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e-LinkCare ACCUGENCE PM900 Manual

Multi-monitoring system
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Multi-Monitoring System
Thank you for choosing ACCUGENCE® Multi-Monitoring System (Model: PM900).
You now have a very simple and accurate way to test your Blood Glucose, β-Ketone
and Uric Acid from fresh whole blood samples in just a few simple steps anytime,
anywhere.
Attention: ACCUGENCE® Blood Glucose Test Strips with ACCUGENCE® Multi-
Monitoring System are intended for in-vitro diagnostic self-testing by people with
diabetes and healthcare professionals in clinical settings. ACCUGENCE® Blood
Ketone Test Strips and ACCUGENCE® Uric Acid Test Strips with ACCUGENCE® Multi-
Monitoring System are intended for in-vitro diagnostic for self-testing and
professional use.
To ensure accurate results from your ACCUGENCE® Multi-Monitoring System,
please follow these guidelines carefully:
•
Read instructions before use.
•
ACCUGENCE® Multi-Monitoring system is intended for in- vitro diagnostic use
only. It is intended to be used with ACCUGENCE® Blood Glucose Test Strips,
ACCUGENCE® Blood β-Ketone Test Strips, and ACCUGENCE® Uric Acid Test
Strips to quantitatively measure glucose, β-hydroxybutyrate (β-ketone), and
uric acid from whole blood sample.
Note: There are two types of ACCUGENCE® Blood Glucose Test Strips available,
ACCUGENCE® Blood Glucose Test Strips using Glucose Oxidase (GLU GOD) and
ACCUGENCE® Blood Glucose Test Strips using Glucose Dehydrogenase FAD-
dependent (GLU GDH).
•
ACCUGENCE® Multi-Monitoring Meter with ACCUGENCE® Blood Glucose Test
Strips are intended for use by people with diabetes mellitus at home and by
healthcare professionals in clinical settings as an aid to monitor the
effectiveness of diabetes control. It is not intended for use in the diagnosis of
or screening for diabetes mellitus.
Note: When ACCUGENCE® Blood Glucose Test Strips (Glucose Oxidase) are used,
only fresh capillary whole blood is allowable to be used for testing. When
ACCUGENCE® Blood Glucose Test Strips (Glucose Dehydrogenase FAD-
dependent) are used, fresh capillary whole blood or venous whole blood is
allowable to be used for testing, but venous whole blood testing is limited for
professional use only.
•
ACCUGENCE® Multi-Monitoring Meter with ACCUGENCE® Blood Ketone Test
Strips are intended for use for the quantitative measurement of β-
hydroxybutyrate (β-ketone) in fresh capillary whole blood or venous whole
i

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Summary of Contents for e-LinkCare ACCUGENCE PM900

  • Page 1 Multi-Monitoring System Thank you for choosing ACCUGENCE® Multi-Monitoring System (Model: PM900). You now have a very simple and accurate way to test your Blood Glucose, β-Ketone and Uric Acid from fresh whole blood samples in just a few simple steps anytime, anywhere.
  • Page 2 blood. It should NOT be used to diagnose DKA, and venous whole blood testing is for professional use only. • ACCUGENCE® Multi-Monitoring Meter with ACCUGENCE® Uric Acid Test Strips are intended for use for the quantitative measurement of uric acid in fresh capillary whole blood or venous whole blood but venous whole blood testing is for professional use only.

  • Page 3: Table Of Contents

    Table of Contents Table of Contents ....................iii Getting Started ....................1 Components Descriptions ..............2 ACCUGENCE Multi-Monitoring Meter ........... 3 ® Meter Display ..................5 ACCUGENCE GLU GOD/GLU GDH/KET/UA Test Strips ......8 ® ACCUGENCE GLU/KET/UA Control Solution ........11 ®...

  • Page 4: Getting Started

    Getting Started Before testing, read the instructions carefully and learn about all the components of your ACCUGENCE® Multi-Monitoring System. Please note that some of the components may need to be purchased separately from your local distributor. Please check the list of contents on the outer box for details on which components are included with your purchase.

  • Page 5: Components Descriptions

    Components Descriptions ACCUGENCE® Multi-Monitoring Meter: Reads the test strips for blood glucose, β-ketone, uric acid and displays each concentration. Test Strips: Strips with a chemical reagent system used with the meter to measure glucose, β-ketone or uric acid concentration in blood. Calibration Chip: Automatically calibrates the meter with the type of test strips a patient wants to perform once inserted into the meter.

  • Page 6: Accugence ® Multi-Monitoring Meter

    ACCUGENCE Multi-Monitoring Meter ® The meter reads the test strips of blood glucose, β-ketone and uric acid and displays each concentration. Please read diagrams below to become familiar with all the parts of your meter. Strip/Calibration Chip Port Up Button Strip Ejector Down Button Liquid Crystal...
  • Page 7 Strip Port: Test strips are inserted into this area to perform a test / Coding the meter by inserting the calibration Chip. Strip Ejector: Slide the ejector forward to discard the used test strip. Liquid Crystal Display (LCD): Shows your test results, and helps you through the testing process.

  • Page 8: Meter Display

    Meter Display Number Symbol Indicator Means Date Indicates the testing date in month/day format. Average glucose in 7, 14, 30, 60 and 90-days. Average Time Indicates the time of 24H format or 12H format. Low Power Warns you when you should replace the battery. Icon Blood Drop / Strip Icon will appear before applying the sample and during the time of meter...
  • Page 9 Strip Indicates different strip type or test parameter. GLU GOD / type or GLU GOD / GLU GDH means the meter is currently GLU GDH Test performing the glucose test with strip of either or KET or Paramet GOD or GDH enzyme. KET means blood β-ketone test, UA stands for uric acid test.
  • Page 10 Meter Use and Precautions • Wait for the Blood Drop / Strip Symbol to appear before applying the sample. • The meter is pre-set to display depending on which unit of measure is standard in your country. Blood glucose concentration in either millimole per liter (mmol/L) or milligrams per deciliter (mg/dL), uric acid concentration in either milligrams per deciliter (mg/dL) or micromole per liter (μmol/L).

  • Page 11: Accugence

    ACCUGENCE GLU GOD/GLU GDH/KET/UA Test Strips ® The ACCUGENCE® GLU GOD/GLU GDH/KET/UA Test Strips are thin strips with a chemical reagent which works with the ACCUGENCE® Multi-Monitoring Meter to measure the glucose, β-ketone or uric acid concentration in whole blood respectively.
  • Page 12 Hold the blood drop to the sample tip of the test strip until the check window is completely full and until the meter begins to count down. If you applied blood but do not see the starting of the count down, you may reapply a second drop of blood within 3 seconds.
  • Page 13 Note: The expiration date is printed in Year-Month format. 2019-01 means January, 2019. Special Instructions for Test strip in the Vial • Test strips must be stored in the original vial with the cap tightly closed. This keeps them in good working condition. •...

  • Page 14: Accugence ® Glu/Ket/Ua Control Solution

    ACCUGENCE GLU/KET/UA Control Solution ® The ACCUGENCE® GLU/KET/UA Control Solution contains a known concentration of glucose, β-ketone and uric acid respectively. It is used to confirm that your ACCUGENCE® Multi-Monitoring Meter and test strips are working together properly and you are performing the test correctly. It is important to run a quality control test regularly to make sure you are getting correct results.
  • Page 15 • The control ranges shown on the test strip vial (or on the foil pouch) are not recommended ranges for your blood glucose/ β-ketone /uric acid level. Your personal blood glucose/ β-ketone / uric acid target ranges should be determined by your healthcare professional. •...

  • Page 16: Installing Batteries

    Installing Batteries The batteries may not be preinstalled in the meter. Two CR2032 3.0V coin cell batteries are required. Please find the batteries in your carrying case and install them according to the following steps: Turn over the meter and slide the battery cover in the direction of the arrow to open it.

  • Page 17: Meter Setup Before Testing

    Meter Setup Before Testing Before using your meter for the first time, you will need to adjust the settings that are listed in detail below: Meter Setup Mode: Press the Power button for 2 seconds. The meter will automatically enter the setup mode for the first time by any method. Please double check the battery level.
  • Page 18 Year Month Date Time: The hour will appear at the top of the display. Adjust the hour with the Up or Down button until the correct hour is displayed. Press the Power button to save your choice and set the minutes. Press the Up or Down button to change to the correct minute.
  • Page 19 Meal Marker: The meter comes with the meal marker feature disabled. The meter allows the user to enable or disable the meal marker option. The words “On” or “Off” will be displayed on the large center segments of the display and the before meal icon together with the after-meal icon will be displayed as shown below.
  • Page 20 When the ketone indicator is enabled, if the test result is higher than 16.7 mmol/L (300 mg/dl) the symbol of "ketone?" will appear on the display. Range Indicator: The meter comes with the Range indicator feature disabled. Press the Up or Down button to turn the Range indicator “On” or “Off”. Press the Power button to confirm your selection.
  • Page 21 Note: The meter default setup level is Level 1 50 mg/dL (2.8 mmol/L), Level 2 70 mg/dL (3.9 mmol/L), Level 3 200 mg/dL (11.1 mmol/L), Level 4 350 mg/dL (19.4 mmol/L) for diabetes. Please Consult your diabetes healthcare professional before determining what your hyper or hypo blood glucose levels are.
  • Page 22 Reminder. When the Test Reminder is “On”, pressing the Power button will lead you to the set-up of the time for the second Test Reminder. • Press the Up or Down button to adjust the second Test Reminder time. (Time is adjusted by every 5 minutes.) Press the Power button to confirm the second Test Reminder time and then go to the third Test Reminder set •...
  • Page 23 The meter beeps 10 seconds at the time you set. During the beeping, inserting a test strip or pressing the power button will turn off the beep. This function will still work with the Audio Feature turned off. When the meter beeps at the time set by the Test Reminder, the date, time and strip symbol will be displayed.

  • Page 24: Coding The Meter

    Coding the Meter It is necessary and important to calibrate the system every time you open a new kit box. To do that, simply insert the calibration chip to the strip port of the meter for corresponding tests every time you change to a new box of test strips. You can easily find a calibration chip in your strip box.
  • Page 25 The meter will automatically log in the last coding information for each parameter, if you forget to code the meter in this parameter, the meter will display “---” when you insert the strip into the strip port of the meter. If the calibration chip is damaged or incorrect, the meter will report E10 or E11 directly.

  • Page 26: Performing A Quality Control Test

    Performing a Quality Control Test The quality control test confirms that the test strips and meter are working together properly, and that you are performing the test correctly. It is important to perform this test: • At the first time of use. •...
  • Page 27 Note: If the test strip has been inserted incorrectly, the meter will not turn on. Compare the strip type and code number on the meter display with the strip vial label (or strip foil pouch) which being tested, and make sure that they match.
  • Page 28 • ACCUGENCE® Ketone Control Solution is a red colored liquid with three levels (Level 1, Level 2, Level 3), and ACCUGENCE® Uric Acid Control Solution is red colored with two levels (Level 1 & Level 2). • Do not apply control solution to the test strip directly from the bottle. •...
  • Page 29 If the result falls outside the indicated control range: • Confirm you are matching the correct range. Control Solution 1 results should be matched to the Level 1 range printed on the test strip vial (or on the foil pouch). •...
  • Page 30 fall within their respective ranges, DO NOT use the system to test blood, as the system may not be working properly. If you cannot fix the problem, please contact your local distributor for help. Please contact your local distributor for information on ordering the ACCUGENCE® Control Solution kit.

  • Page 31: Testing Your Blood

    Testing Your Blood The following steps will show how to use the meter, test strips, lancing device and sterile lancets together to measure your blood Glucose/Ketone/Uric Acid concentration. Step 1 – Getting a Drop of Blood The ACCUGENCE® Multi-Monitoring System requires a very small drop of blood which may be obtained from the fingertip for glucose, or ketone, or uric acid test only.
  • Page 32 Unscrew the lancing device cover from the body of the lancing device. Insert a sterile lancet into the lancet holder and push it until the lancet comes to a complete stop in the lancing device. Hold the lancet firmly in the lancing device and twist the safety tab of the lancet until it loosens.
  • Page 33 Pull the cocking barrel back to set the lancing device. You may hear a click, while the release button changes to orange to indicate the lancing device is now loaded and ready for obtaining a drop of blood. Prior to testing, clean your hands with an alcohol wipe or wash your hands with soap.
  • Page 34 Disposal of the Lancet Unscrew the lancing device cover. Place the safety tab of the lancet on a hard surface. Then carefully insert the lancet needle into the safety tab. Press the release button to make sure that the lancet is in the extended position.

  • Page 35: Step 2 - Testing Your Blood

    Step 2 – Testing Your Blood Note: Insertion of a new test strip at any time, except while in the data transfer mode will cause the meter to automatically enter the test mode. Testing Your Blood Glucose Insert a test strip into the strip port, contact bars end first and facing up, to turn on the meter and display all the display segments.
  • Page 36 Compare the strip type and code number on the meter display with the strip vial label (or strip foil pouch) which is being tested, and make sure that they match. If the code number on the display does not match the code number on the test strip vial (or strip foil pouch), code the meter again by inserting the calibration chip that came with the box of test strips into the meters.
  • Page 37 DO NOT: • Apply the sample to the front or back of the test strip. • Smear the blood drop onto the test strip. • Press your finger against the test strip. The meter will count down from 4 to 1 and then display the measurement’s results.
  • Page 38 When the above display is shown on screen, press the POWER button again to disable all markers for the result. If an invalid result is marked, run the test again with a new test strip. After inspection, record valid results in your logbook with the date and time, and compare them to the target goals set by your diabetes healthcare professional.
  • Page 39 Press the POWER button again to display the “after meal marker” symbol, indicating the result was taken after a meal. Glucose Range Indicator Message The meter comes with the Range indicator feature disabled. Please refer to Meter Setup Before Testing section to find out how to turn the range indicator function When the Glucose Range Indicator is “On”, pressing the Power button will lead you to level set up.
  • Page 40 One Down arrow means your blood glucose value is below your target blood glucose concentration. (Configurable range should be above critical lower range and up to 120 mg/dL or equivalent to 6.67 mmol/L ) OK means your blood glucose value is within safe range. One Up arrow means your blood glucose value is above your target blood glucose concentration.
  • Page 41 Note: These limit values define ranges that can either be configured individually by the system administrator in line with facility guidelines or are the (technical) limits of the system. Please consult your diabetes healthcare professional before determining what your hyper or hypo blood glucose levels are. “HI”...
  • Page 42 “Ketone?” Message If “Ketone?” appears on the display, the measured concentration value is above 16.7 mmol/L (300 mg/dL). This simply suggests that a β-Ketone test is recommended. Consult your healthcare professional about testing for β-Ketones.

  • Page 43: Testing Your Blood Β-Ketone

    Testing Your Blood β-Ketone With your meter turned off, insert the blood ketone calibration chip into the strip port of the meter. It should easily snap into place. Once the calibration chip is inserted into the meter, the meter will automatically turn on, and you should see “KET”...
  • Page 44 5. Touch the blood sample to the sample tip at the end of the test strip. If the audio option is turned on, the meter will beep to indicate the sample is sufficient and the meter starts to count down from 4 to 1. If you applied a drop of blood, but do not see the starting of the count down, you may reapply a second drop of blood within 3 seconds.

  • Page 45: Testing Your Uric Acid

    Testing Your Uric Acid With your meter turned off, insert the uric acid calibration chip into the strip port of the meter. It should easily snap into place. Once the calibration chip is inserted into the meter, the meter will automatically turn on, and you should see UA on the screen with the code number.
  • Page 46 2. Check the display to confirm that all the display segments turn on with no missing components. The display will then show only the date and time, with a dash moving across the display. Check the display to ensure no inappropriate segments or icons are permanently turned on.

  • Page 48: Recall The Meter Memory

    Recall the Meter Memory The meter automatically stores up to 500 test records for blood glucose, 100 for blood β-ketone and uric acid each. Each record includes the test result, date and time. The oldest record will be erased to make room for a new one if memory reaches its limit.
  • Page 49 2. If you are using the meter for the very first time, the meter display will show three dashed lines (---), the word “MEM” and the unit of measure. This shows that no data has been stored in memory.
  • Page 50 3. The date and time will be displayed together with the results stored in memory. 4. Press the Down button again to review the memory. The first result showed on the screen is the latest result that you have taken. Press the Down button to go through the stored records.
  • Page 51 6. If there are fewer than 7, 14, 30, 60 and 90-days in memory, all the readings without the pound ( ) sign currently stored in memory will be averaged. 7. Press the Power button to turn off the display. Note: Results from quality control tests will not be included in the averages.

  • Page 52: Clearing The Memory

    Clearing the Memory Extreme caution should be used when clearing the memory. This is not a reversible operation. To clear the memory: 1. With the meter off, press and hold the Down Button for 2 seconds. This will turn on the meter and enter the delete mode. 2.

  • Page 53: Transferring Records

    (PC) using a data transfer cable and software package. To make use of this feature, you need the ACCUGENCE® Data Management Software and a USB data transfer cable from e-LinkCare. 1. Install the software to your personal computer (PC) according to the instructions from the ACCUGENCE®...
  • Page 54 7. After data transfer from meter to PC is completed, the meter will turn itself off. Press the POWER button to turn off the meter. See the package insert included with your ACCUGENCE® Data Management Software Kit for detailed instructions.

  • Page 55: Maintenance

    Maintenance Proper maintenance is recommended for best results. Replacing the Batteries Your ACCUGENCE® Multi-Monitoring Meter uses two 3.0 Volt CR 2032 lithium batteries. When the battery icon ( ) is showing, it means the Meter Battery is running dry. You should replace the Meter Battery as soon as possible. An “E-7” error message will appear if the Meter Battery is too low to perform any more blood glucose tests.

  • Page 56: Caring For Your Accugence ® Multi-Monitoring System

    Caring for Your ACCUGENCE Multi-Monitoring System ® Meter Your ACCUGENCE® Multi-Monitoring Meter does not require special maintenance or cleaning. A cloth dampened with water and a mild detergent solution can be used to wipe the outside of the meter. Take care to avoid getting liquids, dirt, blood or control solution into the meter through the strip or data ports.

  • Page 57: Suggested Testing Times And Target Goals

    Suggested Testing Times and Target Goals Blood Glucose Tracking your blood glucose concentration through frequent tests is an important part of proper diabetes care. Your healthcare professional will help you to decide the normal target range for your glucose levels. They will also help you to determine when and how often to test your blood glucose.
  • Page 58 well your blood glucose is being controlled. This can help you and your healthcare professional make the best decisions about your glucose control plan. β-Ketone Continuous high blood glucose means your body does not have enough insulin to burn glucose, instead it will start burning fat and this produces a chemical called β- Ketone.

  • Page 59: Comparing Meter And Laboratory Results

    Comparing Meter and Laboratory Results Your ACCUGENCE® Multi-Monitoring System and laboratory results both report the glucose, β-Ketone, uric acid concentration in the serum or plasma component of your blood. However, the results may differ somewhat due to normal variation. The meter results can be affected by factors and conditions that do not affect laboratory results in the same way.

  • Page 60: Troubleshooting Guide

    Troubleshooting Guide The meter has built-in messages to alert you of problems. When error messages appear, note the error number, turn off the meter and then follow these instructions. Display Causes Solution Battery may be damaged or not Replace battery. be charged Meter fails If meter has been exposed to or stored...
  • Page 61 Display Causes Solution Please double check the operation The operation Temperature is condition is steady, then repeat the anomalous changed test. Temperature has exceeded Move to a cooler environment and the operating temperature of repeat the test. the system Temperature is below the Move to a warmer environment and operating temperature of the repeat the test.

  • Page 62: Specifications

    Specifications Feature Specification Parameter Blood Glucose, Blood β-Ketone, and uric acid Blood Glucose: 0.6 - 33.3 mmol/L (10 - 600 mg/dL) Measurement Range Blood β-Ketone: 0.0 - 8.0 mmol/L Uric Acid: 3.0 - 20.0 mg/dL (179 - 1190 μmol/L) Blood Glucose and β-Ketone: 10% - 70 % Hematocrit Range Uric Acid: 25% - 60% Result Calibration...
  • Page 63 Automatic Shutoff 2 minutes Meter Size 86 mm × 52 mm × 18 mm On/Off Source Two CR 2032 3.0V coin cell batteries Battery Life Around 1000 tests Display Size 32 mm × 40 mm Weight 50 g (with battery installed) Operating Glucose and Ketone: 5 - 45 ºC (41 - 113ºF) Temperature...

  • Page 64: Index Of Symbols

    Index of Symbols Consult instructions for use For in vitro diagnostic use only Store between -20 – 50 ºC (-4 – 122 ºF) Contains sufficient for <n> tests Use by Lot Number Manufacturer Authorized Representative Sterilized using irradiation Catalog # Model Number Serial Number Do not reuse...

  • Page 65: Warranty Card

    Warranty Card Please complete the warranty card that came with this product and mail it to your dealer to register your purchase and validate your warranty. If the meter fails to work for any reason other than obvious abuse within the first five (5) years from purchase, we will replace it with a new meter free of charge.
  • Page 66 Contact Address ： Contact Name： Contact Cellphone Number: Address: City: State/Province/Region: Postal Code: Thanks so much for your kind support! Effective Date: 2022-08-15...

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