ForaCare D20 No-Coding Owner'S Manual Download Page 4

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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

Alternative Site Testing

Performing a Blood Glucose Test

TESTING YOUR BLOOD PRESSURE

Before Measurement

Taking a Single Measurement

Summary of Contents for D20 No-Coding

Page 1: ...o 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 you...

Page 2: ...Transmitting Bloodborne Pathogens Initial Communication 2010 http www fda gov MedicalDevices Safety AlertsandNotices ucm224025 htm 2 CDC Clinical Reminder Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM html 1 Use this device ONLY for the intended use described in this manual 2 Do NOT u...

Page 3: ...rd away from hot surfaces 10 Do NOT apply the cuff to areas other than the place directed 11 Use of this device in a dry environment especially if synthetic materials are present synthetic clothing carpets etc may cause damaging static discharges that may cause erroneous results 12 Do NOT use this device in close proximity to sources of strong electro magnetic radiation as these may interfere with...

Page 4: ...p 11 Speaking Function 12 SETTING THE MONITOR 14 TESTING YOUR BLOOD GLUCOSE 18 Control Solution Testing 18 Performing a Control Solution Test 19 TESTING WITH BLOOD SAMPLE 22 Preparing the Lancing Device for Blood Testing 22 Preparing the Puncture Site 23 Alternative Site Testing 25 Performing a Blood Glucose Test 27 TESTING YOUR BLOOD PRESSURE 30 Before Measurement 30 Taking a Single Measurement 3...

Page 5: ...ANCE 37 Battery 37 Using AC Adapter 39 Caring for Your Monitor 40 Caring for Your Test Strips 43 Important Control Solution Information 44 SYSTEM TROUBLESHOOTING 45 Result Readings 45 Error Messages 46 Troubleshooting 48 DETAILED INFORMATION 51 Reference Values 51 Comparing Monitor and Laboratory Results 53 SPECIFICATIONS 55 ...

Page 6: ...reatment advice of your healthcare professional Use only fresh whole blood sample to test your blood glucose Using other substances will lead to incorrect results If you are experiencing symptoms that are inconsistent with your blood glucose test results and you have followed all instructions described in this owner s manual call your healthcare professional We do not recommend using this product ...

Page 7: ...measures the amount of sugar glucose in whole blood The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip Your monitor measures the current calculates the blood glucose level and displays the result The strength of the current produced by the reac tion depends on the amount of glucose in the blood sample The blood p...

Page 8: ...lease make sure you have those items needed for a blood glucose test beforehand NOTE If any items are missing from your kit or opened before use please contact local customer service or place of purchase for assistance 1 4 3 2 7 8 9 6 Warranty Card Lancing Device with One Clear Cap Optional 4 x 1 5V AA alkaline batteries Protective Storage Case 1 4 5 3 2 Monitor Owner s Manual Pressure Cuff arm ty...

Page 9: ... start a single NIBP measurement Speaker M Button Enter the monitor memory S Button Enter and conﬁrm the monitor settings AC DC Adapter Port Connect to a power supply Battery Compartment USB Link Port Download test results with a cable connection Air Plug Connect to air jack Air Tube Pressure Cuff Air jack 1 8 2 9 3 4 5 10 12 13 14 11 7 6 1 8 2 3 4 7 9 6 5 10 14 11 12 13 ...

Page 10: ...bol Heart Symbol Pulse Rate Day Average Result Diastolic Pressure Value Memory Mode Symbol Control Mode Symbol Diastolic Pressure Symbol Blood Drop Symbol Unit for Blood Pressure Unit for Blood Glucose Systolic Pressure Symbol Date Time 1 6 9 4 7 5 8 3 2 10 11 19 17 14 18 15 16 13 12 3 7 6 8 9 4 5 12 13 14 15 16 17 18 19 10 1 2 11 ...

Page 11: ...ndow This is where you conﬁrm if enough blood has been applied to the absorbent hole in the strip Test Strip Handle Hold this part to insert the test strip into the slot Contact Bars Insert this end of the test strip into the meter Push it in ﬁrmly until it will go no further ATTENTION Test results might be wrong if the contact bar is not fully inserted into the test slot The front side of the tes...

Page 12: ...ay When the glucose test is completed the result appears on display or when entering the memory mode When the blood pressure test is completed the result appears on display or when entering the memory mode WHAT does the monitor speak Thank you for using FORA Telehealth product Please relax during measurement Room temperature out of range unable to measure Please apply blood into the strip The bloo...

Page 13: ...sult is outside measurement range which is 20 to 600 mg dL 1 1 to 33 3 mmol L WHAT does the monitor speak The blood glucose out of range unable to measure This monitor has some speaking functions but has not been validated for use by visually impaired users ...

Page 14: ... the steps below and have your desired settings saved Entering the setting mode Start with the monitor off no test strip inserted Press until the monitor turns on Step 1 Setting the date With the year ﬂashing press until the correct year appears Press With the month ﬂashing press until the correct month appears Press SETTING THE MONITOR ...

Page 15: ...ress 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 Press to select mmHg or Kpa the default setting is mmHg Press ...

Page 16: ...ep If you wish to delete ALL the results press twice Step 5 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 Volume 1 to 7 indicates speaking volume from low to high and will be displayed during testing ...

Page 17: ...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: ...Do a control solution test when you ﬁrst receive the monitor at least once a week to routinely check the monitor and test strips you begin using a new vial of test strips you suspect the monitor or test strips are not working properly your blood glucose test results are not consistent with how you feel or if you think the results are not accurate testing process or you have dropped or think you ma...

Page 19: ...t WARNING When doing the control solution test you have to mark it so that the test result will not be stored in the memory Failure to do so will mix up the blood glucose test results with the control solution test results in memory 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 ...

Page 20: ... conﬁrmation window ﬁlls completely the monitor will begin counting down To avoid contaminating the control solution do not directly apply control solution onto a strip Step 4 Read and Compare the Result After counting down to 0 the test result of control solution will appear on the display Compare this result with the range printed on the test strip vial and it should fall within this range If no...

Page 21: ...king properly Do NOT test your blood Contact the local customer service or place of purchase for help NOTE The control solution range printed on the test strip vial is for control solution use only It is not a recommended range for your blood glucose level See the MAINTENANCE section for important information about your control solutions Normal 109 165 ...

Page 22: ...er 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 or the lancing device Wash and dry your hands thoroughly before and after handling the meter lancing device and test strips to prevent infection For more information please refer to the Cleaning and Disinfection section If the me...

Page 23: ...blood extraction the difference was signiﬁcantly reduced Please follow the suggestions below before obtaining a drop of blood Wash and dry your hands before starting Select the puncture site either at ﬁngertips or another body parts please see section Alternative Site Testing AST on how to select the appropriate sites Clean the puncture site using cotton moistened with 70 alcohol and let it air dr...

Page 24: ...for AST Pull the cocking control back until it clicks When lancing the forearm upper arm hand thigh or calf avoid lancing the areas with obvious veins because of excessive bleeding NOTE Choose a different spot each time you test Repeated punctures at the same spot may cause soreness and calluses Please consult your health care professional before you begin AST It is recommended to discard the ﬁrst...

Page 25: ...ther sites Thus when testing blood glucose during or immediately after meal physical exercise or any other event take the blood sample from your finger only 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 This system allows you to test on the palm the forearm the upper arm the calf or the thigh with the e...

Page 26: ...2 hours since the last meal Two hours or more after taking insulin Two hours or more after exercise Do NOT use AST if You think your blood glucose is low You are unaware of hypoglycemia You are testing for hyperglycemia Your AST results do not match the way you feel Your routine glucose results are often ﬂuctuating ...

Page 27: ...p 2 Obtaining a blood sample Use the pre set lancing device to puncture your de sired site After penetration discard the ﬁrst drop of blood with a clean tissue or cotton Gently squeeze the punctured area to obtain another drop of blood Be careful NOT to smear the blood sample The volume of blood sample must be at least 0 7 microliter μL of volume actual size ...

Page 28: ... sample to the test strip within 3 minutes the monitor will automatically turn off You must remove and reinsert the test strip to start a new test The conﬁrmation window should be ﬁlled with blood before the monitor begins to count down NEVER try to add more blood to the test strip after your drop of blood has moved away Discard the used test strip and retest with a new one If you have trouble ﬁll...

Page 29: ...he used test strip and remove the lancet Remove the test strip by hand throw the strip into a disposal con tainer The meter will turn itself off automatically after the test strip is removed Always follow the instructions in the lancing device insert when removing the lancet WARNING The used lancet and test strip may be biohazards Please discard them carefully according to your local regulations ...

Page 30: ...down for at least 10 minutes before measurement 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 doctor as reference Blood pressure varies between each arm Always measure your blood pressure on the same arm To take a blood pressure measurement after perfor...

Page 31: ...e air tube and artery mark region in red toward the lower arm Step 4 Leave a little free space between the arm and the cuff you should be able to ﬁt 2 ﬁngers between them Clothing must not restrict the arm Remove all clothing covering or constricting the measurement arm Wrap and tighten the cuff above your elbow The red line on the edge of the cuff should be approximately 0 8 to 1 2 inches 2 to 3 ...

Page 32: ...on of your heart Remain still and do not talk or move during the measurement Step 4 Measurement is in progress After the monitor is turned on the cuff will begin to inﬂate automati cally Step 5 Press the hook material ﬁrmly against the pile material The top and bottom edges of the cuff should be tightened evenly around your upper arm INDEX RED LINESHOULD BE AT THE INSID INDEX MUST The range index ...

Page 33: ...re turning on the monitor Taking a Single Measurement Step 2 The heart symbol will ﬂash when a pulse is detected during the inﬂation Step 3 After the measurement the monitor displays the systolic pressure diastolic pressure and pulse rate Step 4 Press to switch off Or it will switch off automatically after left idle for 3 minutes Step 1 Press All the LCD symbols will appear Then the cuff will begi...

Page 34: ... 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 Step 2 Press Review all test results stored in the monitor Step 3 Exit the memory Press and the monitor will turn off ...

Page 35: ...urn off NOTE Any time you wish to exit the memory press or leave it without any action for 3 minutes The monitor will turn off automatically Control solution results are NOT included in the day average If using the monitor for the ﬁrst time displays when you recall the test results or review the average result This indicates that there is no test result in the memory The blood pressure results are...

Page 36: ...ting that the monitor is ready to transmit data Data transmission via cable For all ForaCare D20 No Coding Results in memory can be transmitted to the personal computer Health Care Software System and a RS232 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 DOWNLOADING RESULTS ONTO A COM...

Page 37: ...ssages 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 Step 2 If the power is not enough to do a test the symbol starts blinking Please change or recharge the batteries immediately ...

Page 38: ...ill hear a beep afterwards Replacing the Battery 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 If swallowed promptly seek medical assistance Batteries may leak chemicals if unused for a long time Remove the batteries if you are not going to use the device for an extended period i e ...

Page 39: ...nect 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 Step 1 When the monitor is off remove AC adapter power plug from the electrical outlet Step 2 Disconnect AC adapter plug from AC adapter jack of the monitor ...

Page 40: ...infect the meter at least once a week to prevent infection How to clean and disinfect the meter The meter must be cleaned prior to the disinfection Use one disinfecting wipe to clean exposed surfaces of the meter thoroughly and remove any visible dirt or blood or any other body fluid with the wipe Use a second wipe to disinfect the meter Do NOT use organic solvents to clean the meter We recommend ...

Page 41: ...t slot but be careful not to allow excess liquid to get inside Keep the meter moist with disinfection solution contained in the wipe for a minimum of 2 minutes for Micro Kill wipes Follow the instructions on the package label of disinfecting wipe Use two or more wipes if necessary Step 3 Remove the wipe Allow the meter surface to dry completely Step 4 Discard the used wipes and never reuse them Wa...

Page 42: ...cks or becomes cloudy buttons no longer function or outer casing cracks Please contact the customer service or call at 1 866 469 2632 for a replacement meter if any of the signs of dete rioration are noticed NOTE Do NOT clean or disinfect the meter while performing a test If the meter is being operated by a second person the meter and lancing device should be decontaminated prior to handling by an...

Page 43: ...ely after removing it from the vial Write the opening date on the strip vial label when you ﬁrst opened it Discard remaining test strips after 3 months Do not use test strips beyond the expiration date This may cause inac curate results Do not bend cut or alter a test strip in any way Keep the strip vial away from children since the cap and the test strip may be a choking hazard If swallowed promp...

Page 44: ...ntrol solution test should be done at room temperature 68 F to 77 F 20 C to 25 C Make sure your control solution monitor and test strips are at this speciﬁed temperature range before testing Shake the vial before use discard the ﬁrst drop of control solution and wipe off the dispenser tip to ensure a pure sample and an accurate result Store the control solution tightly closed at temperatures betwe...

Page 45: ...der any circumstances Result Readings MESSAGE WHAT IT MEANS BLOOD GLUCOSE Appears when your result is below measurement limit which is less than 20 mg dL 1 1 mmol L 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 ...

Page 46: ...still remains please contact local customer service for help Strip has been used Repeat the test with a new strip Environmental temperature is outside the system s operational range System operational range is 50 F to 104 F 10 C to 40 C Repeat the test after the monitor and test strip have reached the above temperature Error Messages ...

Page 47: ...battery can not provide enough power for a test Replace the battery im mediately Problem with the meter Review the instructions and re test with a new test strip If the problem is still unsolved please contact with local customer service for help ...

Page 48: ...end ﬁrst and facing up Defective monitor or test strips Please contact customer service POSSIBLE CAUSE WHAT TO DO Insufﬁcient blood sample Repeat the test using a new test strip with larger volume of blood sample Defective test strip Repeat the test with a new test strip Sample applied after automatically shutoff 3 minutes after last user action Repeat the test with a new test strip Apply sample o...

Page 49: ...the control solution vigorously and repeat the test again Expired or contaminated control solution Check the expiration date of the control solution Control solution that is too warm or too cold Control solution monitor and test strips should be at room temperature 68 F to 77 F 20 C to 25 C before testing Defective test strip Repeat the test with a new test strip Monitor malfunction Please contact...

Page 50: ... average 3 If the result is higher lower than user s average measurement POSSIBLE CAUSE WHAT TO DO Movement during measurement Repeat measurement Measurement taken just after exercise Rest at least 30 minutes before repeating measurement POSSIBLE CAUSE WHAT TO DO May not be in correct position while measuring Adjust to the correct position to measure Blood pressure naturally varies from time to ti...

Page 51: ...ofessional monitor and adjust your treatment plan to gain better control of your diabetes Source American Diabetes Association 2012 Diabetes Care 35 Suppl 1 64 71 Please consult your doctor to determine a target range that works best for you References 1 American Diabetes Association position statement on the Diabetes Control and Complications Trial 1993 Time of day Normal plasma glucose range for...

Page 52: ...blood vessels Rising blood pressure accelerates hardening of the arteries and the body becomes more susceptible to apoplexy and coronary infarction The recommended blood pressure range is as below References 2 National Heart Lung and Blood Institute Diseases and Conditions 3 The Seventh Report of the Joint National Committee on Prevention Detection Evaluation and Treatment of High Blood Pressure N...

Page 53: ...ween monitor and laboratory results follow the guidelines below Before going to the lab Perform a control solution test to make sure that the monitor is working properly Fast for at least eight hours before doing comparison tests if possible Take your monitor with you to the lab While staying at the lab Make sure that the samples for both tests are taken and tested within 15 minutes of each other ...

Page 54: ...an blood drawn from a vein venous sample used for a lab test 6 There fore 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 dehydration may also cause a monitor result to be different from a laboratory result References 5 Surwit R S and Feinglos M N Diabetes Forecast 1988 Apr...

Page 55: ...inutes RF mode System Operating Condition 50 F to 104 F 10 C to 40 C below 85 RH Monitor Storage Condition 4 F to 140 F 20 C to 60 C below 95 RH Power Supply Input DC 6V 1A max via Power Plug BLOOD GLUCOSE MEASUREMENT PERFORMANCE Measurement Unit mg dL Linear Range 20 to 600 mg dL 1 1 to 33 3mmol L Precision 5 CV Accuracy 15 mg dL 0 83 mmol L when glucose 75mg dL 4 2 mmol L 20 when glucose 75mg dL...

Page 56: ... 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 3 mmHg or 2 of reading Accuracy of Pulse Rate 4 of reading ...

Page 57: ... 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 IEC 60601 1 2 Requirements for EMC EN 1060 4 NIBP clinical investigation AAMI ANSI IEC 80601 2 30 ANSI AAMI ISO 81060 2 NIBP requirements ...

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