Acon PRIVA User Manual
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Acon PRIVA User Manual

Cholesterol monitoring system
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  • Page 2 ® PRIVA Cholesterol Monitoring System ® Welcome and thank you for choosing the PRIVA Cholesterol Monitoring System. High total blood cholesterol has been established as one of the key factors associated with a higher occurrence of coronary heart disease. Lipid and lipoprotein metabolic disorders are closely linked to high total blood cholesterol.
  • Page 3 Agents in Healthcare Settings 2007”, https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html  Misuse of electrical equipment can cause electrocution, burns, fire and other hazards.  The unit can be powered by a GFP051DA-0510B adaptor. If the meter is powered by an AC adaptor, do not leave the equipment unattended and unplug immediately after use.

  • Page 4: Table Of Contents

    Table of Contents   Getting Started .................... 1   Component Descriptions ..................... 2   ® PRIVA Cholesterol Meter ................... 3   Meter Display ....................... 3   ® PRIVA CHOL Total Cholesterol Test Strips ..............5   Inserting the Batteries ................9  ...

  • Page 5: Getting Started

    Getting Started Inspect the kit box, meter, and accessories for any visible damage. Remove the meter and other packaging contents from the kit box. The following items are needed to perform a test:...

  • Page 6: Component Descriptions

    Component Descriptions Cholesterol Meter: Reads the test strips and displays the total cholesterol concentration in whole blood. Carrying Case: Provides portability for cholesterol testing wherever you go. User Manual: Provides detailed instructions on how to use your cholesterol monitoring system. Quick Reference Guide: A short set of instructions to get you started testing with your new cholesterol monitoring system.

  • Page 7: Priva ® Cholesterol Meter

    Note: Treat all blood specimens as infectious materials. Follow strict precautions and obey all local regulations for safely discarding blood specimens and materials. Meter Display ® During testing, the PRIVA Cholesterol Meter’s LCD screen will display icons showing the status, options available, and prompts for testing:...
  • Page 8 Battery Symbol: Appears when the batteries need to be replaced. Blood Drop/Strip Symbol: Indicates when to insert the test strip or to apply specimen. Code: Indicates the code number of the test strips. Control Solution Symbol: Indicates a control solution test is being performed.

  • Page 9: Priva ® Chol Total Cholesterol Test Strips

    CHOL Total Cholesterol Test Strips ® The PRIVA CHOL Total Cholesterol Test Strips are thin strips with a chemical reagent which works with the PRIVA ® Cholesterol Meter to measure the Total Cholesterol concentration in fingertip capillary whole blood. Each test strip appears as shown below.
  • Page 10 IMPORTANT: Apply specimen only to the tip of the test strip. Do not apply blood or control solution to the top surface of the test strip as this may result in an inaccurate reading or failed specimen application. After the strip is inserted into the Strip Port, apply a blood drop directly to the Specimen Tip of the test strip by touching blood drop to the Specimen Tip area (see above illustration).
  • Page 11 Test Strips Storage and Handling Please review the following storage and handling instructions:  Store test strips in a cool, dry place at 2-30°C. Store test strips away from heat or direct sunlight.  Do not freeze or refrigerate.  Do not store or use test strips in a high humidity location such as a bathroom.
  • Page 12 Before performing a Cholesterol test, make sure the code number on the meter display matches the number shown on the test strip canister.  Keep the test strip canister away from children and animals. ® See the PRIVA Cholesterol TOTAL Cholesterol Test Strip Information for Use, for more details.

  • Page 13: Inserting The Batteries

    Inserting the Batteries ® The PRIVA Cholesterol Meter requires three AAA batteries (1.5V) for operation. The batteries can be found in your carrying case. Insert the batteries according to the following steps: Turn the meter over to locate the battery cover. Press in the direction of the arrow on the battery cover and lift the cover to open it.
  • Page 14 Switching the meter on The meter will automatically switch on after the batteries are installed. The meter will display the date and time setup screen. Refer to “Setting up the Meter before Testing” for details. After the date and time have been set, the meter will automatically switch off.

  • Page 15: Setting The Meter Up Before Testing

    Setting the Meter up before Testing Before using your meter for the first time, you will need to adjust the settings that are listed in detail below. Step 1 - Adjusting Meter Settings The meter will automatically enter the setup mode when switched on for the first time after inserting the batteries.

  • Page 16: Step 2 - Coding The Meter

    Time: Once the day is set, the hour will appear at the top of the display. Press the <M> Button until the correct hour is displayed. Press the <S> Button to save the selection and proceed to set the minutes. Press the <M>...
  • Page 17 number on the test strip canister with which it was packaged, please contact your local dealer immediately. With the meter switched off, insert the new code chip into the code chip slot of the meter. It should easily snap into place. The code chip should remain in the meter.

  • Page 18: Performing A Quality Control Test

    Performing a Quality Control Test Follow the same test procedure as for testing Total Cholesterol. Refer to “Step 2 - Testing for Total Cholesterol” in “Performing a Cholesterol Test” and follow the operation steps 1 to 5: Insert a test strip, check the display, observe the meter self check, wait for meter temperature to stabilise and display correct code number.
  • Page 19 compared to the control range printed on the test strip canister. If the control result is within the control range printed on the test strip canister, the blood cholesterol monitoring system is working properly and the procedure is being performed correctly. The display should show a hash sign (#) indicating this test was a control test.
  • Page 20 assistance.  Two levels of control are available, Level 1 control solution is sufficient for most self-testing needs. If you think your meter or strips may not be working correctly, you may also want to do a level 2 test. ...

  • Page 21: Performing A Cholesterol Test

    Approved Guideline-Third Edition” Clinical and Laboratory Standards Institute (CLSI) M29-A3. ® The PRIVA Cholesterol Monitoring System requires a very small drop of blood which may be obtained from the fingertip. Before testing, choose a clean, dry work surface. Familiarise yourself with the procedure and make sure you have all the items needed.
  • Page 22 Blood specimens are obtained by using a lancing device. There is no ® lancing device or safety lancets included with the PRIVA Cholesterol Meter Kit. Consult the Lancing Device or Safety Lancet Instructions for Use on how to prepare, use, discard and safety precautions.
  • Page 23 Clean the testing site with an alcohol swab and then dry the testing site thoroughly. Hold the lancing device against the side of the finger to be lanced with the cover resting on the finger. Push the release button to prick the fingertip.

  • Page 24: Step 2 - Testing For Total Cholesterol

    taken to uniformly distribute red cells throughout the tube several times by several tube inversions. (Please note: Do not mix the blood specimen in the tube excessively.) Step 2 - Testing for Total Cholesterol Note: Insertion of a new test strip at any time, except during the data transfer mode (Refer to “Using the Memory”) will cause the meter to automatically enter the test mode.
  • Page 25 When the CODE flag and CODE number is shown on the LCD, and the temperature has stabilised, the blood drop symbol will start to blink. The following picture shows the code number “200”. Make sure that the code number that appears on the display matches the code number (CODE) on the test strip canister.
  • Page 26 Once a sufficient specimen has been applied, the meter display will countdown from a calculated number to 1 and then will display the result. Test results are displayed in mmol/L. Slide the strip ejector to discard the test strip.

  • Page 27: Hi" And "Lo" Messages

    “LO”, it may indicate severe low blood cholesterol. You should contact your healthcare professional immediately. Precautions and Limitations ® ® PRIVA Cholesterol Meters, test strips and other components of the PRIVA Cholesterol Monitoring Systems have been designed, tested and proven to...
  • Page 28 If you do not know your haematocrit level, consult your healthcare professional. In patients undergoing oxygen therapy, PRIVA may yield inaccurate results. The system is tested to accurately read the measurement of total cholesterol in whole blood within the range of 2.6-11.7mmol/L. For detailed limitations, ®...

  • Page 29: Using The Memory

    Using the Memory The meter automatically stores up to 200 test records. Each record includes the test result, time and date. If there are already 200 records in the memory, the oldest record will be erased to make room for a new one. Viewing Stored Records To view stored records: Press the <M>...

  • Page 30: Transferring Records

    All the records in the log can be erased by pressing <M> and <S> buttons together and holding for 2 seconds. The meter will display the words “MEM” and “- - -” to indicate that the memory has been cleared. The meter will automatically switch off after 2 minutes with no operation, or after the <S>...
  • Page 31 the data being transmitted from the meter. Press <S> and <M> buttons together and the meter will enter PC communication mode. Press <M> button again and the meter will show the PC symbol on the display and start to transfer the data to the PC. During the transfer, “to” will also show on the display.

  • Page 32: Maintenance

    Maintenance Proper maintenance is recommended for best results. Replacing Batteries When the battery icon ( ) is blinking, it means the batteries are running low and it should be replaced as soon as possible. An “E00” error message will appear if the batteries are too low to perform any more blood cholesterol tests.

  • Page 33: Cleaning

    replacement to ensure that the date and time are correctly set. To set the meter date and time, refer to “Setting up the Meter before Testing”. Cleaning Cholesterol Meter For best results, the meter should be cleaned after each test. A cotton cloth can be used to clean the surface of the meter.

  • Page 34: Suggested Testing Times And Target Goals

    Suggested Testing Times and Target Goals The National Cholesterol Education Program (NCEP, 2002) has established guideline to identify risk groups in adults associated with various cholesterol levels in blood. However, you should discuss cholesterol results with your healthcare provider. Initial Classification of Adults Based On Total Cholesterol mmol/L Total Cholesterol <5.17...

  • Page 35: Comparing Meter And Laboratory Results

    Comparing Meter and Laboratory Results ® The PRIVA Cholesterol Monitoring System results report fingertip blood cholesterol concentrations converted to plasma concentrations, while laboratories can report both serum and plasma cholesterol concentrations. However, the results may differ somewhat due to normal variation. To ensure a reasonable comparison, follow these guidelines.

  • Page 36: Troubleshooting Guide

    Troubleshooting Guide Display Causes Solution Meter fails Batteries may be faulty Replace batteries. to switch Temperature is too Move to a cooler environment and wait at high(>40°C) least 30 minutes before repeating the test. Temperature is too Move to a warmer environment and wait at low(<15°C) least 30 minutes before repeating the test.
  • Page 37 Memory error and switch the meter on again. If problem persists, contact your local dealer. Make sure the Code Chip is a PRIVA Cholesterol Code Chip and then repeat the test. If the code is damaged, use a new code chip...

  • Page 38: Specification

    Specification Feature Specification Measurement Range 2.6~11.7 mmol/L Result Calibration Plasma-equivalent Minimum Specimen Size 4 μL Test Time 15-70 seconds 3 AAA Batteries On/Off Source or AC Adaptor (Mini USB, 5V dc, 50 mA, AC input voltage 100-240V) Battery Life Minimum of 1,000 measurements The meter is pre-set to millimoles per liter Cholesterol Units of Measure (mmol/L)

  • Page 39: Warranty

    Warranty ® 1. We warrant the PRIVA Cholesterol Meter to be free of defects in workmanship and materials within the said one year (12 months) warranty period. 2. During the warranty period, if the meter is found to be defective, you may return it, together with the purchase receipt and Warranty Certificate, to our office during normal business hours for warranty service.

  • Page 40: Index Of Symbols

    Index of Symbols Consult instructions In vitro diagnostic medical device for use Catalogue number Serial number Authorised representative in the Manufacturer European Community Batch code Use-by date Contains sufficient Temperature limit for <n> tests Model number Code number Do not discard along with USB Port household waste...

  • Page 41: References

    References “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html...

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