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Related Manuals for Fora D15
Summary of Contents for Fora D15
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Page 1: Blood Glucose
FORA D15 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM English 311-0000000-005 Version 3.0 2009/08... -
Page 2: Blood Pressure
BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM Dear FORA D15 System Owner: This manual contains important information you must know about the system. Please read it thoroughly and carefully. This product can assist you in monitoring your blood glucose level as well as your blood pressure. - Page 3 IMPORTANT SAFTY 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.
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Page 4: Table Of Contents
TABLE OF CONTENTS IMPORTANT INFORMATION Warnings and Precautions Health Information ALTERNATIVE SITE TESTING (AST) INTRODUCTION TO THE SYSTEM Intended Use Principle of Measurement Major Features Contents of the System Appearance and Key Function of the Monitor Monitor Display Test Strip BEFORE USE Battery Replacement Setting the Monitor... - Page 5 Comparing Monitor and Laboratory Results Risk Message BLOOD PRESSURE MEASUREMENT Suggestions Before Measuring Correct Application of the Pressure Cuff Testing Your Blood Pressure USING THE MONITOR MEMORY Viewing Results on the Monitor Deleting Memory VIEWING RESULTS ON A PERSONAL COMPUTER TAKING CARE OF YOUR MONITOR AND TEST STRIPS Cleaning Storage...
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Page 6: Important Information
IMPORTANT INFORMATION Warnings and Precautions • The FORA D15 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 of any symptoms or diseases. -
Page 7: Health Information
60%* . The results you get with the FORA D15 system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes. - Page 8 Blood Pressure Clinical studies show that 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* . Knowing your routine blood pressure patterns can help determine whether or not your body is in good condition.
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Page 9: Alternative Site Testing (Ast)
ALTERNATIVE SITE TESTING (AST) Important: There are limitations for doing AST. Please consult your healthcare professional before you begin AST. What is AST? Alternative site testing (AST) refers to when individuals check their blood glucose levels using areas of the body other than fingertip. This system allows AST at the palm, the forearm, the upper arm, the calf or the thigh with results as... - Page 10 We strongly recommend you perform AST ONLY during the following intervals: • In a pre-meal or fasting state (more than 2 hours since the last meal). • Two or more hours after taking insulin. • Two or more hours after exercise. Do NOT use AST if: • You think your blood glucose is low. • You are unaware of hypoglycemia. • Your AST results do not correspond 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. Blood from a site that has not been rubbed exhibits a measurably different glucose concentration than blood from the...
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Page 11: Introduction To The System
INTRODUCTION TO THE SYSTEM Intended Use The FORA D15 Blood Glucose plus Blood Pressure Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole 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. -
Page 12: Major Features
Major Features Four subtypes of FORA D15 were developed. Each uses a slightly different method of data transmission as the following table indicates. MODEL DATA TRANSMISSION FUNCTION FORA D15c You can view results on the PC through cable connection. You can view results on the PC... -
Page 13: Contents Of The System
(Optional) These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA D15 test strips and FORA control solution with your FORA D15 Monitor. PLEASE NOTE • If your system has been opened prior to use and/or does not contain all parts listed above, please return it to the place of purchase. -
Page 14: Appearance And Key Function Of The Monitor
RF Indicator LCD Screen lights up red or green to assist in data transmission. displays test results are Only for FORA D15b & FORA D15z displayed with symbols and simple messages Memory Button Test Slot is used to enter the system memory and adjust settings. -
Page 15: Monitor Display
Monitor Display Memory Appears when you review the memory. Pulse Symbol Pulse Rate Day Average Indicates that the displayed test result is an average. Temperature Message Appears with the ambient temperature after test strip Date & Time insertion. Low Battery Test Result Area Appears when the battery is low or Test results are displayed here. -
Page 16: Test Strip
Test Strip This 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 consists of the following parts: Contact Bars Insert this end of the test strip into the monitor. -
Page 17: Before Use
BEFORE USE Battery Replacement Your meter comes with two 1.5V AAA alkaline batteries. The meter will alert you when the power is low by displaying two different mes- sages: 1. With battery exhausted symbol “ ” appears on the display: the meter is functional and the result remains accurate for another 30 mea- surements, but battery should be replaced. - Page 18 To replace the battery, make sure that the meter is turned off. Step1 Press the buckle on the battery cover and lift it up to remove cover. Remove old batteries. Step2 Insert four 1.5V AA size alkaline batteries. Make sure the + (positive) and –...
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Page 19: Setting The Monitor
Setting the Monitor Your monitor comes with the time, date, memory deletion, voice vol- ume and language preset. If you need to change the time or replace the batteries, you may have to enter the setting mode and reset. Please set the time, date, memory deletion, voice volume and language according to the following steps. - Page 20 Step5 Step7 Time flashes. Follow Step3 for Unit of blood pressure will changes. flash. Follow Step3 for changes. Step6 Step8 Unit of glucose concentration Temperature will flash. will flash. Follow Step3 for Follow Step3 for changes. changes. NOTE • The time, date, unit of measurement and unit of temperature can ONLY be changed in the setting mode. Therefore, these parameters cannot be changed while performing a glucose or blood pressure test. • The monitor will turn off automatically if left idle in the Setting Mode for 3 minutes.
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Page 21: Blood Glucose Measurement
BLOOD GLUCOSE MEASUREMENT Important Information 1. Severe dehydration and excessive water loss may cause read- ings which are lower than actual values. If you believe you are suffering from severe dehydration, consult a healthcare profes- sional immediately. 2. If your blood glucose results are lower or higher than usual, and you do not have symptoms of illness, repeat the test. -
Page 22: Coding The Monitor
Coding the Monitor When using the system or the fi rst time, or starting to use a new vial of test strips, you need to check the code number. It is important to make sure that the code that appears on the LCD is the same as the code on the test strip vial before you proceed. To ensure accurate test results, only test blood glucose when the codes are identical. -
Page 23: Control Test
Control Test FORA control solutions contains 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, you can ensure that the monitor and the test strips are working together as a system and that you are performing the test correctly. -
Page 24: Important Control Solution Test Information
36-86°F (2-30°C). Do not freeze. PLEASE NOTE The control solution range is printed on FORA test strip vial. Only use FORA control solution with FORA test strips. It is used to evaluate moni- tor and test strip performance. It is not the recommended range for your... -
Page 25: Performing A Control Solution Test
Performing a Control Solution Test Take a test strip out with clean and dry hands first. Step1 Insert Test Strip. Fully insert the test strip, with the contact bars end first facing up into test slot. The meter will turn on automatically. “CHK” and “ ” will appear first, followed by ►ambient temperature ►code number and flashing “ ” Be sure the code number on the screen is the same as the code number on the test strip vial. If the code numbers do not match, please see “Coding the Monitor”... - Page 26 PLEASE NOTE • Contact bars must be inserted all the way into the monitor or you may receive an inaccurate test result. • Every time you perform a control solution test, you must enter into the “CTL” test mode so that the test result will not be stored in the monitor memory. Failure to do so will cause confusion between the glucose test result and the control solution test result in system memory. Step3 Obtain control solution.
- Page 27 Step4 Apply Control Solution. Hold the meter up to meet the absorbent hole of the test strip and the drop will be automatically absorbed. Once the confirmation window is completely filled, the meter will start counting down. To avoid contaminating the control solution with the contents of the test strip, you will have to place a drop of control solution on a clean surface.
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Page 28: Test Procedure
Test Procedure Wash and dry your hands before starting. To test your blood glucose, you need: the monitor, test strips, the lancing device, and lancets. Step1 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. - Page 29 WARNING! 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 lancing device. PLEASE NOTE Your lancing device may operate differently. See manufacture's instruction for your device. Step2 Insert the test strip and check the code number. Fully insert test strip face up with contact bars end first into the test slot. The monitor will turn on auto- matically and display the followings in sequence: “CHK”...
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Page 30: Fingertip Testing
► Fingertip testing 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. ►Sites other than fingertips Please refer to the section, “Alternative Site Testing”, for possible puncture sites. After penetration, discard the first drop of blood with clean tissue paper or cotton. Gently squeeze the punctured area to obtain blood. - Page 31 Step5 Obtain an accurate result in 7 seconds. The result of your blood glucose test will appear after the monitor counting down to 0. This read- ing will automatically be stored in the monitor memory. PLEASE NOTE • Do not push your punctured finger (with blood on it) against the test strip or try to apply a smeared blood sample to the test strip. • If you do not apply a blood sample to the test strip within 3 minutes, the meter will automatically turn off.
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Page 32: Comparing Monitor And Laboratory Results
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). - Page 33 blood glucose level from a finger stick can be up to 70 mg/dL(3.9 mmol/L) higher than blood drawn from a vein (venous sample) used for a lab test.* Therefore, it is best to fast for eight hours before doing comparison tests. Factors such as the amount of red blood cells in the blood (a high or low hematocrit) or the loss of body fluid (severe dehydration) may also cause a monitor result to differ from a laboratory result.
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Page 34: Risk Message
Risk Message Special symbols and messages appear together with your test result. MESSAGE WHAT IT MEANS WHAT TO DO Your result is below You should seek immedi- measurement limit, 20 ate medical assistance. mg/dL (1.1 mmol/L). This indicates hypoglycemia (low blood glucose.) Your result is above You should seek measurement limit, 600... -
Page 35: Blood Pressure Measurement
BLOOD PRESSURE MEASUREMENT Suggestions Before Measuring 1. Avoid caffeine, tea, alcohol, and smoking for at least 30 minutes before measurement. 2. Wait 30 minutes after exercising or bathing before measurement. 3. Sit down for at least 10 minutes before measuring. 4. Do not measure when feeling anxious or tense. 5. Take a 5-10 minutes break between measurements. This break can be longer if necessary, depending on your physical conditions. - Page 36 Step2 Pile Side Material Make sure the smooth cloth is on the Sewn Hook Material inside of the cuff loop and the metal D-ring does not touch your skin. D-Ring Step3 Hold your left arm in front of you with your palm facing up.
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Page 37: Testing Your Blood Pressure
Testing Your Blood Pressure Step1 Sit down for at least 10 minutes before measuring. Step2 Place your elbow on a table or other object. Relax your hand with the palm facing up. Step3 Relax and make sure the cuff is at the same height as your heart. - Page 38 Step5 Read a result. After the measurement, the monitor displays the systolic pressure, diastolic pressure, and heart rate. Press “ ” button to turn off. Otherwise, it will turn off automatically if left idle over 3 minutes. NOTE • If a higher pressure value is needed, the monitor will stop deflation and inflate again.
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Page 39: Using The Monitor Memory
USING THE MONITOR MEMORY Your monitor stores 352 most recent blood glucose test results along with their respective dates and times in its memory. It also provides you with 7-, 14-, 21-, 28-, 60- and 90-day averages of your blood glucose test results. - Page 40 Step2 Recall the Stored Test Results. After 90-day average, the other results will be displayed in the order of time and date taken. You will see the number of the result stored, followed by the result. When the memory is full, the oldest results are deleted as new ones are added.
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Page 41: Deleting Memory
Deleting Memory To clear the memory, turn off the monitor. Press and hold the M button for 3 seconds. “CLr/ALL” then appears to indicate that ALL the memory stored in the monitor will be deleted. -
Page 42: Viewing Results On A Personal Computer
VIEWING RESULTS ON A PERSONAL COMPUTER Results in memory can be transmitted to the personal computer by either cable or wireless connection. Accessories needed to use this function are: • Health Care System Software: downloadable from the home page of Fora Care Inc. • Interface Cable: an accessory for model FORA D15c. • Bluetooth Adapter: an accessory for model FORA D15b. • Zigbee Gateway: an accessory for model FORA D15z. • Telehealth Gateway: an accessory for model FORA D15g. - Page 43 Step1 Install Software Install Health Care System Software on your computer by following the instructions provided on Fora Care's website: www.foracare.com Step2 Connect to Personal Computer Connect the interface cable to a serial port of your computer. With the meter turned off, connect the cable to the data port of the me- ter.
- Page 44 Bluetooth adapter. Step1 Set FORA D15b monitor for Bluetooth pairing: Make sure your FORA D15b monitor is off, then hold down the RF button until “PCL” and time appear. The Bluetooth indicator on the monitor will blink quickly. This indicates that the monitor is now ready for Bluetooth wireless pairing.
- Page 45 Transmitting data via zigbee gateway (FORA D15z) Step1 Install Software Install Zigbee Gateway and turn on the device. (Please contact Customer Care Line at 1-866-469-2632 to set up the device). Step2 Transmit data • After you finish measuring, your results will be transmitted automatically.
- Page 46 GW 9014A (RS232) FORA D15b GW 9014B (Bluetooth) Before transmitting results, turn on the power of FORA Telehealth Gateway. Method one: Taking measurements while interface cable is connected. Connect both ends of the RS232 interface cable to both of the data port of FORA D15g and RS232 port of FORA Telehealth Gateway.
- Page 47 Use the interface cable to transmit results after measuring. When the meter is off, connect both ends of the RS232 interface cable to the data port of FORA D15g and RS232 port of FORA Tele- health respectively. Press S button, PCL will appear on the display to indicate the monitor is switched to the transmission mode.
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Page 48: Taking Care Of Your Monitor And Test Strips
TAKING CARE OF YOUR MONITOR AND TEST STRIPS 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 using a cloth moistened with tap water or a mild cleaning agent. Dry, then the device with a soft and dry cloth. Do not fl ush with water. - Page 49 • Do not over-wring the cuff or turn it inside out. • If you are not going to use the monitor for an extended period of time, please remove the batteries. 2. Strip Storage • Storage condition: 39°F to 104°F (4°C to 40°C), below 85% relative humidity. Do NOT freeze. • Store your test strips in their original vial only. Do not transfer to another 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.
- Page 50 • Do not bend, cut, or alter a test strip in any way. • Keep the strip vial away from children as the cap and the test strip may be a choking hazards. If swallowed, promptly seek medical assis- tance. 3. Control Solution Storage • Storage condition: Store the control solution tightly closed at temperatures 36 to 86°F (2 to 30°C).
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Page 51: Troubleshooting Guide
TROUBLESHOOTING GUIDE The following is a summary of various display messages. These messages help to identify certain problems but do not always appear in all cases when a problem has occurred. Improper use may cause an inaccurate result without producing an error message. -
Page 52: Error Message
Error Message MESSAGE CAUSE WHAT TO DO Err.00 Weak pulse. Refit cuff tightly, relax, and repeat measurement Err.02 Monitor can not determine as shown in the section, systolic pressure. “Correct Application of the Err.04 Monitor can not determine Pressure Cuff ”. Err.07 systolic or distolic pressure Err.08 or it is out of range. -
Page 53: Operating Problem
Operating Problem 1. Blood Glucose Measurement 1. If the monitor does not display a message after you have inserted a test strip. PROBABLE CAUSE WHAT TO DO Batteries exhausted. Replace the batteries. Batteries incorrectly installed or Check that the batteries are absent. - Page 54 3. The test does not start after applying the sample. PROBABLE CAUSE WHAT TO DO Insufficient blood sample. Repeat the test with a new test strip and a larger sample. Defective test strip. Repeat the test with a new test strip. “ ” was not flashing on the display Repeat the test with a new test when sample was applied.
- Page 55 4. The control solution test result is out of range. PROBABLE CAUSE WHAT TO DO Error in performing the test. Read the instructions thoroughly and repeat the test again. Improper code number. Check if the code number on the display matches the code number on the test strip vial.
- Page 56 2. Blood Pressure Measurement 5. No display after pushing the “ ” button. PROBABLE CAUSE WHAT TO DO Batteries exhausted. Replace the batteries. Batteries incorrectly installed or Check that the batteries are absent. correctly installed. 6. Heart rate is higher/lower than user’s average. PROBABLE CAUSE WHAT TO DO Moving during measurement.
- Page 57 7. A result is higher/lower than user’s average measurement. PROBABLE CAUSE WHAT TO DO May not have been in correct Adjust to a correct position to measure. position while measuring. Natural variation of blood pressure Keep in mind for next from time to time. measurement.
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Page 58: Specifications
SPECIFICATIONS Power Source: 4x AA (1.5V) alkaline batteries Size of Monitor w/o Cuff: 137mm (L) x 90 mm (W) x 54 mm (H) Memory: 352 measurement results with respective dates & times Power Saving: Automatic power off if left idle for 3 minutes Data Transmission: RS232/Bluetooth/Zigbee/Telehealth Gateway System Operating Conditions: 50°F to 104°F (10°C to 40°C), below 85% R.H. Monitor Storage Conditions: -4°F to 140°F (-20°C to 60°C), below 95% R.H. - Page 59 Bluetooth Carrier Frequency: 2400MHz to 2483.5MHz Bluetooth Modulation Method: GFSK, 1Mbps, 0.5BT Gaussian Transmission Power: +3dBm to –20dBm; Power control 4 stage Receiving Signal Range: -88dBm to -20 dBm Receiver IF Frequency: 1.5MHz center frequency Maximum Data Rate: Asynchronous:723.2kbps/57.6kbps; Synchronous: 433.9kbps/433.9kbps Telehealth Gateway Specification Model no.: TD-9014A(GW 9014A) /TD-9014B(GW 9014B) Input interface: RS232(TD-9014A) / Bluetooth(TD-9014B)
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Page 60: Fcc Statement
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 with radio communications. - Page 61 FCC RF Radiation Exposure Statement: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. End users must follow the specific operating instructions for satisfying RF exposure compliance. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. NOTE The changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
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