SAE HAN Medical DCD 2IN1 Скачать руководство пользователя

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Intended Use

The

DCD 2IN1 Self Monitoring Blood Glucose Test System

is intended for the quantitative

measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is
done outside the body (

In Vitro

diagnostic use). It is indicated for use at home (over the counter

[OTC]) by persons with diabetes, or in clinical settings by healthcare professional, as an aid to
monitor the effectiveness of diabetes control.

Although

the DCD 2IN1 SMBG System is easy to use, you may need to consult your

healthcare professional (this may be your doctor, pharmacist or diabetes nurse educator)
for instructions on how to use the system. Only the correct use of the system will ensure
accurate results.

Содержание DCD 2IN1

Страница 1: ...1 DCD 2IN1 Self Monitoring Blood Glucose System User s Manual Model Name EasyPlus mini 2IN1 ...

Страница 2: ...ompact lightweight and portable to help you monitor your blood glucose on a regular basis Please read this manual thoroughly before you begin testing This manual provides you and your diabetes care team with important information and step by step direction to use the DCD 2IN1 Self Monitoring Blood Glucose System Thanks again for choosing the DCD 2IN1 SMBG System ...

Страница 3: ...s indicated for use at home over the counter OTC by persons with diabetes or in clinical settings by healthcare professional as an aid to monitor the effectiveness of diabetes control Although the DCD 2IN1 SMBG System is easy to use you may need to consult your healthcare professional this may be your doctor pharmacist or diabetes nurse educator for instructions on how to use the system Only the c...

Страница 4: ...together to measure the amount of glucose in your blood The system includes User s Manual Quick Reference Guide Log Book Test Strip Instructions CR2032 Battery x 1 Blood Glucose Meter Carrying Case Test Strip x 10 ct Normal Control Solution Control Solution Instructions Lancet x 5 ct ...

Страница 5: ...u to use the meter regularly Your meter is easy to use and you can adjust the lancing device for your comfort Do you need Help If you have questions or need assistance please contact your healthcare professional You can also visit www epsbio com for diabetes management tools and product demonstrations Please complete your warranty card and mail it so you receive the best customer service possible ...

Страница 6: ...Do not disassemble the meter as this may cause damage to the components resulting in incorrect reading Disassembling the meter will also void the warranty Always keep the meter clean and store it in a safe place Protect the meter from direct sunlight to ensure a longer lifespan You should not store the meter and test strips in a car a bathroom or a refrigerator Keep the meter and test strips away ...

Страница 7: ...Healthcare professionals using this system on multiple patients should be aware that all products or objects that come in contact with human blood even after cleaning should be handled as if capable of transmitting viral disease Do not touch the strips with wet hands Do not use expired strips the expiration date is shown on the bottle Do not bend cut or twist the strips Altitude up to 10 000 feet ...

Страница 8: ...y If you have followed the steps in the user s manual but still have symptoms that don t seem to match your test results or if you have questions please talk to your doctor Please read your test strip instructions carefully for additional health related information Warning for potential biohazard Healthcare professionals using this system on multiple patients should handle all products or objects ...

Страница 9: ... diagnostic medical device 3V CR2032 x 1 battery only Use by Temperature limitation Manufacturer Catalogue number Serial number Control Sufficient for Authorised representative in the European Community This product meets the requirements of Directive 98 79 EC in vitro diagnostic medical devices ...

Страница 10: ...10 Result amount Blood apply Hypo Control Solution Unit Date Time Memory Battery ...

Страница 11: ...Meter 14 Installing Batteries 15 Setting The Time And Date 16 Using DCD 2IN1 Blood Glucose Test Strip 17 Chapter 2 Control Solution Test 18 Why Run a Control Solution Test 18 About The Control Solutions 19 Running A Control Solution Test 20 Understanding Control Solution Test Results 22 ...

Страница 12: ...nning A Blood Glucose Test With Blood From Your Fingertip 28 Discarding Used Lancets 30 Understanding Your Test Results 31 Unusual Test Results 32 Symptoms of High or Low Blood Glucose 33 Comparing Your Meter Result To A Lab Result 35 Chapter 4 Meter Memory Setup 36 Memory Storing Test Result 36 Viewing Deleting Test Results 37 ...

Страница 13: ...9 Installing Batteries 39 Cleaning Your Meter 40 Maintenance And Testing 41 Cleaning Your Lancing Device 42 Screen Messages And Troubleshooting 43 Chapter 6 Technical Information 47 Specifications 47 Limitation 48 Device Information 51 Warranty 52 ...

Страница 14: ...ip Slot Insert test strip here Button Press to enter memory adjust setting and scroll through results Button Press to turn the meter on confirm setting and scroll through results Depth Indicator Cap Cocking Button Battery Door Display Release Button Carrier Insert lancing here ...

Страница 15: ...es 1 Flip open the battery door by pushing the tab in the direction of the arrow and pulling the door up 2 Insert a battery 3 Put the battery door back in place and snap it closed The meter beeps and turns on automatically ...

Страница 16: ... results to a computer 1 If your meter does not turn on automatically press for 3 seconds to turn on the meter 3 Repeat step 2 to set the date and time The flashing field is the one you are currently setting When finishing the setting the meter beeps 2 The last 2 digits of the year flash at the center of the display Press to adjust the year and press to confirm the setting ...

Страница 17: ...e bottle The strip is for single use only Do not reuse it Record the date you open the test strip bottle Be sure to check the Expiration date on the test strip bottle The test strip is good for three months from the date the bottle is opened or until the expiration date on the bottle whichever comes first Store the test strip bottle and your meter in a cool dry place Store the test strips between ...

Страница 18: ...sults You should run the control solution test when You use the DCD 2IN1 Blood Glucose Meter for the first time You open a new bottle of test strips You think the meter or test strips may be working incorrectly You drop the meter You have repeated a test and the test results are still lower or higher than expected You are practicing the test procedure Professional users are instructed to follow fe...

Страница 19: ...ration date on the bottle whichever comes first Do not use a control solution that is past the expiration date The control solution can stain clothing If you spill it wash your clothes with soap and water Close the bottle tightly after every use Left over control solution should not be added back into the control bottle Store the bottle of control solution at room temperature between 2 C 30 C 35 6...

Страница 20: ... the arrow 4 Place the meter on a flat surface like a table 5 Remove the control solution bottle cap and wipe the tip of the bottle with a tissue 2 The meter beeps and turns on automatically The icon shows itself 3 Press the the icon shows and the meter is ready to run a Control Solution Test Or press to cancel the Control Solution Test Mode ...

Страница 21: ...enough control solution in the test strip 8 The meter starts to count down from 5 seconds the display shows Ok and then shows the test result 9 Do not remove the test strip yet Check if the reading falls within the range printed on the test strip bottle 10 Remove the test strip and throw it away after you have compared the reading to the range printed on the test strip bottle ...

Страница 22: ...rol solution result is inside the range on the test strip bottle your test strips and your meter are working properly If your control solution result is not inside the acceptable range printed on your test strip bottle here are some things you can do to solve the problem Control Solution values will be included in the memory and averages Refer to the section Viewing Deleting Test Results to delete...

Страница 23: ...se control solution to verify the meter s functions Chapter 2 9 Is the control solution expired or contaminated Replace with new control solution to check the performance of SMBG system 9 Were test strips and control solutions stored in cool dry places Repeat the control test with properly stored strips or control solutions 9 Did you follow the testing steps properly Read Chapter 2 Control Solutio...

Страница 24: ...t s right for you Please do not share your lancing device with anyone And always use a new sterile lancet Lancets are for one time use only Used test strips and lancets are considered bio hazardous waste in accordance with local regulations and should be handled as if capable of transmitting infection The users may discuss methods for disposing of used test strips and lancets with their doctor ...

Страница 25: ...nto The Built in Lancing Device You must first load the lancet into the lancing device to get it ready for use 1 Unscrew the Cap 2 Insert a new disposable lancet firmly into the carrier and then twist off the protective cover ...

Страница 26: ...26 3 Recap the front cap 4 Select the desired penetration depth Select 1 2 for thick or calloused skin 3 for average 4 5 for soft or thin skin ...

Страница 27: ...ocking button of the lancing device until it clicks and then release Now the lancing device is ready Do not prick your finger until your meter and strip are prepared 6 Set the lancing device aside until later in the test ...

Страница 28: ...oroughly 2 Put a test strip into the meter in the direction of the arrow The meter beeps and turns on automatically 3 When the blood drop flashes on the display using the lancing device 4 Hold the lancing device firmly against the side of your finger Press the release button Then remove the lancing device from your finger ...

Страница 29: ...he test strip Do not put blood on top of the strip When you hear beeps you have enough blood in the test strip Be sure to get enough blood in the test strip Otherwise an inaccurate reading may result 7 The meter starts to count down from 5 seconds the display shows Ok and then shows the test result 8 Remove the test strip and the meter turns off automatically ...

Страница 30: ...used disposable lancet into an appropriate sharps or biohazard container 1 Unscrew and remove the cap Without touching the used lancet stick the lancet tip into its protective cover Grip the lancet carrier firmly and pull the lancet safely out ...

Страница 31: ...easier comparison to lab results The normal fasting blood glucose range for an adult without diabetes is 70 110 mg dL Two hours after meals the blood glucose range for an adult without diabetes is less than 120 mg dL For people with diabetes please consult your doctor for the blood glucose range appropriate for you ...

Страница 32: ...ur test results still don t reflect the way you feel call your doctor immediately 1 Extremely high humidity may affect the test results A relative humidity greater than 90 may cause inaccurate results 2 A red blood cell count Hematocrit that is either very high above 55 or very low below 30 may not provide accurate results 3 Some studies have shown that electromagnetic fields may affect results Do...

Страница 33: ...normal range 70 110mg dL Symptoms Fatigue increased appetite or thirst frequent urination blurred vision headache general aching or vomiting What to Do If you are experiencing any of these symptoms test your blood glucose If the result displayed is greater than 240 mg dL and you have symptoms of high blood glucose contact your healthcare professional immediately If the result does not match how yo...

Страница 34: ...r numbness around mouth or fingertips What to Do If you are experiencing any of these symptoms test your blood glucose If the result displayed is below 60 mg dL and you have symptoms of low blood glucose contact your healthcare professional immediately If the result does not match how you feel follow the steps under Unusual Test Results Below 60 mg dL ...

Страница 35: ... it just means that time has elapsed and your blood glucose has changed If you want to compare your meter result to the lab result you must be fasting Bring your meter to the doctor s office and test yourself by fingertip within five minutes of having blood drawn from your arm by a healthcare professional Keep in mind that the lab could use different technology than DCD 2IN1 blood glucose meter an...

Страница 36: ...ter 1 Do not change your therapy based on one individual result in memory 2 The memory is not lost when you replace the battery You do need to check that the time and date are still correct See Section Setting the time and date in Chapter 1 3 Once 360 results are in memory adding a new result causes the oldest one to be deleted 4 Control Solution values will be included in the memory and averages ...

Страница 37: ...37 Viewing Deleting Test Results 3 Continue to press to view the test result from latest to oldest 1 Press to turn the meter on 2 Press to view averages for 7 14 30 days ...

Страница 38: ... Press for 3 seconds to turn off the meter or the meter turns off automatically in 120 seconds 4 To delete a test result press for 3 seconds When display shows dEL press to confirm the deletion Or press to cancel the deletion and go back to the total number of the stored results ...

Страница 39: ...r on the display The meter will not turn on the first time the battery is installed Please press and hold button or insert the test strip to turn your meter on The meter will turn off automatically Or you can press and hold button to turn your meter off 1 The meter won t delete earlier records after you replace the battery 2 You should reset the time and date again after you replace the battery 3 ...

Страница 40: ...r stains Follow these guidelines carefully to help you get the best performance possible Do Not Get any moisture in the test strip slot Spray any cleaning solution directly onto the meter Put the meter under water or liquid Pour liquid into the meter Do Make sure the meter is turned off Gently wipe the meter s surface with a soft cloth slightly dampened ...

Страница 41: ...ou turn it on and lets you know if something is wrong See Screen Messages and what to do about them To make sure the display is working properly turn off the meter Press and hold to see the complete display All the indicators should be clear and look exactly like the picture to the left If not please contact your healthcare professional ...

Страница 42: ... wipe with a soft cloth dampened with water and mild detergent DO NOT place the entire device under water To disinfect the cap after cleaning by placing it in 70 75 rubbing alcohol for 10 minutes at least once a week Allow the cap to air dry after disinfecting ...

Страница 43: ...ror message If you have any concerns please contact your healthcare professional What it means System err Humidified or used strip What to do Please replace the batteries first If Err appears again please contact your healthcare professional immediately Please replace with a new strip ...

Страница 44: ...44 What it means Memory err Low power What to do Please replace the batteries first If Err appears again please contact your healthcare professional immediately Please replace with a new battery ...

Страница 45: ... may have a very low blood glucose level severe hypoglycemia lower than 20 mg dL What to do Please test again and if you get the same result please contact your healthcare professional immediately Please test again and if you get the same result please contact your healthcare professional immediately ...

Страница 46: ...cur if the test continues Temperature is too low outside the required range of 10 C 40 C 50 F 104 F This alerts users that an incorrect result may occur if the test continues What to do Relocate the meter to a location with temperature between 10 C 40 C 50 F 104 F Relocate the meter to a location with temperature between 10 C 40 C 50 F 104 F ...

Страница 47: ...Testing time 5 seconds HCT range 30 55 Measuring range 20 630 mg dL Operating range 10 C 40 C 50 F 104 F R H 90 AST N A LCD dimension 37 5 x 21 5 mm Meter dimension 94 x 34 x 14 mm Weight 32 g Battery life Over 1 000 times Power supply CR2032 Lithium battery x 1 Auto shut off 2 minutes Data transferring USB card reader ...

Страница 48: ...0 C 50 F 104 F Outside this range the system may get incorrect results 4 DO NOT reuse the test strips The test strips are for single use only 5 Hematocrit The hematocrits between 30 and 55 will not significantly affect the results Hematocrit below 30 may cause higher results Hematocrit above 55 may cause lower results If you do not know your hematocrit level please consult with your healthcare pro...

Страница 49: ...osmolar state with or without ketosis 9 Lipemic samples Cholesterol level up to 500 mg dL and triglycerides up to 3 000 mg dL do not affect the results Grossly lipemic patient samples have not been tested and are not recommended for testing with DCD 2IN1 Blood Glucose Meter 10 Critically ill patients should not be tested with home use blood glucose meters 11 Interfering Substances depend on the co...

Страница 50: ...g dL Bias at 50 5 mg dL Bias at 250 5 mg dL Bias at 500 5 mg dL Acetaminophen 8 10 2 6 5 3 8 Ascorbic Acid 2 5 11 8 6 8 5 3 Dopamine 2 4 3 12 9 6 3 Gentisic Acid 6 7 8 2 8 4 3 L Dopa 2 3 8 1 2 1 8 Methyldopa 2 5 2 2 3 4 1 Uric Acid 13 7 6 3 9 3 8 ...

Страница 51: ...IN1 High Control Solution 0537 Reference American Diabetes Association Standards of Medical Care for Patients with Diabetes Mellitus Diabetes Care 25 2002 p S37 Manufacturer EPS Bio Technology Corp No 8 R D RD III Hsinchu Science Park Hsinchu City Taiwan Tel 886 3 6686868 Fax 886 3 6686866 E mail info epsbio com tw Website http www epsbio com tw ...

Страница 52: ...lis net Warranty EPS warrants the original purchaser for a period of 3 years from the date of purchase This means during the warranty period if your Self Monitoring Blood Glucose System does not work for any reason other than obvious abuse EPS will replace it with a new system or an equivalent product free of charge ...

Страница 53: ... the requirements of MDD 93 42 EEC Manufacturer SAE HAN MEDICAL CORP 700 113 PUB GOT DONG IL SAN GU GOYANG CITY KYUNGGI DO KOREA TEL 82 31 923 4330 FAX 82 31 923 4331 E mail saehan saehanmed com P N 718049300 Rev A01 ...

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