FORA D40 Blood Glucose plus Blood Pressure Monitoring System Owner’s Manual 09/2009 Version 1.
Dear FORA D40 System Owner: Thank you for purchasing the FORA D40 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. According to the clinical studies from American Diabetes Association, elevated blood pressure often accompanies adult diabetes patients.
IMPORTANT SAFETY INSTRUCTIONS READ THIS BEFORE USE The following basic safety precautions should always be taken. 1. Use the device only for the intended use described in this manual. 2. Do not use accessories which are not supplied by the manufacturer. 3. Keep the equipment and its flexible cord away from hot surfaces. 4. Do not use the equipment where aerosol sprays are being used, or where oxygen is being administered. 5. Do not use the device if it is not working properly or has been damaged. 6.
Table of Contents BEFORE YOU START Warnings and Precautions Health Information Blood Glucose Blood Pressure 06 06 07 07 08 ABOUT ALTERNATIVE SITE TESTING (AST) 09 ABOUT THIS SYSTEM Intended Use Principle of Measurement Major Features Content of the System Appearance and Key Functions of the Monitor LCD Screen Speaking Function 11 11 11 11 13 14 15 Test Strip Description 16 19 PREPARATIONS BEFORE USE Battery and DC adaptor Battery Installation and Replacement Use of the DC Adaptor Setting the Monitor
BLOOD PRESSURE MEASUREMENT Suggestions before Measuring Applying the Pressure Cuff Proper Measurement Position Take a Reading Measurement Average Mode MONITOR MEMORY Viewing Results on the Monitor Reading the Average of Blood Glucose Results Viewing Results on a Personal Computer Data Transmission via Bluetooth Data Transmission via GPRS TAKING CARE OF YOUR MONITOR & STRIP Cleaning Storage 39 39 40 41 42 44 45 45 47 49 50 51 52 53 54 TROUBLESHOOTING 55 SPECIFICATIONS 59 FCC STATEMENT 60 05 A1-5
BEFORE YOU START Warnings and Precautions The FORA D40 system is designed for use on individuals age 16 and above. It shall NOT be used under any circumstances on newborns, infants or persons who cannot communicate. This device does NOT serve as a cure for any symptoms or diseases. The data measured are for reference only. 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 acquire with the FORA D40 system can help you and your healthcare professionals 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*5. 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 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 equivalent results to fingertip testing.
Do NOT use AST if: You think your blood glucose is low. You are unaware of hypoglycemia. Your AST results do not match the way you feel. You are testing for hyperglycemia. Your routine glucose results are often fluctuating. 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.
ABOUT THIS SYSTEM Intended Use The FORA D40 system is a 2 in 1 system designed to measure blood glucose and to measure blood pressure non-invasively (in vitro diagnostic use.) It is intended for use at home and at clinical settings. It shall not be used for the diagnosis of diabetes or hypertension, or for the testing of newborns. Principle of Measurement Blood glucose is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip.
There are three subtypes of FORA D40 system available. Each one of them offers a different way to transmit allowing users to choose their own desired ways to manage their test results. The data transmissions are listed below: Model Data Transmission Function Test results can be viewed on the PC through the cable connection. Test results can be viewed on the PC through a wireless connection by using Bluetooth technology.
CONTENT OF THE SYSTEM 1 Blood glucose plus blood pressure 6 Warranty card monitor 2 Lancing device 7 A clear cap 3 First time user guide 8 Daily log book 4 Owner’s manual 9 An arm cuff 5 Sporty bag Batteries These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA D40 test strips and control solution with your FORA D40 monitor. NOTE One 3.
Appearance and Key Functions of the Monitor 1. TEST SLOT- is where you insert the test strip. 2. LCD SCREEN- guides you through the test using symbols and simple messages. 3. RF BUTTON- assists you with wireless data transmission. AVERAGE BUTTON- assists you with blood pressure average mode. 4. S BUTTON- is used to set up the monitor. 5. M BUTTON- is used to turn on the monitor and enter the memory. 6. ON/OFF BUTTON 7. USER SELECTION BUTTON- assists you with user number selection. 8. SPEAKER 9.
LCD Screen 1. Date 2. Systolic Pressure Symbol 3. PC Mode 4. & 6. Test Result Area 5. Diastolic Pressure Symbol 7. Voice Volume 8. Ketone Warning 9. Time 10. Code Number 11. Unit of Measurement in Blood Glucose 12. Unit of Measurement in Blood Pressure 13. Memory 14. Battery Symbol 15. Smile Symbol 16. Day Average 17. Pulse Rate 18. Blood Drop Symbol 19. Test Strip Symbol 20. User Number 21.
Speaking Function The monitor “speaks” aloud step-by-step instructions on how to test your blood glucose and blood pressure. The following table tells you when and what the monitor“speaks”. WHEN does the monitor speak? WHAT does the monitor speak? When the monitor is turned on. Thank you for using this product. The user’s number is one, please select the user’s number. The user’s number is one, please relax during measurement. When room temperature is outside operating range of 10-40ºC.
WHEN does the monitor speak? WHAT does the monitor speak? Thank you for using this product. Test strip is inserted. Today’s day is (number), the time is (number), the room temperature is (number), the When the test strip is inserted into the user’s number is one, please apply blood onto the test strip. monitor. Now testing. The user’s number is one. Your blood glucose is (number) milligram per deciliter/ millimole per liter. When the glucose test result is outside measurement range of 20-600 mg/dL.
WHEN does the monitor speak? WHAT does the monitor speak? Thank you for using this product. Today’s date is (number), the time is (number), you are now in memory mode, the user’s number is one, please select the user’s number. Memory record for (Time), your blood glucose is (number) milligram per When the monitor is in memory mode. deciliter/ millimole per liter. Your memory record for (Time).
Test Strip Description 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 cell where the reaction takes place. The test strip contains the following parts: See section “Testing Your Blood Glucose” for complete instructions.
PREPARATIONS BEFORE USE Battery and DC adapter The monitor is powered by batteries or a DC adapter. Low Power Signal When the power is low, the monitor will remind you by displaying two messages: ” symbol is displayed on the When the flashing “ main screen, this indicates that batteries are dead and it is time to change the batteries. The power indicator located above the main screen would light up in red as well.
Battery Installation and Replacement Make sure the monitor is off when replacing the batteries. STEP 1- Press the edge of the battery cover and pull up. Lift the battery cover and remove the batteries inside. STEP 2 - Insert four 1.5V AA size alkaline batteries or one 3.7V rechargeable Li-ion battery. (Please refer to CAUTION for use). Make sure the + (positive) and – (negative) marks match as indicated in the battery compartment. CAUTION FORA D40a and FORA D40b can use either four 1.
Use the AC Adapter Connect the AC adapter to the monitor. 1. Connect the AC adapter plug to the AC adapter jack of the monitor. 2. Plug the AC adapter power plug into an electrical outlet. You can press the ON/OFF button to start the measurement. Remove the AC adapter from the monitor. 1. When the monitor is off, remove the AC adapter power plug from the electrical outlet. 2. Disconnect the AC adapter plug from the AC adapter jack of the monitor.
Setting the Monitor Time, date, units of measurement, memory deletion, volume and language can be set in the monitor. Two keys are involved: S button and M button. Step 1 Press the S button to start setting. Step 2 Year will flash first. Step 3 Press M button Step 4 Date will to make changes. flash. Follow Step 3 Press S button to advance to next setting. for changes. Step 5 Time will flash. Step 6 12H/24H mode selection. Follow Step 3 for changes. Follow Step 3 for changes.
NOTE While setting speaking volume, number 0 indicates that the speaking function is off. “ ” will not display. Numbers 1 to 7 indicate speaking volume from low to high. They will be displayed together with “ .” The time, date, speaking volume and memory deletion can ONLY be changed in the setting mode. Therefore, these parameters cannot be changed while performing tests. During the setting mode, you can press On/Off button to turn off the monitor.
User Number Selection This FORA D40 system provides up to four users for both measuring functions, and each user has his/her own individual memory storage. STEP 1 Press the user selection button to select the desired user number. You can change the user number by pressing the user selection button. STEP 2 When you have finished the user selection, press S button to confirm the setting. The monitor will repeat the user number you just selected and then turn off automatically.
BLOOD GLUCOSE MEASUREMENT Important Information 1. Severe dehydration and excessive water loss may cause inaccurate results. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately. 2. If your blood glucose results are lower or higher than usual, and you do not have symptoms of illness, first repeat the test. If you have symptoms or continue to get results higher or lower than usual, follow the treatment advice from your healthcare professional. 3.
Quality Control with FORA Control Solutions FORA 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 FORA control solutions. Check the expiration date on the control solution vial. Do not use if expired. It is recommended to use the control solutions between the temperatures of 20℃ and 25℃ (68℉ and 77℉.) 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 within 3 months after first opening.
Performing a Control Solution Test STEP 1. 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: “ Δ ” and the ambient temperature ” with the user’s number, and a flashing “ .“ STEP 2. Select the User Number After the test strip is fully inserted into the test slot, press the user selection button to select the user (numbers from1 to 4) whose test reading will be stored in its memory.
STEP 3. Press M button and select the symbol "QC." When you do this, this reading will be stored as a control solution data. STEP 4. Obtain Control Solution Shake the control solution vial well. Remove the cap from the control solution bottle. Place cap on flat surface. Squeeze the vial, discard the first drop, and wipe off the dispenser tip to prevent contamination. Squeeze the vial again to produce another drop and place this drop on the top of cap. STEP 5. Apply Control Solution.
STEP 6. The monitor will begin countdown. After 5 seconds, the control solution test result will appear. The result should fall within the range printed on the test strip vial. Out-of-range results If test results fall outside the printed range, check the “Operating Problem” section in the troubleshooting guide and repeat the test. If your results continue to be out-of-range, the system may not be working properly. Do NOT test your blood. Please contact your local customer service for help.
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: the monitor, test strips, lancing device, and sterile lancet. WASH AND DRY YOUR HANDS FIRST BEFORE STARTING. STEP 1. Set the Lancing Device Screw off the cap of the lancing device. Insert a lancet into the lancet holder and push down firmly until it is fully seated.
The adjustable tip offers 5 levels of skin penetration. Twist the adjustable tip in either direction until the number lines up with the arrow: 1-2 for soft or thin skin, 3 for average skin, 4-5 for thick or calloused skin. 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. Blood from sites other than the fingertip A clear cap, together with the kit, make it easier to get a drop of blood for AST.
STEP 2. Insert the 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: “ ” and the ambient temperature Δ ” with the code number, the user’s number and a flashing “ .“ STEP 3. Select the User Number After the test strip is fully inserted into the test slot, press the user selection button to select the user (numbers from1 to 4) whose test reading will be stored in its memory.
STEP 4. Select AC/PC Press M button to select AC/PC mode, or just perform a general test. Select “AC” if performing a blood glucose test before meal, or “PC” for performing a test after meal. STEP 5. Apply Blood into the Test Strip When the “ “ symbol is flashing on the LCD display, apply a drop of blood to the absorbent hole of the test strip. Do not push your finger against the test strip or try to apply a smeared sample.
STEP 6. Obtain an Accurate Result in 5 Seconds Read the test result after 5 seconds. The test result will be automatically stored in the monitor memory. Turn the monitor off by removing the test strip. STEP 7. Discard the Used Lancet Remove the lancing device cap and the lancet. Place the disk on a hard surface and push the exposed needle tip into the protective disk. Always use caution when removing the lancet.
Special Message MESSAGE WHAT IT MEANS ACTION This indicates hypoglycemia Appears when your result (low blood glucose.) is below measurement You should immediately treat limit, which is less than 20 hypoglycemia as mg/dL. recommended by your healthcare professional. This indicates severe Appears when your result hyperglycemia (high blood is above measurement glucose). limit, which is over 600 mg/dL. You should seek immediate medical assistance.
Comparing Monitor and Laboratory Results The monitor provides you with whole blood equivalent 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).
BLOOD PRESSURE MEASUREMENT 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.
Applying the Pressure Cuff STEP 1 Connect the air plug of the tubing to the air jack at the side of the monitor. STEP 2 Assemble the cuff as the left figure. The smooth surface is on the inside of the cuff loop and the metal D-ring should not touch your skin. STEP 3 Extend your left arm in front of you with your palm facing up. Slide the cuff onto your left arm, above your elbow. The red line on the edge of the cuff should be approximately 0.8 inch to 1.2 inch (2 cm to 3 cm) above your elbow.
Proper Measurement Position STEP 1 Sit down for at least 10 minutes before measuring. STEP 2 Place your elbow on a table or other object. Relax your hand with the palm facing up. STEP 3 Relax and make sure the cuff is at the same height as your heart. Press the On/Off button. Then, press the user selection button to select the user’s number. STEP 4 Measurement is in progress. After the monitor turns on, all the LCD display symbols will appear with a long “beep” sound.
Take a Reading Read "Suggestions before Measuring" and "Applying the Pressure Cuff" before you take a reading. Always apply the pressure cuff before turning on the monitor. STEP 1. Press the On/Off button. All the LCD symbols will appear. Press the user selection button to select user (numbers from1 to 4) whose test reading will be stored in its memory. Then the cuff will begin to inflate automatically. STEP 2. After the cuff pressure is reached, the cuff begins deflation.
NOTE This monitor can record up to 4 users’ measurements. If you press the On/Off button during the measurement, the monitor will turn off. If the pulse rate symbol showed as “ ” instead of “ ”, this suggests that the monitor has detected an irregular pulse rate.
Measurement Average Mode Always apply the pressure cuff before turning on the monitor. STEP 1. Press and hold the On/Off button for three (3) seconds. The monitor will turn on and enter the average mode. Then the cuff will begin to inflate automatically. STEP 2. The monitor will take three (3) measurements consecutively with an interval of 20 seconds. The number on the right represents the remaining countdown between each measurement. STEP 3.
MONITOR MEMORY Your monitor stores 864 the most recent results, and also provides the average of blood glucose test results. Please follow the steps below to review those results. Viewing Results on the Monitor: STEP 1. When the monitor is off, press and release the M button. The monitor will enter the memory mode. Press the user selection button to select the desired user symbol in the memory. (numbers from1 to 4) which you used to store STEP 2.
STEP 4. Press the user selection button to select another user’s number and to view the test results stored in the monitor memory (i.e. user number 2). NOTE If you’d like to exit from the memory, press the On/Off button to turn off the monitor or leave it idle for 3 minutes for auto-shut down. When using the monitor for the first time, “---” appears, showing that there is no test result stored in memory.
Reading the Day Average of Blood Glucose Results STEP 1 When the monitor is off, keep pressing the M button for 3 seconds to enter the memory mode. STEP 2 Select the user’s number by pressing the user selection button. After the display, press the S button to switch and review blood glucose or blood pressure test results. STEP 3 Press the M button to review the 14-, 21-, 28-, 60- and 90-day average in order. STEP 4 After viewing the 90-day average, press the M button again to resume to the 7-day average.
When using the monitor for the first time, “---” appears, showing that there are no test result in memory.
Viewing Results on a Personal Computer Stored results in memory can be transmitted to a personal computer via either USB cable or wireless connection. An interface cable and the pairing software system will be needed for the data transmission. Please visit our website at http://www.foracare.ch/products.html and install the Health Care System Software first. If you have any question about this function, please ask the local customer service for assistance.
Data transmission via Bluetooth (For FORA D40b only) STEP 1 With the monitor turned off, press the RF button to initiate the data transmission of the monitor. “PCL” will appear on the display and the RF indicator will light up in blue. When the RF indicator is blinking fast, indicating the monitor is still searching for pairing. When the RF indicator is blinking slowly, indicating the monitor has found the pairing computer.
Data transmission via GPRS (For FORA D40g only) STEP 1 With the monitor turned off, press the RF button to initiate the data transmission from the monitor. “PCL” will appear on the display and the RF indicator will light up in blue. Then test results which have not been uploaded will display on the screen and initiate the transmission in sequence of the user’s number by GPRS service.
TAKING CARE OF YOUR MONITOR & STRIP To protect the monitor and test strips from dirt, dust and other contaminants, please wash and dry your hands thoroughly before use. Cleaning 1. To clean the monitor exterior, wipe with a cloth moistened with tap water or a mild cleaning agent, then dry it with a soft, dry cloth. Do not flush with water. 2. Do not use organic solvents to clean the monitor and cuff. 3. The cuff can be cleaned by wiping with a moistened cloth and soap. Do not immerse in water. Storage 1.
2. Strip Storage Storage conditions: 4 oC to 40oC (39.2℉ to 104℉), below 85% relative humidity. Do not freeze. Store your test strips in their original vial only. Do not transfer to other container. Store test strip packages in a cool, 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 conditions: Store the control solution tightly closed at temperatures 2℃ to 30℃ (4℉ to 86℉). Do not freeze. Record the first opening date on the control solution vial. Discard it after 3 months.
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. MESSAGE CAUSE WHAT TO DO Inflation or pressure error Please contact local customer service for help. Deflation error Cuff pressure is too high. Refit cuff tightly and correctly. Relax and the repeat measurement.
Operating Problem 1. Blood Glucose Measurement What happened? The monitor does not display a message after inserting a test strip. POSSIBLE CAUSE Batteries exhausted. WHAT TO DO Replace the batteries. Batteries incorrectly installed or Check to see if the batteries are absent. correctly installed. Test strip inserted upside down or Insert the test strip correctly with the incompletely. contact bars end first. Defective monitor. Please contact your local customer service.
What happened? The control solution test result is out of range. POSSIBLE CAUSE Error in performing the test. WHAT TO DO Read the instructions thoroughly and repeat the test. Control solution vial shaken poorly. Shake the control solution vigorously and repeat the test. Expired or contaminated control Check the expiration and discard solution. dates of the control solution. Control solution that is too warm or It is recommended to use the control too cold.
2. Blood Pressure Measurement What happened? No display after pushing the On/Off button. POSSIBLE CAUSE WHAT TO DO Batteries exhausted. Replace the batteries. Batteries incorrectly installed or Check that the batteries are correctly absent. installed. What happened? Heart rate is higher/lower than user’s average. POSSIBLE CAUSE WHAT TO DO Moving during measurement. Repeat measurement. Measuring right after exercise. Rest at least 30 minutes before measurement.
SPECIFICATIONS System performance Power source: Four 1.5V AA alkaline batteries Size of monitor w/o cuff: 147 (L) x 105 mm (W) x 80 mm (H), 500g with batteries. Memory: Total 864 memory records Power saving: Automatic power off if system idle for 3 minutes (normal mode) or 5 minutes (RF mode).
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) Federal Communications Commission (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.
CAUTION RISK OF EXPLOSION IF BATTERY IS REPLACED BY AN INCORRECT TYPE. DISPOSE OF USED BATTERIES ACCORDING TO THE INSTRUCTIONS.
