Blood Glucose Monitoring System

Transcription

1 Blood Glucose Monitoring System

2

3 Contents Chapter 1 OMRON Blood Glucose Monitoring System HEA Introduction 1.2 List of Kit Contents 1.3 Product and Meter Display Chapter 2 Installing and Setting up the HEA Inserting / replacing batteries Chapter 3 Finger Blood Glucose Testing 3.1 Preparation before glucose testing 3.2 Fingertip blood measurement Chapter 4 Glucose Control Solution Testing (Optional) 4.1 Control test Chapter 5 Memory Function 5.1 Reviewing past results Chapter 6 Instructions on Caring and Storing for Your Strips and Meter 6.1 Caring for the strip 6.2 Caring for the meter Chapter 7 Troubleshooting Chapter 8 HEA-232 Performance Characteristics Chapter 9 Specification

4 IMPORTANT SAFETY PRECAUTIONS READ BEFORE USE 1. Use this device ONLY for the intended use described in this manual. 2. Do NOT use accessories which are not specified by the manufacturer. 3. Do NOT use the device if it is not working properly or if it is damaged. 4. Do NOT use the equipment in places where aerosol sprays are being used or where oxygen is being administered. 5. Do NOT use under any circumstances use the device on neonates or infants. 6. This device does NOT serve as a cure for any symptoms or diseases. The data measured is for reference only. User should not take any decision of medical relevance without first consultation of medical practitioner. Always consult your doctor to have the results interpreted. 7. Before using this device to test blood glucose, read all instructions thoroughly and practice the test. Carry out all the quality control checks as directed. 8 Use this instrument in a dry environment, if synthetic materials are present (synthetic clothing, carpets etc.) it may cause damaging static discharges that may cause erroneous results. 9. Do not use this instrument in close proximity to sources of strong electromagnetic radiation, as these may interfere with the accurate operation. 10. Do not use this meter near cellular or cordless telephones, walkie talkies, garge door openers, radio transmitter, or other electrical or electronical equipment that are sources of electromagnetic radiation, as these may interfere with the proper operation of the meter. 11. The device for self-testing is used for the monitoring of an existing disease (eg., diabetes) the patient should only adapt the treatment if he has received the appropriate training to do so. 2

5 Chapter 1 OMRON Blood Glucose Monitoring System HEA Introduction The HEA-232 uses state-of-art bioelectrochemistry detecting technology; it needs approximately 1μL of fresh capillary whole blood for one test. The blood glucose concentration is displayed in 5 seconds after the blood has been applied to the test zone. The device is intended for use by diabetics to monitor their own glucose levels. Please read the instruction manual carefully before using. Hea-232 is an in vitro diagnostic medical device for self-testing. Capillary action automatically fills the reaction zone with the test sample from the front channel. The device should not be used for screening or diagnosis of diabetes or for testing on neonates. Intended Use The HEA-232 is an in-vitro diagnostic medical device intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body. It is designed for self-testing to monitor the effectiveness of diabetes control. The device should not be used for screening or diagnosis of diabetes or for testing neonates. Principle of the method The auto-filling process precisely controls the sample volume. The blood glucose test strip is a kind of electrochemical sensor. When the blood sample reacts with the strip, the glucose meter displays a reading that depends on the number of electrons detected as a result of the reaction. The current generated by the reaction on the test strip is used to calculate the glucose concentration of the sample which is then displayed by the device. Warning: The Glucose Results provided by HEA-232 is only for reference; never make significant changes in your diabetes treatment program without consulting a doctor. Warning: Evaluations using the HEA-232 by lay persons in different countries will depend on their fluency, or otherwise, in the understanding and the assessment of ease of use and interpretation of the results. Measuring principle Amperometric biosensors are quite sensitive and more suited for mass production. The working electrode of the amperometric biosensor is usually a screen-printed layer covered by the bio-recognition component. The dried reagent was applied on a pair of carbon electrodes. Glucose can be specifically catalyzed by the enzyme, and then the reaction current can be measured according to the glucose 3

6 levels of the test sample by electronic devices. HEA-232 utilizes electrochemical biosensing technology (Amperometric biosensor) to measure the glucose level in fresh capillary whole blood. At the applied potential after blood draw into the reaction zone of strips, conversion of electroactive species generated in the enzyme layer occurs at the electrode and the resulting current is measured by HEA List of Kit Contents 1. Blood Glucose Meter 2. Sterile Lancets 3. Lancing device 4. Instructions for the lancing device 5. Carrying Case 6. Instruction Manual 7. Log Book 8. CR2032 Battery 1.3 Product and Meter Display A. HEA-232 Blood Glucose Meter Display Strip Port- Insert Strip Here Meter Display Button- Turn / off meter Query test record Battery Cover 4 Caution:The HEA-232 meter measurement unit was set as mg/dl or mmol/l from manufacturer side. the unit exchange ratio is as the followings: 1 mmol / L = mg/dl

7 B. HEA-STP30 Glucose Test Strip Top Edge- Apply blood sample here. Inserting Bar- Insert this test strip port with this side facing up. C. Function Display Battery Error Message Test Unit Test Result Temperature Battery mg/dl Test Unit mmol/l Temperature Error Message Test Result 5

8 Chapter 2 Installing and Setting up the HEA Inserting / replacing batteries When should users change the batteries? If the battery power is too low to perform a test, the and error symbol will appear on the display after the device is powered on. In this case, the system will shut down automatically after 120 seconds. The battery will have to be replaced before the HEA-232 can be used. However previously recorded results will not be lost. There are two conditions which might occur depending on battery power status 1. The battery power is low: However, you can still use HEA-232 and results will still be accurate, but we still strongly suggest you replace the batteries as soon as possible. 2. The battery symbol flashes on the display after powering on: The system will shut down automatically after 120 seconds when only the battery symbol flashes on the display after powering on. It means the battery power is too low to perform a measurement. You have to replace the battery in order to continue using the HEA-232; past results remain recorded. How to replace HEA-232 s batteries 1. Turn HEA-232 meter over and open the battery cover. 2. Replace one CR-2032 battery with the (+) sign side of battery facing up. 3. Insert battery cover back to the battery compartment until a click sound is heard. 4. Turn on the device to see whether the HEA-232 is powered on. If not, please re-examine battery replacing procedures. 5. Please dispose of used batteries according to local regulations. a. Open battery compartment b. Place a new battery inside 6 c. Reinstall battery cover

9 Chapter 3 Finger Blood Glucose Testing 3.1 Preparation before glucose testing Please prepare materials you need as listed below and read this manual to ensure the correct measuring process and results. Blood Glucose Meter. Blood Glucose Test Strip. Lancing Device. Lancet 3.2 Fingertip blood measurement Structure: Cap Ejector Adjustable tip Carrier Trigger Barrel A. Install the Lancet Check if lancet is new before installing it to the lancet holder and ensure it is fully seated. Then remove the protective cap. Adjust the puncture depth by selection dial (normally at 2nd level), twist to suitable number (smaller number for a shallower puncture and a larger number for a deeper puncture depth). a. Remove the cap by twisting it b. Install the lancet c. Twist the protective cap of lancet d. Remove the cap if lancing device and adjust the puncture depth 7

10 B. Cock the sampler Slide the barrel control back until it clicks. The lancing device is now ready for use. Warning Always use a new lancet. Do not use the same lancet to obtain blood samples from different people. Please refer to instruction of lancing device for detail description and proper use. C. Wash your hands and the puncture site Wash hands with soap and warm water. Rinse and dry thoroughly. D. Preparation of strip 1. Insert strip correctly Take a new blood glucose test strip from the vial and insert it into the meter correctly as the following. Insert the test strip (Correctly) 8 Do not insert the strip from reverse side

11 The meter will automatically start and show the last result data; if no data, it will show the following. mg/dl Caution:The HEA-232 meter measurement unit was set as mg/dl or mmol/l from manufacturer side. the unit exchange ratio is as the followings: 1 mmol / L = mg/dl 2. Setting up strip code Please check the code number showed on the display is same as the code number printed on the strip bottle; Code 88 If they are not same, alter the code number within 5 seconds. Press and hold the button to increase the code number quickly. The biggest code number is 99. When the code number is over 99, it will be back to 1, and keep increasing: If press the button and release shortly, the code number will only increae by one. 9

12 3. Ready to test When you set the correct code number, please wait for 5 seconds, and the meter will display with symbol. And then please apply blood sample within 2 minutes. E. Fingertip blood sampling Please massage your fingertip gently to help you obtain blood. We suggest that you puncture a different area each time. Repeated punctures in the same area may cause soreness. The blood sample required is only 1μL, do not squeeze excessively at the puncture area. The HEA-232 will display the code number on the screen when waiting for the blood to drop in, the user needs to make sure the code number is the same as that of the strip container. F. Blood glucose measurement Hold the lancing device firmly against the side of your fingertip. Press release button; gently squeeze your finger to assist the flow of blood. Apply a drop of blood to the tip of the reaction zone of the test strip after the blood drop symbol flashes on the meter display. You will hear beep and the meter will start to count down. The test result will appear on the display after the meter counts down from 5 to 1 (5 seconds). The meter will turn off automatically after the test strip is removed. Place the used strip in a suitable container for proper disposal. 10

13 Caution:The HEA-232 measurement unit was set as mg/dl or mmol/l from manufacturer side. Caution: Do not smear blood on the strip. Touch the blood drop of fingertip to the reaction zone. Sample filled Sample too small The following items will cause inaccurate results: The reaction zone does not fill completely. Applying blood more than once. Not applying blood to a test strip after a period of time. Variation in environment when measuring. Using a false test strip. G. Strip removal Pull up the strip carefully to avoid touching the blood. 11

14 H. Blood glucose value display: The blood glucose test will be performed in 5 seconds when the blood drops into the test strip. The test result will automatically be stored in the meter memory. Please dispose of used test strip and lancet in a sealed container to avoid environmental pollution. Important: Do not use a single test strip more than once. It should not be used for testing newborns. It should be used only for testing fresh capillary whole blood samples drawn from the fingertips only. It should not be used for venous whole blood or plasma. A red blood cell count (hematocrit) that is higher than 55% or lower than 30% may cause false test results. Chapter 4: Glucose Control Solution Testing (Optional) Control test In order to provide you a precise blood glucose value, we suggest the user to run a control test to let you know if the meter and test strips are working properly or not. When the result is within the range of the control solution value written on the test strip vial, the test strips and meter are working properly. When to run the glucose control solution test: You think your test strips have been damaged. Test result is not compatible with how you feel.. You think your glucose meter could be broken. If you will like to perform control solution test or have any question, please contact your local authorized distributor for more information.

15 Important: Use only the OMRON glucose control solution HEA-CTR30 with HEA-232 meter and HEA-STP30 strips. Mark the newly opened bottle of control solution with the date opened; discard any unfinished control solution over three months after opening. Store control solution at room temperature. Do not freeze. Shake control solution before you use it. Please replace new control solution if the control solution deteriorate or coagulate. * Before running the test, place the meter, test strips and glucose control solution at room temperature to reach the new temperature before use. A. Prepare for the HEA-232 and test strip Insert the test strip into the meter. The meter will display the code number. Make sure the code number on the display matches the code number on the test strip vial. (Refer to Chapter 3 Fingertip blood measurement for more information) When the HEA-232 is ready to apply blood sample, press button twice to enter control solution test mode. The Blood symbol will disappear in the control solution test mode. In the control solution test mode, the test result will not be recorded. Finger tip blood test mode Control solution test mode B. Prepare for the control solution Before using the control solution, gently shake the control bottle to ensure it is mixed well. Remove the control bottle cap and wipe the tip of the bottle with a tissue. Squeeze the bottle until a tiny drop forms at the tip of the bottle and drop on a clean surface. C. Run the control solution test Touch the tip of the test strip to the drop of control solution. The control solution test result will show on display after 5 seconds count down. The HEA-232 will automatically power off after the test strip is removed. Discard the used test strip in accordance with local regulations. 13

16 D. Understanding control test results When the control solution test result is inside the range on the printed on the test strip vial, then the HEA-232 and test strips are working properly. Control Solution Range mg/dl mmol/l Caution:The HEA-232 meter measurement unit was set as mg/dl or mmol/l from manufacturer side. the unit exchange ratio is as the followings: 1 mmol / L = mg/dl If the control solution test result is not within the specified range printed on your test strip vial, please repeat the control solution test again. If the result continues to fall out of the specified range, here are some points that need to be checked: Did you follow all of the testing instructions? Are the test strips or control solution expired? Is HEA-232 defective in material or workmanship? Does the code number of the meter matches the code number on the test strip vial? Repeat the control solution test with a new test strip. If you still have problems, please contact your local authorized OMRON distributor for more information. Chapter 5 Memory Function 5.1 Reviewing past results Press button to turn on the HEA-232, the display will show the most recent test result then the index and then the most recent test result after a 1 second delay. Press the button again to display the second recent test result; every time the button is pressed, it will display a previous result. After the 14th result, it will return to the first. HEA-232 is able to store up to 14 test results. 14

17 After 1 second After 2 seconds Then you can press the button to review previous test results. After 1 second After 2 seconds Caution:The HEA-232 meter measurement unit was set as mg/dl or mmol/l from manufacturer side. the unit exchange ratio is as the followings: 1 mmol / L = mg/dl 15

18 Chapter 6 Instructions on Caring and Storing for Your Strips and Meter 6.1 Caring for the strip Wash hands before testing. Do not use a strip that has expired. Check the expiration date printed on the package. When you first open the test strip bottle, record the day you opened it on the label of the bottle. Discard the bottle and any remaining test strips after 90 days from the opening date. Keep the strip bottle away from direct sunlight and heat, and store at ambient temperature between 4-30 (39 ~86 ). Do not refrigerate. The strip bottle should be stored in a dry place at room temperature. Do not put the test strip into other containers. Always close the container tightly immediately after taking a test strip out. Keep the test strip from getting dirty or polluted during storage. Discard the control solution of bottle after 90 days from the opening date. Glucose control solution: Discard the bottle 3 months after the opening date. 6.2 Caring for the meter If the meter s surface gets dirty, gently wipe it with a slightly dampened cloth used with mild detergent. Medical staff may use 10% bleach, 70% alcohol (ethanol), or 10% ammonia scouring reagent. Do not clean the test strip slot. Do not allow any liquid to enter the test strip slot or the button of the meter. Do not put the meter under water or any liquid. The meter must be stored at room temperature 16

19 Chapter 7 Troubleshooting When the meter is used incorrectly, or other unexpected events occur, the screen will show an error message to remind the user to notice the problems and/or how to resolve them. The following messages mean you may have obtained a result that requires immediate attention or there may be a problem with the meter: Message Symbol Mean Action HI LO Blood glucose may be higher than the measuring range of the system ( > 600 mg/dl; 33.3 mmol/l ) Blood glucose may be lower than the measuring range of the system (< 20 mg/dl; 1.1 mmol/l) Although this message could be due to a test error, it is safer to treat first and then do another test. 1. Do control solution test. 2. Redo your glucose test. 3. Contact your healthcare professionals. Although this message could be due to a test error, it is safer to treat first and then do another test. 1. Do control solution test. 2. Redo your glucose test. 3. Contact your healthcare professionals. Temperature symbol continuously flash Battery symbol continuously flash Wrong Test Strip You may have tested in an environment near the low or high end of the system's operating temperature range. (10-40 / ) The power is too low to perform a test. Test strip is over expiration date, broken, or used again. Repeat the test after the meter has reached a temperature within the operating range. Replace the battery. Use other new HEA- STP30 Test Strip. Wrong Blood Enter Timing Obtain blood sample too soon. Follow instruction step. 17

20 Chapter 8 HEA-232 Performance Characteristics Traceability: The HEA-232 test result were calibrated to YSI readings. The YSI analyzer was calibrated using a standard solution(180mg/ dl(10mmol/l) which can be traced to NIST SRM #917A. Accuracy: The results from the HEA-232 were compared with those from YSI glucose analyzer. The study showed the HEA-232 results were consistent with the YSI readings. The following results were obtained from 115 subjects at 2 clinic centers. Slope y-intercept mg/dL (-0.4mmol/L) Correlation factor (R 2 ) Patient number (n) 230 Test range 22~537mg/dL (1.2~29.8mmol/L) Number and % of results within reference (for values were < 75 mg/dl) Within ± 5 mg/dl (0.3mmol/L) Within ± 10 mg/dl (0.6mmol/L) Within ± 15 mg/dl (0.8mmol/L) 10/32 (31.3 %) 26/32 (81.3 %) 32/32 (100 %) Number and % of results within reference (for values were 75 mg/dl) Within ± 5 % Within ± 10 % Within ± 15 % Within ± 20 % 104/198 (52.5 %) 149/198 (75.3 %) 177/198 (89.4 %) 194/198 (98.0 %) When sample concentration < 75mg/dL(4.2mmol/L): 100% data fall within ± 15mg/dL(0.8mmol/L) with reference. When sample concentration 75mg/dL(4.2mmol/L): 98% data fall within ± 20% to reference. Precision: This study shows a variability from strip to strip in sample tests. The results are shown in the following table. 18 Within Run Precision Samples Mean glucose concentration measured CV Sample mg/dl (1.8mmol/L) SD=1.8 mg/dl(0.1mmol/l)

21 Sample mg/dl (4.0mmol/L) 2.7% Sample mg/dl (7.4mmol/L) 1.7% Sample mg/dl (12mmol/L) 1.5% Sample mg/dl (22mmol/L) 1.7% Between Day Precision Control solution mg/dl (2.2mmol/L) SD=1.5 mg/dl(0.1mmol/l) Control solution mg/dl (6.7mmol/L) 1.6% Control solution mg/dl (18.3mmol/L) 1.5% Chapter 9 Specification Measuring range: 20~600mg/dL (1.1 mmol/l ~ mmol/l) Measuring unit: fixed unit of either mg/dl or mmol/l Measuring time: Approximately 5 seconds Sample type: Capillary whole blood samples drawn from the fingertips Blood Sample size: Approximately 1μL Operating temperature: (10 ~40 )/(50 ºF ~104ºF) Relative operating humidity: Below 90% RH Memory capacity: Up to 14 test results Dimension: 10 x 3.5 x 2 cm (L W H) Weight: Approximately 35.5g with batteries Power Supply: One CR-2032 battery Strip storage condition: at ambient temperature 4 ~30 (39 ~86 ). / below 75% RH HCT range: 30~55% warning: The measurement unit either mg/dl or mmol/l is fixed in the meter according to the country demand. You are not able to change the unit in the meter. Caution: Any further service and product information, please contact OMRON distributors. 19

22 MANUFACTURER CONSULT INSTRUCTIONS FOR USE CAUTION BATCH CODE TEMPERATURE LIMITATION IN VITRO DIAGNOSTIC MEDICAL DEVICE AUTHORISED REPRESENTIVE IN THE EUROPEAN COMMUNITY Council Directive 98/79/EEC EC on in vitro diagnostic medical devices DO NOT REUSE KEEP AWAY FROM SUNLIGHT SERIAL NUMBER STERILIZED USING IRRADIATION USE BY KEEP DRY DO NOT USE IF PACKAGE IS DAMAGED PAPER RECYCLE For self-testing DELBio, INC. 3F, 252 Shangying Road, Guishan Industrial Zone, Taoyuan County 33341, Taiwan Deltronics (Netherlands) BV Zandsteen 15, 2132 MZ Hoofddorp, The Netherlands

23

24 REV.00