Prolife PM200 Instruction Manual

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BLOOD GLUCOSE

MONITORING SYSTEM

Prolife PM200

EN Instruction manual

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Page 1 BLOOD GLUCOSE MONITORING SYSTEM Prolife PM200 EN Instruction manual...
Page 2: Table Of Contents
BLOOD GLUCOSE MONITORING SYSTEM PROLIFE PM200 TABLE OF CONTENTS Introduction ..........................................4 1.1 About Blood Glucose Monitoring System Prolife PM200 ....................4 1.2 Intended Use ......................................... 5 1.3 Package of Prolife PM200 BGMS Kit ..............................6 Prolife РМ200 Meter ......................................8 2.1 Caution ...........................................11 Prolife Test Strip PT200 ....................................13 Meter activation and Battery change ..............................
Page 3 7.5 Quality Control* ....................................... 26 7.6 Quality Control Test* ..................................... 27 7.7 Performing a Quality Control Test* ............................... 27 8 Recalling test results ......................................29 8.1 Recalling Test Result and Average ..............................29 Maintain the Products ....................................32 10 Error Messages and Trouble Shooting ..............................35 11 Specification ..........................................
Page 4: Introduction
Thank you for choosing the Blood Glucose Monitoring System Prolife PM200 (BGMS). Please read this manual thoroughly before testing. It provides all information you need to use the product. The Blood Glucose Monitoring Meter Prolife PM200 must only be used with Prolife Test Strip PT200 and Con- trol Solution Prolife PC200*.
Page 5: Intended Use
1.2. INTENDED USE Prolife PM200 BGMS is intended in vitro diagnostic use only (outside the body). The testing result is calibrated to plasma equivalent with whole blood from capillary. Capillary whole blood can sample from the fingertip, palm or forearm. You may consult your healthcare professional for instructions on how to use the system...
Page 6: Package Of Prolife Pm200 Bgms Kit
1.3. PACKAGE OF PROLIFE PM200 BGMS Your Blood Glucose Monitoring System Prolife РМ200 consists of several items. Please identify each item of your system and learn what they’re called and how they’re used. These items are included in your Blood Glucose Monitoring System Prolife РМ200.
Page 7 2＊ Blood Glucose Monitoring System Prolife TEST STRIP PROLIFE 5＊ 6＊ 9＊ 10＊ 7＊ 8＊ 12＊ *Different packages have different bundled items. Some of packages might not include « * » items.
Page 8: Prolife Рм200 Meter
PROLIFE РМ 200METER TEST STRIP PORT Insert test strip here until you hear a click DISPLAY WINDOW Show your test result, messages and relative information MAIN BUTTON For operating the meter, please check details in following sections...
Page 9 METER LABEL PLASTIC TAPE Pull it off to activate meter. (If time and date of your meter has been set in advance, the plastic tape will be removed. Hence, please discard this step) BATTERY COVER Slide cover to change battery...
Page 10 Indicates a test result Tell when to apply the stored in memory blood sample ChecKey ChecKey Indicates a test result, Test strip ChecKey ChecKey No character ChecKey not joining into the « » Average function of this meter ChecKey ChecKey ChecKey Indicates with the Appears after you insert...
Page 11: Caution
2.1 CAUTION (PAGE TITLE) • Before using Prolife PM200 BGMS to test your blood glucose, please read all of the info and conduct all of the tests including the quality control test (Refer to page xx). • Please perform the quality control test regularly to make sure the test results are fine.
Page 12 Please take a minimum of 0.75 µL to do the test on blood glucose monitoring system. Blood sample size above 3.0 µL might contaminate the meter. A blood sample size below 0.75 µL will cause Er4. In this case, repeat the test with a new test strip. Important Safety Notes: •...
Page 13: Prolife Test Strip Pt200
PROLIFE TEST STRIP PT200 The Prolife PM200 Meter must only be used with Prolife Test Strip PT200 and Control Solution PC200*. The application of other Test Strips or control solutions* can lead to incorrect results. SAMPLE ENTRY Apply a drop of blood or control solution* here.The test request is only 0.75 of blood...
Page 14 • Write the date of first opening a new test strip vial on the vial. • Use each test strip immediately after removing from the vial. • For detailed information as validity period after open and storage environment, please refer to Prolife Test Strip PT200 Insert.
Page 15: Meter Activation And Battery Change
METER ACTIVATION AND BATTERY CHANGE Your meter comes with one CR2032, 3 volt, batteries installed. New battery will provide power to perform about 1,000 tests under normal use. You can press the main button or insert a strip to activate your meter. 1.
Page 16: Setting Up Your Meter: Setting The Time, Volume And Date
SETTING UP YOUR METER: SETTING THE TIME, VOLUME AND DATE You can enter Setting Mode by below two ways: 1. Reload battery. After removing the battery, please press the main button for several times until no signal on screen, then follow the battery installation steps to load batteries. The meter will do self test. Press the main button to exit the self test and enter Setting Mode.
Page 17 1. Year setting With the year format blinking, press the Main button to adjust it. Then press the Main button to confirm it. Then it will move to Month setting. 2. Month setting With the month blinking, press the Main button until the current month appears. Then press the Main button to confirm it and move to Day setting.
Page 18 «beep»). NOTE • When you do not do any settings of meter for over б 2 minutes, the meter will leave setting mode and power off automatically. • Your Prolife PM200 Meter default according to your local preference.
Page 19: Turning On / Off Meter
TURNING ON / OFF METER 1. How to turn on the Meter Press the Main button or Insert a test strip. 2. Manual Power off If you want to turn off the meter, please keep pressing the Main button for 4 seconds. 3.
Page 20 4. Twist off and set aside the protective cover of the disposable lancet. 5. Replace the depth adjustable cap. 6. Choose a depth of penetration by rotating the top portion of the depth adjustable cap until the setting depth matches the window. Settings are based on skin type: for soft or thin skin, for average skin,...
Page 21 8. Wash your hands with warm soapy water and dry thoroughly. 9. Take one strip from the vial. Re-cap the vial cap immediately. 10. Insert the strip into the strip port of the meter with the indication symbol facing down. The meter confirms the insertion of the strip with a beep (if volume is turned on).
Page 22 1 3 а 13 б 13 в...
Page 23: Alternative Site Testing (Ast)
7.2 ALTERNATIVE SITE TESTING Alternative site testing-palm or forearm blood sampling 1. Choose Clear Cap and follow step 1-5 on page 18-19. 2. Massage the puncture area of palm or forearm for a few seconds. 3. Immediately after massaging the puncture area, press and hold the lancing device with the Clear Cap against palm or forearm.
Page 24: View Window Appearance
• DO NOT test on the palm or forearm if you are testing for hypoglycemia (Low blood glucose). • The forearm or palm blood flow may be slower than fingertip, we recommend using Prolife GD500 lancing device with Clear Cap for the sampling.
Page 25: Lo" And "Hi" Readings
7.4 «LO» AND «HI» READINGS 1. The Prolife PM200 Meter displays results between 10 and 600 mg / dL (0.6 and 33.3 mmol / L). If your test result is below 10 mg / dL (0.6 mmol / L), «Lo»...
Page 26: Quality Control
Please use Control Solution PC200* tested with Prolife PM200 BGMS under Control Solution Mode. If the test result is within the Control Solution Range* printed on the strip vial label, the Prolife PM200 BGMS passes Quality Control Test. That means your Prolife PM200 BGMS is working correctly.
Page 27: Quality Control Test
5. Malfunction of the meter or the test strip. If Control Solution* results are out of range, your Prolife PM200 BGMS may not be working properly. Repeat the Quality Control Test. If your Control Solution* results outside the range still exist, do not use the BGMS to test your blood glucose and contact your Prolife Customer service.
Page 28 OPEN 4. You will see blinking « », symbol and « », symbol on the screen, prompting you to apply Control Solution*. 5. Shake the bottle of Control Solution* well before opening the cap. Then open the bottle and put the cap on the table. 6.
Page 29: Recalling Test Results
RECALLING TEST RESULTS 8.1 RECALLING TEST RESULT AND AVERAGE The Prolife PM200 Meter is able to store 500 test results with time and date automatically. If your meter has stored 500 results, which is the maximum memory of the meter, the newest test result will replace the oldest one.
Page 30 When you press the main button, the latest result will be displayed. By pressing the main button sequential- ly former test results will be shown in historical order. You will see the sequence number on the lower right corner and the year on the lower left corner of the display followed by date and time of the measurement. NOTE The main button is for reviewing the tests with sequence number increasing.
Page 31 NOTE The average function is related to the time setting. You must set the time right and have enough time intervals on the basis of current inquiry time, to make sure that the average test results will show. Use the 14-days average for example; if your current inquiry time is 1 / 30, then that you must check that you have tested blood glucose in the past 14 days before 1 / 30, including today.
Page 32: Maintain The Products
NOTE • You have to set the time and date to activate the average function. • The «Lo» and «Hi», results, the Control Solution* results and the test result made out of normal temperature range (<10 ˚C, >40 ˚C) are not calculated in the average. MAINTAIN THE PRODUCTS Indirect transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) during the delivery of healthcare services has been increasingly reported.
Page 33 Maintaining Keep your meter and test strip free of dust, water or any other liquid. Store the meter in the carrying case when not in use. If your meter is dropped or damaged, perform a quality control test with the control solution* before performing a blood glucose test. To clean the meter: 1.
Page 34 • Users should wash their hands thoroughly with soap and water after handling the meter, lancing device or test strips. • If you have any questions or concerns, please contact your Prolife PM200 BGMS authorized distributor or contact your local Prolife customer service.
Page 35: Error Messages And Trouble Shooting
Meter has malfunctioned. Reinstall the batteries to check if the meter works properly Signal transmission is disrupted, repeat the test with a new test strip Applied blood volume is insufficient, please repeat the test with a new test strip Above, if error screen still appears contact your local Prolife Customer Service.
Page 36 Battery Error The « » The battery power is low. Please change the meter battery symbol is blinking as soon as you can. You can still do the test The « » and « ». The battery is too low. Meter can not do the strip test. Please change the meter battery immediately Symbols are blinking...
Page 37: Specification
1. Open the battery cover, remove the batteries. 2. Wait for 5 minutes and insert the batteries as described «Meter activation and Battery change». The meter should be working normally after finishing above steps. If not, please contact your local Prolife customer service.
Page 38: Limitations
-10 to +60 ° C (14–140 ° F) Sample Minimum Sample Volume Hematocrit Refer to Strip insert Prolife PT200 Test Strip Storage / Transportation Conditions 12 LIMITATION • Prolife PM200 BGMS is intended for self-testing. • Prolife PM200 BGMS can only use with capillary whole blood samples.
Page 39 • Prolife PM200 BGMS is for over the counter use and single patient use only. It is Not for use on critically ill patients, it is Not for use on neonates either. Not for screening or diagnosis of diabetes. • The blood glucose result of the meter may be much lower than «true glucose levels» in the hyperglycemic-hyperosmolar state, with or without ketosis.
Page 40: Customer Service
We sincerely like to provide complete services to our customers. Please review all the instructions to make sure you are performing the steps correctly. If you have any questions or in case of problems with the Prolife PM200 BGMS, please contact your local Prolife customer service.
Page 41: Warranty
The service life of the device is 5 years. This warranty does not apply to the performance of a Prolife PM200 Meter that has been altered, misused, tampered with or abused in any way.
Page 42 Manufacturer / Изготовитель: Bionime Corporation No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan, China. Authorized Representative in the EU : Emergo Europe, Prinsessegracht 20, 2514 AP The Hague, The Netherlands. Manufacturer of lancet: Tianjin Huahong Technology Co., Ltd. A01, Plant B, No.