Mission PT/INR User Manual
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Mission PT/INR User Manual

Monitoring system
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Summary of Contents for Mission PT/INR

  • Page 2: Table Of Contents

    Component Descriptions: ................. 5   ® Mission PT/INR Meter ................6   ® Mission PT/INR Test Strip ............... 6   Code Chip ....................6   Meter Display ................... 7   Section 4 Initial Setup ................9   Code # ..................... 9  ...

  • Page 3: Section 1 Introduction

    The meter can store up to 200 results and can be operated by 4 AA (1.5V) batteries or the included AC adapter. Note: It is required that the healthcare professional follows the Mission ® PT/INR Monitoring System Training Manual to train the self-testing ®...

  • Page 4: About Prothrombin Time (Pt) Testing

    Other medications ® The Mission PT/INR Monitoring System can report results as INR or INR+PT values in just a few minutes by simply taking a specimen of blood from a fingertip. This information can then be used to adjust the anticoagulant dosage or to determine if further testing is needed.
  • Page 5 provided with each box of test strips, into the slot on the meter. This provides lot specific calibration data to the meter. Then insert a test strip into the meter detection area under the strip holder. After a brief warm-up time, the specimen can be added to the test strip specimen application area.

  • Page 6: Section 2 System Components

    Section 2 System Components The figures below are labeled to identify the major components of the ® Mission PT/INR Monitoring System. Code Chip Test Strip PT/INR Meter Plastic Clamp Control Solution AA Batteries Capillary Transfer Tube Carrying Case Safety Lancet...

  • Page 7: Component Descriptions

    Component Descriptions: PT/INR Meter: Reads the test strips and displays PT and INR values. Test Strip: Single use strip with a sample application well where blood samples or control solutions are applied. These are inserted into the meter to measure PT and INR values.

  • Page 8: Mission ® Pt/Inr Meter

    Power Button Optics Cover ® Mission PT/INR Test Strip Specimen Well The arrows on the test strip indicate the direction to insert the strip into the meter. The specimen well is the circular target area where the blood specimen is applied.

  • Page 9: Meter Display

    6. Menu Selection: Lists setup options and functions ® During testing, the Mission PT/INR meter will display icons showing the status, options available, and prompts for testing. At the bottom of the display are three function labels representing options which can be selected by pressing one of the three keys directly below each of the display labels (programmable key functions).
  • Page 10 Pressing OK will show the submenu for the function selected. The available functions are shown in order below. After the last function is selected, the display will cycle through and return to the first again. The purpose of each function is shown below. Code # Displays the Code Chip Number Data Log...

  • Page 11: Section 4 Initial Setup

    Section 4 Initial Setup Before turning the meter on, insert the code chip (found inside the box of test strips) into the code chip slot on the right side of the meter. This is shown below. This will transfer the test strip testing parameters into the meter. Note: Ensure the code number printed on the code chip is the same as that printed on the test strip box and the same as the number...
  • Page 12 If there is no code chip in the meter when a test strip is inserted or there is a code chip error, the following screen will be shown.

  • Page 13: Section 5 Meter Setup And Options

    Section 5 Meter Setup and Options Memory Review Select Data Log and press OK to review previous PT/INR Meter test results. The following screen will be shown. The last test result will be displayed showing the test INR or INR+PT value, date, time, its test number and corresponding patient ID.

  • Page 14: Setting The Display Contrast

    flashing. Press OK to delete all stored data in the memory or Exit to exit without deleting the stored data and return to the previous data screen. Once all data is deleted, the memory review function will show only dashes for the stored data.

  • Page 15: Setting The Time

    The next screen will show the current date, with the first selection flashing. In the screen below, the month is flashing. If the date format selection is MM-DD-YY, the first number highlighted will be the month. Press Up or Down to increase or decrease the current setting until the correct month is shown.
  • Page 16 time to exit the screen and return to the previous menu selection screen without making any time changes. When the correct time format is shown, press OK to select the chosen format. If 12H format is chosen, the screen below will allow the selection of AM or PM.

  • Page 17: Sound

    Press OK to save the new time settings and exit to the previous menu selection screen. Sound The Audio Menu selection will show the current state of the Audio setting, which is either Audio On or Audio Off. To change this setting, press Next► to move the selection box to the Audio setting and press OK to show the display below.

  • Page 18: Display Language

    Press Exit to return to the previous menu selection screen. Display Language Next on the menu selection screen is the Display Language, which will be displayed either in English or as a landscape picture representing icons shown in the screen below. To change this setting, press OK with the item selected.

  • Page 19: Password

    When the desired setting is selected, press OK to save the new setting and exit to the previous menu selection screen. Press Exit to exit this submenu without making any changes. Password The Password menu provides a method to set and clear a number that will be used to password protect the patient information in the data log.
  • Page 20 To clear the password entered or turn off password protection, enter the password saved then reenter the password with 0000 when Reenter Password screen is prompted. The password will be cleared when OK is pressed.

  • Page 21: Section 6 Testing

    Section 6 Testing The following section explains the steps required to measure the PT and INR results for capillary or venous whole blood. Before testing, choose a clean, dry work surface. Review the procedure and make sure all of the items needed to obtain a drop of blood are available. Warning: Only capillary whole blood or venous whole blood can be used with this meter.
  • Page 22 Insert the test strip into the optical test area under the strip holder, as shown below. The meter will automatically turn on and beep, if the sound is enabled. Observe the display as the meter is turning on. It will show a checkerboard alternating pattern, as seen in the images below.
  • Page 23 Once the diagnostics are complete, the meter will display the Patient ID screen. There are 5 digits for the patient ID and the accepted range is 00000-65535. Press Up or Down to increase or decrease each digit and press OK to save the current flashing digit and advance to the next one. After setting the patient ID, the meter will prompt the user to close the optics cover by displaying the following screen.
  • Page 24 Press the left button under Blood to continue with testing a blood specimen. Alternatively, EC Tst will run an Electronic Calibrator Test, and CS Tst will ® run a Control Solution Test to ensure the accuracy of the Mission PT/INR Monitoring System.

  • Page 25: Specimen Collection

    followed by the countdown timer screen or will go directly to the countdown timer screen if the time to add specimen is less than 30 seconds away. When the screen counts down to zero, the system is ready for specimen application, as indicated by the following screen with a flashing arrow.
  • Page 26 strip as shown in the picture. The required specimen volume is 15 µL or one hanging drop from a capillary blood specimen, as indicated in the figure below. The finger should be held in line with the strip instead of across at an angle.
  • Page 27 The meter display will change to the screen shown below. This is indicating that the test is in progress and will count up until the test is complete. When the test is complete, the results will be displayed in International Normalized Ratio units (INR) if the INR option was previously selected.

  • Page 28: Optional Testing Methods

    waiting for the meter to turn itself off after several minutes. The result is stored in the memory, which can be recalled anytime. Refer to Section 5 Meter Setup and Options. Optional Testing Methods A Capillary Transfer Tube or pipette may be used to collect blood from a fingertip and to apply the specimen to the test strip.

  • Page 29: Venous Blood Testing (For Professional Use Only)

    Venous Blood Testing (For Professional Use Only) For fresh whole venous blood specimens, insert a new test strip into the meter and allow it to proceed to the specimen application icon on the display. Collect the venous blood using a butterfly collection set into a 3 ml syringe with no anticoagulants.

  • Page 30: Section 7 Quality Control

    Section 7 Quality Control ® To ensure the accuracy of test results, the Mission PT/INR Monitoring System can run an internal Level 1 or Level 2 electro-optical calibration check when a strip is inserted and EC Tst is selected. The internal Electronic...
  • Page 31 1. Blood test 3. Control Solution test 2. Electronic Calibrator test 4. Code Number Within 10 seconds, press EC Tst to initiate the Electronic Calibration test process. The next screen will allow selection of Level 1 (Normal) or Level 2 calibration values.

  • Page 32: Liquid Control Test

    PT/INR Control Solutions contain non-human plasma specimens with predetermined acceptable ranges and are packaged as ® Level 1 (Normal) and Level 2 (High) values. If the Mission PT/INR Monitoring System is working properly, the INR value will be within the range of accepted values printed on the control solution pouch label.
  • Page 33 Preparing the Control Solution Check the expiration date on the foil pouch or the box. Do not use if the expiration date has passed. Tear open the foil pouch and remove the control solution vial. Hold the vial upright (vertically). Squeeze the vial firmly using the Plastic Clamp packaged with the control solution until the glass ampoule inside the plastic vial breaks to release the water.
  • Page 34 1. Blood test 3. Control Solution test 2. Electronic Calibrator test 4. Code Number After selecting CS Tst, the meter will indicate the test strip is warming up to its operating temperature (40ºC). This is done either by showing the warming screen below or the countdown timer screen, also shown below, if the time to add control solution is less than 30 seconds away.
  • Page 35 When the test is complete, the results screen will be displayed, indicating the result is a Control Solution Test result. ® If the result is within the range printed on the Mission PT/INR Control Solution label, the meter and test strips are performing properly.

  • Page 36: Section 8 Maintenance

    Section 8 Maintenance It is recommended that the meter be stored in the carrying case after each use. Avoid getting liquids, residue, or control solution inside the meter. The only required periodic maintenance is the following: Check that the code number on the code chip matches the code number on the test strip pouch label for each new lot of test strips (See Section 4).

  • Page 37: Disinfection Process

    After cleaning, the meter may be turned off or it will turn off automatically after two minutes. Disinfection Wipes ® The suggested wipes for your Mission PT/INR meter pre-cleaning and disinfection are DisCide Ultra Disinfecting Wipes (EPA Registration No. 10492-4). The active ingredients include: Isopropyl alcohol 63.25%, n-alkyl dimethyl benzyl ammonium chloride 0.12% and n-alkyl dimethyl ethyl benzyl...

  • Page 38: General Maintenance

    It is recommended that the meter is stored in its carrying case after each use. ® The Mission PT/INR meter is a precision electronic instrument. Please handle it with care. Always check to ensure all display segments appear when the meter is turned on.
  • Page 39 Strip Holder Installation The strip holder comes already installed on the meter. After cleaning the strip holder, it should be re-installed on the meter. To remove the strip holder, push the strip holder away from the optics cover, sliding it off the strip holder grooves towards the bottom of the meter. If blood or debris is present, clean the strip holder using the DisCide Ultra Disinfecting wipes as previously outlined.

  • Page 40: Section 9 Precautions

    Section 9 Precautions Observe the precautions listed below to ensure accurate results and proper operation of the analyzer.  The protection provided by the equipment may be impaired if used in a manner not defined in this instruction manual.  Read the instructions in the User’s Manual and complete any necessary training before use.

  • Page 41: Test Strip Use And Precautions

    For in vitro diagnostic use. Test strips are only to be used outside of the body for testing purposes.  Only use Mission ® PT/INR Test Strips with the Mission ® PT /INR Meter.  Use the code chip that is included in each box of test strips.

  • Page 42: Section 10 Troubleshooting

    Section 10 Troubleshooting Error Codes Causes Solutions Turn the meter off and then on. Power-on diagnostic error persists, contact your local failed distributor. A problem was encountered with the Electronic Calibrator check process or Electronic Calibration results. Remove and inspect the test test failed strip.
  • Page 43 Turn the meter off, check the cables to the computer, then turn the meter back Communication Error on. If error persists, contact your local distributor. Ambient temperature is too high or too Ambient Temperature low to maintain a controlled test strip out of range temperature.

  • Page 44: Appendix 1 Meter Specifications

    Appendix 1 Meter Specifications Feature Specifications Methodology Optical Fluorescence Test Time About 2 minutes Measurement Range 0.7 to 7.0 INR (International Normalized Ratio) Capillary whole blood Specimen Venous whole blood Specimen Volume 15 μL 4 - AA (LR6) Alkaline Batteries AC Adapter Power Source Input: 100-240V...

  • Page 45: Appendix 2 Index Of Symbols

    Appendix 2 Index of Symbols Attention, see Use by instructions for use Manufacturer Code Number For in vitro diagnostic use Catalog # only Store between Lot Number 2-30°C Tests per Kit Serial Number Do not discard along with This Side Up household waste Fragile, handle Keep Dry...
  • Page 46 In addition to the standard symbols above, the user interface may be set to display icons or English text. The following list shows the equivalent of the Iconic interface and the English text interface, including the definitions. No code chip inserted or there is a code Code Chip chip error...
  • Page 47 Once in the Language sub-menu, displays the choice to Icon display Icons or English text Password protects patient data in the Password meter Key to move down Down Key to move up Key to Exit the menu Exit Level 1 EC Test Level 1 Level 2 EC Test Level 2...
  • Page 48 Print one or ten data One/Ten logs Enter Enter the password Password Entered password Incorrect does not match the Password saved password Entered Reenter the Reenter password Password Password reentered Passwords do does not match the not match previous password Password is cleared, Password meter is not...

  • Page 49: Appendix 3 Warranty

    Appendix 3 Warranty Please complete the warranty card included in the packaging. Mail it to your local distributor to register your purchase within 30 days. For your records, write the purchase date of your meter kit here: Note: This warranty applies only to the meter in the original purchase. It does not apply to the other materials included with the meter.

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