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ForaCare D20 No-Coding Owner's Manual

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Dear
System Owner:
Thank you for purchasing the ForaCare D20 No-Coding 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 follow-
ing contents thoroughly and carefully.
According to the clinical studies from American Diabetes Associa-
tion, elevated blood pressure often accompanies adult diabetes
patients. These studies also suggest that diabetes patients could
reduce the risk of cardiovascular diseases by managing their
blood glucose levels and blood pressure. Therefore, with easy op-
eration of this ForaCare D20 No-Coding Blood Glucose plus Blood
Pressure Monitoring System, you can easily monitor your blood
glucose levels and blood pressure by yourself at any place, any
time. In addition, this system can help you and your healthcare
professionals to monitor and adjust your treatment plans, and
keep your diabetes and blood pressure under control.
If you have other questions regarding this product, please contact
the place of purchase.
Version 4.0 2013/01
311-3263100-006
1

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Summary of Contents for ForaCare D20 No-Coding

  • Page 1 Therefore, with easy op- eration of this ForaCare D20 No-Coding Blood Glucose plus Blood Pressure Monitoring System, you can easily monitor your blood glucose levels and blood pressure by yourself at any place, any time.

  • Page 2: Important Safety Precautions

    IMPORTANT SAFETY PRECAUTIONS READ BEFORE USE ● The meter and lancing device are for single patient use. Do not share them with anyone including other family members! Do not use on multiple patients! ● All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.
  • Page 3 6. This device does NOT serve as a cure for any symptoms or diseases. The data measured is for reference only. 7. Before using this device to test blood glucose, read all instructions thoroughly and practice the test. Do all quality control checks as directed.

  • 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 SETTING THE MONITOR TESTING YOUR BLOOD GLUCOSE Control Solution Testing Performing a Control Solution Test TESTING WITH BLOOD SAMPLE Preparing the Lancing Device for Blood Testing Preparing the Puncture Site...
  • Page 5 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 Error Messages Troubleshooting DETAILED INFORMATION Reference Values Comparing Monitor and Laboratory Results SPECIFICATIONS...

  • 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 at home as an aid to monitoring the effectiveness of diabetes control. It shall not be used for the diagnosis of diabetes and hypertension, or for the testing of neonates.

  • Page 8: Contents Of System

    Contents of System Your new ForaCare D20 No-Coding system kit includes: Monitor Warranty Card Owner ’ s Manual Lancing Device with One Clear Cap Pressure Cuff (arm type) (Optional) Quick Start User Guide 4 x 1.5V AA alkaline batteries Daily Log Book...

  • Page 9: Monitor Overview

    Monitor Overview Front Back Side Test Slot Insert test strip here to turn the monitor on for testing. AC/DC Adapter Port Display Screen Connect to a power supply. C Button Battery Compartment Enter control solution test. USB Link Port On/Off Button Download test results with To start a single NIBP measurement.

  • Page 10: Screen Display

    Screen Display Test Strip Symbol Diastolic Pressure Value Volume Symbol Memory Mode Symbol Code Number Control Mode Symbol Special Message Diastolic Pressure Symbol Systolic Pressure Value Blood Drop Symbol Battery Symbol Unit for Blood Pressure Indicator Symbol Unit for Blood Glucose Heart Symbol Systolic Pressure Symbol Pulse Rate...

  • Page 11: Test Strip

    Test results might be wrong if the contact bar is not fully inserted into the test slot. NOTE The ForaCare D20 No-Coding monitor should only be used with FORA D20 Test Strips. Using other test strips with this meter can produce inaccurate results.

  • Page 12: Speaking Function

    Speaking Function ForaCare D20 No-Coding “ 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? does the monitor speak? When turn on the monitor.
  • Page 13 WHEN WHAT does the monitor speak? does the monitor speak? When the glucose test result is The blood glucose out of range, outside measurement range, unable to measure. which is 20 to 600 mg/dL (1.1 to 33.3 mmol/L). This monitor has some speaking functions but has not been validated for use by visually impaired users.

  • Page 14: 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 15 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 unit of measurement.
  • Page 16 Step 4 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 17 Step 6 Choose a language. Press to select LAn1 / LAn2. The default language is English (LAn 1). LAn2 is Spanish. Congratulations! You have completed all settings! NOTE • These parameters can ONLY be changed in the setting mode. • If the monitor is idle for 3 minutes during the setting mode, it will turn off automatically.

  • Page 18: Testing Your Blood Glucose

    TESTING YOUR BLOOD GLUCOSE 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: •...

  • Page 19: 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. Step 2 Press to mark this test as a control solution test.
  • Page 20 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 21 Normal 109~165 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 22: Testing With Blood Sample

    TESTING WITH BLOOD SAMPLE Preparing the Lancing Device for Blood Testing Please follow the instructions in the lancing device insert for collecting a blood sample. WARNING To reduce the chance of infection: • Never share a lancet or the lancing device. •...

  • Page 23: Preparing The Puncture Site

    Preparing the Puncture Site Stimulating blood perfusion by rubbing the puncture site before 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 was rubbed prior to blood extraction, the difference was significantly reduced.
  • Page 24 ► Fingertip Testing Press the lancing device ’ s tip firmly against the side of your fingertip. 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 25: 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. ● AST results should not be used for CGM calibration. ● AST results should not be used for insulin dosing calculations What is AST? Alternative site testing (AST) means that people use parts of the body other than...
  • Page 26 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 27: Performing A Blood Glucose Test

    Performing a Blood Glucose Test Step 1 Insert the test strip to turn on the monitor. Wait for the monitor to display the test strip and blood drop symbol. Step 2 Obtaining a blood sample. Use the pre-set lancing device to puncture your de- sired site.
  • Page 28 Step 3 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 completely filled, the monitor begins counting down. NOTE • Do not press the punctured site against the test strip or try to smear the blood.
  • Page 29 Step 4 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 5 Remove the used test strip and remove the lancet. Remove the test strip by hand, throw the strip into a disposal con- tainer.

  • Page 30: Testing Your Blood Pressure

    TESTING YOUR BLOOD PRESSURE This monitor allows you to measure your blood pressure. • Single measurement Perform an individual blood pressure measurement. Before Measurement • Avoid caffeine, tea, alcohol and tobacco at least 30 minutes before measurement. • Wait 30 minutes after exercising or bathing before measurement. •...
  • Page 31 ► 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 32 Step 5 Press the hook material firmly against RED LINESHOULD BE AT THE INSID the pile material. The top and bottom edges of the cuff should be tightened INDEX MUST evenly around your upper arm. ►The range index of cuff should fall into this range.

  • Page 33: Taking A Single Measurement

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

  • Page 34: Monitor Memory

    MONITOR MEMORY Your monitor stores the 450 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.

  • Page 35: Reviewing Day Average Results

    Reviewing Day Average Results Step 1 Press and hold for 3 seconds. Release and then your blood glucose 7-day average result will appear on the display. Step 2 Press Review your 14-, 21-, 28-, 60- and 90-day average. Step 3 Exit the memory.

  • Page 36: Downloading Results Onto A Computer

    USB cable separately, please contact your place of purchase. Step 1 Installing the Software. Download Health Care System Software and instruction manual provided on Fora Care website: www.foracare.com to your computer. Follow the instructions to install the software in your computer. Step 2 Connecting the USB cable to the data port on PC.

  • Page 37: Maintenance

    MAINTENANCE Battery Your monitor comes with four 1.5V AA size alkaline batteries. ► Low Battery Signal The monitor will display the two messages below to alert you when the monitor power is getting low. Step 1 The “ ” symbol appears along with display messages: The monitor is functional and the result remains accurate, but it is time to change the batteries.
  • Page 38 ► Replacing the Battery To replace the batteries, make sure that the monitor is turned off. Step 1 Press the edge of the battery cover and lift it up to remove. Step 2 Remove the old batteries and replace with four 1.5V AA size alkaline batteries. Step 3 Close the battery cover.

  • Page 39: 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 40: 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. Why the cleaning and disinfection should be performed? Cleaning and disinfection are different. Cleaning is the process of removing dirt (e.g.
  • Page 41 Disinfecting Procedures Step 1 Take out one disinfecting wipe from the package and squeeze out any excess liquid in order to prevent damage to the meter. Step 2 Wipe all exterior surface of the meter including the display and buttons. Hold the meter with the test strip slot pointing down and wipe the area around the test slot but be careful not to allow excess liquid to get inside.
  • Page 42 Improper system cleaning and disinfection may result in meter mal- function. If you have a question, please contact local customer service at 1-866-469-2632 for assistance. This device has been validated to withstand up to 5,000 cleaning and disinfection cycles using the recommended disinfecting wipe/ towelette.

  • Page 43: Caring For Your Test Strips

    Monitor Storage • Storage condition: -4 ° F to 140 ° F (-20 ° C to 60 ° C), below 95% relative humidity. • Always store or transport the monitor in its original storage case. • Avoid dropping and heavy impact. •...

  • Page 44: Important Control Solution Information

    For further information, please refer to the test strip package insert. Important Control Solution Information • Use only FORA control solutions with your monitor. • Do not use the control solution beyond the expiration 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 45: 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 46: Error Messages

    Error Messages MESSAGE CAUSE WHAT TO DO Refit cuff tightly and correctly. Relax and repeat the measurement. If the Inflation or pressure error. error still remains, please contact local customer service for help. Repeat the test with a new Strip has been used. strip.
  • Page 47 MESSAGE CAUSE WHAT TO DO Appear when the battery can Replace the battery im- not provide enough power mediately. for a test. Review the instructions and re-test with a new test strip. If the problem is still Problem with the meter. unsolved, please contact with local customer service for help.

  • Page 48: Troubleshooting

    Troubleshooting ► 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 49 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 50 ► Blood Pressure Measurement 1. If nothing is displayed after pressing 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 51: 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 52 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 53: Comparing Monitor And Laboratory Results

    Comparing Monitor and Laboratory Results The monitor provides you with plasma equivalent results. The result you obtain from your monitor may differ somewhat from your labora- tory result due to normal variation. Monitor results can be affected by factors and conditions that do not affect laboratory results in the same way.
  • Page 54 You may still have a variation from the result because blood glucose levels can change significantly over short periods of time, especially if you have recently eaten , exercised, taken medication, or experienced stress . In addition, if you have eaten recently, the blood glucose level from a finger prick 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 .

  • Page 55: Specifications

    SPECIFICATIONS SYSTEM PERFORMANCE Power Source Four 1.5V AA alkaline batteries 155 (L) x 110 mm (W) x 69 mm (H), Size of Monitor w/o Cuff 340g with batteries Memory Maximum 450 memory records Automatic power off if system idle for 3 Power Saving minutes (normal mode) or 5 minutes (RF mode).
  • Page 56 BLOOD PRESSURE MEASUREMENT PERFORMANCE Pressure Range 0 - 300 mmHg Heart Rate Range 40 -199 beat per minute Measurement Unit mmHg Systolic Measurement Range 50 mmHg -250 mmHg Diastolic Measurement Range 30 mmHg -180 mmHg Pulse Rate Measurement Range 40 -199 beats / minute Maximum Inflation Pressure 300 mmHg Accuracy of Pressure...
  • Page 57 This device has been tested to meet the electrical and safety requirements of: IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 61010-1, IEC/EN 61010-2-101, IEC/EN 61326-2-6. Reference to Standards: • EN 1060-1 / EN 1060-3, NIBP-requirements • IEC 60601-1 General requirement for safety •...

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