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SAE HAN Medical DCD 2IN1 User Manual - About The Control Solution

Manual is about: EasyPlus mini 2IN1 Self-Monitoring Blood Glucose System

Summary of DCD 2IN1

  • Page 1

    1 dcd 2in1 self-monitoring blood glucose system user’s manual (model name: easyplus mini 2in1).

  • Page 2

    2 dear dcd 2in1 smbg system owner, thank you for using the dcd 2in1 self-monitoring blood glucose (smbg) system. We designed this system to be dependable, easy-to-use, compact, lightweight and portable to help you monitor your blood glucose on a regular basis. Please read this manual thoroughly befo...

  • Page 3: Intended Use

    3 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 counte...

  • Page 4: Standard Accessories

    4 standard accessories your new dcd 2in1 blood glucose meter and accessories work 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 • te...

  • Page 5: Do You Need Help?

    5 why is it so important to test blood glucose regularly? Testing your blood glucose regularly can make a big difference in how you manage your diabetes every day. We’ve made this smbg system as simple as possible to help you to use the meter regularly. Your meter is easy to use, and you can adjust ...

  • Page 6

    6 important information about your new dcd 2in1 the dcd 2in1 blood glucose meter is designed and approved for testing fresh capillary blood from fingertip. The meter is for outside the body (in vitro) use. It should not be used to diagnose diabetes. Only use dcd 2in1 blood glucose meter with the dcd...

  • Page 7

    7 incorrect results may occur when performing the test. If you believe you are not feeling well, please contact your healthcare professional. Remove batteries if the meter will not be used for one month or more. Warning for potential biohazard: healthcare professionals using this system on multiple ...

  • Page 8: Health-Related Information

    8 health-related information if you are very dehydrated, urinating frequently, low blood pressure, shock or hyperosmolar hyperglycemic nonketotic coma (hhnkc), you may get a test result that is lower than what your blood glucose really is. If you think you are dehydrated, call your doctor right away...

  • Page 9: Explanation of Symbols

    9 explanation of symbols consult instructions for use caution batch code do not reuse in vitro 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 t...

  • Page 10

    10 ①result amount ②blood apply ③ hypo ④control solution ⑤unit ⑥date ⑦time ⑨memory ⑩battery ⑥ ② ③ ⑦ ⑧ ① ④ ⑤ ⑨.

  • Page 11: Table of Contents

    11 table of contents chapter 1: understanding your meter …......................................................................................14 the dcd 2in1 blood glucose meter …..............................................................14 installing batteries ....................................

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    12 chapter 3: testing your blood glucose .......................................................................................24 using the bulit-in lancing device .................................................................................24 inserting a lancet into the lancing device ...........

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    13 chapter 5: maintenance and troubleshooting ….......................................................................39 installing batteries ….................................................................................................................39 cleaning your meter ……......................

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    14 chapter 1: understanding your meter dcd 2in1 blood glucose meter test strip 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 ...

  • Page 15: Installing Batteries

    15 installing batteries 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..

  • Page 16

    16 setting the time and date—first time use setting the current time and date in your meter is important if you intend to use the meter memory or if you want to download your results to a computer. 1. If your meter does not turn on automatically, press for 3 seconds to turn on the meter. 3. Repeat s...

  • Page 17

    17 using dcd 2in1 blood glucose test strip „ use only with dcd 2in1 blood glucose meter. „ run a control solution test every time you open a new box of test strips (see chapter 2 "control solution testing.") „ keep the test strips in their original bottle. „ close the bottle tightly right away, afte...

  • Page 18

    18 chapter 2: control solution testing why run a control solution test we recommend that you run the dcd 2in1 normal control test because it lets you know that your meter and test strips are working properly to give you reliable results. You should run the control solution test when: „ you use the d...

  • Page 19: About The Control Solution

    19 about the control solution „ use only with dcd 2in1 test strips. „ write the date you opened the bottle on the bottle label. The control solution is good for three months from the date the bottle is opened or until the expiration date on the bottle, whichever comes first. „ do not use a control s...

  • Page 20

    20 running a control solution test you need the meter, a test strip, and control solution. 1. Put a test strip into the meter in the direction of 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. ...

  • Page 21

    21 6. Squeeze the bottle until a tiny drop forms at the tip of the bottle. 7. Touch the drop to the blood collection area at the tip of the test strip. When you hear beeps, you have enough control solution in the test strip. 8. The meter starts to count down from 5 seconds, the display shows “ok”, a...

  • Page 22

    22 understanding control solution test results the label on your test strip bottle shows the acceptable ranges for the control solutions. The result you get should be inside this range. Make sure you compare the result to the correct level of control. When the control solution result is inside the r...

  • Page 23

    23 troubleshooting checks action 9 was the test strip exposed to open air for a long period of time? Repeat the control test with properly stored strips. 9 was the test strip bottle capped tightly? This will humidify strips inside. Replace the test strips. 9 was the meter functioning well? You can u...

  • Page 24

    24 chapter 3: testing your blood glucose using the built-in lancing device the best depth setting is the lowest number that draws enough blood for a test. Try different settings to find the one that’s right for you. „ please do not share your lancing device with anyone. And always use a new, sterile...

  • Page 25

    25 inserting a lancet into 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..

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    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..

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    27 5. Pull on the cocking 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..

  • Page 28

    28 running a blood glucose test with blood from your fingertip 1. Wash your hands with soap and warm water. Rinse and dry thoroughly. 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...

  • Page 29

    29 5. Gently squeeze and/or massage your fingertip until a round drop of blood on your fingertip . 6. Touch the blood drop at the tip of the transparent window of the 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...

  • Page 30: Discarding Used Lancets

    30 discarding used lancets 2. Discard the 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 int o its protecti ve cover. Grip the lancet carrier firmly and pull the lancet safely out..

  • Page 31

    31 understanding your test results the dcd 2in1 blood glucose test strips are plasma referenced and calibrated for 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 witho...

  • Page 32: Unusual Test Results

    32 unusual test results if your test result doesn’t match the way you feel, please follow these steps: 1. Run a control solution test, chapter 2 "control solution testing." 2. Repeat a blood glucose test, chapter 3 "testing your blood glucose." 3. If your test results still don’t reflect the way you...

  • Page 33

    33 symptoms of high or low blood glucose being aware of the symptoms of high or low blood glucose can help you understand your test results and decide what to do if they seem unusual. Here are the most common symptoms: what it means: the test result is higher than reference normal range. (70-110mg/d...

  • Page 34

    34 what it means: the test result is lower than reference normal range. (70-110mg/dl) symptoms: sweating, trembling, blurred vision, rapid heartbeat, tingling, or numbness around mouth or fingertips. What to do: „ if you are experiencing any of these symptoms, test your blood glucose. „ if the resul...

  • Page 35

    35 comparing your meter result to a lab result a common question is how the blood glucose results on your meter compare to the lab results. Your blood glucose can change quickly, especially after eating, taking medication, or exercising. If you test yourself in the morning, then go to the doctor’s o...

  • Page 36: Memory, Storing Test Results

    36 chapter 4: meter memory, setup memory, storing test results your meter stores a maximum of 360 test results with the time and date of the test. You can review them at any time. When the memory is full, the oldest result is dropped as the newest is added, so it is very important to have the correc...

  • Page 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..

  • Page 38

    38 5. Press for 1 second to go back to the total number of the stored results. 6. 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 canc...

  • Page 39: Installing Battery

    39 chapter 5: maintenance and troubleshooting installing battery the meter uses one cr2032 battery. Battery will normally last for more than 1000 tests. Other types of cr2032 batteries are also acceptable, but the capacity of test times may differ. Install the battery when you first use the meter or...

  • Page 40: Cleaning Your Meter

    40 cleaning your meter caring for your dcd 2in1 smbg system does not require special cleaning. Please keep the meter free of dirt, dust, bloodstain, and water stains. Follow these guidelines carefully to help you get the best performance possible: do not: get any moisture in the test strip slot. Spr...

  • Page 41: Maintenance and Testing

    41 maintenance and testing your meter needs little or no maintenance with normal use. It automatically tests its own systems every time you 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 th...

  • Page 42: Cleaning Your Lancing Device

    42 cleaning your lancing device „ to clean the lancing device, 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 ...

  • Page 43

    43 screen messages and troubleshooting never make treatment decisions based on an error 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 ...

  • Page 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..

  • Page 45

    45 what it means ? You may have a very high blood glucose level(severe hypoglycemia), over 600 mg/dl. You 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 imme...

  • Page 46

    46 what it means ? Temperature is too high, 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. Temperature is too low, outside the required range of 10°c - 40°c (50°f - 104°f). This alerts users that an incorrect resu...

  • Page 47

    47 chapter 6: technical information memory capacity 360 results test specimen capillary whole blood sample volume 0.6ul 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 ...

  • Page 48: Limitation

    48 limitation the test strips are used for fresh capillary whole blood samples. 1. Do not use neonate blood sample. 2. Extreme humidity may affect the results. A relative humidity greater than 90% may cause incorrect results. 3. The system should be used at a temperature between 10°c - 40°c (50°f - ...

  • Page 49

    49 healthcare professionals – please note these additional limitations 7. Patients undergoing oxygen therapy may have inaccurate results. 8. If the patient has the following conditions, the result may fail: ♦ severe dehydration ♦ severe hypotension (low blood pressure) ♦ shock ♦ a state of hypoglyce...

  • Page 50

    50 interfering , substance test concentration mg/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...

  • Page 51: Device Information

    51 device information dcd 2in1 smbg system, dcd 2in1 blood glucose test strips, dcd 2in1 blood glucose meter, dcd 2in1 normal control solution, dcd 2in1 high control solution. 0537 reference: ＊ american diabetes association: standards of medical care for patients with diabetes mellitus, diabetes car...

  • Page 52: Warranty

    52 obelis s.A. 34, av. De tervuren, bte 44, b-1040 brussels, belgium tel：(32) 2.732.59 54 fax：(32) 2.732.60 03 e-mail: mail@obelis.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 g...

  • Page 53

    53 lancet meets 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.