Summary of Contents for SAE HAN Medical DCD 2IN1
- Page 1 DCD 2IN1 Self-Monitoring Blood Glucose System User’s Manual (Model Name: EasyPlus mini 2IN1)
- Page 2 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.
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Page 3: Intended Use
[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. - Page 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 • Blood Glucose Meter • Quick Reference Guide • Carrying Case • Log Book •...
- Page 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 the lancing device for your comfort.
- Page 6 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 2IN1 Blood Glucose Test Strips. Other test strips will give inaccurate results.
- Page 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 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.
- Page 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. 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.
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Page 9: Explanation Of Symbols
Explanation of Symbols Consult instructions for use Caution Batch code Do not reuse In vitro diagnostic medical 3V (CR2032) x 1 battery only device Use by Temperature limitation Manufacturer Catalogue number Serial number Control Authorised representative in Sufficient for the European Community This product meets the requirements of Directive 98/79/EC in vitro diagnostic medical devices... - Page 10 ⑥ ① ⑦ ② ⑧ ③ ⑨ ④ ⑤ ①Result amount ②Blood apply ③ Hypo ④Control Solution ⑤Unit ⑥Date ⑦Time ⑨Memory ⑩Battery...
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Page 11: Table Of Contents
The DCD 2IN1 Blood Glucose 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... - Page 12 Chapter 3: Testing Your Blood Glucose ..................24 Using the Bulit-in Lancing Device .................24 Inserting A Lancet into the Lancing Device ................25 Running 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...
- Page 13 Chapter 5: Maintenance And Troubleshooting …...............39 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...
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Page 14: Chapter 1: Understanding Your Meter
Chapter 1: Understanding Your Meter Cocking Button DCD 2IN1 Blood Glucose Meter Display Button- Press to turn the meter on, confirm Depth setting, and Indicator Test Strip Slot- scroll through Insert test strip here. Release results. Button Button- Press to enter... -
Page 15: Installing Batteries
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: Setting The Time And Date
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. -
Page 17: Using Dcd 2In1 Blood Glucose Test Strip
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. -
Page 18: Chapter 2: Control Solution Test
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 DCD 2IN1 Blood Glucose Meter for the first time. -
Page 19: About The Control Solutions
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. -
Page 20: Running A Control Solution Test
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. 2. The meter beeps and turns on automatically. The icon shows itself. 3. - Page 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.
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Page 22: Understanding Control Solution Test Results
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 range on the test strip bottle, your test strips and your meter are working properly. - Page 23 Troubleshooting Checks Action Was the test strip exposed to open air for a Repeat the control test with properly stored strips. long period of time? Was the test strip bottle capped tightly? This will humidify strips inside. Replace the test strips.
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Page 24: Chapter 3: Testing Your Blood Glucose
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 lancet. Lancets are for one time use only. -
Page 25: Inserting A Lancet Into The Lancing Device
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. - Page 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.
- Page 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.
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Page 28: Running A Blood Glucose Test With Blood From Your Fingertip
Running A Blood Glucose Test With Blood From Your Fingertip 1. Wash your hands with soap and warm water. Rinse and dry thoroughly. Put a test strip into the meter in the direction of the arrow. The meter beeps and turns on automatically. 3. - Page 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.
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Page 30: Discarding Used Lancets
Discarding Used Lancets 1. Unscrew and remove the cap. Without 2. Discard the used disposable lancet touching the used lancet, stick the lancet into an appropriate sharps or into its protective cover. Grip the biohazard container. lancet carrier firmly and pull the lancet safely out. -
Page 31: Understanding Your Test Results
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 without diabetes is less than 120 mg/dL. -
Page 32: Unusual Test Results
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. -
Page 33: Symptoms Of High Or Low Blood Glucose
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: Greater than 240 mg/dL What It Means: The test result is higher than reference normal range. - Page 34 Below 60 mg/dL 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 result displayed is below 60 mg/dL and you have symptoms of low blood glucose, contact your healthcare professional immediately.
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Page 35: Comparing Your Meter Result To A Lab Result
Keep in mind that the lab could use different technology than DCD 2IN1 blood glucose meter, and that blood glucose meters for self testing generally read somewhat lower or higher than the lab result. -
Page 36: Chapter 4: Meter Memory, Setup
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 correct time and date set in the meter. -
Page 37: Viewing & Deleting Test Results
Viewing & Deleting Test Results 1. Press to turn the meter on. 2. Press to view averages for 7/14/30 days. 3. Continue to press to view the test result from latest to oldest. - Page 38 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. 5. Press for 1 second to go back to the total number of the stored results.
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Page 39: Chapter 5: Maintenance And Troubleshooting
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 replace with new battery when the "LP"... -
Page 40: Cleaning Your Meter
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: Make sure the meter is turned off. -
Page 41: Maintenance And Testing
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 the meter. -
Page 42: Cleaning Your Lancing Device
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. -
Page 43: Screen Messages And Troubleshooting
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 ? What to do ? System err. Please replace the batteries first. If Err appears again, please contact your healthcare professional immediately. - Page 44 What it means ? What to do ? Memory err. Please replace the batteries first. If Err appears again, please contact your healthcare professional immediately. Low power. Please replace with a new battery.
- Page 45 What it means ? What to do ? You may have a very high Please test again and if you blood glucose level(severe get the same result, please hypoglycemia), over 600 contact your healthcare mg/dL. professional immediately. You may have a very low Please test again and if you blood glucose level(severe get the same result, please...
- Page 46 What it means ? What to do ? Temperature is too high, Relocate the meter to a outside the required range of location with temperature 10°C - 40°C (50°F - 104°F). between 10°C - 40°C This alerts users that an (50°F - 104°F).
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Page 47: Chapter 6: Technical Information
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. LCD dimension 37.5 x 21.5 mm Meter dimension 94 x 34 x 14 mm Weight... -
Page 48: Limitation
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 - 104°F). Outside this range, the system may get incorrect results. - Page 49 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.
- Page 50 Test Interfering , Bias at 50±5 % Bias at 250±5 % Bias at 500±5 Concentration Substance mg/dL mg/dL mg/dL mg/dL Acetaminophen 10.2 Ascorbic Acid 11.8 -6.8 Dopamine 12.9 Gentisic Acid -4.3 L-Dopa -1.2 -1.8 Methyldopa -2.3 Uric Acid...
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Page 51: Device Information
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 Care, 25(2002), p.S37... -
Page 52: Warranty
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 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. - Page 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...
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