The range index of cuff should fall into this range.

  • Page 33: Taking A Single Measurement

    Taking a Single Measurement Always apply the pressure cuff before turning on the monitor. Step 1 Press . All the LCD symbols will appear. Then the cuff will begin to inflate automatically. Step 2 The heart symbol “ ” will flash when a pulse is detected during the inflation.

  • Page 34: Average Mode Measurement

    Average Mode Measurement Always apply the pressure cuff before turning on the monitor. Step 1 Press . The monitor will turn on and enter the averaging mode. Then the cuff will begin to inflate automatically. Step 2 After the first measurement is complete, the monitor will start counting down before the second measurement begins.

  • Page 35: Auto Cycle Mode

    Step 3 After taken three measurements, the results are averaged to produce the blood pressure measurement. Press to turn off the monitor. Auto Cycle Mode Always apply the pressure cuff before turning on the monitor. Step 1 Press to enter cycle mode. The monitor will automatically take blood pressure measurement in 2 minutes for first measurement.
  • Page 36 Step 3 After completion of the cycle mode for 5 hours, the monitor will dis- play “End” and press any key to turn off the monitor. NOTE To discontinue the cycle mode measurement during the time intervals, press and hold for 3 seconds to enter setting mode and select cycle mode OFF.

  • Page 37: Monitor Memory

    MONITOR MEMORY Your monitor stores the 864 most recent test results along with respective dates and times in its memory. To recall the memory, start with the monitor off. Reviewing Test Results Step 1 Press and release “ ”will appear on the display. Step 2 Press Review all test results stored in the monitor.

  • Page 38: Reviewing Day Average Results

    Reviewing Day Average Results Step 1 Press and hold for 3 seconds. When “ ” appears on the display, keep pressing for 3 seconds until the flashing “ ” appears. Release and then your blood glucose or blood pressure 7-day average result will appear on the display.
  • Page 39 NOTE • Any time you wish to exit the memory, press or leave it without any action for 3 minutes. The monitor will turn off automatically. • Control solution results are NOT included in the day average. • If using the monitor for the first time, “---” displays when you recall the test results or review the average result.

  • Page 40: Data Transmission Via Bluetooth

    DATA TRANSMISSION VIA BLUETOOTH (For TD-3261B) You can transmit your data from the meter to your devices via Bluetooth. Please contact your local customer service or place of purchase for assistance. Please note that you must complete the pairing between meter and Bluetooth receiver before transmitting data.
  • Page 41 NOTE • While the meter is in transmission mode, it will be unable to perform a test. • Make sure your device with iOS (7 or above) or Android System (4.3 or above) has turned on Bluetooth before transmitting the data and the meter is within the receiving range.

  • Page 42: Data Transmission Via 4G

    DATA TRANSMISSION VIA 4G (For TD-3261G) For 4G Version Before initiating 4G transmission, make sure the SIM card and the battery are inserted correctly. 1. How to initiate 4G transmission Three methods can initiate 4G transmission (a) with the meter turned off, press...
  • Page 43 When the RF indicator is blinking in blue, the data transmission is waiting for connection. When the RF indicator is in solid blue, the 4G connection is established. Press and the meter will turn off. NOTE • If the SIM card is not inserted, the “PCL” will start blinking, as in the figure shown as right, and the meter will turn off automatically after blinking for 30 seconds.
  • Page 44 The number displayed in the middle of the screen represents the signal quality level from 1 to 31. The greater the number, the better signal you have. We recommend that the signal quality should be above ten (10) when you perform the transmission.

  • Page 45: Maintenance

    MAINTENANCE Battery Your monitor comes with one 3.7V lithium-ion rechargeable battery. ► Low Battery Signal The monitor will display the two messages below to alert you when the monitor power is getting low. The “ ” symbol appears along with display messages: The monitor is functional and the result remains accurate, but it is time to recharge the battery.

  • Page 46: Using Ac Adapter

    NOTE • If the power indicator is blinking in red when connecting AC adapter to a power source, this indicates the monitor is in a pre-charging stage. Do not remove AC adapter power plug. The recharge will begin shortly. • If the battery is full-recharged but the power is getting low soon after use, please contact local customer service for assistance.

  • Page 47: Caring For Your Monitor

    AC adapter to an electrical outlet. Only this 3.7V rechargeable Li- ion battery (battery pack no. S14500 1S4P) can be recharged with TD-3261G by the connection of AC adapter. Any other kind of rechargeable battery is not allowed or it may damage the monitor.

  • Page 48: Caring For Your Test Strips

    Caring for Your Test Strips • Storage condition: 4°C to 40°C (39.2°F to 104°F) for strip vial and 2°C to 30°C (35.6°F to 86°F) for foil package, 10% to 85% relative humidity. Do not freeze. • Store your test strips in their original vial only. Do not transfer to other container.

  • Page 49: Important Control Solution Information

    Important Control Solution Information • Use only our control solutions with your monitor. • Do not use the control solution beyond the expiry 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 50: 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 repair by yourself and never try to disassemble the monitor under any circumstances. Result Readings MESSAGE WHAT IT MEANS...
  • Page 51 Appears when your result is equal to or higher than 240 mg/dL (13.3 mmol/L). This indicates the possibility of ketone accumulation for type 1 diabetes. Please seek medical assistance immediately. Appears when your result is higher than the limit of measurement, which is higher than 600 mg/dL (33.3mmol/L).

  • Page 52: Error Messages

    Error Messages MESSAGE CAUSE WHAT TO DO Problem with the cuff Please contact local Err 1 or meter. customer service for help. Refit cuff tightly and correctly. Relax for 5 minutes and repeat the Problem with the Err 2~Err 8 measurement.
  • Page 53 Error Messages of 4G Transmission MESSAGE CAUSE WHAT TO DO Insert your SIM card and No SIM card place it correctly before inserted. transmitting data. Please start over and PCL Err 27-30 try again. If the problem PCL Err 40-45 Problem with persists, please contact PCL Err 50...

  • Page 54: Troubleshooting

    Troubleshooting 1. Blood Glucose Measurement 1. If the monitor does not display a message after inserting a test strip: POSSIBLE CAUSE WHAT TO DO Test strip inserted upside down or Insert the test strip with contact incompletely. bars end first and facing up. Defective monitor or test strips.
  • Page 55 3. If the control solution testing result is out of range: POSSIBLE CAUSE WHAT TO DO Read instructions thoroughly and Error in performing the test. repeat the test again. Shake the control solution Control solution vial was poorly vigorously and repeat the test shaken.
  • Page 56 2. Blood Pressure Measurement 1. If nothing is displayed after pressing the On/Off button: POSSIBLE CAUSE WHAT TO DO Batteries incorrectly installed or Check that the batteries are absent. correctly installed. 2. If the heart rate is higher/lower than user’s average: POSSIBLE CAUSE WHAT TO DO Movement during measurement.

  • Page 57: Detailed Information

    DETAILED INFORMATION Reference Values Blood Glucose The meter provides you with plasma equivalent results. Time of day Normal plasma glucose range for people without diabetes (mg/dL) Fasting and before meal Less than 100 mg/dL (5.6 mmol/L) 2 hours after meals Less than 140 mg/dL (7.8 mmol/L) Source: American Diabetes Association.
  • Page 58 Definitions and Classification of blood pressure levels according to 2007 ESH-ESC Practice Guidelines for the Management of Arterial Hypertension: Systolic Diastolic Category (mmHg) (mmHg) Optimal < 120 < 80 Normal 120–129 and/or 80–84 High normal 130–139 and/or 85–89 Grade 1 hypertension 140–159 and/or 90–...

  • Page 59: Symbol Information

    SYMBOL INFORMATION Symbol Referent In vitro diagnostic medical device Consult instructions for use Type BF equipment Temperature limit Use-by date Batch code Manufacturer Serial number Caution Authorized representative in the European Community Humidity limitation CE mark This device does not belong to household waste and must be returned to a collection point for recycling electric and electronic devices according to local laws.

  • Page 60: Specifications

    DC +6V / 1A (max) via Power Plug Operating Altitude: Up to 2,000m, for indoor use Degree of Pollution: Pollution degree 2 Expected service life: 3 years Bluetooth (TD-3261B) (Frequency:2.45GHz, Data Transmission: Bandwidth :170MHZ, Modulation:GFSK, ERP:5.46 dBi) / 4G (TD-3261G)
  • Page 61 Blood glucose measurement performance Measurement unit: mg/dL or mmol/L Linear range: 20 to 600 mg/dL (1.1 to 33.3mmol/L) Precision: ±5 % (CV) ±15 mg/dL (0.83 mmol/L) when glucose < 100 mg/ dL (5.5 mmol/L) Accuracy: ±15% when glucose ≥ 100 mg/dL (5.5 mmol/L) Ketone warning: glucose value is above 240 mg/dL (13.3 mmol/L) Blood pressure measurement performance...
  • Page 62 Warning: Medical electrical equipment needs special precautions regarding EMC and needs to be installed according to the EMC information provided. Careful consideration of this information is essential when stacking or collocating equipment and when routing cables and accessories. Warning: RF mobile communications equipment can effect medical electrical equipment.
  • Page 63 Manufacturer’s declaration-electromagnetic emissions The TD-3261G is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the TD-3261G should assure that it is used in such an environment. Emission test...
  • Page 64 Manufacturer’s declaration-electromagnetic immunity The TD-3261G is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the TD-3261G should assure that it is used in such an environment. Immunity test...
  • Page 65 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the TD-3261G is used exceeds the applicable RF compliance level above, the TD-3261G should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the TD-3261G.
  • Page 66 The TD-3261G is intended for use in an electromagnetic environment (for home and professional healthcare) in which radiated RF disturbances are controlled. The customer or the user of the TD-3261G can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the TD-3261G as recommended below, according to the maximum output power of the communications equipment.
  • Page 67 ENCLOSURE PORT IMMUNITY The TD-3261G is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the TD-3261G should assure that it is used in such an environment. Compliance LEVEL...
  • Page 68 Federal Communications Commission (FCC) Statement  15.21  You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the  user’s authority to operate the equipment.    15.105(b)  This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules.  These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment  generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause  harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular  installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning  the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:    ‐Reorient or relocate the receiving antenna.  ‐Increase the separation between the equipment and receiver.  ‐Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.  ‐Consult the dealer or an experienced radio/TV technician for help.    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 of the device.    Innovation, Science and Economic Development Canada (ISED) statement  This Class B digital apparatus complies with Canadian ICES‐003 and RSS‐247.  This device contains licence‐exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development  Canada’s licence‐exempt RSS(s).    Operation is subject to the following two conditions:  (1)this device may not cause interference, and    (2)this device must accept any interference, including interference that may cause undesired operation of the device.    Cet appareil numérique de classe B est conforme à la norme NMB‐003 et RSS‐247  L’émetteur/récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR d’Innovation, Sciences et  Développement économique Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux deux  conditions suivantes :  (1) l'appareil ne doit pas produire de brouillage, et, and  (2) l'utilisateur de l'appareil doit accepter tout brouillage radioelectrique subi, meme si le brouillage est susceptible d'en  compromettre le fonctionnement. ...
  • Page 69 FCC/IC RF Radiation Exposure Statement  This equipment should be installed and operated with a minimum distance of 0 cm between the radiator and your extremity. This  device and its antenna(s) must not be co‐located or operating in conjunction with any other antenna or transmitter.  SAR is measured with the device at 0 mm to the extremity, while transmitting at the highest certified output power level in  all frequency bands of the device.      Déclaration de FCC / IC sur l'exposition aux radiations RF  Cet équipement doit être installé et utilisé avec une distance minimale de 0 cm entre le radiateur et votre extrémité. Cet appareil et  son (ses) antenne (s) ne doivent pas être co‐localisés ou utilisés conjointement avec une autre antenne ou un autre émetteur.  Le SAR est mesuré avec le périphérique à 0 mm de l'extrémité, tout en émettant au niveau de puissance de sortie certifié le plus  élevé dans toutes les bandes de fréquences du périphérique.    NCC Statement  減少電磁波影響，請妥適使用  Support FDD LTE900/1800 ...
  • Page 71 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 Borkstra β e 10, 48163 Münster, Germany...

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