Fora D40 Owner's Manual

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Owner's manual (120 pages)

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Page 1 English Dear System Owner: Thank you for purchasing the FORA D40 Blood Glucose plus Blood Pressure Monitoring System. This manual provides important infor- mation which helps you to operate this system smoothly. Before using this product, please read the following contents thoroughly and carefully.
Page 2: 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 3 8. Keep the device and testing supplies away from young children. Small items such as the battery cover, batteries, test strips, lancets and vial caps are choking hazards. 9. Keep the equipment and its ﬂexible cord away from hot surfaces. 10.
Page 4: Table Of Contents
TABLE OF CONTENTS IMPORTANT SAFETY PRECAUTIONS BEFORE YOU BEGIN Important Information Intended Use Test Principle Contents of System Monitor Overview Screen Display Test Strip Speaking Function Features SETTING THE MONITOR TESTING YOUR BLOOD GLUCOSE The Four Measuring Modes CONTROL SOLUTION TESTING Performing a Control Solution Test TESTING WITH BLOOD SAMPLE Preparing the Lancing Device for Blood Testing...
Page 5 TESTING YOUR BLOOD PRESSURE Before Measurement Taking a Single Measurement Measurement Average Mode MONITOR MEMORY Reviewing Test Results Reviewing Day Average Results DOWNLOADING RESULTS ONTO A COMPUTER MAINTENANCE Battery Using AC Adapter Caring for Your Monitor Caring for Your Test Strips Important Control Solution Information SYSTEM TROUBLESHOOTING Result Readings...
Page 6: 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 7: 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 in the home and in clinical settings as an aid to monitoring the effectiveness of diabetes control.
Page 8: Contents Of System
Contents of System Your new FORA D40 system kit includes: Monitor Lancing Device with One Clear Cap Owner ’ s Manual Batteries Protective Wallet Test Strips Quick Start User Guide Control Solutions Daily Log Book Sterile Lancets Warranty Card Pressure Cuff (arm type)
Page 9: Monitor Overview
Monitor Overview Front Back Side Pressure Cuff...
Page 10 Indicates when a USB cable plug inserted. monitor on for testing. POWER INDICATOR DISPLAY SCREEN Indicates the power status of RF BUTTON (For FORA D40b and the device. D40g) BATTERY COMPART- Assists you with wireless data transmission. MENT AVERAGE BUTTON...
Page 11: Screen Display
Screen Display Date Unit for Blood Pressure Systolic Pressure Symbol Memory Mode Symbol Measurement Mode Battery Symbol Systolic Pressure Value Result Indicator Diastolic Pressure Symbol Day Average Result Diastolic Pressure Value Pulse Rate Volume Symbol Blood Drop Symbol Special Message Test Strip Symbol Time User Number...
Page 12: Test Strip
Test results might be wrong if the contact bar is not fully inserted into the test slot. Front NOTE The FORA D40 monitor should only be used with FORA D40 Test Strips. Using other test strips with this meter can produce inaccurate results.
Page 13: Speaking Function
Speaking Function FORA D40 “ speaks ” aloud with step-by-step instructions to guide you through the process of blood glucose testing. The following table tells you when and what the monitor “ speaks ” . WHEN WHAT does the monitor speak?
Page 14 WHEN WHAT does the monitor speak? does the monitor speak? When the monitor is in the set- Delete memory record func- ting mode. tion, press M key to clear all the records. The year is (number). The month is (month). The day is (num- ber).
Page 15 WHEN WHAT does the monitor speak? does the monitor speak? When the monitor is in blood You are now in testing mode. glucose measurement mode. This is before meal measure- ment. This is after meal measurement. You are now in control solution mode.
Page 16 WHEN WHAT does the monitor speak? does the monitor speak? When the monitor is in memory Memory record for (time), your mode. blood glucose is (number) milli- gram per deciliter. Your memory record for (time). Your systolic blood pressure is (number) millimeter of mercury, the dia- stolic blood pressure is (number) millimeter of mercury and the...
Page 17: Features
Features 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. These feature functions are listed as below:...
Page 18: 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 19 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 20 Step 4 Setting the speaking volume There are seven (7) speaking volume options to let you choose. Press until the desired speaking volume appears. Press Volume 0 indicates that the speaking function is turned off, and will not display “ ”...
Page 21 Step 6 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 22 ► User Number Selection This system provides up to four users for both measuring functions. Each user ’ s test results are stored separately under each user num- ber. Step 1 Press to select the desired user number. Step 2 Press to conﬁrm.
Page 23: 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 (not displayed) meal 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 24 Step 2 Press to switch between General, AC, PC and QC mode.
Page 25: Control Solution Testing
CONTROL SOLUTION TESTING FORA Control Solution contains a known amount of glucose that re- acts with test strips and is used to ensure your monitor and test strips are working together correctly. Do a control solution test when: • you ﬁrst receive the monitor •...
Page 26: Performing A Control Solution Test
Performing a Control Solution Test Step 1 Insert the test strip to turn on the monitor Insert the test strip into the monitor. Wait for the monitor to display the test strip and blood drop symbol. Press to select the desired user number. Step 2 Press to mark this test as a control...
Page 27 Step 3 Apply Control Solution Shake the control solution vial thoroughly before use. Squeeze out a drop and wipe it off, then squeeze another drop and place it on the tip of the vial cap. Hold the monitor to move the absorbent hole of test strip to touch the drop.
Page 28 Out-of-range results If you continue to have test results fall outside the range printed on the test strip vial, the monitor and strips may not be working properly. Do NOT test your blood. Contact the local customer service or place of purchase for help.
Page 29: 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 30: Preparing The Puncture Site
Preparing the Puncture Site 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 ﬁnger. When the puncture site is rubbed before blood extraction, the difference is signiﬁcantly reduced.
Page 31: Fingertip Testing
► Fingertip testing Press the lancing device ’ s tip ﬁrmly against the lower side of your ﬁnger- tip. Press the release button to prick your ﬁnger, then a click indicates that the puncture is complete. ► Blood from sites other than the fingertip Replace the lancing device cap with the clear cap for AST.
Page 32: 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 33: 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 34 Step 2 Select the appropriate measuring mode by pressing For selecting the measurement mode, please refer to the FOUR MEA- SURING MODES section on page 23. Step 3 Obtaining a blood sample Use the pre-set lancing device to puncture your de- sired site.
Page 35 Step 5 Apply the Sample Hold the blood drop to touch the absorbent hole of the test strip. Blood will be drawn in and after the conﬁrmation window is complete- ly ﬁlled, the monitor begins counting down. NOTE • Do not press the punctured site against the test strip or try to smear the blood.
Page 36 Step 6 Read Your Result The result of your blood glucose test will appear after the monitor counts down to 0. This blood glucose result will automatically be stored in the memory. Step 7 Eject the used test strip and remove the lancet To eject the test strip, point the strip at a disposal container for sharp objects.
Page 37: 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 38 ► Fitting the Cuff Correctly Step 1 Connect the air plug of the tubing to the air jack of the monitor. Step 2 Assemble the cuff as shown on the Pile Side Material right. The smooth surface should be RED LINESHOULD BE AT THE INSID inside the cuff loop and the metal D-ring should not touch your skin.
Page 39 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 40: 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. Press to select the desired user number and then press . Then the cuff will begin to inﬂate automatically.
Page 41: Measurement Average Mode
Step 1 Press and hold for 3 seconds (for FORA D40b and D40g), or just press (for FORA D40a). The monitor will turn on and enter the averaging mode. Press to select the desired user number and then press . Then the cuff will begin to inﬂate automatically.
Page 42 Step 3 After taken three measurements, the results are averaged to produce the blood pressure measurement. Press to turn off the monitor.
Page 43: 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. Press to select the desired user number.
Page 44: 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 7-day average result will appear on the display. Press select the desired user number.
Page 45 NOTE • Any time you wish to review the results of different user numbers or the blood glucose and blood pressure for each user number, press • Any time you wish to exit the memory, press or leave it without any action for 3 minutes.
Page 46: Downloading Results Onto A Computer
DOWNLOADING RESULTS ONTO A COMPUTER ► Data transmission via cable (For all FORA D40) Results in memory can be transmitted to the personal computer. Health Care Software System and a USB cable are required before installation. To learn more about Health Care Software System or to obtain a USB cable separately, please contact your place of purchase.
Page 47 ► Data transmission via Bluetooth (For FORA D40b only) You can use your monitor and Health Care Software System to view your test results on your personal computer. To learn more about the Health Care Software System, please contact local customer services or the place of purchase for assistance.
Page 48 Step 2 Connecting to a personal computer With the monitor turned off, press 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, this indicates that the monitor is still searching for pairing.
Page 49 ► Data transmission via GPRS (For FORA D40g only) You can use your monitor and Health Care Software System to view your test results on your personal computer. To learn more about the Health Care Software System, please contact local customer services or the place of purchase for assistance.
Page 50 Step 3 Data transmission Follow the instructions provided in the software and insert the SIM card at the bottom of the monitor battery compartment to transmit data (results that have not been uploaded and their corresponding dates and times). If the SIM card is not inserted, the “ PCL ” will start blinking, as in the ﬁgure below, and the monitor will turn off automatically after blinking for 30 seconds.
Page 51 • You could check the signal quality on your device if having difﬁculties con- necting to the service or before starting data transmission. To begin the quality check, press and hold RF button for 10-15 seconds when the monitor is off. Wait until PCL appears on the screen. The number displayed in the middle of the screen indicates the signal quality of GPRS at where you are.
Page 52: Maintenance
MAINTENANCE Battery Your monitor comes with four 1.5V AA size alkaline batteries (for D40a and D40b) or one 3.7V lithium-ion rechargeable battery (for D40g). ► Low Battery Signal The monitor will display the two messages below to alert you when the monitor power is getting low.
Page 53: Replacing The Battery
► Replacing the Battery WARNING! • FORA D40a and FORA D40b can use ONLY with four 1.5V AA size alkaline batteries, whereas FORA D40g can use with one Li-ion rechargeable battery ONLY (battery pack no.S14500 1S4P). • If the battery is replaced by an incorrect type, it may cause risk of explosion.
Page 54 CAUTION RISK OF EXPLOSION IF BATTERY IS REPLACED BY AN INCORRECT TYPE. DISPOSE OF USED BATTERIES ACCORDING TO THE INSTRUCTIONS. NOTE • Replacing the batteries does not affect the test results stored in memory. • As with all small batteries, these batteries should be kept away from small children.
Page 55: Using Ac Adapter
Using AC Adapter ► Connect AC adapter to the monitor. Step 1 Connect AC adapter plug to AC adapter jack of the monitor. Step 2 Plug AC adapter power plug into an electri- cal outlet. The monitor is ready for use. ►...
Page 56 CAUTION! • For D40g, the Li-ion battery must be recharged with the FORA D40g moni- tor by connecting AC adapter to an electrical outlet. Only this 3.7V rechargeable Li-ion battery (battery pack no. S14500 1S4P) can be recharged with FORA D40 by the connection of AC adapter. Any other kind of rechargeable battery is not allowed or it may damage the monitor.
Page 57: Caring For Your Monitor
Caring for Your Monitor To avoid the meter and test strips attracting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use. ► Cleaning • To clean the monitor exterior, wipe it with a cloth moistened with tap water or a mild cleaning agent, then dry the device with a soft dry cloth.
Page 58: Caring For Your Test Strips
Caring for Your Test Strips • Storage condition: 4 ° C to 40 ° C (39.2 ° F to 104 ° F), below 85% relative humidity. Do not freeze. • Store your test strips in their original vial only. Do not transfer to other container.
Page 59: Important Control Solution Information
Important Control Solution Information • Use only FORA 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 60: System Troubleshooting
SYSTEM TROUBLESHOOTING If you follow the recommended action but the problem persists, or er- ror 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 61 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 mea- surement, which is higher than 600 mg/dL (33.3mmol/L).
Page 62: Error Messages
Error Messages MESSAGE CAUSE WHAT TO DO Please contact local cus- tomer service for help. Inflation or pressure error. Refit cuff tightly and cor- Cuff pressure is too high. rectly. Relax and repeat the measurement. If the error still remains, please contact local customer service for help.
Page 63 MESSAGE CAUSE WHAT TO DO Forced to stop the blood Turn off the device and pressure measurement after start over. Follow the repump for 2 times. instructions and try again. Follow the instructions and try again. If problem Data corrupted. persists, contact the local customer service for as- sistance.
Page 64 Error Messages of D40g GPRS Transmission MESSAGE CAUSE WHAT TO DO Insert your SIM card and place it No SIM card inserted. correctly before transmitting data. Unable to connect to Please start over and try again. the service Incorrect PIN number of SIM card Incorrect PIN 2 num- Check if the entered PIN number...
Page 65 MESSAGE CAUSE WHAT TO DO No response from the server Turn off the device and reconnect to the service. Change to a spot with a better quality of connection and try again. Service error If problem still persists, please contact local customer service for assistance.
Page 66: 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 bars incompletely. end first and facing up. Defective monitor or test strips.
Page 67 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. Control solution vial was poorly Shake the control solution vigorously shaken. and repeat the test again.
Page 68 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 correctly absent. installed. 2. If the heart rate is higher/lower than user ’ s average: POSSIBLE CAUSE WHAT TO DO Movement during measurement.
Page 69: Detailed Information
DETAILED INFORMATION Reference Values Blood Glucose Blood glucose monitoring plays an important role in diabetes control. A long-term study showed that maintaining blood glucose levels close to normal can reduce the risk of diabetes complications by up to 60% . The results provided by this system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes.
Page 70 Blood Pressure Clinical studies show that adult diabetes is often accompanied by ele- vated blood pressure. People with diabetes can reduce their heart risk by managing their blood pressure along with diabetes treatment Knowing your routine blood pressure trend tells whether your body is in good condition or not.
Page 71: Comparing Monitor And Laboratory Results
Source: The European Society of Hypertension and European Society of Cardiol- ogy Task Force Members. 2007 ESH-ESC Practice Guidelines for the Manage- ment of Arterial Hypertension. J Hypertens 2007; 25: 1751-1762. *2: American Diabetes Association: The Diabetes-Heart Disease Link Surveying Attitudes, Knowledge and Risk (2002) Comparing Monitor and Laboratory Results The monitor provides you with plasma equivalent results.
Page 72 While staying at the lab: Make sure that the samples for both tests are taken and tested within 15 minutes of each other. • Wash your hands before obtaining a blood sample. • Never use your monitor with blood that has been collected in a gray-top test tube.
Page 73: Symbol Information
SYMBOL INFORMATION Symbol Referent For in vitro diagnostic use Do not reuse Read instructions before use Keep away from sunlight Keep dry Temperature limitation Use by/ Expiry date Use within three months after first opening Batch code Manufacturer Serial number Caution, consult accompanying documents Sterilized using irradiation STERILE R...
Page 74: Specifications
SPECIFICATIONS System performance Power source: Four 1.5V AA alkaline batteries 147 (L) x 105 mm (W) x 80 mm (H), 500g with Size of monitor w/o cuff: batteries Memory: Maximum 864 memory records Automatic power off if system idle for 3 min- Power saving: utes (normal mode) or 5 minutes (RF mode).
Page 75 Blood pressure measurement performance Pressure range: 0 - 300 mmHg Heart rate range: 40 -199 beat per minute Measurement unit: mmHg Systolic Measurement Range: 55 mmHg -255 mmHg Diastolic Measurement Range: 25 mmHg -195 mmHg Pulse Rate Measurement Range: 40 -199 beats / minute Maximum inflation pressure: 280 mmHg Accuracy of Pressure:...
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