Fora Comfort 2 in 1 Blood Glucose plus Blood Pressure Monitoring System Version 1.
IMPORTANT SAFETY INSTRUCTIONS READ THIS BEFORE USING The following basic safety precautions should always be taken. 1. Close supervision is necessary when the device is used by, on, or near children, handicapped persons or invalids. 2. Use the device only for the intended use described in this manual. 3. Do not use strips and control solutions which are not supplied by the manufacturer. 4. Do not use the device if it is not working properly, or if it has suffered any damage. 5.
Table of Contents BEFORE YOU START Warnings and Precautions Health Information 05 05 06 ABOUT THIS SYSTEM Intended Use Principle of Measurement Alternative Site Testing (AST) Content of the System Appearance and Key Function of the Monitor LCD Display Appearance of the Test Strip PREPARATIONS BEFORE USE Battery Installation and Replacement Setting the Monitor 08 08 08 09 11 12 14 15 16 16 18 HOW TO MEASURE BLOOD GLUCOSE Coding the Monitor Checking the Code Checking the System with Control Solutions I
HOW TO TAKE CARE OF YOUR MONITOR Cleaning Storage Monitor storage Strip storage Control storage 42 42 42 42 43 44 PROBLEM-SOLVING GUIDE 45 ERROR MESSAGE Problem in Opertation 46 47 SPECIFICATIONS 49 04 4
BEFORE YOU START Warnings and Precautions The Fora comfort 2 in 1 blood glucose plus blood pressure monitoring system is designed for use on individuals age 16 and above. It shall NOT be used: 1. To diagnose newborns with diabetes. 2. On infants or persons who cannot communicate. This device does NOT serve as a cure of any symptoms or disease. The data measured are only for reference. Always consult your physician to have the results interpreted.
Health Information Blood Glucose Blood glucose monitoring plays an important role in diabetes control. A long-term study showed that keeping blood glucose levels close to normal can reduce the risk of diabetes complications by up to 60%*1. The results you get with the Fora comfort 2 in 1 blood glucose plus blood pressure monitoring system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes.
Blood Pressure Clinical studies show that the adult diabetes is often accompanied by elevated blood pressure. People with diabetes can reduce their heart risk by managing their blood pressure along with diabetes treatment*2. Knowing your routine blood pressure trend tells whether your body is in good condition or not. Human blood pressure naturally increases after reaching middle age. This symptom is a result of continuous aging of the blood vessel.
ABOUT THIS SYSTEM Intended Use The Fora Comfort TD-3260 2 in 1 Blood Glucose plus Blood Pressure Monitoring System is indicated for the quantitative measurement of glucose in fresh whole blood (capillary blood from the finger, the palm, the forearm, the upper-arm, the calf and the thigh) for self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities.
Alternative Site Testing (AST) Important: There are limitations for doing AST. Please consult your healthcare professional before you do AST. What is AST? Alternative site testing (AST) means that people use parts of the body other than fingertips to check their blood glucose levels. This system provides you to test on the palm, the forearm, the upper arm, the calf, or the thigh with the equivalent results to fingertip testing.
Do NOT use AST if: You think your blood glucose is low. You are unawareness of hypoglycemia. Your AST results do not match the way you feel. You are testing for hyperglycemia. Your routine glucose results are often fluctuating. You are pregnant. How to increase the accuracy? Stimulating blood perfusion by rubbing the puncture site prior to blood extraction has a significant influence on the glucose value obtained.
Content of the System These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only the same brand-name test strips and a control solution with the blood glucose and blood pressure monitor. 1. Blood glucose and blood pressure monitor 2. Pressure cuff 3. Owner’s manual 4.Quick using card 5. Lancing device x1 6. A clear cap X1 x1 X1 X1 x1 7. Carry bag 8.
Appearance and Key Function of the Monitor LCD Display Test result is displayed with symbols and simple messages.
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LCD Display 14 14
Appearance of the Test Strip Your system measures the amount of sugar (glucose) in whole blood. Blood is applied to the absorbent hole of the test strip and is automatically drawn into the reaction chamber where the reaction takes place. See pages 21-36, How to measure blood glucose, for complete instructions. NOTE We recommend that you should hold the test strip by the Test Strip Handle only when you perform blood glucose test. Do not hold the Absorbent Hole in order to avoid contamination.
PREPARATIONS BEFORE USE Battery Installation and Replacement Your monitor comes with batteries already installed. When replacing, use ONLY 1.5V AA size alkaline batteries for best performance and longest life. Low Power Signal The monitor will remind you when the power is getting low by displaying two different messages: 1. Battery Symbol appears while you perform tests (Fig. 1).This means it is about time to change the batteries although still 30 more measurements can be made. (Fig. 1) 2.
Make sure the monitor is off before replacing the batteries. STEP 1- Press the edge of the battery cover and pull up (Fig. 3). Lift the battery cover and remove the batteries inside. (Fig. 3) (Fig. 4) STEP 2- Insert four 1.5V AA size alkaline batteries. Make sure the + (positive) and–(negative) marks match as indicated in the battery compartment (Fig. 4). If inserted correctly, you will hear a "beep". CAUTION 1. Do not use different type, date or brand name batteries together.
Setting the Monitor Your monitor comes with the time, date, units and ambient temperature preset. These options may be changed any time to fit your needs. They also need to be set again when you change the batteries. How to set the monitor? STEP 1- Start with the Monitor Turned Off. Press the S button to enter the Setting Mode. (Fig. 5) (Fig. 5) STEP 2- The year will appear first.(Fig. 6) (Fig. 6) STEP3 - Press the S button to select what you would like to change. The selected one will be flashing.
STEP 5- The hour and minute will appear automatically. Press the M button to select the changes you made and press S button move on to next step.(Fig. 9) (Fig. 9) STEP 6- The blood glucose unit*3 will appear automatically. Press the M button to select the changes you made and press the S button move on to next step.(Fig. 10) (Fig. 10) (Fig. 11) STEP 6- The blood pressure unit will appear automatically. Press the M button to select the changes you made and press the S button move on to next step.(Fig.
NOTE The time, date, unit of measurement and unit of temperature can ONLY be changed in the setting mode. Therefore, when you perform a glucose testing or blood pressure testing, those parameters are not possible to be changed. *3: The milligram per deciliter (mg/dL) is the standard unit in the United States. The millimole per liter (mmol/L) is the standard unit in Canada. Use of the wrong unit of measure may cause you to misinterpret your blood glucose level, and may lead to incorrect treatment.
HOW TO MEASURE BLOOD GLUCOSE Important Information and Possible Interferences Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately. *4 Test results below 60 mg/dL (3.3 mmol/L) mean low blood glucose (hypoglycemia). Test results greater than 240 mg/dL*5 (13.3 mmol/L) mean high blood glucose (hyperglycemia).
Coding the Monitor You must code the monitor every time you begin to use a new vial of test strips. Test results may be wrong if the code number displayed on the monitor does not match the number printed on the strip vial. Step 1- Insert the code strip when the monitor is off. Wait until the code number appears on the LCD display .(Fig.14) Make sure the code number on LCD display, on the code strip, and on strip vial are identical. (Fig.
Checking the Code When you start measuring blood glucose, check the code number first. STEP1- With the monitor off, insert a test strip into the Test Slot. Make sure you insert the end with the contact bars first and facing up. Contact bars must be inserted all the way into the monitor for an accurate result (Fig. 16). (Fig. 16) STEP2- The monitor will display “CHK” and the strip symbol (Fig. 17). Then the ambient temperature will be shown (Fig. 18). (Fig. 17) (Fig.
Checking the System with Control Solutions TaiDoc control solutions contain a known amount of glucose that reacts with test strips. By comparing your control solution test results with the expected range printed on the test strip vial label, it is able to check that the monitor and the test strips are working together as a system and that you are performing the test correctly. It is very important that you do this simple check routinely to make sure you get accurate results.
Important Control Solution Information Use only TaiDoc control solutions. Check the expiry date on the control solution vial. Do not use if expired. Control solution, monitor, and test strips should come to room temperature (68-77℉/20-25℃) before testing. Shake the vial, discard the first drop of control solution, and wipe off the dispenser tip to ensure a good sample and an accurate result. Use only for 90 days after first opening.
Doing a Control Solution Test TAKE A TEST STRIP OUT WITH CLEAN AND DRY HANDS FIRST. . STEP1- Insert Test Strip Insert a test strip with contact bars end first and facing up,into the test slot.The monitor turns on automatically and displays the followings in sequence: “CHK” and “ ” Îambient temperatureÎcode number and flashing“ ”(Fig.20) (Fig.20) Be sure the code number on the display is the same as the code number on the test strip vial.
STEP 3- Obtain control solution Shake the control solution vial well. Remove the cap. Squeeze the vial, discard the first drop, and wipe off the dispenser tip to prevent contamination. Squeeze the vial again to get another drop and place on a clean surface (Fig. 23). (Fig.23) STEP 4- Apply Control Solution Move the monitor to meet the absorbent hole of the test strip and the drop will be automatically drawn into the test strip (Fig 24). Remove the monitor until the confirmation window is filled.
Testing Your Blood Glucose Be sure to read carefully this section and the test strip package insert found in the test strip box before testing. Make sure you have all items needed to test: A. Monitor B. Test Strips C. Lancing Device D. Sterile Lancet. E. Clear Cap A. B. C. E. 28 28 D.
WASH AND DRY YOUR HANDS FIRST BEFORE STARTING. STEP 1- Set the Lancing Device Remove the cap of lancing device. Insert a lancet into the lancet holder and push down firmly until it is fully seated.(Fig.26) (Fig.26) Remove the protective disk.Replace the lancing Device cap.( Fig. 27) ( Fig. 27) Replace the lancet device cap.Turn the cap unit it is snug but not too tight.(Fig.28) (Fig.28) WARNING To reduce the chance of infection: Never share a lancet with anyone. Always use a new, sterile lancet.
Slide the ejection /cocking control back until it clicks. If it does not click the device may have been cocked when the lancet was inserted.(Fig. 30) (Fig.30) ■ Blood from sites other than the fingertip A clear cap, together with the kit, makes it easier to get a drop of blood for AST. When you want to obtain blood from sites other than the finger, replace the lancet device cap with the clear cap (Fig.31) Turn the clear cap until it is snug but not too tight. (Fig.
STEP 2- Insert Test Strip Insert a test strip with contact bars end first and facing up, into the test slot(Fig.32). The monitor turns on automatically and displays the followings in sequence: CHK and” ” Î ambient temperature Î code number and flashing “ ” (Fig.32) Make sure the code number showed on the screen is the same as the code number printed on the test strip vial. If the code numbers are different, please refer to section of “Coding the Monitor”, for the procedure of coding( Fig 33). (Fig.
STEP 3- Get a Drop of Blood Select the puncture site either in finger or in other parts (AST). Clean the puncture site with 70% alcohol cotton and let it air-dry. ■ Fingertip Hold the Lancing Device firmly against the side of your finger. Press the release button. You will hear a click, indicating that the puncture is complete(Fig. 34). (Fig.34) ■ Site other than fingertip Please refer to the section of” About AST” for available punctured sites.
STEP 4- Apply Blood into the Test Strip When “ “is flashing on the screen, apply your blood to the absorbent hole of the test strip until the confirmation window is fully covered with blood(Fig. 36). The monitor then begins to count down automatically. (Fig.36) STEP 5- Obtain an accurate result in 7 seconds The result of your blood glucose test is shown after the meter counts to 0. This reading is automatically stored in the monitor (Fig.37). (Fig.37) PLEASE NOTE 1.
STEP 6- Remove the Lancet Always use caution when removing the lancet. Take the lancet out carefully. Place the disk on a hard surface and push the exposed tip into the protective disk(Fig. 38). (Fig. 38) WARNING The used lancet and the used test strip may be potentially biohazard. Please discard it carefully according to your local regulations.
Special Messages MESSAGE WHAT IT MEANS ACTION This indicates hypoglycemia (low blood glucose.) Appears when your result is below measurement limit, You should immediately treat which is less than 20 mg/dL. hypoglycemia as recommended by your healthcare professional. This indicates severe Appears when your result is hyperglycemia (high blood above measurement limit, glucose). which is higher than 600 mg/dL. You should seek immediate medical assistance.
Comparing Monitor and Laboratory Results The result you obtain from your monitor may differ somewhat from your laboratory result due to normal variation. Monitor results can be affected by factors and conditions that do not affect laboratory results in the same way (See test strip package insert for typical accuracy and precision data and for important information on limitations). To make an accurate comparison between monitor and laboratory results, follow the guidelines below.
HOW TO MEASURE BLOOD PRESSURE Suggestions before Measuring Avoid caffeine, tea, alcohol, and cigarette at least 30 minutes before measurement. Wait 30 minutes after exercising or bathing before measurement. Sit or lie down for at least 10 minutes before measuring. Do not measure when feeling anxious or tense. Take a 5-10 minute break between measurements. This break can be longer if necessary, depending on your physical conditions. Keep the records for your physician as reference.
Testing Your Blood Pressure SETP 1 Please sit and take a rest at least 10 minutes before measuring. STEP 2- Connect the air plug of the tubing to the air jack at the side of the monitor (Fig. 39) . (Fig.39) STEP 3- Assemble the cuff as Figure 40. The smooth cloth is on the inside of the cuff loop and the metal D-ring will not touch your skin (Fig. 40) .. (Fig. 40) (Fig. 41) ( Fig. 42) STEP 4- Hold your left arm in front of you with your palm facing up.
WARINING It is extremely important that the cuff is at the same level of the heart. If the cuff is relatively lower (higher) than the heart, the blood pressure measured will be higher (lower) than the actual value. A 15 cm difference in height may result in an error of 10 mmHg. STEP 6- All the LCD display symbols will appear with a long “beep” sound (Fig. 43). Then cuff begins to inflate automatically. ( Fig. 43) STEP 7- After the cuff pressure is reached, the cuff begins to deflate.
HOW TO USE THE MEMORY FEATURES Viewing Memory in the Monitor Your monitor stores the most 352 recent results of blood glucose and blood pressure with date and time in its memory. You can review the test results in memory with these easy steps. STEP 1- When the monitor is off, press the M Button once. You will see the average of the blood glucose results (Fig. 46). (Fig. 46) STEP 2- Press the M Button again to recall the readings measured previously.
HOW TO USE THE MEMORY FEATURES Deleting Memory To clear the memory, with the monitor turned off, press and hold the M Button for 3 seconds. “CLr/ALL” then appears and indicates that ALL the memories stored in the monitor will be cleared (Fig. 49). (Fig.
HOW TO TAKE CARE OF YOUR MONITOR Cleaning To clean the monitor exterior, wipe with a cloth moistened with tap water or a mild cleaning agent, then dry the device with a soft and dry cloth. Do not flush with water. Do not use organic solvents to clean the monitor and cuff. The cuff can be cleaned by wiping with a moistened cloth and soap. Do not immerse in water. Storage 1. Monitor Storage Storage conditions: -20℃~60℃, 10%~95% relative humidity.
2. Strip Storage Storage condition: 4oC-40oC, below 85% relative humidity. Do NOT refrigerate. Store your test strips in their original vial only. Do not transfer to other container. Store test strip packages in a cool and dry place. Keep away from direct sunlight and heat. After removing a test strip from the vial, immediately replace the vial cap and close it tightly. Touch the test strip with clean and dry hands. Use each test strip immediately after removing it from the vial.
3. Control solution storage Storage condition: Store the control solution tightly closed at temperature below 30℃ (86℉). Do NOT refrigerate. Record the discard date (date opened plus 90 days) on the control solution vial. Discard after 90 days.
PROBLEM-SOLVING GUIDE Following is a summary of some display messages. These messages help to identify certain problems but do not appear in all cases when a problem has occurred. Improper use may cause an inaccurate result without producing an error message. In the event of a problem, refer to the information under action. Never try to disassemble the monitor in any circumstances.
ERROR MESSAGE Message Cause What to Do Err.00 Weak pulse. Err.02 Monitor can not figure out systolic pressure. Err.04 Monitor can not figure out diastolic pressure or it is out of range. Err.22 Invalid coding. Insert the code strip and try coding again. Err.24 Used strip insertion. Use a new strip. Err.25 Ambient temperature is below operating temperature. Err.26 Ambient temperature is over operating temperature. Lo Blood glucose value lower than 20 mg/dL Hi Err.05 Err.06 Err.09 Err.
Problem in Operation Please check the chart below for problems you may encounter during measurement and what to do. If you follow “What to Do” but the problem still exists, please contact Customer Service Line for help. Blood Glucose Function If no message appears after inserting a test strip: Possible Cause What to Do Batteries exhausted. Replace the batteries. Batteries incorrectly installed or absent. Check that the batteries are correctly installed.
Blood Pressure Function If there is no display after pushing the POSSIBLE CAUSE button. WHAT TO DO Batteries exhausted. Replace the batteries. Batteries incorrectly installed Check that the batteries are or absent. correctly installed. What happened? If the heart rate is higher/lower than user’s average. POSSIBLE CAUSE WHAT TO DO Moving during measurement. Repeat measurement. Measuring right after Rest at least 30 minutes exercise. before measurement.
SPECIFICATIONS System Performance Power source: Four 1.5V AA alkaline batteries Size of monitor w/o cuff: 137mm (L) x 90 mm (W) x 54 mm (H) Memory: 352 measurement results with date& time Power saving: Automatic power off if idle for 3 minutes System operating condition: 10℃-40℃ (50-104℉), below 85% RH System storage condition: 4℃ to 40℃ (39-104℉), below 85% RH Blood Glucose Measurement Performance Measurement unit: mg/dL or mmol/L Linear range: 20-600 mg/dL (1.1 -33.
FCC STATEMENT 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.
Manufacturer: U.S.A Agent TaiDoc Technology Corporation Fora Care Inc. 4F, No.88, Sec. 1, Kwang-Fu Rd. 223E Thousand Oaks Blvd. Suite 121, San-Chung, Taipei County, Taiwan Thousand Oaks, CA, 91360 TEL: 886-2-66358080 Customer Care Line: FAX: 886-2-66355959 805-230- 3068 Hours of Operation: 9 am- 4 pm PDT At all other times, you should contact your health care professional for assistance.
